Granted Patent B1

US 12,636,158 · App. 19/354,023 · Granted May 26, 2026

Inventors: Niall Patrick Casey (Carlsbad, CA); Gregory Mundis (La Jolla, CA)

Assignee: Carlsmed, Inc.

A61F2/30942A61B34/10A61F2/447A61B2034/105A61B2034/108A61F2002/30952A61F2002/30953

Abstract

Claims (63)

1 . A computer-implemented method for designing a patient-specific lumbar implant assembly for a patient, the method comprising:

receiving, at a computer system, image data of a lumbar region of a spine of the patient;

generating, using the computer system, a virtual model of the lumbar region based at least in part on the image data;

manipulating, using the computer system, a spatial relationship between a first vertebra and a second vertebra within the virtual model of the lumbar region to reflect a planned surgical correction to the lumbar region;

measuring from the virtual model, using the computer system, a spinal metric of the lumbar region with the planned surgical correction, wherein the spinal metric includes one or more of a lumbar lordosis, a pelvic incidence, or a Cobb angle; and

in response to the measured spinal metric complying with a predetermined criteria, designing, using the computer system, the patient-specific lumbar implant assembly to achieve the planned surgical correction when implanted in the lumbar region of the patient, wherein designing the patient-specific lumbar implant assembly includes—

designing a patient-specific cage sized and shaped to be positioned at a first target position in an intervertebral space between the first vertebra and the second vertebra, the patient-specific cage having a first patient-specific topography designed to mate with contouring of the first vertebra and the second vertebra when seated at the first target position, and

designing a patient-specific plate sized and shaped to be positioned at a second target position at which a first portion of the patient-specific plate engages an anterior or lateral surface of the first vertebra or the second vertebra, and a second portion of the patient-specific plate extends at least partially into the intervertebral space between the first vertebra and the second vertebra to engage the patient-specific cage, wherein the first portion has a second patient-specific topography designed to mate with contouring of the anterior or lateral surface of the first vertebra or the second vertebra,

wherein the patient-specific implant assembly is configured such that placing the patient-specific plate at the second target position causes the second portion of the patient-specific plate to direct the patient-specific cage into the first target position.

2 . The method of claim 1 wherein designing the patient-specific lumbar implant assembly includes:

designing the patient-specific cage to form a generally gapless interface with the first and second vertebra when the patient-specific plate is placed at the second target position, and

designing the patient-specific plate to form a generally gapless interface with the anterior or lateral surface of the first or the second vertebra when the patient-specific plate is seated at the second target position.

3 . The method of claim 1 , further comprising automatically comparing, using the computer system, the measured spinal metric to the predetermined criteria, wherein the predetermined criteria includes a predetermined minimum value and/or a predetermined maximum value for the spinal metric.

4 . The method of claim 3 , further comprising:

in response to the measured spinal metric not complying with the predetermined criteria, further manipulating, using the computer system, the virtual model to redesign the planned surgical correction until the measured spinal metric complies with the predetermined criteria.

5 . The method of claim 1 , further comprising:

causing, using the computer system, the measured spinal metric and the virtual model to be stored on a remote server;

retrieving, using the computer system, the measured spinal metric and the virtual model;

further manipulating, using the computer system, the virtual model to display a revised planned surgical correction; and

automatically redesigning, using the computer system, the patient-specific lumbar implant assembly to provide the revised planned surgical correction.

6 . A computer-implemented method for designing a patient-specific implant assembly for a patient, the method comprising:

receiving, at a computer system, image data of a spinal region of a spine of the patient;

generating, using the computer system, a virtual model of the spinal region based at least in part on the image data;

manipulating, using the computer system, a spatial relationship between a first vertebra and a second vertebra within the virtual model of the spinal region to reflect a planned surgical correction to the spinal region;

measuring from the virtual model, using the computer system, a spinal metric of the spinal region with the planned surgical correction; and

in response to the measured spinal metric complying with a predetermined criteria, designing, using the computer system, the patient-specific implant assembly to achieve the planned surgical correction when implanted in the spinal region of the patient, wherein designing the patient-specific implant assembly includes—

designing a patient-specific cage sized and shaped to be positioned at a first target position in an intervertebral space between the first vertebra and the second vertebra, the patient-specific cage having a first patient-specific topography designed to mate with contouring of the first vertebra and the second vertebra when seated at the first target position, and

designing a patient-specific plate sized and shaped to be positioned at a second target position at which a first portion of the patient-specific plate engages an anterior or lateral surface of the first vertebra or the second vertebra, and a second portion of the patient-specific plate extends at least partially into the intervertebral space between the first vertebra and the second vertebra to engage the patient-specific cage, wherein the first portion has a second patient-specific topography designed to mate with contouring of the anterior or lateral surface of the first vertebra or the second vertebra,

wherein the patient-specific implant assembly is configured such that placing the patient-specific plate at the second target position causes the second portion of the patient-specific plate to direct the patient-specific cage into the first target position.

