Systems, devices, and methods for tissue ablation

By integrating electronic components such as cameras and optical coherence tomography sensors into the steam ablation device, real-time monitoring and precise treatment of the ablation process are achieved, solving the problems of patient discomfort and prolonged recovery time caused by the increased diameter of existing devices.

CN114340533BActive Publication Date: 2025-09-16BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202080059326.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-08-22
Filing Date
2020-08-21
Publication Date
2025-09-16
Estimated Expiration
2040-08-21

AI Technical Summary

Technical Problem

During ablation therapy, existing medical devices have an increased diameter due to the presence of therapeutic elements, visualization components, and working channels, causing discomfort to patients and prolonging recovery time.

Method used

A steam ablation device was designed, which includes a sheath, a steam delivery component, electronic components and a working channel. The electronic components include a camera, an optical coherence tomography sensor, a spectral analysis sensor, etc., which can monitor and adjust the treatment process in real time to reduce invasiveness to the patient.

Benefits of technology

By making the device less invasive, the precision and efficiency of treatment are improved, reducing patient discomfort and recovery time.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for steam ablation may include a sheath extending from a proximal end to a distal portion. The sheath may include a lumen terminating distally at a lumen opening. The device may further include a steam delivery component housed within the lumen. The steam delivery component may include a channel configured to receive steam and at least one orifice configured to deliver the steam to subject tissue. The device may further include an electronic component including a chip. The chip may be positioned proximate the distal lumen opening.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 890,264, filed on August 22, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to devices, systems, and methods for tissue ablation, and more particularly to distal assemblies for vapor ablation devices. Background Art

[0004] Certain medical conditions, such as some conditions of the prostate, can be treated by ablation, including steam ablation. Such ablation can be performed using a device having a sheath that is inserted into a lumen of the body or into the patient's body. During an ablation procedure, visualization of the area being treated can help to perform the procedure efficiently. The user may also wish to use tools or deliver fluids during the procedure. However, components such as therapeutic elements (e.g., needles), visualization components, and / or working channels may increase the diameter of the sheath or the entire device, resulting in increased discomfort or recovery time for the patient.

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

[0006] In one example, a device for steam ablation may include a sheath extending from a proximal end to a distal portion. The sheath may include a lumen that terminates distally at a lumen opening. The device may further include a steam delivery member housed within the lumen. The steam delivery member may include a channel configured to receive steam and at least one orifice configured to deliver the steam to subject tissue. The device may further include an electronic component including a chip. The chip may be positioned proximate the distal lumen opening.

[0007] Any of the devices disclosed herein may have any of the following features. The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectral analysis sensor, or a force sensor. The sheath may include a working channel extending from a proximal end and terminating distally at a working channel opening. The electronic component may be radially disposed between the working channel opening and the distal lumen opening. The working channel may have two convex sides, one concave side, and a straight side. The electronic component may have a distally facing face. The member may be configured to transition from a first configuration to a second configuration. In the first configuration, the member may not extend beyond the distal portion. In the second configuration, the member may extend beyond an opening on a radially outer surface of the distal portion. When in the second configuration, a line extending orthogonally from a surface of the electronic component may be transverse to the member. The electronic component may be disposed distally of the distal lumen opening. The sheath may include a plurality of working channels extending from the proximal end to the distal portion. The electronic component may be a first electronic component, and the chip may be a first chip. The device may further include a second electronic component including a second chip. The second chip may be disposed at the distal portion. Each of the first electronic component and the second electronic component may have a face facing distally. The sheath may have a substantially pear-shaped cross-section. The chip may be configured for spectral analysis.

[0008] In another example, a device for vapor ablation may include a sheath extending from a proximal end to a distal portion and a lumen extending from the proximal end to an inner lumen opening at the distal portion. A vapor delivery member may be disposed within the lumen. The device may further include a working channel extending from the proximal end to a working channel opening at the distal portion and an electronic component including a chip. The chip may be disposed adjacent to the inner lumen opening.

[0009] Any of the devices disclosed herein may have any of the following features: The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectral analysis sensor, or a force sensor. The electronic component may be at least partially distally facing.

[0010] In yet another example, a device for vapor ablation may include a sheath extending from a proximal end to a distal portion and a lumen extending from the proximal end to a lumen opening at the distal portion. A vapor delivery member may be disposed within the lumen. The device may further include a working channel extending from the proximal end to a working channel opening at the distal portion, and electronic components radially disposed between the lumen opening and the working channel opening.

