Biodegradable polymeric endoluminal sealing process, apparatus and polymeric products for use therein

• US 5,749,922 A
• Filed: 06/07/1995
• Issued: 05/12/1998
• Est. Priority Date: 08/24/1988
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Endoluminal Therapeutics Incorporated
• Inventors: Slepian, Marvin J., Schindler, Anton
• Primary Examiner(s): Brittingham, Debra S.
• Application Number:
  US08/472,757
• Time in Patent Office: 1,070 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 424/422, 424/423, 600/48, 600/52, 600/82, 600/83, 600/96, 606/194, 606/195
• US Class Current: 29/469.5
• 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 2/945 hardenable, e.g. stents formed in situ
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/64 Animal cells
• 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 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• 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: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: F16B 37/122 : Threaded inserts, e.g. "rampa bolts"
• CPC Class Codes: F16B 39/06 : with a pin or staple parallel to the bolt axis
• CPC Class Codes: Y10S 623/92 : Method or apparatus for preparing or treating prosthetic
• CPC Class Codes: Y10S 623/921 : Blood vessel
• CPC Class Codes: Y10T 29/49906 : Metal deforming with nonmetallic bonding

Abstract

A novel process for paving or sealing the interior surface of a tissue lumen by entering the interior of the tissue lumen and applying a polymer to the interior surface of the tissue lumen. This is accomplished using a catheter which delivers the polymer to the tissue lumen and causes it to conform to the interior surface of lumen. The polymer can be delivered to the lumen as a monomer or prepolymer solution, or as an at least partially preformed layer on an expansile member.

Claims

1. A substantially cylindrical polymeric article having a radius and axial length constructed and arranged for paving or stabilizing an irregularly contoured tissue surface of a lumen or hollow organ of a mammal, the article being partially preformed and having a surface moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface by way of expansion of the radius of the article with essentially no change in axial length of the article.

2. A polymeric article as in claim 1, wherein the article is made of a biodegradable polymer.

3. A polymeric article as in claim 1, the article including at least one therapeutic agent.

4. A polymeric article as in claim 1, the article including a living cell.

5. A polymeric article as in claim 1, wherein the article has a multi-layered structure.

6. A polymeric article as in claim 5, wherein the entire article is moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface.

7. A polymeric article as in claim 1, further comprising a biocompatible coating.

8. A polymeric article as in claim 1, wherein the article is made of a polymer selected from the group consisting of polymers of caprolactones, anhydrides, polylactides, glycolides, oxyalkylenes, carboxylic acids, urethanes, esters, amides, acrylonitriles, phosphazines, ethylene, vinyl fluoride, ethylene vinyl acetate, and blends and copolymeric combinations thereof.

9. A polymeric article as in claim 1, wherein the article is made of a polymer selected from the group consisting of polymers of glycolic acid, glycolide, lactic acid, lactide, beta-hydroxybutyric acid, delta-valerolactone, p-dioxanone, epsilon-caprolactone, and blends and copolymeric combinations thereof.

10. A polymeric article as in claim 1, wherein the article is made of a polymer of at least one anhydride.

11. A polymeric article as in claim 10, wherein the polymer subunits are at least partially crosslinked.

12. A polymeric article as in claim 1, wherein the surface that is moldable in vivo into intimate and conforming contact with the tissue surface is non-fluent at body temperature, becomes fluent at an altered temperature different from body temperature, and becomes non-fluent on returning to body temperature.

13. A polymeric article as in claim 12, wherein the altered temperature is a temperature higher than body temperature.

14. A polymeric article as in claim 1, wherein the article is non-fluent at body temperature, becomes fluent at an altered temperature different from body temperature, and becomes non-fluent on returning to body temperature.

15. A polymeric article as in claim 14, wherein the altered temperature is a temperature higher than body temperature.

16. A polymeric article as in claim 1, wherein the article is constructed and adapted for application to the tissue surface with a catheter.

17. A polymeric article as in claim 16, wherein the article is adapted for application to the tissue surface with an expandable region of a catheter.

18. A polymer article as in claim 17, wherein the article is an at least partially preformed paving, coating or cylindrical article having radial mechanical strength adequate to provide structural stability to a hollow organ or tissue lumen.

19. A polymer article as in claim 18, wherein the article is a partially preformed essentially cylindrical article having radial mechanical strength adequate to provide structural stability.

20. An article as in claim 18, wherein the article is a cylindrical sleeve.

21. A polymeric article as in claim 1, constructed and arranged for paving or stabilizing an interior surface of a blood vessel.

22. A polymeric article as in claim 21, constructed and arranged for paving or stabilizing an interior surface of an artery.

24. A polymeric article as in claim 1, wherein the entire article is moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface.

23. A polymeric article constructed and arranged for paving or stabilizing an irregularly contoured tissue surface of a lumen or hollow organ of a mammal, the article being partially preformed to approximately match the shape of the surface of the lumen or organ and having a surface moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface.

25. A polymeric article constructed and arranged for paving or stabilizing an irregularly contoured tissue surface of a lumen or hollow organ of a mammal and remaining at the surface for a therapeutically effective period of time, the article having a surface that matches an interior tissue surface of a hollow organ or tissue lumen, the surface formed by molding the article into intimate and conforming contact with the tissue surface in vivo under conditions tolerable by the tissue.

26. A polymeric article as in claim 25, wherein the article includes a fluid pathway adapted for passage of physiological fluid.

27. A polymeric article as in claim 26, wherein the article is substantially cylindrical.

28. A polymeric article as in claim 25, wherein the entire article is moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface.

29. A non-filamentary polymeric article constructed and arranged for paving or stabilizing an irregularly contoured tissue surface of a lumen or hollow organ of a mammal, the article being partially preformed and having a surface moldable in vivo, under conditions tolerable by the tissue surface, into intimate and conforming contact with the tissue surface.