Polymeric endoluminal paving process

• US 5,634,946 A
• Filed: 06/07/1995
• Issued: 06/03/1997
• Est. Priority Date: 08/24/1988
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Slepian, Marvin J.
• Primary Examiner(s): Brittingham, Debra S.
• Application Number:
  US08/474,062
• Time in Patent Office: 727 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 424/422, 424/423, 600/36, 604/36, 604/48, 604/52, 604/82, 604/83, 604/96, 606/194, 606/195
• US Class Current: 128/898
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• 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 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 977/773 : Nanoparticle, i.e. structure having three dimensions of 100 nm or less
• CPC Class Codes: Y10S 977/788 : Of specified organic or carbon-based composition
• CPC Class Codes: Y10S 977/795 : Composed of biological material

Abstract

A method for applying a paving material to a tissue surface is described. The method involves positioning a non-fluent polymeric material at the surface to be paved, rendering the material fluent, contacting the fluent polymer with the tissue surface, and allowing the polymer to return to its non-fluent condition.

Claims

1. A method for forming a biocompatible polymer coating on a tissue surface of a lumen in a body vessel or hollow organ which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature and which is fluent at an elevated temperature;

b) heating the material to render the polymer fluent;

c) contacting the fluent polymer with a surface to be coated; and

d) allowing the fluent polymer to cool into a non-fluent biocompatible polymeric coating on the surface.

2. A method as in claim 1 wherein the polymeric coating is biodegradable.

3. A method as in claim 2 wherein the biodegradable polymeric coating further includes a therapeutic agent.

4. A method as in claim 3 wherein the therapeutic agent is selected from the group consisting of anti-thrombotic agents, thrombolytic agents, vasodilating agents, anti-proliferative agents, intercalating agents, growth modulating factors, monoclonal antibodies, anti-inflammatory agents, lipid and cholesterol sequestrants, antisense oligonucleotides, ribozymes, aptomers and combinations thereof.

5. A method as in claim 1 wherein the biocompatible polymer is selected from the group consisting of polymers and copolymers of hydroxycarboxylic acids, polyurethanes, polyesters, polyamides, polyacrylonitriles, polyphosphazenes, polylactones, polyanhydrides, polyethylenes, polyalkysulfones, polycarbonates, polyhydroxybutyrates, polyhydroxyvalerates, hydrocarbon polymers, polypropylenes polyvinylchlorides, ethylene vinyl acetates and combinations thereof.

6. A method as in claim 1 wherein the polymeric coating has a thickness in the range of approximately 0.001-1.0 mm.

7. A method as in claim 1 wherein the tissue surface comprises a lumen in a body vessel.

8. A method as in claim 1 wherein the body vessel comprises a blood vessel.

9. A method as in claim 1 wherein the coating comprises a substantially continuous layer.

10. A method as in claim 9 wherein the continuous layer includes perforations.

11. A method as in claim 1 wherein the coating comprises a plurality of isolated coating domains, the domains comprising stellate, amorphous or spot geometries.

12. A method as in claim 1 wherein the coating portion opposite the tissue contacting surface is substantially smooth.

13. A method for forming a biocompatible polymer coating on a tissue surface of a lumen in a body vessel or a hollow organ which comprises the steps of:

a) providing a biocompatible polymeric material having a variable degree of fluency in response to a stimulus;

b) providing the stimulus to the material to render the polymer fluent;

c) contacting the fluent polymer with a surface to be coated; and

d) allowing the fluent polymer to return to a non-fluent state, thereby providing a biocompatible polymeric coating on the surface.

14. A method as in claim 13, wherein the polymeric coating is biodegradable.

15. A method as in claim 13, wherein the biodegradable polymeric coating further includes a therapeutic agent.

16. A method as in claim 13 wherein the body vessel comprises a blood vessel.

17. A method for forming a biocompatible polymer coating on a tissue surface which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature and which is fluent at an elevated temperature;

b) heating the material to render the polymer fluent;

c) contacting the fluent polymer with a surface to be coated; and

d) allowing the fluent polymer to cool into a non-fluent biocompatible polymeric coating on the surface, the coating defining a passageway open to fluid flow.

18. A method as in claim 17 wherein the polymeric coating is biodegradable.

19. A method as in claim 17 wherein the biodegradable polymeric coating further includes a therapeutic agent.

20. A method as in claim 17 wherein the tissue surface comprises a lumen in a body vessel or hollow organ.

21. A method as in claim 17 wherein the body vessel comprises a blood vessel.