Shapable catheter using exchangeable core and method of use

• US 5,993,462 A
• Filed: 03/27/1998
• Issued: 11/30/1999
• Est. Priority Date: 07/15/1996
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Cardiac Pathways Corp. (Boston Scientific Corporation)
• Inventors: Chapman, Troy J., Sherman, Darren R., Park, Peter, Pomeranz, Mark L.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/049,342
• Time in Patent Office: 613 Days
• Field of Search: 604/95, 604/280, 604/282, 604/281, 606/1, 606/110, 606/113, 606/129, 606/159, 606/167, 606/170, 606/108, 606/45-52, 606/32, 600/508
• US Class Current: 606/129
• 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. A pull wire may additionally be provided to allow the user to cause deflection at a distal portion of the catheter.

Claims

1. A shapable medical apparatus comprising, in combination:

a core wire having a shaped 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 core wire slidably receivable within the lumen such that when the core wire is advanced so that at least a portion of the shaped portion is within the distal section of the catheter, the catheter is deformed to approximate the non-linear shape of the portion of the shaped portion of the core wire that is within the distal section of the catheter; and

a pull wire within the catheter, the pull wire slidable to cause deflection of the distal section of the catheter.

2. The apparatus of claim 1 further comprising a plurality of electrodes mounted on the distal section of the catheter.

3. The apparatus of claim 1, further comprising:

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 at least one of the electrodes and to cause said fluid to create a conductive path between said at least one electrode and the tissue when said at least one electrode is positioned adjacent body tissue.

4. The apparatus of claim 3 wherein the ablation section further includes a fluid permeable deformable member at least partially covering said at least one of the electrodes.

5. The apparatus of claim 4 wherein the deformable member includes a layer of foam material formed over said at least one of the electrodes.

6. The apparatus of claim 4, 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.

7. The apparatus of claim 2 wherein the electrodes include electrodes configured to measure electrical activity of adjacent body tissue.

8. The apparatus of claim 1, wherein the core wire is a first core wire and wherein the apparatus further comprises 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 wherein the second core wire is slidably receivable within the lumen.

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

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

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

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

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

14. The apparatus of claim 1 wherein the catheter has an elongate cross-section.

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

16. The apparatus of claim 15 wherein the superelastic material is Nitinol.

17. 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 pull wire within the catheter, the pull wire slidable to cause deflection of the distal section of the catheter.

18. The apparatus of claim 17 further comprising a plurality of electrodes mounted on the distal section of the catheter.

19. The apparatus of claim 17, wherein the core wire is a first core wire and wherein the apparatus further comprises 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 wherein the second core wire is slidably receivable within the lumen.

20. The apparatus of claim 19 further comprising a plurality of electrodes mounted on the distal section of the catheter.

21. The apparatus of claim 17, further comprising:

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 at least one of the electrodes and to cause said fluid to create a conductive path between said at least one of the electrodes and the tissue when said at least one of the electrodes is positioned adjacent body tissue.

22. The apparatus of claim 21 wherein the ablation section further includes a fluid permeable deformable member at least partially covering said at least one of the electrodes.

23. The apparatus of claim 22 wherein the deformable member includes a layer of foam material formed over said at least one of the electrodes.

24. The apparatus of claim 22, 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.

25. The apparatus of claim 18 wherein the electrodes include electrodes configured to measure electrical activity of adjacent body tissue.

26. 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 pull wire and a lumen proportioned to slidably receive the core wire, wherein the catheter includes a proximal section and a distal 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 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; and

(e) increasing tension on the pull wire to deflect the distal section of the catheter.

27. The method of claim 26 wherein the catheter further includes at least one electrode on the distal section and wherein the method includes the steps of positioning the distal section adjacent to tissue to be treated and ablating tissue using the electrode.

28. The method of claim 26 wherein the catheter further includes at least one electrode on the distal section and wherein the method includes the steps of positioning the distal section adjacent to tissue to be treated and measuring electrical activity of the tissue using the electrode.

29. 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 pull wire and 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; and

(f) increasing tension on the pull wire to deflect the distal section of the catheter.

30. The method of claim 29 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.

31. The method of claim 29 further comprising the steps of:

(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;

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

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

(i) 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.

32. The method of claim 29 wherein step (a) includes the step of providing electrodes on the distal section of the catheter and wherein the method further comprises the steps of:

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

delivering RF energy to the electrodes to ablate the tissue.

33. The method of claim 29 wherein step (a) includes the step of providing electrodes on the distal section of the catheter and wherein the method further comprises the steps of:

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

using the electrodes to detect electrical activity of the tissue.

34. The method of claim 29 wherein:

step (a) includes the step of further 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, withdrawing the guiding core wire from the lumen.

35. The method of claim 29 further comprising the steps of 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.