CN106659524A - Patient-matched instruments and methods for performing surgical procedures - Google Patents

Abstract

Disclosed herein is a system and method for developing a customized instrument for use in one or more surgical procedures. The system and method incorporate a patient's unique anatomical features or morphology. According to a preferred embodiment, the customized instrument includes a plurality of complementary surfaces. Thus, each instrument can be matched and oriented around the patient's own anatomical structure and can further provide any desired axial alignment or insertion trajectory. In an alternative embodiment, the instrument can further be aligned and/or matched with at least one other instrument used in the surgical procedure.

Description

Patient-matched instruments and methods for performing surgical procedures

technical field

The present disclosure relates to the field of medical devices and is generally directed to instruments configurable for use in a surgical setting for a specific patient based on the patient's unique anatomical characteristics, and methods of making and using the same.

Cross References to Related Applications

This application is a continuation-in-part of US Patent Application Serial No. 13/841,069 filed March 15, 2013. This application also claims priority to US Provisional Patent Application Nos. 61/832,583, filed June 7, 2013, 61/845,463, filed July 12, 2013, and 61/877,837, filed September 13, 2013. These applications are hereby incorporated by reference in their entirety.

Background technique

Given the complexity of surgical procedures and the different tools, instruments, implants, and other devices used in those procedures, and the varying anatomical differences between patients who receive those tools, instruments, implants, and devices , it is often challenging to create a surgical plan that takes into account the unique and sometimes irregular anatomical features of a particular patient. For example, the implantation of pedicle screws in the vertebral body (either as an appendage or as a stand-alone stabilization mechanism) has gained wide acceptance among surgeons treating many different spinal disorders, and although the performance of many different pedicle screw configurations Having become predictable, multiple challenges remain with the placement and insertion of these pedicle screws or other bone anchors. These challenges arise when the surgeon cannot reference bony landmarks or when the patient's anatomy is irregular in shape due to previous surgical procedures.

Surgeons now have the ability to easily convert magnetic resonance imaging (MRI) data or computed tomography (CT) data into data sets readable by computer-aided design (CAD) programs and/or finite element modeling (FEM) programs , this data set can then be used to create, for example, custom implants based on the dynamic properties of the anatomy with which they are associated. While this data is currently used by surgeons in surgical planning, it has largely not been used to create a custom set of instruments or other surgical devices designed to complement a patient's unique anatomy.

The prior art fails to teach a system for creating a set of surgical instruments based on data sets derived from MRI or CT scans. For example, using a patient-specific dataset for vertebral bodies may allow the surgeon to accommodate subtle variations in the position and orientation of plates or other bone anchors to avoid specific bony anatomy or in the positioning and alignment of adjacent vertebral bodies of irregularities. As another example, use of these data sets may also assist the surgeon in selecting a desired trajectory for the implantable device to avoid, for example, crossing the pedicle wall and disrupting the spinal canal during the actual procedure. Using these datasets allows surgeons to avoid these types of errors by creating custom tools and instruments that can include orientation, end stops, or other safety-related features to avoid over-torque and over-stressing of any implantable device. insert. These datasets also allow the surgeon to create a patient contacting surface that is oriented to match the one or more anatomical features represented by the dataset, and thereby quickly and efficiently position and place the one or more anatomical features in the proper position and orientation. or multiple patient contact surfaces.

Accordingly, it would be advantageous to provide an instrument suitable for use in surgery that is adapted and/or configured and/or capable of conforming to a particular patient's anatomical features and/or conforming to one or more additional instruments , so as to assist the surgeon to safely and efficiently perform the one or more surgical procedures, and additionally significantly reduce, if not eliminate, the problems and risks noted above. Other advantages over the prior art will become apparent from a reading of the Summary and Detailed Description of the invention and the appended claims.

Contents of the invention

According to one aspect of the present disclosure, a novel system and method for developing a custom instrument for use in one or more surgical procedures is described. Systems and methods according to this embodiment use the patient's unique morphology, which may be derived from captured MRI data or CT or other data, to derive one or more "patient-matched" Complementary surface of data points. Each "patient-matched" instrument is constructed around the patient's own anatomy, desired insertion trajectory (which can be verified in a preoperative setting using 3D CAD software, such as that disclosed in WO 2008027549, which is incorporated by reference in its incorporated herein in its entirety), and according to one embodiment described herein are fitted and oriented around other instruments used in the surgical procedure.

By providing additional background, context, and to further satisfy the written specification requirements of 35 U.S.C. §112, for the purpose of explaining and further describing the differences commonly associated with minor incision, minimal trauma, or minimally invasive surgery ("MIS") For the express purpose of tools and other instruments, the following documents are incorporated herein by reference in their entirety: U.S. Patent No. 6,309,395 to Smith et al.; U.S. Patent No. 6,142,998 to Smith et al.; U.S. Patent No. to Kemppanien et al. 7,014,640; US Patent No. 7,406,775 to Funk et al.; US Patent No. 7,387,643 to Michelson; US Patent No. 7,341,590 to Ferree; US Patent No. 7,288,093 to Michelson; US Patent No. 7,077,864; US Patent No. 7,025,769 to Ferree; US Patent No. 6,719,795 to Cornwall et al.; US Patent No. 6,364,880 to Michelson; US Patent No. 6,328,738 to Suddab; U.S. Patent No. 6,113,602; U.S. Patent No. 6,030,401 to Marino; U.S. Patent No. 5,865,846 to Bryan et al; U.S. Patent No. 5,569,246 to Ojima et al; U.S. Patent No. 5,527,312 to Ray; /0255564.

A variety of different surgical procedures can be accomplished by introducing rods or plates, screws or other devices into adjacent bony anatomy to join different parts, for example, of vertebrae to corresponding parts on adjacent vertebrae. MIS surgery is typically performed in the patient's sacroiliac region, lumbar, thoracic, or cervical region. MIS procedures performed in this area are usually designed to stop and/or eliminate all motion in the segment by destroying some or all joints in the segment and further utilizing bone graft material and/or rigid implantable This is accomplished by inserting a fixation device to fasten the adjacent vertebrae. By eliminating movement, back pain and further degenerative disc disease can be reduced or avoided. Fusion requires tools for accessing the vertebrae, such as surgical cannula for MIS procedures, and other tools for implanting the desired implant, bioactive material. These tools generally require the introduction of additional tools to prepare the site for implantation. These tools may include drills, drill guides, debridement tools, irrigation devices, vises, clamps, cannulas, and other insertion/retraction tools.

Spine surgery and other surgical procedures can be performed by a variety of different MIS procedures, as opposed to conventional surgical procedures and methods that typically require cutting muscle, removing bone, and retracting other natural elements. During MIS procedures, a less destructive approach to the patient's anatomy is implemented through the use of retractor tubes or openings, which take advantage of anatomy and current technology to limit damage to intervening structures.

In a typical MIS procedure on the spine, skeletal landmarks are created with fluoroscopy and small incisions are made over these landmarks. A series of dilators are applied until one or more cannulas are placed on the anatomy according to a number of different methods known in the art. In some procedures, a microscope is then placed over the surgical site to provide illumination and magnification of the three-dimensional view of the anatomy in order to ensure that the surgeon can accurately locate the desired patient anatomy and properly position and Any tools, instruments, or other surgical devices used in MIS procedures. Microscopes, however, are expensive and not widely available devices, require uncomfortable swivels of the surgeon's back and neck to obtain the necessary views, and are cumbersome to cover (large sterile plastic bags must be placed over the eight-foot-high structure). Using adequate lighting is also difficult due to the size of the microscope.

The main risk of accessing the intervertebral space during MIS surgery, especially on the spine, is inadvertent contact or injury to the paravertebral nerves, including the exiting nerve root, traversing nerve, and cauda equina (cauda equina). The exact location of these paravertebral nerves cannot be precisely determined prior to commencing surgery and therefore depends on the surgeon's ability to visually locate them after making the initial incision. In addition, the intervertebral spaces in the spine have other sensitive nerves disposed at locations that cannot be fully predicted prior to insertion of surgical tools into the intervertebral area. Accordingly, the risk of pinching or damaging spinal nerves when accessing the intervertebral space has proven to be a very limiting method and device for use during minimally invasive spinal surgery. Furthermore, when a cannula is received through a patient's back, such as when performing minimally invasive spinal surgery, small blood vessels rupture, thereby preventing the surgeon from seeing the intervertebral region after the cannula has been inserted. Other anatomical features of a particular patient may also obstruct the surgeon's view or make it difficult to provide illumination within the cannula. Accordingly, one particular shortcoming addressed by the present disclosure is to provide a patient-matched device to facilitate proper positioning and orientation without the need for a microscope or other instrumentation, and also to eliminate the problems associated with prior art MIS procedures.

The customization and integrated mating aspects of the presently disclosed system provide advantages over the prior art, in particular by providing multiple interlocking and/or mating points for each instrument, thereby reducing the number of points in the one or more surgical procedures. Potential for misalignment, misplacement, and subsequent errors during surgery.

Accordingly, one aspect of the present disclosure is to provide a method for preparing a custom surgical device or instrument, which in a preferred embodiment comprises the steps of:

obtaining data associated with the patient's anatomy;

transforming the obtained data into one or more three-dimensional datasets;

determining at least one trajectory or path to facilitate performing a surgical procedure on the patient;

determining at least one surface associated with the patient's anatomy;

generating a three-dimensional representation of the custom surgical device or instrument that incorporates the at least one trajectory or path and a matching surface for the at least one surface associated with the patient's anatomy; and

The three-dimensional surface is used to fabricate the custom surgical device or instrument.

According to another aspect of the present disclosure, a system and method for assisting one or more surgical procedures includes the steps of:

Obtaining data associated with the patient's anatomy from an MRI or CT scan;

converting the MRI or CT scan data into one or more three-dimensional datasets;

determining one or more axes or planes to be configured for orientation of a device to assist in the one or more surgical procedures to be performed on the patient;

modeling the device for assisting the one or more surgical procedures using the determined axis and taking into account any other constraints derived from the transformed one or more data sets;

Producing a prototype of the modeled device by, for example, using a rapid prototyping machine; and

The prototype is prepared for use during the one or more surgical procedures.

According to this aspect described above, the method step of considering any other constraints derived from the transformed data set or sets may include: resizing the modeled device to accommodate the surgeon's spatial constraints, The elements of the modeled device are oriented to avoid certain anatomical features, create one or more a surface, and so on.

According to yet another aspect of the present disclosure, the systems and methods include using data obtained from a radiographic imaging machine, fluoroscopy, ultrasound machine, or nuclear medicine scanning device.

In another aspect, these patient-matching characteristics can be confirmed by one or more additional procedures, such as fluoroscopy or other procedures known to those skilled in the art.

In one aspect of the present disclosure, the method includes using bone density data obtained from a CT scan of the patient's anatomy for planning the trajectory of a surgical guide and corresponding fixation device or instrument, e.g., aimed at penetrating bony anatomy Constructed cutting/pathing/drilling instruments. This data can be used in other ways contemplated and described herein to assist a surgeon in planning, visualizing, or otherwise preparing a patient for surgery.

In yet another alternative embodiment, data from a bone density scanner may be used to supplement or combine data obtained from one of the scanning devices described above to create a device designed to perform the surgical procedure. A device that remains in the patient's body after surgery. It should be expressly understood that the data from the bone density scanner is not necessary to practice the inventions described herein, but can supplement the data and assist the surgeon or other medical personnel in determining the proper position of the various instruments described herein , trajectory, orientation or alignment.

According to yet another aspect of the present disclosure, these data can be supplemented or combined with data from bone density scanners to achieve further control over the orientation of any desired axis, especially if the surgical procedure involves inserting In the case of one or more implantable devices.

According to yet another embodiment, the data obtained from the patient allows the device to be manufactured with defined paths through the device that are operatively associated with at least one tool, instrument or implant and that allow the at least one Tools, instruments or implants are inserted into these defined paths in a consistent and reproducible manner. Examples of devices that are implanted or that remain in the patient include anchoring devices, such as screws, pins, clips, hooks, etc., and implantable devices, such as spacers, replacement joints, replacement systems, stents, and the like.

According to yet another aspect of the present disclosure, a preconfigured surgical template is disclosed that includes one or more guides for receiving at least one tool. According to this embodiment, the one or more guides further comprise a plurality of patient contacting surfaces formed to substantially conform to the anatomy of the patient. The preconfigured surgical template is configured such that the patient contacting surfaces are configured for mating engagement with the anatomical features to ensure proper alignment and installation of the guide or template, and the The guides of the preconfigured surgical template are oriented in an orientation selected prior to manufacture of the preconfigured surgical template to achieve a desired positioning, alignment or advancement of tools within the one or more guides.

According to yet another aspect of the present disclosure, a method for creating a template for use in surgery is disclosed, the method comprising the steps of:

collect data from a patient that corresponds to that patient's unique anatomy;

creating a model of the template from the collected data, the model including multiple matching surfaces for the patient's unique anatomy;

providing data associated with the model to the fabrication machinery;

rapidly generating the template to include the plurality of mating surfaces and further including at least one additional mating surface corresponding to at least one tool or instrument used in the surgical procedure; and

The permanent device used in the surgical procedure is created based on the template.

In one embodiment of the present disclosure, the model is a digital model. In another embodiment of the present disclosure, the model is a solid model.

According to yet another aspect of the present disclosure, a system for performing surgery on a patient is disclosed, the system comprising:

surgical guides;

the surgical guide includes a plurality of surfaces determined from data obtained from the patient scan, the plurality of surfaces configured to match the patient's bony anatomy;

The surgical guide further comprises at least one trajectory or path determined according to the patient's bony anatomy for assisting the surgical procedure;

The surgical guide further includes at least one sleeve comprised of an electrically conductive material and having a first end and a second end;

an instrument comprising at least one first part made of an electrically conductive material and adapted to be received in the at least one sleeve by inserting the at least one first part into the first end of the at least one sleeve, and contacting the conductive material of the at least one sleeve;

wherein the at least one first portion of the instrument is adapted to pass through the at least one sleeve and exit the second end of the at least one sleeve; and

Wherein the surgical guide can receive electrical current to provide intraoperative monitoring (IOM) during contact with the surgical guide and with the patient's anatomy.

