KR102638410B1 - Patient-matched devices and methods for performing surgical procedures - Google Patents

Abstract

Systems and methods are disclosed for developing customized devices for use in one or more surgical procedures. The systems and methods include a patient's unique anatomical features or morphology that can be derived by capturing MRI data or CT data to fabricate at least one custom device. According to a preferred embodiment, the customized device includes a plurality of complementary surfaces based on a plurality of data points from MRI or CT data. Accordingly, each device can be doubly matched and oriented around the patient's own anatomy, further providing any desired axial alignment or insertion trajectory. In other embodiments, the device may be further aligned and/or matched with at least one other device used during a surgical procedure.

Description

Patient-matched devices and methods for performing surgical procedures

The present invention relates to the field of medical devices, and generally to devices that are configurable for use on a specific patient in a surgical environment based on the patient's unique anatomical characteristics, and methods of making and using the same.

Given the complexity of the various instruments, instruments, implants, and other devices used in surgical procedures and procedures, as well as the anatomical differences among patients who receive such instruments, instruments, implants, and devices, the unique and sometimes non-routine nature of a particular patient's Developing a surgical plan that accounts for human anatomical features is often difficult. For example, implanting pedicle screws into the vertebral body (either as an accessory or as a stand-alone stabilization device) is well accepted among surgeons treating a variety of spinal pathologies, and the performance of various pedicle screw constructs has been evaluated. Despite becoming more predictable, the placement and insertion of pedicle screws or other bone anchors still presents several challenges. Problems arise when the surgeon cannot refer to bony landmarks due to previous surgery or when the patient's anatomy is non-traditional in shape.

Surgeons can now easily convert magnetic resonance imaging (MRI) data or computed tomography (CT) data into readable data sets by computer-aided design (CAD) programs and/or finite element modeling (FEM) programs. , which can then be used, for example, to create a custom implant based on the dynamic properties of the anatomical structures to which the custom implant is designed to be associated. This data is currently used by surgeons in surgical planning, but is rarely used to create a customized set of instruments or other surgical devices designed to complement the patient's unique anatomy.

Accordingly, it is adapted and/or configured and/or capable of adapting to multiple anatomical features of a particular patient and/or one or more additional devices to assist the surgeon in completing the surgical procedure(s) safely and efficiently. , it would otherwise be advantageous to provide a device suitable for surgical use that would significantly reduce, and if not eliminate, the problems and risks mentioned above. Other advantages over the prior art will become apparent upon review of the Summary and Detailed Description and the appended claims.

According to one aspect of the present disclosure, a novel system and method for developing a customized device for use in one or more surgical procedures is described. Systems and methods according to this embodiment may be used to capture MRI data or CT or other data to derive one or more “patient matched” devices, including complementary surfaces based on a plurality of data points from the MRI or CT data. Use the patient's unique form that can be derived from Each “patient matched” device will be validated in a preoperative setting using 3D CAD software, such as the software disclosed in WO 2008027549, which is incorporated herein by reference in its entirety, to determine the patient's own anatomy and the desired insertion trajectory. ), and, according to one embodiment described herein, are matched and oriented around other devices used during surgical procedures.

According to embodiments, data obtained from a patient allows a device to be manufactured with a defined path through the device, which is operably coupled to at least one tool, device or implant and wherein the at least one tool, device or implant is Allows insertion into defined paths in a consistent and reproducible manner. Examples of devices that are implanted or left in the patient include anchoring devices such as screws, pins, clips, hooks, etc., and implantable devices such as spacers, replacement joints, replacement systems, cages, etc.

According to another aspect of the invention, a pre-configured surgical template is disclosed that includes one or more guides for receiving at least one instrument. According to this embodiment, the one or more guides further include a patient contact surface configured to substantially match the anatomical features of the patient. The pre-configured surgical template is configured such that the patient contact surface contacts a plurality of anatomical features in conformal engagement to ensure proper alignment and mounting of the guide or template, wherein the guides of the pre-configured surgical template are positioned within one or more guides. The pre-configured surgical template is oriented in a direction selected prior to fabrication to achieve desired positioning, alignment or advancement of the instrument.

In one embodiment, the cutting guide is interconnected to a template or a portion of the guide. The cutting guide includes tracks configured to guide an instrument operable to remove or alter a predetermined portion of the patient's spine. In one embodiment, the tracks of the cutting guide guide the instrument with patient-customized depth, angle, and orientation controls.

In one embodiment, the track is formed through a portion of the body. In another embodiment, the track is formed by a portion of the outer surface of the body. A portion of the outer surface may include a substantially planar surface over which a portion of the instrument can move in a predetermined plane.

In one embodiment, the guide further includes a frame. The frame is configured to be secured to at least one vertebra of the patient. In one embodiment, the frame is secured to screws secured to at least one vertebra. The main body of the guide is configured to be releasably interconnected to the frame. In this way, the guide can be used before, or after the guide of other embodiments of the invention used in surgical procedures.

In one embodiment, the at least one track includes two tracks formed on the body.

In one aspect of the invention, a patient-customized template is provided. The template is suitable for use in surgery and includes, but is not limited to, a body having a proximal portion and a distal portion. The distal portion is formed to substantially conform to a predetermined portion of the patient's spine. The body includes at least one of a bore and a track oriented in a direction determined from the patient's anatomical characteristics. In one embodiment, the bore or track is configured to guide an instrument or fixture.

The portion of the body is configured to at least partially hook and substantially conform about at least a second predetermined portion of the patient's spine. In one embodiment, the hook portion of the body includes an extension of the distal portion of the body. In another embodiment, the extension of the body is designed to hook, at least in part, around a spinal anatomy selected from the group consisting of the laminar, interarticularis, lateral to the transverse process, supraspinous process, inferior articular process, and superior articular process.

In one embodiment, the distal portion of the body of the template is formed to substantially conform to a cutting surface created by removing a portion of the patient's spine. Part of the patient's spine may have been removed during a previous portion of the same surgical procedure. In another embodiment, at least a portion of the distal portion is formed to substantially conform to an unaltered portion of the patient's anatomy.

In one embodiment, the bore is directed into the cortical orbit. In another embodiment, the bore is directed into the pedicle screw raceway.

In one embodiment, the first patient-specific surface is determined from the patient's anatomy and is complementary to the patient's anatomy. In another embodiment, the anatomical feature is a spine, and the first patient-specific surface is configured to anatomically register with one or more of the laminae, pars, articular processes, and supraspinatus of the spine.

In one embodiment, the first trajectory is oriented along the pedicle screw trajectory. Optionally, the first orbit can be oriented to guide the instrument percutaneously in one of the following: (1) cortical orbit; (2) S1 alar orbit; (3) S2 Eiler orbit; (4) and S2 alar-iliac orbit; and (5) iliac orbit.

In one embodiment, the surgical guide is a rapid prototyping machine, a stereolithography (SLA) machine, a selective laser sintering (SLS) machine, a selective thermal sintering (SHM) machine, a fused deposition modeling (FDM) machine, or a direct metal laser sintering machine. It is manufactured by a process selected from the group consisting of (DMLS) machines, powder bed printing (PP) machines, digital light processing (DLP) machines, inkjet photo resin machines, and electron beam melting (EBM) machines. Optionally, the surgical guide may be made of aluminum alloy, chrome alloy, PEEK material, carbon fiber, ABS plastic, polyurethane, resin, fiber-containing resinous material, rubber, latex, synthetic rubber, polymer and natural materials. .

Optionally, the surgical guide may be used in one or more of minimally invasive surgery and minimal access surgery. In one embodiment, the surgical guide is configured for use with a device that uses automated or semi-automated manipulation such that placement of the surgical guide relative to an anatomical feature can be performed remotely by an operator via a computer controller. In other embodiments, the surgical device is identifiable by optical, electronic, or radiological recognition means so that the location and orientation of the surgical device relative to anatomical features can be verified.

Additional aspects of the disclosure will become more readily apparent from the detailed description, especially when taken in conjunction with the drawings.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure.
1 is a perspective view of a device according to another alternative embodiment of the present invention.
2A-2B are perspective views of a cutting guide according to another alternative embodiment of the present invention.
3A-3B are perspective views of a cutting tool according to another alternative embodiment of the present invention.
FIG. 3C is another perspective view according to the embodiment shown in FIG. 3A shown with the cutting guide of FIG. 2A.
Figures 4A-4B are perspective views of the cutting tool of the embodiment shown in Figure 3A shown with the cutting guide of Figure 2A.
Figure 5A is a front view of a guide of another embodiment of the invention positioned relative to the spinal body.
Figure 5b is another front view showing the boring mechanism of an embodiment of the invention inserted within the cannula of the guide of Figure 5a.
Figure 5C is a side view of a guide sleeve of one embodiment of the invention positioned proximate the vertebral body shown in Figure 5A.
Figure 5D is a side view of a cutting tool of one embodiment of the invention inserted into the cannula of the guide sleeve of Figure 5C.
Figure 5E is a perspective view of the cutting tool and guide sleeve of Figure 5D.
Figures 5F-5G are further perspective views of the cutting tool and guide sleeve of Figure 5D.
Figure 6A is a front view of a frame of one embodiment of the invention interconnected to a portion of a patient's spine.
Figure 6b is a front view of a guide of another embodiment of the invention interconnected to the frame of Figure 6a.
Figure 6c is a perspective view of the guide and frame of Figure 6b.
FIG. 6D is another perspective view of the guide and frame of FIG. 6B including hidden lines showing the structure of slots formed in the guide.
Figure 7a is a front view of another guide of the present invention.
Figure 7b is a rear view of the guide of Figure 7a.
Figure 7c is a bottom perspective view of the guide of Figure 7a.
Figures 7D-7E are front and perspective views of the guide of Figure 7A positioned relative to the vertebral body and including hidden lines showing the structure of slots formed in the guide.
Figure 7F is a side view of the guide of Figure 7A positioned relative to the vertebral body.
FIG. 7G is another side view of the guide of FIG. 7A positioned relative to the vertebral body and showing a cut formed in the vertebral body.
Figure 8A is a front view of another guide in an embodiment of the present invention.
Figure 8B is another front view of the guide of Figure 8A positioned relative to the spine.
Figure 8c is a side perspective view of the guide of Figure 8a.
Figure 8D is a side view of the guide of Figure 8A positioned relative to the vertebral body.
Figure 8E is a top view of the guide of Figure 8A positioned relative to the vertebral body.
Figure 9A is a front view of another guide in one embodiment of the present invention.
Figure 9B is another front view of the guide of Figure 9A positioned relative to the vertebral body.
Figure 9c is a side perspective view of the guide of Figure 9a.
Figure 9D is another side perspective view of the guide of Figure 9A positioned relative to the vertebral body.
Figure 9E is a side view of the guide of Figure 9A positioned relative to the spinal body.
Figure 10A is a front view of a frame of one embodiment of the invention interconnected to a portion of a patient's spine.
Figures 10b-10c are front and perspective views of another guide of one embodiment of the present invention interconnected to the frame of Figure 10a.
Figures 11A-11C are perspective views of another guide of one embodiment of the invention, with Figure 11C showing the guide of Figure 11A positioned relative to a modified vertebral body in a surgical procedure.
Figures 11D-11E are front and perspective views of the guide of Figure 11A positioned over a portion of a patient's spine that has been altered surgically, further showing the guide relative to the patient's neural elements.
Figures 12A-12E are perspective views of a guide in another embodiment of the invention, with Figures 12C-12D showing the guide positioned relative to a vertebral body cut to remove portions of the vertebrae, and Figure 12E showing the vertebral body and A guide is shown positioned relative to the patient's neural elements.
Figure 13a is a perspective view of another guide of the present invention.
Figures 13B-13C are side and perspective views of the guide of Figure 13A positioned in contact with a vertebral body including cuts formed using the guide.
FIG. 13D is a front view of the guide of FIG. 13A shown in use position relative to a portion of the patient's spine and showing the patient's neural elements positioned proximate to a recess of the guide.
Figure 13e is a side perspective view of the guide of Figure 13d in a similar use position.
Figure 14A is a perspective view of a model of one embodiment of the present invention.
Figure 14b is a side view of the model of Figure 14a.
Figure 14c is a rear view of the model of Figure 14a.
Figures 14D-14E are perspective and side views of the model of Figure 14A positioned in contact with the spinal body.
Figure 15A is a front view of another model of one embodiment of the present invention.
Figure 15b is a rear view of the model of Figure 15a.
Figure 15C is a rear perspective view of the model of Figure 15A.
Figure 15D is another front elevation view of the model of Figure 15A in use position relative to the spinal body.
Figure 15E is a front perspective view of the model of Figure 15D.
Figure 15F is a top perspective view of the model of Figure 15D.
Figure 16A is a front perspective view of another embodiment of the model of the present invention.
Figures 16B-16C are front and perspective views of a model of the embodiment of Figure 16A positioned adjacent the spinal body.
Figure 17A is a perspective view of another guide of one embodiment of the invention, showing the guide and model in an exploded state and configured to be interconnected to a model of one embodiment of the invention.
Figure 17b is a perspective view of the model and guide of Figure 17a in an assembled state.
Figure 17c is a front view of the model and guide of Figure 17b.
Figures 17D-17E are perspective and front views of the model and guide of Figure 17B positioned adjacent the spinal body.
18A-18B are perspective and side views of another embodiment of the model of the present invention.
Figures 18C-18D are perspective and side views of the model of Figure 18A interconnected to a frame of the invention similar to the frame of Figure 10A, showing the model in a use position adjacent a portion of a patient's spine.
Figure 19a is a perspective view of another embodiment of the model of the present invention.
Figure 19b is a side perspective view of the model of Figure 19a.
Figures 19C-19D are illustrations of the model of Figure 19A in a use position interconnected to a frame of the present invention, with the frame secured to a portion of the patient's spine.
Figure 20A is a perspective view of a three-dimensional model of a unique grouping of portions of a patient's spine in one embodiment of the invention, showing a portion of the spine being removed.
Figure 20b is a side view of the three-dimensional model of Figure 20a.
Figure 20C is a perspective view of a removed spinal segment after a portion of the removed spinal segment has been excised.
Figure 20D is a side view of the three-dimensional model of Figure 20D after the model has been moved to close the gap formed after a portion of the spine has been removed.
Figure 20E is a side view of the three-dimensional model of Figure 20B, showing alignment indicators of the invention interconnected to the three-dimensional model and further showing the model showing the alignment of the patient's spine prior to a planned surgical procedure.
Figure 20F is another side view of the alignment indicator of Figure 20E showing the alignment of the patient's spine after a planned surgical procedure.
Figure 21A is a perspective view of a coronal alignment verification tool of one embodiment of the invention positioned proximate to a portion of a patient's anatomy.
Figures 21b, 21c and 21d are front, bottom and top views, respectively, of the tool of Figure 21a.
Figure 22A is a perspective view of another embodiment of the coronal alignment verification tool of the present invention positioned proximate a portion of a patient's spine.
Figures 22B, 22C and 22D are front, top and right side views of the tool of Figure 22A.
Figure 23A is a front view of another tool of one embodiment of the present invention for verification of coronal plane alignment.
Figure 23b is a right side view of the tool of Figure 23a.
Figure 23c is a perspective view of the tool of Figure 23a.
FIG. 23D is a front view of the instrument of FIG. 23A aligned with the sagittal plane and proximal to a portion of a patient's spine.
FIG. 23E is a side view of the instrument of FIG. 23D aligned relative to the coronal plane and proximal to the patient's spine.
Figures 24A-24B show two side views of an alignment assembly in use position interconnected to a portion of a patient's spine before and after the alignment of the spine is altered during a planned surgical procedure.
25A-25C are various views of another patient-tailored guide of one embodiment of the present invention for contacting the surface and trajectory of a patient's spine.
Figures 26A-26C are various views of the guide of Figures 25A-25C shown in relation to the spinal body of a patient.
27A-27C are various views of another patient-specific guide of another embodiment of the present invention for contacting the surface and trajectory of a patient's spine.
28A to 28B are various views of another embodiment of a patient-customized guide according to an embodiment of the present invention.
Figures 29A to 29C are various views of another patient-customized guide according to an embodiment of the present invention.
30A to 30C are various views of a patient-customized guide for contacting the surface and trajectory of a patient's spine according to another embodiment of the present invention.
Figures 31A-31C are various views of a guide of an embodiment of the invention further comprising second and third sleeves of another embodiment of the invention.
32A to 32B are various views of another embodiment of a patient-customized guide according to an embodiment of the present invention.
33A to 33B are perspective views of another embodiment of the patient-customized guide of the present invention.
Figures 34a to 34b are bottom and perspective views of another patient-customized guide of the present invention.
Figures 35a to 35c are perspective views of another patient-customized guide of the present invention.
Figures 35E-35F are additional perspective views of the patient-specific guide of Figures 35A-35D positioned relative to the spinal body.
Figure 36A is a perspective view of another patient-tailored guide of one embodiment of the invention in which the guide's cannula does not contact the vertebrae of the patient's spinal column.
Figures 36B-36C are perspective views of the patient-specific guide of Figure 36A showing the distal end of the cannula positioned relative to the spinal body and separated by a predetermined distance from the spinal body.
FIGS. 36D-36F are perspective views of another patient-specific guide similar to the guide of FIG. 36A, wherein the guide is configured to be positioned within an incision into the patient's bony anatomy and has an external guide configured to be retained outside the skin envelope. It includes a cannula and further includes an inner cannula positioned within the skin envelope, wherein the outer and inner cannula are collinearly aligned.
37A to 37B are a side perspective view and a top perspective view of another embodiment of the patient-customized guide of the present invention.
Figures 37C-37D are perspective views of the patient-specific guide of Figure 37A positioned relative to the spinal body.
Figure 38 is an exploded perspective view of an intracorporeal guide for facilitating surgical operation according to an embodiment of the present disclosure.
Figure 39 is a right side view of another embodiment of the intracorporeal guide.
Figure 40 is a perspective view of the intracorporeal guide shown in Fig. 38, with different guide sleeves inserted into the holes of the intracorporeal guide.
Figure 41 is another perspective view of the intracorporeal guide shown in Figure 38 with another guide sleeve inserted into the bore.
Figure 42 is a perspective view of the intracorporeal guide shown in Figure 38 between two vertebral bodies.
Figures 43A-43B are bottom rear perspective views of the intracorporeal guide shown in Figure 42 adjacent the upper spinal body.
Figures 44A-44B are perspective views of the intracorporeal guide shown in Figure 42 with the guide sleeve of Figure 40 inserted into the hole.
Figures 45A-45B are perspective views of another intracorporeal guide between two different spinal bodies.

