Closely packed small core optical fiber bundle

Abstract

A medical instrument is disclosed that includes an elongated flexible shaft, a plurality of optical fibers extending along its length, and a laser control module coupled to the optical fibers. The instrument is configured to be inserted into a patient's body and / or into a working channel of an endoscope (e.g., a ureteroscope). The instrument is configured to ablate bodily tissue and / or foreign material within the body, such as stones. The optical fibers may define a cross-sectional diameter in the range of 50 μm to 150 μm. Three or more optical fibers may be bundled together to define a circumscribed circle having a cross-sectional diameter of less than 500 μm. Several optical fibers are circumferentially disposed along the shaft and configured to direct light radially outward. A lumen extending along the length of the shaft is coupled with a fluid port coupled with the shaft.

Description

Technical Field

[0001] The present disclosure relates to a closely packed small core optical fiber bundle.

Background Art

[0002] Laser lithotripsy typically involves inserting and advancing a delivery optical fiber through a patient's vasculature such that the delivery optical fiber approaches a calculus within the vasculature. Further, light is propagated along the delivery optical fiber and delivered to the calculus to break the calculus into smaller pieces or dust. Conventionally, holmium:yttrium aluminum garnet (Ho:YAG) lasers have been utilized for laser lithotripsy applications. However, the core diameter of the smallest delivery optical fiber (delivery fiber) generally available for use with Ho:YAG lasers is on the order of 270 μm. The cladding diameter of these delivery fibers is on the order of about 400 μm. Thus, in applications such as laser lithotripsy where the working channel is extremely small, there are limitations to the size of the cladding diameter. Crystal lasers (e.g., Nd:YAG lasers) have the same drawbacks as Ho:YAG lasers and corresponding size constraints of the delivery fibers.

[0003] As is known, a fiber laser is a particular type of laser in which the active gain medium can be an optical fiber (an "active fiber") doped with a rare earth element. Further, a delivery fiber is optically coupled to the fiber laser and the light generated by the fiber laser is propagated along the delivery fiber. The delivery fibers utilized with fiber lasers often have a smaller cladding diameter than those used with Ho:YAG lasers.

[0004] However, simply using a delivery fiber connected to a fiber laser in processes such as laser lithotripsy still carries the risk of backward thrust and / or damage to the surrounding tissue of the stone during ablation. Therefore, what is needed is a system, device, and method comprising a fiber laser system that reduces backward thrust, provides a use-case laser emission configuration, enables the use of irrigation or aspiration in combination with an optical fiber for ablation, and provides other advantages. [Overview of the project]

[0005] Embodiments of this specification, without limiting or restricting them, disclose systems and methods utilizing fiber laser systems having rare earth elements such as thulium, erbium, ytterbium, neodymium, dysprosium, and praseodymium as dopants. Specific embodiments of this disclosure relate to fiber lasers configured to operate with optical fibers having thulium as a dopant (thulium optical fibers). Some specific embodiments of this disclosure relate to packaging multiple delivery fibers such that multiple delivery fibers are connected to a fiber laser system, for specific configurations for advancement within a patient's vascular system. Additional embodiments disclose configurations of a long shaft containing multiple delivery fibers configured for use in a fiber laser system. In some embodiments, the multiple delivery fibers may be densely packed. In some embodiments, each optical fiber may have a core diameter of 50 μm and a cladding diameter of 74 μm. In other embodiments, the long shaft may include multiple optical fibers surrounding an irrigation lumen and / or aspiration lumen.

[0006] In short, the disclosed herein is a medical device. This medical device includes a long, flexible shaft defining a length between a proximal and distal end, a plurality of optical fibers extending along that length, and a laser control module including a laser light source operably coupled to the optical fibers.

[0007] This instrument is configured to be inserted into the patient's body and / or into the working channel of an endoscope. The endoscope may be a ureteroscope. This instrument is configured to ablate body tissue and / or foreign objects in the body, such as stones.

[0008] The optical fibers may have a diameter in the range of 150 μm to 50 μm. One or more of the optical fibers may be centrally located along the longitudinal axis of the shaft. In some embodiments, three or more optical fibers can be arranged laterally adjacent to one another to form a bundle of optical fibers, and in some embodiments, this bundle may form a circumscribed circle with a diameter of less than 1 mm. The optical fibers in the bundle may be configured to direct light away from the distal end of the shaft in the distal direction.

[0009] In some embodiments, three or more optical fibers are arranged periphery along a shaft to define a peripheral set of optical fibers. The optical fibers in this peripheral set may be configured to direct light radially outward from the shaft at the distal end of the shaft.

[0010] The device may further include a lumen extending along the length of the shaft and a fluid port coupled to the shaft, the fluid port being in fluid communication with the lumen. The lumen may be an annular lumen located radially outward of the bundle, or it may be located radially inward of the periphery set. In some embodiments, the device may include a plurality of lumens located radially inward of the periphery set.

