IP Library Granted Patent US 12,636,163
Granted Patent B2
US 12,636,163 · App. 19/249,682 · Granted May 26, 2026

Patient-specific spinal fusion devices and associated systems and methods

Inventors: Jeremy Winston (San Diego, CA); Kyle Seaman (Vista, CA); Josh Barkhimer (Vista, CA); Alexander Roeca (San Diego, CA); Jade Sommers (Lemon Grove, CA); Niall Patrick Casey (Carlsbad, CA)
Assignee: Carlsmed, Inc.
A61F2/4455A61F2/30749A61F2002/30787A61F2002/30952
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Quick Facts
Patent No.
US 12,636,163
App. No.
19/249,682
Granted
May 26, 2026
Kind
B2
Abstract

The present technology includes patient-specific spinal fusion devices, which may include an interbody implant that is designed to be positioned within a disc space between two vertebral bodies and one or more fixation elements that can anchor the interbody implant to the vertebral bodies. The fusion devices include one or more retention mechanisms for retaining the fixation elements within corresponding lumens or bore holes extending through the interbody implant. Methods for designing and manufacturing patient-specific spinal fusion devices are also described herein.

Claims (101)

1 . A patient-specific spinal fusion device, the device comprising:

an interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, the interbody implant including—

a superior surface configured to contact an inferior surface of the superior vertebral body,

an inferior surface configured to contact a superior surface of the inferior vertebral body, and

an anterior surface;

a first lumen extending through the implant between a first aperture in the anterior surface and a second aperture in the superior surface, wherein the first lumen is configured to receive a first fixation element for anchoring the implant to the superior vertebral body;

a second lumen extending through the implant between a third aperture in the anterior surface and a fourth aperture in the inferior surface, wherein the second lumen is configured to receive a second fixation element for anchoring the implant to the inferior vertebral body;

a rotatable retention mechanism configured to retain the first fixation element and the second fixation element in the implant, the rotatable retention mechanism including—

a head defining one or more drive features for rotating the retention mechanism,

a shaft extending from the head and into to the implant, and

a ridge extending partially around a circumference of the shaft; and

a retention mechanism lumen configured to receive the shaft, wherein the retention mechanism lumen includes a channel extending partially around a circumference of the lumen for receiving the ridge,

wherein the rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture, and wherein a degree of rotation between the unlocked configuration and the locked configuration is defined based at least in part on the ridge and the channel.

2 . The device of claim 1 wherein the ridge has a first circumferential length and the channel has a second circumferential length greater than the first circumferential length such that the ridge can rotate within the channel.

3 . The device of claim 2 wherein a difference between the first circumferential length and the second circumferential length defines the degree of rotation between the unlocked configuration and the locked configuration.

4 . The device of claim 1 wherein the ridge extends around between about 90 degrees and about 270 degrees of the circumference of the shaft, and wherein the channel extends around between about 180 degrees and about 325 degrees of the circumference of the retention mechanism lumen.

5 . The device of claim 1 wherein the ridge extends around about 180 degrees of the circumference of the shaft, and wherein the channel extends around about 270 degrees of the circumference of the retention mechanism lumen.

6 . The device of claim 5 wherein shaft is configured to rotate about 90 degrees between the unlocked configuration and the locked configuration.

7 . The device of claim 1 wherein:

the ridge extends between a first surface and a second surface; and

the channel extends between a first channel wall and a second channel wall,

wherein—

when the retention mechanism is in the unlocked configuration, the first surface is proximate the first channel wall, and

when the retention mechanism is in the locked configuration, the second surface is proximate the second channel wall.

8 . The device of claim 7 wherein:

the first channel wall permits the retention mechanism to rotate in only a first direction when the retention mechanism is in the unlocked position,

the second channel wall permits the retention mechanism to rotate in only a second direction when the retention mechanism is in the locked position, and

the first direction is opposite the second direction.

9 . The device of claim 1 wherein the ridge has a height that is between about 20% and about 80% of a diameter of the shaft.

10 . The device of claim 1 wherein the patient-specific spinal fusion device is configured to provide a patient-specific correction to a patient's spine when the patient-specific spinal fusion device is implanted in the patient.

11 . The device of claim 1 wherein the patient-specific spinal fusion device is an ALIF device.

