Composite material having absorbable and non-absorbable components for use with mammalian tissue

• US 5,141,522 A
• Filed: 01/21/1992
• Issued: 08/25/1992
• Est. Priority Date: 02/06/1990
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: American Cyanamid Co (Pfizer Inc.)
• Inventors: Landi, Henry P.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): PREBILIC, PAUL B
• Application Number:
  US07/823,619
• Time in Patent Office: 217 Days
• Field of Search: 606/151, 606/154, 606/230, 623/11, 623/13, 623/66, 428/225
• US Class Current: 523/114
• CPC Class Codes: A61L 15/24 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 31/04 Homopolymers or copolymers of vinyl acetate
• CPC Class Codes: Y10S 623/924 Material characteristic
• CPC Class Codes: Y10S 623/926 Synthetic
• CPC Class Codes: Y10T 442/167 Fluorinated polyolefin film or sheet
• CPC Class Codes: Y10T 442/3171 Strand material is a blend of polymeric material and a filler material
• CPC Class Codes: Y10T 442/3878 Fluorinated olefin polymer or copolymer sheet or film [e.g., Teflon@, etc.]
• CPC Class Codes: Y10T 442/40 Knit fabric [i.e., knit strand or strip material]
• CPC Class Codes: Y10T 442/677 Fluorinated olefin polymer or copolymer sheet or film [e.g., TeflonR, etc.]

Abstract

The invention is a composite material of two or more biocompatible polymers, at least one of which is polytetrafluoroethylene (PTFE) and one of which is a bioabsorbable polymer. The nonabsorbable PTFE is used in the composite as a reinforcing binder. The reinforcing binder is a network of unsintered, interconnected micro-fibers which are formed, for example, by blending with a thermoplastic polymer vehicle, such as polymethylmethacrylate which is subsequently extracted. The bioabsorbable component is contained within the structure of the PTFE microfibrils. This composite is useful in the repair of mammalian tissue where tissue ingrowth and permenant support is required.

Claims

1. A composite material for use with mammalian tissue consisting essentially of:

(a) an unsintered, microfibrillar, non-absorbable biocompatible component prepared from polytetrafluoroethylene,

(b) a particulate bioabsorbale filler manufactured from a polymer prepared from one or more monomers selected from the group consisting of lactides, carbonates, oxalates and lactones, and

(c) a non-absorbable, biocompatible thermoplastic component manufactured from a polymer which is liquid at a temperature from about 150°

to 200°

C. and solid at ambient temperature, and which provides additional integrity to the unsintered component.

2. The material of claim 1 wherein the particulate bioabsorbable filler is selected from the group consisting of lactides, carbonates and lactones.

3. The material of claim 2 wherein the lactides are selected from the group consisting of glycolide and 3,6-dimethyl-1,4-dioxan-2,5-dione;

the carbonate is 1,3-dioxan-2-one; and

the lactones are selected from the group consisting of e-caprolactone and 1,4-dioxan-2-one.

4. The material of claim 3 wherein the particulates, bioabsorbable filler is manufactured from glycolide.

5. A composite material for use with mammalian tissue comprising a first part consisting of the composite material of claim 1 in the form of a sheet, the sheet having two sides;

and a second part affixed to at least one side of said sheet, the second part comprising a bioabsorbable textile reinforcement component, the bioabsorbable reinforcement component being woven or knitted, and manufactured from the same or a different polymer then the particulate bioabsorable filler of the first part.

6. The material of claim 5 wherein the bioabsorable textile reinforcement component is selected from the group consisting of lactides, carbonates and lactones.

7. The material of claim 6 wherein the lactides are selected from the group consisting of glycolide and 3,6-dimethyl-1,4-dioxan-2,5-dione;

the carbonate is 1,3-dioxan-2-one; and

the lactones are selected from the group consisting of e-caprolactone and 1,4-dioxan-2-one.

8. The material of claim 7 wherein said bioabsorable textile reinforcement material is affixed to both sides of the first part.

9. The material of claim 8 wherein said bioabsorable textile reinforcement component is laminated to said first part.

10. The material of claims 1 or 2 or 3 or 4 wherein the non-absorbable, thermoplastic component is poly(ethylene-vinyl acetate).

15. The material of claim 7 wherein the non-absorbable thermoplastic component is poly(ethylene-vinyl acetate).

11. A composite material for use with mammalian tissue consisting essentially of:

(a) an unsintered, microfibrillar, non-absorbable biocompatible component prepared from polytetrafluoroethylene,

(b) a micropulverized bioabsorbable powder manufactured from a polymer prepared from one or more monomers selected from the group consisting of lactides, carbonates, oxalates and lactones, and

(c) a non-absorbable, biocompatible thermoplastic component manufactured from a polymer which is liquid at a temperature from about 150°

to 200°

C. and solid at ambient temperature, and which provides additional integrity to the unsintered component.

13. The material of claim 11 wherein the composite material is in the form of a sheet.

14. The material of claim 11 wherein the composite material is in the form of a hollow tube.

16. The material of claim 13 wherein said non-absorbable, thermoplastic component is poly(ethylene-vinyl acetate).

17. A composite material for use with mammalian tissue comprising a first part consisting of the composite material of claims 11 or 12 in the form of a sheet, the sheet having two sides;

and a second part affixed to at least one side of said sheet, the second part comprising a bioabsorbable textile reinforcement component, the bioabsorbable textile reinforcement component being woven or knitted, and manufactured from the same or a different polymer than the bioabsorable powder of the first part.

18. The material of claim 17 wherein the bioabsorable powder and textile reinforcement component are selected from the group consisting of lactides, carbonates and lactones.

19. The material of claim 18 wherein the lactides are selected from the group consisting of glycolide and 3,6-dimethyl-1,4-dioxan-2,5-dione;

the carbonate is 1,3-dioxan-2-one; and

the lactones are selected from the group consisting of ε

-caprolactone and 1,4-dioxane-2-one.

20. The material of claim 18 wherein the textile reinforcement component is affixed to both sides of the first part.

12. A composite material for use with mammalian tissue consisting essentially of:

(a) an unsintered, microfibrillar, non-absorbable biocompatible component prepared from polytetrafluoroethylene, and

(b) a bioabsorbable powder manufactured from a polymer prepared from one or more monomers selected from the group consisting of lactides, carbonates, oxalates and lactones, and optionally

(c) a non-absorbable, biocompatible thermoplastic component manufactured from a polymer which is liquid at a temperature from about 150°

to 200°

C. and solid at ambient temperatures, and which provides additional integrity to the unsintered component.