Method and apparatus for providing external perfusion lumens on balloon catheters

• US 5,599,306 A
• Filed: 09/29/1995
• Issued: 02/04/1997
• Est. Priority Date: 04/01/1994
• Status: Expired due to Fees

• Current Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Bajor, Jordan, Alba, Paul, Kaplan, Aaron V., Klein, Enrique J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/536,555
• Time in Patent Office: 494 Days
• Field of Search: 604/96, 604/21, 604/104, 604/97, 604/103, 604/52, 604/53, 604/107, 604/49, 604/28, 604/266, 604/264
• US Class Current: 604/103.01
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter sleeve includes a radially expansible distal region having a plurality of axial blood perfusion lumens or channels formed thereon. The catheter sleeve may be introduced over a conventional angioplasty balloon catheter with the expansible region lying over the balloon. When the balloon of the angioplasty catheter is expanded, the perfusion lumens will provide a flow path for blood around the expanded balloon. Optionally, the catheter sleeve may further include drug infusion lumens over the radially expansible region. In this way, drugs can be delivered over prolonged periods while the underlying angioplasty balloon is inflated and blood flows through the lumens or channels to perfuse the distal myocardium.

Claims

1. A catheter sleeve comprising:

a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and

at least one perfusion lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports distributed substantially uniformly over its length which permit blood flow through the lumen.

3. A catheter sleeve as in claim 1 or 2, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.

4. A catheter sleeve as in claim 3, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.

5. A catheter sleeve as in claim 1, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.

6. A catheter sleeve as in claim 3, wherein the reinforcing structure comprises a helical wire supporting the interior of the lumen.

7. A catheter sleeve as in claim 1, further comprising additional lumens having means for infusing therapeutic agents therethrough.

8. A catheter sleeve as in claim 7, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.

9. A catheter sleeve as in claim 8, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.

10. A catheter sleeve as in claim 1, including at least two perfusin lumens wherein the tubular body is slit between the lumens to enhance radial expansibility.

11. A catheter sleeve as in claim 1, wherein substantially the entire length of the tubular body is radially expansible.

12. A catheter sleeve as in claim 8 wherein a proximal portion of the catheter body is pleated, rolled, or slit to facilitate passage of a large diameter portion of a balloon catheter through the central lumen.

13. A catheter sleeve as in claim 1, wherein a proximal portion of the flexible tubular body has side ports to enhance the flow of perfusion liquid through a guiding catheter when the catheter sleeve is in place therein.

14. A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprise helically arranged flow paths.

15. A catheter sleeve as in claim 14, further comprising at least one helical drug infusion tube formed over the radially expansible portion of the tubular body.

16. A catheter sleeve as in claim 14, wherein the tubular body is helically split between said flow paths.

17. A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprises a pair of adjacent lumens formed on one side of the tubular body, wherein the lumens are separated by a common septum and are split from the remainder of the tubular body to permit radial expansion.

18. A catheter sleeve as in claim 17, further comprising a radiopaque marker attached to the septum.

19. A catheter sleeve as in claim 18, wherein the radiopaque marker comprises a pair of plates secured to each other on opposite sides of the septum.

20. A catheter sleeve as in claim 17, further comprising a plurality of axial spacers on a side of the tubular body opposite to the pair of adjacent lumens.

21. A catheter sleeve as in claim 20, wherein the spacers have solid cross-section.

22. A catheter sleeve as in claim 20, wherein the spacers are inflatable.

23. A catheter sleeve as in claim 1, further comprising a rod having a diameter less than that of the tubular body attached to a proximal end of the tubular body.

24. A catheter sleeve as in claim 17, wherein axially spaced-apart hinges are formed in the tubular body along the adjacent pair of lumens to enhance flexibility.

25. A catheter sleeve as in claim 1, wherein the perfusion-flow-establishing means comprises a triple lumen blood perfusion tube formed over the tubular body, wherein a center lumen includes perfusion ports and the two flanking lumens are closed to permit inflation to selectively reinforce the center lumen.

26. A catheter sleeve as in claim 25, wherein the blood perfusion tube is arranged helically over the tubular body, further comprising a helical drug infusion tube disposed opposite to the blood perfusion tube over the tubular body, wherein the tubular body is split between the blood perfusion tube and the drug infusion tube to permit radial expansion.

