Medical device shafts, end caps, and related methods of manufacturing and / or assembling

Abstract

A medical device includes a handle with a port, a shaft extending from the handle and including a distal end, and an end cap configured to be coupled to the distal end of the shaft. The shaft includes a working channel fluidly connected to the port and one or more of a fluid delivery lumen or a suction lumen. The end cap includes or forms a cavity or a void. When the end cap is coupled to the distal end of the shaft, the cavity or void at least partially aligns with a distal end of the working channel and a distal end of the one or more of the fluid delivery lumen or the suction lumen of the shaft.

Description

Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001MEDICAL DEVICE SHAFTS, END CAPS, AND RELATED METHODS OF MANUFACTURING AND / OR ASSEMBLING CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 682,438, filed on August 13, 2024, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] This disclosure generally relates to medical device shafts, end caps, and related methods of manufacturing or assembling. In some aspects, this disclosure relates to adapters, components, and / or features of the shafts and / or end caps that are coupled together to form a distal end of a medical device, and related methods of manufacturing and / or assembling.BACKGROUND

[0003] Medical devices are often inserted into the body to perform a therapeutic and / or diagnostic procedure inside a subject’s body. An example of such a device is an endoscope or other type of scope or insertion device, which includes a handle and an insertion portion extending distally from the handle. The insertion portion is introduced into the body for diagnostic or therapeutic purposes. For example, an insertion portion of an endoscope is inserted into the subject’s body through an opening (e.g., a natural opening or an incision) and is delivered to a treatment site inside the body, for example, through a body lumen. In one example, an endoscope may be inserted into a subject’s mouth and advanced through the subject’s esophagus.

[0004] The insertion portion of an endoscope or other insertion device includes a shaft that extends from outside the body to the treatment site. The shaft includes a working channel or internal lumen. The shaft often also includes a number of other channels or lumens, for example, for delivering irrigation, for applying suction, for receiving pull or deflection wires, electrical connections, or other components, etc. A distal end of the shaft includes an end cap, for example, including a plurality of openings and / or electronic components (e.g., an imaging device, one or more illumination devices, one or more sensors, etc.). The openings and / or electronic components of the end cap may be aligned with or otherwise in communication with the working channel and other channels / lumens in the shaft. A proximal end of shaft is coupled to a handle, which may control various aspects ofAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 the shaft, including movement of pull or deflection wires, the delivery of irrigation, the application of suction, the activation / deactivation of the electrical components, etc. The working channel or internal lumen of the shaft is often coupled (e.g., fluidly coupled) to a port on the handle, such as a biopsy port on an exterior of the handle.

[0005] In these aspects, one or more tools or other devices may be delivered to the treatment site via the biopsy port, the working channel or internal lumen of the shaft, and out of an opening in the end cap. However, if an opening in the end cap is not properly aligned (e.g., not properly angularly or rotationally aligned) with the distal end of the working channel or internal lumen, the one or more tools or other devices may be damaged or otherwise be interfered with or impaired by the misalignment.SUMMARY

[0006] Examples of this disclosure relate to, among other things, medical device shafts and end caps. For example, examples of this disclosure relate to devices, components, and methods of coupling a distal portion of the insertion portion or shaft to an end cap.

[0007] According to one aspect, a medical device may include a handle with a port, a shaft extending from the handle and including a distal end, and an end cap configured to be coupled to the distal end of the shaft. The shaft may include a working channel fluidly connected to the port and one or more of a fluid delivery lumen or a suction lumen. The end cap may include or form a cavity or a void. When the end cap is coupled to the distal end of the shaft, the cavity or void may at least partially align with a distal end of the working channel and a distal end of the one or more of the fluid delivery lumen or the suction lumen of the shaft.

[0008] The medical device may include one or more of the following features. The cavity or the void may be the cavity, and the cavity may include a concave portion and a convex portion opposite to the concave portion. The cavity further may include two partially circular corner portions. The end cap may include a first side and a second side opposite to the first side, and the first side may include a longitudinal length that is shorter than a longitudinal length of the second side. The end cap may include tapered side portions extending between the first side and the second side of the end cap. The distal end of the shaft may include a nest, and at least a portion of the end cap may be positioned within the nest and forms the void. The shaft may include one or more pull wire lumens that movably receive respectiveAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 pull wires, and the pull wires may be movable to deflect the distal end of the shaft. The medical device may include a plate, and the plate may be coupled to one or more of a distal face of the end cap or a distal face of the shaft. Distal ends of the pull wires may be coupled to the plate. The plate may include one or more radially inward extensions, and respective pull wires may be coupled to the one or more radially inward extensions.

[0009] The medical device may further include a ring, and distal ends of the pull wires may be coupled to the ring. The end cap may further include an imaging device and one or more illumination devices. The imaging device and the one or more illumination devices may be coupled to the handle via one or more cables. The shaft may include a communication lumen. The one or more cables may be positioned within the communication lumen. A distal end of the communication lumen may be adjacent to the nest. The end cap may further be coupled to the shaft via one or more adhesives. The end cap may include a plurality of arms that form a plurality of slots, and the one or more adhesives may fill the plurality of slots of the end cap when coupling the end cap to the shaft.

[0010] In another aspect, a medical device may include a handle including a port, a shaft extending from the handle and including a distal end, and an end cap configured to be coupled to the distal end of the shaft. The shaft may include a working channel fluidly connected to the port, one or more of a fluid delivery lumen or a suction lumen, a communication lumen, and one or more pull wire lumens. The medical device also may include one or more pull wires each movably positioned within a respective pull wire lumen. The end cap may include an imaging device and one or more illumination devices. The end cap may include or may form a cavity or a void. When the end cap is coupled to the distal end of the shaft, the cavity or void may at least partially align with a distal end of the working channel and a distal end of the one or more of the fluid delivery lumen or the suction lumen of the shaft. The distal end of the shaft may include a nest that is adjacent to a distal end of the communication lumen. At least a portion of the end cap may be positioned within the nest.

