Distal tip for a medical device

Abstract

A medical device can include a distal tip having a viewing element, an illumination element, and at least one feature configured to removably couple the distal tip to a shaft. The medical device further includes a working channel coupled with the distal tip and defining a central lumen configured to receive a tool. A wall of the working channel defines at least one additional lumen. The working channel is configured to be removably inserted into the shaft. The medical device can further include at least one of a wire, a cable, or a catheter passing through the at least one additional lumen.

Description

[0001] Cross-citation of relevant literature

[0002] This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 008,152, filed April 10, 2020, the contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to components of medical devices. Aspects of this disclosure relate to devices, systems, and / or methods for the distal tip of an endoscopic device. Background Technology

[0004] A duodenoscope may include a handle portion for operator gripping and control elements for functions such as steering, suction, water, air, light, and imaging. The duodenoscope may also include an insertable portion for the subject. For example, the duodenoscope may include a shaft adapted for insertion into the subject. Such an insertable portion may include one or more lumens. The lumens of the insertable portion of the duodenoscope may support functions such as air delivery, water supply, suction, power, data transmission, light, and / or imaging. Tools may also be inserted through a working channel of the shaft. For example, tools may be inserted into the working channel from a port in or near the handle of the duodenoscope.

[0005] The axis of the duodenoscope may terminate at a steerable distal portion. This distal portion may include exits for air, water, suction, electricity, data, light, imaging, and / or working instruments for the duodenal lumen. The components of the distal tip may be affected by fluids or other substances in the patient's body cavity. The duodenoscope may undergo a reprocessing procedure before being reused on another patient. Summary of the Invention

[0006] Embodiments of this disclosure relate, among other things, to devices, systems, and methods for the distal tip of a medical device. Each example disclosed herein may include one or more features relating to the disclosed example.

[0007] In one example, the medical device may include a distal tip having an observation element, an illumination element, and at least one feature configured to detachably engage a distal tip with a shaft. The medical device may also include a working channel that engages with the distal tip and defines a central cavity configured to receive an instrument. The walls of the working channel may define at least one additional cavity. The working channel may be configured to detachably insert into the shaft. The medical device may also include at least one of a filament, cable, or catheter passing through the at least one additional cavity.

[0008] Any medical device disclosed herein may have any of the following features: At least one of a filament, cable, or catheter may include a filament or cable. The filament or cable may be configured to operate at least one of a lift, observation element, or illumination element of the distal tip. The distal tip may further include a motor for raising or lowering the lift. At least one of the filament, cable, or catheter may include a filament or cable. The filament or cable may be configured to supply power to the motor. The walls of the working channel may define at least two additional cavities. The distal tip may have a post extending from its proximal surface. The post may be configured to be detachably connected to a control line extending through an axis. The post may define at least one slot, and the control line may include at least one protrusion configured to be received by at least one slot. The distal tip may have at least one pin extending from its proximal surface. The pin may be configured to connect the distal tip to the axis. The distal tip may be configured to be rotatable relative to the axis. The distal tip may include a motor configured to rotate the distal tip relative to the axis. The motor may be configured to rotate the gear. The distal tip may include teeth configured to engage with the gear. The distal tip may include a magnet for coupling an element of the distal tip to an element of the shaft. The distal tip may further include a distal tip lift control line for raising and lowering the endoscope. The proximal end of the lift control line may include a notch configured to mate with a slot in the lift control line of the shaft. The proximal end of the working channel may include a plurality of threads on a handle for securing the proximal end to the proximal end of the shaft. The proximal end of the distal tip may define a port for operatively connecting the electronics of the distal tip to a spool or cable extending through the shaft.

[0009] In another example, the medical device may include a distal tip having an observation element, an illumination element, and a nozzle. A working channel may be coupled to the distal tip and define a central cavity configured to receive a tool. The walls of the working channel may define at least one additional cavity. The working channel may be configured to be removably inserted into a shaft. This at least one additional cavity may be configured to be in fluid communication with the nozzle.

[0010] Any medical device disclosed herein may have any of the following features: The distal tip may further include a motor operable to raise or lower the lift. At least one of the filament, cable, or catheter includes a filament or cable, and wherein the filament or cable is configured to supply power to the motor.

[0011] An exemplary method may include: detachably coupling a distal tip to a shaft of a medical device. The distal tip may have: an observation element and an illumination element. The method may further include supplying a working channel through the shaft and detachably coupling the working channel to a handle of the medical device.

[0012] Any method disclosed herein may have any of the following features: A working channel may define a central cavity configured to receive a tool. The walls of the working channel may define at least one additional cavity. At least one of a wire, cable, or conduit may pass through at least one additional cavity. At least one of a wire, cable, or conduit may be configured to be operatively connected to at least one of a lift, observation element, lighting element, or nozzle.

