Method and apparatus for injecting an elastic spinal implant

• US 5,800,549 A
• Filed: 04/30/1997
• Issued: 09/01/1998
• Est. Priority Date: 04/30/1997
• Status: Expired due to Term

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Howmedica Inc.
• Inventors: Bagga, Charanpreet S., Bao, Qi-Bin, Yuan, Hansen A., Higham, Paul A.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/846,791
• Time in Patent Office: 489 Days
• Field of Search: 623/17, 623/16, 623/66, 623/8, 606/61, 606/99, 606/86
• US Class Current: 606/99
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4681 by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2002/4693 hydraulic
• CPC Class Codes: A61F 2002/4694 pneumatic

Abstract

A method and apparatus for injecting an elastic spinal implant into a cavity in a spinal disc so as to treat disc degeneration are given. The method and apparatus can be used in a variety of surgical approaches with respect to the patient. An elastic spinal nucleus prosthesis is very quickly inserted into the cavity through a small opening in the disc so that permanent deformation of the prosthesis is avoided.

Claims

1. An insertion device for inserting an elastic prosthetic spinal nucleus 12 into an intervertebral disc space, said device comprising:

(a) a tapered cannula 14 having a straight zone 48 with a cross-sectional area which approximates the cross-sectional area of said prosthetic spinal nucleus 12 and said tapered cannula 14 having a tapered zone 34 which tapers from said straight zone 48 to a proximal opening 50, wherein the cross-sectional area of said straight zone 48 divided by the cross-sectional area of said proximal opening 50 is a ratio lying between about 3 and about 8; and

(b) a force transmitting element 16 for acting on said elastic prosthetic nucleus 12 at its distal end 13 when said nucleus 12 is positioned within said straight zone 48 of said tapered cannula 14, said force transmitting element 16 causing said nucleus 12 first to move into said tapered zone 34 and then out of said proximal opening 50, the force transmitted by said force transmitting element 16 varying directly with the ratio between the cross-sectional area of said straight zone 48 and the cross-sectional area of said proximal opening 50 so that the speed at which said nucleus 12 passes through said proximal opening 50 is so fast as to avoid permanent deformation of said elastic prosthetic nucleus 12.

2. A device according to claim 1, wherein said force transmitting element 16 is an incompressible biocompatible medium 42 which pressurizes said tapered cannula 14.

3. A device according to claim 2, wherein said medium 42 is saline.

4. A device according to claim 1, wherein said force transmitting element 16 is a plunger.

5. A device according to claim 1, wherein said force transmitting element 16 is a combination of an incompressible biocompatible medium 42 and a plunger 18.

6. A device according to claim 2, and including also a force generator 44 which is a fluid injection device 44 which pressurizes said medium 42 and which injects between about 3 and about 10 cc of said medium 42 in less than 5 seconds so as to generate a pressure greater than about 3 MPa.

7. A device according to claim 1, wherein said force transmitting element 16 includes a sealing element 20 which allows generation of hydraulic pressure when incompressible fluid 42 is injected into said tapered cannula 14 from said force transmitting element 16.

8. A device according to claim 1, wherein said elastic prosthetic spinal nucleus 12 passes through said proximal opening 50 at a speed lying within the range from about 10 milliseconds to about 5 seconds.

9. A method for implanting an elastic prosthetic spinal nucleus 12 into an intervertebral disc space comprises:

(a) making a small opening in the annulus of said disc;

(b) removing a portion of spinal disc tissue; and

(c) inserting a nucleus implant 12 made of elastic material through a tapered cannula 14 with a taper which tapers from a straight zone 48 to a proximal opening 50, with the ratio of the cross-sectional area of straight zone 48 to the cross-sectional area of the proximal opening 50 lying within the range from about 3 to about 8, and at a fast speed so that permanent deformation of said elastic prosthetic nucleus 12 is avoided.

10. A method according to claim 9, wherein said fast speed is within the range from about 10 milliseconds to about 5 seconds.

11. A method according to claim 10, wherein said elastic material is polyvinyl alcohol hydrogel.