HK1153919B - Apparatus for fracture repair - Google Patents

Description

Device for repairing bone fracture

Technical Field

Aspects of the disclosure relate to providing devices and methods for repairing bone fractures. In particular, the present disclosure relates to devices and methods for repairing bone fractures using devices inserted into the bone.

Background

Currently, there are many known methods for treating long bone fractures. Common fracture management includes: (1) non-surgical fixation; (2) osteosynthesis and tension band techniques; (3) percutaneous fixation (e.g., using pins, wires, screws, etc.); (4) rigid intramedullary nails (e.g., using a large rod and external screws); (5) flexible plate osteosynthesis (e.g., "load sharing" sutures); (6) arthroplasty (e.g., using a prosthesis); (7) fracture trim and other indications specific techniques. Severe fractures meeting certain clinical criteria may require surgical repair rather than non-surgical fixation.

The medial axis of an elongated or long bone is often classified as a diaphysis. The ends of such bones are usually classified as epiphyses. Bones that transition between the medial axis and the end are generally classified as the posterior end of the dry bone.

Metaphysis and epiphyseal bone are generally less dense, more cancellous (porous), and less cortical than diaphyseal bone. Repair of metaphysis and epiphyseal fractures is often complicated by their proximity to the joint. Because of this bone quality and anatomical variation, fixation of plates and screws in the posterior and epiphyseal bones is generally more difficult than fixation of plates and screws in the diaphyseal bones. This is especially true if the patient is elderly and has osteoporosis.

In general, fracture fixation can provide longitudinal (along the long axis of the bone), transverse (along the long axis of the bone), and rotational (about the long axis of the bone) stability. Fracture fixation may also maintain normal biological and healing functions.

There are two main types of surgical fixation: (1) devices within the endothelium (internal fixation); and (2) devices extending from the skin (external fixation). There are two common types of internal fixation methods used in long bone surgery: (a) a plate screwed to the outside of the bone; or (b) a rod lowered into the center of the bone.

The plates and screws are characterized by relatively invasive surgery, bracing of fractured bone segments from one side of the bone exterior and anchoring of the screws into the plate and through the entire bone. Successful repair depends on the fracture shape, bone quality, physician skill and patient tolerance to foreign objects. The plate and screws may not properly address the alignment and stability requirements of peri-articular and intra-articular fractures.

Bone marrow rods or needles, for example, for jackshaft treatment, are more effective than plates and screws in minimizing soft tissue injury and complications. However, rods and needles do not generally stabilize multi-segment fractures in many cases. A typical bone marrow shaft or needle is fixed in diameter and is introduced into the medullary canal through an incision. In the case where there are medullary plenums larger than the rod, rotational and lateral stability may be compromised. If larger rods are used, reaming of the entire shaft length may be required. The reaming can make the existing cortical bone scaffold sparse. Moreover, the predetermined threaded screw holes in the rod may limit the manner in which different fracture shapes may be reduced and stabilized.

Flexible bone marrow rod solutions utilize structures that can be inserted into the medullary cavity through an access site and then become rigid. These solutions are easier for the user to install than rigid bone marrow rods. These structures may be reinforced with polymers or cements. Similar to rigid bone marrow rods, flexible bone marrow solutions have limited benefits for peri-articular or intra-articular fractures. Alignment and stability are required for multi-segmented fractures of the medial or end bones in a manner that can generate proper fixation in multiple directions.

Medial axis fractures and end bone fractures are fundamentally different. The loading conditions, fracture shape, alignment required and compression forces to enhance healing are different. A medial axis fracture has sufficient bone material on either side of the fracture in which an anchor can be driven. End bone fractures, particularly on the articular surface, may have thin cortical, cancellous bone and minimal anchoring locations.

Medial axis fractures tend to be loaded primarily in flexion and torsion. End bone fractures tend to be loaded with complex and multidirectional stress shapes. Medial axis repair methods may therefore not be suitable for repair of end bone fractures.

Proper sizing of the implant aids in realignment and healing of the fracture. Accordingly, a variety of different sizes of known repair products are often stored in inventory to ensure proper matching of the implanted device to the patient's anatomy. Inventory is a burden to hospitals and insurance carriers, but may be required to provide surgeons with flexibility in performing surgical procedures.

It is therefore desirable to provide devices and methods for proper anatomical alignment and stability while reducing trauma and complications.

Drawings

The objects and advantages of the present invention will become apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:

FIG. 1 is a side view of an apparatus arranged in accordance with the principles of the present invention;

FIG. 1A is a perspective view of the device shown in FIG. 1;

FIG. 1B is a partial cross-sectional view of the device shown in FIG. 1A;

FIG. 1C is a front view of the device shown in FIG. 1A in accordance with the principles of the present invention;

FIG. 2 is a front view of an exemplary human bone;

FIG. 3 is a partial cross-sectional view of a fractured bone;

FIG. 4 is a perspective view showing a body part that can be treated using the device shown in FIG. 1;

FIG. 5 is a perspective view showing a portion of the body part shown in FIG. 4;

FIG. 6 is a cross-sectional view of a device according to the principles of the present invention;

FIG. 7 is a cross-sectional view of the device shown in FIG. 6, along with additional devices in accordance with the principles of the present invention;

FIG. 8 is a cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 9 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 10 is a partial cross-sectional view illustrating the use of the device shown in FIG. 1 in conjunction with an additional device in accordance with the principles and methods of the present invention;

FIG. 11 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 12 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 13 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 14 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 15 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 16 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 17 is a partial cross-sectional view of the device shown in FIG. 1, along with additional devices in accordance with the principles of the present invention;

FIG. 18 is a partial cross-sectional view of a device according to the principles of the present invention;

FIG. 19 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 20 is a partial cross-sectional view of a device according to the principles of the present invention;

FIG. 21 is an end view of the device shown in FIG. 20;

FIG. 22 is a partial cross-sectional view of the device shown in FIG. 1;

FIG. 23 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 24 is a partial cross-sectional view of the device shown in FIG. 23;

FIG. 25 is a side view of an apparatus according to the principles of the present invention;

FIG. 26 is a side view of an apparatus according to the principles of the present invention;

fig. 27 is a perspective view of a device according to the principles of the present invention;

fig. 28A is a side view of an apparatus according to the principles of the present invention;

fig. 28B is a side view of an apparatus according to the principles of the present invention;

fig. 28C is a partial cross-sectional view of a device according to the principles of the present invention;

FIG. 29 is a side view of a device within a body part according to the principles of the present invention;

FIG. 30 is a cross-sectional view of a portion of the device shown in FIG. 29;

FIG. 31 is a side view of an apparatus according to the principles of the present invention;

FIG. 32 is a cross-sectional view of the device shown in FIG. 31;

FIG. 33 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 34 is a perspective view of a device according to the principles of the present invention;

FIG. 35 is a perspective view of a device according to the principles of the present invention;

FIG. 36 is a perspective view of a device according to the principles of the present invention;

FIG. 37 is a perspective view of a device according to the principles of the present invention;

FIG. 38 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 39 is a perspective view of a device according to the principles of the present invention;

FIG. 40 is a partial cross-sectional view of the device shown in FIG. 39;

FIG. 41 is a perspective view of a device according to the principles of the present invention;

FIG. 42 is a perspective view of a device according to the principles of the present invention;

FIG. 43 is a perspective view of a device according to the principles of the present invention;

FIG. 44 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 45 is a perspective view of a device according to the principles of the present invention;

FIG. 46 is a side view of a device within a body part according to the principles of the present invention;

FIG. 47 is a side view of a device within a body part according to the principles of the present invention;

FIG. 48 is a perspective view of a device according to the principles of the present invention;

FIG. 49 is a perspective view of a device according to the principles of the present invention;

FIG. 50 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 51 is a perspective view of an apparatus according to the principles of the present invention;

FIG. 52 is a perspective view of a device according to the principles of the present invention;

FIG. 53 is a side view of a device within a body part in accordance with the principles of the present invention;

FIG. 54 is a side view of a device within a body part in accordance with the principles of the present invention;

FIG. 55 is a side view of a device within a body part according to the principles of the present invention;

FIG. 56A is a perspective view of a device according to the principles of the present invention;

FIG. 56B is a side view of the device shown in FIG. 56A;

FIG. 56C is an end view of the device shown in FIG. 56A;

FIG. 57A is a perspective view of a device according to the principles of the present invention;

FIG. 57B is a side view of the device shown in FIG. 57A;

FIG. 57C is an end view of the device shown in FIG. 57A;

FIG. 58 is a side view of a device within a body part according to the principles of the present invention;

FIG. 59 is a side view of a device within a body part according to the principles of the present invention;

FIG. 60 is a side view of a device within a body part according to the principles of the present invention;

FIG. 61 is a side view of a device within a body part according to the principles of the present invention;

FIG. 62 is a perspective view of a device according to the principles of the present invention;

FIG. 63 is a side view of a device within a body part according to the principles of the present invention;

FIG. 64 is a side view of a device within a body part according to the principles of the present invention;

FIG. 65 is a perspective view showing the use of a device according to the principles of the present invention;

FIG. 66 is a perspective view of a device according to the principles of the present invention;

FIG. 67 is a perspective view of an apparatus according to the principles of the present invention; and is

Fig. 68 is a schematic flow chart diagram illustrating a method in accordance with the principles of the present invention.

Detailed description of the invention

Devices and methods for fracture repair are provided. The device may include a structural support for positioning the first bone segment relative to the second bone segment. The structural scaffold may be configured to be deployed within a lumen of a bone. The apparatus may include an anchor substrate. The anchoring substrate may be configured to compress the first bone segment to the second bone segment. The anchoring substrate may be configured to be deployed in the lumen.

The term "bone fragment" refers to a portion or fragment of bone. The term "structural scaffold" may include "structural cages".

The structural scaffold may be self-expanding. The structural scaffold may be inflated by a balloon. The structural support may be expanded by mechanical actuation. The anchoring substrate may be self-expanding. The anchoring substrate may be inflated by a balloon. The anchor stent may be expanded by mechanical actuation.

The structural support may be used as a frame to position and align the bone segments. Anchors may be used to secure the bone segments to the anchoring substrate. The anchoring substrate may be tensioned to compress the bone segments against one another. Some embodiments of the apparatus may include a central shaft member. The central axis member may be used in conjunction with one or both of the structural support and the anchoring substrate. The central axis member may be used in conjunction with tensioning of the anchor substrate after anchor placement. The proximal anchor may be used to secure one end of the device to a bone segment to "lock" the tension of the anchoring substrate.

The device may comprise a delivery device. The delivery device may deliver one or more portions of the device, such as the structural scaffold and the anchoring liner, through an access hole in the bone and into a medullary cavity in the bone. The sections may be transported in a collapsed or folded state. These portions are then expanded for repair of the fracture.

The devices and methods may involve reducing, aligning, compressing, and/or stabilizing a fracture from within a bone marrow cavity. In some cases, the resulting stable bone then heals while maintaining the mobility of the patient.

The devices and methods may provide stability in axial bending, torsion, rotation, compression and may provide inter-segment tension or compression.

Stability can repair compact and embedded fractures, control length, and control alignment of fracture fragments. The device can separate the tasks of correction, reset, fixation, stabilization, rotation and compensation.

The devices and methods may distribute loads between the devices and the natural bone. The device may have a flexibility and modulus similar to natural bone. Some embodiments may provide devices that are optionally weaker or stronger than natural bone to enhance a beneficial fracture healing response.

The devices and methods may be used for freehand reduction, open reduction, and minimally invasive surgical procedures ("MIS"). The devices and methods may facilitate arthroscopic surgical procedures. The devices and methods may provide percutaneous fracture repair. In such a repair, the device may be deployed through a small incision into a cavity of a bone.

The device may be delivered at a point other than the fracture site. This helps to reduce soft tissue damage. The device may be delivered into the medullary cavity through a small access hole that may be placed along the long bone's central axis in an area where minimal soft tissue needs to be moved.

The apparatus and method may reduce the need to place foreign objects in muscle, tendon and neural areas. As such, the devices and methods may reduce tissue erosion and breakdown. Protection of soft tissue can reduce chronic pain and stiffness. The device and method may reduce the risk of infection because of its non-invasiveness.

In some embodiments, the devices and methods may be made entirely of bio-friendly metals such as titanium and nitinol. Such materials reduce the risk of infection and do not generally interfere with normal biological processes within the fractured bone.

The devices and methods may be used to repair a variety of different types of bone. For example, the devices and methods may be used to repair long bones, short bones, flat bones, irregular bones, and unginned bones.

The devices and methods may be used to repair a variety of different types of fractures. For example, the devices and methods may be used to repair comminuted fractures, epiphyseal fractures, metaphyseal fractures, fractures of the medial axis, intra-articular fractures, peri-articular fractures, multi-part fractures, and other types of fractures.

The device may be used for reconstruction of fractured joints. The apparatus and method may also facilitate such joint replacement by providing a suitable anchoring substrate. For example, the devices and methods may provide stable anchoring for the prosthesis and reduce aseptic loosening.

The terms "end bone" and "end bone fracture" are used to refer to fractures that occur in the epiphyseal or metaphyseal region of a long bone. Such fractures include peri-articular and intra-articular fractures.

The device and method may be used to treat osteoporotic bone, involving poor indication of bone quality. In connection with such an indication, the device may compensate for defects in natural bone and may reduce concerns regarding stress shielding. The devices and methods may be used in connection with fusion of bones and joints for various indications including arthritis.

The devices and methods may be used in conjunction with or in place of bone cement. In some embodiments, the device may be used as a bone filler. For example, the device may be used to fill bone voids with cysts and tumor treatments. The device may be used as an osteogenic scaffold to promote bone growth.

The devices and methods are used with temporary alignment for a graduated repair procedure, such as revision, high energy injury, or other situations where there is infection or soft tissue that needs to be healed before bone fixation is complete. The devices and methods may be used in conjunction with various antibiotics to enhance healing.

The structural support prevents the bone segments from moving inwardly so that the device reduces the likelihood of fracture collapse. The device can conform to the shape of the bone and thus minimize undue stress. For example, the devices and methods can reduce hoop stress by selecting the degree of implant expansion or stiffness.

