Systems, devices, and methods for tissue ablation

By integrating a sheath, steam delivery components, and electronic components into the steam ablation device, the problems of patient discomfort and prolonged recovery time caused by the increased device diameter in existing technologies are solved, achieving efficient visualization and process control.

CN120938576APending Publication Date: 2025-11-14BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202511216655.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2019-08-22
Filing Date
2020-08-21
Publication Date
2025-11-14

AI Technical Summary

Technical Problem

In existing medical devices used for ablation therapy, the increased diameter of the device due to the addition of treatment elements and visualization components leads to patient discomfort and prolonged recovery time.

Method used

A steam ablation device was designed, comprising a sheath, steam delivery components, electronic components, and a working channel. The electronic components, such as cameras and optical coherence tomography sensors, are located at a remote end, enabling visualization and process feedback without increasing the device diameter.

Benefits of technology

This technology improves the visualization and process control of ablation therapy without increasing the device diameter, and reduces patient discomfort and recovery time.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for vapor ablation may include a sheath extending from a proximal end to a distal end portion. The sheath may include a lumen terminating distally at a lumen opening. The apparatus may further include a vapor delivery member housed within the internal cavity. The vapor delivery member may include a channel configured to receive vapor and at least one orifice configured to deliver vapor to the host tissue. The apparatus may further include an electronic component having a chip. The chip may be disposed proximate the distal lumen opening.
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Description

[0001] This application is a divisional application of Chinese patent application No. 202080059326.5, filed on August 21, 2020. Patent application No. 202080059326.5 is the application that entered the Chinese national phase of international patent application PCT / US2020 / 047442.

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 890,264, filed August 22, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to apparatus, systems, and methods for tissue ablation, and in particular to distal components of vapor ablation apparatuses. Background Technology

[0005] Certain medical conditions, such as some prostate conditions, can be treated with ablation, including steam ablation. This ablation is performed using a device with a sheath that is inserted into a cavity within the body or into the patient's body. Visualization of the area to be treated during the ablation procedure can help to perform the procedure effectively. Users may also wish to use tools or deliver fluids during the procedure. However, components such as treatment elements (e.g., needles), visualization parts, and / or working channels may increase the diameter of the sheath or the entire device, resulting in increased patient discomfort or recovery time.

[0006] The systems, apparatus, and methods disclosed herein can address some of the aforementioned deficiencies and / or other aspects of the prior art. Summary of the Invention

[0007] In one example, a device for vapor ablation may include a sheath extending from a proximal end to a distal portion. The sheath may include an inner cavity terminating distally at an inner cavity opening. The device may further include a vapor delivery member housed within the inner cavity. The vapor delivery member may include a channel configured to receive vapor and at least one orifice configured to deliver vapor to the host tissue. The device may further include electronic components having a chip. The chip may be disposed near the distal inner cavity opening.

[0008] 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 end cavity opening. The working channel may have two convex sides, one concave side, and one straight side. The electronic component may have a distally facing surface. 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 through an opening on the radially outer surface of the distal portion. When in the second configuration, lines orthogonally extending from the surface of the electronic component may be transverse to the member. The electronic component may be disposed distally to the distal end cavity opening. The sheath may include a plurality of working channels extending from a 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 having a second chip. The second chip may be disposed at the distal portion. Each of the first and second electronic components may have a surface facing the distal side. The sheath may have a generally pear-shaped cross-section. The chip may be configured for spectral analysis.

[0009] In another example, a device for vapor ablation may include a sheath extending from a proximal end to a distal portion and an inner cavity with an opening extending from the proximal end to the distal portion. A vapor delivery member may be disposed within this inner cavity. The device may further include a working channel with an opening extending from the proximal end to the distal portion and an electronic component having a chip. The chip may be disposed near the opening of the inner cavity.

[0010] Any device 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 oriented distally.

[0011] In yet another example, a device for vapor ablation may include a sheath extending from a proximal end to a distal portion and an inner cavity with an inner opening extending from the proximal end to the distal portion. A vapor delivery member may be disposed within this inner cavity. The device may further include a working channel with a working channel opening extending from the proximal end to the distal portion, and electronic components radially disposed between the inner cavity opening and the working channel opening.

[0012] Any device 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.

[0013] It is understood that the general description above and the detailed description below are exemplary and explanatory only, and are not intended to limit the invention as described in the claims. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also 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 vapor 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 procedures (e.g., cryoablation, RF ablation, or other types of ablation) or other devices unrelated to ablation. Attached Figure Description

[0014] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate examples of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0015] Figure 1 This is a cross-sectional view of a portion of an exemplary ablation device.

