HK1202791B - Patient matching surgical guide and method for using the same - Google Patents

Abstract

A system and method for developing customized apparatus for use in one or more surgical procedures is disclosed. The system and method incorporates a patient's unique anatomical features or morphology, which may be derived from capturing MRI data or CT data, to fabricate at least one custom apparatus. According to a preferred embodiment, the customized apparatus comprises a plurality of complementary surfaces based on a plurality of data points from the MRI or CT data. Thus, each apparatus may be matched in duplicate and oriented around the patient's own anatomy, and may further provide any desired axial alignments or insertional trajectories. In an alternate embodiment, the apparatus may further be aligned and/or matched with at least one other apparatus used during the surgical procedure.

Description

Patient-matched surgical guide and method of use

Technical Field

The present disclosure relates to the field of medical devices and generally to instruments configurable for use in surgical settings for a particular patient based on the unique anatomical features of the patient, and methods of making and using the same.

Cross Reference to Related Applications

This application is a continuation-in-part application of U.S. patent application No. 13/172,683 filed on 6/29/2011, which in turn claims priority to U.S. provisional patent application No. 61/359,710 filed on 6/29/2010 and U.S. provisional patent application No. 61/393,695 filed on 10/15/2010. This application also claims priority from U.S. provisional patent application No. 61/625,559 filed on day 4, 17, 2012. These applications are all hereby incorporated by reference in their entirety.

Background

Given the complexity of surgical procedures and the varying anatomical differences between the different tools, instruments, implants, and other devices used in these procedures, as well as between patients receiving those tools, instruments, implants, and devices, it is often challenging to create a surgical plan that addresses the unique and sometimes irregular anatomical features of a particular patient. For example, the implantation of pedicle screws in a vertebral body (as an appendage or stand-alone stabilization mechanism) has become widely accepted among surgeons for different treatments of spinal pathologies, and while the performance of different pedicle screw structures has become predictable, multiple challenges remain for the placement and insertion of these pedicle screws or other bone anchors. These challenges arise when the surgeon cannot reference bone landmarks due to previous surgery or when the patient's anatomy is irregular in shape.

Surgeons now have the ability to easily convert Magnetic Resonance Imaging (MRI) data or Computed Tomography (CT) data into a data set readable by Computer Aided Design (CAD) programs and/or Finite Element Modeling (FEM) programs, which can then be used to manufacture, for example, a custom implant based on the dynamic nature of the anatomical structures with which the custom implant is designed to be 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 the patient's unique anatomy.

However, the prior art fails to teach a system for creating a set of surgical instruments based on a data set derived from an MRI or CT scan. For example, using a patient-specific data set for a vertebral body may allow a surgeon to adapt to subtle changes in the position and orientation of one plate or other bone anchor to avoid irregularities in the particular bone anatomy or in the positioning and alignment of adjoining vertebral bodies. As another example, the use of these data sets may also assist the surgeon in selecting a desired trajectory for an implantable device to avoid, for example, crossing the pedicle wall and damaging the spinal canal during the actual procedure. The use of these data sets to create custom tools and instruments that can include end stops or other safety-related features to avoid over-torquing and over-insertion of any implantable device allows the surgeon to avoid these types of errors. The data sets also allow the surgeon to create a patient contact surface that is oriented to match one or more anatomical features represented by the data set, and thereby quickly and efficiently position and place the one or more patient contact surfaces in the proper location and orientation.

It would therefore be advantageous to provide an instrument suitable for use in a surgical procedure that is adapted and/or configured and/or capable of conforming to anatomical features of a particular patient and/or to one or more additional instruments so as to assist a surgeon in safely and effectively completing the one or more surgical procedures, and additionally that can significantly reduce, if not eliminate, the problems and risks identified above. Other advantages over the prior art will be apparent from a review of the summary and detailed description of the invention and the appended claims.

Disclosure of Invention

In accordance with one aspect of the present disclosure, a novel system and method for developing customized instruments for use in one or more surgical procedures is described. Systems and methods according to the present embodiments use a unique morphology of a patient that may result from capturing MRI or CT data or other data that is used to derive one or more "patient matched" instruments that include complementary surfaces based on data points from the MRI or CT data. Each "patient matched" instrument is matched and oriented based on the patient's own anatomy, desired insertion trajectory (which can be verified using 3D CAD software in a preoperative setting, such as that disclosed in WO2008027549, which is incorporated herein by reference in its entirety), and other instruments used during a surgical procedure according to one embodiment described herein.

The customized and integrated mating aspects of the presently disclosed system provide an advantage over the prior art, particularly by providing multiple interlocking and/or mating points for each instrument, thereby reducing the likelihood of misalignment, and subsequent error during the one or more surgical procedures.

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

obtaining data relating to the anatomy of a patient;

converting the obtained data into one or more three-dimensional data sets;

determining at least one trajectory or path for facilitating a surgical procedure to be performed on the patient;

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

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

The customized surgical device or instrument is manufactured using the three-dimensional representation.

In accordance with another aspect of the present disclosure, a system and method for facilitating one or more surgical procedures includes the steps of:

obtaining data relating to the anatomy of a patient by MRI or CT scanning;

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

Determining one or more axes or planes to be configured to facilitate orientation of a device of the one or more surgical procedures to be performed on the patient;

modeling a device for facilitating the one or more surgical procedures using the determined axes and addressing any other constraints of the one or more data sets resulting from the transformation;

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

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

According to this aspect described above, the method step of resolving any other constraints arising from the one or more transformed data sets may comprise: the modeled device is sized to accommodate space constraints for the surgeon, the elements of the modeled device are oriented to avoid certain anatomical features, one or more surfaces are created that may be conveniently operably connected with one or more instruments and/or tools used in one or more surgical procedures, and so forth.

According to yet another aspect of the present disclosure, the system and method includes using data obtained from a radiographic imaging machine, fluoroscopy, an ultrasound machine, or a nuclear medicine scanning device.

In another aspect, patient-matched characteristics may be confirmed by one or more additional methods such as fluoroscopy or other methods known to those skilled in the art.

In one aspect of the disclosure, the method includes using bone density data obtained by CT scanning of a patient's anatomy for use in planning the trajectory of a surgical guide and corresponding fixation device or instrument (such as a cutting/guiding/drilling instrument intended to penetrate bone anatomy). This data may be used in other ways as contemplated and described herein to assist a surgeon in planning, visualizing, or otherwise preparing a surgical procedure for a patient.

In yet another alternative embodiment, data obtained from one of the scanning devices described above may be supplemented with data from a bone density scanner or combined to make a device designed to remain in the patient after the surgical procedure is completed. It should be expressly understood that data from one bone density scanner is not necessary to practice the invention described herein, but may supplement the data and assist a surgeon or other medical professional in determining the correct position, trajectory, orientation, or alignment of the various instruments described herein.

According to yet another aspect of the present disclosure, the data may be supplemented with or merged with data from a bone density scanner to enable further control over the orientation of any desired axis, particularly where the surgical procedure involves the insertion of one or more implantable devices.

According to yet another embodiment, the data obtained from the patient allows the instrument to be manufactured with defined pathways through the instrument that are operably connected with at least one tool, instrument or implant and allows the at least one tool, instrument or implant to be inserted into the defined pathways in a consistent and reproducible manner. Examples of devices implanted or left in the patient include anchoring devices such as screws, pins, clips, hooks, and the like; and implantable devices such as spacers, replacement joints, replacement systems, stents (cages), and the like.

In accordance with 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 anatomical features of the patient. The preconfigured surgical template is configured such that the patient contacting surfaces are configured to contact anatomical features in a mating engagement to ensure proper alignment and installation of the guide or template, and the guides of the preconfigured surgical template are oriented in a direction selected prior to manufacturing the preconfigured surgical template to achieve a desired positioning, alignment, or advancement of a tool within the one or more guides.

In accordance with yet another aspect of the present disclosure, a method for creating a template for use in a surgical procedure is disclosed, the method comprising the steps of:

collecting data from a patient corresponding to the patient's unique anatomy;

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

providing data associated with the model to the manufacturing machine;

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

A permanent device based on the template is created for use in the surgical procedure.

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

In accordance with yet another aspect of the present disclosure, a system for performing a surgical procedure on a patient is disclosed, the system comprising:

a surgical guide;

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

the surgical guide further comprises at least one trajectory or path determined by the patient's bony anatomy for facilitating the surgical procedure;

the surgical guide further includes at least one sleeve comprising a conductive material and having a first end and a second end;

an instrument comprising at least one first portion comprising a conductive material and adapted to be received within the at least one sleeve by inserting the at least one first portion 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 is

Wherein the surgical guide can be subjected to an electrical current for providing intra-operative monitoring (IOM) of the instrument during contact with the surgical guide and the patient anatomy.

