Spine distraction implant and method

• US 7,666,209 B2
• Filed: 03/28/2007
• Issued: 02/23/2010
• Est. Priority Date: 01/02/1997
• Status: Expired due to Fees

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Klyce, Henry A., Zucherman, James F., Fallin, T. Wade, Hsu, Ken Y.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US11/692,303
• Publication Number:
  US 20070219552A1
• Time in Patent Office: 1,063 Days
• Field of Search: 606/61, 606/248, 606/249, 623 1711- 1716
• US Class Current: 606/249
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• 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 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• 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 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
• CPC Class Codes: A61B 17/7071 Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

A spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume in the spine canal and/or neural foramen. The implant provides a spinal extension stop while allowing freedom of spinal flexion.

Claims

1. An apparatus, comprising:

an interspinous process spacer configured to be disposed between a first spinous process and a second spinous process, the interspinous process spacer having a first surface configured to contact the first spinous process and second surface configured to contact the second spinous process, the first surface of the interspinous process spacer configured to limit movement of the interspinous process spacer relative to the first spinous process in a first lateral direction when the interspinous process spacer is disposed between the first spinous process and the second spinous process, the second surface of the interspinous process spacer configured to limit movement of the interspinous process spacer relative to the second spinous process in the first lateral direction when the interspinous process spacer is disposed between the first spinous process and the second spinous process;

the first surface having a first opening therein;

the second surface having a second opening therein;

a first retention member movably coupled to the interspinous process spacer for movement between a deployed position and a retracted position;

the first retention member, in its deployed position, extending out through the first opening and transverse to the first surface;

the first retention member, when in its deployed position, is configured to limit movement of the interspinous process spacer relative to the first spinous process in a second lateral direction opposite the first lateral direction when the interspinous process spacer is disposed between the first spinous process and the second spinous process;

a second retention member movably coupled to the interspinous process spacer for movement between a deployed position and a retracted position;

the second retention member, in the deployed position, extending out through the second opening and transverse to the second surface;

the second retention member, when in its deployed position, is configured to limit movement of the interspinous process spacer relative to the second spinous process in the second lateral direction when the interspinous process spacer is disposed between the first spinous process and the second spinous process;

wherein when the first and second retention members are in their deployed positions;

the first retention member and the first surface form a first saddle configured to receive the first spinous process;

the second retention member and the second surface form a second saddle configured to receive the second spinous process, the second saddle facing in a generally opposite direction from the first saddle;

wherein a theoretical axis extends through the first and second saddles and includes their points of closest approach to each other;

wherein the first and second saddles are open ended such that when the first and second saddles receive the first and second spinous processes respectively, the first and second saddles are the outermost portions of the spacer along the theoretical axis.

2. The apparatus of claim 1 wherein the first retention member, when in its retracted position, is configured to allow movement of the interspinous process spacer relative to the first spinous process in the second lateral direction.

3. The apparatus of claim 1 wherein at least one of the first retention member or the second retention member is slidably coupled to the interspinous process spacer.

4. The apparatus of claim 1 wherein the first retention member includes a first longitudinal portion and a second longitudinal portion, wherein:

the first portion is disposed within the spacer when the first retention member is in the deployed position;

the second portion is disposed within the spacer when the first retention member is in the retracted position;

the second portion is disposed outside of the spacer when the first retention member is in the deployed position.

5. The apparatus of claim 1, wherein the interspinous process spacer, the first retention member, and the second retention member collectively are configured to be inserted between the first spinous process and the second spinous process simultaneously and percutaneously.

6. The apparatus of claim 1 wherein the first and second surfaces of the interspinous process spacer are collectively configured to distract the first spinous process and the second spinous process.

