TWISTER FIBER OPTIC SYSTEMS AND THEIR USE IN MEDICAL APPLICATIONS

• US 20110160713A1
• Filed: 02/26/2010
• Published: 06/30/2011
• Est. Priority Date: 09/24/2009
• Status: Active Grant

• Current Assignee: Biolitec Unternehmensbeteiligungs II AG
• Original Assignee: CeramOptec Industries Incorporated (Biolitec AG)
• Inventors: Neuberger, Wolfgang
• Granted Patent: US 8,721,631 B2
• Time in Patent Office: Days
• US Class Current: 606/15
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2018/0019 vibrating
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2018/2211 Plurality of fibres
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2018/2288 the optical fibre cable having a curved distal end
• CPC Class Codes: G02B 6/3801 Permanent connections, i.e. wherein fibres are kept aligned by mechanical means splices by bonding G02B6/255; fusion splices G02B6/2551

Abstract

An improved device and method for safe, accurate and efficient surgical procedures are disclosed. The disclosed device is an optical fiber set with an asymmetric distal end configuration, comprising a bent tip fiber with a fused sleeve as an integral part of it, placed at the fiber'"'"'s distal (output) end and with a rotatable connector at the proximal (input) side. Fiber tip and tissue-contacting surface located at the distal end of the tip may be constructed with different shape configurations, such as convex tip to improve focusing characteristics, concave tip to achieve diverging irradiation or an expanded beam tip to achieve an effect similar to that obtained by electrosurgical tools. A grip guarantees and enhances the ability to twist and rotate it easily. In another preferred embodiment, twisting maneuvers are enhanced through a special configuration. Both special features (bent tip and rotatable connector), allow for improved and enhanced treatment of diverse pathologies, making possible to efficiently and easily reach and treat specific tissues. Optical fiber'"'"'s steerability, twistability and rotation lead to a more precise and improved effect on tissues. Due to this, easier, faster and more precise and efficient treatments can be performed by its means. For instance, it may be inserted into a cystoscope to perforin high power ablation of prostatic tissue for BPH treatments, or steered into one of the prostatic lobes, which can be excavated from the inside in order to relieve pressure on the urethra while maintaining the urethra'"'"'s integrity. Other uses might be the removal of tumorous, hyperplasic or other unwanted tissue in the body. Optical fiber set disclosed can be used with laser sources of various wavelengths, including dual laser sources, but also higher power LED devices or very bright light sources can be used to generate the radiation to be transmitted as well. Due to this novel design, described fiber is easy to put in place, also easy to maintain in contact with tissue and highly durable. The feel to the doctor is greatly improved too. This results in more effective power transfer into tissue and therefore procedures are more reliable and procedure times are cut by up to 30%.

Claims

1. ) An asymmetric, off-axis radiation emitting fiber optic medical treatment device having twistability.

2. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 1, further comprising one or more fibers with a tip that is bent and reinforced.

3. ) The asymmetric fiber optic medical treatment device according to claim 1, further comprising at least one optical fiber with a distal tip that is bent where the output end is shaped so as to focus the transmitted radiation off-axis towards a desired treatment site.

4. ) The asymmetric fiber optic medical treatment device according to claim 1, further comprising two or more optical fibers with bent distal ends which when extended beyond an introducer can rearrange into one or more configurations to enhance treatment.

5. ) The fiber optic device according to claim 4, wherein said two or more optical fibers is 3 to 7 fibers, and wherein each said distal end is bent and reinforced.

6. ) The fiber optic device according to claim 5, wherein said multiple fibers are deployed either in a circular fashion or in a ‘

rake’

fashion.

7. ) The fiber optic device according to claim 4, further comprising at least 7 fibers with small core diameters to aid flexibility, wherein said fibers are employed in a close contact arrangement and are fused at said distal end and reinforced.

8. ) The asymmetric emitting fiber optic medical treatment device according to claim 1, further comprising generating means to provide a sweeping motion.

9. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 1, further comprising means for vibrating a fiber'"'"'s distal end in a preselected, planned, essentially automatic motion.

11. ) A medical treatment method wherein tissue ablation is aided by sweeping movements of a device as claimed in claim 1.

14. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 1, further comprising a fiber defining an axially-extending portion defining an elongated axis, an axially-extending tip portion located at the distal end of the fiber and oriented at an acute angle relative to elongated axis, and a tissue-contacting surface located at the distal end of the tip portion that is configured to be placed into contact with tissue to be treated, wherein the tip portion of the fiber transmits laser energy from the fiber through the tissue-contacting surface to ablate the tissue in contact with the tissue-contacting surface.

15. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 14, wherein the tissue-contacting surface is a wear surface that is configured to be placed into contact with the tissue at a treatment site, to transmit laser energy from the fiber through the tissue-contacting surface and into the tissue at the treatment site, and wherein the tissue-contacting surface defines a thickness that is sufficient to allow the tissue-contacting surface to wear during ablation of the tissue without preventing the passage of laser energy from the fiber therethrough and into the tissue in contact therewith.

16. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 15, wherein the acute angle is within the range of about 20°

to about 40°

.

17. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 16, wherein the axially-extending tip portion defines an axial length within the range of about 2 mm to about 5 mm.

18. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 15, further comprising a sleeve extending annularly about the tip portion and fog filing at least a portion of the tissue-contacting surface.

19. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 18, wherein fiber defines an emitting face, and the sleeve extends annularly about and is substantially flush with the emitting face, and the emitting face of the fiber and sleeve define the tissue-contacting surface.

20. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 19, wherein the fiber includes an axially-extending core defining the emitting face, and the emitting face of the core and distal portion of the sleeve define the tissue-contacting surface.

21. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 20, wherein the distal portion of the sleeve defining the tissue-contacting surface is curvilinear.

22. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 21, wherein the emitting face defining the tissue-contacting surface is curvilinear and is substantially flush with the distal portion of the sleeve.

23. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 20, wherein the sleeve is fused to the fiber.

24. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 23, wherein the sleeve extends annularly and axially throughout the tip portion of the fiber and a portion of the fiber proximal to the tip portion.

25. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 24, wherein the fiber includes a core and a cladding, and the sleeve and outer portion of the cladding are made of substantially the same material.

26. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 25, wherein the outer portion of the cladding is made of glass, the sleeve is made of glass, and the sleeve is thermally fused to the cladding substantially throughout the interface between the sleeve and the cladding.

27. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 18, wherein the sleeve forms a cap that encloses the distal end of the fiber, the distal end of the cap forms the tissue-contacting surface, the distal end of the fiber defines an emitting face that transmits laser energy therethrough and the tissue-contacting surface of the cap for transmitting the laser energy into tissue in contact with the tissue-contacting surface.

28. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 27, wherein the tissue-contacting surface of the cap defines a thickness that is sufficient to wear during ablation of tissue in contact therewith out forming a hole therethrough.

29. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 28, wherein the tissue contacting surface of the cap defines a thickness within the range of about 1 mm to about 4 mm.

30. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 29, wherein the fiber includes a core and a cladding, and the cap and outer portion of the cladding are made of substantially the same material.

31. ) The asymmetric, off-axis emitting fiber optic medical treatment device according to claim 30, wherein the outer portion of the cladding is made of glass, the sleeve is made of glass, and the sleeve is thermally fused to the cladding substantially throughout the interface between the sleeve and the cladding.

10. ) A treatment method for excavating or ablating a cavity in human or animal tissue utilizing steering and rotating a fiber optic device at the inside of said tissue.

12. ) A medical treatment method for excavating, ablating human or animal tissue using an off-axis emitting fiber optic device in a vibrating motion.

13. ) An asymmetric fiber optic medical treatment device comprising a distal tip where at its output end the core and fiber cross-section is expanded compared with these dimensions at said fiber'"'"'s proximal end.

32. ) A method comprising the following steps:

providing an asymmetric, off-axis emitting fiber optic medical treatment device comprising a fiber defining an axially-extending portion defining an elongated axis, an axially-extending tip portion located at the distal end of the fiber and oriented at an acute angle relative to elongated axis, and a tissue-contacting surface located at the distal end of the tip portion;

placing the tissue-contacting surface into contact with tissue to be treated;

transmitting laser energy from the fiber through the tissue-contacting surface;

moving at least one of the tissue-contacting surface and tissue relative to the other during the step of transmitting laser energy and ablating the tissue in contact with the tissue-contacting surface.

33. ) A method as defined in claim 32, wherein the moving step includes laterally moving the tissue-contacting surface in a sweeping motion across the tissue and ablating the contacted tissue.

34. ) A method as defined in claim 33, wherein the moving step further includes laterally and axially moving the tissue-contacting surface across the tissue and ablating the contacted tissue.

35. ) A method as defined in claim 33, further comprising wearing away the tissue-contacting surface during the transmitting and moving steps without substantially affecting the output of laser energy through the tissue-contacting surface and into the treated tissue.

36. ) A method as defined in claim 35, wherein the method is for treating benign prostatic hyperplasia, and the treated tissue is hyperplasic prostatic tissue.