Additional aspects of the present disclosure relate to the system described above and further including a surgical guide that is subjected to an electrical current by providing at least one electrode on the conductive material of the surgical guide and providing the electrical current to the at least one electrode.

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

Still further aspects of the present disclosure include a surgical guide manufactured using one of the methods described herein, wherein the guide is manufactured by a method selected from the group consisting of: rapid prototyping machines, photocuring rapid prototyping (SLA) machines, Selective Laser Sintering (SLS) machines, selective heat Sintering (SHM) machines, Fused Deposition Modeling (FDM) machines, Direct Metal Laser Sintering (DMLS) machines, powder bed printing (PP) machines, Digital Light Processing (DLP) machines, inkjet photo resin machines, and Electron Beam Melting (EBM) machines.

The following U.S. patents and patent applications, which relate generally to methods and instruments associated with surgical procedures, are incorporated by reference in their entirety to provide written descriptive support for the various aspects of the present disclosure. The U.S. patents and pending applications incorporated by reference are as follows: U.S. patent nos. 7,957,824, 7,844,356, and 7,658,610, and U.S. patent publication nos. 2010/0217336, 2009/0138020, 2009/0087276, and 2008/0114370.

One skilled in the art will appreciate that the various embodiments of the present disclosure may have different sizes. The various elements of embodiments of the present disclosure may be sized based on various factors including, for example, the anatomy of the patient, the individual or other device that operates the instrument or otherwise uses the instrument, the location of the surgical site, the physical characteristics of the devices and instruments used with the devices described herein (including, for example, width, length, and thickness), and the size of the surgical instrument.

Embodiments of the present disclosure present several advantages over the prior art, including, for example, speed and effectiveness of surgery, minimally invasive aspects of surgery, disposability of the prototype devices, the ability to introduce custom instruments or tools to a surgical site with minimal risk and minimal damage to surrounding tissue, lower risk of infection, more optimally placed and/or oriented guides and implantable devices, a more stable and controlled method of placing and inserting instruments associated with the surgical procedure to further reduce the likelihood of misalignment or movement of the instruments, and fewer and/or less expensive tools and instruments in the surgical site, among other advantages. For example, these embodiments reduce the number of and need for multiple trays, instruments, and different sized devices used in a particular surgical procedure, thereby reducing the cost of the equipment required to complete the surgical procedure. These embodiments also reduce the cumulative radiation exposure to both the surgeon and medical professional as well as the patient in the operating environment.

It will be appreciated by those skilled in the art that embodiments of the present disclosure can be constructed from known materials, or predictably manufactured, to provide 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 fiber, ABS plastic, polyurethane, polyethylene, photopolymer, resin (particularly resin material that encases the fibers), rubber, latex, synthetic rubber, synthetic materials, polymers, and natural materials.

It will be understood by those skilled in the art that embodiments of the present disclosure may be used with devices that employ automated or semi-automated operations. Embodiments of the present disclosure may be designed such that the instrument may be shaped and verified, for example, remotely by an operator through a computer controller, by an operator using proportioning devices, programmatically by a computer controller, by servo-controlled mechanisms, by hydraulically driven mechanisms, by pneumatically driven mechanisms, or by piezoelectric actuators. For the purposes of this disclosure, it is expressly understood that other types of machines besides rapid prototyping machines may be employed in the systems and methods described herein, such as, for example, by Computer Numerical Control (CNC) machines.

This summary is not intended to, and should not be construed as, representative of the full scope and breadth of the present disclosure. The present disclosure is illustrated in various levels of detail in the summary of the invention and the figures and detailed description of the invention and is not intended to limit the scope of the disclosure, which is intended to include or exclude elements, components, etc. from the summary of the invention. Other aspects of the disclosure will become more readily apparent from the detailed description, particularly 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. Other benefits, embodiments and/or characterizations of the present disclosure are possible by utilizing, alone or in combination, as set forth above and/or as described in the figures and/or the description below. However, the claims set forth below define the invention.

Drawings

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

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

In the drawings:

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

FIG. 2 is a flow chart illustrating steps of performing a method of making and using an instrument for facilitating surgery according to an embodiment of the present disclosure;

FIG. 3 is a side view of a particular instrument for facilitating surgery according to an embodiment of the present disclosure;

FIG. 4 is a rear elevational view of the instrument illustrated in FIG. 3;

FIG. 5 is a top view of the instrument shown in FIG. 3 relative to a unique grouping of anatomical features and in accordance with an embodiment of the present disclosure;

FIG. 6 is a perspective view of the unique grouping of instruments and anatomical features shown in FIG. 5;

FIG. 7 is another perspective view of the instrument shown in FIG. 3, showing the customized patient-mating surface of the instrument;

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

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

FIG. 10 is another perspective view of the instrument shown in FIG. 3 used in a particular surgical procedure in conjunction with a custom-manufactured instrument;

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

FIG. 12 is a perspective view of the instrument illustrated in FIGS. 11A-11B in an assembled state;

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

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

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

FIG. 16 is a different perspective view of the instrument illustrated in FIG. 15;

FIG. 17 is an exploded perspective view of the instrument illustrated in FIG. 15;

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

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

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

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

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

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

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

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

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

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

FIG. 28 is an elevation view of yet another alternative embodiment according to the present disclosure;

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

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

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

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

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

FIG. 32B is a perspective view in accordance with the embodiment shown in FIG. 32A;

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

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

FIG. 33C is another perspective view according to the embodiment shown in FIG. 33A depicted with the cutting guide of FIG. 32A;

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

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

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

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

FIG. 37 is another top view of the device according to the embodiment shown in FIG. 35;

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

FIG. 39 is another top view of the device according to the embodiment shown in FIG. 38;

fig. 40A to 40D are further top views of these devices according to the embodiments shown in fig. 35 to 39;

41A-41C are perspective views of an apparatus and instrument according to an alternative embodiment of the present disclosure that includes an EMG sensor and the ability to communicate EMG data to a monitoring instrument;

42A-42B include additional perspective views of the embodiment shown in FIGS. 41A-41C; and is

FIG. 43 is a diagram of steps of a method for manufacturing a device or instrument according to an alternative embodiment of the present disclosure.

Detailed Description

As shown in the figures and described in further detail herein, the present disclosure relates to a novel system and method for developing customized patient-matched instruments for use in a number of different surgical procedures. The systems and methods use a unique morphology of a patient that may be derived from capturing MRI data or CT data that is used to derive one or more patient-matched instruments that include surfaces that are complementary to those surfaces encountered during the one or more surgical procedures that are derived from a set of data points. 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 be further matched to at least other instruments used during a surgical procedure. Other features of the present disclosure will become apparent after review of the following disclosure of the invention and the various embodiments.

Various embodiments of the present disclosure are depicted in fig. 1-43. Referring now to fig. 1, a perspective view of a three-dimensional model of a unique grouping of anatomical features is shown in accordance with an embodiment of the present disclosure. The model 2 here comprises a plurality of vertebral bodies 4, 6, but may according to other embodiments also comprise any anatomical grouping for a specific patient. The data relating to model 2 may be captured from an MRI or CT scan or from radiographic images of the patient's corresponding bony 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 the data set represents model 2 and can be used to provide additional data points for forming the contours, size, shape, and orientation of one or more instruments to be used in a surgical procedure.

According to an alternative embodiment, the data may be obtained from an ultrasound or nuclear medicine scanning device. In yet another alternative embodiment, the data may be supplemented with or merged with data from a bone density scanner to produce a device designed to remain in the patient after the surgical procedure is completed, or alternatively, to enable 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 flow chart illustrating various steps performed in a method of manufacturing an instrument for facilitating a surgical procedure according to various embodiments described herein. According to a preferred embodiment, the method comprises the steps of:

A) obtaining data relating to the anatomy of a patient by MRI or CT scanning;

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

C) Determining one or more axes to be configured to facilitate orientation of a device of the one or more surgical procedures to be performed on the patient;

D) modeling a device for facilitating the one or more surgical procedures using the determined axes and addressing any other constraints of the one or more data sets resulting from the transformation;

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

F) The prototype is prepared for use in the one or more surgical procedures.

As shown in fig. 2, the method may include additional steps or may be repeated for additional devices used in a 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 apparatus known in the art. The data is then captured by the device and may be converted into one or more three-dimensional data sets by software or other algorithmic means known in the art, such as by outputting the data into a known modeling software program that allows the data to be represented in, for example, a CAD format. Once the data is transformed, a device can be modeled to complement the one or more data sets and oriented with one or more axes determined by the surgeon previously or by viewing one or more data sets from an initial scan of the patient's anatomy.