Additional aspects of the present disclosure relate to the system described above, and further comprising a surgical lead that receives electrical current by providing at least one electrode on a conductive material of the surgical guide and providing the at least one electrode with electrical current.

Additional aspects of the present disclosure provide a method for manufacturing a surgical guide at an off-site manufacturing site, on-site manufacturing site, clinic, surgery center, surgeon's office, public hospital, or in a private hospital.

Still other aspects of the present disclosure include a surgical guide manufactured using one of the methods described herein, wherein the guide is manufactured by a process selected from the group consisting of: a rapid prototyping machine , stereolithography (SLA) machine, selective laser sintering (SLS) machine, selective thermal sintering (SHM) machine, fused deposition modeling (FDM) machine, direct metal laser sintering (DMLS) machine, powder bed printing (PP ) machines, digital light processing (DLP) machines, inkjet photo resin machines, and electron beam melting (EBM) machines.

The following US patents and patent applications relating generally to methods and instruments related to surgery are hereby incorporated by reference in their entirety to provide written description support for various aspects of the present disclosure. The following US patents and pending applications are incorporated by reference: US Patent Nos. 7,957,824, 7,844,356, and 7,658,610, and US Patent Publication Nos. 2010/0217336, 2009/0138020, 2009/0087276, and 2008/0114370.

Those skilled in the art will appreciate that embodiments of the present disclosure may have different sizes. The sizes of the various elements of the disclosed embodiments can be determined based on a variety of factors including, for example, the anatomy of the patient, the personal or other device operating or otherwise using the instrument, the location of the surgical site, and the location of the device. The physical characteristics of the devices and instruments (including, for example, width, length, and thickness) with which the devices are used, as well as the size of the surgical instrument, are described herein.

Among other advantages, embodiments of the present disclosure present several advantages over the prior art, including, for example, the speed and effectiveness of the procedure, the minimally invasive aspect of the procedure, the disposability of these prototype devices, the ability to operate with minimal risk and Ability to introduce custom instruments or tools to the surgical site with minimal damage to surrounding tissue, lower risk of infection, more optimal placement and orientation of guides and implantable devices, placing instruments associated with that surgical procedure A more stable and controlled method of insertion and insertion to further reduce the likelihood of misalignment or misplacement of the instrument, and fewer and/or less expensive tools and instruments in the surgical site. For example, the embodiments reduce the number and need for multiple trays, instruments, and different sized devices used in a particular surgical procedure, thereby reducing the cost of equipment necessary to complete the surgical procedure. These embodiments also reduce the cumulative radiation exposure of both the surgeon and the medical personnel, as well as the patient, in the surgical setting.

It will be appreciated by those skilled in the art that embodiments of the present disclosure may be constructed from known materials to provide, or be predictably fabricated to provide these various aspects of the present disclosure. These materials may include, for example, stainless steel, titanium alloys, aluminum alloys, chromium alloys, and other metals or metal alloys. These materials may also include, for example, PEEK, carbon fibers, ABS plastics, polyurethanes, polyethylenes, photopolymers, resins, especially fiber-wrapped resinous materials, rubber, latex, synthetic rubber, synthetic materials, polymers, and natural materials.

Those skilled in the art will understand that the embodiments of the present disclosure may be used in conjunction with devices employing automated or semi-automated manipulation. Embodiments of the present disclosure may be designed so that, for example, remotely by an operator, remotely by an operator through a computer controller, by an operator using a proportioning device, programmed by a computer controller, by a servo-controlled mechanism, hydraulically driven mechanism, pneumatically driven mechanism, or piezoelectric actuators to shape and validate the device. It is clearly understood for the purposes of this disclosure that other types of machinery other than rapid prototyping machinery may be employed in the systems and methods disclosed herein, such as by computerized numerical control (CNC) machinery.

This summary of the invention is neither intended nor should be construed as representing the full breadth and scope of the disclosure. The present disclosure has been set forth in various levels of detail in the General Summary of the Invention and the accompanying Drawings and Detailed Description of the Invention sections, and the inclusion or exclusion of certain elements, components, etc. in this general summary of the invention is not intended to The scope of disclosure is limited. Other aspects of the disclosure will become more apparent from the detailed description, especially when taken in conjunction with the accompanying drawings.

The benefits, embodiments and/or characterizations described above are not necessarily complete or exhaustive, particularly with respect to the patentable subject matter disclosed herein. Further benefits, embodiments and/or characterizations of the present disclosure may be realized by utilizing, alone or in combination, what has been set forth above and/or described in the drawings and/or in the description below. However, the invention is defined by the claims set forth below.

Description of drawings

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the disclosure and, together with the general description given above and the detailed description of the drawings given below, serve to explain the principles of these disclosures.

It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary to an understanding of the disclosure or that render other details difficult to understand may have been omitted. It should be understood, of course, that this disclosure is not necessarily limited to the specific embodiments shown herein.

In these drawings:

1 is a perspective view of a three-dimensional model of a unique set of anatomical features from which a set of data points can be derived, according to one embodiment of the present disclosure;

FIG. 2 is a flowchart illustrating the various steps of performing a method of making and using an instrument for assisting surgery, according to one embodiment of the present disclosure;

Figure 3 is a side elevational view of a particular instrument for assisting in a surgical procedure according to one embodiment of the present disclosure;

Figure 4 is a rear elevational view of the instrument shown in Figure 3;

5 is a top plan view of the instrument shown in FIG. 3 relative to a distinct set of anatomical features and according to one embodiment of the present disclosure;

Figure 6 is a perspective view of the instrument and unique set of anatomical features shown in Figure 5;

Figure 7 is another perspective view of the instrument shown in Figure 3, illustrating the custom patient-matched surface of the instrument;

Figure 8 is a perspective view of an instrument according to an alternative embodiment of the present disclosure;

Figure 9 is a perspective view of an instrument according to yet another alternative embodiment of the present disclosure;

Figure 10 is another perspective view of the instrument shown in Figure 3 in use with custom-made instruments in a particular surgical procedure;

11A-B are perspective views of an instrument according to another alternative embodiment of the present disclosure;

Figure 12 is a perspective view of the instrument shown in Figures 11A-B in an assembled state;

Figure 13 is a perspective view of an instrument according to yet another alternative embodiment of the present disclosure;

Figure 14 is a perspective view of an instrument according to yet another alternative embodiment of the present disclosure;

Figure 15 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 16 is a different perspective view of the instrument shown in Figure 15;

Figure 17 is an exploded perspective view of the instrument shown in Figure 15 .

18-19 are perspective views according to yet another alternative embodiment of the present disclosure;

20-21 are perspective views according to yet another alternative embodiment of the present disclosure;

Figure 22 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 23 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 24 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 25 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 26A is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 26B is a perspective view according to the embodiment shown in Figure 26A;

FIG. 27A is a front elevation view according to yet another alternative embodiment of the present disclosure;

Figure 27B is a perspective view according to the embodiment shown in Figure 27A;

Figure 28 is an elevational view according to yet another alternative embodiment of the present disclosure;

Figure 29A is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 29B is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 30 is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 31 is a perspective view of yet another alternative embodiment according to the present disclosure;

Figure 32A is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 32B is a perspective view according to the embodiment shown in Figure 32A;

Figure 33A is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 33B is a perspective view according to the embodiment shown in Figure 33A;

Figure 33C is another perspective view depicting the cutting guide of Figure 32A, according to the embodiment shown in Figure 33A;

Figure 34A is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 34B is a perspective view according to yet another alternative embodiment of the present disclosure;

Figure 35 is a top plan view of yet another alternative embodiment according to the present disclosure;

Figure 36 is a detailed view of the device according to the embodiment shown in Figure 35;

Figure 37 is another top plan view of the device according to the embodiment shown in Figure 35;

Figure 38 is a top plan view of yet another alternative embodiment according to the present disclosure;

Figure 39 is another top plan view of the device according to the embodiment shown in Figure 38;

Figures 40A-D are additional top plan views of the devices according to the embodiment shown in Figures 35-39;

Figure 41 includes a side elevational view of a device according to another alternative embodiment of the present disclosure;

42A-B are top plan views of devices according to another alternative embodiment of the present disclosure;

43A-B are additional top plan views of devices according to yet another alternative embodiment of the present disclosure;

Figures 44A-B are perspective views of the device shown in Figures 43A-B;

45 includes a side elevational view of a drill bushing apparatus according to another alternative embodiment of the present disclosure;

Figure 46 is a front elevational view according to another alternative embodiment of the present disclosure;

47A-D are views of a component tray and arrangement device according to another alternative embodiment of the present disclosure;

48A-C are views of a device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

49A-C are views of another device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

50A-D and 51A-C are views of yet another device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

52A-C are views of yet another device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

53A-E are views of an unassembled and assembled device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

54A-C are views of a device for providing a patient-specific contact surface and track and an instrument for positioning the device;

55A-C are views of yet another device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

56A-D are views of yet another device for providing patient-specific contact surfaces and trajectories in a patient's cervical spine;

Figure 57 is a side elevational view of a patient-specific insert for use with the device shown in Figures 48A-56D referred to above;

58A-C are views of a modeling apparatus for creating patient-specific or general guides with predetermined trajectories;

59A-D are views of yet another embodiment of a guide for use in a patient's cervical spine;

60A-C are additional views of a guide used in a patient's cervical spine;

61A-C show views of yet another embodiment of a guide for use in a patient's cervical spine;

62A-E show views of yet another embodiment of a guide for use in a patient's cervical spine;

63A-H show a number of different views of additional embodiments of guides and associated instruments for use in a patient's cervical spine;

64-66 are views of a device with a custom insert for inserting a guide wire;

Figure 67 is the device shown in Figures 64-66 with the insert removed;

Figure 68 shows Figure 67 with the device removed but the filaments remain; and

69-73 are various views of a device used in MIS surgery according to yet another alternative embodiment of the present disclosure;

Figure 74 is a perspective view of the device shown in Figures 69-73 further comprising one or more optional alignment/depth/position control elements;

Figure 75 is an alternative embodiment of the device shown in Figures 69-73;

76A-C are views of alternative embodiments of devices further comprising one or more optional alignment/depth/position control elements;

77A-G are views of another alternative embodiment of a device further comprising one or more optional alignment/depth/position control elements;

78A-B are views of another alternative embodiment of a device further comprising one or more optional alignment/depth/position control elements;

79A-B are views of another alternative embodiment of a device further comprising one or more optional alignment/depth/position control elements;

Figure 80 is a detailed view of the device of Figures 79A-B;

81A-C are various views of a MIS device according to another embodiment;

82A-B are various views of a MIS device according to yet another embodiment;

83A-D are various views of a MIS device according to yet another embodiment;

84A-C are various views of a MIS device according to yet another embodiment;

Figure 85 is a view of another MIS device according to an alternative embodiment;

86A-C are various views of a MIS device according to yet another embodiment;

87A-B are various views of a MIS device according to yet another embodiment;

88A-B are various views of a MIS device according to yet another embodiment;

89A-B are various views of a MIS device according to yet another embodiment;

90A-C are various views of a MIS device according to yet another embodiment;

91A-D are various views of a MIS device according to yet another embodiment;

92A-D are various views of a MIS device according to yet another embodiment;

93A-D are a number of different views of templates that can be outlined using the methods described herein for creating patient-specific devices;

94A-C are various views of an embodiment of the present disclosure comprising multiple patient-specific guides;

95A-C are side elevational views of a linkage mechanism according to one embodiment of the present disclosure;

96A-C are side perspective views of an attachment mechanism according to another embodiment of the present disclosure;

97A-C are side perspective views of an attachment mechanism according to yet another embodiment of the present disclosure;

98A-C are side perspective views of an inserter and guide sleeve according to one embodiment of the present disclosure;

99A-G show different views of a system for aligning guides according to one of the various embodiments described herein;

100A-D are side perspective views of an insert according to one embodiment of the present disclosure; and

101A-D are various views of a patient-specific guide according to yet another alternative embodiment of the present disclosure.

detailed description

As shown in these figures and described in further detail herein, the present disclosure relates to a novel system and method for developing a variety of customized patient-matched instruments for use in many different surgical procedures. The systems and methods use the patient's unique morphology, which may be derived from captured MRI data or CT data, to derive one or more patient-matched instruments that include relative Complementary surfaces to those surfaces encountered in the process. According to various embodiments described herein, the patient-matched instrument may further include a desired axis and/or insertion trajectory. According to an alternative embodiment described herein, the patient-matched instrument may further be matched to at least one other instrument used during the surgical procedure. Other features of the present disclosure will become apparent after reviewing the following disclosure of the invention together with various embodiments.

Various embodiments of the present disclosure are depicted in Figures 1-101. Referring now to FIG. 1 , a perspective view of a three-dimensional model of a unique set of anatomical features is shown, according to one embodiment of the present disclosure. Here, the model 2 is formed from a plurality of vertebral bodies 4 , 6 , but according to other embodiments can also be formed from any anatomical group of a particular patient. Data associated with model 2 may be captured from MRI or CT scans, or from radiographic images of the patient's corresponding skeletal anatomy (or alternatively from other data sources). Once this data is captured, it can be converted into a CAD program using known software tools, where this data set represents the model 2 and can be used to provide profiles for forming one or more instruments to be used in surgery, Additional data points for size, shape and orientation.

According to alternative embodiments, these data may be obtained from ultrasound or nuclear medicine scanning devices. In yet another alternative embodiment, the data from the bone density scanner may be supplemented or combined with data to make a device designed to remain in the patient after the surgical procedure is completed, or alternatively In order to achieve further control over the orientation of any desired axis, particularly where the surgical procedure involves the insertion of one or more implantable devices.

FIG. 2 is a flowchart illustrating the various steps of performing a method of manufacturing an instrument for assisting surgery, according to various embodiments described herein. According to a preferred embodiment, the method comprises the steps of:

A) Obtain data associated with the patient's anatomy by MRI or CT scan;

B) converting the MRI or CT scan data into one or more three-dimensional datasets;

C) determining one or more axes to be configured to assist in the orientation of the one or more surgical procedures to be performed on the patient;

D) modeling the device for assisting the one or more surgical procedures using the determined axis and taking into account any other constraints derived from the transformed one or more data sets;

E) producing a prototype of the modeled device by, for example, using a rapid prototyping machine; and

F) preparing the prototype for use during the one or more surgical procedures.

