The present disclosure relates generally to devices, systems, and methods for medical devices and, in particular, to devices, systems, and methods for transitioning shafts of medical devices from flexible configurations to rigid configurations.
Certain medical conditions, such as conditions of the prostate, may be treated by ablation, including by vapor ablation. Such ablation may be performed using a device having a sheath that is inserted into a body lumen or otherwise into a body of a subject (e.g., patient). Certain devices may include a rigid, straight shaft that is inserted into, for example, a urethra of a subject and advanced through the urethra to the prostatic urethra (a portion of the urethra passing through the prostate). During insertion, the rigid, straight shaft must navigate curved portions of the urethra carefully, so as to avoid causing a perforation. Therefore, use of the device may require high amounts of skill and increased amounts of procedure time to appropriately navigate the device. A rigid shaft may cause discomfort to a subject during insertion.
The systems, devices, and methods of the current disclosure may rectify some of the deficiencies described above, and/or address other aspects of the prior art.
A medical device may comprise a handle, which may include a grip portion; a body portion; and a ram housing extending proximally of the body portion; and a shaft having a first, proximal portion and a second, distal portion. The first portion of the shaft may include a first outer sheath. The second portion of the shaft may include a second outer sheath. The first outer sheath may be more rigid than the second outer sheath. The medical device may further comprise a rigid ram extending through at least a portion of the body portion and at least a portion of the shaft. The ram may be configured to be transitioned from a first, proximal configuration, in which the second portion of the shaft is flexible, and a second, distal configuration, in which the second portion of the shaft is rigid.
Any of the medical devices disclosed herein may include any or all of the following features. A proximal end of the ram may protrude from a proximal end of the body portion of the handle. The ram may be transitioned from the first configuration to the second configuration by moving the proximal end of the ram distally. The proximal end of the ram may include a tab. The proximal end of the ram may be received within the ram housing. The tab may extend through a slot in the ram housing. In the second configuration, the tab may abut a proximal surface of the body portion of the handle. An axis of the grip portion may be transverse to a longitudinal axis of the first portion of the shaft. In the first configuration, a distal-most end of the ram may be proximal of at least a portion of the second portion of the shaft. The first outer sheath may be approximately as rigid as a distal portion of the ram. At least a portion of the ram may have a cross-sectional shape that is approximately a segment of a circle or approximately an arc of a circle. At least the portion of the ram may include a curved, radially outward-facing surface, and an approximately planar, radially inward-facing surface. A guide, having a first arm and a second arm, may extend radially inwardly from the approximately planar, radially inward-facing surface. A lumen may be received between the first arm and the second arm. A needle may be received within the lumen. A distal opening of the needle may be in fluid communication with a vapor generator in the handle. The second portion of the shaft may include a flexible, tubular sheath.
In another example, a medical device may comprise a handle; a shaft having a first portion, having a rigid outer sheath, and a second portion, having a flexible outer sheath. Each of the first portion and the second portion of the shaft may be configured to be inserted into a body lumen of a subject. The medical device may also comprise a rigid ram that is configured to be transitioned from a first configuration, in which a distal-most end of the ram is proximal of the second portion of the shaft, to a second configuration, in which the distal-most end of the ram is within the second portion of the shaft. A proximal end of the ram may protrude from a proximal end of the handle, and the ram may be transitioned from the first configuration to the second configuration by moving the proximal end of the ram in a distal direction.
Any of the medical devices disclosed herein may include any or all of the following features. The second portion of the shaft may be bendable in the first configuration, and the second portion of the shaft is rigid in the second configuration. The proximal end of the ram is received within a ram housing. A tab of the proximal end of the ram may extend through a slot in the ram housing.
An exemplary medical method may comprise inserting a distal end of a shaft of a medical device into a body lumen of a subject; navigating the distal end of the shaft to a treatment location; and, after navigating the distal end of the shaft to the treatment location, moving a ram distally from a first configuration to a second configuration. A portion of shaft may be bendable in the first configuration. The portion of the shaft may be rigid in the second configuration. The method may further include, in the second configuration, extending a needle from a distal tip of the shaft; and delivering a vapor from the needle.
Any of the methods disclosed herein may include any or all of the following aspects. The body lumen may be a urethra. The vapor may be configured to ablate at least a portion of a prostate of the subject.
