Catheter

• US 6,270,476 B1
• Filed: 04/23/1999
• Issued: 08/07/2001
• Est. Priority Date: 04/23/1999
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: CryoCath Technologies Incorporated (Medtronic Plc)
• Inventors: Wittenberger, Dan, Santoianni, Domenic, Petre, Cristian, Nahon, Daniel, Lalonde, Jean-Pierre
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/298,234
• Time in Patent Office: 837 Days
• Field of Search: 606/20-26, 606/41, 600/585, 604/95.01, 604/95.04, 604/95.05, 607/122
• US Class Current: 604/95.04
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter for ablating tissue, for example to treat a cardiac arrhythmia, includes a handle, a shapeable shaft and a distal ablation segment. The shaft retains a first position until manipulated to a further position with the application of moderate manual pressure. The shaft incorporates plastically deformable elements and is shapeable to conform to an insertion path or the particular anatomy of a patient for accessing a site to be ablated. Once shaped, the shaft retains its shape as the catheter is inserted or manipulated to the predetermined tissue treatment location and the distal segment is urged into contact with the tissue site. A deflection mechanism may be provided to facilitate navigation to, or to deflect the ablation segment into conformal contact with, the tissue target. In a further or alternative embodiment, a second or auxiliary shaft member extends distally from the ablation segment, allowing the segment to be threaded by or pulled past occluding tissue to a remote target tissue site. By gripping the end of the second shaft, the flexible ablation segment may be either tensioned or pulled inward against, or flexed and pushed outward against a treatment site, such as a region of the posterior epicardial wall, thus providing more effective contact for a broad range of dispositions and tissue orientations. In another embodiment, a thermal shield extends over a portion of the ablation segment, shielding adjacent tissue from damage while still effectively exposing the target tissue to ablation energy. The shield may be rotated or moved axially to delimit an area of cryogenic contact and achieve better protection of surrounding tissue structures in occluded or remote treatment target regions.

Claims

1. A catheter for tissue ablation, such catheter comprising

a handle

a primary shaft extending from the handle

an ablation segment, having a proximal end and a distal end, the proximal end of the ablation segment extending from a distal end of the primary shaft and configured to receive ablation energy therethrough for ablation of tissue contacting the segment, and

a second shaft coupled to the distal end of the ablation segment, wherein the second shaft is configured to extend from the distal end of the ablation segment such that by moving the primary shaft and the second shaft the ablation segment is spatially stabilized by the positioning of the primary shaft and the second shaft to be in contact with tissue for forming tissue ablation.

2. A catheter according to claim 1, wherein the primary shaft is formable to a shape-retaining contour for positioning the ablation segment to ablate remotely targeted tissue.

3. A catheter according to claim 2, wherein the primary shaft includes cryogenic passages for circulating a heat transfer medium through the ablation segment.

4. A catheter according to claim 3, wherein the second shaft includes means for fixing said second shaft in position against tissue.

5. A catheter according to claim 4, wherein the second shaft is elongated and flexible for enhanced movement around tissue to position the ablation segment posteriorly of an organ accessed through an anterior opening.

6. A catheter according to claim 1, wherein the second shaft is internally filled with radiographically opaque material.

7. An epicardial ablation device, comprising:

a handle having a proximal portion and a distal portion;

a shaft having a proximal end extending from the distal portion of the handle and a distal end, the shaft having a stiffness such that the shaft retains a first shape until manipulated to a further shape by a user manually applying pressure to the shaft, wherein the further shape is conformable to an anatomy of a patient;

a steering mechanism; and

a distal segment extending from the distal end of the shaft, said distal segment being coupled to the steering mechanism, and said distal segment being continuously flexibly deflectable, the deflection of said distal segment being controllable to contact tissue along an ablation line for treatment thereof.

8. A medical instrument, comprising:

a shaft having a proximal end and a distal end, the shaft having a malleable conformations such that the shaft retains a first shape until manipulated to a second shape, and being sufficiently rigid for pushing the distal end,

a handle coupled to the proximal end of the shaft, the handle having a steering mechanism,

a distal segment coupled to the distal end of the shaft, the distal segment having a transitionable radius of curvature, and

a pull wire having a proximal end and a distal end, the proximal end being coupled to the steering mechanism, and the distal end being coupled to the distal segment, the radius of curvature of the distal segment being continuously transitionable from a first position to a second position,

the handle, shaft, pull wire and distal segment forming a catheter, and operable by shaping the shaft to position the distal segment in contact with tissue.

9. The instrument according to claim 8, wherein the shaft is manually shapeable with the application of moderate pressure.

10. The instrument according to claim 8, wherein the shaft has bending stiffness in the range from about five pound-inches² to about one hundred pound-inches².

11. The instrument according to claim 10, wherein the distal segment has an outer diameter ranging from about 0.05 to about 0.20 inches.

12. The instrument according to claim 8, wherein the distal segment is an ablation segment and the shaft is shapeable to achieve a configuration for reaching around a heart to effectively position the distal segment against the posterior epicardial wall.

13. The instrument according to claim 8, wherein the shaft has a maximum angle of curvature of about 180 degrees in a plane, and a minimum radius of curvature of about 0.25 inches.

14. The instrument according to claim 8, wherein the shaft has a length of between about four and about twenty-five inches.

15. The instrument according to claim 14, wherein the shaft has an outer diameter ranging from about one eighth inch to about three quarter inches.

16. The instrument according to claim 8, wherein the shaft comprises a shape-retaining structure including a helical coil.

17. The instrument according to claim 8, wherein the shaft comprises a shape-retaining structure including a malleable wire rod.

18. The instrument according to claim 17, wherein the malleable wire rod is tapered.

19. The instrument according to claim 8, wherein the distal segment is deflectable so as to form a loop.

20. The instrument according to claim 19, wherein the loop has a radius below about one centimeter.

21. The instrument according to claim 8, further comprising an auxiliary segment removably attached to the distal segment for positioning the distal segment in contact with tissue.

22. The instrument according to claim 8, wherein the catheter is a cryogenic ablation catheter, and the shaft includes passages for circulating a coolant through the distal segment.