As shown in Figure 2, the method may include additional steps or may be repeated for additional devices used in the surgical procedure. The step of obtaining data is typically performed in a conventional manner by subjecting the patient to a scan using MRI or CT or other suitable scanning equipment known in the art. The instrument then captures the data, and by software or other algorithmic tools known in the art, the data can be transformed into one or more three-dimensional data sets, such as by exporting the data into a known modeling software program, the Modeling software programs allow data to be represented in, for example, CAD format. Once the data is transformed, the device can be modeled to complement the one or more datasets, and the one or more data sets from the initial scan of the patient's anatomy either previously or by observation by the surgeon A set of one or more axes is used to orient the device.

This method step of considering any other constraints derived from the transformed one or more datasets may include: resizing the modeled device to accommodate the surgeon's space constraints, modifying elements of the modeled device Orienting to avoid certain anatomical features, creating one or more surfaces that can be conveniently operatively associated with one or more instruments and/or tools used in the one or more surgical procedures, and the like. The prototype may be produced using known rapid prototyping machinery, or alternatively by milling machinery such as a CNC milling machine. Alternatively, an initial device made by this method can be presented in a temporary state for further consideration and/or manipulation by a surgeon, and then finalized using one of the methods described herein. These steps may be repeated for complementary devices, some or all of which may include additional mating surfaces relative to the patient's anatomy or previously fabricated devices (i.e., the devices may be manufactured with features for making a or mating surfaces where multiple devices abut together, as described in more detail below).

Alternatively, the systems and methods described herein may facilitate the alignment of different anatomical features of a particular patient, such as, for example, the alignment of multiple vertebral bodies within a patient in order to correct spinal deformities. For example, the one or more data sets may provide the initial locations of these anatomical features, but may be further processed by the surgeon in the preoperative setting to create the desired one or more data sets, for example in the one or more The final location of these anatomical features when the surgical procedure is complete. In this way, the devices formed by the systems and methods described above can be used in the initial or final positions of the anatomical features and can be matched to those specific positions and orientations for each stage of the surgical procedure. These staged devices will in turn provide visual guidance for the surgeon to determine the degree of correction achieved by the surgical procedure compared to the pre-operative plan. Other variations of the methods of the present disclosure are described in the Summary of the Invention and included in the appended claims.

Fabrication methods may include the use of rapid prototyping machines, such as stereolithography (STL) machines, selective laser sintering (SLS) machines, or fused deposition modeling (FDM) machines, direct metal laser sintering (DMLS), electron beam melting ( EBM) machines, or other additive manufacturing machines. An example of such a rapid prototyping machine is commercially available from the company 3D Systems and is known under the model number SLA-250/50. The rapid prototyping machine selectively hardens liquid, powdered, or otherwise unhardened resin or metal into a three-dimensional structure that can be separated from the remaining unhardened resin, washed/sterilized, and Use it directly as this instrument. The prototyping machine receives the individual sets of digital data and produces a structure corresponding to each desired instrument.

Often, since stereolithography machines produce resins that may have sub-optimal mechanical properties (which often may not be acceptable for specific surgical applications), prototype molding machines may be used instead to produce molds. After making the mold, conventional pressure or vacuum molding machines can be used to produce the device from more suitable materials, such as stainless steel, titanium alloys, aluminum alloys, chrome alloys, PEEK, carbon fiber, or other metals or metal alloys.

According to another alternative embodiment, the system and method may include providing the one or more data sets to a CNC machine, which in turn may be used to fabricate a custom milled instrument. In yet another alternative embodiment, mass production of devices according to embodiments described herein may also be achieved, for example where a particular orientation or insertion trajectory is shared among a large group of patients.

According to one particular embodiment of the present disclosure, a system and method for making instruments for use in various surgical procedures related to a patient's spine is provided. Individuals with degenerative disc disease, natural spinal deformities, herniated discs, spinal injuries, or other spinal conditions often require surgery in the affected area to relieve the individual's pain and prevent further damage. Such spinal surgery may involve removal of damaged joint tissue, insertion of tissue implants, and/or immobilization of two or more adjacent vertebral bodies, where the surgical procedure varies depending on the nature and extent of the injury .

For patients with varying degrees of degenerative disc disease and/or nerve compression associated with low back pain, spinal fusion surgery or lumbar fusion ("fusion") is often used to treat the degenerative disease. Fusion typically involves distracting and/or decompressing one or more intervertebral spaces, followed by removal of any associated facet joints or discs, followed by joining or "fusing" two or more adjacent vertebrae together. Fusion of the vertebrae also typically involves the fixation of two or more adjacent vertebrae, which can be accomplished by introducing rods or plates, and screws or other devices, into the spinal joint to connect different parts of the vertebrae to the adjacent vertebrae on the corresponding part above.

Fusions can be performed in the patient's lumbar, thoracic, or cervical regions. Fusion requires tools for accessing the vertebrae and implanting the desired implant, any bioactive material, etc. Such procedures often require the introduction of additional tools and/or instruments, including drills, drill guides, debridement tools, irrigation devices, vises, clamps, cannulas, retractors, distractors, knives, cutting guides, and other insertion/pulling tools and instruments. The insertion, alignment and placement of these tools, instruments and fixation devices are critical to the success of the surgical procedure. Likewise, providing a custom and patient-specific tool or instrument increases the likelihood that the surgical procedure will be successful.

For example, one particular instrument formed by the systems and methods described above and that may be used in a particular fixation-related surgical procedure is depicted in FIGS. 3 and 4 . According to one embodiment of the present disclosure, the instrument may be in the form of a pedicle screw guide 10 comprising a central body 12 and two generally elongated wings 14 each terminating in a In a generally cylindrical column 16 . In a preferred embodiment, as depicted in Figure 3, each of these cylindrical posts 16 is substantially hollow so as to permit one or more types of devices to be inserted therethrough. The intermediate body 12 further includes a longitudinal cavity 20 formed adjacent the lower surface of the intermediate body 12 (as shown in the perspective view taken in FIG. 3 ). As described in more detail below, each of these cylindrical posts 16 further includes a lower patient contacting surface 18, 19 which, together with a longitudinal cavity 20, provides for contact with anatomical features. Match multiple patient-specific profiles.

The contour and position of these lower patient contacting surfaces 18, 19 and longitudinal cavity 20 are formed using one or more data sets converted from an MRI or CT scan of the patient. The remainder of the pedicle screw guide 10 shown in FIGS. 3 and 4 can be formed to the particular preference of the surgeon. For example, the wings 14 need only be long enough to position the two cylindrical posts 16 in positions corresponding to the patient-matched anatomy. The wings may take other shapes, orientations, thicknesses, etc. without departing from the novel aspects of the present disclosure. Similarly, the intermediate body 12 need only be dimensioned to accommodate the longitudinal cavity 20 and may include other extensions in addition to these wings 14 to assist in grasping or manipulating the pedicle screw guide 10 as desired.

Additionally, these wings 14 may be made of a semi-malleable or semi-rigid material to create at least a partial interference fit when the pedicle screw guide 10 is placed over the corresponding anatomical set for a particular surgical procedure. For example, a snap or interference fit may be formed by slight deflection of the wings 14 when placing the two cylindrical posts 16 adjacent the inferior articular process, and then once the wings are positioned in their final orientation , it deflects to the desired position. Additional aspects of the disclosure in this regard are described in more detail below.

5 is a plan view of the instrument shown in FIG. 3 relative to a unique set of anatomical features, according to one embodiment of the present disclosure. Here, the pedicle screw guide 10 is positioned such that the intermediate body 12 is centrally located over the central portion of the vertebral body 4 such that the longitudinal cavity 20 matches the contour of the spinous process 41 of this particular vertebral body 4 . Also, the cylindrical posts 16 are positioned one at each medial side of the pedicle screw guide 10 such that the wings 14 span the lamina 43 of the vertebral body 4 and the cylindrical posts 16 are located at the inferior articular process Near 44, 45. The lower patient contacting surfaces 18 , 19 of the cylindrical post 16 are formed to mate with the contours of the inferior articular processes 44 , 45 and behind the superior articular processes 42 .

Thus, the pedicle screw guide 10 provides multiple mating or mating locations, any one of which, if not properly positioned, will interfere with seating of the remaining two locations. In this regard the pedicle screw guide provides a significant improvement over the prior art which may be slightly rotated, misaligned or misplaced and still appear to the surgeon to be properly seated. The redundancy and plurality of mating surfaces ensures that the pedicle screw guide 10 is both correctly positioned and properly aligned. If the pedicle screw guide 10 is not properly positioned or aligned, the lower patient-contacting surfaces 18, 19 will not fit over the respective inferior articular process 44, 45 and thus prevent the longitudinal cavity 20 from sitting firmly there. On the spinous process 41.

FIG. 6 is a perspective view of the instrument shown in FIG. 5 . Desired insertion trajectories A, B are shown to illustrate the positioning of each cylindrical post 16 in addition to the orientation of these axes, which may be relative to their connection to the lower joint. The projections 44, 45 are seated adjacently but independently (ie, the orientation of the axis with respect to the normal may be different between the cylindrical posts 16). The orientation of the cylindrical posts 16 is also obtained from the one or more data sets described above, and in a preferred embodiment is selected based on that the orientation will allow the fixation device (i.e., the pedicle screw) is inserted in line with the position of the pedicle and in a direction that prevents the fixation device from penetrating the pedicle (that is, eliminating the screw from extending through the pedicle or in a way that causes the pedicle to The probability that the root screw will be inserted at an angle that exits from the side of the pedicle).

These customized or configured patient contacting surfaces of the instruments shown in FIGS. 3-6 are exemplified by the bottom perspective view of pedicle screw guide 10 in FIG. 7 . Here, the lower patient-contacting surfaces 18, 19 may include dynamic contours having compound radii such that the surfaces 18, 19 conform exactly to the corresponding anatomical features of the vertebrae. Thus, the surfaces substantially conform to the surfaces of the vertebrae where the cylindrical post 16 is to be positioned during surgery, and do not substantially conform to a different surface of the vertebrae. In this way, the surgeon can be informed immediately if the pedicle screw guide 10 is misaligned, since it will not be properly secured to the vertebrae.

Figure 8 illustrates an instrument according to an alternative embodiment of the present disclosure. In this embodiment, a multi-segmented pedicle screw guide 10' is shown relative to several adjoining vertebral bodies 4,6,8. The multi-segment pedicle screw guide 10' includes a plurality of secondary wings 14' and tertiary wings 14", each of which has a corresponding pedicle screw for inserting and aligning a plurality of pedicle screws into adjoining Cylindrical posts 16', 16" in vertebral segments 6, 8. It should be expressly understood that a plurality of segments greater or less than three in number may be implemented without departing from the spirit of the invention.

Figure 9 shows an instrument according to yet another alternative embodiment of the present disclosure comprising a plurality of sections 12", 12'", 12"". Similar to the embodiment shown in Figure 8, this pedicle screw guide 10" allows the alignment and insertion of the pedicle screws into the segments 4, 6, 8 of the spine. However, the segments 12 ", 12'", 12"" each have a modified intermediate body comprising an engaging end and a receiving end such that the plurality of segments 12", 12'", 12"" can be as shown in FIG. The receiving and engaging ends of each of the plurality of segments 12", 12'", 12"" are different so that only these segments 12", 12"" can be achieved during assembly , the correct ordering of 12"" (i.e., segments 12" can only be linked with segments 12'"). This figure illustrates yet another aspect of the present disclosure, in particular pairing or linking specific devices that are adjacent to each other The ability to further ensure the alignment and pairing of specific anatomical features associated with each device, and provide a means of applying corrective forces to the vertebrae and visualize the degree of deformity correction.

Fig. 10 shows an instrument according to the embodiment of Fig. 5 with custom-made instruments that may be used with the instrument during a particular surgical procedure. For example, in spinal fusion procedures such as the one described above, it is common for the surgeon to attach one or more pedicle screws to the patient's vertebrae to achieve the desired intravertebral fusion. The cylindrical post 16 may have an inner diameter corresponding to the gradually increasing outer diameter of the instrument 60, so that the instrument 60 can only be advanced into the cylindrical post 16 a predetermined distance, thereby providing a hard stop action And in turn provides a means for preventing the pedicle screw 62 from being advanced too far into the patient's bony anatomy. According to yet another embodiment, the hollow portion of the cylindrical post 16 may be provided with a section (not shown in FIG. 10 ) with a narrowed inner diameter corresponding in a manner and position to that of the instrument 60. The outer diameter of the instrument fits the end stop so as to prevent the instrument from over-penetrating into the cylindrical post 16 and thereby inserting the pedicle screw 62 beyond a safe limit.

Figure 11 is a perspective view of an instrument according to yet another alternative embodiment of the present disclosure. Here, the instrument is a pedicle screw guide 100, which further includes a narrow bridge 112 around the intermediate body that allows a collar 130 to couple with the modified pedicle screw guide 100, as shown in FIG. shown in 12. The collar 130 can include a contoured lower surface that matches the patient's spinous processes (similar to the longitudinal cavity of the embodiment shown in FIG. The procedure is matched to the specific anatomical features of the operated vertebrae. Thus, in this embodiment, in addition to the lower patient-contacting surfaces 118, 119 of the two cylindrical posts 116, the collar 130 also includes at least one of the patient-matching contours and can be removed and adapted according to Surgical procedures on different vertebrae require replacement with other collars of different contours. In this embodiment, the cylindrical posts 116 may further include one or more apertures 111 to facilitate visualization of the pedicle screws as they are being advanced into the cylindrical posts 116 .

13 is a perspective view of an instrument for assisting surgery according to yet another alternative embodiment of the present disclosure. In this embodiment, the instrument formed by the systems and methods described above includes a laminectomy cutting guide 150 . This laminectomy cutting guide further includes at least one alignment channel 151 for insertion of a guide wire or other fastening element, and a cutting slot 152 for directing the path of a blade or other cutting edge. As with the pedicle screw guide described above in FIG. 3 , this laminectomy cutting guide 150 also includes a lower patient contacting surface 155 that allows the laminectomy cutting guide 150 to interact with one or more paired vertebrae. While shown in FIG. 13 as a generally rectangular prism, it should be expressly understood that other geometries for the laminectomy cutting guide 150 are equally useful and should be considered within the scope of the present disclosure. Inside.