It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.” As used herein, the term “proximal” means a direction closer to an operator and the term “distal” means a direction further from an operator. Although vapor ablation devices may be referenced herein, such references should not be construed as limiting. The examples disclosed herein may also be used with other types of ablation mechanisms (e.g., cryoablation, RF ablation, or other types of ablation) or with other devices not relating to ablation. The terms approximately, substantially, and the like mean +/−10% from the stated value or other characteristic.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and together with the description, serve to explain the principles of the disclosure.
A medical device, such as a medical device for vapor ablation of a prostate, may include a handle and a shaft extending distally from the handle. At least a portion of the shaft may include a flexible sheath. The handle of the device may have a pistol-type grip, such that a portion of the handle that is gripped by a user extends transversely from a longitudinal axis of the shaft. A movable ram may extend parallel or coaxial with the longitudinal axis of the shaft, through at least a portion of the handle and through at least a portion of the shaft. A proximal end of the ram may protrude proximally out of the handle. In a first configuration, a distal end of the ram may be in a first, proximal position, such that the distal portion of the shaft is flexible and can be bent. In a second configuration, a distal end of the ram may be in a second, distal position, such that the ram stiffens at least a distal portion of the shaft. To transition between the first and the second configurations, the user may advance or retract the portion of the ram that protrudes proximally from the handle. Although the Figures and the description below describe different aspects of exemplary devices, the features of any of the devices disclosed herein may be combined in any manner, unless stated otherwise.
Shaft 14 may have a distal tip 16. Distal tip 16 may have an atraumatic shape (e.g., a rounded, bulbous shape) and may be made of any suitable material, including a plastic material, which may be transparent (e.g., acoustically transparent). Distal tip 16 may alternatively be made of metal, resin, Ultem®, polyurethane, or other materials, or a combination of materials. A needle, discussed further below with respect to
Shaft 14 may include a proximal portion 22 and a distal portion 24. Distal portion 24 may extend between a distal end of proximal portion 22 and a proximal end of distal tip 16. Distal portion 24 may include flexible components, such that distal portion 24 may be bendable in some configurations, as discussed below. For example, distal portion 24 may include a flexible, tubular, outer sheath, flexible lumen(s), a flexible needle, and flexible cables/wires. Shaft 14 may have any of the properties of any other shafts described herein, such as a shaft 214 (see
Proximal portion 22 of shaft 14 may be rigid. For example, proximal portion 22 may be rigid in all configurations of device 10/shaft 14. For example, proximal portion 22 may include a rigid, tubular, outer sheath. Proximal portion 22 may include any suitable material, such as, for example, plastic or metal. In alternatives, proximal portion 22 may include flexible components and may include the same or different materials as distal portion 24.
Shaft 14 may be sized and shaped so as to fit within a body lumen of a subject. For example, shaft 14 may have a length and width to accommodate a urethra. Shaft 14 may have a uniform diameter or a variable diameter. For example, shaft 14 may have a diameter that is approximately 20 French or approximately 10-30 French. Shaft 14 (including distal portion 24 and proximal portion 22) may have any suitable length dimensions, such as the length dimensions described below, with respect to a shaft 114 of device 100.
Handle 12 may have an approximately pistol shape, with a housing 52 extending approximately parallel to or coaxial with a central longitudinal axis Y of proximal portion 22 of shaft 14. Handle 12 may also include a grip portion 54, extending transversely to housing 52. Handle 12 (such as grip portion 54 of handle 12) may include a plurality of actuators, such as buttons 42 and 44, for controlling aspects of device 10. For example, button 44 may control a delivery of fluids (e.g., saline) through handle 12 and shaft 14. For example, a user may press button 42 to provide a fluid flush and/or to control deployment of the needle that extends through a lumen of shaft 14. For example, button 42 may include a two-stage button, such that depressing button 42 part-way delivers a fluid flush, and fully depressing button 42 causes the needle to deploy. Button 44 may control delivery of vapor, or another substance, through the needle. For example, a user may press button 42 partially to provide a flush and then further depress button 42 to cause a distal tip of the needle to extend from distal tip 16 of shaft 14. The needle may extend radially outwardly (e.g., transversely) from shaft 14 and may have a lumen extending therethrough to deliver vapor or other fluids through one or more openings at or near a distal-most end of the needle. The user may then press button 44 to deliver vapor or another substance, in order to ablate tissue (e.g., prostate tissue) near the needle.
