Biodegradable polymeric endoluminal sealing process

• US 5,800,538 A
• Filed: 06/07/1995
• Issued: 09/01/1998
• 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:
  US08/478,055
• Time in Patent Office: 1,182 Days
• Field of Search: 623/1, 623/11, 623/12, 623/13, 623/66, 600/36, 604/36, 604/48, 604/52, 604/82, 604/83, 604/96, 606/194, 606/195, 606/198, 424/422, 424/423
• 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 2/945 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 process for forming a polymeric coating on an interior surface of a hollow organ or tissue lumen, comprising:

applying, from a distal end of a catheter, a prepolymer fluid to an interior surface of a hollow organ or tissue lumen to be coated; and

polymerizing the prepolymer fluid adjacent the surface to form thereon a polymer coating.

2. A process as in claim 1, wherein the catheter comprises an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, and includes a lumen associated with the shaft that provides fluid communication between an aperture at the distal end of the shaft and the proximal end of the shaft, and the applying step comprises:

positioning the aperture adjacent the surface to be coated and applying the prepolymer fluid through the aperture to the surface.

3. A process as in claim 2, wherein the polymerization step comprises applying heat to the prepolymer fluid from a heat source in thermal communication with the distal end of the shaft.

4. A process as in claim 3, wherein the heat source comprises a source of heated fluid and the catheter further comprises a heated fluid lumen associated with the shaft that is a fluid conduit between the source of heated fluid and the distal end of the shaft, the polymerization step comprising heating the prepolymer fluid with the heated fluid.

5. A process as in claim 4, the catheter further comprising a drain lumen associated with the shaft that is a fluid conduit between the distal end of the shaft and the proximal end of the shaft, the process further comprising draining the heated fluid from the distal end of the shaft.

6. A process as in claim 4, the catheter further comprising at the distal end an expansile member having an interior in fluid communication with the heated fluid, the polymerization step comprising contacting the prepolymer fluid with the expansile member and heating the expansile member by introducing into it the heated fluid.

7. A process as in claim 6, wherein the expansile member is a balloon.

8. A process as in claim 2, wherein the polymerization step comprises exposing the prepolymer fluid to electromagnetic radiation.

9. A process as in claim 8, wherein the polymerization step comprises exposing the prepolymer fluid to electromagnetic radiation delivered to the distal end of the shaft via a fiber associated with the shaft.

10. A process as in claim 8, wherein the polymerization step comprises exposing the prepolymer fluid to UV radiation delivered to the distal end of the shaft via a fiber associated with the shaft.

11. A process as in claim 2, further comprising prior to the applying step:

occluding an interior region of the hollow organ or tissue lumen including the surface to be coated by expanding a radially-expandable occlusion element near the distal end of the shaft.

12. A process as in claim 11, wherein the occlusion element comprises a radially-expandable balloon.

13. A process as in claim 11, wherein the aperture through which the prepolymer fluid is delivered is located distally relative to the occlusion element.

14. A process as in claim 11, wherein the aperture through which the prepolymer fluid is delivered is located proximally relative to the occlusion element.

15. A process as in claim 11, wherein the polymerization step comprises applying heat to the prepolymer fluid from a heat source in thermal communication with the distal end of the shaft.

16. A process as in claim 15, wherein the heat source comprises a source of heated fluid and the catheter further comprises a heated fluid lumen associated with the shaft that is a fluid conduit between the source of heated fluid and the distal end of the shaft, the polymerization step comprising heating the prepolymer fluid with the heated fluid.

17. A process as in claim 16, the catheter further comprising a drain lumen associated with the shaft that is a fluid conduit between the distal end of the shaft and the proximal end of the shaft, the process further comprising draining the heated fluid from the distal end of the shaft.

18. A process as in claim 16, the catheter further comprising at the distal end an expansile member having an interior in fluid communication with the heated fluid, the polymerization step comprising contacting the prepolymer fluid with the expansile member and heating the expansile member by introducing into it the heated fluid.

19. A process as in claim 18, wherein the expansile member is a balloon.

20. A process as in claim 11, wherein the polymerization step comprises exposing the prepolymer fluid to electromagnetic radiation.

21. A process as in claim 11, wherein the polymerization step comprises exposing the prepolymer fluid to electromagnetic radiation delivered to the distal end of the shaft via a fiber associated with the shaft.

22. A process as in claim 21, wherein the polymerization step comprises exposing the prepolymer fluid to UV radiation delivered to the distal end of the shaft via a fiber associated with the shaft.

23. A process as in claim 11, further comprising prior to the polymerization step:

forming the prepolymer fluid into a desired configuration in the region occluded by the occlusion element with a molding element near the distal end of the shaft.

