Occlusion catheter having compliant balloon for use with complex vasculature

• US 8,486,046 B2
• Filed: 03/11/2011
• Issued: 07/16/2013
• Est. Priority Date: 09/04/2001
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Hayman, Douglas Ray, Davis, Peter Gregory, De Jesus Sanson, Maria, Reedy, Komonn Lim, Hewitt, Todd Jeffrey
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/046,477
• Publication Number:
  US 20110245802A1
• Time in Patent Office: 858 Days
• Field of Search: 604 9601-10314, 604104-109, 604/500, 604/508, 604/509, 606/191, 606/192, 606/194, 606/200
• US Class Current: 604/509
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

Claims

1. A microcatheter system suitable for temporary vascular occlusion comprising:

a microcatheter including a substantially tubular structure with at least one lumen and an inflatable balloon, the inflatable balloon located at the distal portion of said tubular structure and positioned in fluid communication with said at least one lumen, said inflatable balloon being inflatable to an inflated state in which said inflatable balloon deforms at a pressure less than the pressure required to deform the vascular wall when placed into a blood vessel, said inflatable balloon dimensioned to occlude vasculature in said inflated state; and

an injection catheter defining a lumen dimensioned to permit passage of an embolizing agent to treat an aneurysm with said embolizing agent when said inflatable balloon of said microcatheter is in said inflated state, said injection catheter being dimensioned to deliver said embolizing agent to said aneurysm separate from said microcatheter.

2. The microcatheter system of claim 1, wherein the substantially tubular structure includes multiple lumens.

3. The microcatheter system of claim 1, further including one or more radiopaque marker bands disposed in the vicinity of the balloon.

59. The microcatheter system of claim 2, wherein the substantially tubular structure includes concentric lumens.

4. A method for treating an aneurysm in a mammal which method comprises:

identifying an aneurysm in said mammal;

providing a first catheter comprising a substantially tubular structure with at least one lumen and a vascular balloon located at the distal portion of said tubular structure and in fluid communication with said lumen wherein said balloon deforms at a pressure less than the pressure required to deform the vascular wall in the vicinity of the aneurysm;

inserting the catheter into the blood vessel associated with said aneurysm wherein the distal portion of said catheter is located at a position such that upon expansion of said balloon blood flow into the aneurysm is either attenuated and/or diverted prior to deformation of the vascular wall;

inserting a second catheter in the blood vessel associated with said aneurysm separate from said first catheter; and

delivering into said aneurysm, with said second catheter, an embolizing agent which inhibits blood flow into said aneurysm.

5. A catheter system suitable for treating an aneurysm in a vascular wall, comprising:

a first catheter including a substantially tubular structure having at least one lumen and an inflatable balloon, the inflatable balloon located at a distal portion of said tubular structure and in fluid communication with said at least one lumen, at least a portion of said inflatable balloon including a material which deforms at a pressure which is less than the pressure required to deform the vascular wall containing the aneurysm; and

a second catheter dimensioned to permit passage of an embolizing agent to treat the aneurysm with said embolizing agent when said inflatable balloon of said first catheter is in an inflated state, said second catheter being dimensioned to deliver said embolizing agent to said aneurysm separate from said first catheter.

6. The catheter system of claim 5, wherein the at least one lumen is adapted to accommodate a guidewire therein.

7. The catheter system of claim 5, wherein the balloon material is of sufficient rigidity to avoid appreciable entry into the aneurysm when the balloon is inflated in the vicinity of the aneurysm during treatment.

8. The catheter system of claim 5, wherein the balloon material has a modulus at about 300% having a value less than about 300 psi and/or a tensile strength of about 600 psi.

9. The catheter system of claim 5, wherein the balloon material has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 15, a specific gravity of about 0.89, tensile strength of about 600 psi, and elongation of greater than about 1,000%.

10. The catheter system of claim 5, wherein the balloon material has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 40, a specific gravity of about 0.90, tensile strength of about 700 psi, and elongation of about 500%.

11. The catheter system of claim 5, wherein the balloon material is pre-stretched, preoriented or otherwise mechanically and/or thermally manipulated such that the balloon assumes an irregular shape when inflated.

12. The catheter system of claim 5, wherein the thickness of the balloon material is about 0.004 inches to about 0.006 inches.

13. The catheter system of claim 12, wherein the thickness of the balloon material is about 0.005 inches.

14. The catheter system of claim 5, wherein the length of the balloon is about 4 mm to about 30 mm.

15. The catheter system of claim 5, wherein the length of the balloon is about 7 mm to about 20 mm.

16. The catheter system of claim 5, wherein the diameter of the balloon is about 1.5 mm to about 10 mm.

17. The catheter system of claim 5, wherein the diameter of the balloon is about 3 mm to about 7 mm.

18. The catheter system of claim 5, wherein the length-to-diameter ratio of the balloon is about 0.5:

1 to about 5;

1.

19. The catheter system of claim 5, wherein the balloon is inflatable at a pressure which is slightly greater than systolic pressure.

20. The catheter system of claim 5, wherein the balloon is inflatable at a pressure of about 200 mmHg.

21. The catheter system of claim 5, wherein the balloon is inflatable at a pressure of about 600 mmHg.

22. A method for treating an aneurysm formed in the vascular wall of a mammalian patient, the aneurysm being formed in the vicinity of at least one lumen defined by a blood vessel associated with the aneurysm, comprising:

identifying an aneurysm in said mammalian patient;

introducing a balloon into the vicinity of the aneurysm, the balloon being provided on a first catheter which comprises a substantially tubular structure having at least one lumen in communication with the balloon, at least a portion of said balloon comprising a material which deforms at a pressure which is less than the pressure required to deform the vascular wall in which the aneurysm is formed;

inserting a second catheter in the blood vessel associated with said aneurysm separate from said first catheter;

inflating the balloon of the first catheter such that blood flow into the aneurysm is attenuated and/or diverted prior to undesired compression of the vascular wall; and

delivering into said aneurysm, with said second catheter, an embolizing agent which inhibits blood flow into said aneurysm.