7. An apparatus, comprising:

an interspinous process spacer having first and second surfaces facing in divergent directions;

the spacer configured to be disposed between first and second adjacent spinous processes;

the spacer having first and second openings therein;

the first and second openings spaced from each other and facing in divergent directions;

a first retention member having a first portion disposed within the interspinous process spacer when in a retracted configuration, the first portion of the first retention member configured to be movable through the first opening to a deployed configuration wherein it extends out the first opening and into a region outside of the interspinous process spacer so as to be transverse to the first surface;

wherein, with the first portion of the first retention member in its deployed configuration;

the first portion of the first retention member forms a first section of a first saddle for receiving the first spinous process with the spacer'"'"'s first surface forming a second section of the first saddle; and

a first point, along the first retention member, at which the first retention member'"'"'s first portion exits the first opening is disposed closer to the first surface than the second surface;

a second retention member having a first portion disposed within the interspinous process spacer when in a retracted configuration, the first portion of the second retention member configured to be movable through the second opening to a deployed configuration wherein it extends out the second opening and into a region outside of the interspinous process spacer so as to be transverse to the second surface;

wherein, with the first portion of the second retention member in its deployed configuration;

the first portion of the second retention member forms a first section of a second saddle for receiving the second spinous processes with the spacer'"'"'s second surface forming a second section of the second saddle; and

a second point, along the second retention member, at which the second retention member'"'"'s first portion exits the second opening is disposed closer to the second surface than the first surface;

wherein a theoretical axis extends throucih the first and second saddles and includes their points of closest approach to each other;

wherein the first and second saddles are open ended such that when the first and second saddles receive the first and second spinous processes respectively, the first and second saddles are the outermost portions of the spacer alonci the theoretical axis.

8. The apparatus of claim 7 wherein the first retention member is configured to inhibit movement of the interspinous process spacer relative to the adjacent spinous processes when the interspinous process spacer is disposed between the adjacent spinous process and the first portion of the first retention member is in the deployed configuration.

9. The apparatus of claim 7 wherein the first portion of the first retention member is configured to contact the first spinous processes when the interspinous process spacer is disposed between the adjacent spinous process and the first portion of the first retention member is in the deployed configuration.

10. The apparatus of claim 7, wherein the retention member is slidably coupled to the interspinous process spacer.

11. An apparatus, comprising:

an interspinous process spacer configured to be disposed between a first spinous process and a second spinous process;

the spacer having an upper portion and a lower portion;

the upper portion having a first opening therein;

the lower portion having a second opening therein;

the first and second openings spaced from each other and facing in divergent directions;

a first retention member movably coupled to the spacer, the first retention member configured to move from a first position to a second position, a portion of the first retention member and the spacer upper portion collectively forming a first saddle configured to receive a portion of the first spinous process when the first retention member is in its second position;

a second retention member movably coupled to the spacer, the second retention member configured to move from a first position to a second position, a portion of the second retention member and the spacer lower portion collectively forming a second saddle configured to receive a portion of the second spinous process when the second retention member is in its second position;

wherein the first retention member, in its second position, extends through the first opening into a region outside of the interspinous process spacer so as to form a first section of the first saddle with the spacer'"'"'s upper portion forming a second section of the first saddle;

wherein the second retention member, in its second position, extends through the second opening into a region outside of the interspinous process spacer so as to form a first section of the second saddle with the spacer'"'"'s lower portion forming a second section of the second saddle;

wherein a theoretical axis extends through the first and second saddles and includes their points of closest approach to each other;

wherein the first and second saddles are open ended such that when the first and second saddles receive the portions of first and second spinous processes respectively, the first and second saddles are the outermost portions of the spacer along the theoretical axis.

12. The apparatus of claim 11, wherein the interspinous process spacer, the first retention member, and the second retention member are configured to be inserted between the first spinous process and the second spinous process simultaneously.

13. The apparatus of claim 11, wherein the first retention member is slidably coupled to the interspinous process spacer.

14. The apparatus of claim 11, wherein the first surface of the interspinous process spacer and the second surface of the interspinous process spacer collectively form a tapered portion of the interspinous process spacer.

15. The apparatus of claim 11 wherein:

the portion of the first retention member is disposed within the interspinous process spacer when the first retention member is in its first position; and

the portion of the first retention member is disposed outside of the interspinous process spacer when the first retention member is in its second position.

16. The apparatus of claim 11, wherein the interspinous process spacer, the first retention member, and the second retention member are configured to be inserted between the first spinous process and the second spinous process percutaneously.

