Multi-fiber laser catheter

• US 5,830,209 A
• Filed: 09/18/1995
• Issued: 11/03/1998
• Est. Priority Date: 02/05/1992
• Status: Expired due to Term

• Current Assignee: Lightwave Ablation Systems, Inc.
• Original Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Inventors: Brucker, Gregory G., Savage, Steven D.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/529,810
• Time in Patent Office: 1,142 Days
• Field of Search: 606/2, 606/3, 606/7, 606/13-16, 607/100-102, 607/88, 607/89, 607/115, 607/116, 607/122
• US Class Current: 606/15
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00011 with fluids

Abstract

Laser catheters according to the invention include multiple optical fibers for delivery of laser energy to a pre-determined treatment site in the therapeutic treatment of cardiac tissue. A fixation device fixes the distal end of the catheter to the treatment site. Temperature sensing devices disposed on the fixation device provide a temperature depth profile of the tissue treatment site, which can be used to control the treatment. Multi-piece, single-piece and porous tip catheters are disclosed.

Claims

1. A laser catheter, for use in providing therapeutic laser energy to human heart tissue at a pre-selected tissue site, the catheter comprising:

a) a catheter body having a proximal end and a distal end and an inner wall defining a lumen extending generally along a longitudinal axis of said catheter;

b) a multi-fiber optic cable having a proximal end and a distal end located within said catheter body and having a plurality of individual optical fibers to provide laser energy to the tissue site by a laser source;

c) a fixation element, having a proximal end and a distal end and operably carried through said lumen extending past said distal end of said catheter body, constructed to selectively penetrate the tissue to a predetermined depth at said pre-selected tissue site and to fix said distal end of said catheter body to said tissue; and

d) a plurality of temperature sensors, fixedly attached at spaced intervals along the length of said fixation element within the tissue to sense the temperature of said tissue at a plurality of tissue depths corresponding to said spaced intervals while said laser catheter is providing laser energy to said pre-selected tissue site, wherein said plurality of temperature sensors provide temperature readings correlated to the tissue depth at which each temperature sensor is located to create a temperature depth profile of the tissue.

2. The catheter of claim 1, further comprising a laser energy termination device, operably coupled to the plurality of temperature sensors and to the laser source and adapted to terminate provision of laser energy to the tissue site based on temperature readings from at least two of the temperature sensors.

3. The catheter of claim 2, wherein the termination device comprises feedback control circuitry.

4. The catheter of claim 2, wherein the termination device is triggered by an operator.

5. The catheter of claim 1, further comprising an electrophysiological mapping system operably coupled with the catheter body, the fixation element being one pole of the electrophysiological mapping system.

6. The catheter of claim 5, further comprising a metallic tip at the distal end of the catheter body, the metallic tip being a second pole of the electrophysiological mapping system.

7. The catheter of claim 1, wherein the catheter is a one-piece catheter.

8. The catheter of claim 1, wherein the catheter is a multi-piece catheter.

9. A laser catheter for use in a multi-piece catheter system, the laser catheter providing controlled laser energy effective to therapeutically denature human heart tissue at a pre-selected cardiac tissue site, the catheter comprising:

a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter;

b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to the tissue site by a laser source;

c) substantially helically-shaped fixation means, aligned co-axially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected tissue site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; and

d) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means and operably connected to the laser source, for sensing a plurality of temperatures, at depths within the cardiac tissue corresponding to the spaced intervals, while the laser catheter is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site.

10. The catheter of claim 9, wherein the temperature signals control the irradiation of the tissue site by terminating irradiation of the site when the signals indicate that the tissue at the site has reached a predetermined temperature.

11. The catheter of claim 10, wherein the predetermined temperature is 423°

K.

12. The catheter of claim 9, further comprising a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the metal tip holding the distal ends of the optical fibers in an orientation divergent from the longitudinal axis of the catheter.

13. The catheter of claim 12, further comprising access means, located toward the proximal end of the catheter body, for operable communication with the first lumen of the catheter body.

14. The catheter of claim 13, wherein the access means comprises a plurality of separate access ports, each port being in operable communication with the first lumen.

15. The catheter of claim 13, further comprising an electrically conducting wire fixably attached at a distal end to the metal tip of the catheter, the wire extending axially through the inner lumen of the catheter body to and through the access means.

16. The catheter of claim 13, further comprising means for directing a fluid cooling/flushing medium through the access means to the inner lumen of the catheter body.

17. The catheter of claim 9, wherein the fixation means is fixed within the catheter body and wherein the distal end of the fixation means extends a fixed amount beyond the distal end of the catheter.

18. The catheter of claim 9, wherein the fixation means is slidably located within the catheter body.

19. The catheter of claim 18, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

20. The catheter of claim 19, further comprising a tube aligned centrally within the control means and extending co-axially through the catheter body to the distal end of the catheter body, the tube comprising inner walls that define a second lumen, the fixation means passing through the second lumen.

21. The catheter of claim 20, further comprising a plurality of electrically conducting wires, each wire having a distal end and a proximal end, wherein the distal end of each wire is connected to a respective one of the plurality of temperature sensing means attached to the fixation means, wherein the plurality of wires is aligned axially with the second lumen, each of the plurality of wires extending through the second lumen and out from the proximal end of the catheter body.

