EP3361959A1 - Patientenabgestimmte vorrichtung und verfahren zur durchführung von chirurgischen eingriffen - Google Patents

Patientenabgestimmte vorrichtung und verfahren zur durchführung von chirurgischen eingriffen

Info

Publication number
EP3361959A1
EP3361959A1 EP16856238.7A EP16856238A EP3361959A1 EP 3361959 A1 EP3361959 A1 EP 3361959A1 EP 16856238 A EP16856238 A EP 16856238A EP 3361959 A1 EP3361959 A1 EP 3361959A1
Authority
EP
European Patent Office
Prior art keywords
patient
guide
bore
specific
cannulae
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16856238.7A
Other languages
English (en)
French (fr)
Other versions
EP3361959A4 (de
Inventor
George Frey
Paul Ginzburg
Geoff LAI
Caleb VOELKEL
Gregory Cooke KANA
Sean STARKMAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mighty Oak Medical Inc
Original Assignee
Mighty Oak Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/883,299 external-priority patent/US9642633B2/en
Application filed by Mighty Oak Medical Inc filed Critical Mighty Oak Medical Inc
Priority claimed from PCT/US2016/056970 external-priority patent/WO2017066518A1/en
Publication of EP3361959A1 publication Critical patent/EP3361959A1/de
Publication of EP3361959A4 publication Critical patent/EP3361959A4/de
Withdrawn legal-status Critical Current

Links

Classifications

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    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4405—Joints for the spine, e.g. vertebrae, spinal discs for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4687—Mechanical guides for implantation instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00035—Other metals or alloys
    • A61F2310/00047—Aluminium or Al-based alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00035—Other metals or alloys
    • A61F2310/00059—Chromium or Cr-based alloys

Definitions

  • U.S. Patent Application No. 13/841,069 is a continuation in part of U.S. Patent Application No. 13/172,683, filed June 29, 2011, which issued as U.S. Patent No. 8,758,357 on June 24, 2014.
  • U.S. Patent Application No. 13/172,683 claims priority to U.S. Provisional Patent Application No. 61/359,710, filed June 29, 2010.
  • the present disclosure relates to the field of medical devices and is generally directed toward apparatus configurable for use with a specific patient in a surgical setting based on the patient's unique anatomical features, and methods of manufacturing and using the same.
  • MRI magnetic resonance imaging
  • CT computed tomography
  • FEM finite element modeling
  • the use of the data sets permit the surgeon to avoid these types of mistakes by creating customized tools and instruments, which may comprise orientation, end-stops or other safety related features to avoid over-torque and over-insertion of any implantable devices.
  • the data sets also permit the surgeon to create a patient-contacting surface that is oriented to match one or more of the anatomical features represented by the data set, and thereby quickly and efficiently locate and place the patient-contacting surface(s) in the appropriate location and orientation.
  • a novel system and method for developing customized apparatus for use in one or more surgical procedures.
  • the system and method according to this embodiment uses a patient's unique morphology, which may be derived from capturing MRI data or CT or other data to derive one or more "Patient Matched" apparatus, which comprises complementary surfaces based on a plurality of data points from the MRI or CT data.
  • Each "Patient Matched" apparatus is matched and oriented around the patient's own anatomy, the desired insertional trajectories (which may be verified in a pre-operative setting using 3D CAD software, such as the software disclosed in WO 2008027549, which is incorporated by reference herein in its entirety), and according to one embodiment described herein, other apparatus used during the surgical procedure.
  • Surgical procedures may be performed through introduction of rods or plates, screws or other devices into adjacent boney anatomy to join various portions of, for example, a vertebra to a corresponding portion on an adjacent vertebra.
  • Surgical procedures are often performed in the sacroiliac, lumbar, thoracic, interbody, or cervical spine regions of a patient.
  • the procedures performed in these areas are often designed to stop and/or eliminate all motion in the spinal segment by destruction of some or all of the joints in that segment and further utilizing bone graft material and/or rigid implantable fixation devices for securing the adjacent vertebrae. By eliminating movement, back pain and further degenerative disc disease may be reduced or avoided.
  • Fusion requires tools for accessing the vertebrae, such as surgical cannulae for the procedures, and other tools for implanting the desired implant, bioactive material, etc. Such procedures often require introduction of additional tools to prepare a site for implantation.
  • tools may include drills, drill guides, debridement tools, irrigation devices, vises, clamps, cannula, and other insertion/retraction tools.
  • MIS procedures including procedures using the apparatus of the present invention, a less destructive approach to the patient anatomy is carried out by using retractor tubes or portals, which take advantage of anatomy and current technology to limit the damage to intervening structures.
  • skeletal landmarks are established fluoroscopically and a small incision is made over the landmark(s).
  • a series of dilators are applied until one or more cannula is placed over the anatomic structure.
  • a microscope is then placed over the operative site to provide illumination and magnification with a three-dimensional view of the anatomical site to ensure that the surgeon is able to accurately locate the desired patient anatomy and properly position and orient any tool, instrument or other surgical device used during the procedure.
  • the microscope is an expensive and unwieldy device requiring uncomfortable gyrations of the surgeon's back and neck in order to gain the necessary view, and is also a nuisance to drape (a large, sterile plastic bag has to be placed over the eight-foot-tall structure).
  • the use of adequate illumination is also difficult to direct due to the size of the microscope.
  • the customized and integrated matching aspects of this presently disclosed system provides an advantage over the prior art, in particular by providing a plurality of interlocking and/or matching points for each apparatus, which in turn reduces the likelihood of misalignment, misplacement and subsequent mistake during the surgical procedure(s).
  • one aspect of the present disclosure is to provide a method for preparing a customized surgical device or instrument, which in a preferred embodiment comprises, but is not limited to: (1) obtaining data associated with a patient's anatomy; (2) converting the data obtained to a 3-dimensional data set(s); (3) determining at least one trajectory or path for facilitating a surgical procedure to be performed on the patient; (4) determining at least one surface associated with the patient's anatomy; (5) generating a 3- dimensional representation of the customized surgical device or instrument, which incorporates the at least one trajectory of path and a matching surface to the at least one surface associated with the patient's anatomy; and (6) fabricating the customized surgical device or instrument using the 3-dimensional representation.
  • a system and method for facilitating a surgical procedure(s) comprises, but is not limited to: (1) Obtaining data associated with the patient's anatomy by way of a MRI or CT scan; (2) Converting the MRI or CT scan data to a 3-Dimensional data set(s); (3) Determining one or more axes or planes of orientation of a device to be constructed for use in facilitating the surgical procedure(s) to be performed on the patient; (4) Modeling the device for use in facilitating the surgical procedure(s) using the determined axes and accounting for any other constraints derived from the converted data set(s); (5) Generating a prototype of the modeled device by, for example, use of rapid prototyping machinery; and (6) Preparing the prototype for use during the surgical procedure(s).
  • the method step of accounting for any other constraints derived from the converted data set(s) may comprise adjusting the size of the modeled device to accommodate the space limitations on the surgeon, orienting elements of the modeled device to avoid certain anatomical features, creating one or more surfaces that may conveniently be operatively associated with one or more instruments and/or tools used in the surgical procedure(s), etc.
  • the system and method includes use of data obtained from a radiographic imaging machine, a fluoroscopy, an ultrasonic machine or a nuclear medicine scanning device.
  • the body further comprises at least one track.
  • the track includes patient-specific depth control, angle, and orientation adapted to guide an instrument operable to remove a predetermined portion of the vertebrae.
  • the at least one track comprises two tracks formed in the body.
  • a portion of the body is adapted to hook at least partially around, and substantially conform to, at least a second predetermined portion of the vertebrae of the patient.
  • the hook portion of the body comprises an extension of the distal portion of the body.
  • the extension of the body is designed to hook at least partially around vertebral anatomy selected from the group consisting of: a lamina, a pars interarticularis, an aspect of a transverse process, a spinous process, an inferior articular process, and a superior articular process.
  • the distal portion of the body of the template is shaped to substantially conform to cut surfaces generated by removal of a portion of the patient's vertebrae. The portion of the patient's vertebrae may have been removed during a previous portion of the same surgical procedure.
  • at least a portion of the distal portion is shaped to substantially conform to an unaltered portion of the patient's anatomy.
  • the bore is directed in a cortical bone trajectory. In another embodiment, the bore is directed in a pedicle screw trajectory.
  • a cannulae is associated with the body.
  • the cannulae includes a bore that is oriented in a direction for placement of a temporary fixation device.
  • the body may further comprise a second bore.
  • the template further includes a frame configured to be fixed to screws placed in at least one vertebrae of the patient.
  • the body of the template is adapted to releasably interconnect to the frame. In this manner, the template may be used in a surgical procedure before, or after, a different guide or template of the present invention.
  • FIG. 1 Further aspects of the present disclosure are directed to the system described above and further comprising a surgical guide which is subject to an electrical current by providing at least one electrode on the conductive material of the surgical guide and providing electrical current to the at least one electrode.
  • a patient-specific guide for use in a surgical procedure.
  • the guide is adapted to contact, or be positioned between, two adjacent vertebra of a patient and generally comprises: (1) an insert comprising an aperture and two projections, predetermined portions of the projections including patient- specific contours determined from the patient's anatomy and configured to contact and substantially conform to at least a first subcutaneous anatomic feature of a vertebra of the patient; and (2) a guide sleeve selectively retained in the insert aperture.
  • the guide sleeve includes at least one of an aperture and a slot to guide an implant or an instrument into an intervertebral space between the adjacent vertebrae.
  • the insert further comprises at least one bore to guide an instrument or a fixture on a predetermined trajectory.
  • the body further comprises a second bore that is oriented in a direction for placement of a temporary fixation device.
  • at least a portion of one of the projections is adapted to hook at least partially around, and substantially conform to, an anatomic feature of the patient.
  • the guide sleeve includes an aperture to guide a tool.
  • the patient-specific guide includes a second guide sleeve selectively interconnectable to the guide.
  • the second guide sleeve is one of: (1) interconnected to the guide sleeve; and (2) selectively retained in the insert aperture after the guide sleeve is removed from the insert aperture.
  • the second guide sleeve includes an aperture to guide a second tool.
  • Embodiments of the present disclosure also provide systems, methods, and devices for performing drilling operations, including but not limited to in a surgical setting.
  • the embodiments disclosed herein further relate to fixation devices for use with the drilling apparatus described in various embodiments, as well as for use with other apparatus.
  • the drill preferably comprises, but is not limited to: (1) a housing or body, (2) a drill bit.
  • the drill bit is retractable and extendable with respect to the drill body by a predetermined amount.
  • the drill may further include one or more of: a sleeve, a data port, a motor, a power supply, a display, a memory, a sensor, and a processor.
  • the drill bit may be selectively interconnectable to the drill. Accordingly, a first drill bit may be selectively replaced by a second drill bit for use with the drill.
  • the processor may execute instructions that control the extension and retraction of the drill bit from and into the body as well as operation of the motor.
  • the processor is programmed to automatically start or stop the drill bit.
  • the processor may be programmed to control the power (or torque) applied by the motor to the drill bit as well as the rate of rotation of the drill bit.
  • the processor is programmed to control one or more of: the rotation and direction of the drill bit, the length of extension of the drill bit to control depth, and power applied to the drill bit.
  • the processor may be programmed to receive data from the sensor and the motor.
  • the processor is programmed to provide a graphical user interface for the display. The GUI may receive inputs from a user to control the extension of the drill bit, the power applied to the drill bit, and to set a maximum amount of extension of the drill bit.
  • the porous element may comprise a first material that is different than a metal material used to form the thread element.
  • a first longitudinal portion of the shank may be comprised of a first porous material and a second longitudinal portion of the shank may be comprised of a different second porous material.
  • the surgical device generally includes, but is not limited: (1) a medial body having a proximal end and a distal end, wherein the medial body is configured to be positioned adjacent the anatomical feature within a first incision; (2) a first leg with a first patient-specific surface adapted to anatomically mate with at least one first contour of the anatomical feature; and (3) a first external cannulae with a first bore having a first trajectory that intersects a portion of the anatomical feature, wherein, when the surgical device mates with the anatomical feature, the first cannulae is positioned outside of the first incision and the first bore guides an instrument to form a second incision aligned with the first trajectory.
  • the first external cannulae may be releasably interconnected to the surgical device.
  • the first patient-specific surface is determined from and complementary to the patient's anatomy.
  • the anatomical feature is a vertebrae and the first patient-specific surface is adapted to anatomically mate with one or more of a lamina, a pars, an articular process, and a spinous process of the vertebrae.
  • the surgical device further comprises a second internal cannulae with a second bore, wherein, when the surgical device mates with the anatomical feature, the second internal cannulae is positioned within the first incision.
  • the second bore may be substantially concentrically aligned with the first bore to guide the instrument in the first trajectory.
  • the second internal cannulae includes an aperture adapted to release the instrument guided by the first and second bores from the surgical device.
  • the instrument may comprise one or more of a k-wire, an instrument sleeve, an insert, a drill, and a patient-specific fixation device.
  • the second bore of the second internal cannulae is sized to retain the instrument when the instrument is advanced through the first bore and the second incision at least partially into the second bore.
  • the surgical device may include a third external cannulae with a third bore having a second trajectory that intersects another portion of the anatomical feature.
  • the third external cannulae is configured to be positioned outside of the first incision.
  • the third bore is configured to guide an instrument to form a third incision aligned with the second trajectory.
  • the third external cannulae may be releasably interconnectable to the surgical device.
  • the surgical guide may further include a third cannulae including a third bore.
  • the third cannulae may be used to guide a fixation device to be interconnected to the anatomical feature.
  • the fixation device may be a temporary pin.
  • the surgical guide is manufactured by a process selected from the group consisting of a rapid prototyping machine, a stereolithography (SLA) machine, a selective laser sintering (SLS) machine, a selective heat sintering (SHM) machine, a fused deposition modeling (FDM) machine, a direct metal laser sintering (DMLS) machine, a powder bed printing (PP) machine, a digital light processing (DLP) machine, an inkjet photo resin machine, and an electron beam melting (EBM) machine.
  • a rapid prototyping machine a stereolithography (SLA) machine, a selective laser sintering (SLS) machine, a selective heat sintering (SHM) machine, a fused deposition modeling (FDM) machine, a direct metal laser sintering (DMLS) machine, a powder bed printing (PP) machine, a digital light processing (DLP) machine, an inkjet photo resin machine, and an electron beam melting (EBM) machine.
  • SLA stereolithography
  • the surgical guide may be made of an aluminum alloy, a chromium alloy, a PEEK material, a carbon fiber, an ABS plastic, a polyurethane, a resin, a fiber-encased resinous material, a rubber, a latex, a synthetic rubber, a polymer, and a natural material.
  • the surgical device includes a second external cannulae with a second bore, wherein, when the first contact surface of the first leg is positioned on the first portion of the anatomical feature, the second external cannulae is positioned externally to the first incision.
  • the second external cannulae may be selectively interconnectable to the surgical device.
  • the first trajectory is oriented along a pedicle screw trajectory.
  • the first trajectory may be oriented to guide the instrument percutaneously in one of: (1) a cortical trajectory; (2) an SI alar trajectory; (3) an S2 alar trajectory; (4) and S2 alar iliac trajectory; and (5) an iliac trajectory.
  • the surgical device includes a fourth external cannulae with a fourth bore.
  • the fourth external cannulae is configured to be positioned outside of the first incision.
  • the fourth bore may be substantially concentrically aligned with the third bore to guide the instrument along a third incision in the second trajectory.
  • the fourth external cannulae may be releasably interconnectable to the surgical device.
  • the surgical device may be used in one or more of a minimally invasive surgical procedure and a minimal access procedure.
  • the surgical device is configured for use in conjunction with a device that employs automated or semi- automated manipulation such that placement of the surgical device with respect to the anatomical feature may be performed remotely by an operator through a computer controller.
  • the surgical device is identifiable by optical, electronic, or radiological recognition means such that the location and orientation of the surgical device with respect to the anatomical feature is verifiable.
  • the surgical device includes a second leg with a second contact surface configured to be positioned on a second portion of the anatomical feature.
  • the surgical guide also includes one or more of third and fourth legs with a third and fourth contact surfaces configured to be positioned on third and fourth portions of the anatomical feature.
