Distal tip of medical device

Abstract

The medical device may include a distal tip having a viewing element, an illumination element, and at least one mechanism configured to removably couple the distal tip to a shaft. The medical device may also include a working channel coupled to the distal tip and defining a central lumen configured to accommodate a tool. The walls of the working channel may define at least one additional lumen. The working channel may be configured to be removably inserted into the shaft. The medical device may also include at least one of a wire, a cable, or a conduit passing through the at least one additional lumen.

Description

Technical Field

[0001] The present disclosure generally relates to elements of medical devices. Aspects of the present disclosure relate to devices, systems, and / or methods for the distal tip of an endoscopic device.

Background Art

[0002] A duodenoscope may include a handle portion that can be grasped by an operator and, for functionality, may include control elements such as steering, suction, water, air, light, and imaging. A duodenoscope may also include a portion that can be inserted into a subject. For example, a duodenoscope may include a shaft suitable for insertion into a subject. Such an insertion portion may include one or more lumens. The lumens of the insertable portion of a duodenoscope may support functions such as sending air, water, suction, electricity, data, light, and / or images. Tools may also be inserted through the working channel of the shaft. For example, a tool may be inserted into the working channel by a port within or near the handle of the duodenoscope.

[0003] The shaft of a duodenoscope may terminate at a steerable distal portion. The distal portion of a duodenoscope may include outlets for air, water, suction, electricity, data, light, images, and / or working tools from the lumen of the duodenoscope. The components of the distal tip may be exposed to the fluid or other substances of the subject's body lumen. The duodenoscope may be subjected to a reprocessing procedure before being reused on another patient.

Summary of the Invention

[0004] Examples of the present 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 of the features described in relation to the disclosed example.

[0005] In one example, the medical device may include a distal tip having an observation element, an illumination element, and at least one mechanism configured to removably connect the distal tip to a shaft. The medical device may also include a working channel connected to the distal tip and defining a central lumen configured to house a tool. The walls of the working channel may define at least one additional lumen. The working channel may be configured to be removably inserted into the shaft. The medical device may also include at least one of a wire, cable, or conduit passing through at least one additional lumen.

[0006] Any medical device disclosed herein may have any of the following features: At least one of the wires, cables, or conduits may include a wire or cable. The wire or cable may be configured to operate at least one of the elevator, observation element, or illumination element of the distal tip. The distal tip may further include a motor that functions to raise or lower the elevator. At least one of the wires, cables, or conduits may include a wire or cable. The wire or cable may be configured to supply power to the motor. The walls of the working channel may define at least two additional lumens. The distal tip may have a column extending from the proximal surface of the distal tip. The column may be configured to be detachably connected to a control wire extending through a shaft. The column may define at least one slot, and the control wire may include at least one projection configured to be received by at least one slot. The distal tip may have at least one peg extending from the proximal surface of the distal tip. The peg may be configured to connect its distal tip to the shaft. The distal tip may be configured to be rotatable relative to the shaft. The distal tip may include a motor configured to rotate the distal tip relative to the shaft. The motor may be configured to rotate a gear. The distal tip may include teeth configured to mesh with the gear. The distal tip may include magnets for connecting elements of the distal tip to elements of the shaft. The distal tip may further include a distal tip lifter control wire for raising and lowering the endoscope's lifter. The proximal end of the lifter control wire may include a notch configured to mate with a slot in the shaft lifter control wire. The proximal end of the working channel may include multiple threads for securing the proximal end to a handle located at the proximal end of the shaft. The proximal end of the distal tip may define a port for operably connecting the electronic elements of the distal tip to a shaft cable or wire extending into the shaft.

[0007] In another example, a medical device may include a distal tip having an observation element, an illumination element, and a nozzle. A working channel may define a central lumen connected to the distal tip and configured to house a tool. The walls of the working channel may define at least one additional lumen. The working channel may be configured to be removably inserted into a shaft. At least one additional lumen may be configured to communicate fluidly with the nozzle.

[0008] Any medical device disclosed herein may have any of the following features: The distal tip may further include a motor that functions to raise or lower the elevator; At least one of a wire, cable, or conduit includes a wire or cable configured to supply power to the motor.

[0009] An exemplary method may include detachably coupling a distal end to the shaft of a medical device. The distal end may have an observation element and an illumination element. The method may further include supplying a working channel within the shaft and detachably coupling the working channel to the handle of the medical device.

[0010] Any of the methods disclosed herein may have any of the following features: A work channel may define a central lumen configured to accommodate a tool. The walls of the work channel may define at least one additional lumen. At least one of a wire, cable, or conduit may pass through at least one additional lumen. At least one of a wire, cable, or conduit may be configured to be operably connected to at least one of a lift, observation element, illumination element, or nozzle.

[0011] It will be understood that both the above summary and the following detailed description are illustrative and descriptive only and do not limit the claimed invention. As used herein, the terms “comprises,” “comprising,” or any other variation thereof are intended to include non-exclusive inclusion, such that a process, method, article, or apparatus containing a list of elements may not contain only these elements, but may also contain other elements not expressly enumerated or specific to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.” The term “distal” refers to the direction away from the operator / towards the treatment site, and the term “proximal” refers to the direction towards the operator. The term “approximately” or similar terms (e.g., “substantially”) include values ​​within + / - 10% of the stated values.