The device may be self-centering as it expands into the bone cavity. Many cavities are not as straight as tubes; they vary depending on the anatomy. The device may be straight, curved, curvilinear and cavity compliant.

The devices and methods may provide anchoring at the distal end of the device. This feature may be used for the repair of joint fractures and fractures with small or active bone fragments.

The device and method may provide for the use of small anchors because the device provides a structural support for the bone segments that need to be anchored.

The device and method may provide anchoring in any suitable direction. Some embodiments may provide anchoring in any plane.

Because the anchoring substrate may expand toward the inner surface of the bone segment, a relatively short anchor may be used as compared to typical repair methods. For the same reason, a longer screw than is required to engage the anchoring substrate does not result in driving the screw into or through the bone opposite the anchor segment. This is because the screw will end up in the marrow cavity.

The devices and methods may be used in conjunction with plates, screws, pins, external fixators, replacement joints, bone graft matrices, factor-based bone substitutes, and cell-based bone substitutes.

Conveying appliance

The delivery instrument may deliver the device through an access hole in the bone to the intramedullary canal. The delivery instrument may be used to remove the device from the intramedullary canal through the access port. The delivery instrument may be engaged with the device by any suitable mechanism, including one or more of threads, sockets, pins, snaps, collets, cables, and any other suitable mechanism.

The mechanism may deliver, expand, adjust, rotate, lock, release, and capture the device. Each action or other suitable action may be performed individually on the structural cage, the anchor substrate, the central axis member, the locking feature, and the associated coupling mechanism. The delivery device may include a handle set capable of delivering the force required by the drive mechanism or mechanisms.

The delivery instrument may include a sheath to assist in delivering the device in the compact state. The shaft of the sheath may be bent to access the intramedullary canal. In some embodiments, the delivery instrument may not have a sheath. In those embodiments, the delivery instrument can push the device into place without protection.

The delivery instrument may be wholly or partially radiopaque.

In some embodiments, the delivery instrument may be attached to a flexible fiberscope or endoscope. In some embodiments, the delivery instrument may be integrated with a flexible fiberscope or endoscope.

Structural support

The structural support may provide one or more of axial, bending, twisting, and positioning of the structural support to the fracture fragment. The structural support can reduce or eliminate adverse effects such as stress risers. The structural support may provide a guide or surface for alignment of the fracture fragment during reduction and healing.

The structural scaffold may be configured in a collapsed state and introduced through a hole in a shaft of a bone. The structural support may have sufficient flexibility in the collapsed state to follow the curvature of the entry path.

The structural scaffold may be positioned within the intramedullary canal near the fracture site. The structural stent may be expanded. When expanded, the structural scaffold may be rigid. The structural scaffold may be sufficiently expanded to fill the available cavity and/or displace a low density material that may border the cavity. The expansion may vary along the surface of the structural scaffold such that the expanded structural scaffold may conform to irregular cavity shapes.

In some embodiments, the expanded state may be maintained while the structural scaffold may or may not be in a stressed state. The radial pressure on the cavity wall can be tailored along the length of the structural brace. The structural support may provide strain relief at a desired location to promote healing.

The expansion of the structural scaffold may be elastic. This may be achieved by using a spring material that returns to its original deployed shape or pressure after being released from the contracted state.

The expansion of the structural scaffold may be plastic. The structural scaffold can be deformed into a desired expanded configuration. The deformation may be effected by a mechanism such as a rod or reciprocating manipulator that changes the length of the structural support. The rod or manipulator may shorten the distance between the two parts of the structural member. Shortening the distance may result in radial expansion of a portion of the structural scaffold.

The force for shortening the distance may be provided by a central shaft member that transects the structural support. The resulting shape may come from a combination of the expansion and the resistance of the cavity wall.

The deformation may be achieved by direct force, such as a balloon.

The structural support may be torsionally expanded. Torsional expansion can be elastic or plastic in nature. For example, the distal end of the structural support may be rotated relative to the proximal end. The structural scaffold can then be expanded to fill the cavity.

A variety of different materials may be used to achieve the desired expansion and strength characteristics described.

The structural support may comprise a support member forming a cage or part of a cage. The support member may have one or more of a variety of different configurations. The structural support may have any suitable number of support members. For example, the number of support members may be 1, 2, 3, 4, 5, 6, 7, 8, 10, 25, 50, 100, or more.

The support member may have any suitable cross-sectional shape. For example, the support member may have one or more of the following cross-sectional shapes: circular, flat, rectangular, "I" beam, tubular, multi-cored, twisted, and many other shapes.

The structural support may have any suitable shape. For example, the structural scaffold may be circular, cylindrical, flat, rectangular, helical, wisk or whisk-like, egg-shaped or ovoid, branched or free-ended.

The structural support may be constructed of a unitary or multi-component assembly. The structural support may be: machining from tubes, laser cutting, etching from sheets, assembling and joining strips, forming, depositing and/or sintering.

The proximal end of the structural support may be attached and locked to the anchor substrate. The proximal end may also interface with a delivery instrument. The proximal end may have suitable features for delivery, actuation, locking and release. Such features may include, for example, one or more of threads, sockets, pins, snaps, collets, cable mechanisms, and other suitable mechanisms.

Anchoring substrate

The device may include one or more anchoring substrates. The anchor substrate may receive one or more anchors and hold them in a desired position with or without joint assistance of a structural brace and with or without cancellous bone. The anchoring substrate may be sized and shaped so that it may be engaged by an anchor that penetrates into the bone marrow space.

The anchoring substrate may be sized and shaped so that it may engage the anchor once the anchoring element has penetrated into the medullary space. The anchor substrate may provide an anchor tension that complements the tension caused by the engagement of the anchor and the anchor substrate.

There are several ways in which the anchor and anchor substrate can be joined.

Some of these methods are passive joining methods. In passive bonding, the anchor substrate features may be appropriately sized to engage the anchors. For example, the anchor and anchor substrate may be configured such that they engage in a manner similar to a screw and hole. The laser cut structure may take any desired shape as needed to achieve proper anchor engagement and retention. The receiving cavities ("cells") may be circular, square, slotted, triangular, or any shape that facilitates engagement. The geometry of the cell may be that of a shortened design. The cells may form a matrix, "fabric" or "piece goods". The anchoring substrate may comprise a single layer or multiple layers.

The matrix properties may be varied along an axis of the anchoring substrate to provide anchoring features along the axis. For example, the cell geometry may be varied to provide engagement with different types of anchors. The anchor substrate thickness may be varied to provide different degrees of anchor holding strength and force.

There are several ways to activate the engagement. One such method is cell size reduction. The anchoring substrate can be deformed so that the size of the cell is reduced. The reduction in cell size can result in the tightening (or locking) of the cell to the anchor.

Another such method involves relative displacement between the first and second anchor substrates. The relative displacement effectively reduces the cell size when the respective cells are offset from each other. The relative displacement may be axial, rotational, radial, etc. The relative displacement may capture the anchor between the two displaced anchor substrates and may effectively lock or retain the anchor. Selected shaped elements, whether similar or different, of the first and second anchor substrates may be moved in a coordinated manner to capture or engage the anchors.

Another such method involves torsionally anchoring the substrate. This action is analogous to stretching and locking the anchor in the medium of the substrate. Other methods include winding, folding and bunching the anchoring substrate. The folded or bunched configuration may effectively line-tie the anchor by allowing several layers of material to simultaneously bind to the anchor exerting force.

The configuration of the different portions of the anchoring substrate may be selected to facilitate engagement with the anchors. The portion of the anchoring substrate may extend radially away from a center or longitudinal axis of the device or anchoring substrate. The portion of the anchor substrate may be supported in a perpendicular orientation relative to the axis.

After the anchoring substrate is joined with the anchors, the anchoring substrate may apply tension to the anchors. The tension may urge the anchor to move relative to the structural element. This may be achieved by moving the anchoring substrate in an axial direction relative to the structural member. If the anchoring substrate is moved proximally relative to the structural support, tension will be applied to the anchors and their respective fracture fragments.

The tension may be achieved by reducing the diameter of the anchoring substrate. This can be achieved by lengthening and thus reducing the diameter of the anchoring substrate. The tension may be applied by winding, folding, twisting, rotating, or pulling radially in the anchoring substrate. The above mentioned folding or bunching configuration may be used for this method.

In some embodiments, the anchoring substrate may be internal to the structural support. In some embodiments, the anchoring substrate may be external to the structural support. Some embodiments may include one or more anchoring substrates internal to the structural support and one or more anchoring substrates external to the structural support. In some embodiments, the anchoring substrate may be attached to the structural support.

In some embodiments, the anchor substrate may mechanically mate with the structural support. The anchor substrate may provide structural integrity to the device. For example, the matrix may include interlockable features. The interlocking features may become interlocked during or after expansion of the anchoring substrate.

In some embodiments, the anchor substrate may be mechanically independent of the structural support. This may allow relative movement between the anchoring substrate and the structural support.

The anchoring substrate may be expandable. The anchoring substrate may be expanded simultaneously with the structural support. The anchoring substrate may be expanded by the structural support. The anchoring substrate may be inflated by a delivery device, such as a balloon. The substrate may be self-expanding. Embodiments that are self-expanding may include a spring-like element. Embodiments of self-expansion may include elements that include shape storage materials, such as shape memory alloys. In some embodiments, the anchoring substrate may be non-expanded. In some embodiments, the anchoring substrate may be expanded by mechanical actuation.

The anchoring substrate may be constructed in a variety of different forms and from a variety of different materials. Forming may include, for example, braiding, netting, braiding, cabling, laser cutting members, depositing members, or other filamentary structures. The anchoring substrate cells may be circular elements, square elements, rectangular elements, or combinations of shaped or cell types. The anchor substrate unit may be configured to simulate bone and act as a growth or grafting scaffold.

The anchoring substrate may be formed from a unitary element such as an extruded tube or flat plate having a pattern cut into it that will facilitate bonding. Examples include laser cutting of the tube, stamping or etching of thin layers, and other suitable methods.

The anchoring substrate may be made of a number of materials including, but not limited to: nitinol, titanium, steel alloys, polymers, porous materials, sponge-like materials, sintered metals, etched materials, deposited materials, extruded materials, and cast materials.

Anchor

The anchors may facilitate connection of the bone fragments to the anchoring substrate. The anchor may mate, couple, engage, lock or interact with the anchoring substrate. Some anchors may be configured to engage bone. Some anchors may be configured to not engage bone.

The anchor may have an elongate element. The elongated member may include a catch feature configured to engage the anchoring substrate. The bonding may occur substantially immediately after the anchor substrate is penetrated by the anchor. The bonding may occur only after a predetermined length of the elongate member enters the anchor substrate. Some anchors may be locked to the anchoring substrate. Some anchors cannot be locked to the anchoring substrate.

The gripper feature may be self-powered. The catch feature may be user actuated.

The anchor may have any suitable length. Anchors of different lengths may be used in conjunction with the device. The anchor may be configured to enter and engage the anchor substrate with a tail portion of the anchor. Those anchors may end up inside the anchor substrate after they are locked. Some anchors may be configured to pass through the anchoring substrate and engage bone on opposite sides of the anchoring substrate. Some anchors may be configured not to engage bone on either side of the anchor substrate. Examples of anchors include: screws, helical elements, t-steel, barbed features, anchors with fin features cut from the tube.

In some embodiments, the anchor may be used in conjunction with buttress elements such as plates, washers, spacers, and the like.

The proximal anchor may be inserted to anchor the proximal portion of the anchoring substrate to the bone. In some embodiments, the proximal anchor may be engaged to maintain tension in the anchoring substrate. In some embodiments, the proximal anchor may be configured to adjust the tension.

Central shaft component

In embodiments that include a central shaft member, the central shaft member may be used to position the device, drive one or more changes in the device (e.g., an expanded state or a stressed state), move a portion of the device relative to other portions of the device, and provide mechanical support (e.g., stiffness) to the device.

In some embodiments, the device may have a distal end and a proximal end. The scaffold structure may have a distal end and a proximal end. The anchoring substrate may have a distal end and a proximal end. The central shaft member may have a distal end and a proximal end. In some embodiments, the central shaft member may extend proximally beyond the proximal ends of the structural scaffold and the anchoring member. In those embodiments, the intermediate portion of the central axis member is generally aligned with the proximal ends of the structural support and the anchoring substrate.

The central axis member may be used to maintain the stiffness of the structural support and/or the anchoring substrate. In those embodiments, the distal end of the central shaft member may be longitudinally fixed to the distal end of the structural support and/or anchoring substrate. The proximal end or the intermediate portion of the central shaft member may be longitudinally fixed to the proximal end of the structural support and/or the anchoring substrate.

The central axis member may be used to adjust the length of the structural support and/or the anchoring substrate. In those embodiments, the distal end of the central shaft member may be fixed to the structural support and/or the distal end of the anchoring substrate. The proximal end of the structural support and/or anchoring substrate may be longitudinally movable (whether linearly, rotationally or otherwise) relative to the central shaft member. Likewise, the central axis member may be used to expand the structural support or anchor the substrate. The central shaft member may be used to lock the device in the expanded configuration. The central member may be locked in place by other elements of the device.

In some embodiments, the central axis member may be used to place a lower or upper limit on the longitudinal separation between the distal and proximal ends of the scaffold structure and/or the anchoring substrate. This may be achieved by providing stops at selected locations along the central shaft member.

In some embodiments, the central axis member may be used to move the structural support linearly relative to the anchoring substrate or to move the anchoring substrate linearly relative to the support structure. The central axis member may be used to linearly move one anchoring substrate relative to another anchoring substrate. In such an embodiment, the central axis member may be longitudinally fixed to the one of the structural support and the anchoring substrate that is to be moved relative to the other.

The central axis member may be used to mechanically load the structural support and/or anchor the substrate. The load may be tensile, compressive or rotational. The load may be applied by appropriately engaging the central axis member with a portion of the structural support and/or the anchoring substrate. The central shaft member may then be loaded, for example at its proximal end. The central shaft member may then transmit the load through engagement with the structural support and/or the anchoring structure.