27. A catheter sleeve as in claim 1, wherein the lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.

28. A catheter sleeve as in claim 27, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.

2. A catheter sleeve comprising:

a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and

one or more channels disposed over said radially expansible portion of the tubular body, wherein the channels define flow paths between the tubular body and a surrounding blood vessel wall.

29. A method for perfusing blood past a treatment site within a blood vessel, said method comprising:

positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover, wherein said flow path provides both axial flow and radially inward and outward flow over substantially its entire length; and

applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path and radially in and out of the flow path over substantially the entire expanded length of the sleeve.

30. A method as in claim 29, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.

31. A method as in claim 30, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.

32. A method as in claim 29, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.

33. A method as in claim 29, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.

34. A method as in claim 29, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.

35. A method for delivering a therapeutic agent to a treatment site on an interior wall of a blood vessel, said method comprising:

positioning a sleeve at said treatment site, said sleeve having a plurality of axial flow paths thereover;

radially expanding the sleeve to contact an exterior surface thereof against the interior wall of the blood vessel; and

infusing the therapeutic agent through at least some of the flow paths to the blood vessel wall, wherein others of said flow paths establish blood perfusion past the radially expanded sleeve.

36. A method as in claim 35, further comprising positioning a balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.

37. A method as in claim 36, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.

38. A method as in claim 35, wherein the sleeve is positioned at the treatment site after an angioplasty procedure has been performed at the same site.

39. An improved method for treating a target location within a blood vessel, said method being of the type wherein a balloon is expanded against an interior wall of the blood vessel, wherein the improvement comprises providing radially open perfusion flow paths over an outer surface of the balloon, whereby blood flow is established through said perfusion paths.

40. An improved method as in claim 39, further comprising providing drug infusion lumens disposed over an outside surface of the balloon and infusing a therapeutic agent therethrough to the target location.

41. An improved method as in claim 39, wherein the perfusion flow paths are provided by positioning a catheter sleeve over the balloon, wherein the catheter sleeve is radially expansible and includes said perfusion flow paths thereon.

42. An improved method as in claim 39, wherein the balloon is expanded by inflating to a pressure in the range from 0.5 atm to 16 atm.

43. A catheter sleeve comprising:

a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is axially split to permit radial expansion as a result of a radial expansion force applied in the central lumen within said portion; and

means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow.

44. A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises at least one perfusion lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.

45. A catheter sleeve as in claim 43, further comprising structure in at least one of the lumens to reinforce said lumen to prevent compression or collapse of the lumen.

46. A catheter sleeve as in claim 45, wherein reinforcing structure comprising a helical wire supporting interior of the lumen.

47. A catheter sleeve as in claim 44, including at least two prefusion lumens wherein the tubular body is slit between the lumens to enhance radial expansibility.

48. A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises one or more channels disposed over said radially expansible portion of the tubular body, wherein the channels define flow paths between the tubular body and a surrounding blood vessel wall.

49. A catheter sleeve as in claim 43 or 48, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.

50. A catheter sleeve as in claim 49, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.

51. A catheter sleeve as in claim 43, wherein a proximal portion of the flexible tubular body has side ports to enhance the flow of perfusion liquid through a guiding catheter when the catheter sleeve is in place therein.

52. A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprise helically arranged flow paths.

53. A catheter sleeve as in claim 52, further comprising at least one helical drug infusion tube formed over the radially expansible portion of the tubular body.

54. A catheter sleeve as in claim 52, wherein the tubular body is helically split between said flow paths.

55. A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises a pair of adjacent lumens formed on one side of the tubular body, wherein the lumens are separated by a common septum and are split from the remainder of the tubular body to permit radial expansion.

56. A catheter sleeve as in claim 43, further comprising a rod having a diameter less than that of the tubular body attached to a proximal end of the tubular body.

57. A catheter sleeve as in claim 43, wherein the perfusion-flow-establishing means comprises a triple lumen blood perfusion tube formed over the tubular body, wherein a center lumen includes perfusion ports and the two flanking lumens are closed to permit inflation to selectively reinforce the center lumen.