  • Still further aspects of the present disclosure include a surgical guide manufactured using one of the methods described herein, wherein the guide is manufactured by a process selected from the group consisting of a rapid prototyping machine, a stereolithography (SLA) machine, a selective laser sintering (SLS) machine, a selective heat sintering (SHM) machine, a fused deposition modeling (FDM) machine, a direct metal laser sintering (DMLS) machine, a powder bed printing (PP) machine, a digital light processing (DLP) machine, an inkjet photo resin machine, and an electron beam melting (EBM) machine.
  • a rapid prototyping machine a stereolithography (SLA) machine, a selective laser sintering (SLS) machine, a selective heat sintering (SHM) machine, a fused deposition modeling (FDM) machine, a direct metal laser sintering (DMLS) machine, a powder bed printing (PP) machine, a digital light processing (DLP) machine, an ink
  • embodiments of the present disclosure may have various sizes.
  • the sizes of the various elements of embodiments of the present disclosure may be sized based on various factors including, for example, the anatomy of the patient, the person or other device operating with or otherwise using the apparatus, the surgical site location, physical features of the devices and instruments used with the devices described herein, including, for example, width, length and thickness, and the size of the surgical apparatus.
  • the embodiments reduce the number and need for multiple trays, instruments and different size devices used in a particular surgery, thereby reducing the cost of the equipment necessary to complete the surgery.
  • the embodiments also reduce the cumulative radiation exposure to both the surgeon and medical professionals in the operating environment and the patient.
  • embodiments of the present disclosure may be constructed of materials known to provide, or predictably manufactured to provide the various aspects of the present disclosure. These materials may include, for example, stainless steel, titanium alloy, aluminum alloy, chromium alloy, and other metals or metal alloys. These materials may also include, for example, PEEK, carbon fiber, ABS plastic, polyurethane, polyethylene, photo-polymers, resins, particularly fiber-encased resinous materials rubber, latex, synthetic rubber, synthetic materials, polymers, and natural materials.
  • Fig. 2 is a flow chart diagram showing the various steps of performing a method of manufacturing and using an apparatus for facilitating a surgical procedure according to one embodiment of the present disclosure
  • Fig. 7B is another front elevation view illustrating a boring instrument of an embodiment of the present invention inserted in a cannula of the guide of Fig. 7A;
  • Fig. 7C is a side view of a guide sleeve of an embodiment of the present invention positioned proximate to the vertebral body illustrated in Fig. 7A;
  • Fig. 7D is side view of a cutting tool of an embodiment of the present invention inserted into a cannula of the guide sleeve of Fig. 7C;
  • Figs. 7F-7G are additional perspective views of the cutting tool and the guide sleeve of Fig. 7D;
  • Fig. 8A is a front elevation view of a frame of an embodiment of the present invention interconnected to a portion of a patient's spine;
  • Fig. 8B is a front elevation view of a guide of another embodiment of the present invention interconnected to the frame of Fig. 8 A;
  • Fig. 8C is a perspective view of the guide and the frame of Fig. 8B;
  • Fig. 8D is another perspective view of the guide and the frame of Fig. 8B including hidden lines showing the structure of slots formed in the guide;
  • Fig. 9A is a front elevation view of another guide of the present invention.
  • Fig. 9B is a rear elevation view of the guide of Fig. 9 A;
  • Fig. 9C is a bottom perspective view of the guide of Fig. 9A;
  • Figs. 9D-9E are a front elevation view and a perspective view of the guide of Fig. 9A positioned against a vertebral body and including hidden lines showing the structure of slots formed in the guide;
  • Fig. 9F is a side elevation view of the guide of Fig. 9A positioned against the vertebral body;
  • Fig. 9G is another side elevation view of the guide of Fig. 9A positioned against the vertebral body and illustrating cuts formed in the vertebral body;
  • Fig. 10B is another front elevation view of the guide of Fig. 10A positioned against a vertebral body;
  • Fig. IOC is a side perspective view of the guide of Fig. 10A;
  • Fig. 10D is a side view of the guide of Fig. 10A positioned against the vertebral body;
  • Fig. 10E is a top view of the guide of Fig. 10A positioned against the vertebral body;
  • Fig. 11C is a side perspective view of the guide of Fig. 11 A;
  • Fig. 11D is another side perspective view of the guide of Fig. 11A positioned against the vertebral body;
  • Fig. 1 IE is a side view of the guide of Fig. 11 A positioned against the vertebral body;
  • Fig. 12A is a front elevation view of a frame of an embodiment of the present invention interconnected to a portion of a patient's spine;
  • Figs. 12B-12C are an elevation view and a perspective view of another guide of an embodiment of the present invention interconnected to the frame of Fig. 12 A;
  • Figs. 13A-13C are perspective views of still another guide of an embodiment of the present invention with Fig. 13C illustrating the guide of Fig. 13 A positioned against a vertebral body that has been altered in a surgical procedure;
  • Fig. 13 A positioned against a portion of the patient's spine that has been altered in a surgical procedure and further illustrating the guide in relation to a neural element of the patient;
  • Figs. 14A-14E are perspective views of a guide of yet another embodiment of the present invention with Figs. 14C-14D illustrating the guide positioned against a vertebral body that has been cut to remove portions of the vertebrae and Fig. 14E showing the guide positioned against the vertebral body and neural elements of the patient;
  • Fig. 15A is a perspective view of yet another guide of the present invention.
  • Fig. 15D is a front elevation view of the guide of Fig. 15A illustrated in a position of use against a portion of a patient's spine and illustrating a neural element of the patient positioned proximate to a recess of the guide;
  • Fig. 15E is a side perspective view of the guide of Fig. 15D in a similar position of use;
  • Fig. 16A is a perspective view of a model of an embodiment of the present invention.
  • Fig. 16C is rear elevation view of the model of Fig. 16 A;
  • Figs. 16D-16E are a perspective view and a side elevation view of the model of Fig. 16A positioned in contact with a vertebral body;
  • Fig. 17A is a front elevation view of another model of an embodiment of the present invention.
  • Fig. 17C is a rear perspective view of the model of Fig. 17 A;
  • Fig. 17E is a front perspective view of the model of Fig. 17D;
  • Fig. 17F is a top perspective view of the model of Fig. 17D;
  • Fig. 18A is a front perspective view of another embodiment of a model of the present invention.
  • Fig. 18B-18C are a front elevation view and a perspective view of the model of the embodiment of Fig. 18A positioned proximate to a vertebral body;
  • Fig. 19A is a perspective view of yet another guide of an embodiment of the present invention adapted to interconnect to a model of an embodiment of the present invention and showing the guide and the model in a disassembled state;
  • Fig. 19B is a perspective view of the model and the guide of Fig. 19A in an assembled state
  • Fig. 19C is a front elevation view of the model and the guide of Fig. 19B;
  • Figs. 20A-20B are a perspective view and a side elevation view of still another embodiment of a model of the present invention.
  • Figs. 20C-20D are a perspective view and a side elevation view of the model of
  • Fig. 20A interconnected to a frame of the present invention similar to the frame of Fig. 12A, illustrating the model in a position of use proximate to a portion of the patient's spine;
  • Figs. 21C-21D are views of the model of Fig. 21A in a position of use interconnected to a frame of the present invention, the frame fixed to a portion of a patient's spine;
  • Fig. 22A is a perspective view of a three-dimensional model of a unique grouping of a portion of patient's spine of an embodiment of the present invention and illustrating a portion of the spine being removed;
  • Fig. 22B is a side elevation view of the three-dimensional model of Fig. 22 A;
  • Fig. 22C is a perspective view of the removed spine portion after some of the removed spine portion has been cut away;
  • Fig. 22D is a side elevation view of the three-dimensional model of Fig. 22D after the model has been moved to close a gap formed after a portion of the spine was removed;
  • Fig. 22E is a side elevation view of the three-dimensional model of Fig. 22B and further illustrating an alignment indicator of the present invention interconnected to the three-dimensional model and with the model showing the alignment of the patient's spine before the planned surgical procedure;
  • Fig. 22F is another side elevation view of the alignment indicator of Fig. 22E showing the alignment of the patient's spine after the planned surgical procedure;
  • Fig. 23A is a perspective view of a coronal alignment verification tool of an embodiment of the present invention positioned proximate to a portion of a patient's anatomy;
  • Figs. 23B, 23C, and 23D are front, bottom, top elevation views, respectively, of the tool of Fig. 23 A;
  • Fig. 24A is a perspective view of another embodiment of a coronal alignment verification tool of the present invention positioned proximate to a portion of a patient's spine;
  • Figs. 24B, 24C, and 24D are a front, top, and right side elevation views of the tool of Fig. 24 A;
  • Fig. 25A is a front elevation view of another tool of an embodiment of the present invention for verification of coronal alignment
  • Fig. 25B is a right side elevation view of the tool of Fig. 25 A;
  • Fig. 25C is a perspective view of the tool of Fig. 25 A;
  • Fig. 25D is a front view of the tool of Fig. 25A proximate to a portion of the patient's spine and aligned in relation to the sagittal plane;
  • Figs. 32A-C are various views of a patient-specific guide for contacting surfaces and trajectories in a patient's spine according to yet another embodiment of the present invention.
  • Figs. 33A-F are various views of a guide of an embodiment of the present invention further comprising secondary and tertiary sleeves of still another embodiment of the present invention;
  • Figs. 42A-42B are a bottom plan and a perspective view of another patient-specific guide of the present invention.
  • Fig. 44A is a perspective view of yet another patient-specific guide of an embodiment of the present invention in which cannulae of the guide do not contact vertebrae of a patient's spinal column;
  • Figs. 44B-44C are perspective views of the patient-specific guide of Fig. 44A positioned against a vertebral body and illustrating distal ends of the cannulae separated from the vertebral body by a predetermined distance;
  • Figs. 44D-44F are perspective views of another patient-specific guide similar to the guide of Fig. 44A, the guide adapted to be positioned within an incision against a patient's boney anatomy and including external cannula adapted to remain outside of a skin envelope and further including internal cannula arranged to be within the skin envelope, the external and internal cannula being collinearly aligned;
  • Figs. 44G-44I are perspective views of a patient-specific guide of another embodiment comprising external cannula adapted to remain outside of an incision formed to seat the guide against an anatomical feature of a patient;
  • Fig. 47 is a right side elevation view of another embodiment of an interbody guide
  • Fig. 48 is a perspective view of the interbody guide shown in Fig. 46 with a different guide sleeve inserted in the aperture of the interbody guide;
  • Fig. 49 is another perspective view of the interbody guide shown in Fig. 46 with still another guide sleeve inserted in the aperture;
  • Figs. 51A-51B are bottom rear perspective views of the interbody guide shown in
  • Figs. 52A-52B are perspective views of the interbody guide shown in Fig. 50 with the guide sleeve of Fig. 48 inserted in the aperture;
  • Figs. 53A-53B are perspective views of another interbody guide between two different vertebral bodies
  • Figs. 54A-54C are top plan view of a drill apparatus of an embodiment of the present disclosure and respectively illustrating the drill bit in an extended position, a partially extend position, and a retracted position;
  • Fig. 54D is a top plan view showing an external memory device being received in a port of the drill apparatus and further illustrating patient specific surfaces form on a sleeve of the drill apparatus;
  • Fig. 54E is a view of the drill apparatus shown relative to an anatomical structure of a patient and showing the drill bit in hidden lines in an extended position while boring into the anatomical structure;
  • Fig. 54F is a plan view of the drill apparatus illustrated in Fig. 54E with the drill bit illustrated in hidden lines in a retracted position within the drill apparatus after forming a bore in the patient's anatomical structure;
  • Fig. 54G is a view of the drill apparatus of an embodiment of the present invention forming a bore in an anatomical structure in trajectory controlled by a guide of an embodiment of the present invention
  • Fig. 55A is a side elevation view of a fixation device of an embodiment of the present invention with a shank comprising a porous element visible between a thread element of the fixation device;
  • Fig. 55B shows a partial sectional view of a fixation device according to another embodiment of the present disclosure illustrating a porous element in a shank of the fixation device;
  • Fig. 55C is a sectional view of another fixation device according to yet another embodiment of the present disclosure illustrating an inner member positioned within a shank of the fixation device;
  • Fig. 55D is a side elevation view of still another fixation device with a shank comprising a porous element at a proximal end of the shank and a non-porous material at a distal end of the shank;
  • Fig. 55E is an expanded side elevation view of a portion of the shank of a fixation device with a porous element visible between threads of the fixation device;
  • Fig. 55F is a partial sectional perspective view of a fixation device illustrating a porous element in the shank and a fenestration or cannula formed in the shank through the porous element.
  • the present disclosure relates to a novel system and method for developing a variety of customized, patient-matched apparatus for use in a diverse number of surgical procedures.
  • the system and method uses a patient's unique morphology, which may be derived from capturing MRI data, CT data, or any other medical imaging device to derive one or more patient-matched apparatus, which comprise complementary surfaces to those encountered during the surgical procedure(s) as derived from a set of data points.
  • the patient-matched apparatus may further comprise desired axes and/or insertional trajectories.
  • the patient-matched apparatus may be further matched with at least other apparatus used during the surgical procedure.
  • FIG. 1 a perspective view of a three-dimensional model of a unique grouping of anatomical features according to one embodiment of the present disclosure is shown.
  • the model 2 is comprised of multiple vertebral bodies 4, 6 but according to other embodiments may be comprised of any anatomical grouping for a particular patient.
  • Data associated with the model 2 may be captured from a MRI or CT scan or from radiographic images of the patient's corresponding boney anatomy (or alternatively from other data sources).
  • the data may be converted using known software tools to a computer aided design (CAD) program, where the data set is representative of the model 2 and may be used to provide additional data points for forming the contours, sizes, shapes and orientations of one or more apparatus to be used in the surgical procedure.
  • CAD computer aided design
  • the data may be obtained from an ultrasonic or nuclear medicine scanning device.
  • the data may be supplemented or merged with data from a bone density scanner to fabricate a device that is designed to remain in the patient after the surgical procedure is completed, or alternatively to achieve further control over the orientation of any desired axes, particularly where the surgical procedure involves insertion of one or more implantable devices.
  • Fig. 2 is a flow chart showing the various steps of performing a method of manufacturing an apparatus, such as a guide, a spinal fusion rod, a template of a predetermined portion of a patient's anatomy according, and/or any of the devices illustrated and described in conjunction with Figs. 3-53 according to various embodiments described herein, for use in facilitating a surgical procedure. While a general order for the steps of the method is shown in Fig. 2, the method can include more or fewer steps or can arrange the order of the steps differently than those shown in Fig. 2.
  • the method step of accounting for any other constraints derived from the converted data set(s) may comprise adjusting the size of the modeled device to accommodate the space limitations on the surgeon, orienting elements of the modeled device to avoid certain anatomical features, creating one or more surfaces that may conveniently be operatively associated with one or more instruments and/or tools used in the surgical procedure(s), etc.
  • the prototype may be generated using known rapid prototyping machinery, or alternatively by milling machinery such as a CNC milling machine.
  • the initial device fabricated by this method may be in a temporary state for further consideration and or manipulation by the surgeon, and then finally constructed using one of the methodologies described herein.
  • the steps may be repeated for complementary devices, some or all of which may include further matching surfaces for the patient's anatomy or to the previously fabricated devices (i.e., the devices fabricated may have matching surfaces for adjoining together one or more devices, as described in greater detail below).
  • the guide 10 illustrated in Fig. 3 is a laminectomy guide adapted to facilitate the use of surgical cutting instruments to alter the patient's lamina.
  • guides of the present invention may be adapted for use in procedures to alter any portion of the patient's anatomy.
  • the guides of the present invention may be used in procedures to alter posterior portions of the patient's anatomy, including without limitation facet joints, transverse processes, articular processes, and spinous processes of a patient.
  • the laminectomy cutting guide 10 illustrated in Fig. 3 further comprises at least one alignment channel 16 for inserting a guide wire or other securing element, and a cutting slot 20 for directing the path of a blade or other cutting edge.
  • the alignment channel 16 may receive a fixture, such as a temporary fixation device, to temporarily fix the guide 10 to the patient's spine.