Method steps for resolving any other constraints of the data set originating from the one or more transformations may include: the modeled device is sized to accommodate space constraints for the surgeon, the elements of the modeled device are oriented to avoid certain anatomical features, one or more surfaces are created that may be conveniently operably connected with one or more instruments and/or tools used in one or more surgical procedures, and so forth. The prototype may be produced using known rapid prototyping machines, or alternatively by milling machines such as a CNC milling machine. Alternatively, the initial device manufactured by this method may be in a temporary state for further consideration and/or manipulation by the surgeon and then finally constructed using one of the modalities described herein. These steps may be repeated for complementary devices, some or all of which may include additional mating surfaces for the patient's anatomy or previously manufactured devices (i.e., the manufactured devices may have mating surfaces for abutting one or more devices together, as described in more detail below).

Alternatively, the systems and methods described herein may facilitate alignment of different anatomical features for a particular patient, such as, for example, alignment of multiple vertebral bodies within a patient in order to correct a spinal deformity. For example, the one or more data sets may provide an initial position for the anatomical features, but may be further manipulated by the surgeon in a pre-operative setting to create a desired one or more data sets, such as a final position for the anatomical features at the completion of the one or more surgical procedures. In this way, the devices shaped by the system and method described above can be used in either an initial or final position for the anatomical features, and matched to those specific positions and orientations for each stage of the surgical procedure. These phasic devices will in turn provide visual guidance to the surgeon in order to determine the degree of correction achieved by the surgical procedure as compared to the preoperative plan. Other variations of the methods of the present disclosure are described in the summary and are included in the appended claims.

The method of manufacturing may include using a rapid prototyping machine, such as a light-curing rapid prototyping (STL) machine, a Selective Laser Sintering (SLS) machine, or a Fused Deposition Modeling (FDM) machine, a Direct Metal Laser Sintering (DMLS) machine, an Electron Beam Melting (EBM) machine, or other additive manufacturing (additive manufacturing) machine. An example of such a rapid prototyping machine is commercially available from 3D Systems, inc (3D Systems) and is known under the model SLA-250/50. The rapid prototyping machine selectively hardens a liquid, powdered or other non-hardening resin or metal into a three-dimensional structure that can be separated from the remaining non-hardening resin, washed/sterilized and used directly as the instrument. The molding machine receives the individual digital data sets and generates a structure corresponding to each desired instrument.

Typically, the molding machine may alternatively be used to produce molds because stereolithography machines may produce resins with less than optimal mechanical properties (which may generally be unacceptable for particular surgical applications). After the mold is prepared, the device can be produced from a more suitable material, such as stainless steel, titanium alloy, aluminum alloy, chrome alloy, PEEK, carbon fiber, or other metal or metal alloy, using a conventional pressure or vacuum forming machine.

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 manufacture a custom milled instrument from the mechanically good materials listed above. In yet another alternative embodiment, mass manufacturing of instruments according to embodiments described herein may also be achieved, for example, where a particular orientation or insertion trajectory is shared between a large population of patients.

According to a specific embodiment of the present disclosure, a system and method are provided for manufacturing instruments for use in various surgical procedures associated with a spine of a patient. Individuals with degenerative disc disease, natural spinal deformities, disc herniations, spinal injuries, or other spinal disorders often require surgery at the affected site to relieve the individual's pain and prevent further injury. Such spinal surgery may involve the removal of damaged joint tissue, the insertion of a tissue implant, and/or the fixation of two or more adjacent vertebral bodies, with the surgery varying depending on the nature and extent of the injury.

Spinal fusion, or lumbar fusion ("fusion"), is commonly used to treat degenerative disc disease in patients with varying degrees of degenerative disc disease and/or nerve compression with lower back pain. Fusion generally involves distracting and/or decompressing one or more intervertebral spaces, then removing any associated facet joints or discs, and then connecting or "fusing" two or more adjacent vertebrae together. Fusion of vertebral bodies also typically involves fixation of two or more adjacent vertebrae, which may be accomplished by introducing rods or plates, and screws or other devices into a spinal joint to connect different portions of one vertebra to corresponding portions on an adjacent vertebra.

The fusion may occur in the lumbar, thoracic, or cervical regions of the patient. 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, vices, clamps, cannulas, retractors, distractors, cutters, cutting guides, and other insertion/retraction tools and instruments. The insertion, alignment and placement of these tools, instruments and fixation devices is critical to the success of the surgical procedure. Likewise, providing a tool or instrument that is customized and patient-specific increases the likelihood of success of the surgical procedure.

For example, one particular instrument that is formed by the systems and methods described above and that may be used for surgery associated with a particular fixation is depicted in fig. 3 and 4. According to an embodiment of the present disclosure, the instrument may be in the form of a pedicle screw guide 10 including a central body 12 and two generally elongated wings 14, each wing 14 terminating in a generally cylindrical post 16. In a preferred embodiment, as depicted in fig. 3, each of the cylindrical posts 16 is substantially hollow so as to allow one or more types of devices to be inserted therein. The intermediate body 12 further comprises a longitudinal cavity 20 (shown according to the perspective view taken in fig. 3) formed near the lower surface of the intermediate body 12. As described in more detail below, each of the cylindrical posts 16 further includes a lower patient contacting surface 18, 19 that, together with the longitudinal cavity 20, provide patient-specific contours for matching anatomical features.

The contours and locations of these lower patient contacting surfaces 18, 19 and the 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 fig. 3 and 4 may be shaped to conform to the particular preferences of the surgeon. For example, the wings 14 need only be of sufficient length to position the two cylindrical posts 16 in the location of the respective patient-matched anatomical features. The wings may take on other shapes, orientations, thicknesses, etc., without departing from the novel aspects of the present disclosure. Likewise, the central body 12 need only be sized to receive the longitudinal cavity 20 and may include extensions other than the wings 14 to assist in grasping or manipulating the pedicle screw guide 10 as desired.

Additionally, the 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 on the corresponding anatomical grouping 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 to the inferior articular process, and then deflected to the desired position once the wings are positioned in their final orientation. Additional aspects of this disclosure in this regard are described in more detail below.

FIG. 5 is a top view of the instrument shown in FIG. 3 with respect to a unique grouping of anatomical features according to an embodiment of the present disclosure. The pedicle screw guide 10 here is positioned such that the central body 12 is centered over the central portion of one vertebral body 4 such that the longitudinal cavity 20 mates with the profile of the spinous process 41 for this particular vertebral body 4. Likewise, the cylindrical posts 16 are positioned one inside each of the pedicle screw guides 10 such that the wings 14 span the lamina 43 of the vertebral body 4 and the cylindrical posts 16 are positioned adjacent to the inferior articular processes 44, 45. The lower patient contacting surfaces 18, 19 of the cylindrical post 16 are contoured to mate with the contours of the inferior articular processes 44, 45 and are posterior to the superior articular process 42.

Thus, the pedicle screw guide 10 provides a plurality of mating or matching positions, any one of which, if not properly positioned, will affect the fixation of the remaining two. The pedicle screw guide in this respect provides a significant improvement over the prior art in that it may be slightly rotated, misaligned or misaligned while the device still appears to the surgeon to be properly secured. The redundancy and multiplicity of the mating surfaces ensures that the pedicle screw guide 10 is both properly positioned and properly aligned. If the pedicle screw guide 10 is not properly positioned or aligned, the inferior patient contacting surfaces 18, 19 will not fit over each of the inferior articular processes 44, 45 and thereby prevent the longitudinal cavity 20 from being firmly secured to the spinous process 41.

Fig. 6 is a perspective view of the instrument shown in fig. 5. The desired insertion trajectory line A, B is shown to illustrate the positioning of the cylindrical posts 16 in addition to the orientation of the axes for each cylindrical post 16, which may be independent (i.e., the direction of the axis relative to the normal may be different between the cylindrical posts 16) with respect to their fixation adjacent the inferior articular processes 44, 45. The orientation of the cylindrical post 16 is also derived from the one or more data sets described above, and in a preferred embodiment is selected based on an orientation that will permit insertion of a fixation device (i.e., pedicle screw) consistent with the location of the pedicle and in a direction that avoids penetration of the fixation device from the pedicle (i.e., eliminating the possibility of the screw extending through the pedicle or being inserted at an angle that causes the pedicle screw to exit from the side of the pedicle).

