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

• US 7,767,222 B2
• Filed: 07/31/2003
• Issued: 08/03/2010
• Est. Priority Date: 07/31/2002
• Status: Active Grant

• Current Assignee: MAST Biosurgery AG
• Original Assignee: MAST Biosurgery AG
• Inventors: Holmes, Ralph E., Calhoun, Christopher J., Cornwall, G. Bryan
• Primary Examiner(s): Richter; Johann R
• Assistant Examiner(s): Soroush; Ali
• Application Number:
  US10/632,014
• Publication Number:
  US 20040115241A1
• Time in Patent Office: 2,560 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2/12 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
• 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 31/10 Macromolecular materials
• 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

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, whcu 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 using a resorbable polymer base material in combination with an implant for attenuating adhesions between the implant and surrounding tissue following a surgical procedure in a human patient, the method comprising:

providing a nonporous, resorbable polymer base material;

heat-shrinking the resorbable polymer base material in a form of a resorbable thin membrane around the implant to thereby cover surfaces of the implant, wherein the resorbable thin membrane comprises a resorbable polymer consisting essentially of;

a lactide polymer;

or a copolymer of two or more cyclic esters;

applying the implant and the resorbable thin membrane to a human patient in a region, which is susceptible to adhesions as a consequence of the surgical procedure; and

attenuating an occurrence of adhesion between the implant and surrounding tissue at the region within the human patient by way of the presence of the resorbable thin membrane positioned at the region within the patient.

2. The method according to claim 1, wherein:

the resorbable thin 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 substantially planar membrane of resorbable polymer base material comprises a single layer of resorbable polymer base material;

the substantially uniform thickness is measured between the first substantially smooth side and the second substantially smooth side, and is between about 10 microns and about 100 microns;

the resorbable thin membrane comprises an edge which is 2 to 4 times thicker than the substantially uniform thickness; and

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

3. The method according to claim 1, wherein:

an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness;

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

the polymer base material comprises about 60-80% of L-lactide and about 20-40% of D,L-lactide.

4. The method according to claim 1, wherein an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness, and the resorbable thin membrane is in contact with the surfaces of the implant when it is applied to the implant.

5. The method according to claim 1, wherein:

an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness; and

the step of applying the thin membrane onto the implant comprises a technique selected from the group consisting of wrapping, interweaving, blanketing, draping, taping, adjacent placement, juxtaposed positioning and sandwiching of the membrane onto the implant.

6. The method according to claim 1, wherein:

an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness.

7. The method according to claim 1, wherein the step of applying the thin membrane onto the implant comprises:

dissolving a polymer material in a solvent to form a solution; and

coating the implant with the solution.

8. The method according to claim 7, wherein:

the polymer material is selected from the group consisting essentially of a lactide polymer and a copolymer of two or more lactides; and

the solvent is selected from the group comprising ethyl acetate, acetonitrile, acetone, methyl ethyl ketone, tetrahydrofuran, methyl pyrole, and any combination thereof.

9. The method according to claim 8, wherein the solution comprises a concentration in the range of about 0.1 to about 5.0% of the polymer.

10. The method according to claim 7, further comprising a step of drying the coated implant before placement into a surgical site.

11. The method according to claim 10, wherein the step of drying comprises drying the coated implant in a vacuum oven.

12. The method according to claim 11, further comprising the step of air drying the coated implant before placement in the vacuum oven.

13. The method according to claim 7, wherein the step of coating the implant comprises spraying the implant with the solution.

14. The method according to claim 1, wherein an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness, and the implant comprises biological material.

15. The method according to claim 14, wherein the biological material comprises grafting material.

16. The method according to claim 15, wherein the grafting material is selected from the group consisting of autograft material, xenograft material, allograft material, and combinations thereof.

17. The method according to claim 15, wherein the grafting material is selected from the group consisting of veins, arteries, heart valves, skin, dermis, epidermis, nerves, tendons, ligaments, bone, bone marrow, blood, white blood cells, red blood cells, gonadocytes, embryos, cells, adipose, fat, muscle, cartilage, fascia, membranes, pericardium, plura, periostium, peritoneum and dura.

18. The method according to claim 15, wherein the surrounding tissue is selected from the group comprising fascia, soft tissues, muscle, organs, fat, adipose, membranes, pericardium, plura, periostium, peritoneum, dura, bowels, intestines, ovaries, veins, arteries, epidermis, tendons, ligaments, nerves, bone and cartilage.

19. The method according to claim 1, wherein an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness, and the implant comprises a transplanted organ.

20. The method according to claim 19, wherein the surrounding tissue is selected from the group comprising fascia, soft tissues, muscle, organs, fat, adipose, membranes, pericardium, plura, periostium, peritoneum, dura, bowels, intestines, ovaries, veins, arteries, epidermis, tendons, ligaments, nerves, bone and cartilage.

21. The method according to claim 1, wherein an edge of the resorbable thin membrane is 2-4 times thicker than the substantially uniform thickness, and the implant comprises non-biological material.

22. The method according to claim 21, wherein the implant comprises a medical device.

23. The method according to claim 22, wherein the medical device is selected from the group consisting of bone graft substitutes, bone cement, tissue glues and adhesives, bone fixation members, defibrillators, eye spheres, sutures, staples, cochlear implants, pumps, artificial organs, non-resorbable membranes, bone growth stimulators, neurological stimulators, dental implants, guided tissue and guided bone regeneration membranes, eye lid weights and tympanostomy tubes.

24. The method according to claim 22, wherein the medical device comprises a fluid-filled prosthesis.

25. The method according to claim 23, wherein the surrounding tissue is selected from the group comprising fascia, soft tissues, muscle, organs, fat, adipose, membranes, pericardium, plura, periostium, peritoneum, dura, bowels, intestines, ovaries, veins, arteries, epidermis, tendons, ligaments, nerves, bone and cartilage.

26. The method according to claim 24, wherein the surrounding tissue is selected from the group comprising fascia, soft tissues, muscle, organs, fat, adipose, membranes, pericardium, plura, periostium, peritoneum, dura, bowels, intestines, ovaries, veins, arteries, epidermis, tendons, ligaments, nerves, bone and cartilage.

27. The method according to claim 24, wherein the fluid-filled prosthesis comprises a breast implant.

28. The method according to claim 27, wherein the breast implant comprises a saline implant contained within a silicone casing.

29. The method according to claim 22, wherein the implant comprises a pacemaker.

30. The method according to claim 1, wherein the edge is 2-4 times thicker than the substantially uniform thickness, and the implant comprises grafting material selected from the group consisting of autograft material, xenograft material, allograft material, and combinations thereof.

31. The method according to claim 30, wherein the grafting material is selected from the group consisting of veins, arteries, heart valves, skin, dermis, epidermis, nerves, tendons, ligaments, bone, bone marrow, blood, white blood cells, red blood cells, gonadocytes, embryos, cells, adipose, fat, muscle, cartilage, fascia, membranes, pericardium, plura, periostium, peritoneum and dura.

32. The method according to claim 1, wherein the edge is 2-4 times thicker than the substantially uniform thickness, and the surrounding tissue is selected from the group comprising fascia, soft tissues, muscle, organs, fat, adipose, membranes, pericardium, plura, periostium, peritoneum, dura, bowels, intestines, ovaries, veins, arteries, epidermis, tendons, ligaments, nerves, bone and cartilage.