CN1728976A - Minimally invasive joint implant with 3-dimensional geometry matching the articular surfaces - Google Patents

Abstract

This invention is directed to orthopedic implants and systems. The invention also relates to methods of implant design, manufacture, modeling and implantation as well as to surgical tools and kits used therewith. The implants are designed by analyzing the articular surface to be corrected and creating a device with an anatomic or near anatomic fit; or selecting a pre-designed implant having characteristics that give the implant the best fit to the existing defect.

Description

Minimally invasive joint implant with 3D geometry matching articular surface

technical field

The present invention is directed to orthopedic implants and systems. The implant may be a joint implant and/or an interpolated joint implant. The invention also relates to methods of designing, manufacturing, molding and implanting implants and surgical tools and kits for use therewith. The present invention also relates to self-expandable orthopedic implants that can be modified for arthroscopic insertion and contour changes. Finally, the present invention relates to joint implants shaped such that the implant recreates a normal or near normal three-dimensional (3D) joint geometry or alignment and facilitates joint motion beyond the normal range of joint motion. 60% to 99.9%, and can withstand up to 100% of the normal shear force applied to the joint during activity.

Background technique

There are various types of cartilage such as hyaline cartilage and fibrocartilage. Hyaline cartilage is present on the articulating surfaces of bones (eg, in joints) and is responsible for providing the smooth, fluid motion characteristics of the kinematic joint. Considered to vary depending on the joint and specifically the position within the joint, the articular cartilage is firmly connected to the underlying bone and measures generally less than 5 mm in thickness in human joints. In addition, articular cartilage is anervous, avascular, and alymphatic. In adults, cartilage delivers nutrients to chondrocytes present in cartilage connective tissue via a double diffusion system via the synovium and the dense intercellular matrix of cartilage.

Adult cartilage has a limited ability to repair, therefore, damage to cartilage resulting from diseases or trauma such as rheumatoid arthritis and/or osteoarthritis can lead to severe physical disability and debilitation. In addition, as a person's articular cartilage ages, its tensile properties change. Thus, over time, the tensile rigidity and strength of cartilage in adults decreases significantly due to aging.

For example, until the third decade of life, the surface area of the knee articular cartilage exhibits increased tensile strength, and after the third decade of life, when detectable damage to type II collagen occurs on the articular surface, tension Elongation decreases significantly with aging. Although the collagen content does not appear to decrease, the tensile strength of deep cartilage gradually decreases with age. These observations indicate that as aging cartilage undergoes changes in mechanical and thus structural organization, if sufficiently developed, traumatic damage to cartilage can occur.

Typically, severe damage or loss of cartilage is treated by replacing the joint with restorative materials such as silicone or appropriate metal alloys for cosmetic repairs. See, e.g., U.S. Patent Application No. 6,383,228 to Schmotzer, issued May 7, 2002; U.S. Patent Application No. 6,203,576 to Afriat et al., issued March 20, 2001; U.S. Patent Application No. 6,126,690 to et al. Implantation of such prosthetic devices typically involves underlying tissue and femoral defects without including restoration of full function of the original cartilage, and with some devices, serious long-term complications associated with extensive tissue and bone loss can include infection, osteoarthritis, plasma dissolution and implant loosening.

It will be appreciated that arthroplasty is traumatic and requires surgical resection of all or most of the articular surface of one or more bones involved in the repair. Often a considerable area of the medullary space is scraped off during the procedure to fit the stem of the prosthesis into the bone. Curettage results in a defect in the patient's bone stock, and over time, osteolysis will frequently cause the prosthesis to loosen. Additionally, the area where the implant and bone match degenerates over time, eventually requiring replacement with a prosthesis. Because the patient's bone stock is limited, the number of possible replacements is also limited by the arthroplasty. In short, over the course of 15 to 20 years, and in some cases even shorter periods, patients run out of treatment options and end up with painful, nonfunctional joints.

The use of matrices, tissue scaffolds or other carriers implanted with cells (eg, chondrocytes, chondrocyte progenitor cells, stromal cells, mesenchymal stem cells, etc.) has also been described as a potential treatment for cartilage repair. See also, International Publication WO 99/51719 by Fofonoff, issued October 14, 1999; WO 01/91672 by Simon et al., issued December 6, 2001; and WO 01/91672 by Mansmann, issued March 15, 2001 01/17463; and U.S. Patent Application Nos. 6,283,980B1, Vibe-Hansen et al., issued September 4, 2001; 5,842,477, Naughton et al., issued December 1, 1998; Schwartz, June 23, 1998 5,769,899 issued; 4,609,551 issued September 2, 1986 by Caplan et al; 5,041,138 issued August 20, 1991 by Vacanti et al; 5,197,985 issued March 30, 1993 by Caplan et al; July 1993 5,226,914 to Caplan et al. issued 13th; 6,328,765 to Hardwick et al., issued 11 December 2001; 6,281,195 to Rueger et al., issued 28 August 2001; and 4,846,835 to Grande, issued 11 July 1989 . However, clinical outcomes of bioreplacement materials such as allograft and autograft systems and tissue scaffolds have not sure yet,. However, the mechanical durability of the bioreplacement materials remains undetermined.

U.S. Patent Application No. 6,206,927 to Fell et al. issued March 21, 2001 and No. 6,558,421 to Fell et al. issued May 6, 2003 disclose surgically implantable implants that do not require bone resection. inserted knee prosthesis. The prosthesis is generally elliptical with one or more straight edge shapes. Accordingly, the device is not designed to generally conform to the actual shape (contour) of residual cartilage and/or underlying bone in the body. Implant integration is therefore quite difficult due to differences in thickness and curvature between the patient's surrounding cartilage and/or subchondral bone and the prosthesis.

Therefore, there remains a need for a system and method for partially replicating the natural geometry of a joint using one or more implants implanted with minimally invasive techniques and tools for said repair and implantation, and for reconstructing a joint A method for a natural or near-natural three-dimensional geometric relationship between two articular surfaces.

Contents of the invention

The present invention provides methods and compositions for repairing joints, and in particular provides devices and implants for repairing articular cartilage and for promoting the integration of various cartilage and bone repair materials into a subject. Among other things, techniques described herein allow for the production of devices that substantially or completely conform to the contours of the underlying cartilage and/or bone and/or other joint structures of a particular subject. In addition, the device also preferably substantially or completely conforms to the shape (size) of the cartilage. The success of the repair is enhanced when the shape (eg, size, thickness, and/or curvature) of the articular cartilage surface fits anatomically or nearly anatomically to undamaged cartilage, the subject's original cartilage, and/or underlying bone.

The restorative material can be shaped prior to implantation, and said shaping can be based, for example, on electronic images that provide information about the curvature or thickness of any "normal" cartilage surrounding the defect or diseased cartilage area, and and/or the curvature of the underlying or surrounding bone with respect to said diseased cartilage defect or region, and the bone and/or cartilage including the opposing matching surface of the joint.

Among other things, the present invention provides a minimally invasive method for partial joint replacement. The method may result in little or no loss of bone stock resulting from the procedure. Additionally, the methods described herein help restore the integrity of the articular surface by anatomically or nearly anatomically fitting the implant between the surrounding or adjacent cartilage and/or subchondral bone.

In most cases, the joint mobility of the repaired joint will range from 60% to 99.9% of normal flexibility. The range of motion is improved to 85% to 99.9%, better 90% to 99.9%, best 95% to 99.9% and ideally 98% to 99.9%.

Additionally, the incision required to implant the device of the present invention is typically 50% smaller than the incision required to implant currently available implants. For example, whole knee replacements generally require a 6-12 inch (15-30 cm) incision, while single-compartment knee replacements require a 3 inch (7 cm) incision. An implant designed according to the present invention to repair the tibial surface requires only a 3 cm incision (approximately 1.5 inches), whereas the combination of implants used to repair the tibial surface and the femoral condyle requires a 3 inch (7 cm) incision. In another example, a traditional hip replacement requires a single incision between 6 and 12 inches (15-30 cm), or in less invasive techniques, two incisions of 1.5-4 inches (3-9.5 cm) . An implant designed to repair the acetabulum according to the present invention requires a single incision of 1.5 inches (3 cm) to 6 inches (30 cm), depending on whether a single- or double-surface correction is desired.

Advantages of the present invention may include (but are not limited to): (i) customizing joint repairs (e.g., patient-specific designs or solutions) for individual patients, thereby enhancing efficacy and mitigation by procedural procedures; Some embodiments require the surgeon to measure the defect to be repaired intraoperatively; (iii) eliminate the need for the surgeon to shape the material during the implantation procedure; A method for assessing the curvature or shape of the repair material; (v) provides a method for repairing the joint with minimal or, in some instances, no bone stock defect; and (vi) improves the postoperative joint Congruity.

Accordingly, described herein is the design and use of joint repair materials that conform more precisely to defects (eg, sites of implantation) and thus provide improved joint repair.

As will be appreciated by those skilled in the art, an implant may be described as a prosthetic joint implant, cartilage defect shaping implant, cartilage projection implant, and/or subchondral bone shaping implant. The implant has an upper surface and a lower surface. the upper surface is opposite a first articular surface of a joint and the lower surface is opposite a second articular surface of said joint, and further, wherein said lower surface or at least one of said lower surface has a The shape of one of them fully matches the three-dimensional shape. The implant is suitable for placement in any joint, including knee, hip, shoulder, elbow, wrist, finger, toe, and ankle. The superior and inferior surfaces of the implant generally have a three-dimensional shape that substantially matches the shape of at least one of the articular surface adjoining the superior surface of the implant and the inferior surface of the articular surface adjoining the implant. The implant is designed to have a thickness or fraction thereof of the patient's major cartilage defect typically between 65% and 99.9%.

Implants can be fabricated from a variety of suitable materials, including biocompatible materials, metals, metal alloys, bioactive materials, polymers, and the like. Additionally, implants can be fabricated from a number of materials, including coatings.

The implant may further have a mechanism for attachment to the joint. Suitable attachment mechanisms include ridges, pins, pins, crosspieces, teeth and protrusions. Additional mechanisms (eg, crests, rims) that may provide stabilization of the joint, thickened along all or a portion of the peripheral surface.

Implants can also be designed so that they have two or more components. Depending on the desired functionality, the components may be integrally formed, integrally formed, interconnected, and interdependently formed. In the case of multiple components, the knuckle contact component may be designed to engage the knuckle either slidingly or rotationally or a combination thereof. Alternatively, either or both of the knuckle-contacting components may be secured to the knuckle. Any additional component may be integrally formed, integrally formed, interconnected or interdependently formed with any other component with which it engages.

Each component of the implant or the implant itself may have a perimeter or perimeter formed along a peripheral circle, ellipse, oval, reniform, substantially circular, substantially elliptical, substantially oval, substantially reniform shape. Additionally, each component of the implant itself may have a spherical, hemispherical, aspherical, convex, concave, generally convex, and generally concave cross-sectional shape.

The design of the implant facilitates implantation using an incision of 10 cm or less. In addition, the implants are designed to restore joint range of motion between 80% and 99.9% of normal joint motion.

The implant or any component thereof may have various shapes such that the periphery of the implant may be thicker than the central portion of the implant. Alternatively, the implant or any component thereof may be designed such that the central portion of the implant is thicker than the periphery. Viewing the implant from a plurality of directions such as the front portion, the rear portion, the side portions and the middle portion, the implant or any component thereof may have a thickness along the back portion of the device that is equal to or greater than the side, middle, and and the thickness of at least one of the front parts. Alternatively, the implant or any component thereof may have a thickness along the posterior portion of the device that is equal to or less than the thickness of at least one of the lateral, medial, and anterior portions of the implant. In another alternative, the implant, or any component thereof, may have a thickness along a medial portion of the device that is equal to or less than the thickness of at least one of the anterior, posterior, and side portions. In another alternative, the implant may have a thickness along a medial portion of the device that is equal to or greater than the thickness of at least one of the anterior, posterior, and side portions.

The procedure for repairing a joint using the implant described below comprises the steps of arthroscopically implanting an implant having an upper surface and a lower surface, wherein at least one of the upper surface and the lower surface has a joint with the articular surface. A three-dimensional shape that matches the shape well. Analyze images prior to implantation. The images are typically MRI, CT, X-ray, or combinations thereof.

A method of making an implant according to the present invention includes: determining the three-dimensional shape of one or more articular surfaces of a joint; The first and second articular surfaces, and further, wherein at least one of the upper surface and the lower surface substantially matches the three-dimensional shape of the articular surface.

In addition, the present invention provides a novel device and method for replacing a portion (e.g., a diseased area and/or an area slightly larger than the diseased area) of a joint (e.g., cartilage and/or bone) with an implant material, wherein the implant Anatomical or near-anatomical fit of at least one surface of surrounding structures and tissues and restoration of joint mobility to 60% to 99.9% of the joint's normal range of motion. Furthermore, during articulation the implant can withstand (up to) 100% of the shear force applied to the joint. Where the devices and/or methods include subarticular bone-associated elements, the invention also provides for anatomical or near-anatomical alignment of the bone-associated elements with the subchondral bone. The present invention is also capable of pre-treating implant sites with a single incision. The device can be a single component, a dual component, or have a plurality of components.

The method of the present invention comprises the steps of: (a) measuring the size (for example, thickness and/or curvature and/or size) of the desired implant site or the size of the area around the desired implant site; and (b) providing Cartilage substitutes or materials consistent with the measurements obtained in ). In certain aspects, step (a) comprises measuring the thickness of the cartilage surrounding the intended implantation site and measuring the curvature of the cartilage surrounding the intended implantation site. Alternatively, step (a) may include measuring the size of the site to be implanted and measuring the curvature of the cartilage around the site to be implanted; or measuring the thickness of the cartilage around the site to be implanted, measuring the size of the site to be implanted, and measuring Curvature of the cartilage around the intended implant site; or to recreate a healthy cartilage surface at the intended implant site; or to measure the size of the intended implant site and/or to measure subchondral bone at or around the intended implant site curvature or geometry. In addition, the thickness, curvature or surface geometry of the remaining cartilage can be measured at the intended implant site and can be compared to the thickness, curvature or surface geometry of the surrounding cartilage. This comparison can be used to more accurately shape the cartilage substitute or material.

The dimensions of the surrogate material are selected following surgical measurements, eg, measurements made using imaging techniques such as ultrasound, MRI, CT scanning, X-ray imaging obtained with X-ray color matching, and fluoroscopy imaging. Mechanical probes (with or without imaging capabilities) are also available for selected dimensions, such as ultrasonic probes, lasers, optical probes, indented probes, and deformable materials.

One or more implantable devices include three-dimensional objects. In a knee, implants can be used in one (unicompartmental) or multiple (multi-compartmental) compartments. In such knees, the implant is non-elliptical, but conforms to the 3D geometry of articular cartilage, subchondral bone, and/or intra-articular structures. The implant has a pair of opposing faces. One face of the implant is contoured to match or substantially match the underlying cartilage and/or bone contour; while the contour of the opposite face of the implant creates a surface for meeting the matching articular surface. For example, modeling can be used to project opposing surfaces to optimize surfaces for fitting to joints. Alternatively, a circular interface may be used to connect opposing faces. The interface may also extend beyond the articular surface. Implants of the present invention may also be self-expandable and modifiable for arthroscopic insertion.

Each side of the device need not be uniform in size. The length D along an axis via which it is taken at any given point is variable along that axis. Similarly, via a second axis (orthogonal to said first axis) the length 2D is also variable along said axis. Those skilled in the art will appreciate that the ratio between any D length along the first axis to any D length along the second axis may have any ratio suitable for the anatomy of the body to be corrected.

As will be appreciated by those skilled in the art, without departing from the scope of the present invention, any of the implantable joint prostheses described herein may include a plurality of (eg, two or more pieces) object components. For example, two components may be provided in each component having faces contoured (partially or substantially) to the underlying cartilage and/or bone. In some embodiments, opposing surfaces of the engageable components are curved. The curvature may be selected to resemble or mirror the curvature of at least one articular surface of the joint. In other embodiments, the opposing surfaces of the engageable components are flat. In other embodiments, the opposing surfaces of the engageable components are a combination of flat and curved. The opposing surfaces of the engageable components may also be irregular. In this case, the surfaces are preferably designed to match each other in at least one or more positions.

In any of the methods described herein, alternative materials can be selected (eg, selected from an existing library of repair systems). Accordingly, replacement materials can be produced before, during, or after surgery. Additionally, in any of the methods described herein, the replacement material may also be shaped using appropriate techniques known in the art, or before, during, or after surgery. Such techniques include: manually, automatically, or by machine; mechanical abrasion using techniques including polishing, laser ablation, radiofrequency ablation, extrusion, injection, molding, compression molding, and/or machining, or the like. Finally, the implant may include one or more bioactive materials such as drugs, cells, non-cellular materials, pharmacological agents, biological agents, and the like.

The present invention includes a method of repairing cartilage in a subject comprising the step of implanting a cartilage repair material prepared according to any of the methods described herein. Implantation is generally arthroscopic and can be accomplished through relatively small incisions.

The present invention also provides a method for determining the curvature of the articular surface, the method comprising measuring the curvature of the articular surface by using a mechanical probe or a surgical mechanical navigation system during surgery. Articular surfaces may include cartilage and/or subchondral bone. Mechanical probes (with or without imaging capabilities) may include, for example, ultrasound probes, lasers, robotic arms (eg, Titanium FARO arm), optical probes, and/or deformable materials or devices.

Various tools are available to facilitate implantation of the device. The tool is a guide that aids in optimal positioning of the device relative to the articular surface. The design of the tool and guide used in the device is taken from the design of the device that is appropriate for the particular joint. Tools may include trial implants or surgical tools that partially or substantially conform to the implant site or joint cavity.

