Method of making an atrial defibrillation catheter

• US 5,697,965 A
• Filed: 04/01/1996
• Issued: 12/16/1997
• Est. Priority Date: 04/01/1996
• Status: Expired due to Term

• Current Assignee: Dot Medical Products Ltd.
• Original Assignee: Procath Corp. (Abbott Laboratories)
• Inventors: Griffin, Joseph C. III
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US08/625,872
• Time in Patent Office: 624 Days
• Field of Search: 607/122, 607/123, 607/4, 607/5
• US Class Current: 607/123
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion

Abstract

A catheter for facilitating intracardiac atrial defibrillation includes an elongated flexible member that has a proximal end and a distal end. The flexible member further has a plurality of lumens that extend from the proximal end to the distal end thereof. An opening is formed through the flexible member adjacent the distal end thereof. One of the lumens communicates with the opening. A balloon envelope is secured to the periphery of flexible member and surrounds the opening. Connected to one end of the lumen associated with the opening is an air inlet tube. A syringe is provided to supply air through the inlet tube, through the lumen and out the opening in order to inflate the balloon envelope. A plurality of spaced apart electrode bands are secured around the periphery of the flexible member in a predetermined pattern. A plurality of electrical leads extend through the proximal end of the flexible member and through corresponding lumens to supply electrical current to the electrode bands.

Claims

1. A method for manufacturing a catheter adapted for temporary placement in the body of a patient to treat atrial fibrillation, comprising the steps of:

fabricating a small diameter, elongated, flexible member having a proximal end, a distal end, and a central portion between said proximal end and said distal end, wherein said member has a diameter, length, and flexibility adapted to permit it to be introduced into the patient'"'"'s vascular system and maneuvered so that its distal end may be advanced along a path including the right atrium, tricuspid valve, right ventricle, pulmonary valve, and into a predetermined position in the left pulmonary artery adjacent the left atrium of the patient'"'"'s heart;

forming a plurality of lumens in said member, each extending from a respective port at the proximal end and through at least a portion of the length of said member including the central portion thereof and generally axially thereof;

connecting said lumens to a manifold attached at the proximal end of said member;

attaching a plurality of tubes to the proximal end of said manifold such that each tube is connected with a respective lumen;

forming adjacent the distal end of said member an opening into one of said plurality of lumens that terminates at a point short of said distal end;

sealing a balloon envelope to said member adjacent the distal end thereof to place said opening within the envelope, whereby the balloon envelope may be selectively inflated and exhausted from a port and tube at the proximal end of the member via the lumen connected to said opening, so that the balloon may be sufficiently inflated during advancement of said member along said path to aid in floating the distal end of said member into said predetermined position in the pulmonary artery, and fully inflated to anchor the distal end in said predetermined position;

forming one of said plurality of lumens to extend completely through said member from the respective port and tube at the proximal end to a port at the distal end thereof, and with a diameter suitable to accommodate a guide wire to facilitate maneuvering said member along said path, and, when the guide wire is not present after the distal end of said member is anchored in said predetermined position in the pulmonary artery by the inflated balloon, to enable blood sampling, drug infusion or pressure measurement at the distal end of the member via the port thereat;

providing first and second arrays of defibrillation electrodes on said member, each of said arrays including a plurality of axially substantially uniformly spaced-apart electrically conductive relatively low impedance bands circumferentially encircling a respective segment of and conforming in shape to said central portion to maintain a substantially smooth continuous surface therewith without adversely affecting the flexibility of said member, wherein the first electrode array is located relatively more proximally along said central portion and the second electrode array is located relatively more distally along said central portion, and said first and second electrode arrays are spaced apart by a predetermined distance between the respective bands closest to one another in the two arrays, said predetermined distance being selected to place said first electrode array in the right atrium and said second electrode array in the pulmonary artery adjacent the left atrium when the distal end of said member is in said predetermined position in the pulmonary artery, and wherein the plurality of bands of said first electrode array are electrically interconnected for energization from a single source of electrical power and the plurality of bands of said second electrode array are electrically interconnected for energization from a single source of electrical power located external to the patient'"'"'s body;

running at least a first relatively low resistance lead electrically connected to a band of said first electrode array through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, running at least a second relatively low resistance lead electrically connected to a band of said second electrode array through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, and connecting said first and second exiting leads to respective first and second electrical connectors adapted to be connected to a power source for application of electrical defibrillating shocks across said first and second electrode arrays when said member is in said path with the distal end in said predetermined position and the patient'"'"'s heart is detected to be in atrial fibrillation;

providing on the central portion of said member additional first and second electrodes comprising respective electrically conductive relatively low impedance bands circumferentially encircling a respective segment of and conforming in shape to said central portion to maintain a substantially smooth continuous surface therewith, wherein said additional first and second electrodes are positioned and axially spaced apart on said central portion such that when the member is in place along said path with its distal end in said predetermined position in the pulmonary artery the additional first electrode will be positioned in the right atrium and the additional second electrode will be positioned in the right ventricle of the patient'"'"'s heart, for use in pacing and sensing intracardiac activity of the patient'"'"'s heart; and

running an additional first relatively low resistance lead electrically connected to the additional first electrode band through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, running an additional second relatively low resistance lead electrically connected to the additional second electrode band through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, and connecting the additional first and second exiting leads to respective first and second electrical connectors adapted to be connected to pacing and sensing circuitry located external to the patient'"'"'s body.