Figure 14 shows yet another alternative embodiment of the present disclosure. In this embodiment, the instrument formed by the systems and methods described above includes a tube retractor 160 that also includes a lower patient contacting surface 165 . This patient-contacting surface 165 can be formed in a section 164 of the tube retractor that can be selectively removed from the cylindrical body 163 of the tube retractor 165 so that when the section 164 is reformed for each patient and Once coupled to the cylindrical body 163, the tube retractor 165 can be reused in many procedures. The tube retractor also includes a generally hollow lumen 162 for manipulation during insertion and at least one tab 161 that assists the surgeon in ensuring proper alignment of the tube retractor 160 .

15-17 illustrate yet another alternative embodiment of the present disclosure. In this embodiment, the template may include patient-matched guides 180 for assisting in the placement of one or more interbody devices, such as, by way of example and without limitation, for introducing one or more biological Implantable scaffolds of active substances or bone grafts, or artificial intervertebral discs. In FIGS. 15 and 16, the patient-matched guide 180 is shown in one possible position (between two adjacent vertebrae) relative to a unique anatomical set to assist the surgeon in placing one or more vertebral bodies. room device.

A patient-matched guide 180 is shown in an exploded view in FIG. 17 in order to demonstrate how the various components for a particular surgical procedure can be fabricated using the systems and methods described above. These components include a patient-specific insert 182, a guide sleeve 184, and a plurality of connectors 186, which in the final assembled state form the patient-matched guide 180 shown in FIG. 15 .

Referring now to FIGS. 18-19 in detail, another alternative embodiment of the present disclosure is shown. According to this embodiment, a surgical template 190 is depicted, which may further incorporate securing devices 198, 198' which may be used to secure the template 190 in a number of different ways. According to this embodiment, the template 190 includes an intermediate section 192 oriented across the patient's spinous process, and may further include a plurality of apertures for insertion of one or more fixation devices 198, 198' (in FIGS. 18-19 not shown). Template 190 may further include two laterally extending portions or “wings” 194 each terminating in a guide 196 . The description of the guide provided above in connection with other embodiments disclosed herein is hereby incorporated by reference with respect to this embodiment.

According to the embodiment shown in FIGS. 18-19 , a plurality of fixtures 198 , 198 ′ can be inserted through a plurality of apertures (not shown) in the middle section 192 of the template 190 to stabilize and secure the template 190 . Fastened to the spinous process of the patient. According to one embodiment, the orientation and orientation of the first fixture 198 is different from the orientation and orientation of the second fixture 198' to further increase the stability of the template 190 prior to raising the permanent fixtures. According to yet another embodiment, the orifices may be located at locations other than those depicted in FIGS. 18-19 and may be smaller or larger in number depending on the needs of the surgeon and patient-specific bone anatomy.

Referring now to FIGS. 20-21 in detail, yet another alternative embodiment of the present disclosure is shown. In this embodiment, template 200 further comprises two further contact surfaces 205, preferably having hollow openings at the patient contact end, and holes extending therethrough for insertion of fixation devices 199, 199' mouth. As described above in connection with FIGS. 18-19 , the purpose of these fixation devices 199 , 199 ′ is to secure the template 200 to the bony anatomy and to assist in securing the permanent fixation devices through the guides 206 (not shown).

Referring to FIG. 20 , the template 200 includes a protrusion 208 extending from the top surface of the template 200 for insertion into the first fixture 199 , wherein the protrusion 208 is partially hollow to accommodate the shape and length of the fixture 199 . Protrusions 208 extend over laterally extending portions or "wings" 204 of template 200 as shown in FIG. 20 . Protrusions 208 may extend more or less above the template than shown in FIG. 20 in order to provide a hard stop for insertion of fixture 199 . Similarly, the opposite laterally extending portion or "wing" of the template 200 also includes a protrusion 208' for insertion of the second fixture 199'.

In conjunction with the above disclosure regarding determining and modeling patient contact surfaces, the template 200 has at least four patient-specific contact surfaces 205, 207 according to this embodiment. This embodiment improves template stability and positioning and allows the surgeon to achieve a dynamically stable surgical template, which in turn ensures that all permanent fixation devices are positioned and inserted in directions and orientations predetermined for specific surgical needs. This is achieved by providing these four patient contacting surfaces that act like the legs of a table and are positioned at different positions (and on different planes) with respect to the patient's bony anatomy to further refine the template 200 for stability and positioning.

According to the embodiment shown in FIGS. 18-21 , these guides and other patient contacting surfaces may be depth specific and may further incorporate specific inner diameters to accommodate insertion of the temporary fixation device into the patient's bony anatomy to Controlled depth. Additionally, these guides may have specific threaded inner surfaces to accommodate specific fastening devices and facilitate insertion of threaded fastening devices such as screws. In some embodiments, the templates may be patient-specific designed to prevent over-penetration of the fixation devices into the bony anatomy, or to facilitate temporary fastening of the templates by a depth-controlled first set of fixation devices.

According to yet another embodiment, each of the patient-contacting surfaces may have an integrated blade with a patient-contacting cutting surface integrated around at least a portion of the patient-contacting surface to precede insertion of the fixation devices. The template is further set and fastened to the bony anatomy. The purpose of the blade is to cut through soft tissue to achieve better template-to-bone contact between the template and the patient's bone anatomy. The hollow portions of these guides and other patient contacting surfaces of the template further allow soft tissue to become located within these hollow surfaces after the template has been set in the desired position, thereby further securing the template to the patient's bony anatomy. The blade may be substantially cylindrical or circular to match the shape of the guide, or may be elliptical, polygonal or otherwise shaped to match the patient contacting surface.

To further increase the stability of the seating and placement of the patient contacting surfaces described herein to the patient's anatomy, these contacting surfaces may further include one or more spikes or teeth for contacting and at least partially Penetrate the patient's anatomy to secure the device in place. In one embodiment, these spikes or teeth can be made of the same material and can be permanently attached to the patient contacting surface. In another embodiment, the spikes or teeth can be made of different materials, such as those described herein, and can be further selectively inserted into one or more of the patient contacting surfaces as desired.

Referring now to FIG. 22, yet another alternative embodiment of the present disclosure is shown. According to this embodiment, template 220 has a plurality of patient-contacting surfaces 212, 219 achieved through the use of "floating" patient-matched components 214 that can be positioned over the first set of patient-contacting surfaces. 212 is inserted into one of guides 216 before or after being positioned. Patient-matched component 214 may further include a longitudinal key 218 corresponding to a slot or groove (not shown in FIG. 22 ) in guide 216 to facilitate proper alignment of patient-matched component 214 relative to template 220. positioning (rotationally).

Thus, according to this embodiment, formwork 220 may be secured in a first position using at least two fixtures (not shown) that secure formwork 220 to its desired position, and then a plurality of The patient matched component 214 is inserted into the guides 216 of the template 220 and seated around two different locations of the patient's bony anatomy.

Referring now to FIG. 23 , there is shown yet another embodiment according to the present disclosure, wherein an instrument 240 can be used to assist in inserting a template 230 according to various embodiments disclosed herein. The instrument 240 is preferably comprised of a handle 242 and an extension arm 244, the length of which may vary depending on a particular patient's anatomy and/or surgeon preference. At the distal end of the extension arm 244 is a tab 246 formed to mate with a corresponding slot 236 on one surface of the template 230 . In operation, instrument 240 may be coupled to template 230 and used to insert and position template 230 within a patient's surgical site.

Referring now to FIG. 24, another alternative embodiment of the present disclosure is shown. According to this embodiment, a template 250 may be provided which is not patient-specific (but may be in alternative embodiments) and which further provides for the attachment of a plurality of patient-specific components 254 to the template 250 on means. As shown in FIG. 24, these components 254 can be fastened by aligning the apertures 252, 258 and attaching one or more fastening devices (not shown in FIG. 24) such as screws, pins or other similar devices. to the template 250. Once the components 254 are secured to the template 250, the patient contacting surfaces 262 can be used to guide and position the template 250 with the integrated components 254 in a desired position. In this way, a standard template 250 can be provided before any patient data is obtained and combined with patient-specific components 254 formed after the patient's anatomical data has been captured, thereby eliminating the need for specific surgical applications. And custom machining or fabrication of the template.

According to this embodiment, template 250 may be reusable, or may be disposable in an alternative embodiment. Template 250 may be constructed of any of the materials listed herein, but in preferred embodiments is formed of a metal, metal alloy, or polymer-based material. According to yet another alternative embodiment, these parts 254 may snap into place or have a friction fit connection, and thus require no screws or other fastening means to attach to the formwork 250 . In another alternative embodiment, the template 250 may be provided in a variety of set sizes and orientations to cover variations in the patient's anatomy as well as different sized vertebral bodies (with respect to different segments or regions of the patient's spine). Word).

Referring now to FIG. 25 in detail, another embodiment of the present disclosure is shown. In this embodiment, the template 270 has a plurality of patient contacting surfaces 276, 278 and further includes a plurality of clamps 272 for securing the template 270 to the patient's spinous processes. According to this embodiment, the clamps 272 each have a patient contacting surface 274 (here designed for contacting the spinous processes around the respective lateral sides) to secure the template to the desired location on the patient's anatomy. Each of these clamps 272 may be positioned laterally relative to formwork 270 (shown in elevation) and attached at a set position relative to the body of formwork 270 . The clamps 272 may be secured in a fixed position against the spinous processes by various known means, including keyed structures, ratchet mechanisms, direction-specific blocking mechanisms, or selectively releasable tightening mechanisms. In this embodiment, the clamps 272 allow opposing forces occurring in the bony anatomy to be balanced against the patient's template 270 . In turn, the clamping mechanism ensures and maintains the alignment of the template 270 relative to the bone surface, further ensuring accuracy with respect to insertion of the permanent fixation device. These clamps may take a variety of shapes or embodiments including pins, paddles, or any other type of opposing surfaces that apply opposing stabilizing forces.

According to one embodiment, the surgical guides depicted in FIGS. 24 and 25 may include surfaces around the patient-contacting ends of these guide sleeves (see 254, FIG. 24 ) to conform to the soft tissue present at the facet complex, at Here the patient engaging end of the guide sleeve contacts the patient's vertebrae (see 278, Figure 25). Thus, according to this embodiment, the one or more generally cylindrical guide sleeves include patient contacting surfaces that appear as half cylinders or part cylinders (as shown in FIGS. 24 and 25 ) to avoid interference with them. Soft tissue contact.

In an alternative embodiment, the surgical guide may further include one or more portions that have been cut, or may be selectively cut or broken, to facilitate placement. One such surgical guide is shown in Figures 26A and 26B. According to this embodiment, the surgical guide includes a plurality of patient contacting surfaces, one or more of which have been modified to facilitate clearance when the guide is being placed in place (see surface 282 in FIG. 26A ). ). Additionally, the surgical guides described herein may include one or more clamping elements, such as clamp 284 depicted in FIGS. 26A and 26B , for securing the guide in a preferred position.

According to yet another embodiment, the one or more guide sleeves 254 may further allow insertion of one or more insert and guide sleeves 288, as shown in FIGS. 27A and 27B. The inserts 288 may be sized such that the outer diameter mates with the inner diameter of the one or more guide sleeves 254, and have a longitudinally extending through the inserts 288 to accommodate drill bits or taps of different sizes (for example, Words) the internal orifice. In practice, the insert 288 may facilitate and guide the drill tip to create a pilot hole for further insertion of a fixation device, such as a screw. According to one embodiment, the insert 288 may further include one or more markings for identifying a particular insert 288 for a particular segment of the patient's spine, or other markings indicating the direction, orientation, use or purpose of said insert 288 .

Referring now to FIG. 28 , the inserts 288 equipped with surgical guides for mating with the guide sleeve 254 may have different lengths L and may depend on the geometry of the guides, patient anatomy, purpose of the insert and so on are made longer or shorter. For example, if a particular drill bit of greater depth is required, insert 288 may be shorter to accommodate the drill tip penetrating further into the patient's vertebrae. Likewise, the internal bore of insert 288 may have different diameters (as depicted in FIGS. 29A and 29B ) depending on the particular tool or instrument with which the insert is intended to be used. In this way, the surgeon can ensure that he or she is passing through each of these inserts (the inserts may further include one or more markings to indicate the intended location or specific use of the insert) while performing the surgical procedure. mark) using the correct tool, such as a drill or tap. A further illustration of these principles is described above with reference to FIGS. 29A and 29B , which respectively depict an insert with a 4.5 mm bore for placing a tap instrument, and a 1/8 inch drill for use with a 1/8 inch drill bit. inch bore inserts.

Referring now to FIG. 30 , according to one embodiment, the inserts 288 described above may also include patient-specific contact surfaces 294 for further aligning the inserts 288 to patient-specific anatomy in addition to the guide sleeve 254 . The structure matches. This allows greater stability and positioning of the insert 288 and allows the guide including the insert 288 to be in the correct position. In addition, for inserts 288 used in conjunction with drills or other vibrating or oscillating tools, these patient-matched surfaces 294 on inserts 288 will also prevent the distal end of the drill from "walking" on the surface of the vertebral body when creating the initial pilot hole. ” or move, thereby reducing the risk of incorrect trajectories for fixtures.

According to further embodiments of the present disclosure, the patient contacting surfaces formed by one or more protrusions extending from the body of the surgical guide described in more detail above (and according to several embodiments described herein) may include sharp Or semi-sharp contact edge for penetrating and attaching to the soft tissue surrounding the patient's anatomical features (eg, facet joints). According to this embodiment, the contact surfaces may comprise concave cavities for soft tissue invasion. These concave cavities have edges around the outside of the legs that may be sharpened or selectively sharpened to facilitate cutting through soft tissue to rest on/mate with the underlying bone. This is especially important for spinal surgery where the exact position of the patient contacting surfaces must lie within a small margin of error and must be maintained permanently throughout the procedure.

Referring now to FIG. 31 in detail, the insert may further include a key or notch 296 around a surface of the generally cylindrical body of the insert configured for mating with the guide of the device. Cutouts or slots 298 on barrel 254 mate. In this way, proper rotation/orientation of the guide insert 288 is ensured as it enters the hollow body of the guide sleeve 254 .

