Catheter devices and methods for delivering

• US 5,304,171 A
• Filed: 02/02/1993
• Issued: 04/19/1994
• Est. Priority Date: 10/18/1990
• Status: Expired due to Fees

• Current Assignee: Anderson R. Rox, Kenton W. Gregory
• Original Assignee: Anderson R. Rox, Kenton W. Gregory
• Inventors: Gregory, Kenton W., Anderson, R. Rox
• Primary Examiner(s): ASCHENBRENNER, PETER
• Application Number:
  US08/012,789
• Time in Patent Office: 441 Days
• Field of Search: 606/2-19, 385/125, 385/31, 385/33, 385/142
• US Class Current: 606/15
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2018/206 the laser light passing along a liquid-filled conduit
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/067 using laser light

Abstract

A method for conducting laser energy to a site includes steps of bringing the proximal end of a flexible tube near the site, filling at least a proximal portion of the tube with a liquid by introducing the liquid into the tube, allowing a portion of the liquid to flow out from the proximal end of the tube toward the site, and directing laser energy from a laser energy source into the distal end of the tube, whereby a portion of the laser energy emerges from the proximal end of the tube at the site. Also, such a method in which the liquid is a radiographic contrast medium. Also, such a method for removing an obstruction from a blood vessel in an animal. Also, apparatus for delivering laser energy to a site includes a flexible tube, a liquid, the tube having an opening in a first end through which the liquid can pass, means for providing a flow of the liquid into the tube, and a source of laser energy operationally associated with a second end of the tube, wherein the tube and the liquid are adapted to cooperate, when the tube contains the liquid, to conduct laser energy from the source and to emit a portion of the laser energy from the first end of the liquid-containing tube.

Claims

1. A flowing fluid laser catheter for delivering laser energy from a laser generating device to a target location within a mammalian body, said catheter comprising:

an elongate flexible catheter body having a distal end, a proximal end, an outer surface and a hollow lumen defined by a luminal surface extending longitudinally therethrough;

a laser transmitting optical fiber disposed within a proximal portion of said catheter lumen such that the proximal and of said fiber is coupleable to a said laser generating device and such that the distal end of said fiber terminates within the catheter lumen at a launch point proximal to the distal end of said catheter lumen;

a liquid inflow opening proximal to said launch point for infusing a laser transmitting liquid through said catheter lumen;

a liquid outflow opening formed distal to said launch point for permitting said laser transmitting liquid to flow out of said catheter lumen;

a fluid flow restricting endcap positioned on the distal end of said catheter lumen, said end cap having said liquid outflow opening formed therein, the size of said liquid outflow opening being smaller than the transverse dimension of said catheter lumen so as to restrict the outflow of liquid from the distal end of said catheter lumen; and

whereby laser energy is transmitted from said laser generating device, through said optical fiber, and into a flow of laser transmitting liquid being infused through said lumen and out of said outflow opening.

2. The flowing fluid laser catheter of claim 1 wherein said optical fiber has a transverse dimension less than the transverse dimension of said lumen, thereby providing a space between said luminal surface and said optical fiber such that said laser transmitting liquid entering said inflow opening may flow through said space, through said lumen, and out of said outflow aperture.

3. The flowing fluid laser catheter of claim 1 further comprising:

a centering device for holding said optical fiber in a substantially co-axial position within said catheter lumen, thereby providing for substantially co-axially directed launch of laser energy from the distal end of said fiber into laser transmitting liquid being infused through said catheter lumen.

4. The flowing fluid laser catheter of claim 2 wherein said optical fiber has a transverse dimension of about 300-600 microns and said catheter lumen has a transverse dimension of about 1-3 mm.

5. The flowing fluid laser catheter of claim 1 further comprising:

a Y-connector positioned on the proximal end of said catheter body, said Y-connector having a first furcation through which said optical fiber is inserted, and a second furcation forming said liquid infusion opening through which said laser transmitting liquid is infused.

6. The flowing fluid laser catheter of claim 1 further comprising:

a bubble filter for filtering gas bubbles from said laser transmitting liquid.

