medical devices

Abstract

The medical device includes a shaft, an end cap, and an electrode. The shaft includes a conductive element. The end cap is coupled to a distal end of the shaft. The electrode is coupled to the distal end of the shaft and passes through the end cap. The electrode includes an electrode shaft and a distal tip, the electrode is electrically connected to the conductive element. The end cap includes a visualization feature.

Description

[Technical Field]

[0001] Aspects of the present disclosure relate generally to medical devices and related methods. Embodiments of the present disclosure relate to medical devices that can treat tissue by delivering electrical energy to or within the tissue and / or injecting fluids into and / or under the tissue. [Background technology]

[0002] Medical devices such as endoscopes or other suitable insertion devices are used in various types of diagnostic and surgical procedures, such as endoscopy, laparoscopy, arthroscopy, gynecological examinations, thoracoscopy, cystoscopy, etc. Many of these procedures involve delivering energy to organ or glandular tissue to treat tumors, infections, etc. Examples of such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polypectomy, mucosal resection, etc. In particular, such procedures may be performed by inserting the insertion device into a subject's body through a surgical incision or through a natural anatomical orifice (e.g., the mouth, vagina, or rectum) and performing the procedure or task at the target site with ancillary devices inserted through the insertion device.

[0003] Sometimes, during a medical procedure, a user may use an auxiliary device that includes a catheter and a distally extending electrode. The electrode may be energized for the purpose of cutting, ablatating, ablating, marking, coagulating, cauterizing, or otherwise treating and / or manipulating tissue. The user may rely on a visualization device at the distal end of the insertion device or at the distal end of another device inserted at or near the target site. With the electrode extending from the distal end of the insertion device, the insertion device may at least partially impair the user's ability to visualize the electrode. As a result, the user may have to manipulate the visualization device closer to the electrode, which may be difficult in small target sites or may cause other problems. Summary of the Invention [Problem to be solved by the invention]

[0004] The devices and methods of the present disclosure may correct one or more of the deficiencies discussed above or address other aspects of the art. [Means for solving the problem]

[0005] Examples of the present disclosure relate, inter alia, to medical devices and related methods for treating tissue by delivering electrical energy to the tissue through an electrode while visualizing at least a portion of the electrode. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0006] The medical device may include a shaft, an end cap, and an electrode. The shaft may include a conductive element. The end cap may be coupled to a distal end of the shaft. The electrode may be coupled to the distal end of the shaft and may pass through the end cap. The electrode may include an electrode shaft and a distal tip, and the electrode may be electrically connected to the conductive element. The end cap may include a visualization feature.

[0007] The medical device may include one or more of the following features: The end cap may be at least partially insulating and may include an opening for the electrode to pass through. The visualization feature may form a blind angle of about 30 degrees or less when the distal tip of the electrode extends from the distal end face of the end cap by about 1 mm to about 3 mm, such as about 1.5 mm. The visualization feature may be formed by a tapered portion of the end cap. The tapered portion of the end cap may include a straight tapered portion. The straight tapered portion may form a blind angle of about 25 degrees or less. The tapered portion of the end cap may include a curved tapered portion. The curved tapered portion may form a blind angle of about 25 degrees or less. The tapered portion of the end cap may include one or more tapered side portions and, optionally, one or more partially cylindrical portions. The tapered side portion of the end cap may form a blind angle of about 25 degrees on at least one side of the end cap. The tapered portion of the end cap may extend over approximately 80% of the length of the end cap.

[0008] The end cap may be at least partially transparent. The end cap may comprise a ceramic material, such as synthetic sapphire or synthetic crystal. The visualization feature may form a blind spot angle of approximately 21 degrees. The distal portion of the shaft may be at least partially transparent, and the end cap and the distal portion of the shaft may form the visualization feature. The distal portion of the shaft may be about 5 mm to about 15 mm long, and the visualization feature may form a blind spot angle of approximately 11 degrees.

[0009] In another aspect, a medical device may include a shaft, an end cap, and an electrode. The shaft may include a conductive element. The end cap may be coupled to a distal end of the shaft. The end cap may include a tapered portion. An electrode may be coupled to the distal end of the shaft, and the electrode may pass through the end cap. The electrode may include an electrode shaft and a distal tip, and the electrode may be electrically connected to the conductive element. When the distal tip of the electrode extends from a distal end face of the end cap by about 1 mm to about 3 mm, the tapered portion of the end cap may form a blind angle of about 20 degrees to about 30 degrees.

[0010] The medical device may include one or more of the following features: The end cap may be at least partially insulating; The tapered portion of the end cap may include a curved taper; The tapered portion of the end cap may include one or more tapered side portions and one or more partially cylindrical portions.

[0011] In yet another aspect, a medical device may include a shaft, an end cap, and an electrode. The shaft may include a conductive element. The end cap may be coupled to a distal end of the shaft. The end cap may be at least partially transparent. The electrode may be coupled to the distal end of the shaft and may pass through the end cap. The electrode may include an electrode shaft and a distal tip, and the electrode may be electrically connected to the conductive element. When the distal tip of the electrode extends approximately 1.5 mm from the distal end face of the end cap, the at least partially transparent end cap may form a blind spot angle of approximately 21 degrees or less.

[0012] The medical device may include one or more of the following features: The end cap may be at least partially insulating; The at least partially transparent end cap may comprise synthetic sapphire or synthetic crystal; The distal portion of the shaft may be at least partially transparent to form a blind spot angle of approximately 11 degrees.