[0011] The medical device may include one or more of the following features. The medical device may further include a plate. The plate may be coupled to one or more of a distal face of the end cap or a distal face of the shaft. The plate may include one or more radially inward extensions, and respective pull wires may beAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 coupled to the one or more radially inward extensions. The medical device may further include a ring. Distal ends of the one or more pull wires may be coupled to the ring.

[0012] In yet another aspect, a medical device may include a handle including a port, a shaft extending from the handle and including a distal end, and an end cap configured to be coupled to the distal end of the shaft. The shaft may include a working channel fluidly connected to the port, and one or more of a fluid delivery lumen or a suction lumen. The end cap may include or form a cavity. When the end cap is coupled to the distal end of the shaft, the cavity may at least partially align with a distal end of the working channel and a distal end of one or more of the fluid delivery lumen or the suction lumen of the shaft. The cavity may include a concave portion and a convex portion opposite to the concave portion. The cavity further may include two partially circular corner portions. The end cap may include a first side and a second side opposite to the first side. The first side may include a longitudinal length that is shorter than a longitudinal length of the second side.

[0013] The medical device may include one or more of the following features. The shaft may include one or more pull wire lumens that movably receives a respective one of one or more pull wires. The one or more pull wires may be movable to deflect the distal end of the shaft. Each distal end of the one or more pull wires may be coupled to the end cap.

[0014] Any of the examples described herein may have any of these features in any combination.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and together with the description, serve to explain the principles of the disclosure.

[0016] FIG. 1A is a perspective view of a proximal portion of a medical device, according to aspects of this disclosure.

[0017] FIG. 1 B is a perspective view of a distal portion of the medical device, according to aspects of this disclosure.

[0018] FIG. 2A illustrates an interior portion of a handle of the medical device, according to aspects of this disclosure.

[0019] FIG. 2B is a cross-sectional view of a portion of an insertion portion or shaft of the medical device, according to aspects of this disclosure.Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001

[0020] FIGs. 3A and 3B are perspective views of a distal portion of the insertion portion or shaft of the medical device and an exemplary end cap, according to aspects of this disclosure.

[0021] FIGs. 4A and 4B are perspective views of another exemplary end cap and of the end cap coupled to a distal portion of the insertion portion or shaft of the medical device, respectively, according to aspects of this disclosure.

[0022] FIGs. 5A and 5B are perspective views of a distal portion of another insertion portion or shaft of a medical device and yet another exemplary end cap coupled to the distal portion, respectively, according to aspects of this disclosure.

[0023] FIGs. 6A and 6B are perspective views of a distal portion of the insertion portion or shaft of the medical device and an exemplary end cap, with portions of the insertion portion or shaft shown as being partially transparent, according to aspects of this disclosure.

[0024] FIGs. 7A and 7B are perspective views of a distal portion of another insertion portion or shaft of the medical device and another exemplary end cap coupled to the distal portion, with portions of the insertion portion or shaft shown as being partially transparent, according to aspects of this disclosure.

[0025] FIGs. 8A and 8B are perspective views of a distal portion of yet another insertion portion or shaft of the medical device and yet another exemplary end cap, according to aspects of this disclosure.DETAILED DESCRIPTION

[0026] Reference will now be made in detail to aspects of this disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used throughout the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term “proximal” refers to a portion closest to the user when introducing the device into the subject. Proximal and distal directions are labeled with arrows marked “P” and “D,” respectively, throughout various figures.

[0027] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus thatAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic. Additionally, terms that indicate the geometric shape of a component / surface encompass both exact and approximate shapes.

[0028] Although a treatment site is discussed herein as being in the subject’s gastrointestinal tract, this disclosure is not so limited, as the treatment site may be any internal lumen, organ, cavity, or other tissue within the subject. Additionally, although endoscopes are referenced herein, it will be appreciated that the disclosure encompasses various devices that may be inserted into a body of a subject, such as ureteroscopes, cholangioscopes, duodenoscopes, gastroscopes, endoscopic ultrasonography (“EUS”) scopes, colonoscopes, bronchoscopes, laparoscopes, arthroscopes, cystoscopes, aspiration scopes, sheaths, or catheters.

[0029] This disclosure is described with reference to exemplary medical devices, components, assemblies, and / or systems having a handle, an insertion portion, and an end cap. It should be noted that reference to any particular device and / or any particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and application methods may be utilized in any suitable procedure, medical or otherwise. The assemblies and systems described herein may be used in conjunction with other types of medical devices. This disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

[0030] FIG. 1A illustrates a medical device 100, according to an exemplary embodiment. Medical device 100 includes a handle 102 and an insertion portion 104 (including, e.g., a shaft 140). Insertion portion 104 may be connected to and extend from a distal portion of handle 102. Insertion portion 104 may terminate distally in a distal portion 150, as shown in FIG. 1 B. In embodiments, the distal end of medical device 100 may include an end cap 152 that incorporates components at the distal end. In some aspects, end cap 152 may be coupled to distal portion 150 of insertion portion 104 via one or more rings 160. Additionally, handle 102 includes an openingAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 or a port 106 (e.g., a biopsy port), which may be fluidly connected to a working channel 108 and / or one or more lumens of insertion portion 104. As discussed in detail below, a portion of insertion portion 104 may be formed of shaft 140 (e.g., a multi-lumen extrusion).

