Surgical devices having a polymeric material with a therapeutic agent and methods for making same

• US 7,128,753 B1
• Filed: 07/30/2003
• Issued: 10/31/2006
• Est. Priority Date: 06/28/1990
• Status: Expired due to Fees

• Current Assignee: P TECH, LLC
• Original Assignee: MarcTec LLC
• Inventors: Brillhart, Mark V., Bonutti, Peter M.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/630,321
• Time in Patent Office: 1,189 Days
• Field of Search: 606/232, 606/220, 606/228
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0619 thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it suture cutters A61B17/0467; ultrasonic cutters A61B17/320068; electrically heated instruments A61B18/08
• CPC Class Codes: A61B 2017/867 with integral locking or clamping means
• CPC Class Codes: A61F 2/30734 Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
• CPC Class Codes: A61F 2/367 Proximal or metaphyseal parts of shafts trochanteric devices connected to said proximal parts A61F2/30739
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: B29C 65/602 using hollow rivets B29C65/607 takes precedence
• CPC Class Codes: B29C 66/7212 : characterised by the composition of the fibres
• CPC Class Codes: B29C 66/73791 : biodegradable
• CPC Class Codes: B29C 66/7392 : characterised by the material of at least one of the parts being a thermoplastic
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2277/10 : Aromatic polyamides [Polyaramides] or derivatives thereof
• CPC Class Codes: B29K 2307/04 : Carbon
• CPC Class Codes: Y10S 606/908 : Bioabsorbable material
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

Surgical devices such as implants or suture fastenings are assembled from a plurality of discrete components, one of which components includes a heat bondable plastic material for bonding the components together. At least two components are bonded to each other by the applying heat to the heat bondable plastic material of one component. The heat bondable plastic material is preferably a polymeric or composite material suitable for surgical applications and implantation in humans, and may be a biodegradable material. A laser may be used as the heat source. The present invention is advantageously embodied in heat bonded fastenings for sutures or K-wires, in which a variety of different suture anchors are usable, including expandable distal suture anchors. Other embodiments include a metal bone plate which is held to bone by a metal bone screw and a nut of bondable material bonded to the plate to secure the connection; a piece of bondable material bonded to a metal prosthesis to custom fit the prosthesis; and a surgical implant custom formed by bonding together a plurality of discrete elements one or more of which is bondable.

Claims

1. A surgical device for implantation in a body comprising:

an implant, at least a portion of which is expandable; and

a polymeric material bonded to the implant,

wherein the polymeric material is a thermoplastic, includes a therapeutic agent, is non-flowable and non-adherent at room temperature, and becomes flowable, tacky, and adherent upon the application of heat.

2. The surgical device of claim 1 wherein the therapeutic agent is a tissue ingrowth promoter.

3. The surgical device of claim 1 wherein the therapeutic agent is an antibiotic.

4. The surgical device of claim 3 wherein at least a portion of the implant is made of metal.

5. The surgical device of claim 4 wherein the implant includes a plurality of transverse ribs and a plurality of longitudinal ribs.

6. The surgical device of claim 4 wherein the implant includes a plurality of barbs for enhancing tissue engagement.

7. The surgical device of claim 6 wherein the polymeric material covers at least a portion of the implant.

8. The surgical device of claim 7 wherein the polymeric material is bonded to the implant by the application of heat.

9. The surgical device of claim 8 wherein the heat is limited to a temperature tolerated by a human body.

10. The surgical device of claim 9 wherein the polymeric material has a transition temperature below about 190°

C.

11. An implantable device for implantation in a human patient having a generally cylindrical body with a lumen extending longitudinally therethrough, at least a portion of the body including a metallic material and at least another portion of the body including a polymeric material bonded to the metallic material, the polymeric material including a therapeutic agent, being non-flowable and non-adherent at room temperature, and becoming flowable, tacky, and adherent upon the application of heat.

12. The device of claim 11 wherein a tissue-contacting surface of the body includes the polymeric material.

13. The device of claim 12 wherein the therapeutic agent is included within the polymeric material.

14. The device of claim 13 wherein the therapeutic agent is an antibiotic.

15. The device of claim 11 wherein at least a portion of the body is expandable.

16. The device of claim 15 wherein the expandable portion of the body conforms to tissue against which the expandable portion abuts.

17. The device of claim 16 wherein a tissue-contacting surface of the expandable portion of the body conforms to the tissue.

18. The device of claim 17 wherein the tissue-contacting surface is a vessel-contacting surface.

19. The device of claim 11 wherein the body includes ribs.

20. The device of claim 19 wherein the ribs are generally longitudinal to the body.