[0013] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0014] [Figure 1A] 1 illustrates an exemplary medical device according to aspects of the present disclosure. [Figure 1B] 1 is a cross-sectional view of a medical device with a distal portion of the medical device enlarged, according to aspects of the present disclosure. [Figure 2] FIG. 1C is a side view of a distal portion of the medical device of FIGS. 1A and 1B, according to an embodiment of the present disclosure. [Figure 3] FIG. 10 is a side view of a distal portion of another exemplary medical device according to aspects of the present disclosure. [Figure 4A] 10A-10C are views of a distal portion of another exemplary medical device according to aspects of the present disclosure. [Figure 4B] FIG. 10 is another view of a distal portion of another exemplary medical device according to aspects of the present disclosure. [Figure 4C] FIG. 10 is another view of a distal portion of another exemplary medical device according to aspects of the present disclosure. [Figure 5] FIG. 10 is a side view of a distal portion of another exemplary medical device according to aspects of the present disclosure. [Figure 6] FIG. 10 is a side view of a distal portion of a further exemplary medical device according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015] Examples of the present disclosure include devices and methods for facilitating and / or improving the effectiveness, efficiency, and safety of treating and / or manipulating tissue, for example, when applying electrical energy to tissue via electrodes. For example, embodiments of the present disclosure may provide a user (e.g., a physician, medical technician, or other healthcare provider) with a treatment device for delivering energy to a target site via electrodes while also facilitating visualization of the electrodes via a proximally located visualization device. Embodiments of the present disclosure may provide a user with the ability to apply electrical energy and / or heat to tissue using a medical device with electrodes. Embodiments of the present disclosure may provide a user with the ability to manipulate at a target site using, for example, smaller electrodes while still visualizing the electrodes. Alternatively, or additionally, a user may use larger electrodes (e.g., electrodes extending farther from the distal end of the catheter to expose a larger portion of the electrode) to better visualize the electrodes during a procedure. However, larger electrodes may be more difficult to manipulate, more prone to unintentional tissue contact, etc. Thus, embodiments of the present disclosure may provide a user with the ability to apply electrical energy and / or heat while reducing the likelihood of damaging tissue and / or contacting unintended portions of tissue. Additionally, embodiments of the present disclosure may be selectively coupled to existing medical devices to improve visualization of the electrodes. Furthermore, embodiments of the present disclosure may aid a user in delivering the distal end of a medical device to a target site. Some embodiments of the present disclosure may be used in performing endoscopy, laparoscopy, arthroscopy, gynecological examinations, thoracoscopy, cystoscopy, or other types of procedures.

[0016] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0017] The terms "proximal" and "distal" are used herein to indicate the relative locations of components of exemplary medical devices. As used herein, "proximal" refers to a location relatively closer to the outside of a subject's body or closer to a user, such as a medical professional, holding or otherwise using the medical device. In contrast, "distal" refers to a location relatively farther away from a medical professional or other user holding or otherwise using the medical device or closer to the inside of a subject's body. As used herein, the terms "comprises," "comprising," "having," "including," or other variations of these terms are intended to cover non-exclusive inclusions, such that a device or method comprising a list of elements may include not only those elements but also other elements not expressly listed or inherent therein. Unless otherwise stated, the term "exemplary" is used in the sense of "example" rather than "ideal." As used herein, the terms "approximately," "substantially," and "about" indicate a range of values ​​within + / - 10% of the stated value.

[0018] 1A and 1B show a medical device 10 including a handle 12 and a shaft 14 having a distal end 16. The handle 12 may include a main body 18 and a movable body 20. The handle 12 may also include a port 22 configured to receive fluid and a hub 24 configured to receive electrical energy, similar to an electrical plug or socket. The distal end 16 includes an end effector, such as an energy delivery portion or electrode portion 26 (hereinafter "electrode 26"). The electrode 26 is electrically connected to the hub 24 and may include a channel fluidly connected to or otherwise in fluid communication with the port 22, as discussed in detail below. Additionally, as shown in FIG. 1B and discussed in detail below, the electrode 26 includes a distal tip 28 and an electrode shaft 30. In some embodiments, the distal tip 28 may be wider than the electrode shaft 30 (e.g., laterally away from the longitudinal direction of the electrode shaft 30). For example, distal tip 28 may include a mushroom-like or hemispherical tip. In some embodiments, the size and / or shape of distal tip 28 may aid the user in delivering energy and / or treating tissue.

[0019] The medical device 10 may be inserted into a body lumen of a subject through an insertion device or by itself, such that at least a portion of the shaft 14 may be within the subject, while the handle 12 may remain outside the subject. The distal end 16 may be positioned at a target site within the subject. From outside the subject, a user can manipulate the handle 12. Additionally, a user may utilize a visualization device (e.g., a camera) disposed at the distal end of the insertion device or another medical device to visualize the distal end 16, including the electrode 26, at the target site. Movement of the movable body 20 relative to the main body 18 in a first direction (e.g., distally) may extend the electrode 26 relative to the shaft 14 (e.g., move the electrode 26 distally relative to the distal end of the shaft 14). Movement of the movable body 20 relative to the main body 18 in a second direction (e.g., proximal) may retract the electrode 26 relative to the shaft 14 (e.g., move the electrode 26 proximally relative to the distal end of the shaft 14). Although not shown, the movable body 20 or additional components of the handle 12 may articulate the electrode 26 (or the electrode 26 and distal end 16 ) side to side and / or up and down relative to the shaft 14 .

[0020] In some embodiments, the handle 12 may be coupled to a fluid source via a port 22. The port 22 may be in fluid communication with the electrode 26 via a lumen 31, which may extend through the handle 12 ( FIG. 1B ) and the shaft 14. It is noted that the various portions of the handle 12 shown in FIG. 1B are not necessarily drawn to scale to more fully illustrate the various portions of the handle 12. In at least one embodiment, the lumen 31 may extend longitudinally through the main body 18 and the shaft 14 of the handle 12 to fluidly connect the port 22 to the electrode 26. The port 22 may be located on a proximal portion of the main body 18, e.g., the proximal end of the main body 18. Alternatively, the port 22 may be located on a distal or central portion of the main body 18. Additionally, the port 22 may include a one-way valve, luer, seal, threading, and / or any suitable connecting or mating element to help maintain a tight connection between the handle 12 and the fluid source, minimize or prevent backflow (e.g., fluid flowing proximally from the port 22), and / or minimize or prevent leakage. In at least one example, the port 22 may include a one-way valve having an outer housing that includes an inner elastomeric and / or gel-like sealing member. In some examples, the handle 12 does not include the port 22, for example, in which case the medical device 10 is not used for fluid delivery.