22. A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient'"'"'s heart without ablating that tissue, the catheter system comprising:

a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter;

b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source;

c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip;

d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body;

e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals along the fixation means within the cardiac tissue, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while laser energy is being provided to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site and to create a temperature depth profile of the cardiac tissue;

f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and

g) steering means for guiding the catheter system through anatomical structures within the patient'"'"'s body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

23. The system of claim 22, wherein the temperature signals control the irradiation of the tissue site by terminating irradiation of the site when the signals indicate that the tissue at the site has reached a pre-determined temperature.

24. The system of claim 22, wherein the fixation means is slidably located within the catheter body.

25. The system of claim 24, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

26. The system of claim 25, further comprising a tube aligned centrally within the control means and extending co-axially through the catheter body to the distal end of the catheter body, the tube comprising inner walls that define a second lumen, the fixation means passing through the second lumen.

27. The system of claim 26, further comprising a plurality of electrically conducting wires, each wire having a distal end and a proximal end, wherein the distal end of each wire is connected to a respective one of the plurality of temperature sensing means attached to the fixation means, wherein the plurality of wires is aligned axially with the second lumen, each of the plurality of wires extending through the second lumen and out from the proximal end of the catheter body.

28. The system of claim 22, further comprising access means, located toward the proximal end of the catheter for operable communication with the first lumen of the catheter.

29. The system of claim 28, further comprising means for directing a fluid cooling/flushing medium through the access means to the inner lumen of the catheter body.

30. The system of claim 22, wherein the metal tip is a porous metal tip.

31. The laser catheter of claim 22, wherein the distal end of the fixation means is helically shaped.

32. The laser catheter of claim 31, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the helically shaped distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

33. The laser catheter of claim 32, wherein the control means rotatably moves the distal end of the helically shaped fixation means to securely fix the fixation means to the cardiac tissue.

34. A method for the controlled laser irridation of cardiac tissue at a pre-selected tissue site to therapeutically denature cardiac tissue at the site, the method comprising:

(a) introducing a distal end of a laser catheter proximate to the pre-selected cardiac tissue site;

(b) denaturing cardiac tissue at the pre-selected tissue site by irradiating the cardiac tissue with laser energy provided via the catheter by a laser source;

(c) fixing the distal end of the catheter to the pre-selected tissue site by penetrating cardiac tissue at the pre-selected tissue site with a fixation element extending from the distal end of the catheter;

(d) flushing the pre-selected tissue site with a fluid flushing medium introduced to the pre-selected tissue site through the catheter; and

(e) monitoring, during step (d), the temperature of the cardiac tissue at the pre-selected tissue site with at least one temperature sensor at the fixation element.

35. The method of claim 34, wherein step (e) includes creating a temperature depth profile of the cardiac tissue at the pre-selected tissue site by a plurality of spaced temperature sensors on the fixation element.

36. The method of claim 34, further comprising electrophysiologically mapping the pre-selected tissue site with the laser catheter to determine a precise location for irradiation of tissue by the laser catheter.

37. The method of claim 36, further comprising steering the laser catheter with an externally accessible steering control device through anatomical structures to the pre-selected tissue site.

38. The method of claim 34, wherein step (b) includes irradiating the cardiac tissue with laser energy provided via a multi-fiber optic cable having a plurality of optical fibers, the optical fibers diverging from a longitudinal axis of the catheter.

39. The method of claim 38, wherein step (d) includes directing the fluid flushing medium along the plurality of optical fibers diverging from the longitudinal axis of the catheter, the flushing flow surrounding the optical fibers to thoroughly bathe the pre-selected tissue site.

40. A method of providing both laser energy and radio frequency energy to denature cardiac tissue at a pre-selected tissue site by a catheter, the method comprising:

(a) introducing a distal end of a catheter proximate to the pre-selected cardiac tissue site;

(b) irradiating the cardiac tissue with laser energy provided via the catheter by a laser source;

(c) irradiating the cardiac tissue with radio frequency energy provided via the catheter by a radio frequency energy source;

(d) flushing the pre-selected tissue site with a fluid flushing medium introduced to the pre-selected tissue site through a porous tip of the catheter;

(e) fixing the distal end of the catheter to the pre-selected tissue site by penetrating cardiac tissue at the pre-selected tissue site with a fixation element extending from the distal end of the catheter; and

(f) monitoring the temperature of the cardiac tissue at the pre-selected tissue site with at least one temperature sensor at the fixation element.

41. The method of claim 40, wherein step (f) includes creating a temperature depth profile of the cardiac tissue at the pre-selected tissue site by a plurality of spaced temperature sensors on the fixation element.

42. A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient'"'"'s heart without ablating that tissue, the catheter system comprising:

a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter;

b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source;

c) a porous metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip;

d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body;

e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site;

f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and

g) steering means for guiding the catheter system through anatomical structures within the patient'"'"'s body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

43. A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient'"'"'s heart without ablating that tissue, the catheter system comprising:

a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter;

b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source;

c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip;

d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a helically-shaped distal end and a length sufficient to extend beyond the distal end of the catheter body;

e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site;

f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and

g) steering means for guiding the catheter system through anatomical structures within the patient'"'"'s body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.