[0013] It is understood that the foregoing general description and the following detailed description are exemplary and illustrative only, and are not intended to limit the claimed invention. As used herein, the terms “comprising,” “including,” or any other variation thereof are intended to cover a non-exclusive inclusion, a list of elements including not only those elements but also other elements not expressly listed or elements inherent to such processes, methods, articles, or devices. The term “exemplary” is used in the sense of “example” rather than “ideal.” The term “distal” refers to a direction away from the operator / away from the direction toward the treatment site, while the term “proximal” refers to a direction toward the operator. The term “about” or similar terms (e.g., “substantially”) include numerical values ​​of + / - 10% of the specified value. Attached Figure Description

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

[0015] Figure 1 An exemplary duodenoscope is described.

[0016] Figure 2A and 2B An exemplary distal tip of a duodenoscope is described.

[0017] Figure 3 Described for Figure 2A and 2B An exemplary working channel at the distal tip.

[0018] Figures 4A-4D The distal tip and the components used with it are shown.

[0019] Figures 5A-5C An exemplary fixing mechanism is shown.

[0020] Figures 6A-6B Examples of rotating elements are depicted in 7A-7C. Detailed Implementation

[0021] During reprocessing, it may be difficult to adequately clean the distal tip and / or working channel of the duodenoscope. Therefore, it may be necessary to remove the distal tip and / or working channel from the rest of the duodenoscope. The distal tip and / or working channel may be disposable to avoid the need for reprocessing. The distal tip and / or the axis of the duodenoscope may include features to facilitate connection between elements of the distal tip (e.g., lift, air / water nozzle, observation element, and / or illumination element) and elements in the axis and handle of the duodenoscope for control of the distal tip elements. The distal tip may also have rotatable elements to allow rotation of the distal tip relative to the axis of the duodenoscope.

[0022] Figure 1 An exemplary duodenoscope 10 is described, having a handle 12 and an insertion portion 14. The duodenoscope 10 may also include a cable 16 for connecting the duodenoscope 10 to a source such as air, water, suction, power, etc., and to an image processing and / or observation device. Although the term duodenoscope may be used herein, it is understood that other devices, including but not limited to endoscopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, sheaths, catheters, or any other suitable delivery device or medical device, may be connected and used with the connection devices and methods of this disclosure. Although lateral devices have been specifically discussed, the embodiments described herein can also be used with antegrade endoscopes (e.g., endoscopes with the observation element facing longitudinally forward).

[0023] The insertion portion 14 may include a sheath or shaft 18 and a distal tip 20. The distal tip 20 may include an imaging device (e.g., a camera) 22 and an illumination source 24 (e.g., an LED or fiber optic). The distal tip 20 may also include a lifting mechanism 26 for changing the orientation of the instrument inserted into the working channel of the duodenoscopy 10 (further details regarding the insertion instrument will be provided below). The lifting mechanism 26 may be pivoted via, for example, an actuation line. The distal tip 20 may be lateral. That is, the imaging device 22 and the illumination source 24 may be radially outward, perpendicular or approximately perpendicular to the longitudinal axis of shaft 18 and the distal tip 20.

[0024] The distal portion of the shaft 18, connected to the distal tip 20, may have a steerable section 28. The steerable section 28 may be, for example, a hinged joint. The shaft 18 and the steerable section 28 may include various structures known in the art or that may become known herein. In this document, regarding... Figure 2A-7C Exemplary features of the distal tip 20 are described in further detail.

[0025] Handle 12 may have one or more control mechanisms 30. Control mechanisms 30 may provide control over the steerable section 28, or may allow the supply of air, water, suction, etc. For example, handle 12 may include control knobs 32, 34 for controlling the left, right, up, and / or down of the steerable section 28. For example, one of knobs 32, 34 may provide left / right control over the steerable section 28, while another of knobs 32, 34 may provide up / down control over the steerable section 28. Handle 12 may further include one or more locking mechanisms 36 (e.g., knobs or levers) for preventing the steerable section 28 from turning in at least one of the up, down, left, or right directions. Handle 12 may include a lifting mechanism control link 38. Lifting mechanism control link 38 may raise and / or lower the lifting mechanism 20. A port 40 may allow tools to enter the working channel of the duodenoscope 10 through the sheath 18 and reach the distal tip 20.

[0026] In use, the operator can insert at least a portion of shaft 18 into the subject's body cavity. The distal tip 20 can be navigated to the surgical site within the body cavity. The operator can insert a tool (not shown) into port 40 and guide it through the working channel via shaft 18 to the distal tip 20. The tool can exit the working channel at the distal tip 20. The user can use lifting mechanism control linkage 38 to raise lifting mechanism 26 and tilt the tool toward the desired location (e.g., the papilla of the pancreaticobiliary duct). The user can use this tool to perform medical procedures.

[0027] Figure 2A and 2B Different views of the exemplary distal tip 100 are provided. Figure 2A A 3D model was provided, and Figure 2B A cross-sectional view is provided. The distal tip 100 can be used to replace the distal tip 20 of the duodenoscopy 10 and can have any of the characteristics of the distal tip 20. The distal tip 100 can be disposable. The distal tip 100 can be positioned on the axis 18 before use of the duodenoscopy 10 and removed from the axis 18 after use. The distal tip 100 can be processed, while the other parts of the duodenoscopy 10 can be reused.

