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

• US 6,699,272 B2
• Filed: 12/13/2001
• Issued: 03/02/2004
• Est. Priority Date: 08/24/1988
• Status: Expired due to Fees

• Current Assignee: Endoluminal Therapeutics Incorporated
• Original Assignee: Endoluminal Therapeutics Incorporated
• Inventors: Slepian, Marvin J., Schindler, Anton
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/020,083
• Publication Number:
  US 20020099332A1
• Time in Patent Office: 810 Days
• Field of Search: 606/108, 604/103.02, 604/103.01, 604/101.01, 604/101.05, 604/101.03, 607/80, 607/88, 607/92-93, 623/1.1, 623/1.11, 623/1.21
• US Class Current: 623/1.11
• 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 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 expansile member.

Claims

1. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient;

a radially expandable balloon near the distal end of the shaft;

a polymeric article, formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient, positioned on the balloon; and

an emitter of electromagnetic radiation near the distal end of the shaft positioned in optical communication with the polymeric article.

2. A catheter apparatus as in claim 1, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

3. A catheter apparatus as in claim 1, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

4. A catheter apparatus as in claim 1, characterized in that the apparatus includes a mechanically retractable protective sheath.

5. A catheter apparatus as in claim 1, characterized in that the polymeric article includes one or more therapeutic agents.

6. A catheter apparatus 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 emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article that contains a therapeutic agent positioned on the article-forming element, formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient,

wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article.

7. The catheter apparatus of claim 6, wherein the tissue is a blood vessel.

8. The catheter apparatus of claim 6, wherein the therapeutic agent comprises a growth factor.

9. The catheter apparatus of claim 6, wherein the therapeutic agent comprises an anti-thrombotic agent.

10. The catheter apparatus of claim 9, wherein the anti-thrombotic agent is prostacyclin.

11. The catheter apparatus of claim 9, wherein the anti-thrombotic agent is a salicylate.

12. The catheter apparatus of claim 6, wherein the therapeutic agent comprises a thrombolytic agent.

13. The catheter apparatus of claim 12, wherein the thrombolytic agent is streptokinase.

14. The catheter apparatus of claim 12, wherein the thrombolytic agent is urokinase.

15. The catheter apparatus of claim 12, wherein the thrombolytic agent is tissue plasminogen activator.

16. The catheter apparatus of claim 12, wherein the thrombolytic agent is anisoylated plasminogen-streptokinase activator complex.

17. The catheter apparatus of claim 6, wherein the therapeutic agent comprises a vasodilating agent.

18. The catheter apparatus of claim 17, wherein the vasodilating agent is a nitrate.

19. The catheter apparatus of claim 17, wherein the vasodilating agent is a calcium channel blocker.

20. The catheter apparatus of claim 6, wherein the therapeutic agent comprises an anti-proliferative agent.

21. The catheter apparatus of claim 20, wherein the anti-proliferative agent is colchicine.

22. The catheter apparatus of claim 20, wherein the anti-proliferative agent is an alkylating agent.

23. The catheter apparatus of claim 6, wherein the therapeutic agent comprises an intercalating agent.

24. The catheter apparatus of claim 6, wherein the therapeutic agent comprises a growth modulating factor.

25. The catheter apparatus of claim 24, wherein the growth modulating factor is an interleukin.

26. The catheter apparatus of claim 24, wherein the growth modulating factor is transformation growth factor β

.

27. The catheter apparatus of claim 24, wherein the growth modulating factor is a congener of a platelet derived growth factor.

28. The catheter apparatus of claim 6, wherein the therapeutic agent comprises a monoclonal antibody.

29. The catheter apparatus of claim 6, wherein the therapeutic agent comprises an anti-inflammatory agent.

30. The catheter apparatus of claim 29, wherein the anti-inflammatory agent is steroidal.

31. The catheter apparatus of claim 29, wherein the anti-inflammatory agent is non-steroidal.

32. The catheter apparatus of claim 6, wherein the therapeutic agent modulates vessel tone.

33. The catheter apparatus of claim 6, wherein the therapeutic agent modulates arteriosclerosis.

34. The catheter apparatus of claim 6, wherein the therapeutic agent modulates the healing response of the tissue surface.