[0031] Additionally, the distal end of medical device 100 (e.g., end cap 152) may include one or more illumination devices 110 (e.g., lights, LEDs, optical fibers, etc.) and / or one or more visualization devices 112 (e.g., cameras, imagers, etc.). Insertion portion 104 (e.g., shaft 140 and end cap 152) may also include one or more channels or lumens, for example, one or more fluid delivery lumens 114 and / or one or more negative pressure or suction lumens 116. It is noted that, in some examples, insertion portion 104 may include two lumens 114 and 116, and both lumens 114 and 116 may be fluid delivery lumens. In some aspects, suction or negative pressure may be applied via working channel 108. Furthermore, as discussed in detail below, insertion portion 104 may include one or more additional channels or lumens, for example, to receive one or more pull or deflection wires, optical fibers, cables, electrical wires, communication wires, etc.

[0032] Additionally, as discussed in detail below, end cap 152 may include one or more openings, hollows, or cavities, and the openings of two or more channels or lumens of shaft 140 may be fluidly connected via the one or more cavities. Stated another way, and as discussed in detail below, fluids, suction, and / or devices delivered through the two or more channels or lumens of shaft 140 may each pass through or extend through the same cavity of end cap 152.

[0033] Handle 102 may include one or more actuators 117, for example, a first actuator 117A and a second actuator 117B. Actuators 117A, 117B may be manipulated (e.g., rotated about their respective axis) to control the deflection, movement, position, etc. of one or more portions of insertion portion 104, for example, distal portion 150. In these aspects and as discussed in detail below, actuators 117A, 117B may be connected to one or more pull or deflection wires or cables that extend through one or more portions of insertion portion 104 and connect to distal portion 150 of insertion portion 104.

[0034] Rotation of first actuator 117A and / or second actuator 117B may cause a portion of insertion portion 104 (e.g., distal portion 150 or a deflection portion) to bend, for example, via an articulating joint (not shown). For example, rotation of first actuator 117A in a first direction (e.g., clockwise) may pull a first pull wire proximally,Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 such that distal portion 150 deflects in a first deflection direction (e.g., up). Rotation of first actuator 117A in a second direction (e.g., counterclockwise) may pull a second pull wire proximally, such that distal portion 150 deflects in a second deflection direction (e.g., down). The second deflection direction may be opposite to the first deflection direction. Additionally, in some examples, rotation of second actuator 117B a first direction (e.g., clockwise) may pull a third pull wire proximally, such that distal portion 150 deflects in a third deflection direction (e.g., left). Rotation of second actuator 117B in a second direction (e.g., counterclockwise) may pull a fourth pull wire proximally, such that distal portion 150 deflects in a fourth deflection direction (e.g., right).

[0035] Although not shown, handle 102 may include one or more locking mechanisms to secure one or more of first actuator 117A and / or second actuator 117B, and thus help to secure the position of distal portion 150. Although actuators 117A, 117B are illustrated as knobs, actuators 117A, 117B may instead be buttons, levers, sliders, etc. Additionally or alternatively, handle 102 may include one or more additional actuators (e.g., buttons, knobs, levers, etc.) to, for example, close or open an end effector, rotate an end effector about a longitudinal axis, raise or lower an elevator (not shown) to move a device delivered through the working channel, capture an image and / or video, and / or provide other functionality to an end effector and / or distal portion 150.

[0036] Handle 102 may also include one or more valves 118, for example, a first valve 118A and a second valve 118B. Although two valves (i.e., first valve 118A and second valve 118B) are shown, handle 102 may include additional (e.g., a third valve, a fourth valve, etc.) or fewer valves (e.g., no valves or only one of first valve 118A or second valve 118B). In some embodiments, first valve 118A may be configured to control the supply of air and / or water through insertion portion 104 to distal portion 150. Second valve 118B may be configured to control the application of suction through insertion portion 104 to distal portion 150. Additional valves may be used, for example, to control the application of one or more medicines, agents, materials, etc. from distal portion 150.

[0037] An umbilicus 120 may extend from handle 102 (e.g., from a proximal portion of handle 102). Umbilicus 120 may be removably coupled (e.g., directly or indirectly) to a processing unit (not shown). The processing unit may be configured to process information (e.g., sensor data, imaging data, light data, etc.) receivedAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 from medical device 100. In some aspects, the processing unit may be a controller associated with medical device 100. Illumination device(s) 110 and / or imaging device(s) 112 may be electrically coupled (e.g., directly or indirectly) to the processing unit, for example, via one or more wires and / or cables extending through insertion portion 104, through handle 102, and through umbilicus 120. For example, umbilicus 120 may include one or more electrical cables and / or light cables (e.g., one or more optical fibers) for coupling to the processing unit via, e.g., a removable connector. In some aspects, umbilicus 120 may also provide air, water, and / or suction to handle 102, and thus to insertion portion 104.

[0038] Although not shown, the processing unit may include or be coupled to a visual output (e.g., an embedded monitor or screen, or an external or separate monitor or screen). Although not shown, umbilicus 120 may additionally or alternatively include one or more lumens for supplying a gas or a liquid, or applying suction or negative pressure, to handle 102 and / or insertion portion 104. For example, the gas or the liquid may be applied, or delivered, through one or more channels, or lumens, of medical device 100.

[0039] Handle 102 may be coupled to a proximal portion of insertion portion 104 (e.g., shaft 140) via a strain relief portion 122. Strain relief portion 122 may extend from a distal end of handle 102, and may overlap with a proximal portion of shaft 140, for example, helping to maintain the coupling of handle 102 to insertion portion 104.

