Spine distraction implant and method

• US 6,183,471 B1
• Filed: 11/25/1998
• Issued: 02/06/2001
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St. Francis Medical Technologies, Inc. (Medtronic Plc)
• Inventors: Zucherman, James F., Hsu, Ken Y.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/200,266
• Time in Patent Office: 804 Days
• Field of Search: 606/60, 606/61, 606/105, 623/17.11, 623/17.14, 623/17.16
• 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable and extending along at least one of opposite second sides of the spinous processes.

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

3. The implant of claim 1 wherein:

said body has an oval cross-section which is substantially perpendicular to said longitudinal axis.

4. The implant of claim 1 wherein:

along said longitudinal axis, said body has varying cross-sections that are substantially perpendicular to said longitudinal axis.

5. The implant of claim 4 wherein:

there is a smooth transition between the varying cross-sections.

6. The implant of claim 4 wherein:

said body has first and second end portions and a central portion located between the first and second end portions; and

from said central portion toward both the first end portion and the second end portion the varying cross-sections become larger.

7. The implant of claim 6 wherein:

there is a smooth transition between the varying cross-sections.

8. 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and 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.

9. 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and 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.

10. 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and wherein the spinous processes of the spinal column extend from respective vertebrae 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.

11. 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body alone a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and 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.

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;

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

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable alone at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and 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.

13. 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 body adapted to be positioned between adjacent spinous processes;

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and wherein;

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

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

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is substantially perpendicular to the longitudinal axis of said body, with the first wind adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable along at least one of opposite second sides of the spinous processes, and wherein;

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

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

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 and a first wing;

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

a second wing;

a device that secures the second wing to the body such that said second wing is secured substantially perpendicular to the longitudinal axis of said body; and

said device can receive said second wing as said second wing is urged toward said body along a direction that is other than parallel to the longitudinal axis of said body, with the first wing adapted to be positionable along at least one of first sides of the adjacent spinous processes and the second wing adapted to be positionable and extending along at least one of opposite second sides of the spinous processes.