35. A catheter apparatus as in claim 6, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

36. A catheter apparatus as in claim 6, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

37. A catheter apparatus as in claim 6, characterized in that an expansile member is disposed around the tubular shaft.

38. A catheter apparatus as in claim 6, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

39. A catheter apparatus as in claim 6, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

40. A catheter apparatus as in claim 6, characterized in that the apparatus includes a mechanically retractable protective sheath.

41. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a vessel of a patient and a proximal end adapted to remain outside of the patient;

an emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article formable into a stent within the vessel when the shaft is inserted into the patient, the polymeric article positioned on the article-forming element, wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article.

42. A catheter apparatus as in claim 41, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

43. A catheter apparatus as in claim 41, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

44. A catheter apparatus as in claim 41, characterized in that an expansile member is disposed around the tubular shaft.

45. A catheter apparatus as in claim 41, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

46. A catheter apparatus as in claim 41, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

47. A catheter apparatus as in claim 41, characterized in that the apparatus includes a mechanically retractable protective sheath.

48. A catheter apparatus as in claim 41, characterized in that the polymeric article includes one or more therapeutic agents.

49. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a vessel of a patient and a proximal end adapted to remain outside of the patient;

an emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article formable into a polymeric, non-fluent material able to resist radial compressive forces within the vessel when the shaft is inserted into the patient, the polymeric article positioned on the article-forming element, wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article.

50. A catheter apparatus as in claim 49, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

51. A catheter apparatus as in claim 49, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

52. A catheter apparatus as in claim 49, characterized in that an expansile member is disposed around the tubular shaft.

53. A catheter apparatus as in claim 49, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

54. A catheter apparatus as in claim 49, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

55. A catheter apparatus as in claim 49, characterized in that the apparatus includes a mechanically retractable protective sheath.

56. A catheter apparatus as in claim 49, characterized in that the polymeric article includes one or more therapeutic agents.

57. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a vessel of a patient and a proximal end adapted to remain outside of the patient;

a radially expandable balloon near the distal end of the shaft;

a polymeric article formable into a stent within the vessel when the shaft is inserted into the patient, positioned on the balloon; and

an emitter of electromagnetic radiation near the distal end of the shaft positioned in optical communication with the polymeric article.

58. A catheter apparatus as in claim 57, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

59. A catheter apparatus as in claim 57, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

60. A catheter apparatus as in claim 57, characterized in that the apparatus includes a mechanically retractable protective sheath.

61. A catheter apparatus as in claim 57, characterized in that the polymeric article includes one or more therapeutic agents.

62. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a vessel of a patient and a proximal end adapted to remain outside of the patient;

a radially expandable balloon near the distal end of the shaft;

a polymeric article formable into a polymeric, non-fluent material able to resist radial compressive forces within the vessel when the shaft is inserted into the patient, positioned on the balloon; and

an emitter of electromagnetic radiation near the distal end of the shaft positioned in optical communication with the polymeric article.

63. A catheter apparatus as in claim 62, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

64. A catheter apparatus as in claim 62, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

65. A catheter apparatus as in claim 62, characterized in that the apparatus includes a mechanically retractable protective sheath.

66. A catheter apparatus as in claim 62, characterized in that the polymeric article includes one or more therapeutic agents.

67. A catheter apparatus, 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 emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article positioned on the article-forming element that is formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient,

wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article and wherein the article is made of a material selected from the group consisting of polymers of carboxylic acids, polyurethanes, polyesters, polyamides, polyacrylonitriles, polyphosphazines, polylactones, polyanhydrides, polyethylenes, polyvinyl chlorides, ethylene vinyl acetate, delta-valerolactone, and p-dioxanone.

68. A catheter apparatus as in claim 67, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

69. A catheter apparatus as in claim 67, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

70. A catheter apparatus as in claim 67, characterized in that an expansile member is disposed around the tubular shaft.

71. A catheter apparatus as in claim 67, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

72. A catheter apparatus as in claim 67, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

73. A catheter apparatus as in claim 67, characterized in that the apparatus includes a mechanically retractable protective sheath.