[0028] The distal tip 100 may include features such as an observation element 102 (e.g., a camera), an illumination source 104, air and / or water nozzle(s), and / or a lift mechanism 110. The lift mechanism 110 may have any of the characteristics of the lift mechanism 20. The lift mechanism 110 may include an attachment point 112 for connecting the lift mechanism 110 to a mechanism (e.g., a wire or electric element, as described below) for raising and / or lowering the lift mechanism 110. The observation element 102 may have any of the characteristics of the observation element 22. The observation element 102 may include, for example, a charge-coupled device ("CCD") unit, an image sensor, and / or an objective lens. The illumination source 104 may have any of the characteristics of the illumination source 24. The illumination source 104 may include, for example, an LED or optical fiber. The distal tip 100 may also include internal components, such as a motor and / or gears, for rotation of the distal tip 100 (see [link to relevant documentation]). Figures 6A-7C (As described below). The distal tip 100 may also accommodate a motor for raising and lowering the elevator 110, as per [reference to...]. Figures 6A-6B Further description.

[0029] The working channel 120 can extend proximally from the distal tip 100. The working channel 120 can define a cavity (e.g., a central cavity) for receiving instruments, delivering suction, and / or receiving bodily fluids or tissue. The working channel 120 can be detached from or fixedly attached to the distal tip 100. The working channel 120 can extend proximally from the distal tip 100 to the handle 12. When the distal tip 100 is attached to the distal end of the duodenoscope, the working channel 120 can be returned to the handle 12 via a shaft 18. In the handle 12, the working channel 120 can be attached to a suitable structure (e.g., instrument port 40, among others). As described below, the walls of the working channel 120 can accommodate various components, such as wires and / or cables for the observation element 102, the illumination element 104, and / or motors for rotating the distal tip 100 or operating the lift 110. The working channel 120 may also accommodate a conduit in fluid communication with the control mechanism (e.g., a wire) of the air and / or water nozzle and / or the elevator 110.

[0030] The distal tip 100 may accommodate complementary components that are integral with the components of the working channel 120 (e.g., where the working channel 120 is fixedly attached to the distal tip 100) or separate components operatively connected / attached to the components of the working channel 120. Threads and / or cables, conduits, and lift control elements may be present in each of the handle 12, shaft 18, and distal tip 100, and may comprise individual, single components or components operatively connected to each other.

[0031] A cavity may extend through the working channel 120, and this cavity may allow instruments, suction, and / or body tissue to pass through the channel. The working channel 120 may terminate at the proximal end of the distal tip 100 or within the distal tip 100. The cavity of the working channel 120 may communicate with the opening 130 of the distal tip. The cavity of the working channel 120 may terminate at the opening 130, or the structure of the distal tip 100 (e.g., the wall of the distal tip 100) may form a channel communicating with the cavity of the working channel 120. Instruments may pass through the cavity of the working channel 120 and exit from the opening 130. The lifting mechanism 110 may be actuated by the lifting mechanism control link 28 to raise or lower, thereby changing the orientation of the instrument extending out of the opening 130.

[0032] The proximal edge of the distal tip 110 may include one or more mating parts 140. For example... Figure 2A As shown, the distal tip 110 may have two mating parts 140. The mating parts 140 may include various structures, such as those described below. Figures 4A-4C Those described. For example... Figure 2A As shown, the mating member 140 may include a protrusion (e.g., a nail) extending proximally from the proximal surface of the distal tip 100. The mating member 140 may include a post and a head. The mating member 140 may have, for example, a shape like a screw head. The mating member 140 may mate with a component of the shaft 18 of a duodenoscope, or otherwise secure the distal tip 100 to the shaft 18. For example, the distal surface of the shaft 18 may include an arcuate slot (not shown) for receiving the mating member 140. Rotation of the distal tip 100 relative to the shaft 18 may cause the mating member 140 to engage with the slot to secure the distal tip 100 to the shaft 18. Alternatively, the distal surface of the shaft 18 may include an opening having a circular or other shape for receiving and engaging the component 140 to secure the distal tip 100 to the shaft 18. Further details regarding exemplary mating mechanisms will be provided below.

[0033] Figure 3 Various aspects of an exemplary working channel 220 are shown, which may have any of the characteristics of working channel 120 and may be used with a distal tip, such as distal tip 100. Alternatively, working channel 220 may also be used with other duodenoscopes. Figure 2A A working channel 220 terminating in the proximal end 222 is shown. A lumen 224 may extend through the length of the working channel 220 from the proximal end 222 to the distal end of the working channel. The lumen 224 may be used to pass instruments from a port in the duodenoscope handle through an opening 130 in the distal tip. Body fluids may also pass proximally through the lumen 224 via the opening 130.

[0034] The proximal end 222 of the working channel 220 may include a mating structure 226 to facilitate the mating of the working channel 220 with the handle 12. For example, as Figure 2A As shown, the mating structure 226 may include threads to provide a threaded engagement between the working channel 220 and a socket in the handle that can communicate with the port 40.

