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US-12622785-B2 - Systems and methods for orthopedic implants

US12622785B2US 12622785 B2US12622785 B2US 12622785B2US-12622785-B2

Abstract

A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.

Inventors

  • Niall Patrick Casey
  • Michael J. Cordonnier

Assignees

  • CARLSMED, INC.

Dates

Publication Date
20260512
Application Date
20230622

Claims (20)

  1. 1 . A method comprising: sending at least one image of a patient to a computer system programmed to perform an orthopedic implant design process for achieving a planned orthopedic correction, the orthopedic implant design process including: generating a virtual model representing anatomy of the patient based on anatomy of interest in the at least one image; manipulating one or more spatial relationships between anatomic elements of the virtual model to generate a corrected virtual model of the patient; and after manipulating the one or more spatial relationships, filling a negative space between the anatomic elements of the corrected virtual model with a virtual orthopedic implant; and displaying, via a display, at least a portion of the corrected virtual model and one or more metrics associated with the portion of the corrected virtual model.
  2. 2 . The method of claim 1 , wherein the one or more metrics includes: a first set of pre-corrective pathologic anatomy metrics for the patient, and a second set of post-corrections corrected anatomy metrics for the patient.
  3. 3 . The method of claim 1 , further comprising displaying, via the display: a pathology virtual model representing pre-correction pathology and associated pre-correction anatomic metrics; and the corrected virtual model representing at least one planned anatomical correction and associated planned post-correction anatomic metrics.
  4. 4 . The method of claim 3 , further comprising displaying, via the display, a visual comparison of the pathology virtual model and the corrected virtual model.
  5. 5 . The method of claim 3 , wherein the pathology virtual model representing the anatomy of the patient based on segmented images of the anatomy of interest.
  6. 6 . The method of claim 1 , wherein the computer system is programmed to identify one or more implant locations along the virtual model for an anatomical correction, wherein the method further includes: displaying the identified implant locations along the corrected virtual model representing the planned orthopedic correction.
  7. 7 . The method of claim 1 , further comprising generating one or more parameters of the virtual orthopedic implant based on relative positions of the anatomic elements of the corrected virtual model.
  8. 8 . The method of claim 1 , further comprising receiving user input for treating the patient, wherein manipulating the one or more spatial relationships between the anatomic elements is based on the received user input.
  9. 9 . The method of claim 1 , wherein manipulating the one or more spatial relationships includes positioning the anatomic elements at positions corresponding to a spinal correction.
  10. 10 . The method of claim 1 , further comprising: sending user-inputted approval of the planned orthopedic correction prior to manufacturing the virtual orthopedic implant.
  11. 11 . The method of claim 1 , wherein the virtual orthopedic implant design process further includes: creating a 3D model of the virtual orthopedic implant based on the filling of the negative space; converting the 3D model into 3D fabrication data; and manufacturing at least a portion of the virtual orthopedic implant based on the 3D fabrication data.
  12. 12 . A system comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising: sending at least one image of a patient to a computer system programmed to perform an orthopedic implant design process for achieving a planned orthopedic correction, the orthopedic implant design process including: generating a virtual model representing anatomy of the patient based on anatomy of interest in the at least one image; manipulating one or more spatial relationships between anatomic elements of the virtual model to generate a corrected virtual model of the patient; and after manipulating the one or more spatial relationships, filling a negative space between the anatomic elements of the corrected virtual model with a virtual orthopedic implant; and displaying, via a display, at least a portion of the corrected virtual model and one or more metrics associated with the portion of the corrected virtual model.
  13. 13 . The system of claim 12 , wherein the one or more metrics includes: a first set of pre-corrective pathologic anatomy metrics for the patient, and a second set of post-corrections corrected anatomy metrics for the patient.
  14. 14 . The system of claim 12 , further comprising displaying, via the display: a pathology virtual model representing pre-correction pathology and associated pre-correction anatomic metrics of the patient; and the corrected virtual model representing at least one planned anatomical correction and associated planned post-correction anatomic metrics.
  15. 15 . The system of claim 12 , after manipulating the one or more spatial relationships, generating one or more parameters of the virtual orthopedic implant based on at least one relative position of the anatomic elements.
  16. 16 . A non-transitory computer-readable storage medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising: sending at least one image of a patient to a computer system programmed to perform an orthopedic implant design process for achieving a planned orthopedic correction, the orthopedic implant design process including: generating a virtual model representing anatomy of the patient based on anatomy of interest in the at least one image; manipulating one or more spatial relationships between anatomic elements of the virtual model to generate a corrected virtual model of the patient; and after manipulating the one or more spatial relationships, filling a negative space between the anatomic elements of the corrected virtual model with a virtual orthopedic implant; and displaying, via a display, at least a portion of the corrected virtual model and one or more metrics associated with the portion of the corrected virtual model.
