Shapable catheter using exchangeable core and method of use

• US 5,882,346 A
• Filed: 07/15/1996
• Issued: 03/16/1999
• Est. Priority Date: 07/15/1996
• Status: Expired due to Fees

• Current Assignee: Cardiac Pathways Corp. (Boston Scientific Corporation)
• Original Assignee: Cardiac Pathways Corp. (Boston Scientific Corporation)
• Inventors: Park, Peter, Pomeranz, Mark L.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/680,426
• Time in Patent Office: 974 Days
• Field of Search: 604/280, 604/281, 604/282, 604/283, 604/264, 604/49, 604/51-53, 604/95, 604/96, 604/164, 128/772, 128/657, 128/658, 607/122, 607/119, 607/116
• US Class Current: 604/525
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00113 with foam
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: C08L 2201/12 Shape memory

Abstract

In a shapable catheter and method for positioning a shapable catheter within a body cavity, a core wire is provided which includes a pre-shaped region bent into a predetermined shape. A catheter is provided which includes a lumen proportioned to slidably receive the core wire. The catheter includes a rigid proximal section and a flexible distal section. During use, the distal end of the catheter is inserted through a patient'"'"'s vasculature and is passed into a body cavity. The pre-shaped region of the core wire is passed into the lumen and is straightened by the rigid proximal section of the catheter. The pre-shaped region is passed further into the catheter until it reaches the flexible distal region, in which the pre-shaped section re-assumes its predetermined shape and causes the core wire to form the distal section of the catheter into the predetermined shape. The distal section of the catheter is positioned in contact with tissue in the body cavity, and electrodes carried by the distal end are used to map and/or ablate the tissue.

Claims

1. A shapable medical apparatus comprising, in combination:

a core wire having a distal portion with a predetermined non-linear shape; and

a catheter having a lumen proportioned to slidably receive the core wire, the catheter including a proximal section and a distal section, the distal section having greater flexibility than the proximal section, the core wire slidably receivable within the lumen such that when the core wire is introduced into the proximal section of the catheter, said distal portion is substantially straightened by the proximal section of the catheter, and when said core wire is advanced so that at least a portion of the distal portion is within the distal section of the catheter, the catheter is deformed to approximate the non-linear shape of the portion of the distal portion of the core wire that is within the distal section.

2. The apparatus of claim 1 wherein the predetermined shape is a spiral.

3. The apparatus of claim 1 wherein the predetermined shape is an approximate Z-curve.

4. The apparatus of claim 1 wherein the predetermined shape is an approximate C-curve.

5. The apparatus of claim 1 wherein the predetermined shape is an approximate J-curve.

6. The apparatus of claim 1 wherein the catheter and core wire are configured for preferential bending across a preferential bend plane.

7. The apparatus of claim 6 wherein the catheter has an elongate cross-section.

8. The apparatus of claim 1 wherein the core wire is formed of a superelastic material.

9. The apparatus of claim 8 wherein the superelastic material is Nitinol.

10. A method of positioning a catheter within a body cavity comprising the steps of:

(a) providing a core wire including a distal portion having a predetermined non-linear shape and further providing a catheter having a lumen proportioned to slidably receive the core wire, wherein the catheter includes a proximal section and a distal section, the distal section having greater flexibility than the proximal section;

(b) passing the catheter through a vessel and into a body cavity;

(c) inserting the distal portion of the core wire into the lumen;

(d) passing the distal portion of the core wire through the proximal section of the catheter, causing the distal portion of the core wire to substantially straighten; and

(e) passing at least a portion of the distal portion of the core wire into the distal section of the catheter, causing the portion of the distal portion of the core wire to deform the distal section of the catheter to approximate the non-linear shape of the portion of the distal portion that is within the distal section of the catheter.

11. The method of claim 10 further comprising the steps of:

(f) withdrawing the core wire from the catheter distal section into the catheter proximal section, causing the core wire to substantially straighten;

(g) withdrawing the core wire from the lumen; and

(h) after step (g), withdrawing the catheter from the body cavity.

12. The method of claim 10 wherein:

step (a) includes the step of providing a guiding core wire having a distal portion; and

step (b) includes the step of inserting the distal portion of the guiding core wire into the lumen and, after passing the catheter into the body cavity, withdrawings the guiding core wire from the lumen.

13. A shapable medical apparatus comprising, in combination:

a core wire having a distal portion with a predetermined non-linear shape;

a catheter having a lumen proportioned to slidably receive the core wire, the catheter including a proximal section and a distal section, the distal section having greater flexibility than the proximal section, the core wire slidably receivable within the lumen such that when the core wire is introduced into the proximal section of the catheter, said distal portion is substantially straightened by the proximal section of the catheter, and when said core wire is advanced so that at least a portion of the distal portion is within the distal section of the catheter, the catheter is deformed to approximate the non-linear shape of the portion of the distal portion of the core wire that is within the distal section; and

a plurality of electrodes mounted on the distal section of the catheter.

