Close-packed small-core optical fiber bundles.
Patent Information
- Application Number
- JP2023574238
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-06-01
- Filing Date
- 2022-05-31
- Publication Date
- 2025-05-12
- Estimated Expiration
- 2042-05-31
AI Technical Summary
Existing laser lithotripsy technologies face limitations due to the large diameter of delivery fibers, leading to back thrust and tissue damage during ablation, and lack of irrigation or suction capabilities.
The use of fiber lasers with rare earth elements as dopants, such as thulium, and configurations with multiple delivery fibers arranged in close packing, allowing for a flexible shaft with small core diameters and integrated irrigation/suction lumens, enabling precise ablation and debris removal.
Reduces back thrust and tissue damage while allowing for efficient ablation and debris management, enhancing the effectiveness of laser lithotripsy procedures.
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Abstract
Description
[Technical field]
[0001] The present disclosure relates to close-packed small core optical fiber bundles. [Background technology]
[0002] Laser lithotripsy typically involves inserting and advancing a delivery optical fiber through the patient's vascular system so that the delivery optical fiber approaches the stone within the vascular system. Light is then propagated along the delivery optical fiber and delivered to the stone to break the stone into smaller pieces or dust. Traditionally, Holmium:Yag (Ho:YAG) lasers have been utilized for laser lithotripsy applications. However, the smallest delivery optical fibers commonly available for use with Ho:YAG lasers have a core diameter of about 270 μm. The cladding diameter of these delivery fibers is about 400 μm. Thus, for applications where the working channel is extremely small, such as laser lithotripsy, there is a limit to the size of the cladding diameter. Crystalline lasers (e.g., Nd:YAG lasers) have the same disadvantages as the Ho:YAG lasers, and the corresponding size limitations 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 doped with a rare earth element (the "active fiber"). Furthermore, a delivery fiber is optically coupled to the fiber laser, and light generated by the fiber laser propagates along the delivery fiber. The delivery fibers utilized in fiber lasers often have smaller cladding diameters than those used in Ho:YAG lasers.
[0004] However, simply utilizing a delivery fiber connected to a fiber laser for processes such as laser lithotripsy can still result in back-pulling and / or damage to tissue surrounding the stone during ablation. Therefore, what is needed are systems, devices, and methods including fiber laser systems that reduce back-pulling, provide use case laser delivery configurations, and provide system configurations that allow the use of irrigation or suction in combination with optical fibers for ablation, as well as other benefits. Summary of the Invention
[0005] Embodiments herein disclose systems and methods that utilize a fiber laser system having a rare earth element as a dopant, such as, but not limited to, thulium, erbium, ytterbium, neodymium, dysprosium, praseodymium, etc. Particular embodiments of the disclosure relate to a fiber laser configured to operate with an optical fiber having thulium as a dopant (thulium optical fiber). Some particular embodiments of the disclosure relate to packaging a plurality of delivery fibers in a particular configuration for advancement within a patient's vasculature, where the plurality of delivery fibers are connected to a fiber laser system. Additional embodiments disclose an elongated shaft configuration including a plurality of delivery fibers configured for use with a fiber laser system. In some embodiments, the plurality of delivery fibers may be arranged in a close-packed arrangement. In some embodiments, each of the optical fibers may have a core diameter of 50 μm and a cladding diameter of 74 μm. In other embodiments, the elongated shaft may include a plurality of optical fibers surrounding an irrigation lumen and / or an aspiration lumen.
[0006] Briefly summarized, disclosed herein is a medical instrument that includes an elongate flexible shaft defining a length extending between a proximal end and a distal end, a plurality of optical fibers extending along the length, and a laser control module including a laser source operably coupled to the optical fibers.
[0007] The instrument is configured to be inserted into a patient's body and / or into a working channel of an endoscope, which may be a ureteroscope, and is configured to ablate body tissue and / or foreign material within the body, such as stones.