[0040] FIG. 2A is a side view of internal components of handle 102 and a portion of insertion portion 104, without umbilicus 120, and FIG. 2B is a lateral cross- sectional view of a portion of insertion portion 104. As shown in FIG. 2A, handle 102 includes a handle body 102A that encloses one or more components of medical device 100. For example, handle body 102A may be formed of two halves that are coupled together (e.g., adhered, welded, snap fit, etc.) to form handle body 102A. Moreover, handle 102 includes port 106, for example, including a port body 106A. A portion of shaft 140 may extend proximally to be positioned within a portion of handle body 102A. Furthermore, a portion of shaft 140 (e.g., at least a portion that forms working channel 108, shown in FIG. 2B) extends through handle body 102A to be coupled to a portion of port 106 (e.g., to port body 106A).Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001

[0041] Additionally, a portion of shaft 140 may be coupled to or extend through an adapter or hub 144. Hub 144 may help to securely couple shaft 140 to handle 102.

[0042] As shown, medical device 100 includes one or more articulation, deflection, or pull wires 146, which may be coupled to one or more of actuators 117 (FIG. 1A), for example, to an internal actuator portion 119. Rotation of one or more of actuators 117 may also rotate internal actuator portion 119. As discussed above, rotation or manipulation of actuators 117 may thus also control one or more of pull wires 146 to control an articulation, movement, or position of a portion of insertion portion 104 (e.g., distal portion 150). Although only one internal actuator portion 119 and two pull wires are shown, it is noted that handle 102 may include two internal actuator portions (e.g., each coupled to one of actuators 117A and 117B), and that medical device 100 may include four pull wires 146 (e.g., with two pull wires 146 coupled to each internal actuator portion 119). Additionally, each pull wire 146 may extend through a lumen or channel within shaft 140 (as discussed below), for example, through respective proximal openings (e.g., adjacent to hub 144 and where skived portion 142 extends from the remainder of shaft 140).

[0043] Medical device 100 also includes one or more fluid tubes, for example, coupling portions of shaft 140 to one or more portions of handle 102. For example, medical device 100 may include a fluid tube 148, such as an irrigation tube, which may convey a fluid such as water and / or air to distal portion 150. In some aspects, fluid tube 148 may be coupled (e.g., at a proximal ends) to an irrigation or air hub or adapter 154. Although not shown, medical device 100 may also include one or more additional fluid tubes for irrigation (water), air (insufflation) and / or or suction (aspiration). The one or more fluid tubes 148 may extend through or couple one or more fluid lumens in shaft 140 to one or more valves 118 (e.g., one tube extending to first valve 118A, and one tube extending to second valve 118B). In these aspects, valve(s) 118 may control the delivery of fluid and / or application of suction to a treatment site via one or more channels or lumens in shaft 140. In some aspects, adapter 154 may help to couple valve(s) 118 (FIG. 1A) to fluid tube 148 or other tubes.

[0044] Although not shown, medical device 100 may include one or more communication wires or cables. The one or more communication wires or cables may extend from a portion of shaft 140 through one or more portions of handle 102.Attorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001For example, the one or more communication wires or cables may extend from shaft 140 to (or through) umbilicus 120 (FIG. 1A). The one or more communication wires or cables may extend through one or more channels or lumens in shaft 140, for example, to couple one or more components of distal portion 150 (e.g., illumination device(s) 110 and / or visualization device(s) 112) to handle 102 and / or umbilicus 120.

[0045] As shown in FIG. 2B, insertion portion 104 includes shaft 140. As mentioned, shaft 140 may be a multi-lumen extrusion, for example, formed of polytetrafluoroethylene (PTFE) and / or additive-filled polymers, which may help to lubricate one or more lumens (e.g., working channel 108). Shaft 140 may be formed of a single piece of material, e.g., to form a single, integral body. Lumens of shaft 140 may be formed integrally from shaft 140. For example, shaft 140 may be a multilumen extrudate. In some aspects, shaft 140 may be formed of two or more materials. For example, one or more portions of shaft 140 may be formed a high- density PTFE, and one or more portions of shaft 140 (e.g., distal portion 150 or the deflection portion) may be formed of an expanded PTFE, for example, which may be softer, more malleable, more easily deflectable or bendable, etc. compared to the high-density PTFE.

[0046] Shaft 140 includes working channel 208. Working channel 208 may be positioned in a central portion of shaft 140, or may be slightly off-center (as shown). Shaft 140 also may include one or more fluid delivery lumens 214 and / or one or more negative pressure or suction lumens 216. It is noted that, in some examples, insertion shaft 140 may include two lumens 214 and 216, and both lumens 214 and 216 may be fluid delivery lumens. In some aspects, suction or negative pressure may be applied via working channel 208. A communication lumen 224 may receive one or more cables, wires, etc. to electrically connect one or more of illumination device(s) 110 and / or imaging device(s) 112 (FIG. 1 B) to handle 102 and / or umbilicus 120. Shaft 140 also includes one or more wire lumens 226, for example, to movably receive respective pull wires 146 (FIG. 2A). Wire lumens 226 may be evenly or unevenly spaced around outer portions of shaft 140, for example, above or below one or more of lumens 214 and / or adjacent to (e.g., radially outside of) one or more of working channel 208 and / or communication lumen 224.

[0047] FIGs. 3A and 3B illustrate perspective views of distal portion 150 of the shaft 140 and an end cap 352. As mentioned, shaft 140 includes working channel 208 that terminates in a distal opening 208D. Shaft 140 also includes one or moreAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 fluid delivery lumens 214 that terminate in a distal opening 214D and / or one or more suction lumens 216 that terminate in a distal opening 216D. As mentioned above, in some examples, both lumens 214 and 216 may be fluid delivery lumens, and suction or negative pressure may be applied via working channel 208.