These customized or configured patient contacting surfaces of the instruments shown in fig. 3-6 are illustrated by the bottom perspective view of the pedicle screw guide 10 in fig. 7. The inferior patient contacting surfaces 18, 19 herein may include a dynamic profile having multiple compound radii (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 to which cylindrical post 16 is to be positioned during surgery, and do not substantially conform to a different surface of the vertebrae. In this way, if the pedicle screw guide 10 is misaligned, the surgeon can be immediately informed that it will not be properly secured to these vertebrae.

FIG. 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 adjacent vertebral bodies 4, 6, 8. The multi-segmented pedicle screw guide 10' includes a plurality of secondary wings 14' and tertiary wings 14 ", each of which has a corresponding cylindrical post 16', 16" for inserting and aligning a plurality of pedicle screws into the adjoining vertebral levels 6, 8. It should be clearly understood that a number of segments greater or less than three in number may be implemented without departing from the spirit of the present invention.

FIG. 9 illustrates an instrument according to yet another alternative embodiment of the present disclosure that includes a plurality of segments 12 ", 12'", 12 "". Similar to the embodiment shown in fig. 8, this pedicle screw guide 10 "allows for the alignment and insertion of pedicle screws in multiple levels 4, 6, 8 of the spine. However, each of the plurality of segments 12 ", 12 '", 12 "" has a modified intermediate body that includes a mating end and a receiving end such that the plurality of segments 12 ", 12'", 12 "" can be joined as shown in fig. 9. The receiving and engaging ends of each of the plurality of segments 12 ", 12 '", 12 "" are different such that only the correct order of the segments 12 ", 12 '", 12 "" is achieved upon assembly (i.e., the segment 12 "can only be connected to the segment 12 '"). This figure illustrates yet another aspect of the present disclosure, particularly the ability to pair or connect specific devices adjacent to each other to further ensure alignment and pairing with specific anatomical features associated with each device, as well as to provide a means for applying corrective forces to the vertebrae and to visualize the extent of deformity correction.

Fig. 10 illustrates an instrument according to the embodiment of fig. 5 having a custom instrument that may be used with the instrument during a particular surgical procedure. For example, during a spinal fusion procedure (such as the one described above), it is common for a surgeon to attach one or more pedicle screws to a 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 such that the instrument 60 can only be advanced into the cylindrical post 16 to a predetermined distance, thereby providing a hard stop and, in turn, 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) having a narrowed inner diameter that corresponds in a manner and location to an end stop that mates with the outer diameter of the instrument 60 to prevent over-penetration of the instrument into the cylindrical post 16 and thereby insertion of the pedicle screw 62 beyond a safety limit.

FIG. 11 is a perspective view of an instrument according to yet another alternative embodiment of the present disclosure. The instrument here is a pedicle screw guide 100 further comprising a narrow bridge 112 around the central body that allows for the incorporation of a collar 130 with the improved pedicle screw guide 100, as shown in fig. 12. The collar 130 may include a contoured lower surface (similar to the longitudinal cavity of the embodiment shown in fig. 3) that matches the patient's spinous process and may be inserted into the pedicle screw guide 100 to match the particular anatomical features for the vertebrae undergoing surgery during the surgical procedure. Thus, in this embodiment, in addition to the lower patient contacting surfaces 118, 119 of the two cylindrical posts 116, the collar 130 includes at least one patient-matching contour and can be disassembled and replaced with other collars having different contours as needed for the surgical procedure being performed on the different vertebrae. In this embodiment, the cylindrical post 116 may further include one or more apertures 111 to facilitate visualization of the pedicle screw as it is being advanced into the cylindrical post 116.

FIG. 13 is a perspective view of an instrument for facilitating surgery in accordance with 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. The laminectomy cutting guide further includes at least one alignment channel 151 for inserting a guide wire or other fixation element, and a cutting slot 152 for guiding the path of a blade or other cutting edge. As with the pedicle screw guide described above in fig. 3, the laminectomy cutting guide 150 also includes a lower patient contacting surface 155 that allows the laminectomy cutting guide 150 to mate with one or more vertebral bodies. Although shown as a generally rectangular prism in fig. 13, it should be expressly understood that other geometries are equally practical for the laminectomy cutting guide 150 and should be considered within the scope of the present disclosure.

Fig. 14 illustrates 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 segment 164 of the tube retractor that can be selectively detached from the cylindrical body 163 of the tube retractor 165, such that the tube retractor 165 can be reused in many procedures as the segment 164 is reassembled and bonded to the cylindrical body 163 for each patient. The tube retractor also includes a generally hollow lumen 162 and at least one tab 161 for manipulation during insertion, and this helps the surgeon to ensure proper alignment of the tube retractor 160.

Fig. 15-17 illustrate yet another alternative embodiment of the present disclosure. In this embodiment, the template may include a patient-matched guide 180 for facilitating placement of one or more interbody devices, such as, for example and without limitation, an implantable stent for introducing one or more bioactive substances or bone grafts, or an artificial intervertebral disc. In fig. 15 and 16, patient-matched guide 180 is shown in one possible position (between two adjacent vertebrae) relative to a unique anatomical grouping for assisting a surgeon in the placement of one or more interbody devices.

In fig. 17, the patient-matched guide 180 is shown in an exploded view to demonstrate how multiple components for a particular surgical procedure may be manufactured using the systems and methods described above. These components include a patient-specific insert 182, a guide sleeve 184, and connectors 186 that, in a final assembled state, form the patient-matched guide 180 shown in fig. 15.

Referring now in detail to fig. 18-19, another alternative embodiment of the present disclosure is shown. According to this embodiment, a surgical template 190 is depicted that may further incorporate a plurality of fixation devices 198, 198' that may be used to secure the template 190 in a variety of different ways. According to this embodiment, the template 190 includes a middle section 192 oriented to bridge the spinous process of the patient, and may further include apertures (not shown in fig. 18-19) for inserting one or more fixation devices 198, 198'. Template 190 may further include two laterally extending portions or "wings" 194 each terminating in a guide 196. The descriptions of the guides provided above in connection with the other embodiments disclosed herein are incorporated by reference with respect to this embodiment.

According to the embodiment shown in fig. 18-19, fixation devices 198, 198' may be inserted through apertures (not shown) in the middle section 192 of the template 190 for stabilizing and securing the template 190 to the spinous process of a patient. According to one embodiment, the orientation and orientation of a first fixture 198 is different from the orientation and orientation of a second fixture 198' to further improve the stability of the form 190 prior to insertion and placement of the permanent fixtures. According to yet another embodiment, the orifices may be located in different positions than depicted in fig. 18-19, and the number of holes may be fewer or greater depending on the needs of the surgical procedure and the specific bony anatomy of the patient.

Referring now in detail to fig. 20-21, yet another alternative embodiment of the present disclosure is shown. In this embodiment, the template 200 further comprises two additional contact surfaces 205 preferably having a hollow opening at the patient contacting end and an aperture extending therethrough for insertion of a fixation device 199, 199'. The purpose of these fixation devices 199, 199' is to secure template 200 to the bony anatomy and to facilitate fixation of permanent fixation devices (not shown) by a plurality of guides 206, as described above in connection with fig. 18-19.

Referring to fig. 20, template 200 includes a boss 208 extending from the top surface of template 200 for insertion of a first fixture 199, wherein boss 208 is partially hollow to accommodate the shape and length of fixture 199. The boss 208 extends above one of the laterally extending portions or "wings" 204 of the template 200, as shown in fig. 20. The projections 208 may extend more or less above the template than shown in fig. 20 to provide a snap stop against over-insertion of the fixture 199. Similarly, the opposing laterally extending portions or "wings" of template 200 also include a boss 208 'for insertion of a second fixture 199'.

In combination with the above disclosure regarding determining and modeling patient contact surfaces, according to this embodiment, the template 200 has at least four patient-specific contact surfaces 205, 207. This embodiment improves the stability and positioning of the template 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 one direction and orientation that is predetermined for the particular surgical needs. This is accomplished by providing four patient contacting surfaces that act like independent legs of a table and are positioned at different locations (and different planes) relative to the patient's bony anatomy in order to further improve the stability and positioning of template 200.

According to the embodiment shown in fig. 18-21, the guides and other patient contacting surfaces can be depth specific and can further incorporate specific inner diameters to accommodate insertion of a temporary fixation device to a controlled depth within the patient's bony anatomy. In addition, the guides may have specially threaded inner surfaces to accommodate a particular fixture and facilitate insertion of a threaded fixture (e.g., screw). In some embodiments, the templates may be designed for a particular patient to prevent excessive penetration of the fixation devices into the bony anatomy or to facilitate temporary fixation of the templates by a first set of depth-controlled fixation devices.

