Systems, instruments, and methods for medical devices

Abstract

A medical device may include a handle that may include a grip portion, a body portion, and a pusher housing extending proximal to 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 include a rigid pusher extending through at least a portion of the body portion and at least a portion of the shaft. The pusher may be configured to transition between 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.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63 / 366,539, filed on June 17, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to devices, systems, and methods for medical devices, and in particular, to devices, systems, and methods for transitioning a shaft of a medical device from a flexible configuration to a rigid configuration. Background Art

[0004] Certain medical conditions (such as prostate conditions) can be treated by ablation (including by steam ablation). Such ablation can be performed using a device having a sheath that is inserted into a body cavity or otherwise inserted into the body of a subject (patient). Certain devices may include a rigid straight shaft that is inserted into, for example, the urethra of a subject and advanced through the urethra to the prostatic urethra (a portion of the urethra that passes through the prostate). During insertion, the rigid straight shaft must be carefully guided through the curved portion of the urethra to avoid causing perforations. Therefore, the use of the device may require a great deal of skill and increased surgical time to properly guide the device. The rigid shaft may cause discomfort to the subject during insertion.

[0005] The systems, devices, and methods of the present disclosure may remedy some of the deficiencies described above and / or address other aspects of the prior art. Summary of the invention

[0006] A medical device may include a handle that may include a grip portion, a body portion, and a pusher 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 include a rigid pusher extending through at least a portion of the body portion and at least a portion of the shaft. The pusher may be configured to switch between a first proximal configuration and a second distal configuration, in which the second portion of the shaft is flexible and in which the second portion of the shaft is rigid.

[0007] Any medical device disclosed herein may include any or all of the following features. The proximal end of the pusher may protrude from the proximal end of the main body of the handle. The pusher may be converted from the first configuration to the second configuration by moving the proximal end of the pusher distally. The proximal end of the pusher may include a tab. The proximal end of the pusher may be received in the pusher housing. The tab may extend through a slot in the pusher housing. In the second configuration, the tab may abut the proximal surface of the main body of the handle. The axis of the gripping portion may be transverse to the longitudinal axis of the first portion of the shaft. In the first configuration, the distal end of the pusher may be located proximal to at least a portion of the second portion of the shaft. The first outer sheath may have substantially the same rigidity as the distal portion of the pusher. The cross-sectional shape of at least a portion of the pusher may be a substantially circular segment or a substantially circular arc. At least a portion of the pusher may include a curved radially outwardly facing surface and a substantially flat radially inwardly facing surface. A guide having a first arm and a second arm may extend radially inwardly from a substantially flat radially inwardly facing surface. The lumen may be received between the first arm and the second arm. The needle may be received in the lumen. The distal opening of the needle may be in fluid communication with a steam generator in the handle. The second portion of the shaft may include a flexible tubular sheath.

[0008] In another example, a medical device may include a handle; a shaft having a first portion and a second portion, the first portion having a rigid outer sheath, the second portion having a flexible outer sheath. Each of the first portion and the second portion of the shaft can be configured to be inserted into a body cavity of a subject. The medical device may also include a rigid pusher configured to be converted from a first configuration to a second configuration, in which the distal end of the pusher is located proximal to the second portion of the shaft, and in the second configuration, the distal end of the pusher is within the second portion of the shaft. The proximal end of the pusher may protrude from the proximal end of the handle, and the pusher may be converted from the first configuration to the second configuration by moving the proximal end of the pusher in a distal direction.

[0009] Any medical device disclosed herein may include any or all of the following features. The second portion of the shaft may be bendable in the first configuration, while the second portion of the shaft is rigid in the second configuration. The proximal end of the pusher is received within the pusher housing. The tab of the proximal end of the pusher may extend through a slot in the pusher housing.

[0010] An exemplary medical method may include inserting a distal end of a shaft of a medical device into a body cavity of a subject; directing the distal end of the shaft to a treatment location; and after directing the distal end of the shaft to the treatment location, moving a pusher distally from a first configuration to a second configuration. A portion of the 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 extending a needle from the distal end of the shaft in the second configuration; and delivering steam from the needle.

[0011] Any of the methods disclosed herein may include any or all of the following aspects. The body cavity may be a urethra. The steam may be configured to ablate at least a portion of a prostate of the subject.

[0012] It is understood that the general description above and the detailed description below are only exemplary and explanatory and do not limit the present invention as claimed. As used herein, the terms "include", "comprising" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus including a series of elements includes not only those elements explicitly listed, but also other elements that are not explicitly listed or inherent to such process, method, article or apparatus. The term "exemplary" is used to mean "example" rather than "ideal". As used herein, the term "proximal" means the direction closer to the operator, and the term "distal" means the direction farther away from the operator. Although this article may refer to a steam ablation device, such reference should not be interpreted as limiting. The examples disclosed herein may also be used in conjunction with other types of ablation mechanisms (e.g., cryoablation, RF ablation or other types of ablation) or other devices unrelated to ablation. The terms "substantially", "substantially", etc., mean a difference of + / -10% from the stated value or other features. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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 present disclosure.

[0014] Figure 1A and Figure 1B A side view of an exemplary medical device is depicted.

[0015] Figure 2A and Figure 2B A partial schematic side view of another exemplary medical device is depicted.

[0016] Figure 2C Depicted Figure 2A and Figure 2B A partially transparent perspective view of a portion of an exemplary medical device.

[0017] Figure 3 Depicted Figure 1A-Figure 2BA schematic diagram of a portion of the distal end of any medical device.

[0018] Figure 4-Figure 6 Alternative medical devices are depicted. DETAILED DESCRIPTION

[0019] A medical device (such as a medical device for steam ablation of the 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 grip so that the portion of the handle gripped by the user extends transversely from the longitudinal axis of the shaft. A movable pusher may extend parallel or coaxially with the longitudinal axis of the shaft, pass through at least a portion of the handle and pass through at least a portion of the shaft. The proximal end of the pusher may protrude proximally out of the handle. In a first configuration, the distal end of the pusher may be in a first proximal position so that the distal portion of the shaft is flexible and can be bent. In a second configuration, the distal end of the pusher may be in a second distal position so that the pusher hardens at least the distal portion of the shaft. In order to switch between the first configuration and the second configuration, the user may advance or retract the portion of the pusher protruding proximally from the handle. Although the drawings and the following description describe different aspects of the exemplary device, unless otherwise described, the features of any device disclosed herein can be combined in any manner.

