Compliant tissue sealants

• US 6,531,147 B2
• Filed: 11/07/2001
• Issued: 03/11/2003
• 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:
  US10/053,356
• Publication Number:
  US 20020127266A1
• Time in Patent Office: 489 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 device comprising on its surface a compliant polymeric material, wherein the material is formed by the polymerization of an aqueous solution or suspension of a polymerizable monomer in contact with the surface which has been primed by application of an initiator.

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

3. The device of claim 2 wherein the biologically active material is selected from the group consisting of proteins, peptides, organic synthetic molecules, inorganic compounds, nucleic acids, lipids, steroids, carbohydrates, and combinations thereof.

4. The device of claim 3 wherein the biologically active material is selected from the group consisting of hyaluronic acid, hormones, antibodies, enzymes, antibiotics, and genes.

5. The device of claim 1, wherein the material is biodegradable.

6. The device of claim 1, wherein the compliant polymeric material has an adherence to the surface of the device of at least 20 grams per square centimeter.

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

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

9. The device of claim 1, wherein the device is selected from the group consisting of a medical device, an implant, and a wound dressing.

10. The device of claim 9, 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 device of claim 9 wherein the device is a stent.

12. The device of claim 9, wherein the surface is a surface of a medical implant selected from the group consisting of pacemakers, defibrillators and tissue augmentation devices.

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

14. The device of claim 13, 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).

15. The device of claim 1 wherein the initiator is a photoinitiator.

16. The device of claim 1 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 imine.