[0011] In some embodiments, the device includes a hollow outer shaft, the shaft being positioned within this outer shaft. In such embodiments, the lumen is defined by an annular space between the shaft and the outer shaft, the fluid port is attached to the outer shaft, and the outer shaft is displaceable longitudinally relative to the shaft.

[0012] Another embodiment of a medical device is also disclosed herein, which includes a long flexible shaft defining a length between a proximal and distal end, a single optical fiber extending along the length thereof, a fluid lumen extending along the length thereof, and a laser control module including a laser light source operably coupled to the optical fiber.

[0013] A method for providing treatment to a patient's urinary tract is also disclosed herein. The method includes advancing a long medical device along the urinary tract and positioning the distal end of the device at a desired location within the urinary tract. The device includes a plurality of optical fibers extending along the long shaft of the device to the distal end of the device, and a laser control module located at the proximal end of the device, the control module including a plurality of corresponding light sources individually coupled to the plurality of optical fibers. The method further includes propagating laser light along one or more of the optical fibers to define ablation within the urinary tract as required for treatment.

[0014] In some embodiments of this method, a first set of fibers is defined, in which one or more optical fibers are configured to direct light distally away from the distal end. Similarly, a second set of fibers is defined, in which one or more optical fibers are configured to direct light radially away from the shaft at the distal end.

[0015] In some embodiments of this method, the device includes a lumen extending along the shaft between the proximal and distal ends of the shaft, and a fluid port coupled to the shaft, the fluid port being in fluid communication with the lumen.

[0016] This method may further include coupling a fluid device to a fluid port and passing a liquid through the lumen, thereby cooling the optical fiber. In some embodiments of this method, the treatment includes laser lithotripsy of a stone located in the urinary tract, wherein propagating laser light along one or more optical fibers includes propagating laser light along a first set of optical fibers to illuminate the stone and create a hole in it. In such embodiments, positioning the distal end of the device at a desired location includes inserting the distal end of the device into the hole in the stone, and propagating laser light along one or more optical fibers includes propagating laser light along a second set of optical fibers to illuminate the inner surface of the hole in the stone and break the stone into smaller pieces.

[0017] This method may further include generating suction within the lumen to draw the stone toward the distal end of the shaft and / or transporting the fragments proximal along the lumen. In some embodiments, positioning the distal end of the device at a desired location includes positioning the distal end within the prostate, and propagating laser light along one or more optical fibers includes propagating laser light along a second set of optical fibers to illuminate the inner surface of the prostate and ablate the prostate tissue as needed.

[0018] In some embodiments of this method, the device includes a hollow outer shaft. In such embodiments, the shaft is positioned within the outer shaft such that a lumen is defined by an annular space between the shaft and the outer shaft. A fluid port is coupled to the outer shaft, and the outer shaft is displaceable longitudinally relative to the shaft. In such embodiments, the method further includes displacing the outer shaft relative to the shaft.

[0019] These and other features of the concepts provided herein will become apparent to those skilled in the art by looking at the accompanying drawings and the following description, which disclose specific embodiments of such concepts in more detail.

[0020] Embodiments of this disclosure are shown in the accompanying drawings as examples, not as limitations, and similar reference numerals indicate similar elements.

Brief Description of the Drawings

[0021] [Figure 1A] An embodiment of a medical device including an optical fiber extending along a long shaft according to some embodiments is shown. [Figure 1B] An embodiment of the distal end face view of the shaft of FIG. 1A according to some embodiments is shown. [Figure 1C] An embodiment of the distal end face view of the shaft of FIG. 1A according to some embodiments is shown. [Figure 1D] An embodiment of the distal end face view of the shaft of FIG. 1A according to some embodiments is shown. [Figure 1E] An embodiment of the distal end face view of the shaft of FIG. 1A according to some embodiments is shown. [Figure 2] A distal end face view of a second embodiment of the shaft according to some embodiments. [Figure 3] A distal end face view of a third embodiment of the shaft according to some embodiments. [Figure 4A] A side view of a fourth embodiment of the shaft according to some embodiments. [Figure 4B] A detailed perspective view of the distal portion of the shaft of FIG. 4A according to some embodiments. [Figure 4C] A distal end face view of the shaft of FIG. 4A according to some embodiments. [Figure 5A] An exemplary usage case of the laser of FIG. 1A is shown. [Figure 5B] An exemplary usage case of the laser of FIG. 1A is shown.

Modes for Carrying Out the Invention

[0022] Before disclosing some specific embodiments in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that can be easily separated from a particular embodiment and that can be optionally combined with or substituted for features of any of several other embodiments disclosed herein.

