Helical spiral balloon catheter

• US 6,190,356 B1
• Filed: 10/20/1998
• Issued: 02/20/2001
• Est. Priority Date: 10/20/1997
• Status: Expired due to Fees

• Current Assignee: Robert M. Bersin
• Original Assignee: Robert M. Bersin
• Inventors: Bersin, Robert M.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Application Number:
  US09/175,773
• Time in Patent Office: 854 Days
• Field of Search: 604/96, 604/101, 604/103, 604/509, 604/508, 604/96.01, 604/101.01, 604/101.05, 604/103.01, 604/103.06, 604/103.07
• US Class Current: 604/101.01
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A balloon catheter device designed to be especially well suited for use in providing medical treatment within a blood vessel, and a method for conducting such medical treatment are provided, wherein the balloon catheter has a central support tube or lumen, and has, near a distal end of the catheter, a plurality of inflatable balloon elements extending along the catheter in helical patterns, with the balloon elements spaced equidistantly around the central support tube. The catheter thus provides the ability to apply pressure, by way of the inflated balloon elements, to center the central support tube in the blood vessel, while at the same time preserving blood flow in the blood vessel past the catheter as well as in side branch blood vessels extending from the blood vessel under repair.

Claims

1. A method for providing medical treatment from within a blood vessel of a patient comprising the steps of:

(a) providing a catheter comprising an elongated support tube having distal and proximal ends, said support tube defining a central lumen, said catheter further having a radially expandable balloon means carried by and integrally connected to said support tube at a predetermined point between the proximal end and the distal end thereof, and means for expanding and contracting said balloon means, said balloon means comprising at least two spiral-shaped balloon elements extending helically around said support tube along a predetermined length of said support tube, said at least two balloon elements being spaced equidistantly around said support tube, and a flexible membrane surrounding said balloon means and said support tube, said flexible membrane being secured to and closely conforming to outer surfaces of said balloon elements whereby said membrane moves to an expanded position when said balloon means is expanded, and moves to a contracted position when said balloon means is contracted,

(b) inserting said distal end of said catheter into a cardiovascular system of the patient with said balloon means in an unexpanded condition;

(c) advancing said catheter within the cardiovascular system until said balloon means is situated in the blood vessel at a region where said medical treatment is to be administered;

(d) centering said portion of said support tube having said balloon elements disposed thereon by expanding said balloon means to bring said at least two balloon elements into intimate contact with an inner wall of the blood vessel, while permitting blood to flow past the balloon means through open paths left between said balloon element, and permitting blood to flow to unobstructed side branches of blood vessels in the region in which the balloon means is disposed;

(e) retaining said balloon elements in said expanded condition;

(f) inserting a treatment agent through said support tube to a treatment position at which said expanded balloon elements are located, and maintaining said treatment agent at the treatment position for a predetermined period of time;

(g) withdrawing said treatment agent from the treatment position;

(h) contracting the balloon means; and

(i) withdrawing said catheter from the body of the patient.

2. The method as set forth in claim 1, wherein said balloon means comprises only two balloon elements, and said two balloon elements extend in diametrically opposed helical paths along said support tube.

3. The method as set forth in claim 1, wherein said treatment agent is a radiation therapy treatment agent.

4. The method as set forth in claim 1, wherein said treatment agent is a biologically active agent.

5. A method for providing medical treatment from within a blood vessel of a patient comprising the steps of:

(a) providing a catheter comprising an elongated support tube having distal and proximal ends, said support tube defining a central lumen, said catheter further having a radially expandable balloon means carried by and integrally connected to said support tube at a predetermined point between the proximal end and the distal end thereof, and means for expanding and contracting said balloon means, said balloon means comprising at least two spiral-shaped balloon elements extending helically around said support tube along a predetermined length of said support tube, said at least two balloon elements being spaced equidistantly around said support tube,

(b) inserting said distal end of said catheter into a cardiovascular system of the patient with said balloon means in an unexpanded condition;