[0016] Figures 2A-2B yes Figure 1 A partial cross-sectional view of an exemplary ablation device.

[0017] Figure 3 yes Figure 1 A perspective view of an exemplary ablation device.

[0018] Figure 4A This is a partial cross-sectional view of another exemplary ablation device.

[0019] Figures 4B-4C yes Figure 4A A perspective view of an exemplary ablation device. Detailed Implementation

[0020] An apparatus for vapor ablation may include one or more electronic components, including a camera, a light source, an ultrasonic sensor, or other sensors. The components may be located near the distal end of the apparatus. The components may be arranged such that the apparatus has a sufficient cross-sectional area for use as a working channel. In one example, the electronic components may be at least partially oriented distally. In another example, the electronic components may be at least partially oriented proximally. Furthermore, 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 be oriented in combinations of multiple directions (e.g., partially distal / partially proximally and partially radially inward / partially radially outward). The examples described herein can be used in combination. For example, an apparatus may have electronic components oriented distally and proximally.

[0021] Figure 1 A cross-sectional view of an exemplary distal component of an ablation device 10 is shown. The ablation device 10 may include a shaft 11. The shaft 11 may be inserted into a patient's body cavity or otherwise inserted into the patient's body (e.g., through the patient's tissues, such as via the perineum). The shaft 11 may have a distal end 12. The distal end 12 may include a distal surface 14. The distal surface 14 may have a shape that prevents damage (e.g., a circular or spherical shape). The distal end 12 and / or the distal surface 14 may be made of any suitable material, including plastic materials, which may be transparent (e.g., acoustically transparent). The distal end 12 may alternatively be made of metal, resin, Made of polyurethane or other materials or combinations of materials.

[0022] The device 10 may include a needle lumen 20 extending from a proximal end (not shown) of a 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 the proximal end (not shown) of the needle 24 to a distal end 28 of the needle 24, and a plurality of orifices 38 near 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 where the distal end 28 is located, 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 fluidly coupled to the proximal end of the needle 24) and deliver the steam to the tissue via the orifices 38. The needle 24 may be configured to have a first insertion configuration, wherein the needle 24 is received, received, or otherwise positioned within the lumen 20 (e.g., such that no portion of the distal end 28 extends radially outward relative to the longitudinal axis of the distal end 12 beyond the distal end 12). The needle 24 may have a second therapeutic configuration ( Figure 1In the treatment configuration, the distal end 28 of the needle 24 extends outward from the distal opening 22 (e.g., and optionally, radially outward from the distal end 12 relative to the longitudinal axis of the distal end 12). In the treatment configuration, the needle 24 may bend radially outward relative to the longitudinal axis of the sheath 11. The needle 24 may extend through the gap 25 in the distal end 12 and through the radial surface opening 26. In some aspects, the distal end 12 may 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 end 12 may be bent, tilted, or otherwise guided toward the radial surface opening 26, such that as the needle 24 advances through the lumen 20 and the distal opening 22 (e.g., distal advance), one or more portions of the needle 24 (e.g., the distal end 28) may impact or otherwise contact one or more portions of the distal end 12, such that continued advance of the needle 24 may cause the needle 24 to bend, deflect, or otherwise be guided (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, through Figure 1 A cross-sectional view of the distal end 12 taken from the cross section AA, facing the proximal side, wherein the needle 24 extends out of the distal opening 22.

[0023] The distal end 12 may also include one or more electronic components 30A, 30B, such as Figure 1 As shown, the electronic components may be oriented distally and / or radially outward in the direction toward the radial surface opening 26. The direction in which components 30A and 30B face may include the direction in which one surface of components 30A and 30B is guided. Although Figure 1 Two electronic components, 30A and 30B, are shown, but it should be understood that any number of electronic components can be used. Figure 1 The orientation and positioning of the electronic components 30A and 30B shown are merely exemplary. The electronic components 30A and 30B can face any suitable direction and can be positioned in any suitable manner. The electronic components 30A and 30B can assist in the navigation of the needle 24.