[0048] End cap 352 includes one or more illumination device openings 358, for example, to receive one or more illumination devices 310. Additionally, end cap 352 may include one or more imaging device openings 360, for example, to receive one or more imaging devices 312. In some aspects, illumination device 310 and / or imaging device 312 may at least partially align with or be adjacent to communication lumen 224 (FIG. 2B), for example, such that wires, cables, etc. coupling illumination device(s) 310 and / or imaging device 312 to handle 102 and / or umbilicus 120 extend through communication lumen 224.

[0049] Additionally, end cap 352 includes a working channel or central cavity 356. When end cap 352 is coupled to shaft 140, central cavity 356 may at least partially align with working channel 208 and one or more of fluid delivery lumen(s) 214 and suction lumen(s) 216. As such, central cavity 356 may include a lateral or radial cross-sectional area that is larger than a lateral or radial cross-sectional area of working channel 208. As discussed below, the size or shape of central cavity 356 may help to ensure that end cap 352 does not overlap with, interfere with, or otherwise impede one or more instruments or end effectors delivered through working channel 208.

[0050] As shown in FIGs. 3A and 3B, central cavity 356 may include an upper or first side wall 356A, for example, that includes a shape that may be at least partially circular and / or concave. Central cavity 356 may also include a lower or second side wall 356B, for example, opposite to first side wall 356A. Second side wall 356B may include a shape that is at least partially rounded, circular, convex, or otherwise curved. Furthermore, central cavity 356 may include one or more (e.g., two) corner portions 356C. For example, corner portions 356C may include walls that are partially circular (e.g., approximately 180 degrees to approximately 330 degrees, for example, approximately 270 degrees, and corner portion 356C may at least partially overlap with one or more of fluid delivery lumen(s) 214 and suction lumen(s) 216 (e.g., with distal openings 214D and / or 216D). Corner portions 356C may be indented, and second side wall 356B may be curved to a position above (relative to the orientation of FIGs. 3A and 3B) corner portions 356C.Attorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001

[0051] As shown particularly in FIG. 3B, one or more portions of end cap 352 may be tapered. For example, a top or first side or portion 352A of end cap 352 may have a shorter longitudinal length than a bottom or second side or portion 352B of end cap 352. In these aspects, end cap 352 may include one or more (e.g., two) side portions 352C that taper between first portion 352A and second portion 352B of end cap 352. In some aspects, the taper in end cap 352 may aid in the insertion, positioning, or other movement of the distal end of shaft 140. Additionally, as shown, working channel 108 and one or more of fluid delivery lumen(s) 214 and suction lumen(s) 216 may open (e.g. distally open) into central cavity 356 and thus not be separated by walls, partitions, or other portions of end cap 352.

[0052] As mentioned, end cap 352 may be coupled to a distal end of shaft 140. For example, end cap 352 may be coupled to shaft 140 via one or more of an adhesive (e.g., a glue, an epoxy, a resin, etc.), heat shrink tubing, and / or a distal ring 362. For example, distal ring 362 may be crimped or otherwise secured onto one or more of end cap 352 and / or shaft 140 (e.g., via a snap fit, friction fit, etc.) to help couple end cap 352 and shaft 140. In some aspects, one or more pull wires may be coupled to (e.g., welded or otherwise attached) to one or more portions of distal ring 362 (e.g., an inner face of distal ring 362) and / or to one or more portions of end cap 352 (e.g., a proximal face or portion of end cap 352). In these aspects, end cap 352 and its central cavity 356 may be large enough to accommodate various sizes of shafts or other devices delivered through working channel 208, while also allowing for end cap 352 to have structural integrity when passing through an insertion device (e.g., a duodenoscope or other device) or otherwise being delivered to a treatment site.

[0053] FIG. 4A illustrates a perspective view of an end cap 452, and FIG. 4B illustrates a perspective view of end cap 452 coupled to distal portion 150 of shaft 140. It is noted that shaft 140 in FIG. 4B is rotated approximately 180 degrees about a central or longitudinal axis relative to shaft 140 in FIGs. 3A and 3B. For example, although working channel 208 is in a top portion of shaft 140 in FIGs. 3A and 3B, working channel 208 is in a bottom portion of shaft 140 in FIG. 4B.

[0054] End cap 452 includes one or more illumination device openings 458, for example, to receive one or more illumination devices 410. Additionally, end cap 452 may include one or more imaging device openings 460, for example, to receive one or more imaging devices 412. Illumination device opening(s) 458 or imagingAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 device opening(s) 460 may be positioned in a distal portion 452D of end cap 452. In some aspects, illumination device 410 and / or imaging device 412 may at least partially align with communication lumen 224 (FIG. 2B), for example, such that wires, cables, etc. (e.g., electronic connections 462) coupling illumination device(s) 412 and / or imaging device(s) 412 to handle 102 and / or umbilicus 120 extend through communication lumen 224 (FIG. 2B).

[0055] Additionally, end cap 452 includes a working channel or central cavity 456. When end cap 452 is coupled to shaft 140, central cavity 456 may at least partially align with working channel 208 and one or more of fluid delivery lumen(s) 214 and suction lumen(s) 216. As such, central cavity 456 may include a lateral or cross-sectional diameter or area larger than a lateral or cross-sectional diameter or area of working channel 208. In some aspects, central cavity 456 may be a similar size and / or shape as central cavity 356. Additionally, in some aspects, central cavity 456 is recessed or proximal of other portions of end cap 452, for example, distal portion 452D, including illumination device opening(s) 458 and imaging device opening 460.