[0035] The wall 227 of the working channel 220 may define one or more cavities 228 extending longitudinally through the wall 227. The cavity 228 may be defined by a circular surface. Alternatively, the cavity 228 may have alternative shapes. For example, the cavity 228 may include a slot extending radially inward from the outer surface of the working channel 220. The cavity 228 may be completely closed, or it may include a portion open to the outer surface of the working channel 220.

[0036] Cavity 228 may be in addition to the central cavity for receiving / transmitting tools, suction, and body fluids / tissues. Cavity 228 may extend along the longitudinal axis of the working channel 220, but may not be coaxial with the central longitudinal axis of the working channel 220. Cavity 228 may surround the central cavity. Each cavity 228 may extend from the proximal end 222 of the working channel 220 to the distal end. Cavity 228 may open at both the proximal end 222 and the distal end of the working channel 220. Wall 227 may define any suitable number of cavities 228. For example, as shown in FIG2, wall 227 may define four cavities 228. Cavity 228 may form channels for filaments and / or cables, catheters, and / or lifting mechanism control elements extending from the handle, through shaft 18, to the distal tip 110 of the duodenoscope. For example, cables and / or filaments for powering and / or controlling the observation element 102 and illumination element 104 and / or for receiving signals from the observation element 102. Water and / or air supply may also be provided through lumen 228. A catheter may pass through lumen 228 to supply water and / or air from the handle to the distal tip of the duodenoscope. Alternatively, water and / or air may travel directly through lumen 228 without passing through the intermediate catheter structure of lumen 228.

[0037] As an example, the working channel 220 may include four chambers 228. The first of the four chambers 228 may be used to supply air or other fluid, and the second may be used to supply water or other fluid. The third chamber 228 may be used to transmit signal cables from the observation element 102. The fourth chamber 228 may be used to transmit power cables that can power, for example, the observation element 102, the lighting element 104, and motors for raising and lowering the lifting mechanism 110 and / or rotating the distal tip 100.

[0038] The socket in the handle 12 can provide an automatic connection between the element in the cavity 228 of the working channel 220 and the corresponding structure in the handle 12. For example, screwing the working channel 220 into the appropriate socket can provide an electrical connection between the control element in the handle 12 and the corresponding wire in the cavity 228. In such an example, after the working channel 220 has been fed back through the shaft 18, the proximal end 222 of the working channel 220 can be positioned in the socket of the handle 12, providing a single step for forming a connection between the element in the cavity 228 and the corresponding element of the handle 12. Alternatively, the element conveyed in the cavity 228 can be connected to the corresponding element of the handle 12 before or after the proximal end 222 is secured to the handle 12. For example, the thread conveyed in the cavity 228 can terminate proximally in a plug portion that inserts into the socket of the handle 12.

[0039] Figure 4A and 4B Alternative distal tip 100' and alternative working channel 220' are shown. While distal tip 100' and working channel 220' are described together herein, features of distal tip 100' and / or working channel 220' may be combined with other aspects described herein. For example, features of distal tip 100 may be used with features of working channel 220', and vice versa. Distal tip 100' and working channel 220' may each have any of the features of distal tip 100 and working channel 220, unless specifically indicated.

[0040] Compared to the working channel 220, the working channel 220' may have fewer cavities 228' formed therein. Some components may pass outside the working channel 220' instead of through the cavities 228'. For example, the working channel 220' may define two cavities 228'. These two cavities 228' may respectively transmit air (or another fluid) and water (or another fluid). Cables or threads for providing power and / or receiving image signals from the observation element 102 may pass through the outside of the working channel 220, through the shaft 18. The cables or threads may extend through a port 260 on the proximal side of the distal end 100'. The port 260 may be an opening through which the cables and / or threads may extend proximally from electronic components (e.g., a motor, observation element 102, and / or illumination element 104). When the distal tip 100' is positioned on the shaft 18, the cables and / or threads may be fed back through the shaft 18 and connected to a portion of the handle 12. In such an example, port 260 may include a sealing element to prevent fluids (such as bodily fluids) from passing through port 260. Alternatively, port 260 may form a socket for receiving a connector. For example, disposable or reusable threads and / or cables may extend distally from handle 12 toward distal tip 110'. The threads and / or cables may be fixedly or detachably attached to elements of handle 12. The threads and / or cables may terminate distally in a connector that can be inserted into port 260 to form an electrical connection with elements of distal tip 100'.

[0041] As described above regarding the distal tip 100, the lifting mechanism 110 can be operated (raised or lowered) via a motor in the distal tip 100. Alternatively, control line 214 ( Figure 4D It can be connected to the lifting mechanism control link 38 and can be connected via shaft 18. Movement of the lifting mechanism control link 38 causes movement of the control line 214 proximally and distally. The control line 214 can terminate in the distal end 215, such as... Figure 4D As shown. The distal end 215 may include a shaft 216 and a head 218. The head 218 may extend radially outward relative to the shaft 216. One or more protrusions 220 may extend radially outward from the surface of the head 218. For example, as Figure 4D As shown, two protrusions 220 can extend from the head 218. The protrusions 220 can have any suitable shape. For example, as... Figure 4D As shown, the protrusion 220 may have a longitudinal dimension larger than the circumferential dimension (it may extend longitudinally along the head 218 further than it extends circumferentially around the head 218).

