Interspinous spacer

• US 9,572,603 B2
• Filed: 09/14/2012
• Issued: 02/21/2017
• 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:
  US13/616,547
• Publication Number:
  US 20130150886A1
• Time in Patent Office: 1,621 Days
• Field of Search: 606246-279, 623 1711- 1716
• US Class Current: 1/1
• 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 camming 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 implantable interspinous spacer for engaging adjacent spinous processes of a subject, the implantable interspinous spacer comprising:

a body defining a passageway;

arms connected to the body, each arm having a pair of extensions spaced apart from one another to define an opening, wherein the arms are rotatable with respect to the body such that the arms move from an undeployed configuration for inserting the implantable interspinous spacer between the spinous processes to a first deployed configuration for positioning each spinous process within one of the openings between the extensions, and wherein the arms are linearly movable with respect to the body such that the arms move from the first deployed configuration to a second deployed configuration for distracting the spinous processes; and

an actuator assembly configured to deploy the arms and comprising an actuator, wherein the actuator is movable along the passageway to rotate the arms from the undeployed configuration to the first deployed configuration and to linearly move the arms from the first deployed configuration to the second deployed configuration.

2. The implantable interspinous spacer of claim 1 wherein the actuator includes a proximal end, a distal end, at least one bearing surface at the distal end, wherein the at least one bearing surface is configured to engage caroming surfaces of the arms when the actuator moves along the passageway to cause the arms to roll along the at least one bearing surface such that the arms move from the undeployed configuration toward the first deployed configuration, and wherein each arm has a substantially flat surface for contacting the at least one bearing surface when the arms are in the first deployed configuration.

3. The implantable interspinous spacer of claim 1 wherein the arms in the undeployed configuration are substantially parallel to a longitudinal axis of the body, and wherein the arms in the first deployed configuration are substantially perpendicular to the longitudinal axis of the body.

4. The implantable interspinous spacer of claim 1 wherein the actuator is movable along the passageway to cause the arms to rotate from the undeployed configuration to the first deployed configuration, and the actuator is further movable along the passageway to push the arms away from each other toward the second deployed configuration.

5. The implantable interspinous spacer of claim 1 wherein at least one of the arms includes

a first pin positioned in a first slot in the body and defining an axis of rotation about which the at least one arm rotates to move from the undeployed configuration to the first deployed configuration, and

a second pin positioned in a second slot in the body and movable along the second slot to move the arm from the undeployed configuration and the second deployed configuration.

6. The implantable interspinous spacer of claim 1 wherein each arm rotates approximately 90 degrees when that arm moves from the undeployed configuration to the first deployed configuration.

7. The implantable interspinous spacer of claim 1 wherein each arm is configured to rotate outwardly into a planar space that is substantially transverse to a longitudinal axis of the body, and wherein each arm is configured to translate in the planar space away from the longitudinal axis when the arm moves from the first deployed configuration toward the second deployed configuration.

8. The implantable interspinous spacer of claim 1 wherein the actuator includes two bearing surfaces that converge towards a distal end of the actuator, and wherein each bearing surface is positioned to contact and move one of the arms.

9. The implantable interspinous spacer of claim 1 wherein a proximal end of the actuator assembly is configured for attachment to an instrument capable of causing movement of actuator with respect to the body.

10. The implantable interspinous spacer of claim 1 wherein each of the openings is configured to receive one of the spinous processes such that the extensions are located on opposite sides of the spinous process.

11. The implantable interspinous spacer of claim 1 wherein the actuator is linearly movable along the passageway so as to push the arms away from one another to translate the arms outwardly a sufficient distance to distract the spinous processes.

12. The implantable interspinous spacer of claim 1 wherein the actuator assembly is configured to begin linearly moving the arms after the arms have rotated from the undeployed configuration to the deployed configuration.

13. The implantable interspinous spacer of claim 1 wherein the arms include a first arm and a second arm, wherein the first arm is linearly movable in a first direction when the first arm moves toward the second deployed configuration, and wherein the second arm is linearly movable in a second direction generally opposite the first direction when the second arm moves toward the second deployed configuration.