Where the central shaft member is longitudinally fixed to the structural support and/or the anchoring substrate, it may remain free to rotate. Where the central shaft member is not longitudinally fixed, the apparatus may include suitable bushings, bearings, friction surfaces or the like to allow suitable linear displacement and/or rotation between the central shaft member and the structural support and/or anchoring substrate.

For example, the central shaft member may be longitudinally fixed to the distal end of the structural support and rotatably fixed to the proximal end of the anchoring substrate. The distal end of the anchoring substrate may or may not be rotatably fixed to the distal end of the support structure. The central axis may therefore be used in different configurations to deform (e.g., wind, fold, twist, etc.) the anchoring substrate. Similar configurations may be used to deform the structural brace.

In some embodiments, the central shaft member may include or serve as an anchoring substrate. The central shaft member may be movable such that it may be removed from the device after its desired effect is achieved.

The central member may be flexible or rigid. The central member may be integral with one or both of the structural support and the anchoring substrate. The central shaft member may comprise one or more of a cable, coil, thread, braid, extrusion, bead, rod, bundle, strand, mesh, nesting element, and the like.

Device removal

The device may be removed from the bone. The method for removing may include folding the device.

In some cases, tissue may grow into the interstices of the device. Energy (e.g., vibration, ultrasonic energy, heat, etc.) may be coupled into the device to release tissue. When thermal energy is used, the heat may be generated by any form of energy such as radio frequency, microwave, induction, electrical resistance, and others.

The apparatus and method may include a removal instrument such as a core drill, or the like. The device may be fitted inside one or more of such appliances.

Bone ingrowth

One or more surfaces of the device may be coated with an agent that promotes bone ingrowth. The formulation may include calcium phosphate, heat treated hydroxyapatite, basic fibroblast growth factor (bFGF) -coated hydroxyapatite, hydroxyapatite/tricalcium phosphate (HA/TCP), and other suitable formulations, including one or more of those listed in table 1.

One or more surfaces of the device may be coated with an agent that inhibits or inhibits bone ingrowth. Such surfaces may include impermeable and other materials, such as one or more of those listed in table 1.

Drug delivery

One or more surfaces of the device may be coated with a formulation that can elute a therapeutic substance, such as a drug.

Complications of the disease

The devices and methods may include means to address complications associated with bone implants. One such complication is infection. The devices and methods may include features to counteract infection. Such features may include, for example, coatings. The coating may include an antibiotic such as tobramycin or other effective antibacterial agent. Another such feature may be the delivery of heat to raise the temperature of the device high enough to kill bacteria and other unwanted tissue on or near the implant.

Mounting of

The following is an exemplary method of mounting the device on a bone having a fracture. This procedure can be performed in an in-patient or out-patient setting.

1. Temporary reduction of bone fractures using standard techniques

2. Accessing the bone marrow cavity in a position that causes minimal tissue damage to the patient and has sufficient access to the surgeon; into the proximal or distal end.

3. The delivery catheter is introduced into the bone adjacent the fracture region. The position can be confirmed using fluoroscopy.

4. The structural stent is deployed. Positioning assistance may be used, and the positioning assistance may be a central shaft member. External manipulation may be applied.

5. Repositioning the fractured bone into its ideal healing position. The positioning aid can then be locked into the wall of the marrow cavity by deploying the anchoring mechanism.

6. An anchor tensioning element (e.g., an anchor substrate) is deployed into the space inside the structural scaffold and near the fracture site.

7. The anchors are deployed in the fracture fragment, either outward or inward, depending on accessibility. The anchor is driven through the debris and the anchor substrate.

8. The position of the fragments is confirmed by X-ray, fluoro or direct visualization. Tension is applied as needed to place the fracture in the desired location and appropriate pressure is on the fragment surface to stabilize the fracture for healing.

9. Locking the device in place.

10. The delivery instrument is detached from the device. The delivery instrument is removed from the patient and the patient is sutured.

Many other steps may be involved and many different orders of steps may be performed without departing from the principles of the invention.

Material

The device and portions thereof may comprise any suitable material. Table 1 lists exemplary materials that may be included in the device and portions thereof.

TABLE 1 materials

The apparatus may be provided as a kit that may include one or more of a structural stent, an anchoring substrate, a central shaft member, an anchor, a delivery instrument, and associated items.

The apparatus and method according to the present invention will now be described with reference to the accompanying drawings. The drawings show illustrative features of apparatus and methods in accordance with the principles of the invention. The features are shown in the context of the selected embodiment. It is to be understood that features shown in connection with one embodiment may be implemented in accordance with the principles of the invention in conjunction with features shown in another embodiment.

The devices and methods described herein are illustrative. The apparatus and methods of the present disclosure may involve some or all of the features of the illustrative apparatus and/or some or all of the steps of the illustrative method. The steps of the methods may be performed in an order different than that shown and described herein. Some embodiments may omit steps shown and described in connection with the illustrative methods. Some embodiments may include steps not shown or described in connection with the illustrative methods.

Illustrative embodiments will now be described with reference to the accompanying drawings, which form a part hereof.

The apparatus and methods of the present invention will be described in connection with embodiments and illustrative bone repair devices and associated hardware and instrumentation. The apparatus and associated hardware and appliances will now be described with reference to the accompanying drawings. It is to be understood that other embodiments may be utilized and structural, functional, and procedural modifications may be made without departing from the scope and spirit of the present invention.

Fig. 1 shows an illustrative device 100 implanted in a bone B shown at a radius. Bone B includes a bone portion P in a distal end D_B、P_hAnd P_a. Bone fragment P_BIs the largest part of bone B. Bone fragment P_hIs the head. Bone fragment P_hAnd P_aIncluding the articular surface AS. Bone part P_B、P_hAnd P_aAlong fracture F_aAnd F_hSeparated or partially separated. Fracture F_aTransecting the articular surface AS. Fracture F_hTransecting the head H.

It should be understood that bone portion P_B、P_hAnd P_aA schematic fracture in bone B is defined. Device 100 may be used to treat fractures having a greater or lesser number of bone portions. The bony portions can have different shapes, orientations, and sizes than shown in fig. 1. It should also be apparent that although the fracture shown in fig. 1 is shown as a fracture near the end of a long bone, device 100 may be used to treat fractures in other portions of the long bone, such as the medial axis, as well as bones identified as different from the long bone, such as the vertebrae.

The apparatus 100 is along its longitudinal axis L_D(wherein D indicates the device) is elongated. The device 100 IS in the intramedullary space IS of the bone B. The distal end 102 of the device 100 is in the epiphyseal region E of the bone B. The proximal end 104 is in or near the diaphyseal region D of bone B. The portion of the device 100 between the distal end 102 and the proximal end 104 is in the metaphyseal region M of the bone B.

The device 100 may include a structural cage 105. The structural cage 105 may include support members 106. The support member 106 may extend from the cage base 108 to the distal hub 110. (the direction extending from the cage base 108 will be referred to as the "distal direction". An opposite direction will be referred to as the "proximal direction". The "distal" relative to "proximal" generally refers to the leading end of a device inserted or to be inserted in the body.) the distance between the cage base 108 and the distal hub 110 along the axis LD can be adjusted to change the shape of the support member 106.

The structural cage 105 is in a compressed state when the cage base 108 is maximally spaced away from the distal hub 110. When the cageWhen base 108 and distal hub 110 are pushed or pulled together, structural member 106 will be in radial direction R_D(where "D" indicates the device) is deflected radially outward. In this manner, the structural cage 105 may be expanded. The device 100 is shown in an expanded state. In some embodiments, the structural member 106 and the anchor substrate 124 may be radially self-expanding. This may longitudinally draw the base 108 and distal hub 110 together.

The structural cage 105 may be used for the bone-facing portion P_B、P_aAnd P_hA scaffold is provided. Scaffolding can include aligning and stabilizing bone segments P during reduction and/or healing_B、P_aAnd P_h. The scaffold may be a subchondral scaffold. The structural cage 105 may be used to provide load resistance to the bone B during healing.

The device 100 may include an anchor substrate 112. Substrate 112 may be joined by anchors, such as 114 and 116. The anchor 114 anchors the bone fragment P_hIs secured to the substrate 112. The anchor 116 anchors the bone fragment P_aIs secured to the substrate 112. The anchors can engage the substrate 112 in a wide range of positions. The anchors can engage the substrate 112 from a wide range of angles. Each anchor may apply a force to its respective bone portion. The force may be directed to properly position the bone portions for healing. The force may be at least partially directed towards the axis L_DAnd (4) indicating. This force may be considered an inward force (at least partially in the direction-R)_D). The structural cage 105 may apply an at least partial distancing from the axis L to the bony portion_DThe indicated force. This force from the structural cage 105 may be considered an outward force (at least partially in the direction R)_D)。

Although anchors 114 and 116 are shown as threaded screws, any suitable anchor may be used.

The anchor, anchoring substrate and scaffold cage may thus be used in cooperation with one another for selecting one or more desired positions, orientations and forces for each bone portion. One or both of the location and orientation may be selected by appropriate selection of anchor size, anchor location, anchor tension, structural cage size, and support member configuration and location. Because the position and orientation are selectable, the bony portions can be properly aligned with respect to each other.

The device 100 may include a lever 128. The rod 128 may extend in a proximal direction from the cage base 108. The stem 128 may include the stem anchor substrate 118 and the proximal mount 120. The stem anchor substrate 118 may support a proximal mount 120. Anchor 122 may secure rod 128 to portion P of bone B_B. The anchor 122 may be engaged such that it applies a longitudinal and/or rotational force to the device 100. The anchor 122 may be engaged such that it applies a radial force to the device 100. The radial force may cause or counteract the device 100 along the axis L_DBending of (2). The anchor 122 may apply a longitudinal force to the device 100. The resistance to longitudinal forces may resist the resistance applied to the device 100 by the distal anchors 114 and 116.

Proximal mount 120 may support device retention feature 122. Device retention member 126 may be used to engage device 100 for insertion and manipulation. A device manipulator (not shown) may be associated with device holding member 126 for pulling device 100 in a proximal direction.

The apparatus may include an illustrative center member hub 130. The central member hub 130 may be used to capture and remove the device 100 after deployment.

Pulling the device 100 can adjust the bone portion P in the proximal direction_a、P_hAnd P_BForce (tension, pressure, or both). Pulling the device 100 in the proximal direction may adjust the bone portion P_aRelative to P_BThe orientation and position of. In some embodiments, the anchor 122 can be used to maintain the compressive force after pulling the device 100 in the proximal direction.

The apparatus 100 may include a central shaft member 124. The central shaft member 124 may extend from the distal hub 110, through the cage base 108, and through the proximal base 120 into the intramedullary space IS of the bone B. The central shaft member 124 may be used to effect expansion of the structural cage 105. Some embodiments may not include a central shaft member 124. (in some embodiments, the anchoring substrate 112 may be pulled proximally relative to the structural cage 105 to adjust the tension while maintaining the position and scaffolding of the bone segments.)

In some embodiments, the central shaft member 124 may be used to expand the structural cage 105 by applying tension between the hub 100 and the cage base 108 and/or 120. In some embodiments, this may be accomplished by simultaneously applying a proximally directed force to the central shaft member 124 and a distally directed force to the cage base 108. In some embodiments, the central shaft member may be rotatably connected to the hub 110 and threaded through the cage base 108. In these embodiments, the structural cage 105 may be expanded by rotating the central shaft member 124. In some embodiments, the structural cage 105 may be self-expanding.

The final expanded shape may be designed into the structure of the structural cage 105. The final expanded shape may be limited by the space available in the cavity. The expansion may be elastic and may be based on the spring material returning to a predetermined shape.

The device 100 in its compressed state can be delivered into the body through a small entry incision along the medial shaft portion bone (D in fig. 1) in the region where soft tissue disruption can be minimized.

Fig. 1A shows the apparatus 100 in an isometric view. The structural cage 105 includes support members 106. Support member 106 may be based on cage base 108 and hub 110 along an apparatus axis L_DAlong direction R_DExpand or contract. The support cage 105 IS collapsible for introduction into the intramedullary space IS.

The support cage 105 is shown with six support members 106. It should be understood that any suitable number of support members may be used. For example, the support cage 105 may have a plurality of support members 106 in the range of 2-40 or greater than 40.

The support member 106 is shown as having a rectangular cross-sectional shape. It should be appreciated that the support member 106 may have any suitable cross-sectional shape. For example, the cross-sectional shape may be circular, square, braided, multi-cored, or contoured. The support cage 105 may include support members having different cross-sectional shapes, sizes, or material properties. When supportingThe support cage 105 may undergo non-radial deformation when the members have different shapes, sizes, or material properties. Such deformation may help conform device 100 to bone B (including bone fragment P)_a、P_hAnd P_B) Of the inner part of (a).

The support member 106 is shown connected at a cage base 108 and a hub 110. The ends of the members are shown connected at both ends. In some embodiments, the support member 106 may have one or more free or partially free ends.

The support member 106 may be cut out of a single tube or separately manufactured and then connected.

An anchor substrate 112 is present within the structural cage 105. The anchoring substrate 112 may have a folded state and an expanded state. The folded state may be used for transport. The expanded state may be used for deployment and fracture repair.

In some embodiments, the anchoring substrate 112 may include a laser cut structure. The anchor substrate 112 may be configured to engage anchors, such as 114 (shown in fig. 1) and hold the anchors under mechanical load. In some embodiments, the anchoring substrate 112 may be attached to the support cage 105. The anchoring substrate 112 may be attached to one or more of the hub 110, one or more portions of the support member 106, the central shaft member 124, the cage base 108, and the proximal base 120.

In some embodiments, the anchor substrate 112 may not be attached to the apparatus 100 (although it may be held by the support cage 105). This lack of connection can facilitate tension adjustment and loading of the bone fragments.

FIG. 1B is a cross-sectional view taken along line 1B-1B (shown in FIG. 1A). Fig. 1B shows central shaft member 124 extending from hub 110 (not shown) through anchor substrate mount 132 (located concentrically within cage mount 108), rod 128, proximal mount 120, and device retaining member 126.

A central member hub 130 projects proximally from the device retaining member 126. The center member hub 130 can be configured to be engaged to adjust or control the tension or rotation of the center member 124. Manipulation of the central member hub 130 can facilitate transport and expansion of the structural cage 105 and/or the anchor substrate 112. The central member hub 130 may maintain tension between the distal and proximal ends of the structural cage 105 or the anchoring substrate 112.