[0020] Figure 1A and Figure 1B The first configuration ( Figure 1A ) and the second construction ( Figure 1B ) is a side view of an exemplary medical device 10 of the present invention. Medical device 10 (also referred to herein as device 10) (or any other medical device disclosed herein) may include a duodenoscope, an endoscope, a gastroscope, an endoscopic ultrasound ("EUS") scope, a colonoscope, a ureteroscope, a bronchoscope, a laparoscope, a cystoscope, an aspirator, a sheath, a catheter, or other device having a shaft for insertion into a body cavity or other opening in the body. Medical device 10 may include a medical tool, such as an ablation device. Device 10 may include a handle 12 and a shaft 14, which may be inserted into a body cavity of a subject or otherwise enter the body of a subject (e.g., through tissue of a subject, such as via a transperineal approach or a laparoscopic approach). Device 10 may also include a pusher (at the Figure 1A and Figure 1B Not shown, but having any characteristics of the pusher 130, such as Figure 2A and Figure 2B ), the pusher can be moved between a first (proximal) configuration and a second (distal) configuration, as described below.

[0021] The shaft 14 can have a distal tip 16. The distal tip 16 can have an atraumatic shape (e.g., a round, spherical shape) and can be made of any suitable material, including a plastic material that can be transparent (e.g., acoustically transparent). Alternatively, the distal tip 16 can be made of metal, resin, Polyurethane or other materials or combinations of materials. Figure 3 A needle, discussed further, may extend through the lumen of shaft 14 and through the opening of distal tip 16. Other lumens, cables, wires, etc. may also extend through shaft 14 and / or distal tip 16.

[0022] The shaft 14 may include a proximal portion 22 and a distal portion 24. The distal portion 24 may extend between a distal end of the proximal portion 22 and a proximal end of the distal tip 16. The distal portion 24 may include a flexible component so that the distal portion 24 may be bendable in some configurations, as described below. For example, the distal portion 24 may include a flexible tubular outer sheath, a flexible lumen, a flexible needle, and a flexible cable / wire. The shaft 14 may have any other shaft described herein (such as the shaft 214 discussed below (see Figure 2A -B)). Some of the shaft 14 (e.g., the distal portion 24) or all of the shaft 14 may include, for example, polytetrafluoroethylene ("PTFE"), thermoplastic elastomer ("TPE"), nylon, or polyethylene urethane. In some configurations, the distal portion 24 can be passively bendable so that when the shaft 14 is inserted into a body cavity, the shaft 14 can bend when it encounters a body structure. For example, the shaft 14 can bend when it passes through a curved portion of the subject's urethra. In an alternative, the distal portion 24 can be articulated by the user via one or more actuators of the handle 12 connected to a wire or cable that is fixed or otherwise operably coupled to the distal portion 24.

[0023] The proximal portion 22 of the shaft 14 can be rigid. For example, the proximal portion 22 can be rigid in all configurations of the device 10 / shaft 14. For example, the proximal portion 22 can include a rigid tubular outer sheath. The proximal portion 22 can include any suitable material, such as plastic or metal. In an alternative, the proximal portion 22 can include a flexible component and can include the same or different material as the distal portion 24.

[0024] The size and shape of shaft 14 can be designed to fit the body cavity of the subject. For example, shaft 14 can have a length and width to accommodate the urethra. Shaft 14 can have a uniform diameter or a variable diameter. For example, shaft 14 can have a diameter of about 20 French or about 10-30 French. Relative to shaft 114 of device 100, shaft 14 (including distal portion 24 and proximal portion 22) can have any suitable length dimension, such as the length dimension described below.

[0025] The handle 12 can have a generally pistol-like shape, wherein the housing 52 extends generally parallel to or coaxially with the central longitudinal axis Y of the proximal portion 22 of the shaft 14. The handle 12 can also include a grip portion 54 extending transversely to the housing 52. The handle 12 (such as the grip portion 54 of the handle 12) can include a plurality of actuators, such as buttons 42 and 44, for controlling various aspects of the device 10. For example, the button 44 can control the delivery of a fluid (e.g., saline) through the handle 12 and the shaft 14. For example, a user can press the button 42 to provide a fluid flush and / or control the deployment of a needle extending through the lumen of the shaft 14. For example, the button 42 can include a two-stage button, so that partially pressing the button 42 delivers a fluid flush, and fully pressing the button 42 causes the needle to deploy. The button 44 can control the delivery of steam or another substance through the needle. For example, the user can partially press the button 42 to provide a flush, and then further press the button 42 to cause the distal end of the needle to extend from the distal end 16 of the shaft 14. The needle may extend radially outward (e.g., laterally) from the shaft 14 and may have a lumen extending therethrough to deliver steam or other fluids through one or more openings at or near the distal end of the needle. The user may then press button 44 to deliver steam or another substance to ablate tissue near the needle (e.g., prostate tissue).

[0026] Pusher( Figure 1A and 1B The pusher (not shown) may extend through at least a portion of the shaft 14 and at least a portion of the housing 52 of the handle 12 and protrude proximally from the proximal end of the housing 52. The pusher may have a configuration as described below with reference to Figure 2A and Figure 2BThe pusher 130 of any feature. The pusher housing 36 can extend proximally from the handle 12, and can receive the proximal portion of the pusher. The lug 32 can be fixed to the most proximal end (or another part) of the pusher. The lug 32 can extend radially outward from the pusher. The pusher housing 36 can include a slot or other opening extending longitudinally along the pusher housing 36, so that the lug 32 can extend through the slot to protrude radially outward from the pusher housing 36. The pusher housing 36 can be roughly the same length as the distal portion 24. The pusher, lug 32 and / or the pusher housing 36 can include one or more locking members to keep the pusher in a selected position. Such locking members can include, for example, connecting rods, knobs, slots or other features, and can be operated according to friction or by blocking the portion of the slot extending longitudinally along the pusher housing 36.