Any of the repair systems or prostheses (eg, exterior surfaces) described herein may include polymeric or fluid materials. Polymer materials can be joined to metals or metal alloys. The polymeric material can be infused and, for example, self-harden or harden when the polymeric material is exposed to chemicals, energy beams, light sources, ultrasound, and others. Furthermore, any of the systems or prostheses described herein may be adapted to receive injections, eg, through openings in the outer surface of the cartilage replacement material (eg, an opening in the outer surface creates openings on the surface of the bone). Bone cement, therapeutic agents, and/or other biologically active substances may be injected through the opening. In certain embodiments, it may be desirable to inject the bone cement under compression of the articular surface or subchondral bone or bone marrow to complete the penetration of the bone cement into the implant site. Additionally, any of the prosthetic systems or prostheses described herein may be anchored in the bone marrow or in subchondral bone. One or more reinforcing extensions (eg, pins, etc.) may extend through the bone and/or bone marrow.

In certain embodiments, the cartilage replacement system can be implanted without destroying the subchondral bone or using only a small number of pins or anchors extending to or through the subchondral bone. This technique has the advantage of avoiding future implant "sinking" and osteolysis leading to joint dissonance or implant loosening or other complications.

As will be appreciated by those skilled in the art, suitable joints may include (to name a few) knee, shoulder, hip, spine, disc, elbow, ankle, wrist, finger, carpus metacarpal, midfoot, and forefoot joints. The described technique is likewise not limited to the joints found in humans, but can be extended to any mammalian joint.

These and other embodiments of the invention will be apparent to those skilled in the art from the disclosure herein.

Description of drawings

1A is a block diagram of a method for assessing the need for repair of a joint according to the present invention, wherein the existing joint surface is unchanged or substantially unchanged prior to receipt of a selected implant. Figure IB is a block diagram of a method for assessing the need to repair a joint according to the present invention, wherein the existing joint surface is unchanged or substantially unchanged prior to designing an implant suitable for completing the repair.

Figure 2 is a reproduction of a three-dimensional thickness image of the articular cartilage of the distal femur. Three-dimensional thickness images can be generated, for example, from ultrasound, CT or MRI data. Black holes within the cartilage material indicate areas of full-thickness cartilage defect.

Figure 3A is an example of a Placido disk with concentrically aligned apertures. Figure 3B is an example of a projected pracido disc on a surface of fixed curvature.

Figure 4 is the mirror image produced by the projection of a concentric aperture (Placido disc) on each femoral condyle.

Figure 5 is an example of a 2D color-coded topological image of a regularly curved surface.

Figure 6 is an example of a 3D color-coded topological image of a regularly curved surface.

7A-B are block diagrams of a method for assessing the need to repair a joint according to the present invention, wherein the articular surface present prior to receipt of the implant is altered.

Figure 8A is a perspective view of the joint implant of the present invention suitable for implantation at the tibial plateau of the knee joint. Figure 8B is a top view of the implant of Figure 8A. Figure 8C is a cross-sectional view of the implant of Figure 8B along line C-C shown in Figure 8B. Figure 8D is a cross-sectional view along line D-D shown in Figure 8B. Figure 8E is a cross-sectional view along line E-E shown in Figure 8B. Figure 8F is a side view of the implant of Figure 8A. 8G is a cross-sectional view showing the implant of FIG. 8A implanted, taken along a plane parallel to the radial plane. Figure 8H is a cross-sectional view showing the implant of Figure 8A implanted, taken along a plane parallel to the coronal plane. 81 is a cross-sectional view showing the implant of FIG. 8A implanted, taken along a plane parallel to the axial plane. Figure 8J is a slightly larger implant extending medially (toward the edge of the tibial plateau) and anteriorly and posteriorly close to the bone. 8K is a side view of an alternate embodiment of the joint implant of FIG. 8A showing an anchor. 8L is a bottom view of an alternative embodiment of the joint implant of FIG. 8A showing an anchor. Figures 8M and 8N are an alternate embodiment of a two piece implant viewed from the front and viewed from the side.

9A and 9B are perspective views of an articulating implant suitable for use on the femoral condyle from inferior and superior viewpoints, respectively. Figure 9C is a side view of the implant of Figure 9A. Figure 9D is a view of the underside of the implant. Figure 9E is a top view of the implant and Figure 9F is a cross-section of the implant. Figure 9G is a superior view of an articulating implant suitable for use on both condyles of the tibia. Figure 9H is a side perspective view of the implant of Figure 9G.

Figure 10A is a side view of the acetabulum. Figure 10B is a rotational view of the proximal femur. 10C is a cross-sectional view of an implant for a hip joint demonstrating a generally constant radius.

10D is a cross-sectional view of an implant similar to that seen in FIG. 10C with rounded edges and an asymmetric radius.

11A is a cross-sectional view of an implant with a member extending into a concave head of a femoral head. FIG. 11B shows the implant as a hemisphere, FIG. 11C as a partial hemisphere, and FIG. 11D as a fence, all showing additional and alternative plan views. Figure 11 is a diagram of an alternate embodiment of an implant having a spoke arrangement.

12A is a cross-sectional view of an implant with members extending into the acetabular socket. 12B-E are various perspective views in which the implant is hemispherical, partially hemispherical, a rail and a spoke.

Figure 13A is a cross-sectional view of a two-component "weight-bearing movable" implant showing two pieces of construction and smooth mating surfaces. Also shown is a plan view showing a bicomponent with two hemispheres, a single hemisphere with a fence or fence-like exterior component (that is, hemispherical in one dimension but not in the remaining dimensions), a single hemisphere with a fence interior. A single hemisphere, a single hemisphere with a spoked inner component, and a single hemisphere with a spoked outer component.

Figures 13B-J are an alternate embodiment of a two-component implant in which the inner surface of the outer component has a nodule that engages in a zigzag pattern on the outer surface of the inner component. Additional changes are also shown.

Figure 14A is an alternate embodiment of an implant with a member extending into the concave head of the femoral head. Figures 14B and 14C are cross-sectional embodiments where one of the components forms a hemisphere and the second component does not.

15A is a cross-sectional view of a two-component "weight-bearing movable" implant with members extending into the acetabular fossa. Figures 15B and 15C are cross-sectional embodiments where one of the components forms a hemisphere and the second component does not.

Figure 16A is a cross-sectional view of a three-component "weight-bearing movable" implant. 16B-D are cross-sectional views of a three-component "weight-bearing movable" implant having one or more components that form a hemisphere, while at least one other component does not form a hemisphere.

17A is a cross-sectional view of a two-component "weight-bearing movable" implant with members extending into the acetabular fossa. Figures 17B and 17C are cross-sectional embodiments where one of the components forms a hemisphere and the second component does not.

Figure 18A is a cross-sectional view of a two-component "weight-bearing movable" implant with members extending into the acetabular fossa. Figure 18B is four vertical stabilizing surfaces on the top of the member shown in Figure 18A extending into the acetabular socket on the top of the acetabular component.

Figure 19A is a cross-sectional view of a two-member "weight-bearing movable" implant with extension into the concave head of the femoral head. Figure 19B is a cross-sectional view of a two-component fixation implant.

20A is a cross-sectional view of implants with varying radii and thicknesses for use in a hip joint. Figure 20B is a cross-sectional view of implants of varying radii and thicknesses for use in a hip joint. Fig. 20C is a cross-sectional view of implants with varying radii and thicknesses for use in a hip joint. 20D is a cross-sectional view of an implant for use in a hip joint with inferiorly and superiorly extending edges.

Figure 21A is a frontal view of the bony structures in the shoulder joint such as the clavicle, scapula, glenoid, acromion, coracoid, and humerus. Figure 21B is a view of the arthroplasty device placed between the humeral head and the socket. 21C is an oblique frontal cross-sectional view of an arthroplasty device having a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the shoulder socket. 21D is an axial cross-sectional view of an arthroplasty device having a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the shoulder socket. Figure 21E is a frontal view showing the articular cartilage and tilt of the shoulder at the superior and inferior rims. Figure 21F is an axial view showing the articular cartilage and the shoulder at the upper and lower rims. 21G is an oblique frontal cross-sectional view of an arthroplasty device having a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the socket and rim. 21H is an axial cross-sectional view of an arthroplasty with a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the acetabular socket and rim. 21I is an oblique frontal cross-sectional view of an arthroplasty device having a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the shoulder socket. An edge is shown extending superiorly and/or inferiorly, which provides stability on the shoulder socket. 21J is an axial cross-sectional view of an arthroplasty device having a humeral surface generally conforming to the shape of the humeral head and a shoulder acetabular surface generally conforming to the shape of the shoulder socket. Exhibits a marginal anterior and/or posterior extension which provides stability on the shoulder socket. 21K is an oblique frontal cross-sectional view of a two-component "weight-bearing mobile" arthroplasty device having a humerus-forming surface generally conforming to the shape of the humeral head and a shoulder socket surface generally conforming to the shape of the shoulder socket.

21L is an axial cross-sectional view of a two-component "weight bearing mobile" arthroplasty device having a humerus forming surface generally conforming to the shape of the humeral head and a socket forming surface generally conforming to the shape of the socket.

21M is an alternate view of a two-component "weight-bearing mobility" arthroplasty device having a humerus-forming surface generally conforming to the shape of the humeral head and a socket-forming surface generally conforming to the shape of the socket. The device has a knuckle on the surface of the first component that mates with a serration on the surface of the second component to enhance articulation.

21N is an oblique frontal cross-sectional view of a two-component "weight-bearing mobile" arthroplasty device. Figure 21O is an oblique frontal cross-sectional view of a two-component "weight-bearing mobile" arthroplasty device. Figures 21P and Q are cross-sectional views of an alternative embodiment of the two-component "weight-bearing movable" device shown in Figure 21O.

Figure 22 is a longitudinal view showing the tilt of the distal humerus, cubitus and radial head through the elbow joint. Cartilage surfaces are also shown.

Figure 23A is a longitudinal view showing the distal radius, ulna, and several carpal bones, in place through the wrist joint with the arthroplasty system. Figure 23B is a longitudinal view through the wrist joint showing the distal radius, ulna, and several carpal bones. 23C is a longitudinal view through the wrist joint showing the distal radius, ulna, and several carpal bones with the arthroplasty system in place. Figure 23D is a longitudinal view of a two-component "weight-bearing mobility" arthroplasty device adapted to the wrist. Figure 23E is a longitudinal view of another two-component forming device, in this condition without edges. Figure 23F is a longitudinal view of a two-component "weight-bearing mobile" arthroplasty device.

Figure 24 is a sagittal view through a finger. Demonstration of insertion of an arthroplasty device between the head of the metacarpal and the base of the proximal phalanx.

25A is a radial view through the ankle joint showing the distal tibia, talus and calcaneus and other bones with the arthroplasty system in place. Figure 25B is a coronal view through the ankle joint showing the distal tibia, distal fibula, and talus. Demonstration of insertion of an arthroplasty device between the distal tibial and tibiotalar articular surfaces. Figure 25C is a radial view through the ankle joint showing the distal tibia, talus and calcaneus and other bones. . Cartilage surfaces are also shown. Demonstration of insertion of an arthroplasty device between the distal tibial and tibiotalar articular surfaces. Figure 25D is a coronal section through the ankle joint showing the distal tibia, distal fibula, and talus. Demonstration of insertion of an arthroplasty device between the distal tibial and tibiotalar articular surfaces.

Figure 26 is a radial view through the toes. Demonstration of insertion of an arthroplasty device between the metatarsal head and the base of the proximal phalanx.

27A-D are block diagrams of method steps used when implanting a device of the present invention into a target joint.

Figure 28 is a plan view of an implant guide tool suitable for implanting the device shown in Figure 8L.

Figures 29A and B are plan views of an implant guide tool suitable for implanting the device shown in Figure 9B.

Detailed ways

The following description is given to enable any person skilled in the art to make and use the invention. Various modifications to the embodiments will become apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the spirit and scope defined by the appended claims and in application. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded a wide scope consistent with the principles and features disclosed herein. The detailed descriptions and drawings of all issued patents, patent publications, and patent applications cited in this application are hereby incorporated by reference to the extent necessary to a complete understanding of the invention disclosed herein .

As will be appreciated by those skilled in the art, the practice of the present invention uses (unless otherwise indicated) conventional x-ray imaging and processing, tomosynthesis, ultrasound including A-scans, B-scans and C-scans, Methods of computed tomography (CT scan), magnetic resonance imaging (MRI), optical coherence tomography, single photon emission tomography (SPECT) and positron emission tomography (PET). Such techniques are explained in detail in the literature and need not be described herein. See, for example, X-RAY Structure Determination: A Practical Guide, 2nd Edition, eds. Stout and Jensen, 1989, John Wiley & Sons, Press; Body CT: A Practical Approach, ed. Slone, 1999, McGraw-Hill Press; X-ray Diagnosis: A Physician's Approach, edited by Lam, 1998 Springer-Verlag, Press; and Dental Radiology: Understanding the X-Ray Image, edited by Laetitia Brocklebank 1997, Harvard University Press.

1. Two-sided or multi-sided evaluation of joints

Among other things, the invention allows the practitioner to assess and treat joint defects resulting from, for example, joint disease, cartilage decline, osteoarthritis, seropositive and seronegative arthritis, bone damage, cartilage damage , trauma and/or deterioration due to overuse or age. The size, volume and shape of the area of interest may include only the area of cartilage with the defect, but may also preferably include the portion of cartilage surrounding said cartilage defect. Additionally, the size, volume, and shape of the area of interest may include subchondral bone, bone marrow, and other joint structures such as menisci, ligaments, and tendons.

Figure 1A is a flowchart of the steps taken by a practitioner to assess a joint. First, the practitioner obtains measurements of the target joint 10 . Obtaining the measurements is accomplished by obtaining an image of the joint. This step can be repeated 11 to obtain multiple images as necessary to further improve the joint assessment process. Once the practitioner obtains the necessary measurements, this information is used to generate a model representation 30 of the target joint to be evaluated. This model representation can take the form of a configuration map or an image. The model representation of the joints can be 1D, 2D or 3D. It may include a physical model. Multiple models 31 can be generated as desired. Either the original model or the subsequently produced model or both may be used. After generating the model representation 30 of the joint, the practitioner can optionally generate a projected model representation 40 of the target joint under the correct conditions. This process can still be repeated41 as necessary or desired. The selection process 50 is repeated as necessary to achieve the desired result, using the difference between the configuration condition of the joint and the projected image of the joint.

As will be appreciated by those skilled in the art, the practitioner may proceed directly from the step of generating a model representation 30 of the target joint to the step of selecting an appropriate joint replacement implant 50 , as indicated by arrow 32 . In addition, after selecting a suitable joint replacement implant 50, as shown in processes 24, 25, 26, the steps of obtaining the measurement results 10 of the target joint, generating the model representation 30 of the target joint, and generating the projection model 40 may be performed continuously or Repeat in parallel.

Figure IB is an alternative flowchart showing the steps taken by a practitioner to assess a joint. First, the practitioner obtains measurements 10 of the target joint. Obtaining the measurements is accomplished by obtaining an image of the joint. This step can be repeated 11 as necessary to obtain multiple images to further improve the joint assessment process. Once the practitioner obtains the necessary measurements, this information is used to generate a model representation 30 of the target joint to be evaluated. This model representation can take the form of a configuration map or an image. The model representation of the joints can be 1D, 2D or 3D. This process 31 can be repeated as necessary or desired. A physical model can be included. After evaluating the model representation 30 of the joint, the practitioner can optionally generate a protected model representation 40 of the target joint under the correct conditions. This process can be repeated 41 as necessary or desired. Using the difference between the topographical condition of the joint and the projected image of the joint, the practitioner can then design a suitable joint implant 52 to achieve the correct joint anatomy, repeating the design process 53 as necessary to achieve the desired implant design . The practitioner can also evaluate whether providing additional features (eg, edges, pins, or anchors) can improve implant performance in the target joint.

As will be appreciated by those skilled in the art, a practitioner may proceed directly from the step of generating a model representation 30 of the target joint to the step of designing a suitable joint replacement implant 52 , as indicated by arrow 38 . Similar to the process shown above, after designing a suitable joint replacement implant 52, as shown in the processes 42, 43, 44, obtain the measurement results 10 of the target joint, generate the model representation 30 of the target joint and generate the projection model The steps of 40 can be repeated serially or in parallel.

The joint implant is selected or designed to achieve an anatomy that conforms or approximates the anatomy to the existing surface of the joint while presenting a matching surface for the opposing articular surface that replicates the natural joint anatomy. In this case, the existing surface of the joint as well as the desired resulting joint surface can be assessed. This technique is especially useful for implants that are not anchored into bone.

Figure 2 illustrates the color rendering of a three-dimensional thickness map of the articular cartilage of the distal femur. A 3-dimensional thickness map can be generated from, for example, ultrasound, CT or MRI data. Black holes within the cartilage material indicate areas of loss of cartilage throughout the thickness. The size and shape of cartilage damage can be judged from the 3D thickness map.

Size, curvature and/or thickness measurements may be obtained using any suitable technique, as will be appreciated by those skilled in the art. For example, suitable mechanical components, laser devices, electromagnetic or optical tracking systems, casts, materials applied to articular surfaces that harden and "memory surface contours" and/or one or more known in the art may be used. One-dimensional, two-dimensional and/or three-dimensional measurements can be obtained using an imaging technique. Measurements may be obtained without interpolation and/or surgery (eg, using a probe or other surgical device). As will be appreciated by those skilled in the art, the thickness of the repair device may vary at any given moment, depending on the depth of cartilage and/or bone damage to be repaired at any particular location on the articular surface.

