Patient-specific spinal implants and related systems and methods

• US 8,246,680 B2
• Filed: 05/25/2007
• Issued: 08/21/2012
• Est. Priority Date: 05/25/2006
• Status: Expired due to Fees

• Current Assignee: MiMedx Processing Services LLC (Mimedx Group Incorporated)
• Original Assignee: Spinemedica, LLC (Mimedx Group Incorporated)
• Inventors: Betz, Randal, Denoziere, Guilhem
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/753,755
• Publication Number:
  US 20070276501A1
• Time in Patent Office: 1,915 Days
• Field of Search: 606/130, 623 1714- 17, 623/15, 623/17.11, 600/425, 600/594
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• 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 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30943 using mathematical models
• 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 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Methods and systems for generating custom implants by programmatically analyzing a patient'"'"'s image data to electronically obtain shapes and dimensions of relevant anatomical features of a target region of the patient; and fabricating a patient-specific replacement implant for the patient using the analyzed patient image data. Related patient-specific spinal implants are also described.

Claims

1. A method for generating custom implants, comprising:

programmatically analyzing a patient'"'"'s image data to electronically obtain shapes and dimensions of relevant anatomical features of a target region of the patient;

displaying an electronic model of a spinal implant based on the programmatically analyzing step;

accepting user input to electronically modify the model with a change in at least one of shape, size and material formulation of moldable material for the molded spinal implant; and

displaying a modified electronic model based on the user input with a corresponding change in anatomical structure in an anatomical model of the patient'"'"'s spine to thereby allow a user to view potential therapeutic outcomes or affect on a patient using different models of the spinal implant;

then

fabricating a patient-specific replacement, non-articulating molded spinal implant for the patient using the analyzed patient image data, wherein the molded spinal implant has a molded custom 3-D bone interface surface that has contours that match excisable natural bone at a contact surface of adjacent local bone of the patient.

2. A method according to claim 1, wherein the programmatically analyzing step comprises analyzing patient image data of superior and inferior vertebral endplates associated with the at least one target disc space, and wherein the fabricating step comprises molding the intervertebral total disc replacement implant with superior and inferior surfaces having the custom 3-D bone interface surface with contours that match excisable bone and engage superior and inferior vertebral endplate surfaces, respectively.

3. A method according to claim 1, wherein the spinal implant comprises at least one total disc replacement implant, the method further comprising programmatically defining a mold configuration for generating a single-use disposable mold to fabricate the patient-specific total disc replacement spinal implant using the analyzed patient image data, and wherein the fabricating step comprises molding the disc replacement spinal implant using the defined mold.

4. A method according to claim 1,

wherein the spinal implant is a replacement disc, and wherein the displaying the modified electronic model comprises electronically graphically simulating a post-surgical affect on (i) posture, height and -wedge angle or (ii) at least a wedge angle on the patient'"'"'s spinal column using the model of the spinal implant replacement disc.

5. A method according to claim 4, wherein the simulating comprises accepting user input to allow a clinician to modify at least one of a lateral wedge angle or a thickness of selected features to view changes in therapeutic effect.

6. A method according to claim 1, further comprising:

electronically determining 3-D surface contours of vertebral endplates at the at least one target disc level to be treated using the patient image data.

7. A method according to claim 1, wherein the programmatically analyzing step comprises:

obtaining medical image data of a patient'"'"'s lumbar spine;

measuring relevant dimensions of at least one healthy intervertebral disc based on the medical image data;

measuring relevant dimensions of at least one vertebrae based on the medical image data; and

measuring relevant dimensions of a level of degeneration of at least one intervertebral disc (“

IVD”

) to be treated based on the medical image data.

8. A method according to claim 7, wherein the displaying the electronic model is a model of the patient'"'"'s lumbar spine generated using the obtained medical image data and measured dimensions.

9. A method according to claim 8, wherein the spinal implant is an IVD implant, and wherein the accepting user input is carried out to electronically adjust the obtained shape, the obtained dimensions or the obtained shape and dimensions of the patient'"'"'s IVD implant based on a desired therapeutic outcome, wherein the displaying the modified electronic model includes electronically displaying simulations of the anatomical model of the patient'"'"'s lumbar spine, in response to virtual placement of different IVD implant shapes in the anatomical model.

10. A method according to claim 9, further comprising simulating restoring a desired height and wedge angle of a disc space of the patient based on the adjusted shape and dimensions.

11. A method according to claim 1, wherein the patient-specific implant is an arthroplasty implant comprising an elastomeric body.

12. A method according to claim 1, wherein the implant is a non-articulating elastomeric implant devoid of rigid endplates with a custom moldable material formulation for selected mechanical properties based on the patient to provide locally increased or decreased hardness at a superior or inferior surface of the implant to thereby comply with bone density or bone strength of the patient or bone density and bone strength of the patient.

13. A method according to claim 1, wherein the implant comprises crystalline polyvinylalcohol hydrogel.

14. A method according to claim 1, further comprising, before the fabricating step, accepting clinician input to adjust stiffness and flexibility of the custom molded implant at local bone interface regions, wherein the stiffness and flexibility is defined by a mold material used for the molded implant.

15. A method according to claim 1, further comprising accepting clinician input to define a patient-specific implant configuration with locally softer or more flexible regions relative to other regions in a superior or inferior surface defined by the molded implant to thereby comply with the bone density/strength of the patient at the interface with the implant.

16. A method for generating custom spinal implants, comprising:

programmatically analyzing a patient'"'"'s image data to electronically obtain shapes and dimensions of relevant anatomical features of a spinal region of the patient;

electronically defining an electronic model of a molded implant using the analysis of the patient image data;

accepting user input to adjust the electronic model of the molded implant including to electronically select different moldable material formulations for the electronic model of the molded implant to define at least one of the following;

stiffness, hardness, flexibility, compression, tensile strength, torsional strength, or locally increased or decreased hardness at an inferior or superior surface, to thereby further customize the implant to the patient;

electronically displaying different electronic models of the molded implant, with at least one of (i) different sizes, (ii) different shapes, (iii) different shapes and sizes, or (iv) different material formulations, in an anatomical model of the patient'"'"'s spine in a manner that shows a change in spine alignment or position based on the different implant models; and

electronically defining a configuration of a single-use custom mold with an enclosed mold cavity shape based on a user selected electronic model of the molded implant.

17. A method according to claim 16, further comprising fabricating a patient-specific replacement non-articulating molded spinal implant for the patient using the custom mold, wherein the implant has molded superior and inferior custom 3-D bone interface surfaces that substantially match surface contours of adjacent local bone of the patient.

18. A method according to claim 16, wherein the implant is a total disc replacement implant, and wherein the electronically displaying step comprises displaying electronic simulations of post-surgical anatomical changes in a patient'"'"'s spine using the different electronic models of the molded implant.