As shown in the accompanying drawings and described in more detail herein, the present disclosure relates to novel systems and methods for developing a variety of customized, patient-matched devices for use in a diverse number of surgical procedures. The systems and methods use the patient's unique morphology, which may be derived by capturing MRI data, CT data, or any other medical imaging device, to determine the surface encountered during the surgical procedure(s) as derived from the set of data points. Deriving one or more patient-matched devices comprising surfaces complementary to According to various embodiments described herein, the patient-matched device may further include a desired axis and/or insertion trajectory.

Multiple embodiments of the present disclosure are shown in Figures 1-45. 1 is a perspective view of a device for facilitating surgical operations according to an embodiment of the present disclosure. In this embodiment, the device formed by the system and method described above includes a cutting guide (10). Guide 10 may be used to orient a cutting tool to alter and selectively remove portions of the patient's anatomy. A variety of cutting tools can be used with the guide, including but not limited to routers, burrs, and cutters. Guide 10, shown in Figure 1, is a laminectomy guide configured to facilitate the use of surgical cutting instruments to alter a patient's laminae. However, the guide of the present invention can be adapted for use in surgery to alter any part of the patient's anatomy. In one embodiment, the guide of the present invention may be used in surgery to alter the posterior portion of a patient's anatomy, including but not limited to the facet joint, transverse process, articular process, and supraspinatus.

In the embodiment of the invention shown in Figure 1, the guide 10 is configured to fit directly into the side of the patient's anatomy. More specifically, the guide is positioned proximal to the mid-vertebrae (VM) between the upper and lower vertebrae (VS, VI). Accordingly, the laminectomy cutting guide 10 also includes a lower patient contact surface 14 that allows the laminectomy cutting guide 10 to mate with one or more vertebral bodies. Patient contact surface 14 may be tailored to any part of the patient's anatomy, such as the laminae, transverse processes, articular processes, spinous processes, etc. Alternatively, the guides 10 may be interconnected to the frame as described in greater detail herein. Surface 14 may be configured to at least partially hook around a portion of the patient's anatomy. For example, surface 14 may include a plurality of portions 14A, 14B configured to contact two different planes formed by two distinct portions of the patient's anatomy.

The laminectomy cutting guide 10 shown in Figure 1 further includes at least one alignment channel 16 for inserting a guide wire or other fastening element and a cutting slot 20 for directing the path of the blade or other cutting edge. Includes. Alignment channel 16 may accommodate a fixture, such as a temporary fixation device, to temporarily secure guide 10 to the patient's spine. Temporary fastening devices may be pins or screws as known to those skilled in the art. Placing fixtures through channels 16 may increase the stability of the guide during use in amputation surgery. Optionally, channel 16 may include a cannula configured to receive a tool, such as a tool for forming a bore in a patient's anatomy. Accordingly, in one embodiment, alignment channel 16 may optionally include a bore configured to guide a fixture or mechanism, such as a pedicle screw.

Slot 20 may have any shape determined to guide the incision for the surgical procedure planned for a particular patient. For example, the slot may be shaped to guide the instrument to provide a straight, concave, convex or 'chevron' shaped cut. In one embodiment, the slot includes a plurality of portions 20A, 20B, and 20C.

Cutting slots 20 may be sized or shaped to prevent use of inappropriate tools. Additionally, slots can be formed to guide the cut around the patient's nerve elements. Accordingly, slots 20 can be used to guide instruments along a planned path prior to surgery while controlling instrument orientation and depth. Additionally, the width of the slot 20 can be varied to control the size of the cutting tool that fits through the slot. For example, slot portion 20A may have different dimensions than portions 20B and 20C. In one embodiment of the invention, slot portion 20A has a different width than slot portions 20B and 20C.

A stop may be formed in the slot 20 to limit or control the insertion depth of the cutting tool. The stop can be customized to the patient's anatomy and protect the patient's neural elements. Slots 20 may also be keyed to ensure depth control during cutting. For example, slot 20 may include a key that changes the depth of cut by the tool as it is guided through the slot. The key may correspond to a feature, such as a protrusion 144 on the tool 140 described in greater detail with respect to FIG. 3 , that limits the insertion depth of the tool.

Optionally, a sleeve 24 or insert may be selectively retained in slot 20. Insert 24 includes a slot 26 for a cutting tool. The sleeve 24 protects the guide 10 by separating it from the cutting tool. For example, if the guide 10 is formed of a material that can be cut by a cutting tool, the size and shape of the slot 20 may be changed by the cutting tool. The insert 24 is provided to prevent the cutting tool from altering the slot 20. In this way, the insert can be prevented from straying from the planned surgical procedure.

It will be appreciated that insert 24 may have any size and shape selected to be at least partially received within slot 20. Additionally, the insert may at least partially protrude from the proximal side of the guide 10 . In one embodiment, insert 24 has a cross-sectional profile that is substantially the same as the cross-sectional profile of slot 20. Insert 24 may have a length equal to or similar to the depth of the slot.

In one embodiment, slot 20 may be sized to accommodate one or more sleeves 24. Each sleeve may be configured to guide a different tool or define a different cut. For example, a first sleeve can be introduced into the slot to guide the first tool to create the first cut. The first sleeve can then be replaced with a second sleeve introduced into the slot. The second sleeve can guide the second tool to create the second cut. The second sleeve may have a different size and shape than the first tool. In one embodiment, the second cut modifies the first cut. Alternatively, in other embodiments, the second cut does not intersect the first cut.

Insert 24 may be formed of any material of sufficient strength that fracture and/or peeling of the insert material is avoided. Accordingly, the insert 24 can withstand the effects of high-speed cutting tools without damaging the insert or allowing material from the insert to adhere to the cut site as well as reuse of the insert. Insert materials must also withstand the high temperatures encountered during sterilization. In one embodiment, the insert is formed of metal or metal alloy, although other materials are contemplated. One advantage of metal inserts is that the cutting surface can be "trephine" or machined so that the distal end of the insert can "bite" into the bone and provide a means to secure the insert. It is an ability. Forming a trephine at the distal end can provide additional stabilization of the guide during cutting operations. In other embodiments, the insert is formed from any material that is harder than the material of the guide.

Insert 24 may be configured to accommodate different types and sizes of tools. Additionally or alternatively, the insert may be operable to accommodate only one specific tool. Inserts may be provided to ensure that cuts are performed in a pre-planned sequence. For example, when the slot of the guide 10 has a complex shape, such as the slot 20 having three different portions 20A, 20B, and 20C, the surgical plan may be divided into portion 20B and then portion 20c. It may include a first operation through the slot portion 20A followed by an operation through . Accordingly, first insert 24A may be provided to receive a tool in portion 20A through slot 26A while blocking access to slot portions 20B, 20C. After the first operation is complete, the first insert may be replaced with second and third inserts 24B, 24C to allow access to the slot portions 20B, 20C. One of the inserts, for example insert 24B, may have a different length than the other inserts.

Additionally or alternatively, insert 24 may include stops that limit the angle of use of the cutting tool during surgical procedures. Indicia can be placed on guides and inserts to indicate a series of uses that correspond to the series of tasks for which the guides are used. The indicia can also indicate the tool to be used, the direction of the cut to be performed, or the specific part of the patient's anatomy to be targeted by the cut. Indicia may include computer-readable elements such as barcodes or RFID. Accordingly, indicia can be used to identify a guide and retrieve information regarding the surgery to be performed with the guide 10.

In one embodiment, the cutting guide 10 is designed after acquiring a scan of the patient's anatomy with a medical imaging device. The scan may be performed by a CT scanner, MRI scanner, or any other medical imaging device. The scan is broken down into 3D models of each vertebra. These 3D models are transformed in CAD to simulate the surgeon's desired correction. Once the desired correction is appropriately simulated, a guide 10 is created that allows the surgeon to make the planned correction during surgery.

Although shown in Figure 1 as a generally right-angled prism, it is clearly understood that other geometries for the laminectomy cutting guide 10 are equally practical and are contemplated within the scope of the invention. The cutting guide of the present invention can be used as a physical cutting guide. Cutting guides can also be used as an aid to indicate to the surgeon the angle and location of the osteotomy cuts to avoid damaging the neural elements in the patient's spine. The guide may be used pre-operatively on a model of the patient's anatomy to test or perform a planned surgical procedure.

Referring now to FIGS. 2A-2B , another view of the cutting guide 110 is provided. According to one embodiment, cutting guide 110 includes a plurality of patient-specific contact surfaces 114 and alignment channels 116 around at least one surface of the cutting guide. The contact surface may include portions 114A, 114B configured to at least partially hook around a portion of the patient's anatomy. In one embodiment, contact surface 114 is configured to conform to a cutting surface created by removing a portion of the patient's anatomy. The cutting guide, in a preferred embodiment, further includes patient-specific slots or “tracks” 120 to facilitate insertion of cutting instruments (as shown in FIGS. 3-4) and to control insertion depth for the instruments. This additionally provides one or more instrument contact surfaces 122 to prevent unnecessary cutting of the underlying surface during certain surgical procedures.

According to the embodiment shown in relation to FIGS. 2 to 4, a cutting guide 110 may be provided for laminectomy. According to another embodiment, the patient-specific guide is used to perform corpectomies, pedicle removal osteotomies (PSO), Smith-Peterson osteotomies (SPO), vertebrectomy (VCR), or asymmetric osteotomies (in the sagittal or coronal plane), among others. It can be manufactured for use in:

These patient-specific cutting guides 10, 110 can be manufactured from the patient's anatomical data and can help perform complex surgeries with greater certainty in the results. For example, certain osteotomies, especially PSO and SPO, require a lot of surgical skill and are often time-consuming. Using a patient-specific guide, the surgeon can confirm the positioning and alignment of the amputation trajectory and path before commencing surgery, and, in addition to the disclosure provided above with respect to Figures 2 to 4, also with vascular and neural elements. can provide the degree of depth control essential to avoid contact.

In one embodiment, the cutting tool 140 associated with the cutting guide 110 shown in FIGS. 2-4 is representative of the types of tools currently used in surgical procedures. According to other embodiments, as described in more detail below, special cutting burrs or tips 142 may be included with the instrument to facilitate further control of the position and depth of the instrument. For example, as shown in FIGS. 3A-3C, the cutting portion of the instrument has protrusions 144 that prevent greater insertion of the instrument 140 into the cutting guide 110 than is required for patient-specific surgery. ) can have. In one embodiment, the position of protrusion 144 on cutting tip 142 can be adjusted by the user. Protrusion 144 may be of any shape configured to interact with contact surface 122 of slot 120 to control use of cutting tool 140 . In one embodiment, protrusion 144 is a bearing. In another embodiment, the protrusion is a trackball. In another embodiment, the protrusion is generally disk shaped.

As shown in more detail in FIGS. 4A and 4B , protrusion 144 may be inserted into first portion 120C of “track” 120 of cutting guide 110 . The second or third deeper portions 120A, 120B of the “track” of the cutting guide (through which the cutting surface is allowed to pass) prevent insertion or retraction of the protrusion 144, thereby ensuring proper depth of the cutting tool. can do. Additional geometric configurations other than those shown in FIGS. 4A and 4B may be used such that the protrusion 144 is horizontal relative to the top surface of the cutting guide and, in some cases, laterally and downwardly into the track 120 of the cutting guide. May be provided to allow movement. Accordingly, in this embodiment, the cutting instrument 140 is permitted to move to a certain depth relative to the patient's anatomy at a certain location on the “track” 120 of the cutting guide, but Achieve greater depth in another position for "(120). Accordingly, the depth allowed for the instrument 140 relative to the cutting guide 110 may be variable relative to the “track” 120 of the cutting guide.

Those skilled in the art will appreciate that the size and location of surface 122 may be varied as desired. Accordingly, in other embodiments of the invention, instrument 140 may be inserted and removed from different portions of track 120 or from more than one portion of track. Additionally, in one embodiment, track 120 and instrument 140 allow the tool to be inserted only into a first portion of the track, such as portion 120C, and only into a second portion of the track, such as portion 120A or 120B. Includes protrusions that interact to be removed.

Referring now to Figures 5A-5F, a guide sleeve 210 of another embodiment of the present invention is described. Sleeve 210 is configured for use in a posterior osteotomy, also known as Smith-Peterson osteotomy (SPO) or “ponte osteotomy” surgery. As understood by those skilled in the art, during a posterior osteotomy, a portion of bone is removed from the back of the patient's spine. Portions of the posterior ligaments and facet joints may also be removed from the targeted portion of the patient's spine. Osteotomies may be performed at one or multiple locations along the spine to correct the alignment of a patient's spine.

In one embodiment of the present invention, the surgical guide 246, guide sleeve 248, and drilling insert or sleeve 249 assembly according to embodiments of the present disclosure is positioned proximate to a targeted portion of the patient's anatomy. do. Drill sleeves 249 (opposed via patient-matched guide sleeves 248 and positioned into the bone at different angles) provide additional anchorage of guides 246 to vertebrae V.