[0011] Any of the devices disclosed herein may have any of the following features: The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectroscopy sensor, or a force sensor.

[0012] It will be understood that both the general description above and the detailed description below are exemplary and explanatory only and are not limitations on the invention as claimed. As used herein, the terms "comprises," "comprising," or any other variant thereof are intended to cover non-exclusive inclusions such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but may also 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" refers to a direction closer to the operator and the term "distal" refers to a direction further away from the operator. Although steam ablation is mentioned 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 other devices not related to ablation. 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 1 is a cross-sectional view of a portion of an exemplary ablation device.

[0015] Figure 2A-2B yes Figure 1 A partial cross-sectional view of an exemplary ablation device.

[0016] Figure 3 yes Figure 1 A perspective view of an exemplary ablation device.

[0017] Figure 4A is a partial cross-sectional view of another exemplary ablation device.

[0018] Figure 4B-4C yes Figure 4A A perspective view of an exemplary ablation device. DETAILED DESCRIPTION

[0019] A device for steam ablation may include one or more electronic components, including a camera, a light source, an ultrasonic sensor or other sensor. The components may be located near the distal end of the device. The components may be arranged so that the device has sufficient cross-sectional area available for a working channel. In one example, the electronic components may be at least partially facing the distal side. In another example, the electronic components may be at least partially facing the proximal side. In addition, in other examples, the electronic components may be at least partially radially inward or partially radially outward relative to the longitudinal axis of the distal end. The electronic components may face a combination of multiple directions (e.g., partially distal / partially proximal and partially radially inward / partially radially outward). The examples described herein may be used in combination. For example, a device may have electronic components facing distally and proximally.

[0020] Figure 1 A cross-sectional view of an exemplary distal assembly of an ablation device 10 is shown. The ablation device 10 may include a shaft 11. The shaft 11 may be inserted into a body cavity of a patient or otherwise inserted into the patient's body (e.g., through the patient's tissue, such as via a perineal approach). The shaft 11 may have a distal tip 12. The distal tip 12 may include a distal-most surface 14. The distal-most surface 14 may have an atraumatic shape (e.g., a round, spherical shape). The distal tip 12 and / or distal-most surface 14 may be made of any suitable material, including a plastic material, which may be transparent (e.g., sound-transparent). The distal tip 12 may alternatively be made of metal, resin, Made of polyurethane or other materials or combinations of materials.

[0021] The device 10 may include a needle lumen 20 extending from a proximal end (not shown) of the sheath 11 to a distal opening 22. A needle 24 may be inserted into the needle lumen 20. The needle 24 may be a member having a central lumen or channel extending from a proximal end (not shown) of the needle 24 to a distal end 28 of the needle 24, and a plurality of orifices 38 proximate to the distal end 28. The plurality of orifices 38 may be configured to communicate the contents of the central lumen or channel (e.g., steam, water vapor) to surrounding tissue into which the distal end 28 is positioned, received, or otherwise inserted. For example, the central lumen or channel of the needle 24 may be configured to receive steam therein (e.g., via a steam generator fluidically coupled to the proximal end of the needle 24) and deliver the steam to the tissue via the orifices 38. Needle 24 can be configured to have a first insertion configuration in which needle 24 is housed, received, or otherwise positioned within lumen 20 (e.g., such that no portion of distal tip 28 extends radially outwardly beyond distal tip 12 relative to the longitudinal axis of distal tip 12). Needle 24 can have a second treatment configuration ( Figure 1), wherein the distal tip 28 of the needle 24 extends out of the distal opening 22 (e.g., and optionally, radially outward from the distal tip 12 relative to the longitudinal axis of the distal tip 12). In the treatment configuration, the needle 24 can be bent radially outward relative to the longitudinal axis of the sheath 11. The needle 24 can extend through the gap 25 in the distal tip 12 and through the radial surface opening 26. In some aspects, the distal tip 12 can include one or more surface features to guide the needle 24 from the insertion configuration to the treatment configuration. For example, one or more portions of the distal tip 12 can be bent, angled, or otherwise directed toward the radial surface opening 26 such that during advancement (e.g., distal advancement) of the needle 24 through the lumen 20 and distal opening 22, one or more portions of the needle 24 (e.g., the distal tip 28) can impact or otherwise contact one or more portions of the distal tip 12, such that continued advancement of the needle 24 can cause the needle 24 to bend, deflect, or otherwise be directed toward (and through) the radial surface opening 26. As will be described in further detail below, Figure 2A and Figure 2B According to the first exemplary arrangement and the second exemplary arrangement, respectively, a Figure 1 FIG. 1 is a proximally facing cross-sectional view of distal tip 12 taken at cross-section AA with needle 24 extending out of distal opening 22 .