[0008] The optical fibers may define a diameter in the range of 150 μm to 50 μm. One or more of the plurality of optical fibers may be centrally located along the longitudinal axis of the shaft. In some embodiments, three or more optical fibers may be positioned laterally adjacent one another to define a bundle of optical fibers, which in some embodiments may define a circumscribed circle having a diameter of less than 1 mm. The optical fibers of the bundle may be configured to direct light distally away from the distal end of the shaft.
[0009] In some embodiments, three or more optical fibers are circumferentially disposed along the shaft to define a peripheral set of optical fibers, the optical fibers of the peripheral set may be configured to direct light radially outward from the shaft at a distal end of the shaft.
[0010] The instrument 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, and the lumen may be located radially inward of the peripheral set. In some embodiments, the instrument may include multiple lumens located radially inward of the peripheral set.
[0011] In some embodiments, the instrument may include a hollow outer shaft, with the shaft disposed within the 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 longitudinally displaceable relative to the shaft.
[0012] Another embodiment of a medical instrument is also disclosed herein, the instrument including an elongate flexible shaft defining a length extending between a proximal end and a distal end, an optical fiber extending along the length, a fluid lumen extending along the length, and a laser control module including a laser source operably coupled to the optical fiber.
[0013] Also disclosed herein is a method of providing treatment to the urinary tract of a patient. The method includes advancing an elongate medical device along the urinary tract and positioning a distal end of the device at a desired location within the urinary tract. The device includes a plurality of optical fibers extending along an elongate shaft of the device to the distal end of the device, and a laser control module disposed at a proximal end of the device, the control module including a corresponding plurality of 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 an ablation within the urinary tract in response to the treatment.
[0014] In some embodiments of the method, the one or more optical fibers define a first set of fibers configured to direct light distally away from the distal end Similarly, the one or more optical fibers define a second set of fibers configured to direct light radially away from the shaft at the distal end.
[0015] In some embodiments of the 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] The method may further include coupling a fluidic device to the fluid port and passing a liquid through the lumen, where passing the liquid through the lumen cools the optical fiber. In some embodiments of the method, the treatment includes laser lithotripsy of a concretion disposed within the urinary tract, and propagating laser light along the one or more optical fibers includes propagating laser light along a first set of optical fibers to illuminate the concretion and form a hole in the concretion. In such embodiments, positioning the distal end of the device at the desired location includes inserting the distal end of the device into a hole in the concretion, and propagating laser light along the one or more optical fibers includes propagating laser light along a second set of optical fibers to illuminate an inner surface of the hole in the concretion and fragmenting the concretion into small pieces.
[0017] The method may further include creating suction within the lumen to draw stones toward the distal end of the shaft and / or carry debris proximally along the lumen. In some embodiments, positioning the distal end of the device at the desired location includes positioning the distal end within the prostate, and propagating laser light along the one or more optical fibers includes propagating laser light along a second set of optical fibers to illuminate an inner surface of the prostate and ablate prostate tissue in response to the treatment.
[0018] In some embodiments of the method, the device includes a hollow outer shaft. In such embodiments, the shaft is disposed within the outer shaft such that a lumen is defined by an annular space between the shaft and the outer shaft. The fluid port is coupled to the outer shaft, and the outer shaft is longitudinally displaceable 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 presented herein will become apparent to those of ordinary skill in the art upon review of the accompanying drawings and following description, which disclose in greater detail certain embodiments of such concepts.