[0023] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or processes within a group of features or processes and do not provide a sequential or numerical limitation. For example, the “first,” “second,” and “third” features or processes do not necessarily have to appear in that order, and a particular embodiment containing such features or processes is not necessarily limited to three features or processes. Labels such as “left,” “right,” “up,” “down,” “front,” and “back” are used for convenience and are not intended to suggest any particular fixed position, orientation, or direction, for example. Instead, such labels are used to reflect a relative position, orientation, or direction, for example. The singular forms “a,” “an,” and “the” include plural references unless otherwise explicitly indicated in the context.

[0024] In this specification, the directional terms “proximal” and “distal” are used to refer to opposite ends in a medical device. The proximal end of a device is defined as the end of the device closest to the end user when the device is being used by the end user. The distal end is the end of the device opposite the proximal end along its longitudinal direction, or the end furthest from the end user.

[0025] Any method disclosed herein includes one or more steps or actions to perform the described method. The steps and / or actions of a method may be substituted for one another. In other words, the order and / or use of a given step and / or action may be changed unless a given order of steps or actions is required for the proper operation of the embodiment. Furthermore, only a subroutine or part of a method described herein may constitute a separate method within the scope of this disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method.

[0026] Figure 1A shows one embodiment of a medical device 100, which may be a fiber laser system including a laser control module 110 coupled to a long shaft 120, where one or more optical fibers 130 (which may also be called "delivery fibers") are arranged inside the shaft 120. In some embodiments, as shown in Figure 1A, the first end of the optical interconnect 113 may be connected to the laser control module 100, and the second end of the optical interconnect 113 may be connected to a module connector 114, which may be connected to a shaft connector 123. The shaft 120 may extend from the shaft connector 123 by a length 124. In some embodiments, the shaft 120 includes one or more lumens (see Figure 1B), and a fluid port 124 can be in fluid communication with one or more lumens.

[0027] In some specific embodiments, the laser control module 110 may be a fiber laser including one or more electronically modulated diode lasers 111A-111B. It should be understood that additional diode lasers, e.g., 111A-111i (where i≧1), can be coupled. The diode lasers 111A-111B can be optically coupled to a rare-earth element-doped silica fiber 112, which can be used as a gain medium to generate a laser beam, which in the case of a fiber laser is typically a uniform laser beam (the fiber 112 is sometimes referred to as the “active fiber 112”). This uniform laser beam may be output from the laser control module 110 to a shaft 120, where, in some embodiments, an interconnect shown in Figure 1A is optionally located between the laser control module 110 and the shaft 120. Each of the optical fibers 130 extends along at least a portion of the elongated shaft 120.

[0028] In some embodiments, the instrument 100 may be used to perform medical procedures related to the urinary tract of a patient's body. These procedures may include laser lithotripsy, treatment of benign prostatic hyperplasia, or other medical procedures including ablation of body tissue and / or foreign bodies. In some cases, the medical instrument 100 may be used in conjunction with an endoscope (e.g., a ureteroscope) during the performance of the medical procedure. For example, in some cases, the medical instrument 100 may be inserted through the working channel of the endoscope.

[0029] In some embodiments, as described above, the long, flexible shaft 120 is operably coupled to the laser control module 110 via a module connector 114 (also referred to herein as the “fiber optical connector”) connected to a shaft connector 123. In some embodiments, an optical interconnect 113 may be located between the laser control module 110 and the module connector 114. The interconnect 113 may be flexible and relatively long (e.g., about 60.96 to 304.8 centimeters (about 2 to 10 feet)) so that the laser control module 110 can be conveniently positioned away from the patient. The laser control module 110 includes one or more diode lasers 111A to 111B, which are configured to excite light into an active fiber 112, induce radiative emission within the active fiber 112, and generate a laser beam, which then propagates distally along a delivery fiber located in the shaft 120. The interconnect 113 includes one or more optical fibers for propagating light from diode lasers 111A to 111B into optical fibers 130. The laser controller 110 may include multiple light sources (e.g., diode lasers 111A to 111i). In some embodiments, the first diode laser 111A may correspond to the first optical fiber 130, and the second diode laser 111B may correspond to the second optical fiber 130. In some embodiments, the laser controller 110 may be configured to operate the diode lasers 111A to 111B individually or as a group. In some embodiments, the laser controller 110 can operate the diode lasers 111A to 111B at pulse repetition rates of up to 2000 Hz or more using a low pulse energy of 0.025 joules. In some embodiments, the laser controller 110 may operate the diode lasers 111A to 111B to selectively propagate laser light through individual optical fibers 130 or a subset of optical fibers 130. Examples of configurations of multiple optical fibers 130 are described below with reference to Figures 1B to 4B, for example.

[0030] Fiber 130 may be an end-firing (or end-on firing) fiber. In other words, fiber 130 may be configured to direct light 135 distally away from the distal end 122 of shaft 120.

