IP Library Granted Patent US 11,707,302
Granted Patent B2
US 11,707,302 · App. 17/182,476 · Granted Jul 25, 2023

Interspinous spacers and associated methods of use and manufacture

Inventors: Andy Wonyong Choi (Irvine, CA); Kim Thien Nguyen (Oceanside, CA); Robert Leslie Richards (Hamden, CT)
Assignee: Howmedica Osteonics Corp.
A61B17/7047A61B17/7065A61B17/7074
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Quick Facts
Patent No.
US 11,707,302
App. No.
17/182,476
Granted
Jul 25, 2023
Kind
B2
Abstract

Systems, devices, and methods for treating the spine are disclosed herein. Medical devices can be positioned along a subject's spine to treat various conditions and diseases. The medical device can include an actuator assembly and a clamp assembly. The actuator assembly can be positioned at an interspinous space between a superior spinous process and an inferior spinous process. The actuator assembly can be used to reconfigure the clamp assembly such that the clamp assembly clamps onto the superior and inferior spinous processes.

Claims (33)

1. A spacer, comprising:

an actuator assembly including an actuator body having a longitudinal axis and an actuator rotatable about the longitudinal axis, a portion of the actuator assembly arranged to be inserted between a superior spinous process and an inferior spinous process of a subject such that the longitudinal axis is generally parallel to a sagittal plane of the subject; and

a clamp assembly including:

a first wing having a first surface and a first engagement feature extending from the first surface; and

a second wing having a second surface and a second engagement feature extending from the second surface,

wherein at least one of the first or second wings is moveable relative to the actuator body within a first plane to transition the clamp assembly between a first configuration and a second configuration, and wherein the at least one of the first or second wings is further moveable relative to the actuator body within a second plane transverse to the first plane to transition the clamp assembly between the second configuration and a third configuration in which the first and second engagement features engage the superior and inferior spinous processes.

2. The spacer of claim 1 , wherein rotation of the actuator about the longitudinal axis moves the clamp assembly from the first configuration to the second configuration to position the at least one of the first or second wings relative to the superior spinous process and the inferior spinous process.

3. The spacer of claim 1 , wherein the first and second planes are perpendicular to one another.

4. The spacer of claim 1 , wherein the at least one of the first or second wings moves towards the actuator body when the clamp assembly moves from the second configuration to the third configuration.

5. The spacer of claim 1 , wherein, with the clamp assembly in the third configuration, the first and second wings clamp onto the superior spinous process and the inferior spinous process and fix the superior spinous process and the inferior spinous process relative to one another.

6. A system, comprising:

a delivery instrument including a working end; and

a spacer, comprising:

an actuator assembly including an actuator body having a longitudinal axis and an actuator, the actuator body arranged to be inserted between a superior spinous process and an inferior spinous process of a subject such that the longitudinal axis is generally parallel to a sagittal plane of the subject, the actuator configured to engage a portion of the working end of the delivery instrument and arranged to rotate about the longitudinal axis of the actuator body; and

a clamp assembly including:

a first wing having a first surface and a first engagement feature extending from the first surface; and

a second wing having a second surface and a second engagement feature extending from the second surface,

wherein at least one of the first or second wings is moveable relative to the actuator body within a first plane to transition the clamp assembly between a first configuration and a second configuration, and wherein the at least one of the first or second wings is further moveable relative to the actuator body within a second plane transverse to the first plane to transition the clamp assembly between the second configuration and a third configuration in which the first and second engagement features engage the superior and inferior spinous processes.

7. The system of claim 6 , wherein rotation of the actuator about the longitudinal axis moves the clamp assembly from the first configuration to the second configuration to position the at least one of the first or second wings relative to the superior spinous process and the inferior spinous process.

8. The system of claim 6 , wherein the first and second planes are perpendicular to one another.

9. The system of claim 6 , wherein the at least one of the first or second wings moves towards the sagittal plane of the subject when the clamp assembly moves from the second configuration to the third configuration.

10. The system of claim 6 , wherein, with the clamp assembly in the third configuration, the first and second wings clamp onto the superior spinous process and the inferior spinous process and fix the superior spinous process and the inferior spinous process relative to one another.

11. The system of claim 6 , wherein the actuator assembly convers rotational motion of the actuator into linear motion of the at least one of the first or second wings.

12. A method for delivering a spacer including an actuator assembly and a clamp assembly into a subject comprising the steps of:

inserting a portion of the actuator assembly between a superior spinous process and an inferior spinous process of the subject, the actuator assembly having a rotatable actuator;

rotating the actuator about a sagittal axis of the subject to move at least one of a first wing or a second wing of the clamp assembly relative to the actuator assembly and within a first plane to transition the clamp assembly from a first configuration to a second configuration; and

moving the at least one of the first wing or the second wing relative to the actuator assembly within a second plane transverse to the first plane to transition the clamp assembly from the second configuration to a third configuration such that the first and second wings engage the superior spinous process and the inferior spinous and fix the superior and inferior spinous processes relative to one another.

13. The method of claim 12 , wherein the rotating step includes positioning the first wing of the clamp assembly along a first side of the superior spinous process and a first side of the inferior spinous process and positioning the second wing of the clamp assembly along a second side of the superior spinous process and a second side of the inferior spinous process.

14. The method of claim 12 , wherein the first wing and the second wing are provided with at least one protrusion that engages with at least one of the superior and inferior spinous processes when the clamp assembly is in the third configuration.

15. The method of claim 12 , wherein the rotating step is performed after the inserting step.

16. The method of claim 12 , wherein the rotating step is performed with a delivery instrument oriented in an anterior-posterior direction.

17. The method of claim 12 , wherein each of the first and second wings include a planar surface and the planar surfaces have the same angulation relative to one another in both the second configuration and the third configuration.

18. The method of claim 12 , wherein the at least one of the first wing or the second wing translates relative to the actuator assembly during the moving step.

Assignments (5)
SECURITY INTEREST Recorded Aug 8, 2025
From: K2M, INC.; VB SPINE US OPCO LLC
To: TEXAS CAPITAL BANK, AS COLLATERAL AGENT
Reel/Frame 072340/0397 →
PATENT SECURITY AGREEMENT Recorded Jun 16, 2025
From: K2M, INC.; VB SPINE US OPCO LLC; VB SPINE LLC
To: ANKURA TRUST COMPANY, LLC, AS COLLATERAL AGENT
Reel/Frame 071682/0116 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 8, 2025
From: HOWMEDICA OSTEONICS CORP.
To: VB SPINE US OPCO LLC
Reel/Frame 071224/0768 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 14, 2021
From: VERTIFLEX, INC.
To: HOWMEDICA OSTEONICS CORP.
Reel/Frame 055912/0530 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2021
From: CHOI, ANDY WONYONG; NGUYEN, KIM THIEN; RICHARDS, ROBERT LESLIE
To: VERTIFLEX, INC.
Reel/Frame 055902/0153 →
Cited By (1)
US 1,131,794