7. The flowing fluid laser catheter of claim 1 wherein:

said luminal surface has a refractive index (N_f);

said laser transmitting liquid has a refractive index (N_w); and

the refractive index (N_f) of said luminal surface being greater than the refractive index of said liquid (N_w) and the ratio (N_f /N_w) of the refractive index (N_f) of said luminal surface to the refractive index of said liquid (N_w) being greater than 1.0.

8. The flowing fluid laser catheter of claim 1 wherein:

said luminal surface has a refractive index (N_f);

said laser transmitting liquid has a refractive index (N_w); and

the refractive index (N_f) of said luminal surface being greater than the refractive index (N_w) of said liquid and the ratio (N_f /N_w) of the refractive index of said luminal surface (N_f) to the refractive index of said liquid (N_w) being greater than 1.05.

9. The flowing fluid laser catheter of claim 1 wherein:

said luminal surface has a refractive index (N_f);

said laser transmitting liquid has a refractive index (N_w); and

the refractive index (N_f) of said luminal surface being greater than the refractive index (N_w) of said liquid and the ratio (N_f /N_w) of the refractive index of said luminal surface (N_f) to the refractive index of said liquid (N_w) being greater than 1.1.

10. The flowing fluid laser catheter of claim 7 wherein the value of N_f is at least about 1.46.

11. The flowing fluid laser catheter of claim 7 wherein the value of N_w is at least about 1.33.

12. The flowing fluid laser catheter of claim 7 wherein the value of N_f is about 1.46.

13. The flowing fluid laser catheter of claim 7 wherein the value of N_w is about 1.33.

14. The flowing fluid laser catheter of claim 1 wherein the luminal surface of said catheter lumen is formed of fluorinated ethylenepropylene.

15. The flowing fluid laser catheter of claim 1 wherein the luminal surface of said catheter lumen is formed of fluorinated polypropylene.

16. The flowing fluid laser catheter of claim 1 wherein sufficient space exists between said luminal surface and said optical fiber to permit passage of a guidewire through said catheter lumen, next to said optical fiber.

17. The flowing fluid laser catheter of claim 1 further comprising:

a separate guidewire passage lumen extending longitudinally through said catheter body to permit passage of a guidewire therethrough.

18. The flowing fluid laser catheter of claim 16 wherein said catheter lumen has a transverse dimension of about 1-3 mm and wherein said liquid outflow has a diameter of about 500 microns.

19. The flowing fluid laser catheter of claim 1 wherein said luminal surface comprises a reflective layer.

20. The flowing fluid laser catheter of claim 19 wherein said reflective layer is bonded to said luminal surface.

21. The flowing fluid laser catheter of claim 19 wherein said reflective layer comprises a metallized layer.

22. The flowing fluid laser catheter of claim 1 wherein the portion of said catheter which extends distally beyond the distal end of said optical fiber is bendable into a curve having a radius of curvature of 20 mm without substantial change in the cross-sectional shape of said catheter body.

23. The flowing fluid laser catheter of claim 1 wherein the portion of said catheter which extends distally beyond the distal end of said optical fiber is bendable into a curve having a radius of curvature of 10 mm without substantial change in the cross-sectional shape of said catheter body.

24. The flowing fluid laser catheter of claim 1 further in combination with a laser generating device coupled to the proximal end of said optical fiber.

25. The flowing fluid laser catheter of claim 23 wherein said laser generating device is a pulse dye laser.

26. The flowing fluid laser catheter of claim 23 wherein said laser generating device is an excimer laser.

27. The flowing fluid laser catheter of claim 23 wherein said laser generating device is an Holmium laser.

28. The flowing fluid laser catheter of claim 23 wherein said laser generating device is an Erbium YAG laser.

29. The flowing fluid laser catheter of claim 1 further comprising:

a dilation balloon positioned on the outer surface of said catheter body; and

a balloon inflation fluid channel extending through said catheter body for passing balloon inflation fluid into and out of said balloon.