A. Imaging technology

As will be appreciated by those skilled in the art, imaging techniques suitable for measuring the thickness and/or curvature (e.g., of cartilage and/or bone) or size of diseased cartilage regions or cartilage loss include the use of x-rays, magnetic resonance imaging (MRI ), computed tomography scan (CT, also known as computed axial tomography or CAT), optical coherence tomography, SPECT, PET, ultrasound imaging, and optical imaging. (See International Patent Publication WO02/22014, Alexander et al., published March 21, 2002; U.S. Patent No. 6,373,250, issued April 16, 2002 to Tsoref et al.; and Vandeberg et al. (2002) Radiology (Radiology) 222:430-436). Contrast or other enhancing agents may be used using any route of administration (eg, intravenous, intra-articular, etc.).

In certain embodiments, CT or MRI is used to assess tissue, bone, and any defects therein (e.g., cartilage damage or areas of diseased cartilage) to obtain information related to subchondral bone or cartilage decline and to provide morphological or Biochemical or biomechanical information. In particular, changes such as fissures, partial thickness or full thickness cartilage loss and signal changes within remaining cartilage can be detected using one or more of these methods. For a discussion of basic NMR principles and techniques, see MRI Basic Principles and Applications, Second Edition, Mark A. Brown and Richard C. Semelka, Wiley-Liss Ltd. (1999). For MRI (including conventional T1- and T2-weighted spin echo imaging, gradient echo (GRE) imaging, magnetic transition contrast (MTC) imaging, fast spin echo (FSE) imaging, enhanced contrast imaging, rapidly acquired relaxation enhancement (RARE) ) imaging, Gradient Echo Acquisition in Steady State (GRASS) and Drive Equilibrium Fourier Transform (DEFT) Imaging) for obtaining cartilage related information, see WO 02/22014 by Alexander et al. Thus, in a preferred embodiment, the measurements obtained are based on obtained 3D images of the joint as described in Alexander et al. WO 02/22014 or sets of 2D images resulting in 3D information. Two-dimensional, three-dimensional images or maps of the cartilage alone or in combination with the movement pattern of the joint (eg, flexion to extension, translation and/or soft rotation) can be obtained. The three-dimensional image may include information about movement patterns, contact points, contact zones of two or more opposing articular surfaces, and movement of the contact points or zones during movement of the joint. The two-dimensional or three-dimensional images can include information related to the biochemical composition of articular cartilage. Additionally, imaging techniques can be compared over time (for example), providing up-to-date information on the shape and type of restorative material needed.

Any of the imaging devices described herein may also be used intraoperatively (see below), eg, to image joint surfaces during surgery using hand-held ultrasound and/or optical probes.

B. Surgical Measurements

Additionally, or in addition to the non-interpolative imaging techniques described above, measurements of the size of diseased or cartilage-deficient areas, cartilage thickness, and and/or measurements of cartilage or bone curvature. Intraoperative measurements may or may not involve actual contact with one or more articular surface areas.

Apparatus suitable for obtaining in-surgical measurements of cartilage or bone or other cartilaginous articular structures and generating a topographical map of the surface include, but are not limited to, pracido discs and laser interferometers, and/or deformable materials or device. (See, e.g., U.S. Patent Nos. 6,382,028 issued May 17, 2002 to Wooh et al; 6,057,927 issued May 2, 2000 to Levesque et al; 5,523,843 issued June 4, 1996 to Yamane et al; 5,847,804 issued December 8, 1998 to Sarver et al. and 5,684,562 issued November 4, 1997 to Fujida).

Figure 3A illustrates a pracido disk with centrally arranged halos. A concentrated array of pracido disks projects well-defined halos of varying radii that can be generated by laser light or white light delivered through fiber optics. A placidol disc can be attached to the end of the endoscopic device (or to any probe, such as a hand-held probe) so that a halo of light can be projected onto the cartilage surface. Figure 3B illustrates an example of a pracido disc projected onto a surface of fixed curvature. Reflections of the halo can be captured using one or more cameras (eg, attached to the device). Surface curvature is determined using mathematical analysis. This curvature can then be visualized on a monitor, for example, as a color-coded topography of the cartilage surface. Additionally, a mathematical model of the topography can be used to determine the ideal surface topography to replace any cartilage defects in the analyzed area. This calculated ideal surface can also be visualized on a monitor (such as the 3-dimensional thickness map shown in Figure 2) and can be used to select the surface curvature of an alternative or recycled material.

Figure 4 shows the reflection produced by projecting a focused halo (Placido disk) on each femoral condyle, demonstrating the effect of changes in surface profile on the reflective annulus.

Similarly, a laser interferometer can also be attached to the end of the endoscopic device. Additionally, a small sensor can be replicated on the device to determine the cartilage surface or bone curvature using phase-shift interferometry, resulting in a fringe pattern analysis phase vision map (leading wave) of the cartilage surface. The curvature can then be visualized on the monitor as a color-coded topography of the cartilage surface. Additionally, a mathematical model of the topography can be used to determine the ideal surface topography to replace any cartilage or bone defects in the area being analyzed. This calculated ideal surface can also be visualized on a monitor and can be used to select the curvature of the replacement cartilage.

Those skilled in the art will readily appreciate that other techniques for optically measuring the curvature of the cartilage surface may be used without departing from the scope of the present invention. For example, 2-dimensional or 3-dimensional graphs such as those shown in FIGS. 5 and 6 may be generated.

Mechanisms can also be used for surgical measurements, such as deformable materials (eg, gels, casts, any material that hardens (eg, material that is not deformable until heated, cooled, or otherwise manipulated)). See WO 02/34310 published May 2, 2002 by Dickson et al. For example, a deformable gel can be applied to the femoral condyles. The side of the gel body directed towards the condyle creates a negative mold of the surface profile of the condyle. This negative cast can then be used to determine the size of the defect, the depth of the defect, and the curvature of the articular surface in or around the defect. This information can be used to select a therapy, for example, a joint surface repair system. In another example, a stiffening material may be applied to articular surfaces such as the femoral condyle or tibial plateau. The hardened material may remain on the articular surface until hardened. The hardened material can then be removed from the articular surface. The side of the hardened material directed toward the articular surface creates a negative mold of the articular surface. This negative cast can then be used to determine the size of the defect, the depth of the defect, and the curvature of the articular surface in or around the defect. This information can be used to select a therapy, for example, a joint surface repair system. In some instances, the stiffening system can remain in place and form an actual articular surface repair system.

In some embodiments, the deformable material includes a plurality of individually movable mechanical elements. When pressed against the surface of interest, each element may be pushed in opposite directions and the extent of its pushing (deformation) may correspond to the curvature of the surface of interest. The device may include a detent mechanism so that the element may be fixed in position to conform to the surface of the cartilage and/or bone. The device can then be removed from the patient and analyzed for curvature. Alternatively, each individually movable element may include indicia indicating the amount and/or degree of deformation to a given degree. A camera can be used during surgery to image the device and the images can be saved and used to analyze curvature information. Suitable markings include, but are not limited to, actual linear measurements (metric or imperial), different colors corresponding to different amounts of deformation and/or different shades and hues of the same color. Electronic means can also be used to measure the displacement of the movable element.

Other devices for measuring cartilage and subchondral bone in surgery include, for example, ultrasound probes. A (preferably hand-held) ultrasound probe can be applied to the cartilage and the curvature of the cartilage and/or subchondral bone can be measured. Additionally, the size of the cartilage defect can be assessed and the thickness of the articular cartilage can be determined. Such ultrasonic measurements can be obtained in A-mode, B-mode or C-mode. If A-mode measurements are obtained, the operator can typically repeat these measurements with several different probe orientations (eg, lateral oblique and anteroposterior views) to obtain a three-dimensional assessment of size, curvature, and thickness.

Those skilled in the art will readily appreciate that different probe designs are possible using optical, laser interferometer, mechanical and ultrasonic probes. Probes are preferably persistent. In certain embodiments, the probe, or at least a portion of the probe, generally the probe that is in contact with the tissue, is sterile. Sterility can be achieved using a sterile cap, such as that disclosed in WO 99/08598A1, published February 25, 1999 to Lang.

Analysis related to articular cartilage or subchondral bone using imaging tests and/or surgical measurements can be used to determine the size of diseased cartilage or areas of cartilage loss. For example, curvature can change abruptly in areas of cartilage loss. This sudden or unexpected change in curvature can be used to detect the boundaries of diseased cartilage or cartilage defects.

II. Evaluation of Individual Surfaces of the Joint

Turning now to FIG. 7A , a block diagram is provided showing the steps used to perform the evaluation of a single surface of a joint. As in FIGS. 1A and 1B , it obtains images or measurements 60 of the target joint. Thereafter, a measurement is taken to aid in selecting an appropriate device to correct the defect 70 . The measurement or imaging steps can be repeated as needed to facilitate identification of the most appropriate means to repair the defect 80 . Once measurements have been taken, a device is selected for correcting the defect 90 . In this case, only one surface of the joint is copied. This technique is especially useful for implants that include a mechanism for anchoring the implant into bone. Thus, the implant has at least one surface that replicates the articular surface with at least one second surface associated with some or all of the articular surface or bone of the damaged joint to be repaired.

As will be appreciated by those skilled in the art, a practitioner may proceed directly from the step of measuring the joint defect 70 to the step of selecting an appropriate device to repair the defect 80 as indicated by arrow 38 . Additionally, any or all of the steps of obtaining measurements 60 of the target joint, measuring the joint defect 70, identifying a suitable device to repair the defect 80, selecting a device to repair the defect 90 may be repeated one or more times 61, 71 as desired , 81, 91.

Similar to the flow described above, after selecting a device to repair the defect 90, as indicated by arrows 65, 66, 67, the steps of obtaining measurements 60 of the target joint, measuring the joint defect 70, identifying a suitable device to repair the defect 80 may be sequential or repeat in parallel.

Figure 7B shows an alternative approach. A structural diagram is provided showing the steps to perform the evaluation of a single surface of a joint. As in FIGS. 1A and 1B , it obtains images or measurements 60 of the target joint. Thereafter, a measurement is taken to aid in selecting an appropriate device to correct the defect 70 . The measurement or imaging steps can be repeated as needed to facilitate identification of the most appropriate means to repair the defect 80 . Once the measurements are taken, a device is fabricated for correcting the defect 92 .

As will be appreciated by those skilled in the art, a practitioner may proceed directly from the step of measuring the joint defect 70 to the step of selecting a fabrication device to repair the defect 92 as indicated by arrow 39 . Additionally, any or all of the steps of obtaining measurements 60 of the target joint, measuring the joint defect 70, identifying a suitable device to repair the defect 80, fabricating a device to repair the defect 92 may be repeated one or more times 61, 71 as desired , 81, 93.

Similar to the procedure described above, after manufacturing a device to repair the defect 92, as indicated by arrows 76, 77, 78, the steps of obtaining measurements 60 of the target joint, measuring the joint defect 70, identifying a suitable device to repair the defect 80 may be continued Repeatedly or in parallel.

Various methods are available to facilitate joint modeling during the evaluation of individual surfaces. For example, using information about the thickness and curvature of the cartilage, a surface model of the articular cartilage and/or underlying bone can be generated for any joint. The model representation of the joints can be 1D, 2D or 3D. A physical model may be included. This physical model can represent a limited area within the joint or can encompass the entire joint.

More specifically, in the knee joint, the physical model can only cover the medial or lateral femoral condyle, femoral condyle and incision area, medial tibial plateau, lateral tibial plateau, entire tibial plateau, medial patella, lateral patella , the entire kneecap, or the entire joint. The location of the joint lesion can be determined, for example, using a 3D coordinate system or the 3D Euclidean distance transformation or Laplace transformation as described in WO02/22014 by Alexander et al.

In this way, the size of the defect to be repaired can be precisely determined. As will be apparent, some, but not all defects may include less than the entire cartilage. Normal onset or only mild onset cartilage thickness is measured around one or more cartilage defects. This thickness measurement can be obtained at a single point or a plurality of points. The more measurement steps taken, the more precise and precise the measurement becomes. Thus, measurements can be made, for example, at points 2, 4-6, 7-10, greater than 10, or throughout the remaining cartilage. 2D and 3D measurements are available. In addition, once the size of the defect is determined, selection can be made regarding appropriate therapy (e.g., replacement or implants equal to or slightly larger than the diseased cartilage covering one or more articular surfaces) so that as much healthy bone as possible can be preserved. surrounding tissue.

Alternatively, the curvature of the articular surface or underlying bone can be measured to design and/or shape the prosthetic material. In such cases, the thickness of the remaining cartilage and the curvature of the articular surface can be measured to design and/or shape the prosthetic material. Alternatively, the curvature of the subchondral bone can be measured, and the resulting measurements can be used to design, manufacture, select and/or shape a cartilage replacement material.

III. Joint device

The current device is a prosthesis. The shape of the prosthesis or device is determined by projecting the contours of existing cartilage and/or bone onto an effective mimic of the natural joint structure. The device substantially restores normal articular alignment and/or provides a conforming or substantially conforming surface to the original or native articular surface of the closely fitting opposed articular surface. In addition, it can substantially eliminate other recessions since the conforming surface of the device provides an anatomy or near-anatomy that matches the existing articular surface of the joint. Insertion of the device is accomplished through a small (eg, 3 cm to 5 cm) incision and does not require removal of bone or mechanical fixation of the device. However, those skilled in the art will appreciate that additional structures may be provided, such as cross arms, fins, pins, teeth (such as tapered, triangular, spherical or conical protrusions), or pins , these structures enhance the ability of the device to more effectively fixate on the articular surface. Osteophytes or other structures interfering with device placement can be easily removed. By occupying the joint space within the anatomy or near-anatomy, the device improves the stability of the joint and restores the joint's normal or near-normal mechanical alignment.

The accuracy of the devices described herein can be determined by obtaining and analyzing subject-specific images and designing a device that generally conforms to the patient's joint anatomy (cartilage and/or bone), while taking into account the existing articular surface anatomy described above. size. Thus, the actual shape of the device can be tailored to the individual.

The prosthetic device of the present invention may be a device suitable for minimally invasive, surgical implantation that does not require removal of bone. The device may, but need not necessarily, be adhered to the bone. In the knee, for example, the device may be undivided, that is, positioned in a compartment where the natural meniscus normally rests. Depending on its condition, the natural meniscus may remain in place or may be removed in whole or in part. In general, the natural meniscal piece that has been pulled away is removed and the damaged area is trimmed if necessary. Alternatively, all remaining meniscus may be removed. This can be done by a cutting step for inserting the device. For many implants, this can also be done arthroscopically, creating an incision 1-15 cm long, but preferably 1-8 cm long, and more preferably 1-4 cm long.

The implants described herein may have varying curvatures and radii within the same plane (eg, anterior-posterior or medial-lateral or inferior or oblique planes) or within multiple planes. In this manner, the articular surface repair system can be shaped to achieve anatomical or near-anatomical alignment between the implant and the implant site. This design allows not only varying degrees of convexity or concavity, but also concave portions within the convexity of the body or vice versa. The surface of an implant that mates closely with a joint being repaired can have an indeterminate layout, which can be a function of physical damage to the joint surface being repaired. Nonetheless, those skilled in the art will appreciate that implants can be fabricated based on typical lesion patterns. Implants can also be made based on the expected normal coordination of the joint structure prior to injury.

Additionally, implants can be fabricated to account for changes in the shape of opposing surfaces that occur during joint movement. Thus, the implant can account for changes in the shape of one or more articular surfaces during flexion, extension, abduction, rotation, translation, sliding, and combinations thereof.

The devices described herein are preferably edge-transferable and self-centering. Thus, during the natural articulation of the joint, the device is allowed to move slightly, or change its position as appropriate to coordinate the natural movement of the joint. However, the device is not free-floating in the joint. Additionally, by translating from a first position to a second position during movement of the joint, the device tends to return to substantially its original position when the joint is moved in reverse and the previous position is reached. As a result, the device does not tend to progressively "climb" to the side of the compartment in which it is located. The irregular layout of the surface and the slightly irregular shape of the implant facilitate the self-centering properties of the implant.

The device may also remain immobilized on an articular surface. For example, in the knee joint, the device may remain centered on the tibia while the femoral condyle is free to move over the device. The slightly irregular shape of the implant, which closely matches the inferior articular surface, contributes to this stability on the articular surface.

Intra-articular motion of the devices described herein can optionally be limited by accessory mechanical components as desired. These mechanical components may, for example, allow the device to rotate, but not translate. It may also allow the device to translate in one direction while preventing the device from translating in the other direction. The mechanical member may further secure the device in the joint while allowing the device to tilt. Suitable accessory mechanical members include ridges, pins, pins, crosspieces, teeth and protrusions. The configuration of these mechanical components can be parallel to each other, or a non-parallel orientation. The mechanical member may be conical, triangular, spherical, conical or any shape that achieves the effect. One or more accessory mechanical components may be provided. Wherein, when more than one mechanical component is provided, the mechanical component may cover the entire surface of the device, or a part of the surface. Additional stabilizing mechanical members may be provided, such as ridges, edges and thickening along all or a portion of the peripheral surface.

The shape of the implant can also be combined with the shape of the joint where it is located (eg, the musculoskeletal portion of the spine). Increased conformity with the tibial spine (eg, the base of the tibial spine) can help stabilize the implant against the tibial plateau.

The height or profile of the selected implant can be selected to vary the load bearing capacity relative to the joint. In addition, the height of the implant can be adjusted to account for anatomical topological abnormalities of bone or joint structures. Additionally, as with any of the implants taught herein, when ligamentous laxity is encountered, the height, profile, or other dimensions of the implant can be adjusted to allow tensioning of the ligamentous device to improve function. It is best that the above behaviors do not interfere with the pivot cone arrangement of the bones in general. Typically, a joint can withstand 100% of the shear force applied to a moving joint.

