Wire guided laser catheter

• US 4,850,351 A
• Filed: 11/25/1986
• Issued: 07/25/1989
• Est. Priority Date: 05/22/1985
• Status: Expired due to Term

• Current Assignee: Cardiofocus Incorporated
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Roth, Laurence A., Dickinson, Douglas W. Jr., Herman, Stephen J., Sinofsky, Edward L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/934,629
• Time in Patent Office: 973 Days
• Field of Search: 604/21, 604/20, 604/280, 128/6, 128/4, 128/303.1, 128/634, 128/633, 128/348.1, 138/120, 138/121
• US Class Current: 606/7
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: Y10T 74/20444 including rolling antifriction elements
• CPC Class Codes: Y10T 74/20456 Specific cable or sheath structure

Abstract

A catheter having optical fibers for delivering laser energy to a blood vessel to remove obstructions in the blood vessel is adapted to be guided controllably and selectively by a guide wire to the site to be treated. The catheter includes a central lumen which is open at the distal end of the catheter and which receives the guide wire so that the catheter may be advanced over the guide wire. A relatively few number of optical fibers are contained within and extend longitudinally of the catheter wall. The distal tip of the catheter is provided with a cylindrical optically transparent end cap and means are provided to securely mount the distal ends of the optical fibers with respect to the end cap so that the light emitted from the ends of the fibers passes through the cylindrical wall of the end cap and is emitted at the distal emissions face of the end cap. The catheter embodies a special construction of an inner catheter core and a surrounding sheath which provides for a high degree of flexibility to enable the catheter to be passed through tortuous passages in a patient'"'"'s vasculature. The inner core is formed from a plurality of articulated segments and is surrounded by a thin flexible sheath. Longitudinal flutes formed along the articulated segments of the core receive and retain the optical fibers in a manner which permits the fibers, sheath and core to shift longitudinally with respect to each other to provide a very high degree of flexibility for the composition catheter.

Claims

1. A catheter for removing biological material by laser energy, the catheter having a proximal end and a distal end and comprising:

means defining a lumen extending through the catheter, the lumen being open at the distal end of the catheter, said means including a catheter wall;

means at the proximal end of the lumen for permitting fluid communication with the lumen and to permit a guide wire to be received within the lumen;

a plurality of flexible optical conductors extending longitudinally of the catheter and within the catheter wall;

a distal cap mounted on the distal end of the catheter and covering the distal end of the fibers, the distal cap having a distal surface defining an emission surface and providing an optical path from the distal end of the fibers to the emission surface;

an aperture formed through the distal cap in communication with the catheter lumen;

the flexible optical conductors being unattached to the catheter except at the ends of the conductor;

the catheter wall being defined by an elongate core having said lumen extending therethrough and a flexible sheath surrounding the core;

a plurality of flutes formed longitudinally along he outside of the core, the conductors being received in and extending along the flutes and being retained in the flutes by the sheath;

said conductors, core and sheath being substantially unattached to each other along their lengths thereby to enable the core, conductors and sheath to shift longitudinally with respect to each other thereby to permit their simultaneous bending but without any of said core, conductor or sheath restricting the bending of the others.

2. A catheter as defined in claim 1 further comprising means for connecting the conductors securely with respect to the core at the distal end of the core.

3. A catheter as defined in claim 2 further comprising:

the proximal end of the catheter having a plurality of optical connectors, each associated with a conductor thereby to enable independent control of the optical conductors.

4. A catheter as defined in claim 2 further comprising:

said conductors being secured by a holder ring having a central aperture and a plurality of circumferentially spaced apertures in the ring, each of the circumferentially spaced apertures receiving the distal end of a conductor,

said holder ring being secured to the cap.

5. A catheter as defined in claim 4 wherein the holder ring is radiopaque.

6. A catheter as defined in claim 4 wherein the distal cap comprises:

a cylindrical member having a proximal bore adapted to receive the holder ring and the distal end of the core,

the cap having a smaller aperture formed distally of and in communication with the proximal bore, the smaller aperture opening at the distal end of the cap;

the juncture of the bore and aperture defining a shoulder;

the distal face of the holder being in engagement with the shoulder.

7. A catheter as defined in claim 6 wherein the distal end of the sheath butts against the proximal end of the cap and is of substantially the same diameters the cap.

8. A catheter as defined in claim 4 further comprising:

the distal face of the holder and the conductors secured thereto being flush and being highly polished to define a highly reflective surface adapted to reflect light which is directed proximally from the biological material thereby to minimize absorption of the reflected light by the holder.