30. A method for effectuating laser treatment of obstructive matter within a mammalian blood vessel, said method comprising the steps of:

catheter comprising;

(i.) an elongate catheter body having a distal end, a proximal end and a hollow lumen extending longitudinally therethrough;

(ii.) a laser transmitting optical fiber extending longitudinally through a proximal portion of said catheter, said fiber having a proximal end which is coupleable to a laser generating device and a distal end which is positioned within said catheter lumen at a launch point which is proximal to the distal end of said catheter lumen;

(iii.) a liquid inflow port located proximal to said launch point for infusing laser transmitting liquid into said catheter lumen;

(iv). a liquid outflow aperture located distal to said launch point to permit said laser transmitting liquid to flow out of said catheter lumen;

(b.) inserting said catheter into said mammalian blood vessel and advancing said catheter to a position whereat the outflow aperture of said catheter is directed at the obstructive matter to be treated;

(c.) coupling the laser transmitting optical fiber of said catheter to said laser generating device;

(d.) infusing a laser transmitting liquid through said liquid inflow port, through said catheter lumen, and out of said outflow aperture;

(e.) operating said laser generating device to pass laser energy through said optical fiber such that said laser energy will pass out of the distal end of said optical fiber and into the flow of laser transmitting liquid being infused through said catheter lumen and out of said outflow aperture; and

(f.) maintaining the rate of flow of said laser transmitting liquid so that the liquid exiting said outflow aperture, and the laser energy contained therein, will strike the obstructive matter at which said outflow aperture is directed.

31. The method of claim 30 wherein step (d.) comprises infusing a radiographic contrast medium.

32. The method of claim 31 wherein the infusing of said radiographic contrast medium comprises infusing a non-ionic radiographic contrast medium.

33. The method of claim 31 wherein said infusing of said radiographic contrast medium comprises infusing an ionic radiographic contrast medium.

34. The method of claim 31 wherein the radiographic contrast medium infused in Step (d.) is selected from the group of commercially available contrast media consisting of:

Renographin 76®

;

Angiovist®

;

Hexabrix®

; and

Omnipaque®

.

35. The method of claim 30 wherein said obstructive matter comprises an intravascular thrombus and wherein step (e.) comprises:

utilizing said laser generating device to emit laser energy at a wavelength, pulse duration and interval duration suitable for destruction of thrombotic matter.

36. The method of claim 30 wherein said obstructive matter comprises atheromatous plague and wherein step (e.) comprises:

utilizing said laser generating device to emit laser energy at a wavelength, pulse duration and interval duration suitable for destruction of atheromatous plaque.

37. The method of claim 30 wherein said obstructive matter comprises an atheroembolus and wherein step (e.) comprises:

utilizing said laser generating device to emit laser energy at a wavelength, pulse duration and interval duration suitable for destruction of atheroembolic matter.

38. The method of claim 30 wherein said obstructive matter comprises an intravascular mineral deposit and wherein step (e.) comprises:

utilizing said laser generating device to emit laser energy at a wavelength, pulse duration and interval duration suitable for destruction of said mineral deposit.

39. The method of claim 30 wherein the flowing fluid laser catheter provided in step (a.) further comprises:

(v.) an inflatable dilation balloon positioned on said catheter to effect dilation of said blood vessel;

and wherein said method further comprises the step of;

(g.) inflating said dilation balloon to effect dilation of said blood vessel.

40. The method of claim 30 further comprising the step of:

(g.) maintaining the flow of laser transmitting liquid out of said outflow aperture at a rate sufficient to project a column of liquid beyond said outflow aperture, thereby permitting said laser energy to be transmitted within said column of liquid beyond the body of said catheter.

41. The method of claim 40 wherein step (g.) further comprises:

maintaining said flow of said laser transmitting liquid such that the column of liquid projected beyond said outflow aperture, and the laser energy contained therein, will strike obstructive matter.

42. The method of claim 30 wherein step (b.) comprises:

inserting said flowing fluid laser catheter and advancing said laser catheter over a pre-inserted guidewire.

43. The method of claim 30 wherein step (b.) comprises:

inserting and advancing said flowing fluid laser catheter through a guiding catheter which as been previously emplaced within said flow vessel.

44. The method of claim 30 further comprising the step of:

(g.) infusing said laser transmitting liquid at a rate sufficient to cause the liquid passing out of said outflow aperture, and the laser energy contained therein, to impinge against said blood vessel to prevent platelets from adhering and aggregating to the region of said blood vessel whereagainst said liquid has impinged.

45. The method of claim 44 further comprising the step of:

(h.) controlling the wavelength and pulse duration of said laser energy so as to prevent adhesion and aggregation of platelets without exceeding the thermal relaxation constant of the blood vessel against which said liquid is impinged.