74. A catheter apparatus as in claim 67, characterized in that the polymeric article includes one or more therapeutic agents.

75. A catheter apparatus, 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 emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article that contains living cells, formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient, positioned on the article-forming element,

wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article.

76. A catheter apparatus as in claim 75, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

77. A catheter apparatus as in claim 75, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

78. A catheter apparatus as in claim 75, characterized in that an expansile member is disposed around the tubular shaft.

79. A catheter apparatus as in claim 75, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

80. A catheter apparatus as in claim 75, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

81. A catheter apparatus as in claim 75, characterized in that the apparatus includes a mechanically retractable protective sheath.

82. A catheter apparatus as in claim 75, characterized in that the polymeric article includes one or more therapeutic agents.

83. A catheter apparatus, 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 emitter of electromagnetic radiation near the distal end of the shaft;

an article-forming element near the distal end of the shaft; and

a polymeric article, formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient, positioned on the article-forming element,

wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article and the polymeric article is non-fluent at normal patient temperature, becomes fluent when its temperature is raised above normal patient temperature, and becomes non-fluent when its temperature returns to normal patient temperature.

84. A catheter apparatus as in claim 83, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

85. A catheter apparatus as in claim 83, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

86. A catheter apparatus as in claim 83, characterized in that an expansile member is disposed around the tubular shaft.

87. A catheter apparatus as in claim 83, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

88. A catheter apparatus as in claim 83, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

89. A catheter apparatus as in claim 83, characterized in that the apparatus includes a mechanically retractable protective sheath.

90. A catheter apparatus as in claim 83, characterized in that the polymeric article includes one or more therapeutic agents.

91. A catheter apparatus, comprising:

an elongate tubular shaft having a distal end insertable into a patient and a proximal end adopted to remain outside of the patient;

an emitter of electromagnetic radiation near the distal end of the shaft;

a radially expandable article-forming element near the distal end of the shaft;

a polymeric article, formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient, positioned on the article-forming element wherein the emitter of electromagnetic radiation is positioned in optical communication with the polymeric article; and

a lumen associated with the shaft that provides fluid communication between the distal end and the proximal end, wherein the radially expandable article-forming element is connected via the lumen to a source of pressurized fluid.

92. A catheter apparatus as in claim 91, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

93. A catheter apparatus as in claim 91, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

94. A catheter apparatus as in claim 91, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

95. A catheter apparatus as in claim 91, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

96. A catheter apparatus as in claim 91, characterized in that the apparatus includes a mechanically retractable protective sheath.

97. A catheter apparatus as in claim 91, characterized in that the polymeric article includes one or more therapeutic agents.

98. A catheter apparatus comprising:

an elongate tubular shaft having a distal end insertable into a patient and a proximal end adapted to remain outside of the patient;

a lumen associated with the shaft that provides fluid communication between the distal end and the proximal end;

a reservoir of pre-polymer fluid in fluid communication with the distal end of the shaft via the lumen that is formable into a layer of biodegradable polymeric material in intimate contact with a tissue surface that is near the distal end of the shaft when the shaft is inserted into a patient; and

an emitter of electromagnetic radiation near the distal end of the shaft.

99. A catheter apparatus as in claim 98, characterized in that the catheter apparatus includes at least one occluding balloon member disposed around the tubular shaft.

100. A catheter apparatus as in claim 98, characterized in that the apparatus includes two occluding balloons, one disposed toward the proximal end of the tubular shaft, and the other disposed toward the distal end of the tubular shaft.

101. A catheter apparatus as in claim 98, characterized in that an expansile member is disposed around the tubular shaft.

102. A catheter apparatus as in claim 98, characterized in that the apparatus includes a heating element, whereby the polymeric article can be heated prior or subsequent to delivery to the patient.

103. A catheter apparatus as in claim 98, characterized in that the apparatus includes an optical fiber whereby light can be delivered to the polymeric article.

104. A catheter apparatus as in claim 98, characterized in that the apparatus includes a mechanically retractable protective sheath.

105. A catheter apparatus as in claim 98, characterized in that the polymeric article includes one or more therapeutic agents.