9. A catheter as defined in claim 8 wherein said proximally directed light comprises one or both of reflected laser light or infrared radiation emitted by the biological material.

10. A catheter as define in claim 4 wherein the distal cap comprises:

a cylindrical member having a proximal bore adapted to receive the holder ring and a distal end of the core, the cap having a small aperture formed distally of and in communication with the proximal bore, the smaller aperture opening at the distal end of the cap;

the juncture of the bore and aperture defining a shoulder;

the gasket in engagement with the shoulder;

the distal face of the holder being in engagement with the proximal face of the gasket and cooperating with the cap to secure the gasket therebetween;

the gasket having a central opening in registry with the smaller aperture of the cap and having cut-out portions in alignment with the conductor means.

11. A catheter as defined in claim 10 wherein the gasket is optically transparent.

12. A catheter as defined in claim 10 further comprising:

the distal face of the holder and the conductors secured thereto being flush and being highly polished to define a highly reflective surface adapted to reflect light which is directed proximally from the biologically material thereby to minimize absorption of the reflected light by the holder.

13. A catheter as defined in claim 1 further comprising:

said core having at least one radiopaque stripe extending longitudinally of the core.

14. A catheter as defined in claim 1 wherein at least the inner surface of the core which defines the lumen is a low friction material.

15. A catheter as defined in claim 1 further comprising:

a gasket interposed between the holder and the cap, the gasket having cut-out regions in alignment with the optical fibers so as to be out of the path of the beam emitted from the conductors.

28. A catheter as defined in any of claims 1-27 further comprising, in combination, said guide wire.

29. A catheter as defined in claim 28 further comprising:

said catheter being of a length and being dimensioned for advancement to and into a patient'"'"'s coronary arteries whereby said biological material may be removed from said coronary arteries.

31. A catheter as defined in claim 29 further comprising:

the spacing of the articulations connecting the articulated segments being varied, thereby to vary the flexibility of the composite catheter along its length.

37. A catheter as defined in any of claims 15, 10, 11, 12, 23, 24, 25, wherein said gasket is formed from medical grade silicone rubber.

38. A catheter as defined in claim 37 further comprising:

said catheter being of a length and being dimensioned for advancement to and into a patient'"'"'s coronary arteries whereby said biological material may be removed from said coronary arteries.

39. A catheter as defined in any of claims 1-27 or 30-36 further comprising said catheter being of a length and being dimensioned for advancement to and into a patient'"'"'s coronary arteries whereby said biological material may be removed from said coronary arteries.

16. A catheter for removing biological material by laser energy, the catheter having a proximal end and a distal end and comprising:

a unitary catheter core surrounded by a catheter sheath, said core and sheath defining a catheter wall;

means defining a lumen extending through the catheter core, the lumen being open at the distal end of the catheter;

means at the proximal end of the lumen for permitting fluid communication with the lumen and to permit a guide wire to be received within the lumen;

a plurality of flexible optical conductors extending longitudinally of the catheter and within the catheter wall;

a distal cap mounted on the distal end of the catheter and covering the distal end of the fibers, the distal cap having a distal surface defining an emission surface and providing an optical path from the distal end of the fibers to the emission surface;

an aperture formed through the distal cap in communication with the catheter lumen;

the flexibility of the catheter being varied along its length by means comprising;

the core being formed from a plurality of articulated segments connected end to end and flexible joints; and

the outer sheath being thin and flexible and being unconnected to the core so as not to restrict flexure of the core.

17. A catheter as defined in claim 16 further comprising:

the spacing of the articulations varying along the length of the core thereby to vary the flexibility of the catheter, the catheter having greater flexibility in those regions where the articulations are more closely spaced.

18. A catheter as defined in claim 17 wherein the articulations at the distal end of the catheter are more closely spaced than at the proximal end.

19. A catheter as defined in claim 16 wherein the articulated segments are defined by a plurality of circumferentially formed notches, spaced longitudinally along the core, the circumferential notches defining smaller diameter connecting segments between the articulated segments.

20. A catheter as defined in claim 16 further comprising:

a plurality of flutes formed longitudinally along the outside of the core, the conductors being received in and extending along the flutes;

a flexible sheath surrounding the core to retain the conductors within the flutes;

said conductors, core and sheath being substantially unattached to each other thereby to enable the core, conductors and sheath to shift longitudinally with respect to each other thereby to permit their simultaneous bending but without any of said core, conductor or sheath restricting the bending of the others.