The device retaining member 126 may be used in connection with the delivery, manipulation, and/or removal of the device 100.

May be moved by movement in direction D relative to the rod 128_PPulling the center member hub 130 to the proximal direction D_PPulling the stop 134 on the central shaft member 124. In some embodiments, this is through the distal ground (-D)_P) Pushing on the device holding member 126 while pulling the center member hub 130 proximally. Pushing and pulling may be accomplished using the apparatus and methods shown and described herein or known grasping device implements.

The stop 134 will be in the direction D_PPushing the anchor substrate mount 108. The anchoring substrate pedestal 108 will then follow the direction D_PPulling the anchor substrate 112. Anchoring substrate 112 in direction D_PWill apply a force to anchors 114 and 116. The force may have a distal component and a radially inward (-R)_D) And (4) components. The force can thus move the bone segment P_aAnd P_hCompressed to bone fragment P_BUpper (as shown in the figure).

The stop 134 may transmit a longitudinal force from the device retaining member 126 to the anchor substrate 112 in a proximal direction through a coupling mechanism between the device retaining member 126, the proximal mount 120, and the central member hub 130. Or the central shaft member 124 may be mechanically coupled to the cage base 108 by a ratchet, screw, or other suitable mechanism.

FIG. 1C shows a view taken along line 1C-1C (shown in FIG. 1A). Fig. 1C shows the expanded support cage 105 (including the hub 110) and the expanded anchoring substrate 112. A lock anchor 122 is also shown.

One or more surfaces or elements of the apparatus 100 may include a coating. The coating may include an agent. The agent may provide a bone growth promoting agent, a bone growth inhibiting or inhibiting agent, a pharmaceutical eluting agent, or any other suitable agent.

Fig. 2 shows a schematic bone S. The skeleton S includes a schematic bone S_iWherein the device 100 (shown in fig. 1) may be used as shown and described in connection with bone B (shown in fig. 1). Table 2 includes bone S_iPart list of (a).

TABLE 2 bone S_i

Reference numerals in bone fig. 2

Distal radius S₀

Humerus S₁

Proximal radius ulna (elbow) S₂

Metacarpal bone S₃

Clavicle S₄

Rib S₅

Vertebra S₆

Ulna S₇

Hip S₈

Femur S₉

Tibia S₁₀

Fibula S₁₁

Metatarsal bone S₁₂

Fig. 3 schematically shows the anatomy of bone B (shown in fig. 1). The anatomical features of bone B are listed in table 3. An apparatus and method in accordance with the principles of the present invention may involve one of the displays shown in Table 3Or a plurality of anatomical features. Can be referenced to the bone axis L_B(wherein B denotes bone) and a radius R_B(where B indicates bone) features of bone B.

Table 3. some anatomical features of bone type that can be treated using the device and method.

Anatomical features reference numerals are used in figure 3

Articular surface B₀

Cancellous, spongy or trabecular bone B₁

Marrow cavity B₂

Cortical or compact bone B₃

Periosteum B₄

Proximal articular surface B₅

Backbone or medial axis B₆

The posterior or end region B of the dry bone₇

Epiphysis B₈

Articular surface B₉

The terms "end bone" and "end bone fracture" are used to refer to fractures that occur in the epiphyseal or metaphyseal region of a long bone. Such fractures include peri-articular and intra-articular fractures.

Fig. 4 shows a portion 400 of an illustrative surgical environment in which a fracture in bone B may be diagnosed and treated. Patient P may be suitably sedated. A limb nerve block may be performed. The pressure band may be used to maintain the limb Q in a relatively bloodless state. The limb Q may be supported by the procedure table 402 and any other suitable support to manage the position of the bone B during surgery. The environment 400 may include an imaging system 404.

Fig. 5 shows an exemplary treatment scenario 500. In scenario 500, a manual distraction technique is applied to reconstruct a fracture F in bone B_pAnatomical reduction of (a).

Temporary or provisional reduction is often undertaken in fracture repair to restore the bone fragments to their normal position prior to anchoring.

Freehand reduction techniques may be applied when the number of bone fragments is small and/or dislocation of bone fragments is moderate. The freehand reduction does not involve an incision and is performed by one or more physicians using manual distraction. The surgeon will use different tensioning, compression and bending motions to re-establish normal bone fragment positioning. The physician or assistant can maintain a normal bone fragment position during implantation.

For more displaced fracture shapes, limited open reduction may be utilized. The k-wire outer probe and special fixture can be applied for temporary reduction. A small incision can be made to allow the probe and clamp to assist in repositioning the fractured fragments. Once the bone fragments are in place, the k-line can be used to maintain the reduction. The k-wire is a metal wire of about 1-2mm in diameter that can be driven along the fracture line to provide a temporary scaffold. The k-wires can be positioned and then strategically removed to facilitate this process in a manner that reduces interference with bone cavity preparation or implant deployment.

Fig. 6 shows an exemplary sheath 600. The hollow sheath 600 IS shown entering the intramedullary space IS of the bone B. Sheath 600 may include a lumen 610. Lumen 610 may provide access to intramedullary space IS. Sheath 600 enters intramedullary space IS at location 602. Location 602 may be in the diaphyseal portion D of bone B. Location 602 may be selected to minimize soft tissue damage. Near location 602, a small incision may be made in soft tissue (not shown). The tissue may be moved to expose the bone surface BS.

Standard orthopaedic drilling apparatusFor creating an access hole 604 in bone B. May be along the axis L_hAn axial bore 604 is drilled. Axis L_hCan be aligned with the bone axis L_BForming an angle a. Angle a may be an acute angle.

The hole 604 may be similar to a commonly drilled bone entry hole. The holes 604 may be small enough that the holes 604 do not cause stress risers at the locations 602. The distal end 606 of the sheath 600 may extend through the intramedullary canal IC into the metaphyseal region M of the bone B. The proximal end 608 of the sheath 600 may be disposed in the bore 604. Distal end 606 can be placed in any portion of intramedullary space IS, such as the distal bone.

Sheath 600 may be a thin-walled flexible sleeve. The sheath 600 may be similar to a cannula typically used in minimally invasive or percutaneous interventional procedures elsewhere in the body. Sheath 600 may be made of a rigid metal shaped to facilitate access to intramedullary space IS.

Fig. 7 shows an illustrative intramedullary spatial reamer 700. The reamer 700 may expand and contract. The reamer 700 may be inserted into the proximal end 608 of the sheath 600 (shown in fig. 6) in a collapsed state. A reamer shaft 702 can be used to advance the reamer 700 through the lumen 610 into the metaphyseal region M of the bone B. Reamer 700 may have suitable features at or near surface 704 for removing undesirable tissue, such as cancellous bone, from the end bone. The reamer shaft 702 can suitably rotate the reamer surface 704 about the bone axis L and translate it along the bone axis L to prepare the end bone for further processing.

In some embodiments, the use of the reamer 700 may be consistent with the procedure used in the implantation of an intramedullary nail. Such procedures may employ the application of one or more of ultrasonic energy, vibration, radiofrequency energy, pressure, rotation, water jet, suction, and other suitable mechanisms to remove unwanted tissue. In some embodiments, the reamer 700 may have one or more of the following features: expanded, fixed size (non-expanded), uni-directional reaming, multi-directional reaming, rigid reamer shaft 702, flexible reamer shaft 702, and maneuverability.

Fig. 8 shows the stage of delivery of the device 100 into the terminal bone of bone B. In fig. 8, device delivery apparatus 800 is engaged with device holding element 126 at the proximal end of device 100. The shaft 802 may control the positioning and rotation of the device transporter 800. The delivery device 800 may include a key grasper for engaging and disengaging portions of the apparatus 100 (shown in fig. 1). The device 100 is in a compressed state. Device 100 is positioned within lumen 610 of sheath 600. The distal hub 110 of the device 100 is in the epiphyseal region E of the bone B. Support member 106 and rod 128 are also shown within lumen 610.

Fig. 9 shows a subsequent step in the delivery of the device 100 into the end bone of bone B. In fig. 9, the device delivery apparatus 800 has moved the device 100 distally out of the sheath 600. The structural cage 105 has been expanded in the terminal bone. In the example shown, the end bones span from the bone fragments to the central axis D of the intramedullary space IS of the bone B.

Fig. 9 also shows a proximal delivery device controller 900. The controller 900 may include a handle 902, a trigger mechanism 904, and a set screw 906. The handle 902 may be used to apply the force required to position and expand the device 100 via the shaft 802. The trigger mechanism 904 may be used to engage or disengage the device retaining member 126.

FIG. 10 shows a bone fragment P_aFastening to the anchor substrate 112. A small incision can be made in the skin K in the optimal position. Then, can be in the bone segment P_aA small positioning hole is formed in the middle. Temporary reduction may be maintained by the hand 1002 of the assistant, a clamp/clamp-type instrument, a k-wire, or other known methods. A bracket 1004 may be provided to position the bone fragment P_a、P_hAnd P_BFor insertion of anchor 116. The instrument 1000 can then be used to drive the anchor 116 through the bone segment P_a. Tool 1000 may be a screwdriver or other suitable tool.

FIG. 11 shows the anchor 114 anchoring a bone fragment P_hSecured to the anchor substrate 112. The device 100 may be stabilized in the bone B using the device delivery apparatus 800.

Fig. 12 shows the device 100 being tightened in the intramedullary space IS of the bone B. Anchors 114 and 116 have been driven fully or nearly fully, respectively, into the bone fragmentsSegment P_hAnd P_aIn (1). Anchors 114 and 116 are secured within bone B by anchor substrate 112. The inward force exerted by the anchors 114 and 116 mated with the anchor substrate 112 and the outward force exerted by the support members 106 of the structural cage 105 cause the bone fragments P to form_hAnd P_aAlong fracture F_aAligned and with closed fracture F_a. The torque, angle and positioning of (to) anchors 114 and 116 may be selected to be at bone segment P_hAnd P_aInterventricular edge fracture F_aProviding the desired contact force. The anchor may be locked to the anchor substrate 112 to prevent inadvertent removal.

Fracture F_hMaintaining an open spacing Δ f which is such that P_aAnd P_hAnd main segment P of bone B_BAnd (4) separating. The bone fragments P may be provided using one or more of the apparatus 100, the apparatus delivery device 800, and the delivery device controller 900_a、P_hAnd P_BInternode compression of (2). Compression may help reduce or eliminate Δ f. Compression may improve healing. Compression may provide stability in rotation and bending to the bone fragments.

In some embodiments, the proximal direction may be generally in the proximal direction D_PPulling the device 100 provides compression. The length T of the device 100 may be fixed, at least temporarily. For example, the length T may be held fixed using the mechanical relationship of the central shaft member 124 with the cage base 108 and hub 110. May then be conveyed by the equipment conveying device 800 in direction D_PPulling the device 100. The equipment handler 800 may be oriented in direction D by axis 802_PAnd (4) pulling. The delivery device controller 900 can be used to pull the shaft 802 through the lumen 610.

The device 900 may include a mechanism that may be activated by a trigger or lever 904 or 906. Can pass along the axis L_hIn the direction D_hThe conveyor controller 900 is pulled to pull the shaft 802. The distal end 606 of sheath 600 IS generally along direction D to the extent that it remains within intramedullary space IS_PMoves and pulls the apparatus 100 in that direction via the apparatus transport 800.

In some casesIn the embodiment, when along the direction D_PThe length T is allowed to lengthen when pulling the device 100. Hub 110 may be substantially opposite bone segment P_aHeld in place. May allow the cage base 108 to be oriented in direction D_PAnd (4) moving. This may reduce the radius R of the structural cage 105_D. As the radius of the structural cage 105 decreases, radially outward forces on the bone may be reduced, eliminated, or reversed.

As the length of the apparatus 100 increases and its radius decreases, the apparatus 100 may be partially or fully folded into its transport state. Depending on the diameter of the intramedullary space IS of the bone B, such contraction IS desirable to obtain proper placement of the bone fragments. After the proper bone fragment position is achieved, the radial diameter may be adjusted to achieve the desired shape and radial force. This condition can then be maintained by locking the central shaft member 124 at the distal and proximal ends of the device 100.

In some embodiments, direction D may be followed_PPulling on the proximal portion of the anchoring substrate 112. This may be in the direction D_PAnd the direction-R_BPulling anchors such as 114 and 116. Greater than, less than, or equal to along direction D may be used_PThe force of the force pulling the structural cage 105 is in the direction D_PPulling the anchor substrate 112.

In some embodiments, the physician can estimate and, if appropriate, adjust the segment P_a、P_hAnd P_BTo achieve the desired alignment. Such assessment may be performed using fluoroscopic imaging, for example, using imaging system 404 (shown in fig. 4). Evaluation can be done under direct visualization during all surgical excisions.

FIG. 13 shows a view in the direction D_PA force phi is applied. A force phi is applied by the equipment conveyor 800 to the equipment 100 at the equipment holding member 126. Δ F of fracture F has been stabilized, reduced or substantially eliminated. The anchor 122 is now inserted into the rod 128 through the bone B. The anchor 122 may direct the proximal portion of the device 100 along the bone axis L_BHeld on or near the device 100. The anchor 122 may prevent the device 100 from encircling the bone axis L_BAnd (4) rotating. The anchor 122 mayTo retain bone fragment P_a、P_hAnd P_BInternode compression between. More generally, the anchor 122 may retain one or more of a desired position, orientation, and stress state for each of the various bone fragments. The anchor 122 may bear all or part of the load. Friction between the structural cage 105 and other parts of the device 100 may carry part of the load.

In some embodiments, the role of anchor 122 may be fulfilled by several anchors used to lock device 100 in bone B while maintaining compression. The proximal anchor may be obtained from both sides of the bone or only one side. The angle of the anchor may be from almost parallel to the axis L_DTo perpendicular to the axis L_D。

Fig. 14 shows the release of the device retaining member 126 (shown in fig. 14 as having been withdrawn into the sheath 600 by the device delivery apparatus 800). Device retention member 126 is shown as a simple keyed ball end that may be retained using known grasping implements. Other types of retention mechanisms that are also contemplated and envisioned with respect to embodiments of the present invention include, but are not limited to: threaded, socket, pinned, snap, collet, and any other mechanism known in the art.