[0020] Embodiments of the present disclosure are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which like reference symbols indicate similar elements and in which: [Brief description of the drawings]
[0021] [Figure 1A] 1 illustrates an embodiment of a medical device including an optical fiber extending along an elongate shaft, according to some embodiments. [Figure 1B] 1B illustrates an embodiment of a distal end view of the shaft of FIG. 1A, according to some embodiments. [Figure 1C] 1B illustrates an embodiment of a distal end view of the shaft of FIG. 1A, according to some embodiments. [Figure 1D] 1B illustrates an embodiment of a distal end view of the shaft of FIG. 1A, according to some embodiments. [Figure 1E] 1B illustrates an embodiment of a distal end view of the shaft of FIG. 1A, according to some embodiments. [Diagram 2] FIG. 13 is a distal end view of a second embodiment of a shaft, according to some embodiments. [Diagram 3] FIG. 13 is a distal end view of a third embodiment of a shaft, according to some embodiments. [Figure 4A] FIG. 13 is a side view of a fourth embodiment of a shaft, according to some embodiments. [Figure 4B] FIG. 4B is a detailed perspective view of a distal portion of the shaft of FIG. 4A according to some embodiments. [Figure 4C] FIG. 4B is a distal end view of the shaft of FIG. 4A according to some embodiments. [Figure 5A] 1B illustrates an exemplary use case of the laser of FIG. 1A. [Figure 5B] 1B illustrates an exemplary use case of the laser of FIG. 1A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are easily separable from the specific embodiment and that can, optionally, be combined with or substituted for features of any of the other several embodiments disclosed herein.
[0023] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms are not intended to 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 steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and are not intended to suggest, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.
[0024] The directional terms "proximal" and "distal" are used herein to refer to opposing locations on a medical device. The proximal end of the device is defined as the end of the device that is closest to an end user when the device is in use by the end user. The distal end is the end of the device opposite the proximal end along the length of the device, or the end that is furthest from the end user.
[0025] Any method disclosed herein includes one or more steps or acts of performing the described method. Method steps and / or acts may be interchanged with one another. In other words, the order and / or use of certain steps and / or acts may be changed unless a certain order of steps or acts is required for proper operation of the embodiment. Furthermore, only subroutines or portions of the methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only some of the steps described in a more detailed method.
[0026] FIG. 1A illustrates an embodiment of a medical instrument 100, which may be a fiber laser system including a laser control module 110 coupled to an elongated shaft (shaft) 120, within which one or more optical fibers 130 (which may also be referred to as "delivery fibers") are disposed. In some embodiments, as shown in FIG. 1A, a first end of an optical interconnect 113 may be connected to the laser control module 100, and a 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 a length 124 from the shaft connector 123. In some embodiments, the shaft 120 includes one or more lumens (see FIG. 1B) such that a fluid port 124 may be in fluid communication with the one or more lumens.
[0027] In some particular embodiments, the laser control module 110 may be a fiber laser including one or more diode lasers 111A-111B that may be electronically modulated. It should be understood that additional diode lasers, e.g., 111A-111i (where i≧1), may be coupled. The diode lasers 111A-111B may be optically coupled to a rare-earth doped silica fiber 112 that may be utilized 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 may be referred to as the “active fiber 112”). This uniform laser beam may be output from the laser control module 110 to the shaft 120, where in some embodiments, an interconnect as shown in FIG. 1A is optionally disposed 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 a medical procedure related to the urinary tract of a patient's body. The procedure may include laser lithotripsy, treatment of benign prostatic hyperplasia, or other medical procedures involving 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 a 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 a "fiber optic connector") connected to a shaft connector 123. In some embodiments, an optical interconnect 113 may be disposed between the laser control module 110 and the module connector 114. The interconnect 113 may be flexible and relatively long (e.g., approximately 2-10 feet long) so that the laser control module 110 may be conveniently located away from the patient. The laser control module 110 includes one or more diode lasers 111A-111B configured to excite light in the active fiber 112 to stimulate radiative emission in the active fiber 112 and generate a laser beam that then propagates distally along a delivery fiber disposed within the shaft 120. The interconnect 113 includes one or more optical fibers for carrying light from the diode lasers 111A-111B to the optical fiber 130. The laser controller 110 may include multiple light sources (e.g., diode lasers 111A-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-111B individually or as a group. In some embodiments, the laser controller 110 may operate the diode lasers 111A-111B at pulse repetition rates of up to 2000 Hz or more with energies per pulse as low as 0.025 Joules. In some embodiments, the laser controller 110 may operate the diode lasers 111A-111B to selectively propagate laser light to individual ones of the optical fibers 130 or to subsets of the optical fibers 130. Example configurations of multiple optical fibers 130 are described below, e.g., with respect to Figures 1B-4B.
