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

• US 7,744,915 B2
• Filed: 01/12/2007
• Issued: 06/29/2010
• 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:
  US11/653,064
• Publication Number:
  US 20070116735A1
• Time in Patent Office: 1,264 Days
• Field of Search: 424/426, 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, 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. An apparatus, comprising:

an implant comprising a transplanted organ and being configured to be inserted into a surgical site of a patient surrounded by tissue, wherein when the implant is inserted into the surgical site, tissue surrounds and contacts an exterior surface of the apparatus; and

a resorbable membrane surrounding the implant for attenuating adhesions between the implant and the surrounding tissue, the resorbable membrane comprising a substantially planar membrane having a first substantially smooth side and second substantially smooth side and being heat-shrunk over the exterior surface of the implant;

wherein the substantially planar membrane is substantially non-porous and comprise a polymer base material selected from the group consisting essentially of;

a lactide polymer; and

a copolymer of two or more cyclic esters.

2. The apparatus according to claim 1, wherein the biological implant comprises grafting material.

3. The apparatus according to claim 1, wherein the implant comprises a non-biological body.

4. The apparatus according to claim 3, wherein the non-biological body comprises a medical device 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, eyelid weights and tympanostomy tubes.

11. The apparatus according to claim 3, wherein the non-biological body comprises a pacemaker.

12. The apparatus according to claim 1, wherein the polymer base material is selected from the group consisting essentially of a lactide polymer and a copolymer of two or more lactides.

5. An apparatus, comprising:

an implant configured to be inserted into a surgical site of a patient surrounded by tissue, wherein when the implant is inserted into the surgical site, tissue surrounds and contacts an exterior surface of the apparatus; and

a resorbable membrane surrounding the implant for attenuating adhesions between the implant and the surrounding tissue, the resorbable membrane comprising a layer of resorbable polymer base material having a substantially uniform composition, consisting essentially of a material selected from the group consisting essentially of a lactide polymer and a copolymer of two or more cyclic esters, and comprising a heat-shrunk disposition around the implant.

6. The apparatus according to claim 5, wherein the membrane comprises a single layer of resorbable polymer base material.

7. The apparatus according to claim 6, wherein the single layer of resorbable material has a thickness between about 10 microns and about 100 microns.

8. An apparatus, comprising:

an implant comprising a fluid-filled implantable prosthesis and being configured to be inserted into a surgical site of a patient surrounded by tissue, wherein when the implant is inserted into the surgical site, tissue surrounds and contacts an exterior surface of the apparatus; and

a resorbable membrane surrounding the implant for attenuating adhesions between the implant and the surrounding tissue, the resorbable membrane being heat-shrunk over the exterior of surface.

9. The apparatus according to claim 8, wherein the fluid-filled implantable prosthesis comprises a breast implant.

10. The apparatus according to claim 9, wherein the breast implant comprises a saline-type implant in a silicone casing.