[0031] The shaft 120 is configured to be inserted into the urinary tract of the patient's body. Therefore, the shaft 120 defines a length 124 extending between a proximal end 121 and a distal end 122, the length 124 being sufficient to extend from an external position to a position within the patient's kidney. As described above, the shaft 120 may be inserted into the working channel of the ureteroscope. Therefore, the length 124 may exceed the length of the ureteroscope, and the cross-sectional diameter of the shaft 120 may be sized to be inserted into the working channel, i.e., less than the diameter of the working channel. In some embodiments, the cross-sectional diameter of the shaft 120 may be substantially smaller than the diameter of the ureteroscope. The diameter of the shaft 120 may be about 1.2 mm, 600 μm, 300 μm, or less than 150 μm. The relatively small diameter of the shaft 120 compared to the inner diameter of the ureteroscope allows the shaft 120 to improve fluid flow through the working channel in which it is located.

[0032] Figure 1B shows a first embodiment of a distal end view of a shaft 120 according to several embodiments. One or more optical fibers 130 extend along the length 124 of the shaft 120 to the distal end 122. The shaft 120 can contain one, two, three, four, five, or more fibers 130. In some embodiments, the shaft 120 may contain up to 10, 20, 30, or more fibers 130. The fibers 130 may have a cross-sectional diameter of about 150 μm, 100 μm, 75 μm, or less than 50 μm (for example, they may have a cross-sectional diameter in the range of 50 μm to 150 μm).

[0033] In some embodiments, two or more fibers 130 may be arranged laterally adjacent to one another to form a close-packed bundle of fibers 130. For example, as shown in Figure 1B, three or more fibers 130 may form a bundle 131. The bundle 131 may be located at the center of the cross-section of the shaft 120, or at any other location in the cross-section. The other fibers 130 may be located at other positions in the cross-section, either individually or in bundle form. In some embodiments, the circle 132 circumscribing the bundle 131 may be 1 mm, 500 μm, 250 μm, 225 μm, 200 μm, 180 μm, or less than 160 μm.

[0034] The shaft 120 may include one or more lumens 140 extending along its length between a fluid port 125 (Figure 1A) and a distal end 122. The port 125 is in fluid communication with the lumens 140. The lumens 140 may be positioned radially outward relative to the bundle 131. As shown in Figure 1B, the shaft 120 may include three lumens. In other embodiments, the shaft 120 may include one, two, three, four, five, or more lumens 140. The lumens 140 may be configured to provide cooling to the fibers 130. During operation, stimulated emission of radiation occurs within each fiber 130, generating heat that can cause the temperature of the fibers 130 to exceed the desired operating temperature. Therefore, the lumens 140 (or the shaft 120 in general) may be configured to cool the fibers 130 during use by causing thermal energy transfer such that the fluid passing through the lumens 140 moves away from the fibers 130. Figure 1C shows a second embodiment of the distal end view of shaft 120 according to several embodiments. In some exemplary embodiments, each of the fibers shown in the embodiments of Figures 1B to 1C may be a side-firing fiber.

[0035] Figure 1D shows a third embodiment of a distal end view of shaft 120 according to several embodiments. The embodiment in Figure 1D provides a physician or other medical professional with the ability to apply laser energy, in particular, using a subset of fibers. For example, laser energy may be applied by activating a first subset of bundle 131 consisting of fibers 130A-130D while fibers 130E-130G are not activated. Similarly, laser energy may be applied by activating a second subset of bundle 131 consisting of fibers 130A and 130E-130G while fibers 130B-130D are not activated. However, laser energy may also be applied by activating any combination of fibers 130A-130G. In other words, laser energy may be applied by activating the first subset while the second subset is not activated. Such embodiments are advantageous because they allow a physician or other medical professional to apply laser energy while protecting surrounding tissue.

[0036] Figure 1E shows a fourth embodiment of a distal end view of the shaft 120 according to several embodiments. Such embodiments may be used to treat larger kidney stones, for example, the first fiber 130A may be an end-launched fiber configured to "drill" a hole in the kidney stone (not shown), with the fiber bundle 131 positioned within the opened hole. Furthermore, the second to fifth fibers 130B to 130E may be lateral-launched fibers configured to ablate the kidney stone from the hole inside. Such embodiments can favorably reduce posterior thrust because the ablation force is uniform over the kidney stone. The embodiment in Figure 1E may be used in other situations, for example, such as the treatment of benign prostatic hyperplasia (BPH).

[0037] Figure 2 shows a shaft 220 of another embodiment that may be included by system 100. Shaft 220 may be similar in some respects to the components of shaft 120 described in relation to Figures 1A-1B. It will be understood that all illustrated embodiments may have similar features. Therefore, similar features are indicated by similar reference numbers incremented to "2". For example, a lumen is indicated as "140" in Figures 1A-1B, and a similar lumen is indicated as "240" in Figure 2. Therefore, relevant disclosures described above with respect to similarly identified features may not be repeated below. Furthermore, certain features of shaft 120 and related components shown in Figures 1A-1B may not be indicated by reference numbers in the drawings, or may not be identified, or may not be specifically described below. However, such features may be clearly the same as, or substantially the same as, those shown in other embodiments and / or described in relation to such embodiments. Therefore, relevant descriptions of such features also apply equally to the features of shaft 220. Any suitable combination of the features and variations thereof described for the shaft 120 and its components shown in Figures 1A and 1B can be used for the shaft 220 and its components in Figure 2, and vice versa.