[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 distal end 122 of shaft 120.
[0031] The shaft 120 is configured to be inserted into the urinary tract of a patient's body. As such, 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 a location outside the patient to a location within the patient's kidney. As described above, the shaft 120 may be inserted into a working channel of a ureteroscope. Thus, the length 124 may exceed the length of the ureteroscope, and the cross-sectional diameter of the shaft 120 may be sized for insertion 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 less than about 1.2 mm, 600 μm, 300 μm, or 150 μm. The relatively small diameter of the shaft 120 relative to the inner diameter of the ureteroscope may enhance the flow of fluid through the working channel within which the shaft 120 is disposed.
[0032] 1B illustrates a first embodiment of a distal end view of a shaft 120, according to some embodiments. One or more optical fibers (fibers) 130 extend along the length 124 of the shaft 120 to the distal end 122. The shaft 120 can include 1, 2, 3, 4, 5, or more fibers 130. In some embodiments, the shaft 120 can include up to 10, 20, 30, or more fibers 130. The fibers 130 can have a cross-sectional diameter of less than about 150 μm, 100 μm, 75 μm, or 50 μm (e.g., a cross-sectional diameter in the range of 50 μm to 150 μm).
[0033] In some embodiments, two or more fibers 130 may be positioned laterally adjacent to one another to form a close-packed bundle of fibers 130. For example, as shown in FIG. 1B, three or more fibers 130 may form a bundle 131. The bundle 131 may be centrally located within the cross section of the shaft 120 or may be anywhere else in the cross section. Other fibers 130, either individually or in bundles, may be located at other positions in the cross section. In some embodiments, a circle 132 circumscribing the bundle 131 may be less than 1 mm, 500 μm, 250 μm, 225 μm, 200 μm, 180 μm, or 160 μm.
[0034] The shaft 120 may include one or more lumens 140 extending along its length between the fluid port 125 (FIG. 1A) and the distal end 122. The port 125 is in fluid communication with the lumen 140. The lumen 140 may be disposed radially outward relative to the bundle 131. As shown in FIG. 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 within each fiber 130 may generate heat that may cause the temperature of the fibers 130 to exceed a desired operating temperature. Thus, the lumen 140 (or the shaft 120 in general) may be configured such that, in use, the fibers 130 may be cooled by causing a transfer of thermal energy such that a liquid passing through the lumen 140 away from the fibers 130. 1C shows a second embodiment of a distal end view of shaft 120, according to some embodiments. In some exemplary embodiments, each of the fibers shown in the embodiments of FIGS. 1B-1C may be a side-firing fiber.
[0035] FIG. 1D illustrates a third embodiment of a distal end view of shaft 120, according to some embodiments. The embodiment of FIG. 1D provides a physician or other medical professional with the ability to apply laser energy using a particular subset of fibers. For example, laser energy may be applied by activating a first subset of fibers 130A-130D in bundle 131 while fibers 130E-130G are not activated. Similarly, laser energy may be applied by activating fibers 130A and a second subset of fibers 130E-130G in bundle 131 while fibers 130B-130D are not activated. However, any combination of fibers 130A-130G may be activated to apply laser energy. Stated another way, the first subset may be activated to apply laser energy while the second subset is not activated. Such an embodiment is advantageous because it allows a physician or other medical professional to apply laser energy while protecting surrounding tissue.
