Biodegradable polymeric endoluminal sealing process

• US 5,213,580 A
• Filed: 03/25/1992
• Issued: 05/25/1993
• 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): Isabella, David
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US07/857,700
• Time in Patent Office: 426 Days
• Field of Search: 623/1, 623/66, 623/12, 623/13
• 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 2/88 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 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/604 Biodegradation
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• 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 27/54 : 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 31/10 : Macromolecular materials
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 35/00 : Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 623/921 : Blood vessel

Abstract

A novel process for paving or stabilizing sealing the interior surface of a body vessel or organ by entering the interior of the vessel or organ and applying a polymer to the interior surface of the vessel or organ.

Claims

1. A process for paving or stabilizing an irregularly contoured interior surface of a body vessel or organ in an animal, including man, comprising introducing flowable polymeric material onto and filling said irregularly contoured interior surface of the vessel or organ and reconfiguring the polymeric material to form a layer of polymer, said polymer layer having an outer surface which conforms with and is affixed to the irregularly contoured interior surfaces of the vessel or organ and a smooth inner luminal surface.

2. A process as described in claim 1, wherein the polymeric material is a biodegradable polymer.

3. A process as described in claim 1 or 2 wherein the polymeric material is applied in a preshaped form to the interior surface of the vessel or organ.

4. A process as described in claim 2, wherein the layer of biodegradable polymer as applied has a thickness of about 0.005 mm to 0.50 mm, so as to create a thin layer.

5. A process as described in claim 2, wherein the layer of biodegradable polymer is about 0.05 mm to 5.0 mm so as to impart structural stability to the organ or vessel.

6. A process as described in claim 2 wherein the biodegradable polymer is selected from the group consisting of a homopolymer, a binary and ternary copolymer.

7. A process as described in claim 6 wherein the polymer is selected from the group consisting of glycolic acid, lactic acid, delta-valerolactone, p-dioxanone, and epsilon-caprolactone.

8. A process as described in claim 6 wherein the biodegradable polymer constitutes a blend of homopolymers or copolymers.

9. A process as described in claim 6 wherein the biodegradable polymer is cross-linked with a biscaprolactone.

10. A process as described in claim 2, wherein the biodegradable polymer is poly (epsilon-caprolactone).

11. A process as described in claim 2, wherein the polymer contains a pharmaceutical agent.

12. The process as described in claim 11, wherein multiple polymers containing various pharmacological agents are applied.

13. A process as described in claim 2 wherein the vessel is a coronary artery.

14. A process as described in claim 1, wherein a catheter is used to enter the interior of the vessel or organ and to apply the polymer layer.

17. A process as described in claim 1 wherein the polymer is applied in such a manner as to shape the vessel or organ.

15. A process for paving an irregularly contoured interior surface of a coronary artery in an animal, including man, comprising flowing poly(epsilon-caprolactone) onto the irregularly contoured interior surface of the artery and reconfiguring the poly(epsilon-caprolactone) to form a layer, said layer having an outer surface which conforms with and is affixed to the irregularly contoured interior surface of the artery and a smooth inner luminal surface.

16. A process as described in claim 15 wherein a catheter is used to introduce poly(epsilon-caprolactone) into the artery.