Interspinous spacer

• US 10,835,297 B2
• Filed: 12/27/2018
• Issued: 11/17/2020
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Altarac, Moti, Tebbe, Shawn
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US16/234,213
• Publication Number:
  US 20190201057A1
• Time in Patent Office: 691 Days
• Field of Search: 606 86 A, 606 86 B, 606 99, 606 96, 606248-279, 623 1711- 1716
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

An implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a U-shaped configuration for seating a spinous process therein. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, the actuator assembly contacts ramming surfaces of the arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the U-shaped portion of the arms providing sufficient distraction to open the neural foramen. An insertion instrument is provided for implanting the interspinous process spacer. The system is configured for implantation through a small percutaneous incision employing minimally invasive techniques.

Claims

1. An instrument for deploying a spacer, the instrument comprising:

a handle assembly;

a spacer holder assembly connected to the handle assembly and configured to clamp onto a body of the spacer; and

a driver configured to extend through at least a portion of the handle assembly and the spacer holder assembly, the driver is operable to drive an actuator of the spacer within a passageway of the spacer to move holders of the spacer away from one another while the spacer holder assembly holds the body, wherein the spacer holder assembly is configured to release the body of the spacer while the holders surround and contact respective bony protrusions of adjacent vertebrae of a subject.

2. The instrument of claim 1, wherein the driver includes a driver handle and a shaft, wherein rotation of the driver handle relative to the handle assembly causes the shaft to translate along the spacer holder assembly while the spacer holder assembly holds the body of the spacer.

3. The instrument of claim 1, wherein the driver includes a driver handle and a drive shaft, wherein the driver handle is positioned proximally of at least a portion of the handle assembly when the drive shaft extends distally through the spacer holder assembly.

4. The instrument of claim 1, wherein the spacer holder assembly includes a control element and a jaw, the control element is operable to move the jaw between a gripping configuration for holding the body of the spacer and an open configuration for releasing the body of the spacer.

5. The instrument of claim 1, wherein the driver has a handle that rotates relative to the handle assembly to reconfigure the spacer.

6. The instrument of claim 1, wherein the spacer holder assembly includes prongs, an outer shaft, and a clamp shaft, wherein a first relative movement between the outer shaft and the clamp shaft cause the prongs to move inwardly for connecting with the body of the spacer, and a second relative movement between the outer shaft and the clamp shaft allows the prongs to move outwardly for releasing the body of the spacer.

7. The instrument of claim 1, wherein the driver is insertable through the spacer holder assembly to move the driver into engagement with the spacer.

8. A kit, comprising:

the instrument of claim 1; and

the spacer comprising the body of the spacer and the holders of the spacer coupled to the body of the spacer.

9. The kit of claim 8, wherein each of the holders of the spacer is a U-shaped member configured to hold a spinous process.

17. The instrument of claim 6, wherein the first relative movement is rotation in a first direction and the second relative movement is rotation in a second direction opposite the first direction.

10. An instrument for deploying a spacer, the instrument comprising:

a handle assembly;

a spacer holder assembly connected to the handle assembly and configured to hold a body of the spacer while the spacer is delivered between adjacent vertebrae; and

a driver insertable through the handle assembly and the spacer holder assembly to move the driver into engagement with the spacer, the driver is rotatable relative to the spacer holder assembly to linearly drive an actuator of the spacer within a passageway of the spacer to drive spinous process holders of the spacer away from one another while the spacer holder assembly holds the body, wherein the spacer holder assembly is reconfigurable to release the body of the spacer while the spinous process holders contact respective bony protrusions of adjacent vertebrae.

11. The instrument of claim 10, wherein the driver includes a driver handle and a shaft, wherein rotation of the driver handle relative the spacer causes the shaft to translate along the spacer holder assembly while the spacer holder assembly holds the body of the spacer.

12. The instrument of claim 10, wherein the driver includes a driver handle and a drive shaft, wherein the driver handle is positioned proximally of at least a portion of the handle assembly when the drive shaft extends distally through the spacer holder assembly.

13. The instrument of claim 10, wherein the spacer holder assembly includes a control element and a jaw, the control element is operable to move the jaw between a gripping configuration for holding the body of the spacer and an open configuration for releasing the body of the spacer.

14. The instrument of claim 10, wherein the driver has a handle that rotates relative to the handle assembly to reconfigure the spacer.

15. The instrument of claim 10, wherein the spacer holder assembly includes prongs, an outer shaft, and an inner shaft, wherein a first relative movement between the outer shaft and the inner shaft cause the prongs to move inwardly for connecting with the body of the spacer, and a second relative movement between the outer shaft and the inner shaft allows the prongs to move outwardly for releasing the body of the spacer.

16. The instrument of claim 15, wherein the first relative movement is rotation in a first direction and the second relative movement is rotation in a second direction opposite the first direction.

18. A kit, comprising:

the instrument of claim 10; and

the spacer comprising the body of the spacer and the spinous process holders of the spacer coupled to the body of the spacer.

19. The kit of claim 18, wherein each of the spinous process holders is a U-shaped member configured to hold a spinous process.

20. The kit of claim 18, wherein the driver and the spacer are configured to operate the driver by rotating the driver to drive the actuator of the spacer.