A ram (not shown in
As shown in
In the first configuration (
Materials of distal portion 24 may be selected so as to provide a desired radius of curvature of distal portion 24. Any suitable radius of curvature may be chosen. The radius of curvature may correspond to a shape of a subject's anatomy. For example, a radius of curvature of distal portion 24 when it is bent may correspond to a curvature of a portion of the urethra, such as the membranous urethra, which passes through the pelvic floor and into the penis, between the prostatic urethra and the spongy urethra. As shown in
In the second configuration (
In use, an operator may perform a medical method, including inserting a distal tip of shaft 14 into a urethra of a subject in the first, flexible configuration (
An operator may additionally or alternatively slide tab 32 distally or proximally to positions between the proximal end of ram housing 36 and the distal end of ram housing 36, such that the distal end of the ram is within distal portion 24 of shaft 14 (between a proximal end of distal portion 24 and a proximal end of distal tip 16). A portion of distal portion 24 that is distal to the distal end of the ram may be relatively more flexible than a portion of distal portion 24 that is proximal to the distal end of the ram. In other words, the ram may extend partially through distal portion 24, with a portion of distal portion 24 through which the ram extends being relatively more rigid than a portion of distal portion 24 through which the ram does not extend. Ram housing 36 may include markings or intermediate stops or locks to allow an operator to adjust the ram to a predefined position within distal portion 24.
Thus, device 10 may provide for a desired flexibility during insertion, while providing a stiffness that is familiar to operators who have used existing devices during delivery of the treatment. An operator may also opt to operate device 10 only in the second configuration. In such a scenario, an operator may activate a lock to retain the ram and other elements of device 10 in the rigid configuration. An operator may prefer to insert shaft 14 into a body lumen with shaft 14 in the rigid configuration (
Device 100 may include a handle 112 and a shaft 114. Shaft 114 may include a distal tip 116. Handle 112, shaft 114, and distal tip 116 may have any of the properties of handle 12, shaft 14, and distal tip 16, respectively, described above. Handle 112 may include buttons 142, 144, which may have any of the properties of buttons 42, 44, respectively, discussed above.
Shaft 114 may include a proximal portion 122 and a distal portion 124. Proximal portion 122 may have any of the features of proximal portion 22, described above. Distal portion 124, like distal portion 24, may include flexible materials and any of the same features. Shaft 114 may have any suitable length. For example, a total length of shaft 114 (including distal tip 116) may be approximately 23.12 cm, or a total length of approximately 15 cm to approximately 30 cm. A length “A” of distal tip 116 may be approximately 2.8 cm, or a length “A” of distal tip 116 may be approximately 2.5 cm to approximately 3 cm. A length “B” of proximal portion 122 may be approximately 12.7 cm, or a length “B” of proximal portion 122 may be approximately 10 cm to approximately 15 cm. A length “C” (see
Materials of distal portion 124 may be selected so as to provide a desired radius of curvature of distal portion 124 when distal portion 124 is in the first configuration. Any suitable radius of curvature may be chosen. The radius of curvature may correspond to a shape of a subject's anatomy. For example, a radius of curvature of distal portion 124 when it is bent may be approximately 5 cm, or approximately 3 m to approximately 7 cm, corresponding to a curvature of a portion of the urethra, such as the membranous urethra, which passes through the pelvic floor and into the penis, between the prostatic urethra and the spongy urethra. As shown in
Ram 130 may extend through a housing 152 of handle 112, parallel to or coaxial with a central longitudinal axis Z of shaft 114. Ram 130 may pass through handle 112 without interfering with other components housed in handle 112 (e.g., conduits, wires, actuators, generators, etc.). For example, a vapor generator 160 may be disposed within a grip 154 of handle 112. The vapor generator 160 may be in fluid communication with a lumen (not shown) of a needle 172 extending through shaft 114, and with one or more openings at or near a distal end of the needle 172. For example, a flexible tube (not shown) may be attached to and extend from vapor generator 160 to the proximal end of needle 172. A fluid connector 164 (
A position of ram 130 within shaft 114 may depend upon whether ram 130 is in the first (flexible) configuration of