2. The method of claim 1, including the step of fabricating said member from a biocompatible plastic material.

3. The method of claim 2 wherein said biocompatible plastic material is selected from the group consisting of polyurethane, silicone rubber, and plasticized PVC.

4. The method of claim 1, wherein the bands in said first and second defibrillation electrode arrays are each approximately 5 millimeters wide and spaced apart from their respective neighboring bands in the respective array by a distance of about 4 to 5millimeters.

5. The method of claim 4, wherein said member has a length of approximately 110 centimeters, and an outer diameter of about 2.5millimeters.

6. A method for manufacturing a catheter adapted for temporary placement in the body of a patient to treat atrial fibrillation, comprising the steps of:

fabricating a small diameter, elongated, flexible member having a proximal end, a distal end, and a central portion between said proximal end and said distal end, wherein said member has a diameter, length, and flexibility adapted to permit it to be introduced into the patient'"'"'s vascular system and maneuvered so that its distal end may be advanced along a path including the right atrium, tricuspid valve, right ventricle, pulmonary valve, and into a predetermined position in the left pulmonary artery adjacent the left atrium of the patient'"'"'s heart;

forming at least six lumens in said member, each extending from a respective port at the proximal end and through at least a portion of the length of said member including the central portion thereof and generally axially thereof, a first one of said lumens communicating with a balloon at the distal end of said member, a second one of said lumens being arranged along the longitudinal axis of said member and extending from end to end of the member with a port at the distal end and having a diameter suitable to accommodate a guide wire to facilitate maneuvering said member along said path, and, when the guide wire is not present after the distal end of said member is anchored in said predetermined position in the pulmonary artery by the inflated balloon, to enable blood sampling, drug infusion or pressure measurement at the distal end of the member via the port thereat, another four of said lumens accommodating electrical leads to enable defibrillation and pacing;

connecting said lumens to a manifold attached at the proximal end of said member; and

attaching at least six tubes to the proximal end of said manifold such that each tube is connected with a respective one of said at least six lumens.

7. The method of claim 6, further including the steps of:

forming at least a seventh lumen in said member radially offset from the longitudinal axis and extending from a respective port at the proximal end and through at least a portion of the length of said member including the central portion and generally axially thereof;

inserting a stiffening wire in said seventh lumen; and

anchoring said stiffening wire to said manifold.

8. The method of claim 6, further including the steps of:

forming adjacent the distal end of said member an opening into the first one of said at least six lumens that terminates at a point short of said distal end; and

sealing a balloon envelope to said member adjacent the distal end thereof to place said opening within the envelope, whereby the balloon envelope may be selectively inflated and exhausted from a port and tube at the proximal end of the member via the lumen connected to said opening, so that the balloon may be sufficiently inflated during advancement of said member along said path to aid in floating the distal end of said member into said predetermined position in the pulmonary artery, and fully inflated to anchor the distal end in said predetermined position.

9. The method of claim 8, further including the steps of:

attaching a syringe and stopcock to the tube connected to the lumen in which said opening is formed for inflating and deflating said balloon envelope.

10. The method of claim 9, further including the steps of:

providing first and second arrays of defibrillation electrodes on said member, each of said arrays including a plurality of axially substantially uniformly spaced-apart electrically conductive relatively low impedance bands circumferentially encircling a respective segment of and conforming in shape to said central portion to maintain a substantially smooth continuous surface therewith without adversely affecting the flexibility of said member, wherein the first electrode array is located relatively more proximally along said central portion and the second electrode array is located relatively more distally along said central portion, and said first and second electrode arrays are spaced apart by a predetermined distance between the respective bands closest to one another in the two arrays, said predetermined distance being selected to place said first electrode array in the right atrium and said second electrode array in the pulmonary artery adjacent the left atrium when the distal end of said member is in said predetermined position in the pulmonary artery, and wherein the plurality of bands of said first electrode array are electrically interconnected for energization from a single source of electrical power and the plurality of bands of said second electrode array are electrically interconnected for energization from a single source of electrical power located external to the patient'"'"'s body;

running first and second relatively low resistance leads electrically connected to a respective band of said first and second electrode array through a respective lumen in said member for exit through the respective lumen port and tube at the proximal end thereof;

connecting said first and second exiting leads to respective first and second electrical connectors adapted to be connected to a power source for application of electrical defibrillating shocks across said first and second electrode arrays when said member is in said path with the distal end in said predetermined position and the patient'"'"'s heart is detected to be in atrial fibrillation;

providing on the central portion of said member third and fourth electrodes comprising respective electrically conductive relatively low impedance bands circumferentially encircling a respective segment of and conforming in shape to said central portion to maintain a substantially smooth continuous surface therewith, wherein said third and fourth electrodes are positioned and axially spaced apart on said central portion such that when the member is in place alone said path with its distal end in said predetermined position in the pulmonary artery, the third electrode will be positioned in the right atrium and the fourth electrode will be positioned in the right ventricle of the patient'"'"'s heart, for use in pacing and sensing intracardiac activity of the patient'"'"'s heart; and

running a third relatively low resistance lead electrically connected to the third electrode band through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, running a fourth relatively low resistance lead electrically connected to the fourth electrode band through a lumen in said member for exit through the respective lumen port and tube at the proximal end thereof, and connecting the third and fourth exiting leads to respective third and fourth electrical connectors adapted to be connected to pacing and sensing circuitry located external to the patient'"'"'s body.