[0036] FIG. 1E illustrates a fourth embodiment of a distal end view of the shaft 120, according to some embodiments. Such an embodiment may be utilized to treat larger kidney stones, for example, the first fiber 130A may be an end-firing fiber configured to "drill" a hole in the kidney stone (not shown), with the fiber bundle 131 being disposed within the drilled hole. Additionally, the second fiber 130B through the fifth fiber 130E may be side-firing fibers configured to ablate the kidney stone from its internal hole. Such an embodiment may advantageously reduce retropulsion, since the ablation force is uniform on the kidney stone. The embodiment of FIG. 1E may be used in other contexts, such as, for example, the treatment of benign prostatic hyperplasia (BPH).
[0037] FIG. 2 illustrates another embodiment of a shaft 220 that may be included by the system 100. The shaft 220 may be similar in some respects to the components of the shaft 120 described in connection with FIGS. 1A-1B. It will be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are indicated with similar reference numbers with the leading digit incremented to "2." For example, a lumen is indicated as "140" in FIGS. 1A-1B, and a similar lumen is indicated as "240" in FIG. 2. Accordingly, the relevant disclosure set forth above with respect to similarly identified features may not be repeated below. Additionally, certain features of the shaft 120 and related components illustrated in FIGS. 1A-1B may not be indicated or identified by reference numbers in the drawings or specifically described in the following description. However, such features may be clearly the same or substantially the same as features shown in and / or described in connection with other embodiments. Accordingly, the relevant discussion of such features applies equally to the features of the shaft 220. Any suitable combination of the features and variations thereof described with respect to shaft 120 and components shown in FIGS. 1A-1B may be used with shaft 220 and components of FIG. 2, and vice versa.
[0038] 2 is an end view of a shaft 220. The shaft 220 includes a centrally located lumen 240 and one or more fibers 230 (designated as a set as 230A, 230B) disposed radially outward of the lumen 240. The shaft 220 may include 1, 2, 3, 4, 5, or more fibers 230. In some embodiments, the shaft 220 may include up to 10, 20, 30, or more fibers 230. In some embodiments, the fibers 230 may be combined into one or more close-packed fiber bundles (not shown).
[0039] In some embodiments, the fibers 230 may be divided into subsets. For example, the first subset 230A of the fibers 230 may be end-fired fibers. In other words, the first subset 230A of the fibers may be configured to direct the light 235 away from the distal end 222 of the shaft 220 in a distal direction (i.e., outside the page). The second subset 230B of the fibers 230 may be configured to direct the light 235 away from the shaft 220 in a radial / lateral direction. In use, the laser control module 110 may individually activate the fibers 230 of the subsets 230A, 230B at different times. For example, the laser control module 110 may activate the first subset 230A of the fibers 230 while keeping the second subset 230B of the fibers 230 deactivated, or vice versa. In other embodiments, the laser control module 110 may activate all the fibers 230 simultaneously. The shaft 220 may further include other fibers 230 that are not included in the subsets 230A, 230B.
[0040] The shaft 220 may be configured to allow light 235 to pass laterally through the shaft material from the fibers 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 the light 235. In other embodiments, the shaft 220, or portions thereof, may be formed from any material that is suitably transparent to the light 235, such as, for example, acrylic or polycarbonate.
[0041] The lumen 240 extends the length of the shaft 220 between a fluid port (not shown, but see FIG. 1A) and the distal end 222. The lumen 240 may be configured to provide cooling to the fibers 230. During operation, stimulated emission of radiation within each fiber 230 generates heat and may cause the temperature of the fibers 230 to exceed a desired operating temperature. Thus, the lumen 240 (or the shaft 120 generally) may be configured such that, in use, the lumen 240 (or the shaft 120 generally) may be configured to cool the fibers 230 by inducing thermal energy transfer away from the fibers 230 as liquid passing through the lumen 240 passes through the lumen 240. The lumen 240 may also provide a path for ablated material, such as stone dust, to be carried proximally along the shaft 220 and out of the body.