According to yet another embodiment, each patient contacting surface may have an integral blade with a patient contacting cutting surface integrated around at least a portion of the patient contacting surface to further position and secure the template to the bony anatomy prior to insertion of the fixation devices. The purpose of the blade is to cut into soft tissue to achieve better template-to-bone contact between the template and the patient's bony anatomy. The hollow portions of the guides and other patient contacting surfaces of the template further allow soft tissue to be positioned within the hollow surfaces after the template has been placed in a desired location, further securing the template to the patient's bony anatomy. The blade may be substantially cylindrical or annular to match the shape of the guide, or may be oval, polygonal, or otherwise shaped to match a patient contacting surface.

To further increase the stability of securing and placing the patient contacting surfaces described herein onto the patient's anatomy, these contacting surfaces may further include one or more pegs or teeth for contacting and at least partially penetrating the patient's anatomy to secure the device in place. In one embodiment, the pegs or teeth may be made of the same material and may be permanently attached to the patient contacting surfaces. In another embodiment, the pegs or teeth can be made of different materials, such as those described herein, and can be further selectively inserted onto 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, the template 220 has a plurality of patient contacting surfaces 212, 219 that are achieved by using a "floating" patient mating member 214 that can be inserted into one of the plurality of guides 216 either before or after positioning the first set of patient contacting surfaces 212. The patient mating part 214 may further include a longitudinal key 218 corresponding to a slot or groove (not shown in fig. 22) in the guide 216 for facilitating proper positioning (rotationally) of the corresponding patient mating part 214 of the template 220.

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

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

Referring now to FIG. 24, another alternative embodiment of the present disclosure is shown. According to this embodiment, one template 250 may be provided that is not patient-specific (but in an alternative embodiment may be patient-specific) and further provides a means of attaching a plurality of patient-specific components 254 to the template 250. As shown in fig. 24, the member 254 may be secured to the template 250 by aligning the apertures 252, 258 and attaching one or more securing devices (not shown in fig. 24) such as screws, pins, or other similar devices. Once the component 254 is secured to the template 250, the patient contacting surface 262 can be used to guide and position the template 250 with the integrated component 254 in a desired position. In this manner, a standard template 250 may be provided prior to obtaining any patient data and combined with the patient-specific component 254 formed after the patient anatomical data has been captured, thereby eliminating custom machining or fabrication of the template for a particular surgical application.

According to this embodiment, the template 250 may be reusable or, in an alternative embodiment, disposable. The template 250 may comprise any of the materials listed herein, but in a preferred embodiment is formed from a metal, metal alloy, or polymer-based material. According to yet another alternative embodiment, the part 254 may snap into place or have a friction fit connection and therefore not require screws or other securing means to attach to the template 250. In yet another alternative embodiment, the template 250 can be provided in a variety of settings sizes and orientations to cover the variability of the patient's anatomy and different sized vertebral bodies (relative to different sections or regions of the patient's spine).

Referring now in detail to FIG. 25, another alternative 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 spinous processes of the patient. According to this embodiment, the clamps 272 each have a patient contacting surface 274 (here designed to contact the spinous process around each side) to secure the template to the desired location of the patient's anatomy. Each clamp 272 may be positioned laterally relative to the template 270 (shown in elevation) and attached to a set position relative to the body of the template 270. The clamp 272 can be secured in a fixed position against the spinous process by a variety of known means including a latch mechanism, a ratchet mechanism, a direction-specific resistance mechanism, or a selectively releasable fastening mechanism. In this embodiment, the clamp 272 allows opposing forces to occur in the bone anatomy to become balanced with respect to the patient's template 270. In turn, the clamping mechanism ensures and maintains alignment of the template 270 relative to these bone surfaces, thereby further ensuring accuracy with respect to insertion of the permanent fixation device. These clamps may take on a variety of shapes or embodiments, including pins, paddles, or any other type of opposing surface that exerts a side-by-side stabilizing force.

According to one embodiment, the surgical guides depicted in fig. 24 and 25 may include surfaces around the patient contacting end of the guide sleeve (see 254, fig. 24) that contact the patient's vertebrae to conform to the soft tissue present at the facet complex (see 278, fig. 25). Thus, according to this embodiment, one or more generally cylindrical guide sleeves include a patient contacting surface resembling a semi-cylinder or partial cylinder (as shown in fig. 24 and 25) to avoid contact with this soft tissue.

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 fig. 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 clearing of the guide when it is placed in position (see surface 282 on fig. 26A). In addition, a surgical guide as described herein can include one or more clamping elements, such as the clamp 284 depicted in fig. 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 for the insertion of one or more inserts 288, as shown in fig. 27A and 27B. The inserts 288 may be sized with an outer diameter for mating with the inner diameter of the one or more guide sleeves 254, and with an internal bore extending longitudinally through the insert 288 for accommodating different sized drill bits or taps (as an example). In practice, the insert 288 may facilitate and guide a drill bit for forming 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 the insert 288.

Referring now to fig. 28, the inserts 288 provided with the surgical guides for mating with the guide sleeves 254 may have a varying length L and may be made longer or shorter depending on the geometry of the guides, the anatomy of the patient, the purpose of the insert, and so forth. For example, if a greater depth of a particular drill is desired, the insert 288 may be shorter to accommodate further penetration of the drill bit into the patient's vertebra. Likewise, the internal bore of the insert 288 may have a diameter that varies depending on the precision tool or instrument intended to be used with the insert (as depicted in fig. 29A and 29B). In this manner, the surgeon can ensure that he or she is using the correct tool (e.g., drill or tap) with each insert (which may further include one or more markings indicating the location or specific use intended for the insert) when performing a surgical procedure. Further description of the principles described above reference is made to fig. 29A and 29B, which respectively depict an insert having a 4.5 millimeter orifice diameter for placement of a tap instrument and an insert having an 1/8 inch orifice diameter for use in conjunction with a 1/8 inch drill bit.

Referring now to fig. 30, according to one embodiment, the insert 288 described above may also include a patient-specific contact surface 294 for further mating the insert 288 (in addition to the guide sleeve 254) with the patient-specific anatomy. This allows for greater stability and positioning of the insert 288 and the guide comprising the insert 288 in the correct position. In addition, for the insert 288 to be used in conjunction with a drill bit or other vibrating or oscillating tool, the patient-mating surfaces 294 on the insert 288 will also prevent the distal end of the drill bit from "walking" or moving over the surface of the vertebral body when the initial pilot hole is formed, thereby reducing the risk of incorrect tracking of a fixation device.

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 disclosed herein) may include a sharp or semi-sharp contacting edge for penetrating into and adhering to soft tissue surrounding a patient's anatomical feature, such as a facet joint. According to this embodiment, the contact surfaces may comprise a cavity for soft tissue intrusion. The cavities form edges around the exterior of the legs that may be sharp or selectively sharpened to facilitate cutting into soft tissue to rest on/mate with underlying bone. This is particularly important for spinal surgery where the precise location of the patient contact surface must be within a small degree of error and must remain permanent throughout the procedure.

Referring now in detail to fig. 31, the insert may further include a key or notch 296 around a surface of the generally cylindrical body of the insert that is configured to mate with a cut-out or slot 298 on the guide sleeve 254 of the device. In this manner, proper rotation/orientation of the insert 288 is ensured as it is guided into the hollow body of the guide sleeve 254.

Referring now to fig. 32A-34B, further illustration of a cutting guide (such as the one depicted in fig. 13 above) is provided. According to one embodiment, the cutting guide includes a plurality of patient-specific contact surfaces 302 surrounding at least one surface of the cutting guide. In a preferred embodiment, the cutting guide further comprises a patient-specific "rail" 303 for facilitating insertion of a cutting instrument (as shown in fig. 33A-33C) and controlling the depth of insertion of the instrument to prevent unnecessary cutting of underlying surfaces during a particular surgical procedure by further providing one or more instrument contact surfaces 304. According to the embodiment shown in connection with fig. 32A-34B, the cutting guide may be provided for a laminectomy. According to other embodiments, patient-specific guides can be manufactured for performing vertebrectomy, transpedicular centrum Osteotomy (PSO), Smith Peterson Osteotomy (SPO), spine resection (VCR), or asymmetric Osteotomy (either in the sagittal or coronal planes), among other procedures.

