Occlusion catheter having compliant balloon for use with complex vasculature

• US 8,235,941 B2
• Filed: 10/05/2007
• Issued: 08/07/2012
• Est. Priority Date: 09/04/2001
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group 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): Eisenberg, Rebecca E
• Application Number:
  US11/868,049
• Publication Number:
  US 20080027378A1
• Time in Patent Office: 1,768 Days
• Field of Search: 604/103.06, 604/103.07, 604/103.1
• US Class Current: 604/103.06
• 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 catheter suitable for use in a complex vessel comprising:

a substantially tubular structure having at least one lumen; and

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

wherein at least a portion of said inflatable balloon comprises a material which is based on styrenic olefinic rubber and hydrogenated isoprene having a durometer hardness of 5 Shore A to 25 Shore A and is pre-stretched or mechanically or thermally manipulated during fabrication to take on the irregular shapes matching those of a vessel to which it is to be introduced; and

further wherein, 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 and still further wherein the catheter does not significantly deform the vessel when fully inflated.

2. The catheter of claim 1, wherein the lumen is adapted to accommodate a guidewire therein.

3. The catheter of claim 1, where in 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.

4. The catheter of claim 1, 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%.

5. The catheter of claim 1, wherein the length of the balloon when inflated is about 4 mm to about 30 mm.

6. The catheter of claim 1, wherein the length of the balloon when inflated is about 7 mm to about 20 mm.

7. The catheter of claim 1, wherein the diameter of the balloon when inflated is about 1.5 mm to about 10 mm.

8. The catheter of claim 1, wherein the diameter of the balloon when inflated is about 3 mm to about 7 mm.

9. The catheter of claim 1, wherein the length-to-diameter ratio of the balloon when inflated is about 0.5:

1 to about 5;

1.

10. The catheter of claim 1, wherein the balloon is inflated to conform to the shape of the vessel at a pressure which is slightly greater than systolic pressure.

11. The catheter of claim 1, wherein the balloon is inflated to conform to the shape of the vessel at a pressure of up to about 600 mmHg.

12. The catheter of claim 1, wherein the balloon is inflated to conform to the shape of the vessel at a pressure of about 200 mmHg.

13. The catheter of claim 1, wherein the substantially tubular structure includes multiple lumens.

14. The catheter of claim 1, further including one or more radiopaque marker bands disposed in the vicinity of the balloon.

15. The catheter of claim 1, wherein the thickness of the balloon material is about 0.004 inches to about 0.006 inches.

16. The catheter of claim 15, wherein the thickness of the balloon material is about 0.005 inches.