Device 100 may be operated similarly to device 10, discussed above, to perform a medical method. An operator may insert distal tip 116 of shaft 114 into a urethra of a subject, and advance shaft 114 distally into the urethra. After shaft 114 is positioned such that distal tip 116 is within the prostatic urethra and in a desired location to deliver treatment, the operator may transition the device 100 to the second, rigid configuration. To transition device 100 to the second configuration, the operator may slide tab 132 and the ram 130 distally, relative to ram housing 136, handle 112, and shaft 114. In the second configuration, tab 132 may abut a proximal end of housing 152 of handle 112, such that housing 152 acts as a stop for tab 132 (and the ram 130). The distal end of the ram 130 may extend to or near to distal tip 116 and a distal end of distal portion 124. The ram 130 may stiffen distal portion 124, such that it becomes rigid. With shaft 114 in the second configuration, the operator may deliver a treatment to the subject. For example, the user may depress button 142 in order to deploy a vapor delivery needle and button 144 in order to transurethrally deliver vapor to a prostate of the subject. An operator also may transition device 100 from the second (rigid) configuration to a first (flexible) configuration during a procedure. For example, the operator may move or otherwise slide tab 132 and ram 130 proximally, relative to ram housing 136, handle 112, and shaft 114. The operator may then move a position of distal tip 116, deliver further treatment, and/or withdraw shaft 114 from the body lumen.
Thus, device 100 may provide for a desired flexibility during insertion, while providing a stiffness that is familiar to operators who have used existing devices during delivery of the treatment. An operator may also opt to operate device 100 only in the second configuration. An operator may prefer to insert shaft 114 into a body lumen with shaft 114 in a rigid configuration. For example, the operator may prefer to use the rigid configuration due to operator preference, an anatomy of the subject, a type of treatment, or any other reason. Device 100 may thus provide adaptability in use, such that different operators may use device 100 subject to their own preferences. Device 100 thus may help institutions to avoid needing to buy multiple different types of devices to satisfy the preferences of different operators.
A rigid ram 230 may extend through shaft 214. At least portions of ram 230 may be more rigid than an outer sheath of distal portion 224 of shaft 214. Ram 230 may have any of the properties of the rams discussed above with respect to
Other, more proximal portions of ram 230, not shown in
A size of second portion 238 (e.g., its relatively larger size as compared to first portion 234) may facilitate stiffening of distal portion 224 of shaft 214. For example, second portion 238 may occupy a large enough area within an interior of sheath 226 and/or extend around a sufficient portion of a circumference of sheath 226 to provide a stiffening of distal portion 224. A curved surface of second portion 238 may be near to an inner surface of sheath 226 or may abut the inner surface of sheath 226, to provide stiffening. It may be beneficial to have first portion 234 occupy a smaller cross-sectional space, to provide more room for other components to pass through a proximal portion of shaft 214. The larger size of second portion 238 may also result in second portion 238 being relatively stiffer than first portion 234. The larger size of second portion 238 may prevent inadvertent bending of ram 230 within shaft 214.
A third portion 236 of ram 230 may extend between first portion 234 and second portion 238. Third portion 236 may remain within proximal portion 222 of shaft 214 in any configuration of ram 230 (discussed in further detail below). Third portion 236 may have any of the properties of second portion 238 and may additionally include the features described below. Third portion 236 may include a guide 237 may protrude radially inwardly toward the central longitudinal axis of shaft 214, from a radially inner surface of third portion 236 (e.g., from a planar surface of third portion 236). Guide 237 may include two arms. Radially outer surfaces of the arms may be curved. A radius of curvature of the outer surfaces of the arm may be substantially the same as a radius of curvature of the radially-outer, curved surface of third portion 236. Radially inner surfaces of the arms of guide 237 may be approximately planar. Alternatively, radially inner surfaces of the arms of guide 237 may be curved. For example, a curved radially inner surface of the arms of guide 237 may complement an outer surface of needle lumen 272. Needle lumen 272 may be received between the arms of guide 237. The arms of guide 237 may be movable (e.g., slidable) relative to needle lumen 272. Ram 230, including first portion 234, second portion 238, guide 237, and distal-most end 239, may be formed of a single, integral piece (i.e., may be a monolithic structure) or may be formed of separate components that are joined together.