[0042] Control line 214 is operatively connected to pin 250 extending from the proximal side of distal tip 100'. Pin 250 may form the proximal end of control line extending within distal tip 100', which is operatively connected to lifting mechanism 110 such that lifting mechanism 110 rises when pin 250 moves proximally and lowers when pin 250 moves distally. Alternatively, pin 250 may be operatively connected to a separate control line within lifting mechanism 110 such that lifting mechanism rises and falls when pin 250 moves proximally and distally. Figure 4C A detailed view of pin 250 is provided. Pin 250 may include a shaft 252 and a head 254, the head 254 having a radial dimension larger than the shaft 252. Alternatively, pin 250 may have the same radial dimension. Head 254 may define a cavity 255 that may open at a proximal end of head 254. A portion of pin 250 (e.g., head 254) may define one or more slots 256. For example, as... Figure 4C As shown, pin 250 can define two slots 256 that extend through the wall of head 254. Slots 256 can be L-shaped. The distal portion of slot 256 can extend in a circumferential direction, while the proximal portion of slot 256 can extend in a longitudinal direction.

[0043] To operatively connect control line 214 to pin 250, distal end 215, including head 218, is inserted into cavity 255, aligning protrusion 220 with slot 256. Distal end 215 can be moved distally to allow protrusion 220 to move along slot 256. Distal end 215 can then be rotated to allow protrusion 220 to continue moving along a portion of slot 256 that extends circumferentially around pin 250.

[0044] Control line 214 can be coupled to pin 250, while pin 140 is simultaneously (or subsequently or previously) coupled to a feature of shaft 18. For example, when distal tip 100' and shaft 18 are brought together, distal end 215 of control line 214 can be inserted into cavity 255 of pin 250, and pin 140 can be inserted into hole, slot, or other feature of shaft 18. Distal tip 100' can then be twisted relative to shaft 18. Twisting engages control line 214 and pin 250 together while simultaneously engaging pin 140 to shaft 18, thus securing distal tip 100' relative to shaft 18. Distal tip 100 or 100' can also be attached to shaft 18 via twisting, even without pin 250 on distal tip 100'. To further secure the distal tip 100 / 100' to the shaft 18 and to inhibit fluid inflow and outflow between the distal tip 100 / 100' and the shaft 18, a baffle may be provided between the distal tip 100 / 100' and the shaft 18. After surgery, the distal tip 100 or 100' can be detached from the shaft 18 (e.g., by twisting in the opposite direction). The distal tip 100 or 100' may be disposable or can be reused for further surgery.

[0045] Although the light-emitting diodes with respect to the distal tips 100, 100' have been discussed, it is understood that optical fibers may be used alternatively or additionally. The optical fibers may extend through the shaft 18 and the distal tips 100 or 100'. The optical fibers of the shaft 18 and the distal tips 100 or 100' may be joined at the junction of the shaft 18 and the distal tips 100 or 100'. The optical fibers may be flush with the proximal surface of the distal tips 100 or 100' and the distal surface of the shaft 18. This flushness of the optical fibers can result in easier cleaning of components such as the shaft 18, as fluids may not seep into gaps or adhere to the outer surface of the optical fibers.

[0046] Figures 5A-5C Alternative attachment mechanisms are shown for attaching a portion of the control line in shaft 18 to a distal tip, such as a portion of the control line in distal tip 100 or 100'. Although Figures 5A-5C The attachment mechanism described herein can be described in relation to the control lines used to raise and lower the lifting mechanism, but it is understood that the attachment mechanism can additionally or alternatively be used to secure the distal tip (e.g., distal tip 100 or 100') to the shaft 18.

[0047] Figures 5A-5BA fixing mechanism 300 is shown, which functions like a finger clamp. A distal tip control line 312 can be connected to a lifting mechanism (e.g., lifting mechanism 110) and can extend proximally toward the shaft 18 through the distal tip. A shaft control line 314 extending through the shaft 18 may have a sleeve 316 fixed around it. The sleeve 316 may define a cavity and can extend circumferentially around the distal portion of the shaft control line 314, which may be disposed within the cavity.

[0048] One or more protrusions 318 may extend radially inward from the inner surface of the sleeve 316. One or more notches 319 may be formed in the distal tip control line 312. A single protrusion 318 may extend around the inner circumference of the sleeve 316, and a single notch 319 may extend around the circumference of the distal tip control line 312. Alternatively, the sleeve 316 may have a plurality of discontinuous protrusions, and the distal tip control line 312 may have a plurality of discontinuous notches.

