DISPOSABLE SLEEVE FOR PROTECTING SURGICAL LASER DELIVERY FIBER ASSEMBLY, AND LASER DELIVERY FIBER WITH METAL TIP

Abstract

A disposable sleeve is fitted over a surgical optical fiber assembly before carrying out a treatment procedure. The optical fiber assembly includes an optical fiber, a laser-transparent protective cap that surrounds the fiber tip, and any additional components assembled to the optical fiber and protective cap, such as a coolant jacket. The disposable sleeve includes a transparent end portion corresponding to the transparent protective cap to permit passage of laser light, the sleeve protecting the surgical optical fiber and the protective cap in order to enable re-use of the surgical optical fiber. After the surgical procedure is performed, the sleeve is removed from the optical fiber assembly and the fiber is sterilized. Another sleeve is then placed over the optical fiber assembly so that the optical fiber assembly may be re-used to carry out a second treatment procedure. The disposable sleeve may optionally be preloaded with an index matching and/or cooling material to modulate the laser output, in which case a pressure-relief mechanism such as a spring-biased sealing gasket may be provided to accommodate expansion of the index matching and/or cooling material upon heating during a treatment procedure. The optical fiber assembly may include a side-firing fiber tip, and the fiber tip may optionally be reflectively coated or provided with a metal reflector.

Claims

1. A disposable sleeve for an optical fiber assembly including a surgical optical fiber and a laser-transparent protective cap at a distal end of the optical fiber, comprising a sleeve-shaped protective structure that removably fits over optical fiber assembly at least at a distal end of the optical fiber assembly, the sleeve-shaped protective structure including a transparent end portion corresponding to the laser-transparent protective cap to permit passage of laser light, wherein said disposable sleeve is arranged to be protect the surgical optical fiber and the protective cap in order to enable re-use of the surgical optical fiber.

2. A disposable sleeve as claimed in claim 1, wherein the surgical optical fiber has a conical tip.

3. A disposable sleeve as claimed in claim 1, wherein the surgical optical fiber is a side-firing surgical optical fiber having a single-facet tip.

4. A disposable sleeve as claimed in claim 1, wherein the surgical optical fiber has a reflectively coated tip.

5. A disposable sleeve as claimed in claim 1, further comprising a metal reflector positioned at the distal end of the fiber to direct laser light exiting the fiber at one or more predetermined angles.

6. A disposable sleeve as claimed in claim 1, wherein the surgical optical fiber is a side-firing surgical optical fiber with assisted cooling having a coolant jacket surrounding the fiber and through which coolant is supplied, said coolant jacket including an opening at a distal end of the jacket and said sleeve being arranged to fit over said coolant jacket, and wherein said sleeve includes a fluid opening for passage of said coolant.

7. A disposable sleeve as claimed in claim 6, wherein said fluid opening in said sleeve is oriented away from a side of the sleeve through which the laser is fired.

8. A disposable sleeve as claimed in claim 1, wherein the disposable sleeve is made of a transparent material different than a transparent material included in the fiber.

9. A disposable sleeve as claimed in claim 8, wherein the different transparent material is sapphire.

10. A disposable sleeve as claimed in claim 1, arranged to be preloaded with an index matching and/or cooling material.

11. A disposable sleeve as claimed in claim 10, further comprising a gasket for sealing a front chamber of the disposable sleeve to contain the index matching and/or cooling material, and an expansion spring to accommodate movement of the gasket and provide pressure-relief in response to heating of the index matching and/or cooling material, the gasket maintaining a seal upon insertion of the optical fiber into the front chamber.

12. A method enabling reuse of a surgical optical fiber assembly that includes an optical fiber and a protective cap that encloses a tip of the fiber and that is affixed to the fiber, comprising the steps of: before using the fiber, inserting the optical fiber assembly into a disposable sleeve having a laser-transparent section, and positioning the disposable sleeve such that the laser-transparent section is aligned with a path of laser energy to be emitted from the tip of the optical fiber during a surgical procedure; performing at least one surgical procedure; and removing the sleeve after the at least one surgical procedure without disassembling the optical fiber assembly.

13. A method as claimed in claim 12, wherein the sleeve is removed after a single surgical procedure.

14. A method as claimed in claim 12, further comprising the steps of: sterilizing the fiber, inserting the fiber into another disposable sleeve, and performing another surgical procedure using the fiber.

15. A method as claimed in claim 12, wherein the optical fiber assembly includes a side-firing optical fiber tip, a protective cap surrounding the tip, and a coolant jacket surrounding the optical fiber and protective cap, and the surgical procedure is a benign prostate hyperplasia treatment procedure.

16. A method as claimed in claim 12, further comprising the step of moving the optical fiber within the disposable sleeve during the surgical procedure to increase an area targeted by the laser.