[0022] The distal tip 12 may also include one or more electronic components 30A, 30B, such as Figure 1 As shown, the electronic components may be facing distally and / or radially outward in a direction toward the radial surface opening 26. The direction in which the components 30A, 30B face may include the direction in which one face of the components 30A, 30B is oriented. Figure 1 Two electronic components 30A, 30B are shown in FIG, but it should be understood that any number of electronic components may be used. Figure 1 The orientation and positioning of the electronic components 30A, 30B shown are exemplary only. The electronic components 30A, 30B may face any suitable direction and may be positioned in any suitable manner. The electronic components 30A, 30B may assist in the navigation of the needle 24.

[0023] The electronic components 30A and 30B may utilize wafer-based chip technology. The chips for the electronic components 30A and 30B may be located or disposed at or near the distal tip 12. For example, the electronic components 30A and 30B may include a camera, a light source, an ultrasonic sensor, a thermal electronic component, an optical coherence tomography sensor, a spectral analysis sensor, a force sensor, an infrared sensor (such as a near-infrared sensor), an ultraviolet sensor, a pressure sensor, a temperature sensor, a chemical sensor, an accelerometer, a force sensor, a magnetoresistive sensor, a tunnel magnetoresistive sensor, or other types of sensors or electronic devices. The electronic components 30A and 30B may facilitate real-time process analysis and efficiency and may be used in conjunction with various algorithms. The electronic components 30A and 30B may be used for subsurface visualization, process feedback, tissue mapping, and / or tissue labeling. Different or similar types of sensors may be used in conjunction with one another. When multiple electronic components 30A and 30B are used, all of the electronic components 30A and 30B may be used simultaneously, or different electronic components 30A and 30B may be activated depending on the type of surgery, the stage of surgery, findings during surgery, etc. The electronic components 30A, 30B can be flexible, rigid, or semi-flexible. In addition, one or more wires (not shown) can electrically couple the electronic components 30A, 30B to one or more actuators 52 located on the handle 50 of the sheath 11, as will be described in further detail below. For example, the one or more wires can extend proximally from the electronic components 30A, 30B toward the proximal end of the sheath 11 and can pass through a lumen in the sheath 11 (e.g., different from the working channel 40 (described in further detail below) or the lumen 20).

[0024] In particular, if Figure 2A and Figure 2B As shown, the electronic component 30A may include components such as a camera 32 and a light source 34. Although the camera 32 and the light source 34 are shown as exemplary elements of the electronic component 30A, it should be understood that a variety of types of devices may be used. The electronic component 30A may have a distal surface, and a line extending orthogonally from the surface may be transverse to the needle 24 when the needle 24 is in the second treatment configuration.

[0025] The camera 32 may be oriented to allow the user to view the needle 24 as it extends from the opening 22 and / or the radial surface opening 26 (e.g., as shown in FIG. Figure 1 and Figure 2A-2B) viewing needle 24. The camera 32 may include any suitable components, such as lenses, imagers, circuits, etc. The camera 32 may be capable of performing spectral analysis and / or analyzing types of light outside the visual spectrum. For example, the camera 32 may include an RBG-infrared chip or module or a chip capable of infrared spectral analysis, which may provide spectral analysis and information about temperature gradients during treatment. More than one camera 32 may be used. For example, different types of cameras 32 may be used, or multiple cameras 32 of the same type may be used to provide different views of the surgical site. A single camera 32 may also include multiple chips, including multiple types of chips capable of performing multiple analyses.

[0026] The light source 34 can be, for example, one or more light emitting diode (LED) devices (which can include multiple colors of light), a fiber optic device, a fiber optic bundle (FOB) device, or other type of lighting device (e.g., illuminating the entire distal tip 12 to produce diffuse light). The light source 34 can be a single light source or can include multiple light sources. The light source 34 can provide different light spectra to facilitate analysis at the surgical site. The light source 34 can be integrated with the camera 32 as a single structure. Alternatively, the light source 34 and the camera 32 can be separate structures.

