Interspinous spacer

• US 10,166,047 B2
• Filed: 02/21/2017
• Issued: 01/01/2019
• 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:
  US15/437,720
• Publication Number:
  US 20170258501A1
• Time in Patent Office: 679 Days
• Field of Search: 606246-279, 606 86 A, 606 86 B, 606 96, 606 99, 606100, 606104, 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 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 insertion instrument configured for delivering a spacer to an interspinous process space of a patient and deploying the spacer from an undeployed configuration to at least one deployed configuration to relieve pain;

the spacer including a body, at least one arm connected to and movable with respect to the body and a spacer actuator having a proximal end and a distal end disposed at least partially inside the body that is configured to move the at least one arm from an undeployed configuration to at least one deployed configuration;

the insertion instrument comprising;

a handle assembly;

a first assembly connected to the handle assembly, the first assembly being configured to connect to the body of the spacer at the distal end of the insertion instrument, the first assembly having a first control at the handle assembly configured to connect and release the body of the spacer and the first assembly;

a second assembly connected to the handle assembly, the second assembly being configured to connect to the proximal end of the actuator of the spacer at the distal end of the insertion instrument, the second assembly having a second control at the handle assembly configured to connect and release the actuator and the second assembly; and

a third assembly connected to the handle assembly;

the third assembly being configured to move the second assembly relative to the body of the spacer for arranging the spacer from an undeployed configuration to at least one deployed configuration.

2. The insertion instrument of claim 1 wherein the first assembly includes:

a first outer shaft;

a first clamp shaft connected to the first outer shaft and located concentrically inside the first outer shaft;

the first clamp shaft having two first prongs configured to flex and connect to the spacer body;

wherein the first outer shaft is configured to move relative to the first clamp shaft such that distal movement of the first outer shaft relative to the first clamp shaft deflects the first prongs inwardly for connecting with the spacer body and proximal movement of the first outer shaft relative to the first clamp shaft uncovers the first prongs allowing them to splay outwardly to their normal position to release the spacer body.

3. The insertion instrument of claim 1 wherein the second assembly includes:

a second outer shaft;

a second clamp shaft connected to the second outer shaft and located concentrically inside the second outer shaft;

the second clamp shaft having two second prongs configured to flex and connect to the spacer actuator;

wherein the second outer shaft is configured to move relative to the second clamp shaft such that distal movement of the second outer shaft relative to the second clamp shaft deflects the second prongs inwardly for connecting with the spacer actuator and proximal movement of the second outer shaft relative to the second clamp shaft uncovers the second prongs allowing them to splay outwardly to their normal position to release the spacer actuator.

4. The insertion instrument of claim 1 wherein the second assembly is located concentrically inside the first assembly.

5. An insertion instrument for moving a spacer from an undeployed configuration to at least one deployed configuration, the insertion instrument comprising:

a handle assembly;

a spacer holder assembly connected to the handle assembly and connectable to a body of the spacer, the spacer holder assembly having a control located along or proximate to the handle assembly, the control is operable to cause the spacer holder assembly to connect to and to release the body of the spacer; and

a spacer deployment assembly configured to extend through the handle assembly and the spacer holder assembly, the spacer deployment assembly is operable to cause the spacer to move from the undeployed configuration to the at least one deployed configuration for contacting bony protrusions of adjacent vertebrae, and wherein the spacer deployment assembly is configured to drive an actuator of the spacer to move arms of the spacer away from each other.

6. The insertion instrument of claim 5, wherein the spacer deployment assembly includes a drive handle and an elongated member, wherein rotation of the drive handle relative to the handle assembly causes the elongated member to translate along the spacer holder assembly while the spacer holder assembly holds the spacer.

7. The insertion instrument of claim 5, wherein the spacer deployment assembly has a handle that rotates to drive the spacer from the undeployed configuration to the at least one deployed configuration.

8. The insertion instrument of claim 5, wherein the insertion instrument is configured to deploy the spacer at an interspinous space between the adjacent vertebrae of a subject while the insertion instrument extends through the subject'"'"'s supraspinous ligament.