[0049] The protrusion 318 and the notch 319 may have the same or complementary shapes, such that when the distal tip control line 312 is inserted into the sleeve 316, the protrusion 318 engages with the notch 319 to retain the distal tip control line 312 within the sleeve 316, and the protrusion 318 is aligned with the notch 319. For example, the proximal sides of the protrusion 318 and the notch 319 may be substantially perpendicular to the longitudinal axis of the shaft control line 314, the sleeve 316, and / or the distal tip control line 312. The distal edges of the protrusion 318 and the notch 319 may be radially outwardly inclined / tapered towards the first side. The protrusion 318 and the notch 319 may have a triangular or wedge-shaped shape.

[0050] Figure 5A The distal tip control line 312 and shaft control line 314 are shown before the distal tip control line 312 is fully inserted into the sleeve 316. To connect the distal tip control line 312 to the shaft control line 314, the proximal end of the distal tip control line 312 can be inserted into the sleeve 316. The distal tip control line 312 can move proximally. The distal tip control line 312 can contact the protrusion 318 and cause the protrusion 318 to deflect radially outward. The sleeve 316 and / or the protrusion 318 may be formed of an elastic, flexible, and / or shape-memory material and be able to bend to allow the proximal end of the distal tip control line 312 to pass through the protrusion 318. Figure 5B As shown, the protrusion 318 can engage with the notch 319 to retain the distal tip control line 312 within the sleeve 316. Pulling the distal tip control line 312 distally with sufficient force can disengage the distal tip control line 312 from the sleeve 316 without damaging the sleeve 316.

[0051] Although sleeve 316 is described as being fixed around shaft control line 314, sleeve 316 may alternatively be fixed around distal tip control line 312, and shaft control line 314 may include one or more notches, similar to notch 319. Although protrusion 318 is described as extending radially inward from sleeve 316, it is understood that protrusion 318 may extend radially outward from distal tip control line 312 (or shaft control line 314). Notches (similar to notch 319) may be formed on the wall of sleeve 316.

[0052] Figure 5C An alternative mechanism for attaching shaft 618 (having any characteristics of shaft 18) to distal tip 600 (having any characteristics of distal tips 100, 100') is shown. Distal tip 600 may include observation element 602 (which may have any characteristics of observation element 102) and illumination source 604 (having any characteristics of illumination source 104). Distal tip 600 may also include a lifting mechanism 610, which may have any characteristics of lifting mechanism 110. A shaft control line 614 may extend through the length of shaft 618 and may have any characteristics of shaft control line 314. Shaft control line 614 is operatively connected to an actuator in a duodenoscope handle (such as handle 12) to move shaft control line 614 proximally and distally. The distal tip control line 612 may extend longitudinally through the distal tip 600 and be operatively connected to the lifting mechanism 110, such that the proximal and distal movement of the distal tip control line 612 may raise and / or lower the lifting mechanism 110.

[0053] The distal tip control line 612 may terminate proximally in the magnetic element 640. The magnetic element 640 may be formed of the same material as the remainder of the distal tip control line 612, or it may be a separate component fixedly attached to the distal tip control line 612. The axis control line 614 may terminate distally in the magnetic element 642. The magnetic element 642 may be formed of the same material as the remainder of the axis control line 614, or it may be a separate component fixedly attached to the axis control line 614. The portions of magnetic elements 640 and 642 facing each other may have opposite polarities, such that magnetic elements 640 and 642 attract each other. The magnetic force between magnetic elements 640 and 642 can be calibrated so that magnetic elements 640 and 642 secure the distal tip control line 612 to the axis control line 614. After use, the user can use sufficient force to separate magnetic element 640 from magnetic element 642. Alternatively, at least one of magnetic element 640 and magnetic element 642 may be electromagnetic and can be switched off to release magnetic element 640 from magnetic element 642. Alternatively, a key or other device may be configured to release magnetic element 640 and magnetic element 642 after use.

[0054] Figure 6A and 6B A transparent view of an exemplary distal tip 600 is depicted, which may have any of the features described above. The distal tip 600 may define a longitudinally extending cavity 624. The cavity 624 may open from a proximal opening on the proximal side of the distal tip 600 to a distal opening. The distal opening of the cavity 624 may open to a lifting mechanism 610. The lifting mechanism 610 may have any of the features described above. The lifting mechanism 610 may be configured to raise and lower to change the orientation of an instrument passing through the cavity 624 and exiting from the distal end of the cavity 624. Figure 6B As shown, the working channel 620 can be received into the cavity 624. The working channel 620 can have any of the characteristics of the working channels 120, 220, 220' described above. For example, the working channel 620 can have the characteristics of the working channel 220.

[0055] The distal tip 600 may include a rotary motor 660. As described above, the rotary motor 660 relative to the working channel 220 may be powered by, for example, a built-in power source (e.g., a lithium-ion battery), a wire or cable passing through the cavity of the working channel 620. The rotary motor 660 may power the gear 662. The rotary motor 660 may cause the gear 662 to rotate in a first direction or a second direction. The gear 662 may have teeth formed around at least a portion of its circumference.