Fig. 15 shows the device in the final implanted state and the sheath 600 (not shown) removed from the intramedullary space IS of the bone B. Device 100 holds segment P_a、P_hAnd P_BAre compressed relative to each other. Fracture F_aAnd F_hAnd decreases.

Fig. 16 shows that the device 100 can be captured in the intramedullary space IS and removed from the bone B. The illustrative delivery/capture apparatus 1600 may engage the central member hub 130. An engagement member 1602 at the distal end of the delivery/capture device 1600 may skip over the central member hub 130 and engage the device retention member 126. The support members 106 supporting the cage 105 may contract when pulled into the sheath 600.

Fig. 17 shows a closure assembly 1700 that can be used to close the hole 604 and maintain access to the device 100 in bone B. The closure assembly 1700 may include a plug 1702. The plug 1702 may seal or substantially seal the aperture 604. The plug 1702 may shroud the sleeve 1704. The sleeve 1704 may provide access to the central member hub 130 (not shown) and the device retaining member 126 (not shown). The flange 1706 may engage with one or both of the center member hub 130 (not shown) and the device retaining member 126 (not shown). Flange 1706 may be attached to sheath 1704. The sleeve 1704 may be configured to apply a force to the apparatus 100 to adjust the tension or radial diameter in the structural cage 105 or the anchoring substrate 112.

In some embodiments, some or all of the functionality provided by the casing 1704 may be provided by a cable or shaft (not shown). In some embodiments, plug 1702 may be a threaded or ribbed plug or a screw-like plug linked to a cable.

Cover 1702 can be removed to insert an implement, such as engaging member 1602, to capture device 100 in the manner shown in fig. 16.

Fig. 18 shows an illustrative delivery/capture member 1802, which in some embodiments may be an alternative to device retention member 126 (shown in fig. 1) in a device such as 100. The delivery/capture member 1802 may be formed from a tube. The cuts 1810 may cut into the tube. Any suitable number of cuts such as 1810 may be present in the delivery/capture member 1802. The delivery/capture member 1802 can include a collar 1804, which can be attached to the proximal end 1806 of the device stem 1806. The rod 1806 may correspond to the rod 128 of the device 100 (shown in fig. 1).

Capture instruments 1812 may include one or more blades, such as blade 1814. Capture instrument 1812 and blade 1814 can be cut out of the tube to match delivery/capture member 1802 and cut-out 1810, respectively. Capture instrument 1812 may be delivered through a sheath, such as 600 (shown in fig. 6), into the bone marrow space to retrieve a device attached to rod 1808.

Capture instrument 1812 can be aligned with delivery/capture member 1802. The blades 1814 may be inserted into cutouts 1816 in the delivery/capture member 1802. The capture instrument 1812 can be rotated so that the blade 1814 moves into the cut 1810. The capture instrument 1812 can thus engage delivery/captureTo the member 1802 to be in the proximal direction D_PPulling the device. The vanes 1814 and delivery/capture member 1802 can be flexed radially away from the plane with respect to each other to disengage. The bending may be achieved by bending or releasing a spring-like mechanism or by plastic deformation of the capture means 1812.

Fig. 19 shows an illustrative device 1900. Device 1900 may have features that function similarly to some or all of the corresponding features of device 100 (shown in fig. 1). For example, the device 1900 may include a stand 1906 that forms a cage 1905. The cage 1905 may include a cage base 1908. The anchor substrate mount 1932 may appear concentrically within the cage mount 1908. Device retention member 1926 may extend proximally from anchor substrate base 1932. Device 1900 does not include a rod such as rod 128. The proximal anchor 1932 may be used to join a bone, such as bone B (shown in fig. 1), with the proximal end of the anchoring substrate 1912.

FIG. 20 shows a cross-sectional view of device 1900 taken along line 20-20 (shown in FIG. 19). The illustrative central shaft member 1924 is fixed at the hub 1910 of the support cage 1905. The central shaft member 1924 may include a flange 1902. Flange 1902 may be mechanically locked into cavity 1904 of device retention member 1926. In some embodiments, the central shaft member 1924 may be moved axially until the flange 1902 snaps into the cavity 1904. This may lock the central shaft member 1924 between the proximal end 1920 and the distal end 1922 of the device 1900 and thus provide an axial tension that may support the radial stiffness of the device 1900. The central shaft member 1924 can distribute tension that can be applied to the device retention member 1926 between the proximal end 1920 and the distal end 1922 of the device 1900.

In some embodiments, device 1900 may be expanded prior to deployment (e.g., in an open reduction). In such embodiments, the structural support 1905 and the anchoring substrate 1932 may be longitudinally fixed relative to one another at the proximal end 1920 and the distal end 1922 of the device 1900.

Fig. 21 shows an exemplary ratchet mechanism 2100 in cross-section. The ratchet mechanism 2100 may be used to maintain tension in a central shaft member such as 124 (shown in fig. 1). One of such central shaft membersPortions may be implemented as ribbed members 2102. Ribbed member 2102 may be oriented in proximal direction D_PIs pulled through the wing member 2104. May be deflected in direction D by deflecting annular flap 2108_PPulling on the rib 2106. After the rib 2106 passes the annular fin 2108, the annular fin 2108 moves back to its rest position (as shown) and prevents the rib 2106 from moving back to a position distal to the annular fin 2108.

The ratchet mechanism 2100 may be disposed in or near an anchoring substrate mount, e.g., 132, in or near a stem, e.g., 128, in or near a proximal mount, e.g., 120, or in or near a device holding member 126 (all shown in fig. 1). The flap member 2104 may be longitudinally fixed to the apparatus. The central shaft member may be provided with a rib member 2102 over a portion of its length. Thus, may be provided by the annular flap 2108 in the proximal direction D_PThe central shaft member and locks it in place. This may maintain tension in the portion of the center pin member distal to the tab 2108.

The ratchet feature may take any shape or form to facilitate one-way locking. The one-way locking may be permanent or releasable. In some embodiments, the tabs 2104 can be releasable such that the ribbed member 2102 can be adjusted in either longitudinal direction.

A ratchet feature may be incorporated into the device. The ratchet feature may be integral with one or more portions of the device. For example, device levers such as those shown in fig. 25 may include a complementary ratchet feature such that the inner lever may only move in one direction when the levers are in a concentric relationship.

Fig. 22 shows an end view of the ratchet mechanism 2100 (shown in cross-section along line 21-21 in fig. 21).

Fig. 23 shows an illustrative stacked ring 2300 that may form all or a portion of a central shaft member, such as 124 (shown in fig. 1). The loop is shown as a continuous spiral. In some embodiments, the rings may be individual annular rings having stacking features similar to the spiral stacked rings 2300.

Fig. 24 is a cross-sectional view taken along line 24-24. The helical loops form S-links that interlock with each other under longitudinal load-compression or tension of the stack. The stacking rings 2300 are shaped such that they can be wedged together under compression or tension and effectively reduce the mechanical freedom to move relative to each other. All or a portion of the central shaft member, such as 124 (shown in fig. 1), may comprise a segment of a helical ring 2300. The central shaft member may straighten and stiffen when loaded in tension or compression. Straightness and stiffness may increase the amount of load that may be supported by the device, e.g., 100, whether in tension, compression, or bending.

Fig. 25 shows an illustrative device 2500 in accordance with the principles of the invention. Apparatus 2500 may include a central shaft member 2502. The central shaft member 2502 may include a porous body 2504. The central shaft member 2502 can include a device retaining member 2506.

Device 2500 may include an intermediate member 2507. Intermediate member 2507 may include an anchoring substrate 2506. The anchoring substrate 2506 is shown in an expanded state. Intermediate member 2507 may include a rod 2508. Rod 2508 can be attached to an anchoring substrate 2506. The neck support 2510 can provide structural support and connection between the anchoring substrate 2506 and the rod 2508. When the anchoring substrate 2506 is in the contracted state, the intermediate member 2507 can be contracted to a diameter substantially corresponding to the diameter of the rod 2508. Device retaining member 2512 may be present at the end of rod 2508.

Device 2500 may include an outer member 2514. The outer member 2514 may include a support cage 2516. The support cage 2516 is shown in an expanded state. The outer member 2514 may include a rod 2518. The rod 2518 may be connected to a support cage 2516. The neck support 2520 may provide structural support and connection between the support cage 2516 and the rod 2518. When the support cage 2516 is in the collapsed state, the outer member 2514 may be collapsed to a diameter substantially corresponding to the diameter of the rod 2528. Device retaining member 2522 may be present at the end of rod 2518.

Fig. 25 shows inner member 2502, intermediate member 2507, and outer member 2514 separate from one another, but they may be used together to perform some or all of the functions of apparatus 100 (shown in fig. 1). Inner member 2502, intermediate member 2507, and outer member 2514 may correspond at least in part to central axis members, e.g., 124, anchoring substrates, e.g., 112, and support cages, e.g., 105, respectively (shown in fig. 1).

One or both of intermediate member 2507 and outer member 2514 may be self-expanding. One or both of intermediate member 2507 and outer member 2514 may be expanded by mechanical actuation.

Fig. 26 shows the device 2500 in an assembled and expanded configuration. Inner member 2502 extends longitudinally within intermediate member 2507. Intermediate member 2507 extends longitudinally inside outer member 2514. Device retention elements 2506, 2512, and 2522 extend from the proximal end of device 2500. The proximal anchor 2524 transects the shaft 2518 (of the outer member 2514) and 2508 (of the intermediate member 2507, not shown) and the porous body 2504 of the inner member 2502.

Without proximal anchors 2524, inner member 2502, intermediate member 2507, and outer member 2514 can be along axis L_DMove longitudinally relative to each other. The relative movement may be caused by a delivery/capture instrument engaged with each device retention member. For example, a delivery/capture instrument such as 1812 (shown in fig. 18) may be provided for each device holding member. The three capture instruments may be coaxial with one another.

In some embodiments, one or more of inner member 2502, intermediate member 2507, and outer member 2514 may be connected to one another at the distal end of device 2500 to obtain an appropriate response to the application of longitudinal and rotational forces, which may be applied to one or more of inner member 2502, intermediate member 2507, and outer member 2514. The response may be altered by connecting one or more of inner member 2502, intermediate member 2507, and outer member 2514 to one another at a more proximal portion of device 2500.

Inner member 2502, intermediate member 2507, and outer member 2514 are shown as having closed distal ends. In some embodiments, one or more of the members may have an open or free distal end.

In some embodiments of the invention, the device 2500 may not include an inner member 2502. Those embodiments may include intermediate member 2507 and outer member 2514. In some embodiments, device 2500 may include two or more intermediate members 2507 and/or two or more outer members 2514. For example, in some embodiments, device 2500 may include an inner member 2502, an intermediate member 2507, an outer member 2514, and a fourth member (not shown) similar to intermediate member 2507 external to outer member 2514. In some embodiments, device 2500 may include a fourth member (not shown) similar to outer member 2514, inside the other members. In some embodiments, the apparatus may include intermediate member 2507, a fifth member (not shown) similar to intermediate member 2507, and outer member 2514 radially outward of the fourth member.

Fig. 27 shows the outer member 2514 in a contracted state. In some embodiments, outer member 2514 may have a longitudinal axis L_DAs shown in fig. 27. Inner member 2502 and intermediate member 2507 can also have a longitudinal axis L along which they lie_DFlexibility of bending. Flexibility allows access to the intramedullary space IS near the bone B. In some embodiments, the collapsed configuration of the device 2500 may include bending to facilitate entry into the intramedullary space IS of the bone B.

Fig. 28A shows an illustrative two-component fracture repair device 2800. Device 2800 is shown in a collapsed state. The device 2800 may be self-expanding or balloon expandable. The device 2800 may include a cage member 2802 and an anchor member 2804 (within the cage member 2802).

The cage member 2804 may include a support cage 2806. The support cage 2806 may include a support member 2810. The support member 2810 may end at a distal hub 2812 and a cage base 2814. A cage stem 2816 may extend proximally from the cage base 2814. Cage bar 2816 may terminate at device retention member 2818. The support cage 2806 may be expanded within the intramedullary space IS (shown in fig. 1).

The anchor member 2804 may include an anchor substrate 2820. The anchor member 2804 may include an anchor rod 2822 and a device retaining member 2824. In the collapsed state, the anchor member 2804 may slide longitudinally within the cage member 2804.

Fig. 28B shows device 2800 in an expanded state. The support cage 2806 is expanded. The anchor substrate 2820 is expanded.

Fig. 28C shows a partial cross-sectional view taken along line 28C-28C (shown in fig. 28B) of the device 2800 in an expanded state. An anchor substrate 2820 is present inside the support cage 2806. An anchor rod 2822 is present inside the cage rod 2816. A device retaining member 2824 is present inside cage bar 2816.

The distal anchor may connect the bone segments to an anchoring substrate 2820. Device retention members 2824 and 2818 may translate longitudinally together or relative to each other to follow proximal direction D_PAnd inward radial direction-R_DA force is applied.

The device 2800 may be self-expanding. The device 2800 may be plastically deformed and expanded by an external force. One or more elements of apparatus 2800 may be made from a unitary member, such as a laser cut tube. One or more elements of device 2800 can be separately formed and then assembled.

Fig. 29 shows an illustrative fracture repair device 2900 in accordance with the principles of the invention. Apparatus 2900 is shown inserted into humerus B_HInside. Humerus B_HIncluding bone fractures F₁And F₂Which separate the bone fragments P from the bone fragments P, respectively₁And P₂. Apparatus 2900 may include a support cage 2902. The apparatus 2900 may include an anchor substrate 2904. Support cage 2902 and anchor substrate 2906 are shown in an expanded state. Apparatus 2900 may include a central axial member 2924.

Anchors 2907 and 2908 may be provided to respectively anchor bone fragments P₁And P₂Anchored to anchor substrate 2904.