[0042] 3 is an end view of another embodiment shaft 320 that may be included by system 100. The fibers 330 of shaft 320 may be divided into subsets. For example, a first subset 330A of fibers may be end-fired fibers centrally located within shaft 320. A second subset 330B of fibers may be side-fired fibers disposed adjacent to the exterior surface 326 of shaft 320. Any subset of fibers 330 may be combined into a close-packed fiber bundle.
[0043] In use, the laser control module 110 (FIG. 1A) may activate the fibers 330A, 330B at different times. For example, the laser control module 110 may activate the end-firing fiber 330A while keeping the side-firing fiber 330B deactivated, or vice versa. In other embodiments, the laser control module 110 may activate the fibers 330A, 330B simultaneously. Any of the fibers 330 may be activated individually or in groups with the others.
[0044] The shaft 320 may be configured to allow light 335 to pass laterally through the shaft material from the side firing 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 the light 335. In other embodiments, the shaft 320 may be formed from a material that is suitably transparent to the light 335.
[0045] The shaft 320 further includes one or more lumens 340 that extend the length of the shaft 320 between a fluid port (not shown, but see FIG. 1A) and the distal end 322. The lumens 340 may be interspersed between the fibers 330A, 330B.
[0046] 4A-4C show another embodiment shaft 420 that may be included by the system 100. FIG. 4A is a side view of the shaft 420, FIG. 4B is a detailed side perspective view of a distal portion of the shaft 420, and FIG. 4C is a distal end view of the shaft 420 with the outer shaft 420B shown in cross section taken along section line 4C-4C of FIG. 4A. The shaft 420 includes an inner shaft 420A and an outer shaft 420B. The outer shaft 420B is slidably coupled to the inner shaft 420A such that the outer shaft 420B may be longitudinally displaced along the inner shaft 420A as indicated by arrow 404. In use, the outer shaft 420B may be distally displaced along the inner shaft 420A such that a distal end of the outer shaft 420B extends beyond the inner shaft 420A. Alternatively, the outer shaft 420B may be displaced proximally 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 disposed 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 disposed at a proximal end of the outer shaft 420B, the fluid port 425 being 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 a proximal end of the lumen 440. The outer shaft 420B may include a protrusion 427 extending inwardly toward the inner shaft 420A, concentrically constraining the inner shaft 420A to the outer shaft 420B. In an alternative embodiment, the protrusion 427 may extend outwardly from the inner shaft 420A to 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 to define a radially oriented fluid pathway extending between the lumen 440 and the exterior of the outer shaft 420B. In use, a clinician may couple a fluidic device (e.g., a syringe) to the fluid port 425 and push liquid distally through the lumen 440 such that the liquid exits through the openings 440A and / or the end of the outer shaft 420B. The clinician may also draw liquid proximally through the lumen 440.
[0048] The inner shaft 420A includes a plurality of fibers 430 that may be divided into one or more end-fired fibers 430A centrally located within the inner shaft 420A and one or more side-fired fibers 430B disposed adjacent the outer surface 426 of the inner shaft 420B. Any subset of the fibers 430 may be combined into a close-packed fiber bundle.
[0049] In use, the laser control module 110 may activate the fibers 430A, 430B at different times. For example, the laser control module 110 may activate the end-fired fiber 430A to direct the light 435A distally away from the inner shaft 420A while keeping the side-fired fiber 430B deactivated, or vice versa. In other embodiments, the laser control module 110 may activate the fibers 430A, 430B simultaneously. Similarly, the laser control module 110 may activate a subset of the end-fired fibers 430A or a subset of the side-fired fibers 430B while keeping another subset of the end-fired fibers 430A or another subset of the side-fired fibers 430B deactivated. 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 firing fiber 430B to the exterior of the inner shaft 420B. In some embodiments, the inner shaft 420B may include an opening (not shown) that provides a path for the light 435B. In other embodiments, the shaft 420B may be formed from a material that is suitably transparent to the light 435B.
