Method for surgical implantation of a prosthetic spinal disc nucleus

• US 5,562,736 A
• Filed: 10/17/1994
• Issued: 10/08/1996
• Est. Priority Date: 10/17/1994
• Status: Expired due to Term

• Current Assignee: Raymedica, Inc.
• Original Assignee: Raymedica, Inc.
• Inventors: Dickhudt, Eugene A., Ray, Charles D.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/324,138
• Time in Patent Office: 722 Days
• Field of Search: 623/17, 606/1, 606/61, 606/79, 606/99, 606/184, 606/185
• US Class Current: 606/86.00A
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A method for surgically implanting a prosthetic spinal disc nucleus body into a human spinal disc space is disclosed. The spinal disc space contains adjacent vertebrae and an anulus having a posterior side. The method includes cutting a flap through the anulus in the disc space to create an opening. The vertebrae adjacent to the disc space are slightly separated and a prosthetic spinal disc nucleus body is inserted through the opening into the disc space.

Claims

1. A surgical procedure for implanting a prosthetic spinal disc nucleus body into a human disc space, the procedure comprising:

exposing an anulus comprised of fibrous tissue positioned between adjacent vertebrae;

making an incision through the fibrous tissue of the anulus to form a flap comprised of the fibrous anulus tissue wherein a portion of the flap remains attached to the anulus;

maneuvering the flap to provide an opening;

inserting a prosthetic spinal disc nucleus body through the opening; and

securing the flap to the anulus to close the opening.

2. The surgical procedure of claim 1 wherein the incision is made through a posterior side of the anulus.

3. The surgical procedure of claim 1 wherein the flap is C-shaped.

4. A surgical procedure for implantation of two prosthetic spinal disc nucleus bodies side-by-side into a human disc space, the procedure comprising:

exposing an anulus comprised of fibrous tissue positioned between adjacent vertebrae;

cutting the fibrous tissue of the anulus to form a first flap comprised of the fibrous anulus tissue, wherein a portion of the first flap remains attached to the anulus;

cutting the fibrous tissue of the anulus to form a second flap comprised of the fibrous anulus tissue wherein a portion Of the second flap remains attached to the anulus;

maneuvering the first flap to provide a first opening through the anulus;

inserting a first prosthetic spinal disc nucleus body into the human disc space through the first opening;

maneuvering the second flap to provide a second opening through the anulus; and

inserting a second prosthetic spinal disc nucleus body into the human disc space through the second opening.

5. The surgical procedure of claim 4, wherein the first flap and the second flap are cut on a posterior side of the anulus, near a sagittal center of the disc.

6. The surgical procedure of claim 4 wherein the first flap and the second flap are symmetric with respect to a sagittal center of the disc.

7. The surgical procedure of claim 4 wherein the anulus has a transverse height and the first flap and the second flap each have a height less than the transverse height of the anulus.

8. The surgical procedure of claim 4 wherein the first flap and the second flap have a height of about 0.25 inches and a length of about 0.75 inches.

9. The surgical procedure of claim 8 wherein the first flap and the second flap are C-shaped and have a radius of curvature of about 0.125 inches.

10. The surgical procedure of claim 4 further including:

removing at least a portion of material located within the anulus prior to inserting the first prosthetic spinal disc nucleus body and the second prosthetic spinal disc nucleus body.

11. The surgical procedure of claim 4 further including:

12. The surgical procedure of claim 4 and further including:

inserting a jack into the disc space through the second opening in the anulus prior to inserting the first prosthetic spinal disc nucleus body;

separating the adjacent vertebrae by activating the jack; and

removing the jack from the disc space prior to inserting the second prosthetic spinal disc nucleus body.

13. The surgical procedure of claim 4 wherein the disc space has a sagittal plane parallel to which the first and second prosthetic spinal disc nucleus bodies are inserted.

14. The surgical procedure of claim 4 further including securing the first flap and the second flap to the anulus after inserting the first prosthetic spinal disc nucleus body and the second prosthetic spinal disc nucleus body.

15. The surgical procedure of claim 4 wherein the first and second prosthetic spinal disc nucleus bodies have an obround configuration in two planes and an oval configuration in a third plane.

16. The surgical procedure of claim 4 and further including:

performing a minor laminectomy, before cutting the first flap or the second flap through the anulus, when a lamina bone partially surrounds a posterior portion of the disc space.

17. A surgical procedure for implantation of two prosthetic spinal disc nucleus bodies side-by-side into a human disc space defined by adjacent vertebrae, an anulus comprised of a fibrous tissue with a posterior side, and a nucleus, the procedure comprising:

exposing the posterior side of the anulus;

cutting the posterior side of the fibrous tissue of the anulus to form a first flap comprised of the fibrous anulus tissue, wherein a portion of the first flap remains attached to the anulus;

cutting the posterior side of the fibrous tissue of the anulus to form a second flap comprised of the fibrous anulus tissue, wherein a portion of the second flap remains attached to the anulus;

maneuvering the first flap to provide a first opening through the anulus;

maneuvering the second flap to provide a second opening through the anulus;

removing at least a portion of the nucleus through either the first opening or the second opening;

inserting a jack through the first opening in the anulus;

separating the adjacent vertebrae with the jack;

inserting a first prosthetic spinal disc nucleus body through the second opening in the anulus;

removing the jack;

inserting a second prosthetic spinal disc nucleus body through the first opening in the anulus;

securing the first flap to the anulus; and

securing the second flap to the anulus.