Occlusion catheter having compliant balloon for use with complex vasculature

• US 8,974,409 B2
• Filed: 06/11/2013
• Issued: 03/10/2015
• 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): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/915,037
• Publication Number:
  US 20130281836A1
• Time in Patent Office: 637 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: 604/96.01
• 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 suitable for treating an aneurysm, comprising:

a substantially tubular structure dimensioned for insertion within diseased or compromised vasculature containing an aneurysmal sac, said tubular structure having at least one lumen and an inflatable balloon, said inflatable balloon located at a 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 conforms to the shape of the diseased vasculature at a pressure less than the pressure required to deform the vascular wall of the diseased vasculature, said inflatable balloon dimensioned to be more deformable than the vascular wall of the diseased vasculature when in said inflated state to have minimal impact on the shape and integrity of the vascular wall, and being further dimensioned to occlude the diseased vasculature when in said inflated state without substantially penetrating the neck or opening of the aneurysmal sac; and

one or more radiopaque markers disposed in the vicinity of said inflatable balloon.

2. The microcatheter of claim 1, wherein said at least one lumen is adapted to accommodate a guidewire.

3. The microcatheter of claim 1, wherein said inflatable balloon is formed of a material that 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%.

4. The microcatheter of claim 1, wherein said inflatable balloon is formed of a material that 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%.

5. The microcatheter of claim 1, wherein said inflatable balloon is formed of a material that is pre-stretched, preoriented or otherwise mechanically and/or thermally manipulated such that said inflatable balloon assumes an irregular shape when in said inflated state to take on irregular shapes matching those of the diseased vasculature to which it is to be introduced.

6. The microcatheter of claim 1, wherein the thickness of said inflatable balloon is about 0.004 inches to about 0.006 inches.

7. The microcatheter of claim 1, wherein the thickness of said inflatable balloon is about 0.005 inches.

8. The microcatheter of claim 1, wherein the length of said inflatable balloon is about 4 mm to about 30 mm.

9. The microcatheter of claim 1, wherein the length of said inflatable balloon is about 7 mm to about 20 mm.

10. The microcatheter of claim 1, wherein the diameter of said inflatable balloon is about 1.5 mm to about 10 mm.

11. The microcatheter of claim 1, wherein the diameter of said inflatable balloon is about 3 mm to about 7 mm.

12. The microcatheter of claim 1, wherein the length-to-diameter ratio of said inflatable balloon is about 0.5:

1 to about 5;

1.

13. The microcatheter of claim 1, wherein said inflatable balloon is inflatable at a pressure which is slightly greater than systolic pressure.

14. The microcatheter of claim 1, wherein the said inflatable balloon is inflatable at a pressure of about 200 mmHg.

15. The microcatheter of claim 1, wherein said inflatable balloon is inflatable at a pressure of about 600 mmHg.

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

17. The microcatheter of claim 16, wherein the substantially tubular structure includes concentric lumens.

20. The microcatheter of claim 1 including first and second radiopaque marker bands mounted to said distal portion of said tubular structure within said inflatable balloon.

21. The microcatheter of claim 20 including first and second marker retainers dimensioned to retain respective said first and second marker bands on said distal portion of said tubular structure.

22. The microcatheter of claim 20 including a single marker retainer for retaining said first and second marker bands on said distal portion of said tubular structure.

23. The microcatheter of claim 22 wherein said tubular structure defines holes in fluid communication with said at least one lumen and wherein said single marker retainer defines holes in registry with said holes of said tubular structure.

24. The microcatheter of claim 1 including a catheter defining a lumen dimensioned to permit passage of an embolizing agent to treat the aneurysmal sac with the embolizing agent when said inflatable balloon is in said inflated state.

25. The microcatheter of claim 24 wherein said catheter is dimensioned to deliver the embolizing agent separate from said tubular structure.

18. A catheter suitable for use in a complex vessel containing an aneurysmal sac, the catheter comprising:

a substantially tubular structure having at least one lumen and being dimensioned for insertion within a complex vessel with diseased or compromised vasculature containing an aneurysmal sac;

a single compliant inflatable balloon located at a distal portion of the tubular structure and in fluid communication with the lumen; and

one or more radiopaque marker bands disposed adjacent the inflatable balloon;

wherein at least a portion of the inflatable balloon comprises a material which is pre-stretched or mechanically or thermally manipulated during fabrication to take on the irregular shapes matching those of the complex vessel;

wherein when the inflatable balloon is fully inflated, the inflatable balloon conforms to the shape of the complex vessel for a sufficient length of the complex vessel to attenuate and/or occlude blood flow therein; and

wherein the inflatable balloon is dimensioned to be more deformable than the vascular wall of the diseased vasculature of the complex vessel to have minimal impact on the shape and integrity of the vascular wall to not significantly deform the vascular wall when fully inflated.

19. The catheter of claim 18, wherein the material of the inflatable balloon comprises styrenic olefinic rubber and hydrogenated isoprene.

26. The microcatheter of claim 18 wherein the inflatable balloon is dimensioned and configured to attenuate and/or occlude blood flow within the complex vasculature without substantially penetrating an opening or neck of the aneurysmal sac when fully inflated.

27. The microcatheter of claim 18 including a catheter defining a lumen dimensioned to permit passage of an embolizing agent to treat an aneurysm with the embolizing agent when the inflatable balloon is fully inflated.

28. The microcatheter of claim 27 wherein the catheter is dimensioned to deliver the embolizing agent separate from the tubular structure.