[0021] The handle 12 may be coupled to an energy source via a hub 24. The hub 24 may include one or more prongs or pins 32 for coupling to the energy source. The hub 24 may be electrically coupled to the electrode 26 via a conductive element 33, which may be electrically coupled to the pin 32 and extend through the handle 12 and through at least a portion of the shaft 14. The energy source may be, for example, an electrocautery source, a radiofrequency generator, a heating source, a current generator, etc. In other embodiments, the energy source may be part of the handle 12 (e.g., an internal battery within the handle 12).

[0022] In at least one embodiment, medical device 10 may be used for monopolar electrosurgery and may include a return electrode positioned remotely from electrode 26 on or otherwise adjacent to the subject. In other embodiments, medical device 10 may be used for bipolar electrosurgery. In such cases, electrode 26 may include an active electrode portion, and a return electrode may be provided on or near electrode 26 and / or another portion of shaft 14. In at least one example, two conductive elements may extend through shaft 14, in which case the conductive elements may be electrically isolated from each other to allow one conductive element to conduct energy to the active electrode and the other conductive element to conduct energy from the return electrode.

[0023] The hub 24 may be disposed on the main body 18, for example, on the proximal end of the main body 18. In at least one embodiment, the port 22 may extend from the proximal end of the main body 18 in a direction parallel to or coaxial with the longitudinal axis of the main body 18, and the hub 24 may extend from the proximal end of the main body 18 at a transverse angle (e.g., about 45 degrees) relative to the longitudinal axis of the main body 18. In other embodiments, the hub 24 may be disposed on a distal or central portion of the main body 18 or on the movable body 20. According to some examples, the main body 18 and / or hub 24 may include one-way valves, luers, seals, threads, and / or any suitable connecting or mating element to help maintain a tight connection between the handle 12 and the energy source, minimize or prevent backflow (e.g., fluid flowing from the port 22 and / or lumen 31 and exiting the hub 24 proximally), and / or minimize or prevent leakage.

[0024] In at least one embodiment, as shown in FIG. 1B , a pin 32 may extend through the hub 24 transverse to the longitudinal axis of the handle 12 and may be electrically and physically connected to a conductive element 33, such as a wire, cable, and / or braided sheath. The conductive element 33 may be electrically conductive or may otherwise include a conductive component or portion, and may extend longitudinally through the lumen 31 and through the shaft 14. As shown in FIG. 1B , fluid delivered through the port 22 may surround at least a portion of the conductive element 33. In at least one embodiment, the conductive element 33 may include one or more insulating layers to help insulate the conductive element 33 from the fluid within the lumen 31. As mentioned above, a second conductive element may be provided as a return path when the medical device 10 is in a bipolar configuration.

[0025] As mentioned, the handle 12 may control the extension and / or retraction of the electrode 26 relative to the distal end 16 of the shaft 14. For example, the main body 18 may include a slot 34, and the movable body 20 may be slidably disposed within the slot 34. For example, the main body 18 may be configured to be held by a user's hand, and the movable body 20 may be configured to be controlled by movement of the user's thumb. For example, the side of the main body 18 opposite the movable body 20 may include one or more contours 36 that may help the user grip the main body 18. The movable body 20 may be lockable in one or more positions relative to the main body 18 and / or may be spring biased in a direction (e.g., toward a proximally retracted position).

[0026] The movable body 20 may be coupled to a drive element, which may impart distal and / or proximal movement to at least a portion of the electrode 26 based on relative movement between the main body 18 and the movable body 20. In at least one embodiment, the drive element may be physically coupled to the movable body 20 (directly or indirectly) such that movement of the movable body 20 extends or retracts the drive element, and thus extends or retracts the electrode 26. In such an embodiment, the conductive element 33 may electrically connect the pin 32 to the electrode 26. For example, the conductive element 33 may include slack (e.g., may be longer than the distance from the pin 32 to the electrode 26 or another electrical coupling element) to help account for twisting of the shaft 14 that may occur during delivery and / or to help account for movement (e.g., elongation) of the electrode 26 or another electrical coupling element.

[0027] In some embodiments, conductive element 33 may also act as a drive wire, rod, cable, or the like, whereby conductive element 33 may impart distal or proximal movement to at least a portion of electrode 26 while coupling electrode 26 to hub 24, e.g., to one or more pins 32, for delivering energy to (and / or from) electrode 26. As shown in FIG. 1B , movable body 20 may be coupled to conductive element 33 via a coupling mechanism, e.g., coupler 38. In at least one embodiment, coupler 38 may be physically coupled (directly or indirectly) to movable body 20 and may also be physically coupled (directly or indirectly) to conductive element 33 such that movement of movable body 20 extends and / or retracts conductive element 33, and thus extends and / or retracts electrode 26. It is noted that the coupler 38 and / or other components within the handle 12 may help maintain an electrical connection between the pin 32 and the conductive element 33 when the conductive element 33, and thus the electrode 26, is in a retracted or extended position. Alternatively, in other embodiments, the coupler 38 and / or other components within the handle 12 may be configured to electrically connect the pin 32 and the conductive element 33 only when the conductive element 33, and thus the electrode 26, is in an extended or at least partially extended position.

[0028] 1A , the handle 12 may also include one or more indicators, such as indicators 39A and 39B. In at least one embodiment, the indicators 39A and 39B may visually indicate to the user the position of the electrode 26 relative to the shaft 14. The positions of the indicators 39A and 39B may also correspond to the position of the moveable body 20. For example, the indicator 39A may be positioned on the handle 12 at a location corresponding to the retracted position of the moveable body 20 and may indicate that the electrode 26 is retracted relative to the shaft 14. Similarly, the indicator 39B may be positioned on the handle 12 at a location corresponding to the extended position of the moveable body 20 and may indicate that the electrode 26 is extended relative to the shaft 14.

[0029] 1A and 1B, shaft 14 may extend from a distal portion of main body 18 to distal end 16 and surround at least a portion of electrode 26. Shaft 14 may include a sheath surrounding at least a portion of one or more lumens (e.g., lumen 31) and drive wire (e.g., conductive element 33). In other embodiments, shaft 14 may be an extrusion including one or more lumens extending from handle 12 to distal end 16.