7 . The method of claim 6 wherein designing the patient-specific implant assembly includes:

designing the patient-specific cage to form a generally gapless interface with the first and second vertebra when the patient-specific plate is placed at the second target position, and

designing the patient-specific plate to form a generally gapless interface with the anterior or lateral surface of the first or the second vertebra when the patient-specific plate is seated at the second target position.

8 . The method of claim 6 , further comprising automatically comparing, using the computer system, the measured spinal metric to the predetermined criteria, wherein the predetermined criteria includes a predetermined minimum value and/or a predetermined maximum value for the spinal metric.

9 . The method of claim 8 , further comprising:

in response to the measured spinal metric not complying with the predetermined criteria, further manipulating, using the computer system, the virtual model to redesign the planned surgical correction until the measured spinal metric complies with the predetermined criteria.

10 . The method of claim 6 , further comprising:

causing, using the computer system, the measured spinal metric and the virtual model to be stored on a remote server;

retrieving, using the computer system, the measured spinal metric and the virtual model;

further manipulating, using the computer system, the virtual model to display a revised planned surgical correction; and

automatically redesigning, using the computer system, the patient-specific implant assembly to provide the revised planned surgical correction.

11 . The method of claim 6 wherein designing the patient-specific plate includes designing the second portion of the patient-specific plate to include a rigid interface between the patient-specific plate and the patient-specific cage.

12 . The method of claim 11 wherein the rigid interface includes a screw, a bolt, a rivet, or a key-and-slot mechanism.

13 . The method of claim 6 wherein the patient-specific implant assembly further includes a fastener configured to cause the patient-specific plate to engage with the patient-specific cage.

14 . A computer-implemented method for designing a patient-specific implant assembly for a patient, the method comprising:

receiving, at a computer system, image data of a spine of the patient;

generating, using the computer system, a virtual model of the spine based at least in part on the image data;

manipulating, using the computer system, a spatial relationship between a first vertebra and a second vertebra within the virtual model of the spine to reflect a planned surgical correction to the spine; and

designing, using the computer system, the patient-specific implant assembly to achieve the planned surgical correction when implanted in the spine of the patient, wherein designing the patient-specific implant assembly includes—

designing a patient-specific cage sized and shaped to be positioned at a first target position in an intervertebral space between the first vertebra and the second vertebra, the patient-specific cage having a first patient-specific topography designed to mate with contouring of the first vertebra and the second vertebra when seated at the first target position, and

designing a patient-specific plate sized and shaped to be positioned at a second target position at which a first portion of the patient-specific plate engages an anterior or lateral surface of the first vertebra or the second vertebra, and a second portion of the patient-specific plate extends at least partially into the intervertebral space between the first vertebra and the second vertebra to engage the patient-specific cage, wherein the first portion has a second patient-specific topography designed to mate with contouring of the anterior or lateral surface of the first vertebra or the second vertebra,

wherein the patient-specific implant assembly is configured such that placing the patient-specific plate at the second target position causes the second portion of the patient-specific plate to direct the patient-specific cage into the first target position.

15 . The method of claim 14 wherein designing the patient-specific implant assembly includes:

designing the patient-specific cage to form a generally gapless interface with the first and second vertebra when the patient-specific plate is placed at the second target position, and

designing the patient-specific plate to form a generally gapless interface with the anterior or lateral surface of the first or the second vertebra when the patient-specific plate is seated at the second target position.

16 . The method of claim 14 wherein designing the patient-specific plate includes designing the second portion of the patient-specific plate to include a rigid interface between the patient-specific plate and the patient-specific cage.

17 . The method of claim 16 wherein the rigid interface includes a screw, a bolt, a rivet, or a key-and-slot mechanism.

18 . The method of claim 14 wherein the patient-specific implant assembly further includes a fastener configured to cause the patient-specific plate to engage with the patient-specific cage.

19 . The method of claim 14 wherein the patient is a particular patient, the method further comprising:

accessing a reference patient data set corresponding to one or more reference patients different from the particular patient, wherein the reference patient data set includes data representative of the one or more reference patients' anatomy and/or pathology,

wherein the patient-specific implant assembly is designed based at least in part on the reference patient data set.

20 . The method of claim 19 , further comprising:

determining a similarity score between the one or more reference patients and the particular patient, wherein the similarity score is based on a comparison of the anatomy and/or pathology of the one or more reference patients with an anatomy and/or pathology of the particular patient; and

selecting the one or more reference patients based on the similarity score meeting or exceeding a threshold similarity score.

Assignments (1)

Continuity (1)

References Cited (377)