Spine distraction implant and method

• US 5,860,977 A
• Filed: 10/27/1997
• Issued: 01/19/1999
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Saint Francis Medical Technologies, LLC
• Inventors: Zucherman, James F., Hsu, Ken Y.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US08/958,281
• Time in Patent Office: 449 Days
• Field of Search: 606/61, 606/105, 623/17
• US Class Current: 606/249
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• 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 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen

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 implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

said body having a longitudinal axis and said first wing being connected to an end of said body and extending substantially perpendicular to the longitudinal axis, said body adapted to be positioned between adjacent spinous processes;

a second wing;

said body including a groove that can receive said second wing, said groove being substantially perpendicular to the longitudinal axis, such that said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis until said second wing is received in said groove with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along opposite second sides of the spinous processes and opposite to the first wing; and

a device that secures the second wing to the body.

2. The implant of claim 1 wherein:

at least one of said first wing and said second wing include a recess in order to accommodate the anatomical form of the vertebrae.

3. The implant of claim 1 wherein:

said first wing has upper and lower portions;

said second wing has upper and lower portions; and

at least one upper portion has a recess in order to accommodate the anatomical form of the vertebrae.

4. The implant of claim 1 wherein the spinous processes of the spinal column extend from respective vertebral bodies and wherein:

at least one of the first and the second wings has an upper portion;

said upper portion has a recess in order to accommodate the anatomical form of the spinal column; and

wherein said recess is shaped for location adjacent to laminae of the vertebrae.

5. The implant of claim 1 wherein:

said groove is tapered in order to assist the seating of the second wing in the groove.

6. The implant of claim 1 wherein:

said device includes a first bore in the body;

said second wing has a tab extending therefrom, which tab includes a second bore there through;

wherein with said second wing received in said groove of said body, said first and second bores are aligned; and

said device includes a member that is positioned through the first and the second bores in order to secure the second wing to the body.

7. The implant of claim 6 wherein:

said body includes a recess that can receive said tab of said second wing.

8. The implant of claim 1 which does not limit flexion of the spinal column while limiting extension of the spinal column.

9. The implant of claim 1 wherein:

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings; and

wherein at least one of the upper width and the lower width is wider than a spinous process around which the implant may be positioned.

10. The implant of claim 1 wherein:

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings;

there is a height between the upper and the lower saddles; and

wherein the upper width is from about 6 mm to about 8 mm, with the lower width being from about 5 mm to about 7 mm and the height is from about 8 mm to about 10 mm.

11. The implant of claim 1 wherein:

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings;

there is a height between the upper and the lower saddles; and

the implant has at least one of the following combinations of dimensions;

(a) an upper width of about 6 mm, a lower width of about 5 mm and a height of about 8 mm;

(b) an upper width of about 7 mm, a lower width of about 6 mm and a height of about 9 mm; and

(c) an upper width of about 8 mm, a lower width of about 7 mm and a height of about 10 mm.

12. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing;

a device that secures the second wing to the body;

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings;

the implant comprising multiple second wings with each second wing having said lower portion of a different thickness; and

wherein the lower width can be selected by choosing said second wing with said lower portion of the desired thickness.

13. The implant of claim 12 wherein:

each second wing has said upper portion with a different thickness; and

wherein the upper width can be selected by choosing said second wing with said upper portion of the desired thickness.

14. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing;

a device that secures the second wing to the guide;

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings;

the implant comprising multiple second wings with each second wing having said upper portion of a different thickness; and

wherein the upper width can be selected by choosing said second wing with said portion of the desired thickness.

15. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body, a guide extending from said body, and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing; and

a device that secures the second wing to the body;

said guide is located distally from the first wing; and

wherein said guide is bulbous so as to be adapted to guide the body between adjacent spinous processes without requiring that the shape of the spinous processes be altered, and wherein the guide extends in a direction of insertion of the body between the spinous processes; and

wherein said guide is of sufficient length to extend beyond the spinous processes with the body remaining between the spinous processes.

16. The implant of claim 15 wherein:

said first wing has a longitudinal axis and said body extends substantially perpendicular from said longitudinal axis; and

said body has a substantially square cross-section.

17. The implant of claim 15 wherein:

said first wing has a longitudinal axis and said body extends substantially perpendicular from said longitudinal axis; and

said body has a cross-section that has about the same width as height.

18. The implant of claim 15 wherein:

said first wing has a longitudinal axis and a length along said longitudinal axis and said body extends substantially perpendicular from said longitudinal axis; and

said body has a cross-section which extends along said longitudinal axis for less than half the length of said first wing.

19. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body, a guide extending from said body, and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing; and

a device that secures the second wing to the body;

said guide is located distally from the first wing; and

wherein said guide is pointed so as to be adapted to guide the body between adjacent spinous processes without requiring that the shape of the spinous process be altered, and wherein the guide extends in a direction of insertion of the body between the spinous processes; and

wherein said guide is of sufficient length to extend beyond the spinous processes with the body remaining between the spinous processes.

20. The implant of claim 19, wherein said pointed guide is shaped so that the guide distracts the adjacent spinous processes as the guide passes between the adjacent spinous processes.

21. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body, a guide extending from said body, and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing; and

a device that secures the second wing to the body;

said guide is located distally from the first wing; and

wherein said guide has first and second sides that are provided at an angle of about 30°

to about 60°

from a longitudinal axis of the body so as to be adapted to guide the body between adjacent spinous processes without requiring that the shape of the spinous process be altered, and wherein the guide extends in a direction of insertion of the body between the spinous processes; and

wherein said guide is of sufficient length to extend beyond the spinous processes with the body remaining between the spinous processes.

22. The implant of claim 21, wherein said guide is shaped so that the guide distracts the adjacent spinous processes as the guide passes between the adjacent spinous processes.

23. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

said body having a longitudinal axis and said first wing being connected to an end of said body and extending substantially perpendicular to the longitudinal axis, said body adapted to be positioned between adjacent spinous processes;

a second wing;

said body including a means for engaging said second wing along a direction which is substantially perpendicular to said longitudinal axis with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing; and

said engaging means is operable along said direction which is substantially perpendicular to said longitudinal axis.

24. The implant of claim 23 which does not limit flexion of the spinal column while limiting extension of the spinal column.

25. An implant for relieving pain associated with the spinal column which implant is positionable between adjacent spinous processes of the spinal column, comprising:

a distracting unit including a body having a longitudinal axis and a first wing;

said first wing being connected to an end of said body and extending substantially perpendicular to the longitudinal axis;

a retaining unit unit including a second wing and a tab extending from said second wing;

said distracting unit defining a groove that receives at least a portion of said second wing and said distraction unit also defining a recess for receiving said tab;

said groove being substantially perpendicular to said longitudinal axis;

said body including a first bore;

said tab including a second bore;

said first and second bores being alignable with the second wing received in said groove; and

a device that is positionable through the first and second bores in order to secure the retaining unit to the distraction unit.

26. The implant of claim 25 wherein;

said first bore is threaded; and

said device is a screw.

27. The implant of claim 25:

wherein said first and second bores are alignable along a line which is substantially perpendicular to said longitudinal axis.

28. A method of relieving pain due to the development of spinal stenosis and the like in the spinal column including the steps of:

accessing adjacent first and second spinous processes of the spinal column;

implanting a distracting unit between the spinous processes, which distracting unit has (1) a body that can maintain a distraction between the first and second spinous processes, which body has a longitudinal axis and a groove which is substantially perpendicular to said longitudinal axis and (2) a wing which extends from an end of said body substantially perpendicular to said longitudinal axis and along the spinous processes; and

positioning a retaining wing unit in the groove of said distracting unit by urging said retaining wing unit along a line which is substantially perpendicular to said longitudinal axis until said retaining wing unit is received in said groove.

29. The method of claim 28 wherein the positioning step includes:

positioning a screw through the retaining wing unit and the distracting unit along a line which is substantially perpendicular to said longitudinal axis.

30. The method of claim 28 wherein said wing of said distracting unit is a first wing and said retaining unit is a second wing, and wherein said first and second wings have first and second planes respectively, and the method includes positioning said second wing relative to the first wing by moving the second wing such that the second plane of the second wing remains substantially parallel to the first plane of the first wing as the second wing is moved into engagement with the distracting unit.

31. The method of claim 30, wherein the second wing is secured to the distracting unit with a fastener which moved along a line that is substantially parallel to the second plane of the second wing in order to secure the retaining unit to the distracting unit.

32. The method of claim 28 including the step of:

distracting the first and second spinous processes apart prior to inserting the distracting unit between the first and second spinous processes.

33. The method of claim of 28 wherein:

said implanting step includes using the distracting unit to distract the first and the second spinous processes as the distracting unit is inserted between the first and the second spinous processes.

34. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing;

a device that secures the second wing to the body;

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings; and

there is a height between the upper and the lower saddles; and

wherein a trapezoidal shape is defined between the upper width, the lower width and the height.

35. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along second sides of the spinous processes and opposite to the first wing;

a device that secures the second wing to the body; and

a portion of said body located between the first and second wings defines a trapezoidal shape.