9. The insertion instrument of claim 5, wherein rotational operation of the spacer deployment assembly causes controlled deployment of the spacer.

10. An insertion instrument for moving a spacer from an undeployed configuration to at least one deployed configuration, the insertion instrument comprising;

a handle assembly;

spacer holder assembly connected to the handle assembly and connectable to a body of the spacer, the spacer holder assembly having a control located along or proximate to the handle assembly, the control is operable to cause the spacer holder assembly to connect to and to release the body of the spacer, wherein the spacer holder assembly includes;

an outer shaft, and

a clamp shaft located inside the outer shaft and having two prongs,

wherein the outer shaft is movable relative to the clamp shaft such that distal movement of the outer shaft relative to the clamp shaft deflects the prongs inwardly for connecting with the body of the spacer and proximal movement of the outer shaft relative to the clamp shaft allows the prongs to move outwardly for releasing the body of the spacer; and

a spacer deployment assembly configured to extend through the handle assembly and the spacer holder assembly, the spacer deployment assembly is operable to cause the spacer to move from the undeployed configuration to the at least one deployed configuration for contacting bony protrusions of adjacent vertebrae.

11. An insertion instrument for moving a spacer from an undeployed configuration to at least one deployed configuration, the insertion instrument comprising:

a handle assembly;

a spacer holder assembly connected to the handle assembly and connectable to a body of the spacer, the spacer holder assembly having a control located along or proximate to the handle assembly, the control is operable to cause the spacer holder assembly to connect to and to release the body of the spacer, wherein the spacer holder assembly has a jaw with a gripping configuration for gripping the spacer and an open configuration for releasing the spacer, and wherein the control is operable to cause the jaw to move from the gripping configuration to the open configuration; and

a spacer deployment assembly configured to extend through the handle assembly and the spacer holder assembly, the spacer deployment assembly is operable to cause the spacer to move from the undeployed configuration to the at least one deployed configuration for contacting bony protrusions of adjacent vertebrea.

12. An insertion instrument for moving a spacer from an undeployed configuration to at least one deployed configuration, the insertion instrument comprising:

a handle assembly;

a spacer holder assembly connected to the handle assembly and connectable to a body of the spacer, the spacer holder assembly having a control located along or proximate to the handle assembly, the control is operable to cause the spacer holder assembly to connect to and to release the body of the spacer; and

a spacer deployment assembly configured to extend through the handle assembly and the spacer holder assembly, the spacer deployment assembly is operable to cause the spacer to move from the undeployed configuration to the at least one deployed configuration for contacting bony protrusions of adjacent vertebrae,

wherein the spacer holder assembly includes a first assembly and a second assembly, wherein

the first assembly includes

a first outer shaft, and

a first clamp shaft located concentrically inside the first outer shaft, the first clamp shaft having two first prongs,

wherein distal movement of the first outer shaft relative to the first clamp shaft cause the first prongs to move inwardly for connecting with the body of the spacer and proximal movement of the first outer shaft relative to the first clamp shaft uncovers the first prongs allowing the first prongs to splay outwardly to release the body of spacer, and

the second assembly includes

a second outer shaft, and

a second clamp shaft connected to the second outer shaft and located concentrically inside the second outer shaft, the second clamp shaft having two second prongs,

wherein distal movement of the second outer shaft relative to the second clamp shaft cause the second prongs to move inwardly for connecting with the spacer actuator and proximal movement of the second outer shaft relative to the second clamp shaft allows the second prongs to splay outwardly to release the spacer actuator.

13. The insertion instrument of claim 12, wherein the first and second assemblies are configured to operate independently of one another.

14. The insertion instrument of claim 12, wherein the second assembly is configured to translate an actuator of the spacer to move the spacer to the at least one deployed configuration while the first assembly holds the body of the spacer.

15. The insertion instrument of claim 12, wherein the second assembly causes an actuator of the spacer to drive arms of the spacer while the second prongs are coupled to the actuator.