Compliant tissue sealants

• US 6,352,710 B2
• Filed: 12/07/2000
• Issued: 03/05/2002
• Est. Priority Date: 03/22/1996
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Lyman, Michelle D., Jarrett, Peter K., Rudowsky, Ronald S., Sawhney, Amapreet S.
• Primary Examiner(s): Nutter, Nathan M.
• Application Number:
  US09/732,419
• Publication Number:
  US 20010000728A1
• Time in Patent Office: 453 Days
• Field of Search: 424/426, 424/489, 424/490, 528/354, 528/361, 128/898, 128/899, 525/54.1, 525/54.2, 525/408, 525/413, 525/415, 514/772.1
• US Class Current: 424/426
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 26/0019 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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: C08G 63/64 Polyesters containing both carboxylic ester groups and carbonate groups
• CPC Class Codes: C08G 63/676 in which at least one of the two components contains aliphatic unsaturation
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

An improved barrier or drug delivery system which is highly adherent to the surface to which it is applied is disclosed, along with methods for making the barrier. In the preferred embodiment, the system is compliant, in that it is capable of conforming to the three dimensional structure of a tissue surface as the tissue bends and deforms during healing processes. The barrier or drug delivery systems is formed as a polymeric coating on tissue surfaces by applied a polymerizable monomer to the surface, and then polymerizing the monomer. The polymerized compliant coating preferably is biodegradable and biocompatible, and can be designed with selected properties of compliancy and elasticity for different surgical and therapeutic applications.

Claims

1. A compliant polymeric material on a surface, wherein the material is formed by the polymerization of an aqueous solution or suspension of a polymerizable monomer in contact with the surface,

wherein the polymerization reaction occurs between at least one first reactant selected from the group consisting of an amine, an alcohol, and a thiol and at least one second reactant selected from the group consisting of an isocyanate, an isothiolcyanate, an aldehyde, an epoxide, an oxirane, and a cyclic amine,

wherein at least one reactant is covalently attached to the monomer, and

wherein the compliant polymeric material has an adherence to the surface of at least 20 grams per square centimeter.

2. The material of claim 1 wherein the material further comprises a biologically active material.

3. The material of claim 1, wherein the material is biodegradable.

4. The material of claim 1 wherein the material forms a sealant on a tissue surface.

5. The material of claim 1 wherein the material adheres two surfaces together, and wherein at least one of the surfaces is a tissue surface.

6. The material of claim 1, wherein the normalized compliance ratio of the material and the surface is in the range of about 0.05 to about 3.

7. The material of claim 1, wherein the normalized compliance ratio of the material and the surface is greater than 1.

8. The material of claim 1, wherein the surface is selected from the group consisting of a bodily surface, a surface of a medical device, a surface of an implant, or a surface of a wound dressing.

9. The material of claim 8, wherein the surface is a bodily surface, selected from the group consisting of the respiratory tract, the meninges, the synovial spaces of the body, the peritoneum, the pericardium, the synovia of the tendons and joints, the renal capsule and other serosae, the dermis and epidermis, the site of an anastomosis, a suture, a staple, a puncture, an incision, a laceration, or an apposition of tissue, a ureter or urethra, a bowel, the esophagus, the patella, a tendon or ligament, bone or cartilage, the stomach, the bile duct, the bladder, the arteries, and the veins.

10. The material of claim 8, wherein the surface is a surface of a medical device, selected from the group consisting of percutaneous catheters, percutaneous cannulae, urinary catheters, percutaneous electrical wires, ostomy appliances, and electrodes.

11. The material of claim 8, wherein the surface is a surface of a medical implant selected from the group consisting of pacemakers, defibrillators and tissue augmentations.

12. The material of claim 1, wherein the material comprises biodegradable regions.

13. The material of claim 12, wherein the biodegradable regions are selected from the group consisting of poly(alpha-hydroxy acids), poly(amino acids), polycarbonates, poly(anhydrides), poly(orthoesters), poly(phosphazines) and poly(phosphoesters).

14. The material of claim 1, wherein the material is applied to a surface in a body to treat or prevent a medical condition selected from the group consisting of wounds, leakage of blood, serum, urine, cerebrospinal fluid, air, mucus, tears, bowel contents, or other bodily fluids, post-surgical adhesions, abrasions, bums, inflammation of the skin, and restenosis.