These patient-specific cutting guides can be manufactured from patient anatomical data and can help perform complex procedures with greater certainty of their outcome. For example, certain osteotomies (particularly PSOs and SPOs) require high surgical skills and are often time consuming. This is due in part to the close relationship of blood vessels and neural elements to the bone structure, which creates a guidance challenge for the surgeon to safely and effectively resect bone during one of these procedures. This is particularly true for the latter approach. By using a patient-specific guide, the surgeon can confirm the positioning and alignment of the cutting trajectory and path prior to beginning the procedure, and in further aspects of the disclosure provided above with respect to fig. 32A-34B, can also provide the degree of depth control necessary to avoid contact with the vessels and neural elements.

In one embodiment, the cutting tools associated with the cutting guide shown in fig. 32A-34B are typically of the type commonly used in surgical procedures today. According to another embodiment, the instrument may include a specialized cutting drill or tip to facilitate further control of the position and depth of the instrument, as described in further detail below. For example, as shown in fig. 33A-33C, the cutting portion of the instrument may have a trackball 308 that prevents the instrument from being inserted into the cutting guide larger than required for patient-specific surgery.

As shown in more detail in fig. 34A-34B, a trackball 308 may be inserted into a first portion of a "track" 303 of a cutting guide, but not allowed to be inserted into a second or deeper portion of a "track" of a cutting guide (allowing the cutting surface to travel through the track), to ensure the correct depth of the cutting instrument. Additional geometries different from those shown in fig. 34A-34B may be provided that allow the trackball 308 to move horizontally relative to the top surface of the cutting guide, and in some cases laterally and downwardly into the track 303 of the cutting guide. In this embodiment, the cutting instrument would thus be allowed to move at a certain depth around the anatomy of the patient in a certain position of the "track" 303 of the cutting guide, but a greater depth is achieved at other positions around the "track" 303 of the cutting guide. Thus, the depth allowed with respect to the cutting guide with respect to the instrument may be variable about the "track" 303 of the cutting guide.

Other benefits achieved by using these patient-specific cutting guides include: providing a means to achieve rapid and controlled removal of bone; providing a spatial orientation of a cutting tool used during a surgical procedure; ensuring correct orientation of the incision by controlling both guidance and visualization of the instrument during preoperative planning; providing accurate calculation of deformity correction prior to cutting; providing precise bone resection, which in turn ensures deformity correction; a depth-controlled cutting restriction to protect nerve and vascular elements; control the cutting vector and avoid contact with or damage to neural elements; and the ability to provide a route for posterior, anterior, posterolateral, transforaminal or direct lateral cutting.

FIG. 35 is a top view of yet another alternative embodiment according to the present disclosure. In this embodiment, the device 310 may provide one or more patient contacting elements that include a plurality of breakaway portions 314 that allow placement of a fixation device (e.g., pedicle screws) without the need to detach the device from the patient's bony anatomy. The separating side edges can be formed by creating slots 315 in the surface of the surgical guide portion of the device that provide the perforation axis of the portion to be separated 314.

According to this embodiment, the guide sleeve may be asymmetric, which will allow for two different inner diameters: one internal diameter facilitates guidance of hand tools (i.e., drills, taps) and one internal diameter accommodates the boss or cap of the device (e.g., the flare of a pedicle screw). Once the distraction portion 314 of the guide sleeve is removed, a clear view and path to the vertebrae is possible and allows pedicle screw placement without removing the guide device.

Fig. 36 is a detailed view of the device according to the embodiment shown in fig. 35. In fig. 36, a detailed view of slots 315 is shown, which in a preferred embodiment may be formed during the manufacture of device 310, but in alternate embodiments, the slots may be formed by perforation or other techniques for forming a slot 315 around a surface of the guide sleeve of device 310 after the device has been manufactured.

Fig. 37-39 are additional views of the device according to the embodiment shown and described with respect to fig. 35. In fig. 37, an asymmetric guide sleeve is shown having two separate portions 314 that are separate from the device 310. In fig. 38, the embodiment shown and described with respect to fig. 26A-26B is shown, but now with an asymmetric guide sleeve with multiple separate portions 314 as described above.

Fig. 40A-40D are additional perspective views of the devices described above with respect to fig. 35-39, according to embodiments having at least one or more separate portions. Once removed, these separated portions are preferably disposed of by the surgeon.

Each of the embodiments described herein may be provided in a modular (i.e., single-stage) or monolithic (i.e., multi-stage) configuration. Thus, to facilitate the description provided herein, certain embodiments have been shown in one (modular or unitary) embodiment, but these embodiments may be provided in a different (unitary or modular) configuration without departing from the spirit of the disclosure. In various aspects, these unitary embodiments can include any position relative to two to ten segments of a vertebral body, or multiple positions of a patient's bony anatomy other than the spine. It should be clearly understood that the embodiments described herein are for the purpose of illustrating certain embodiments of the disclosure and are not intended to limit the scope of the disclosure.

According to the various embodiments described herein, a plurality of fixation devices including, but not limited to, pins, screws, hooks, clamps, rods, plates, spacers, wedges, implants, and the like, may be quickly and easily manufactured for use in a surgical setting or an educational setting. Similarly, a variety of instruments and/or other devices may be manufactured based on patient-specific data, including but not limited to patient-matched inserters, spatulas, cutters, elevators, curettes, ronguers, probes, screwdrivers, paddles, ratchet mechanisms, removal and rescue tools, cannulas, surgical mesh, and the like.

Included in an instrument that can be manufactured using patient-specific data and includes a plurality of patient-matched surfaces is a device for use as an implant, including a variety of implants for restoring disc space height within a patient's vertebrae. For example, the methods described herein can be used to manufacture patient-matched metallic, polymeric, or elastomeric implants, wherein certain patient-contacting surfaces of the implant accurately and precisely match the patient's anatomy. In one embodiment, the implant may be matched to anatomical features of a patient that have degenerated and require restoration. In another embodiment, the implant may be necessary to correct structural or physiological deformities present in the patient's anatomy, and thus, to correct the position or alignment of the patient's anatomy. Other implants may be patient specific, but do not serve a restorative or other structural function (i.e., hearing aid implant housing).

The implants described herein may be manufactured via additive manufacturing. In the context of spinal implants, these implants may be used in all approaches (anterior, direct lateral, transforaminal, posterior, postero-lateral, direct postero-lateral, etc.). The specific features of the implant may address certain surgical goals, such as restoring lordosis, restoring disc height, restoring sagittal or coronal balance, and the like.

Other applications contemplated by the present disclosure include interbody fusion implants, disc space height restoration implants, implants having a shape and contour that matches the footprint (footprint), maximizes surface area, matches the endplates or other spinal defects; and may further specify contact surfaces such as relative roughness or other surface features. For example, an implant can be manufactured based on a patient's anatomy, the implant further including an orientation-specific shape such that the implant can fit through an access port and into the intervertebral disc space without difficulty. Alternatively, the implant may be manufactured in a manner that addresses anatomical constraints at both the implant point and the path through which the implant must travel, and may further compensate for anatomical defects. In the context of a spinal implant, the implant may further specify the angle of lordosis or coronal defect correction desired, specify the patient-specific height of the implant or (desired height after disc height restoration), specify the degree of expansion allowed (for an expandable implant), and may be unidirectional or multidirectional depending on the surgery and surgeon preference.

According to one embodiment, the manufacture of a patient-matched device can be used to create a patient-matched lamina. By way of example and not limitation, patient data may be obtained to create a plurality of matching surfaces for one or more cervical or lumbar anterior plates of a spinal reconstruction surgery. The plate may include a plurality of contours or surface features that match the bony anatomy, including a plurality of matching surfaces that span more than one segment or vertebra. In yet another embodiment, the patient data may be used to create a specific patient matching plate with an identifier of the position of the plate, and may further include a plurality of custom boreholes or other alignment points specific to the patient. In addition to those plates used and described in spinal surgery, other types of plates may incorporate the patient-matching features described herein without departing from the disclosure.

According to another embodiment of the present disclosure, an instrument is provided having the capability of monitoring one or more biological signals during a surgical procedure using the instrument described herein. In a preferred embodiment, the biosignals obtained from the patient include at least one Electromyography (EMG) component that can be measured and observed during at least a portion of the surgical procedure. In alternative embodiments, the system includes a somatosensory evoked potential (SSEP) component and/or a motion-evoked potential (MEP) component. Other neuromonitoring modalities for this embodiment are also contemplated. An analysis of the biological signals may be performed to determine whether a fixation device or instrument (such as a drill tip) has been properly placed, or alternatively whether the device or instrument is in contact with neural elements present near the surgical site.