[0056] The tooth 664 may extend around the entire circumference of the distal tip 600 to allow approximately 360 degrees of rotation of the rotatable portion 670. Alternatively, as shown, the tooth 664 may extend only around a portion of the circumference of the distal end 600 to allow rotation less than 360 degrees (e.g., approximately 90 degrees, approximately 180 degrees, or approximately 270 degrees). Stops may be positioned at both ends of the rotation (e.g., on the inner circumference of the distal end 600) to limit the rotation to the amounts described above. The rotatable portion 670 may be coupled to the fixed portion 672 via a bearing unit such as a polymer bearing unit.

[0057] The distal tip 600 may also include a lifting mechanism motor 680 (see...) Figure 6B The lifting mechanism motor 680 can cause the lifting mechanism 610 to move up and down. The lifting mechanism motor can be powered by wires, ropes or cables that can extend through the cavity of the working channel 620 (e.g., as described with respect to the working channel 220).

[0058] Although the rotary motor 660, gear 662, tooth 664 and lifting mechanism motor 680 are described specifically for disposable distal tips (such as those described above), it is understood that these components can be used for various distal tips of duodenoscopes or other types of endoscopes.

[0059] Figure 7A and 7B A component is described that can be used to facilitate rotation of the distal tip of the duodenoscope 10 relative to the axis 18 of the duodenoscope 10. Figure 7A and 7B The component can be used with the distal tip or alternative distal tip described herein.

[0060] Figure 7A A separator 860 is described that can be used to assist in suppressing twisting and tangling of components such as filaments or cables extending between the rotating portion (e.g., distal tip) and the non-rotating portion (e.g., shaft) of a duodenoscope or other endoscope.

[0061] For example, cable 804 may extend through a shaft, such as shaft 18. Cable 804 may extend through or be secured to plate 812. Alternatively, plate 812 may be omitted. Plate 812 may be part of the distal end of the shaft (e.g., the distal side of the shaft). The distal portion 808 of cable 804 may extend distal to plate 812. Figure 7AAs shown, cable 804 can be Bowden wire. The distal portion 808 of cable 804 may lack the outer covering or sheath of the proximal portion of cable 804, wherein cable 804 is Bowden wire. Alternatively, cable 804 can be other types of cable or wire, and the distal portion 808 can be consistent with the rest of cable 804. Although two cables 804 are shown, it is understood that other numbers (e.g., four) of cables 804 can be used.

[0062] The distal end of cable 804 can be coupled to a separating element 820. Separating element 820 may include a plate 830 and a ring 822. Ring 822 may be received within an opening in plate 830 and is rotatable relative to plate 830. The edge of ring 822 may be on the distal side of plate 830. A ball bearing may be disposed between ring 822 and plate 830 to facilitate rotation between ring 822 and plate 830. Ring 822, passing through the opening in plate 830, may have an arm 824 extending proximally. Arm 824 may define a slot for receiving cable 804 (e.g., for receiving distal portion 808). The distal end of cable 804 may include a cap 826 (e.g., a rounded, projecting end of cable 804) to retain each of cables 804 within the slot of arm 824.

[0063] Cable 802 may extend through the distal tip of a duodenoscopy or other endoscope (e.g., any distal tip described herein). Cable 802 may extend through or be secured to plate 810. Alternatively, plate 810 may be omitted. Plate 810 may be part of the distal tip (e.g., the proximal side of the distal tip). A proximal portion 806 of cable 802 may extend proximally to plate 810. Figure 7A As shown, the proximal cable 802 can be Bowden wire, and the proximal portion 806 can include strands or cables of Bowden wire without an outer sheath / cover. Although two cables 802 are described, it is understood that alternative numbers of cables (e.g., four) can be used.

[0064] The plate 830 of the detachment element 820 may define a slot 832 for receiving cables 802 (e.g., proximal portion 806). The proximal end of the cable 804 may include a cap (e.g., a rounded, projecting end of the cable 802, which may have any properties of cap 826) to retain each of the cables 802 within the slot of the plate 830.

[0065] Because ring 822 is rotatable relative to plate 830, cable 802 can rotate about the axis of separating element 820 without rotating cable 804, thereby avoiding tangling of cable 804 (or cable 802) due to cable twisting. Separating element 820 may have properties (e.g., conductivity) or features (e.g., traces) that allow cable 804 and cable 802 to communicate through separating element 820. Additionally, cables 802 and 804 may be connectors / cables that allow the distal ends of the axis to turn. In the case where cables 802 and 804 are connectors, it is understood that additional cables can also be used to provide up / down / left / right connections. Additional cables may have properties similar to cables 802 and 804 and can engage with separating element 820 in a similar manner.

[0066] The separator 860 may also include a ring 814 (on the sheath side of the separator element 820) and a ring 816 (on the distal tip side of the separator element 820), which facilitates the installation of the separator 860 and can mate with the duodenoscopy and / or the elements of the separator 860. For example, the ring 814 may be fitted into the central opening of the ring 822 and may be secured to the plate 812. In such a configuration, the ring 814 facilitates the positioning of the plate 812 relative to the separator element 820. The ring 814 may additionally or alternatively form a seal.

