WO2014090908A1

WO2014090908A1 - Surgical guiding tools for orthopedic surgery and systems and methods of manufacturing the same

Info

Publication number: WO2014090908A1
Application number: PCT/EP2013/076296
Authority: WO
Inventors: Benjamin Geebelen
Original assignee: Materialise N.V.
Priority date: 2012-12-14
Filing date: 2013-12-11
Publication date: 2014-06-19

Abstract

The present application relates to surgical guiding tools that can be used for guiding a surgical instrument during orthopedic surgery. A surgical guiding tool for removable engagement with a vertebra comprises one or more apertures for guiding a surgical instrument and configured to contact one or more sections of a posterior side of the vertebra; and a clamp assembly coupled to the one or more apertures, the clamp assembly comprising one or more clamps configured to grip the spinous process of the vertebra. The present application further provides methods for manufacturing surgical guiding tools and uses of the tools for placement onto a vertebra.

Description

SURGICAL GUIDING TOOLS FOR ORTHOPEDIC SURGERY AND SYSTEMS AND METHODS OF MANUFACTURING THE SAME

BACKGROUND OF THE INVENTION

Field of the Invention

[0001] This application relates to surgical guiding tools for use in guiding a surgical instrument during orthopedic surgery. This application also relates to methods of manufacturing surgical guiding tools and methods of using the tools for placement onto a vertebra.

Description of the Related Technology

[0002] Surgical guiding tools assist surgeons and have wide applications in orthopedic surgery. Surgical guiding tools can allow a surgeon to accurately transfer a pre-operative surgical plan into the operating room. Further, surgical guiding tools can help guide a surgical instrument, such as a cutting or drilling instrument, along a predefined cutting or drilling path.

[0003] There have been many attempts to design surgical guiding tools that are supported by the posterior sides of vertebrae, such as for guiding the placement of pedicle or lateral mass screws. A common problem of these surgical guiding tools is the lack of stability in the sagittal plane, as most of the available support surface on a vertebra consists out of two narrow strips of roughly fiat surface. This lack of stability can cause an incorrect angulation of a guided drill, and consequently damage to blood vessels or nerves.

[0004] As such, there is a need for surgical guiding tools that provide secure and stable attachment to a patient's vertebrae and that provide the ability to accurately and efficiently guide a surgical instrument into or onto the patient's bone.

SUMMARY

[0005] Various implementations of systems, methods and devices within the scope of the appended claims each have several aspects, no single one of which is solely responsible for the desirable attributes described herein. Without limiting the scope of the appended claims, some prominent features are described herein.

[0006] The present application relates generally to surgical guiding tools that can be patient-specific. Details of one or more implementations of the subject matter described in this specification are set forth in the accompanying drawings and the description below. Other features, aspects, and advantages will become apparent from the description, the drawings, and the claims.

[0007] One aspect of the subject matter described in the disclosure provides a surgical guiding tool for removable engagement with a vertebra. The surgical guiding tool comprises one or more apertures for guiding a surgical instrument and configured to contact one or more sections of a posterior side of the vertebra; and a clamp assembly coupled to the one or more apertures, the clamp assembly comprising one or more clamps configured to grip the spinous process of the vertebra.

[0008] Another aspect of the subject matter described in the disclosure provides a method of manufacturing a surgical guiding tool. The method includes designing the surgical guiding tool to create a surgical guiding tool design, wherein the surgical tool design includes one or more apertures for guiding a surgical instrument and configured to contact one or more sections of a posterior side of the vertebra; and a clamp assembly coupled to the one or more apertures, the clamp assembly comprising one or more clamps configured to grip the spinous process of the vertebra. Furthermore, the method includes manufacturing the surgical guiding tool based on the surgical guiding tool design.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following description of the figures is merely exemplary in nature and is not intended to limit the present teachings, their application or uses. Throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. Note that the relative dimensions of the following figures may not be drawn to scale.

[0010] FIG. 1 illustrates an example of an axial view of a vertebra. [0011] FIG. 2 illustrates an example of a surgical guiding tool configured to attach to a vertebra.

[0012] FIG. 3 illustrates yet another example of a surgical guiding tool configured to attach to a vertebra.