[0038] Figure 2 is an end view of the shaft 220. The shaft 220 includes a centrally located lumen 240 and one or more fibers 230 (designated as a set, 230A, 230B) positioned radially outward from the lumen 240. The shaft 220 may contain one, two, three, four, five, or more fibers 230. In some embodiments, the shaft 220 may contain up to 10, 20, 30, or more fibers 230. In some embodiments, the fibers 230 may be combined to form one or more closely packed fiber bundles (not shown).

[0039] In some embodiments, the fiber 230 may be divided into subsets. For example, a first subset 230A of the fiber 230 may be an end-emitting fiber. In other words, the first subset 230A of the fiber may be configured to direct the light 235 distally (i.e., outward from the page) from the distal end 222 of the shaft 220. A second subset 230B of the fiber 230 may be configured to direct the light 235 radially / laterally away from the shaft 220. During use, the laser control module 110 may operate the fibers 230 of subsets 230A and 230B individually at different timings. For example, the laser control module 110 may operate the first subset 230A of the fiber 230 while keeping the second subset 230B of the fiber 230 inactive, and vice versa. In other embodiments, the laser control module 110 may operate all the fibers 230 simultaneously. Shaft 220 may further include other fibers 230 not included in subsets 230A and 230B.

[0040] The shaft 220 may be configured to allow light 235 to pass laterally through the shaft material from the fiber 230 to the outer surface 226 of the shaft 220. In some embodiments, the shaft 220 may include an opening (not shown) that provides a path for light 235. In other embodiments, the shaft 220 or a portion thereof may be formed from any material that is preferably transparent to light 235, such as acrylic or polycarbonate.

[0041] Lumen 240 extends for the same length as the shaft 220 between the fluid port (not shown, see Figure 1A) and the distal end 222. Lumen 240 may be configured to provide cooling to the fibers 230. During operation, stimulated emission of radiation occurs within each fiber 230, generating heat, which can cause the temperature of the fibers 230 to exceed the desired operating temperature. Therefore, lumen 240 (or generally shaft 120) may be configured to cool the fibers 230 during use by causing thermal energy transfer such that the fluid passing through the lumen 240 moves away from the fibers 230. Lumen 240 may also provide a pathway for ablated material, such as lithiasis, to be carried proximal along shaft 220 and expelled from the body.

[0042] Figure 3 is an end view of a shaft 320 in another embodiment that may be included by system 100. The fibers 330 of the shaft 320 may be divided into subsets. For example, a first subset 330A of fibers may be end-emitting fibers located in the center of the shaft 320. A second subset 330B of fibers may be side-emitting fibers located adjacent to the outer surface 326 of the shaft 320. Any subset of fibers 330 may be combined to form a closely packed fiber bundle.

[0043] During use, the laser control module 110 (Figure 1A) may activate fibers 330A and 330B at different timings. For example, the laser control module 110 may activate the end-emitting fiber 330A while keeping the side-emitting fiber 330B inactive, and vice versa. In other embodiments, the laser control module 110 may activate fibers 330A and 330B simultaneously. Any of the fibers 330 may be activated individually or in groups.

[0044] The shaft 320 may be configured to allow light 335 to pass laterally through the shaft material from the side-emitting fiber 330B to the outer surface 326 of the shaft. In some embodiments, the shaft 320 may include an opening (not shown) that provides a path for light 335. In other embodiments, the shaft 320 may be formed from a material that is preferably transparent to light 335.

[0045] The shaft 320 further includes one or more lumens 340 that extend for the length of the shaft 320 between the fluid port (not shown, see Figure 1A) and the distal end 322. The lumens 340 may be interspersed between the fibers 330A and 330B.

[0046] Figures 4A to 4C show shafts 420 of another embodiment that may be included by system 100. Figure 4A is a side view of shaft 420, Figure 4B is a detailed side perspective view of the distal portion of shaft 420, and Figure 4C is a distal end view of shaft 420, shown in a cross section in which the outer shaft 420B is cut along the cutting line 4C-4C in Figure 4A. Shaft 420 includes an inner shaft 420A and an outer shaft 420B. The outer shaft 420B is slidably coupled to the inner shaft 420A so that the outer shaft 420B can be displaced longitudinally along the inner shaft 420A as indicated by arrow 404. During use, the outer shaft 420B can be displaced distally along the inner shaft 420A so that the distal end of the outer shaft 420B extends beyond the inner shaft 420A. Alternatively, the outer shaft 420B may be displaced proximal along the inner shaft 420A such that the distal end of the inner shaft 420A extends beyond the outer shaft 420B. A shaft coupling 423 is shown positioned at the proximal end 421 of the inner shaft 420A.