[0027] like Figure 1A and Figure 1B As shown, the pusher can be used to convert the device 10 from a first configuration, in which the distal portion 24 of the shaft 14 is flexible, to a second configuration, in which the distal portion 24 of the shaft 14 (and the proximal portion 22 of the shaft 14) are rigid. Figure 1A ), the pusher can be in a first proximal configuration (e.g., a retracted configuration). In a second configuration ( Figure 1B ), the pusher can be in a second distal configuration (e.g., an extended configuration). The first configuration can be used during the insertion of shaft 14 into a body cavity (e.g., the urethra) of a subject. Because distal portion 24 is flexible in the first configuration, it can be guided through curved portions of the subject's anatomical structure. The flexibility of distal portion 24 can make insertion easier, less time-consuming, less prone to accidental perforations through the body cavity, and more comfortable for the subject. As described below, the operator can use the pusher to convert device 10 to the second configuration ( Figure 1B ). For example, the operator can convert the device 10 to the second configuration after positioning the shaft 14 in the body cavity. In the example where the device 10 is a steam ablation device, when the device is in the second (rigid) configuration, steam can be delivered to the prostate through the needle. The steam can be configured to ablate at least a portion of the prostate. In the rigid configuration, the features of the device 10 can be similar to the features of a device having a shaft that is always rigid. Delivering treatment with the device 10 in the second configuration can provide familiarity to operators who are already familiar with devices having rigid shafts. Therefore, the operator may not require extensive retraining and can provide performance similar to that of a device having a completely rigid shaft.

[0028] In the first construction ( Figure 1A), the protrusion 32 can be located at or near the proximal end of the pusher housing 36, and the pusher can be in a proximal configuration so that the distal-most end of the pusher is located at or near the proximal end of the distal portion 24 of the shaft 14. Since the pusher does not extend through the distal portion 24, the distal portion 24 can be flexible and can be passively bent when the distal portion 24 moves through the anatomical structure of the subject. For example, the distal portion 24 can bend when it passes through a tortuous portion of a body cavity (such as the urethra). In the first configuration, the distal portion 24 can have sufficient columnar force so that it can be advanced through the anatomical structure of the subject (e.g., through the body cavity of the subject). The locking member can be activated to hold the pusher in the first configuration.

[0029] The material of the distal portion 24 can be selected to provide a desired radius of curvature of the distal portion 24. Any suitable radius of curvature can be selected. The radius of curvature can correspond to the shape of the subject's anatomy. For example, the radius of curvature of the distal portion 24 when it is curved can correspond to the curvature of a portion of the urethra located between the prostatic urethra and the spongy urethra, such as the membranous urethra that passes through the pelvic floor and enters the penis. Figure 1A As shown, the distal portion 24 may be bendable such that the distal tip 16 deflects more than 90 degrees from the longitudinal axis Y of the proximal portion 22 .

[0030] In the second construction ( Figure 1B ), the protrusion 32 can be located at or near the distal end of the pusher housing 36, and the pusher can be in a distal configuration so that the distal-most end of the pusher is located at or near the distal tip 16. Because the pusher extends through the distal portion 24, the distal portion 24 can be more rigid than the first configuration (FIG. 1). For example, in the second configuration, the entire shaft 14 (including the proximal portion 22 and the distal portion 24) can have a uniform stiffness. In other words, in the second configuration, the distal portion 24 can have the same stiffness as the proximal portion 22. When delivering treatment at a desired treatment location, the distal portion 24 can be used to deliver the desired treatment location. Figure 1B In the second configuration, the distal portion 24 and the proximal portion 22 may be substantially coaxial regardless of the force exerted on the distal portion 24 by the subject's anatomy. The locking member may be activated to hold the pusher in the second configuration.

[0031] In use, an operator can perform a medical procedure, including placing the device in a first flexible configuration ( Figure 1A ) is inserted into the subject's urethra and the distal tip 16 is advanced distally within the urethra. After the shaft 14 is positioned so that the distal tip 16 is within the prostatic urethra and in a desired position for delivering treatment, the operator can switch the device to a second rigid configuration ( Figure 1B ). To convert the device 10 to the second configuration, the operator can move or otherwise slide the lug 32 and the pusher relative to the pusher housing 36, the handle 12, and the shaft 14 distally. In the second configuration, the lug 32 can abut the proximal end of the housing 52 of the handle 12, so that the housing 52 serves as a stop for the lug 32 (and the pusher). The distal end of the pusher can extend to or near the distal end 16 and the distal end of the distal portion 24. During the extension or advancement of the pusher relative to the shaft 14, the pusher hardens the distal portion 24, thereby making the distal portion have become more rigid. When the shaft 14 is in the second configuration, the operator can deliver treatment to the subject. For example, the user can press the button 42 to advance the needle, and press the button 44 to deliver steam to the prostate of the subject through the urethra. During surgery, the operator can also convert the device 10 from the second (rigid) configuration to the first (flexible) configuration. For example, the operator may move or otherwise slide the tab 32 and pusher proximally relative to the pusher housing 36, the handle 12, and the shaft 14. The operator may then move the position of the distal tip 16, deliver further therapy, and / or withdraw the shaft 14 from the body cavity.

[0032] The operator can additionally or alternatively slide the tab 32 distally or proximally to a position between the proximal end of the pusher housing 36 and the distal end of the pusher housing 36 so that the distal end of the pusher is located within the distal portion 24 of the shaft 14 (between the proximal end of the distal portion 24 and the proximal end of the distal tip 16). The portion of the distal portion 24 distal to the distal end of the pusher can be relatively more flexible than the portion of the distal portion 24 proximal to the distal end of the pusher. In other words, the pusher can partially extend through the distal portion 24, and the portion of the distal portion 24 through which the pusher extends is relatively more rigid than the portion of the distal portion 24 through which the pusher does not extend. The pusher housing 36 can include a marking or an intermediate stop or lock to allow the operator to adjust the pusher to a predetermined position within the distal portion 24.