[0027] The light source 34 may be oriented in the same or similar direction as the camera 32, such as Figure 2A and Figure 2B As shown. The orientation of the light source 34 can assist in visualization by the camera 32. The camera 32 and the light source 34 can be aligned at approximately equal distances from the central longitudinal axis of the sheath 11. The camera 32 and / or the light source 34 can be located proximal to the gap 25 or elsewhere so that the camera 32 and / or the light source 34 face a medium (e.g., air) that facilitates the function of the camera 32 and / or the light source 34. The camera 32 and / or the light source 34 can face the gap 25 or another open area, or can be encapsulated with a suitable material, such as the material of the distal end 12. For example, the material of the distal end 12 can cover the camera 32 and / or the light source 34 and can provide light guidance, deflection, or other features. The camera 32 can be oriented so that the opening 22 is in a direction toward the top of the image generated by the camera 32 (and which can be displayed to the user on a display), and the radial surface opening 26 is in a direction toward the bottom of the image generated by the camera 32. The display displayed to the user can be a hands-free system, such as an augmented reality system. The camera 32 and / or light source 34 may be between (in the radial direction) the opening 22 and the radial surface opening 26. The camera 32 and / or light source 34 may be closer to the central longitudinal axis of the sheath 11 than the opening 22.

[0028] like Figure 1 、 Figure 2A and Figure 2BAs shown, the electronic component 30B may include an ultrasonic sensor 36. The ultrasonic sensor 36 may face in any direction, including at least partially radially outward. The area of ​​the sheath 11 surrounding the ultrasonic sensor 36 may be acoustically transparent to transmit signals from the ultrasonic sensor 36 or other types of sensors (such as those discussed above).

[0029] The sheath 11 may also include a working channel 40. The working channel 40 may have a distal opening 42 (see Figure 2A ). For example, the working channel 40 can be used to pass fluids or tools. The working channel 40 can be located (in the radial direction) between the electronic component 30A and the radial surface opening 26. The working channel 40 can be located at the bottom of the image generated by the camera 32 and displayed to the user. The working channel 40 can have a shape that complements the shape of the sheath 11 and / or other components of the device 10 (including the electronic components 30A, 30B). For example, the working channel 40 (see Figure 2A ) may have a cross-sectional shape having two convexly curved sides, one concavely curved side, and one flat side, which together define the inner cavity of the working channel 40. The electronic component 30A may be closest to the concavely curved side of the working channel 40.

[0030] like Figure 2B As shown, the working channel 40 can be divided by a divider 44 to form two sub-channels. The sub-channels can terminate at two openings 42A and 42B. The working channel 40 can be divided along the entire length of the working channel 40. Alternatively, the working channel 40 can be divided along only a portion of the working channel 140 (e.g., the distal portion, near the openings 42A and 42B). The openings 42A and 42B (and the sub-channels of the working channel 40) can have the same shape and / or size, such as Figure 2B As shown, or may have different shapes and / or sizes, without departing from the scope of this disclosure. The subchannels that terminate at openings 42A and 42B can be used for the same purpose or different purposes. For example, the subchannel that terminates at opening 42A can be used for a kind of fluid, and the subchannel that terminates at opening 42B can be used for another kind of fluid. Additionally or alternatively, the subchannel that terminates at opening 42A can be used for the position that fluid source is delivered to patient's body, and the subchannel that terminates at opening 42B can be used for returning fluid (for example, via suction) from patient's body. Additionally or alternatively, the subchannel that terminates at openings 42A and 42B can be used for different tools, or one of the subchannels that terminate at openings 42A and 42B can receive one or more tools, and another can receive one or more fluids.

[0031] Figure 1 、 Figure 2A and Figure 2BThe illustrated configuration of working channel 40 is exemplary only. Working channel 40 may have any suitable shape or features and may be positioned in a variety of ways relative to other components of distal tip 10 (such as electronic components 30A, 30B and lumen 20).

[0032] like Figure 1 、 Figure 2A and Figure 2B As shown, the electronic components 30B can be located between the working channel 40 and the outer surface of the sheath 11. It should be understood that the arrangement of the electronic components 30A, 30B is merely exemplary and that the electronic components 30A, 30B can be arranged in any suitable position. Although the electronic components 30A, 30B are shown as facing distally, it should be understood that the electronic components 30A, 30B can face in any direction.