Guide 246 is used to introduce a bore (not shown) into the pedicle for guide sleeve 210. The trajectory of the bore is specifically planned and controlled by the sleeve 248, especially for the drilling sleeve 249. The arrangement of the bore is chosen in such a way that the nerve elements are protected from the tool 247 inserted through the drilling sleeve 249. The trajectory of the bore is chosen to be spaced a predetermined distance from the nerve element such that the tool 247 is a safe distance away. In one embodiment, the bore is at least 0.25 mm away from the patient's neural elements. However, it will be understood that any desired distance separating the bore from the neural element may be used. In another embodiment, the distance is from about 0.1 mm to about 3 mm.

Referring now to FIGS. 5C-5G, once the pedicle is cannulated, surgical guide 246 can be removed from vertebrae V. Guide sleeve 210 is inserted at a controlled depth within the bore. The cutting tool 240 is inserted into the cannula 225 of the sleeve 210 and activated. The tool includes a surface 242 that cuts from the inside to the outside of the pedicle. In one embodiment of the invention, guide sleeve 210 includes a hole 218 for a cutting surface 242. Holes 218 may be spaced from the distal end of guide sleeve 210 by a predetermined amount to control the depth of the cut. In another embodiment, the hole is located at the distal end of sleeve 210.

Cutting surface 242 can be actuated mechanically or electrically. Cutting surface 242 may include a reciprocating or rotating blade, or any other type of cutting tool. In one embodiment, the orientation or length of cutting surface 242 can be changed by the surgeon during the surgical procedure. Optionally, in another embodiment of the invention, the tool is operable to remove a portion of the pedicle to complete the cut. For example, the tool may include a laser configured to burn through a portion of the pedicle within the bore. In other embodiments, the tool may include a heated surface for burning or otherwise removing portions of bone or tissue. Once the amputation is complete, the posterior column of the spine can be removed.

Referring now to FIGS. 6A-6D , one embodiment of a guide 310 including a frame 330 is shown. Guide 310 is suitable for use in posterior osteotomies although other surgeries may be considered. Frame 330 may have a patient-customized shape. For example, the frame may be configured to bend or snap into a position in contact with the transverse process (T) or other portions of the patient's anatomy. Alternatively, frame 330 may be designed for use in surgical procedures on any patient.

In use, frame 330 is interconnected to a fixation device 334 positioned over a portion of the patient's anatomy, such as the patient's spine (V). In one embodiment, as shown, the spine (V) includes the inferior spine (VI), the middle spine (VM), and the superior spine (VS). Fixation device 334 may be a pedicle screw.

Although two fixation devices 334 in each lower vertebra (VI) and upper vertebra (VS) are shown for use with frame 330 of the embodiment of FIG. 6, any number, including fewer screws, may be used. You will notice that the screws of can be used with the frame. The size and shape of frame 330 may be selected such that the frame can be interconnected to the screw when the frame is in a pre-planned orientation. For example, the embodiment of frame 330 shown in Figure 6A has a shape that allows the frame to be interconnected to four pedicle screws 334 when the frame is in one desired orientation.

Pedicle screws 334 or other fixation devices may be placed within the spine using any tool or guide. Existing pedicle screws from previous surgery can be used with the frame. One or more pedicle screws may also be positioned using a pedicle screw guide of an embodiment of the invention, such as guide 246 described above. Another embodiment of a pedicle screw guide is described in U.S. Pat. No. 9,198,678, incorporated herein in its entirety.

Frame 330 may retract soft tissue within the surgical area. Additionally, reference points or indicia for docking the osteotomy guide 310 may be provided on the frame 330 . Indicia can indicate the planned orientation or alignment of the guide. The shape of frame 330 may allow docking of guide 310 when it is in a pre-planned orientation with respect to the targeted spine.

Frame 330 may also be used to distract the spine a predetermined amount in a target area of the patient's spine. The pull provided by the frame can ensure that the cut is formed at a desired angle. Pulling may be necessary to provide access to certain parts of the patient's anatomy. Once interconnected to the pedicle screws 334, the frame 330 may also prevent unintentional movement of the vertebrae during surgical procedures. The frame may be designed to increase the pull of the structure to provide the surgeon with a larger window to complete the surgery. In this embodiment, the frame connects the superior vertebra (VS) (above the osteotomy site of the middle vertebra (VM)) and the inferior vertebra (VI) (below the osteotomy site). In one embodiment, the frame is positioned lateral to the pedicle such that the posterior anatomy of the middle vertebrae (VM) is substantially unobstructed by frame 330. It will be appreciated by those skilled in the art that the frame may be sized to span any number of vertebrae.

When the frame 330 is interconnected to the pedicle screw, the guide 310 is interconnected to the frame. Guides 310 are planned pre-operatively to align on frame 330 with a targeted portion of the middle vertebrae (VM) in a patient-specific position to ensure that the cut is made accurately.

Although the embodiment of guide 310 shown in FIGS. 6B-6D is shown as one piece, in other embodiments, the guide may be comprised of multiple pieces or a series of pieces arranged in a particular order to create a series of planned cuts. It will be appreciated that a cutting guide may be included. In embodiments of guides comprising multiple pieces, each piece of the guide may be keyed to interconnect with other pieces of the guide in a specific order and location. In one embodiment, guide 310 does not contact the patient's anatomy. In other words, guide 310 is configured to float above the surgical field when the guide is interconnected to frame 330. In another embodiment, at least a portion of guide 310 is configured to contact the patient's anatomy.

The guide may include slots 320 and holes 328. Holes 328 may be positioned to prevent contact with portions of the patient's anatomy. For example, the guide 310 of the embodiment shown in FIGS. 6A-6D includes an aperture 328 for at least partially receiving the supraspinous process S of the middle vertebra VM. The surfaces and openings 328 of the guide proximate to the patient's anatomy may include a patient-specific contour configured to substantially conform to a given portion of the patient's anatomy. In this way, the alignment of the guide with the planned portion of the patient's anatomy can be improved. Patient-specific contact contours may also improve the stability of guide 310 during surgery.

Slots 320 are positioned and sized to guide instruments used during surgical procedures, similar to slots 20, 120 of guides 10, 110 described above. Slot 320 may have a shape and may be positioned at various angles relative to a guide tool, including a cutting tool. Each slot 320 may have a unique size and orientation. Accordingly, the slots may be configured to accommodate different tools or only one specific tool. Features, such as protrusions, may be formed in the slot and interact with features of the tool to control the insertion depth of the tool, the direction of use of the tool, and the insertion and removal points of the tool. An insert similar to the insert 24 described above may be formed to be positioned within the slot 320 to ensure proper use of the tool or to prevent damage to the slot during surgery.

Referring now to Figures 7A-7G, another embodiment of a guide 410 of the present invention is shown. Guide 410 is suitable for use in pedicle removal osteotomy (PSO) and asymmetric pedicle removal osteotomy (APSO) for a single vertebral level. The size and shape of the guide may be selected to fit the guide across the surface of the spine (V).

Guide 410 may include one piece configured to target a portion of the spine. Alternatively, the guide may be formed of two or more pieces to target various locations on the spine. The pieces can guide a sequential series of cuts in the spine. In one embodiment, the pieces may be sequentially interconnected to form guide 410 during a surgical procedure.

In one embodiment, guide 410 may fit directly into the posterior aspect of a patient's anatomy, such as the laminae, transverse processes, articular processes, supraspinous processes, etc. Accordingly, various patient-matched surfaces 414 may be provided on guide 410. Additionally or alternatively, guide 410 may also be fitted to the surface of a previously amputated vertebra. In one embodiment, the previous cut may be performed using the initial guide of the present invention. The initial guide is configured to guide the cutting tool used to create the surface of the spine. Guide 410 may be designed to fit into the surface created using the initial guide. Additional cuts of the altered spine may be performed using guide 410. Alternatively, guide 410 may be interconnected to any of the frames described herein, including frames 330 and 730.

Guide 410 includes slots 420 for guiding surgical tools, including cutting tools such as routers, burrs and other similar devices, along the track to assist in removal of the vertebrae. The slot 420 may be the same as or similar to the slots of the guides 10 and 110 described above. The slots have a selected size and orientation to confine the cutting tool during surgery to the preoperatively planned entry point and cutting angle. As can be seen, slots 420 may be oriented in a plane transverse to the proximal surface portion of guide 410 . The slots may be designed to guide the tool for making cuts that are substantially linear, concave, convex, curved or “chevron”. Additionally, as described above, slot 410 may accommodate sleeve 24 and may include stops and keys to guide or limit movement of the surgical tool.

Optionally, guide 410 includes an alignment channel or cannula 416. Cannula 416 is configured to guide a fixation tool, such as fixture 434 or anchor, to the spine. It will be appreciated that cannula 416 may be positioned at various locations on the guide. Additionally, one or more cannulas may be provided.

In one embodiment, as shown in Figures 7E-7G, guide 410 is secured to the spine by anchors 434. After the cut 450 (shown in FIG. 7G) is completed in the pedicle of the vertebra V, the entire cut portion of the pedicle can be removed along with the guide 410 by pulling the anchor 434 away from the vertebra V. You can.

8A-8E show another embodiment of the guide 510 of the present invention. In one embodiment, guide 510 is suitable for use in PSO and APSO surgeries. This guide is sized to partially span the adjacent upper spine (VS) and lower spine (VI). Similar to guide 410, guide 510 includes a patient-specific contact surface 514 configured to substantially match the patient's anatomy. For example, in one embodiment, the distal surface 515 of the guide includes a plurality of patient-specific contours. At least one portion of distal surface 515 may be configured to contact a cutting surface formed by removing a portion of the patient's anatomy.

A plurality of apertures may be formed through the guide to target, avoid, or align predetermined portions of the patient's anatomy. For example, the hole 528 may be formed through the guide 510 having a shape selected to allow the spinous protrusion S to at least partially pass through the guide. A patient-specific surface 514 may be formed within the hole 528 .

The guide may further include a pedicle hole 529 having a pre-planned shape to at least partially accommodate the patient's pedicle P. Pedicle aperture 529 may also include a patient-specific internal surface. The surgeon may insert a cutting tool into hole 529 to remove a portion of the pedicle (P). The pedicle hole may be shaped to prevent excessive insertion of the instrument into the spine. Additionally, a key may be formed around the hole 529. In conjunction with protrusions formed on the tool, such as protrusion 144 described above, keys can control or change the insertion depth of the tool as the surgeon moves the tool around hole 529.

Guide 510 may also include cutting tracks 520 . Track 520 is similar to the slots 20, 120, and 320 described above and can accommodate a guide sleeve that is the same or similar to sleeve 24. In one embodiment of the invention, cutting track 520 is adapted to target each facet capsule of the upper spine (VS) and lower spine (VI). The surgeon may use the cutting track 520 to separate adjacent facet capsules of adjacent vertebrae. As can be seen, different cutting tracks or cutting slots may be provided on the guide to control different planned cuts.

Although not shown, guide 510 may include a cannula similar to cannula 16, 416 described above. A fixture implanted in the spine may be received in the cannula to at least temporarily connect the guide 510 to the spine. Optionally, the cannula may be configured to guide an instrument including a boring instrument or cutting tool 240.

Referring now to Figures 9A-9E, another embodiment of a guide 610 of the present invention is shown. Guide 610 is similar to guide 510 and includes a distal surface 615 that may include a patient-specific contact surface. At least one of the contact surfaces can be configured to substantially match an unaltered portion of the patient's anatomy. Other portions of distal surface 615 may be configured to substantially conform to a portion of the patient's anatomy that has been altered, for example, by amputation. A hole 628 configured to at least partially receive the spinous process S may be provided. Hole 628 may include a patient-specific surface 614.

Guide 610 is configured to target each pedicle (P) of the spine (V). Accordingly, the guide includes two pedicle holes 629. The hole is the same or similar to the pedicle hole 529 of the guide 510 described above. In one embodiment, each pedicle hole 629A, 629B may have a unique shape specific to the patient's anatomy. Optionally, the guide 610 may have a thickness determined such that the pedicle P does not protrude beyond the plane defined by the proximal surface, as shown in FIGS. 9D and 9E.

Voids 617 may also be formed in a portion of the guide to align the guide with the spine V. Voids can be located in several locations. Additionally, void 617 may extend partially or fully through guide 610. Additionally, protrusion 619 may extend from the distal surface 615 of the guide. The protrusion may be configured to fit into a selected portion of the posterior spine. Optionally, voids 617 or protrusions 619 may at least partially hook some portion of the patient's anatomy. In this way, voids 617 and protrusions 619 contact distinct portions of the patient's anatomy compared to other portions of distal surface 615 . Accordingly, the voids and protrusions provide a reference to indicate when the guide 610 is positioned at a given location relative to the patient's anatomy. In other words, voids 617 or protrusions 619 will prevent the guide 610 from seating properly when the guide is in an improper position. Therefore, the guide is not stable and therefore provides tactile feedback to the user that the guide is not in the correct position. In one embodiment, the protrusion 619 is configured to fit the guide to the transverse protrusion or laminar portion. Each void 617 or protrusion 619 may further include a patient-specific surface.

Referring now to Figures 10A-10C, a guide 710 of another embodiment of the present invention is shown. In one embodiment, guide 710 is suitable for use in PSO or APSO surgery. The posterior portions of the superior vertebrae (VS), middle vertebrae (VM), and inferior vertebrae (VI) (e.g., transverse process, supraspinatus, laminar, and/or pedicle) are subjected to section 750 prior to using guide 710. ) is removed.

Frame 730 is interconnected with a portion of the patient's spine. The frame generally includes an intermediate member 732 connecting two transverse members 733. In one embodiment, frame 730 is interconnected to the upper spine (VS) and the lower spine (VI). Pedicle screws 734 located on the upper and lower spine may be used to secure the frame to the spine. Frame 730 may be similar to and include features of frame 330 described above. Accordingly, frame 730 can preserve the amount of pull present. In one embodiment, the frame is used to preserve the relationship between the middle vertebrae (VM) and the adjacent superior vertebrae (VS) and inferior vertebrae (VI). Alternatively, the frame can be adjusted to change the pull of the structure as needed. For example, in another embodiment of the invention, the intermediate members 732 of the frame may have a length that can be adjusted surgically to increase or decrease the distance between the transverse members 733. The inner member 732 may include a first portion that fits within or adjacent to the second portion. The inner member may further include a rack and pinion system, screws or other means to change the length of the inner member 732 to provide a desired amount of pull between the vertebrae (VS, VM, VI). As will be understood by those skilled in the art, frames can have different shapes and sizes. For example, in another embodiment, frame 730 may include two intermediate members. Each intermediate member 732 may have an independently adjustable length.

Once the frame is in place, guides 710 are interconnected to the frame. In one embodiment, at least a portion of the guide 710 is configured to contact the cutting surface 750 of the patient's spine. Other portions of guide 710 may have patient-specific surfaces configured to match the uncut portion of the patient's spine.

The guide includes a cutting track 720. Track 720 is similar to other slots described herein, including without limitation slots 20, 120, and 320. After the guides are interconnected to the frame, the tracks are used to guide the cut to the spine along a predetermined trajectory. Each track 720A, 720B may have a unique patient-specific shape. Additionally, track 720A may have a size and width configured to accommodate a specific tool that is different from the tool associated with track 720B.

In one embodiment, guide 710 includes two tracks to separate the pedicle from the middle vertebra (VM). The track may enable separation of the pedicle with a single cut. Guide 710 may include holes to guide cuts in different parts of the spine (VS, VM and VI) similar to guides 510 and 610.

Although not shown, guide 710 may also include a cannula similar to cannula 16, 416 described above. The cannula may receive a fixture (similar to fixture 434 ) to interconnect the guide 710 to the targeted vertebra (VM). Optionally, the fixture may be placed on a portion of the spine, such as the pedicle, intended for removal by cutting guided by track 720. In this way, after the cut is complete, guide 710 can be removed from the frame to remove various portions of the pedicle. In another embodiment, the cannula is configured to guide an instrument, such as a boring device.

