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

• US 5,674,287 A
• Filed: 01/14/1994
• Issued: 10/07/1997
• 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
• Application Number:
  US08/182,516
• Time in Patent Office: 1,362 Days
• Field of Search: 623/1, 623/66, 623/12, 623/11, 623/13, 600/36, 604/36, 604/48, 604/52, 604/82, 604/83, 604/96, 424/422, 424/423, 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 2/945 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 process for paving or sealing the interior surface of a tissue lumen by entering the interior tissue lument 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 lument and causes it to conform to the interior surface of the 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 expansible member.

Claims

1. A process for paving or sealing an interior surface of a hollow organ or tissue lumen comprising providing a thermoplastic material in a fluent state in a hollow organ or tissue lumen at a location requiring structural support, reconfiguring the thermoplastic material to form a layer of thermoplastic material on the interior surface, allowing the thermoplastic material to be converted into a non-fluent state in intimate and conforming contact with the tissue surface thereby paving or sealing the hollow organ or tissue lumen, and allowing the material to remain in intimate and conforming contact with the interior surface for a period of time effective for said structural support.

2. A process as in claim 1, comprising using a catheter to position the thermoplastic material while the thermoplastic material is in a fluent state.

3. A process as in claim 1, comprising introducing a preshaped thermoplastic material into the hollow organ or tissue lumen in a non-fluent state, rendering the material fluent in the hollow organ or tissue lumen, and subsequently applying the material to the interior surface.

4. A process as in claim 3, comprising rendering the thermoplastic material fluent by applying heat to the material.

5. A process as in claim 4, comprising rendering the thermoplastic material fluent by applying to the material heated liquid.

6. A process as in claim 4, comprising providing the thermoplastic material in the hollow organ or tissue lumen with a catheter, and reconfiguring the material with the catheter, the catheter comprising an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, an expansile member at the distal end of the shaft, and a lumen associated with the shaft that provides fluid communication between the proximal end of the shaft and an interior surface of the expansile member, and the step of rendering the thermoplastic material fluent involves contacting the material with an exterior wall of the expansile member and delivering a heated liquid to the interior wall of the expansile member through the lumen.

7. A process as in claim 4, comprising rendering the thermoplastic material fluent by applying to the material electromagnetic radiation thereby heating it.

8. A process as in claim 7, comprising irradiating the thermoplastic material through an optical fiber internal of the catheter shaft.

9. A process as in claim 8, wherein the optical fiber is connected to a laser.

10. A process for paving or sealing an interior surface of a hollow organ or a tissue lumen comprising providing a biodegradable thermoplastic material in a fluent state in the hollow organ or tissue lumen, reconfiguring the biodegradable thermoplastic material to form a layer of thermoplastic material on the interior surface, and allowing the biodegradable thermoplastic material to be converted into a non-fluent state in intimate and conforming contact with the tissue surface.

11. A process as in claim 10, wherein the thermoplastic material contains a therapeutic agent.

12. A process as in claim 10, wherein the thermoplastic material comprises a plurality of polymers containing therapeutic agents.

13. A process as in claim 10, comprising using a catheter to position the thermoplastic material while the thermoplastic material is in a fluent state.

14. A process as in claim 10, wherein the thermoplastic material contains living cells which promote organ regeneration.

15. A process as in claim 10, further comprising allowing the non-fluent thermoplastic material to remain in intimate and conforming contact with the tissue surface for a therapeutically effective period of time.

16. A process as in claim 10, further comprising allowing the thermoplastic material to remain in intimate and conforming contact with the tissue surface for a period of time effective to prevent restenosis.

17. A process as in claim 10, comprising introducing a preshaped thermoplastic material into the hollow organ or tissue lumen in a non-fluent state, rendering the material fluent in the hollow organ or tissue lumen, and subsequently applying the material to the interior surface.

18. A process as in claim 17, comprising rendering the thermoplastic material fluent by applying heat to the material.

19. A process as in claim 18, comprising rendering the thermoplastic material fluent by applying to the material heated liquid.

20. A process as in claim 18, comprising providing the thermoplastic material in the hollow organ or tissue lumen with a catheter, and reconfiguring the material with the catheter, the catheter comprising an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, an expansile member at the distal end of the shaft, and a lumen associated with the shaft that provides fluid communication between the proximal end of the shaft and an interior surface of the expansile member, and the step of rendering the thermoplastic material fluent involves contacting the material with an exterior wall of the expansile member and delivering a heated liquid to the interior wall of the expansile member through the lumen.

21. A process as in claim 18, comprising rendering the thermoplastic material fluent by applying to the material electromagnetic radiation thereby heating it.

22. A process as in claim 21, comprising irradiating the thermoplastic material through a optical fiber internal of the catheter shaft.

23. A process as in claim 22, wherein the optical fiber is connected to a laser.

24. A process for paving or sealing an interior surface of a hollow organ or a tissue lumen comprising providing a thermoplastic material that contains a therapeutic agent in a fluent state in the hollow organ or tissue lumen, reconfiguring the thermoplastic material to form a layer of thermoplastic material on the interior surface, and allowing the thermoplastic material to be converted into a non-fluent state in intimate and conforming contact with the tissue surface.

25. A process as in claim 24, wherein the thermoplastic material comprises a plurality of polymers containing therapeutic agents.

26. A process as in claim 24, comprising using a catheter to position the thermoplastic material while the thermoplastic material is in a fluent state.

27. A process as in claim 24, wherein the thermoplastic material contains living cells which promote organ regeneration.

28. A process as in claim 24, further comprising allowing the non-fluent thermoplastic material to remain in intimate and conforming contact with the tissue surface for a therapeutically effective period of time.