[0013] FIG. 4 illustrates an example of a clamp portion of a clamp assembly.

[0014] FIG. 5 illustrates an aspect of a method of manufacturing a surgical guiding tool.

DETAILED DESCRIPTION

[0015] The following detailed description is directed to certain specific embodiments. However, the teachings herein can be applied in a multitude of different ways. In this description, reference is made to the drawings wherein like parts are designated with like numerals throughout.

[0016] The present application will be described with respect to particular embodiments, but the invention is , limited ,only by the claims.

[0017] As used herein, the singular forms "a", "an", and "the" include both singular and plural referents unless the context clearly dictates otherwise.

[0018] The terms "comprising", "comprises" and "comprised of as used herein are synonymous with "including", "includes" or "containing", "contains", and are inclusive or open-ended and do not exclude additional, non-recited members, elements or method steps. The terms "comprising", "comprises" and "comprised of when referring to recited components, elements or method steps also include embodiments which "consist of said recited components, elements or method steps.

[0019] Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order, unless specified. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

[0020] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics can be combined in any suitable manner, as would be apparent to a person skilled in the art from this disclosure, in one or more embodiments. Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the application, and form different embodiments, as would be understood by those of skill in the art. For example, in the appended claims, any of the features of the claimed embodiments can be used in any combination.

[0021] The present application discloses surgical guiding tools that can be patient-specific. The surgical guiding tools provide accurate and stable attachment to a vertebra, which allows stable and accurate introduction of a surgical instrument into the vertebra. This application further describes medical-image-based surgical guiding tools that can be patient- specific. These patient- specific tools can provide the ability to accurately insert a surgical instrument into the patient's bone according to a predefined plan.

[0022] The term "patient-specific" as used herein refers to surgical devices, tools, and/or guides that are designed starting from an individual patient's anatomy to provide a custom fit and/or function for the particular individual patient. The use of patient-specific devices, tools, or guides allows for improved or optimized surgical interventions, orthopedic structures, and/or kinematics for the patient. Similar benefits are obtained when such patient-specific devices are used in combination with standard implants, tools, devices, surgical procedures, and/or other methods.

[0023] In some embodiments, pre-operative procedures can be performed to identify various regions of a bone of a specific patient, such as those described below with respect to a vertebra, and to determine, based on the identified regions of the bone, an optimal design for various surgical guiding tool components (e.g., a clamp, body, aperture, etc. of a surgical guiding tool). Pre-operative procedures can also be performed to determine optimal locations for attaching a surgical guiding tool based on the identified regions of the bone. Pre-operative procedures often involve obtaining an image of a patient's bone prior to performing surgery. Digital patient- specific image information can be provided by any suitable means known in the art, such as, for example, a computer tomography (CT) scanner, a magnetic resonance imaging (MRI) scanner, or an ultrasound ultrasound scanner.

[0024] Pre-operative planning can include the construction of a two- dimensional (2D) image or a three-dimensional (3D) virtual model of a bone, or a part thereof. A 3D virtual model can be created from 2D images, such as X-rays. In some embodiments, construction of the 2D image or 3D virtual model can begin with scanning of a patient. For example, the scanning can include using a scanning technique that generates medical volumetric data, such as a CT scan, a MRI scan, or the like. In some embodiments, the output of the scan can include a stack of 2D slices forming a 3D data set. The output of the scan can be digitally imported into a computer program and can be converted using algorithms known in the field of image processing technology to produce a 3D computer model of the vertebra. For example, the virtual 3D model can be constructed from the data set using a computer program such as Mimics® as supplied by Materialise N.V., Leuven, Belgium. Once the 3D volume of the bone, or a part thereof, is reconstructed, the preferred position, orientation, depth and diameter of the bores and drill paths that are needed for the surgery can be defined. Based on the determined surgical needs, a surgical guiding tool can be designed, manufactured, and/or manipulated to meet the needs of the specific patient.