[0030] The enlarged portion of FIG. 1B shows additional exemplary features of the shaft 14 and distal end 16. The electrode 26 includes a distal tip 28 and an electrode shaft 30. The electrode 26 may be disposed within a portion of an end cap 42 of the distal end 16. The end cap 42 may be coupled to the distal end 16 of the shaft 14, or the shaft 14 and end cap 42 may partially overlap, as shown in FIG. 1B. The end cap 42 may include a distal end face 44. The end cap 42 may be at least partially electrically insulating. For example, all or a portion of the end cap 42 may be formed of a ceramic material or another non-conductive material. In some examples, only the distal end face 44 and the interior portion of the end cap 42 that contacts and / or surrounds the electrode 26 may be electrically insulating. The distal end face 44 includes a central opening 52 through which the electrode 26 may extend and / or retract. The end cap 42 includes a central portion 74 through which the electrode shaft 30 may travel during extension and / or retraction. The end cap 42 may be fixedly coupled to the shaft 14 by welding, adhesive, crimping, friction fit, or other suitable coupling material or mechanism.

[0031] The electrode 26 may be coupled to a proximal support 54 at the distal end 16, which may include an extension 56, which may be cylindrical in shape. The proximal support 54 may be coupled to a portion of the drive wire (e.g., conductive element 33) via a drive wire-receiving portion 58, for example, by welding, adhesive, crimping, friction fit, or any other permanent or temporary coupling material or mechanism. The extension 56 may extend distally and receive at least a portion of the electrode 26. The electrode 26 and extension 56 may be coupled by welding, adhesive, crimping, friction fit, or other suitable coupling material or mechanism. In at least one embodiment, the extension 56 may allow a different electrode 26 to be removably coupled to the distal end 16. The proximal support 54 includes a support lumen 70, which fluidly connects the port 22 to the electrode 26, for example, via a lumen (e.g., lumen 31) through the shaft 14.

[0032] The electrode 26 and proximal support 54 may be movable relative to the end cap 42 in response to relative movement of the movable body 20 and main body 18 of the handle 12. For example, the electrode shaft 30 may be substantially retracted within the end cap 42 with the movable body 20 in a proximal position relative to the main body 18. In the example shown in FIG. 1B , the distal tip 28 has a larger cross-sectional dimension than the central opening 52 such that only a distal portion of the electrode 26 (e.g., the distal tip 28) extends distally beyond the end cap 42. Then, when the movable body 20 is translated distally relative to the main body 18, the electrode 26 and proximal support 54 translate distally relative to the end cap 42, causing a larger portion of the electrode 26 (e.g., the electrode shaft 30) to extend distally beyond the end cap 42 through the central opening 52.

[0033] Alternatively, the central opening 52 may be larger than the distal tip 28, and with the movable body 20 in its proximal-most position, the electrode 26 (including the distal tip 28) may be fully retracted within the central opening 52 of the end cap 42. Furthermore, in at least one embodiment, the movable body 20 may have an equilibrium position relative to the main body 18, which may correspond to the electrode shaft 30 being partially extended from the end cap 42.

[0034] As shown in the enlarged portion of FIG. 1B , the electrode shaft 30 includes a distal portion 60 adjacent the distal tip 28 and a longitudinal portion 62. The electrode shaft 30 may include one or more graduated portions, e.g., having varying diameters, which may aid in coupling the electrode shaft 30 to the proximal support 54 and may help form one or more stop surfaces (e.g., abutting the interior of the end cap 42). In some embodiments, the electrode shaft 30 may also include a lumen 64 extending therethrough, e.g., extending longitudinally through a central portion of the electrode shaft 30. The lumen 64 may be in fluid communication with the port 22 via a support lumen 70 through the proximal support 54. In at least one embodiment, the inner sheath 40 may form at least a portion of the fluid connection between the lumen 70 and the port 22. Additionally, the lumen 64 of the electrode shaft 30 may be in fluid communication with the outlet 28A to form a channel for delivering fluid from the distal end (eg, distal tip 28) of the electrode 26.

[0035] As mentioned above, in some embodiments, the medical device 10 may be configured to deliver only energy, and not fluid. In such embodiments, the electrode shaft 30 optionally does not include a lumen 64, the proximal support 54 optionally does not include a support lumen 70, and / or the distal tip 28 optionally does not include an outlet 28A. Additionally, in some embodiments, the electrode 26 may include one or more insulating portions.

[0036] The electrode 26 may have a length of about 5 mm to about 20 mm, e.g., about 10 mm. The electrode 26, e.g., the electrode shaft 30, may have a cross-sectional dimension (e.g., diameter) of about 0.3 mm to about 1.0 mm, e.g., about 0.4 mm to about 0.6 mm. The largest portion of the distal tip 28 (e.g., the proximal end of the distal tip 28) may have a diameter of about 0.4 mm to about 1.5 mm, e.g., about 0.6 mm to about 1.0 mm. These dimensions are exemplary only. The distal tip 28 and / or the electrode shaft 30 may have sizes and / or shapes different from those described above.

[0037] 2 shows additional exemplary embodiments of the distal end 16 of the shaft 14 and the electrode 26. As shown in FIG. 2, the electrode 26 may be extended relative to the end cap 42 and the distal end 16 of the shaft 14. In the exemplary configuration shown, when the electrode 26 is extended, the distal tip 28 is spaced apart from the distal end face 44 and the electrode shaft 30 is exposed. For example, the electrode 26 may extend from the distal end face 44 a distance of about 3 mm, about 2 mm, about 1.5 mm, about 1 mm, etc., such as, for example, from about 1 mm to about 3 mm.

[0038] As shown in Figure 1B and in more detail in Figure 2, the distal end 16 includes a visualization feature. In this exemplary embodiment, the visualization feature is formed, for example, by the end cap 42 including an outer surface that is tapered, such that its radial width and / or cross-sectional dimension (Figure 1B) decreases from the proximal end of the end cap 42 to the distal end of the end cap 42. For example, the end cap 42 may have a tapered profile.