[0056] A proximal portion 452P of end cap 452 includes one or more arms 464. For example, in some aspects, proximal portion 452P includes a plurality of arms 464 separated by one or more slots 466. Arms 464 may be positioned around distal portion 150 of shaft 140 to help couple end cap 452 to shaft 140. In some aspects, slots 466 may allow for arms 464 to flex, bend, or otherwise move to help couple end cap 452 to shaft 140. In some aspects, although not shown, arms 464 or one or more other portions of end cap 452 may be coupled to shaft 140 via one or more of heat shrink tubing, one or more rings (e.g., to be crimped), etc. Alternatively or additionally, slots 466 may receive a glue, epoxy (e.g., a two-part epoxy), resin, or other adhesive 468, for example, such that adhesive 468 fills slots 466 and helps couple end cap 452 to shaft 140. Adhesive 468 may also flow or otherwise be positioned around one or more other components of end cap 452. In some aspects, adhesive 468 may flow or otherwise be positioned around (e.g., form an overmolded material) between (e.g., positioned longitudinally between) proximal portion 452P of end cap 452 and an outer portion of shaft 140. Adhesive 468 may harden, for example, when heated, cured, dried (e.g., over time), etc.

[0057] In some aspects, one or more sacrificial elements (e.g., rods, plugs, etc.) may be positioned within one or more portions of end cap 452 (e.g., withinAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 cavity 456) to help ensure that adhesive 468 does not flow into or otherwise harden within the one or more portions of end cap 452. Furthermore, distal ends or portions of one or more pull wires (not shown) may be secured within adhesive 468, which may help the one or more pull wires to deflect end cap 452 and distal portion 150 of shaft 140 when the one or more pull wires are manipulated (e.g., pulled or otherwise urged proximally or pushed or otherwise urged distally).

[0058] FIG. 5A illustrates a perspective view of a distal portion 550 of an exemplary shaft 540, and FIG. 5B illustrates a perspective view of an end cap 552 coupled to distal portion 550 of shaft 540. As discussed above with respect to shaft 140, shaft 540 may be a may be a multi-lumen extrusion, for example, formed of PTFE and / or additive-filled polymers. Additionally, shaft 540 includes a working channel 508. Working channel 508 may be positioned in a central portion of shaft 540, or may be slightly off-center (as shown). Shaft 540 also may include one or more fluid delivery lumens 514 and / or one or more negative pressure or suction lumens 516. As mentioned above, in some aspects, lumens 514 and 516 may both be fluid delivery lumens. Furthermore, in some aspects, negative pressure or suction may be applied through working channel 508. A communication lumen 524 may receive one or more cables, wires, etc. to electrically connect one or more of illumination device(s) 510 and / or imaging device(s) 512 (FIG. 5B) to handle 102 and / or umbilicus 120. Shaft 540 also includes one or more wire lumens 526, for example, to movably receive respective pull wires (FIG. 2A). Wire lumens 526 may be evenly or unevenly spaced around outer portions of shaft 540, for example, above or below one or more of lumens 514 and / or adjacent to (e.g., radially outside of) one or more of working channel 508 and / or communication lumen 524. One or more pull wires (e.g., movably positioned within respective wire lumens 526) may be fixedly coupled to distal end face 540D of shaft 540.

[0059] Furthermore, a distal portion of communication lumen 524 may be skived back, cut (e.g., with a razor blade, trimming tool, etc.), or otherwise removed to form a nest 570. For example, a distal end 524D (e.g., a distalmost end) of communication lumen 524 may be proximal of a distalmost end face 540D of shaft 540. At least a portion of nest 570 may receive a portion of end cap 552. End cap 552 may include an end cap body 552A, and at least a portion of end cap body 552A may be received within a portion of nest 570. End cap body 552A may be coupled to nest 570 via one or more of a snap fit, a press fit, a friction fit, adhesive, crimping, aAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 coupling ring, etc. With end cap body 552A positioned within a portion of nest 570, end cap 552 and shaft 540 may form an at least partially cylindrical distal portion 550. For example, an outer portion of end cap body 552A may at least partially correspond to an angle of curvature or shape of shaft 540. Additionally, end cap 552 may form a void 572 in front of (e.g., distal to) at least working channel 508. For example, a distal portion of end cap body 552A may extend distal to distalmost face 540D of shaft 540, such that a distal face 552D of end cap 552 is distal to distalmost face 540D of shaft 540. As discussed above, end cap 552 may include illumination device opening(s) 558 and imaging device opening(s) 560.

[0060] In these aspects, lumens or channels of shaft 540 (e.g., working channel 508, lumens 514 and 516, wire lumen(s) 526 may be continuous, for example, from a proximal end of shaft 540 to distalmost end face 540D. End cap 552 may not intersect a portion of distalmost end face 540D defining working channel 508, lumens 514 and 516, and wire lumens 526. In these aspects, end cap 552 may not interfere or otherwise inhibit the lumens or channels of shaft 540. Additionally, in some aspects, positioning a portion of end cap 552 within nest 570 of shaft 540 may help to align end cap 552 with communication lumen 524. Further, in some aspects, positioning a portion of end cap 552 within nest 570 of shaft 540 may help to protect end cap 552 or the electronics contained within (e.g., illumination device(s) 510 or imaging device(s) 512). For example, the nested coupling may help to protect end cap 552 from forces (e.g., forces perpendicular or otherwise at an angle relative to a longitudinal axis of end cap 552 or shaft 540) when distal portion 550 contacts tissue or other objects or impediments during insertion or during treatment. In some aspects, end cap 552 may be formed via a molding process (e.g., injection molding), for example, with various electronics (e.g., illumination device(s) 510 or imaging device 512) potted, overmolded, or otherwise positioned within end cap 552 in the molding process.