17. A method as claimed in claim 16, wherein the movement is a ratcheting movement in which the sleeve and cap rotate together in one direction and only the cap rotates in the second direction so as to constantly change the area of the sleeve exposed to the laser and allow tissue to be burned-off for a self-cleaning effect.

18. A method as claimed in claim 12, further comprising the step of preloading the disposable sleeve with an index matching and/or cooling material before insertion of the optical fiber into the disposable sleeve.

19. A method as claimed in claim 12, further comprising the step of monitoring for thermal runaway resulting from debris accidentally trapped between the optical fiber and the disposable sleeve.

20. An optical fiber assembly including a surgical optical fiber and a laser-transparent protective cap at a distal end of the optical fiber, wherein a metal reflector is positioned at the distal end of the optical fiber to reflect laser light exiting the fiber at one or more predetermined angles.

21. An optical fiber assembly as claimed in claim 20, wherein the one or more predetermined angles include an angle of greater than 90.

22. An optical fiber assembly as claimed in claim 20, wherein the protective cap includes a cap for enabling flow of coolant or irrigation fluid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG. 1 shows a conventional radial tip surgical optical fiber.

[0035] FIG. 2A shows a conventional side-firing surgical optical fiber.

[0036] FIG. 2B shows conventional side-firing surgical optical fiber assembly with a reflectively coated fiber tip.

[0037] FIG. 2C shows a side-firing surgical optical fiber assembly to which a metal reflector has been added.

[0038] FIG. 3A shows a side-firing laser tip with assisted cooling.

[0039] FIGS. 3B and 3C illustrate the problem with conventional BPH surgery using assisted cooling.

[0040] FIG. 4 shows the radial tip surgical optical fiber of FIG. 1, after it has been inserted into a disposable sleeve according to the principles of a preferred embodiment of the present invention.

[0041] FIG. 5 shows the side-firing laser tip with assisted cooling of FIG. 3, after it has been inserted into a variation of the disposable sleeve of FIG. 4.

[0042] FIG. 6 illustrates use of the arrangement of FIG. 5 for BPH surgery.

[0043] FIG. 7 is a cross-sectional side view of an arrangement in which a disposable sleeve is preloaded with an output-modulating index-matching and/or cooling material.

[0044] FIG. 8 is a cross-sectional side view of FIG. 7, after insertion of an optical fiber.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] As illustrated in FIG. 4, a radial tip surgical optical fiber assembly 20 of the type illustrated in FIG. 1, including a fiber core 10 having a radial tip 16, a cladding layer 13, and a laser-transparent protective cap 14, is inserted into a disposable sleeve 34 that includes a laser-transparent distal end section 36. With the disposable sleeve 34 over the optical fiber assembly 20, the fiber cap 14 will remain pristine while the transparent tip of the sleeve 34 will now erode. If, at any time, too much erosion occurs to end section 36 of the disposable sleeve 34 occurs, then the sleeve can be readjusted to a new unused transparent tip 36 material, or the disposable sleeve can simply be replaced with another disposable sleeve 34.

[0046] Instead of a bare fiber tip, it will be appreciated that a fiber tip with a reflective coating 25 of the type illustrated in FIG. 2B and described above, or a fiber tip with a metal reflector 26 as illustrated in FIG. 2C, may be included in the radial tip surgical optical fiber assembly 20 of FIG. 4. As illustrated in FIG. 2C, the metal reflector includes a sleeve portion that fits over the fiber 10 and an extension that is bent at a predetermined angle, or angles, to reflect light exiting the fiber at the predetermined angle(s). Suitable metals for the reflector 26 include but are not limited to gold, aluminum, and alloys thereof. Although an open-ended, transparent, quartz or sapphire cap 14 that facilitates coolant flow is illustrated in FIG. 2C, the optical fiber assembly may also include a closed cap and the cap is not limited to a particular material or construction.

[0047] As shown in FIG. 4, the disposable sleeve 34 can extend from the laser-transparent section 36 back toward the proximal end of the fiber and terminate at any desired location. This has the added benefit of preventing the optical fiber assembly 20 from making patient contact and improves the ability to ensure good reprocess sterility and eliminate cross contamination. When the disposable sleeve 34 no longer has a sufficiently protective effect, or after completion of a surgical procedure or treatment, the sleeve may simply be removed from the optical fiber assembly 20 so that the optical fiber assembly can be sterilized for re-use.

[0048] If the procedure permits sterilization by disinfectant, then the fiber connector (not shown) that couples the optical fiber to the laser source machine could even be left permanently on the machine to help prevent damage to the connector or laser during sterilization or handling. This reduction in the possibility of damage to the fiber connector helps solve the problem that, if connector damage goes unnoticed, firing into the damaged connector could damage the laser or worse cause injury to the patient and/or operator.

[0049] Because the disposable sleeve 34 is not welded to the fiber, it can be made of different transparent materials than those included in the fiber. For example, the disposable sleeve may be made of sapphire, which is able to withstand higher temperatures than fused silica.

