Interspinous spacer

• US 9,956,011 B2
• Filed: 10/19/2015
• Issued: 05/01/2018
• 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, Reglos, Joey Camia, Cheng, Yang, Kadaba, Murali P., Kim, Daniel H.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/887,201
• Publication Number:
  US 20160242822A1
• Time in Patent Office: 925 Days
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• 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 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 axis and 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. Each arm has a proximal caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the passageway and connected to the body. When advanced, a threaded shaft of the actuator assembly contacts the caming surfaces of 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.

Claims

1. An implantable spacer, comprising:

a body;

a first arm rotatably coupled to the body and configured to receive a first protrusion of a first vertebra;

a second arm rotatably coupled to the body and configured to receive a second protrusion of a second vertebra; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body when driven by an insertion instrument detachably connected to the actuator assembly to translate the actuator element along the body such that the actuator element causes rotation of the first and second arms from a delivery configuration to a deployed configuration, wherein the first arm is positioned to hold the first protrusion and the second arm is positioned to hold the second protrusion when the first and second arms are in the deployed configuration, and wherein the rotatable element is a spindle with an internally threaded surface.

2. The implantable spacer of claim 1, wherein the shaft has external threads that threadably engage internal threads of the rotatable element.

3. The implantable spacer of claim 1, wherein the actuator element moves along a longitudinal axis of the body when the rotatable element rotates relative to the body.

4. The implantable spacer of claim 1, wherein the rotatable element is translationally fixed with respect to the body.

5. The implantable spacer of claim 1, further comprising:

a first pin pivotally coupling the first arm to the body; and

a second pin pivotally coupling the second arm to the body.

6. The implantable spacer of claim 1, wherein each of the first and second arms has a U-shaped end.

7. An implantable spacer, comprising:

a body;

a first arm rotatably coupled to the body and configured to receive a first protrusion of a first vertebra;

a second arm rotatably coupled to the body and configured to receive a second protrusion of a second vertebra; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body when driven by an insertion instrument detachably connected to the actuator assembly to translate the actuator element along the body such that the actuator element causes rotation of the first and second arms from a delivery configuration to a deployed configuration, and wherein the first arm is positioned to hold the first protrusion and the second arm is positioned to hold the second protrusion when the first and second arms are in the deployed configuration, and

wherein the actuator element includes

at least one bearing surface, and

a shaft positioned in a passageway in the body and extending through an opening in the rotatable element, and wherein the at least one bearing surface contacts and moves the first and second arms toward the deployed configuration when the rotatable element rotates relative to the shaft to translate the shaft along the passageway.

8. An implantable spacer, comprising:

a body;

a first arm rotatably coupled to the body and configured to receive a first protrusion of a first vertebra;

a second arm rotatably coupled to the body and configured to receive a second protrusion of a second vertebra; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body when driven by an insertion instrument detachably connected to the actuator assembly to translate the actuator element along the body such that the actuator element causes rotation of the first and second arms from a delivery configuration to a deployed configuration, wherein the first arm is positioned to hold the first protrusion and the second arm is positioned to hold the second protrusion when the first and second arms are in the deployed configuration,

wherein the first and second arms each have U-shaped portions.

9. An implantable spacer, comprising:

a body;

a first arm rotatably coupled to the body and configured to receive a first protrusion of a first vertebra;

a second arm rotatably coupled to the body and configured to receive a second protrusion of a second vertebra; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body when driven by an insertion instrument detachably connected to the actuator assembly to translate the actuator element along the body such that the actuator element causes rotation of the first and second arms from a delivery configuration to a deployed configuration, wherein the first arm is positioned to hold the first protrusion and the second arm is positioned to hold the second protrusion when the first and second arms are in the deployed configuration, and wherein the rotatable element is configured to cause the actuator element to move from a first position to a second position, wherein the actuator element in the first position is spaced apart from both of the first and second arms, and wherein the actuator element in the second position contacts both the first and second arms.

10. An implantable spacer, comprising:

a body;

a first arm rotatably coupled to the body and configured to receive a first protrusion of a first vertebra;

a second arm rotatably coupled to the body and configured to receive a second protrusion of a second vertebra; and

an actuator assembly including

an actuator element movable from a first position to a second position, wherein an externally threaded portion of the actuator element protrudes from the body when the actuator element is in the first position, and wherein most of the threaded portion protruding from the body moves into the body when the actuator element moves from the first position to the second position, and

a rotatable element that rotates relative to the body when driven by an insertion instrument detachably connected to the actuator assembly to translate the actuator element along the body such that the actuator element causes rotation of the first and second arms from a delivery configuration to a deployed configuration, wherein the first arm is positioned to hold the first protrusion and the second arm is positioned to hold the second protrusion when the first and second arms are in the deployed configuration.

11. An implantable spacer, comprising:

a body;

a plurality of deployable arms; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body to move the actuator element along the body such that the actuator element moves the deployable arms to reconfigure the implantable spacer from a delivery configuration for delivery between first and second vertebrae to a deployed configuration for holding a first protrusion of the first vertebra and a second protrusion of the second vertebra when the implantable spacer is between the first and second vertebrae and the actuator assembly is driven by an insertion instrument detachably connected to the actuator assembly, wherein the actuator element includes a wedged shaped head and an externally threaded shaft that engages internal threads of the rotatable element.

12. The implantable spacer of claim 11, wherein the plurality of deployable arms includes:

a first arm rotatably coupled to the body and including a pair of first extensions defining a first window for receiving the first protrusion, and

a second arm rotatably coupled to the body and including a pair of second extensions defining a second window for receiving the second protrusion.

13. The implantable spacer of claim 11, wherein the actuator element is moved into contact with the deployable arms in response to rotation of the rotatable element.

14. An implantable spacer, comprising:

a body;

a plurality of deployable arms; and

an actuator assembly including

an actuator element, and

a rotatable element that rotates relative to the body to move the actuator element along the body such that the actuator element moves the deployable arms to reconfigure the implantable spacer from a delivery configuration for delivery between first and second vertebrae to a deployed configuration for holding a first protrusion of the first vertebra and a second protrusion of the second vertebra when the implantable spacer is between the first and second vertebrae and the actuator assembly is driven by an insertion instrument detachably connected to the actuator assembly

wherein the actuator element includes

at least one bearing surface, and

a shaft positioned in a passageway in the body and protruding from the body when the implantable spacer is in the deployed configuration, and wherein the shaft translates along the passageway such that the at least one bearing surface contacts at least one of the first and second arms to move the first and second arms toward the deployed configuration when the rotatable element rotates relative to the shaft.