Referring now to Figures 11-12, embodiments 810A and 810B of guides of embodiments of the present invention are shown. The guide is configured to fit into a cutting surface 850 of the spine (VM), which is formed by removing a portion of the spine. Surface 850 may be formed by cutting guided by another optional guide of the present invention. Guides 810A, 810B may also include a patient-specific surface 814 configured to substantially conform to a portion of the spine. First portion 814A may be configured to contact and substantially conform to a cutting surface 850 of the patient's anatomy. The second portion 814B of the guide may include a patient-specific contour configured to substantially match an unaltered portion of the patient's anatomy. The second portion 814B may generally hook around the patient's anatomy. In this way, second portion 814B contacts a different plane of the patient's anatomy compared to portion 814A.

Although the guide 810 shown in FIGS. 11-12 includes two slots, it will be appreciated that the guide may include any number of slots. The slots may have other shapes, including arcuate shapes. Additionally, the guide 810 may include slots for targeting both sides of the spine. In other embodiments, different guides 810 may be formed to target each posterior aspect of the spine. In this embodiment, two guides for each side of the spine can be keyed in. The key allows the guides to connect to each other during surgery. In this way, guides 810 can be assembled to target both sides of the spine while still protecting the neural elements. The keys can optionally be configured to require a specific assembly sequence for the individual guides.

A recess 854 may be formed in a portion of the guide 810. Recess 854 has a cross-sectional shape selected to at least partially enclose a neural element N, such as the patient's spinal cord. In one embodiment, recess 854 has a shape similar to a “C” or vault. Recess 854 includes an interior surface 856 shown in FIG. 11A that is spaced from the interior surface of slot 820. In this way, recess 854 protects neural element N from inadvertent damage when a tool is guided within slot 820 to make a cut in the spine.

Referring now to Figure 12, guide 810B is similar to guide 810A. Guide 810B also includes a second recess 854A shaped to protect the second neural network N2, such as a nerve root, from damage.

Referring now to Figures 13A-13E, another guide 910 of an embodiment of the present invention is shown. Guide 910 is similar to guides 810A and 810B. In one embodiment, guide 910 is suitable for use in making the required final cut 950 during a pedicle removal osteotomy (or APSO). Guide 910 generally includes rounded corners 958, recesses 954, and guide slots 920. After the portion of the spine exposing the spinal cord-like neural network (N) is removed, a guide 910 is placed between the spinal cord and the vertebrae (VM). The rounded corners 958 of the guide are shaped to press against the neural elements and create space for the guide between the spinal cord and the vertebrae. The nerve element N is then received in a recess 954 that protects the nerve element from damage during cutting, which is performed using the slot 920 of the guide 910. The guide includes patient-specific features 914 that can be fitted in any desired location. These features may match the patient's anatomy (anterior portion of the spinal canal) or match the cutting surface 950 created with a previous guide.

Slot 920 is similar to the slots of all embodiments of the inventive guide described herein. Additionally, a sleeve may be placed in the slot 920 to prevent damage or deformation of the slot by cutting tools used in surgical procedures. The slots can be aligned with previously completed cuts. In this way, the new cut guided by the slot intersects the previous cut so that part of the spine can be removed. In one embodiment, slots 920 are aligned to complete the cut to remove the medial portion of the vertebral body.

Referring now to Figures 14-19, an embodiment of a model of the present invention is shown. The model is adapted for use during surgical procedures such as osteotomies as a reference for surgeons. The model can be designed with patient-specific features and holes or surfaces aligned with the procedure to be performed during the surgical procedure. The model includes preoperatively planned modifications to the patient's anatomy. For example, the model may include an indication of the angles and starting positions of the various cuts required to perform the planned modifications to the patient's alignment. Models can include surfaces and markings to match cuts of any size and shape, including cuts that are straight, concave, convex, curved or 'chevron'. Additionally, the model is designed to be modular so that the separate parts can be interconnected to form a complete model during a surgical procedure. This can be useful for models designed to fit around or conform to parts of a patient's anatomy that have complex external contours.

Referring now to Figures 14A-14E, one embodiment of a model 1002 of the present invention is shown. The model 1002 is designed to include a patient-specific surface 1014 that substantially matches a portion of the posterior surface of the spine (V). In one embodiment, the model is configured to fit at least partially around a portion of the spine that is planned to be removed during a surgical procedure. In another embodiment, at least a portion of the model is configured to substantially conform to or “hook” a predetermined portion of the patient's anatomy, such as the spine. In other words, the model can be configured to be biased in a predetermined orientation relative to the patient's anatomy. Accordingly, the material of model 1002 may be selected to allow the surgeon to bend or straighten model 1002 to hook the patient's anatomy. In one embodiment, model 1002, or a portion thereof, may be made at least partially from a bendable or deformable material. In another embodiment, the model is made from a material with shape memory, such as Nitinol.

Model 1002 is configured to indicate the entry point and angle of the planned cut. In one embodiment, the model includes indicia representing the entry point. In another embodiment, at least one outer surface of the model is parallel to the plane of the planned cut. For example, in the embodiment of model 1002 shown in Figure 14E, outer surface 1013 is substantially parallel to the plane of the cut planned to remove spinous process S. Although not shown, the model may include slots and cannulas to guide the cuts and bores into portions of the spine (V). As can be seen, the size and shape of model 1002 can be varied as designed to guide any of a variety of cuts. For example, if the thickness of model 1002 shown in FIG. 14E is increased, a small portion of the spinous protuberances S will be removed by cuts guided by surface 1013. Alternatively, more of the spinous process S can be removed by reducing the height of model 1002.

Referring now to Figures 15A-15F, another model 1102 of the present invention is shown. Model 1102 is suitable for use in an asymmetric pedicle removal osteotomy in one embodiment of the invention. Model 1102 is similar to model 1002. Therefore, the model may include indicia and other representations of the entry point and angle of the cut. However, model 1102 further includes a hole 1128 that fits around the portion of the spine that is planned to be removed. In one embodiment, hole 1128 has an asymmetric shape about a vertical axis substantially parallel to the short side of model 1102. Accordingly, hole 1128 forms a window representing the bone to be removed during an asymmetric pedicle removal osteotomy. In one embodiment, the proximal surface 1113 of model 1102 is approximately parallel to the plane of the cut planned to remove a portion of the spinous process S.

As can be seen, model 1102 and hole 1128 can be of any size and shape. The model also includes various patient-matched surfaces 1114 associated with portions of the patient's anatomy similar to the patient-matched surfaces 1014 of model 1002. Additionally, patient-specific surfaces can be formed in voids 1117 formed in the model. The void is configured to align the model with the patient's anatomy. The model 1102 may further include protrusions 1119 having a patient-specific surface 1114 configured to mate with a portion of the patient's anatomy. The combination of voids 1117 and protrusions 1119 may reduce the likelihood of improper placement of model 1102 in relation to the patient's anatomy.

16A-16C show model 1102A of another embodiment of the present invention. Model 1102A is similar to model 1102. However, hole 1128A has a different shape that is substantially symmetrical about the vertical axis. Accordingly, hole 1128A forms a window representing the bone to be removed. As can be seen, the model and hole 1128A can be of any size and shape. In one embodiment, model 1102A is thicker than model 1102. Accordingly, model 1102A may be designed for surgeries where less of the supraspinatus S is planned to be removed compared to surgeries using model 1102.

Model 1102A also includes various patient-specific surfaces associated with portions of the patient's anatomy similar to patient-specific surfaces 1114 of model 1102. Additionally, voids and protrusions similar to the voids and protrusions of model 1102 described above may be formed on model 1102A.

Referring now to Figures 17A-17E, another model 1202 of an embodiment of the present invention is shown. Model 1202 generally includes a first portion 1208 and a guide portion 1210. In one embodiment, the first portion and the guide portion are integrally formed as one piece. In other embodiments, portions 1208 and 1210 are individual pieces configured to be interconnected before or during a surgical procedure. Features 1260, 1262 are provided to align and interconnect guide portion 1210 with first portion 1208. In one embodiment, the feature includes a protrusion 1260 formed on one of the portions configured to be retained within a bore 1262 formed on the other portion. Although protrusions are shown on guide portion 1210 and bores are shown on first portion 1208, the guide portion and first portion may each include a protrusion and a corresponding bore. Additionally, other features configured to interconnect and/or align portions 1208, 1210 may be considered and used with model 1202.

First portion 1208 is similar to models 1002-1102 described above. Accordingly, the first portion generally has the same (or similar) patient-specific surfaces 1214, voids 1217, protrusions 1219, and holes 1228 as the corresponding features of the other models and guides described herein. Includes.

Guide portion 1210 generally includes tracks 1220 for guiding a cutting tool, similar to the slots of all embodiments of guides described herein. Accordingly, track 1220 may be of any size and shape. Additionally, the track can be sized to accommodate the sleeve and can include stops and keys to guide the direction of use of the cutting tool or to limit the insertion depth of the tool. Additionally, tracks 1220 may have asymmetric alignment.

Referring now to Figures 18-19, another embodiment of models 1302A and 1302B of the present invention is shown. The models are configured to dock to frame 1330. Frame 1330 may be the same or similar to frames 330 and 730 described above. Accordingly, model 1302 is configured to fit into an existing or planned pedicle screw 1334. The model may optionally contact the surface 1350 of the middle vertebrae (VM) prepared in a previous amputation surgery.

Models 1302A, 1302B generally include holes 1328 and voids 1317 for interconnection to the frame. In one embodiment, model 1302A includes a closed hole 1328. Accordingly, model 1302A is generally interconnected to the middle portion of frame 1330 before the frame is interconnected to pedicle screw 1334.

Additionally, the model may include a recess 1354 similar to the recesses 854 and 954 described above. The recess has a similar cross-sectional shape to at least partially wrap around the neural elements containing the patient's spinal cord. The model may also include indicia indicating where to start the cut and the angle of the cut.

Model 1302A generally consists of two parts 1307A and 1307B. Each portion includes a leg or intermediate surface 1309 that represents the angle of the planned cut. For example, the medial surface 1309 is generally in a plane parallel to the location formed by the planned cut into the spine. Accordingly, the space between portions 1307A and 1307B generally represents the shape of the portion of vertebrae (VM) to be removed. In one embodiment, medial surface 1309 includes a distal portion with a patient-specific contour 1314. The patient-customized contour may substantially match a cut portion 1350 of the patient's anatomy. Optionally, the distal portion of medial surface 1309 may be configured to contact and substantially conform to an uncut portion of the patient's anatomy.

In contrast, model 1302B includes one piece. The planned cutting angle is indicated by the legs or outer surfaces 1309 of model 1302B proximate the upper spine (VS) and lower spine (VI). Therefore, the shape of the model generally represents the shape of the portion of the vertebra (VM) planned for removal. Model 1302B also has a void 1317 with an opening for interconnection to frame 1330. Accordingly, model 1302B can be added to and removed from frame 1330 without disassembling it. In one embodiment, the distal portion of surface 1309 includes a patient-specific contour 1314.

Referring now to Figures 20A-20F, another embodiment of model 1402 of one embodiment of the present invention is shown. Model 1402 is a patient-customized three-dimensional model that groups the patient's spine. The model is created for use in planning and performing a surgical procedure involving removal of a section 1405 of the patient's spine. In one embodiment, the model is applied to spinal osteotomy surgery.

The section 1405 of the spine to be removed during surgery is formed as a separate piece from the other parts of the model. The handles may be interconnected to removable sections 1405. In this way, removable section 1405 can be separated from or returned to a position within model 1402.

Removable section 1405 can be used as a template or measuring jig during surgery. A portion of removable section 1405A may be cut to avoid contact with the patient's neural elements during surgery, as shown in FIG. 20C. The removed portion may correspond to the portion of the patient's spine that was removed during surgery. Accordingly, the distal end of modified section 1405A may be configured to be substantially aligned with the surface of the target vertebra.

The upper portion (VS) and lower portion (VI) of the spine may also be formed as separate pieces. Afterwards, the upper and lower parts can be interconnected. In one embodiment, spinal segments VS and VI are interconnected by hinges 1464. However, those skilled in the art will understand that other means may be used to interconnect the upper and lower spinal segments. For example, in another embodiment, flexible members may be used to interconnect the spinal segments VS and VI. In another embodiment, ball and socket joints may be provided to interconnect the spinal segments (VS, VI).

After the removable section 1405 of the model is retrieved, the superior spinal portion (VS) and inferior spinal portion (VI) can be repositioned as shown in Figure 20D, resulting in the corrected alignment of the spine provided by surgery. can be explained. Model 1405 may indicate that another or additional surgery will be needed to correct the spinal abnormality.

To further visualize the alignment of the patient's spine before and after the planned surgery, indicators 1466A, 1466B are positioned in the superior spinal segment (VS) and inferior spinal segment (VI), respectively, as shown, for example, in FIGS. 20E-20F. can be interconnected. In one embodiment, indicator 1466 includes a curved rod. It will be appreciated that indicators may include different forms. The indicator simulates how the sagittal alignment of the patient's spine changes depending on the osteotomy angle planned before surgery.

Various patient-specific verification tools shown in FIGS. 21 and 24 may be planned and manufactured preoperatively to assist in verifying final sagittal and/or coronal alignment and/or matching screw placement. Verification tools are unique to each patient and may include the ability to register with patient-matched surfaces, implant contact surfaces, and/or guides. The verification tool of the present invention, described in conjunction with Figures 21 and 24, provides visual or tactical feedback to the surgeon during or after a surgical procedure.

Referring now to Figures 21-22, tools 1501A and 1501B of an embodiment of the present invention are shown. This tool is configured to verify coronal plane alignment during surgical procedures. In other words, the tool 1501 is used by the surgeon to verify that the planned correction of the spine has actually been achieved.

Tools 1501A, 1501B can be designed using patient-specific data and manufactured in any manner. Tool 1501 generally includes an armature 1570 extending from an intermediate body 1572. Intermediate body 1572 simulates the planned coronal plane alignment.

Some armatures may be interconnected to parts of the patient's anatomy. In one embodiment, as shown in FIGS. 21A-21D, the armature may be interconnected with a pedicle screw located in at least one of the iliotibial axis and the sacrum. In another embodiment, tool 1501B is interconnected only to the sacrum.

The screws may be from a previous surgery or may be specifically placed to interconnect the instrument 1501 to the patient's anatomy. Optionally, in other embodiments, intermediate body 1572 includes a patient-specific contact surface selected to substantially match the posterior surface of the perforation. Accordingly, the intermediate body 1572 may be retained on the sacrum with or without the use of pedicle screws.

Armature 1570A may be configured to extend from the midbody to one or more upper vertebrae. Armature 1570A may have a non-linear shape configured to be substantially aligned with a predetermined portion of the upper spine when a planned correction of the spine is created. In one embodiment, armature 1570A is configured to align with the posterior portion of the supraspinous process (S) of the upper plurality of vertebrae. Optionally, armature 1570A may contact a portion of the upper spine when the planned correction is produced. In one embodiment, tool 1501A includes five armatures 1570 extending from middle body 1572. In another embodiment, tool 1501B includes three armatures 1570 extending from the middle body.

In another embodiment, tool 1501 includes an electronic alignment indicator. The electronic indicator may include a light source or laser aligned to produce visible light indicative of the planned position of one or more vertebrae. The electronic indicator may be located in the intermediate body or armature.

Another embodiment of tool 1601 of one embodiment of the present invention is shown in Figures 23A-23E. Tool 1601 is similar to tool 1501 and is also used to verify coronal plane alignment during surgical procedures. The tool generally includes an armature 1670 interconnected to a guide 1646. In one embodiment, armature 1670 extends from the middle body 1672 of the guide. Intermediate body 1672 may include fixtures to interconnect armature 1670 to guide 1646. The guide may be a sacroiliac joint guide. In one embodiment of the invention, guide 1646 is similar to guide 246 described above. Alternatively, in another embodiment, guide 1646 is one of the guides described later with respect to FIGS. 25-31.