23. The method of claim 22, wherein the aneurysm is a bifurcated aneurysm.

24. The method of claim 22, wherein a lumen of said aneurysm is smaller than an opening of a vessel associated with said aneurysm.

25. The method of claim 22, further including guiding the catheter using a guidewire disposed in said lumen.

26. The method of claim 22, wherein inflating the balloon does not result in appreciable entry of the balloon into the aneurysm.

27. The method of claim 22, further including forming the balloon with a material having a modulus at about 300% having a value less than about 300 psi and/or a tensile strength of about 600 psi.

28. The method of claim 22, further including forming the balloon with a material having a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 15, a specific gravity of about 0.89, tensile strength of about 600 psi, and elongation of greater than about 1,000%.

29. The method of claim 22, further including forming the balloon with a material having a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 40, a specific gravity of about 0.90, tensile strength of about 700 psi, and elongation of about 500%.

30. The method of claim 22, further including forming the balloon with a material which is pre-stretched, preoriented or otherwise mechanically and/or thermally manipulated such that the balloon assumes an irregular shape when inflated.

31. The method of claim 22, further including inflating the balloon to a length of about 4 mm to about 30 mm.

32. The method of claim 22, further including inflating the balloon to a length of about 7 mm to about 20 mm.

33. The method of claim 22, further including inflating the balloon to a diameter of about 1.5 mm to about 10 mm.

34. The method of claim 22, further including inflating the balloon to a diameter of about 3 mm to about 7 mm.

35. The method of claim 22, further including inflating the balloon to have a length-to-diameter ratio of about 0.5:

1 to about 5;

1.

36. The method of claim 22, further including inflating the balloon to a pressure which is slightly greater than systolic pressure before delivering the embolizing agent to the aneurysm.

37. The method of claim 22, further including inflating the balloon to a pressure of about 200 mmHg before delivering the embolizing agent to the aneurysm.

38. The method of claim 22, further including inflating the balloon to a pressure of about 600 mmHg before delivering the embolizing agent to the aneurysm.

39. The method of claim 22, further including forming the balloon to have a thickness of about 0.004 inches to about 0.006 inches.

40. The method of claim 39, further including forming the balloon to have a thickness of about 0.005 inches.

41. A catheter system suitable for use in a complex vessel comprising:

a microcatheter including a substantially tubular structure having at least one lumen and an inflatable balloon, the inflatable balloon located at a distal portion of said tubular structure and positioned in fluid communication with said at least one lumen, at least a portion of said inflatable balloon including a material which, when the balloon is inflated, conforms to the shape of the vessel for a sufficient length of the vessel to attenuate and/or occlude blood flow therein without significantly deforming the vessel; and

an injection catheter dimensioned to permit passage of an embolizing agent to treat an aneurysm with said embolizing agent, said injection catheter being dimensioned to deliver said embolizing agent to said aneurysm separate from said microcatheter.

42. A catheter system of claim 41, wherein the lumen is adapted to accommodate a guidewire therein.

43. A catheter system of claim 41, wherein the balloon material has a modulus at about 300% having a value less than about 300 psi and/or a tensile strength of about 600 psi.

44. A catheter system of claim 41, wherein the balloon material has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 15, a specific gravity of about 0.89, tensile strength of about 600 psi, and elongation of greater than about 1,000%.

45. A catheter system of claim 41, wherein the balloon material has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 40, a specific gravity of about 0.90, tensile strength of about 700 psi, and elongation of about 500%.

46. A catheter system of claim 41, wherein the balloon material is pre-stretched, preoriented or otherwise mechanically and/or thermally manipulated such that the balloon assumes an irregular shape when inflated.

47. A catheter system of claim 41, wherein the length of the balloon when inflated is about 4 mm to about 30 mm.

48. A catheter system of claim 41, wherein the length of the balloon when inflated is about 7 mm to about 20 mm.

49. A catheter system of claim 41, wherein the diameter of the balloon when inflated is about 1.5 mm to about 10 mm.

50. A catheter system of claim 41, wherein the diameter of the balloon when inflated is about 3 mm to about 7 mm.

51. A catheter system of claim 41, wherein the length-to-diameter ratio of the balloon when inflated is about 0.5:

1 to about 5;

1.

52. A catheter system of claim 41, wherein the balloon is inflated to conform to the shape of the vessel at a pressure which is slightly greater than systolic pressure.

53. A catheter system of claim 41, wherein the balloon is inflated to conform to the shape of the vessel at a pressure of about 200 mmHg.

54. A catheter system of claim 41, wherein the balloon is inflated to conform to the shape of the vessel at a pressure of about 600 mmHg.

55. A catheter system of claim 41, wherein the substantially tubular structure includes multiple lumens.

56. A catheter system of claim 41, further including one or more radiopaque marker bands disposed in the vicinity of the balloon.

57. A catheter system of claim 41, wherein the thickness of the balloon material is about 0.004 inches to about 0.006 inches.

58. A catheter system of claim 57, wherein the thickness of the balloon material is about 0.005 inches.