Referring now to FIGS. 32A-34B , further illustration of a cutting guide, such as the one depicted above in FIG. 13 , is provided. According to one embodiment, the cutting guide comprises a plurality of patient-specific contact surfaces 302 around at least one surface of the cutting guide. The cutting guide further includes in a preferred embodiment a patient-specific "track" 303 for facilitating insertion of cutting instruments (as shown in FIGS. 33A-C ) and is controlled by further providing one or more instrument contact surfaces 304. The depth of insertion of the instrument in order to prevent unnecessary cutting of the underlying surface during a particular surgical procedure. According to the embodiment shown in connection with Figures 32A-34B, the cutting guide may be provided for laminectomy. According to other embodiments, the patient-specific guide may be manufactured to perform, inter alia, subtotal corpectomy, transpedicular osteotomy (PSO), Smith-Petersen osteotomy (SPO), Total vertebrate resection (VCR), or asymmetrical osteotomy (in sagittal or coronal plane).

These patient-specific cutting guides are fabricated from patient anatomy data and can assist in performing complex procedures with greater certainty of outcome. For example, certain osteotomies such as PSO and SPO require very high surgical skill and are often time consuming. This is due in part to the close relationship of the vascular and neural elements to the bone structure, which presents guidance challenges for the surgeon to safely and efficiently resect the bone during one of these procedures. This is especially true for the posterior approach. By using patient-specific guides, the surgeon can confirm the location and alignment of the cutting trajectory and path prior to commencing the procedure, and in further context of the present disclosure provided above with respect to FIGS. A certain degree of depth control is essential for the exposure of neural elements.

In one embodiment, the cutting tools associated with the cutting guides shown in FIGS. 32A-34B are typically of the type currently being used in current surgical procedures. According to another embodiment, the instrument may include a dedicated cutting burr or tip to facilitate further control of the instrument's position and depth, as described in more detail below. For example, as shown in Figures 33A-33C, the cutting portion of the instrument may have a trackball 308 that prevents the instrument from being inserted into the cutting guide further than is required for the patient-specific procedure.

As shown in more detail in FIGS. 34A-34B , trackball 308 may be inserted into a first portion of the "track" 303 of the cutting guide, but not permitted to be inserted into a second or deeper portion of the "track" of the cutting guide. (allowing the cutting surface to advance through the second or deeper portion), thereby ensuring the correct depth of the cutting instrument. Additional geometric configurations other than those shown in FIGS. 34A-34B may be provided that allow the trackball 308 to move horizontally, and in some cases laterally and toward the top surface of the cutting guide. Move down into the track 303 of the cutting guide. In this embodiment, the cutting instrument will therefore be allowed to move to a certain depth in a certain position in the track 303 of the cutting guide around the patient's anatomy, but other positions around the "track" 303 of the cutting guide will be allowed to move to a certain depth. Achieve greater depth in position. Thus, the allowable depth with respect to the instrument relative to the cutting guide may be variable around the "track" 303 of the cutting guide.

Other benefits achieved through the use of these patient-specific cutting guides include: providing a means to achieve rapid and controlled bone resection; providing spatial orientation of the cutting tools used during the procedure; Both guidance and visualization during preoperative planning ensure correct orientation of the incision; provide accurate calculation of deformity correction prior to cutting; provide accurate bone resection, which in turn ensures deformity correction; depth-controlled Cutting restrictions to protect neurological and vascular elements; controlled cutting vectors and to avoid contact or injury to neurological elements; and in posterior, anterior, posterolateral, transforaminal, or direct The ability to provide incisional access in the lateral approach.

Figure 35 is a top plan view of yet another alternative embodiment according to the present disclosure. In this embodiment, device 310 may provide one or more patient contacting elements including break-off portions 314 that allow for placement of fixation devices (e.g., pedicle screws) without separating the device from the patient's bony anatomy. . The break-off side edges may be formed by creating slots 315 in the surface of the surgical guide portion of the device that provide perforation axes for breaking the portions 314 off.

According to this embodiment, the guide sleeve may be asymmetrical, which allows for two different inner diameters: one to facilitate the guidance of hand tools (i.e., drill bits, taps) and the other to accommodate the protrusion or cap of the device (e.g. , the nose (tulip) of the pedicle screw). Once the break-off portion 314 of the guide sleeve is removed, a clear line of sight and path to the vertebrae is possible and allows pedicle screw placement without removing the guide.

FIG. 36 is a detailed view of the device according to the embodiment shown in FIG. 35 . A detailed view of these slots 315 is shown in FIG. 36, which in the preferred embodiment may be formed during fabrication of 310, but in alternative examples may be punched or otherwise formed after the device has been fabricated. The technique used to create a slot 315 around a surface of the guide sleeve of the device 310 is formed.

37-39 are additional views of the device according to the embodiment shown in FIG. 35 and described with respect to that figure. In FIG. 37 , the asymmetrical guide sleeve is shown with the two break-off portions 314 separated from the device 310 . The embodiment shown and described in relation to FIGS. 26A-B is shown in FIG. 38 , but now with an asymmetric guide sleeve with break-off portion 314 as described above.

Figures 40A-D are additional perspective views of the device described above with respect to Figures 35-39, according to an embodiment having at least one or more break-off portions. Once removed, these broken portions are preferably discarded by the surgeon.

Each of the embodiments described herein may be provided in a modular (ie, single-section) or monolithic (ie, multi-section) configuration. Therefore, to facilitate the description provided herein, certain embodiments have been shown in one (modular or monolithic) embodiment, but may be provided in a different (monolithic or modular) configuration without depart from the spirit of this disclosure. In various aspects, these monolithic embodiments may include anywhere from two to ten levels relative to the vertebral body, or multiple locations other than the spine to encompass the patient's skeletal anatomy. It is to be expressly understood that these embodiments described herein are for the purpose of illustrating certain embodiments of the present disclosure and are not intended to limit the scope of the present disclosure.

According to the various embodiments described herein, a wide variety of fixation devices can be quickly and easily fabricated for use in surgical or educational settings, including but not limited to pins, screws, hooks, clamps, rods, plates , spacers, wedges, implants, etc. Similarly, a wide variety of instruments and/or other devices can be fabricated based on patient-specific data, including but not limited to patient-matched inserters, spatulas, cutters, extractors, curettes, rongeurs, probes , screwdrivers, paddles, ratchet mechanisms, removal and salvage tools, cannulas, surgical mesh, etc.

Among the instruments that can be fabricated using patient-specific data and that include multiple patient-matched surfaces are devices used as implants, including numerous implants for restoring intervertebral space height in a patient's vertebrae. For example, a wide variety of patient-matched metal, polymer, or elastomeric implants can be fabricated using the methods described herein, wherein certain patient-contacting surfaces of the implant accurately and precisely match the patient's anatomy . In one embodiment, the implant can be matched to the patient's anatomical features that have regressed and require restoration. In another embodiment, the implant may be necessary to correct a structural or physiological deformity present in the patient's anatomy, and thereby serve to correct the position or alignment of the patient's anatomy. Other implants may be patient specific but not used for restorative or other structural functions (ie hearing aid implant housings).

The implants described herein can be manufactured by additive manufacturing. In the context of spinal implants, these implants can be used in all approaches (anterior, directly lateral, transforaminal, posterior, posterolateral, directly posterolateral, etc.). Specific features of this implant can address certain surgical objectives such as restoration of lordosis, restoration of intervertebral space height, restoration of sagittal or coronal balance, etc.

Other applications contemplated by the present disclosure include interbody fusion implants, intervertebral space height restoration implants, implants that have footprint matching, surface area maximization, shape and contour matching to endplates or other vertebral defects, and can Further specify the contact area, such as relative roughness or other surface characteristics. For example, an implant further comprising a direction-specific shape can be fabricated based on the patient's anatomy so that the implant can fit without difficulty through the access port and into the intervertebral space. Alternatively, the implant may be fabricated in a manner that takes into account anatomical constraints at the point of implantation and through the path the implant must travel, and may further compensate for anatomical deficiencies. In the context of spinal implants, these implants may further specify a desired angle for lordotic or coronal defect alignment, specify a patient-specific height for the implant, or (desired height after intervertebral space height restoration ), specifies the degree of opening allowed (for expandable implants), and can be unidirectional or multidirectional depending on the surgery and the surgeon's preference.

According to one embodiment, the patient-matched laminae may be created using a fabricated patient-matched device. By way of example and not limitation, patient data may be obtained to create matching surfaces for one or more cervical or lumbar anterior plates for spinal reconstructive surgery. The plates may include contours or surface features that match the anatomy of the bone, including matching surfaces across more than one level or vertebrae. In yet another embodiment, this patient data can be used to create a specific patient-matched plate with a plate position identifier, and can further include patient-specific custom drill holes or other alignment points. In addition to those utilized in spinal surgery and described, other types of plates may incorporate the patient matching features described herein without departing from this disclosure.

Referring now to Figures 41-44, an alternative embodiment of the present disclosure is shown. In some procedures, multiple trajectories are required in or near a particular surgical site. For example, it may be desirable to fasten a first fixture in a first trajectory, and it may also be desirable to secure a second fixture in a second trajectory that differs from the first trajectory. According to this embodiment, multiple trajectories can be achieved without the need for multiple guides, and indeed can be facilitated by custom made guides or parts thereof.

41-44, the current embodiment may include a first guide sleeve 320 having a first trajectory through a plurality of apertures 325, may further include a second guide sleeve 320' having a second trajectory D and Insert with third locus C. According to this embodiment, the insert may be used with a surgical guide or guide sleeve, for example of the type described herein, or with the guide depicted in Figs. 42-44. The insert can be generally cylindrical in shape and can be similarly sized so that it can be inserted into the guide sleeve, and preferably includes at least one tab 322, 322' for proper alignment with the slot (in not shown in Figure 41). Seating of the guide against the bony anatomy allows the surgeon to verify proper positioning of the guide and thereby the custom orientation of the insert, providing an orientation for placing the fixation device in the desired location.

The concept of this additional embodiment includes using at least a portion of the guide (when placed/attached to the patient's anatomy) to create an additional trajectory into the patient's anatomy. By way of example and not limitation, the following aspects of the surgical guides described herein can be used to determine and create alternate trajectories without creating new guides:

the one or more lead conductors;

the one or more guide sleeve inserts;

The holder attachment area;

• Arms of the guide (eg, via clips, holes, seating points, etc.).

Any reference point associated with the above components may be used to determine the second or further trajectories. For example, axes, tangents, lines of intersection, radii, predetermined markers (eg, radiographic markers), surface features, endpoints, or other seatable locations may be used as references for determining the orientation of the second insert.

Similarly, any known point or geometry on these guides can be used to create another modular section that can "snap" into the guide to provide multiple trajectories. For example, the guide's retainer attachment area can be used to attach "splash" arms to provide different trajectories. This may also apply to holes through the arms of the guide, into which the brace arms can be inserted, such as fixing screw holes.

Another embodiment may use fixation screws or pedicle screws as additional spatial orientation features. These fixation and pedicle screws are placed in the specific orientation planned. Since the length and orientation of these screws are predetermined, the trajectory of adjacent segments may not be based on the orientation and characteristics of these screws.

Alternatively, the surgeon can use the location of the set screw holes in the guide to create additional trajectories, including cases where custom inserts are required or not. In another alternative embodiment, the surgeon may use pedicle screws placed in a specific orientation to create additional trajectories.

42A-B are top plan views of a guide 400 according to another alternative embodiment of the present disclosure. The guide 400 preferably includes at least a first set of guide sleeves 410 and a second set of guide sleeves 412 . This embodiment is particularly useful, by way of example and not limitation, for sacroiliac joint fixation, in part because patient matching surface data is not ascertainable in certain areas that require access during the procedure. More specifically, in order to reach the ilium from both sides, a very large soft tissue exposure is required, which is overly disruptive to normal anatomy. By using the position of the guide for eg the S1 pedicle screw, a custom guide trajectory can be made. The orientation of this trajectory can be determined by employing a more intermediate seating position, and thus allows access to a variety of iliac and sacral trajectories without the need to create new guides or other custom-made instruments.

In a preferred embodiment, the guide of Figures 42A-B floats over the iliac crest and does not necessarily touch the iliac crest, which is desirable in certain patients with unstable or sensitive anatomy. Additional trajectories may be based on the original orientation of the guide sleeve or guide sleeve insert. In addition, trajectories into other sacral structures such as the sacral ala, S2 pedicle, or transsacral iliac joints may also be achieved.

According to at least one embodiment, the patient-contacting end of the insert may not be patient-matched, and according to other embodiments, orientation and depth control may be provided for placing the fixation device through the second trajectory. While Figures 41-44 show only one different trajectory, it is expressly understood that additional trajectories may be provided with a single guide insert.

Figure 43A is a top plan view of a guide for a three-segment procedure (sacral iliac plus 1 additional segment), this figure depicts a pair of inserts with two trajectories different from the first pair of guide sleeves . Figure 43B is a detailed plan view of the device shown in Figure 43A. Rather, the guide sleeves 422, 423 provided by this embodiment allow the insert 424 used with the guide to be altered to provide a customized and unique trajectory that differs from one or more of the guides. General trajectory of the sleeves 422,423. The inserts 424 may include different and/or additional tracks as shown in FIGS. 43-44, or alternatively may extend outwardly from the body of the guide in a desired direction, which may not or multiple guide sleeves coaxial.

This embodiment can also be used in oncological surgery or in cases where the bone surface is absent or altered (revision). These additional trajectories can be provided with these guides from adjacent segments.