14. A shapable medical apparatus comprising, in combination:

a first core wire having a distal portion with a predetermined non-linear shape;

a second core wire having a distal portion with a second predetermined non-linear shape, the second predetermined shape being different from the predetermined shape of the first core wire; and

a catheter having a lumen proportioned to slidably receive the core wires, the catheter including a proximal section and a distal section, the distal section having greater flexibility than the proximal section, each core wire slidably receivable within the lumen such that when one of the core wires is introduced into the proximal section of the catheter, said distal portion is substantially straightened by the proximal section of the catheter, and when said core wire is advanced so that at least a portion of the distal portion is within the distal section of the catheter, the catheter is deformed to approximate the non-linear shape of the portion of the distal portion of the core wire that is within the distal section.

15. A method of positioning a catheter within a body cavity comprising the steps of:

(a) providing a core wire including a distal portion having a predetermined non-linear shape and further providing a catheter having a lumen proportioned to slidably receive the core wire, wherein the catheter includes a proximal section and a distal section, the distal section having greater flexibility than the proximal section;

(b) passing the catheter through a vessel and into a body cavity;

(c) inserting the distal portion of the core wire into the lumen;

(d) passing the distal portion of the core wire through the proximal section of the catheter, causing the distal portion of the core wire to substantially straighten;

(e) passing at least a portion of the distal portion of the core wire into the distal section of the catheter, causing the portion of the distal portion of the core wire to deform the distal section of the catheter to approximate the non-linear shape of the portion of the distal portion that is within the distal section of the catheter;

(f) removing the core wire from the catheter;

(g) providing a second core wire, the second core wire including a second distal portion having a second predetermined non-linear shape;

(h) inserting the second distal portion of the second core wire into the lumen;

(i) passing the second distal portion through the proximal section of the catheter, causing the second core wire to substantially straighten; and

(j) passing at least a portion of the second distal portion of the second core wire into the distal section of the catheter, causing the distal section of the catheter to deform to approximate the non-linear shape of the portion of the second distal portion that is within the distal section of the catheter.

23. The apparatus of claim 15 further comprising the steps of:

after steps (e) and (j), positioning the catheter in a desired location within the body and using it to gather diagnostic information and/or to deliver therapy to adjacent tissue.

16. A method of positioning a catheter within a body cavity comprising the steps of:

(a) providing a core wire including a distal portion having a predetermined non-linear shape and further providing a catheter having a lumen proportioned to slidably receive the core wire, wherein the catheter includes a proximal section and a distal section, the distal section having greater flexibility than the proximal section, and further providing electrodes on the distal section of the catheter;

(b) passing the catheter through a vessel and into a body cavity;

(c) inserting the distal portion of the core wire into the lumen;

(d) passing the distal portion of the core wire through the proximal section of the catheter, causing the distal portion of the core wire to substantially straighten;

(e) passing at least a portion of the distal portion of the core wire into the distal section of the catheter, causing the portion of the distal portion of the core wire to deform the distal section of the catheter to approximate the non-linear shape of the portion of the distal portion that is within the distal section of the catheter;

(f) positioning the electrodes into contact with tissue in the body cavity; and

(g) delivering RF energy to the electrodes to ablate the tissue.

17. A method of positioning a catheter within a body cavity comprising the steps of:

(a) providing a core wire including a distal portion having a predetermined non-linear shape and further providing a catheter having a lumen proportioned to slidably receive the core wire, wherein the catheter includes a proximal section and a distal section, the distal section having greater flexibility than the proximal section, and further providing electrodes on the distal section of the catheter;

(b) passing the catheter through a vessel and into a body cavity;

(c) inserting the distal portion of the core wire into the lumen;

(d) passing the distal portion of the core wire through the proximal section of the catheter, causing the distal portion of the core wire to substantially straighten;

(e) passing at least a portion of the distal portion of the core wire into the distal section of the catheter, causing the portion of the distal portion of the core wire to deform the distal section of the catheter to approximate the non-linear shape of the portion of the distal portion that is within the distal section of the catheter;

(f) positioning the electrodes into contact with tissue in the body cavity; and

(g) using the electrode to detect electrical activity of the tissue.

18. A shapable medical apparatus comprising, in combination:

a core wire having a distal portion with a predetermined non-linear shape;

a catheter having a lumen proportioned to slidably receive the core wire, the catheter including a proximal section and a distal section, the distal section having greater flexibility than the proximal section, the core wire slidably receivable within the lumen such that when the core wire is introduced into the proximal section of the catheter, said distal portion is substantially straightened by the proximal section of the catheter, and when said core wire is advanced so that at least a portion of the distal portion is within the distal section of the catheter, the catheter is deformed to approximate the non-linear shape of the portion of the distal portion of the core wire that is within the distal section;

a source of ablation energy;

an ablation section on the distal section of the catheter, the ablation section including at least one electrode coupled to the source of ablation energy, and a fluid port for delivering conductive fluid into contact with the electrodes and to cause said fluid to create a conductive path between the electrodes and the tissue when the electrodes are positioned adjacent body tissue.

19. The apparatus of claim 18 wherein the ablation section further includes a fluid permeable deformable member at least partially covering the electrodes.

20. The apparatus of claim 19 wherein the deformable member includes a layer of foam material formed over the electrodes.

21. The apparatus of claim 19, further comprising a covering on the deformable member, the covering formed of a material substantially impermeable to fluid, the covering including at least one opening sized to allow passage of fluid out of the covering.

22. The apparatus of claim 18 wherein the ablation section further includes electrodes configured to measure electrical activity of adjacent body tissue.