[0047] The shaft 420 is configured to define a lumen 440 between the outer shaft 420B and the inner shaft 420A. The outer shaft 420B includes a fluid port 425 located at its proximal end, which is in fluid communication with the lumen 440. The fluid port 425 also includes a sliding fluid seal 425A between the outer shaft 420B and the inner shaft 420A, defining the proximal end of the lumen 440. The outer shaft 420B may include a projection 427 extending inward toward the inner shaft 420A, concentrically constraining the inner shaft 420A with respect to the outer shaft 420B. In an alternative embodiment, the projection 427 may extend outward from the inner shaft 420A toward the outer shaft 420B. The outer shaft 420B may include one or more openings 440A extending through the annular wall of the outer shaft 420B, defining a radially oriented fluid path extending between the lumen 440 and the outside of the outer shaft 420B. During use, a clinician may connect a fluid device (e.g., a syringe) to the fluid port 425 and push the fluid distally through the lumen 440 so that the fluid exits through the openings 440A and / or the ends of the outer shaft 420B. The clinician may also draw the fluid proximal through the lumen 440.

[0048] The inner shaft 420A includes a plurality of fibers 430, which may be divided into one or more end-emitting fibers 430A located in the center of the inner shaft 420A and one or more side-emitting fibers 430B located adjacent to the outer surface 426 of the inner shaft 420B. Any subset of the fibers 430 may be combined to form a closely packed fiber bundle.

[0049] During use, the laser control module 110 may activate fibers 430A and 430B at different timings. For example, the laser control module 110 may activate the end-emitting fiber 430A while keeping the side-emitting fiber 430B inactive to direct the light 435A distal to the inner shaft 420A, and vice versa. In other embodiments, the laser control module 110 may activate fibers 430A and 430B simultaneously. Similarly, the laser control module 110 may activate a subset of end-emitting fibers 430A or a subset of side-emitting fibers 430B, while keeping another subset of end-emitting fibers 430A or another subset of side-emitting fibers 430B inactive. In other words, the laser control module 110 may activate any of the fibers 430 individually or in groups.

[0050] The inner shaft 420A may be configured to allow light 435B to pass laterally through the shaft material from the side-emitting fiber 430B to the outside of the inner shaft 420B. In some embodiments, the inner shaft 420B may include an opening (not shown) that provides a path for light 435B. In other embodiments, the shaft 420B may be formed from a material that is preferably transparent to light 435B.

[0051] Figures 5A and 5B show an exemplary use case of the system 100 including the shaft 420. This use case uses the system 100 to perform laser lithotripsy on a stone 503. As shown in Figure 5A, the shaft 420 is inserted into the urinary tract 501 such that its distal end 422 is positioned adjacent to the stone 503. In some cases, the outer shaft 420B may be displaced distally such that its distal end extends beyond the inner shaft 420A. In addition to performing laser lithotripsy on stones, the system 100 can be used to perform such procedures on various mineral deposits formed in the patient's body. For example, the system 100 can be used to perform laser lithotripsy on mineral and salt deposits formed in the patient's kidneys, typically called nephrolithiasis.

[0052] The laser control module 110 (Figure 1A) can activate the end-emitting fiber 430A to drill a hole 504 in the stone 503. Optionally, the clinician may configure suction into the lumen 440, thereby allowing stone fragments or debris 503A to be carried proximal through the lumen 440 and expelled from the patient. Optionally, this suction can pull the stone 503 toward the distal end 422 of the shaft, preventing the stone 503 from recoiling during the drilling process.

[0053] After the hole 504 is made, the outer shaft 420B may be displaced proximal to such that the distal end of the inner shaft 420A extends beyond the outer shaft 420B, as shown in Figure 5B. The distal end of the inner shaft 420A is positioned within the hole 504. With the distal end of the inner shaft 420A positioned within the hole 504, the lateral firing fiber 430B can be activated to fragment the stone 503 and / or ablate the stone 503 from inside to outside. The lateral firing fiber 430B may generate a force directed radially outward toward the stone from the inner shaft 420A. Thus, the rebound of the stone 503 can be prevented or minimized during lithotripsy. Alternatively, the clinician may also configure suction within the lumen 440 to carry the stone fragments proximal through the lumen 440 and expel them from the patient during the inside-to-outside ablation process.

