Spiral catheter with multiple guide holes

• US 5,873,865 A
• Filed: 02/07/1997
• Issued: 02/23/1999
• Est. Priority Date: 02/07/1997
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Horzewski, Michael, Giba, Jeffrey
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/797,240
• Time in Patent Office: 746 Days
• Field of Search: 604/20, 604/280, 604/282, 604/283, 604/264, 604/281, 128/656, 128/633, 128/634, 600/433, 600/310, 600/34, 600/2, 600/434, 600/435, 600/585, 606/14, 606/15, 606/16, 606/31, 607/88, 607/89
• US Class Current: 604/523
• CPC Class Codes: A61M 2210/125 Heart
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A spiral catheter apparatus for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus comprising a flexible, main catheter shaft defining a central axis of the apparatus, the catheter shaft having a proximal end, a distal end and a first hollow lumen region extending therethrough, the catheter shaft further having a spiral portion adjacent the distal end with a selected curvilinear shape, the curvilinear shape defining an inner arcuate sidewall and an outer arcuate sidewall, the catheter shaft flexible enough to assume a temporarily elongated shape such that the apparatus can be extended through at least a portion of the body in the temporarily elongated shape and will assume the selected curvilinear shape when extended into a body cavity or organ, the selected curvilinear shape serving to securely position the apparatus adjacent a selected surface within the body cavity or organ, at least the spiral portion of the catheter shaft having a plurality of guide holes thereon, the plurality of guide holes disposed at least on the outer arcuate sidewall in communication with the first lumen such that a distal end of a laser delivery means or other functional device can be controllably advanced through the plurality of guide holes for laser or other treatment on the selected surface.

Claims

1. A catheter device for performing an interventional procedure in a body cavity, the device comprising:

a flexible guide tube having proximal and distal ends, and at least a first one lumen, the distal end of the flexible guide tube transformable from a substantially elongated shape for passage within the vasculature into a spiral shape within a body cavity;

a plurality of guide holes disposed at least at the distal end of the guide tube and in communication with a first lumen of the guide tube; and

an interventional procedural device having proximal and distal ends, slidably disposed in the first lumen in the guide tube and controllably extendable through any of the guide holes to create an interventional treatment pattern;

whereby the spiral shape of the distal end of the flexible guide tube facilitates positioning of the plurality of guide holes for the interventional treatment device to extend there through and the stabilization of the catheter device within the body cavity during the interventional procedure.

2. The device of claim 1 wherein at least the spiral shape of the flexible guide tube is at least partially comprised of at least one material selected from the group consisting of superelastic and shape memory material.

3. The device of claim 1 wherein the flexible guide tube has a second lumen and further including a wire within the second lumen coextensive therewith, the wire extends at least through the spiral shape of the flexible guide tube and is at least partially comprised of at least one material selected from the group consisting of superelastic or shape memory material.

4. The device of claim 3 wherein the wire is slidably extendable through the second lumen in the guide tube.

5. The device of claim 4 wherein the second lumen of the guide tube has a sidewall and the sidewall of the second lumen of the guide tube and the wire each have a complementary conformal cross-sectional geometry that is substantially non-circular thereby preventing rotation of the wire within the second lumen.

6. The device of claim 1 wherein the catheter device has proximal and distal ends and further including an advancement member attached at the proximal end of the catheter device for controllably extending the distal end of the interventional procedural device through any of the guide holes.

7. The device of claim 6 further including a handle, in which the advancement member is housed, and a slider member attached to the proximal end of the interventional procedural device and biased by a spring member, wherein the slider member moves relative to the handle.

8. The device of claim 6 wherein the handle attaches to a member for coupling to the proximal end of the interventional procedural device.

9. The device of claim 6 wherein the advancement member includes a depth stop member for delimiting advancement of the interventional procedural device through any of the guide holes.

10. The device of claim 9 further including a handle in which the advancement member is housed and to which the depth stop member is attached.

11. The device of claim 1 wherein the catheter device has proximal and distal ends and further including a fluid seal means around the interventional procedural device for preventing fluid escape from the proximal end of the catheter device.

12. The device of claim 1 further including a guide catheter through which the catheter device extends for introduction of the catheter device into the body vasculature.

13. The device of claim 1 wherein the guide holes are axially located on a positive curvature surface of the distal end of the guide tube that is configured in the spiral shape, whereby the interventional procedural device can egress substantially in a tangential direction from the spiral shape from any of the guide holes.

14. The device of claim 1 wherein the interventional procedural device is a laser energy delivery device comprised of at least one optical fiber element having proximal and distal ends.

