PATIENT-MATCHED APPARATUS AND METHODS FOR PERFORMING SURGICAL PROCEDURES

• US 20170135706A1
• Filed: 01/26/2017
• Published: 05/18/2017
• Est. Priority Date: 06/29/2010
• Status: Active Grant

• Current Assignee: Mighty Oak Medical Inc
• Original Assignee: Mighty Oak Medical Inc
• Inventors: Voelkel, Caleb, Kana, Gregory Cooke, Starkman, Sean, Frey, George, Lai, Geoff
• Granted Patent: US 9,987,024 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/151 for corrective osteotomy
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1732 for bone breaking devices
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7013 the shape of the element being adjustable before use adjustable length plates A61B17/7014
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7043 with a longitudinal element fixed to one or more transverse elements which connect multiple screws or hooks
• CPC Class Codes: A61B 17/7047 Clamps comprising opposed elements which grasp one vertebra between them
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/7074 Tools specially adapted for spinal fixation operations other than for bone removal or filler handling A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2017/00022 : Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00115 : with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00526 : Methods of manufacturing
• CPC Class Codes: A61B 2017/00725 : Calibration or performance testing
• CPC Class Codes: A61B 2017/0256 : for the spine
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2017/568 : produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/102 : Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 : Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 : Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/108 : Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2090/036 : abutting on tissue or skin
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 2090/067 : for measuring angles
• CPC Class Codes: A61B 2090/0807 : Indication means
• CPC Class Codes: A61B 34/10 : Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 50/20 : Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/33 : Trays
• CPC Class Codes: A61B 90/90 : Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61F 2/30965 : Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/44 : for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4405 : for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/4687 : Mechanical guides for implantation instruments
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00059 : Chromium or Cr-based alloys
• CPC Class Codes: G09B 23/30 : Anatomical models G09B23/281 - G09B23/288 take precedence

Abstract

A system and method for developing customized apparatus, such as guides, for use in one or more surgical procedures is disclosed. The system and method incorporates a patient'"'"'s unique anatomical features or morphology, which may be derived from capturing MRI data or CT data, to fabricate at least one custom apparatus or guide. According to a preferred embodiment, the customized apparatus comprises at least one patient-specific surface and or contour, which may be derived from MRI or CT data. Apparatus may be matched in duplicate and oriented around the patient'"'"'s own anatomy, and may further provide any desired axial alignments or insertional trajectories. In an alternate embodiment, the apparatus may further be aligned and/or matched with at least one other apparatus during the surgical procedure.

Claims

1. A surgical device that mates with an anatomical feature of a particular patient, comprising:

a body having a proximal end and a distal end, wherein the distal end is configured to be positioned adjacent the anatomical feature;

a first leg with a first patient-specific surface adapted to anatomically mate with at least one contour of the anatomical feature within a first incision; and

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 external cannulae is positioned substantially outside of the first incision and the first bore guides an instrument through a second incision aligned with the first trajectory.

2. The surgical device of claim 1, wherein the first patient-specific surface is determined from and complementary to the patient'"'"'s anatomy.

3. The surgical device of claim 1, wherein the first trajectory is oriented along one of:

(1) a cortical bone trajectory;

(2) a pedicle screw trajectory;

(3) a cortical trajectory;

(4) a sacral pedicle trajectory;

(5) a sacral alar trajectory;

(6) an S2-alar-iliac trajectory; and

(7) an iliac trajectory.

4. The surgical device of claim 1, wherein the first cannulae is releasably interconnected to the body.

5. The surgical device of claim 1, wherein the instrument comprises one or more of a k-wire, an instrument sleeve, an insert, a drill, a Jamshidi needle, and a patient-specific fixation device.

6. The surgical device of claim 1, further comprising a second internal cannulae with a second bore substantially concentric with the first bore to guide the instrument in the first trajectory, wherein, when the surgical device mates with the anatomical feature, the second internal cannulae is positioned within the first incision.

7. The surgical device of claim 6, wherein the first and second cannulae are configured to allow removal of the surgical device from the first incision while the instrument remains in place along the first trajectory.

8. The surgical device of claim 6, wherein the second cannulae comprises a patient-specific surface adapted to anatomically mate with at least one contour of the anatomical feature.

9. The surgical device of claim 1, wherein the first cannulae is releasably interconnected to the body.

10. The surgical device of claim 1, further comprising a third cannulae including a third bore having a second trajectory, the third cannulae to guide a fixation device to be interconnected to the anatomical feature.

11. The surgical device of claim 10, wherein the third cannulae comprises a patient-specific surface adapted to anatomically mate with at least one contour of the anatomical feature within the first incision.

12. The surgical device of claim 1, wherein the surgical device is configured for use in conjunction with a navigation device such that placement of the surgical device with respect to the anatomical feature assists with one or more of registration, stability, and motion tracking by the navigation device.

13. A surgical device formed by using anatomical data for a specific patient, comprising:

a body configured to be positioned near an anatomical feature of the patient;

a first contact surface configured to be positioned on a first portion of the anatomical feature within a first incision; and

a first internal cannulae with a first bore having a first trajectory that intersects a portion of the anatomical feature, wherein, when the first contact surface is positioned on the first portion, the first internal cannulae is positioned within the first incision and the first bore is aligned to guide an instrument advanced along the first trajectory through a second incision.

14. The surgical device of claim 13, wherein the first cannulae is releasably interconnected to the body.

15. The surgical device of claim 13, wherein the first cannulae is configured to allow removal of the surgical device from the first incision while the instrument remains in place along the first trajectory.

16. The surgical device of claim 13, further comprising a second, releasably interconnectable cannulae with a second bore substantially concentric with the first bore to guide the instrument in the first trajectory, wherein, when the surgical device mates with the anatomical feature, the second cannulae is positioned substantially externally to the first incision.

17. The surgical device of claim 13, further comprising a second contact surface configured to be positioned on a second portion of the anatomical feature.

18. A surgical device that utilizes anatomic landmarks of a patient, comprising:

a body with a proximal portion and a distal portion;

a first contact element with a patient-matched surface that is substantially congruent to a first surface of an anatomical feature of the patient, the first contact element configured to be positioned at least partially within a first incision; and

a first cannulae with a first bore having a first trajectory that intersects a portion of the anatomical feature, the first bore configured to guide an instrument advanced through a second incision when the patient-matched surface of the first contact element is positioned on the first surface.

19. The surgical device of claim 18, wherein, when the first contact element is positioned on the first surface, the first cannulae is configured to be positioned one of:

within the first incision; and

substantially outside of the first incision.

20. The surgical device of claim 18, further comprising:

a second cannulae with a second bore substantially concentric with the first bore to guide the instrument in the first trajectory such that;

when the first cannulae is configured to be positioned within the first incision, the second cannulae is configured to be positioned substantially outside of the first incision; and

when the first cannulae is configured to be positioned substantially outside of the first incision, the second cannulae is configured to be positioned inside the first incision.