Armature 1670 may be formed integrally with guide 1646. Optionally, the armature and guide can be formed as separate pieces and interconnected before or during the surgical procedure. The curved shape of the armature 1670 is configured to indicate the planned sagittal and coronal alignment of the patient's spine after the surgical procedure is completed, as shown in FIGS. 23D-23E. Similar to armature 1570A described above, armature 1670 has a length selected to extend proximate the upper plurality of vertebrae. The armature may be shaped to be close to or in contact with portions of a plurality of vertebrae.

Referring now to Figures 24A-24B, an embodiment of an alignment assembly 1700 of an embodiment of the present invention is shown. Assembly 1700 generally includes an armature 1770 interconnected to an intermediate body 1772. The intermediate body may have a predetermined shape and size. In one embodiment, intermediate body 1772 has an arc shape. The middle body 1772 includes indicia 1774 indicating the relative alignment of the patient's spine, such as the inferior vertebrae (VI) and the superior vertebrae (VS) proximal to the middle vertebra (VM). Indicia may include a series of lines, optionally graduated, to indicate predetermined angles or distances. The intermediate body 1772 may be a conventional tool, such as a protractor or the scale of a ruler. In one embodiment, indicia 1774 includes protrusions 1776 that represent planned corrections.

At least one of the armatures 1770 is movably interconnected to the intermediate body 1772. In one embodiment, armature 1770 includes a proximal portion that forms a pointer. Pointer 1771 indicates the position of the armature on the indicia of the intermediate body 1772.

The distal portion of each armature is interconnected to a fixture (not shown) located on the patient's spine. The fixture may include a pedicle screw. Optionally, armature 1770 may have features configured to be received directly into a cannula formed in the spine. In one embodiment, one armature 1770 is interconnected to the lower spine (VM) and a second armature is interconnected to the upper spine (VS). However, other interconnection positions of the armature are considered. For example, in one embodiment of the invention, one of the armatures 1770 is interconnected to a portion of the middle vertebrae (VM).

In use, alignment assembly 1700 can provide a first reading before the alignment of the spine changes, as shown in FIG. 24A. After the cut 1750 is formed in the middle vertebrae (VM), the alignment of the upper vertebrae (VS) and the lower vertebrae (VI) can be changed so that the two cutting edges 1750 of the middle vertebrae (VM) are pulled closer together. . A second reading of the alignment of the spine is then provided by alignment assembly 1700, as shown in FIG. 24B.

Referring now in detail to Figures 25-26, a patient-specific guide 1810 of an embodiment of the present invention is shown. Guide 1810 may include a spanning member or intermediate body 1812, an arm 1814, a cannula 1816, and a patient-matched leg 1824. In one embodiment of the invention, guide 1810 includes two arms 1814, two cannulas 1816 and two legs 1824. However, the guide 1810 of the present invention may include any number of cannulas and legs. Both cannula 1816 and leg 1824 can have different lengths. Additionally, the angle and orientation of each cannula and leg can be varied to match the patient's anatomy or to avoid portions of the patient's anatomy. In one embodiment of the invention, cannula 1816 has a generally cylindrical shape.

Guide 1810 shown in FIGS. 25-26 generally shows a cannula 1816 and a leg 1824 interconnected with two arms 1814, but those skilled in the art will understand that the cannula 1816 and leg 1824 can be used in any You will see that they can be interconnected in a number manner. For example, in one embodiment, cannulas 1816 may be interconnected by a curved middle body. Alternatively, in one embodiment, cannula 1816 and leg 1824 may be formed as separate pieces that are individually positioned relative to the patient's anatomy and then interconnected during a surgical procedure.

The cannula 1816 is configured to contact one or more of the laminae, the articular shaft, and the sides of the transverse and superior articular processes of the patient. Cutouts 1817 may be selectively formed on portions of cannula 1816 to prevent guide 1810 from contacting the patient's supraspinatus or other patient anatomy. In other embodiments, cutout 1817 may include one or more patient-matched surfaces or features for contacting surrounding patient anatomy in a complementary manner. In certain embodiments, cutouts 1817 may be oriented to provide a greater field of view for the surgeon/user or to facilitate placement of one or more instruments or other devices as disclosed herein. In another embodiment, cutout 1817 is not provided with a cannula. In one embodiment, cutout 1817 may be configured to provide a patient-specific contour that matches the supraspinatus or other unique patient anatomical features and provides another surface to ensure alignment and seating of the guide. .

The cannula may include a generally hollow bore 1820 configured to guide instruments and fixtures into the cortical orbit. The bore 1820 of each cannula 1816 may have an inner diameter that corresponds to a specific instrument or fixture to prevent use of the incorrect instrument or device. Accordingly, the dimensions of the bores of the two cannulas may be different. The inner diameter of the bore 1820 may be selected to provide a rigid stop, preventing the instrument or device from advancing beyond a predetermined distance into the cannula 1816. Alternatively, projections, keys, notches or voids may be placed on the cannula or within the bore to prevent incorrect use of equipment or devices; To prevent incorrect orientation of the correct tool or device; It may be configured to do one or more of the following: prevent excessive insertion of a tool or device.

Additionally, the cannula 1816 can have a variable length and can be made longer or shorter depending on the geometry of the cannula 1816, the patient's anatomy, the purpose of the guide 1810, etc. For example, if greater depth of a particular instrument or fixation device is needed, cannula 1816 can be made shorter to allow the instrument or fixation device to penetrate further into the patient's spine.

Guide 1810 may include patient-matched legs 1824 configured to contact a portion of the patient's anatomy. In one embodiment, leg 1824 contacts one or more of the inferior articular process, the laminar process, and the transverse process. Optionally, the guide may include two or more legs. In one embodiment, the leg includes a distal portion 1824A and a proximal portion 1824B. As can be seen, leg 1824 may also extend from cannula 1816. For example, in one embodiment, the leg includes only a distal portion 1824A extending from cannula 1816.

Additionally or alternatively, patient-specific contact surfaces 1818, 1826 may be formed on each of the cannula 1816 and/or legs 1824, respectively. Surfaces 1818, 1826 provide multiple patient-specific contours for matching multiple anatomical features. Additionally, the lower patient contact surfaces 1818, 1826 may include dynamic contours with multiple compound radii. Accordingly, surfaces 1818, 1826 substantially correspond to corresponding anatomical features of the patient's spine or other anatomical features. Additionally, surfaces 1818, 1826 may contact or project around one or more of the group including the medial aspect of the inferior articular process, the lateral aspect of the laminar, the intersection between the pars and transverse processes, and other anatomical features of the patient. However, it is not limited to this.

The guide 1810 may further include a slot 1830 formed in the intermediate body 1812, arm 1814, cannula 1816, or leg 1824. Slot 1830 may be a cutting slot that directs the path of a blade or other cutting mechanism, as will be appreciated by those skilled in the art. In other embodiments, slots 1830 may be configured to accommodate measurement aids or tools for the surgeon/user to identify landmarks, surround lumbar anatomy, place implanted devices, and facilitate surgical planning. You can.

Alternatively, slot 1830 may be configured to receive one or more secondary or tertiary cannulas 1840, 1850, as further described with respect to FIG. 31. In certain embodiments, third cannula 1840, 1850 may further include patient-matched surfaces or features for contacting anatomical surfaces or features of a particular patient. In an alternative embodiment, the third cannula is generally smooth and does not include patient-matched surfaces or features.

Referring now to Figures 27A-27C, another patient-specific guide 1910 of an embodiment of the present invention is shown. Guide 1910 includes an intermediate body 1912 and at least one cannula 1916. In one embodiment, guide 1910 is formed as two separate pieces that can be individually positioned in contact with desired features of the patient's anatomy and then interconnected during a surgical procedure. The two parts 1912A, 1912B of the intermediate body are configured to be interconnected. In one embodiment, intermediate body 1912B includes a coupling 1913 configured to releasably interconnect the individual pieces of guide 1910 together. Accordingly, in one embodiment, the two portions of the guide may be interconnected by positioning couplings 1913 in corresponding voids within intermediate body 1912A. The coupling may be retained within the void by friction. Additionally or alternatively, a biasing force may be provided to maintain coupling 1913 within the cavity. In one embodiment, the coupling and void include snaps. In other embodiments, the intermediate body may include a magnet. Optionally, in another embodiment, the intermediate body portions 1912A, 1912B may be interconnected by flexible or expandable members, such as hinges or any type of biasing member including springs. Those skilled in the art will understand that the middle body portions 1912A, 1912B may be interconnected by any other suitable means. Optionally, in another embodiment of the invention, guide 1910 is formed as a single unitary member.

Cannula 1916 is the same or similar to cannula 1816 described above with respect to FIGS. 25-26. In one embodiment, cannula 1916 has a generally cylindrical shape. In a similar manner, the cannula 1916 is configured to contact one or more of the laminae, pars, and sides of the transverse and superior articular processes of the patient or other portions of the patient's anatomy. The cannula can be formed without a bore. In another embodiment, cannula 1916 may include a bore 1920 similar to bore 1820. Bore 1920 includes a predetermined inner diameter configured to accommodate a specific instrument or fixture to prevent incorrect instrument or device use. The inner diameter of bore 1920 may be selected to provide a rigid stop, preventing the instrument or device from advancing beyond a predetermined distance into cannula 1916. Additionally, bore 1920 may have a shape configured to align a tool or fixture in a desired orientation of use. Additionally, the cannula may be of any length based at least in part on the particular patient's anatomical features, the surgeon's preferences, the orientation of the guide 1910 and the type of instrument or fixation device associated with the cannula 1916.

Additionally or alternatively, a patient-specific contact surface may be formed on any of the patient-contacting surfaces 1918 of the cannula 1916 and/or the contacting surfaces 1926 of the intermediate body 1912. Surfaces 1918, 1926 provide a plurality of patient-specific contours for matching a plurality of anatomical features, as described in greater detail above. The surface 1926 of the intermediate body 1912 may contact at least the front surface of the spinous protrusion S. The surface (1918) of the cannula (1916) includes, but is limited to, one or more of the group including the medial aspect of the inferior articular process, the lateral aspect of the laminar process, the supraspinous process, the intersection between the pars and transverse processes, and other anatomical features of the patient. It is constructed to touch or protrude around something that is not. These patient contact surfaces 1918, 1926 help position the guide 1910 and keep it in place at the desired position and orientation.

Referring now to Figures 28A-28B, a patient-specific guide 2010 of another embodiment of the present invention is shown. Guide 2010 generally includes a cannula 2016 and one or more legs 2024. Cannula 2016 is the same or similar to the cannula described above with respect to FIGS. 27-28. Although only one cannula 2016 is shown in FIG. 28, those skilled in the art will understand that the guide 2010 can have any number of cannulas. Cannula 2016 includes a bore 2020 that is the same or similar to bores 1820 and 1920 and includes an inner diameter for receiving a particular instrument or fixture. Accordingly, Boer 2020 can prevent incorrect use of an instrument or device and prevent incorrect use of an instrument or device. Accordingly, the inner diameter of the bore, the shape of the bore, and/or features formed on or within the bore may be selected to provide a rigid stop by preventing the instrument or device from advancing beyond a predetermined distance into the cannula 2016. there is.

The length of cannula 2016 may also be increased or decreased based at least in part on the instruments or devices associated with cannula 2016, the orientation of the guide relative to the patient's anatomy, and the surgeon's preferences. Accordingly, the cannula may be configured to prevent the instrument or fixation device from advancing too far into the patient's lumbar anatomy.

Additionally or alternatively, cannula 2016 may include a second bore. The second bore may be oriented in a different orbit for placement of the temporary fixture. Optionally, the cannula may include tracks or slots configured to guide an instrument operable to remove a portion of the spine. Slots can include patient-specific depth control, angle control, and orientation. The slot may be the same as or similar to any slot described herein, such as slot 20, 120, 320, 420, 520, 720, 820 or 1220.

In one embodiment of the invention, cannula 2016 has a length such that the distal end or terminal portion 2018 of cannula 2016 does not contact the patient's anatomy. In other words, the distal end 2018 of the cannula 2016 is configured to float over a predetermined portion of the patient's anatomy. In another embodiment of the invention, the cannula 2016 has different lengths such that the distal end 2018 of the cannula 2016 intentionally contacts a predetermined portion of the patient's anatomy. Continuing with this example, a patient-specific contact surface may be formed on the distal end 2018 of the cannula 2016. Accordingly, the distal end 2018 of the cannula 2016 may optionally provide another guiding surface to align and/or stabilize the guide 2010 in a desired orientation during a surgical procedure.

The legs 2024 of the guide 2010 may each include different lengths. Additionally, the position and alignment of leg 2024 relative to cannula 2016 may vary based on patient-specific anatomical features, planned orientation of guide 2010, or surgeon preference. Legs 2024 are configured to contact a portion of the patient's anatomy. In one embodiment, one or more of the legs 2024 may be configured to at least partially conform or hook around some portion of the patient's anatomy. Accordingly, guide 2010, or portions thereof, may be made of a material of choice so that a surgeon can bend or deform guide 2010 to fit it around a patient's anatomy. In one embodiment, legs 2024 or portions thereof are made at least partially from a flexible or deformable material. In another embodiment, at least a portion of legs 2024 are made from a material with shape memory, such as Nitinol. Accordingly, the legs may provide a biasing force to releasably maintain the guide 2010 in a predetermined alignment with respect to the patient's anatomy.

Accordingly, in one embodiment, the at least one leg includes a curved shape, or a cutout similar to the cutout 1817 described above with respect to FIGS. 25-26, to form a guide 2010 and a spinous projection S. or prevent unintentional or inadvertent contact between other anatomical features of the patient. Alternatively, in other embodiments, at least one of the legs may include a curved shape or cutout with a patient-matched surface configured to still create one or more other patient-matched contact surfaces that align and stabilize the guide 2010. You can.

In one embodiment, at least one of the legs 2024 contacts one or more of the group including the inferior articular process, the laminar process, the superior articular process, the transverse process, and other anatomical features. The end portion 2026 of the leg 2024 may include a patient-specific contact surface that is the same or similar to the contact surfaces 1826, 1926 described above with respect to FIGS. 25-27. Additional patient-specific contact surfaces may also be formed on one or more other surfaces of legs 2024.

Referring now to Figures 29A-29C, another patient-specific guide 2110 of another embodiment of the present invention is shown. Guide 2110 generally includes an intermediate body 2112 and at least one cannula 2116. The intermediate body 2112 includes a distal surface 2113 configured to contact a portion of the patient's anatomy. In one embodiment, the distal surface 2113 is configured to contact one or more of the group including the inferior articular process, the laminar process, the supraspinous process, the pars, the transverse process, and other features of the patient's anatomy. Accordingly, the distal surface 2113 of the intermediate body 2112 provides a patient-specific surface to align the guide 2110 in a desired orientation. Optionally, one or more of the side surfaces 2111 may have a patient-specific shape configured to contact or interconnect with other parts of the patient's anatomy. For example, guide 2110 may include an extension or leg configured to hook around a portion of the patient's anatomy, similar to leg 2024. The legs may be made of flexible or deformable materials, including nitinol. In one embodiment, the legs are configured to provide a biasing force to “hook” the guide in a desired orientation relative to the patient's anatomy.

Additionally, surface 2113 may include two or more surface portions 2113A, 2113B configured to contact different portions of the patient's anatomy. Accordingly, surfaces 2111, 2113A, 2113B form complex shapes selected to provide a substantially tight fit of guide 2110 to the patient's anatomy, thereby preventing unintentional or inadvertent movement of guide 2110 during surgical procedures. One or more of the following may be achieved: preventing movement and positioning the guide 2110 at a desired location relative to the patient's anatomy. Distal surface 2113 may further include a relief portion 2115 that prevents unnecessary contact with the patient's anatomy to avoid unnecessary or unintended tissue dissection or damage. Optionally, one or more surfaces 2111, 2113A, 2113B may have a shape or protrusion configured to displace soft tissue.