[0050] FIG. 5 shows an example of the application of the disposable sleeve to an optical fiber having a side-firing fiber tip 16 and a protective cap 14 with an assisted cooling jacket 16 of the type shown in FIG. 3, according to another preferred embodiment of the invention. The disposable sleeve 34 of this embodiment again has a transparent tip 32, but the transparent tip 32 is provided with a coolant exit hole 35. Since the sheath is disposable and the transparent tip can be adjusted toward or clean surface or simply exchanged for another sheath, the cooling can now be directed away from the target tissue 40, preventing the coolant from directly cooling the target tissue 40 and therefore providing improved vaporization. While the transparent tip 32 is now subject to faster erosion, this effect can easily be compensated for by disposing of and replacing the sleeve 34 or transparent tip 32 as often as necessary. The sleeve 34 also has the advantage of preventing cap 14 from being perforated during insertion, avoiding the problem that, if the cap 14 perforates, fluids will fill the cap and the cap will heat up and blow off the fiber 30.

[0051] As illustrated in FIG. 6, when the optical fiber assembly with assisted cooling is used as a Moxy instrument for BPH surgery, the addition of disposable sleeve 34 has the further advantage of allowing freer movement of the optical fiber assembly 20 relative to the kissing lobes 40 of the prostate gland, while preventing tissue from sticking to the optical fiber assembly 20 with the sleeve. This allows translation and/or rotation of the fiber or fiber assembly 20 within the sleeve, as indicated by respective arrows 100 and 110. As a result, the laser output can be modulated by rapid, reciprocal, sliding or rotating to effectively enlarge the spot size, which will help keep the surface of the clean and lower power density. In addition, movement of the fiber or fiber assembly permits a user to increase power while maintaining a given power density, resulting in faster vaporization rates.

[0052] The use of a disposable sleeve may have the further benefit of reducing the power density of the laser, by making the sleeve from a material having appropriate optical properties, or by preloading the sleeve with a material having optical properties, such as index of refraction, that result in modulation of the laser output. One advantage of reducing the power density of the laser in this manner is that the sleeve may advantageously be used with a flat tipped laser, to reduce the power density.

[0053] An example of a preloaded disposable sleeve 120 is illustrated in FIG. 7. A front section of the sleeve is sealed by a gasket 117 to form a compartment or chamber that is preloaded or filled with a material 112 having desired optical and/or coolant properties, such as index matching. Material 112 may be a liquid, gel, or any other fluid material having the desired properties. To accommodate expansion of the material 112 and provide pressure relief upon heating by the laser, the disposable sleeve preferably further includes an expansion spring 110 to accommodate axial displacement of the gasket 117. Spring 110 may be seated against a fixed gasket or annular structure 115. Those skilled in the art will appreciate that the spring-biased gasket may be replaced by other pressure-relief arrangements, such as a pressure-relief valve.

[0054] As shown in FIG. 8, a fiber including a fiber 112 including core 111 and buffer 115 is inserted through spring-mounting gasket 115, expansion spring 110, and sealing gasket 117 into the chamber containing index matching and/or cooling material 112. During a treatment procedure, the laser is fired through the material 112 and through the sleeve 120, with the material 112 modulating the laser so as to reduce the power density. While FIG. 8 shows an end-firing fiber tip, it will be appreciated that the disposable sleeve of this embodiment may also be used with side-firing fiber tips, as well as fiber tips having any other configuration.

[0055] The present invention also provides a method of using the disposable sleeve of FIGS. 4-8. In a preferred embodiment, the method involves the steps of inserting an optical fiber assembly into the disposable sleeve, inserting the optical fiber assembly with the disposable sleeve into a patient and performing a surgical procedure or treatment, and removing the disposable sleeve from the optical fiber assembly following the surgical procedure or treatment. The method may further include the step of rapidly translating or rotating the fiber or fiber assembly during the treatment to increase the area targeted by the laser.

[0056] In one preferred embodiment, the movement may be a ratcheting movement that can be achieved by adding a ratcheting mechanism to a Luer fitting coupling the sleeve and cap. The ratcheting mechanism rotates the sleeve and cap in one direction and just the cap is a second direction so as to constantly change the area of the sleeve exposed to the laser, which allows tissue to be burned-off for a self-cleaning effect.

[0057] Even though the protective single-use sleeve is sterile when initial placed over the fiber, and protects the fiber against contamination, it may still be possible for the fiber to become contaminated and for debris to become trapped between the fiber and the sleeve when a new sleeve is placed over the fiber. As a result, the method of the invention may optionally include monitoring steps to detect thermal runaway, including for example monitoring for radiation emitted by the fiber or sleeve during overheating, at which time a signal may be generated that interrupts the laser or warns the operator to take necessary action. Monitoring may be carried out from the proximal end of the fiber, or by a monitor or sensor included at the distal end of the fiber adjacent the treatment site.