[0051] 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 of a concretion 503. As shown in FIG. 5A, the shaft 420 is inserted into the urinary tract 501 such that the distal end 422 is positioned adjacent to the concretion 503. In some cases, the outer shaft 420B may be displaced distally such that the distal end of the outer shaft 420B extends beyond the inner shaft 420A. In addition to performing laser lithotripsy on concretions, the system 100 may be utilized to perform such procedures on various mineral deposits formed within a patient's body. For example, the system 100 may be utilized to perform laser lithotripsy on mineral and salt deposits formed in a patient's kidneys, typically referred to as kidney stones.
[0052] The laser control module 110 (FIG. 1A) can activate the end-firing fiber 430A to drill a hole 504 in the stone 503. Optionally, the clinician can provide suction within the lumen 440, which can carry stone fragments or debris 503A proximally through the lumen 440 and out of the patient. Optionally, this suction can draw the stone 503 toward the distal end 422 of the shaft, preventing the stone 503 from recoiling during the drilling process.
[0053] After drilling the hole 504, the outer shaft 420B may be displaced proximally so that the distal end of the inner shaft 420A extends beyond the outer shaft 420B, as shown in FIG. 5B. The distal end of the inner shaft 420A is disposed within the hole 504. With the distal end of the inner shaft 420A disposed within the hole 504, the side-firing fiber 430B may be actuated to fragment the stone 503 and / or ablate the stone 503 from the inside out. The side-firing fiber 430B may generate a force directed radially outward from the inner shaft 420A against the stone. Thus, repulsion of the stone 503 may be prevented or minimized during lithotripsy. Also, optionally, the clinician may define suction within the lumen 440 to carry stone dust proximally through the lumen 440 and out of the patient during the ablation process from the inside out.
[0054] Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects of the present invention encompass these adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.
Claims
1. A medical device comprising: an elongate flexible shaft defining a length extending between a proximal end and a distal end; a plurality of optical fibers extending along said length, one or more of said plurality of optical fibers having a cross-sectional diameter in the range of 150 μm to 50 μm; a fiber optic connector disposed at the proximal end; a laser control module including a laser source operably coupled to the plurality of optical fibers.
2. The device of claim 1 , wherein the device is configured to be inserted into a patient's body.
3. The instrument of claim 1 or 2, wherein the instrument is configured to be inserted into a working channel of an endoscope.
4. The instrument of claim 3 , wherein the endoscope is a ureteroscope.
5. The device of claim 1 or 2, wherein the device is configured to ablate body tissue.
6. The device of claim 1 or 2, wherein the device is configured to ablate stones.
7. The instrument of claim 1 or 2, wherein one or more of the plurality of optical fibers are centrally located along a longitudinal axis of the flexible shaft.
8. The device of claim 1 or 2, wherein three or more of the plurality of optical fibers are disposed laterally adjacent one another to define a bundle of the plurality of optical fibers.
9. 9. The device of claim 8, wherein the bundle defines a circumscribed circle having a diameter of less than 1 mm.
10. The instrument of claim 8 , wherein the optical fibers of the bundle are configured to direct light distally away from the distal end of the flexible shaft.
11. The instrument of claim 8 , wherein three or more of the optical fibers are circumferentially arranged along the flexible shaft to define a circumferential set of the optical fibers.
12. The instrument of claim 11 , wherein the optical fibers of the peripheral set are configured to direct light radially outward from the flexible shaft at the distal end thereof.
13. The device of claim 12 further comprising a lumen extending along the length.
14. The instrument of claim 13 , further comprising a fluid port coupled to the flexible shaft, the fluid port in fluid communication with the lumen.