Cannula 2116 is the same or similar to the cannula described above with respect to FIGS. 25-28. Those skilled in the art will understand that guide 2110 can have any number of cannulas. In one embodiment of the invention, guide 2110A includes two cannulas 2116 and 2116A. Additionally, the cannulas may each have different orientations to target different parts of the patient's anatomy. The cannula generally passes from the proximal surface of the guide 2112 to the distal surface 2113. Additionally, although shown protruding from the proximal surface of the guide 2112, those skilled in the art will understand that the cannula 2116 may terminate at a point substantially at the same level as the proximal surface of the guide. Additionally, the cannula can have any desired orientation relative to the middle body 2112 of the guide 2110. In one embodiment, the cannula has an orientation that penetrates the proximal and distal surfaces of the guide. In another embodiment of the invention, at least one end of cannula 2116A passes through side surface 2111 of guide 2110.

Cannulas 2116, 2116A include bores 2120 similar to bores 1820, 1920, 2020. Bore 2120 includes an inner diameter or shape to accommodate a particular instrument or fixture. Accordingly, bore 2120 can prevent the use of incorrect instruments or devices. Bore 2120 may also be configured to prevent improper use of the instrument or device. Accordingly, the inner diameter or shape of bore 2120 may be selected to provide a rigid stop, preventing the instrument or device from advancing beyond a predetermined distance into cannula 2116. In this way, the cannula can be configured to prevent the instrument or fixation device from advancing too far into the patient's lumbar anatomy.

Two or more guides 2110 may be used during a surgical procedure. As shown in Figure 29C, each guide can be positioned in contact with a different part of the patient's anatomy. Additionally, although not shown in FIG. 29, individual guides 2110B, 2110C may be interconnected together before or during a surgical procedure. Accordingly, in one embodiment of the invention, guides 2110B and 2110C include structures similar to intermediate body 1912 described above with respect to FIG. 27, configured to releasably interconnect the guides together. In another embodiment, guides 2110B and 2110C include structures similar to arm 1814 to permanently interconnect the guides together.

In one embodiment, guide 2110 may be interconnected to a similar frame as guide 2010. Accordingly, guide 310 may be used with one or more frames 330, 730, 1330 before or after one or more of guides 310, 710, 1302, and 2010.

Referring now to Figures 30A-30C, a patient-specific guide 2210 of another embodiment of the present invention is shown. Guide 2210 generally includes an intermediate body 2212, a cannula 2216, one or more legs 2224, and a second leg or bridge 2230.

Cannula 2216 may be the same or similar to the cannula described above with respect to FIGS. 25-29. Although two cannulas 2216 are shown in FIG. 30, those skilled in the art will understand that guide 2210 can have any number of cannulas. Additionally, each cannula 2216 has a predetermined length that is shorter or longer than the length of the other cannula of the guide. Cannula 2216 may include bore 2220 similar to bores 1820, 1920, 2020, 2120. Bore 2220 includes an inner diameter configured to receive a particular instrument or fixture. Accordingly, bore 2220 can prevent the use of incorrect instruments or devices. The shape and/or inner diameter of the bore 2220 and the length of the cannula 2216 prevent the device or device from advancing beyond a predetermined distance into the cannula 2216 and prevent incorrect use of the device or device, It may be selected for one or more of the following: ensuring proper alignment and use of the correct instrument or device.

Although shown in FIG. 30 as having a generally linear shape, it will be apparent to those skilled in the art that one or more legs 2224 may have a curved shape. Accordingly, the shape, length and orientation of the legs can be tailored to contact certain portions of the patient's anatomy while avoiding contact with other features of the patient's anatomy. Accordingly, in one embodiment, at least one leg includes a curved shape, or a cutout similar to the cutout 1817 described above with respect to FIGS. 25-26, thereby providing the guide 2210 and the spinous protuberance, laminer. Prevent unintentional or inadvertent contact between , or other anatomical features of the patient. Alternatively, in other embodiments, at least one of the legs 2224 may have one or more other patient-specific contact surfaces (similar to surfaces 1926 described above with respect to FIG. 27) that align and stabilize the guide 2210. It may still include a curved shape or cutout with a patient-matched surface configured to create.

In one embodiment, at least one of the legs 2224 contacts one or more of the group comprising the inferior articular process and the laminar. Terminal portion 2226 of leg 2224 may include a patient-specific contact surface that is the same or similar to contact surface 1826 described above with respect to FIGS. 25-26. Additional patient-specific contact surfaces may also be formed on one or more other surfaces of legs 2224. Although not shown, contact surface 2226 aligns guide 2210 to a desired position relative to the patient's anatomy, prevents unintentional or inadvertent movement of guide 2210 during surgical procedures, and protects soft tissue. It may include a protrusion configured to accomplish one or more of the following: displacing. In one embodiment, contact surface 2226 includes a relatively thin extension.

The second leg or bridge 2230 is configured to contact one or more of the patient's spinous process (S) and laminae. In the embodiment of the invention shown in Figure 30, bridge 2230 extends inwardly from cannula 2216. In another embodiment, bridge 2230 extends inwardly from legs 2224. Bridge 2230 may be formed as a single piece and may include a longitudinal cavity. In this way, the longitudinal cavity is configured to substantially conform to the contour of a given portion of the patient's anatomy. In one embodiment, the longitudinal cavity is configured to contact the contour of the supraspinous process (S) of a particular vertebral body (V) of the patient. In another embodiment, bridge 2230 is formed of two separate portions 2230A and 2230B. In all embodiments of the invention, bridge 2230 may include one or more contact surfaces 2234 configured to register the contour of one or more of the spinous process, laminae, and other anatomical features. Accordingly, bridge 2230 facilitates one or more of ensuring desired alignment of guide 2210 and preventing inadvertent or unintentional movement of guide 2210 during surgical procedures.

Guide 2210 may also include an extension configured to hook at least partially around or over a portion of the patient's anatomy. For example, in one embodiment of the invention, one or more of midbody 2212, legs 2224, and bridge 2230 may have a shape suitable for hooking to a patient's anatomy. In other embodiments, portions of guide 2210, such as one of the legs, mid-body, or bridge, may include a flexible or bendable material as described above. In use, the surgeon can bend or modify the guide 2210 to hook it to the patient's anatomy. As can be seen, guide 2210 may also include cutting guide 10. The cutting guide 10 may be interconnected to any portion of the guide 2210 similar to the cutting guide 10 shown in FIG. 27D.

Referring now to Figure 31, another embodiment of a patient-specific guide 2310 of one embodiment of the present invention is shown. Guide 2310 is substantially the same as guide 1810 described above with respect to FIGS. 25-26. Accordingly, the guide 2310 includes an intermediate body 2312, arms 2314 that are identical to (or similar to) the body 1812, arms 1814, cannula 1816, and patient-matched legs 1824 of the guide 1810. ), cannula 2316, and patient-matched leg 2324. In one embodiment of the invention, guide 2310 includes two arms 2314, two cannulas 2316, and two legs 2324. However, the guide 2310 of the present invention may include any number of cannulas and legs. Cannula 2316 and leg 2324 can each have different lengths. Additionally, the angle and orientation of each cannula and leg can be changed to match the patient's anatomy.

The guide 2310 may further include a slot 2330 formed in one or more of the intermediate body 2312, arm 2314, cannula 2316, and leg 2324. Slot 2330 may be a cutting slot that guides the path of a blade or other cutting mechanism, as described above. Alternatively, slot 2330 may be configured to receive one or more second cannula 2340 or third cannula 2350.

Second and third cannulas 2340, 2350 may be positioned within slot 2330 to target one or more of the patient's second level and third level anatomical features. In one embodiment, cannulas 2340, 2350 are configured to target one or more predetermined portions of the cervical spine (i.e., C1-S1 and iliac spine). Cannulas 2340, 2350 include bores 2320 that are the same or similar to bores 1820, 1920, 2020, 2120, and 2220 described above with respect to FIGS. 25-30. Accordingly, bore 1820 may guide one or more of other instruments including, but not limited to, guide wires, drill bits, taps, fixation devices (such as screws), and tools for harvesting bone graft. Additionally, the bores and/or cannulas 2340, 2350 may have a length, shape selected to prevent the use of an inappropriate tool or device, prevent inappropriate use of a given tool or device, and ensure proper use of a given tool or device. , may have a protrusion and/or a diameter.

Optionally, in other embodiments of the invention, the second and third cannulas 2340, 2350 may include tracks or slots. The slot may be configured to guide an instrument operable to remove a portion of the spine. Slots can include patient-specific depth control, angle control, and orientation. In one embodiment of the invention, the slots of cannulas 2340, 2350 are the same or similar to any of the slots described herein. For example, cannulas 2340, 2350 may include slots similar to slots 20, 120, 320, 420, 520, 720, 820, or 1220.

The ends of cannulas 2340, 2350 may include patient-specific contact surfaces described above with respect to FIGS. 25-30. Additionally, the angle and orientation of each cannula 2340 and 2350 may be changed to match the patient's anatomy. The third cannula 2350 may be releasably interconnected to the second cannula 2340. Cannulas 2340, 2350 may be releasably interconnected to guide 2310 before or during a surgical procedure. The cannulas 2340 and 2350 may include an extension 2344 or a plurality of extensions 2344A to engage the slot 2330 formed on the guide 2310. Each slot 2330 can have a different shape, width, depth, and orientation configured to receive a given cannula 2340, 2350 in a particular orientation. Alternatively, in one embodiment, cannulas 2340, 2350 are formed with guide 2310 as one integral piece.

Referring now to Figures 32A-32B, another patient-specific guide 2810 of an embodiment of the present invention is shown. In one embodiment, guide 2810 includes an intermediate body 2812, at least one cannula 2816, and legs 2824. Cannula 2816 may be the same or similar to cannula 1816 described above with respect to FIGS. 25-26. Optionally, cannula 2816 may be configured to contact one or more of the patient's laminae, pars interarticularis, transverse process, and lateral and superior articular process of the inferior articular process. A guide 2810 may be formed on a portion of the cannula 2816 to prevent contact with the patient's supraspinatus, adjacent vertebrae, and to avoid other patient anatomy.

In one embodiment, guide 2810 includes two cannulas 2816, although it will be appreciated that guide 2810 may include any number of cannulas. Cannula 2816 may have a generally cylindrical shape, although other shapes are contemplated. Each of the two cannulas 2816 may have a unique orientation and size. The cannula can be of any length based at least in part on the particular patient's anatomical features, the surgeon's preferences, the orientation of the guide 2810, and the type of instrument or fixation device associated with the cannula 2816. The length of cannula 2816 may also be selected to provide depth control of the instrument guided by cannula 2816.

Cannula 2816 may optionally include an extension 2819 of any size or shape. In one embodiment, extension 2819 is positioned proximate the distal end of cannula 2816. In another embodiment, extensions 2819 at least partially wrap around the outer perimeter of cannula 2816. Additionally, extension 2819 may protrude at least partially beyond the distal end of cannula 2816. The extensions are configured to at least partially wrap around a portion of the patient's anatomy. In one embodiment, extension 2819 is configured to wrap around a portion of one of the pars and superior articular processes.

Optionally, guide 2810 may include one or more legs 2824. Legs may extend from one or more intermediate bodies 2812 and cannula 2816. The angle and orientation of each leg 2824 relative to the midbody 2812 can be varied to match the patient's anatomy or to avoid portions of the patient's anatomy.

In one embodiment, at least a portion of the midbody 2812, cannula 2816, and legs 2824 are configured to contact the patient's anatomy. For example, patient-specific contact surfaces 2818, 2825 may be formed on one or more cannulae 2816 each including protrusions 2819 and one or more legs 2824. Optionally, at least a portion of midbody 2812 can be configured to contact a portion of the patient's anatomy. Accordingly, midbody 2812 may optionally also include a patient-specific contact surface 2826.

Contact surfaces 2818, 2825, 2826 may be located on the sides of the patient's anatomy, such as the medial aspect of the inferior articular process, the lateral aspect of the laminae, the supraspinous process, the intersection between the pars and transverse processes, and other anatomical features of the patient. It may be configured to fit directly into one or more. Patient-specific contact surface 2826 of midbody 2812 may optionally contact at least a portion of the supraspinatus. The contact surfaces 2818, 2825, 2826 have at least a portion of the curvature of the patient's anatomy to facilitate placement of the guide 2810 in a predetermined alignment with respect to a predetermined portion of the patient's anatomy during a surgical procedure. It is decided to match.

Patient contact surfaces 2818, 2825, 2826 may include any number of projections, depressions, and contours that substantially match the patient's anatomy. For example, contact surfaces 2818, 2825, 2826 may include a plurality of portions configured to contact two different planes formed by two distinct portions of the patient's anatomy. In this manner, contact surfaces 2818, 2825, 2826 align guide 2810 in a predetermined position and orientation relative to the patient's anatomy, hook a portion of the patient's anatomy, and guide the guide during surgical procedures. (2810) is configured to achieve one of the following: preventing unintentional or inadvertent movement of the tissue, and displacing soft tissue. In one embodiment, contact surfaces 2818, 2825, 2826 include relatively thin extensions to displace soft tissue. By at least partially protruding around and substantially conforming to different portions of the patient's anatomy, the contact surfaces 2818, 2825, 2826 generally are at least partially "about" (or at) the patient's anatomy. To “hook”. Accordingly, surfaces 2818, 2825, and 2826 may contact at least two different planes formed by distinct surfaces of the patient's anatomy.

At least one of the cannulas 2816 may include a bore 2820 that guides the instrument and fixation device. The bore 2820 of each cannula 2816 may have a unique inner diameter adapted to accommodate a particular instrument or fixture. The inner diameter may also be selected to prevent use of an incorrect instrument or device with guide 2810. The bore diameter and/or length of the cannula 2816 may also provide a rigid stop for depth control by preventing the instrument or device from advancing beyond a predetermined distance into the cannula 2816.

Bore 2820 may have a shape suitable for aligning a tool or fixture to a desired orientation of use. Additionally, protrusions, keys, notches or voids may be formed on the cannula 2816 or in the bore 2820 to prevent use of incorrect equipment or devices, prevent incorrect orientation of the correct tool or device, and prevent incorrect orientation of the correct tool or device. Achieves one or more of the following: preventing over-insertion of the device. For example, in one embodiment of the invention, cannula bore 2820 may include an instrument contact surface associated with a feature of the instrument, such as a protrusion, to control the insertion depth or orientation of the instrument. Accordingly, cannula 2816 may be configured to prevent the instrument or fixation device from being misused or advanced too far into the patient's lumbar anatomy.

Guide 2810 may include features configured to be grasped or manipulated by a surgeon. Accordingly, gripping features 2829 may be formed on a portion of guide 2810. In one embodiment, gripping feature 2829 includes a protrusion. Protrusions 2829 may be of any shape or size selected to facilitate gripping of guide 2810 in a surgical environment. In one embodiment, protrusion 2829 is formed on a portion of intermediate body 2812. Protrusions 2829 may include ridges or bumps. In one embodiment, protrusion 2829 includes three generally parallel ridges formed on opposite sides of each portion 2812A, 2812B of intermediate body 2812. However, it will be appreciated that any number of protrusions may be formed into gripping features 2829. Optionally, the gripping features 2829 of middle body portion 2812A can be different from the gripping features of middle body portion 2812B. In this way, the surgeon or other user can determine the orientation of the guide 2810 by feel without having to see the guide. In one embodiment, gripping features 2829 are formed on a portion of guide 2810 that extends beyond the patient's anatomy when guide 2810 is in a predetermined position in contact with the patient's anatomy. .

Although not shown in FIG. 32 , guide 2810 may further include attachment points formed on one or more of midbody 2812, cannula 2816, and legs 2824. The attachment point is configured to receive one or more secondary cannula 2840 or tertiary cannula 2850. Cannula 2840/2850 may include a cutting slot or bore 2820A to guide the instrument to target different parts of the patient's anatomy. In one embodiment, cannulas 2840, 2850 are configured to target one or more predetermined portions of the cervical spine (i.e., C1-S1 and iliac spine).