  17. 17 . The non-transitory computer-readable storage medium of claim 16 , wherein the one or more metrics includes: a first set of pre-corrective pathologic anatomy metrics for the patient, and a second set of post-corrections corrected anatomy metrics for the patient.
  18. 18 . The non-transitory computer-readable storage medium of claim 16 , wherein the operations further comprise displaying: a pathology virtual model representing pre-correction pathology and associated pre-correction anatomic metrics of the patient; and the corrected virtual model representing at least one planned anatomical correction and associated planned post-correction anatomic metrics.
  19. 19 . The non-transitory computer-readable storage medium of claim 16 , wherein the operations further include after manipulating the one or more spatial relationships, generating one or more parameters of the virtual orthopedic implant based on at least one relative position of the anatomic elements.
  20. 20 . The non-transitory computer-readable storage medium of claim 16 , further comprising: sending user-inputted approval of a planned correction to manufacture the virtual orthopedic implant.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 18/071,555, filed Nov. 29, 2022 (U.S. Pat. No. 11,717,412), which is a continuation of U.S. application Ser. No. 16/569,494, filed Sep. 12, 2019 (U.S. Pat. No. 11,696,833), which claims priority to and the benefit of U.S. Provisional Patent Application No. 62/730,336, filed Sep. 12, 2018, which are hereby incorporated by reference in their entireties. FIELD OF THE INVENTION The field of the invention generally relates to orthopedic implants, including spinal implants, and methods for designing and producing them. BACKGROUND Orthopedic implants are used to correct a variety of different maladies. Orthopedic surgery utilizing orthopedic implants may include one of a number of specialties, including: spine surgery, hand surgery, shoulder and elbow surgery, total joint reconstruction (arthroplasty), skull reconstruction, pediatric orthopedics, foot and ankle surgery, musculoskeletal oncology, surgical sports medicine, and orthopedic trauma. Spine surgery may encompass one or more of the cervical, thoracic, lumbar spine, or the sacrum, and may treat a deformity or degeneration of the spine, or related back pain, leg pain, or other body pain. Irregular spinal curvature may include scoliosis, lordosis, or kyphosis (hyper- or hypo-), and irregular spinal displacement may include spondylolisthesis. Other spinal disorders include osteoarthritis, lumbar degenerative disc disease or cervical degenerative disc disease, lumbar spinal stenosis or cervical spinal stenosis. Spinal fusion surgery may be performed to set and hold purposeful changes imparted on the spine during surgery. Spinal fusion procedures include PLIF (posterior lumbar interbody fusion), ALIF (anterior lumbar interbody fusion), TLIF (transverse or transforaminal lumbar interbody fusion), or LLIF (lateral lumbar interbody fusion), including DLIF (direct lateral lumbar interbody fusion) or XLIF (extreme lateral lumbar interbody fusion). The goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants). BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a variety of traditional interbody implants. FIG. 2 shows a representation of a spine with a pathological deformity such as adult degenerative scoliosis. FIG. 3 shows a representation of a typical surgical implant kit containing stock implants delivered to spinal surgery. FIG. 4 shows a representation of a typical stock implant including several views. FIG. 5 shows a representation of a spine with a pathological deformity that has been surgically corrected with traditional stock interbodies. FIG. 6 shows isolated lumbar vertebrae and coordinate systems to guide adjustment of relative positions between vertebrae. FIG. 7 shows a representation of a patient specific-implant and packaging as delivered to spinal surgery. FIG. 8 shows a representation of a spine with a pathological deformity that has been surgically corrected with patient-specific interbodies. FIG. 9 shows a representation of a surgical planning user interface. FIG. 10 shows a representation of a surgical planning user interface with tools to enable relative adjustments of vertebrae positioning. FIG. 11 shows a representation of a lumbar spine with the negative space between the vertebrae highlighted. FIG. 12 shows the details of an individual negative space resulting from the adjustment of the relative positions of the vertebrae. FIG. 13 shows the details of an individual patient-specific implant designed to fill at least a portion of the negative space including bi-planar angulation and endplate topography. FIG. 14 shows the contents of one embodiment of a patient-specific surgical implant kit, including implants and implant inserter. FIG. 15 shows three lumbar vertebrae and highlighted vertebral endplates. FIG. 16 shows top and side views of a vertebra. FIG. 17 illustrates a system for providing assistance for manufacturing a patient specific-implant. FIG. 18 is a flow diagram illustrating a method for manufacturing an implant in accordance with an embodiment. FIG. 19 is a flow diagram illustrating a method for manufacturing an implant in accordance with another embodiment. DETAILED DESCRIPTION A patient-specific medical device and an efficient method of producing a patient-specific interbody implant is described in the embodiments herein. Devices according to embodimen