[0061] Additionally, in some aspects, distal portion 550 of shaft 540 may be less flexible or stronger than one or more proximal portions (not shown) of shaft 540. For example, distal portion 550 may be formed of a more rigid or stronger material (e.g., a high density polytetrafluoroethylene), and one or more proximal portions of shaft 540 may be formed of a more flexible or softer material (e.g., an expanded polytetrafluoroethylene). In these aspects, the one or more proximal portions of shaft 540 may be more flexible for deflection (e.g., via manipulation of the pull wires in pullAttorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001 wire lumens 526), while distal portion 550 may be less flexible or otherwise help to more securely retain end cap 552. In some aspects, the one or more proximal portions formed of the more flexible or softer material may be an intermediate portion of shaft 540. Stated another way, distal portion 550 may be formed of the more rigid or stronger material, and a portion of shaft 540 proximal of distal portion 550 may be formed of the more flexible or softer material. Additionally, another portion of shaft 540 proximal of the portion of shaft 540 formed of the more flexible or softer material may also be formed of a more rigid or stronger material, which may help in the delivery, positioning, or movement (proximal or distal movement) of shaft 540.

[0062] FIG. 6A and 6B illustrate perspective views of a distal portion 650 of an exemplary insertion portion that includes a shaft 640 and an end cap 652, with shaft 640 shown as partially transparent. Shaft 640 is similar to shaft 540, and includes a nest 670 to receive at least a portion of end cap 652. End cap 652 may be similar to end cap 552, as detailed above. As shown in FIG. 6B, shaft 640 may include or otherwise receive on or more electrical connections or cables 662, for example, connecting electrical, optical, illumination, etc. components of end cap 652 to proximal components.

[0063] Additionally, distal portion 650 includes a plate 674. Plate 674 may be coupled to one or more of a distal face 640D of shaft 640 or a distal face 552D of end cap 552. For example, plate 674 may include a plate opening 676, and at least a portion of end cap 552 may be positioned within (e.g., extend through and / or distally beyond) plate opening 676. In some aspects, plate 674 may include one or more extensions 678, for example, extending radially inward. In some aspects, shaft 640 may include one or more pull wires 646. Additionally, distal ends of the one or more pull wires 646 may be anchored, welded, adhered, or otherwise coupled to plate 674, for example, to a proximal face of a respective extension 678. In these aspects, urging pull wire(s) 646 proximally or distally may help to deflect or otherwise move shaft 640.

[0064] Furthermore, when end cap 652 and plate 674 are coupled to shaft 640, end cap 652 and plate 674 form a void 672, as discussed above. For example, in these aspects, end cap 652 and plate 674 may not interfere or otherwise inhibit the lumens or channels of shaft 640.

[0065] FIG. 7A and 7B illustrate perspective views of a distal portion 750 of an exemplary insertion portion that includes a shaft 740 and an end cap 752, withAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 shaft 740 shown as partially transparent in FIG. 7B. Shaft 740 is similar to shafts 540 and 640, and includes a nest 770 to receive at least a portion of end cap 752. End cap 752 may be similar to end caps 552 and 652, as detailed above. As shown in FIG. 6B, shaft 740 may include or otherwise receive on or more electrical connections or cables 762, for example, connecting electrical, optical, illumination, etc. components of end cap 752 to proximal components (e.g., via communication lumen 224 (FIG. 2B)).

[0066] Additionally, distal portion 750 includes a ring 780. Ring 780 may be coupled to and radially surround portions of one or more of shaft 740 or end cap 752 (e.g., portions of both shaft 740 and end cap 752). For example, ring 780 may be generally cylindrical, and an inner surface may abut respective portions of an outer surface of shaft 740 and an outer surface of end cap 752. Ring 780 may be positioned proximal of a distal end face 740D of shaft 740, such that ring 780 abuts a proximal portion of end cap 752 and a portion of shaft 740 that is proximal of distal end face 740D. Ring 780 may be coupled to shaft 740 and end cap 752 via a crimp, snap fit, friction fit, adhesive, etc. In these aspects, ring 780 may help to secure, retain, or otherwise couple end cap 752 to shaft 740.

[0067] Additionally, in some aspects and as shown in FIG. 7B, shaft 740 may receive one or more pull wires 746. Distal portions of the one or more pull wires 746 may be anchored, welded, adhered, or otherwise coupled to ring 780, for example, to respective inner portions of ring 780. In these aspects, urging pull wire(s) 746 proximally or distally may help to deflect or otherwise move shaft 740.

[0068] Furthermore, when end cap 752 and ring 780 are coupled to shaft 640, end cap 752 and ring 780 form a void 772, as discussed above. For example, in these aspects, end cap 752 and ring 780 may not interfere or otherwise inhibit the lumens or channels of shaft 740.

[0069] FIGs. 8A and 8B illustrate perspective views of a distal portion 850 of an exemplary insertion portion that includes a shaft 840 and an end cap 852. It is noted that FIG. 8A only shows a distal section of shaft 840, for example, in order to illustrate a pull wire 846 extending proximally.