In one embodiment, the attachment point includes a slot to receive the extension 2842 of the cannula 2840, 2850. In one embodiment, the slot may also be used to guide the path of a blade or other cutting instrument, or to allow the surgeon/user to identify landmarks, surround lumbar anatomy, position implanted devices, and facilitate surgical planning. It may be configured to receive a measuring aid or tool.

The guide 2810 may further include a slot formed in the intermediate body 2812 or the cannula 2816. The slot may be the same or similar to slot 1830. In one embodiment, the slot is configured to guide the path of a blade or other cutting mechanism in a manner similar to the cutting slots 20-820 of all embodiments described herein. Alternatively, the slot in guide 2810 may be configured to receive a second cannula 2840 or a third cannula 2850 as further described with respect to FIG. 31 . In another embodiment, guide 2810 is configured to receive cutting guide 10 in a similar manner to guide 1810A shown in FIG. 25D. Cutting guide 10 may be received by slots formed in one or more of the intermediate body, cannula, and legs. Optionally, the cutting guide 10 may be formed integrally with the guide 2810.

Referring now to Figures 33A-33B, another embodiment of a patient-specific guide 2910 of the present invention is shown. Guide 2910 is similar to guide 2810 and generally includes a midbody 2912 and a cannula 2916. Cannula 2916 may be the same as or similar to cannula 2816 and include an extension 2919 and a bore 2920. Extension 2919 generally extends radially compared to extension 2819 of guide 2810. Accordingly, extension 2919 wraps around the patient's anatomy and contact surface 2918 has a larger surface area than contact surface 2818. More specifically, the increased radial size of extension 2919 allows contact surface 2918 to contact a more variable bone surface of the patient. In one embodiment, extension 2919 is configured to contact at least a portion of one or more of the patient's gastric articular process and pars.

Extensions 2919A, 2919B may have similar or different shapes as needed based on the patient's anatomy. For example, extension 2919A wraps around a circumferential portion of cannula 2916A and extension 2919B wraps around the entire circumference of cannula 2916B. Additionally, the radius of the extension portion 2919 may be changed. In one embodiment, the radius of extension 2919A is different than extension 2919B.

Guide 2910 also includes gripping features 2929 of another embodiment of the present invention. Gripping feature 2929 includes a depression 2930 formed in a portion of intermediate body 2912. One or more protrusions 2932 may be associated with or disposed about depressions 2930.

Guide 2910 may also include indicia 2928 to identify the sequence of use or the portion of the patient's anatomy for which the guide 2910 will be used.

Referring now to FIGS. 34A and 34B, another embodiment of a patient-specific guide 3010 of one embodiment of the present invention is shown. Guide 3010 is similar to guides 2810 and 2910 and generally includes a midbody 3012, legs 3024, cannula 3016, and gripping features including depressions 3030 and projections 3032. 3029). Patient-specific contact surfaces 3018, 3025, 3026 may be formed identically (or similarly) to those on guides 2810, 2910 on one or more of cannula 3016, legs 3024, and midbody 3026. .

Each cannula 3016 may include an extension 3019 and a bore 3020. Bore 3020 is identical to any of bores 1820, 1920, 2820, and 2920 described herein. Extension 3019 is similar to extension 2919 and has an expanded radius compared to extension 2819. However, extension 3019 has a different alignment and shape compared to extension 2919. More specifically, as best seen in FIG. 34B, extension 3019 has a contact surface 3018 that varies in length axially around the circumference of cannula 3016.

Additionally, extension 3019, cannula 3016, and contact surface 3018 form a chamber or recess 3034 proximate bore 3020. A recess 3036 similar to recess 3034 may also be formed at the distal end of each leg 3024. Recesses 3034, 3036 provide focused contact between the patient-specific contact surfaces 3018, 3025 of cannula 3016 and leg 3024 and the patient's anatomy. More specifically, without the recesses 3034, 3036, the smooth surface of the cannula 3016 and/or leg 3024 may contact the patient's soft tissue that has not been removed from the bone. This contact may prevent proper alignment of the guide 3010. In other words, recesses 3034, 3036 prevent cannula 3016 and leg 3024 from contacting soft tissue that has not been removed from bone. Accordingly, recesses 3034, 3036 assist guide 3010 in proper alignment with the targeted portion of the patient's anatomy.

Recess 3034 of cannula 3016 may also receive and collect bone material produced by a boring instrument, such as a drill bit, guided by bore 3020. In this manner, bone material may exit the hole formed in the patient's bone and be received within recess 3034. Accordingly, bone material generated during a medical surgery is collected and the guide 3010 is not pushed away from the target portion of the patient's anatomy, ensuring that the guide 3010 is maintained in the desired orientation.

Referring now to Figures 35A-35C, another embodiment of a patient-specific guide 3110 of the present invention is shown. Guide 3110 is similar to guides 2810, 2910, and 3010 and generally includes a middle body 3112, cannula 3116, and legs 3124. Cannula 3116 may include bore 3120 that is the same as bore 1820, 2820, 2920, or 3020. An extension 3119 with an increased radius may be formed on each cannula 3116 similar to the extensions 2919 and 3019 of the guides 2910 and 3010. Patient-specific contact surfaces 3118, 3125 may be formed on one or more of cannula 3116 and legs 3124 as described herein with respect to guide 2810.

Guide 3110 also includes at least one cut or hole 3138, shown in FIGS. 43A and 43B, passing through cannula 3116. Hole 3138 intersects at least a portion of bore 3120 and allows bone material to exit the cannula while drilling the patient's bone. As a result, bone material is not collected between guide 3110 and the patient's anatomy, such as the spine 4, which could potentially interfere with the alignment of guide 3110.

Although only one hole 3138 is shown on cannula 3116A, a hole 3138 may be formed on each cannula 3116 of guide 3110. Additionally, hole 3138 may be formed in a different portion of cannula 3116 than shown in FIG. 35 . Hole 3138 may also be formed to have a shape configured to avoid patient anatomy, such as adjacent vertebrae. For example, the hole may have one or more of a different length, width, and shape than that shown in FIG. 35 . In this way, holes 3138 ensure that guide 3110 is in predetermined alignment with the target portion of the patient's anatomy.

Referring now to Figures 36A-36F, a more patient-specific guide 3210 of an embodiment of the present invention is shown. Guide 3210 generally includes an intermediate body 3212, a cannula 3216, a leg 3224, and an auxiliary leg 3242. Auxiliary leg 3242 has a contact surface 3225A configured to contact a predetermined portion of the patient's anatomy. Contact surface 3225A is formed in the same manner as contact surfaces 2818 and 2825 of guide 2810. In one embodiment, contact surface 3225A is formed using the method of FIG. 2. The contact surfaces 3225, 3225A of the legs 3224, 3242 are aligned to contact one or more of the laminae, pars, articular processes, and supraspinous processes of the patient's anatomy 4. Additionally, contact surfaces 3325, 3225A may be patient-specific as described herein. The contact surfaces 3225, 3225A of the legs may also include recesses that are the same or similar to the recesses 3036 of the guide 3010.

In one embodiment, one or more cannulas 3216 have a length selected such that the distal end of the cannula 3216 does not contact the patient's anatomy. Accordingly, as shown in FIGS. 36B and 36C, the distal end of cannula 3216 is separated a predetermined distance from the patient's spine 4 when the guide is aligned with the spine 4.

Alternatively, one or more cannulas 3216 may have an increased length such that the distal end of the cannula 3216 contacts a predetermined portion of the patient's anatomy. Accordingly, the distal end of cannula 3216 may have patient-specific features identical or similar to contact surfaces 2818, 2918, 3018, 3118, extensions 2819, 2919, 3019, 3119, recesses 3034, and apertures 3138. It may include one or more of a contact surface, an extension, a recess, and a hole.

Referring now to Figures 36D-36F, a perspective view of another patient-specific guide 3210A is provided that is configured to be positioned within an incision into the patient's bony anatomy. In one embodiment, guide 3210A is suitable for use in a surgical procedure involving a patient's spine 4 to guide instruments and fixation devices along one or more trajectories A, B. However, guide 3210A may be used for placement of fixation devices in surgical procedures involving the guidance of instruments and other bony anatomy of a patient.

Guide 3210A is similar to guide 3210 described in FIGS. 36A-36C. Accordingly, guide 3210A generally includes one or more of an intermediate body 3212, legs 3224, and auxiliary legs 3242 that are the same as or similar to the intermediate body, legs, and auxiliary legs of guide 3210. Optionally, guide 3210 may include one or more cannulas 3216. The optional cannula 3216 may further include a bore 3220 for disposing a temporary fixation pin for temporarily securing the guide 3210A to the patient's anatomy 4 during a surgical procedure.

Guide 3210A also includes at least one outer cannula 3250 (or “posterior cannula”) associated with at least one inner cannula 3260 (or “anterior cannula”). The associated pair of external and internal cannulas 3250, 3260 are aligned substantially collinear. After guide 3210A is positioned against the patient's anatomy 4 through a first incision, internal cannula 3260 is targeted by the surgeon through a second incision within the patient's soft tissue. Internal cannula 3260 improves mechanical guidance of the instrument into the patient's anatomy 4. In one embodiment, external cannula 3250 is interconnected to support element 3254. Support element 3254 can be of any size. Optionally, support element 3254 is sized to laterally position external cannula 3250 beyond the width of guide 3210A.

External cannula 3250 may optionally be releasably interconnected to intermediate body 3212. For example, as shown in Figure 36E, external cannula 3250 may include a protrusion 3256 configured to be received within a corresponding slot 3213 formed in guide 3210A. In one embodiment, slot 3213 is formed in intermediate body 3212 and is identical (or similar) to one of the slots 1830 of guide 1810.

Internal cannula 3260 is interconnected to a portion of guide 3210A to be positioned within an incision through the patient's skin S. In one embodiment, inner cannula 3260 is interconnected to the distal portion of cannula 3216. However, inner cannula 3260 may optionally be interconnected to other portions of guide 3210A, including leg 3224 and/or auxiliary leg 3242.

The outer cannula 3250 includes a bore 3252 that is generally concentrically aligned with the bore 3262 of the corresponding inner cannula 3260. Accordingly, in combination, corresponding pairs of outer and inner cannulas 3250, 3260 define a virtual cannula of extended length. However, by using a pair of corresponding outer and inner cannulas 3250, 3260, the size of the incision required to position the guide 3210A allows for a length of cannula extending from the outer cannula 3250 to the inner cannula 3260. It can be reduced compared to the incision required for a guide with. Additionally, by positioning the inner cannula 3260 in the distal portion of guide 3210A closer to the patient's anatomy, the center of gravity of guide 3210A is moved closer to the patient's anatomy 4. Accordingly, the guide 3210A is docked low and stable to the patient's bone 4, improving the accuracy of the k-wire and other instruments guided along the trajectories A and B.

The inner cannula 3260 further includes an aperture 3264. Hole 3264 forms a channel from bore 3262 to the exterior of inner cannula 3260. Hole 3264 allows a k-wire oriented by guide 3210A to pass through hole 3264 so that guide 3210A can be removed from the patient after the k-wire is positioned within the patient's anatomy. It has a size that In one embodiment, hole 3264 includes a slot extending longitudinally from the outer surface of cannula 3260 to bore 3262. 36F, when a device such as sleeve 1854 is at least partially received within bore 3262, hole 3264 is closed and positioned within bore 1856 of sleeve 1854. A k-wire or other instrument is maintained within bore 3262 of inner cannula 3260B.

Referring now to Figures 37A-37D, another patient-specific guide 3310 of the present invention is shown. In one embodiment, guide 3310 is configured to be positioned proximate the patient's ilium 8, as indicated by indicia 3328, which indicates a direction toward sacrum S1 and S2.

Guide 3310 is similar to guide 3210 and generally includes an intermediate body 3312, a cannula 3316 including a bore 3320, a leg 3324, and an auxiliary leg 3342. Legs 3324 and 3342 may include patient-specific contact surfaces that are the same or similar to contact surfaces 3225 and 3225A, respectively. In one embodiment, the distal end of cannula 3316 does not contact the patient's anatomy. Alternatively, one or more cannulae 3316 may include a patient-specific contact surface similar to the contact surface 2818 of guide 2810.

The guide also includes a second cannula 3340. Each second cannula 3340A, 3340B may have a unique trajectory to a target portion of the patient's anatomy. Second cannula 3340 is similar to cannula 3316 and has a predetermined length and orientation relative to guide 3310. Cannula 3340 includes bore 3320A formed in a similar manner to bores 1820, 2820, and 3320. Accordingly, bore 3320A of each second cannula 3340 may be used to guide instruments to other targeted portions of the patient's anatomy.

In one embodiment, the second cannula 3340 is oriented to guide the instrument into the S2-Ailor or S2-Ailor-iliac orbit. In one embodiment, the bore 3320A of second cannula 3340 is oriented to guide a drill bit to form a pilot hole in the S2-Ailor or S2-Ailor-iliac orbit.

The second cannula 3340 is spaced apart from the guide 3310 by a support element 3341 of a predetermined length. In one embodiment, support elements 3341 are interconnected to cannula 3316. However, support elements 3341 may be interconnected to other parts of guide 3310, such as intermediate body 3312 and/or legs 3324. Optionally, second cannula 3340 may be releasably interconnected to guide 3310. Accordingly, the second cannula 3340 can be added to or removed from the guide 3310 during a surgical procedure. Additionally, second cannulae 3340A, 3340B may be used to perform a first surgery on the patient's anatomy and then replaced by a subsequent second cannula 3340 used to perform additional surgeries. there is. In another embodiment, the second cannula 3340 may be formed integrally with the guide 3310.

Referring now to Figures 38-45, patient-matched intracorporeal guide 3410 is described. Guide 3410 is suitable for placement of one or more in vivo devices, such as an implant cage for introducing one or more bioactive materials or bone graft material or an artificial disc. Optionally, guide 3410 may be used to align one or more tools used in surgery. Guide 3410 is inserted between two adjacent vertebrae and is configured to pull on two or more anatomical features. For example, anterior, posterior, posterior lateral or direct lateral access to the disc space may be achieved with guide 3410 to facilitate placement of the implant in an oblique, direct lateral or posterior approach.

In one embodiment, the intracorporeal guide 3410 is designed based on obtaining a scan of the patient's anatomy with a medical imaging device. The scan is broken down into 3D models of each vertebra. These 3D models are transformed in CAD to simulate the surgeon's desired correction. Once the desired correction is appropriately simulated, a guide 3410 is created that allows the surgeon to make the planned correction intraoperatively. The guides can then be manufactured through 3D printing, rapid prototyping, or alternative methods described here.

Guide 3410 may have other shapes, orientations, thicknesses, etc. without departing from the novel aspects of the present specification. Similarly, guide 3410 can be of any size and can include extensions or handles to assist in gripping or manipulating guide 3410 as desired.

Referring now to Figure 38, patient-matched guide 3410 is shown in an exploded view to illustrate how a plurality of components may be fabricated using the systems and methods described above for a particular surgical procedure. Components of the guide 3410 generally include a patient-specific insert 3412, a guide sleeve 3414, and a connector 3416, which in the final assembled state form the patient-matched guide 3410 shown in FIG. 50. Includes.

Referring now to Figures 38-39, insert 3412 generally has a proximal surface 3418, a distal surface 3420, two protrusions 3422, 3424 extending from the distal surface, a hole 3426, and a bore ( 3428). Protrusions 3422 and 3424 are configured to fit directly into sides of the patient's anatomy. More specifically, projections 3422 and 3424 are configured to be positioned between the upper and lower vertebrae within the intervertebral disc space. The shape of the projections 3422, 3424 is predetermined to match at least a portion of the curvature of an adjacent vertebra and to facilitate insertion of an implant of a predetermined size and shape into the intervertebral space.