29. A process as in claim 24, further comprising allowing the thermoplastic material to remain in intimate and conforming contact with the tissue surface for a period of time effective to prevent restenosis.

30. A process as in claim 24, comprising introducing a preshaped thermoplastic material into the hollow organ or tissue lumen in a non-fluent state, rendering the material fluent in the hollow organ or tissue lumen, and subsequently applying the material to the interior surface.

31. A process as in claim 30, comprising rendering the thermoplastic material fluent by applying heat to the material.

32. A process as in claim 31, comprising rendering the thermoplastic material fluent by applying to the material heated liquid.

33. A process as in claim 31, comprising providing the thermoplastic material in the hollow organ or tissue lumen with a catheter, and reconfiguring the material with the catheter, the catheter comprising an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, an expansile member at the distal end of the shaft, and a lumen associated with the shaft that provides fluid communication between the proximal end of the shaft and an interior surface of the expansile member, and the step of rendering the thermoplastic material fluent involves contacting the material with an exterior wall of the expansile member and delivering a heated liquid to the interior wall of the expansile member through the lumen.

34. A process as in claim 31, comprising rendering the thermoplastic material fluent by applying to the material electromagnetic radiation thereby heating it.

35. A process as in claim 34, comprising irradiating the thermoplastic material through a optical fiber internal of the catheter shaft.

36. A process as in claim 35, wherein the optical fiber is connected to a laser.

37. A process for paving or sealing an interior surface of a hollow organ or a tissue lumen comprising providing a thermoplastic material that comprises a plurality of polymers containing therapeutic agents in a fluent state in the hollow organ or tissue lumen, reconfiguring the thermoplastic material to form a layer of thermoplastic material on the interior surface, and allowing the thermoplastic material to be converted into a non-fluent state in intimate and conforming contact with the tissue surface.

38. A process as in claim 37, comprising using a catheter to position the thermoplastic material while the thermoplastic material is in a fluent state.

39. A process as in claim 37, wherein the thermoplastic material contains living cells which promote organ regeneration.

40. A process as in claim 37, further comprising allowing the non-fluent thermoplastic material to remain in intimate and conforming contact with the tissue surface for a therapeutically effective period of time.

41. A process as in claim 37, further comprising allowing the thermoplastic material to remain in intimate and conforming contact with the tissue surface for a period of time effective to prevent restenosis.

42. A process as in claim 37, comprising introducing a preshaped thermoplastic material into the hollow organ or tissue lumen in a non-fluent state, rendering the material fluent in the hollow organ or tissue lumen, and subsequently applying the material to the interior surface.

43. A process as in claim 42, comprising rendering the thermoplastic material fluent by applying heat to the material.

44. A process as in claim 43, comprising rendering the thermoplastic material fluent by applying to the material heated liquid.

45. A process as in claim 43, comprising providing the thermoplastic material in the hollow organ or tissue lumen with a catheter, and reconfiguring the material with the catheter, the catheter comprising an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, an expansile member at the distal end of the shaft, and a lumen associated with the shaft that provides fluid communication between the proximal end of the shaft and an interior surface of the expansile member, and the step of rendering the thermoplastic material fluent involves contacting the material with an exterior wall of the expansile member and delivering a heated liquid to the interior wall of the expansile member through the lumen.

46. A process as in claim 43, comprising rendering the thermoplastic material fluent by applying to the material electromagnetic radiation thereby heating it.

47. A process as in claim 46, comprising irradiating the thermoplastic material through a optical fiber internal of the catheter shaft.

48. A process as in claim 47, wherein the optical fiber is connected to a laser.

51. A process as in claim 44, further comprising allowing the non-fluent thermoplastic material to remain in intimate and conforming contact with the tissue surface for a therapeutically effective period of time.

49. A process for paving or sealing an interior surface of a hollow organ or a tissue lumen comprising providing a thermoplastic material that contains living cells which promote organ regeneration in a fluent state in the hollow organ or tissue lumen, reconfiguring the thermoplastic material to form a layer of thermoplastic material on the interior surface, and allowing the thermoplastic material to be converted into a non-fluent state in intimate and conforming contact with the tissue surface.

50. A process as in claim 49, comprising using a catheter to position the thermoplastic material while the thermoplastic material is in a fluent state.

52. A process as in claim 49, further comprising allowing the thermoplastic material to remain in intimate and conforming contact with the tissue surface for a period of time effective to prevent restenosis.

53. A process as in claim 49, comprising introducing a preshaped thermoplastic material into the hollow organ or tissue lumen in a non-fluent state, rendering the material fluent in the hollow organ or tissue lumen, and subsequently applying the material to the interior surface.

54. A process as in claim 53, comprising rendering the thermoplastic material fluent by applying heat to the material.

55. A process as in claim 54, comprising rendering the thermoplastic material fluent by applying to the material heated liquid.

56. A process as in claim 54, comprising providing the thermoplastic material in the hollow organ or tissue lumen with a catheter, and reconfiguring the material with the catheter, the catheter comprising an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient, an expansile member at the distal end of the shaft, and a lumen associated with the shaft that provides fluid communication between the proximal end of the shaft and an interior surface of the expansile member, and the step of rendering the thermoplastic material fluent involves contacting the material with an exterior wall of the expansile member and delivering a heated liquid to the interior wall of the expansile member through the lumen.

57. A process as in claim 54, comprising rendering the thermoplastic material fluent by applying to the material electromagnetic radiation thereby heating it.

58. A process as in claim 57, comprising irradiating the thermoplastic material through a optical fiber internal of the catheter shaft.

59. A process as in claim 58, wherein the optical fiber is connected to a laser.