According to this embodiment, one or more devices or instruments may be in communication with a monitoring instrument that receives and reports EMG signal data from the patient via a measurement channel from the device or instrument. The monitoring instrument preferably obtains this data and presents it to the user in graphical or other visual form. Based on the data presentation obtained from the monitoring instrument, the surgeon can determine whether the final placement of a device or instrument is received in the patient's bony anatomy or muscle tissue or in contact with, for example, neural elements.

In practice, one or more devices or instruments may incorporate an EMG sensor (such as an electrode) in communication with at least one measurement channel, which in turn provides EMG data to the monitoring instrument. The monitoring instrument then displays the data received from the one or more EMG sensors and preferably allows the surgeon or other medical professional to compare values associated with the EMG data to predetermined EMG data, including EMG data associated with different types of tissue. In a preferred embodiment, the predetermined EMG data comprises data relating to at least muscle, nerve, blood vessel and bone regions of the patient's anatomy. By comparing the measured EMG data with the predetermined EMG data, a surgeon or other medical professional can determine whether the EMG sensor has sensed a particular tissue type, which in turn guides the placement of the device or instrument with which the EMG sensor is associated.

Referring now to fig. 41A-41C and 42A-42B, various embodiments of intraoperative monitoring (IOM) enabled devices and instruments are depicted. Referring to fig. 41A, this embodiment includes an instrument, such as a drill, that further includes a conductive drill bit 324. The drill bit 324 may be inserted into a conductive drill sleeve 326, the drill sleeve 326 being in electrical communication 330 with a power controller (not shown in fig. 41A). The relationship between the bit 324 and the drill sleeve 326 is such that the two have a close tolerance 333 to ensure substantially constant contact between the length of the bit 324 and the drill sleeve 326. The drill sleeve 326 may further be inserted and secured within a guide sleeve 354, which in turn may be secured to a surgical guide 410.

Referring now to fig. 41B, once assembled, the drill bit 324 and the drill sleeve 326 are inserted into the guide sleeve 354, and the drill bit 324 extends through the guide sleeve 354 to allow contact with the patient's anatomy. In one embodiment, the drill bit may penetrate the pedicle of a patient positioned on a vertebra of the patient. In a preferred embodiment, the drill bit 324 further includes a generally cylindrical stop abutting a plate located on the distal end of the drill sleeve 326 (as shown in fig. 41B). This connection provides a secure connection and prevents the drill bit 324 from penetrating beyond the range permitted for a particular surgical application. This connection also ensures a high fidelity electrical pathway by communicating from the power controller (not shown) to the conductive drill sleeve 326 and thus the drill bit 324. In this manner, an electrical signal (preferably EMG) may be induced from the drill bit and transmitted to one or more monitoring instruments (not shown) during the surgical procedure. An alternative view of the assembly is depicted in fig. 41C.

In yet another embodiment, the guide sleeve 354 may induce EMG signals, as in the embodiment shown in fig. 42A-42B. According to this embodiment, the guide sleeve 354 is embedded with one or more electrodes 332 in communication 330 with a power controller (not shown) to provide intraoperative monitoring. In this embodiment, the one or more electrodes 332 are embedded in the one or more guide sleeves 354 to provide electrical communication with a conductive drill sleeve 336 or other conductive element placed in contact with the one or more electrodes of the guide sleeve 354. For example, the one or more electrodes may contact other conductive elements, such as a tapping instrument or a fixture, such as a screw. The conductive elements are in electrical communication with the power controller and one or more monitoring instruments (not shown) to allow a surgeon or other medical professional to compare EMG data obtained from the conductive elements to predetermined EMG data for different tissue types. This enables the surgical devices, instruments, and guides described herein to be IOM enabled and provide monitoring of the placement of different inserts, fixation devices, or other conductive elements during a surgical procedure.

According to yet another embodiment, a device and guide for improving sacral fixation are disclosed. In this embodiment, a device or guide is fabricated from patient data that includes one or more trajectories that cause a fixation device to enter an intervertebral disc space (as opposed to entering a pedicle), and in a preferred embodiment, may include trajectories that allow the fixation device to intersect with one or more implants, including but not limited to an interbody fusion device. In a preferred embodiment, sacral fixation occurs by providing trajectories in one or more surgical guides that are generally located in the region of the endplates and the promontory of the sacrum (S1). Via these trajectories, placement of a pair of pedicle screw anchors in the pedicles extending to the sacral promontory (preferably in conjunction with an interbody implant) is achievable. In a preferred embodiment, the one or more guides and interbody implants for ensuring the trajectories of the sacral fixation devices are formed using the methods described herein.

According to this embodiment, the patient-specific spinal implant and associated fixation device provide a significant improvement in implant design. In the disclosed design, an interbody fusion device may be placed through either bilateral PLIF or unilateral TLIF approaches, and may further become mechanically interlocked with a spinal anchoring or fixation device. The fixation device may be, by way of example and not limitation, a modified spinal pedicle screw. The surgical guide can be fabricated using patient data to provide a predictable and reproducible trajectory and to ensure that the fixation devices inserted through the guide interlock with the interbody fusion device. Although such a patient-matched implant has been described for use in the lumbosacral joint (L5S1), this embodiment may also be used for all other segments of the cervical, thoracic, and lumbar vertebrae.

To maintain the proper spatial relationship between the spacer and the screw, a patient-matched guide may also register the position of the fixation device and a spacer, and provide the proper convergent and sagittal pedicle screw angles without piercing the medial cortex and entering the spinal canal. In a preferred embodiment, a plastic or composite material (i.e., a metal frame with patient-matched plastic inserts) patient-specific device may provide these desired trajectories.

The instruments described herein may be used in a minimally invasive setting, and may further include a plurality of interlocking modules that may be assembled after delivery to a surgical site through a cannula or other minimally invasive pathway. Alternatively, one or more portions of an instrument may be nested within another portion of the instrument, or alternatively within an instrument or other device for delivering the instrument through a cannula or other minimally invasive portal. According to the manufacturing modes described above, the instrument may be manufactured with specific mating surfaces that only allow assembly in the correct manner, and may further include markings or other means to indicate which parts are nested within other parts or which modules abut other modules of the instrument.

For example, in one embodiment, it is contemplated to provide a plurality of nested patient matched guides, whereby at least one, but possibly several modules are assembled to create one "bottom guide". This bottom guide may span several spinal segments of the patient and may be secured to the vertebrae by one or more anchors. The one or more anchors may include, but are not necessarily limited to, a pedicle screw fixation device for use in final configuration. Once the bottom guide has been fixed in the correct position (by, for example, aligning the patient-matched surfaces with their respective bony anatomy), additional guides can be introduced and "nested" onto the bottom guide. In one embodiment, these additional guides may include cutting/drilling/routing guides. In another embodiment, these additional guides may comprise fixation device trajectory guides. In yet another embodiment, these additional guides may include a disc space restoration guide or an implant insertion guide.

According to embodiments in which these additional guides include at least one cutting/drilling/routing guide, the surgeon may then introduce one or more sequentially nested guides onto the bottom guide, the one or more sequentially nested guides being designed to conform to the surface of the completed cutting/drilling/routing bony anatomy (i.e., the one or more sequentially nested guides fit into the area of the recently resected bone, allowing deeper and deeper sequential cuts to be made into the bony anatomy, or allowing the final placement of fixation devices adjacent to the area of these cuts). In this way, the embodiments described herein may be used in combination to achieve even more reliable results by using a first guide for inserting a fixation device with a reliable trajectory before providing one or more second or subsequent guides to ensure reliable cutting (and reliable correction of deformities).

According to an embodiment in which a surgical guide is prepared to facilitate a cutting operation, the guide may include a plurality of cutting planes such that a cutting instrument is used through the plurality of cutting planes to provide a measured and accurate cut through bone anatomy. Thus, one or more cutting guides manufactured by the methods described herein will produce a measured and accurate correction of anatomical deformity by cutting through the plurality of cutting planes and subsequently removing the bony anatomy that has been cut using the one or more cutting guides. In the context of spinal surgery, these cutting guides may be used in different regions of the spine or in different sections of the patient's vertebrae to correct complex deformities.

The instruments disclosed herein can be made from a variety of different materials. These materials may include, by way of example and not limitation, stainless steel, titanium alloys, aluminum alloys, chromium alloys, and other metals or metal alloys. These materials may also include, for example, PEEK, carbon fiber, ABS plastic, polyurethane, resin (particularly resin material encasing the fiber), rubber, latex, synthetic rubber, synthetic materials, polymers, and natural materials. According to one embodiment, the instrument may be made of a first material used to plan or demonstrate the surgical procedure prior to making the instrument in a second material used for use during the surgical procedure. In this manner, a surgeon or other medical professional may use a guide and/or mapped solid model (made of a first material) of the patient's anatomy prior to performing a surgical procedure using instruments prepared based on patient data and/or a surgical planning process facilitated by the solid model guide or any other solid model of the patient's anatomy. By way of example and not limitation, such use of the first set of instruments may be used to practice techniques to be employed during a surgical procedure, or otherwise allow a surgeon to perform "exercises" of the procedure. The practical ability also provides the surgeon with the opportunity to visualize and confirm the fit of different instruments and fixation devices with these dummies guides or other instruments. In addition, these solid models can provide surgeons with an inexpensive way to educate other medical professionals or patients prior to surgery.