[0070] End cap 852 includes one or more illumination device openings 858, for example, to receive one or more illumination devices 810. Additionally, end cap 852 may include one or more imaging device openings 860, for example, to receive one or more imaging devices 812. Illumination device opening(s) 858 or imagingAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 device opening(s) 860 may be positioned in a distal portion of end cap 852. In some aspects, illumination device 810 and / or imaging device 812 may at least partially align with communication lumen 224 (FIG. 2B), for example, such that wires, cables, etc. (e.g., electronic connections) coupling illumination device(s) 810 and / or imaging device(s) 812 to handle 102 and / or umbilicus 120 extend through communication lumen 224 (FIG. 2B).

[0071] Additionally, end cap 852 includes a working channel or central cavity 856. When end cap 852 is coupled to shaft 840 (e.g., to distal face 840D), central cavity 856 may at least partially align with working channel 808 and one or more of fluid delivery lumen(s) 814 and suction lumen(s) 816. As such, central cavity 856 may include a lateral or cross-sectional diameter or area larger than a lateral or cross-sectional diameter or area of working channel 808. In some aspects, central cavity 856 may be a similar size and / or shape as central cavities 356 and 456.

[0072] Further, shaft 840 includes one or more pull wire lumens 826 to each movably receive a respective pull wire 846. End cap 852 may include or otherwise be coupled to a plate 874, for example, similar to plate 674 discussed above. In these aspects, distal ends of each pull wire 846 may be coupled to (e.g., welded) to one or more of end cap 852 or plate 872. Additionally or alternatively, a ring 880 may be positioned around respective portions of shaft 840 and end cap 852, for example, to help couple shaft 840 and end cap 852. In some aspects, portions of each pull wire 846 may also be coupled to respective portions of ring 880. In any of these aspects, manipulation of pull wire(s) 846 may help to deflect, position, or otherwise move distal portion 850. Additionally, although not shown, end cap 852 or plate 874 may be discontinuous. For example, portions (e.g., bottom portions relative to the orientations shown in FIGs. 8A and 8B) of end cap 852 or plate 874 may be omitted. Nevertheless, in any of these aspects, the cavity 856 formed by end cap 852 and plate 874 may be larger than the distal opening of working channel 808.

[0073] In any of the embodiments discussed here, the cavity, opening, or void in the end cap through which an instrument may be delivered to the treatment site may be larger than the working channel of insertion portion 104 (e.g., shaft 140). For example, the cavity, opening, or void in the end cap may include a larger diameter or area (e.g., lateral cross-sectional diameter or area) than the diameter or area (e.g., lateral cross-sectional diameter or area) than the working channel of insertion portion 104. In these aspects, one or more tools or other devices may be delivered to theAttorney Docket No.: 06530-1469-00304 Client Ref. No. 24-0262W001 treatment site via the biopsy port, the working channel or internal lumen of the shaft, and out of an opening in the end cap. Additionally, if the cavity, opening, or void in the end cap is not properly aligned (e.g., not properly angularly or rotationally aligned) with the distal end of the working channel of the insertion portion, the one or more tools or other devices may still be extended distally through or adjacent to the end cap, for example, with a reduced risk of being damaged or otherwise being interfered with or impaired by the misalignment of the end cap with the working channel of the insertion portion.

[0074] Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W001CLAIMSWe claim:1 . A medical device, comprising: a handle including a port; a shaft extending from the handle, wherein the shaft includes a distal end, and wherein the shaft includes: a working channel fluidly connected to the port; and one or more of a fluid delivery lumen or a suction lumen; and an end cap configured to be coupled to the distal end of the shaft, wherein the end cap includes or forms a cavity or a void, and wherein, when the end cap is coupled to the distal end of the shaft, the cavity or void at least partially aligns with a distal end of the working channel and a distal end of the one or more of the fluid delivery lumen or the suction lumen of the shaft.

2. The medical device of claim 1 , wherein the cavity or the void is the cavity, and wherein the cavity includes a concave portion and a convex portion opposite to the concave portion.

3. The medical device of claim 2, wherein the cavity further includes two partially circular corner portions.

4. The medical device of any preceding claim, wherein the end cap includes a first side and a second side opposite to the first side, and wherein the first side includes a longitudinal length that is shorter than a longitudinal length of the second side.

5. The medical device of claim 4, wherein the end cap includes tapered side portions extending between the first side and the second side of the end cap.

6. The medical device of claim 1 , wherein the distal end of the shaft includes a nest, and wherein at least a portion of the end cap is positioned within the nest and forms the void.Attorney Docket No.: 06530-1469-00304Client Ref. No. 24-0262W0017. The medical device of claim 6, wherein the shaft includes one or more pull wire lumens that movably receive respective pull wires, and wherein the pull wires are movable to deflect the distal end of the shaft.

8. The medical device of claim 7, further comprising a plate, wherein the plate is coupled to one or more of a distal face of the end cap or a distal face of the shaft.

9. The medical device of claim 8, wherein distal ends of the pull wires are coupled to the plate.

10. The medical device of claim 9, wherein the plate includes one or more radially inward extensions, and wherein respective pull wires are coupled to the one or more radially inward extensions.11 . The medical device of claim 7, further comprising a ring, and wherein distal ends of the pull wires are coupled to the ring.

12. The medical device of any preceding claim, wherein the end cap further includes an imaging device and one or more illumination devices.

13. The medical device of claim 12, wherein the imaging device and the one or more illumination devices are coupled to the handle via one or more cables, wherein the shaft includes a communication lumen, wherein the one or more cables are positioned within the communication lumen, and wherein a distal end of the communication lumen is adjacent to the nest.

14. The medical device of any preceding claim, wherein the end cap is further coupled to the shaft via one or more adhesives.

15. The medical device of claim 14, wherein the end cap includes a plurality of arms that form a plurality of slots, and wherein the one or more adhesives fills the plurality of slots of the end cap when coupling the end cap to the shaft.

Images