[0024] Electronic components 30A and 30B can utilize chip-based technology. The chips of electronic components 30A and 30B can be located / placed at or near the distal end 12. For example, electronic components 30A and 30B may include cameras, light sources, ultrasonic sensors, thermal electronics, optical coherence tomography sensors, spectral analysis sensors, force sensors, infrared sensors (such as near-infrared sensors), ultraviolet sensors, pressure sensors, temperature sensors, chemical sensors, accelerometers, force sensors, magnetoresistive sensors, tunneling magnetoresistive sensors, or other types of sensors or electronic devices. Electronic components 30A and 30B can facilitate real-time process analysis and efficiency and can be used in conjunction with various algorithms. Electronic components 30A and 30B can be used for underground visualization, process feedback, tissue mapping, and / or tissue marking. Different or similar types of sensors can be used in combination. When using multiple electronic components 30A and 30B, all electronic components 30A and 30B can be used simultaneously, or different electronic components 30A and 30B can be activated depending on the type of surgery, the stage of surgery, findings during surgery, etc. Electronic components 30A and 30B may be flexible, rigid, or semi-flexible. Furthermore, one or more wires (not shown) may electrically connect electronic components 30A and 30B to one or more actuators 52 located on a handle 50 of the sheath 11, as will be described in further detail below. For example, the one or more wires may extend proximally from electronic components 30A and 30B toward the proximal end of the sheath 11 and may pass through an inner cavity in the sheath 11 (e.g., different from the working channel 40 (described in further detail below) or the inner cavity 20).

[0025] In particular, such as Figure 2A and Figure 2B As shown, electronic component 30A may include components such as camera 32 and light source 34. Although camera 32 and light source 34 are given as exemplary elements of electronic component 30A, it should be understood that various types of devices may be used. Electronic component 30A may have a distal surface, and when needle 24 is in the second treatment configuration, lines extending orthogonally from this surface may be transverse to needle 24.

[0026] The camera 32 can 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 the image). Figure 1 and Figures 2A-2B(As shown) Observation needle 24. Camera 32 may include any suitable components, such as lenses, imagers, circuitry, etc. Camera 32 may be capable of performing spectral analysis and / or analyzing types of light beyond the visual spectrum. For example, camera 32 may include an RBG-infrared chip or module or a chip capable of performing infrared spectral analysis, which can 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 various analyses.

[0027] The light source 34 can be, for example, one or more light-emitting diode (LED) devices (which may include light of multiple colors), fiber optic devices, fiber optic bundle (FOB) devices, or other types of illumination devices (e.g., illuminating the entire distal end 12 to produce diffused light). The light source 34 can be a single light source or may include multiple light sources. The light source 34 can provide different spectra to facilitate analysis at the surgical site. The light source 34 can be integrated with the camera 32 into a single structure. Alternatively, the light source 34 and the camera 32 can be separate structures.

[0028] The light source 34 can 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 aids in visualization via 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 near the gap 25 or elsewhere, such 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 opening 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 provide light guiding, deflection, or other features. The camera 32 can be oriented such that the opening 22 is in a direction toward the top of the image produced by the camera 32 (and 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 produced by the camera 32. The display shown to the user can be a hands-free system, such as an augmented reality system. The camera 32 and / or the light source 34 may be located between the opening 22 and the radial surface opening 26 (in the radial direction). The camera 32 and / or the light source 34 may be closer to the central longitudinal axis of the sheath 11 than the opening 22.

[0029] like Figure 1 , Figure 2A and Figure 2BAs shown, electronic component 30B may include an ultrasonic sensor 36. The ultrasonic sensor 36 may be oriented in any direction, including at least a partially radially outward direction. The area of ​​the sheath 11 surrounding the ultrasonic sensor 36 may be acoustically transparent in order to transmit signals from the ultrasonic sensor 36 or other types of sensors (such as those discussed above).

[0030] 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 for the passage of fluid or tools. The working channel 40 may be located between the electronic component 30A and the radial surface opening 26 (in the radial direction). The working channel 40 may be located at the bottom of the image generated by the camera 32 and displayed to the user. The working channel 40 may have a shape complementary to the shape of the sheath 11 and / or other components of the device 10 (including electronic components 30A, 30B). For example, the working channel 40 (see...) Figure 2A The cross-sectional shape of the component may have two convex curved sides, one concave 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 concave curved side of the working channel 40.