[0054] While several specific embodiments are disclosed herein, and these specific embodiments are disclosed in some degree of detail, they are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may be apparent to those skilled in the art, and these adaptations and / or modifications are also encompassed in broader embodiments. Thus, it is possible to carry out developments from specific embodiments disclosed herein without departing from the scope of the concepts provided herein. The technical concepts included in this disclosure are described below. (Note 1) It is a medical device, A long, flexible shaft that defines the length extending between the proximal and distal ends, A plurality of optical fibers extending along the aforementioned length, wherein one or more of the plurality of optical fibers have a cross-sectional diameter in the range of 150 μm to 50 μm, The fiber optic connector located at the proximal end, A medical device comprising a laser control module including a laser light source operably coupled to the plurality of optical fibers. (Note 2) The aforementioned device is the device described in Appendix 1, which is configured to be inserted into the patient's body. (Note 3) The instrument is the instrument described in Appendix 1 or 2, configured to be inserted into the working channel of an endoscope. (Note 4) The endoscope is a ureteroscope, as described in Appendix 3. (Note 5) The aforementioned device is the device described in Appendix 1 or 2, configured to ablate body tissue. (Note 6) The aforementioned device is the device described in Appendix 1 or 2, configured to ablate kidney stones. (Note 7) The apparatus according to Appendix 1 or 2, wherein one or more of the aforementioned optical fibers are located centrally along the longitudinal axis of the flexible shaft. (Note 8) The apparatus according to Appendix 1 or 2, wherein three or more of the plurality of optical fibers are arranged laterally adjacent to one another to define a bundle of the plurality of optical fibers. (Note 9) The aforementioned bundle is the apparatus described in Appendix 8, which defines a circumscribed circle having a diameter of less than 1 mm. (Note 10) The apparatus as described in Appendix 8, wherein the optical fibers of the bundle are configured to direct the light so as to move away from the distal end of the flexible shaft in the distal direction. (Note 11) The apparatus according to Appendix 8, wherein three or more of the optical fibers are arranged periphery along the flexible shaft to define a peripheral set of the optical fibers. (Note 12) The apparatus as described in Appendix 11, wherein the optical fiber of the peripheral set is configured to direct light radially outward from the flexible shaft at the distal end of the flexible shaft. (Note 13) The apparatus as described in Appendix 12, further comprising a lumen extending along the aforementioned length. (Note 14) The apparatus according to Appendix 13, further comprising a fluid port coupled to the flexible shaft, wherein the fluid port is in fluid communication with the lumen. (Note 15) The apparatus as described in Appendix 13, wherein the lumen is an annular lumen located radially outward of the bundle. (Note 16) The lumen is the instrument described in Appendix 13, located radially inward of the surrounding set. (Note 17) The apparatus as described in Appendix 14, further comprising a plurality of lumens located radially inward of the aforementioned peripheral set, wherein the fluid port is in fluid communication with the plurality of lumens. (Note 18) It also features a hollow outer shaft, The flexible shaft is disposed within the outer shaft, The lumen is defined by the annular space between the flexible shaft and the outer shaft, The fluid port is attached to the outer shaft, The apparatus as described in Appendix 14, wherein the outer shaft is displaceable in the longitudinal direction relative to the flexible shaft. (Note 19) The apparatus as described in Appendix 8, wherein the bundle includes a first subset of the plurality of optical fibers configured to operate in a first time, and a second subset of the plurality of optical fibers configured to operate in a second time. (Note 20) The aforementioned bundle includes an end-emitting optical fiber and a plurality of side-emitting fibers, as described in Appendix 8. (Note 21) The laser control module is a component of a fiber laser system and includes at least a first laser diode, as described in Appendix 1 or 2. (Note 22) It is a medical device, A long, flexible shaft that defines the length extending between the proximal and distal ends, An optical fiber extending along the aforementioned length, wherein the optical fiber has a cross-sectional diameter in the range of 150 μm to 50 μm, A lumen extending along the aforementioned length, A medical device comprising a laser control module including a laser light source operably coupled to the optical fiber. (Note 23) The aforementioned device is the device described in Appendix 22, which is configured to be inserted into the patient's body. (Note 24) The instrument is the instrument described in Appendix 22 or 23, configured to be inserted into the working channel of an endoscope. (Note 25) The endoscope is a ureteroscope, as described in Appendix 24. (Note 26) The aforementioned device is the device described in Appendix 22 or 23, configured to ablate body tissue. (Note 27) The aforementioned instrument is the instrument described in Appendix 22 or 23, configured to ablate gallstones. (Note 28) The optical fiber is located at the center along the longitudinal axis of the flexible shaft, as described in Appendix 22 or 23. (Note 29) The apparatus according to Appendix 22 or 23, wherein the lumen is an annular lumen located radially outward of the optical fiber. (Note 30) The apparatus according to Appendix 22 or 23, wherein the optical fiber is configured to direct the light so as to move away from the distal end of the flexible shaft in the distal direction. (Note 31) The apparatus according to appendix 22 or 23, further comprising three or more optical fibers arranged laterally adjacent to one another to define the bundle of optical fibers. (Note 32) The bundle of optical fibers is located at the center along the longitudinal axis of the flexible shaft, as described in Appendix 31. (Note 33) The apparatus as described in Appendix 31, wherein the optical fibers of the bundle are configured to direct the light so as to move away from the distal end of the flexible shaft in the distal direction. (Note 34) The apparatus as described in Appendix 31, wherein the bundle includes a first subset of the plurality of optical fibers configured to operate in a first time, and a second subset of the plurality of optical fibers configured to operate in a second time. (Note 35) The apparatus described in Appendix 31, wherein the bundle includes end-emitting optical fibers and a plurality of side-emitting fibers. (Note 36) The apparatus according to appendix 22 or 23, further comprising three or more of the optical fibers arranged periphery along the flexible shaft to define a peripheral set of the optical fibers. (Note 37) The apparatus as described in Appendix 36, wherein the optical fiber of the peripheral set is configured to direct light radially outward from the flexible shaft at the distal end of the flexible shaft. (Note 38) The lumen is the instrument described in Appendix 36, located radially inward of the surrounding set. (Note 39) The apparatus according to Appendix 36, further comprising a fluid port coupled to the flexible shaft, wherein the fluid port is in fluid communication with the lumen. (Note 40) The apparatus according to Appendix 39, further comprising a plurality of lumens located radially inward of the aforementioned peripheral set, wherein the fluid port is in fluid communication with the plurality of lumens. (Note 41) It also features a hollow outer shaft, The flexible shaft is disposed within the outer shaft, The lumen is defined by the annular space between the flexible shaft and the outer shaft, The fluid port is connected to the outer shaft, The apparatus as described in Appendix 39, wherein the outer shaft is displaceable in the longitudinal direction relative to the flexible shaft. (Note 42) The laser control module is a component of a fiber laser system and includes at least a first laser diode, as described in Appendix 22 or 23.