36. An implant for relieving pain associated with the spinal column which implant is positionable between adjacent spinous processes of the spinal column, comprising:

a distracting unit including a body and a first wing;

a retaining unit including a second wing which is securable to the body;

the first and second wings having upper portions and lower portions respectively;

the upper portions of the first and second wings and the portion of the body located there between defining an upper saddle;

the lower portions of the first and second wings and the portion of the body located there between defining a lower saddle; and

the portion of the body located between the first and the second saddles defining a trapezoidal shape.

37. An implant for relieving pain associated with the spinal column which implant is positionable between adjacent spinous processes of the spinal column, comprising:

a distracting unit including a body;

a retaining unit which is securable to the body;

said distracting unit and the retaining unit together defining a first saddle and a second saddle, each saddle adapted for receiving a spinous process;

wherein the first saddle has a first width and the second saddle has a second width and wherein the first width is different from the second width; and

a portion of the body located between the first and the second saddles is substantially trapezoidal shaped.

38. The implant of claim 37 wherein:

said first saddle is for receiving an upper spinous process and the second saddle is for receiving a lower spinous process.

39. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit including a body and a guide extending from said body, and a first wing;

a second wing;

said body including a groove that can receive said second wing, said body adapted for positioning between the adjacent spinous processes, with the first wing adapted to be positionable along first sides of the adjacent spinous processes and the second wing adapted to be positionable along opposite second sides of the spinous processes and opposite to the first wing; and

a device that secures the second wing to the body;

said first wing has upper and lower portions;

said second wing has upper and lower portions;

an upper saddle is defined among the body and the upper portions of the first and second wings;

a lower saddle is defined among the body and the lower portions of the first and second wing;

wherein an upper width of the upper saddle is defined between the upper portions of the first and second wings;

wherein a lower width of the lower saddle is defined between the lower portions of the first and second wings;

the implant comprising multiple second wings with each second wing having at least one of said upper portion and said lower portion of a different thickness; and

wherein at least one of said upper width and the lower width can be selected by choosing said second wing with said upper position and the lower portion of the desired thickness.

40. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a body which includes a first wing;

said body having a longitudinal axis and said body adapted to be positioned between adjacent spinous processes;

a second wing; and

said body including a means for receiving said second wing along a direction which is substantially perpendicular to the longitudinal axis, such that said second wing is urged toward said body along a direction which is substantially perpendicular to the longitudinal axis until said receiving means received said second wing.

41. The implant of claim 40 wherein:

said means for receiving includes a groove provided in said body; and

wherein said groove is substantially perpendicular to said longitudinal axis.

42. The implant of claim 40 including:

a means for securing said second wing to said body along a direction which is substantially perpendicular to the longitudinal axis of said body.

43. The implant of claim 42 wherein:

said securing means includes a bore provided in said body, which bore is substantially perpendicular to said longitudinal axis; and

a screw which can be received in said bore.

44. The implant of claim 42 wherein said securing means includes:

a first bore provided in said body, which bore is substantially perpendicular to said longitudinal axis;

a tab extending from said second wing, said tab including a second bore, said second bore alignable with said first bore with said second wing engaged with said body; and

a screw which can be received through said second bore and in said first bore in order to secure said second wing to said body.

45. An implant for relieving pain associated with the spinal column which implant is positionable between adjacent spinous processes of the spinal column, comprising:

a distracting unit including a body which has a longitudinal axis and a first wing, said first wing being connected to an end of said body and extending substantially perpendicular to the longitudinal axis, with the body adapted to be positionable between adjacent spinous processes and said first wing adapted to be positionable along first sides of adjacent spinous processes;

a retaining unit including a second wing, which second wing is adapted to be positionable along second sides of adjacent spinous processes which are opposite to the first sides of the spinous processes; and

said body including a groove which is substantially perpendicular to said longitudinal axis, which groove receives at least a portion of said second wing.

46. An implant for relieving pain associated with the spinal column which is positionable between adjacent spinous processes of the spinal column, comprising:

a first unit with a body and a first wing, and a guide which extends from the body and is located distally from the first wing and wherein said body has a longitudinal axis;

wherein said guide has an increasingly reduced cross section in a direction extending along the longitudinal axis distally from the first wing so that said guide is shaped in order to guide the body into a location between the adjacent spinous processes without requiring the spinous processes to be modified;

a second wing; and

said body including a groove provide therein, said groove provided substantially perpendicular to and intersecting said longitudinal axis, said groove shaped to receive said second wing such that said second wing can be urged along a direction which is substantially perpendicular to said longitudinal axis until said second wing is received in said groove.

47. The implant of claim 46, wherein said guide is shaped so that the guide distracts the adjacent spinous processes as the guide passes between the adjacent spinous processes.