The protrusions include various patient contact surfaces that allow insert 3412 to mate with one or more portions of the spinal body. For example, the top surfaces 3430, 3432, bottom surfaces 3434, 3436, and interior surfaces 3438, 3440 of each of the protrusions 3422, 3424 may include patient-specific contact surfaces. Distal surface 3420 of insert 3412 may also include a patient-specific contact surface.

The patient-specific surface aligns insert 3412 to a predetermined location relative to the patient's anatomy; hooks around a portion of the patient's anatomy; prevent unintentional or inadvertent movement of insert 3412 during surgical procedures; and is configured to enable one or more of the following to replace soft tissue. In one embodiment, the patient-specific surface includes relatively thin extensions to displace soft tissue.

In one embodiment, insert 3412, or a portion thereof, may be made at least partially from a flexible or deformable material. In another embodiment, insert 3412 is made from a material with shape memory, such as Nitinol.

Additionally or alternatively, protrusions 3422 and 3424 may be asymmetric. Accordingly, in one embodiment, one protrusion has a different shape and/or size than the other protrusion. Additionally, the angle and orientation of each protrusion relative to the distal surface 3420 of insert 3412 can be altered to match or avoid portions of the patient's anatomy. In one embodiment, the shape of protrusions 3422, 3424 does not provide correction for variations in the patient's anatomy. In another embodiment, the shape of the protrusion provides at least partial correction of the patient's deformity.

Some of the protrusions may have a tapered shape that can be used to pull the spine. For example, the distal portions 3442, 3444 of each protrusion 3422, 3424 may include a full radius or bullet shaped nose to facilitate insertion. Additionally or alternatively, the distal portion may have a wedge shape.

The upper surfaces 3430, 3432 of the protrusions 3422, 3424 may be non-parallel with the lower surfaces 3434, 3436. Additionally, the top and bottom surfaces may have different shapes. For example, referring now to FIG. 39 , the protrusion may be tapered as it extends distally away from the distal surface 3420 of the insert 3412. Optionally, the distal portion of protrusion 3422 may have a first thickness 3446 that is substantially equal to or slightly greater than the thickness of the implant. The proximal portion of protrusion 3422 may have a second thickness 3448 that is greater than first thickness 3446 and greater than the thickness of the implant. In this way, the surgeon can “over distract” adjacent vertebrae. Over-pulling facilitates easy and safe access to the intervertebral space, placement of the implant, and produces lordosis or other planned correction of the patient's anatomy.

Protrusions 3422, 3424 may also be configured to prevent the user from advancing insert 3412 beyond a predetermined distance into the intervertebral space. For example, a protrusion or notch may be formed in at least one portion of protrusions 3422 and 3424 to provide a rigid stop. Alternatively, a protrusion or notch may be formed on a protrusion or some other portion of the insert 3412, such as the distal surface 3420, to prevent incorrect orientation of the guide 3410. The stops, protrusions or notches may be customized to the patient's anatomy and may protect neural elements or other features of the patient's anatomy.

Guide 3410 and insert 3412 may further include a guide for a particular patient, one or more indicia to identify the level of the patient's spine, or other indicia to indicate the direction, orientation, use or purpose of the guide. . Additionally or alternatively, the protrusions 3422, 3424 and other portions of the body guide 3410 may provide means for indicating the relative position of the protrusions 3422, 3424 within the intervertebral space when the insert 3412 is advanced or retracted. It can be included. The display method may be the same or different for each protrusion.

Manual or mechanical impact forces may be applied to insert 3412 to advance protrusions 3422, 3424 between adjacent vertebrae. Accordingly, in one embodiment of the invention, insert 3412 is made of a material that is sufficiently rigid and durable to receive impact forces from a hammer or other impact device.

Although shown as generally oval, those skilled in the art will understand that hole 3426 may have any desired shape, including asymmetric shapes. For example, hole 3426 can be formed to accommodate a curved or asymmetrically shaped implant. Optionally, slots or protrusions may be formed on the side walls 3450 of the hole to ensure that the implant is inserted in a predetermined orientation. Additionally, the size or shape of the holes 3426 can be designed to achieve greater visibility to the surgeon/user or to facilitate placement of one or more instruments or other devices into the intervertebral space.

Notch 3452 may be formed in hole 3426 that aligns with key 3454 of guide sleeve 3414. The interaction of notch 3452 and key 3454 may ensure that guide sleeve 3414 is properly aligned with hole 3426. The guide sleeve may include holes 3456 that guide instruments and/or implants inserted into the intervertebral space to a planned depth and orientation. It will be appreciated that guide sleeve hole 3456 may have a different size and shape than insert hole 3426. Additionally or alternatively, hole 3456 may include a slot or protrusion to ensure that the implant or device is inserted in a predetermined orientation.

Guide sleeve 3414 can have any size and shape selected to be at least partially received within insert hole 3426. Additionally, guide sleeve 3414 may protrude at least partially from adjacent surface 3418 of insert 3412. Optionally, the proximal portion of guide sleeve 3414 may protrude at least partially beyond the incision and the patient's skin during a surgical procedure. Guide sleeve 3414 may be formed of any material. Optionally, the material of the guide sleeve may be the same or different than the material of insert 3412. In one embodiment, the guide sleeve is formed of a material having sufficient strength such that failure and/or delamination of the sleeve material is avoided. Accordingly, the guide sleeve can withstand the effects of high-speed cutting tools without damage without allowing material from the guide sleeve to be deposited in the intervertebral space.

Any number of different guide sleeves 3414...3414N may be releasably received within insert hole 3426 for use with in vivo guide 3410. Each guide sleeve 3414 may be configured to guide a different insert or instrument during a surgical procedure. For example, a first guide sleeve can be introduced into the insert hole 3426 to guide the first tool or insert. The first guide sleeve can then be replaced by a second guide sleeve introduced into the insert hole. The second guide sleeve can guide a second tool or insert. The second tool or insert may be different in size, shape, or purpose from the first tool or insert.

Referring now to FIG. 40 , an embodiment of guide sleeve 3414A with guide slots 3458 is shown in use position in insert hole 26 . Guide slots 3458 have a size and orientation selected to direct the path of the implant, blade, cutting tool, or other instrument. In one embodiment, guide slot 3458 has the same or similar features as, and includes, any of the slots 20, 120, 320, 420, 520, 720, and 820 described herein. . Some implants, such as motion preservation and disc replacement implants, include pins or other surfaces that extend into the endplate of an adjacent level of the patient's spine. To properly place these implants, the surgeon must remove a portion of bone from each adjacent level of the spine. Accordingly, slots 3458 may have any shape determined to guide cutting for planned removal of each portion of an adjacent vertebra in a particular patient. For example, the slot may have a shape that guides the instrument to provide a straight, concave, convex or other shaped cut.

Slots 3458 may be sized or shaped to accommodate specific cutting tools, prevent inappropriate use of specific cutting tools, and prevent use of inappropriate tools. Additionally, the slots may be formed to guide cutting around the patient's nerve elements or to prevent cutting into the nerve elements. Accordingly, slots 3458 can be used to guide instruments along a path planned prior to surgery while controlling instrument orientation and depth. Additionally, the width of the slot can be varied to control the size of the cutting tool that fits through the slot or into another portion of the slot. By using slots 3458 of guide sleeve 3414A inserted into insert hole 3426, the surgeon can confirm positioning and alignment of the cutting trajectory and path before initiating surgery.

A stop may be formed in slot 3458 to limit or control the depth of insertion of the cutting tool. The stop may be customized to the patient's anatomy and may protect the patient's neural elements or prevent unintended removal of a portion of the spine. Slots 3458 may also be keyed to ensure depth control during cutting. For example, the slot may include a key that changes the depth of the cut by the tool as it is guided through the slot. The key may correspond to a feature on the tool, such as a protrusion that limits the depth of insertion of the tool.

Slots 3458 of guide sleeve 3414A may be configured to accommodate different types and sizes of instruments or implants. Additionally or alternatively, guide sleeve 3414A may be operable to receive only one specific tool or implant.

Additionally or alternatively, now referring to FIG. 41 , another embodiment guide sleeve 3414B may include a guide surface 3460 formed on the sidewall of hole 3456B. Guide surface 3460 has a predetermined angle for guiding the instrument or implant during a surgical procedure. For example, surface 3460 can guide instruments for disk space preparation. Additionally, surface 3460 may be formed to guide implants, such as, but not limited to, motion-saving implants, intracorporeal fusion devices, plates, for oblique insertion angles. Guide sleeve 3414B may also include a guide surface with a track defined according to a planned oblique approach angle to facilitate insertion and alignment of the implant. It will be appreciated that guide surface 3460 may be formed on any portion of hole 3456B of guide sleeve 3414B.

The different guide sleeves 3414, 3414A, 3414B... 3414N may be equipped with features that ensure that the operations are performed in a pre-planned sequence. In one embodiment, the guide sleeves 3414, 3414A... 3414N are formed to be interconnected together in a planned sequence. Accordingly, the first surgery may be performed with sleeve 3414 and insert 3412. Sleeve 3414A is then interconnected to sleeve 3414 and insert 3412 for use during a second surgery. Sleeve 3414B may then be interconnected to sleeves 3414A, 3414 and insert 3412 for use during a third surgery. In this way, sleeves 3414 can be used sequentially without removing the previous sleeve from insert 3412. This may be beneficial, for example, when sleeve 3414 holds a mechanism such as a pin. The instrument will not need to be adjusted when subsequent sleeves 3414A are added to insert 3412.

Bore 3428 of insert 3412 may also be patient-specific. Accordingly, the size, location, and trajectory of bore 3428 can be determined based on the patient's anatomy. Additionally, the trajectory of each bore can be selected to target or avoid specific parts of the patient's anatomy. Accordingly, each of the bores may have a different shape, width, depth, and orientation configured to guide a particular instrument or fixture in a particular orientation. Although three bores are shown, it will be understood that any number of bores may be formed in the insert, including no bores. The bore may receive a connector or fixture 3416, such as a pedicle screw, to temporarily secure the guide 3410 to the patient's spine. Placing fixtures through bore 3428 may increase the stability of guide 3410 during use.

Optionally, bore 3428 may be configured to receive a tool, such as a tool for forming a bore in a patient's anatomy. Accordingly, each bore 28 has a length, shape, projection and/or selected to prevent the use of an inappropriate tool or device, prevent inappropriate use of a predetermined tool or device, and ensure proper use of a predetermined tool or device. Or it may have a diameter.

Additionally, bore 3428 may be used to deliver implant material into the intervertebral space. For example, in one embodiment, the bore is operable to deliver bone graft material and other substances from a surgical tool, such as a syringe, to a predetermined portion of the intervertebral space.

Referring now to FIGS. 42-43 , patient-matched guide 3410 is shown at one potential site of use in relation to a unique anatomical grouping to assist a surgeon in positioning one or more intracorporeal devices. More specifically, Figure 42 shows a guide 3410 between superior (VS) and inferior (VI) adjacent vertebrae. The lower spine is not shown in Figure 43 for clarity. FIGS. 44A and 44B show the guide 3410 of FIG. 42 with a different guide sleeve 3414A including a guide slot 3458 inserted into the hole of the insert 3412.

Guide 3410 of the present disclosure can be adapted for use between any two adjacent vertebrae. For example, now referring to Figure 45, another embodiment of guide 3410A is shown between two different vertebrae (VS, VI). The guide includes a first protrusion 3422A and a second protrusion (not shown) similar to protrusion 3424 comprising a patient-specific contact surface configured to contact two vertebrae (VS, VI) shown in FIG. 45. Includes insert 3412A. However, the first and second protrusions of insert 3412A have different sizes or shapes compared to the protrusions of insert 3412. Additionally or alternatively, insert hole 3426A of guide 3410A may have a different size or shape than the size and shape of hole 3426 of guide 3410. In this way, guide sleeves 3414A...3414N suitable for use in surgery by guide 3410 cannot fit with guide 3410A and thus be misused. Optionally, insert hole 3426A can have the same size and shape as hole 3426.

It is expressly understood that other configurations for the intracorporeal guide 3410 and its components are equally practical and contemplated within the scope of the present disclosure. Additionally or alternatively, at least a portion of the proximal end of the guide may be configured to extend outside of the patient during a surgical procedure.

The foregoing description of the disclosure has been provided for purposes of illustration and description. The foregoing description is not intended to limit the disclosure to the form or forms disclosed herein.

Claims (15)

As a patient-tailored cutting guide,
a body having a proximal portion and a distal portion; and
a first slot portion having a first width, the first slot portion extending from the proximal portion to the distal portion of the body of the guide;
a second slot portion having a second width, the second slot portion extending from the proximal portion of the body of the guide to the distal portion and the second width being different from the first width;
Including,
The distal portion of the body includes a first patient-customized contour on at least one side of the first slot portion and a second patient-customized contour on an opposite side of the first slot portion to match the patient's bony anatomy. do,
the distal portion of the body further comprises a third patient-specific contour on at least one side of the second slot portion to match the patient's bony anatomy;
Wherein the at least first, second and third patient-specific contours are determined from anatomical data of the patient and are formed to substantially conform to a specific portion of the patient's bony anatomy. According to paragraph 1,
The first and second slot portions have predetermined trajectories determined from the patient's anatomical features and configured to cause the instrument to pass through the body of the guide and make a plurality of incisions along the patient's bony anatomy. A patient-tailored cutting guide. According to paragraph 1,
Wherein the path of the first and second slot portions include depth control, angle, and orientation to facilitate insertion and movement of the instrument along the path. According to paragraph 1,
A patient-specific cutting guide further comprising a first insert configured to be received in a first slot portion of the body of the guide and a second insert configured to be received in a second slot portion of the body of the guide. According to clause 4,
The first insert defines a first path for guiding the instrument or tool and the second insert defines a second path for guiding the instrument or tool, each of the first and second paths comprising: A patient-specific cutting guide comprising unique depth control, angle and orientation to facilitate movement of the instrument or tool along a second path. According to clause 5,
The first and second paths of the first and second inserts each have a predetermined trajectory determined from anatomical characteristics of the patient, wherein the predetermined trajectory of the first path is different from the predetermined trajectory of the second path. A patient-tailored cutting guide. According to clause 6,
wherein the first and second paths are independently configured to allow the instrument or tool to make a plurality of incisions along different depths and trajectories through the body of the guide. According to clause 5,
wherein one of the first and second paths of the first and second inserts is configured to guide the instrument or tool to remove a specific portion of the patient's bony anatomy. According to paragraph 1,
The patient-specific cutting guide, wherein the at least the first, second and third patient-specific contours are configured to contact one or more of the laminar, the articular shaft, a portion of the transverse process, the superior articular process, and the inferior articular process. According to paragraph 1,
wherein the at least first, second and third patient-specific contours are configured to contact a portion of the patient's bony anatomy that has been previously altered by the surgeon. According to paragraph 1,
wherein the first and second slot portions are configured to receive and guide instruments for accomplishing pedicle subtraction, osteotomy, laminectomy, Smith-Peterson osteotomy, and vertebral resection, respectively. Custom cutting guide. According to paragraph 1,
A patient-customized cutting guide further comprising a frame configured to be at least partially disposed on the bony anatomy of the patient, wherein the body of the guide is selectively interconnectable to the frame. According to paragraph 1,
wherein the body is comprised of at least first and second sections selectively interconnected with each other to form the guide. According to paragraph 1,
The guide is used to perform a first set of incisions along the patient's bony anatomy, and a second patient-specific cutting guide is used to perform a second set of incisions along the patient's bony anatomy. A patient-tailored cutting guide that further includes a. According to clause 14,
Wherein the second patient-specific cutting guide includes at least one patient-specific contour determined from the patient's anatomical data and formed to substantially conform to a specific portion of the patient's bone anatomy. guide.

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