[0033] Thus, the device 10 can provide the desired flexibility during insertion while providing a stiffness during treatment delivery that is familiar to operators using existing devices. The operator may also choose to operate the device 10 only in the second configuration. In this case, the operator can actuate the locking member to maintain the pusher and other elements of the device 10 in the rigid configuration. The operator may prefer to operate the device 10 in the rigid configuration ( Figure 1B) is inserted into the body cavity. For example, due to operator preference, subject anatomy, treatment type, or any other reason, an operator may prefer to use a rigid configuration. Thus, the device 10 can provide adaptability in use so that different operators can use the device 10 according to their own preferences. Therefore, the device 10 can help institutions avoid purchasing multiple different types of devices to meet the preferences of different operators.

[0034] Figure 2A and Figure 2B The first flexible configuration ( Figure 2A ) and the second rigid structure ( Figure 2B ) device 100. Figure 2C A partially transparent perspective view of a portion of device 100 is shown. Unless otherwise specified, device 100 may have any of the features of device 10 described above. Where possible, Figure 2A-2C The reference numerals are in Figure 1A and Figure 1B Add 100 to a similar structure.

[0035] 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 characteristics 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 characteristics of buttons 42, 44, respectively, described above.

[0036] The shaft 114 can include a proximal portion 122 and a distal portion 124. The proximal portion 122 can have any of the features of the proximal portion 22 described above. Similar to the distal portion 24, the distal portion 124 can include a flexible material and any of the same features. The shaft 114 can have any suitable length. For example, the total length of the shaft 114 (including the distal end 116) can be approximately 23.12 cm, or a total length of approximately 15 cm to approximately 30 cm. The length "A" of the distal end 116 can be approximately 2.8 cm, or the length "A" of the distal end 116 can be approximately 2.5 cm to approximately 3 cm. The length "B" of the proximal portion 122 can be approximately 12.7 cm, or the length "B" of the proximal portion 122 can be approximately 10 cm to approximately 15 cm. The length "C" of the distal portion 124 (see Figure 2B ) can be approximately 7.62 cm, or the length "C" of the distal portion 124 can be approximately 2 cm to approximately 112 cm. The above dimensions are merely exemplary, and other dimensions can be used. For example, for medical devices 100 configured for different types or sizes of anatomical structures, the size of the portion of the shaft 114 can vary.

[0037] The material of the distal portion 124 can be selected to provide a desired radius of curvature of the distal portion 124 when the distal portion 124 is in the first configuration. Any suitable radius of curvature can be selected. The radius of curvature can correspond to the shape of the subject's anatomy. For example, the radius of curvature of the distal portion 124 when bent can be about 5 cm, or about 3 cm to about 7 cm, corresponding to the curvature of a portion of the urethra, such as the membranous urethra that passes through the pelvic floor and enters the penis, between the prostatic urethra and the spongy urethra. Figure 2A As shown, the distal portion 124 can be bendable in a first configuration such that the distal tip 116 deflects approximately 90 degrees from the longitudinal axis of the proximal portion 122. As compared to the device 10, the distal tip of the device 100 can deflect a smaller amount.

[0038] Figure 2A and Figure 2B A pusher 130 is shown extending through a pusher housing 136 that protrudes proximally from the proximal end of the handle 112. The proximal end of the pusher 130 may include a body 133 that may be fixed to a tab 132. The body 133 may include or be similar to a plunger. For example, the body 133 may have a generally cylindrical shape with a wider radius / diameter than the pusher 130. The body 133 may facilitate linear longitudinal movement of the pusher 130 without the pusher 130 bending or otherwise deflecting. In fact, in one arrangement, the radially outer surface of the body 133 may contact and slide along the radially inner surface of the pusher housing 136. The tab 132 may extend radially outward from the body 133 of the pusher 130, through the pusher housing 136 (e.g., via a slot 137 ( Figure 2C ) or other openings). The tab 132 may include any suitable features, such as a hole that facilitates the operator's grip. For example, such a slot or opening may extend along the length of the pusher housing 136, so that manipulating the tab 132 in the axial direction will cause the tab 132 to translate relative to the slot or opening, thereby advancing and retracting the pusher 130 relative to the pusher housing, the handle 112, and the shaft 114. In other words, the length of the slot or opening of the pusher housing 136 may define the stroke length of the pusher 130. In some arrangements, the opening or slot may extend through the most proximal end of the pusher housing 136, so that the tab 132 and, accordingly, the pusher 130 may be withdrawn proximally from the device 100. In other arrangements, the slot or opening may terminate at a position proximal to the most proximal end of the pusher housing 136, so that the proximal end of the slot or opening forms a stop to limit further axial withdrawal of the pusher 130. In other words, in this arrangement, the pusher 130 cannot be removed from the pusher housing 136 and the device 100 .

[0039] The pusher 130 can extend through the housing 152 of the handle 112, parallel to or coaxial with the central longitudinal axis Z of the shaft 114. The pusher 130 can pass through the handle 112 without interfering with other components (e.g., catheters, wires, actuators, generators, etc.) contained in the handle 112. For example, the steam generator 160 can be disposed within the grip 154 ​​of the handle 112. The steam generator 160 can be fluidically connected to a lumen (not shown) of a needle 172 extending through the shaft 114, and to one or more openings at or near the distal end of the needle 172. For example, a flexible tube (not shown) can be attached to the steam generator 160 and extend from the steam generator to the proximal end of the needle 172. The fluid connector 164 ( Figure 2C ) can provide a connection between a source of fluid (e.g., fluid that can provide irrigation, cooling, and / or steam) and / or a catheter. For example, the fluid connector 164 may include two legs 165, 166 for receiving tubing that provides fluid for irrigation, cooling, and / or steam ablation. The pusher 130 can extend longitudinally through the fluid connector 164. One or more seals (e.g., O-ring seals) can be used between the fluid connector 164, the pusher 130, and / or other tubing of the handle 112 to prevent or stop fluid leakage. The pusher 130 can pass through an actuator 162, such as a magnetic actuator (e.g., a solenoid actuator) or other type of actuator, for actuating a steam delivery needle. For example, as Figure 2C As shown, the actuator 162 can define a central opening through which the pusher 130 can pass. The pusher 130 can further extend into the shaft 114 so that axial advancement of the pusher 130 will cause the shaft 114 to move from the first flexible configuration ( Figure 2A ) to the second rigid configuration ( Figure 2B ).