12 . A patient-specific spinal fusion device, the device comprising:

an interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, the interbody implant including—

a superior surface configured to contact an inferior surface of the superior vertebral body,

an inferior surface configured to contact a superior surface of the inferior vertebral body, and

an anterior surface;

a first lumen extending through the implant between a first aperture in the anterior surface and a second aperture in the superior surface, wherein the first lumen is configured to receive a first fixation element for anchoring the implant to the superior vertebral body;

a second lumen extending through the implant between a third aperture in the anterior surface and a fourth aperture in the inferior surface, wherein the second lumen is configured to receive a second fixation element for anchoring the implant to the inferior vertebral body;

a rotatable retention mechanism configured to retain the first fixation element and the second fixation element in the implant, the rotatable retention mechanism including—

a head defining one or more drive features for rotating the retention mechanism, and

a shaft extending from the head and into to the implant, wherein the shaft includes a projection extending transverse to a longitudinal axis of the shaft; and

a retention mechanism lumen configured to receive the shaft, wherein the retention mechanism lumen includes at least a first groove and a second groove,

wherein the rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture and in which the projection is in the first groove, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture and in which the projection is in the second groove.

13 . The device of claim 12 wherein the projection is configured to at least partially restrict rotational movement of the retention mechanism when the projection is in the first groove or the second groove.

14 . The device of claim 12 wherein the unlocked configuration and the locked configuration are relatively low energy states, and wherein the device is configured such that transitioning the retention mechanism between the unlocked configuration and the locked configuration includes passing the retention mechanism through a relatively higher energy state.

15 . The device of claim 12 wherein the retention mechanism lumen includes a third groove, and wherein the rotatable retention mechanism is rotatable through an intermediate configuration between the unlocked configuration and the locked configuration, and wherein the projection is in the third groove when the retention mechanism is in the intermediate configuration.

16 . The device of claim 12 wherein the shaft includes at least two prongs spaced at least partially apart by a gap.

17 . The device of claim 16 wherein the projection is formed on at least one of the two prongs.

18 . The device of claim 16 wherein each of the at least two prongs includes a projection.

19 . The device of claim 16 wherein the at least two prongs include a back surface configured to abut a step of the retention mechanism lumen.

20 . The device of claim 12 wherein the patient-specific spinal fusion device is configured to provide a patient-specific correction to a patient's spine when the patient-specific spinal fusion device is implanted in the patient.

21 . The device of claim 12 wherein the patient-specific spinal fusion device is an ALIF device.

22 . A spinal implant comprising:

a patient-specific intervertebral spacer having a one-piece unitary spacer body including:

a first face configured to contact a first endplate of a first vertebra of a patient,

a second face configured to contact a second endplate of a second vertebra of the patient,

a sidewall, and

a first anchor channel extending from the sidewall to the first face, wherein a contoured portion of the first face surrounds an exit opening of the first anchor channel, wherein the contoured portion has irregular contours configured to match contours of a contoured region of the first endplate, and wherein a tubular sidewall defining a continuous surface that extends from an entrance opening at the sidewall to the exit opening; and

a first screw configured to extend through the first anchor channel, out the exit opening, and into the first vertebra such that the first screw fixedly holds the contoured portion against of the contoured region of the first endplate,

wherein the one-piece unitary spacer body has a dense load-bearing portion and a porous portion coupling the tubular sidewall to the dense load-bearing portion, and

wherein the dense load-bearing portion is configured to bear a majority of the loading applied by a spine of the patient when the patient stands upright.

23 . The spinal implant of claim 22 , wherein the contoured portion comprises layers of material that define an endplate contact surface at the first face, and wherein the layers of material are fused, melted, and/or bonded together.

24 . The spinal implant of claim 22 , wherein a mass of the dense load-bearing portion is majority of the total mass of the one-piece unitary spacer body.

25 . The spinal implant of claim 22 , wherein the one-piece unitary spacer body further includes a second anchor channel extending from the sidewall to the second face, the spinal implant further including:

a retention mechanism rotatably coupled to the one-piece unitary spacer body and rotatable between an unlocked position for allowing the first screw to be inserted into the first anchor channel and a second screw to be inserted into the second anchor channel and a locked position for captively holding the first and second screws in the first and second anchor channels, respectively.

26 . The spinal implant of claim 22 , wherein the one-piece unitary spacer body is asymmetrical with respect to a mid-sagittal plane of the one-piece unitary spacer and is asymmetrical with respect to a transverse plane of the one-piece unitary spacer.