The apparatus 2900 may include a relative displacement actuator 2910. The actuator 2910 may enable relative displacement of the support cage 2902, anchor mount 2904, and central member 2906. Delivery to intramedullary space IS at device 2900During this time, the device 2900 may be in a collapsed state (not shown). During deployment, the device 2900 may be inflated. Expansion may be along the device longitudinal axis L by, for example, the proximal portion 2912 of the support cage 2902 and the proximal portion 2914 of the anchoring substrate 2904_DIs performed. During deployment, anchors 2907 and 2908 may be inserted after device 2900 is inflated.

The apparatus 2900 may include a relative displacement actuator 2910 for effecting differential displacement. The actuator 2910 may include a threaded support cage base 2916. The threaded support cage base 2916 may be longitudinally fixed to the proximal end 2912 of the support cage 2902. The threaded support cage base 2916 may include a first threaded longitudinal bore (not shown).

The actuator 2910 may include a double threaded anchor substrate mount 2918. The double threaded substrate mount 2918 may be secured to the proximal portion 2914 of the anchor substrate 2904. The double threaded substrate mount 2918 may have external threads 2920 that may be threaded onto a first longitudinal threaded hole of the support cage mount 2916. The dual threaded substrate mount 2918 may include a second threaded longitudinal bore (not shown).

The actuator 2910 may include a threaded central shaft member base 2922. Threaded central shaft member base 2922 may be secured to the proximal end of central shaft member 2906. The threaded central shaft member base 2922 may have external threads 2924 that may be screwed into a second threaded longitudinal bore in the double threaded substrate base 2918.

One or more control instruments may be deployed by the catheter to rotate one or more of the cage mount 2916, the dual threaded anchoring substrate mount 2918, and the threaded central shaft member mount 2922 to achieve a desired displacement of the support cage 2902, anchoring substrate 2904, and central shaft member 2906, or displacement between proximal portions thereof. The differential displacement may expand the device during deployment.

After deployment of device 2901, anchors 2907 and 2908 may be inserted through bone fragments P, respectively₁And P₂Into anchor substrate 2904. After insertion of anchors 2907 and 2908, relative displacement actuator 2910 may be used to adjust bone fragment P₁And P₂The stress state of (a). For example, the double threaded anchoring substrate mount 2918 may be rotated such that it will be in the proximal direction D relative to the support cage mount 2916_PAnd (4) moving. The relative movement will be in the proximal direction D_PAnd inward radial direction-R_DPulling bone fragment P relative to support cage 2902₁And P₂。

After proper positioning of the apparatus 2900 and proper relative displacement of the support cage 2902 and anchor substrate 2904, a proximal anchor, such as 1922 (shown in fig. 19), may be inserted through the femur BF and anchor substrate 2904 to hold the apparatus 2900 in place.

Fig. 30 shows a cross-sectional view of device 2910 taken along line 29-29 in fig. 29. Fig. 29 shows the threaded support cage base 2916 longitudinally secured to the proximal portion 2912 of the support cage 2902. The double threaded anchoring substrate mount 2918 is threaded into a first threaded hole of the support cage mount 2916. The double threaded anchor substrate mount 2918 is longitudinally fixed to the proximal portion 2914 of the anchor substrate 2904. The threaded central shaft member 2922 is threaded into a second threaded hole of the double threaded anchor substrate mount 2918. Central shaft member 2906 extends in the distal direction (-D) from threaded central shaft member 2922_P) And (4) extending.

Fig. 31 shows an illustrative balloon-expandable fracture repair device 3100. Device 3100 can include an outer structural member 3102. The outer structural member 3102 may include a structural cage 3104, rods 3106, and device retaining members 3108. Device 3100 can include an anchor member 3110. Anchor 3110 may include an anchor substrate 3112, anchor bar 3114, and device retention member 3116.

The structural cage 3104 and the anchor substrate 3112 may be positioned within the medullary space of a bone in a collapsed state using the device retention members 3108 and 3116, respectively. The device retaining member may be used to longitudinally position the structural cage 3104 and the substrate 3112 relative to each other.

Balloon 3118 may be present inside anchoring substrate 3112. The conduit 3120 may provide an appropriate gas pressure for inflation of the anchoring substrate 3112.

The membrane 3130 may be present near the outer structural member 3102. The membrane 3130 may cover substantially the entire device 3130. The membrane 3130 may be arranged outside or inside the device 3100, or between said elements of the device 3100.

The membrane 3130 may comprise an elastic material. The membrane 3130 may comprise a non-elastic material. The membrane 3130 may comprise braided polyester, EPTFE film, PET balloon, silicon film, polyurethane film, any suitable material that can be produced in film form, any suitable material that can inhibit tissue growth, any suitable biocompatible, biodegradable and/or bioabsorbable material, and any other suitable material.

The membrane 3130 may facilitate removal of the device 100 by inhibiting bone growth into the device 100. In some embodiments, the septum 3130 may inhibit tissue ingrowth in the void space of the device 3100.

In some embodiments, the membrane 3130 may facilitate the delivery or capture of materials, such as bone cement, that may be used in connection with the device 3100.

The membrane 3130 may be structurally integrated into the device 3100. The membrane 3130 may be configured to be used with the apparatus 3100 as an auxiliary or additional component. The component may be used as required for fracture repair.

In some embodiments, a membrane 3130 may be used to expand the structural cage 3104. In some embodiments, the membrane 3130 may be used to inflate the anchoring substrate 3112. In such embodiments, the membrane 3130 may be detachable from the structural cage 3104 and/or the anchoring substrate 3112. The septum 3130 may then remain implanted in the intramedullary space IS.

In some embodiments, the diaphragm 3130 may move independently of the other elements of the device 3100.

The membrane 3130 may comprise the formulation. The formulation may be impregnated in a membrane 3130. The formulation may be present as a coating on the membrane 3130. The agent may provide a bone growth promoting agent, a bone growth inhibiting or inhibiting agent, a pharmaceutical eluting agent, or any other suitable agent.

Fig. 32 shows a cross-sectional view taken along line 32-32 of device 3100. Fig. 32 shows conduit 3120 entering anchoring substrate 3112. Balloon 3118 may be filled from port 3122 in catheter 3120. The anchoring substrate profile 3124 may be predetermined by its material and structure (or both).

Fig. 33 shows an exemplary anchor member 3300. Anchor member 3300 may be used in an apparatus such as apparatus 3100 (shown in fig. 31) and may correspond to anchor member 3110. Anchor members 3300 may include distal ring 3302, anchor substrate 3304, posts 3306, and device retention members 3308.

In some embodiments, a balloon such as 3118 (shown in fig. 31) may be inserted inside the anchoring member 3300 to expand the anchoring member 200. In some embodiments, device 3300 may be self-expanding.

The collar 3302 has a substantially fixed radius and cannot expand. The collar 3302 may include a ring 3303. The rings 3303 may be arranged in a nested configuration, where the rings 3303 are partially or substantially perpendicular to the axis L_D. Ring 3303 may be aligned with axis L_DAnd (4) coaxial. In such a configuration, the ring 3303 may facilitate connection to a central shaft member, such as 124 (shown in fig. 1), and/or a structural cage, such as 105 (shown in fig. 1).

When a balloon is used for inflation, the shaft 3306 may be located a sufficient distance from the shaft 3306 such that the radius of the shaft 3306 remains substantially the same during inflation of the balloon.

Anchor substrate 3304 may include expansion straps 3310. The inflation band 3310 includes inflation elements, e.g., 3312, which may be radially outward (direction R) of the inflation balloon_D) Under stress along direction C_Dand-C_DAnd (5) deforming. The band 3310 has a number of expansion cells along its circumference. The number of expansion cells along the circumference of a band, e.g., 3310, is referred to as the cell density.

A group of cells that expand relatively in response to longitudinal compression may be considered to have a high "expansion ratio". A group of cells that do not expand relatively in response to the same longitudinal compression may be considered to have a low "expansion ratio". Variations in cell density, cell shape, cell "leg" (material bordering the cell(s) separating the cell(s) from other cells or materials) (or "struts") length, cell leg thickness, and other suitable parameters may be used to vary the expansion ratio.

Anchor substrate 3304 may include expansion straps 3314. Expanding band 3310 has a cell density greater than that of band 3310. The expanding band 3314 thus expands in the radial direction R when subjected to the outward radial force of the balloon_DTo expand more than band 3310 is about to expand. Expansion band 3316 has the same cell density as expansion band 3314. Expansion band 3318 has the greatest cell density and thus may be more radially R than the other expansion bands_DExpand more.

The variation in cell density along the longitudinal direction of the longitudinal anchoring substrate 3340 may result in a varying radial expansion. Along the axis L_DMay be selected to provide an expansion profile that conforms to the anchoring substrate 3304 of the support cage, e.g., 105 (shown in fig. 1), or bone marrow space, e.g., IS (shown in fig. 1), in a desired manner. Circumferential variation in cell density (along direction C)_D) A circumferentially varying expansion radius may be provided. Such variations may be used to provide a profile having a shape corresponding to or contoured to an asymmetric marrow cavity at, for example, the humerus end.

Fig. 34 shows an illustrative anchoring substrate 3402 for a fracture repair device in accordance with the principles of the present invention. The anchor substrate 3402 may be supported at the distal end 3404 by a flange 3406. The anchor substrate 3402 may be supported at the proximal end 3408 by the flange 3410. The central shaft member 3412 may be longitudinally fixed to the flange 3406. Flange 3410 may be substantially free to translate relative to central shaft member 3412. This allows the distance T between the flanges to be reduced so that the anchor substrate 3402 may be radially R_DAnd (4) expanding.

The device 3400 may be self-expanding. The anchoring substrate 3402 may include a woven mesh. In some embodiments, the device 3400 may include a plurality of anchor substrates.

Fig. 35 shows anchoring substrate 3414 in an expanded state between flanges 3406 and 3410. Flange 3410 has moved distally on central shaft member 3412. The anchor substrate 3414 corresponds to the anchor substrate 3402 (shown in fig. 34), but may have a longitudinally varying cell density and thus may expand to a larger radius, and then the anchor substrate 3402 may also expand to a larger radius.

After the anchor is attached to the anchor substrate 3414, the flange 3410 can be pulled proximally to reduce the diameter of the substrate and apply tension to the attached anchor elements. During such diameter repositioning, the shape of the cell within the anchor substrate 3414 may change. For example, the cells are substantially square in the expanded state. In the contracted (or relatively contracted) state, the cells may be diamond-shaped or trapezoidal. The shape change may improve the strength of the bond between the anchor substrates 3414. The shape change may effectively lock the anchor to the anchor substrate 3414.

Fig. 36 shows an illustrative anchoring substrate 3600 for use in a fracture repair device in accordance with the principles of the present invention. The anchor substrate 3600 may be attached to a central shaft member (not shown). The anchor substrate 3600 may be welded, crimped, braided or otherwise attached to the central shaft member along its length. For example, the radially inner portion 3602 may be attached to the central shaft member.

In some embodiments, the anchor substrate 3600 may be attached at its distal and proximal ends to a central member such as 124 (shown in fig. 1) and along its length to a structural cage such as 105 (shown in fig. 1). This type of attachment may facilitate packaging or folding by relative rotation between the cage and the central member. In some embodiments, the anchoring substrate 3600 may be present within a structural cage, such as 105 (shown in fig. 1), but may be unattached or unattached from the structural cage.

The anchor substrate 3600 may be sufficiently elastic to maintain the fold 3603. Surface 3604 and radially outer portion 3606 may engage anchors that compress bone segments against a support cage such as 105 (shown in fig. 1). The anchor substrate 3600 may include a secondary fold 3608 to improve the usability of the surface 3604 to receive anchors.

The central shaft member may be oriented in the direction-C_DRotated to approximately inwardly in a direction-R toward the central shaft member_DThe anchor is pulled. The central shaft member may be pulled proximally to apply a longitudinal force to the bone segments.

Fig. 37 shows an illustrative anchoring substrate 3700 for a fracture repair device in accordance with the principles of the present invention. Anchor substrate 3700 can be configured to be attached to a central shaft member and driven as anchor substrate 3600 (shown in fig. 36). The anchoring substrate 3700 can include a main fold 3702. Anchor substrate 3700 may not include auxiliary folds such as 3608 in anchor substrate 3600.

Some embodiments may include wire-like elements wrapped with an anchoring substrate 3600 and/or a structural cage such as 105 (shown in fig. 1). The thread-like elements may be connected to the central axis member so as to pull the anchoring substrate or the portion of the structural cage towards the device axis. In some embodiments, the thread-like element may be pulled through the central shaft member by the delivery instrument.

Fig. 38 shows an illustrative anchoring substrate 3800 for use in a fracture repair device in accordance with the principles of the invention. The anchor substrate 3800 can be attached to a central shaft member (not shown). The anchor substrate 3800 can be welded, crimped, braided or otherwise attached to the central shaft member near the proximal end of the central shaft member. For example, the radially inner and proximal portions 3802 may be attached to the central shaft member. The anchoring substrate may be sufficiently elastic to retain the spiral fold 3803. The folded surface 3804 may engage an anchor that presses the bone fragment against a support cage, such as 105 (shown in fig. 1).

The distal end 3808 of the anchor member 3800 may be secured to a flange such as 3406 (shown in fig. 35). The central shaft member may be oriented in the direction-C_DFree to rotate relative to the flange. When the central shaft member is thus rotated, it can be screwed down and spirally folded3803 and approximately inwards towards the central spindle member in a direction-R_DThe anchor is pulled. The central shaft member may be pulled proximally to apply a longitudinal force to the bone segments.

FIG. 39 shows an illustrative anchoring substrate 3900 for use in a fracture repair device in accordance with the principles of the present invention. The anchoring substrate may include stacked disk-like folds 3902. The disc-like folds may expand and contract longitudinally and radially in an accordion-like manner.

Fig. 40 shows anchoring substrate 3900 in cross-section as viewed along line 40-40 (shown in fig. 39). As the proximal end 3904 and the distal end 3906 (e.g., at the flange 3908) are moved longitudinally toward each other, the anchoring substrate 3900 may be longitudinally compressed and the disk-shaped fold 3902 may be along the direction R_DAnd (4) expanding. As the proximal end 3904 and the distal end 3906 (e.g., at the flange 3908) are moved longitudinally away from each other, the anchoring substrate 3900 may extend longitudinally and the disk-shaped fold 3902 may be in the direction-R_DAnd (4) shrinking.