(c) advancing said catheter within the cardiovascular system until said balloon means is situated in the blood vessel at a region where said medical treatment is to be administered;

(d) centering said portion of said support tube having said balloon elements disposed thereon by expanding said balloon means to bring said at least two balloon elements into intimate contact with an inner wall of the blood vessel, while permitting blood to flow past the balloon means through open paths left between said balloon element, and permitting blood to flow to unobstructed side branches of blood vessels in the region in which the balloon means is disposed;

(e) retaining said balloon elements in said expanded condition;

(f) inserting a radiation therapy treatment agent through said support tube to a treatment position at which said expanded balloon elements are located, and maintaining said radiation therapy treatment agent at the treatment position for a predetermined period of time;

(g) withdrawing said radiation therapy treatment agent from the treatment position;

(h) contracting the balloon means; and

(i) withdrawing said catheter from the body of the patient.

6. A method for providing medical treatment from within a blood vessel of a patient comprising the steps of:

(a) providing a catheter comprising an elongated support tube having distal and proximal ends, said support tube defining a central lumen, said catheter further having a radially expandable balloon means carried by and integrally connected to said support tube at a predetermined point between the proximal end and the distal end thereof, and means for expanding and contracting said balloon means, said balloon means comprising at least two spiral-shaped balloon elements extending helically around said support tube along a predetermined length of said support tube, said at least two balloon elements being spaced equidistantly around said support tube,

(b) inserting said distal end of said catheter into a cardiovascular system of the patient with said balloon means in an unexpanded condition;

(c) advancing said catheter within the cardiovascular system until said balloon means is situated in the blood vessel at a region where said medical treatment is to be administered;

(d) centering said portion of said support tube having said balloon elements disposed thereon by expanding said balloon means to bring said at least two balloon elements into intimate contact with an inner wall of the blood vessel, while permitting blood to flow past the balloon means through open paths left between said balloon element, and permitting blood to flow to unobstructed side branches of blood vessels in the region in which the balloon means is disposed;

(e) retaining said balloon elements in said expanded condition;

(f) inserting a biologically active treatment agent through said support tube to a treatment position at which said expanded balloon elements are located, and maintaining said biologically active treatment agent at the treatment position for a predetermined period of time;

(g) withdrawing said biologically active treatment agent from the treatment position;

(h) contracting the balloon means; and

(i) withdrawing said catheter from the body of the patient.

7. A balloon catheter comprising:

a central support tube;

means for centering a portion of said central support tube within a blood vessel, said centering means comprising a plurality of balloon elements disposed at a predetermined point between a proximal end and a distal end of said central support tube;

each of said plurality of balloon elements having a longitudinal extent, each of said plurality of balloon elements winding around said central support tube in a helical pattern, wherein said plurality of balloon elements are spaced equidistantly around a circumference of said central support tube; and

means fluidly coupled to said balloon elements for expanding said balloon elements into contact with an inner wall of a blood vessel of a patient when said catheter and said balloon elements are in a desired position within the blood vessel to center said central support tube within the blood vessel;

means for returning said balloons to an unexpanded condition;

means for administering treatment disposed within said central support tube; and

wherein said balloon catheter further comprises a flexible membrane extending around said plurality of balloon elements and said central support tube, said flexible membrane being secured to and closely conforming with outer portions of said balloon elements that are brought into contact with said blood vessel inner wall.

8. A balloon catheter as recited in claim 7, wherein said flexible membrane and said balloon elements form a coextruded structure.

9. A balloon catheter as recited in claim 7, wherein each of said plurality of balloon elements is bonded to said central support tube along substantially an entire length of said balloon.

10. A balloon catheter as recited in claim 7, further comprising a guide wire removably housed within said central support tube.

11. A balloon catheter as recited in claim 7, wherein said means for administering treatment comprises a biologically active agent positioned in said central support tube.

12. A balloon catheter as recited in claim 7, wherein said means for administering treatment comprises a radiation therapy agent positioned in said central support tube.