58. A catheter sleeve as in claim 43, further comprising additional lumens having means for infusing therapeutic agents therethrough.

59. A catheter sleeve as in claim 58, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.

60. A catheter sleeve as in claim 59, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.

61. A method for perfusing blood past a treatment site within a blood vessel, said method comprising:

positioning a sleeve having a central lumen at said treatment site, said sleeve defining at least one flow path thereover and being axially split in the region of the flow path; and

applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one flow path, wherein radial expansion causes circumferential separation of the axial split(s).

62. A method as in claim 61, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.

63. A method as in claim 61, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.

64. A method as in claim 61, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.

65. A method as in claim 61, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.

66. A method as in claim 61, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.

70. A catheter sleeve as in claim 66, including at least two integrally formed perfusion lumens, wherein the tubular body is slit between the lumens to enhance radial expansibility.

67. A catheter sleeve comprising:

a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion; and

at least one perfusion lumen integrally formed as a single extrusion as part of the tubular body near the distal end for establishing blood perfusion flow.

68. A catheter sleeve as in claim 67, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.

69. A catheter sleeve as in claim 68, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.

71. A catheter sleeve as in claim 67, further comprising additional integrally formed lumens having means for infusing therapeutic agents therethrough.

72. A method for perfusing blood past a treatment site within a blood vessel, said method comprising:

positioning a sleeve having a central lumen at said treatment site, said sleeve including at least one perfusion lumen integrally formed as a single extrusion thereover; and

applying a radial force within the central lumen to expand the sleeve within the treatment site while blood flows past the expanded sleeve through said at least one perfusion lumen.

73. A method as in claim 72, wherein the radially expanding step comprises inflating a balloon within the sleeve at low pressure for a prolonged period to preserve the initial inflation perimeter of the balloon.

74. A method as in claim 72, further comprising positioning a dilatation balloon catheter within a distal end of the sleeve and inflating said balloon to radially expand said sleeve.

75. A method as in claim 74, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 16 atm.

76. A method as in claim 72, further comprising delivering a therapeutic agent to said treatment site through said sleeve while said sleeve is radially expanded.

77. A method as in claim 72, wherein the sleeve is positioned in the blood vessel so that blood flowing past the expanded sleeve enters a branch blood vessel.

78. A method for perfusing blood past a treatment site within a blood vessel, said method comprising:

inflating a balloon catheter to dilate a blood vessel treatment site to an initial inflation perimeter;

deflating the balloon;

positioning a sleeve having a central lumen over the deflated balloon at said treatment site, said sleeve defining at least one flow path thereover; and

reinflating the balloon within the sleeve at low pressure in the range from 0.5 atm to 5 atm for a prolonged period to preserve the initial inflation perimeter of the balloon.

79. A catheter sleeve comprising:

a flexible tubular body having a proximal end, a distal end, and a central lumen therethrough, wherein at least a portion of the tubular body is radially expansible as a result of a radial expansion force applied in the central lumen within said portion;

means over a radially expansible portion of the tubular body near the distal end for establishing blood perfusion flow; and

means over the radially expansible portion of the tubular body near the distal end for infusing therapeutic agents.

80. A catheter sleeve as in claim 79, wherein the perfusion-flow-establishing means comprises at least one lumen disposed over said radially expansible portion of the tubular body, wherein said lumen has a plurality of axially spaced-apart ports which permit blood flow through the lumen.

81. A catheter sleeve as in claim 80, wherein the tubular body is radially expansible over a length in the range from about 1.5 cm to 5 cm near the distal end.

82. A catheter sleeve as in claim 81, wherein the tubular body has a diameter which is radially expansible to a diameter of 5 mm.

83. A catheter sleeve as in claim 79, wherein the therapeutic agent infusing means comprises at least one infusion lumen having means for releasing the agent therethrough.

84. A catheter sleeve as in claim 83, wherein the lumens having therapeutic agent infusing means are paired with lumens having perfusion flow means with a common wall therebetween, wherein the tubular body is slit between adjacent pairs.

85. A catheter sleeve as in claim 84, wherein the tubular body is slit between adjacent lumen pairs along a length in the range from 1.5 cm to 5 cm near the distal end.