[0033] like Figure 2A and Figure 2B As shown, the cross-section of sheath 11 may have an outermost surface that is approximately pear-shaped. However, this shape is merely exemplary, and any other shape may be used. For example, sheath 11 may have a circular cross-section, an oval cross-section, or any other suitable shape. The dimensions of sheath 11 may vary to suit the patient, the treatment being performed, etc. The maximum dimension of the cross-section of sheath 11 may be less than 22 French inches.

[0034] like Figure 3 As shown, the device 10 can have a handle 50 for grasping by the user during the surgical procedure. The handle 50 can include a mechanism for controlling the device 10, such as a controller for the needle 24. The handle 50 can also include an actuator 52, which can be an image or video capture button. The actuator 52 can work in conjunction with one or more electronic components 30A, 30B to obtain current readings through the electronic components 30A, 30B. For example, the actuator 52 can capture still images or motion video from the camera 32. Figure 3 The location of actuator 52 shown in FIG. 5 is exemplary only, and actuator 52 may be located at any suitable location, including on a separate generator or elsewhere on handle 50 .

[0035] Figures 4A-4C Another example ablation device 100 is shown. Figure 4A A partial cross-section of ablation device 100 is shown. Figure 4B A perspective view of ablation device 100 is shown, with certain portions shown as transparent. Figure 4CAnother perspective view of ablation device 100 is shown, without transparency. Ablation device 100 can have any of the features of ablation device 10 described above, with like features being indicated by like reference numerals plus "100." Ablation device 100 can include a shaft 111 that can be inserted into a body cavity of a patient or otherwise inserted into the patient's body (e.g., through the patient's tissue, such as via a perineal approach). Shaft 111 can have a distal tip 112. Distal tip 112 can include a distal-most surface 114. The distal-most surface 114 can have an atraumatic shape (e.g., a rounded, spherical shape). Distal tip 112 and / or distal-most surface 114 can be made of any suitable material, including a plastic material, which can be transparent. Distal tip 112 can alternatively be made of metal, resin, Made of polyurethane or other materials or combinations of materials.

[0036] The device 100 may include a needle lumen 120 extending from a proximal end (not shown) of the sheath 111 to a distal opening 122 (see FIG. Figure 4B ). Needle 124 (which may have any of the features of needle 24) can be inserted into needle lumen 120. Needle 124 can have a central lumen extending from the proximal end of the needle to the distal tip 128 of needle 124, and a plurality of orifices 138 near the distal tip. The plurality of orifices 138 can be configured to communicate the contents of the central lumen or channel (e.g., steam, water vapor) to the surrounding tissue into which distal tip 128 is positioned, received, or otherwise inserted. For example, the central lumen or channel of needle 124 can be configured to receive steam therein (e.g., via a steam generator fluidically coupled to the proximal end of needle 124) and deliver the steam to the tissue via orifices 138. Needle 124 can be configured to have a first insertion configuration, wherein needle 124 is accommodated, received, or otherwise positioned within lumen 120 (e.g., such that no portion of distal tip 128 extends radially outwardly beyond distal tip 112 relative to the longitudinal axis of distal tip 112). Needle 124 may have a second treatment configuration ( Figures 4A-4C), wherein a distal tip 128 of the needle 124 extends out of the distal opening 122 (e.g., and optionally, radially outward from the distal tip 112 relative to the longitudinal axis of the distal tip 112). In the treatment configuration, the needle 124 can be bent radially outward relative to the longitudinal axis of the sheath 111. The needle 124 can extend through a gap 125 in the distal tip 112 and through a radial surface opening 126. In some aspects, the distal tip 112 can include one or more surface features to guide the needle 124 from the insertion configuration to the treatment configuration. For example, one or more portions of the distal tip 112 may be bent, angled, or otherwise directed toward the radial surface opening 126 such that, during advancement (e.g., distal advancement) of the needle 124 through the lumen 120 and the distal opening 122, one or more portions of the needle 124 (e.g., the distal tip 128) may impact or otherwise contact one or more portions of the distal tip 112 such that continued advancement of the needle 124 may cause the needle 124 to bend, deflect, or otherwise be directed toward (and through) the radial surface opening 126.

