Apparatus and method for preventing adhesions between an implant and surrounding tissues

• US 8,048,444 B2
• Filed: 01/11/2007
• Issued: 11/01/2011
• Est. Priority Date: 07/31/2002
• Status: Expired due to Fees

• Current Assignee: MAST Biosurgery AG
• Original Assignee: MAST Biosurgery AG
• Inventors: Calhoun, Christopher J., Cornwall, G. Bryan, Holmes, Ralph E.
• Primary Examiner(s): Skowronek; Karlheinz R
• Assistant Examiner(s): Soroush; Ali
• Application Number:
  US11/652,724
• Publication Number:
  US 20070154525A1
• Time in Patent Office: 1,755 Days
• Field of Search: 424/426, 424/450, 623/8
• US Class Current: 424/426
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61C 8/0016 polymeric material
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61N 1/375 : Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor

Abstract

An anti-adhesion membrane is placed onto an implant introduced into a surgical site of a patient to prevent post-surgical adhesions between the implant and surrounding tissue. The implant may comprise either biological material, such as a transplanted organ, or non-biological material such as a medical device. The membrane may be applied in a variety of ways. In one example, a membrane according to the present invention is shrink-wrapped around a pace-maker. In another example, a breast implant is spray-coated or dipped with the membrane material.

Claims

1. A method of forming an implant, comprising:

providing a non-porous, resorbable polymer base material comprising a property of resorbing from more than 6 months to 24 months and a viscosity property from 1 g/dL to 3.5 g/dL; and

applying the resorbable polymer base material in a form of a resorbable membrane to an implant to thereby envelop substantially all of the implant;

wherein;

the resorbable membrane is substantially non-porous, and comprises a layer having a thickness of about 0.01 mm to 0.300 mm and a polymer material consisting essentially of one or more of a lactide polymer and a copolymer of two or more cyclic esters;

the resorbable membrane comprises a substantially planar membrane of resorbable polymer base material having a first substantially smooth side and a second substantially smooth side;

the membrane of polymer base material comprises a single layer of resorbable polymer base material; and

the single layer of resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the implant and substantially all surrounding tissue.

2. The method according to claim 1, wherein:

the substantially planar membrane of resorbable polymer base material has a substantially uniform composition;

the single layer of resorbable polymer base material has a thickness, measured between the first substantially smooth side and the second substantially smooth side, that is between about 10 microns and about 100 microns; and

the single layer of resorbable polymer base material is adapted to be resorbed into a mammalian body within a period of less than approximately 24 months from an initial implantation of the implant into the patient.

3. The method according to claim 1, wherein the polymer base material comprises about 60-80% of L-tactide and about 20-40% of D,L-lactide.

4. The method according to claim 1, wherein the resorbable membrane is in contact with surfaces of the implant when it is applied to the implant.

5. The method according to claim 1, wherein the implant comprises one or more of veins, arteries, heart valves, muscle, membranes and pericardium.

6. The method according to claim 1, wherein:

the resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the implant and surrounding tissue; and

the surrounding tissue comprises one or more of bone, soft tissues, muscle, organs, membranes, pericardium, veins and arteries.

7. A method of forming an implant, comprising:

providing a nonporous, resorbable polymer base material; and

applying the resorbable polymer base material in a form of a resorbable membrane around an implant to thereby cover substantially all exposed surfaces of the implant and to maintain a smooth-surfaced barrier between the implant and substantially all surrounding tissue, wherein the implant comprises mammalian tissue and the resorbable membrane is substantially nonporous, and comprises;

a layer having a thickness of about 0.01 mm to 0.300 mm; and

a polymer material consisting essentially of one or more of a betide polymer and a copolymer of two or more cyclic esters.

8. The method according to claim 7, wherein:

the mammalian tissue comprises transplanted coronary tissue;

the resorbable membrane comprises a substantially planar membrane of resorbable polymer base material having a first substantially smooth side and a second substantially smooth side, the substantially planar membrane of resorbable polymer base material having a substantially uniform composition;

the membrane of polymer base material comprises a single layer of resorbable polymer base material having a thickness, measured between the first substantially smooth side and the second substantially smooth side, that is between about 10 microns and about 100 microns; and

the single layer of resorbable polymer base material is adapted to be resorbed into a mammalian body within a period of less than approximately 24 months from an initial implantation of the implant into the patient.

9. The method according to claim 7, wherein the polymer base material comprises about 60-80% of L-tactide and about 20-40% of D,L-lactide.

10. The method according to claim 7, wherein the resorbable membrane is in contact with the surfaces of the implant when it is applied to the implant.

11. The method according to claim 7, wherein the resorbable membrane is adapted to maintain a barrier between the implant and one or more of bone, soft tissues, muscle, organs, membranes, pericardium, veins and arteries.

12. The method according to claim 7, wherein the mammalian tissue comprises one or more of a heart, veins, arteries, heart valves, muscle, membranes and pericardium.

13. A method of forming an implant for attenuating adhesions between the implant and surrounding tissue following a surgical procedure in a patient, the method comprising:

providing a non-porous, resorbable polymer base material comprising a resorbability greater than 6 months to 24 months and a viscosity property from 1 g/dL to 3.5 g/dL; and

applying the resorbable polymer base material in a form of a resorbable membrane around the implant to thereby cover substantially all exposed surfaces of the implant,

wherein;

the implant comprises a medical device and the resorbable membrane is substantially non-porous, and comprises a layer having a thickness of about 0.01 mm to 0.300 mm and a polymer material consisting essentially of one or more of a lactide polymer and a copolymer of two or more cyclic esters;

the resorbable membrane comprises a substantially planar membrane of resorbable polymer base material having a first substantially smooth side and a second substantially smooth side;

the membrane of polymer base material comprises a single layer of resorbable polymer base material having a thickness, measured between the first substantially smooth side and the second substantially smooth side, that is between about 10 microns and about 100 microns; and

the single layer of resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the implant and substantially all surrounding tissue, and is adapted to be resorbed into a mammalian body within a period of less than approximately 24 months from an initial implantation of the implant into the patient.

14. The method according to claim 13, wherein:

the substantially planar membrane of resorbable polymer base material having a substantially uniform composition;

the single layer of resorbable polymer base material has a thickness, measured between the first substantially smooth side and the second substantially smooth side, that is between about 10 microns and about 100 microns; and

the single layer of resorbable polymer base material is adapted to be resorbed into a mammalian body within a period of less than approximately 24 months from an initial implantation of the implant into the patient.

15. The method according to claim 13, wherein the polymer base material comprises about 60-80% of L-tactide and about 20-40% of D,L-lactide.

16. The method according to claim 13, wherein the resorbable membrane is in contact with the surfaces of the implant when it is applied to the implant.

17. The method according to claim 13, wherein the medical device comprises one or more of tissue glues and adhesives, sutures, staples, defibrillators, pacemakers, pumps, artificial organs or parts or components thereof, non-resorbable or partially non-resorbable membranes, and guided tissue regeneration membranes.

18. The method according to claim 17, wherein the single layer of resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the implant and the surrounding tissue, which comprises one or more of bone, soft tissues, muscle, organs, membranes, pericardium, veins and arteries.