Referring now to FIG. 45 , depicted in side elevation are two surgical drill sleeves 432 , 434 that may be used with surgical guides according to alternative examples of the present disclosure. Drilling sleeves are generally known in the art, however, the current embodiment involves custom drilling sleeves 432, 434 that may pass through one or more patient-matched insert or guide sleeves to be placed so as to provide contact with the bone surface at the distal end of the drilling sleeve (see FIG. 46 ). While the custom drilling sleeves 432, 434 may be made of any material, preferred embodiments will use a metal or metal alloy of sufficient strength and brittleness to avoid fracture and/or spalling of the drilling sleeve material to make them. Sleeves 432,434. Accordingly, the drilling sleeves 432, 434 can withstand the effects of high speed drilling without damaging the sleeves 432, 434 or allowing material from the drilling sleeves to deposit at the drilled hole site, and without allowing the drilling sleeves 432, 434, 434 reuse. These drilling sleeves 432, 434 must also withstand the high temperatures encountered during the sterilization process. Another benefit of the metal sleeves 432, 434 is the ability to "trenate" or machine with the cutting surface to allow the distal end 435 of the guide to "bite" into the bone and provide a means of fixation.

FIG. 46 is a front elevation view of a surgical guide 450 , guide sleeve 452 , and drilling sleeve 432 assembly according to an alternative embodiment of the present disclosure. In this embodiment, the drilling sleeve 432 is provided to allow clearance between the intersecting bony anatomy and the sleeve 432 . Alternatively, a trepanned or patient-specific edge of the sleeve may provide better contact with the underlying bone surface.

Additional fixation of the guide to the vertebrae is provided by the drill sleeves passing through the patient-matched guide sleeves and into the bone at opposite and dissimilar angles. The convergence of these drilling sleeves through the insert also eliminates the need for additional fixation. It is expressly understood that more or fewer inserts and/or guide sleeves may be provided for patient-specific guides to assist in the drilling operation during surgery without departing from the spirit of the present disclosure. In one embodiment, the sleeves are disposable, and in other embodiments the sleeves are reusable.

47A-D are views of a component tray and method for arranging patient-matched surgical devices according to one embodiment of the present disclosure. According to this embodiment, the component tray 460 is equipped with a plurality of patient-specific devices D, which enhances the efficiency of collation, structure and arrangement of the plurality of devices D according to the surgeon's preference or a specific surgical procedure.

The component tray provides an arrangement essential to user success in the operating room, including but not limited to the following:

The number of segments to be operated on and the specific segments Z1-Z4 (in case multiple guides are to be used);

Pedicle screw implant diameter and length selection (including optional variations);

- one or more navigation guides corresponding to the selected implant;

• Combinations of guides and/or sleeves, including multiple guides provided in series and/or in one piece for specific applications.

According to one embodiment, the component tray 460 is made up of a plurality of "zones" Z1-Z5 that contain all the necessary components needed to operate on a particular area of a particular segment. The tray 460 is preferably sorted and the devices D are arranged at the desired location prior to the surgical procedure, and can also arrive at the facility for sterilization immediately before the surgical procedure. By way of example and not limitation, each "zone" on the tray may contain guides D, inserts I, and pedicle screws S for a particular vertebral segment. Additionally, any drilling sleeves, set screws or other attachments specific to a particular vertebral segment may also be included in this "zone". The tray preferably includes unique surgery-specific markings 462 that correspond to different devices, regions, segments, and the like.

These trays can come in different sizes depending on the size of the surgical procedure being performed (i.e., 2-level vs. 3-level) and can be labeled to match zones to segments of the spine (zone 1 will be used for L1 ) or include other unique markers. For example, the zones may be color coded, and the different corresponding inserts that are complementary to a particular guide can be similarly coded to facilitate matching the insert to the guide for a certain region or segment. In another embodiment, these parts may be barcoded, RFID coded, or have other unique features that can be read by appropriate scanning equipment.

In addition, the tray provides more secure packaging and orientation of the leads. This is especially important for plastic guides, which may require protection during transport or steam sterilization due to the fragile nature of the material and these different protrusions being made to the specific guide. Packaging is required to ensure dimensional integrity during these critical steps.

As described above, certain embodiments of the present disclosure may be incorporated into surgical methods and instruments for operating on the cervical spine (ie, C1 to C7). Due to the similarity in vertebral geometry between the lumbar thoracic and cervical spine, many of the concepts described above can be incorporated into patient-matched surgical guides for use in cervical spine surgery. However, orienting and placing a patient-matched cervical guide requires consideration of the unique characteristics of the cervical vertebrae and surrounding anatomy, several of which are discussed below with respect to FIGS. 48-63 .

Referring now to FIGS. 48A-C , an embodiment of the present disclosure used in a procedure performed on segment C7 is shown. According to this embodiment, the cervical guide 470 includes a plurality of patient-matched contact surfaces in a manner that allows the surgeon to accurately and reliably place the cervical guide in the proper position relative to the patient's bony anatomy. As shown in Figure 48A, the cervical guide of this embodiment includes an arch or bridge section 471 in the intermediate body of the guide 470 that is oriented to avoid the spinous processes and placed in contact with the vertebral body ( In this example, at segment C7). The cervical guide 470 preferably includes a first patient-specific surface configured preoperatively to mate with a corresponding surface of the first transverse process, and a first patient-specific surface configured preoperatively to mate with the corresponding surface of the first transverse process The corresponding surface of the second transverse process is paired with a second patient-specific surface. The cervical guide 470 further includes first and second legs 472 having corresponding first and second ends, wherein the first and second ends provide a corresponding position configured to correspond to the first and second transverse processes of a vertebra. The locations of the first and second patient-specific surfaces that are partially matched.

In one embodiment, the first and second legs 472 are substantially cylindrical as shown in FIGS. 48A-C and may further be hollow to allow insertion of a sleeve therein. In one embodiment, as described in more detail above, the sleeve may include a distal end having a corresponding position to the patient after the sleeve is inserted through the hollow portion of the first or second leg 472 . Patient-specific surfaces paired with anatomical features. In certain embodiments, the sleeve and the legs 472 include patient-specific surfaces. In another embodiment, only one of the sleeve and the legs 472 includes a patient-specific surface.

These sleeves may include apertures for insertion of devices or instruments or tools such as screws, Kirschner wires, or drills. In certain embodiments, the guide 470 is oriented to allow insertion of a pedicle screw, a lateral mass screw, a cortical bone screw, or a facet screw configured to be inserted. These screws and other devices contemplated for use with the guides of the present disclosure may be standard, or may be custom made for use only on a specific guide or at a specific segment.

As shown in FIG. 48B, the guide may further include first and second extensions 474 on the first and second legs 472, which extensions may include auxiliary apertures and paths for insertion of, for example, set screws. . According to this embodiment, the extension 474 may receive a set screw for insertion through the aperture of the extension and into the transverse process to secure the cervical guide 470 to the patient's bony anatomy. It should be expressly understood that other types of devices may be utilized to temporarily ensure that the cervical guide is seated on the patient without departing from the novelty of the present disclosure discussed herein.

Referring now to FIG. 48C , there is shown a top plan view of the cervical guide described with respect to FIGS. 48A-B . The arch or bridge 471 is shown avoiding the spinous process, but in alternative embodiments the lower surface of the bridge 471 may further include a patient-specific surface for mating with the corresponding surface of the spinous process. An example of this embodiment is described below with respect to Figure 54A. Cervical guide 470 may further include information related to the patient, the specific guide, the spinal location or segment where the guide will be used, the size of the device or instrument or tool to be received by the specific guide, the orientation of the guide, etc. markup. Several labeling examples are depicted in Figures 48A-C. The cervical guide 470 may also include a slot, channel, groove or keyhole for receiving the distal end of an instrument such as an inserter.

Referring now to FIGS. 49A-C , another embodiment of the present disclosure involving a cervical guide for use at segment C2 is shown. This particular segment of the cervical spine requires the orientation of the bridge 491, legs 492, and sleeves described above with respect to Figures 48A-C. Specifically, the first and second legs 492 are oriented in a slightly upward trajectory for placement therethrough of a device, instrument or tool that is ideally oriented to contact the pedicles of the vertebrae. While this embodiment does not depict extensions for receiving set screws or other means of temporarily seating guide 490, it is contemplated that such extensions could be provided to the cervical guide for segment C2. As described with respect to Figures 48-49, segments other than C7 and C2 are also contemplated for application of the present disclosure.

Referring now to Figures 50A-D, another embodiment of the present disclosure is shown. This particular cervical guide 500 includes a plurality of sleeves 510 oriented to receive inserts (not shown) for receiving, for example, lateral mass screws. This particular guide shown is designed to be applied at segment C5 of the cervical spine. As best shown in Figure 50C, the bridge 502 includes a slot 503 for receiving the distal end of an instrument (eg, an inserter). In another embodiment, the slotted portion of the bridge 502 may include a connector in the middle region for joining the two separate portions of the cervical guide. Further details regarding this particular embodiment are described with reference to Figures 53A-E. In addition to the patient-specific legs shown in Figures 50C-D, this embodiment further includes first and second tabs 520 for placement below the laminar surface of the vertebrae. These tabs 520 assist in securing the cervical guide to the patient-specific anatomy and are described in more detail in the next paragraph.

Referring to Figures 51A-C, additional views of the embodiment depicted in Figures 50A-D are shown. According to this embodiment, the tabs 520 are oriented to separate the facet joint capsule and enter the facet joint when the cervical guide 500 is placed in place. One or both sides of these tabs 520 may be patient matched. These patient-matched tabs 520 can go either above or below the facet joint, or in some embodiments provide both. In the embodiment shown, the tabs 520 create an interference fit with the facet joint and secure the cervical guide in place. The tabs 520 may be made of a material adapted to flex to allow for the interference fit described above, which may be the same or a different material than the remainder of the surgical guide. The tabs 520 may also be made of a non-flexible material, taking advantage of the flexibility of the guide material to allow for the interference fit described above.

Referring now to FIGS. 52A-C , one embodiment of the present disclosure is shown that depicts a slotted bridge 502 that further includes an aperture 504 for receiving a device such as a set screw, in this embodiment In the example the device was placed into the spinous process. In one embodiment, the aperture 504 is threaded, while in another embodiment (as depicted in Figure 55B) it is not. The aperture 504 may further include specific trajectories, such as by orienting the set screw shown in Figures 52A-C in a more upward direction as desired, for securing the cervical guide to a particular segment of the cervical spine. The embodiment shown in Figures 52A-C can also be incorporated into an embodiment that includes a patient-specific surface on the lower surface of the bridge 502 for mating with the corresponding surface of the spinous process, for example with respect to The embodiment depicted in Figure 54A.

According to an alternative embodiment, the cervical guide described above may further comprise locking means. 53A-E, such embodiments may include means for locking the first section 525 of the guide to the second section 527 of the guide, and further include means oriented around specific anatomical features (eg, spinous process) first loop segment 526 and second loop segment 528 that mate with each other. The first and second segments 525, 527 and the first collar segment 526 and the second collar segment 528 may be joined by suitable techniques known in the art, including but not limited to by joining one or more The tabs are inserted into complementary slots on the adjoining surfaces, as shown in Figures 53A-C. In this way, by first placing the first and second legs of the cervical guide in place and then joining the first and second sections 525, 527 of the guide, the first and second sections 525 , 527 links can allow interference fit. The interference fit is due to the coupling of the first and second sections 525, 527 of the guide while the first and second legs (and corresponding first and second patient-specific surfaces) remain positioned against the patient's bone Anatomical construction results from tension in the first and second segments. In addition to or instead of an interference fit, one or more pins and/or screws may be passed between the first and second sections 525, 527 of the guide to join them into a rigid assembly. The pins and/or screws may also pierce the spinous processes, or any other part of the vertebral anatomy, in order to stabilize and secure the guide assembly to the bone. While the first and second loop segments 526, 528 shown in the figures do not have patient-specific surfaces, it is expressly understood that including such a feature is within the scope of the present disclosure.

As mentioned above, the cervical guides may further include patient-specific surfaces on the lower portion of the bridge for mating with spinous processes, as depicted in Figures 54A-C. The patient-specific surface is substantially concave for receiving a complementary convex surface of a spinous process underlying the location of the bridge. In some embodiments the cervical guide may also include a slot, channel, groove or keyhole for receiving the distal end of an instrument (eg, inserter). An exemplary inserter mated with a slotted portion of a cervical guide is depicted in Figures 54B-C. As best seen in FIG. 54C , the distal end of the inserter can include two tines, one of which can be received in a slot on the bridge of the guide and the other tine placed in the on the lateral side of the bridge. The insertion instrument can also be rotated 180 degrees to allow a second tine to be placed on the opposite lateral side of the bridge. In some embodiments, the tines may include a textured or tabbed inner surface to grip into, or with complementary dimples in, one or more of the surfaces of the bridge. (not shown in Figure 54C) come into contact with or become associated with.

According to yet another embodiment, the cervical guide may further comprise one or more apertures for placement of clamps such as the type shown in Figures 55A-C. Clamp 540 may be fastened and tightened by providing threaded apertures and corresponding threaded studs of clamp 540 and may have threaded studs and corresponding nuts to lock clamp 540 in place. As shown in Figure 55B, the clamp 540 can be positioned on the anatomical surface of the vertebrae and then tightened into a secure position through the threaded stud and bolt holes or nuts, as in the embodiment shown in Figure 55C Case. More than one clamp 540 may be provided to improve this action of securing the cervical guide. In this same manner, the cervical guide may be provided with one or more tabs or hooks to secure the guide to the patient's bony anatomy, as shown in Figures 59A-B. In practice, the clamp 540 or hook may first be placed in the desired position and location, and then the guide lowered such that the stub or hook of the clamp 540 enters a corresponding aperture on the guide. Once the post is positioned through the aperture (as shown in Figures 55C and 56C-D), a nut can be threaded onto the threaded post and tightened to secure the cervical guide to the patient's anatomy .

As described above for the thoracolumbar guides, the cervical guides described herein may provide axial, or alternatively off-axis, trajectories into the patient-specific anatomy. Such an off-axis trajectory may be provided for the sleeve 550 described above and now shown in FIG. 57 . This trajectory may be determined using the scanning equipment described above and selected based on optimal patient anatomy, bone density, and the like. This off-axis trajectory can be particularly important in areas of the cervical spine where the generally smaller vertebrae do not allow the legs or corresponding sleeves to be positioned to enable the device, instrument or device to be used with the guide. The desired axis of the tool is achieved in a coaxial relationship. By providing an off-axis trajectory, the guide can be used to secure the device or allow insertion of tools or instruments in directions that would otherwise not be possible.