[0039] As shown in FIGS. 1B and 2, the proximal-most portion 46 of the end cap 42 is not tapered in this example. For example, the outermost surface of the proximal-most portion 46 may be parallel to the longitudinal axis of the distal end 16, as shown. A tapered portion 48 of the end cap 42 may then extend from the proximal-most portion 46 to the distal end face 44, as shown. The tapered portion 48 may include a straight taper, as shown in the cross-sectional view of FIG. 1B and the side view of FIG. 2. For example, across the extent of the tapered portion 48, the cross-sectional diameter of the end cap 42 may decrease at a constant rate from the proximal portion of the tapered portion 48 to the distal portion of the tapered portion 48. In at least one embodiment, and as shown in FIGS. 1B and 2, the distal-most portion 50 of the end cap 42 may gradually transition (e.g., curve) from the tapered portion 48 to the distal end face 44.

[0040] According to some embodiments of the present disclosure, the end cap 42 may have a length of about 2 mm to 6 mm, e.g., about 3 mm, and the end cap 42 may include a cross-sectional diameter of about 1.5 mm to about 3 mm, e.g., about 1.8 mm to about 2.5 mm (e.g., as shown in FIG. 1B ). For example, the proximal-most portion 46 of the end cap 42 may have a cross-sectional diameter of about 2.2 mm, and the distal-most portion 50 of the end cap 42 may have a cross-sectional diameter of about 1.4 mm. The distal-most portion 50 of the end cap 42 may transition (e.g., curve) from the tapered portion 48 to the distal end face 44 with a radius of curvature of about 0.3 mm. The tapered portion 48 may extend over a majority of the end cap 42 (e.g., greater than 50%, such as about 60% to about 98% of the length, e.g., about 60%, about 70%, about 80%, about 90%, etc. of the length). In at least one embodiment, tapered portion 48 may include a longitudinal length of about 1.8 mm to about 2.2 mm, for example about 1.95 mm.

[0041] In at least one embodiment, in a longitudinal cross section, tapered portion 48 subtends an angle A, e.g., from about 20 degrees to about 40 degrees. In at least one embodiment, tapered portion subtends an angle A of about 25 degrees. In at least one embodiment, tapered portion 48 may extend at an angle of about 12.5 degrees relative to longitudinal axis L on each side of longitudinal axis L. In this manner, tapered portion 48 may help improve visualization of electrode 26 by not blocking the field of view of a visualization device (e.g., a camera) at the distal end of the insertion device or separate device except at angle A. For example, with electrode 26 extended from end cap 42, a user may be able to visualize electrode 26 as long as the visualization device (e.g., a camera) is not within angle A. For example, the electrode 26 may extend approximately 1.5 mm from the end cap 42, and the tapered portion 48 may allow for increased visualization of the electrode 26, including the distal tip 28, when treating tissue or manipulating the electrode 26 at a target site. The tapered portion 48 may also aid in delivering the distal end 16 to the target site.

[0042] Additionally, in some embodiments, the distal portion of shaft 14 may include one or more sections, e.g., sections 14A, 14B, and 14C. Sections 14A, 14B, and 14C may include different material properties (e.g., different flexibility or stiffness, different conductivity or insulation properties, etc.). In at least one embodiment, one or more sections, e.g., section 14B, may be at least partially conductive, such that energy may be delivered through an electrical connection from electrode 26 to section 14B with electrode 26 in a particular position (e.g., retracted), for example, to aid in marking tissue at or near a target site. In other embodiments, one or more of sections 14A, 14B, or 14C may include different colors, indicia, etc., that may aid a user in delivering, maneuvering, etc., medical device 10 to and / or around a target site.

[0043] 3 shows a side view of a shaft 114 and distal end 116 of another exemplary medical device that may include any of the components of medical device 10 described above. Shaft 114 and distal end 116 may be similar to shaft 14 and distal end 16, respectively, with corresponding components. For example, distal end 116 includes an electrode 126 having a distal tip 128 and an electrode shaft 130, and an end cap 142 having a distal end face 144.

[0044] The distal end 116 includes a visualization feature formed by the end cap 142. In this example, the visualization feature is provided by, for example, the outer surface of the end cap 142, which is tapered so that its radial width and / or cross-sectional thickness decreases from the proximal end of the end cap 142 to the distal end of the end cap 142. As shown in FIG. 3, in this example, the end cap 142 includes a curved or curvilinear taper (rather than, for example, the straight taper shown in FIG. 2). As shown in FIG. 3, the proximal-most portion 146 of the end cap 142 does not include a taper. For example, the outer surface of the proximal-most portion 146 may be parallel to the longitudinal axis of the distal end 116. A tapered portion 148 of the end cap 142 may then extend from the proximal-most portion 146 to the distal end face 144. The tapered portion 148 may include a curved taper, for example, a taper of varying rate. For example, the slope of the taper of tapered portion 148 may increase from the proximal portion of tapered portion 148 to the distal portion of tapered portion 146. Additionally, tapered portion 148 may include a curved transition from proximal-most portion 146 to distal end face 144. In at least one embodiment, and as shown in FIG. 3 , distal-most portion 150 of end cap 142 may gradually transition (e.g., curve) from tapered portion 148 to distal end face 144.

[0045] In at least one embodiment, end cap 142 may have a length of about 2 mm to 6 mm, and end cap 142 may include a cross-sectional diameter of about 1.5 mm to about 3 mm, e.g., about 1.8 mm to about 2.5 mm. For example, proximal-most portion 146 may include a cross-sectional diameter of about 2.2 mm, and distal-most portion 50 of end cap 142 may have a cross-sectional diameter of about 1 mm to about 1.4 mm. Tapered portion 148 may span a majority of end cap 142 (e.g., greater than 50%, such as about 60% to about 98% of the length, e.g., about 60%, about 70%, about 80%, about 90%, etc. of the length). In at least one embodiment, tapered portion 148 may include a longitudinal length of about 2 mm to about 3 mm, e.g., about 2.5 mm.