The longitudinally extending length may be used to expand the anchoring substrate in a radially compressed state. After deployment, the anchoring substrate may be compressed longitudinally such that fold 3902 follows radial direction R_DAnd (4) expanding. The anchor may then be engaged with fold 3902. The anchoring substrate 3900 can then be extended longitudinally to apply a radially inward force to the anchors. The anchor is then applied in direction D by pulling on proximal end 3904_PThe tension of (2). Fold 3902 may correspond to direction-D_PBiased at an angle B such that when end 3904 is pulled, fold axis Lf is pre-aligned with the anchor.

Proximal portion 3904 can be attached to a pulling member (not shown) similar to a portion of central shaft member, such as 124 (shown in fig. 1B). The distal end 3906 at flange 3908 can be attached to a portion of the device that remains substantially longitudinally stationary when the device is pulled onto the proximal portion 3904. For example, flange 3908 may be secured to a distal end of a corresponding support cage, such as 105 (shown in fig. 1).

FIG. 41 shows a schematic support for a fracture repair device according to the principles of the present inventionA cage 4100. The support cage 4100 may include a hub 4102 and a base ring 4104. A helical support member 4106 extends between the hub 4102 and the base ring 4104. The central shaft member (not shown) may be along the apparatus axis L_DAnd (4) extending. The central shaft member may have a distal end longitudinally fixed to the hub 4102. The central shaft member can extend through the base ring 4104. The base ring 4104 can move along the central axis member. When the base ring 4104 is away from the hub 4102, the helical support member 4106 can extend longitudinally and straighten. When the helical support member 4106 is straightened, the ring 4104 may be rotated.

The longitudinal extension of the support cage 4100 may configure the support cage 4100 for deployment. Longitudinal compression of the support cage 4100 may configure the support cage 4100 for deployment and engagement with bone fragment anchors. In some embodiments, the support cage 4100 may be expanded and collapsed by applying an external rotational force.

In some embodiments, the support cage 4100 may be self-expanding. In those embodiments, the support cage 4100 may have a relaxed state that is longitudinally compressed. The support cage 4100 may extend longitudinally for deployment. The support cage 4100 may then return to its relaxed state after deployment.

Fig. 42 shows an illustrative hybrid support cage and anchoring substrate 4200. The hybrid cage/substrate 4200 may include support members 4202. Support member 4202 may support a bone segment such as P_a、P_hAnd P_B(shown in figure 1). The hybrid cage/substrate 4200 may include a substrate member 4204 for engaging anchors, such as 114 and 116 (shown in fig. 1). The substrate member 4204 may be supported by the support member 4202. The substrate members 4204 and 4202 may expand and contract radially as a unit.

The hybrid cage/substrate 4200 may include a stem 4206 and a device retaining member 4208. The support member 4202 may be integrated with the substrate member 4204 in a single-layer structure. Substrate member 4204 may have features described herein in connection with an anchor substrate such as 112 (shown in fig. 1). For example, the substrate member 4204 may be formed to facilitate anchor mating and retention. The hybrid cage/substrate 4200 may be used alone or in combination with other layers of hybrid cages/substrates such as 4200 or other structures such as layers of devices previously described herein such as central shaft member 2502 (shown in fig. 25), intermediate member 2507 (shown in fig. 25), anchor member 3300 (shown in fig. 33), and outer member 2514 (shown in fig. 25).

Fig. 43 shows an illustrative fracture repair device 4300 in accordance with the principles of the present invention. The apparatus 4300 includes an anchor substrate 4302 and a support cage 4304. The anchor substrate 4302 is radially outward of the support cage 4304. The apparatus 4300 may include a distal hub 4306. The distal hub 4306 may provide support to the proximal end 4308 of the central shaft member 4310. The proximal base 4312 may support the anchoring substrate 4302 and a proximal portion of the support cage 4304. The central shaft member 4310 may pass through the proximal base 4312. The central shaft member 4310 may support the apparatus holding member 4314.

Fig. 44 shows an illustrative fracture repair device 4400 in accordance with the principles of the present invention. The device 4400 may include a structure cage 4402 and an anchor substrate 4404. The structure cage 4402 may include a bushing 4406 for sliding the proximal portion 4408 of the structure cage 4402 along the central axis member 4410. The anchor substrate 4404 may include a bushing 4412 for sliding the proximal portion 4414 of the anchor substrate 4404 along the central axis member 4410. The bushing may support a device retention member such as 1802 (shown in fig. 18). A device retaining member may be used to expand and contract device 4400. The spherical or spheroid-shaped embodiment of the device 440 may provide a high radial compressive strength and generate a high radial compressive force based on shape.

Fig. 45 shows an illustrative fracture repair device 4500 in accordance with the principles of the present invention. The device 4500 may include an array of substantially spherical or spheroid-shaped structure cages 4502, 4504, and 4506 inside an outer structure cage 4508. The apparatus 4500 may include a number of cages if desired to form a column of desired lengths. In some embodiments, an anchoring substrate such as 4300 (shown in fig. 43) may be present. The anchor substrate may be present within or outside of the structural cage 4508.

In some embodiments, the cage may be partially spherical. An anchoring substrate is present inside each structural cage. The apparatus 4500 may include bushings 4510 and 4512 for positioning the proximal ends 4516 and 4514 of the outer structure cage 4508 and the column, respectively, along a central shaft member 4518. The central shaft member 4518 may be rigidly fixed at the outer structure cage hub 4520. The structure cages 4502, 4504, and 4506, the outer structure cage 4508, and the anchor substrate can be expanded and collapsed by sliding the bushings 4510 and 4512 along the central shaft member 4518.

Fig. 46 shows an illustrative fracture repair device 4600 in accordance with the principles of the present invention. Device 4600 is shown in long bone B_LSimilar to the view of device 4500 along line 46-46 shown in fig. 45. Device 4600 may include substantially spherical structural cages 4602, 4604, and 4606 inside an outer structural cage 4608. Device 4600 can transect fracture F_L。

An anchoring substrate may be present inside each of the structural cages 4602, 4604 and 4606. Device 4600 may include a device holding member 4610. The device holding member 4610 may be configured to slide relative to the central shaft member 4612. The central shaft member 4612 may terminate proximally at a device capture member 4614. The central shaft member 4612 may terminate distally at an outer structural cage hub 4616 to which the central shaft member 4612 is rigidly secured.

The structural cages 4602, 4604 and 4606, the outer structural cage 4608 and the anchoring substrate may be expanded and folded by a sliding device retaining member 4610 relative to a device capture member 4614. A ratchet sleeve 4618 may be provided to maintain the device 4600 in an expanded state. After expansion of the device 4600, the anchors 4620, 4622 and 4624 may be inserted through bone segment B_L1And B_L2To engage the anchor substrate.

May be inserted relative to bone segment B by initially inserting anchors 4620 and 4622_L2In the proximal direction D_PPulling the device 4600 and then inserting the anchors 4624 to orient the fracture F_LCompressive traction is applied.

Fig. 47 shows an illustrative fracture repair device 4700 in accordance with the principles of the invention. Device 47 is shown deployed on long bone B_LIn the intramedullary space IS. Device 47 spans boneFold F_L. The apparatus 47 may include a structural cage 4702. The device 47 may include an anchor substrate 4704. The structural cage 4072 may be deployed within the intramedullary space IS. Structural cage 4072 may be oriented toward bone segment B_L1And B_L2Providing radially outward support. The anchor substrate 4704 may be deployed within the structural cage 4072.

The anchor substrate 4704 may be joined by anchors 4706, 4708, 4710, and 4712 to join bone segment B_L1And B_L2Stabilized on the structural cage 4702. May be inserted relative to bone segment B by initially inserting anchors 4706 and 4708_L2In the proximal direction D_PPulling the device 4700 and then inserting the anchors 4710 and 4712 to treat the fracture F_LCompressive traction is applied.

The device 4700 is shown with substantially open ends. In some embodiments, the apparatus 4700 may have an end that ends at a hub or base such as shown and described herein. The device 4700 can be used in combination with other devices as shown or shown and described herein.

FIG. 48 shows an illustrative anchor 4800 that may be used with a fracture repair device in accordance with the principles of the present invention. Anchor 4800 can include elongated member 4802, head 4804, and wings 4806. Anchor 4800 can be deployed using torque, axial compression, or both. Elongated member 4802 may be inserted through a bone fragment. The tabs 4806 may be elastically deformed such that when the anchor 4800 is inserted through a bone fragment, the tabs 4806 are substantially flush with the outer surface of the elongated member 4802.

The end portion 4808 can be passed through a cell in an anchor substrate such as 112 (shown in fig. 1). One or more tabs 4806 can engage the anchor substrate and prevent anchors 4800 from disengaging the anchor substrate. The tabs 4806 can deflect to be substantially flush with the outer surface of the elongated member 4802 as the anchors 4800 penetrate the anchor substrate.

In some embodiments, the fins 4806 can have a pre-deployed state, wherein the fins 4806 can be substantially flush with the outer surface of the elongated member 4802. Tabs 4806 can be deployed after insertion of anchor 4800 through the bone and anchoring substrate. The wings 4806 can be deployed by inserting an actuator shaft (not shown) in the lumen of the elongate member 4802. The actuator shaft may push the fins 4806 radially outward.

Wings 4806 can include protrusions (not shown) that extend into the lumen of anchor 4800. The projection may extend away from the "plane" of the tab. The protrusion may facilitate deployment of the flap as the actuator shaft drives the lumen down and into contact with the protrusion.

The elongated member 4802 may be composed of a tube blank. The fins 4806 may be stamped or laser cut from the tube. The head 4804 may be welded to the elongated member 4802. Head 4804 may include a drive socket 4804. The diameter of the tube blank can be selected to correspond to the diameter of the anchoring substrate unit to maximize the interference between the fins 4806 and the anchoring substrate. This option may provide for proper retention of the anchor.

Fig. 49 shows an illustrative anchor 4900 that may be used with a fracture repair device in accordance with the principles of the present invention. Anchor 4900 may include an elongate member 4902, a head 4904, and a thread segment 4906. The anchor 4900 may be deployed using torque, axial compression, or both. The elongate member 4902 may be inserted through a bone fragment. Thread segment 4906 can be elastically deformed for easy insertion into a bone segment and engagement with an anchoring substrate. The parameters of thread segment 4906 may be selected for engagement with an anchoring substrate. The parameters may include inner diameter, outer diameter, spacing, and any other suitable parameter.

Thread segment 4906 may include a circumferential surface 4908 and a corresponding circumferential locking surface 4910. The circumferential locking surface 4910 may be captured in the anchor substrate and prevent the anchor 4900 from unscrewing from the anchor substrate.

Fig. 50 shows an illustrative anchor 5000 that may be used in a fracture repair device in accordance with the principles of the invention. Anchor 5000 can include an elongated member 5002, a head 5004, and a threaded segment 5006. Thread segment 5006 can have some or all of the features of thread segment 4906 (shown in fig. 49). For example, the thread segment 5006 can include a circumferential face 5008 and a corresponding circumferential locking face 5010. The circumferential locking face 5010 can be captured in the anchor substrate and prevent the anchor 5000 from unscrewing from the anchor substrate.

The anchor 5000 may be deployed using torque, axial pressure, or both.

The anchor 5000 may include a joint gripper 5012. The articular grippers 5012 can be in a non-deployed state when present in the lumen 5014 of the elongate member 5002. The rod 5014 can be depressed within the lumen 5014 and pushed onto the legs 5018 of the grippers 5012. The legs 5018 can push the hinges 5020 out of the ports 5022 in the elongate members 5002. The corresponding grippers 5024 can be deployed in a similar manner. After the grippers 5012 and 5024 are deployed, the legs 5018 and 5026 can be captured in the anchoring substrate. The anchor 5000 can thus be locked to the anchoring substrate.

Fig. 51 shows an illustrative anchor 5100 that may be used with a fracture repair device in accordance with the principles of the present invention. Anchor 5100 may include a helical member 5102, a head 5104, and a cut 5106. The anchor 5100 may be deployed using torque, axial pressure, or both.

The elongate member 5102 may be inserted through a bone fragment. The guide hole in the bone fragment may have a diameter corresponding to the diameter d of the helical member 5102. The helical member 5102 can thus pass through a bone fragment without substantial rotation. In some embodiments, an anchor access hole can be created in the bone for the anchor 5100. The anchor access hole may have a diameter no less than the diameter d' of the elongate member 5102 and large enough to allow the elongate member 5102 to be helically threaded through the hole. Such access holes may be smaller than standard anchor holes.

The tips 5108 can then engage the anchor substrate. Rotation of the anchor 5100 may then drive the anchor 5100 relatively deeper into the anchor substrate. The cut 5106 may be captured in the anchor substrate and prevent the anchor 5100 from rotating out of engagement with the anchor substrate. The tail 5110 may be configured without a notch such that the anchor 5100 may be withdrawn from the anchor substrate if desired prior to driving the anchor 5100 into locking relationship with the anchor substrate.

Fig. 52 shows an illustrative anchor 5200 that may be used in a fracture repair device in accordance with the principles of the present invention. The anchor 5200 may include an elongated member 5202, a head 5204, and a catch 5206. The gripper 5206 may be supported by and rotate about a pin 5208. The catch 5206 in the non-expanded state may be present or partially present within a slot 5210 in the elongate member 5202. For example, the catch 5206 can be rotated in the direction m so that the tip 5212 rotates into the slot 5210 and 5214 rotates into a position extending beyond the elongate member 5202.

In this configuration, the elongate member 5202 may be inserted through a bone fragment. The tips 5214 then traverse a portion of the anchoring substrate. After traversing, the tip 5214 can be rotated in the-m direction, such that the anchor 5200 returns to the configuration shown in fig. 52. The gripper 5206 may span beyond the diameter of the cells in the anchoring substrate. The anchor 5200 can thus be locked to the anchoring substrate.

In some embodiments, the screw actuator 5216 can be present in a hole 5218 of the elongate member 5202. The screw actuator 5216 can be threaded into the bore. This action may reduce the effective length of the anchor 5200 and thus reduce the tension of the bone fragment to the anchor substrate. In some embodiments, a tip (not shown) of the screw actuator 5216 can deflect the tip 5212 out of the slot 5210 to rotate the catch 5206. The tip 5212 can be angled so as to be deflected by the tip of the screw actuator 5216.