24. A process as in claim 23, wherein the molding element comprises a radially-expandable balloon.

25. A process as in claim 23, wherein the molding element is positioned distally relative to the occlusion element.

26. A process as in claim 23, wherein the molding element is positioned proximally relative to the occlusion element.

27. A process as in claim 2, further comprising prior to the applying step:

occluding an interior region of the hollow organ or tissue lumen including the surface to be coated by expanding a first radially-expandable occlusion element near the distal end of the shaft proximal to the region and expanding a second radially-expandable occlusion element near the distal end of the shaft distal of the region.

28. A process as in claim 27, wherein at least one of the occlusion elements comprises a radially-expandable balloon.

29. A process as in claim 27, wherein each of the first and second occlusion elements comprises a radially-expandable balloon.

30. A process as in claim 27, wherein the aperture through which the prepolymer fluid is delivered is located between the first and second occlusion elements.

31. A process as in claim 27, wherein the polymerization step comprises applying heat to the prepolymer fluid from a heat source in thermal communication with the region at the distal end of the shaft that is occluded by the first and second occlusion elements.

32. A process as in claim 31, wherein the heat source comprises a source of heated fluid and the catheter further comprises a heated fluid lumen associated with the shaft that is a fluid conduit between the source of heated fluid and the distal end of the shaft, the polymerization step comprising heating the prepolymer fluid with the heated fluid.

33. A process for forming a polymeric coating on an interior surface of a hollow organ or tissue lumen comprising:

spraying a prepolymer fluid from a distal end of a tubular device onto an interior surface of a hollow organ or tissue lumen; and

polymerizing the prepolymer fluid on the surface of the hollow organ or tissue lumen to form thereon a polymer coating.

34. A process as in claim 33, wherein the tubular device comprises an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, and includes a lumen associated with the shaft that provides fluid communication between an aperture at the distal end of the shaft from which the prepolymer fluid can be sprayed, and the proximal end of the shaft.

35. A process as in claim 34, wherein the polymerization step comprises applying heat to the prepolymer fluid from a heat source in thermal communication with the distal end of the shaft.

36. A process as in claim 35, wherein the heat source comprises a source of heated fluid and the tubular device further comprises a heated fluid lumen associated with the shaft that is a fluid conduit between the source of heated fluid and the distal end of the shaft, the polymerization step comprising heating the prepolymer fluid with the heated fluid.

37. A process as in claim 34, wherein the polymerizing step comprises exposing the prepolymer fluid to electromagnetic radiation.

38. A process as in claim 37, wherein the polymerizing step comprises exposing the prepolymer fluid to electromagnetic radiation delivered to the distal end of the shaft via a fiber associated with the shaft.

39. A process as in claim 33, wherein the tubular device comprises a flexible elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, and includes a lumen associated with the shaft that provides fluid communication between an aperture at the distal end of the shaft from which the prepolymer fluid can be sprayed, and the proximal end of the shaft.

40. A process as in claim 33, wherein the polymerizing step comprises exposing the prepolymer fluid to electromagnetic radiation.

41. A process for forming a polymeric coating on an interior surface of a hollow organ or tissue lumen comprising:

positioning a partially polymerized polymeric article proximate to an interior surface of a hollow organ or tissue lumen to be coated;

molding the article into a desired shape on the surface;

polymerizing the article on the surface.

42. A process as in claim 41, wherein the polymerizing step comprising heating the article.

43. A process as in claim 41, wherein the polymerizing step comprising irradiating the article.

44. A method of forming a layer of polymeric material on a tissue surface internally of a mammal, comprising:

applying to a tissue surface internally of a mammal an initially entirely fluent, pre-polymeric material that is activatable to a non-fluent, polymeric condition; and

polymerizing the pre-polymeric material on the tissue surface to form thereon a layer of polymeric, non-fluent material.

45. A method comprising:

applying to a tissue surface internally of a mammal an initially entirely fluent, pre-polymeric material that is activatable to a non-fluent, polymeric condition by exposure to actinic light; and

thereafter applying to the material actinic light for a sufficient length of time to effect in situ conversion of the material from a pre-polymeric, fluent to a polymeric, non-fluent condition.

46. A method for applying to a surface of mammalian tissue a polymeric, non-fluent material comprising:

via minimally-invasive surgery, applying internally of a mammal an initially entirely fluent, pre-polymeric material to the tissue, the material being activatable to a non-fluent, polymeric condition by exposure to actinic light; and

thereafter applying to the material actinic light for a sufficient length of time to effect in situ conversion of the material from a pre-polymeric, fluent to a polymeric, non-fluent condition.