14. An implantable spacer for distracting adjacent spinous processes of a subject, the implantable spacer comprising:

a spacer body defining a passageway;

arms coupled to the spacer body and each arm including a pair of extensions spaced apart from one another to define an opening between the extensions; and

an actuator assembly in the passageway and operable to cause the arms to rotate from an undeployed configuration for delivering the implantable spacer between the spinous processes toward a deployed configuration for positioning spinous processes in the openings, and wherein the actuator assembly is operable to translate the arms relative to the spacer body such that the arms move linearly from the deployed configuration to a distracted configuration for distracting the spinous processes positioned in the openings.

15. The implantable spacer of claim 14 wherein the actuator assembly includes an actuator with a tapered head, and wherein the actuator is linearly movable along the passageway to cause the arms to roll along the tapered head as the arms rotate from the undeployed configuration to the deployed configuration.

16. The implantable spacer of claim 14 wherein the arms have camming surfaces and locking surfaces, wherein the camming surfaces roll along a tapered head of the actuator assembly when the tapered head moves linearly along the passageway and the arms move toward the deployed configuration, and wherein the locking surfaces engage the tapered head when the arms are in the distracted configuration.

17. The implantable spacer of claim 14 wherein the arms in the undeployed configuration are substantially parallel to a longitudinal axis of the spacer body, and wherein the arms in the deployed configuration are substantially perpendicular to the longitudinal axis of the spacer body.

18. The implantable spacer of claim 14 wherein the arms include a first arm and a second arm, wherein the first arm includes

a first pin positioned in a first slot in the spacer body and about which the extensions of the first arm rotate when the first arm moves from the undeployed configuration toward the deployed configuration, and

a second pin positioned in a second slot in the spacer body and movable along the second slot to move the first arm toward the deployed configuration.

19. The implantable spacer of claim 14 wherein the actuator assembly is connected to the spacer body and is configured to mechanically drive the arms from the undeployed configuration to the distracted configuration in response to operation of the actuator assembly.

20. The implantable spacer of claim 14 wherein the arms are U-shaped.

21. The implantable spacer of claim 14 wherein each of the openings is configured to receive one of the spinous processes such that the extensions are located on opposite sides of the spinous process.

22. The implantable spacer of claim 14 wherein the actuator assembly has a linearly movable actuator configured to push the arms away from one another to translate the arms a sufficient distance to distract the spinous processes when the actuator moves through the passageway.

23. The implantable spacer of claim 14 wherein the actuator assembly is configured to begin translating the arms after the arms have rotated from the undeployed configuration to the deployed configuration.

24. The implantable spacer of claim 14 wherein the actuator assembly is configured to begin linearly moving the arms after the arms have rotated from the undeployed configuration to the deployed configuration.

25. An implantable spacer for distracting adjacent spinous processes of a subject, the implantable spacer comprising:

a spacer body defining a passageway;

arms coupled to the spacer body and each arm including a pair of extensions spaced apart from one another to define an opening between the extensions, wherein the arms include a first arm and a second arm, wherein the first arm includes

a first pin positioned in a first slot in the spacer body and about which the extensions of the first arm rotate when the first arm moves from the undeployed configuration toward the deployed configuration, and

a second pin positioned in a second slot in the spacer body and movable along the second slot to move the first arm toward the deployed configuration, wherein the second slot has an arcuate section and a linear section, wherein the second pin moves along the arcuate section when the first arm rotates toward the deployed configuration, and wherein the second pin moves along the linear section when the first arm moves toward the distracted configuration; and

an actuator assembly in the passageway and operable to cause the arms to rotate from an undeployed configuration for delivering the implantable spacer between the spinous processes toward a deployed configuration for positioning spinous processes in the openings, and wherein the actuator assembly is operable to drive the arms from the deployed configuration to a distracted configuration for distracting the spinous processes positioned in the openings.

26. The implantable spacer of claim 25 wherein the actuator assembly pushes the first and second arms away from each other when the first and second arms move toward the distracted configuration.

27. An implantable interspinous spacer for engaging adjacent first and second vertebrae of a subject, comprising:

a body;

first and second arms each rotatable with respect to the body to move from a delivery configuration to a rotated configuration for engaging the first and second vertebrae, and wherein the first and second arms are linearly movable with respect to the body to move from the rotated configuration to a distraction configuration; and

an actuator movable along the body to rotate the first and second arms toward the rotated configuration and to linearly move the first and second arms toward the distracted configuration.

28. The implantable interspinous spacer of claim 27, wherein the actuator moves linearly along a passage in the body to drive the first and second arms away from the delivery configuration.