Spine distraction implant and method

• US 6,156,038 A
• Filed: 05/06/1999
• Issued: 12/05/2000
• 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:
  US09/306,140
• Time in Patent Office: 579 Days
• Field of Search: 606/60, 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 17/7053 with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• 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, a guide extending from said body, and a first wing;

a second wing;

said body including a second wing receiver that can receive said second wing, said body adapted to be positioned 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;

said second wing receiver located adjacent to said guide;

said guide is located distally from the first wing; and

wherein said guide has a varying cross-section 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.

2. 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 device that can receive said second wing, said body adapted to be positioned 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;

said guide is located distally from the first wing;

wherein said guide has a varying cross-section 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

said guide is shaped in order to distract the spinous processes as said guide is used to guide the body between the adjacent spinous processes.

3. 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 means for receiving 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

a device that secures the second wing to the body;

said guide is located distally from the first wing; and

wherein said guide has a varying cross-section 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 process with the body remaining between the spinous process.

4. 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 second wing receiver that can receive said second wing, said body adapted to be positioned 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

a device that secures the second wing to the body;

said guide is located distally from the first wing; and

wherein said guide has a varying cross-section 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 process with the body remaining between the spinous process.

5. 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 wing receiver and (2) a first wing which extends from a first end of said body substantially perpendicular to said longitudinal axis and along first sides of the first and second spinous processes; and

positioning a second wing in the wing receiver of said distracting unit by urging said second wing along a line which is substantially perpendicular to said longitudinal axis until said second wing is received by said wing receiver and until said second wing extends along second sides of the first and second spinous processes.

6. 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 second wing receiver that can receive said second wing, said body adapted to be positioned 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

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.

7. 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 second wing receiver that can receive 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 second wing receiver receives said second wing with the second wing extending along sides of the adjacent spinous processes.

8. 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 extend along second sides of adjacent spinous processes which are opposite to the first sides of the spinous processes; and

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

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 guide extending from said body, and a first wing;

a second wing;

said body including a means for receiving 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

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.

10. An improved apparatus that stabilizes a spinous process relative to another spinous process, said apparatus having at least two pieces and said apparatus adapted to be implanted in a region between said spinous process and said another spinous process, wherein said improvement comprises:

at least one of said two pieces is adapted to be introduced into the region in an anterior-posterior direction so as to extend along sides of the adjacent spinous process.