The implants of the present invention generally restore joint flexibility to 99% of the natural flexibility of a given subject's joint. For example, in the case of the total knee joint, the usual range is 0 to 140°. Currently effective solutions typically restore the joint to substantially less than 99.9% of its range. In contrast, the implants of the present invention typically restore the range of motion to between 95-99.9% of the patient's normal range of motion.

Table 1 describes the joint range of motion of the hands and arms of healthy males obtained from the National Institute of Standards and Technology (http://ovrt.nist.gov).

Table 1

Range of motion of the hand and arm joints joint movement Average range (degrees) Range (degrees) bent wrist 90 12 wrist stretch 99 13 wrist adduction 27 9 Wrist spread 47 7 supine forearm 113 twenty two Forearm Pronation 77 twenty four bent elbow 142 10 shoulder bend 188 12 shoulder stretch 61 14 shoulder adduction 48 9 shoulder spread 134 17

Table 2 describes foot and leg joint range of motion obtained from the National Institute of Standards and Technology (http://ovrt.nist.gov) in healthy males.

Table 2

Range of motion of the foot and leg joints joint movement Average range (degrees) Range (degrees) SD ankle flexion 35 7 ankle stretch 38 12 ankle adduction twenty four 9 ankle spread twenty three 7 knee bent - standing 113 13 knee bend - kneeling 159 9 knee bend tilt 125 10 Knee Rotation - Intermediate 35 12 Knee Rotation - Lateral 43 12 hip flexion 113 13 hip adduction 31 12 hip spread 53 12 Hip Rotation - Sitting (Intermediate) 31 9 Hip Rotation - Sitting (Side) 30 9 Hip Rotation-Incline (Intermediate) 39 10 Hip Rotation - Tilt (Side) 34 10

The implant of the present invention should generally restore the range of motion of any joint at one or more of the measurements in Tables 1 and 2 to between 60-99.9% of the patient's normal range of motion, and preferably within the patient's normal range of motion between 95-99.9%.

As discussed in more detail below, any of the devices taught herein can be fabricated in various ways such that the device expands, for example, after insertion. The expansion can be automatic, semi-automatic or adjusted by the user.

An illustrative example of a joint implant according to the scope and teaching of the invention follows.

A. Knee

Figure 8A shows a perspective view of the joint implant 100 of the present invention suitable for implantation at the tibial plateau of the knee joint. As shown in FIG. 8A , implant maps were generated using dual surface evaluation as described above with respect to FIGS. 1A and 1B .

Implant 100 has an upper surface 102 and a lower surface 104 and a periphery 106 . The superior surface 102 is formed such that it forms a mating surface that accommodates an opposing articular surface; in this example partially recessed to accommodate a femur. The concavity may be a variable concavity such that it presents a surface to an opposing articular surface similar to its corrected articular counterpart. The inferior surface 104 has a convexity that matches or approximates the tibial plateau of the joint such that it creates an anatomy or approximate anatomy that matches the musculoskeletal plateau. Depending on the shape of the tibial plateau, the lower surface may be partially convex. Thus, the inferior surface 104 presents a surface to the tibial plateau that fits within the existing surface. As will be appreciated by those skilled in the art, the convexity of the lower surface 104 need not be completely convex. Instead, the lower surface 104 is more composed of male and female elements to fit the existing surface of the tibial plateau. Thus, the surface is variable convex and concave in nature.

Figure 8B shows a top view of the implant of Figure 8A. As shown in Figure 8B, the internal shape 108 of the implant can be elongated. The elongated form can take a variety of shapes, including elliptical, quasi-elliptical, racetrack, and the like. However, as will be appreciated, the internal dimensions are generally irregular and thus do not form a true geometric ellipse. As will be appreciated by those skilled in the art, the actual internal shape of the implant may vary depending on the joint defect to be corrected. Thus the ratio of length L to width W may vary from, for example, 0.5 to 1.5, and more specifically 0.25 to 2.0. As further shown in FIG. 8B, the length across the axis of the implant 100 varies when taking points along the width of the implant. For example, as shown in FIG. 8B , L ₁ ≠L ₂ ≠L ₃ .

Turning now to FIGS. 8C-8E , there is depicted a cross-section of the implant shown in FIG. 8B taken along the lines C-C, D-D, and E-E shown. The implants have thicknesses t1, t2 and t3, respectively. The thickness of the implant varies along its length L as illustrated by the cross-section. The actual thickness of implant 100 at a particular location is a function of the thickness of the cartilage and/or bone to be replaced and the joint mating surface to be replicated. Additionally, the profile of the implant 100 at any location along the length and width of the implant 100 is a function of the cartilage and/or bone to be replaced.

Figure 8F is a side view of the implant 100 of Figure 8A. In this example, the height _hi of the implant 100 at the first end is different from the height _h2 of the implant at the second end. Additionally, the upper edge 108 may have an overall slope in the downward direction. However, as illustrated, the actual slope of upper edge 108 varies along its length and may be positive in some instances. Additionally, the line edge 110 may have an overall slope in the downward direction, however, as illustrated, the actual slope of the lower edge 110 varies along its length and may be positive in some instances.

8G is a cross-section taken along the sagittal plane in the human body showing that the implant 100 is implanted in the knee joint 120 so that the implant is on the tibial plateau 122 and the femur 124 is on the side of the implant 100. on the upper surface 102 . FIG. 8H is a cross-section taken along a coronal plane in a human body showing implant 100 implanted in knee joint 120 . As can be appreciated from this view, the implant 100 is positioned such that it fits the higher articular surface 124 . As will be appreciated by those skilled in the art, the articular surface may be a medial or lateral surface as desired.

Figure 81 is a cross-section taken along the axial plane of the human body showing the implant 100 implanted in the knee joint 120, showing the view from the air or from above. Figure 8J is a cross-section of an alternative embodiment in which the implant is slightly larger so that it extends medially (ie, towards the edge of the tibial plateau, and the anterior and posterior extensions) closer to the bone.

Figure 8K is a cross-section of an implant 100 of the present invention according to an alternative embodiment. In this embodiment, the lower surface 104 further includes a joint anchor 112 . As shown in this embodiment, the joint anchor 112 forms a protrusion, keel or vertical element extending from the lower surface 104 of the implant 100 and projects into, for example, the bone of the joint. In addition, as shown in FIG. 8L , the joint anchor 112 may have a cross piece 114 such that the joint anchor 112 may appear as a fork or an "X" when viewed from the bottom. As will be appreciated by those skilled in the art, the joint anchor 112 may take various other forms while still achieving the same goal of providing increased stability of the implant in the joint. These forms include, but are not limited to, pins, bulbs, teeth, balls, and the like. Additionally, one or more anchors 112 may be provided as desired.

The device may have two or more components, one substantially closely mated to the tibial surface and the other substantially connected to the femoral component. The two components may have a flat opposing surface. Alternatively, the opposing surfaces may be curved. The curvature may be a reflection of the shape of the tibia, the shape of the femur including the shape during articulation and the meniscus-like shape, and combinations thereof. 8M and 8N illustrate cross-sections of an alternate embodiment of a two-component implant viewed from the side and from the front.

Turning now to FIGS. 9A-9F , there is shown an implant suitable for providing opposing articular surfaces to the implant of FIG. 8A . This implant corrects defects on the inner surface of the femur (ie, the portion of the femur that mates closely with the tibial plateau, for example) and can be used alone, ie, on the femur, or in combination with another joint repair device. FIG. 9A shows a perspective view of an implant 150 having a curved mating surface 152 and a convex articular abutment surface 154 . Given that anchors 156 are provided to facilitate attachment of the implant to the femur, the articular abutment surface 154 need not form an anatomical or near-anatomical configuration of the femur. In this example, the anchor 156 is shown as a pin with a female head. The notch facilitates the anchoring process within the femur. However, pins without notches can also be used as pins with other configurations to facilitate the anchoring process. The pins and other parts of the implant may be porous coated. The implant can be inserted without cementing the bone or using a bone cement. The implant may be designed to abut the subchondral bone, ie it may generally follow the contour of the subchondral bone. This has the advantage that no bone needs to be removed other than to replace the pin holes, thereby significantly preserving the bone stock. As will be appreciated by those skilled in the art, the multi-component solution for repairing the hip joint illustrated in Figure 9 can also be applied to other joints in the human body.

Figures 9G and 9H illustrate an implant 151 suitable for providing an opposing surface for the implant of Figure 8A, wherein the implant will cover the femoral condyle and optionally face one or more of the implants of Figure 8A.

The arthroplasty system can be designed to mirror the shape of the tibia and/or the shape of the femur. The tibial shape and the femoral shape can include cartilage and bone. In addition, the shape of the implant may also include some or all components of other joint structures such as the menisci. The meniscus is compressible, especially during walking or loading. For this reason, implants can be designed to incorporate the shape of the meniscus to address compression of the meniscus during loading or physical activity. For example, the inferior surface of the implant can be designed to match the shape of the tibial plateau (including cartilage or bone or both). The higher surface of the implant may be a combination of the tibia (especially in areas not covered by the meniscus) and the articular surface of the meniscus. Thus, the shape of the device may be a reflection of the height of the meniscus. Compression can account for, for example, 20%, 40%, 60%, or 80% of the uncompressed meniscal height.

In some embodiments, the shape of the device that mirrors the shape of the meniscus may be made from another material, preferably a compressed material. If a compressible material is selected, it is preferably designed to substantially match the compressibility and biomechanical properties of the menisci. The entire device can generally be made of such materials or non-metallic materials.

The height and shape of the menisci can be directly measured with an imaging test. If part or all of the meniscus is damaged, the height and shape of the meniscus can be obtained by measuring the contralateral joint or using measurements of other joint structures that can provide an estimate related to meniscal size.

In another embodiment, the higher face of the implant can be shaped to the femur. The shape is preferably derived from the mode of motion of the femur relative to the tibial plateau, thereby accounting for changes in femoral shape and tibiofemoral contact area as the femoral condyle flexes, extends, rotates, translates, and slides on the tibia and menisci.

Activity patterns can be measured using current or future testing methods known in the art (eg, fluoroscopy, MRI, ambulation analysis, and combinations thereof).

B. Hip joint

Figure 10A is a side view of the acetabulum 200 of the hip joint. The cartilage-covered region 202 has an inverted U-shape. The triangular radiating cartilaginous area or superior acetabular groove 204 is located within the cartilage overlay area. FIG. 10B is a rotated view of the proximal femur 210 . Also shown is the cartilage covered area 202 and the femoral head recess 206 .

Turning now to the implant for the hip joint, FIG. 10C is a cross-section of an implant for the hip joint 220 . The radius r of this implant is substantially constant when taken at any point along the length of the implant. The radius of the implant may be chosen to approximate the radius of the femoral head the implant will correct and may measure the radius of the inner surface of the implant 220 engaging the femoral head. Alternatively, the radius of the implant may be selected to approximate the radius of the acetabulum or a combination thereof. The radius of the inner surface 222 of the implant faces the femur and may also match the radius of the femur or be similar to the radius of the acetabulum; the radius of the implant surface facing the acetabulum may also match the radius of the acetabulum 224 or similar to the radius of the femur;

Those skilled in the art will appreciate that the natural geometry of the acetabulum is generally aspherical, somewhat different from a true sphere. If necessary, the radius of the implant can be adjusted to the varying radius of the acetabulum to provide a better fit. Thus, both the upper surface and/or the inner surface of the implant may be spherical or aspheric in radius.

FIG. 10D is a cross-section of an implant suitable for use in a hip joint similar to that seen in FIG. 10C , featuring a rounded edge 226 . The rounded edge 226 is advantageous as it tends to avoid locking the implant in use and minimizes any pain associated with the implant.

11A is a cross-section of an implant 220 suitable for a hip joint similar to the hip joint shown in FIG. The inner surface 222 of the bone cavity extends into the femoral head cavity of the femoral head 240 . Element 230 may be made of the same material as implant 220 or a different material than the remainder of the implant. An advantage of the implant having a protrusion 230 that engages the recess of the femoral head is that the protrusion 230 constrains movement of the implant 220 relative to the femoral head (as shown in FIG. 10B ). As will be appreciated by those skilled in the art, the protrusions 230 can have various configurations while still achieving the same effect as when engaging the femoral head recess by implantation. Various plans of the implant are shown, either hemispherical, partially hemispherical or in the form of a fence. Other shapes will become apparent to those skilled in the art. Additionally, the edges of the implant may be rounded, beveled, or any size that facilitates manipulation of the implant. 11B-11E illustrate alternative embodiments of the implant shown in FIG. 11A in which the implant is hemispherical, partially hemispherical, fence-shaped, and spoke-shaped.

FIG. 12A is a cross-section of an implant 220 suitable for use in a hip joint with a flange 232 extending into the superior acetabular groove 204 on the outer surface 224 of the superior acetabular groove 204. middle. The flange 232 may be made of the same material as the remainder of the implant 220 or a different material. The flange 232 can be used to constrain the movement of the implant 220 relative to the supraacetabular groove. As will be appreciated by those skilled in the art, the flange 232 can have various configurations while still achieving the same effect in engaging the superior acetabular groove. Various plans of the implant are shown, either hemispherical, part hemispherical, or in the form of a fence or a quadrangular crown. Other shapes will become apparent to those skilled in the art. Additionally, the edges of the implant may be rounded, beveled, or any size that facilitates manipulation of the implant. Figures 12B-12E illustrate alternative embodiments of the implant shown in Figure 12A, wherein the implant is hemispherical, partially hemispherical, fence-shaped, and spoke-shaped.

Figure 13A is a cross-section of a two-component "weight-bearing movable" implant 221 with various plan views. The implant has a first component 230 and a second component 231 . The first component matches the second component and has two smooth surfaces. The second component engages the outer surface of the first component and also has two smooth surfaces. Various configurations are contemplated and possible without departing from the scope of the present invention. For example, each component can be hemispherical. One component may be hemispherical while the other takes the shape of a partial hemisphere, shorter hemisphere, fence, or quadrome. Figures 13B through 13F illustrate alternative embodiments of the implant shown in Figure 13A, wherein the implant has at least one component that is hemispherical, partially hemispherical, fence-like, or spoke-like.

Figures 13G-13J are cross-sections of a two-component "weight-bearing movable" implant. The implant has a first component and a second component. The first component matches the second component. The second component is engaged with the outer surface of the first component. As shown herein, a protrusion is provided on the second component that engages a notch on the first component, as will be understood by those skilled in the art, although not shown, without departing from the scope of the present invention. Next, the protrusions may be located on the first component and match wells on the second component. As shown, it is also possible to provide other anchoring mechanisms on the first component, on the second component or both. Various configurations are contemplated, but not illustrated, possible without departing from the scope of the invention. For example, each component can be hemispherical. One component may be hemispherical while the other takes the shape of a partial hemisphere, a slightly shorter hemisphere, a fence, or a four-pronged dome.

Figure 14A is a cross-section of a two-component "weight-bearing movable" implant 240 having a protrusion 246 extending into the femoral head recess 206 of the femoral head. The dual component implant 240 has a first component 242 and a second component 244 . A protrusion 246 is provided on the second component 244 . As described above in relation to FIG. 11C , the protrusions 246 can be used to constrain movement of the second component 244 of the implant 240 relative to the femoral head. The first component 242 facing the acetabulum is free to move relative to the second component 244 facing the femoral head. As will be appreciated by those skilled in the art, a dual component implant may be configured such that the surfaces of the first component 243 that engage the surfaces of the second component 245 are of the same length or substantially the same length. This results in mated assemblies that substantially match each other. Alternatively, the components may be configured so that one component may be shorter than the other as shown in Figures 14B and 14C. Figure 15A is a cross-section of another two-component "weight-bearing movable" implant 240 having a flange 248 extending into the superior acetabular groove. The dual component implant 240 has a first component 242 and a second component 244 . A flange 248 is provided on the first component 242 . The flange 248 may serve to constrain movement of the first component 242 of the implant 240 relative to the acetabulum. The second component 244 facing the femoral head is free to move relative to the first component 242 facing the acetabulum. As described above with respect to Figure 13A, the implant shown in Figure 15A can also be configured such that one component can be shorter than the other as shown in Figures 15B and 15C.

FIG. 16A is a cross-section of a three-component "weight-bearing movable" implant 250. FIG. The first component 252 facing the hipbone has a protrusion 253 that extends into the acetabulum 204 . As noted above, the protrusions 253 can be used to constrain movement of the implant 250 relative to the hip bone. The second component 254 facing the femoral head has a flange 255 that extends into the femoral head recess 206 . As described above with respect to single-element and dual-element implants, the flange 255 can be used to constrain movement of the second component 254 of the implant 250 relative to the femoral head. The third component 256 is interposed between the other two components and is free to move between the two. As will be appreciated by those skilled in the art, the third component 256 can be interposed between the first component 252 and the second component 254 such that its length can be shorter than both the first component 252 and the second component 254 (as shown in FIG. 16B ). shown) can be longer than the length of the first component 252 and the second component 254 (as shown in Figure 16C and Figure 16D). Similarly, the length of the third component can also be longer than the lengths of the first component 252 and the second component 254 .

Figure 17A is a cross-section of another two-component "weight-bearing movable" implant 240 similar to the implant shown above. In this embodiment, an anchor is provided to anchor the first component 242 to the superior acetabular groove 204 . The anchor is shown in the form of one or more pins 262 . The component facing the acetabulum is secured to the acetabulum using two roughly parallel pins. The second component 244 facing the femoral head is free to move over the first component 242 facing the acetabulum. As with the previous embodiments, the length of the first component 242 relative to the second component 244 may vary. 17B and 17C show alternative cross-sectional views in which the first component is larger than the second component and vice versa. As with the previous embodiments, various configurations are contemplated and possible without departing from the scope of the present invention. For example, each component can be hemispherical. One component may be hemispherical while the other takes the shape of a partial hemisphere, a slightly shorter hemisphere, a fence, or a four-pronged dome.