[0040] The position of the pusher 130 within the shaft 114 may vary depending on whether the pusher 130 is in a Figure 2A The first (flexible) configuration is still Figure 2B. In the first configuration, the pusher 130 may be in a first proximal configuration. In the second configuration, the pusher 130 may be in a second distal configuration. In the first (flexible) configuration, the distal-most end of the pusher 130 may be disposed at or near the proximal end of the distal portion 124. In the second (rigid) configuration, the distal-most end of the pusher 130 may be disposed at or near the distal end of the distal portion 124 / at or near the proximal end of the distal tip 116. In the first (flexible) configuration, the proximal-most end of the pusher 130 may be disposed at or near the proximal end of the pusher housing 136. In the second (rigid) configuration, the proximal-most end of the pusher 130 may be disposed at or near the distal end of the pusher housing 136 so that the protrusion 132 abuts the housing 152. As described above with respect to Figure 1A and Figure 1B As discussed, the pusher 130, the tab 132, and / or the pusher housing 136 may include one or more locking members having any of the characteristics discussed above. The locking member may be used to maintain the pusher 130 in a predetermined position (e.g., in the first configuration or the second configuration). Additionally or alternatively, the locking member may help maintain the pusher 130 at a position between the positions in the first configuration and the second configuration. As discussed above with respect to Figure 1A and Figure 1B As discussed, such intermediate positions of the pusher 130 may allow an operator to select to make the shaft 14 more or less flexible.

[0041] Device 100 can be operated similar to device 10 described above to perform a medical method. The operator can insert the distal end 116 of shaft 114 into the urethra of the subject and advance shaft 114 distally into the urethra. After shaft 114 is positioned so that distal end 116 is located in the prostatic urethra and in a desired position to deliver treatment, the operator can switch device 100 to a second rigid configuration. In order to switch device 100 to a second configuration, the operator can slide lug 132 and pusher 130 distally relative to pusher housing 136, handle 112 and shaft 114. In the second configuration, lug 132 can abut the proximal end of the housing 152 of handle 112 so that housing 152 serves as a stopper for lug 132 (and pusher 130). The distal end of pusher 130 can extend to or near the distal end 116 and the distal end of distal portion 124. The pusher 130 can harden the distal portion 124 so that the distal portion becomes more rigid. When the shaft 114 is in the second configuration, the operator can deliver treatment to the subject. For example, the user can press button 142 to deploy the steam delivery needle, and press button 144 to deliver steam to the subject's prostate through the urethra. During surgery, the operator can also convert the device 100 from the second (rigid) configuration to the first (flexible) configuration. For example, the operator can move the proximal tab 132 and the pusher 130 relative to the pusher housing 136, the handle 112 and the shaft 114 or otherwise slide the protrusion 132 and the pusher 130. Then, the operator can move the position of the distal end 116, deliver further treatment, and / or withdraw the shaft 114 from the body cavity.

[0042] Therefore, the device 100 can provide the flexibility desired during insertion while providing a hardness familiar to operators using existing devices during treatment delivery. The operator can also choose to operate the device 100 only in the second structure. The operator may prefer to insert the shaft 114 into the body cavity when the shaft 114 is in a rigid structure. For example, due to the operator's preference, the subject's anatomical structure, the type of treatment, or any other reason, the operator may prefer to use a rigid structure. Therefore, the device 100 can provide adaptability in use, so that different operators can use the device 100 according to their own preferences. Therefore, the device 100 can help institutions avoid purchasing multiple different types of devices to meet the needs of different operators' preferences.

[0043] Figure 3A portion of the shaft 214 is depicted, including a distal portion 224 and a proximal portion 222. Any features of the shaft 214 may be used in conjunction with the device 10 or 100. Components of the shaft 214 may have any of the characteristics described above for the shafts 14, 114. An outer flexible sheath 226 may surround the other components of the distal portion 224 of the shaft 214. As discussed above with respect to the proximal portions 22, 122, the proximal portion 222 may be relatively more rigid than the distal portion 224. The shaft 214 may include a distal end 216 that may have any of the characteristics of the distal ends 16, 116 described above. The needle 270 may extend through a needle lumen 272 of the shaft 214, which may serve as an isolation barrier to protect the needle 270 from fluid (e.g., an irrigation fluid) flowing through the shaft 214. The needle 270 may comprise any suitable material, such as, for example, As described above, the needle 270 can be moved proximally and distally relative to the shaft 214 to move the needle 270 from a first configuration (eg, Figure 3 14. The shaft 214 may be configured to extend from the distal end 216 to the distal end 216 of the shaft 214. The shaft 214 may be configured to extend from the distal end 216 to the distal end 216 of the shaft 214. The shaft 214 may be configured to extend from the distal end 216 to the distal end 216 of the shaft 214. The shaft 214 may be configured to extend from the distal end 216 to the distal end 216 of the shaft 214. The shaft 214 may be configured to extend from the distal end 216 of the shaft 214 ...

