Steerable catheter with preformed distal shape and method for use

• US 6,096,036 A
• Filed: 05/05/1998
• Issued: 08/01/2000
• Est. Priority Date: 05/05/1998
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Simpson, John A., Bowe, Wade A., Hayzelden, Robert C.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/072,962
• Time in Patent Office: 819 Days
• Field of Search: 607/117, 607/122, 600/372, 600/373, 600/374, 600/585, 604/204, 604/523, 604/525, 604/528, 604/530
• US Class Current: 606/41
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors

Abstract

A catheter has a stylet formed of a shape-retentive and resilient material having a preformed curved shape at its distal end resulting in the catheter sheath having the preformed curved shape. The catheter sheath has a plurality of electrodes at its distal end for contacting selected biological tissue for imparting ablation energy thereto. The catheter sheath also has an axially mounted tendon for causing deflection of the distal end. The stylet material permits straightening the catheter sheath during insertion into the patient and advancing the electrodes to the target tissue. Upon removal of the straightening forces, such as by entry into a chamber of the heart, the stylet material resumes its preformed curved distal shape thereby forcing the catheter distal end with the electrodes into the same preformed curved shape. The operator may place the curved distal end into contact with the target tissue and axially move the tendon as desired to gain greater control over the bend in the distal end of the catheter sheath to adjust the radius of curvature of the distal end to obtain greater contact of the electrodes with the heart tissue. Preferably, the stylet is formed of nitinol.

Claims

1. A catheter for positioning at least one electrode at a selected biological site, said catheter comprising:

a sheath having a distal end carrying the at least one electrode;

a stylet disposed within the sheath and attached to the distal end of the sheath, the stylet having a distal end region having a preformed shape with a radius of curvature, the stylet formed of a shape-retentive and resilient material such that the stylet distal end region changes shape upon the application of force and upon the removal of force, returns to the preformed shape, the stylet disposed in the sheath such that the stylet distal end region is located in the distal end region of the sheath and causes the sheath to assume the preformed shape; and

a tendon housed within the sheath and attached to the distal end of the sheath such that axial displacement of the tendon changes the radius of curvature of the stylet distal end region and the sheath distal end region.

2. The catheter of claim 1 wherein the radius of curvature conforms the sheath distal end region to the selected biological site.

3. The catheter of claim 1 wherein the tendon is disposed in the sheath such that pulling the tendon in the proximal direction decreases the radius of curvature of the stylet distal end region and the sheath distal end region and subsequent movement of the tendon in the distal direction allows an increase in the radius of curvature of the stylet distal end region and the sheath distal end region.

4. The catheter of claim 1 wherein the stylet is formed of nitinol.

5. The catheter of claim 1 further comprising a tip component positioned at the distal tip of the sheath wherein the stylet and tendon are attached to the tip component.

6. The catheter of claim 1 further comprising a steering member positioned at the proximal end of the sheath wherein the tendon is attached to the steering member for moving the tendon in an axial direction.

7. The catheter of claim 1 further comprising a handle disposed at the proximal end of the sheath and the stylet and connected thereto such that rotation of the handle results in rotation of the sheath and stylet.

8. The catheter of claim 1 wherein there are a plurality of band electrodes spaced apart at the distal end of the sheath.

9. The catheter of claim 8 wherein the plurality of band electrodes are positioned on the sheath in the region of the preformed shape.

10. An ablation system for use in applying energy to heart tissue, said system comprising:

a catheter sheath having a distal end region and a lumen;

a plurality of electrodes located at the distal end region of the catheter sheath;

a stylet disposed within the sheath and attached to the distal end of the catheter sheath, the stylet having a distal end region with a preformed shape with a radius of curvature, the stylet formed of a shape-retentive and resilient material such that the stylet distal end region changes shape upon the application of force and upon the removal of the force, returns to the preformed shape, the stylet disposed in the catheter sheath such that the stylet distal end region is located in the distal end region of the sheath and causes the sheath to assume the preformed shape;

a tendon housed within the catheter sheath and attached to the distal end of the sheath such that axial displacement of the tendon changes the radius of curvature of the stylet distal end region and the sheath distal end region;

a handle attached to the proximal end of the catheter sheath and the stylet such that rotation of the handle causes rotation in the catheter sheath and the stylet; and

a control member disposed at the handle and connected to the tendon such that a predetermined movement of the control member causes axial movement of the tendon to control changes in the radius of curvature of the stylet distal end region and the sheath distal end region.

11. The ablation system of claim 10 wherein the plurality of electrodes are spaced apart on the distal end region of the catheter sheath to form a linear array.

12. The ablation system of claim 10 wherein the stylet is formed of nitinol.

13. The ablation system of claim 10 wherein the preformed shape has a degree of curvature generally the same as that of the selected biological site.

14. The ablation system of claim 10 wherein the catheter sheath has a longitudinal axis and the tendon is attached to the distal end at a point off the axis.

15. The catheter of claim 10 wherein the tendon is disposed in the catheter sheath such that pulling the tendon in the proximal direction decreases the radius of curvature of the stylet distal end region and the sheath distal end region and subsequent movement of the tendon in the distal direction allows an increase in the radius of curvature of the stylet distal end region and the sheath distal end region.