[0046] In at least one embodiment, in a longitudinal cross section, tapered portion 148 subtends at angle B, e.g., from about 20 degrees to about 40 degrees. In at least one embodiment, tapered portion 148 subtends at angle B of about 25 degrees. In at least one embodiment, tapered portion 148 may extend at an angle of about 12.5 degrees relative to the longitudinal axis of distal end 116 on each side of the longitudinal axis of distal end 116. In this manner, tapered portion 148 may help improve visualization of electrode 126 by not blocking the field of view of a visualization device (e.g., a camera) of an insertion device or a separate device except at angle B. For example, with electrode 126 extended from end cap 142, a user may be able to visualize electrode 126 as long as the visualization device (e.g., a camera) is not within angle B. For example, electrode 126 may extend approximately 1.5 mm from end cap 142, and tapered portion 148 may allow for increased visualization of electrode 126, including distal tip 128, when treating tissue or manipulating electrode 126 at a target site. Tapered portion 148 may also aid in delivering distal end 116 to the target site.

[0047] 4A-4C show various views of a shaft 214 and distal end 216 of another exemplary medical device that may include any of the components of medical device 10 described above. Shaft 214 and distal end 216 may be similar to shaft 14 and distal end 16, respectively, having similar components. For example, distal end 216 includes an electrode 226 having a distal tip 228 and an electrode shaft 230, and an end cap 242 having a distal end face 244. FIG. 4A shows a perspective view of distal end 216. FIG. 4B shows a side view of distal end 216, and FIG. 4C shows another side view of distal end 216.

[0048] The distal end 216 includes a visualization feature formed by the end cap 242. In this example, the visualization feature is provided by, for example, one or more wedge-like or tapered side portions 266 of the end cap 242 that are tapered, such that its radial width and / or cross-sectional thickness decreases from the proximal end of the end cap 242 to the distal end of the end cap 242. The end cap 242 also includes one or more curved, non-tapered or partially cylindrical portions 268. For example, as shown in FIGS. 4A-4C , the end cap 242 may include two tapered side portions 266. The tapered side portions 266 may form opposing (e.g., circumferentially opposing) sides of the end cap 242. Additionally, as shown, the end cap 242 may include two cylindrical portions 268 connecting the tapered side portions 266. The cylindrical portion 268 of the end cap 242 may be substantially the same size (cross-sectional diameter) as the shaft 214 and may include substantially the same circumferential curvature (eg, partially circular).

[0049] In at least one embodiment, as shown in FIGS. 4A-4C , the tapered side portions 266 may be substantially straight in the longitudinal direction, for example, including a constant taper from the proximal-most portion 246 to the distal end surface 244 of the distal-most portion 250. Alternatively, one or more of the tapered side portions 266 may include a curved or variable taper similar to the curvature shown in FIG. 3 . For example, as discussed with respect to the tapered portion 146 of FIG. 3 , the slope of the taper of the tapered side portion 266 may increase from the proximal portion of the tapered side portion 266 to the distal portion of the tapered side portion 266. Furthermore, in some examples, the proximal-most portion 246 of the end cap 242 does not include a taper. For example, the outer surface of the proximal-most portion 246 may be parallel to the longitudinal axis of the distal end 216. In at least one embodiment, the distal-most portion 250 of the end cap 242 may gradually transition (eg, curve) from the tapered side portions 266 to the distal end face 244 .

[0050] In at least one embodiment, the end cap 242 may have a length of about 2 mm to 6 mm, and the end cap 242 may have a cross-sectional diameter of about 1.5 mm to about 3 mm, e.g., about 1.8 mm to about 2.5 mm. For example, the proximal-most portion 246 of the end cap 242 may have a cross-sectional diameter of about 2.2 mm, and the distal-most portion 250 of the end cap 242 may have a cross-sectional diameter of about 0.5 mm to about 1.6 mm, e.g., about 0.8 mm to about 1.3 mm. The distal-most portion 250 of the end cap 242 may transition (e.g., curve) from the tapered portion 248 to the distal end face 244 with a radius of curvature of about 0.3 mm. The tapered side portion 266 may extend over a majority of the length of the end cap 242 (e.g., greater than 50%, such as about 60% to about 98%, e.g., about 60%, about 70%, about 80%, about 90%, etc.). In at least one embodiment, the tapered side portion 266 may include a longitudinal length of about 2.4 mm to about 2.8 mm, e.g., about 2.6 mm. Furthermore, the end cap 242 may include one, three, four, or more tapered side portions 266. One or more tapered side portions 266 may be substantially the same size (e.g., longitudinal length, circumferential width, etc.) or may have a different size and / or angle from the other side portions 266. The one or more tapered side portions 266 may be evenly or unevenly positioned or spaced around the circumference of the end cap 242 and may optionally be connected by a cylindrical portion 268. In at least one example, the end cap 242 includes two or more tapered side portions 266 directly connected to each other without a cylindrical portion 268.

[0051] In at least one embodiment, in longitudinal cross section, the two tapered side portions 266 of the end cap 242 subtend at an angle C (the angle C formed by the slopes of the two tapered side portions 266), e.g., from about 20 degrees to about 40 degrees. In at least one embodiment, the tapered portions 266 subtend at an angle C of about 25 degrees. In one embodiment, the tapered side portions 266 may extend at an angle of about 12.5 degrees relative to the longitudinal axis of the distal end 216, on each side of the longitudinal axis of the distal end 216. In this manner, the tapered side portions 266 may help improve visualization of the electrode 226 by not blocking the field of view of a visualization device (e.g., a camera) of an insertion device or a separate device except at angle C. For example, with the electrode 226 extended from the end cap 242, a user may be able to visualize the electrode 226 as long as the visualization device (e.g., a camera) is not within angle C. For example, the electrode 226 may extend approximately 1.5 mm from the end cap 242, and the tapered side portion 266 may allow for increased visualization of the electrode 226, including the distal tip 228, when treating tissue or manipulating the electrode 226 at a target site. It is noted that the tapered side portion 266 may aid in visualization of the electrode 226 and / or may further aid in delivery of the distal end 216 to the target site.

[0052] 5 shows a side view of a shaft 314 and distal end 316 of another exemplary medical device that may include any of the components of medical device 10 described above. Shaft 314 and distal end 316 may be similar to shaft 14 and distal end 16, respectively, having similar components. Distal end 316 includes an electrode 326 having a distal tip 328 and an electrode shaft 330, and an end cap 342 having a distal end face 344.