FIG. 18A is a cross-section of another two-component "weight-bearing movable" implant 240 having an anchor extending into the superior acetabular groove 204. FIG. The anchor facing the acetabulum takes the form of a protrusion having one or more fins 264 . The second component 244 facing the femoral head is free to move over the first component 242 facing the acetabulum. Figure 18B is a view of the implant of Figure 18A seen from the top showing four fins (264, 264', 264", 264''') on the top of the element extending to the acetabulum on the top of the acetabular component The fins may be pointed or generally pointed as shown or may have rounded sides.

Figure 19A is a cross-section of another two-component "weight-bearing movable" implant 240 having an anchor 266 that can extend into the femoral head recess 206 of the femoral head. In the illustrated embodiment, the second assembly 244 facing the femoral head is secured to the femoral head using one or more generally parallel pins (shown as 268, 268'). As shown in previous embodiments, the first component 242 faces the acetabulum and is free to move over the component facing the femoral head.

FIG. 19B is a cross-section of another two-component implant 240 . In this embodiment, dual assembly 240 is fixed. As described herein, the femoral component is attached to the femoral head using 3 pins or other attachment members. The number of pins can be greater or less than 3 as desired. Preferably, the subchondral bone maintains this intact design except for the entry points of the pins. The acetabular component is attached to the acetabulum using fins 264 or similar attachment members such as pins (shown in FIG. 17A ). The attachment member may be molded into the superior acetabular groove, allowing the elements to extend into the femur. Apart from the entry area of the attachment member, preferably the subchondral bone is also left intact.

20A is a cross-section of an implant 470 of varying radii (r ₁ , r ₂ , r ₃ ) and thicknesses (t ₁ , t ₂ , t ₃ ) for the hip joint; where r ₁ ≠r ₂ ≠ r ₃ and thickness t ₁ ≠t ₂ ≠t ₃ . As will be appreciated by those skilled in the art, three measurements of radius and thickness are used to illustrate points, but more or fewer measurements may be used without departing from the scope of the invention. Additionally, other combinations of radii and thicknesses may be used, eg r ₁ =r ₂ ≠r ₃ , r ₁ ≠r ₂ =r ₃ , t ₁ =t ₂ ≠t ₃ and t ₁ ≠t ₂ =t ₃ . Other combinations will become apparent to those skilled in the art. As illustrated in Figure 20A, the central portion c has a relatively thicker thickness t than one or both peripheral portions _p1 , _p2 .

Figure 20B is a cross-section of an alternative implant 470 of varying radii and thickness for use in the hip joint. In this embodiment, the central portion c has a relatively thinner thickness t _c than the one or more peripheral portions (p ₁ , p ₂ ).

Figure 20C is a cross-section of an alternative implant 470 of varying radii and thickness for use in the hip joint. In this embodiment, the central portion c has a thickness t _c relatively thinner than the thickness t ₁ of the first peripheral end p ₁ , and relatively thicker than a thickness t ₂ of the second peripheral end p ₂ of the peripheral portion.

20D is a cross-section of an alternative implant 470 for a hip joint having one or more edges or anchoring extensions extending upward L _i and/or downward extending L _s . The edges are designed to extend beyond the articular surface into, for example, non-cartilaginous areas. It may generally conform to the surrounding, peripheral anatomy. Edges provide extra stability. This design can be combined with two-component and three-component and "movable under load" designs.

As will be appreciated by those skilled in the art, the spatial shape of the implant shown in Figures 10 to 20 can be a semicircle (i.e. 180°) in one or more dimensions, but this is not necessarily required . When the implant is semicircular in all dimensions, the implant forms a hemisphere (that is, half a sphere obtained by cutting a plane through its center). While the implant is semicircular in some, but not all dimensions, its shape will not be hemispherical. One or both of the upper and lower sides of the shape may be aspherical for coordinating the acetabulum. Additionally, combinations of three-dimensional shapes may be used when there is more than one component. For example, a first component may be hemispherical while a second component is not, and so on.

Additionally, while these implants are shown as having from one to three components, it is understood that each component may be further modified into a plurality of intermeshing components without departing from the scope of the present invention.

Those skilled in the art will further appreciate that the design considerations taught in FIGS. 10-20 can be used to design implants for other joints, such as knees, ankles, shoulders, elbows, and wrists. To avoid obscuring the present invention, all possible configurations of the implants taught herein have not been shown.

C. Shoulder

FIG. 21A is a front view of the bony structures in the shoulder joint 300 , such as the clavicle 302 , scapula 304 , acetabular socket 306 , acromion 308 , coracoid process 310 , and humerus 312 . Cartilage covered regions 314, 316 are indicated by oblique lines.

FIG. 21B is a view of the arthroplasty device 320 placed between the humeral head 313 and the socket 306 . The arthroplasty device 320 may have design features similar to those shown in FIGS. 4A-4R , such as multiple components, weight-bearing movable designs, attached and unattached designs, designs with varying thickness and curvature, and A design conforming to the humeral head 313 or the socket 306 or both, conforming to the articular cartilage and/or subchondral bone, having a rim or element for stabilization purposes.

21C is an oblique cross-sectional view of an arthroplasty device 320 having a humerus contacting surface 322 at least partially conforming to the shape of the humeral head 313 and a shoulder socket contacting surface 324 at least partially conforming to the shape of the shoulder socket 306.

21D is an axial cross-sectional view of an arthroplasty device 520 having a humerus contacting surface 322 conforming to the shape of the humeral head and a shoulder socket contacting surface 324 conforming to the shape of the shoulder socket 306 .

Figure 21E is an oblique front view of the shoulder joint illustrating the articular cartilage 316 and the superior and inferior labrum 306' and 306", respectively. Figure 21F is an axial view of the shoulder joint illustrating the articular cartilage 316 and the anterior labrum 307, respectively ' and posterior labrum 307".

21G is an oblique frontal cross-sectional view of an arthroplasty device 320 having a humeral contact surface 322 conforming to the shape of the humeral head 313 and a shoulder conforming to the shape of the shoulder socket 306 and labrum (306', 306"). socket contact surface 324. Figure 21H is an axial cross-sectional view of the arthroplasty device 320 shown in Figure 21G. As noted above, a humerus contact surface 322 is provided that conforms to the shape of the humeral head 313 and provides a The acetabular contact surface 324 of the socket 306 conforms to the shape of the labrum.

21I is an oblique frontal cross-sectional view of an alternative embodiment of an arthroplasty device 340 having a humerus contact surface 342 conforming to the shape of the humeral head 313 and a shoulder socket contact surface substantially conforming to the shape of the shoulder socket 306 344. One or more flanges or edges 346, 346' extending above and/or below may be provided. The rim can be configured to provide stability on the shoulder socket. 21J is an axial cross-sectional view of the arthroplasty device 340 shown in FIG. 21I, which has a humeral contact surface 342 consistent with the shape of the humeral head 313, and a shoulder socket substantially consistent with the shape of the shoulder socket 306 contact surface 344 . One or more edges 346″, 346″ extending superiorly and/or inferiorly may be provided to provide stability on the shoulder socket 306.

Figure 21 K is two components, the oblique frontal cross-sectional view of " weight-bearing movable " arthroplasty device 350, and it has the humerus contacting surface 354 of the first component 351 conforming to at least a part of the humeral head and conforming to the shape of at least a part of the shoulder socket Conforms to the acetabular contact surface 354 of the second component 353 . As will be appreciated by those skilled in the art, the radii of the two articulating implant surfaces can be selected to match or substantially match the humerus or the shoulder socket or both. In addition, the implant may have a generally or as closely as possible a contact surface with the humerus or socket to achieve the desired corrective and functional effect. Additionally, the center of rotation of the two articulating implant surfaces 356, 358 generally matches the center of rotation of the brachial head. As will be appreciated by those skilled in the art, the two articulating implant surfaces 356, 358 may have any shape including planar.

Figure 21L is an axial cross-sectional view of the two-component, "weight-bearing movable" arthroplasty device shown in Figure 21K. The humeral contact surface 352 is configured in this embodiment to generally conform to the shape of the humeral head 313 and the shoulder socket contact surface 354 is configured to generally conform to the shape of the shoulder socket 306 in this embodiment. The radii of the two articular implant surfaces can be selected to match the surfaces of the humerus, the shoulder socket, or both. Additionally, the centers of rotation of the two articulating implant surfaces may be selected to generally match the center of rotation of the brachial head. Figure 21M is an alternate embodiment showing the implant with a notch on the first component and a ball on the second component. The arrangement of the notches and spheres may be reversed so that they are on opposite surfaces without departing from the scope of the invention. As will be appreciated, the ball and socket arrangement shown will facilitate movement of the implant components relative to one another, but can help prevent unwanted movement of the components during operation.

FIG. 21N is an oblique frontal cross-sectional view of another embodiment of a two-component, "mobility with weight" arthroplasty device 360 . Implant 360 has a first component 362 and a second component 364 . The acetabular component 364 is configured to have two surfaces. The first surface 363 is configured to articulately oppose the first component 362 . The second surface 363 is configured to mate with the socket 306 . Use one or more anchors 365 to attach the second or shoulder socket component 364 to the shoulder socket. The anchors 365 may be in the form of pins or fins or other suitable configurations to achieve the desired result of anchoring the acetabular component 364 to the acetabular. These pins or fins may be bonded, porous coated or both. Similarly, the acetabular contact surface 363 of the component 362 may be bonded, porous coated, or both. Preferably only the anchor 365 extends into the subchondral bone.

210 is an oblique frontal cross-sectional view of an alternate embodiment of a two-component, "weight-bearing mobile" arthroplasty device 370. FIG. Humeral contact assembly 372 is attached to humeral head 312 using an attachment mechanism such as a pin, fin, or spike 373 as shown in this embodiment. These pins, fins, teeth or spikes may be bonded, porous coated, or both. Similarly, the lower surface of the humeral component may be bonded or porous coated or both. Preferably only the attachment mechanism itself (ie, the pin, fin or spike) can extend into the subchondral bone. The pins, fins, teeth or spikes can be tapered, conical, triangular, spherical, crowned or any type of flange and can be randomly or organized on the surface (e.g. ,List). As explained herein, the abulum side of the joint has an articular cartilage 374 . Implant 370 may be designed to conform to articular cartilage 374 or subchondral bone, or both. As shown in Figures 21P and 21Q, the fins and spikes may have other lengths and may be configured such that the fins are parallel to each other.

In another embodiment, the implant may be adapted for soft tissue injuries. For example, in the event of a rotator tendon tear, the implant may have an extent covering some or all of the upper humeral head. In this way, advanced grafting of the humeral head after a tear of the rotator flexor tendon does not result in pathological articulation of the humeral head with the acromioclavicular joint, producing pain and disability. Alternatively, the upper face of the humeral head can be connected with the extension element of the implant, thereby avoiding ivory of the AC joint.

D. Elbow

FIG. 22 is an oblique longitudinal view through the elbow joint 600 demonstrating the distal humerus 602 , cubitus 604 and radial head 606 . The cartilage surface can be seen from 603, 605, and 607, respectively. The arthroplasty device 620 is illustrated between the distal end of the humerus and the connecting surfaces on the ulna 608 and radius 610 . The arthroplasty device 620 may have the same design features as those shown with respect to the devices shown in FIGS. Designs of varying thickness and curvature, designs conforming to the humerus or ulna or radius or combinations thereof, designs conforming to articular cartilage and/or subchondral bone, designs with edges or elements for stabilization purposes. However, to avoid obscuring the present invention, this joint is not addressed in every possible variation of the design considerations taught in this application.

E. Wrist joint

23A is a longitudinal view through wrist joint 700 illustrating distal humerus 702, ulna 704, and several carpal bones forming carpal column 706 (eg, navicular, lunate, triquetral, capitate, and hook bones). The arthroplasty device 720 is illustrated as being interposed between the connecting surfaces 706', 706", 706'' of the distal end of the humerus 702, the distal end of the ulna 704, and the proximal end of the carpal row. The shape of the arthroplasty device 720 to the distal end of the radius 702, The shape of the proximal end 706 of the carpal column corresponds to the shape of the triangular fibrocartilage 708 (dashed line) in this example.

As will be appreciated by those skilled in the art, the arthroplasty device 720 may have the same design features as those described with respect to the devices shown in FIGS. Movable designs; attached (e.g., to the distal radius) and unattached designs, designs with varying thickness and curvature, designs conforming to the radius or ulna or carpus or combinations thereof, articular cartilage and/or Design of subchondral bone and also conforming to other joint structures such as triangular fibrocartilage, design with edges or elements for stabilization purposes.

23B is a longitudinal view through wrist joint 700 illustrating distal radius 702, ulna 704, and several carpal bones forming carpal column 706 (eg, scaphoid, lunate, triquetral, capitate, and hook bones). The arthroplasty device 720 is illustrated as being interposed between the connecting surfaces 706', 706", 706''' of the distal humerus 702, the distal ulna 704, and the proximal end of the carpal column 706. The arthroplasty device 720 is configured such that it is in contact with at least a portion The shape of the distal radius 702, the distal ulna 704 and the proximal carpal row 706 are identical.

FIG. 23C is also a longitudinal view through the wrist joint 700 demonstrating the distal radius 702 , the ulna 704 and several carpal bones 706 . The arthroplasty device 730 is shown between the connecting surfaces 706', 706", 706'' of the distal humerus 702, the distal ulna 704, and the proximal carpal row 706. The arthroplasty device 730 is shown It is generally consistent with the shape of the distal radius 702, the proximal end of the carpal row 706, and the distal ulna 704 including the ulnar styloid 710. Edge 732 is seen along the middle of the distal radius and the ulnar styloid 710 The lateral portion of the distal ulna 704 extends; this can provide stability of the implant relative to these bones. One or more edges 732, or other suitably configured flanges, can extend toward the dorsal or medial portion of any articular bone.

FIG. 23D is a longitudinal view of a two-component, "weight-bearing mobile" arthroplasty device 740. FIG. The device 740 has a first component 742 and a second component 744 . Each component has surfaces 743, 745 that interface with surfaces of other components. The radii of the two connecting implant surfaces can be selected to match the radius 702 or ulna 704 or carpus 706 or a combination thereof. Additionally, the centers of rotation of the two connecting implant surfaces may be selected to match or approximate the centers of rotation of joint 700 . As will be appreciated by those skilled in the art, the two connecting implant surfaces 743, 745 may have any shape, including planar, that facilitates joint motion. Note that the edges 746, 748 of the proximal assembly extend medially and laterally. The edges can also extend towards the back and the middle.

Figure 23E is a longitudinal view of another two-component, "weight-bearing mobile" arthroplasty device 750, in this case without the edges. The device 750 has a first component 752 and a second component 754 . Each component has surfaces 753, 755 that interface with surfaces of other components. As is apparent from the cross-sectional view, the length of the connection surface 753 of the first component is longer than the length of the connection surface 755 of the second component.

Figure 23F is a longitudinal view of a two-component, "weight-bearing mobile" arthroplasty device 760. As depicted, an attachment mechanism or anchor 766 is used to attach the first component 762 facing the radius and ulna to these bones. Suitable anchors 766 include pins, as shown in this example, spikes and/or fins, not listed. As will be appreciated by those skilled in the art, attachment of device 760 may be limited to only one bone (eg, ulna or radius).

F. fingers

FIG. 24 is a radial view through finger 800 . The arthroplasty device 820 is illustrated between the metacarpal head 802 and the base of the proximal phalanx 804 . One side 822 of the arthroplasty device 820 conforms to the shape of the metacarpal head 802 and its opposite side 824 conforms to the base of the proximal phalanx 804 . The arthroplasty device 820 can have the same design features as those seen in FIGS. 10-20 , such as one-component, two-component, three-component; above) and unattached designs, designs with varying thickness and curvature, designs conforming to proximal or distal articular surfaces or combinations thereof, conforming to articular cartilage and/or subchondral bone and also to other articular structures design with edges or elements for stabilizing purposes. Similar designs can be applied to the rearfoot, midfoot and forefoot, including the toes.

G. Ankle

25A is a radial view through the ankle joint 900 showing the distal tibia 902, talus 904, and calcaneus 906, among other bones. The cartilage surface is also shown. The arthroplasty device 920 is illustrated between the distal tibia 902 and the talar dome 904'. In this embodiment, the arthroplasty system 920 conforms to the shape of the talus 904 . As will be appreciated by those skilled in the art, and previously discussed, the device may conform to the shape of cartilage or subchondral bone, or both. The arthroplasty device 920 may have design features similar to those of the devices illustrated in FIGS. 10-20 , such as one-component, two-component, three-component; weight-bearing movable designs; attached and non-attached designs, with varying thicknesses and curvature, design conforming to tibia or talus or fibula, designing conforming to articular cartilage and/or subchondral bone, designing with edges or elements for stabilization purposes.

FIG. 25B is a coronal section view through the ankle joint 900 illustrating the distal tibia 902 , distal fibula 908 and talus 904 . The arthroplasty device 930 is illustrated between the distal tibia 902 and the talar dome 904'. In this example, the arthroplasty system 930 is shown conforming to the shape of the talus 904 .

25C is a radial view through the ankle joint 900 illustrating the distal tibia 902, talus 904, and calcaneus 906, among other bones. The cartilage surface is also shown. The arthroplasty device 940 is depicted between the distal tibial end 902 and the tibiotalar articular surface 904 ′, and in this example, the lower surface of the arthroplasty system 942 generally conforms to the shape of the talus 904 . Superior surface 944 generally conforms to the shape of distal tibia 902 and fibula (908, not shown). Edge 946 is shown engaging upper surface 942 of talus 904 .