21. A catheter as defined in claim 20 further comprising:

said conductors being secured by a holder ring having a central aperture and a plurality of circumferentially spaced apertures in the ring, each of the circumferentially spaced apertures receiving the distal end of a conductor,

said holder being secured to the cap.

22. A catheter as defined in claim 21 wherein the distal cap further comprises:

a cylindrical member having a proximal bore adapted to receive the holder ring and the distal end of the core;

the cap having a smaller aperture formed distally of and in communication with the proximal bore, the smaller aperture opening at the distal end of the cap;

the juncture of the bore aperture defining a shoulder;

the distal face of the holder being in engagement with the shoulder.

23. A catheter as defined in claim 21 further comprising:

a gasket interposed between the holder and the cap and having a plurality of cut-outs in alignment with the conductors.

24. A catheter as defined in claim 23 wherein the gasket is optically transparent.

25. A catheter as defined in claim 24 wherein the distal cap further comprises:

a cylindrical member having a proximal bore adapted to receive the holder ring and a distal end of the core;

a cap having a smaller aperture formed distally of and in communication with the proximal bore, the smaller aperture opening at the distal end of the cap;

the juncture of the bore and aperture defining a shoulder;

said gasket being interposed between said shoulder and the distal face of the holder.

26. A catheter for removing biological material by laser energy, the catheter having a proximal end and a distal end and comprising:

means defining a lumen extending through the catheter, the lumen being open at the distal end of the catheter, said means including a catheter wall;

means at the proximal end of the lumen for permitting fluid communication with the lumen and to permit a guide wire to be received within the lumen;

a plurality of flexible optical conductors extending longitudinally of the catheter and within the catheter wall;

a distal cap mounted on the distal end of the catheter and covering the distal end of the fibers, the distal cap having a distal surface defining an emission surface and providing an optical path from the distal end of the fibers to the emission surface;

an aperture formed through the distal cap in communication with the catheter lumen;

the flexible optical conductors being contained in circumferentially spaced relation within the catheter wall;

the distal cap including an annular portion which terminates in the emission surface;

means for holding the distal faces of the conductor in optically transmissive relation to the cap to direct light from the conductors through the annular portion of the cap, the conductors being constructed and arranged to emit light in a divergent beam whereby the light emitted from each of the circumferentially spaced fibers may overlap increasingly in a distal direction;

the distance of the emission surface of the cap from the distal ends of the fibers being such that the distance between the emission surface of the cap and the image plane in which the overlapping beams have diverge to define a peripheral envelope which is at least as great in diameter as the outer diameter of the catheter, said distance between the emission face and said image plane being not substantially greater than the diameter of the catheter.

27. A catheter as defined in claim 26 wherein said distance is not more than about 1.5 millimeters.

30. A flexible catheter construction comprising:

an elongate one-piece, flexible core having a lumen extending therethrough, the core being formed from a plurality of articulated segments, the articulated segments being defined by a plurality of circumferentially formed notches, spaced longitudinally along the core, the circumferential notches defining smaller diameter connecting segments between the articulated segments; and

a flexible outer sheath surrounding the core.

32. A catheter for delivering laser energy to biological material at a selected location internally of a patient comprising:

an elongate catheter body adapted to be placed internally of the patient, the catheter body having proximal and distal ends;

optical fiber means carried by the catheter body and being constructed and arranged to direct laser light from the proximal end to the distal end and to emit a beam of laser light at the distal end of the catheter; and

means at the distal end of the catheter for reflecting light reflected or radiated from the biological material thereby to reduce absorption of energy by the distal end of the catheter.

33. A catheter as defined in claim 32 further comprising:

the catheter having a fiber holder at the distal end, the fiber holder having a distal face, the distal end of the optical fiber means being attached to the fiber holder, wherein the reflecting means comprises the distal face of the holder and the distal end of the fiber being highly polished.

34. A catheter as defined in claim 33 further comprising:

a transparent end cap mounted to the catheter over and covering the distal end of the holder and the optical fiber means;

the proximal face of the end cap being coated with an antireflection coating.

35. A catheter as defined in claim 33 wherein the fiber holder is formed from a metal.

36. A catheter as defined in claim 33 further comprising:

said end cap and holder having a central aperture formed therethrough

a gasket between the distal face of the holder and the proximal face of the end cap, the gasket being formed from an optically transparent material and having an opening in registry with the lumen.