Fig. 53 shows the anchor 5200 deployed and locked into the anchoring substrate 112 (also shown in fig. 1) of the device 100. The anchor 5200 thus attaches the bone fragment P_aAnd P_hSecured to the anchor substrate 112.

Fig. 54 shows an illustrative fracture repair device 5400 in accordance with the principles of the present invention. The apparatus 5400 is implanted in bone B. Wire 5402 passes through bone fragment P_aDrilled holes, anchoring substrate 5404 and bone segments P_BTo form the loop 5406. The ends of wire 5402 may be secured to each other to secure bony portion P_a、P_hAnd P_BAre fixed to each other.

Fig. 55 shows an illustrative fracture repair device 5500 in accordance with the principles of the present invention. Apparatus 5500 is shown deployed and locked on humerus B_HIn (1). The support member 5502 substantially conforms to a boneB_HThe profile of the intermedullary space IS. The anchor substrate applies a force in direction D to anchors 5504 and 5506_PThe tension of (2). The proximal anchor 5508 maintains tension.

An expanding cylindrical anchor 5510 is provided coaxially around the structural cage base 5512. When along the axis L_DUpon compression, the anchor 5510 can expand radially. When the anchor 5510 is expanded, the circumferential vanes 5514 will extend radially into the bone B_HIn (1). The anchor 5510 may be compressed by longitudinally securing the distal end 5516 into position on the structural cage base 5512 and pushing the proximal end 5518 distally. A stopper (not shown) may be provided to prevent the anchor 5510 from extending longitudinally. When locked in the compressed state, the anchor 5510 cuts longitudinally into the bone B_HAnd locking device 5500 or portions thereof. The anchor 5510 can be self-expanding when released from constraint. The anchor 5510 can be rotated during expansion to improve engagement with the bone.

The expanded cylindrical anchor 5522 is shown directly connected to an anchor substrate 5530. The anchor 5522 can be locked after a desired tension is achieved in the apparatus 5500. The expanded cylindrical anchor 5522 can have some or all of the features of the expanded cylindrical anchor 5510.

Fig. 56A shows an illustrative expansion anchor 5600 that can be used in accordance with the principles of the present invention. The anchor 5600 may have some or all of the features of the anchor 5510 (shown in fig. 55). Anchor 5600 may be cut from a tube. Along the axis L_DResulting in articulation of living hinge 5604. Articulation causing blade 5602 to move radially away from axis L_DAnd (4) extending. The anchor 5600 may be self-expanding.

FIG. 56B shows a view of anchor 5600 along direction 56B-56B (shown in FIG. 56A). FIG. 56C shows a view of anchor 5600 along direction 56C-56C (shown in FIG. 56A).

FIG. 57A shows an illustrative expanding helical anchor 5700 that may be used in accordance with the principles of the present invention. The helical anchor 5700 may have some or all of the features of the anchor 5510 (shown in fig. 55). The anchor 5700 may be cut from a tube. Along the axis L_DResulting in the snap-fit of living hinge 5704. Closing deviceThe segments cause the blades 5702 to be radially spaced from the axis L_DAnd (4) extending. The anchor 5700 may be self-expanding.

FIG. 57B shows a view of anchor 5700 in direction 57B-57B (shown in FIG. 57A). FIG. 57C shows a view of anchor 5700 in direction 57C-57C (shown in FIG. 57A).

When the screw anchor 5700 is rotated relative to the surrounding bone, it can move like a screw because of the helical form of the blades 5702. When the screw anchor 5700 is rotationally compressed and simultaneously rotated, the blades 5702 may carve out bone material while the anchor 5700 is engaged in bone. Carving out bone material can reduce hoop stress in the bone.

Fig. 58 shows an illustrative fracture repair device 5800 in accordance with the principles of the present invention in a femoral BF. Apparatus 5800 includes a structural cage 5802 and an anchor substrate 5804. The anchors 5806 secure portions of the femur BF (individual bone segments not shown) to the anchoring substrate 5804. The structural cage 5800 can include a cage base 5808 that can be configured to receive a proximal anchor 5810. The proximal anchor 5810 may apply tension to the central shaft member 5812. The proximal anchor 5810 may apply tension to the anchor substrate 5804.

The device 5800 may be introduced at a point near point 5814 on the bone BF so that the device 5800 may be delivered in an orientation and position that approximates the desired deployment orientation and position.

Buttress plates 5816 may be disposed adjacent the bone BF. Buttress plate 5816 may provide stability to anchors 5806 and 5814. The buttress plate 5816 may distribute forces from the anchors 5806 and 5814 to different portions of the bone BF. Buttress plate 5816 may receive an amount of anchors 5806 to fix the fracture. Buttress plate 5816 may have specially configured mating features to lock device 5800 at a desired angle relative to buttress plate 5816.

Fig. 59 shows in the humerus B_HAccording to the principles of the present invention 5900. In some embodiments, the device 5900 can be fully transported and deployed through a single access port (not shown). The apparatus 5900 includes a structural cage 5902. The structural cage 5902 may be oriented toward the boneSegment P, P₁And P₂Providing outward radial and longitudinal support.

The anchor can be delivered to the bone B by a steerable catheter_HAnd through a cage base such as 108 (shown in figure 1). Tethers 5904 and 5906 may be oriented toward bone segments P, respectively₁And P₂An inward radial and proximal tension is applied. The tether may be delivered to the humerus bone B through an access port (not shown) as proximal apparatus 5900_HAnd (4) the following steps. The apparatus 5900 can include no anchor substrate.

The t-steel anchor 5908 may anchor the tether 5904 to the bone segment P₁. The t-steel anchor 5908 may have some or all of the features of the anchor 5200 (shown in fig. 52). Screw-type anchor 5910 may anchor tether 5906 to bone segment P₂。

The tether may be fed through the flared support tube 5912. The flared support tube 5912 may include a one-way cleat 5914. The tether may be pulled in a proximal direction Pd to apply tension to the bone segments. The one-way cleat 5914 may prevent the release of tension.

FIG. 60 shows in the humerus B_HAn illustrative fracture repair device 6000 in accordance with the principles of the present invention. The apparatus 6000 comprises a structural cage 6002. The structural cage 6002 may be oriented towards the bony segment P, P₁And P₂Providing outward radial and longitudinal support. A structural cage 6002 and an anchoring substrate 6004. Anchors 6006, 6008 and 6010 may be delivered by a steerable catheter through the cage base 6012 and into the interior of the anchoring substrate 6004. The anchor may then be inserted into the bone fragment P₁And P₂In (1). The steerable catheter is then withdrawn. And then in the proximal direction D using the approaches shown and described herein or other suitable approaches_PPulling the anchor substrate 6004. In the direction D_PPulling the anchoring substrate 6004 may anchor the bone fragments P₁And P₂Pressing against the bone fragment P.

Fig. 61 shows an illustrative fracture repair device 6100 in accordance with the principles of the present invention in bone B. The device 6100 may be delivered through an access hole 6101 in the radial styloid S into the intramedullary space IS of the bone B.

The apparatus 6100 may include a structural cage 6102, an anchor substrate 6104, and a central shaft member 6106. The structural cage 6102 can include a hub 6108 in which a support member 6110 is rigidly connected. The hub 6108 can support the device retaining member 6112.

The delivery sheath 6114 may provide access to the bone marrow space through the styloid process S. A delivery instrument (not shown) can extend through the delivery sheath 6114 and engage with the device retaining member 6112 for positioning and deployment of the device 6100.

Fig. 62 shows an illustrative plate 6200 for use in a fracture repair device in accordance with the principles of the invention. The plate 6200 includes a plurality of apertures 6202 for the anchors to pass through.

The plate 6200 may support bone fragments and devices such as 6300 (shown in FIG. 63) within the bone. The plate 6200 may be used during open surgery on the outer surface of the bone. The board 6200 may be rigid or flexible. The shape of the plate 6200 may be selected for capturing some or all of the bone fragments of the bone.

Fig. 63 shows an illustrative fracture repair device 6300 in accordance with the principles of the present invention. The device 6300 may be used in connection with a board such as 6200 (shown in fig. 62). Device 6300 may include a structural cage 6302 and an anchor substrate 6304. An anchor, such as a helical anchor 6306, may be passed through the aperture 6202 and bone segment P_BAnd P_a. Anchor 6306 may have some or all of the features of anchor 5100 (shown in fig. 51). The anchor 6306 may be anchored and locked in the anchoring substrate 6304.

Fig. 64 shows device 4600 (shown in fig. 46) deployed inside vertebra V. Device 4600 provides radial support outward. Device 4600 can be used in vertebra V without an anchor.

Fig. 65 shows a schematic scenario for providing access to the proximal humerus PH. The introducer appliance 6502 may provide an access hole in the proximal humerus PH. The device 6504 may be introduced, positioned, deployed and anchored near the end of the proximal humerus PH. An imaging device 6506 may be provided to provide visual information regarding the anatomical features of the proximal humerus PH and the location of the device 6504.

FIG. 66 shows an open fracture F for bone B_hAn exemplary scenario of an exemplary fracture repair device 6600 in accordance with the principles of the present invention is developed. The apparatus 6600 may include a structural cage 6602, an anchor substrate 6604, and a central shaft member 6606. Device 6600 can be administered via fracture F_hInserted into the medullary space of bone B. The device 6600 can be inserted in a collapsed state. The device 6600 can be inserted in the expanded state.

Fig. 67 shows an illustrative anchoring substrate 6700 that may be used in a fracture repair device in accordance with the principles of the present invention. The anchor substrate 6700 can include an elongated portion 6702. Elongated portion 6702 terminates in an end cap 6704. One or both of elongate portion 6702 and end cap 6704 can include an aperture 6706. The holes 6706 can be engaged with anchors to hold the bone segments in place.

The anchoring substrate 6700 can be used to repair a fracture F having an open fracture, such as bone B shown in FIG. 66_hThe bone of (2). The anchor substrate 6700 can be expandable. The anchor substrate 6700 can be non-expanded.

The devices and methods described herein are illustrative. The apparatus and methods of the present disclosure may involve some or all of the features of the illustrative apparatus and/or some or all of the steps of the illustrative method. The steps of the methods may be performed in an order different than that shown and described herein. Some embodiments may omit steps shown and described in connection with the illustrative methods. Some embodiments may include steps not shown or described in connection with the illustrative methods.

A process according to the principles of the present invention may include one or more of the features of the process shown in fig. 68. Some steps of the procedure may be performed in an in-patient. Some steps of the procedure may be performed in an outpatient setting.

FIG. 68 shows exemplary steps of a process 6800 for repairing a bone fracture. Process 6800 can begin at step 6802. At step 6802, the caregiver may temporarily reduce the fracture. At step 6804, the caregiver may establish access to the marrow cavity in the fractured bone. At step 6806, the caregiver may insert the catheter into the fractured bone. At step 6808, the caregiver can confirm the positioning of the catheter using fluoroscopy (or any other suitable imaging method). At step 6810, the caregiver may deploy a structural support, such as the structural cage 105 (shown in FIG. 1). At step 6812, the caregiver can unroll an anchor substrate, such as anchor substrate 112 (shown in FIG. 1). At step 6814, the caregiver can insert anchors into the bone segments and the anchor substrate. At step 6815, the caregiver may apply tension. Tension may be applied to one or more of the anchors, anchoring substrates, structural supports, or any of the devices shown and described herein using any of the methods shown and described herein. At step 6816, the caregiver can confirm the bone fragment location using medical imaging. At step 6818, the caregiver may lock the insertion device into the bone marrow cavity. At step 6820, the inserted device can be disengaged from the delivery system for the delivery device.

There are different combinations of implantation sequences. Table 4 shows the sequence of different exemplary processing steps. Other processing steps and different orders may also be carried out in accordance with the principles of the invention.

TABLE 4 exemplary fracture repair sequence

Many other steps may be included. Different embodiments of the apparatus shown and described herein may be used in conjunction with different steps of process 6800, whether shown in FIG. 68 or Table 4. For example, bone cement may be applied, a hydrophobic record (canelous autograph) may be inserted, local or internal antibiotics may be administered and any other suitable treatment may be used.

Accordingly, devices and methods for fracture repair have been provided. One of ordinary skill in the art will appreciate that the present invention can be practiced by other than the described embodiments, which are presented for purposes of illustration and not of limitation. The invention is limited only by the following claims.

Claims (2)

1. A device for treating a fracture of a bone, the fracture comprising fragments, the bone having an inner cavity, the device comprising:

a structural scaffold for positioning the first bone segment relative to the second bone segment, the structural scaffold configured to be deployed in the lumen; and

an anchoring substrate configured to position the first and second bone segments, the anchoring substrate configured to be deployed in the lumen,

the apparatus further includes a central shaft member disposed at least partially within the structural support and at least partially within the anchoring substrate,

wherein the central shaft member defines a longitudinal direction; and a proximal portion of the central shaft member is longitudinally fixed to a proximal portion of the structural support at a proximal portion of the anchoring substrate,

the apparatus further includes a one-way lock configured to substantially prevent displacement of the central shaft member in a distal direction relative to the proximal portion of the structural brace,

wherein the one-way lock is a releasable linear ratchet mechanism.

2. A device for treating a fracture of a bone, the fracture comprising fragments, the bone having an inner cavity, the device comprising:

a structural scaffold for positioning the first bone segment relative to the second bone segment, the structural scaffold configured to be deployed in the lumen; and

an anchoring substrate configured to position the first and second bone segments, the anchoring substrate configured to be deployed in the lumen,

the apparatus further includes a central shaft member disposed at least partially within the structural support and at least partially within the anchoring substrate,

wherein the central shaft member defines a longitudinal direction; and a proximal portion of the central axis member is longitudinally fixed to a proximal portion of the anchoring substrate at the proximal portion of the anchoring substrate,

the apparatus further includes a one-way lock configured to substantially prevent displacement of the central shaft member in a distal direction relative to the proximal portion of the anchor substrate,

wherein the one-way lock is a releasable linear ratchet mechanism.