Devices and methods for application of intraluminal photopolymerized gels

• US 5,779,673 A
• Filed: 06/26/1995
• Issued: 07/14/1998
• Est. Priority Date: 06/26/1995
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Melanson, David, Dumont, Michael, Khosravi, Farhad, Herman, Stephen J., Spiridigliozzi, John C., Roth, Laurence A., Campbell, Patrick K.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/494,333
• Time in Patent Office: 1,114 Days
• Field of Search: 604/22, 604/96, 604/102, 604/265, 604/266, 604/280, 604/264, 606/191-194, 606/198, 128/657, 128/772
• US Class Current: 604/101.03
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Devices for providing polymeric layers on the interior surface of body lumens and spaces are disclosed. The devices can include proximal and distal occlusion elements to define the treatment space and an optical emitter to provide light for a photopolymerization procedure. The devices may include a molding member for providing a thick polymeric gel. Alternatively, devices without a molding member may be used to carry out an interfacial polymerization procedure.

Claims

1. A device for delivery of a therapeutic agent to a body cavity or lumen, comprising:

one or more elongated shafts, each with a proximal end, and a distal portion adapted for insertion into a body lumen or cavity;

at least one occlusion element mounted on one or more of the shafts;

at least one injection lumen in at least one shaft, suitable for injection of an agent into a treatment space defined at least at one end by the occlusion element, wherein said injection lumen communicates with at least one injection port located on the shaft; and

a flushing sleeve mounted about the injection port, and arranged on the shaft so as to create at least one axially-directed flushing port.

2. A device as in claim 1, comprising at least two shafts that are concentric and are movable with respect to each other.

3. A device as in claim 1, comprising two occlusion elements.

4. A device as in claim 1, wherein the flushing sleeve comprises a tube with multiple radial distribution points in its surface, arranged on the shaft so as to create at least one radially-directed flushing port.

5. A device as in claim 1, wherein the at least one occlusion element is an inflatable balloon.

6. A device as in claim 1, further comprising, in fluid communication with the distal portion of the shaft, a solution containing at least one pharmaceutical agent for infusion into the treatment space.

7. A device as in claim 1, wherein the device includes a proximal occlusion element and a distal occlusion element that define therebetween the treatment space, one of the elements comprising a valve-occlusion balloon.

8. A device as in claim 1, wherein the flushing sleeve has an end that is affixed to the shaft so as to create an axially-directed flushing port.

9. A device as in claim 1, wherein the flushing sleeve is elastomeric.

10. A device as in claim 1, further comprising a lumen for a guidewire.

11. A device as in claim 10, further comprising an occlusion element mounted on a guidewire.

12. A device as in claim 1, wherein the device further comprises a sheath covering the outer surface of the outermost shaft and moveable with respect to said shaft.

13. A device as in claim 12, further comprising an occlusion element mounted on the sheath.

14. A device as in claim 1, wherein the device includes a proximal occlusion element and a distal occlusion element that define therebetween the treatment space.

15. A device as in claim 14, wherein the proximal and distal occlusion elements are radially-expandable balloons.

16. A device as in claim 1, further comprising:

an emitter of electromagnetic radiation associated with the shaft.

17. A device as in claim 16, wherein the emitter of electromagnetic radiation is movable axially relative to the occlusion element.

18. A device as in claim 16, wherein the emitter of electromagnetic radiation is connected via an optical fiber to a source of electromagnetic radiation near the proximal end of the shaft.

19. A device as in claim 1, further comprising a reservoir of fluid prepolymer in fluid communication with the injection lumen.

20. A device as in claim 19, wherein the prepolymer fluid is photopolymerizable upon application of electromagnetic radiation.

21. A device as in claim 19, wherein the prepolymer fluid is photopolymerizable to form a biodegradable polymeric material.

22. A device as in claim 19, further comprising a reservoir of photoinitiator in fluid communication with the distal portion of the shaft.

23. A device as in claim 1, further comprising at least one inflation lumen in the shaft, communicating with the occlusion element and with the proximal end of the shaft.