[0025] FIG. 1 illustrates one example of an axial view of a vertebra 100. One or more sections of a posterior side of the vertebrae 101 can be used as a contact surface or point to secure a surgical guiding tool to the vertebrae 100. A section of the posterior side of the vertebra 101 includes any sections suited for providing stable support to a surgical guiding tool on the posterior side of the vertebra. Examples of a section of a posterior side of the vertebra 101 include, but are not limited to, the lamina 103 and 104, the transverse process 105 and 106, and the articular process 107 and 108. The spinous process 102 can be used to attach and secure a surgical guiding tool to the vertebra. While the description herein may describe a vertebra 100 as an example of the bone, one of skill in the art will understand that the content of the present application applies equally to other bones with a pronounced feature and ligaments surrounding the bone, such as the femoral or humerus bones. Details regarding various embodiments of surgical guiding tools will be discussed below.

[0026] In some embodiments, as indicated above, the patient-specific regions of a vertebra can comprise specific anatomical features that can be used to attach a surgical guiding tool. Detailed geometrical, patient-specific information is used in the design and manufacture of a surgical guiding tool in order to determine those sections of the vertebra that are suitable for this purpose. For example, as described above, the posterior side of the vertebra can provide one or more sections from which a surgical guiding tool can contact. Examples of a contact between the posterior side of the vertebra and the surgical guiding tool include, but are not limited to, a surface contact, a line contact, and a point contact. In addition, the spinous process can provide one or more portions that can be used to attach and secure a surgical guiding tool thereto.

[0027] A method of manufacturing a surgical guiding tool can include designing the surgical guiding tool to create a surgical guiding tool design, which can include identifying and selecting at least one part of a vertebra that contains specific features that can allow attachment of the surgical guiding tool. For example, a surgical guiding tool for a vertebra may be designed and manufactured, and may comprise one or more apertures for guiding a surgical instrument and configured to contact one or more sections of a posterior side of the vertebra; and a clamp assembly coupled to the one or more apertures. The clamp assembly further comprises one or more clamps configured to grip the spinous process of the vertebra. The clamp assembly can include any structure that can be used to increase the stability of the surgical guiding tool in the sagittal plane to allow the ease of engagement or removal of the surgical guiding tool. In some embodiments, the one or more clamps can include one or more ends configured to penetrate a soft tissue of at least one ligament. In other embodiments, the clamp assembly can include an opening structure configured to open the one or more clamps and allow the spinous process and one or more ligaments to pass through the one or more clamps. In some embodiments, a clamp assembly can include a closing structure configured to close the one or more clamps and allow the one or more clamps to grip the spinous process of the vertebra. In other embodiments, the closing structure is configured to be closed by exerting a force towards the one or more sections of the posterior side of the vertebra. In some embodiments, the one or more apertures are patient- specific. In some embodiments, the one or more sections of the posterior side can be selected from a lamina, a transverse process, and an articular process.

[0028] Manufacturing and/or designing of a surgical guiding tool can further include determining the appropriate position of a guiding component of the surgical guiding tool (e.g., an aperture) with regard to the vertebra. In particular embodiments, this can be done based on the pre-operative planning of the desired path of the surgical tool in the vertebra. The orientation of the guiding component can be such that the surgical instrument is guided in the predetermined direction. Pre-operative planning by a physician makes it possible to determine the required path of the surgical instrument, and accordingly, the required orientation of the guiding component. The pre-operative planning can be done using suitable dedicated software, based on suitable medical images (of which CT, MRI, are examples), taking into account factors like bone quality and proximity to nerve bundles/blood vessels, or other anatomically sensitive objects. In some embodiments, preoperative images are imported into a computer workstation running 3D software in order to plan and simulate the surgery. The imported images can be manipulated as 3D volumes, and a computer simulation can be created, which outputs a planning containing the information necessary for adapting the orientation of the guiding component.

[0029] Manufacturing of a surgical guiding tool can further comprise manufacturing the surgical guiding tool based on the surgical guiding tool design. FIG. 5 provides an example of a method of manufacturing a surgical guiding tool, and is described in further detail below.