[0031] like Figure 2B As shown, the working channel 40 can be divided by the dispenser 44 to form two sub-channels. The sub-channels may terminate at two openings 42A and 42B. The working channel 40 may be divided along its entire length. Alternatively, the working channel 40 may be divided only along a portion of the working channel 140 (e.g., the distal portion, near openings 42A and 42B). Openings 42A and 42B (and the sub-channels of the working channel 40) may have the same shape and / or dimensions, such as... Figure 2B As shown, or may have different shapes and / or sizes, without departing from the scope of this disclosure. Subchannels terminating at openings 42A and 42B may be used for the same or different purposes. For example, a subchannel terminating at opening 42A may be used for one fluid, and a subchannel terminating at opening 42B may be used for another fluid. Additionally or alternatively, a subchannel terminating at opening 42A may be used to deliver a fluid source to a site within a patient's body, and a subchannel terminating at opening 42B may be used to return fluid from the patient's body (e.g., via aspiration). Additionally or alternatively, subchannels terminating at openings 42A and 42B may be used for different instruments, or one of the subchannels terminating at openings 42A and 42B may receive one or more instruments, while the other may receive one or more fluids.

[0032] Figure 1 , Figure 2A and Figure 2BThe configuration of the working channel 40 shown is merely exemplary. The working channel 40 may have any suitable shape or feature and may be positioned in various ways relative to other components of the distal end 10 (such as electronic components 30A, 30B and the cavity 20).

[0033] like Figure 1 , Figure 2A and Figure 2B As shown, electronic component 30B may be located between the working channel 40 and the outer surface of the sheath 11. It should be understood that the arrangement of electronic components 30A and 30B is merely exemplary, and electronic components 30A and 30B may be arranged in any suitable location. Although electronic components 30A and 30B are shown facing the distal side, it should be understood that electronic components 30A and 30B may face in any direction.

[0034] like Figure 2A and Figure 2B As shown, the sheath 11 may have an outermost surface that is approximately pear-shaped in cross-section. However, this shape is merely exemplary, and any other shape may be used. For example, the sheath 11 may have a circular cross-section, an oval cross-section, or any other suitable shape. The dimensions of the sheath 11 may vary to suit the patient, the ongoing treatment, etc. The maximum dimension of the cross-section of the sheath 11 may be less than 22 French.

[0035] like Figure 3 As shown, the device 10 may have a handle 50 for the user to grip during surgery. The handle 50 may include mechanisms for controlling the device 10, such as a controller for the needle 24. The handle 50 may also include an actuator 52, which may be an image or video capture button. The actuator 52 may work in conjunction with one or more electronic components 30A, 30B to acquire current readings via the electronic components 30A, 30B. For example, the actuator 52 may acquire still images or moving video from the camera 32. Figure 3 The position of actuator 52 shown is merely exemplary, and actuator 52 can be located in any suitable position, including other positions on a separate generator or on handle 50.

[0036] Figures 4A-4C Another example ablation device 100 is shown. Figure 4A A partial cross-section of the ablation device 100 is shown. Figure 4B A perspective view of the ablation device 100 is shown, in which certain portions are shown as transparent. Figure 4CAnother perspective view of the ablation device 100 is shown, without transparency. The ablation device 100 may have any of the features of the ablation device 10 as described above, with similar features indicated by similar reference numerals followed by "100". The ablation device 100 may include a shaft 111 that can be inserted into a patient's body cavity or otherwise inserted into the patient's body (e.g., through the patient's tissues, such as via the perineum). The shaft 111 may have a distal end 112. The distal end 112 may include a distal surface 114. The distal surface 114 may have a shape that prevents damage (e.g., a circular or spherical shape). The distal end 112 and / or the distal surface 114 may be made of any suitable material, including plastic materials, which may be transparent. The distal end 112 may alternatively be made of metal, resin, Made of polyurethane or other materials or combinations of materials.

[0037] Device 100 may include a needle lumen 120 extending from the proximal end (not shown) of sheath 111 to the distal opening 122 (see Figure 4B A needle 124 (which may have any of the features of needle 24) is insertable into a needle lumen 120. Needle 124 may have a central lumen extending from a proximal end of the needle to a distal end 128 of the needle 124, and a plurality of orifices 138 near the distal end. The plurality of orifices 138 may be configured to communicate the contents of the central lumen or channel (e.g., steam, water vapor) to surrounding tissue where the distal end 128 is positioned, received, or otherwise inserted. For example, the central lumen or channel of needle 124 may be configured to receive steam therein (e.g., via a steam generator fluidly connected to the proximal end of needle 124) and deliver steam to tissue via the orifices 138. Needle 124 may be configured to have a first insertion configuration in which needle 124 is received, received, or otherwise positioned within lumen 120 (e.g., such that no portion of the distal end 128 extends radially outward relative to the longitudinal axis of the distal end 112 beyond the distal end 112). Needle 124 can have a second therapeutic configuration ( Figures 4A-4CIn this configuration, the distal end 128 of the needle 124 extends into a distal opening 122 (e.g., and optionally, radially outward from the distal end 112 relative to its longitudinal axis). In the treatment configuration, the needle 124 may be bent radially outward relative to the longitudinal axis of the sheath 111. The needle 124 may extend through a gap 125 in the distal end 112 and through a radial surface opening 126. In some aspects, the distal end 112 may 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 end 112 may be bent, tilted, or otherwise oriented toward the radial surface opening 126, such that as the needle 124 advances through the cavity 120 and the distal opening 122 (e.g., distal advance), one or more portions of the needle 124 (e.g., the distal end 128) may strike or otherwise contact one or more portions of the distal end 112, such that the continued advance of the needle 124 may cause the needle 124 to bend, deflect, or otherwise be guided (through) the radial surface opening 126.