FIG. 25D is a coronal section view through the ankle joint 900 illustrating the distal tibia 902 , distal fibula 908 and talus 904 . The arthroplasty device 950 is shown between the distal tibia 902 and the tibiotalar articular surface 904'. In this example, the inferior surface 952 of the arthroplasty conforms to the shape of the talus 904 . Superior surface 954 conforms to the shape of distal tibia 902 and fibula 908 .

H. toes

FIG. 26 is a radial view through toe 1000 . The arthroplasty device 1020 is illustrated between the metacarpal head 1002 and the base of the proximal phalanx 1004 . The illustrated arthroplasty device 1020 has a first surface 1022 conforming to the shape of the metacarpal head and a second surface 1024 conforming to the base of the proximal phalanx. As will be appreciated by those skilled in the art, the arthroplasty device may have design features similar to those seen in FIGS. , attached to the metacarpal head or the base of the phalanx) and unattached designs, designs with varying thickness and curvature, designs conforming to proximal or distal articular surfaces or combinations thereof, articular cartilage and/or subchondral A design that conforms to the bone and also other joint structures, with edges or elements for stabilization purposes. Similar designs can be applied to the rearfoot, midfoot and forefoot.

D. Device Fabrication, Assembly and Characterization

The devices described above, or any device made in accordance with the teachings of the present invention, can be fabricated from a variety of suitable materials known in the art. A wide variety of materials that find use in examples of the present invention include, but are not limited to, plastics, metals, ceramics, biological materials (e.g., collagen or other extracellular matrix materials), hydroxyapatite, cells (e.g., stem cells, cartilage cells, etc.), or a combination thereof. A suitable material may be selected based on information about the defect and/or articular surface and/or subchondral bone. Additionally, using one or more of these techniques described herein, cartilage replacement parts or regenerative materials can be formed that have curved portions that match specific cartilage defects, that conform to the contour and shape of articular surfaces, and Can match the thickness of the surrounding cartilage. Additionally, using one or more of the techniques described herein, an articulation device can be shaped that can fit in the joint space and that can conform to the contour and shape of the articular surface or other articular structures. The material may comprise a combination of materials, and preferably comprises at least one substantially non-yielding material.

Additionally, the material may have a hardness gradient. Thus, for example, the hardness gradient may decrease from the center of the device to the outer edges. A device is thus produced that is solid across the board but has a small amount of bendability to the surface along some or all of the outer surfaces. Providing an outer surface made of a material with some flexibility can improve the ability of the implant to mate with the joint. Alternatively, in some cases, a device may be produced in which the outer surface of the device has a Shore hardness value that is greater than that of the interior.

The internal stiffness of the device can make the implant suitable for performing in the joint. Suitable hardness will become apparent to those skilled in the art and may encompass a range. Typically, hardness is discussed in terms of the Shore hardness scale, and can range from common engineering grade materials plastics to reinforced steel and titanium, and is preferably the typical Rockwell hardness scale portion on steel, hard plastics and ceramic materials. From the required high stiffness of the device, it is clear that the device operates in a completely different way from the prior art. The purpose of the device of the present invention is to achieve a spanning-like effect to bridge the defect area. However, in composite variations, any single component (like the bioactive material component described below) can be softer than the support material.

Currently, joint repair systems, including devices, use metallic and/or polymeric materials. See, for example, U.S. Patent Nos. 6,203,576 to Afriat et al., issued March 20, 2001; U.S. Patent Nos. 6,206,927 to Fell et al., issued March 27, 2001; US Patent No. 6,322,588 to et al. and references cited therein. Similarly, a wide variety of metals find use in embodiments of the present invention, and may be selected based on any criteria, for example, based on elasticity to provide the desired stiffness. Non-limiting examples of suitable metals include silver, gold, platinum, palladium, iridium, copper, tin, lead, antimony, bismuth, zinc, titanium, cobalt, stainless steel, nickel, iron alloys, cobalt alloys (such as Erkiloy alloys (Elgiloy), cobalt-chromium-nickel and MP35N, nickel-cobalt-chromium-molybdenum, and Nitinol ^™ , nickel-titanium alloys, aluminum, manganese, iron, tantalum, and iron that can slowly form polyvalent metals to (for example) inhibit Calcified other metals of implanted substrates in contact with patient body fluids or tissues, and combinations thereof.

Suitable synthetic polymers include, but are not limited to, polyamides (e.g., nylon), polyesters, polystyrenes, polyacrylates, vinyl polymers (e.g., polyethylene, polytetrafluoroethylene, polypropylene, and polyvinyl chloride) , polycarbonate, polyurethane, polydimethylsiloxane, cellulose acetate, polymethacrylate, polyether ether ketone, polyether ketone ketone, ethylene vinyl acetate, polysulfone, nylon cellulose, Similar copolymers and mixtures thereof. Bioresorbable synthetic polymers can also be used, such as dextran, hydroxyethyl starch, gelatin derivatives, polyethylpyrrolidone, polyethyl alcohol, poly[N-(2-hydroxypropyl)methyl Acryloyl], poly(hydroxy acid), poly(ε caprolactam), polylactic acid, polyglycolic acid, poly(dimethylglycolic acid), poly(hydroxybutyric acid), and similar polymers can also be used.

These polymers may be prepared using any of a variety of methods, including conventional polymer processing methods. Preferred methods include, for example, injection molding, which is suitable for producing polymer components with pronounced structural features; and rapid prototyping methods, such as reactive injection molding and stereolithography. The substrate can be roughened or porous through physical abrasion or chemical modification to facilitate metal coating bonding.

The polymer can be injected into a mold that mirrors the appearance of the articular surface or other articular structures.

More than one metal and/or polymer may be used in combination. And liquid metal can also be used. For example, one or more regions of one or more metal-containing substrates may be coated with a polymer, or one or more metals may be used to coat one or more regions of a polymer-containing substrate. Area.

A device or portion thereof may be porous or have a porous coating. Porous surface components can be made from a variety of materials including metals, ceramics, and polymers. These surface assemblies can then be enclosed by various components in many structural cores formed from various materials. Suitable porous coatings include, but are not limited to, metals, ceramics, polymers (eg, bioneutral elastomers such as silicone rubber, polyethylene terephthalate, and/or combinations thereof), or combinations thereof. See, e.g., U.S. Patent No. 3,605,123 issued September 20, 1971 to Hahn et al.; U.S. Patent No. 3,808,606 issued April 23, 1974 to Tronzo; 3,843,975, US Patent 3,314,420 to Smith, US Patent 3,987,499 to Scharchach, October 26, 1976, and German Offenlegungsschrift 2,306,552. There may be more than one coating and the coatings may have the same or different porosity. See, eg, US Patent No. 3,938,198, issued February 17, 1976 to Kahn et al.

The coating can be applied by using a powdered polymer around the core and heating until a coating with an internal network of interconnected pores forms. The tortuosity of the aperture (eg, a measure of the length to diameter of the path through the aperture) is important in assessing the success of such coatings for use on prosthetic devices. See also US Patent No. 4,213,816 issued July 22, 1980 to Morris. Porous coatings can be applied in the form of powders and granules that are subjected as a whole to high temperatures that bond the powder to the substrate. Given the teachings herein and the references cited, a suitable choice of polymer and/or powder coating can be determined, for example, based on the melt index of each.

Any of the devices described herein may also include one or more biological materials, either alone or in combination with non-biological materials. Non-limiting examples of biological materials include cells (e.g., fetal chondrocytes), biopolymers (e.g., collagen, elastin, silk, keratin, gels, polyamino acids, feline visceral structures, feline intestinal sutures, e.g., fiber Glycans of protein and starch), autografts, allografts, xenografts, etc. See Nos. 5,478,739, 26 December 1995 to Slivka et al; 5,842,477, 1 December 1998 to Naughton et al; 6,283,980, 4 September 2001 to Vibe-Hansen et al No., and US Patent No. 6,365,405, issued February 4, 2002 to Salzmann et al.

In certain embodiments, a device may comprise one or more separate (but preferably engageable) components. For example, a two-piece device may include two components, where each component includes a mating surface. Two components can be interlocked. When mated with each other, the contoured faces oppose each other and form a device that fits within the defect to be corrected and provides an articular surface that mimics or replicates a natural articular surface. Any suitable interlocking mechanism may be used, including movable (eg, keyway) systems; interlocking catches; ball and keyway interlocking systems; groove and flange systems, and the like. In some embodiments, the engageable component surfaces are curved. The curvature may reflect one or more joint structures.

In other embodiments, the configuration of the device changes after installation into the joint. Thus, the device can be designed into an initial configuration. After installation, the device assumes a subsequent configuration different from the initial configuration. For example, the device may be a multi-component device which, in a first configuration, has a small profile or a small three-dimensional shape. After installation, the surgeon allows (or causes) the device to assume a second configuration, which may have a larger profile or overall three-dimensional shape. The device may form its secondary configuration by itself, or may be manipulated to form a secondary configuration, such as by mechanical means (e.g., deploying the device or sliding components of the device relative to each other to assume a larger second configuration) . An advantage of these embodiments is that smaller incisions are required. The device can be mounted in this manner, for example, arthroscopically. Thus, subsequent configurations can be taken automatically, semi-automatically or manually.

The methods and combinations described herein can be used to replace only a portion of an articular surface, eg, an area of diseased or missing cartilage on an articular surface. In these systems, the articular surface repair system can be designed to replace only the diseased or missing cartilage area or it can extend beyond the diseased or missing cartilage, eg, 3 or 5 mm into normally adjacent cartilage. In certain embodiments, the prosthesis replaces no more than about 70% to 80% of the articular surface (e.g., any given articular surface of a single femoral condyle, etc.), preferably less than about 50% to 70% (or any value), preferably less than about 30% to 50% (or any value therein), preferably less than about 20% to 30% (or any value therein), and even more preferably less than about 20% of the articular surface.

E. Alternative Attachment Mechanism

As will be appreciated by those skilled in the art, various attachment mechanisms can be provided to attach the implant in the target joint. By way of example, the attachment mechanism may be ridges, pins, pins, crosspieces, and other flanges that engage mating surfaces of the implant. These flanges or mechanisms can have a variety of shapes and cross-sections, including conical, triangular, conical, spherical, cylindrical, annular, and the like. A single attachment mechanism may be used or multiple mechanisms may be used as desired. Combinations of the shapes can be used to achieve better substitutions. When multiple mechanisms are used, the mechanisms may be formed in an organized fashion (eg, columns, circles, etc.) or in a random (random) fashion. A cone-shaped portion is provided on the lower surface of the implant. Additionally, where more than one attachment mechanism is used, the directions relative to each other may be parallel or non-parallel.

In one example, a cone is positioned on the lower surface of the device such that it rests on the bottom of, for example, a depressed portion of the tibial cartilage. The cone may, like the sphere, also be separated from the lower surface of the implant by, for example, a cylindrical element. Other suitable geometries for attachment will be apparent to those skilled in the art.

In another example, one or more cylindrical or substantially cylindrical pins are provided on the surface of the implant. Position the pins so that each pin is parallel to at least one other pin.

In another example, a magnet semi-fixed attachment mechanism is placed beneath the subchondral bone layer, such as in the tibia. Another magnet or magnetic material is embedded or attached to the lower surface of the device, which is then held in place by the first magnet. As will be appreciated by those skilled in the art, a plurality of magnets in relation to one another may be used. Additionally, a combination of magnets may be used such that each surface has one or more magnets with a first pole and one or more magnets with a second pole, with magnets of opposite poles on (or associated with) the opposite surface. on the surface) to engage the surface with the magnet. This arrangement is useful where it is desired to prevent rotation of the device within the joint while ensuring contact between the two surfaces.

In another example, the attachment mechanism is a screw or anchor that is inserted into the subchondral bone of the tibia at the bottom of the concave portion of the tibial cartilage. The device may be fixed to the screw or anchor or may have a semi-fixed design, for example by incorporating a slot that slides over the screw or anchor.

The height of the implant can be adjusted to correct topological abnormalities or axis deviations of the joint. In the knee joint, for example, the joint height can be adjusted to correct arched legs or valgus foot deformities. Correction can be determined using measurements of the joint and adjacent joint axes. For example, CT or MRI scans or weight-bearing radiographs of extremities can be used for this purpose.

Implant thickness can also be selected or adjusted to correct ligament laxity. In the knee, for example, a slightly thicker implant may be chosen to address laxity or tearing of one or more cruciate or indirect ligaments. The increase in thickness of the implant may be uniform or non-uniform, for example predominantly peripheral. A surgeon may use one or more experimental prostheses or actual implants at the time of surgery to test which implant thickness produces the best results with respect to joint and implant laxity.

V. Implantation

Typically, the devices described herein are implanted in the area of a joint defect. Implantation may be performed using cartilage replacement or regenerative material that remains attached to or removed from the base material. Any suitable method and device may be used for implantation, for example, U.S. Patent Nos. 6,375,658 issued April 2002 to Hangody et al; 6,358,253 issued March 19, 2002 to Torrie et al; 6,328,765, issued to Hardwick et al., and International Publication WO 01/19254, published March 22, 2001, to Cummings et al.

An arthroscopic aid may be used to insert the implant. The device does not require a 15 to 30 cm incision in some unilateral and total knee arthroplasties. The procedure is performed under local anesthesia, usually an epidural. A tourniquet may be applied to the proximal portion of the extremity. Antiseptic techniques are used to prepare and drape the area of the body where the joint is to be repaired. In the case of the knee, for example, using conventional arthroscopic techniques, a stylette can be used to create two small 2mm ostia at the anteromedial and anterolateral aspects of the joint. Insert the arthroscope through the side port. Insert arthroscopic instruments through the central port. Cartilage defects can be seen with arthroscopy. The cartilage defect positioning device can be placed in the diseased cartilage. The probe may be U-shaped, with a first arm contacting the central region of the diseased cartilage within the joint while the second arm of the U remains outside the joint. The second arm of the U indicates the position of the cartilage relative to the skin. The surgeon marks the location of the cartilage defect in the skin. A 3 cm incision was made above the defect. Insert a tissue retractor and visualize the defect.

The implant is then inserted into the joint. The anterior and posterior positions of the implant can be colored. For example, the front pins could be marked red with a small letter "A", while the rear pins could be green and marked with a small letter "P". Similarly, the center of the implant may be marked yellow and marked with a small letter "M", while the sides of the implant may be marked with a small letter "L".

Regions of cartilage can be imaged as described herein to detect regions of missing and/or diseased cartilage. The margins and shape of cartilage and subchondral bone adjacent to the affected area can be determined. The thickness of the cartilage can be determined. The shape of the meniscus or other joint structure can be determined. The size and shape of the device can be determined from one or more of the above measurements. In particular, the prosthetic system can be selected (as best fit) from a catalog of existing or prefabricated implants with a range of different sizes and curvatures or custom designed or patient customized using CAD/CAM techniques. A custom implant can be created using one or more patient-specific parameters. The patient-specific parameters may be obtained using measurements of one or more joints of the patient to be repaired. In addition, existing shape libraries may have about 30 size classes. As will be appreciated by those skilled in the art, the library may contain more than 30 shapes or less than 30 shapes as desired without departing from the scope of the present invention.

In more detail, to implant the device in the hip joint, the surgeon makes a small incision as described above. The hip joint can be exposed using tissue retractors and other surgical instruments commonly used in hip surgery. The capsule can then be opened. The second surgeon can continue to pull on the femur or tibia to open the space between the femoral head and the acetabulum. The first physician performing the procedure may then insert the arthroplasty device into the joint. If necessary, the surgeon may resect the ligamentum capitis femoris and clear portions of the joint surface (for example) to remove labral tissue or a cartilage flap. Surgeons also have the option of removing fat located in the pulvinar region.

Alternatively, in arthroplasty systems that include self-extending materials such as nitinol, the surgeon can gain access to the hip joint through standard or modified arthroscopic approaches. The implant can be delivered through the same or a second entrance or through a small incision. Once in the joint, the implant can stretch and assume its final shape. To facilitate replacement of the extendable implant, catheters or casts may be used. A catheter or cast can be adapted to the 3D contours of the femoral or acetabular articular surface and can be placed at the intended location of the implant. The implant can then be advanced along the catheter, or within a cavity in the catheter or cast, for example. Once the implant has reached its intended location, the catheter or cast can be removed leaving the implant in place.

VI. Device casting mold

In another embodiment of the invention, containers or wells of selected dimensions may be formed, for example, to match the material required by a particular subject or to form a reserve of restorations and/or materials of various sizes. Use the thickness and curvature information obtained from the joint and from the cartilage defect to design the size and shape of the vessel. In more detail, the interior of the container may be shaped to conform to any selected measurements, eg, as obtained from a cartilage defect of a particular subject. The container (mold) can be filled with replacement material to form the device to be implanted.

The casting mold is generated using any suitable technique, such as computer means and automatic control, such as computer aided design (CAD) and, for example, computer aided molding (CAM). Because the resulting material generally conforms to the internal contours of the container, it better matches defects and facilitates integration.

VII. Implantation of Catheters and Surgical Tools

The casting molds described above can also be used to design catheters and tools for surgical implantation that have at least one outer surface that matches or approximately matches the contour of the underlying articular surface (bone and/or cartilage). In certain embodiments, two or more outer surfaces match corresponding articular surfaces. The entire tool can be round, circular, oval, ellipsoidal, curved or irregular in shape. The shape may be selected or adjusted to match or surround an area of diseased cartilage or an area slightly larger than the diseased cartilage. Alternatively, the tool can be designed to be larger than the diseased cartilage area. The tool can be designed to include most or the entire articular surface. Two or more tools can be used in combination for two or more articular surfaces, for example.