[0030] FIG. 2 illustrates an example of a surgical guiding tool 200 configured to attach to a vertebra 201. The surgical guiding tool 200 includes apertures 204, 205, and 206 that are configured to contact one or more sections of a posterior side of the vertebra 201. The surgical guiding tool 200 also includes a clamp assembly 202 that is coupled to the apertures 204, 205, and 206. The clamp assembly 202 includes one or more clamps configured to grip the spinous process of the vertebrae 201. For example, the clamp assembly 202 can include one clamp 203 as illustrated in FIG. 2. The secure attachment of clamp 203 to the spinous process provides stability in the sagittal plane and ensures that the surgical guiding tool 200 remains in a stable and secure position during surgery.

[0031] In some embodiments, the clamp assembly 202 also includes an opening structure 207 that is configured to open the clamp 203 and allow the ligaments to pass through the clamp 203. In some embodiments, the clamp assembly 202 includes a closing structure 208 that is configured to close the clamp 203 and allow the clamp 203 to grip the spinous process of the vertebrae 201. In yet other embodiments, the closing structure 208 can be operated by exerting a force towards the one or more sections of the posterior side of the vertebra 201.

[0032] The surgical guiding tool 200 can be positioned on the vertebra 201 by opening the clamp 203 and sliding the apertures 204, 205, and 206 towards the one or more sections of the posterior side of the vertebra 201. The surgical guiding tool 200 can then be attached to the vertebra 201 by exerting a force on the closing structure 208 towards sections of the posterior side of the vertebra 201 to close the clamp 203, while pushing the apertures into contact with the posterior side of the vertebra 201. In FIG. 2, the clamp 203 is illustrated in an engaged position. In this position, the clamp 203 grips the spinous process and the apertures 204, 205, and 206 are positioned in close contact with the posterior side of the vertebra 201, which produces a secure and stable locking fit. While the figure herein illustrates one clamp, one of skill in the art will understand that more than one clamps may also be included in the surgical guiding tool 200 for attaching to other portions to the vertebra 201.

[0033] The use of the clamp assembly 202 along with the apertures 204, 205, and 206 ensures that the surgical guiding tool 200 remains secured to the vertebra 201 even with limited attachment regions on the vertebra 201 for attaching the guiding tool 200. By securing the surgical guiding tool 200 in a stable manner using the apertures 204, 205, and 206 and the clamp assembly 202, the surgical guiding tool 200 can be securely and accurately placed on the vertebra 201 so that surgery can be performed more accurately and safely with reduced or even no movement of the guide 200. For example, by contacting one or more of the apertures 204, 205, and 206 to sections of the posterior side of the vertebra 201 (e.g. to the two transverse processes), and further attaching the clamp assembly 202 to the spinous process, the surgical guiding tool 200 will be stable in the sagittal plane and be restricted from various translational and rotational movements (e.g., posterior and anterior sliding, distal and proximal sliding, mediolateral sliding, internal-external rotation, varus-valgus movements, and/or flexion- extension).

[0034] In some embodiments, apertures are patient-specific. For example, in FIG 2, the apertures 204, 205, and 206 can be aligned with areas of the vertebra 201 corresponding to locations that need to be accessed for surgery, such as locations where holes are to be drilled. For example, holes can be created using a surgical tool device inserted into the apertures 204, 205 and 206 such as a drill, bur, saw, jig saw, lateral drill or any other cutting, milling or drilling instrument. The apertures 204, 205, and 206 are positioned so that a surgical tool device that is passed through one or more of the apertures 204, 205, and 206 can reach the vertebra 201 at the desired location. The apertures 204, 205, and 206 can be positioned in any direction relative to the vertebra 201 as long as it provides access for a surgical tool device to reach the vertebra 201 at the desired location. While the description herein describes apertures 204, 205, and 206 located at specific locations, one of skill in the art will understand that the content of the present application applies equally to aperture locations relating to patient-specific locations on different type of bones, which can be determined using pre-operative procedures described above. Further, the orientation and position of the apertures can correspond to pre-operative planning and procedures.

[0035] In some embodiments, the surgical guiding tool 200 can be a single, continuous structure (e.g., a single mold) that includes all of the guiding tool components, including the clamp assembly 202, the clamp 203, and the apertures 204, 205, and 206. In some embodiments, each component of the surgical guiding tool 200 can be a separate structure that is integrated with the other components to create the surgical guiding tool 200.