24. A device for delivery of a fluid to a body cavity or lumen, comprising:

an elongated shaft having a proximal end, and a distal portion adapted for insertion into a body lumen or cavity; and

a flushing sleeve mounted about an injection port on the shaft, and arranged on the shaft so as to direct at least a portion of agent ejected from the injection port axially.

25. A device as in claim 24, further comprising an emitter of electromagnetic radiation associated with the shaft.

26. A device as in claim 24, further comprising at least one injection lumen communicating with the injection port at the distal portion of the shaft, suitable for injection of a fluid into a treatment space at the distal portion of the shaft.

27. A device as in claim 26, further comprising a reservoir of therapeutic agent in communication with the injection lumen.

28. A device as in claim 26, further comprising a reservoir of photoinitiator in communication with the injection lumen.

29. A device as in claim 26, further comprising a reservoir of fluent prepolymer in communication with the injection lumen.

30. A device as in claim 26, wherein the flushing sleeve is an elastomeric sleeve having a first end and a second end, mounted about the injection port and secured to the shaft at its first end so as to direct at least a portion of fluid ejected from the injection port axially from the second end.

31. A device as in claim 30, wherein the flushing sleeve includes multiple radial distribution ports in its surface and is arranged so as to create at least one radially-directed flushing port.

32. Apparatus for treatment of a hollow organ or tissue lumen of a mammal comprising:

an elongated shaft having a distal portion adapted to be inserted into a hollow organ or tissue lumen of a mammal during treatment and a proximal portion adapted to remain outside the mammal during treatment;

a first occlusion element at the distal portion of the shaft adapted to occlude the hollow organ or lumen and thereby, during the treatment of the organ or lumen, to prevent fluid flow therepast while fluid pressure in the lumen or organ does not exceed a threshold value; and

a second occlusion element at the distal region of the shaft having an essentially circular cross section when expanded, spaced from the first occlusion element, adapted to occlude the hollow organ or tissue lumen and prevent fluid flow therepast, and being constructed and arranged to withstand during treatment a second fluid pressure, less than the threshold pressure, applied within the hollow organ or tissue lumen between the first and second occlusion elements thereby preventing fluid flow therepast and to allow fluid flow therepast during treatment at the threshold fluid pressure.

33. Apparatus as in claim 32, further comprising a reservoir of therapeutic material in communication with an injection port located between the first and second occlusion elements at the distal portion of the shaft.

34. Apparatus as in claim 32, further comprising a flushing sleeve mounted about the injection port, and arranged on the shaft so as to create at least one axially-directed flushing port.

35. Apparatus of claim 32, wherein the second occlusion element is more compliant than is the first occlusion element.

36. Apparatus of claim 32, wherein the second occlusion element is shaped so as to allow fluid to flow past it more readily than the first occlusion element.

37. Apparatus as in claim 32, further comprising a reservoir of prepolymeric fluid in communication with an injection port between the first and second occlusion elements at the distal portion of the shaft.

38. Apparatus as in claim 37, further comprising a flushing sleeve mounted about the injection port, and arranged on the shaft so as to create at least one axially-directed flushing port.

39. Apparatus as in claim 32, further comprising a reservoir of photoinitiator in communication with an injection port between the first and second occlusion elements at the distal portion of the shaft.

40. Apparatus as in claim 39, further comprising a flushing sleeve mounted about the injection port, and arranged on the shaft so as to create at least one axially-directed flushing port.

41. Apparatus as in claim 32, further comprising an emitter of electromagnetic radiation associated with the shaft.

42. A device as in claim 41, wherein the emitter of electromagnetic radiation is connected via an optical fiber to a source of electromagnetic radiation near the proximal end of the shaft.

43. Apparatus as in claim 32, wherein the first and second occlusion elements comprise radially-expandable balloons.

44. Apparatus of claim 43, wherein the second occlusion element is inflated to a lesser extent than is the first occlusion element.

45. A method of applying a fluid to the interior surface of a body lumen or cavity, comprising:

entering the lumen or cavity with a catheter having an elongated shaft that includes a distal end insertable into the lumen or cavity and a proximal end adapted to remain outside of the lumen or cavity;

occluding the lumen or cavity with an occlusion element near the distal end of the shaft; and

directing fluid toward the occlusion element so as to flush a region at an interface of the occlusion element and the surface of the lumen or cavity.