[0037] The distal tip 112 may also include one or more electronic components 130. The electronic components 130 may have any of the features of the electronic components 30A, 30B described above. The ablation device 100 may include, for example, a combination of Figure 1 as well as Figure 2A-2B The electronic components 130 are positioned as shown and described, although in Figures 4A-4C The electronic component 130 is not shown separately. Figures 4A-4C As shown, the electronic component 130 may alternatively or additionally be positioned within / on a surface of the atraumatic tip 132 distal to the openings 122, 126, and / or gap 125. The electronic component 130 may face proximally and may be angled in a radial direction toward the opening 126. This positioning may allow the electronic component 130 to have any of the functions described above for the electronic component 30. Although Figures 4A-4C One exemplary electronic component 130 is shown, but it should be understood that any number of electronic components 130 may be used. For example, the electronic component 130 may also be similar to Figure 1 、 Figure 2A and Figure 2B The electronic components 30A and 30B are positioned as shown.

[0038] Sheath 111 may also include a working channel 140 having a distal opening 142. Working channel 140 may have any of the features of working channel 40 and may include multiple subchannels (e.g., see Figure 2B Positioning the electronic components 130 within / on the surface of the atraumatic tip 132 may further help increase the diameter of the working channel 140 as the components do not need to be positioned near the opening 142 .

[0039] The use of electronic components, such as components 30A, 30B, 130, can facilitate various aspects of an ablation procedure. For example, if electronic components 30 or 130 have ultrasound or other types of imaging capabilities, electronic components 30, 30A, and / or 130 can help position a needle, such as needle 24 / 124. This functionality can be particularly useful when needle 24 / 124 can be positioned at a variable distance from openings 22 / 122 and 26 / 126. In addition, one or more wires (not shown) can electrically couple electronic component 130 to one or more actuators (not shown), which can have any of the features of actuator 52 described above. For example, the one or more wires can extend proximally from electronic component 30 toward the proximal end of sheath 111 and can pass through a lumen in sheath 111 (e.g., different from working channel 140 or lumen 120).

[0040] 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 skilled in the art and those having access to the teachings provided herein will recognize that other modifications, applications, and substitutions of equivalents 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 device for steam ablation, comprising: a sheath extending from a proximal end to a distal portion, wherein the sheath includes a lumen terminating distally at a distal lumen opening; a vapor delivery member housed within the lumen, wherein the vapor delivery member comprises a passageway configured to receive vapor and at least one orifice configured to deliver vapor to tissue of the subject; and An electronic component having a chip, wherein the chip is arranged near the distal end cavity opening, The sheath includes a working channel extending from the proximal end and terminating distally at a working channel opening, wherein the electronic component is radially disposed between the working channel opening and the distal lumen opening.

2. The device according to claim 1, wherein The electronic component includes at least one of a camera, an optical coherence tomography sensor, a spectral analysis sensor, or a force sensor.

3. The device according to any one of the preceding claims, wherein The sheath includes a distal tip including a distal-most surface, wherein the electronic component is located at the distal tip.

4. The device according to claim 3, wherein The material of the distal tip covers the electronic components.

5. The device according to claim 1, wherein The working channel has two convex sides, one concave side and one straight side.

6. The device according to any one of claims 1 to 2, wherein The electronic component has a distally facing surface.

7. The device according to any one of claims 1 to 2, wherein: The member is configured to transition from a first configuration to a second configuration, wherein, in the first configuration, the member does not extend beyond the distal portion, and wherein, in the second configuration, the member extends beyond the opening in the outer surface of the distal portion.

8. The device according to claim 7, wherein The opening is located on a radially outer surface of the distal portion.

9. The device according to claim 7, wherein When in the second configuration, a line extending orthogonally from the surface of the electronic component is transverse to the member.

10. The device according to any one of claims 1 to 2, wherein The electronic component is disposed distal to the distal end inner cavity opening.

11. The device according to any one of claims 1 to 2, wherein The sheath includes a plurality of working channels extending from the proximal end to the distal portion.

12. The device according to any one of claims 1 to 2, wherein The electronic component is a first electronic component and the chip is a first chip, and wherein the apparatus further comprises a second electronic component having a second chip, wherein the second chip is disposed at the distal portion.

13. The device according to claim 12, wherein Each of the first electronic component and the second electronic component has a distally facing face.

14. The device according to claim 1, wherein The sheath has a generally pear-shaped cross-section.

15. The device according to claim 1, wherein The chip is configured for spectral analysis.

Citation Information

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