[0036] FIG. 3 an example of a surgical guiding tool 300 configured to attach to a vertebra 301. The surgical guiding tool 300 includes apertures 304, 305 and 306 that are configured to contact one or more sections of a posterior side of the vertebra 301. The surgical guiding tool 300 also includes a clamp assembly 302 that is coupled to the apertures 304, 305, and 306. The clamp assembly 302 also includes clamp 303 that is configured to grip the spinous process of the vertebra 301. The secure attachment of clamp 303 to the spinous process of vertebra 301 provides stability in the sagittal plane and ensures that the surgical guiding tool 300 remains in a stable and secure position during surgery. In some embodiments, the clamp assembly 302 also includes an opening structure 307 that is configured to open the clamp 303 and allow the ligaments to pass through the clamp 303. In other embodiments, the clamp assembly 302 can include a closing structure 308 that is configured to close the clamp 303 and allow the clamp 303 to grip the spinous process of the vertebra 301. The closing structure 308 can be operated by exerting a force towards sections of the posterior side of the vertebra 301.

[0037] The surgical guiding tool 300 can be positioned on vertebra 301 by opening the clamp 303 and sliding the apertures 304, 305, and 306 towards sections of the posterior side of the vertebra 301. The surgical guiding tool 300 can then be attached to the vertebra 301 by exerting a force on the closing structure 308 towards the posterior side of the vertebra 301 to close the clamp 303, while also pushing the apertures 304, 305, and 306 into contact with sections of the posterior side of the vertebra 301. In FIG. 3, the clamp 303 is illustrated in an engaged position. In this position, the clamp 303 grips the spinous process of the vertebra 301 and the apertures 304, 305, and 306 are positioned in close contact with sections of the posterior side of the vertebra 301 , which produces a secure and stable locking fit. While FIG. 3 illustrates one embodiment of clamp 303, one of skill in the art will understand that more than one clamp can also be included in the surgical guiding tool 300 for attaching to other portions to the vertebra 301.

[0038] The use of the clamp assembly 302 along with apertures 304, 305, and 306 ensures that the surgical guiding tool 300 remains secured to the vertebra 301 even with limited attachment regions on the vertebra 301 for attaching the guiding tool 300. By securing the surgical guiding tool 300 in a stable manner using the apertures 304, 305, and 306 and the clamp assembly 302, the surgical guiding tool 300 can be securely and accurately placed on the vertebra 301 so that surgery can be performed more accurately and safely due to little or no movement of the surgical guiding tool 300. For example, by contacting the apertures 304, 305, and 306 to sections of the posterior side of the vertebra 301 (e.g. to the two transverse processes), and further attaching the clamp assembly 302 to the spinous process of the vertebra 301, the surgical guiding tool 300 will be stable in the sagittal plane and be restricted from various translational and rotational movements (e.g., posterior and anterior sliding, distal and proximal sliding, mediolateral sliding, internal-external rotation, varus-valgus movements, and/or flexion- extension).

[0039] In some embodiments, the apertures 304, 305, and 306 can be aligned with areas of the vertebra 301 corresponding to locations that need to be accessed for surgery, such as locations where holes are to be drilled. For example, holes can be created using a surgical tool device inserted into the apertures 304, 305, and 306 such as a drill, bur, saw, jig saw, lateral drill or any other cutting, milling or drilling instrument. The apertures 304, 305, and 306 are positioned so that a surgical tool device that is passed through one or more of the apertures 304, 305, and 306 can reach the vertebra 301 at the desired location. The apertures 304, 305, and 306 can be positioned in any direction relative to the vertebra 301 as long as it provides access for a surgical tool device to reach the vertebra 301 at the desired location. While the description herein describes apertures 304, 305, and 306 located at specific locations, one of skill in the art will understand that the content of the present application applies equally to aperture locations relating to patient-specific locations on different type of bones, which can be determined using pre-operative procedures described above. Further, the orientation and position of the apertures can correspond to pre-operative planning and procedures.