46. A method as in claim 45, wherein the fluid contains a therapeutic agent.

47. A method as in claim 45, wherein the fluid comprises a photoinitiator.

48. A method as in claim 45, wherein the fluid comprises a photopolymerizable prepolymer.

49. A method as in claim 45, comprising expelling the fluid from an injection port near the distal and end of the shaft and directing the fluid toward the occlusion element via a flushing sleeve having a first end and a second end, mounted about the injection port and secured to the shaft at the first end, the second end directed toward the occlusion element.

50. A method as in claim 49, wherein the sleeve is mounted between the occlusion element and a second occlusion element, and the second occlusion element is a valve-occlusion balloon.

51. A method as in claim 49, wherein the flushing sleeve comprises an elastomeric tube having multiple radial distribution ports, the method involving allowing the fluid to be directed by the sleeve axially from a space between the second end of the sleeve of the shaft toward the occlusion element, and radially through the multiple radial distribution ports.

52. A method as in claim 51, wherein the flushing sleeve is mounted between the occlusion element and a second occlusion element.

53. A method as in claim 52, wherein the second occlusion element is a valve-occlusion balloon.

54. A method of applying a fluid from an applicator to an interior surface of a body lumen or cavity having an axis of elongation, comprising:

directing fluid in a first, radial direction from the applicator towards the surface of the body lumen or cavity and simultaneously directing fluid from the applicator within the body lumen or cavity in a second, axial direction perpendicular to the first direction.

55. A method as in claim 54, further comprising, prior to the directing step, occluding a region of the body lumen or cavity to define a treatment space, wherein the fluid is applied within the treatment space.

56. A method as in claim 54, wherein the fluid contains a therapeutic agent.

57. A method as in claim 54, involving directing the fluid from at least one injection port located between proximal and distal occlusion elements at the distal portion of a catheter shaft.

58. A method as in claim 54, wherein the fluid comprises a photoinitiator.

59. A method as in claim 54, wherein the fluid comprises a photopolymerizable prepolymer.

60. A method as in claim 54, further comprising photopolymerizing a fluid prepolymer within the body lumen or cavity.

61. A method as in claim 54, comprising directing the fluid from an injection port at a distal portion of a catheter, and allowing the fluid to be directed by a flushing sleeve mounted about the injection port.

62. A method as in claim 61, wherein the flushing sleeve comprises a tube having a first end and a second end and multiple radial distribution ports, the sleeve being affixed to the catheter shaft at its first end, the method involving allowing the fluid to be directed by the sleeve axially from a space between the second end of the sleeve and the shaft, and radially through the multiple radial distribution ports.

63. A method as in claim 62, wherein the sleeve is elastomeric.

64. A method of applying a fluid to the interior surface of a body lumen or cavity, comprising:

occluding a diseased region of a hollow organ or tissue lumen of a mammal by positioning a first occlusion element in the hollow organ or lumen and positioning a second occlusion element, spaced from the first occlusion element, in the hollow organ or lumen, thereby defining a treatment space including the diseased region isolated by the occlusion elements;

applying fluid to the occluded region;

increasing pressure of the fluid; and

allowing the pressurized fluid to escape from the occluded region past the second occlusion element, while preventing the fluid from escaping past the first occlusion element.

65. The method of claim 64, wherein at least one of the occlusion elements comprises an inflatable balloon.

66. The method of claim 64, wherein the fluid contains a therapeutic agent.

67. The method of claim 64, wherein the fluid comprises a photoinitiator.

68. The method of claim 64, wherein the fluid is a fluent prepolymer, the method further comprising photopolymerizing the fluent prepolymer at the diseased region of the hollow organ or tissue lumen.

69. The method of claim 64, wherein the first and second occlusion elements are radially-expandable balloons.

70. The method of claim 69, wherein the second occlusion element is inflated to a lesser extent than is the first occlusion element.

71. The method of claim 69, wherein the second occlusion element is more compliant than is the first occlusion element.

72. The method of claim 69, wherein the second occlusion element is shaped so as to allow fluid to flow past it more readily than the first occlusion element.