[0038] The distal end 112 may also include one or more electronic components 130. The electronic components 130 may have any of the features of electronic components 30A, 30B as described above. The ablation device 100 may include, for example, a combination of... Figure 1 as well as Figures 2A-2B The electronic component 130 shown and positioned, although in Figures 4A-4C Electronic component 130 is not shown separately. For example... Figures 4A-4C As shown, electronic component 130 may alternatively or additionally be positioned on the surface of the damage-resistant end 132, away from the openings 122, 126, and / or gap 125. Electronic component 130 may face proximally and may be angled radially toward the opening 126. This positioning allows electronic component 130 to have any of the functions of electronic component 30 as described above. Although Figures 4A-4C An exemplary electronic component 130 is shown, but it should be understood that any number of electronic components 130 can be used. For example, electronic component 130 may also be similar to Figure 1 , Figure 2A and Figure 2B The electronic components 30A and 30B are positioned in the same way.

[0039] The sheath 111 may also include a working channel 140 having a distal opening 142. The working channel 140 may have any of the features of the working channel 40 and may include multiple sub-channels (e.g., see...). Figure 2B Positioning the electronic component 130 within / on the surface of the damage-resistant end 132 can further help increase the diameter of the working channel 140, since the component does not need to be positioned near the opening 142.

[0040] The use of electronic components, such as components 30A, 30B, and 130, can facilitate multiple aspects of the ablation procedure. For example, if electronic components 30 or 130 have ultrasound or other types of imaging capabilities, they can help position needles, such as needle 24 / 124. This capability can be particularly useful when needle 24 / 124 can be positioned at variable distances from openings 22 / 122 and 26 / 126. Additionally, 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 characteristics of actuator 52 as 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 an inner cavity in sheath 111 (e.g., different from working channel 140 or inner cavity 120).

[0041] While the principles of this disclosure have been described herein with reference to illustrative examples for specific applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art and those who have received the teachings provided herein will recognize that other modifications, applications, and equivalents fall within the scope of the examples described herein. Therefore, this invention should not be considered as limited to the foregoing description.

Claims

1. An apparatus for steam ablation, the apparatus comprising: A sheath extending from a proximal end to a distal portion, wherein the sheath includes an inner cavity terminating distally at an inner cavity opening; A steam conveying member, housed within the cavity, wherein the steam conveying member includes a channel configured to receive steam and at least one orifice configured to convey steam to the main tissue; and An electronic component having a chip, wherein the chip is disposed near a distal internal cavity opening.

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

3. The apparatus according to any one of the preceding claims, wherein, The sheath includes a working channel that extends from the proximal end and terminates distally at the opening of the working channel.

4. The apparatus according to claim 3, wherein, The electronic component is radially disposed between the working channel opening and the distal inner cavity opening.

5. The apparatus according to claim 3 or claim 4, wherein, The working channel has two convex sides, one concave side, and one straight side.

6. The apparatus according to any one of the preceding claims, wherein, The electronic component has a surface facing the distal side.

7. The apparatus according to any one of the preceding claims, wherein, The component is configured to transition from a first configuration to a second configuration, wherein in the first configuration, the component does not extend beyond the distal portion, and wherein in the second configuration, the component extends beyond an opening on the outer surface of the distal portion.

8. The apparatus according to claim 7, wherein, The opening is located on the radial outer surface of the distal portion.

9. The apparatus according to claim 7, wherein, When in the second configuration, lines extending orthogonally from the surface of the electronic component are transverse to the component.

10. The apparatus according to any one of the preceding claims, wherein, The electronic component is located on the distal side of the distal cavity opening.