Wound implant materials

• US 5,766,631 A
• Filed: 06/05/1995
• Issued: 06/16/1998
• Est. Priority Date: 09/21/1993
• Status: Expired due to Term

• Current Assignee: KCI USA Incorporated (3M Company)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Arnold, Peter Stuart
• Primary Examiner(s): Kulkosky, Peter F.
• Application Number:
  US08/461,791
• Time in Patent Office: 1,107 Days
• Field of Search: 424/486
• US Class Current: 424/486
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 1/00 Compositions of cellulose, modified cellulose or cellulose derivatives
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Wound implant materials are described comprising a plurality of bioabsorbable microspheres bound together by a bioabsorbable matrix, such as in a freeze-dried collagen matrix. The microspheres preferably comprise over 30% of the volume of the material, and preferably have diameters of 10 μm to 1500 μm. The microspheres and/or the matrix preferably comprise a polylactic/polyglycolic copolymer, collagen, cross-linked collagen, hyaluronic acid, cross-linked hyaluronic acid, an alginate or a cellulose derivative. The resulting implants are stronger and more slowly resorbed than conventional collagen sponge implants. Better control over the porosity of the implant is achieved.

Claims

1. A reticulated wound implant material comprising a plurality of bioabsorable microspheres bound together by a bioabsorable matrix which extends between adjacent microspheres, the wound implant having open pores formed by and between adjacent microspheres and the matrix material, the approximate size and volume fraction of the microspheres in the implant material being preselected to provide an approximate size of the pores of between 50 mm and 250 mm whereby to enhance tissue ingrowth into the wound implant material, and wherein at least one of the microspheres and the matrix contains a medicament selected from the group consisting of:

fibronectin, a cytokine, a growth factor, an antiseptic, an antibiotic, steroid and an analgesic; and

wherein the microspheres are formed of a first bioadsorable biopolymer and the matrix is formed of a second bioabsorable bipolymer, wherein the first bioabsorable biopolymer and the second bioabsorable biopolymer are the same or different and wherein each of the first and second bioabsorable biopolymers are selected from the group consisting of;

a polymer or copolymer of lactic acid and/or glycolic acid, collagen, cross-linked collagen, hyaluronic acid, cross-linked hyaluronic acid, an alaginate and a cellulose derivative.

2. A wound implant material according to claim 1 wherein the microspheres comprise at least 30 percent of the volume of the material.

3. A wound implant material according to claim 1 wherein the microspheres comprise at least 40 percent of the volume of the material.

4. A wound implant material according to claim 1 wherein the microspheres comprise at least 50% of the volume of the material.

5. A wound implant material according to claim 1 wherein the matrix, is a solid material.

6. A wound implant material according to claim 5, wherein the matrix material is freeze-dried.

7. A wound implant material according to claim 1 wherein the microspheres comprise hollow microspheres or hollow capsules.

8. A wound implant material according to claim 1 wherein the microspheres are formed of a first bioabsorbable biopolymer and the matrix is formed of a second bioabsorbable biopolymer, wherein the first bioabsorbable biopolymer and the second bioabsorbable biopolymer are the same or different and wherein each of the first and second bioabsorbable biopolymers are selected from the group consisting of:

comprise! a polymer or copolymer of lactic acid and/or glycolic acid, collagen, cross-linked collagen, hyaluronic acid, cross-linked hyaluronic acid, an alginate and a cellulose derivative.

9. A wound implant material according to claim 1 wherein at least 90% of the microspheres have diameters between 50 μ

m and 1500 μ

m.

10. A wound implant material according to claim 9 wherein at least 90% of the microspheres have diameters between 200 μ

m and 1000 μ

m.

11. A wound implant material according to claim 10, wherein at least 90% of the microspheres have diameters between 500 μ

m and 800 μ

m.

14. A wound implant material according to claim 1 wherein the medicament comprises fibronectin.

15. A wound implant material according to claim 1 wherein the medicament comprises a cytokine.

16. A wound implant material according to claim 1 wherein the medicament comprises a growth factor.

17. A wound implant material according to claim 1 wherein the medicament comprises an antiseptic.

18. A wound implant material according to claim 1 wherein the medicament comprises a steroid.

19. A wound implant material according to claim 1 wherein the medicament comprises an antibiotic.

20. A wound implant material according to claim 1 wherein the medicament comprises an analgesic drug.

21. A wound implant material according to claim 2 wherein the first and second bioabsorbable biopolymers each comprise collagen.

12. A process of preparing a reticulated wound implant material, comprising the steps of:

preparing bioabsorbable microspheres;

dispersing the bioabsorbable microspheres in a solution or suspension of a bioabsqrbable material in a solvent; and

removing the solvent by evaporation;

forming pores by and between the microspheres and matrix, and adjusting the size of the microspheres and their density within the matrix to achieve an average pore size of between 50 mm and 250 mm;

wherein the microspheres and/or the bioabsorbable material contain a medicament selected from the group consisting of;

fibronectin, a cytokine, a growth factor, an antiseptic, an antibiotic, a steroid and an analgesic; and

wherein the microspheres are formed of a first bioabsorbable biopolymer and the matrix is formed of a second bioabsorbable biopolymer, wherein the first bioabsorbable biopolymer and the second bioabsorbable biopolymer are the same or different and wherein each of the first and second bioabsorbable biopolymers are selected from the group consisting of;

a polymer or copolymer of lactic acid and/or glycolic acid, collagen, cross-linked collagen, hyaluronic acid, cross-linked hyaluronic acid, an alginate and a cellulose derivative.

13. A process according to claim 12, wherein the solvent is removed by freeze-drying.