One or more electronic images may be obtained to provide target coordinates that define joint and/or bone surfaces and shapes. For example, the biomechanical axis of the joint can also be defined using imaging tests such as CT or MRI scans or standing weight-bearing x-ray scans. For example, if the surgery involves the knee, a CT scan or helical CT scan can be obtained through the knee. CT scans may be limited to the knee joint area and the distal femur and proximal tibia. Alternatively, the scan may include images through the hip and, optionally, the ankle. In this way, anatomical axes can be defined and preferred planes can be selected for surgical replacement of the knee implant. Scans can be adjacent.

Alternatively, selected scan planes may be acquired through the hip and ankle region to define an anatomical axis. CT scanning can be combined with medial arthroscopic management to visualize the articular cartilage. In another example, a non-contrast CT scan can be used. If non-radiography is used, remaining cartilage thickness can be assessed, for example, with a reference database of age, sex, race, height and weight matched individuals. In severe arthritis, a decrease in normal cartilage thickness may be present. For example, in the knee joint, cartilage thickness may appear to be zero or close to zero in the weight-bearing region of a patient with severe arthritis, while a value of 2 mm or less may be chosen in the posterior non-weight-bearing region. These estimated cartilage thicknesses can then be added to the curvature of the subchondral bone to provide an estimate of the shape of the articular surface. With MRI, a high-resolution scan is obtained through the knee the surgeon is working on. This scan is useful for defining the joint geometry. High resolution scans can be attached with low resolution scans to define anatomical axes by adjoining joints and bones.

If the full knee arthroplasty is covered, a high resolution scan may be required in the knee, a lower resolution scan may be required in the hip, and optionally the ankle. Such lower resolution scans can be obtained using body coils or incomplete phased array coils.

Imaging tests can also be combined. For example, a knee MRI scan can be used to define the 3D joint geometry of the knee joint including subchondral bone and cartilage. An MRI scan of the knee can be combined with a standing, weight-bearing x-ray of the extremity depicting the anatomical axis. In this way, target coordinates and anatomical axes are available, which can be used to define preferred planes for surgical intervention.

The target coordinates can be used (eg, using CAD/CAM techniques) to shape the device to fit the patient's anatomy or to select a prefabricated device that fits the patient's joint anatomy. As indicated above, the tool may have a surface and shape that matches all or part of the joint or bone surface and shape, for example, resembling a "mirror image" of the device to be implanted. The tool may include holes, slots and/or holes to accommodate surgical instruments such as drills and saws, and the tool may be used for partial joint replacement as well as total joint replacement. For example, in total knee arthroplasty, tools can be used for precise placement of incision planes required for implant insertion. In this way, more reproducible implant sites can be achieved with the potential to improve clinical outcomes and long-term implant survival.

Tools can have one, two or more components. A part of the tool can be made of metal, while other parts can be made of plastic. For example, the surface that contacts the articular surface during surgery can be made of plastic. In this way, it can be manufactured easily and at low cost, for example using rapid prototyping techniques. Plastic components can be made individually for each patient or pre-selected from an existing range of sizes. Articular surfaces indicate that plastic component parts can have the same surface geometry, eg block, in any patient. In this way, prefabricated metal components can be applied to plastic components. The metal component may include a surgical catheter, such as the opening of a saw or drill. Plastic components can often have openings through which surgical instruments can be moved toward bone or cartilage without damaging the plastic.

The plastic component positions the metal component and surgical catheter relative to the articular surface. A spacer (for example) can be introduced between the two components to adjust the depth of the bone incision. Thus, in the knee, the surgeon can use the spacers to test the flexion and deployment gaps, adjust the gaps and select the most appropriate cutting plane. Additionally, if two or more assemblies are used, rotational adjustments may be allowed between the assemblies. In this way, the surgeon can, for example, balance medial and lateral spacing in the knee joint. After any optional rotational adjustments are made, the components can be fixed relative to each other or to the bone or cartilage before the surgeon makes the incision or does any other manipulation.

Components and tools can be designed to coordinate with existing surgical instrument kits used for arthroplasty (eg, total knee arthroplasty). It should be noted that the tool can help reduce the number of surgical instruments used for arthroplasty. Ultimately, this embodiment can help improve postoperative placement of the implant relative to the desired location and anatomical axis, thereby reducing prosthetic laxity, implant wear, stress on bone, and thereby improving long-term outcomes.

Typically, the location is chosen to result in a cutting plane or drilling direction required for the anatomy that subsequently places the implant. Additionally, the catheter device can be designed so that the depth of the drill or saw is controlled, e.g. the drill or saw cannot penetrate deeper into the tissue than the depth defined by the thickness of the device, the size of the hole in the block can be designed to match the depth of the implant substantially match in size. When selecting the orientation of these slots or holes, information about other joints or axes and alignment of joints or limbs can be included. Catheters can be prepared for use with any of the implants of the invention.

Turning now to specific examples of implant catheters shown in Figures 28 and 17, these examples are provided for illustration purposes. Figure 28 illustrates an implant catheter 1100 suitable for use with the implant shown in Figure 8L. An arthroplasty body 1110 is provided. The arthroplasty body can be configured to have at least one outer surface configuration that matches the outer surface configuration of the implant 100 to be used. A handle 1112 is provided to allow the user to place the catheter in the joint where the implant 100 will be seated. Additionally, an anchor catheter 1114 is provided. In this example, the anchor catheter 1114 is in an opening in the body 1110 in the shape of a cross. As will be appreciated by those skilled in the art, the anchoring catheter 1114 may take a variety of suitable shapes to enable the catheter to perform its intended function. In this example, the cross shape allows the user to identify the articular surface of the joint where anchor 112 (shown in FIG. 3L ) is oriented. Once the catheter 1100 is placed on the target joint surface, the anchor catheter 1114 can be used to: mark where the anchor can enter the joint; determine where the anchor can enter the joint; prepare the joint surface where the anchor can be placed ; or a combination thereof.

Turning now to catheter 1200 shown in FIGS. 25A-25B , a plan view of a catheter suitable for use with the implant shown in FIGS. 9A-9C is shown. A body 1210 is provided. The body is configured to have at least one outer surface configuration that matches or approximately matches the outer surface configuration of the implant 150 to be implanted. A handle 1212 is provided to allow the user to place the catheter on the joint surface where the implant 150 is seated. Additionally, one or more anchor catheters 1214 are provided. In this example, the anchoring catheters (1214', 1214", 1214'') are annular or generally annular, and the diameter of the opening in the body 1210 is large enough to accommodate a drill bit for drilling a hole in the bone in which The stylet of the anchor 156 of the implant 150 will be placed. As will be appreciated by those skilled in the art, the anchoring catheter 1214 can exhibit various suitable shapes to enable the catheter to perform its intended function. Additional catheter 1216. The additional catheter may perform the same function as the first catheter 1214 or may perform a secondary function. In this example, the anchoring catheter 1214 may be used to identify the articular surface of the joint where the anchor 156 (shown in FIGS. 9B to 9C ) can be oriented on the joint. Once the catheter 1200 is placed on the target joint surface, the anchoring catheter 1214 can be used to: mark where the anchor can enter the joint; A location to enter the joint; prepare the joint surface at a location where the anchor can be placed; or a combination thereof. In addition, the catheter 1216 can be used to mark where the anchor can enter the joint; Preparation of the articular surface where the anchor is placed; or a combination thereof.

In another embodiment, a framework may be applied to bone or cartilage in areas other than the diseased bone or cartilage area. The frame may include holders and conduits for surgical instruments. The frame can be attached to one or preferably earlier defined anatomical reference points. Alternatively, using imaging tests (eg, one or more fluoroscopic images desired during surgery), the position of the frame can be cross-registered relative to one, preferably more, anatomical landmarks. One or more electronic images may be obtained to provide target coordinates defining the surface and shape of the joint and/or bone. These target coordinates can be entered or transferred into the device, for example, manually or electronically or a combination thereof, and the information can be used to move one or more fixtures or catheters used by surgical instruments. Typically, the selected location may result in a surgically or anatomically desired cutting plane or drill orientation for subsequent placement of one or other implants, including hemilateral, unilateral, or global arthroplasties. When selecting the orientation of these slots or holes, information about other joints or axes and alignment of joints or limbs can be included.

Because of its anatomical placement with the selected inferior articular surface, the preferred position and orientation of the saw guide, drill bit, or guide guide for the expansion device can be created with appropriate tools. During surgery, surgical aids are applied to the articular surface to achieve a near-perfect or perfect anatomical fit. The surgeon can then introduce a saw (or other tool) through the catheter and prepare the joint for this procedure. By cutting the cartilage and/or bone along anatomically defined planes, more reproducible sites can be achieved, which can ultimately lead to improved postoperative outcomes through optimization of biomechanical stress.

The anatomical corrective tools described herein can be constructed in a variety of ways and can be made of any material, preferably transparent materials such as plastic, transparent synthetic resin, silicone rubber, SLA, etc., and typically in block form prior to casting. Additionally, reusable tools (eg, casting molds) can be made and used. Non-limiting examples of reusable materials include cloth leggings and other deformable materials (eg, an array of adjustable closely spaced pins that can be configured to match the topography of an articular surface). In these embodiments, a cast can be created from the joint during surgery, for example, using one or more computer programs to determine the surface contours that define the joint and transfer (e.g., dial in) these coordinates to the target coordinates of the tool, Or generate a cast from an image of a joint. The tools can then be precisely positioned on the joint, and thus the drill and implant can be placed more precisely in and over the joint surface.

In a single-use and reusable embodiment, the tool can be designed such that the depth of the block controls the depth of the drill or saw, that is, the drill or saw cannot go deeper than the depth of the block, and the depth of the block The size of the hole can be designed to substantially match the size of the implant. The tool can be used for general prosthetic implantation, including (but not limited to) joint repair implants described herein and for use in the context of hemi or unilateral or global arthroplasty or other joint systems including biological repairs Expand bone marrow.

These surgical tools can also be used to remove areas of diseased cartilage or areas slightly larger than diseased cartilage.

The identification and preparation of the implant site and the insertion of the implant can be supported by an image-guided surgical system (surgical navigation system). In such a system, the position and orientation of the surgical instrument in relation to the patient's anatomy can be tracked in real-time in one-dimensional or 2D or 3D images. These 2D or 3D images can be calculated from images obtained after surgery (eg MR or CT images). The position and orientation of the surgical instrument is determined by markers attached to the instrument. These markers can be located by detectors using, for example, optical, acoustic or electromagnetic signals. Surgical navigation systems can also be used without image guidance, for example, by using motion studies of the extremities to identify anatomical axes.

In other embodiments, the surgical tools described herein may include one or more materials that harden to form a cast of the articular surface. A variety of materials have been described that can be hardened in situ, including polymers that can be excited to undergo a phase change, such as liquid polymers or semi-liquid polymers, and by exposure to air, application of ultraviolet light, visible light, exposure to A polymer that hardens into a solid or gel when altered by blood, water, or other ions. (See US Patent No. 6,443,988 and references cited therein). Non-limiting examples of suitable curable and hardening materials include polyurethane materials (such as U.S. Patent No. 6,443,988 issued September 3, 2002 to Felt et al.; issued February 22, 1994 to Khalil 5,288,797, 4,098,626 to Graham et al., July 4, 1978, and 4,594,380, June 10, 1986 to Chapin et al., and Lu et al. (2000) Biomaterials (BioMaterials) 21(15):1595-1595-1605 described porous poly(L-lactide acid foams); such as the hydrophilic polymers disclosed in U.S. Patent No. 5,162,430 issued Nov. 10, 1992 to Rhee et al. People such as Wake (1995) " cell transplantation (Cell Transplantation) " 4 (3): 275-279, (2001) " J. Biomedical Materials Research (J.Biomedical Materials Research) " 54 (2 ): 179-188 and hydrogel materials as described in Marier et al.'s (2000) "Plastic Reconstruct. Surgery" 105(6): 2049-2058; hyaluronic acid materials (e.g. Duranti et al. (1998) "Dermatologic Surgery" 24 (12): 1317-1325); expansion beads such as shell beads (eg Yusof et al. (2001) "J. Biomedical Materials Research (J.Biomedical Materials Research )” 54(1):59-68); and/or materials used in dental applications (see, e.g., Brauer and Antonucci, "Dental Applications" pp. 257-258 and U.S. Patent No. 4,368,040 issued Jan. 11, 1983 to Weissman). Any biocompatible material can be used that is sufficiently flowable to It is allowed to be delivered to the joint and undergo complete healing in situ under pathophysiologically acceptable conditions.The material may also be biodegradable.

Curable materials can be used in conjunction with the surgical tools described herein. For example, a surgical tool may include one or more holes therein for receiving an injection and through which a curable material may be injected. The material can conform to the articular surface facing the surgical tool before setting in situ, and thus harden to imprint the surface, thereby recreating a normal or near-normal articular surface. Additionally, curable materials or surgical tools may also be used in conjunction with the imaging tests and analyzes described herein, eg, by molding the material or surgical tool based on images of the joint.

Turning now to Figures 27A to 27D, there are shown the steps of a method of implanting a device as taught by the present invention. First, the user makes an incision to access the target joint 2610 . Thereafter, the articular surface is prepared 2620 using an implant catheter. Preparing the articular surface can include, for example, identifying the location of the implant in the joint, marking where the implant can be attached, and/or preparing the articular surface to receive the implant. This preparation can be repeated as necessary. As will be appreciated by those skilled in the art, in preparing the articular surface, the user may first identify the location of the implant and then prepare the surface by marking the articular surface or removing bone or cartilage. Once the articular surface is prepared, the implant 2640 is installed. Implants can be installed by placing the implant on a surface using the techniques described herein or by adhering the implant to the surface. After the implant is installed in the joint, the wound 2650 is closed.

Turning now to the step shown in FIG. 27B , the user makes an incision to access the target joint 2610 . Thereafter, a frame is attached to the joint 2660. Although not shown in this flowchart, the steps of preparing the joint shown in Figure 27A can be performed. The implant is then mounted 2665 on the frame. After the implant is installed in the joint, the wound is closed 2650.

Turning now to the step shown in FIG. 27C , the user makes an incision to access the target joint 2610 . Thereafter, the diseased cartilage is removed 2670 from the joint. Although not shown in this flowchart, additional steps of preparing the joint shown in Figure 27A may also be performed without departing from the scope of the present invention. Implant 2675 is then installed. After the implant is installed in the joint, the wound 2650 is closed.

Turning now to the step shown in FIG. 27D , the user makes an incision to access the target joint 2610 . Although not shown in this flowchart, additional steps of preparing the joint shown in Figure 27A may also be performed without departing from the scope of the present invention. Implant 2680 is thereafter inserted. An optional adjustment 2682 is then made to the position of the implant. After the implant is inserted and positioned, the contour of the implant is adjusted 2684. After the implant is installed in the joint and adjusted, the wound 2650 is closed. A selected implant height or profile can be selected to alter the weight-bearing capacity relative to the joint. Additionally, the height of the implant can be adjusted to account for abnormal anatomical topologies of bone or joint structures.

VII. Kit

Also described herein are kits that include one or more of the methods, systems, and/or compositions described herein. Specifically, a kit may include one or more of the following: instructions (methods) for obtaining electronic images; systems or instructions for evaluating electronic images; one or more computer components capable of analyzing or processing electronic images; and/or One or more surgical tools used to place an implant. A kit can include other materials such as instructions, reagents, containers, and/or imaging aids (eg, films, holders, digitizers, etc.).

The following examples are included to more fully illustrate the invention. Additionally, these examples provide preferred embodiments of the invention and are not meant to limit its scope.

The foregoing description of the embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will become apparent to practitioners in the art. The embodiment was chosen and described in order to best explain the principles of the invention and its implementation, thereby enabling others skilled in the art to understand the invention and various embodiments, with various modifications suited to a particular use. It is intended that the scope of the invention be defined by the following claims and their equivalents.

Claims (157)

1. joint implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface in a part of one or at least a portion have with described first and second articular surfaces in one the shape 3D shape of fully mating.

2. joint implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least one at least a portion have the 3D shape that approaches one shape in described first and second articular surfaces.

3. cartilage defect shaping implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least one at least a portion have with described first and second articular surfaces in one the shape 3D shape of fully mating.

4. cartilage defect shaping implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least one at least a portion have of approaching in described first and second articular surfaces 3D shape.

5. cartilage projection implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least one at least a portion have with described first and second articular surfaces in one the shape 3D shape of fully mating.

6. cartilage projection implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least one at least a portion have the 3D shape that approaches one shape in described first and second articular surfaces.

7. subchondral bone shaping implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least a portion of one have one with described first and second articular surfaces in one the shape 3D shape of fully mating.

8. subchondral bone shaping implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least a portion of one have the 3D shape that approaches one shape in described first and second articular surfaces.

9. subchondral bone projection implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least a portion of one have with described first and second articular surfaces in one the shape 3D shape of fully mating.

10. subchondral bone projection implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of described second surface, and further, wherein said first or second surface at least a portion of one have the 3D shape that approaches one shape in described first and second articular surfaces.

11. joint implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of second surface, and further, wherein said first or second surface at least a portion of one have with described first and second articular surfaces in one the shape 3D shape of fully mating, and further, wherein said implant recovery joint motions can return to 90% to 99.9% of natural joint motility.

12. implant with a first surface and a second surface, one first articular surface in the relative joint of wherein said first surface and a second joint surface in the described relatively joint of second surface, and further, wherein said first or second surface at least a portion of one have with described first and second articular surfaces in one the shape 3D shape of fully mating, and further wherein said implant can be born 100% of the shearing force that puts on described joint.

