Surgically implantable fastening system

• US 6,004,323 A
• Filed: 02/04/1997
• Issued: 12/21/1999
• Est. Priority Date: 02/04/1997
• Status: Expired due to Fees

• Current Assignee: University of Iowa Research Foundation
• Original Assignee: University of Iowa Research Foundation
• Inventors: Weinstein, James N., Park, Joon B., Goel, Vijay K., Pope, Malcolm H.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): BUI, VY Q
• Application Number:
  US08/795,611
• Time in Patent Office: 1,050 Days
• Field of Search: 606/77, 606/76, 606/73, 606/61, 606/70, 606/71, 606/69, 606/86, 606/105
• US Class Current: 606/246
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7007 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
• CPC Class Codes: A61B 17/701 Longitudinal elements with a non-circular, e.g. rectangular, cross-section A61B17/7005, A61B17/7007 take precedence
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8665 Nuts
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: Y10S 606/908 Bioabsorbable material
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

The present invention discloses a nut to be used in a spinal screw and plate assembly to affix the screw and plate assembly to the spinal bone. The nut has a polymer insert that when contacted with a screw allows a bone plate and screw structure to relax over time.

Claims

1. A fastener for connecting a surgically implantable device for connecting together at least one pair of vertebral bodies of the spinal column, the fastener comprising:

a) a nut casing defining a central passageway and having an outside surface and an inside surface; and

b) a relaxative polymeric material lining the inside surface.

2. The fastener of claim 1 wherein the polymeric lining is adapted to engage a surgical screw in a firm threaded relationship.

3. The fastener of claim 1, wherein the polymeric lining is sufficiently relaxative to deform as a function of time and stress.

4. The fastener of claim 3 wherein the polymeric lining comprises a ultra high molecular weight polymer.

5. The fastener of claim 3, wherein the relaxative polymeric material comprises polyethylene, polypropylene, polytetrafluoroethylene, polycarbonate, nylon, styrene butadiene rubber, copolymers of vinylidene fluoride and hexafluoropropylene, butyl rubber, or nitrile rubber.

6. The fastener of claim 3, wherein the polymeric lining comprises an ultra high molecular weight polyethylene.

7. The fastener of claim 3 wherein the polymeric lining is bioresorbable.

8. The fastener of claim 7, wherein the polymeric lining comprises polylactic acid, polyglycolic acid, or copolymers thereof.

9. The fastener of claim 1, wherein the casing comprises a biocompatible material that is rigid and durable.

10. The fastener of claim 9, wherein the biocompatible material comprises stainless steel, cobalt-chromium-molybdenum alloy or titanium alloy.

11. A method for surgically implanting a device for connecting together at least one pair of vertebral bodies of the spinal column, the method comprising:

a) anchoring bone screws into at least two vertebral bodies;

b) placing a pedicle plate between the vertebral bodies and longitudinally with the spinal column, said plate defining holes configured to receive the surgical screws and compressively force the bone together at the fracture when the plate is urged against the fractured bone; and

c) engaging the threads of each surgical screw with a relaxatively lined nut to urge the plate against the fractured bone for a time sufficient to allow the spinal column to heal but relaxes the compressive force during the course of such healing.

12. The method of claim 11 which further comprises engaging each surgical screw with its respective nut to a torque level sufficient to provide for the healing time but also to relax the compressive force in time to inhibit osteoporosis.

13. A fastening system for connecting a surgically implantable pedicle plate to a fractured bone, the fastener comprising:

(a) at least two surgical screws for affixing the pedicle plate across the fracture to fractured parts of the bone and compressing the parts across the fracture; and

(b) a nut casing for each screw, said nut casing defining a central passageway and having an outside surface and an inside surface and including a relaxative polymeric lining that engages the inside surface of said casing and receives said surgical screw in a threaded relationship.

15. The fastening system of claim 13 wherein the nut is adjustable by selective tightening to thereby adjust the load transmitted between the bone and the pedicle plate.

16. The fastening system of claim 13 wherein the nut is tightened to allow creep over time.

14. A kit for connecting a surgically implantable pedicle plate to a fractured bone said kit comprising:

(a) a surgically implantable pedicle plate; and

(b) a fastener comprising;

(1) at least two surgical screws for affixing the pedicle plate across the fracture to fractured parts of the bone and compressing the parts across the fracture; and

(2) a nut casing for each screw, said nut casing defining a central passageway and having an outside surface and an inside surface and including a relaxative polymeric lining that engages the inside surface of said casing and receives said surgical screw in a threaded relationship.

17. A kit for connecting together at least one pair of vertebral bodies of the spinal column with a surgically implantable device, the kit comprising:

a) a pedicle plate configured to be placed between the vertebral bodies and longitudinally with the spinal column, said plate defining holes configured to receive surgical screws;

b) a plurality of surgical screws adapted at a first end to be anchored in the vertebrae and threaded at a second end to pass through said holes in a structural relationship to apply a compressive force with said vertebrae; and

c) a nut for each surgical screw, said nut including a nut casing and a polymeric lining within the nut casing, said polymeric lining having a outer surface adapted to engage the nut casing and an inner surface configured to receive the second end of said surgical screw in a threaded engagement, said polymeric lining being capable of sufficient creep to relax the extent of such threaded engagement with time.

18. A kit as defined in claim 17, wherein each said nut casing includes a lip at one end facing away from the surgical screw within the nut casing and configured to restrain polymeric lining within the nut casing from exiting the nut casing.

19. A nut for securing a surgically implantable device comprising:

a) a nut casing which is biocompatible and has a central passageway and a top surface, and

b) a relaxative polymeric member insertable within said passageway and capable of engaging a screw member in a threaded relation.

20. A nut of claim 19, wherein the polymeric member plastically deforms as a function of time and stress.

21. A nut of claim 20, wherein the polymeric member that plastically deforms comprises polyethylene, polypropylene, polytetrafluoroethylene, polycarbonate, nylon, styrene butadiene rubber, copolymers of vinylidene fluoride and hexafluoropropylene, butyl rubber, or nitrile rubber.

22. A nut of claim 21, wherein the polymeric member is biosorbable.

23. A nut of claim 20, wherein the top surface of the nut is capped.

24. A nut of claim 20, wherein the polymeric member comprises a threaded inside surface.

25. A nut of claim 20 wherein the polymeric member has a smooth inside surface.