15. The device of claim 14 wherein the distal end of the optical fiber element has a bend whereby the optical fiber element penetrates tissue at a generally perpendicular angle after passing through any of the guide holes during the interventional procedure.

16. The device of claim 1 wherein the catheter device has proximal and distal ends and further including a piercing member at the distal end of the catheter device for mechanically piercing tissue during the interventional procedure.

17. The device of claim 16 wherein the interventional procedural device is a laser energy delivery device comprising at least one optical fiber element and the piercing member is a portion of the distal end of the interventional procedural device.

18. The device of claim 16 wherein the guide tube is a conduit for drug delivery.

19. The device of claim 1 wherein the interventional procedural device includes a viewing device for visualizing affected tissue during the interventional procedure.

20. An interventional procedural method within a body cavity using a catheter device, the method comprising the steps of:

a) providing a catheter device having proximal and distal ends that includes, a flexible guide tube having proximal and distal ends and at least a first lumen, a plurality of guide holes disposed at least at the distal end of the guide tube and in communication with a first lumen of the guide tube, and an interventional procedural device having proximal and distal ends slidably disposed in the first lumen in the guide tube;

b) positioning the distal end of the flexible guide tube adjacent a procedural site within a body cavity and transforming the distal end of the guide tube into a spiral shape that securely positions the distal end of the catheter device adjacent a selected surface within the body cavity;

c) extending the interventional procedural device through any of the guide holes adjacent the procedural site;

d) effectuating the interventional procedure; and

e) creating an interventional treatment pattern in the body cavity.

21. The method of claim 20 wherein prior to step a) the step of positioning a guide catheter in the body and extending the guide tube through the guide catheter in proximity to the procedural site.

22. The method of claim 21 wherein prior to step b) of positioning the distal end of the guide tube further includes a step of extending the guiding catheter over a guide wire pre-positioned in proximity to the procedural site.

23. The method of claim 20 wherein step b) includes transforming the curvature of the guide tube by a wire extended to the distal end of the guide tube;

the step c) of extending the interventional procedural device is through a first guide hole;

the step e) of creating an interventional treatment pattern includes the steps of;

retracting the interventional procedural device into the guide tube;

repeating the steps c) and d) at least one subsequent procedural site.

24. The method of claim 20 wherein the step b) of positioning the guide tube includes positioning the interventional procedural device adjacent a first guide hole at an extremity position on the guide tube prior to causing transformation of the guide tube to a spiral shape;

the step c) of extending the interventional procedural device is through the first guide hole;

the step e) of creating a treatment pattern includes the steps of;

retracting the interventional procedural device into the guide tube until adjacent a second guide hole; and

repeating the steps c) and d) at a subsequent procedural site.

25. The method of claim 20 wherein the interventional procedure is a percutaneous transluminal myocardial revascularization procedure, the procedural site is within a ventricle of the heart, the interventional procedural device is a laser energy delivery device for effectuating tissue irradiation during the percutaneous transluminal myocardial revascularization procedure and further including prior to step b), a step of advancing the catheter device through the vasculature into the heart.

26. The method of claim 25 wherein the percutaneous transluminal myocardial revascularization procedure includes a step for creating tissue pockets by ablating tissue to form voids within myocardium.

27. The method of claim 25 wherein the procedural site is an endocardial surface within the ventricle of the heart, the step d) of extending the laser energy delivery member is from the endocardial surface into myocardium and includes irradiating tissue with laser energy thereby creating a channel.

28. The method of claim 25 wherein the step a) of providing the catheter device includes a piercing member for penetrating tissue at the distal end of the interventional procedural device and the step d) is preceded by a step of piercing through the endocardial surface with the laser delivery member.

29. The method of claim 25 wherein the step a) of providing the catheter device further includes providing a piercing member for penetrating tissue that is attached at the distal end of the laser energy delivery device and the step d) is preceded by a step of piercing through an endocardial surface into myocardium with the laser energy delivery device and the step d) includes retracting the laser energy delivery device from the myocardium while simultaneously irradiating tissue with laser energy thereby creating a channel.

30. The method of claim 20 wherein the catheter device has a proximal and distal end and step e) includes the steps of:

retracting the interventional procedural device into the guide tube;

rotating the proximal end of the catheter device whereby the spiral shape within the body is adjacent a second selected surface within the body cavity; and

repeating steps c) and step d) at the second selected surface within the body cavity.

31. The method of claim 20 wherein the interventional procedure is a stimulation procedure, the procedural site is within a cavity of the heart, the interventional procedural device is a laser energy delivery device, and wherein step d) includes creating tissue pockets by ablating tissue to form voids within myocardium.

32. The method of claim 20 subsequent to step d) a step of delivering fluid agents through the guide tube to the procedural site.