  • the temporary fixation device may be a pin or screw such as those known to one of skill in the art. Placing a fixture through the channel 16 can increase stability of the guide during use of the guide in a cutting procedure.
  • the channel 16 may comprise a cannula adapted to receive a tool, such as a tool for forming a bore in the patient's anatomy.
  • Stops may be formed in the slot 20 to limit or control the depth of insertion of the cutting tool.
  • the stops may be specific to the patient's anatomy and allow for protection of neural elements of the patient.
  • the slot 20 may also be keyed to ensure depth control while cutting.
  • the slot 20 may include a key that alters the depth of cutting by the tool as the tool is guided through the slot.
  • the key may correspond to a feature, such as a protrusion 144 on the tool 140, described in more detail in conjunction with Fig. 5, that limits the depth of insertion of the tool.
  • a sleeve 24 or an insert may be selectively retained in the slot 20.
  • the insert 24 includes a slot 26 for a cutting tool.
  • the sleeve 24 separates and protects the guide 10 from the cutting tool.
  • the guide 10 is formed of a material that may be cut by the cutting tool, the size and shape of the slot 20 could be changed by the cutting tool.
  • the insert 24 is provided to prevent the cutting tool from altering the slot 20. In this manner, the insert may prevent deviation from a planned surgical procedure.
  • the insert 24 may have any size and shape selected to be at least partially received in the slot 20. Further, the insert may project at least partially from the proximal side of the guide 10. In one embodiment, the insert 24 has a cross- sectional profile substantially the same as the cross-sectional profile of the slot 20. The insert 24 may have a length that is the same as, or similar to, the depth of the slot.
  • the insert 24 may include stops to limit an angle of use of the cutting tool during the surgical procedure.
  • Indicia may be positioned on the guide and the inserts to indicate a sequence of use conforming to the sequence of operations in which the guide is to be used.
  • the indicia may also indicate a tool to be used, a direction of a cut to be performed, or a particular portion of the patient's anatomy targeted by a cut.
  • the indicia may comprise computer readable elements, such as a bar code or an RFID.
  • the indicia may be used to identify the guide and to retrieve information about a procedure to be performed with the guide 10.
  • the indicia are readable by a sensor 3574 of a drill 3547 used with the guide 10.
  • the cutting guide 110 comprises a plurality of patient-specific contacting surfaces 114 about at least one surface of the cutting guide and an alignment channel 116.
  • the contacting surfaces may comprise portions 114A, 114B adapted to hook at least partially around portions of the patient's anatomy.
  • the contacting surfaces 114 are adapted to conform to cut surface generated by removal of a portion of the patient's anatomy.
  • the cutting guide further comprises, in a preferred embodiment, a patient-specific slot or "track” 120 for facilitating insertion of a cutting instrument (as shown in Figures 5-6) and controlling the depth of insertion for that instrument to prevent unnecessary cutting of the underlying surface during a particular surgical procedure by further providing one or more instrument contacting surfaces 122.
  • a patient-specific slot or "track” 120 for facilitating insertion of a cutting instrument (as shown in Figures 5-6) and controlling the depth of insertion for that instrument to prevent unnecessary cutting of the underlying surface during a particular surgical procedure by further providing one or more instrument contacting surfaces 122.
  • the cutting tool 140 associated with the cutting guide 110 shown in Figs. 4-6 is typical of the type of tools currently used in surgical procedures today.
  • a specialty cutting bur or tip 142 may be included with the instrument to facilitate further control of the location and depth of the instrument, as described in further detail below.
  • the cutting portion of the instrument may have a protrusion 144 that prevents greater insertion of the instrument 140 into the cutting guide 110 than required for the patient- specific procedure.
  • the position of the protrusion 144 on the cutting tip 142 may be adjusted by a user.
  • the protrusion 144 may be of any form adapted to interact with contact surfaces 122 of the slot 120 to control the use of the cutting tool 140.
  • the protrusion 144 is a bearing.
  • the protrusion is a track ball.
  • the protrusion is generally discshaped.
  • the protrusion 144 may be inserted into a first portion 120C of the "track" 120 of the cutting guide 110.
  • Second or third deeper portions 120A, 120B of the "track" of a cutting guide may prevent insertion or withdrawal of the protrusion 144, thereby insuring proper depth of the cutting instrument.
  • Further geometrical configurations other than those shown in Figs. 6A-6B may be provided that allow the protrusion 144 to move horizontally with respect to the top surface of the cutting guide, and in some instances laterally and downwardly into the track 120 of the cutting guide.
  • the instrument 140 may be inserted and removed from different portions of the track 120, or from two or more portions of the track.
  • the track 120 and the instrument 140 include protrusions that interact to permit the tool to be inserted in only a first portion of the track, for example portion 120C, and removed from only a second portion of the track, such as portions 120 A or 120B.
  • patient-specific cutting guides include: providing means to achieve quick and controlled removal of bone; providing spatial orientation of cutting tools used during the procedure; ensuring correct orientation of cuts, both through controlled guiding of the instrument and visualization during the pre- surgical planning process; providing accurate calculation of deformity correction, prior to cutting; providing accurate bone resection, which in turn ensures deformity correction; depth controlled cutting restrictions to protect neural and vascular elements; controlled cutting vector and avoiding contact or injury to neural elements; and ability to provide approach for cuts in a posterior, anterior, posterior lateral, transforaminal or direct lateral approach.
  • the sleeve 210 is adapted for use in a posterior osteotomy, also known as a Smith-Petersen Osteotomy (SPO) or a "ponte osteotomy" procedure.
  • a posterior osteotomy also known as a Smith-Petersen Osteotomy (SPO) or a "ponte osteotomy” procedure.
  • SPO Smith-Petersen Osteotomy
  • ponte osteotomy a portion of bone is removed from the back of the patient's spine. Portions of the posterior ligament and facet joints may also be removed from targeted portions of the patient's spine.
  • the osteotomy may be performed at one or multiple locations along the spine to correct the alignment of the patient's spine.
  • a guide 310 comprising a frame 330 is illustrated.
  • the guide 310 is adapted for use in a posterior osteotomy, although other procedures are contemplated.
  • the frame 330 may have a patient-specific shape.
  • the frame may be adapted to flex or snap into a position in contact with a transverse process T or other portion of the patient's anatomy.
  • the frame 330 may be designed to be used in surgical procedures for any patient.
  • fixation devices 334 in each of the inferior and superior vertebra VI, VS are illustrated in use with the frame 330 of the embodiment of Fig. 8, it will be appreciated that any number, including fewer screws, may be used with the frame.
  • the size and shape of the frame 330 may be selected to only permit the frame to be interconnected to the screws when the frame is in a pre-planned orientation.
  • the embodiment of the frame 330 illustrated in Fig. 8 A has a shape that only permits the frame to be interconnected to the four pedicle screws 334 when the frame is in one predetermined orientation. Accordingly, the shape of the frame is adapted to ensure proper alignment of the frame and the guide, limiting the possibility of misuse of the frame and guide.
  • the pedicle screws 334 or other fixation devices may be placed in the vertebrae using any tool or guide.
  • the fixation devices are placed in bores formed in the patient's vertebrae formed by a drill apparatus such as described in conjunctions with Figs. 54A-54F.
  • Pre-existing pedicle screws from a previous surgery may be used with the frame.
  • One or more of the pedicle screws may also be positioned using a pedicle screw guide of an embodiment of the present invention, for example, the guide 246 described above.
  • Other embodiments of pedicle screw guides are described in the Applicant's U.S. Patent 9, 198,678 which is incorporated herein in its entirety.
  • the frame 330 serves multiple purposes.
  • the frame may retract soft tissue in the surgical area.
  • reference points or indicia may be provided on the frame 330 for docking the osteotomy guide 310.
  • the indicia may indicate a planned orientation or alignment of the guide.
  • the shape of the frame 330 may only permit docking of the guide when the guide 310 is in a pre-planned orientation with respect to the targeted vertebrae.
  • the guide 310 is interconnected to the frame.
  • the guide 310 is presurgically planned to align on the frame 330 with targeted portions of the medial vertebrae VM in a patient-specific location so that cuts are made accurately.
  • the guide 310 illustrated in Figs. 8B-8D is shown as one piece, it will be appreciated that in other embodiments the guide could include multiple pieces or a series of cutting guides that are placed in a specific order to generate a series of planned cuts. In embodiments of guides comprising multiple pieces, each piece of the guide may be keyed to interconnect in a specific order and location to other pieces of the guide. In one embodiment, the guide 310 does not contact the patient's anatomy. Said another way, the guide 310 is adapted to float over a surgical area when the guide is interconnected to the frame 330. In another embodiment, at least a portion of the guide 310 is adapted to contact the patient's anatomy.
  • the slots 320 are positioned and have sizes to guide tools used during the surgical procedure, similar to the slots 20, 120 of the guides 10, 110 described above.
  • the slots 320 may have shapes and be positioned at a variety of angles to guide tools, including cutting tools.
  • Each slot 320 may have a unique size and orientation.
  • slots may be adapted to receive different tools, or only one specific tool.
  • Features, such as protrusions may be formed in the slot and interact with features of the tools to control the depth of insertion of the tool, direction of use of the tool, and insertion and removal points of the tool.
  • Inserts similar to the insert 24 described above, may be formed to be positioned in the slots 320 to prevent damage to the slots or to ensure proper use of tools during the procedure.
  • the guide 310 includes a bore the same as, or similar to, the alignment channels 16, 116 described above.
  • a guide 410 of the present invention is illustrated.
  • the guide 410 is adapted for use in pedicle subtraction osteotomies (PSO) and asymmetrical pedicle subtraction osteotomies (APSO) for a single vertebral level.
  • PSO pedicle subtraction osteotomies
  • APSO asymmetrical pedicle subtraction osteotomies
  • the size and shape of the guide may be selected to fit the guide across the surface of the vertebra V.
  • the guide 410 may comprise one piece adapted to target one portion of the vertebra.
  • the guide may be formed in two or more pieces to target a variety of locations of the vertebra.
  • the pieces can guide an ordered sequence of cuts in the vertebra.
  • the pieces may be interconnected in sequence during the surgical procedure to form the guide 410.
  • the guide 410 may fit directly to the posterior aspects of a patient's anatomy, such as lamina, transverse processes, articular processes, spinous processes, etc. Accordingly, a variety of patient matching surfaces 414 may be provided on the guide 410. Additionally, or alternatively, the guide 410 could also fit to a surface of the spine that has previously been cut. In one embodiment, the previous cut may be performed using an initial guide of the present invention.
  • the initial guide is adapted to guide a cutting tool used to generate a surface of the vertebrae.
  • the guide 410 may be designed to fit to the surface generated using the initial guide. Additional cuts in the altered vertebrae can then be performed using the guide 410.
  • the guide 410 may be interconnected to any frame described herein, including frames 330, 730.
  • the guide 410 includes slots 420 to guide surgical tools, including cutting tools such as routers, burrs, and other similar device, along a track to aid in removal of pedicles.
  • the slots 420 may be the same as, or similar to, the slots of guides 10, 110 described above.
  • the slots have a size and orientation selected to constrain cutting tools to presurgically planned entry points and angles of cuts for the procedure.
  • the slots 420 may be oriented in a plane transverse to the proximal surface portion of the guide 410.
  • the slots can be planned to guide tools to make cuts that are substantially linear, concave, convex, curvilinear, or "chevron" shaped.
  • the slots 410 may receive sleeves 24 and can include stops and keys to guide or restrict movement of the surgical tool.
  • the guide 410 includes an alignment channel or cannula 416.
  • the cannula 416 is adapted to guide a fixture tool or anchor, such as fixture 434, into the vertebra. It will be appreciated that the cannula 416 may be positioned in a variety of locations on the guide. Further, more than one cannula can be provided.
  • the guide 410 is anchored to the vertebrae by an anchor 434.
  • the cuts 450 illustrated in Fig. 9G
  • the entire cut portion of the pedicle can be removed along with the guide 410 by pulling the anchor 434 away from the vertebrae V.
  • Figs. 10A-10E illustrate another embodiment of a guide 510 of the present invention.
  • the guide 510 is adapted for use in PSO and APSO procedures.
  • the guide is sized to partially span adjacent superior VS and inferior VI vertebrae.
  • guide 510 includes patient specific contact surfaces 514 adapted to substantially conform to the patient's anatomy.
  • the distal surface 515 of the guide includes a plurality of patient specific contours. At least one portion of the distal surface 515 may be adapted to contact a cut surface formed by removal of a portion of the patient's anatomy.
  • a number of apertures may be formed through the guide to target, avoid, or align with, predetermined portions of the patient's anatomy.
  • an aperture 528 may be formed through the guide 510 with a shape selected to allow the spinous process S to at least partially pass through the guide.
  • Patient specific surfaces 514 may be formed within the aperture 528.
  • the guide may further include a pedicle aperture 529 with a pre-planned shape to at least partially receive the pedicle P of the patient.
  • the pedicle aperture 529 may also include interior surfaces that are patient specific. A surgeon may insert cutting tools into the aperture 529 to remove portions of the pedicle P.
  • the pedicle aperture may be shaped to prevent over insertion of a tool into the vertebrae.
  • keys may be formed around the aperture 529. In conjunction with a protrusion formed on the tool, such as the protrusion 144 described above, the keys may control or alter the depth of insertion of the tool as the surgeon move the tool around the aperture 529.
  • the guide 510 may also include a cutting track 520.
  • the track 520 is similar to slots 20, 120, 320 described above and may receive a guide sleeve the same as, or similar to, sleeve 24.
  • the cutting track 520 is adapted to target facet capsules of each of the superior VS and inferior VI vertebrae. The surgeon may use the cutting track 520 to separate the adjacent facet capsules of the adjacent vertebrae. As will be appreciated, other cutting tracks or cutting slots may be provided on the guide to control other planned cuts.
  • the guide 510 may include a cannula similar to cannula
  • a fixture implanted in the vertebrae may be received in the cannula to at least temporarily interconnect the guide 510 to the vertebrae.
  • the cannula may be adapted to guide an instrument, including a boring instrument or cutting tool 240.
  • the guide 610 is similar to guide 510 and includes a distal surface 615 that may include patient specific contact surfaces. At least one of the contact surfaces may be adapted to substantially conform to an unaltered portion of the patient's anatomy. Another portion of the distal surface 615 may be adapted to substantially conform to a portion of the patient's anatomy altered, for example, by a cut.
  • An aperture 628 adapted to at least partially receive the spinous process S may be provided.
  • the aperture 628 may include patient specific surface 614.
  • the guide 610 is adapted to target each pedicle P of a vertebrae V. Accordingly, the guide includes two pedicle apertures 629. The apertures are the same as, or similar to, the pedicle aperture 529 of the guide 510 describes above. In one embodiment, each pedicle aperture 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 pedicles P do not project beyond a plane formed by a proximal surface as illustrated in Figs. 1 ID, 1 IE.
  • Voids 617 may also be formed in portions of the guide to align the guide with the vertebrae V.
  • the voids may be in various positions. Further, the voids 617 may extend partially or completely through the guide 610.
  • a protrusion 619 may extend from the distal surface 615 of the guide. The protrusion may be adapted to fit to a selected portion of the posterior of the vertebrae.
  • the void 617 or the protrusion 619 may at least partially hook around a portion of the patient's anatomy. In this manner, the void 617 and protrusion 619 contact distinct portions of the patient's anatomy compared to other portions of the distal surface 615.
  • the void and protrusion thus provide references to indicate when the guide 610 is positioned in a predetermined position in relation to the patient's anatomy. Said another way, the void 617 or protrusion 619 will prevent the guide 610 from seating properly when the guide is in an improper position. Thus, the guide will not be stable, providing tactile feedback to the user that the guide is not in the correct position.
  • the protrusion 619 is adapted to fit the guide to a portion of a transverse process or a lamina. Each void 617 or protrusion 619 may further include patient specific surfaces.
  • a guide 710 of another embodiment of the present invention is illustrated.
  • the guide 710 is adapted for use in a PSO or an APSO procedure. Portions of the posterior of the superior vertebrae VS, medial vertebrae VM, and the inferior vertebrae VI (such as the transverse process, spinous process, lamina, and/or pedicles) are removed by cuts 750 prior to the use of the guide 710.