Claims

1. It is a medical device, A long, flexible shaft that defines the length extending between the proximal and distal ends, A plurality of optical fibers extending along the aforementioned length, wherein one or more of the plurality of optical fibers have a cross-sectional diameter in the range of 150 μm to 50 μm, three or more of the plurality of optical fibers are arranged laterally adjacent to one another to define a bundle of the plurality of optical fibers, the bundle is centrally located along the longitudinal axis of the flexible shaft, and three or more of the optical fibers are arranged circumferentially around the longitudinal axis of the flexible shaft to define a peripheral set of the optical fibers, the optical fibers of the peripheral set are configured to direct light radially outward from the flexible shaft at the distal end of the flexible shaft, A fluid port connected to the aforementioned flexible shaft, An at least one annular lumen extending along the length of the flexible shaft and in fluid communication with the fluid port, wherein the at least one annular lumen is located radially outward of the bundle, The fiber optic connector located at the proximal end, A medical device comprising a laser control module including a laser light source operably coupled to the plurality of optical fibers.

2. The device according to claim 1, wherein the device is configured to be inserted into the body of a patient.

3. The instrument according to claim 1 or 2, wherein the instrument is configured to be inserted into the working channel of an endoscope.

4. The instrument according to claim 3, wherein the endoscope is a ureteroscope.

5. The apparatus according to claim 1 or 2, wherein the apparatus is configured to propagate laser light along the optical fiber to irradiate body tissue with light and ablate the body tissue.

6. The apparatus according to claim 1 or 2, wherein the apparatus is configured to propagate laser light along the optical fiber to irradiate the calculus with light and ablate the calculus.

7. The apparatus according to claim 1 or 2, wherein the bundle defines a circumscribed circle having a diameter of less than 1 mm.

8. The apparatus according to claim 1 or 2, wherein the optical fibers in the bundle are configured to direct light so as to move away from the distal end of the flexible shaft in the distal direction.

9. The apparatus according to claim 1 or 2, wherein the lumen is located radially inward of the surrounding set.

10. The apparatus according to claim 1 or 2, further comprising a plurality of lumens located radially inward of the peripheral set, wherein the fluid port is in fluid communication with the plurality of lumens.

11. It further includes a hollow outer shaft, The flexible shaft is disposed within the outer shaft, The lumen is defined by the annular space between the flexible shaft and the outer shaft, The fluid port is attached to the outer shaft, The apparatus according to claim 1 or 2, wherein the outer shaft is displaceable in the longitudinal direction relative to the flexible shaft.

12. The apparatus according to claim 1 or 2, wherein the bundle includes a first subset of the plurality of optical fibers configured to operate in a first time, and a second subset of the plurality of optical fibers configured to operate in a second time.

13. The apparatus according to claim 1 or 2, wherein the bundle includes an end-emitting optical fiber and a plurality of side-emitting fibers.

14. The apparatus according to claim 1 or 2, wherein the laser control module is a component of a fiber laser system and includes at least a first laser diode.

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