[0044] A rigid pusher 230 may extend through the shaft 214. At least a portion of the pusher 230 may be more rigid than the outer sheath of the distal portion 224 of the shaft 214. The pusher 230 may have any of the characteristics of the pushers discussed above with reference to FIGS. 1 and 2. Figure 3As shown, the first portion 234 of the pusher 230 can have a generally cylindrical, rod-shaped or tubular shape. The cross-sectional shape of the second portion 238 of the pusher 230 located at the distal end of the first portion 234 (perpendicular to the longitudinal axis of the pusher 230) is substantially a circular segment or arc. The second portion 238 can have a solid cross section perpendicular to the longitudinal axis of the pusher 230 (e.g., a cross section having a generally D-shaped and filled shape). Alternatively, the second portion 238 can have a generally "C"-shaped or arc-shaped cross section perpendicular to the longitudinal axis of the pusher 230. The curved surface of the second portion 238 can face radially outward relative to the central longitudinal axis of the shaft 214. The shape of the curved surface of the second portion 238 can be complementary to the inner surface of the sheath 226. In the configuration in which the second portion 238 has a solid cross section, the second portion 238 can have a generally flat surface facing toward the central longitudinal axis of the shaft 214 in a radially inward direction. In a configuration where the second portion 238 has a generally "C" shaped cross section, the ends of the "C" shape may face radially inward toward the central longitudinal axis of the shaft 214. The second portion 238 may have a greater radius of curvature and may have a greater width perpendicular to the longitudinal axis of the pusher 230 than the first portion 234.

[0045] Figure 3 In the embodiment of the present invention, the proximal part of the pusher 230 not shown in the figure can have a consistent cross-sectional shape (such as the shape of the first portion 234) or can have a cross-sectional shape of variation. Alternatively, the part of the pusher 230 can be flexible. For example, the first portion 234 can be flexible, and the second portion 238 can be rigid. In this alternative, the more proximal part of the first portion 234 and / or the pusher 230 can be similar to the actuating wire rod, which can be used for moving the second portion 238 proximally and / or distally. The proximal / distal motion of the pusher 230 will be discussed in further detail below. The second portion 238 can have the same rigidity as the sheath of the proximal portion 222 (with any property of the proximal portion 22, 122) of the shaft 214.

[0046] The size of second portion 238 (e.g., its relatively large size compared to first portion 234) can contribute to the hardening of distal portion 224 of shaft 214. For example, second portion 238 can occupy a sufficiently large area inside sheath 226, and / or extend around a sufficient portion of the periphery of sheath 226 to provide hardening of distal portion 224. The curved surface of second portion 238 can be close to the inner surface of sheath 226, or can abut the inner surface of sheath 226 to provide hardening. It may be beneficial to make first portion 234 occupy a smaller cross-sectional space, so that more space is provided for the proximal portion of shaft 214 for other components to pass. The larger size of second portion 238 can also make second portion 238 relatively harder than first portion 234. The larger size of second portion 238 can prevent the accidental bending of pusher 230 in shaft 214.

[0047] The third portion 236 of the pusher 230 can extend between the first portion 234 and the second portion 238. In any configuration of the pusher 230, the third portion 236 can be retained within the proximal portion 222 of the shaft 214 (discussed in further detail below). The third portion 236 can have any characteristics of the second portion 238, and can additionally include the features described below. The third portion 236 can include a guide 237 that can protrude radially inward from the radial inner surface of the third portion 236 (e.g., from the flat surface of the third portion 236) toward the central longitudinal axis of the shaft 214. The guide 237 can include two arms. The radial outer surface of the arm can be curved. The radius of curvature of the outer surface of the arm can be substantially the same as the radius of curvature of the curved surface of the radial outer portion of the third portion 236. The radial inner surface of the arm of the guide 237 can be substantially flat. Alternatively, the radial inner surface of the arm of the guide 237 can be curved. For example, the curved radial inner surface of the arm of the guide 237 can be complementary to the outer surface of the needle lumen 272. The needle lumen 272 can be received between the arms of the guide 237. The arms of the guide 237 can move (e.g., slide) relative to the needle lumen 272. The pusher 230 including the first portion 234, the second portion 238, the guide 237, and the distal-most end 239 can be formed of a single integral piece (i.e., can be a unitary structure), or can be formed of separate components that are coupled together.

[0048] The pusher 230 can be movable (e.g., slidable) proximally and distally relative to the sheath 226 and other components of the shaft 214. In a first configuration (not shown), the distal-most end 239 of the pusher 230 can be located proximal to the distal portion 224 of the shaft 214. Since the distal portion 224 can be flexible, when the pusher 230 is in the first configuration and not extended into the distal portion 224, the distal portion 224 can bend (e.g., passively or actively via a hinge mechanism). In a second configuration (e.g., Figure 3 ), the pusher 230 (e.g., the second portion 238 of the pusher 230) can extend into the distal portion 224. The distal-most end 239 of the pusher 230 can be near the distal tip 216. For example, Figure 3 As shown, the distal-most end 239 of the pusher 230 can abut or can be close to a housing 274 for components of the distal tip 216 (e.g., a camera, lighting, circuitry, a conduit for fluid (e.g., irrigation fluid), a lumen for receiving the needle 270, etc.). The proximal side of the housing 274 can serve as a stop for the distal-most end 239 of the pusher 230. Since at least the second portion 238 of the pusher 230 can be rigid, the shaft 214 can be rigid / inflexible in the second configuration.

[0049] As the pusher 230 moves proximally and / or distally, the needle lumen 272 can be maintained in the arm of the guide 237. The guide 237 can maintain the pusher 230 and the needle lumen 272 in their respective positions in the sheath 226. For example, the guide 237 can maintain a gap between the surface of the pusher 230 and the surface of the needle lumen 272. The guide 237 can help maintain the position of the second portion 238 close to or in contact with the inner surface of the sheath 226 to provide the desired hardness of the distal portion 224. In the first configuration and the second configuration, the third portion 236 can be maintained in the proximal portion 222 of the shaft 214. Since the outer surface shape of the third portion 236 can be very similar to the inner surface shape of the sheath 226 (e.g., the outer diameter of the third portion 236 can be substantially the same as the inner diameter of the sheath 226), very little play (e.g., non-axial movement) can be allowed between the third portion 236 and the sheath 226. The pusher 230 functions like a cantilever beam fixed at one end, where the fixed end may be comparable to the third portion 236 and the beam may be comparable to the second portion 234. Thus, the third portion 236 may enhance the rigidity of the shaft 214 when the pusher 230 is in the second configuration.