27 . A spinal implant comprising:

a patient-specific intervertebral spacer having a unitary spacer body, including:

a superior face configured to contact a first endplate of a first vertebra of a patient,

an inferior face configured to contact a second endplate of a second vertebra of the patient,

an anterior face, and

a first anchor channel extending between the anterior face and the superior face, wherein—

a contoured portion of the superior face surrounds an exit opening of the first anchor channel, wherein the contoured portion has irregular contours configured to match contours of the first endplate, and

a continuous lumen extending from an entrance opening at the anterior face to the exit opening; and

a first fixation element configured to extend through the lumen, out the exit opening, and into the first vertebra such that the first fixation element fixedly holds the contoured portion against of the first endplate,

wherein the unitary spacer body has a dense load-bearing portion and a lattice structure extending between at least a portion of the first anchor channel and the dense load-bearing portion.

28 . The spinal implant of claim 27 , wherein the dense load-bearing portion includes:

a left corner solid portion between the superior face and the inferior face, and a right corner solid portion between the superior face and the inferior face.

29 . The spinal implant of claim 27 , wherein the dense load-bearing portion is between the entrance opening and at least one of the superior face or the inferior face.

30 . The spinal implant of claim 27 , wherein the unitary spacer body further includes a second anchor channel extending between the anterior face and the inferior face, and wherein the inferior face includes a contoured portion surrounding an exit opening of the second anchor channel that has irregular contours configured to match contours of the second endplate.

31 . The spinal implant of claim 27 , further comprising a retention mechanism coupled to the unitary spacer body and moveable between an unlocked position for allowing the fixation element to be inserted into the first anchor channel and a locked position for captively holding the fixation element in the first anchor channel.

32 . The spinal implant of claim 27 , wherein the unitary spacer body is asymmetrical with respect to a mid-sagittal plane of the unitary spacer body and is asymmetrical with respect to a transverse plane of the unitary spacer body.

33 . A spinal implant comprising:

a patient-specific intervertebral spacer having a unitary spacer body, including:

a first face configured to contact a first endplate of a first vertebra of a patient, the first face including a first contoured portion surrounding a first aperture in the first face, wherein the first contoured portion has first irregular contours configured to mate with a corresponding first contouring of the first endplate;

a second face configured to contact a second endplate of a second vertebra of the patient;

an anterior face having a second aperture; and

an anchor channel extending between the second aperture in the anterior face and the first aperture in the superior face, wherein the anchor channel includes a tubular wall defining a continuous lumen between the first aperture and the second aperture, and wherein the anchor channel is configured to receive a fixation element to fixedly hold the first contoured portion of the first face against the corresponding first contouring of the first endplate,

wherein the unitary spacer body has a dense load-bearing portion and a lattice structure positioned between at least a portion of the anchor channel and the dense load-bearing portion.

34 . The spinal implant of claim 33 , wherein the dense load-bearing portion defines a load-bearing perimeter extending along the anterior face and defining a portion of the anchor channel.

35 . The spinal implant of claim 33 , wherein a mass of the dense load-bearing portion is a majority of the total mass of the unitary spacer body.

36 . The spinal implant of claim 33 , wherein the unitary spacer body is asymmetrical with respect to a transverse plane of the unitary spacer body.

37 . The spinal implant of claim 33 , wherein the anchor channel is a first anchor channel, and wherein:

the unitary spacer body further includes a second anchor channel extending between a third aperture in the anterior face and a fourth aperture in the second face,

the second face includes a second contoured portion surrounding the fourth aperture, the second contoured portion having second irregular contours configured to mate with a corresponding second contouring of the second endplate, and

the second anchor channel is configured to receive a second fixation element to fixedly hold the second contoured portion against the corresponding second contouring of the second endplate.

38 . The spinal implant of claim 33 , wherein the dense load-bearing portion includes a solid portion extending between at least a portion of the second aperture and at least one of the superior face or the inferior face.

39 . The spinal implant of claim 33 , wherein the dense load-bearing portion includes:

a left corner solid portion between the superior face and the inferior face, and

a right corner solid portion between the superior face and the inferior face.

40 . The spinal implant of claim 33 , further comprising a means for retaining the fixation element positioned in the anchor channel.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 22, 2025
From: WINSTON, JEREMY; SEAMAN, KYLE; BARKHIMER, JOSH; ROECA, ALEXANDER; SOMMERS, JADE; CASEY, NIALL PATRICK
To: CARLSMED, INC.
Reel/Frame 072644/0944 →
Continuity (3)
Continuation PCTUS2024010202 · Jan 3, 2024
Provisional Application 63436860 · Jan 3, 2023
Related Publication 20250318936A1 · Oct 16, 2025
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