  • a frame 730 is interconnected a portion of the patient's spine.
  • the frame generally comprises a medial member 732 connecting two transverse members 733.
  • the frame 730 is interconnected to the superior vertebrae VS and the inferior vertebrae VI.
  • Pedicle screws 734 positioned in the superior and inferior vertebrae may be used to secure the frame to the vertebrae.
  • the pedicle screws comprise fixation devices 3634 with a porous material as described in conjunction with Figs. 55A-55F.
  • the frame 730 may be similar to, and include the features of, the frame 330 described above. Thus, the frame 730 may preserve an existing amount of distraction. In one embodiment, the frame is used to preserve the relationship between the medial vertebrae VM and the adjacent superior and inferior vertebrae VS, VI. Alternatively, the frame is adjustable in order to change the distraction of the construct as necessary.
  • the medial member 732 of the frame may have a length that is adjustable during a surgical procedure. Changing the length of the medial member 732 increases or decreases the distance between the transverse members 733.
  • the medial member 732 may comprise a first portion that fits within, or adjacent to, a second portion.
  • the guide includes cutting tracks 720.
  • the tracks 720 are similar to the other slots described herein, including, without limitation, slots 20, 120, 320. After the guide is interconnected to the frame, the tracks are used to guide cuts into the vertebrae along a predetermined trajectory.
  • Each track 720A, 720B may have a unique patient specific shape. Further, track 720A may have a size and width adapted to receive a specific tool that is different than the tool associated with track 720B.
  • the guide 710 may also include cannula similar to cannula
  • the cannula may receive a fixture (similar to fixture 434) to interconnect the guide 710 to the targeted vertebrae VM.
  • the fixture may be placed in a portion of the vertebrae, such as the pedicle, planned for removal by cuts guided by the tracks 720. In this manner, after the cuts are completed, the guide 710 can be removed from the frame to remove the severed portions of the pedicle.
  • the cannula is adapted to guide an instrument, such as a boring device.
  • the guides are adapted fit to a cut surface 850 of a vertebrae VM that has been formed by removing a portion of the vertebrae.
  • the surface 850 may be formed by a cut guided by another any other guide of the present invention.
  • the guides 810A, 810B may also include patient-specific surfaces 814 that are adapted to substantially conform to predetermined portions of the vertebrae.
  • a first portion 814A may be adapted to contact and substantially conform to a cut surface 850 of the patient's anatomy.
  • a second portion 814B of the guide may include patient specific contours adapted to substantially conform to an unaltered portion of the patient's anatomy.
  • the second portion 814B may generally hook around the patient's anatomy. In this manner, the second portion 814B contacts a different plane of the patient's anatomy compared to portion 814A.
  • the guides 81 OA, 81 OB can have a variety of sizes and shapes. In one embodiment, the guides 810 have a size selected to fit at least partially across the surface of the vertebra. Additionally, or alternatively, each guide may include armatures. The armatures may interconnect the guides 810 to a fixture, such as a screw, located in the vertebrae VM or in an adjacent superior or inferior vertebrae VS, VI. The armatures may also contact the vertebra in various locations. Further, the guides 810 may include a cannula similar to cannula 16, 116, 416.
  • the neural element N is then received in the recess 954 which protects the neural element from damage during cutting performed using the slots 920 of the guide 910.
  • the guide includes patient-specific features 914 that allow it to fit in a predetermined location. These features may match with the patient's anatomy (the anterior portion of the spinal canal) or may match to the cutting surfaces 950 generated with earlier guides.
  • the slots 920 are similar to slots of all embodiments of guides of the present invention described herein. Further, sleeves may be placed in the slots 920 to prevent damage or alteration of the slots by cutting tools used in the surgical procedure.
  • the slots may align with previously completed cuts. In this manner, new cuts guided by the slots will intersect the previous cuts so that a portion of the vertebrae may be removed.
  • the slots 920 are aligned to complete a cut to remove a medial portion of the vertebral body.
  • the slots 920 are illustrated on only one side of the guide, it will be appreciated that slots may be formed on each side of the guide.
  • the guide may include a bore or a cannula adapted to guide an instrument or fixation device.
  • the models may be manufactured by any method.
  • the models are manufactured using a rapid manufacturing process such as 3D printing, although other processes are contemplated.
  • the models can be fit to the patient's anatomy during surgery to help the surgeon visualize the correct angles and starting locations for cuts, including osteotomy cuts.
  • the models include cannula.
  • the cannula are adapted to receive fixtures to at least temporarily interconnect the model to portions of the patient's anatomy. Fixtures may also be received in the cannula to interconnect portions of a modular model together.
  • the model 1002 is adapted to indicate entry points and angles of the planned cuts.
  • the model includes indicia that indicated the entry points.
  • at least one exterior surface of the model is parallel to the plane of a planned cut.
  • exterior surface 1013 is substantially parallel to the plane of a cut planned to remove the spinous process S.
  • the model may include slots and cannula to guide cuts and bores into portions of the vertebrae V.
  • the size and shape of the model 1002 may vary as planned to guide any variety of cuts. For example, if the thickness of the model 1002 illustrated in Fig. 16E is increased, less of the spinous process S will be removed by a cut guided by surface 1013. In the alternative, more of the spinous process S can be removed by decreasing the height of the model 1002.
  • the model 1102 and the aperture 1128 may be of any size and shape.
  • the model also includes a variety of patient matched surfaces 1114 associated with portions of the patient's anatomy similar to the patient specific surfaces 1014 of model 1002. Further, the patient specific surfaces may be formed in voids 1117 formed in the model. The voids are adapted to align the model with the patient's anatomy.
  • the model 1102 may further include projections 1119 with patient specific surfaces 1114 adapted to mate with portions of the patient's anatomy. The combination of voids 1117 and projections 1119 may decrease the possibility of improper placement of the model 1102 in relation to the patient's anatomy.
  • models 1302A, 1302B of the present invention are illustrated.
  • the models are adapted to dock to a frame 1330.
  • the frame 1330 may be the same as, or similar to, frames 330, 730 described above.
  • models 1302 are adapted to fit with either pre-existing or planned pedicle screws 1334.
  • the models may optionally contact a surface 1350 of the medial vertebrae VM prepared in a previous cutting procedure. However, as will be appreciated by one of skill in the art, the models are not required to contact the medial vertebrae.
  • the models 1302A, 1302B generally include apertures 1328 and voids 1317 for interconnection to the frame.
  • the model 1302 A includes a closed aperture 1328. Accordingly, the model 1302A is generally interconnected to a medial portion of the frame 1330 before the frame is interconnected to the pedicle screws 1334.
  • indicators 1466 A, 1466B may be interconnected to the superior and inferior spine portions VS, VI, respectively, as illustrated, for example, in Figs. 22E-22F.
  • the indicators 1466 comprise rods with a curvilinear shape. It will be appreciated that the indicators may comprise different forms.
  • the indicators simulate how the sagittal alignment of the patient's spine is altered by the presurgically planned osteotomy angles.
  • a variety of patient specific verification tools, illustrated in Figs. 23-26, can be pre-operatively planned and manufactured in order to aid in verifying final sagittal and/or coronal alignment and/or confirm screw placement.
  • the medial body 2112 comprises a distal surface 21 13 adapted to contact predetermined portions of the patient's anatomy.
  • the distal surface 2113 is adapted to contact one or more of the group comprising the inferior articular process, lamina, spinous process, pars, the transverse process, and other features of the patient's anatomy.
  • the distal surface 2113 of the medial body 2112 provides a patient specific surface to align the guide 2110 in a predetermined orientation.
  • one or more of the lateral surfaces 2111 may have patient specific shapes adapted to contact, or interconnect to, other portions of the patient's anatomy.
  • the guide 2110 may include extensions or legs, similar to legs 2024, adapted to hook around, portions of the patient's anatomy.
  • the legs may be made of a flexible or deformable material, including Nitinol.
  • the legs are adapted to provide a bias force to "hook" the guide in a predetermined orientation with respect to the patient's anatomy.
  • the guide 2110 may further comprise slots formed in the medial body 2112.
  • the slots may be adapted to direct the path of a blade or other cutting instrument in a manner similar to cutting slot as will be appreciated by one of skill in the art.
  • the slots of guide 21 10 may be adapted to receive one or more secondary 2140 or tertiary cannulae 2150 as further described in conjunction with Fig. 33.
  • the guide 2110 may take on other shapes, orientations, thicknesses, etc. without deviating from the novel aspects of this disclosure.
  • the guide 2110 may include one or more legs similar to legs 1824, 2024.
  • guide 2110 may be of any size and may comprise extensions or handles to aid in grasping or manipulating the guide 2110 as desired.
  • patient-specific contact surfaces may be formed on the terminal end 2218 of the cannulae 2216 as well as other surfaces of the cannulae.
  • the terminal ends 2218 of the cannulae 2216 and other surfaces may optionally provide still other guide surfaces to align and/or stabilize the guide 2210 in a predetermined orientation during a surgical procedure.
  • one or more of the legs 2224 may have a curvilinear shape.
  • the shape, length, and orientation of the legs may be customized to contact predetermined portions of the patient's anatomy while avoiding contact with other features of the patient's anatomy.
  • at least one of the legs includes a curved shape, or a cutout similar to cutouts 1817 described above in conjunction with Figs. 27-28, to prevent unintended or inadvertent contact between the guide 2210 and the spinous process, the lamina, or another anatomical feature of the patient.
  • the legs 2224 contacts one or more of the group comprising the inferior articular process and the lamina.
  • the terminal ends 2226 of the legs 2224 may include patient-specific contact surfaces the same as or similar to contact surfaces 1826 described above in conjunction with Figs. 27-28. Additional patient specific contact surfaces may also be formed on one or more other surface of the legs 2224.
  • the contact surfaces 2226 may include protrusions adapted to one or more of: align the guide 2210 in a predetermined position with respect to the patient's anatomy, prevent unintended or inadvertent movement of the guide 2210 during a surgical procedure, and displace soft tissue.
  • the contact surfaces 2226 comprise relatively thin extensions.
  • the second legs or bridge 2230 is adapted to contact one or more of the spinous process S and the lamina of the patient.
  • the bridge 2230 extends medially from the cannulae 2216.
  • the bridge 2230 extends medially from the legs 2224.
  • the bridge 2230 may be formed as a single piece and include a longitudinal cavity.
  • the longitudinal cavity may be formed by use of data set(s) converted from an MRI or CT scan of the patient as described above in conjunction with Fig. 2. In this manner, the longitudinal cavity is adapted to substantially mate with the contours of a predetermined portion of the patient's anatomy.
  • the longitudinal cavity is adapted to contact the contours of the spinous process S of a particular vertebral body V of the patient.
  • the bridge 2230 is formed of two separate portions 2230A, 2230B.
  • the bridge 2230 may include one or more contact surfaces 2234 adapted to mate with the contours of one or more of the spinous process, the lamina, and other anatomical features.
  • the bridge 2230 facilitates one or more of ensuring a predetermined alignment of the guide 2210 and preventing inadvertent or unintended movement of the guide 2210 during a surgical procedure.
  • the guide 2210 may also include extensions adapted to hook at least partially around, or to, a portion of the patient's anatomy.
  • one or more of the medial body 2212, the legs 2224, and the bridge 2230 may have a shape adapted hook to the patient's anatomy.
  • a portion of the guide 2210, such as one of the legs, medial body, or the bridge may comprise a flexible or bendable material as previously described. In use, a surgeon may bend or alter the guide 2210 to hook to the patient's anatomy.
  • the guide 2210 may further comprise slots formed in one or more of the medial body 2212, the cannulae 2216, and the legs 2224.
  • the slots may be the same as or similar to slot 1830 and adapted to direct the path of a blade or other cutting instrument in a manner similar to cutting slot described above.
  • the slots of guide 2210 may be adapted to receive one or more secondary or tertiary cannulae 2240, 2250 as further described in conjunction with Fig. 33.
  • the guide 2210 may also include a cutting guide 10.
  • the cutting guide 10 may be interconnected to any portion of the guide 2210, similar to the cutting guide 10 illustrated in Fig. 27D.
  • guide 2310 is substantially the same as guide 1810 described above in conjunction with Figs. 27-28. Accordingly, the guide 2310 may comprise a medial body 2312, arms 2314, cannulae 2316, and patient- matched legs 2324 the same as (or similar to) body 1812, arms 1814, cannulae 1816, and patient-matched legs 1824 of guide 1810. In one embodiment of the present invention, the guide 2310 includes two arms 2314, two cannulae 2316, and two legs 2324. However, the guide 2310 of the present invention may include any number of cannulae and legs.
  • the cannulae 2316 and legs 2324 can each have different lengths. Additionally, the angle and orientation of each cannulae and legs can be varied to match the anatomy of the patient.
  • the guide 2310 may further comprise slots 2330 formed in one or more of the medial body 2312, arms 2314, cannulae 2316, and the legs 2324.
  • the slots 2330 may be cutting slots to direct the path of a blade or other cutting instrument as described above. Alternatively, the slots 2330 may be adapted to receive one or more secondary 2340 or tertiary cannulae 2350.
  • the secondary and tertiary cannulae 2340, 2350 may be positioned in the slots 2330 to target a predetermined portion of one or more of a second level and a third level anatomical feature of the patient.
  • the cannulae 2340, 2350 are adapted to target one or more predetermined portions of the cervical spine (i.e., Cl-Sl and ilium).
  • the cannulae 2340, 2350 include a bore 2320 the same as or similar to bores 1820, 1920, 2020, 2120, and 2220 described above in conjunction with Figs. 27-32.
  • the bore 1820 can guide one or more of a guide wire, a drill bit, a tap, a fixation device (such as a screw), and other instrumentation, including without limitation, tools for harvesting bone grafts.
  • a fixation device such as a screw
  • the bore and/or the cannulae 2340, 2350 may have a length, shape, protrusion, and/or a diameter selected to prevent the use of the improper tool or device, prevent improper use of a predetermined tool or device, and ensure proper use of the predetermined tool or device.
  • Each of the slots 2330 may have a different shape, width, depth, and orientation adapted to receive a predetermined cannulae 2340, 2350 in a specific orientation.
  • the cannulae 2340, 2350 are formed with the guide 2310 as one integral piece.
  • locations of fixation devices e.g. pedicle screws, cortical bone screws, spinal hooks
  • the locations of the fixation devices includes, but is not limited to, entry point of each fixation device, the trajectory and orientation of each fixation device, and the size and type of the fixation devices.
  • the trajectory may be determined from the use of scanning equipment described above, and selected based on optimal patient anatomy, bone density, etc.
  • the diameter, size, and height of the rod or other implant is considered when determining the locations of the fixation devices.
  • the entry points and locations of each fixation device are mapped in three dimensions in reference to a given origin. Screw head location may be with or without correction of the patient's abnormality.
  • the map of the fixation devices is used to presurgically plan the contours of a rod.
  • the rod planning can be conducted manually by a surgeon or technician or automatically conducted by a software algorithm that uses information such as angles, lengths, radii, etc. to generate the optimal correction for a patient.
  • the rod planning may also consider a surgeon's preferred "textbook” or preferred correction as well as physical limitations of the patient's anatomy (e.g. resistance from soft tissue).
  • the rods 2420 may have any size or shape for any planned surgical procedure.
  • the patient specific rod has a shape that substantially aligns with the planned locations and orientations of screw heads intended to interconnect the rod to the patient's anatomy.
  • the patient specific rod can be planned to be produced with bends or contours in three dimensions to match a planned contour of the patient's spine.
  • the patient specific rod only matches the patient's pre-operative anatomy and the planned screw locations. This allows the surgeon to induce any desired correction by making additional bends to the baseline (pre-operative) curvature of the rod.
  • the patient specific rod substantially matches the planned screw locations and also accounts for preoperatively planned correction of the patient's deformity (accounting, for example, for sagittal and/or coronal alignment of the patient's spine).
  • the surgeon may manually reshape the patient specific rod to generate any additional desired correction to the patient's spine.
  • the map of the fixation devices is used to manufacture a rod template as described above in conjunction with Fig. 2.
  • the rod template has a shape substantially matching the planned locations and orientations of the screw heads.