Referring now to FIG. 43, a method in accordance with an alternative embodiment of the present disclosure is described. According to this method, a patient-matched device, guide or implant can be prepared following one or more of the following steps. First, the surgeon receives information 510 indicating the benefits of employing patient matching techniques. Second, the patient is scanned to capture data 512 relating to anatomical features suitable for three-dimensional reconstruction. The surgeon then reviews the data 514 and prepares an initial surgical plan 516. The image data captured from the patient scan is then passed to an engineering team 518 or other medical professional for processing 520. During processing, the patient data is used to create a precise anatomical region around the surgical site. In this process, the data may be transformed to create an anatomical file 522. The next step is to prepare a surgical plan 524 by locating one or more regions of interest using the three-dimensional anatomical region data, which in turn provides the surgeon with one or more patient-matched surfaces and one or more trajectories. The surgeon then modifies and approves the surgical plan 526 and begins designing patient matched devices, guides, and instruments for the final plan 528. After the design stage, the fabrication 530 of these devices is performed and, once verified, supplied to the operating location 532. The remaining steps of sterilization 534 at the time of surgery and use of the patient-matched device 536 during surgery are performed. It should be expressly understood that fewer than all of the above-described steps may be followed without departing from the spirit of the present disclosure.

It should also be expressly understood that while rapid prototyping and related manufacturing techniques (e.g., CNC) have been used to illustrate the present disclosure, it is contemplated that other manufacturing modes may be employed without sacrificing the benefits of the present disclosure. For example, methods unrelated to additive manufacturing (e.g., alternative imaging techniques may be employed) may be utilized to fabricate a custom device, guide, or instrument using the steps described herein.

Furthermore, the present disclosure may also be advantageous in view of recent improvements in decentralized manufacturing. For example, using equipment that is present in a surgeon's office or office, or in a public or private hospital, a variety of devices, guides, and instruments may be quickly able to be manufactured in a variety of different and convenient settings, including but not limited to off-site manufacturing locations, on-site manufacturing locations. In this manner, patient data and methods of obtaining accurate and matching devices, guides, or instruments may be facilitated by proximity manufacturing methods and are considered to be within the scope of the present disclosure.

While various embodiments of the present disclosure have been described in detail, it should be apparent that modifications and adaptations to those embodiments may occur to one skilled in the art. It is to be expressly understood, however, that such modifications and adaptations are within the scope and spirit of the present disclosure, as set forth in the following claims. For further explanation, the information and materials provided in the provisional and non-provisional patent applications to which this application claims priority are expressly incorporated herein by reference in their entirety.

It should be expressly understood that where the term "patient" is used to describe various embodiments of the present disclosure, the term should not be construed as limiting in any way. For example, the patient may be a human patient or an animal patient, and the instruments and methods described herein are equally applicable to veterinary medicine, as they would be applicable to surgery on the human anatomy. Thus, the instruments and methods described herein have application 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 foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing detailed description for purposes of example, 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 the detailed description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

Moreover, while the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. This is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims (20)

1. A surgical device that matches anatomical features of a particular vertebra of a patient, the surgical device comprising:

an intermediate body configured to be positioned adjacent to a vertebra and having a proximal end and a distal end;

a first guide sleeve extending from the intermediate body;

a first insert selectively interconnectable with the first guide sleeve and including a first distal surface that automatically mates with at least one first contour of the particular vertebra when the first insert is interconnected with the first guide sleeve;

a second guide sleeve extending from the intermediate body;

a second insert selectively interconnectable with the second guide sleeve and including a second distal surface that automatically mates with at least one second contour of the particular vertebra when the second insert is interconnected with the second guide sleeve; and is

Wherein the first and second distal surfaces are defined by and complementary to the patient's anatomy.

2. The surgical device of claim 1, further comprising at least one wing extending from the distal end of the intermediate body, wherein the at least one wing includes a lower surface that automatically mates with at least one contour of the patient's anatomy.

3. The surgical device of claim 2, wherein a lower surface of the at least one wing automatically conforms to at least one of a lamina or inferior articular process of the particular vertebra.

4. The surgical device of claim 2, wherein a lower surface of the at least one wing automatically conforms to at least one of a lamina or inferior articular process of one or more vertebrae.

5. The surgical device of claim 1, wherein at least one of the first and second guide sleeves includes a lower surface that automatically conforms to a predetermined portion of the patient's vertebra.

6. The surgical device of claim 1, wherein at least one guide in the first and second inserts comprises an aperture.

7. The surgical device of claim 6, the aperture defining a path for guiding at least one instrument.

8. The surgical device of claim 7, wherein the at least one instrument is one of a drill and a tap.

9. The surgical device of claim 8, wherein the aperture is oriented along a predetermined trajectory for placement of a fixation device into the particular vertebra, and

wherein the predetermined trajectory is determined by an anatomical feature of the patient.

10. The surgical device of claim 9, wherein each of the first and second inserts has a length determined by a depth at which the fixation device is to be placed in the particular vertebra.

11. The surgical device of claim 1, wherein the surgical device is configured for use on one or more vertebrae of the patient.

12. The surgical device of claim 1, wherein the surgical device is combinable with a plurality of additional surgical devices for spanning a plurality of anatomical features associated with the patient.

13. The surgical device according to claim 1, wherein the surgical device is comprised of a plurality of surgical devices that may be arranged in a unitary or multi-stage configuration for spanning a plurality of anatomical features associated with the patient.

14. The surgical device according to claim 1, wherein the surgical device is manufactured by a method selected from the group consisting of: rapid prototyping machines, stereolithography machines, selective laser sintering machines, selective hot sintering machines, fused deposition modeling machines, direct metal laser sintering machines, powder bed printers, digital photo processors, ink jet photo resin machines, and electron beam melting machines.

15. A surgical device formed from anatomical data for a particular patient, the surgical device comprising:

a central body having a proximal end and a distal end;

a first guide sleeve;

a first insert selectively positioned within a first guide sleeve of the surgical device and configured to be positioned over a first patient subcutaneous anatomical feature corresponding to the first insert, the first insert including a first aperture;

a second guide sleeve; and

a second insert selectively positioned within a second guide sleeve of the surgical device and configured to be positioned over a second patient subcutaneous anatomical feature corresponding to the second insert, the second insert including a second aperture.

16. The surgical device of claim 15, further comprising a first guide sleeve and a second guide sleeve extending from the intermediate body, wherein the first guide sleeve has a first patient-specific orientation and the second guide sleeve has a second, different patient-specific orientation.

17. The surgical device of claim 15, wherein at least one of the first insert and the second insert has a patient-specific length.

18. A system for performing a surgical procedure on a patient, comprising:

a surgical device, comprising:

an intermediate body having a proximal end and a distal end; and

a first guide sleeve and a second guide sleeve extending from the intermediate body, wherein each of the first guide sleeve and the second guide sleeve comprises a plurality of surfaces determined from data scanned from the patient, the plurality of surfaces configured to match a bone anatomy of the patient;

a first insert selectively interconnectable with the first guide sleeve, and a second insert selectively interconnectable with the second guide sleeve, wherein the first insert includes a first aperture and the second insert includes a second aperture, the first and second apertures each defining a trajectory or path determined by the patient's bony anatomy for facilitating a surgical procedure; and

at least one sleeve securable within at least one of said first and second apertures, said at least one sleeve comprising a conductive material and having a first end and a second end;

an instrument comprising at least one first portion comprising a conductive material and adapted to be received within the at least one sleeve by inserting the at least one first portion into the first end of the at least one sleeve such that said first portion contacts 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 is

Wherein the surgical device can be subjected to an electrical current for providing intraoperative monitoring of the instrument during contact with the at least one sleeve and the patient anatomy.

19. The system according to claim 18, wherein the surgical device is subjected to an electrical current by providing at least one electrode on one or more of the first and second inserts and providing electrical current to the at least one electrode.

20. The system according to claim 19, wherein the instrument is a cutting instrument, a drilling instrument, or a guide instrument.