[0040] In some embodiments, the surgical guiding tool 300 can be a single, continuous structure (e.g., a single mold) that includes all of the guiding tool components, including the clamp assembly 302, the clamp 303, and the apertures 304, 305, and 306. In some embodiments, each component of the surgical guiding tool 300 can be a separate structure that is integrated with the other components to create the surgical guiding tool 300.

[0041] FIG. 4 illustrates an example of a clamp portion 400 of a clamp assembly. The clamp portion 400 includes two clamp ends 402 and 403. In some embodiments, the clamp ends 402 and 403 can be configured to penetrate a soft tissue of at least one ligament. For example, the clamp ends 402 and 403 can include sharp or pointy structure to pierce through the ligaments attached to the spinous process, allowing the clamp portion 400 to grip the spinous process without removing the ligaments. The clamp portion also includes an opening 401 to grip the spinous process. The attachment of the clamp portion 400 to the spinous process provides stability in the sagittal plane and ensures a stable and secure attachment of the surgical guiding tool to a vertebra. The clamp portion 400 can be coupled with an opening structure and a closing structure to provide removable engagement with a spinous process, allowing a physician to engage or remove the surgical guiding tool with ease.

[0042] FIG. 5 illustrates a method of manufacturing a surgical guiding tool. At block 502, the method includes designing the surgical guiding tool to create a surgical tool design, wherein the surgical guiding tool design includes: one or more apertures for guiding a surgical instrument and configured to contact one or more sections of a posterior side of the vertebra; and a clamp assembly coupled to the one or more apertures, the clamp assembly comprising one or more clamps configured to grip the spinous process of the vertebra. At block 504, the method includes manufacturing the surgical guiding tool based on the surgical guiding tool design. The surgical guiding tool can be designed and/or manufactured according to the pre-operative planning procedures using patient-specific features of a patient's bone discussed above.

[0043] In some embodiments, the surgical guiding tools described above are partially or completely made by additive manufacturing, which allows the integration of patient-specific components (e.g., the body, the one or more clamps, the apertures, etc.) that further increases the accuracy of the guiding tools. The patient-specific components of the surgical guiding tools can be designed based on patient-specific parts of a particular bone of a patient. The patient specific components of the surgical guiding tools can be made by generating portions that are complementary to the patient-specific parts of the bone. For converting digital image information of the bone into a basic model, template, or mold that at least in part shows the positive or negative form of at least a portion of the bone, any suitable technique known in the art can be used, such as for example a rapid prototyping technique.

[0044] Rapid Prototyping and Manufacturing (RP&M) can be defined as a group of techniques used to quickly fabricate a scale model of an object typically using three-dimensional (3D) computer aided design (CAD) data of the object. Currently, a multitude of Rapid Prototyping techniques are available, including stereo lithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), foil-based techniques, etc.

[0045] A common feature of these techniques is that objects are typically built layer by layer. Stereo lithography, for example, utilizes a vat of liquid photopolymer "resin" to build an object a layer at a time. On each layer, an electromagnetic ray, e.g. one or several laser beams which are computer-controlled, traces a specific pattern on the surface of the liquid resin that is defined by the two-dimensional cross-sections of the object to be formed. Exposure to the electromagnetic ray cures, or, solidifies the pattern traced on the resin and adheres it to the layer below. After a coat had been polymerized, the platform descends by a single layer thickness and a subsequent layer pattern is traced, adhering to the previous layer. A complete 3-D object is formed by this process.

[0046] Selective laser sintering (SLS) uses a high power laser or another focused heat source to sinter or weld small particles of plastic, metal, or ceramic powders into a mass representing the three-dimensional object to be formed.

[0047] Fused deposition modeling (FDM) and related techniques make use of a temporary transition from a solid material to a liquid state, usually due to heating. The material is driven through an extrusion nozzle in a controlled way and deposited in the required place as described, for example, in U.S. Pat. No. 5,141,680, the entire disclosure of which is hereby incorporated by reference.

[0048] Foil-based techniques fix coats to one another by means of gluing or photo polymerization or other techniques and cut the object from these coats or polymerize the object. Such a technique is described in, for example, U.S. Pat. No. 5,192,539, also incorporated by reference in its entirety.