15. The device of claim 13 , wherein the lumen is an annular lumen located radially outward of the bundle.
16. The instrument of claim 13 , wherein the lumen is located radially inward of the circumferential set.
17. The instrument of claim 14 , further comprising a plurality of lumens located radially inward of the circumferential set, the fluid port being in fluid communication with the plurality of lumens.
18. Further comprising a hollow outer shaft; the flexible shaft is disposed within the outer shaft; the lumen is defined by an annular space between the flexible shaft and the outer shaft; the fluid port is attached to the outer shaft; The instrument of claim 14 , wherein the outer shaft is longitudinally displaceable relative to the flexible shaft.
19. 9. The instrument of claim 8, wherein the bundle includes a first subset of the plurality of optical fibers configured to operate at a first time and a second subset of the plurality of optical fibers configured to operate at a second time.
20. The instrument of claim 8 , wherein the bundle comprises an end-fired optical fiber and a plurality of side-fired fibers.
21. The instrument of 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.
22. A medical device comprising: an elongate flexible shaft defining a length extending between a proximal end and a distal end; an optical fiber extending along said length, said optical fiber having a cross-sectional diameter in the range of 150 μm to 50 μm; a lumen extending along said length; a laser control module including a laser light source operably coupled to the optical fiber.
23. 23. The device of claim 22, wherein the device is configured to be inserted into a patient's body.
24. 24. The instrument of claim 22 or 23, wherein the instrument is configured to be inserted into a working channel of an endoscope.
25. 25. The apparatus of claim 24, wherein the endoscope is a ureteroscope.
26. 24. The device of claim 22 or 23, wherein the device is configured to ablate body tissue.
27. 24. The device of claim 22 or 23, wherein the device is configured to ablate stones.
28. 24. The device of claim 22 or 23, wherein the optical fiber is centrally located along the longitudinal axis of the flexible shaft.
29. 24. The device of claim 22 or 23, wherein the lumen is an annular lumen disposed radially outward of the optical fiber.
30. 24. The instrument of claim 22 or 23, wherein the optical fiber is configured to direct light distally away from the distal end of the flexible shaft.
31. 24. The apparatus of claim 22 or 23, further comprising three or more optical fibers disposed laterally adjacent one another to define the optical fiber bundle.
32. 32. The instrument of claim 31, wherein the bundle of optical fibers is centrally located along a longitudinal axis of the flexible shaft.
33. 32. The instrument of claim 31 , wherein the optical fibers of the bundle are configured to direct light distally away from the distal end of the flexible shaft.
34. 32. The instrument of claim 31 , wherein the bundle includes a first subset of the plurality of optical fibers configured to operate at a first time and a second subset of the plurality of optical fibers configured to operate at a second time.
35. 32. The instrument of claim 31, wherein the bundle comprises an end-fired optical fiber and a plurality of side-fired fibers.
36. 24. The instrument of claim 22 or 23, further comprising three or more of the optical fibers arranged circumferentially along the flexible shaft to define a circumferential set of the optical fibers.
37. 37. The instrument of claim 36, wherein the optical fibers of the peripheral set are configured to direct light radially outwardly of the flexible shaft at the distal end of the flexible shaft.
38. 37. The instrument of claim 36, wherein the lumen is located radially inward of the circumferential set.
39. 37. The instrument of claim 36, further comprising a fluid port coupled to the flexible shaft, the fluid port in fluid communication with the lumen.
40. 40. The instrument of claim 39, further comprising a plurality of lumens located radially inward of said circumferential set, said fluid port being in fluid communication with said plurality of lumens.
41. Further comprising a hollow outer shaft; the flexible shaft is disposed within the outer shaft; the lumen is defined by an annular space between the flexible shaft and the outer shaft; the fluid port is coupled to the outer shaft; 40. The instrument of claim 39, wherein the outer shaft is longitudinally displaceable relative to the flexible shaft.
42. 24. The instrument of claim 22 or 23, wherein the laser control module is a component of a fiber laser system and includes at least a first laser diode.