  • a generic rod is then manually re-shaped by the operator to substantially conform to the rod template and form a patient specific rod.
  • the rod template includes a recess adapted to receive the generic rod.
  • the rod template includes a number of protrusions adapted to receive the generic rod which is then bent to align with the planned screw locations.
  • the generic rod has no patient-specific contours before being manually re-shaped.
  • a patient-specific bone model 2402 of one embodiment of the present invention is used to form a rod 2420 prior to, or during, a surgical procedure.
  • the model 2402 is generated from patient imaging data (CT, MRI, etc.) and converted to 3D CAD or FEM models.
  • the data for the model may also be captured by an optical system.
  • the underlying anatomy is a portion of the patient's spine.
  • the model 2402 may include any number of the patient's vertebrae.
  • the model 2402 may be made to represent any predetermined portion of the patient's anatomy.
  • the model may include a reproduction of the deformity associated with these levels of the patient's spine.
  • the model 2402 provides a user with both a visual and tactile representation of the patient's anatomy for creating a patient-specific rod, including one or more predetermined screw trajectories.
  • cylindrical members 2404 may be used with the model 2402 to represent planned screw trajectories.
  • the user may manipulate the members 2404 during the design of the model to change the location and trajectory of each screw.
  • the modeling of predetermined screw trajectories assists in the orientation and placement of the rod.
  • the model 2402 may help the surgeon determine the shape and length of the rod necessary to correct the patient's deformity as well as different positions and alternate arrangement of the planned screws.
  • Planned screw locations and trajectories may be simulated by bores 2408 in the model 2402.
  • Each screw may have a different planned trajectory.
  • the bores 2408 are illustrated with a generally cylindrical shape, it will be appreciated by one of skill in the art that the bores 2408 may have any predetermined shape. Further, the bores 2408 may have a predetermined depth and diameter. In one embodiment, each bore has a unique cross-section.
  • the screw trajectories are designed using generic cylinders in the CAD system.
  • the model 2402 is generated.
  • the model is formed using any 3D printing process or rapid prototyping process as will be appreciated by one of skill in the art.
  • the model 2402 may be formed as describe above in conjunction with Fig. 2.
  • the vertebra VI -V3 of the model 2402 are flexibly interconnected to enable movement of the model 2402.
  • the model 2402 with the pegs 2440 is used as a template by the surgeon (or other operator) to presurgically bend rods 2420 to the planned shape. Placing the rod 2420 on the model 2402 as illustrated in Figs. 34E-34F permits the surgeon to determine the length and orientation (including curvature) of the fixation rod required to correct the deformity or otherwise treat the patient.
  • the model 2402 may also assist the user in other aspects of the surgical procedure. For instance, placing the rod on the model allows the surgeon to visualize the difference in height of each level of the patient's spine and differences from one level to the next and also allow the user to visualize whether the rod is misaligned or requires modification to correct the patient's deformity.
  • the surgeon may identify unwanted contact between the patient's anatomy and either the screws or the rod.
  • the surgeon may also receive tactile feedback when placing the rod on the model 2402, such as a clip or snap when the rod is properly aligned with, and received by, the pegs.
  • the model 2402 may be flexible to reproduce movement of the patient's spine.
  • the surgeon can move the model to determine if rod and screws optimally correct the patient's deformity.
  • a generic rod may be bent by the surgeon until it fits substantially in the planned screw locations represented by the heads 2444 of the pegs 2440.
  • the generic rod is bent by any suitable method as will be appreciated by one of skill in the art.
  • the rod is retained within the recesses 2446 of the heads 2444.
  • the rod may "click" into place and can be locked once the user has finished their adjustments to achieve optimal fit and correction of the patient's anatomy.
  • the template 2502 includes peg holders 2508 adapted to retain pegs 2440 is predetermined positions.
  • the pegs 2440 represent the positions and orientations of fixation implants, such as screws, in the map of fixation devices planned to be used in a surgical procedure.
  • the location, orientation, and height of each peg may be adjusted using the template 2502.
  • the pegs 2440 can have various lengths and configurations in order to account for the height and orientation of each planned screw.
  • the heads 2444 or entire pegs 2440 may be rotated to simulate planned placement of spinal fixation devices.
  • peg holders 2508 protrude from the surface of the template 2502 and the pegs 2440 fit onto the holders.
  • the peg holders 2508 comprise a plurality of voids sized to receive at least a portion of a peg.
  • the holders 2508 are arranged in a grid of rows and columns.
  • the template 2502 is a generic device, such as a peg-board.
  • the pegs may be slidingly retained by the template. Thus, the position and alignment of one or more of the pegs may be altered by the user.
  • the template may be modeled within a CAD system. The coordinates and sizes of the pegs may then be modeled in the CAD system. When an appropriate amount of correction is provided by a rod by the pegs, the data related to the pegs are saved in the CAD system.
  • the pegs and rod, or rod template may then be manufactured as described below.
  • pegs 2440 are arranged in predetermined positions on the template 2502 according to the planned surgical positions of the screws.
  • a sufficient number of pegs necessary to provide inflection points of the rod in three-dimensional space may be used with the template 2502.
  • arranging the pegs on the template comprises preparing a map to identify the location and trajectory of each screw.
  • the map is used to determine entry points of the planned trajectory of each of the screws.
  • the entry points are mapped in three dimensions in reference to a given origin.
  • the coordinates and height of the entry points is used to orient the pegs on the template 2502 to substantially duplicate the presurgically planned screw trajectory for a specific patient.
  • the screw map is created using a CAD or FEM program or other planning tool.
  • the location of the entry points can then be exported as a CAD file and re-mapped into a second CAD file containing the template 2502.
  • the entry point locations can be oriented such they have a known location in relation to the template 2502.
  • the template 2502 and pegs 2440 are manufactured after the screw map with the screw locations and orientations has been created.
  • the template 2502 is then manufactured with a number of peg holders 2508 in the positions of the planned screw locations.
  • the number of peg holders may be equal to the number of screws planned to be used in the surgical procedure.
  • Each peg holder 2508 may have a unique cross-sectional profile corresponding to the cross-sectional profile of a corresponding portion of the body of one of the pegs 2440.
  • each peg may have a unique length and head orientation. In one embodiment, the length and head orientation of the pegs is determined from the screw map. In this manner, each peg 2440 may be placed in the correct location and orientation.
  • the template can be used to adjust a rod 2420 as illustrated in Figs. 35C-35E.
  • a surgeon or other user can then change the orientation or location of one or more of the pegs 2440.
  • the surgeon may then bend the rod 2420 to correspond to the new positions of the pegs 2440 to change the shape of the rod 2420.
  • Each rod 2420A, 2420B may have unique contours and a different length and size.
  • the rod 2420 can be a generic rod, described above, that is bent to substantially align with the heads 2444 of the pegs.
  • the generic rod When the generic rod is substantially aligned with the heads, it will fit with the planned screw trajectories without further correction.
  • the surgeon can change the shape of the rod 2420, for example, to alter the amount of correction provided by the rod.
  • the template 2502 can be used to modify the shape of a pre- manufactured patient specific rod.
  • the patient specific rod will substantially align with the heads of the pegs.
  • the patient specific rod is retained in recesses 2446 of the heads 2444.
  • the surgeon may optionally change the shape of the patient specific rod as necessary, desired, or for any other reason.
  • pegs 2440 of embodiments of the present invention are illustrated.
  • the pegs are used with used in conjunction with the models 2402 and templates 2502 of the present invention to simulate surgical screws adapted to hold the rods 2420.
  • the pegs generally include a body 2448 and a head 2444.
  • the body 2448 has a size and shape to be engaged by a bore 2408 of the model 2402 or a holder 2508 of the template 2502.
  • the body 2448 has a size selected to frictionally engage the interior surface of a bore 2408 or a holder 2508 to retain the peg in a selected orientation with respect to the model 2402 or the template 2502.
  • the shape of the body 2448 is selected to prevent unintended rotation or movement of the peg in relation to the model 2402 or the template 2502.
  • the cross- sectional shape of the body is one of round, triangular, and square.
  • the head 2444 is adapted to receive a rod 2420.
  • the head includes a receiver or recess 2446 adapted to releasably interconnect the rod 2420 to the peg.
  • the recess 2446 has a generally U-shaped cross-section.
  • the recess may have any other cross-sectional configuration, including, for example, V-shaped, W-shaped, polygonal- shaped, or tapered.
  • the head 2444 may be stationary or movably interconnected to the body 2448.
  • the peg 2440A includes a head and body that are formed as one integral piece.
  • the peg 2440B includes a head 2444 and body 2448 that are formed separately. The head and body may be joined by suitable techniques known in the art.
  • the pegs 2440B include an extension 2550 of the head 2444 for insertion into complementary receiver 2552 of the body 2448.
  • one or more tabs may be formed on one of the head or the body and complementary slots on the other of the head and body for receiving the tabs.
  • Bodies 2448 of a variety of lengths may interchangeably be used with the head to adjust the length of the peg 2440B. Further, the orientation of the recess 2446 may be modified by rotating one of the head and the body.
  • the peg 2440C includes a head 2444 pivotally interconnected to the body 2448. Further, the head 2444 can be moved around one or more axis with respect to the body. Accordingly, the head may be capable of monoaxial or polyaxial movement.
  • the pegs may be made of any desired material, including plastic, metal, and wood and combinations thereof.
  • a peg 2440 is manufactured by a 3D printing process. In another embodiment, a peg 2440 is machined.
  • a template 2602 of a surgical tool, instrument or device is provided.
  • the template 2602 may be customized or contoured as described above in conjunction with Fig. 2 to conform to a specific patient's anatomy.
  • the template 2602 may provide a surgeon with a particular dimension, shape, orientation, etc. for a device such as a rod 2420.
  • a map or plan of the locations and orientations of fixation devices that are planned to be used in a surgical procedure is created, as described above.
  • the map includes planned screw trajectories in relation to a specific portion of the patient's anatomy.
  • Patient specific bone models the same as or similar to model 2402, may be used to create the screw map.
  • a template 2502 and pegs 2440 may be used to create the screw map.
  • the screw map is created using a CAD program or other planning tool.
  • the map plan is used to create a patient-specific rod.
  • the rod 2420 is machined using the screw map.
  • the CAD program uses the screw map to model the rod by connecting each individual planned screw head. This generates a digital model of a rod that will fit into the planned screw locations.
  • the CAD program can then create a template 2602 that includes a negative 2608 of the rod.
  • the shape of the negative 2608 does not include correction of the deformity of the patient.
  • the shape of the negative 2608 includes at least some correction of the patient's deformity.
  • the template 2602 and the negative are manufactured using any suitable manufacturing method.
  • the template is manufactured using any 3D printing system as described above or developed in the future.
  • the surgeon may use this negative template 2602 to manually generate three- dimensional patient-specific contours in a generic rod 2420. Once the rod fits in the negative 2608 of the template, it will fit with the planned screw trajectories. Additional correction can be added by the surgeon as necessary or desired. Alternatively, a patient specific rod may be formed with contours that substantially fit in the negative 2608 without additional shaping by the surgeon. The surgeon may then bend the patient- specific rod to alter the shape of the rod. For example, the surgeon may add additional correction to the rod, or change the amount of correction in the rod to correct the patient's deformity.
  • the template 2602 may optionally include indicia to indicate a position of use, portions of the patient's anatomy, direction, orientation, or the purpose of the rod.
  • the embodiment of the template illustrated in Fig. 37 includes indicia to indicate an alignment of the template.
  • indicia 261 OA indicates a posterior direction and an anterior direction.
  • the template may also include indicia 2610B to identify portions of the patient's anatomy, such as a level of the patient's spine.
  • indicia 2610B is associated with the L5 vertebrae and indicia 26 IOC is associated with the T3 vertebrae.
  • any number and type of indicia can be provided associated with different portions of the patient's anatomy.
  • FIGs. 38A-38B an example of a rod 2420 formed according to one embodiment of the present invention is illustrated in relation to a patient's spine.
  • the screws used to interconnect the rod to the patient's spine have been removed for clarity.
  • the surgeon may further adjust the shape of the rod during a surgical procedure.
  • FIG. 39 an embodiment of a method 2704 of configuring a rod 2420 for use in a surgical procedure is illustrated.
  • a general order for the steps of the method 2704 is shown in Fig. 39.
  • the method 2704 can include more or fewer steps or can arrange the order of the steps differently than those shown in Fig. 39.
  • the method 2704 shall be explained with reference to the embodiments of the present invention described above in conjunction with Figs. 34-38.
  • the method 2704 starts 2708 by obtaining data of the patient's anatomy.
  • the data can be obtained from one or more of a radiographic imaging machine, a fluoroscopy, an ultrasonic machine, or a nuclear medicine scanning device.
  • the data is converted into a digital model at step 2712.
  • the digital model can be produced using known software tools and used in a CAD program.
  • the size, location and orientation of fixtures, such as screws, is planned using the digital model.
  • a model 2402, a configurable template 2502, or template 2602 with a rod negative may be produced as described above in conjunction with Figs. 34-37.
  • a rod 2420 is produced at step 2724.
  • the rod may be a patient-specific rod with pre-formed bends or contours produced using the planned screw placement.
  • a patient-specific rod can be produced using additional data obtained using one of the models or templates from step 2720.
  • the rod may also be a generic rod without a patient specific shape.
  • a generic rod 2420 may be reshaped to fit the model 2402, configurable template 2502, or negative template 2602.
  • the surgeon determines if additional shaping or correction of the rod is necessary.
  • the surgeon may use one or more of the model 2402 or templates 2502-2602 to adjust the shape of either a pre-formed patient-specific rod or a generic rod.
  • the shape may be adjusted to change the amount of correction of the patient's deformity provided by the rod, to avoid a portion of the patient's anatomy, or due to the surgeon's preferred correction or technique.
  • the method proceeds YES to step 2736 and the rod is reshaped. If no additional correction is necessary or required, the method proceeds NO to step 2740 and the rod ready for use in a surgical procedure.
  • the rod may be used in a surgical procedure.
  • Figs. 40A-B yet another patient-specific guide 2810 of an embodiment of the present invention is illustrated.
  • the guide 2810 is formed by the system and method described above in conjunction with Fig. 2 for use during a particular surgery.
  • the guide 2810 is similar to guide 1810 described above and comprises similar features.
  • guide 2810 comprises a medial body 2812, at least one cannulae 2816, and a leg 2824.
  • the cannula 2816 may be the same as, or similar to, the cannulae 1816 described above in conjunction with Figs. 27-28.
  • the cannula 2816 may be configured to contact one or more of the lamina, pars interarticularis, aspects of the transverse process, the interior articular process, and the superior articular process of the patient. Cutouts (not illustrated) may be formed on a portion of the cannulae 2816 to prevent the guide 2810 from contacting the spinous process of the patient, an adjacent vertebrae, or to avoid other patient anatomy.
  • the guide 2810 comprises two cannulae 2816; however, it will be appreciated that the guide 2810 may include any number of cannulae.
  • the cannulae 2816 may have a generally cylindrical shape but other shapes are contemplated.
  • Each of the two cannulae 2816 may have a unique orientation and size.
  • the cannulae may be of any length based at least in part on the specific patient's anatomical features, preferences of the surgeon, orientation of the guide 2810, and the type of tool or fixation device associated with the cannulae 2816.
  • the length of the cannulae 2816 may also be selected to provide depth control of instruments guided by the cannulae 2816.
  • the cannulae 2816 has a first length to allow a drill bit to penetrate a first depth into the patient's anatomy.
  • the cannulae 2816 has a second length that is greater than the first length. Accordingly, the cannulae 2816 prevents the drill bit from penetrating the first depth into the patient's anatomy.
  • the cannulae 2816 may optionally include extensions 2819 of any size or shape.
  • the extensions 2819 are positioned proximate to a distal end of the cannulae 2816.
  • the extensions 2819 wrap at least partially around the exterior of the cannulae 2816.
  • the extensions 2819 may also project at least partially beyond the distal end of the cannulae 2816.
  • the extensions are adapted to wrap at least partially around a predetermined portion of the patient's anatomy.
  • the extensions 2819 are adapted to wrap around a portion of one of the pars and the superior articular process.
  • the projections 2819 may be asymmetrical.