[0050] Figure 4-Figure 6 Alternative devices with alternative actuation mechanisms are depicted. Unless otherwise stated below, Figure 4-Figure 6 The device may combine any of the features of the above devices, including the features of the pusher described above. Figure 4-Figure 6 Certain features of the handle described above may be omitted to facilitate description of elements different from the device described above, but it should be understood that Figure 4-Figure 6 The handle may include any of the features described above. Wherever feasible, the same reference numerals are used to represent the same features.

[0051] Figure 4 A device 300 having a handle 312 is depicted. The device 300 may include a pusher 330, which may have any of the features of the pushers discussed above, unless otherwise specified herein. The handle 312 may have a housing 152. A motor 332 (e.g., a micromotor) may be positioned within the housing 152, which may be operable to rotate a lead screw 334. In addition to rotating, the lead screw 334 may be prevented from moving in an axial direction of the lead screw 334. The lead screw 334 may extend through the housing 152 of the handle 312 in a direction substantially parallel to the longitudinal axis of the shaft 114 and / or the pusher 330. The lead screw 334 may include a plurality of threads. A nut 333 may be positioned around the lead screw 334. When the lead screw 334 is rotated in a first direction, the nut 333 may move in a first direction (e.g., distally, toward the shaft 114). When the lead screw 334 is rotated in a second direction opposite to the first direction, the nut 333 may move in a second direction opposite to the first direction (e.g., proximally, away from the shaft 114). The lead screw 334 may be coupled to the pusher 330 via a truss 335. The truss 335 may extend transversely to the lead screw 334 and the pusher 330. For example, the truss 335 may be substantially perpendicular to the lead screw 334 and the pusher 330. The truss 335 may be fixed relative to the lead screw 334 and the pusher 330.

[0052] As the motor 332 rotates the lead screw 334 in the first direction, the nut 333 can travel distally along the lead screw 334. Because the truss 335 is fixed to the nut 333, the nut 333 can move the truss 335 distally. Because the truss 335 is fixed to the pusher 330, the truss 335 can in turn move the pusher 330 distally. The pusher 330 can eventually move to a position where the pusher 330 is fully extended distally (e.g., Figure 3 As described above with respect to Figure 1A-Figure 3As discussed, when the pusher 330 is extended distally, the distal end of the shaft 114 can have a rigid construction. As the motor 332 rotates the lead screw 334 in the second direction, the nut 333 can travel proximally along the lead screw 334. Because the truss 335 is fixed to the nut 333, the nut 333 can move the truss 335 proximally. Because the truss 335 is fixed to the pusher 330, the truss 335 can in turn move the pusher 330 proximally. The pusher 330 can eventually move to a position where the pusher 330 is fully retracted proximally. As described above with respect to Figure 1A-Figure 3 As discussed, when the pusher 330 is in the proximal position, the distal end of the shaft 114 can be relatively more flexible than when the pusher 330 is extended distally.

[0053] Any suitable actuator may be used to actuate the motor 332 and thereby move the pusher 330 proximally or distally. In some examples, in addition to or in lieu of the functions of the buttons 42, 44, 142, 144 described above, one of the buttons 142, 144 may actuate the motor 332. Alternatively, the handle 312 may include an additional actuator (e.g., a button, switch, linkage, knob, or other actuator, not shown) for actuating the motor 332 and moving the pusher 330 proximally or distally.

[0054] Figure 5 An alternative device 400 is depicted having a handle 412. The device 400 may include a pusher 430, which may have any of the features of the pushers discussed above, unless otherwise noted herein. Within the housing 152, the proximal end of the pusher 430 may be secured to a flexible cable or wire 434. Although the term "wire" may be used herein, it should be understood that the present disclosure is not limited to wires and includes any flexible structure (e.g., cables, microtubes, wires, filaments, etc.). Alternatively, the proximal end of the pusher 430 may itself be flexible, and the wire 434 may be omitted. The wire 434 may be wound around the pulley 433. The end of the wire 434 not secured to the pusher 430 may be secured to the actuator 432. As Figure 5 As shown, the actuator 432 may include a slider. However, the actuator 432 is not limited thereto and may include a link, a knob, etc. The actuator 432 may pass through an opening of the housing 152 (e.g., a slot in the housing 152). The operator may contact a portion of the actuator 432 outside the housing 152. Additionally or alternatively, one or more of the buttons 142 or 144 may be configured to actuate the actuator 432 when the button 142 / 144 is pressed.

[0055] exist Figure 5In the example shown, wire 434 can extend proximally from pusher 430 toward pulley 433 approximately coaxially with pusher 430. Pulley 433 can be positioned near the proximal end of housing 152. Wire 434 can be attached to actuator 432 in such a manner, that is, after winding around pulley 433, wire 434 extends approximately parallel to pusher 430. However, alternative arrangements are included within the scope of the present disclosure. Sleeve 435 (e.g., tube, channel or guide) can be positioned around pulley 433. Wire 434 can pass through or around sleeve 435 to keep wire 434 in the desired position around pulley 433 and prevent wire 434 from slipping off from pulley 433.

[0056] In the example where the actuator 432 is a slide, the actuator 432 may be moved by Figure 5 As the actuator 432 moves proximally, the end of the wire 434 attached to the pusher 430 can move distally. The distal movement of the end of the wire 434 attached to the pusher 430 can then exert a distal force on the pusher 430 to move the pusher 430 distally. The pusher 430 can ultimately be converted into a configuration in which the pusher 430 is fully extended in the distal direction. As described above with respect to Figure 1A-Figure 3 As discussed, when the pusher 430 is extended distally, the distal end of the shaft 114 can have a rigid construction. As the actuator 432 moves distally, the end of the wire 434 attached to the pusher 430 can move proximally. The wire 434 can thus pull the pusher 430 proximally. The pusher 430 can eventually move to a position where the pusher 430 is fully retracted proximally. As described above with respect to Figure 1A-Figure 3 As discussed, when the pusher 430 is in the proximal position, the distal end of the shaft 114 can be relatively more flexible than when the pusher 430 is extended distally.