Ram 230 may be movable (e.g., slidable) proximally and distally relative to sheath 226 and other components of shaft 214. In a first configuration (not shown), a distal-most end 239 of ram 230 may be proximal of distal portion 224 of shaft 214. Because distal portion 224 may be flexible, distal portion 224 may bend (e.g., passively or actively, via articulation mechanisms) when ram 230 is in the first configuration and does not extend into distal portion 224. In a second configuration (shown in
As ram 230 moves proximally and/or distally, needle lumen 272 may remain within the arms of guide 237. Guide 237 may retain both ram 230 and needle lumen 272 in their respective positions within sheath 226. For example, guide 237 may maintain a gap between a surface of ram 230 and a surface of needle lumen 272. Guide 237 may assist in maintaining a position of second portion 238 near or contacting an inner surface of sheath 226, to provide for a desired stiffness of distal portion 224. Third portion 236 may remain within proximal portion 222 of shaft 214 in both the first and the second configurations. Because an outer surface shape of third portion 236 may be very similar to an inner surface shape of sheath 226 (e.g., an outer diameter of third portion 236 may be approximately the same as an inner diameter of sheath 226), very little play (e.g., non-axial movement) may be permitted between third portion 236 and sheath 226. Ram 230 may function similarly to a cantilever beam fixed on one end, with a fixed end being comparable to third portion 236, and the beam being comparable to second portion 234. Third portion 236 may thus enhance rigidity of shaft 214 when ram 230 is in the second configuration.
As motor 332 rotates lead screw 334 in the first direction, nut 333 may travel distally along lead screw 334. Nut 333 may move truss 335 distally, as truss 335 is fixed to nut 333. Truss 335 may, in turn, move ram 330 distally, as truss 335 is fixed to ram 330. Ram 330 may eventually move into a position in which ram 330 is fully extended distally (e.g., a position of ram 230 in
Any suitable actuator may be utilized in order to actuate motor 332 and, in turn, move ram 330 proximally or distally. In some examples, one of buttons 142, 144 may actuate motor 332, in addition to or in alternative to the functions described above for buttons 42, 44, 142, 144. Alternatively, handle 312 may include an additional actuator (e.g., button, switch, lever, knob, or other actuator, not shown) for actuating motor 332 and moving ram 330 proximally or distally.
In the example depicted in
In the example in which actuator 432 is a slider, actuator 432 may be moved proximally or distally, in the directions shown by the arrows of
A range of motion of actuator 432 may correspond to configurations in which ram 430 is moved fully proximally or fully distally. For example, when actuator 432 is moved as distally as possible (e.g., to a distal end of a slot in housing 152), ram 430 may be fully retracted proximally. When actuator 432 is moved as proximally as possible (e.g., to a proximal end of a slot in housing 152), ram 430 may be fully extended distally.
An operator may rotate handle 537 about an axis of pivot 535, in directions shown by the arrow of
A range of motion of lever 532 may correspond to configurations in which ram 530 is moved fully proximally or fully distally. For example, when lever 532 is moved fully counter-clockwise (e.g., until handle 537 contacts housing 152 or until lever 532 reaches an end of a slot in housing 152), ram 430 may be fully retracted proximally. When lever 532 is moved as far clockwise as possible (e.g., until handle 537 contacts housing 152 or until lever 532 reaches an end of a slot in housing 152), ram 430 may be fully extended distally.
The above-described mechanisms for actuating the rams discussed above are merely exemplary. It will be appreciated that other mechanisms, including a slide on an outside of a shaft (e.g., shaft 14, 114) that is magnetically coupled to any of the rams discussed above, linkages, hydraulic/pneumatic internal cylinders, or solenoid actuators may be used to actuate the rams discussed above.
While principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, and substitution of equivalents all fall within the scope of the examples described herein. Accordingly, the invention is not to be considered as limited by the foregoing description.
This patent application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63/366,539, filed Jun. 17, 2022, which is herein incorporated by reference in its entirety.
Number | Date | Country | |
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63366539 | Jun 2022 | US |