Embodiments of the present disclosure depicted in FIGS. 58A-C include patient-specific guide calibration models. The model provides the user with a visual and tactile representation of the patient's anatomy in order to create patient-specific guides, including one or more predetermined screw trajectories. Modeling of predetermined screw trajectories facilitates the orientation and placement of patient-matched surfaces, as well as the orientation of the components of the guide (ie, legs, sleeves, inserts, etc.). Using this model, users can create adjustable and reusable non-patient-specific guides. An example of this could be a surgical guide with hinges, ratchets, swivels, pivots, set screws, etc. that "snap" into place when adjusted or turned and once the user has completed their adjustments can be locked. Guide sleeves can then be placed over these protruding pegs 560 (as shown in Figures 58A-C) to provide the desired drill/tap/screw trajectory, while the rest of the guide can be freely configured by the user or Configured for optimal fit with patient-specific anatomy.

59A-D illustrate another embodiment of a surgical device that may preferably be used in procedures involving a patient's cervical spine. According to this embodiment, the devices include a plurality of sleeves 572, and one or more of the plurality of sleeves 572 may receive a selectively removable clip, such as clip 574 shown in Figures 59C-D. In one embodiment, the selectively removable clips 574 are received by placing a stub 573 associated with the clips 574 into a slot 571 in the body of the sleeve, as shown in FIG. 59A . This reception may be a friction fit, but is more preferably a snap or snap attachment that prevents removal of the clip 574 once the device has been positioned on the patient's anatomy. Other connections known to those of ordinary skill in the art are also contemplated for use with this embodiment.

60A-C include additional views of the device described in the preceding paragraph. Figure 60A is a side elevational view of the device having at least one clip 574 engaged with the body of the sleeve of the device and further engaged with the underside of an adjacent bony structure. Here, the bony structure is the lamina of the cervical vertebrae, but the use of these clips for other anatomical features is also contemplated. Figure 60B shows a device having two clips 574' similar to the clip 574' shown in Figure 59D. Figure 60C shows details of the connection between the clips and the sleeve of the device according to one embodiment.

61A-C illustrate yet another embodiment of a guide and associated clip. Here, the clips 575 are preferably spring clips and are normally biased with their distal ends away from the sleeve body, as best seen in Figure 61A. The connection between the clips 575 of the guide and the sleeves is such that the clips 575 can be pressed onto or closer to the bodies of the sleeves against which the normal bias associated with the clips acts. . Once depressed, these clips 575 can be inserted under adjacent anatomical features, as shown in Figures 61B-C. In this embodiment, the clips 575 can be oriented so as not to cause undesired damage to the associated patient anatomy, here the superior facet joints of the patient's vertebrae. By placing the distal end of the clip 575 in the superior facet complex, the clip 575 can wedge between the bony anatomy without passing through the anatomy and otherwise causing damage to the patient. Although the attachment between the clip 575 and the sleeve is depicted as a permanent attachment, it is contemplated that the clip 575 shown in FIGS. 61A-C may be selectively removable, as shown in the embodiment of FIGS. 59 and 60 describe.

62A-E show views of yet another embodiment of the device of FIGS. 59-61. According to this embodiment, the clips 575 may be selectively coupled to rigid connectors 576 for adjustment relative to the body of the device. According to a preferred embodiment, adjustment may be made by threaded studs 577 inserted into corresponding threaded holes on the face of the device, as best shown in Figures 62A-B. The positioning of the threaded stud 577 relative to the device preferably causes rotation of the camming elements, which in turn provide secure points of contact about the patient's anatomically configured surface.

Adjustment of the threaded stud 577 may also allow the user to selectively engage and disengage the distal end of the clip 575 with the patient's anatomy. In one embodiment, this adjustment is accomplished by holding the clip 575 away from the body of the device via the post 577 and rigid connector 576, as best shown in Figures 62B and 62D. A rigid connector 576 can be coupled to each of the plurality of clips 575, which preferably includes a cam element 580 at the distal end of each clip, as shown in Figures 62A-E. Other connections and orientations of rigid connector 576 are contemplated for use with this embodiment.

The clips described above may be tapered or pointed such that the distal end of the clip contacts and penetrates the bone surface of the patient's anatomy. In other embodiments, the clips may further include textured or machined surfaces that engage and create a frictional engagement with the patient's anatomy. Other surface variations and geometries can be incorporated into the clip design to improve attachment to the patient's anatomy.

These clips are preferably not patient specific, but they may include patient specific surfaces, which is desired. These clips may also be deformable in nature to accommodate differences in patient anatomy. These clips may also be permanently or selectively attached to the insert of the device rather than to the sleeve of the device as described above.

The device in one embodiment may further allow for engagement with a spacer, such as the one depicted in Figures 63A-H. The spacer 590 can include one or more patient-specific surfaces as shown in Figures 63A-B, or can be fabricated for a variety of different applications. In spinal surgery, the spacer 590 allows the device to have patient-specific surfaces around multiple segments of the patient's spine. A spacer 590 is preferably also coupled to the device, as best shown in Figures 63C-E. The spacer in this embodiment provides another surface or surfaces for aligning the device with the desired anatomy and/or orientation of the guide elements described above.

The concepts described above with respect to Figures 48-63 have been described for convenience in the context of cervical spine surgery, but they are not limited to application in the cervical spine and may also be applied to the thoracolumbosacral spine and ilium.

Referring now to FIGS. 64-67 , there are shown a number of different embodiments in accordance with an aspect of the present invention involving guidewires/pins and cannulated devices, such as screws, and corresponding instruments and/or implants. into things. According to these embodiments, the surgical guides described above may further include a "cannulated" system, wherein a Kirschner wire or guide pin/guide wire is passed through these sleeves or inserts associated with the patient-specific guide One of them is placed, and any subsequent instruments and/or implants are guided using the wire into its proper position along the wire's longitudinal axis.

64-65, the guide has received a plurality of instrumentation sleeves, each having a longitudinal channel for receiving a wire 600, preferably through the center of each insert, which can then be used to Center other instruments and/or implants. As shown in Figure 66, these instrumentation sleeves can extend over the top surface of the guide, which in turn can accommodate a longer guide wire 600 and stabilize the wire 600 in place during insertion of the wire 600 into the patient's bony anatomy. in the right place.

Next, the instrument sleeves can be removed as depicted in FIG. 67 . The surgical guide can be retained if the guide assists the surgeon in performing the surgical procedure. However, it is contemplated that once the wires 600 are properly seated as shown in FIG. 68, the guide could be completely removed.

Once the wires 600 are in place, one or more instruments or implants, such as cannulated screws, can be received by the wires 600 and thus placed in the proper position and trajectory. By way of further example and not limitation, a cannulated screw including at least one hole therethrough may be positioned over wire 600 established by the guide depicted in FIG. 64 . It is expressly understood that these embodiments may utilize other implants in addition to cannulated screws, as well as a wide variety of instruments, including those listed above and forming part of this disclosure.

Referring now to Figures 69-73 in more detail, an apparatus for performing a MIS procedure on a vertebral body is shown. The device includes a generally cylindrical hollow retractor 692 having a first end and a second end. The body of the retractor 692 is hollow throughout its longitudinal axis, which enables the retractor 692 to receive the dilator and progressively expand the retractors described above, and further to receive tools, instruments or devices therethrough, including Custom or standard fabricated inserts, as shown in Figure 69. The first end of the retractor 692 is preferably designed to matingly receive one or more patient-specific end pieces 694, which are also shown in FIG. 69 . The retractor 692 may also include an attachment joint for receiving the coupling device 710 preferably positioned along the outer wall of the generally cylindrical body of the retractor 692 .

Coupling device 710 preferably has a slot or groove on each end for receiving one or more attachment tabs. In one embodiment, the attachment joint is complementary to the slot or groove of the particular coupling device 710 and creates a secure connection when joined. In some embodiments, the connection between the attachment joint and the slot or groove of the coupling device 710 is such that, once the joint is mated with the groove or slot, a desired angle or orientation of the coupling device (such as Best seen in Figure 72). In one embodiment, the connection is a locked connection. In another embodiment, the connection is a snap fit connection. In another embodiment, the connection is a frictional engagement between the joint and the groove or slot. For further illustration, see Figures 95-97.

Coupling device 710 may be used to secure one or more retractors 692 to each other and, in a preferred embodiment, over the surface of the patient's skin (ie, percutaneously). The coupling device 710 may be sized and shaped to secure the first retractor 692 and the second retractor 692 to each other in a desired position. According to yet another embodiment, coupling device 710 may be secured to one or more retractors 692 to provide a desired orientation or trajectory for the associated insert. Linking device 710 may also be used in multi-segment MIS procedures and, according to at least one embodiment, may be joined to other linking devices to fix both lateral and longitudinal spacing within the array of retractors 692 .

Insert 695 may have varying shapes and sizes, and may include features such as those associated with the inserts described above with respect to FIGS. 1-68 . Different views of the instruments described above are shown in Figures 70-73, and include embodiments involving multi-segment MIS applications.

Referring now to FIG. 74 , an embodiment similar to FIGS. 69-73 is shown, except that the coupling device includes a plurality of channels, which are preferably custom fabricated through the body of the coupling device 710 and can receive one or more alignment elements. 695. These alignment elements 695 may be fixation pins, as shown in FIG. 74, and are used to secure the assembly shown in FIG. 74 to a specific bony anatomy. Variations of this embodiment are depicted in FIGS. 86A-C that include custom made channels oriented to guide alignment elements through the patient's lamina, facets, pars, spines protrusions, or other anatomical features. Furthermore, these channels may be provided in different or multiple locations, such as those shown in Figures 87A-B, which provides the benefits described above where coupling elements are required. In some embodiments, channels may be used in combination in the coupling element and in the body of the retractor, as shown in FIGS. 88A-B .

The alignment elements 695 may also include first and second dimensions that provide the surgeon with the ability to estimate the depth of the alignment elements. For example, the alignment element 695 can include a collar that is thicker than the alignment element's first dimension so as to prevent the alignment element 695 from penetrating into the bony anatomy.

Referring to Figure 75, another embodiment is shown wherein the assembly further comprises a bridge element 715 for joining two or more coupling elements 711,712. In this embodiment, the bridge element 715 and link elements 711, 712 create a more stable assembly. As also shown in Figure 75, the inserts for each of the retractor tubes shown include openings of different shapes and sizes to accommodate different tools, instruments or devices. In this way, a custom insert can be specific to a particular application associated with a particular retractor tube, and only accept particular tools, instruments, or devices.

Referring now to Figures 76A-C, an alternative embodiment of a surgical device is shown. In this embodiment, the preferably reusable handle includes first and second portions 732, 734 that are selectively coupleable to each other and to the device. This handle is preferably attached to the device during minimally invasive surgery and provides both alignment and stability to the associated device or devices. The first and second portions 732, 734 of the handle preferably include an ergonomic shape that facilitates grasping with the user's one hand, and are preferably offset from the vertical axis of the one or more devices to avoid incisions during the surgical procedure. interfere with the user's line of sight. Alternatively, the handle portions 732, 734 may be contoured and/or angled to avoid interfering with the user's line of sight. While a slotted connection is shown in Figures 76A-C, other means of connecting the handle portions 732, 734 to the one or more devices are contemplated. In particular, the embodiments shown in Figures 76A-C can be combined with the different connection arrangements described below in Figures 95-97.

77A-G depict another alternative embodiment of a surgical device including one or more optional alignment/depth/position control elements. Here, the handle includes at least first and second portions 732, 734 that can be positioned in a plurality of positions relative to each other to adjust the width of the handle. At least one of the first and second portions 732, 734 includes indicia 744 of known dimension to indicate a width. The device of Figures 77A-G preferably includes at least one rotational adjustment 742, which allows the angle of the handle to be changed according to the desired orientation of the device or devices. The handle is preferably coupled to one or more inserts that are placed into one or more devices (not shown in Figures 77A-G). Preferred embodiments also include one or more depth control adjustment elements 740, as shown in Figure 77C. This allows the "legs" of the device to translate. The device preferably includes markings on the legs that reflect known dimensions for ease of use when adjusting the device for a particular procedure and patient anatomy.

78A-B depict adjustment guides 790, 792 that assist in achieving desired angle and/or width and/or height adjustments. The adjustment guides 790, 792 are preferably coupled to the handle, or legs of the device, and are fixed in place when the desired position or orientation is achieved. For example, the width may be set by placing an adjustment guide 790 on the handle, as best shown in FIG. 78B , which prevents movement of the handle once the adjustment guide is secured in place. Similarly, angle adjustment guides 792 act as wedges and prevent major or minor rotation of the legs relative to the handle once securely placed on the device (as shown in FIG. 78B ).

79A-B include views of devices used to assist in determining incision and access locations for a particular surgical procedure. The device preferably includes at least one reference element 802 that can be aligned with a known anatomical feature. Here, the feature is the centerline of the patient's spine and/or the longitudinal axis of the spinous processes. The device further includes height, width and angle adjustments 803 , 800 , 806 . Angle adjustment 806 is associated with at least one guide member 804 that can be rotated or pivoted to a desired position according to user preference. The guide member 804 is also preferably height adjustable and may further include a distal end that includes a marking surface that allows the user to mark a desired location on the patient for future reference. The marking surface may be in direct or indirect contact with a laser or other optical marking device. Fig. 79B depicts the device according to this embodiment in the final position with the guide member in the desired position and pointing down the patient's anatomy for the associated procedure. Figure 80 is a detailed view of the device of Figures 79A-B.

Referring now to FIGS. 81A-C , another example of an embodiment is provided wherein the connection between the attachment joint and the slot or groove of coupling device 710 is such that, once the joint is mated with the groove or slot, coupling is achieved. The desired angle or orientation of the device 710. See again Figures 69-75 previously described. 81A-C also depict an embodiment in which the retractors can be coupled across the spinous processes and between different segments of the patient's spine. Other variations of this embodiment for use in non-spine procedures are also expressly contemplated. In addition, as discussed in some detail above, the retractor and coupling elements 710 and bridge elements may also include one or more unique markings that provide identification information to the surgeon or other medical personnel to ensure that each The components are assembled in place and attached to the proper instruments.