  • one projection has a shape and/or size that is different than another projection.
  • one projection may have a different thickness, contour, or length than the other projection.
  • the asymmetric shape or size of the projections 2819 may be planned to contact, or avoid, a predetermined portion of the patient's anatomy.
  • the angle and orientation of each projection 2819 with respect to the distal end of the cannulae 2816 can be varied to match the anatomy of the patient, or to avoid a portion of the patient's anatomy.
  • the guide 2810 may include one or more legs 2824.
  • the legs may extend from one or more of the medial body 2812 and the cannulae 2816.
  • the angle and orientation of each leg 2824 with respect to the medial body 2812 may be varied to match the anatomy of the patient, or to avoid a portion of the patient's anatomy.
  • At least a portion of the medial body 2812, the cannulae 2816, and the legs 2824 are configured to contact the patient's anatomy.
  • patient specific contact surfaces 2818, 2825 may be formed on one or more of the cannulae 2816, including the projections 2819, and one or more of the legs 2824, respectively.
  • at least a portion of the medial body 2812 may be configured to contact a portion of the patient's anatomy.
  • the medial body 2812 may also optionally include patient specific contact surfaces 2826.
  • the contact surfaces 2818, 2825, 2826 may be adapted to fit directly to aspects of the patient's anatomy, such as one or more of the medial side of the inferior articular process, the lateral sides of the lamina, the spinous process, and the junction between the pars and the transverse process, and other anatomical features of the patient.
  • the patient- specific contact surfaces 2826 of the medial body 2812 may optionally contact at least a portion of the spinous process.
  • the contact surfaces 2818, 2825, 2826 are determined to match at least a portion of a 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.
  • the contact surfaces 2818, 2825, 2826 may be matched to substantially conform to a predetermined portion of the patient's anatomy by using the method described in conjunction with Fig. 2.
  • the patient contact surfaces 2818, 2825, 2826 may include any number of protrusions, depressions, and contours to substantially conform to the patient's anatomy.
  • the contact surfaces 2818, 2825, 2826 may comprise multiple portions that are adapted to contact two different planes formed by two distinct portions of the patient's anatomy.
  • the contact surfaces 2818, 2825, 2826 are adapted to one or more of: align the guide 2810 in a predetermined position and orientation with respect to the patient's anatomy; hook around a portion of the patient's anatomy; prevent unintended or inadvertent movement of the guide 2810 during a surgical procedure; and displace soft tissue.
  • the contact surfaces 2818, 2825, 2826 comprise relatively thin extensions to displace soft tissue.
  • the contact surfaces 2818, 2825, 2826 generally "hook” at least partially around (or to) the patient's anatomy.
  • the surfaces 2818, 2825, 2826 may contact at least two different planes formed by distinct surfaces of the patient's anatomy.
  • the surfaces 2818, 2825, 2826 provide a plurality of patient-specific contours for matching with a plurality of anatomical features of a patient. In this manner, the patient contact surfaces 2818, 2825, 2826 help position the guide 2810 and keep it in position in a predetermined position and orientation.
  • the combination of patient specific surfaces 2818, 2825, 2826 formed on various locations of the guide 2810 may decrease the possibility of improper placement of the guide 2810 in relation to the patient's anatomy.
  • the surgeon may also receive tactile feedback when advancing the guide 2810 into position with respect to a targeted portion of the patient's anatomy, such as a clip, snap, or vibration when the guide 2810 is properly aligned.
  • the cannulae 2816 are adapted to guide an instrument or fixation device without contacting the patient's anatomy.
  • a portion of a patient's anatomy may not be strong enough to provide a stable contact point for the guide. This may occur when the patient's anatomy has degenerated, is damaged, or is otherwise unstable.
  • the cannulae 2816 of the guide 2810 may be adapted to float above the targeted portion of the patient's anatomy without touching the targeted portion.
  • At least one of the cannulae 2816 may include a bore 2820 to guide instruments and fixation devices.
  • the bore 2820 of each cannulae 2816 can have a unique internal diameter that is adapted to receive a particular instrument or fixation device.
  • the internal diameter may also be selected to prevent the use of the incorrect instrument or device with the guide 2810.
  • the bore diameter and/or the length of the cannulae 2816 may also prevent the instrument or device from advancing into the cannulae 2816 beyond a predetermined distance, thereby providing a hard stop for depth control.
  • the bore 2820 may also have a shape adapted to align the tool or fixation device in a predetermined orientation of use. Additionally, a protrusion, key, notch, or void may be formed on the cannulae 2816 or in the bore 2820 to one or more of: prevent the use of the incorrect instrument or device; prevent an incorrect orientation of the correct tool or device; and prevent over insertion of the tool or device.
  • the cannulae bore 2820 may include an instrument contact surface that is associated with a feature of the tool, such as a protrusion, to control the depth or orientation of insertion of the tool.
  • the cannulae 2816 may be adapted to prevent the instrument or fixation device from advancing too far into the boney anatomy of the patient or otherwise being misused.
  • the bore 2820 of the cannulae 2816 may facilitate and guide a drill bit or any other suitable instrument to drill and tap a pilot hole in the cortical trajectory. After the pilot hole is created, the bore 2820 may further guide insertion of a fixation device, such as a cortical screw, into the pilot hole. In another embodiment of the present invention, the bore 2820 may be adapted to receive one or more inserts or guide wires such as the inserts 1854.
  • the bore 2820 is oriented in a cortical bone trajectory.
  • the bores may be oriented to target different portions of the patient's anatomy.
  • each bore 2820 of two or more cannulae is oriented in a cortical bone trajectory.
  • the cannulae 2816 is manufactured out of, or the bore 2820 is lined with, a metal or metal alloy that is of sufficient strength and brittleness that breaking and/or flaking is avoided. Further, at least the interior surfaces of the bore 2820 may be formed of a material that can withstand the effects of high-speed drilling without damaging the bore 2820 or the cannulae 2816 or permitting material from the cannulae 2816 to become deposited in the drilling site, as well as facilitating re-use of the cannulae. The material of the cannulae 2816 may also be selected to withstand temperatures used to sterilize surgical instruments.
  • the guide 2810 may include features adapted to be grasped or manipulated by a surgeon. Accordingly, gripping features 2829 may be formed on a portion of the guide 2810. In one embodiment, the gripping features 2829 comprise protrusions. The protrusions 2829 may be of any shape or size selected to facilitate grasping of the guide 2810 in a surgical environment. In one embodiment, the protrusions 2829 are formed on a portion of the medial body 2812. The protrusions 2829 may comprise ridges or bumps. In one embodiment, the protrusions 2829 comprise three generally parallel ridges formed on opposing sides of each portion 2812A, 2812B of the medial body 2812.
  • the gripping features 2829 of the medial body portion 2812A may be different than the gripping features of medial body portion 2812B. In this manner, a surgeon or other user can determine an orientation of the guide 2810 by feel without being required to look at the guide.
  • the gripping features 2829 are formed on a portion of the guide 2810 that extends beyond the patient's anatomy when the guide 2810 is in a predetermined position in contact with the patient's anatomy.
  • the guide 2810 may further comprise attachment points formed in one or more of the medial body 2812, the cannulae 2816, and the legs 2824.
  • the attachment points are adapted to receive one or more secondary 2840 or tertiary cannulae 2850.
  • the cannulae 2840/2850 may include a bore 2820A or a cutting slot to guide an instrument to target another portion of the patient's anatomy.
  • the cannulae 2840, 2850 are adapted to target one or more predetermined portions of the cervical spine (i.e., Cl-Sl and ilium).
  • the attachment points comprise slots to receive extensions 2842 of the cannulae 2840, 2850.
  • the slots may also direct the path of a blade or other cutting instrument, or to receive a measurement aid or tool for facilitating the surgeon/user in identifying landmarks, surrounding boney anatomy, placement of implanted devices, or for surgical planning.
  • the guide 2810 may further comprise slots formed in the medial body 2812 or the cannulae 2816.
  • the slots may be the same as or similar to slots 1830.
  • the slots are adapted to direct the path of a blade or other cutting instrument in a manner similar to cutting slots 20-820 of all embodiments described herein.
  • the slots of guide 2810 may be adapted to receive the secondary 2840 or tertiary cannulae 2850 as further described in conjunction with Fig. 33.
  • the guide 2810 is adapted to receive a cutting guide 10 in a manner similar to guide 1810A illustrated in Fig. 27D.
  • the cutting guide 10 may be received by a slot formed in one or more of the medial body, cannulae, and legs.
  • the cutting guide 10 may be integrally formed with the guide 2810.
  • the guide 2810 may comprise individual pieces adapted to be assembled by a surgeon before, or during, a surgical procedure. In this manner, the guide 2810, or portions and components of the guide 2810 may be disassembled and reassembled by a surgeon. Additionally, one or more portions of the guide 2810, or the entire guide 2810, may be passed through a cannula of another tool and assembled during a minimally invasive surgical procedure. In one embodiment, one or more of the medial body 2812, cannulae 2816, legs 2824, and secondary/tertiary cannulae 2840, 2850 are releasably interconnected. In another embodiment, the medial body 2812 is formed as two separate portions 2812 A, 2812B. The portions 2812 A, 2812B may be individually positioned in contact with a predetermined feature of the patient's anatomy. Further, the portions are adapted to be interconnected at joint 2815.
  • one portion of the medial body 2812 includes a coupling adapted to releasably interconnect the individual portions 2812A, 2812B of the guide 2810 together.
  • the two portions 2812A, 2812B of the guide 2810 may be interconnected by positioning the coupling in a corresponding void in the other portion of the medial body.
  • the coupling may be held in the void by friction.
  • a biasing force may be provided to retain the coupling in the void.
  • the coupling and void comprise a snap.
  • the medial body portions 2812A, 2812B may include magnets.
  • the medial body portions 2812A, 2812B may be interconnected by a flexible or expandable member, such as a hinge or a biasing member of any type, including a spring. It will be appreciated by one of skill in the art that the medial body portions 2812A, 2812B may be interconnected by any other suitable means.
  • the guide 2810 is formed as one integral piece.
  • FIGs. 41A-41B another embodiment of a patient-specific guide
  • the guide 2910 is similar to guide 2810 and generally includes a medial body 2912 and a cannulae 2916.
  • the cannulae 2916 are the same as, or similar to, the cannulae 2816 and may include an extension 2919 and a bore 2920.
  • the extensions 2919 are generally expanded radially compared to the extension
  • the extensions 2919 cup around the patient's anatomy and the contact surfaces 2918 have a larger surface area than contact surfaces 2818. More specifically, the increased radial size of the extensions 2919 enable the contact surfaces 2918 to contact more variable bone surfaces of the patient.
  • the extensions 2919 are adapted to contact at least a portion of one or more of the patient' superior articular process and the pars.
  • the extensions 2919 A, 2919B can have similar or different shapes as needed based on the patient's anatomy. For example, extension 2919A wraps around a portion of the circumference of cannulae 2916A and extension 2919B wraps around the entire circumference of cannulae 2916B. Additionally, the radius of the extensions 2919 may be varied. In one embodiment, the radius of extension 2919A is different than extension 2919B.
  • the guide 2910 also includes a gripping feature 2929 of another embodiment of the present invention.
  • the gripping feature 2929 comprises a depression 2930 formed in a portion of the medial body 2912.
  • One or more protrusions 2932 may be associated with, or arranged around, the depression 2930.
  • the gripping feature 2929 includes three protrusions 2932; however, any number of protrusions 2932 may be used with the guide 2910.
  • the gripping feature 2929 on one side of the medial body has a different number of protrusions compared to the gripping feature 2929 on the other side of the medial body. In this manner, a surgeon can determine the orientation of the guide 2910 by touch.
  • the guide 2910 may also include indicia 2928 to identify a sequence of use or portions of the patient's anatomy with which the guide 2910 is to be used.
  • the indicia 2928 indicate the guide is adapted for use with the L4 vertebrae level of a patient's spine. It will be appreciated by one of skill in the art, any number and type of indicia 2928 can be provided associated with different portions of the patient's anatomy.
  • the indicia 2928 may also indicate a tool to be used, a direction of a cut to be performed, or a planned orientation or alignment of the guide 2910.
  • the guide 2910 may further comprise one or more indicia 2928 A for identifying the guide with a particular patient.
  • the guide 3010 is similar to guides 2810 and 2910 and generally includes a medial body 3012, legs 3024, cannulae 3016, and gripping features 3029 comprising a depression 3030 and protrusions 3032.
  • Patient specific contact surfaces 3018, 3025, 3026 may be formed on one or more of the cannulae 3016, legs 3024, and medial body 3026 the same as (or similar to) those on the guides 2810, 2910.
  • the legs 3024 extend from the medial body 3012 and a cannulae 3016 extends from each leg 3024.
  • the cannulae 3016 are illustrated extending from the legs 3024, alternatively the cannulae 3016 may extend from the medial body 3012.
  • the legs 3024 generally include a proximal portion 3024A interconnected to the medial body 3012 and a distal portion 3024B.
  • the proximal and distal portions 3024A, 3024B of the legs may have different slopes and may be non-linear. In this manner, the legs 3024 are adapted to be patient specific using the method of Fig. 2.
  • Each of the cannulae 3016 may include an extension 3019 and a bore 3020.
  • the bore 3020 is the same as any of the bores 1820, 1920, 2820, 2920 described herein.
  • the extensions 3019 are similar to the extensions 2919 and have an expanded radius compared to the extensions 2819. However, the extensions 3019 have a different alignment and shape compared to the extensions 2919. More specifically, as best seen in Fig. 42B, the extensions 3019 have contact surfaces 3018 that vary in length axially around the circumference of the cannulae 3016.
  • the extensions 3019, cannulae 3016, and the contact surfaces 3018 define a chamber or concavity 3034 proximate to the bore 3020.
  • a concavity 3036 similar to concavity 3034 may also be formed in the distal end of each leg 3024.
  • the concavities 3034, 3036 provide a focused contact between the patient specific contact surfaces 3018, 3025 of the cannulae 3016 and legs 3024 and the patient's anatomy. More specifically, without the concavities 3034, 3036, the smooth surfaces of the cannulae 3016 and/or legs 3024 may contact soft tissue of the patient that has not been cleaned from the bone. This contact may prevent proper alignment of the guide 3010.
  • the concavities 3034, 3036 prevent the cannulae 3016 and legs 3024 from contacting soft tissue that may not have been cleaned off of the bone. Accordingly, the concavities 3034, 3036 help ensure proper alignment of the guide 3010 with the targeted portion of the patient's anatomy.
  • the concavity 3034 of the cannulae 3016 may also receive and collect bone material created by a boring instrument, such as a drill bit, guided by the bore 3020. In this manner, bone material may exit a hole formed in bone of the patient and be received within the concavity 3034. The bone material created during the medical procedure is thus collected and does not push the guide 3010 away from the target portion of the patient's anatomy, ensuring that the guide 3010 remains in a predetermined orientation. In contrast, in some known bone drill guides, bone material created by a drill bit collects between the patient's bone and a distal portion of the drill guide, moving the bone drill guide out of a proper alignment.
  • the concavity 3034 also beneficially collects bone material for later reuse as described in U.S. Patent Application No. 9,216,063 which is incorporated herein by reference in its entirety.
  • the guide 3110 is similar to guides 2810, 2910, and 3010 and generally includes a medial body 3112, cannulae 3116, and legs 3124.
  • the cannulae 3116 may include a bore 3120 that is the same as bores 1820, 2820, 2920, or 3020. Extensions 3119 with an increased radius may be formed on each cannulae 3116 similar to the extensions 2919, 3019 of guides 2910, 3010.
  • Patient specific contact surfaces 3118, 3125 may be formed on one or more of the cannulae 3116 and legs 3124 as described herein in conjunction with guide 2810.
  • concavities may be formed at the distal ends of the cannulae 3116 and legs 3124 that are the same as, or similar to, the concavities 3034, 3036 of guide 3010.
  • the guide 3110 also includes at least one cutaway or aperture 3138, illustrated in Figs. 43 A, 43B, through the cannulae 3116.
  • the aperture 3138 intersects at least a portion of the bore 3120 and enables bone material to exit the cannula during drilling of the patient's bone. As a consequence, the bone material does not collect between the guide 3110 and the patient's anatomy, such as a vertebrae 4, which may potentially interfere with the alignment of the guide 3110.