[0049] Typically RP&M techniques start from a digital representation of the 3D object to be formed. Generally, the digital is sliced into a series of cross-sectional layers which can be overlaid to form the object as a whole. The RP&M apparatus uses this data for building the object on a layer-by-layer basic. The cross-sectional data representing the layer data of the 3D object can be generated using a computer system and computer aided design and manufacturing (CAD/CAM) software. [0050] A selective laser sintering (SLS) apparatus can be used for the manufacture of a surgical guiding tool template instead of a computer model. It should be understood however, that various types of rapid manufacturing and tooling can be used for accurately fabricating these surgical templates including, but not limited to, stereolithography (SLA), Fused Deposition Modeling (FDM) or milling.

[0051] The surgical guiding tools described above (or parts thereof) can be manufactured using different materials. In some embodiments, only materials that are biocompatible (e.g. USP class VI compatible) with the human body are used. In some embodiments, a surgical guiding tool template can be formed from a heat-tolerable material allowing it to tolerate high-temperature sterilization. In some embodiments, if selective laser sintering is used as a RP&M technique, the surgical guiding tool template can be fabricated from a polyamide such as PA 2200 as supplied by EOS, Munich, Germany, or any other material known by those skilled in the art can also be used.

[0052] The invention disclosed herein can be implemented as a method, apparatus, or article of manufacture using standard programming or engineering techniques to produce software, firmware, hardware, or any combination thereof. The term "article of manufacture" as used herein refers to code or logic implemented in hardware or non-transitory computer readable media such as optical storage devices, and volatile or non-volatile memory devices or transitory computer readable media such as signals, carrier waves, etc. Such hardware can include, but is not limited to, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic arrays (PLAs), microprocessors, or other similar processing devices.

[0053] It will be appreciated by persons skilled in the art that numerous variations and/or modifications can be made to the embodiments described herein without departing from the spirit or the scope of the invention as broadly described. The above described embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A surgical guiding tool for removable engagement with a vertebra comprising:

an aperture for guiding a surgical instrument configured to contact a section of a posterior side of the vertebra; and

a clamp assembly coupled to the aperture, the clamp assembly comprising a clamp configured to grip a spinous process of the vertebra.

2. The surgical guiding tool of Claim 1, wherein the clamp comprises a clamp end configured to penetrate a soft tissue of at least one ligament.

3. The surgical guiding tool of Claim 1, wherein the clamp assembly further comprises an opening structure configured to open the clamp and allow the spinous process and one or more ligaments to pass through an open end of the clamp.

4. The surgical guiding tool of Claim 3, wherein the clamp assembly further comprises a closing structure configured to close the clamp and cause the clamp to grip the spinous process of the vertebra.

5. The surgical guiding tool of Claim 4, wherein the closing structure is configured to be operated by exerting a force towards the section of the posterior side of the vertebra.

6. The surgical guiding tool of Claim 1, wherein the aperture is patient- specific.

7. The surgical tool of Claim 1, wherein the section of the posterior side of the vertebra is selected from a lamina, a transverse process, and an articular process.

8. A method of manufacturing a surgical guiding tool, the method comprising, creating a surgical guiding tool design, wherein the surgical tool design comprises:

an aperture for guiding a surgical instrument configured to contact a section of a posterior side of the vertebra, and

a clamp assembly coupled to the aperture, the clamp assembly comprising a clamp configured to grip a spinous process of the vertebra; and

manufacturing the surgical tool based on the surgical guiding tool design.

9. The method of Claim 8, wherein the clamp comprises a clamp end configured to penetrate a soft tissue of at least one ligament.

10. The method of Claim 8, wherein the clamp assembly further comprises an opening structure configured to open the clamp and allow the spinous process and one or more ligaments to pass through an open end of the clamp.

1 1. The method of Claim 10, wherein the clamp assembly further comprises a closing structure configured to close the clamp and cause the clamp to grip the spinous process of the vertebra.

12. The method of Claim 1 1, wherein the closing structure is configured to be operated by exerting a force towards the section of the posterior side of the vertebra.

13. The method of Claim 8, wherein the aperture is patient- specific.

14. The method of Claim 8, wherein the section of the posterior side of the vertebra is selected from a lamina, a transverse process, and an articular process.