13. implant that is applicable to a mammiferous joint, wherein said joint has one first articular surface and a second joint surface, wherein said implant has a first surface and a second surface, the at least a portion at least a portion of relative one first articular surface of wherein said first surface and the relative second joint surface of described second surface, and further, wherein said first or second surface at least one at least a portion have with described first articular surface and described second joint surface in one the shape 3D shape of fully mating.

The intraarticular in the group that 14. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is placed in and is selected from by knee joint, hip, shoulder, elbow, wrist, refers to, toe and ankle are formed.

15. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said upper surface and described lower surface have with described articular surface in one the shape 3D shape of fully mating.

16. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has patient's cartilage defect thickness.

17. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has 85% of patient's cartilage defect thickness.

18. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has 65% to 100% of patient's cartilage defect thickness.

19. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has patient's cartilage defect thickness, adds a deviant.

20. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has 85% of patient's cartilage defect thickness, adds a deviant.

21. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has 65% to 100% of patient's cartilage defect thickness, adds a deviant.

22. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is constructed by the material that comprises metal or metal alloy.

23. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said material comprises one or more bioactive materials.

24. implant according to claim 22, wherein said implant is covered by a biological active material.

25. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant comprises metal or metal alloy and polymer.

26. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, it further has attached to being selected from described first surface in the group that is made up of ridge, pin, contact pin, cross member, tooth and projection or the structure in the described second surface at least one.

27. implant according to claim 26, it further has a plurality of structures that are used to adhere to.

28. implant according to claim 27, the relative orientation that wherein is used to the structure of adhering to are selected from by symmetrical, asymmetric, capable, round, triangle and the group that forms arbitrarily.

29. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, it further has a peripheral structure that is selected from the group that is made up of ridge and edge.

30. implant according to claim 29, wherein said peripheral structure is extended along the whole girth of described implant.

31. implant according to claim 30, wherein said peripheral structure is extended along its perimeter of described implant.

32. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, each of wherein said first surface and second surface has the slope about the longitudinal axis that passes described implant, and further, wherein be selected from the group that forms by positive and negative and zero about the first surface slope of described second surface slope.

33. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is near one shape in described first and second articular surfaces.

34. implant according to claim 33, wherein said implant are selected from an implant storehouse.

35. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has changed configuration after inserting a joint.

36. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant changes configuration at loading days.

37. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant further comprises one first assembly and one second assembly.

38. implant according to claim 36, wherein said first and second assemblies are monolithic molding, indivisible shaping, interconnection be shaped and interdepend be shaped in one.

39. implant according to claim 36, wherein said first assembly with regularly, slidably, at least one and the engagement of described joint in rotatably.

40. implant according to claim 36, wherein said second assembly with regularly, slidably, in rotatably at least one come and the engagement of described joint.

41. according to claim 36,37,38 and 39 described implants, wherein said first assembly and the engagement of described second assembly.

42. according to claim 36,37,38 and 39 described implants, wherein said first assembled is in described second assembly.

43. according to claim 36,37,38 and 39 described implants, wherein said first assembly meshes with described second assembly slidably.

44. according to claim 36,37,38 and 39 described implants, wherein said first assembly meshes with described second assembly rotatably.

45. according to claim 36,37,38 and 39 described implants, the part of wherein said implant has a magnet.

46. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has plurality of element.

47. according to the described implant of claim 46, one first assembly of wherein said plurality of element with regularly, slidably, at least one and the engagement of described joint in rotatably.

48. according to the described implant of claim 46, one second assembly of wherein said plurality of element with regularly, slidably, at least one and the engagement of described joint in rotatably.

49. according to claim 46,47 and 48 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element.

50. according to claim 46,47 and 48 described implants, first assembled of wherein said plurality of element is in second assembly of described plurality of element.

51. according to claim 46,47 and 48 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element slidably.

52. according to claim 46,47 and 48 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element rotatably.

53. according to claim 46,47 and 48 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element rotatably and slidably.

54. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has one along being selected from by circle, ellipse, avette, kidney shape, circle substantially, ellipse substantially, the shape that girth in the group that substantially kidney shape avette, substantially is formed forms.

55. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant has one and is selected from by sphere, hemispherical, aspheric surface, convex surface, concave surface, substantially convex surface and lower surface in the group that forms of concave surface substantially and at least one the shape of cross section in the upper surface.

56. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is a cartilage defect shaping implant.

57. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is a cartilage projection implant.

58. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is a subchondral bone shaping implant.

59. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is implanted via a 10cm or littler otch on surgery.

60. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is implanted via a 6cm or littler otch on surgery.

61. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said implant is implanted via a 4cm or littler otch on surgery.

62. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the range of activity in wherein said joint is restored to natural joint active 80% to 99.9%.

63. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the range of activity in wherein said joint is restored to natural joint activity 90% to 99.9%.

64. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the range of activity in wherein said joint is restored to natural joint active 95% to 99.9%.

65. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the range of activity in wherein said joint is restored to natural joint active 98% to 99.9%.

66. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is a knee joint, and wherein shape forms along being selected from by circle, ellipse, avette, kidney shape, circle substantially, ellipse substantially, the girth in the group that substantially kidney shape avette, substantially is formed.

67. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is a knee joint, and the upper surface of wherein said implant is a convex surface substantially.

68. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is a knee joint, and the lower surface of wherein said implant is a concave surface substantially.

69. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is a knee joint, and the upper surface of wherein said implant comprises convex surface and concave surface cross section.

70. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is that the lower surface of knee joint and described implant is concave surface substantially.

71. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, wherein said joint is a knee joint, and the cross section of wherein said implant is selected from the group that is made up of spherical and aspheric surface.

72. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the periphery of described implant has the thickness thicker than the middle body of described implant.

73. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants, the middle body of described implant has the thickness thicker than periphery.

74. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has along the thickness of the aft section of described device, and it is equal to or greater than at least one the thickness in side, centre and the previous section of described implant.

75. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has along the thickness of the aft section of described device, and it is equal to or less than at least one the thickness in side, centre and the previous section of described implant.

76. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has along the thickness of the mid portion of described device, and it is equal to or less than at least one the thickness in previous section, aft section and the lateral parts.

77. according to claim 1,2,3,4,5,6,7,8,9,10,11,12 and 13 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has along the thickness of the mid portion of described device, and it is equal to or greater than at least one the thickness in previous section, aft section and the lateral parts.

78. according to claim 37 and 46 described implants with previous section, aft section, lateral parts and mid portion, at least one assembly of wherein said implant has along the thickness of the aft section of described device, and it is equal to or greater than at least one the thickness in side, centre and the previous section of described implant.

79. according to claim 37 and 46 described implants with previous section, aft section, lateral parts and mid portion, at least one assembly of wherein said implant has along the thickness of the aft section of described device, and it is equal to or less than at least one the thickness in side, centre and the previous section of described implant.

80. according to claim 37 and 46 described implants with previous section, aft section, lateral parts and mid portion, at least one assembly of wherein said implant has along the thickness of the mid portion of described device, and it is equal to or less than at least one the thickness in previous section, aft section and the lateral parts.

81. according to claim 37 and 46 described implants with previous section, aft section, lateral parts and mid portion, at least one assembly of wherein said implant has along the thickness of the mid portion of described device, and it is equal to or greater than at least one the thickness in previous section, aft section and the lateral parts.

82. program that is used to repair the joint, it is included under the arthroscopy implants or with the auxiliary step of implanting the implant with first and second surfaces of arthroscope, wherein said first or second surface at least one have the 3D shape of fully mating with the shape of an articular surface.

83. 2 described programs according to Claim 8, and further be included in the step of analyzing the image in described joint before implanting.

84. 2 described programs according to Claim 8, wherein said image is the 3-D view that is selected from by in MRI, CT, X-ray and its group that forms.

85. 2 described programs according to Claim 8, it further comprises the step of doing 10cm or littler otch.

86. 2 described programs according to Claim 8, it further comprises the step of doing 6cm or littler otch.

87. 2 described programs according to Claim 8, it further comprises the step of doing 4cm or littler otch.

88. a manufacturing is suitable for the method for the implant in a joint, said method comprising the steps of:

Judge the 3D shape of the one or more articular surface in described joint; With

Manufacturing has the implant of a first surface and a second surface, first and second articular surfaces in wherein said first surface and the relative described joint of second surface, and further, wherein said first or second surface at least one a part or the 3D shape of whole and described articular surface fully mate.

89. 8 described methods according to Claim 8, wherein said 3D shape is by the image decision that obtains described joint.

90. 9 described methods according to Claim 8, wherein said image is selected from by MRI, CT, X-ray and its group that forms.

91. kneed implant that is suitable for having upper surface and lower surface, wherein said upper surface is with respect at least a portion of femur and at least a portion on the relative tibia of described lower surface surface, and further, at least one in wherein said upper surface or the lower surface have with described femur and tibia surface in one the shape 3D shape of fully mating.

92. implant that is suitable for having the hip joint of upper surface and lower surface, the at least a portion and the described lower surface of wherein said upper surface engagement acetabular bone mesh capital at least a portion, and further, at least a portion of at least one in wherein said upper surface or the lower surface have with described acetabular bone and described femoral head surface in one the shape 3D shape of fully mating.

93. implant that is suitable for having the hip joint of upper surface and lower surface, wherein said upper surface mesh described shin bone at least a portion and at least a portion of described lower surface engagement acetabular bone, and further, at least a portion of at least one in wherein said upper surface or the lower surface have with described acetabular bone and described femoral head surface in one the shape 3D shape of fully mating.

94. implant that is suitable for having the ankle joint of upper surface and lower surface, at least a portion of at least a portion of wherein said upper surface engagement distal tibial and described lower surface engagement tibial astragaloid joint face, and further, at least a portion of at least one in wherein said upper surface or the lower surface have with described distal tibial and tibial astragaloid joint face surface in one the shape 3D shape of fully mating.

95. implant that is suitable for having the ankle joint of upper surface and lower surface, at least a portion of wherein said upper surface engagement tibial astragaloid joint face and at least a portion of described lower surface engagement distal tibial, and further, at least a portion of at least one in wherein said upper surface or the lower surface have with described distal tibial and tibial astragaloid joint face surface in one the shape 3D shape of fully mating.

96. implant that is suitable for having the toe joint of a proximal end face and a distal surface, at least a portion of at least a portion of wherein said proximal end face engagement head of metatarsal bone and described distal surface engagement proximal phalanx, and further, at least a portion of at least one in wherein said near-end or the distal surface have with described head of metatarsal bone and proximal phalanx surface in one the shape two-dimensional shapes of fully mating.

97. implant that is suitable for having the shoulder joint of a first surface and a second surface, at least a portion of at least a portion of wherein said first surface engagement upper arm head and described second surface engagement shoulder mortar, and further, wherein said first or second surface at least one at least a portion have with described upper arm head and shoulder mortar surface in one the shape two-dimensional shapes of fully mating.

98. implant that is suitable for having the elbow joint of a first surface and a second surface, wherein said first surface meshes at least one at least a portion at least a portion of a distal humerus and described second surface engagement ulna and the radius, and further, wherein said first or second surface at least one at least a portion have with described distal humerus, ulna and radius surface in one the shape 3D shape of fully mating.

99. carpal implant that is suitable for having a first surface and a second surface, at least a portion of at least a portion of wherein said first surface engagement distal radius and described second surface engagement ulna far-end, and further, wherein said first or second surface at least one at least a portion have with described distal radius and ulna distal surface in one the shape 3D shape of fully mating.

100. implant that is suitable for having the articulations digitorum manus of a first surface and a second surface, at least a portion of at least a portion of wherein said first surface engagement head of metacarpal bone and described second surface engagement proximal extremity of phalanx of finger bottom, and further, wherein said first or second surface at least one at least a portion have with described head of metacarpal bone and proximal extremity of phalanx of finger surface in one the shape 3D shape of fully mating.

101. kneed interpolation implant that is suitable for having upper surface and lower surface, wherein said upper surface is with respect at least a portion of femur and at least a portion on the relative tibia surface of described lower surface, and further, at least a portion of at least one in wherein said upper surface or the lower surface have with described femur and tibia surface in one the shape 3D shape of fully mating.

102. one kind is suitable for mammiferous implant with joint of a first surface and a second surface, wherein said first surface is with respect at least a portion of first articular surface and at least a portion on the relative second joint of described second surface surface, and further, wherein said first or second surface at least one at least a portion have with described femur and tibia surface in one the shape 3D shape of fully mating.

103. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said upper surface and described lower surface have the 3D shape of fully mating with at least one shape of the articular surface of the lower surface adjacency of the upper surface abut of described implant and described implant.

104. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has the thickness of patient's cartilage defect.

105. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has 85% of patient's cartilage defect thickness.

106. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has 65% to 100% of patient's cartilage defect thickness.

107. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has the thickness of cartilage defect, adds a predetermined deviant.

108., wherein can select for use described deviant to adjust malalignement according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants.

109. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is by the material structure that comprises metal or metal alloy.

110. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said material comprises one or more bioactive materials.

111. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant covers with bioactive materials.

112. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant comprises metal or metal alloy and polymer.

113., and further have at least one the structure that is used for attached in described upper surface that is selected from the group that forms by ridge, pin, contact pin, cross member, tooth and projection and the described lower surface according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants.

114. according to the described implant of claim 113, it further has a plurality of structures that are used to adhere to.

115. according to the described implant of claim 114, the relative orientation that wherein is used for the structure of adnexa is selected from by symmetrical, asymmetric, capable, round, triangle and the group that forms arbitrarily.

116. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, it further has the peripheral structure that is selected from the group that is made up of ridge and edge.

117. according to the described implant of claim 116, wherein said peripheral structure is extended along the whole girth of described implant.

118. according to the described implant of claim 116, wherein said peripheral structure is extended along its perimeter of described implant.

119. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, each of wherein said upper surface and lower surface has the slope about the longitudinal axis of at least a portion of passing described implant, and further, wherein be selected from the group that forms by positive and negative and zero about the slope of the first surface of described slope at lower surface.

120. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is near one shape in described first and second articular surfaces.

121. according to the described implant of claim 120, wherein said implant is selected from an implant storehouse.

122. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has changed configuration after inserting the joint.

123. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant further comprises one first assembly and one second assembly.

124. according to the described implant of claim 123, wherein said first and second assemblies are in integrally formed, indivisible shaping, interconnection shaping and the shaping that interdepends.

125. according to the described implant of claim 123, wherein said first assembly with regularly, slidably, at least one and the engagement of described joint in rotatably.

126. according to the described implant of claim 123, wherein said second assembly with regularly, slidably, at least one and the engagement of described joint in rotatably.

127. according to claim 123,124,125 and 126 described implants, wherein said first assembly meshes described second assembly.

128. according to claim 123,124,125 and 126 described implants, wherein said first assembled is in described second assembly.

129. according to claim 123,124,125 and 126 described implants, wherein said first assembly meshes described second assembly slidably.

130. according to claim 123,124,125 and 126 described implants, wherein said first assembly meshes described second assembly rotatably.

131. according to claim 123,124,125 and 126 described implants, the part of wherein said implant has a magnet.

132. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has plurality of element.

133. according to the described implant of claim 132, one first assembly of wherein said plurality of element with regularly, slidably, at least one and the engagement of described joint in rotatably.

134. according to the described implant of claim 132, one second assembly of wherein said plurality of element with regularly, slidably, at least one and the engagement of described joint in rotatably.

135. according to claim 132,133 and 134 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element.

136. according to claim 132,133 and 134 described implants, first assembled of wherein said plurality of element is in second assembly of described plurality of element.

137. according to claim 132,133 and 134 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element slidably.

138. according to claim 132,133 and 134 described implants, first assembly of wherein said plurality of element meshes second assembly of described plurality of element rotatably.

139. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has along being selected from by circle, ellipse, avette, kidney shape, square, rectangle, circle substantially, ellipse substantially, avette, substantially kidney shape substantially, square substantially, the shape that girth in the group that substantially rectangle is formed forms.

140. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant has and is selected from by sphere, hemispherical, aspheric surface, convex surface, concave surface, substantially convex surface and lower surface in the group that forms of concave surface substantially and at least one the shape of cross section in the upper surface.

141. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is a cartilage defect shaping implant.

142. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is a cartilage projection implant.

143. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is a subchondral bone shaping implant.

144. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is via 10cm or littler otch and surgical operation is implanted.

145. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is via 6cm or littler otch and surgical operation is implanted.

146. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said implant is via 4cm or littler otch and surgical operation is implanted.

147. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the active scope in wherein said joint is restored to natural joint active 80% to 99.9%.

148. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the active scope in wherein said joint is restored to natural joint active 90% to 99.9%.

149. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the active scope in wherein said joint is restored to natural joint active 95% to 99.9%.

150. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the active scope in wherein said joint is restored between the natural joint active 98% to 99.9%.

151. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, at least a portion of the periphery of described implant has the thickness thicker than the middle body of described implant.

152. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the middle body of described implant has the thickness thicker than at least a portion of periphery.

153. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, the edge of wherein said implant is around one or more position.

154. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said top edge further extends in centre, side, front and/or the back of lower limb.

155. according to claim 91,92,93,94,95,96,97,98,99,100,101 and 102 described implants, wherein said lower limb further on top extend by the centre of edge, side, front and/or back.

156. according to claim 91,123 and 132 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has at least one the thickness in previous section, aft section, lateral parts and the mid portion along described device, and it is equal to or greater than at least one the thickness in the side, centre, front and back part of described implant.

157. according to claim 91,123 and 132 described implants with previous section, aft section, lateral parts and mid portion, wherein said implant has at least one the thickness in previous section, aft section, lateral parts and the mid portion along described device, and it is equal to or less than at least one the thickness in the side, centre, front and back part of described implant.

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