[0067] Only certain aspects of the separator 860 can be used with a duodenoscope or other endoscopes. For example, separator element 820 (or a similar structure with the same or similar function) can be used, but plates 812 and 810 can be omitted. The separator 860 can be used with other aspects described herein (e.g., with...). Figure 6A and 6B (Used with a 600mm telemetry tip motor).

[0068] Figure 7B and 7C Various aspects of a duodenoscope 900 with rotational features are shown, which can be used with a separator 860 or a distal tip 600 or with other elements described herein. Figure 7C Showing Figure 7B A cross-sectional view of the device. The duodenoscope 900 may include an axis 918, which may have any characteristics of the axes described herein (e.g., axis 18). The duodenoscope 900 may have a distal tip 901, which has any characteristics of the distal tips described herein. The distal tip 901 may have an observation element 902 and an illumination element 904, which have any characteristics of other observation and illumination elements described herein. The distal tip 901 may also have a lifting mechanism 910, which has any features of the lifting mechanisms described herein.

[0069] The distal tip 901 can be connected to the shaft 918 via a rotary bearing 960. The rotary bearing 960 may include a retaining plate 962 and a rotating plate 964 that are separable from each other. The rotating plate 964 can rotate 360 ​​degrees (or less) relative to the retaining plate 962. The rotary bearing 960 can be used with any of the exemplary distal tips described herein to facilitate rotation of the distal tip relative to the duodenoscope shaft, or vice versa. The rotary bearing 960 can be, for example, an inert Susan-type bearing. The rotary bearing 960 can have any of the characteristics of the separation element 820 described above, and also includes two components (plate 830 and ring 822) that are rotatable relative to each other. Cables can be secured to the rotary bearing 960 in a manner similar to that of the separator 860 described above. For example, the cable of the shaft 918 can be secured to the retaining plate 962, while the cable of the distal tip 901 can be secured to the rotating plate 964.

[0070] While the principles of this disclosure have been described herein with reference to illustrative examples of specific applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art and who have been given the teachings herein will recognize that additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, this invention should not be considered as limited to the foregoing description.

Claims

1. A medical device, the medical device comprising: The distal tip has: Observation element, Lighting components, At least one feature configured to detachably connect the distal tip to the shaft; and The distal tip lifting mechanism control line for raising and lowering an endoscope, wherein the proximal end of the distal tip lifting mechanism control line includes: (a) a notch or slot; or (b) a protrusion, which are respectively configured to mate with (a) the protrusion or (b) the slot or notch of the lifting mechanism control line. A working channel, connected to the distal tip and defining a central cavity configured to receive a tool, wherein the walls of the working channel define at least one additional cavity, and wherein the working channel is configured to be removably inserted into the shaft; and At least one of the silk thread, cable, or conduit passing through the at least one additional cavity.

2. The medical device of claim 1, wherein at least one of the filament, cable, or catheter includes the filament or cable, and wherein the filament or cable is configured to operate at least one of the observation element or the illumination element.

3. The medical device as claimed in any of the preceding claims, wherein the distal tip further includes a motor for raising or lowering the lifting mechanism.

4. The medical device of claim 3, wherein at least one of the filament, the cable, or the catheter includes the filament or the cable, and wherein the filament or the cable is configured to provide power to the motor.

5. The medical device of claim 1 or 2, wherein the wall of the working channel defines at least two additional cavities.

6. The medical device of claim 1 or 2, wherein the distal tip lifting mechanism control line includes a post extending from the proximal surface of the distal tip, wherein the post is configured to be detachably connected to the shaft lifting mechanism control line extending through the shaft.

7. The medical device of claim 6, wherein the column defines at least one slot, and wherein the shaft lifting mechanism control line includes the protrusion configured to be received by the slot.

8. The medical device of claim 1 or 2, wherein the distal tip has at least one nail extending from its proximal surface, wherein the nail is configured to connect the distal tip to the shaft.

9. The medical device of claim 1 or 2, wherein the distal tip is configured to rotate relative to the axis.

10. The medical device of claim 1 or 2, wherein the distal tip includes a motor configured to rotate the distal tip relative to the axis.

11. The medical device of claim 10, wherein the motor is configured to rotate the gear, and wherein the distal tip includes teeth configured to engage the gear.

12. The medical device of claim 1 or 2, wherein the distal tip includes a magnet for connecting an element of the distal tip to an element of the shaft.

13. The medical device as claimed in claim 1 or 2, wherein the distal tip lifting mechanism control line includes the notch, the notch being configured to engage with a protrusion of a sleeve that extends circumferentially about the distal portion of the lifting mechanism control line.

14. The medical device of claim 1, wherein the proximal end of the working channel includes a plurality of threads on a handle for securing the proximal end at the proximal end of the shaft and the working channel being fixedly coupled to the distal tip.

15. The medical device of claim 1, wherein the proximal end of the distal tip defines a port for operatively connecting electronic components of the distal tip to a cable or wire extending through the axis.

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