[0053] The distal end 316 includes a visualization feature formed by an end cap 342. In this example, the end cap 342 is at least partially transparent. As shown in FIG. 5 , the end cap 342 may include a substantially constant cross-sectional dimension (e.g., diameter), and the circumference of the end cap 342 may be substantially similar to the circumference of the shaft 314. The end cap 342 may comprise a transparent material, for example, a ceramic material such as synthetic sapphire, synthetic crystal, or another material that is at least partially ceramic and at least partially insulating. In some configurations, one or more proximal portions, e.g., longitudinal portion 362, of the electrode 326 disposed within the end cap 342 may be at least partially visible through the end cap 342.

[0054] In at least one embodiment, the end cap 342 may have a length of about 2 mm to 6 mm, and the end cap 342 may have a cross-sectional diameter of about 1.5 mm to about 3 mm, e.g., about 1.8 mm to about 2.5 mm. The exposed portion of the end cap 342 may include a length of about 2.4 mm to about 2.8 mm, e.g., about 2.6 mm, and a cross-sectional diameter of about 2.0 mm to about 2.4 mm, e.g., about 2.2 mm. The end cap 342 may transition (e.g., curve) from the side portion to the distal end face 344 with a radius of curvature of about 0.3 mm. In at least one embodiment, with the end cap 342 at least partially transparent, the shaft 314 may be the only obstacle to visualization of the electrode 326, including the distal tip 328. In such an embodiment, the shaft 314 may form an angle D with the proximal end of the distal tip 328.

[0055] As shown, because end cap 342 is at least partially transparent in this example, angle D can be less than the angle formed by the outer surface of end cap 342. For example, angle D may be about 15 degrees to about 40 degrees. In at least one embodiment, angle D is about 18 degrees to about 25 degrees, e.g., about 21 degrees. In at least one embodiment, the sides of the distal end (e.g., in a longitudinal cross section) of shaft 314 and the sides of distal tip 328 may form an angle of about 10.5 degrees (corresponding to half of angle D). For example, as shown in FIG. 5 , each side of the distal end of shaft 314 and each side of distal tip 328 of electrode 326 may extend at an angle of about 10.5 degrees relative to the longitudinal axis of distal end 316. In this embodiment, because end cap 342 is at least partially transparent, distal end 316 may include angle D of about 21 degrees. Thus, end cap 342 may help improve visualization of electrode 326 by not blocking the field of view of a visualization device (e.g., a camera) of an insertion device or a separate device, except at angle D. For example, with electrode 326 extended from end cap 342, a user may be able to visualize electrode 326 as long as the visualization device (e.g., a camera) is not within angle D. In at least one embodiment, electrode 326 may extend approximately 1.5 mm from end cap 342, and transparent end cap 342 may allow for increased visualization of electrode 326, including distal tip 328, when treating tissue or manipulating electrode 326 at a target site.

[0056] 6 shows a side view of a shaft 414 and distal end 416 of another exemplary medical device that may include any of the components of medical device 10 described above. Shaft 414 and distal end 416 may be similar to shaft 14 and distal end 16, respectively, with corresponding components. For example, distal end 416 includes an electrode 426 having a distal tip 428 and an electrode shaft 430, and an end cap 442 having a distal end face 444.

[0057] The distal end 416 includes a visualization feature formed by the end cap 442 and at least a portion (e.g., a distal portion) of the shaft 414 that is at least partially transparent. As shown in FIG. 6, the end cap 442 may include a substantially constant cross-sectional dimension (e.g., a diameter), and the circumference of the end cap 442 may be substantially similar to the circumference of the shaft 414. Additionally, in some embodiments, the end cap 442 may include an exposed portion having a shorter longitudinal length than other exemplary end caps discussed herein (e.g., end caps 42, 142, 242, or 342). As shown in FIG. 6, the end cap 442 may include a proximal extension 442A, and a portion (e.g., a portion of the distal end 416) of the shaft 414 may overlap at least a portion of the proximal extension 442A. End cap 442 may comprise a transparent material, for example a ceramic material such as synthetic sapphire, synthetic crystal, or another material that is at least partially transparent and at least partially insulating.

[0058] Additionally, at least a distal portion of the shaft 414 (e.g., distal end 416) may comprise, for example, an at least partially transparent and at least partially insulating material. In at least one embodiment, about 5 mm to about 15 mm, e.g., about 10 mm, of the distal-most portion of the shaft 414 (e.g., distal end 416) may comprise an at least partially transparent and at least partially insulating material. In at least one embodiment, the distal-most portion of the shaft 414 may be formed from polypropylene (PP), polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC), polyethylene terephthalate (PET), polycarbonate (PC), or the like. In some embodiments, the at least partially transparent and at least partially insulating material forming at least the distal portion of the shaft 414 may be the same material forming the end cap 442. In other embodiments, the at least partially transparent and at least partially insulating material forming at least the distal portion of the shaft 414 may be a different material from the material forming the end cap 442. For example, a distal portion of the shaft 414 (e.g., the distal end 416) may be at least partially deflectable and insulating. In these embodiments, in some configurations, a proximal portion of the electrode 426, e.g., the longitudinal portion 462 and / or the proximal support elements, e.g., the electrode proximal support 454 and the electrode cylindrical extension 456, may be at least partially visible through the end cap 442 and / or the shaft 414.

[0059] In at least one embodiment, end cap 442 may have a length of about 1 mm to 4 mm, and end cap 442 may have a cross-sectional diameter of about 1.5 mm to about 3 mm, e.g., about 1.8 mm to about 2.5 mm. The exposed portion of end cap 442 may include a length of about 0.4 mm to about 0.8 mm, e.g., about 0.6 mm, and the exposed portion of end cap 442 may include a cross-sectional diameter of about 2.2 mm. End cap 442 may transition (e.g., curve) from the side portion to distal end face 444 with a radius of curvature of about 0.3 mm. The at least partially transparent portion of shaft 414 may have a length of about 5 mm to about 15 mm, e.g., about 10 mm.