  • apertures 3138 may be formed on each cannulae 3116 of the guide 31 10. Additionally, the apertures 3138 can be formed in different portions of the cannulae 3116 than illustrated in Fig. 43.
  • the apertures 3138 may also be formed to have a shape adapted to avoid anatomy of the patient, such as an adjacent vertebra. For example, the aperture may have one or more of a different length, width, and shape than illustrated in Fig. 43. In this manner, the apertures 3138 ensure the guide 3110 is in a predetermined alignment with a target portion of the patient's anatomy.
  • the guides 3210 generally includes a medial body 3212, cannulae 3216, legs 3224, and secondary legs 3242.
  • the secondary legs 3242 have contact surfaces 3225A adapted to contact predetermined portions of the patient's anatomy.
  • the contact surfaces 3225 A are formed in the same manner as contact surfaces 2818, 2825 of guide 2810. In one embodiment, the contact surfaces 3225 A are 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 lamina, pars, articular processes, and spinous process of the patient's anatomy 4.
  • the contact surfaces 3325, 3225A may be patient specific as described herein.
  • the contact surfaces 3225, 3225A of the legs may also include concavities the same as or similar to the concavity 3036 of guide 3010.
  • one or more of the cannulae 3216 have a length selected such that distal ends of the cannulae 3216 do not contact the patient's anatomy. Accordingly, as illustrated in Figs. 44B, 44C, the distal ends of the cannulae 3216 are separated by a predetermined distance from a vertebrae 4 of the patient when the guide is aligned with the vertebrae 4. This may be beneficial for several reasons and in a variety of situations.
  • the distal ends of the cannulae 3216 may be adapted to be separated from the patient's anatomy when the bores 3220 are oriented to target a portion of the vertebrae 4 that is not sufficiently strong to provide a support to the guide 3210.
  • the patient's anatomy proximate to a planned entry point may also be overgrown or irregularly shaped.
  • the guide 3210 may fit within a smaller incision width while still providing access to planned entry points that are laterally spaced from an area of soft tissue dissection compared to a guide in which the cannulae contact the patient's anatomy proximate to the planned entry points.
  • bone fragments created by a drill bit guided by the cannulae bores 3220 can exit from the bore hole without collecting between the vertebrae 4 and the guide 3210.
  • a portion of the cannulae may include an increased diameter and an associated concavity the same as, or similar to, the extension 3019 and concavity 3034 of guide 3010.
  • one or more of the cannulae 3216 may have an increased length such that the distal end of the cannulae 3216 contacts a predetermined portion of the patient's anatomy.
  • the distal end of the cannulae 3216 may include one or more of patient-specific contact surfaces, an extension, a concavity, and an aperture the same as, or similar to, contact surfaces 2818, 2918, 3018, 3118, extensions 2819, 2919, 3019, 3119, concavities 3034, and aperture 3138.
  • the bores 3220 may be used to guide instruments, including k-wires, inserts 1854, drills 3547, and patient specific fixation devices 3634 along predetermined trajectories with respect to the patient's anatomy 4.
  • the bores 3220 of the cannula 3216 are adapted to guide an instrument to cannulate the pedicle and remove bone.
  • FIGs. 44D-44F perspective views of another patient-specific guide 321 OA adapted to be positioned within an incision against a patient's boney anatomy are provided.
  • the guide 3210A is adapted for use in a surgical procedure involved a vertebrae 4 of a patient to guide instruments and fixation devices along one or more trajectories A, B.
  • the guide 3210A may be used to guide instruments and for placement of fixation devices in surgical procedures involving other boney anatomy of the patient.
  • the guide 321 OA is similar to the guide 3210 described in Figs. 44A-44C.
  • the guide 3210A generally includes one or more of a medial body 3212, legs 3224, and secondary legs 3242 that are the same as, or similar to, the medial body, legs, and secondary legs of guide 3210.
  • the guide 3210 may include one or more cannulae 3216.
  • the optional cannulae 3216 may further include a bore 3220 for placement of a temporary fixation pin to temporarily fix the guide 3210A to the patient's anatomy 4 during a surgical procedure.
  • the guide 321 OA may also include a grip feature 3229 and indicia 3228 the same as, or similar to, those of guide 3210.
  • Guide 321 OA also includes at least one external cannula 3250 (or "posterior cannula") associated with at least one internal cannula 3260 (or “anterior cannula”). Pairs of associated external and internal cannula 3250, 3260 are substantially collinearly aligned. After the guide 321 OA is positioned against the patient's anatomy 4 through a first incision, the internal cannula 3260 is targeted by the surgeon through a second incision in the patient's soft tissue. The internal cannula 3260 improves the mechanical guidance of instruments into the patient' s anatomy 4.
  • the external cannula 3250 are interconnected to a support element 3254.
  • the support element 3254 may be of any size.
  • the support element 3254 is sized to position the external cannula 3250 laterally beyond the width of the guide 3210 A.
  • the external cannula 3250 may optionally be releasably interconnectable to the medial body 3212.
  • the external cannula 3250 may include a projection 3256 adapted to be received within a corresponding slot 3213 formed in the guide 3210A.
  • the slot 3213 is formed in the medial body 3212 and is the same as (or similar to) one of the slots 1830 of guide 1810.
  • the internal cannula 3260 are interconnected to a portion of the guide 321 OA to be positioned within an incision through the patient's skin S.
  • the internal cannula 3260 are interconnected to a distal portion of the cannula 3216.
  • the internal cannula 3260 may optionally be interconnected to other portions of the guide 321 OA including the legs 3224 and/or the secondary legs 3242.
  • the external cannula 3250 include bores 3252 that are generally concentrically aligned with bores 3262 of the corresponding internal cannula 3260. Accordingly, in combination, corresponding pairs of external and internal cannula 3250, 3260 define a virtual cannula of an extended length.
  • the size of an incision required to position the guide 321 OA may be decreased compared to an incision required for a guide with a cannula of a length extending from the external cannula 3250 to the internal cannula 3260.
  • the internal cannula 3260 on a distal portion of the guide 321 OA proximate to the patient's anatomy, the center of gravity of the guide 321 OA is moved closer to the patient's anatomy 4.
  • the guide 3210A is docked low and stably on the patient's bone 4, improving the accuracy of k-wires and other instruments guided along trajectories A, B.
  • the bores cannula 3252, 3262 may be of any predetermined diameter.
  • the bores may receive one or more inserts 1854 described in conjunction with Fig. 27.
  • the cannula bores 3252, 3262 may guide one or more of a k- wire, a drill apparatus 3547 (such as described in Figs 54A-54G), and a patient specific fixation device 3634.
  • the internal cannula 3260 or other portion of the guide 321 OA may include a radiological marker.
  • a surgeon or other user may determine the location of the internal cannula 3260 using intraoperative radiation to guide insertion of an instrument sleeve into the bore 3262. Examples of radiolucent markers that may be used with the guide 3210A are described in U.S. Patent Application Publication No. 2013/0053680 which is incorporated herein in its entirety.
  • the internal cannula 3260 further include an aperture 3264.
  • the aperture 3264 forms a channel from the bore 3262 to an exterior of the internal cannula 3260.
  • the aperture 3264 is sized to allow a k-wire to pass through the aperture 3264 such that the guide 321 OA may be removed from the patient after a k-wire oriented by the guide 321 OA is positioned within the patient's anatomy.
  • the aperture 3264 comprises a slot that extends longitudinally from an exterior surface of the cannula 3260 to the bore 3262. As illustrated in one embodiment in Fig.
  • each corresponding pair of external and internal cannula 3250, 3260 may be aligned with a unique patient specific insertion trajectory A, B. Accordingly, the orientation of the external and internal cannula 3250, 3260 are derived from the data set(s) described above in conjunction with Figs. 1, 2.
  • the trajectories A, B are selected based on an orientation that will permit a fixation device or instrument to be inserted consistent with the location of a targeted portion of the patient's anatomy in a direction that avoids other portion's of the patient's anatomy.
  • the trajectories A, B are selected to permit a fixation device (such as a k-wire or pedicle screw) to be inserted consistent with the location of the pedicle and in a direction that avoids penetration of fixation device from the pedicle.
  • the trajectories A, B eliminate (or reduce) the possibility of the fixation device either extending through the pedicle or becoming inserted at an orientation that causes the fixation device to exit the side of the pedicle.
  • the trajectories A, B are generally divergent. However, in one embodiment, trajectories A, B may be parallel.
  • the guide 3210A is intended to be placed in position with the patient's anatomy 4 in a minimal access approach.
  • the guide 3210A may also be used in a minimally invasive surgical procedure.
  • the trajectories A, B of guide 321 OA are oriented to place fixation devices, such as screws, in pedicle screw trajectories percutaneously.
  • the trajectories A, B may be oriented to guide fixation devices in one or more other trajectories, including: (1) a cortical trajectory; (2) an SI alar trajectory; (3) an S2 alar trajectory; (4) and S2 alar iliac trajectory; and (5) an iliac trajectory percutaneously.
  • the surgeon makes a normal midline incision through the patient's skin S.
  • the incision is posterior to the vertebra 4 to be instrumented.
  • the bone is cleaned and/or prepared by methods known to those of skill in the art to receive the guide 321 OA.
  • the cleaning may include preparing one or more of the lamina, the articular processes (inferior and superior), the pars, the spinous process, and potentially the transverse process for contact by one or more patient specific portions of the guide 321 OA.
  • the guide 3210A can be placed at least partially within the incision in contact with the patient's vertebra 4.
  • the skin envelope may then be closed around the guide 321 OA.
  • at least a portion of the guide 3210A extends out of the incision external to the patient's skin S.
  • a portion of the medial body 3212 extends above the patient's skin S.
  • at least the external cannula 3250 are positioned external to the incision above the patient's skin S.
  • the internal cannula 3260 are positioned within the incision.
  • the surgeon then targets the internal cannula 3260 by one or more second incisions generally aligned with trajectories A, B.
  • the second incision may be formed by an instrument sleeve (or Jamshidi needle known to those of sill in the art) guided by the bore 3252 of the external cannula 3250 and through soft tissue.
  • the surgeon may use a medical imaging device to guide the instrument sleeve to the bore 3252.
  • the instrument sleeve is the same as, or similar to, one of the inserts 1854 described in Fig. 27.
  • the instrument sleeve may be a guide sleeve 210 or a drilling sleeve 249 as described in Fig. 7.
  • the instrument sleeve is advanced through the soft tissue until the sleeve contacts the bore 3262 of internal cannula 3260.
  • the sleeve is retained in the bore 3262 by an interference fit.
  • the sleeve may be retained in the bore 3262 by a threaded engagement.
  • the bore 3262 is threaded and engages a corresponding thread formed on an exterior surface portion of the instrument sleeve.
  • the instrument sleeve and the bore 3262 have corresponding cross-sectional shapes.
  • the bore 3262 has a cross-section of one of an oval, a triangle, a square, a star, or another shape that corresponds to a cross-section of the instrument sleeve.
  • the instrument sleeve and the bore 3262 have a locking engagement.
  • a first one of the instrument sleeve and the bore may include a feature that is selectively retained within a receptacle of a second one of the instrument sleeve and the bore.
  • the feature comprises a projection and the receptacle comprises a slot.
  • the surgeon can advance a k-wire (or drill bit, etc.) down a cannula of the instrument sleeve until the bone surface 4 has been contacted.
  • Linking an associated pair of external and internal cannula 3250, 3260 with an instrument sleeve provides intraoperative verification that a predetermined trajectory A, B has been located.
  • the instrument sleeve also prevents the k-wire from exiting the internal cannula through the cannula aperture 3264. Said another way, when the instrument sleeve is positioned within the bore 3262, the aperture 3264 is sealed by the instrument sleeve.
  • the k-wire may be used to cannulate the patient's anatomy 4.
  • the k-wire is used to cannulate the pedicle of the vertebrae 4.
  • the instrument sleeve is removed from the pair of external and internal cannula 3250, 3260.
  • the k-wire is still in place within the bore 3262 but the guide 321 OA needs to be removed.
  • the aperture 3264 allows the k-wire to disconnect from the guide 321 OA.
  • the guide 321 OA can be removed from the patient while leaving the k-wire seated in the pedicle.
  • the k-wire may then be used in subsequent procedures as will be appreciated by one of skill in the art.
  • guide 321 OB is substantially the same as guide 321 OA.
  • guide 321 OB generally includes one or more of a medial body 3212, legs 3224, secondary legs 3242, and external cannula 3250.
  • the guide 3210B may include one or more cannulae 3216 that can include bores 3220 for placement of a temporary fixation devices.
  • the guide 3210B may also include a grip feature 3229 and indicia 3228 the same as, or similar to, those of guide 3210.
  • guide 3210B is devoid of the internal cannula 3260.
  • the external cannula 3250 include bores 3252 to guide instruments or fixation devices along predetermined trajectories A, B.
  • the external cannula 3250 may be releasable interconnected to the guide 3210B as describe above.
  • the guide 3210B is used in a manner similar to guide 321 OA.
  • the guide 3210B is placed in a predetermined orientation in contact with the patient anatomy 4.
  • At least the external cannula 3250 are located external of the incision above the patient's skin S.
  • the surgeon guides an instrument or k-wire through the bore 3252 of the external cannula 3250 along trajectory A, B.
  • the external cannula 3250 helps the surgeon orient the instrument in the predetermined trajectory A, B as the surgeon verifies the correct entry point for the instrument or k-wire using anatomy landmarks according to current procedures known to those of skill in the art.
  • the external cannula 3250 generally guides the surgeon along the predetermined trajectory to the correct entry point.
  • the guide 3210B provides more freedom to the surgeon to manually confirm the trajectory and the entry point than the guide 321 OA.
  • the surgeon creates a first incision as described above.
  • the patient's anatomy 4 is cleaned and the guide 32 IOC is positioned in a predetermined alignment with respect to the patient's anatomy.
  • the surgeon then creates one or more second incisions through the patient's soft tissue and locates the interior cannula 3260 using freehand techniques known to those of skill in the art.
  • the second incisions may be formed using an instrument sleeve as described above in conjunction with guide 321 OA.
  • the instrument sleeve may then be received within the bore 3262 of the interior cannula 3260.
  • the instrument sleeve is retained in the bore 3262 by one or more of: an interference fit; a threaded engagement; and a matching cross-sectional shape.
  • the interior cannula 3260 provides guidance for one or more instruments, including k-wires, drills 3547, and patient specific fixation devices 3634 to be placed in the patient's anatomy 4 along the predetermined trajectories A, B.
  • the guide 3210C may subsequently be removed from the patient by passing the instrument through the aperture 3264.
  • the guide 3310 is adapted to be positioned proximate to a patient's ilium 8, as indicated by indicia 3328 that indicate a direction toward the sacral vertebrae SI and S2.
  • the guide 3310 is similar to guide 3210 and generally comprises a medial body 3312, cannulae 3316 including bores 3320, legs 3324, and secondary legs 3342.
  • the legs 3324, 3342 may each include patient specific contact surfaces the same as, or similar to, the contact surfaces 3225, 3225A.
  • distal ends of the cannulae 3316 do not contact the patient's anatomy.
  • one or more of the cannulae 3316 may include patient specific contact surfaces similar to the contact surfaces 2818 of guide 2810.
  • the secondary cannulae 3340 are oriented to guide an instrument in an S2-alar or an S2-alar-iliac trajectory.
  • the bores 3320A of the secondary cannulae 3340 are oriented to guide a drill bit to form a pilot hole in the S2-alar or an S2-alar-iliac trajectory.
  • these trajectories are similar to other trajectories described herein.
  • S2-alar trajectories have entry points in the S2 vertebra and trajectories that advance towards the sacral ala but remain within the sacrum and do not cross the sacroiliac joint.
  • the S2-alar-iliac trajectory crosses the sacroiliac joint.
  • the entry point for the S2-alar-iliac trajectory is in the S2 vertebra but the trajectory traverses the Sacroiliac joint and advances into the ilium to provide fixation/fusion of the sacroiliac joint.