In certain applications, it may be desirable to provide the surgeon with an expandable retractor tube, such as the embodiment shown in Figures 82A-84C. In this embodiment, the collapsed retractor tube 820 is shown in FIG. 82A in a first orientation and has a smaller cross-section than the retractor in a second orientation as shown in FIG. 82B. The retractor of FIG. 82A can be inserted through a small incision and paired with patient-specific anatomical features. After the retractor 820 is properly positioned, the retractor 820 can be moved, such as by way of example and not limitation, by using an instrument or tool provided with the retractor 820 (not shown in FIGS. 82A-B ). 820 open. Once the retractor 820 is positioned in its second position, additional instruments, tools, devices, or even retractors can be positioned therethrough, as shown in Figure 82C. Referring to the embodiment shown in Figures 82A-D, the expandable retractor 820 may further include means for attaching a patient-specific end piece 825, such as described above with respect to Figures 69-73.

A variation of this embodiment described in the preceding paragraph is depicted in Figures 83-84. According to these embodiments, the retractor tube is expandable by a plurality of longitudinal hinges placed along the inner circumference of the retractor tube, as best shown in Figure 84B. These hinges may be mechanical hinges or may be living hinges (ie, formed from the material of the retractor tube). In other embodiments, variations of the hinge may be combined without departing from the novelty of the embodiment described herein. In certain embodiments, the retractor tube is disposable. In other embodiments, the retractor tube is reusable.

Referring now to FIG. 85 , an insert equipped with a retractor tube as described herein may further include longitudinal holes of varying dimensions that allow for safe and effective application of one or more surgical tools or instruments in practice. For example, as shown in FIG. 85, an insert 830 may by virtue of its geometry provide a safety stop or depth control stop 832 (i.e., prevent an instrument or tool from advancing beyond a certain depth within the longitudinal bore of the insert). depth). According to another embodiment, the patient-specific tip 834 may provide the ability to prevent the instrument or tool from protruding beyond a controlled depth.

Referring now to FIGS. 89A-90C , it is often desirable to provide a coupling 900 between retractors positioned around various levels of a patient's spine when performing MIS procedures. As shown in Figures 89A-B, one embodiment of the present disclosure is to provide a coupler 900 that further includes a secondary retractor tube 910 for an additional retractor tube located between two adjacent retractor tubes. level position. The combination of these two adjacent retractor tubes (including their secure fixation to the patient's bony anatomy) and the rigid structure provided by the coupler 900 shown in FIGS. Passing through the secondary location between the two positioned retractors provides a well-defined reference point. This additional retractor 910 can then be used to perform additional surgery at, for example, a location between two adjacent vertebrae without the need for additional fixation of the retractor to the patient's anatomy.

Referring now to FIGS. 91A-92D , various other embodiments are shown with respect to the retractors and associated elements described above. One embodiment, as shown in FIGS. 91A-D , provides an adjustable coupling element 920 . Adjustable features may include, but are not limited to, length, width, height, orientation, and depth. In this embodiment, there is no need to pre-configure the patient-specific coupling element or bridge, and the adjustable coupling element may be reusable. In one embodiment, patient-specific data can be used to provide the surgeon with specific settings for adjusting the adjustable coupling element 920 to the desired setting for use in a particular MIS procedure. This data can be provided prior to the MIS procedure and include the specific surgical plan, with or without any patient-customized instruments.

A wide variety of mechanical features may be incorporated in the coupling devices described above without departing from the spirit of the disclosure made herein. The applicants hereby incorporate by reference, in its entirety, U.S. Patent Publication No. 2009/0105760 (which publication is co-pending and names Dr. George Frey as the sole inventor) for the purpose of further complements the present disclosure and provides additional support for the various mechanical properties that can be employed in the coupling.

Another embodiment is shown in Figs. 93A-D, where a template of a surgical tool, instrument or device is provided, which may be customized or contoured to conform to a particular patient's anatomy. In certain embodiments, the template can provide the surgeon with specific dimensions, shapes, orientations, etc. of a device, such as a rod, as shown in Figures 93A-B. In yet another embodiment, the template can be, for example, the device shown in Figures 93C-D.

94A-C are various views of an embodiment of the present disclosure including multiple patient-specific guides. The plurality of guides can receive and be manipulated by an instrument, such as the inserter depicted in Figure 54B. Alternatively, the plurality of guides may receive elongate shafts or "pointers" to assist the user in visualizing the position, orientation, curvature and/or deformity associated with the patient's underlying anatomy. Here, the underlying anatomy is the patient's spine from T10 to L4. These indicators create a visual image of the deformity associated with these segments of the patient's spine. In addition, these indicators allow the surgeon to determine the length and orientation (including curvature) of fixation rods or other implants used to correct the deformity or otherwise treat the patient, and may also be useful in determining correction, rod shape/length, Or the purpose of correctly positioning the guide is captured by the optical system to digitally reproduce the curvature. These indicators can assist the user in other aspects of the surgical procedure. For example, FIG. 94C shows a side elevation view of the plurality of indicators, which allows the surgeon to visualize the difference in height for each segment of the patient's spine, as well as the difference from one segment to another. These indicators also allow the user to see if a specific patient-specific guide is misaligned or has become misaligned.

95A-C are side elevation views of a connector for attachment to a sleeve or insert, according to an embodiment of the disclosure. This connector includes a threaded hole received by a threaded stud and secured in a rotational sense to the stud by threaded engagement. This type of connection can be used in different ways, including but not limited to the connection between the alignment device and the surgical guide device described herein. 96A-C illustrate a clamping connector according to another alternative embodiment of the present disclosure. 97A-C illustrate a screw or pin connector according to yet another embodiment of the present disclosure. Here, the screw is inserted through a slot in the sleeve element and further inserted through a slot in the distal end of an instrument associated with the device. For example, the instrument may include legs of an alignment device, such as those described above.

98A-C are side perspective views of an inserter and guide sleeve according to one embodiment of the present disclosure. Here, the insert includes a reference marker, which may include cutouts, grooves, notches, scratches, or other markers for aligning the insert into a desired orientation. The marker is preferably visible both with the naked eye and by fluoroscopy, and may be visible by other known scanning techniques. This embodiment is particularly useful for aligning the insert for receiving a cutting or drilling instrument, or for inserting an implant therethrough.

99A-G show different views of a system for aligning guides according to one of the various embodiments described herein. The system further includes an adjustable arm assembly that can be attached to the surgical surface or alternatively to the patient. Figure 99A shows the arm assembly in a first position away from the one or more devices, and Figure 99B shows the arm assembly attached to the one or more devices to provide stability by resting on the patient's skin. This attachment between the one or more devices and the arm assembly allows the user to set and fix the sagittal angle of the one or more devices while performing surgery on the patient's spine. Figure 99C shows a perspective view of the embodiment of Figures 99A-B.

Figures 99D-E illustrate an alternative example in which the arm assembly includes a telescoping member resting on the patient's skin that can be adjusted to a desired length and angle relative to the associated device or devices. This serves to hold the handle of the device or devices in place when the user is not grasping the handle. 99F-G depict yet another embodiment of the arm assembly where the assembly is attached to an operating table or side table or other horizontal surface. Each of these embodiments preferably includes a locking mechanism for securing the arm assembly component in place once the desired orientation and position has been established.

100A-D are side perspective views of a transdermal delivery device according to one embodiment of the present disclosure. The device preferably includes a distal end having an expandable/retractable tip. When in the first position as shown in Figure 100C, the device may be inserted through any of the guides and/or inserts described herein. After insertion, the device can be deployed and locked in the deployed position as shown in Figure 100D. The shaft of the device may further comprise a collar for preventing insertion into the guide and/or insert beyond a desired distance.

101A-D are various views of a patient-specific guide according to yet another alternative embodiment of the present disclosure. In this embodiment, the patient contacting surface of the lead further comprises surface contacting elements. These elements may engage, for example, soft tissue surrounding the underlying bone surface and are beneficial for penetrating soft tissue. These elements also provide better stability and improve tactile feedback, which in turn allows the user to determine whether the guide is in the correct position. In a preferred embodiment, these contact elements are shaped like barbs or blades, but may have different sharpness, radius, length, and orientation in other embodiments.

Although the devices described above have been shown for use with certain guide screws and/or instruments, it should be expressly understood that these devices may be used with a wide variety of other implantable and non-implantable devices, Examples include medially to bilaterally placed transpedicular screws (commonly referred to as cortical bone trajectory screws). Other screws and instruments may be used with the surgical devices described above without departing from the scope of the present disclosure and are considered to be within the scope of the appended claims.

Although various embodiments of the present disclosure have been described in detail, it should be apparent that various modifications and alterations to those embodiments will occur to those skilled in the art. However, it should be expressly understood that such modifications and alterations are within the scope and spirit of this disclosure as set forth in the following claims. For further demonstration, the information and materials provided in these provisional and non-provisional patent applications from which this application claims priority are expressly made part of this disclosure and are hereby incorporated by reference in their entirety.

Furthermore, while the fusion scaffold of the present invention is particularly suited for implantation in the spine between two target vertebrae, and while much of the discussion of the invention is directed to use in spinal applications, it may be desirable to fuse two or Implantation in other locations of more bony structures can also realize the advantages provided by the embodiments of the present invention. Those skilled in the art will appreciate that the present invention has application in the combined fields of bone repair and therapy, and particularly in the treatment of spinal injuries and diseases. It should be appreciated, however, that the principles of the invention may be applied in other fields as well.

It should be expressly understood that while the term "patient" is used to describe these various embodiments of the present disclosure, that term should not be construed as limiting in any way. For example, the patient can be a human patient or an animal patient, and the devices and methods described herein are equally applicable to veterinary medicine as they are to surgery performed on human anatomy. Accordingly, the instruments and methods described herein have applications beyond surgical procedures used by spinal surgeons, and the concepts may be applied to other types of "patients" and procedures without departing from the spirit of the present disclosure.

The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The above is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for illustration, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

The invention includes, in various embodiments, components, methods, processes, systems and/or apparatuses substantially as depicted and described herein, thereby including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present invention after understanding the present disclosure. The present invention is encompassed in many different embodiments in the absence of matters not depicted and/or described herein, or in its many different embodiments including in the absence of prior devices or processes that may have been used Apparatus and processes are provided with such matters in mind, eg, for improved performance, ease of implementation, and/or reduced cost of implementation.

Moreover, while this disclosure has included a description of one or more embodiments and certain alterations and modifications, other alterations and modifications are also within the scope of this disclosure, for example, as may occur in the art after understanding this disclosure within the skill and knowledge of the technicians. It is intended to acquire rights to include within the scope of permissible alternative embodiments, including alternative interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, regardless of such alternative This is true regardless of whether interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and there is no intention to publicly dedicate any patentable subject matter.

Claims (14)

1. A surgical device for use in minimally invasive surgery, comprising: one or more guides having a proximal end and a distal end comprising a plurality of distinct and independent patient contacting surfaces formed to substantially conform to a plurality of corresponding anatomical features of the patient; a coupling member selectively attachable to the proximal end of the one or more guides; wherein the coupling member is configured to be selectively attached to at least a second guide; wherein the surgical device is configured to contact corresponding anatomical features of the patient to ensure proper alignment and placement of the surgical device; and Wherein the one or more guides are oriented in a predetermined direction when coupled with the coupling member. 2. The surgical device of claim 1, wherein the one or more guides are configured to receive: bone anchors, implants, drills, rasps, blades, screwdrivers, curettes, retractors, A distractor, jerk, or debridement device. 3. The surgical device of claim 1, wherein the one or more guides are substantially cylindrical for use as or in connection with a tubular retractor. 4. The surgical device of claim 1, wherein the device is made of a material selected from the group consisting of stainless steel, titanium alloy, aluminum alloy, chrome alloy, PEEK material, carbon fiber , ABS plastic, polyurethane, resin, fiber wrapped resin material, rubber, latex, synthetic rubber, polymer, and natural materials. 5. A surgical device formed from patient-specific anatomical data, comprising: an intermediate body of the surgical device, the intermediate body having a proximal end and a distal end; at least one patient-specific element selectively coupled to the distal end of the intermediate body and configured to be positioned over a patient-specific anatomical feature corresponding to the patient-specific element; The intermediate body further includes a central aperture configured to receive at least one insert; The at least one insert includes an aperture for receiving an instrument or implant; Wherein the aperture of the at least one insert is tailored for receiving only an instrument or insert into the aperture to a predetermined depth. 6. The surgical device of claim 5, further comprising at least one coupling member selectively attachable to the proximal end of the intermediate body. 7. The surgical device of claim 6, wherein the surgical device is discernible by means of optical or electronic identification, which facilitates verification of the position and orientation of the surgical device relative to the patient-specific anatomical features. 8. The surgical device of claim 5, wherein the surgical device further comprises surfaces configured to operatively associate the surgical device with at least one other surgical device, which in combination Alignment and orientation of the surgical device and the at least one additional surgical device to the patient-specific anatomy are facilitated. 9. The surgical device according to claim 8, wherein the at least one additional surgical device is designed to remain in the patient and is selected from the group consisting of bone anchoring devices, implantable devices , scaffolds, plates, and bioactive devices. 10. The surgical device of claim 5, wherein the intermediate body includes a central bore having a patient-matched surface. 11. An orthopedic surgical device for use in minimally invasive surgery, comprising: a first patient-specific element having a first patient-specific surface, the first patient-specific surface being modified preoperatively based on a medical scan of the patient configured for pairing with and conforming to the first anatomical portion of a particular patient; a second patient-specific element having a second patient-specific surface that was preoperatively modified based on a medical scan of the patient; configured to mate with and conform to a second anatomical portion of a particular patient; and an arcuate bridge coupling the first and second patient-specific portions, the arcuate bridge being configured for use in the first and second anatomical Provides clearance above the patient anatomy between the medical sections. 12. The orthopedic surgical device of claim 11 , further comprising first and second patient-specific holes passing through corresponding first and second patient-specific elements and having Patient-specific orientations for guiding the fixation element into respective first and second anatomical portions of the patient. 13. The orthopedic surgical device of claim 11 , wherein a portion configured to mate with the corresponding first and second transverse processes of the patient's vertebra is included in the first and second patient-specific surfaces . 14. The orthopedic surgical device of claim 11, wherein the arcuate bridge includes surfaces configured to permit a user to apply pressure and transmit force through the first and second patient-specific elements.