[0060] In at least one embodiment, with the end cap 442 and the distal portion of the shaft 414 at least partially transparent, the proximal support elements, e.g., the electrode proximal support 454 and the electrode cylindrical extension 456, may be the only obstacles to visualization of the electrode 426, including the distal tip 428. In this embodiment, the proximal support elements may form an angle E with respect to the proximal end of the distal tip 428. As shown, the electrode proximal support 454 may be the widest component of the electrode 426 that is not transparent. Because the end cap 442 and the distal portion of the shaft 414 are at least partially transparent, the electrode proximal support 454 may form an angle E of about 5 degrees to about 20 degrees. In at least one embodiment, the angle E is about 8 degrees to about 15 degrees, e.g., about 11 degrees. In one embodiment, the distal end of each side (e.g., in a longitudinal cross section) of the electrode proximal support 454 may form an angle that is half of the angle E, e.g., about 5.5 degrees. 6, each side of the distal end of the electrode proximal support 454 and each side of the distal tip 428 of the electrode 426 may extend at an angle of approximately 5.5 degrees relative to the longitudinal axis of the distal end 416. In this embodiment, the end cap 442 and the distal portion of the shaft 414 are at least partially transparent, so that the distal end 416 may include an angle of approximately 11 degrees.

[0061] Thus, end cap 442 and shaft 414 may help improve visualization of electrode 426 by not blocking the field of view of a visualization device (e.g., a camera) of an insertion device or a separate device except at angle E. For example, with electrode 426 extended from end cap 442, a user may be able to visualize electrode 426 as long as the visualization device (e.g., a camera) is not within angle E. In at least one embodiment, electrode 426 may extend approximately 1.5 mm from end cap 442, and the distal portion of end cap 442 and shaft 414 may allow for increased visualization of electrode 426, including distal tip 428, when treating tissue or manipulating electrode 426 at a target site.

[0062] The various electrodes discussed herein can alter the physical properties of tissue upon contact with the tissue by delivering energy (e.g., radiofrequency energy). As discussed above, the delivered energy may be monopolar or bipolar energy. The various electrodes may be coupled to a shaft configured to extend into a body lumen or cavity of a subject. The shaft includes an electrical element that traverses the shaft and connects the electrode to an energy source, for example, in or coupled to the handle. Additionally, various aspects of the present disclosure (e.g., curved distal tip 28, end cap 42, 142, 242, 342, 442, etc.) may help form an atraumatic tip on the distal end of the medical device when the medical device is delivered to a target site.

[0063] As discussed, the electrode may also be coupled to an actuation member (e.g., movable body 20) within or coupled to the handle that allows a user to translate the electrode relative to the shaft. The electrode may be translatable between at least a first position in which the electrode's cutting shaft (e.g., longitudinal portion 62) is retracted within the shaft and a second position in which the cutting shaft is extended and exposed beyond the shaft. In both the first and second positions, the distal portion (e.g., distal tip 28) may be extended and exposed beyond the shaft rather than retracted within it. Additionally, the handle may allow the electrode to be positioned in one or more intermediate positions (i.e., positions in which only a portion of the electrode shaft 30 is exposed).

[0064] For example, with the electrodes in an extended position to treat a target site, a user may utilize a visualization device (e.g., a camera) positioned proximal to the distal end of a medical device, such as a separate insertion device, catheter, or the like. Various visualization features discussed herein may improve the user's ability to visualize the electrodes with the visualization device. For example, various visualization features discussed herein may reduce the angle (e.g., blind spot angle) formed by the distal end of the medical device. As a result, the electrodes may be extended from the distal end of the medical device, and the electrodes will be within the field of view of the visualization device as long as the visualization device is not within the blind spot angle formed by one or more elements at the distal end of the medical device. Furthermore, with an increased field of view, the visualization device may be positioned further from the electrodes, and the electrodes do not need to extend far from the distal end of the medical device. With the electrodes extending a shorter distance from the medical device, a user may apply electrical energy or heat to tissue at the target site while reducing the likelihood of damaging the tissue or contacting unintended portions of the tissue.

[0065] While the principles of the present disclosure have been described herein with reference to illustrative embodiments of particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art who have the benefit of the teachings provided herein will recognize additional modifications, applications, embodiments, and equivalent substitutions, all of which are included within the scope of the embodiments described herein. Accordingly, the present disclosure is not to be considered as limited by the foregoing description.

Claims

1. A medical device comprising: a shaft including a conductive element; an end cap coupled to a distal end of the shaft; an electrode coupled to the distal end of the shaft and passing through the end cap; the electrode includes an electrode shaft and a distal tip; the electrodes are electrically connected to the conductive elements; the end cap includes a visualization feature; the visualization feature is formed by a tapered portion of the end cap; the tapered portion of the end cap includes one or more tapered side portions and one or more partially cylindrical portions; A medical device wherein the one or more tapered side portions include a constant taper from a proximal-most portion to a distal end face of a distal-most portion.

2. 2. The medical device of claim 1, wherein the visualization feature forms a blind spot angle of 30 degrees or less when the distal tip of the electrode extends a distance of 1 mm to 3 mm from the distal end face of the end cap.

3. 3. The medical device of claim 1 or 2, wherein the tapered side portions of the end cap form a 25 degree dead angle on at least one side of the end cap.

4. 4. The medical device of claim 1, wherein the tapered portion of the end cap extends 80% of the length of the end cap.

5. The medical device of claim 1 or 2, wherein the end cap is at least partially transparent.

6. The medical device of claim 5 , wherein the end cap comprises a ceramic material such as synthetic sapphire or synthetic crystal.

7. 7. The medical device of claim 5 or 6, wherein the visualization features form a blind spot angle of 21 degrees.

8. 8. The medical device of claim 1, wherein a distal portion of the shaft is at least partially transparent, and wherein the end cap and the distal portion of the shaft form the visualization feature.

9. 9. The medical device of claim 8, wherein the distal portion of the shaft is 5 to 15 mm in length and the visualization features form a blind spot angle of 11 degrees.

Images