[0057] The range of motion of the actuator 432 can correspond to a configuration in which the pusher 430 is fully moved proximally or fully moved distally. For example, when the actuator 432 is moved as far distally as possible (e.g., to the distal end of the slot in the housing 152), the pusher 430 can be fully retracted proximally. When the actuator 432 is moved as far proximally as possible (e.g., to the proximal end of the slot in the housing 152), the pusher 430 can be fully extended distally.

[0058] Figure 6 The device 500 is depicted with a handle 512. The device 500 may include a pusher 530, which may have any of the features of the pushers discussed above unless otherwise noted herein. Within the housing 152, the pusher 530 may be rotatably coupled to a link 532 at a pivot point 534. For example, as Figure 6As shown, the connecting rod 532 may include two legs 533. The proximal end of the pusher 530 may extend between the legs 533 and may be coupled to the legs 533 via, for example, a pin, a rivet, or other coupling means. The pusher 530 may be limited to axial movement (i.e., not rotatable or laterally movable). For example, a support structure (not shown) may limit the pusher 530 to movement along the longitudinal axis of the pusher 530. The handle 537 of the connecting rod 532 may extend through an opening of the housing 152 (e.g., a slot of the housing 152). The connecting rod 532 may be rotatably coupled to a protrusion 536 extending from the housing 152 via a pivot 535 (e.g., a pin, a rivet, or other coupling means).

[0059] The operator can Figure 6 The handle 537 is rotated about the axis of the pivot 535 in the direction indicated by the arrow in FIG. Figure 6 The connecting rod 532 can be rotated in the clockwise direction of the push member 530 to exert a distal force on the push member 530, so that the push member 530 moves distally. The push member 530 can eventually be converted into a configuration in which the push member 530 is fully extended in the distal direction. Figure 1A-Figure 3 As discussed, when the pusher 530 is extended distally, the distal end of the shaft 114 can have a rigid construction. The connecting rod 532 including the legs 533 can pivot / rotate relative to the pusher 530. The space between the legs 533 can facilitate the rotation of the connecting rod 532 while keeping the pusher 530 in axial motion only. As the handle 537 is rotated in a counterclockwise direction, the connecting rod 532 can exert a proximal force on the pusher 530, causing the pusher 530 to move proximally. The pusher 530 can eventually move to a position where the pusher 530 is fully retracted proximally. As described above with respect to Figure 1A-Figure 3 As discussed, when the pusher 530 is in the proximal position, the distal end of the shaft 114 can be relatively more flexible than when the pusher 530 is extended distally.

[0060] The range of motion of the link 532 can correspond to a configuration in which the pusher 530 is fully moved proximally or fully moved distally. For example, when the link 532 is fully moved counterclockwise (e.g., until the handle 537 contacts the housing 152 or until the link 532 reaches the end of the slot in the housing 152), the pusher 430 can be fully retracted proximally. When the link 532 is moved as far clockwise as possible (e.g., until the handle 537 contacts the housing 152 or until the link 532 reaches the end of the slot in the housing 152), the pusher 430 can be fully extended distally.

[0061] The mechanisms described above for actuating the pushers described above are merely exemplary. It should be understood that other mechanisms, including slides, linkages, hydraulic / pneumatic internal cylinders or solenoid actuators on the outside of the shaft (e.g., shaft 14, 114) magnetically coupled to any of the pushers discussed above, can be used to actuate the pushers described above.

[0062] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those receiving the teachings provided herein will recognize that other modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device, the medical device comprising: A handle, the handle comprising: Grip part; the main body; and A pusher housing extending toward the proximal side of the main body portion; a shaft having a first proximal portion and a second distal portion, wherein the first portion of the shaft comprises a first outer sheath, wherein the second portion of the shaft comprises a second outer sheath, and wherein the first outer sheath is more rigid than the second outer sheath; and a rigid pusher extending through at least a portion of the body portion and at least a portion of the shaft, wherein the pusher is configured to transition between 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.

2. The medical device according to claim 1, wherein: The proximal end of the pusher protrudes from the proximal end of the main body portion of the handle, and wherein the pusher is transitioned from a first configuration to a second configuration by moving the proximal end of the pusher distally.

3. The medical device according to claim 2, wherein: The proximal end of the pusher includes a tab.

4. The medical device according to claim 3, wherein: The proximal end of the pusher is received within the pusher housing, and the tab extends through a slot in the pusher housing.

5. The medical device according to any one of claims 3 or 4, wherein: In the second configuration, the tab abuts a proximal surface of the body portion of the handle.

6. The medical device according to any one of claims 2 to 4, wherein: The grip portion has an axis that is transverse to the longitudinal axis of the first portion of the shaft.

7. A medical device according to any one of the preceding claims, wherein: In the first configuration, a distal-most end of the pusher is located proximal to at least a portion of the second portion of the shaft.

8. The medical device according to any one of the preceding claims, wherein: The first outer sheath has substantially the same rigidity as the distal portion of the pusher.

9. The medical device according to any one of the preceding claims, wherein: The cross-sectional shape of at least a portion of the pushing member is substantially a circular segment or substantially an arc.

10. The medical device according to claim 9, wherein: At least a portion of the pusher includes a curved radially outwardly facing surface and a generally flat radially inwardly facing surface.

11. The medical device according to claim 10, wherein: A guide having a first arm and a second arm extends radially inwardly from the generally planar radially inwardly facing surface.

12. The medical device according to claim 11, wherein: A lumen is received between the first arm and the second arm.

13. The medical device according to claim 12, wherein: A needle is received within the lumen.

14. The medical device according to claim 13, wherein: The distal opening of the needle is in fluid communication with a steam generator in the handle.

15. The medical device according to any one of the preceding claims, wherein: The second portion of the shaft includes a flexible tubular sheath.

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