  • the upper surfaces 3430, 3432 of the projections 3422, 3424 may not be parallel to the lower surfaces 3434, 3436. Further, the upper and lower surfaces may have different shapes. For example, and referring now to Fig. 47, the projections may taper as they extend distally away from the distal surface 3420 of the insert 3412.
  • a distal portion of the projection 3422 may have a first thickness 3446 substantially equal to, or slightly greater than, a thickness of an implant.
  • a proximal portion of the projection 3422 may have a second thickness 3448 that is greater than the first thickness 3446 and greater than the thickness of the implant. In this manner, a surgeon may "over distract" the adjacent vertebrae. The over distraction facilitates easier and safer access to the intervertebral space, placement of the implant, and generates lordosis or other planned correction of the patient's anatomy.
  • the slot 3458 can have any shape determined to guide cuts for a planned removal of a portion of each of the adjacent vertebrae of the particular patient.
  • the slot may have a shape to guide instruments to provide straight, concave, convex, or other shaped cuts.
  • the bores 3428 may be used to deliver graft material into the intervertebral space.
  • the bores are operable to conduct bone graft material and other substances from a surgical tool, such as a syringe, to a predetermined portion of the intervertebral space.
  • interbody guide 3410 and its components are equally practical and considered within the scope of the 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 interbody guide may be used pre-surgically on models of the patient's anatomy to test or practice the planned surgical procedure.
  • a model of the patient's anatomy may be formed, such as the model 2 described above in conjunction with Fig. 1 or any of the models 1002, 1102, 1202, 1302, 1402, 2402.
  • the interbody guide 3410 may be tested using the models to plan the surgical procedure and to provide a visual and tactile representation of the correction of the patient's spine provided by the guide 3410.
  • the model may also include representations of supplemental fixation devices planned to be used in the surgical procedure. In this manner, the model may be used with the interbody guide 3410 to ensure the guide and the supplemental fixation devices do not interfere with each other.
  • the surgeon can use the model to preoperatively test the guide. After placing the interbody guide on the model, the surgeon may determine that the shape of the guide should be adjusted or that the orientation or location of the supplemental fixation devices should be altered.
  • the interbody guide 3410 may also be used with any variety of tools used to prepare or alter an intervertebral space. Additionally, any variety of implants or devices may be delivered through the aperture 3426 of the insert 3412 to the intervertebral space. Examples of implants that may be used with the interbody guide are described in, but not limited to, U.S. Patent No. 8,734,515, U.S. Patent Application Publication No. 2014/0257313, and U.S. Patent Application Publication No. US 2016/0007983 which are each incorporated herein in their entirety.
  • the data sets for the surgical procedures may be loaded into the drill to limit the operation of the drill 3547.
  • end-stops such as limitations on extension of the drill bit
  • other safety related features including preventing operation of the drill when an incorrect drill bit is associated with a guide or cannula
  • the data sets are loaded into a card slot 3570 as illustrated in Fig. 54D.
  • the display indicates that the user is to "Load Mem.” or "memory" for programming the drill or achieving other functionality described herein.
  • a flash-drive or memory card 3571 can also be loaded with information and accepted by (i.e., downloaded to) the memory and processor housed within the drill body 3550.
  • the drill 3547 may accept one or more types of external devices, such as memory cards 3571, for downloading information to be accessed and/or used by the processor.
  • the drill 3547 may include a communications module to communicate wirelessly with a communication system. Accordingly, the drill 3547 may receive data wirelessly by one or more of BluetoothTM, Wifi, WIMAXTM, and NFC connection to an external data source.
  • the drill apparatus 3547 may comprise a hard stop to prevent penetration of the drill bit 3564 into the anatomical feature by limiting the extension of the drill bit 3564 from the drill body 3550 and out of the bore 3562.
  • the amount of extension of the drill bit 3564 is programmable and may be pre-determined before the drill apparatus 3547 is to be used.
  • the drill 3547 improves patient safety, in part by reducing the risk of anterior breaches during certain surgical procedures requiring the use of drilling apparatus.
  • the display 3568 may be touch sensitive and can include a graphical user interface with user selectable icons. In this manner, the user may control the extension of the drill bit 3564 and other features of the drill. For example, as illustrated in Fig. 54E, the display 3568 indicates that the drill 3547 has been programmed to extend the drill bit 3564, the "Drill To" indicia, by an amount of 35 mm. Further, the display 3568 indicates a current extension of the drill bit 3564 is 35 mm with the "Depth" indicia. The drill bit 3564 is shown in hidden lines having formed a bore 3580 in a patient's anatomical feature V.
  • the display 3568 may present various parameters or other information of importance to the user.
  • the display 3568 may present one or more of a speed (in RPMs) of the drill bit 3564, an amount of power or torque applied by the motor to the drill bit, and a measurement of the resistance encountered by the drill bit.
  • the display 3568 may be located in another portion of the body 3550.
  • the display 3568 may be centrally located in the drill body 3550 or closer to the drill sleeve 3558.
  • the user may adjust the operation of the drill 3547 by the touch sensitive display 3568. More specifically, the user may adjust the extension of the drill bit, the power applied by the motor, or the speed of rotation of the drill bit by using the display 3568.
  • the drill 3547 may then limit the extension of the drill bit 3564 to the depth of a bore 3580 planned to be formed in the patient's anatomy in association with the particular cannula.
  • Fig. 54G the drill 3547 is illustrated in a position of use with a guide 3110 previously described in conjunction with Fig. 43E.
  • the sensor 3574 of the drill 3547 may sense data associated with the guide 3110.
  • the sensor 3574 reads one of the indicia associated with the guide, such as an RFID, a barcode, or a visual indicia 3128 that identifies the particular guide and/or components of the guide. In this manner, the drill 3547 may be "keyed" to the guide and control the depth and other features of bores 3580 planned to be formed with one or more cannula of the guide.
  • the processor of the drill may use the information from the sensor 3574 to determine an identity of the guide 3110.
  • the processor of the drill 3547 may retrieve data associated with the guide 3110 as well as the patient to determine a location and orientation of the guide 3110 with respect to the patient's anatomy.
  • the retrieved data may indicate depths of bore's planned to be formed by the drill bit 3564 and guided by the cannula 3116.
  • the retrieved data may also provide maximum amounts the drill bit 3564 should extend for each cannula 3116A, 3116B as well as a particular drill bit 3564 to be used with each of the cannula.
  • the retrieved data may indicate an alignment of the drill with respect to the guide and/or the patient's anatomy 4 as well as an axis of a bore 3580 to be formed by the drill.
  • the processor of the drill may determine if the drill is in the predetermined alignment with respect to the patient's anatomy 4 before and/or during a drilling procedure.
  • the drill 3547 may light up different colors to match the trajectories of the patient specific surgical plan on the display 3568 such that the current level to be drilled would be displayed on the display 3568 at any given time.
  • the display 3568 indicates that the guide 3110 is associated with the "LI" vertebrae 4 of the patient.
  • the drill 3547 may then control extension of the drill bit 3564 as planned during pre-surgical planning used to create the guide 3110.
  • the sleeve 3558 contained within the drill 3547 advances into the bore 3120 of the cannula 3116B to prevent the drill bit 3564 from contacting the guide 3110.
  • the user may then press a button 3572 or an icon on the user interface of the display 3568.
  • the processor can send a signal to the motor to rotate and advance the drill bit 3564.
  • the drill bit 3564 is then advanced as described above.
  • the processor of the drill 3547 may determine from sensor data or signal received from the motor that the drill is slipping or moving out of alignment with a predetermined trajectory.
  • the drill bit 3564 may initially deflect or move out of alignment.
  • the processor may receive a signal from the motor indicating that the RPMs are greater than expected indicating that the drill bit 3564 has not entered the targeted bone but is instead spinning along an exterior surface of the bone.
  • the processor may also receive data from sensors, such as an alignment sensor, indicating that the drill bit 3564 has movement out of alignment with respect to the planned bore or the patient's anatomy 4.
  • a sensor may also be associated with the drill bit 3564 to determine if the drill bit is rotating at a rate equivalent to the rotation of the motor.
  • the sensor data may also indicate that the drill bit 3564 is vibrating or otherwise operating in an unexpected manner.
  • the processor may send a signal to the motor to stop rotation of the drill bit 3564.
  • the processor may send a signal to an actuator associated with the drill bit 3564 to move the drill bit in a cyclic fashion axially in and then out of the sleeve distal end 3560. In this manner, the drill bit 3564 generates a pocket that acts as a better seat for the tip of the drill bit.
  • the processor may vary the rate of the cyclic movement of the drill bit. In one embodiment, the processor may move the drill bit in an out cyclically at up to 100 cycles per minute. The cyclic movement of the drill bit may be pre-planned based on the patient information.
  • the processor advances the drill bit 3564 axially until the drill bit contacts the patient's anatomy 4 to zero (or calibrate) the depth of the drill bit in relation to the patient's anatomy 4.
  • the processor may then send a signal to the motor to rotate the drill bit 3564 at a predetermined number of rotations per minute.
  • the processor may send a signal to an actuator to advance the drill bit axially up to the predetermined depth.
  • the drill 3547 may further comprise a setting that achieves an "auto zero" when the drill bit 3564 contacts a certain hardness of materials, for example, cortical bone.
  • the drill may further comprise an automatic shut off if a second material density is contacted by the drill bit, such as in the event the bone face of a patient is pierced.
  • the processor may stop extension of the drill bit 3564 at a pre-determined depth associated with the particular guide 3110, the imported patient data, or both.
  • the display 3568 of Fig. 54G indicates the planned extension of the drill bit 3564 for cannula 3116B is 25 mm.
  • the current depth of the drill bit is 5mm into the LI vertebrae 4.
  • the drill 3547 may prevent operation when the drill bit 3564 installed is not correct for a planned for use with a particular guide, such as the guide 3110. In another embodiment, the drill 3547 may prevent operation when an improper drill bit is installed when the drill 3547 is brought into contact with a cannula. For example, procedures planned for use with cannula 3116A and 3116B of guide 3110 may require different drill bits. Accordingly, the processor may prevent operation of the drill 3547 with cannula 3116B if the wrong drill bit is installed in the drill, such as a drill bit planned for use with cannula 3116 A.
  • embodiments of the drill 3547 may be used in conjunction devices that employ automated or semi -automated manipulation.
  • Embodiments of the drill 3547 may also be designed such that the drill may be formed and verified, for example, remotely by an operator, remotely by an operator through a computer controller, by an operator using proportioning devices, programmatically by a computer controller, by servo-controlled mechanisms, by hydraulically-driven mechanisms, by pneumatically-driven mechanisms or by piezoelectric actuators.
  • CNC computerized numerical control
  • the drill body 3550 is sized to be held by a surgeon.
  • the drill 3547 is associated with, or controlled by, a robot used to perform a surgical procedure.
  • the drill 3547 may include a battery such that no external power cords are required during drilling operations.
  • fixation devices 3634 of embodiments of the present invention are illustrated. Variations and combinations are disclosed in Figures 55A-F, and illustrate at least several embodiments of this portion of the disclosure.
  • the fixation devices 3634 generally comprise a head 3636, a shank 3640, a thread element 3642, and a porous element 3646.
  • the fixation devices 3634 comprise screws, such as pedicle screws.
  • the fixation devices 3634 may be used with any of the guides described herein.
  • the fixation devices 3634 may optionally include patient specific elements such as porous elements 3646 designed for a specific patient.
  • the fixation device 3634 may be a manufactured as a single part, fixed angle screw, or may be poly-axial.
  • only a portion of the screw 3634 is manufactured to include the porous element 3646.
  • the exposed porous aspects 3646 of the screw 3634A may be localized along the minor diameter 3644 of the thread element 3642.
  • the screw shank 3640 may therefore comprise hollow, porous, or solid core elements to allow for varying levels of implant stiffness. These areas may be surrounded by a mostly solid thread form 3642 to facilitate smooth implantation of the screw 3634.
  • the inner member 3650 may be removed from the shank 3640C to expose a channel or cannula 3658C.
  • the cannula 3658C may be at least partially accessible from the screw head 3636C and optionally extends from the proximal portion 3654 of the shank 3640C through the distal end 3656 of the shank.
  • the cannula 3658C may be used to introduce the osteogenic agents through the fixation device 3634C, such as to portion of a bore 3580 formed by a drill 3547.
  • the cannula 3658C may also be used to guide a k-wire or other fixation devices.
  • the porous elements 3646 are preferably exposed at specific regions of the fixation devices 3634 to aid with osteo-integration and increase the mechanical stability of the fixation devices 3634. Accordingly, and referring now to Fig. 55D, the exposed porous element 3646 may be located on the proximal portion 3654 of the screw 3634D, adjacent the screw head 3636, in order to localize ingrowth. Localization of ingrowth is intended to increase mechanical characteristics of the bone-screw interface and subsequently allow for easier removal of the screw 3634D in the case of revision surgery.
  • the localized porous elements 3646 may be tapered outward to increase the interference fit of the porous elements with the surrounding anatomy.
  • the porous elements 3646 are representative of porous cancellous bone with porosity.
  • the pours elements 3646 may have any porosity selected to substantially match the porosity of a section of the patient's anatomy in which the fixation device 3634 will be placed.
  • the porosity preferably ranges from between about 30% to about 80% to allow for ingrowth of osteocytes and supporting vasculature.
  • the porous element 3646 may be regular and geometric or irregular in form.
  • the density of the porous element 3646 may be homogenous throughout the screw 3634.
  • the screw 3634 may have a heterogeneous porous element 3646 in order to attain desired stiffness and or improve the structural interface of the solid and porous elements.
  • the fixation devices 3634 enable bony ingrowth through the porous section/portion 3646 of the fixation devices 3634, and thereby facilitate biocompatibility and improve biomechanical characteristics.
  • the porous elements 3646 of the fixation device 3634 may be designed to more closely resemble that of normal patient anatomy. Bony ingrowth in turn facilitates increased screw pullout strength, and may reduce the risk of loosening of a fixation device 3634 under dynamic loading situations.
  • the fixation devices 3634 of the present invention are an improvement over known fixation devices, such as pedicle screws, which are subject to relatively high failure rates which is often attributed to a failure of the bone-screw interface.
  • such devices may be further optimized with respect to the unique data associated with the patient, such that the device may be matched with specific devices for use during the surgical procedure, or oriented around the patient's own anatomy to achieve, for example, one or more desired insertional trajectories (which may be verified in a pre-operative setting).
  • Variations on this step, and the inclusion or exclusion of additional steps described herein are expressly contemplated by the present disclosure. While various embodiments of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims. For further illustration, the information and materials supplied with the provisional and non-provisional patent applications from which this application claims priority are expressly made a part of this disclosure and incorporated by reference herein in their entirety.
  • the fusion cages of the present invention are particularly well-suited for implantation into the spinal column between two target vertebrae, and although much of the discussion of the present invention is directed toward their use in spinal applications, advantages offered by embodiments of the present invention may also be realized by implantation at other locations within a patient where the fusion of two or more bony structures may be desired.
  • the present invention has applications in the general field of skeletal repair and treatment, with particular application to the treatment of spinal injuries and diseases. It should be appreciated, however that the principles of the present invention can also find application in other areas.
  • a patient could be either a human patient or an animal patient, and the apparatus and methods described herein apply equally to veterinary science as they would to surgical procedures performed on human anatomy.
  • the apparatus and methods described herein therefore have application beyond surgical procedures used by spinal surgeons, and the concepts may be applied to other types of "patients” and procedures without departing from the spirit of the present disclosure.
  • the present inventions include components, methods, processes, systems and/or apparatuses substantially as depicted and described herein, including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present inventions after understanding the present disclosure.
  • the present inventions include providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and ⁇ or reducing cost of implementation.

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EP16856238.7A 2015-10-14 2016-10-14 Patientenabgestimmte vorrichtung und verfahren zur durchführung von chirurgischen eingriffen Withdrawn EP3361959A4 (de)

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US14/883,299 US9642633B2 (en) 2010-06-29 2015-10-14 Patient-matched apparatus and methods for performing surgical procedures
US201662287134P 2016-01-26 2016-01-26
US201662362440P 2016-07-14 2016-07-14
US201662373855P 2016-08-11 2016-08-11
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KR20180077182A (ko) 2018-07-06
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