17. The apparatus of claim 11, wherein:

the first saddle defines an opening facing outwardly from the interspinous process spacer in a first direction; and

the second saddle defines an opening facing outwardly from the interspinous process spacer in a second direction opposite the first direction.

18. An interspinous device, comprising:

an interspinous process spacer for placement between first and second adjacent spinous processes;

the spacer having first and second surfaces facing in divergent directions;

the first and second surfaces configured to contact the first and second spinous process respectively when the spacer is disposed therebetween;

a first opening in the first surface;

a second opening in the second surface;

the first and second openings spaced from each other and facing in divergent directions;

a first retention member having a first portion disposed within the spacer when in a retracted configuration;

the first portion movable through the first opening to a deployed configuration wherein the first portion extends out the first opening and into a region outside of the spacer so as to be transverse to the first surface;

a second retention member having a second portion disposed within the spacer when in a retracted configuration;

the second portion movable through the second opening to a deployed configuration wherein the second portion extends out the second opening and into a region outside of the spacer so as to be transverse to the second surface;

wherein, with the first retention member'"'"'s first portion in its deployed configuration, the first portion forms one section of a first saddle for receiving the first spinous process with the spacer'"'"'s first surface forming a second section of the first saddle;

wherein, with the second retention member'"'"'s second portion in its deployed configuration, the second portion forms one section of a second saddle for receiving the second spinous process with the spacer'"'"'s second surface forming a second section of the second saddle;

wherein a theoretical axis extends through the first and second saddles and includes their points of closest approach to each other;

wherein the first and second saddles are open ended such that when the first and second saddles receive the first and second spinous processes respectively, the first and second saddles are the outermost portions of the spacer along the theoretical axis.

19. The apparatus of claim 18 wherein the first retention member is configured to inhibit movement of the spacer relative to the first and second spinous processes when the spacer is disposed between the first and second spinous process and the first retention member'"'"'s first portion is in its deployed configuration.

20. The apparatus of claim 18 wherein the first retention member'"'"'s first portion is configured to contact the first spinous process when the spacer is disposed between the first and second spinous process and the first retention member'"'"'s first portion is in its deployed configuration.

21. The apparatus of claim 18 wherein the first and second retention members are slidably coupled to the spacer.

22. An interspinous device, comprising:

an interspinous process spacer body sized to define a minimum space between first and second adjacent spinous processes of a human spine when placed between the spinous processes;

the spacer body having first and second exterior holes;

a first retention member movably coupled to the spacer body so as to be movable between a retracted position and a deployed position;

in the retracted position, a distal end of the first retention member disposed internal to the spacer body;

in the deployed position, the distal end extending away from the spacer body such that the distal end and the spacer body form sections of a first saddle for receiving the first spinous process;

the first distal end moving through the first hole when changing from the retracted position to the deployed position;

a second retention member movably coupled to the spacer body so as to be movable between a retracted position and a deployed position;

in the retracted position, a distal end of the second retention member disposed internal to the spacer body;

in the deployed position, the distal end extending away from the spacer body such that the second distal end and the spacer body form sections of a second saddle for receiving the second spinous process;

the second distal end moving through the second hole when changing from the retracted position to the deployed position;

wherein a theoretical axis extends through the first and second saddles and includes their points of closest approach to each other;

wherein the first and second saddles are open ended such that when the first and second saddles receive the first and second spinous processes respectively, the first and second saddles are the outermost portions of the spacer along the theoretical axis.

23. The interspinous device of claim 22 wherein the first and second retention members include respective proximal portions that are disposed internal to the spacer body when the first and second retention members are in their respective deployed positions.

24. The interspinous device of claim 22 wherein the first retention member is configured to inhibit movement of the spacer relative to the first and second spinous processes when the spacer is disposed between the first and second spinous process and the first retention member is in its deployed position.

25. The interspinous device of claim 22 wherein the first retention member is configured to contact the first spinous process when the spacer is disposed between the first and second spinous process and the first retention member is in its deployed position.

26. The interspinous device of claim 22 wherein the first and second retention members are slidably coupled to the spacer body.

27. The interspinous device of claim 22 wherein the first hole is located at a corner of the first saddle and the second hole is located at a corner of the second saddle.