[0012] The accompanying drawings incorporated herein and forming part of this specification illustrate examples of the present disclosure and, together with the specification, serve to illustrate the principles of the present disclosure. [Brief explanation of the drawing]

[0013] [Figure 1] A diagram showing an example of a duodenal endoscope. [Figure 2A] A diagram showing an exemplary distal tip of a duodenal endoscope. [Figure 2B] A diagram showing an exemplary distal tip of a duodenal endoscope. [Figure 3] Figures 2A and 2B show an exemplary working channel for use with the distal tip. [Figure 4A] A diagram showing the distal tip and elements used in conjunction with it. [Figure 4B] A diagram showing the distal tip and elements used in conjunction with it. [Figure 4C] A diagram showing the distal tip and elements used in conjunction with it. [Figure 4D] A diagram showing the distal tip and elements used in conjunction with it. [Figure 5A] A diagram illustrating a typical fixation mechanism. [Figure 5B] A diagram illustrating a typical fixation mechanism. [Figure 5C] A diagram illustrating a typical fixation mechanism. [Figure 6A] A diagram illustrating an exemplary rotation element. [Figure 6B] A diagram illustrating an exemplary rotation element. [Figure 7A] A diagram illustrating an exemplary rotation element. [Figure 7B] A diagram illustrating an exemplary rotation element. [Figure 7C] A diagram illustrating an exemplary rotation element. [Modes for carrying out the invention]

[0014] During reprocessing, it may be difficult to thoroughly clean the distal tip and / or working channel of the duodenal endoscope. Therefore, it may be desirable that the distal tip and / or working channel of the duodenal endoscope be detachable from the rest of the duodenal endoscope. The distal tip and / or working channel may be disposable to eliminate the need for reprocessing the distal tip and / or working channel. The distal tip and / or shaft of the duodenal endoscope may include features to facilitate the connection between the elements of the distal tip (e.g., elevator, air / water nozzle, observation element, and / or illumination element) and the elements in the shaft and handle of the duodenal endoscope for controlling the elements of the distal tip. The distal tip may also have a rotatable element to allow rotation of the distal tip relative to the shaft of the duodenal endoscope.

[0015] FIG. 1 shows an exemplary duodenoscope 10 having a handle 12 and an insertion portion 14. The duodenoscope 10 may also include, for example, a source for supplying air, water, suction, electricity, etc., and an umbilicus 16 for connecting the duodenoscope 10 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 or medical device may be used with the coupling devices and methods of the present disclosure. Although side-facing devices are described in particular, the embodiments described herein may also be used with forward-facing endoscopes (e.g., endoscopes where the observation element faces longitudinally forward).

[0016] 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 a light source 24 (e.g., an LED or an optical fiber). The distal tip 20 may also include a lifter 26 for changing the orientation of a tool inserted into the working channel of the duodenoscope 10 (further details regarding tool insertion are described below). The lifter 26 may be swingable, for example, by an operating wire. The distal tip 20 may be side-facing. That is, the imaging device 22 and the light source 24 may face radially outwardly perpendicular or substantially perpendicular to the longitudinal axis of the shaft 18 and the distal tip 20.

[0017] 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 joint joint. The shaft 18 and the steerable section 28 may include various structures known or becoming known in the art. Exemplary features of the distal tip 20 are described in further detail with respect to FIGS. 2A-7C herein.

[0018] The handle 12 may have one or more control mechanisms 30. The control mechanism 30 may provide control of the steerable section 28. Alternatively, it may enable the provision of air, water, suction, etc. For example, the handle 12 may include control knobs 32, 34 for left, right, up and / or down control of the steerable section 28. For example, one of the knobs 32, 34 may provide left / right control of the steerable section 28, and the other of the knobs 32, 34 may provide up / down control of the steerable section 28. The handle 12 may further include one or more locking mechanisms 36 (e.g., a knob or lever) for preventing steering of the steerable section 28 in at least one of the up, down, left, or right directions. The handle 12 may include an elevator control lever 38. The elevator control lever 38 can raise and / or lower the elevator 20. The port 40 may enable a tool to pass through the port 40 into the working channel of the duodenoscope 10 and through the sheath 18 to the distal tip 20.

[0019] In use, the operator may insert at least a portion of the shaft 18 into the body lumen of the subject. The distal tip 20 may be navigated to the treatment site within the body lumen. The operator can insert a tool (not shown) into the port 40 and pass the tool through the working channel within the shaft 18 to the distal tip 20. The tool can exit the working channel at the distal tip 20. The user can use the elevator control lever 38 to raise the elevator 26 and tilt the tool towards a desired position (e.g., the papilla of the pancreaticobiliary duct). The user may perform a medical treatment using the tool.

[0020] Figures 2A and 2B provide different views of an exemplary distal tip 100. Figure 2A provides an oblique view, and Figure 2B provides a side view. The distal tip 100 may be used in place of the distal tip 20 of the duodenal endoscope 10 and may have any of the characteristics of the distal tip 20. The distal tip 100 may be disposable. The distal tip 100 may be placed on the shaft 18 before use of the duodenal endoscope 10 and removed from the shaft 18 after use. The distal tip 100 may be discarded, and the other parts of the duodenal endoscope 10 may be reprocessed.

[0021] The distal tip 100 may include a mechanism, which may include: an observation element 102 (e.g., a camera), an illumination source 104, air and / or water nozzles, and / or a lift 110. The lift 110 may have any of the characteristics of the lift 20. The lift 110 may include mounting points 112 for connecting the lift 110 to a mechanism for raising and / or lowering the lift 110 (e.g., wires or motorized elements as described below). 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 an optical fiber. The distal tip 100 may also include internal components such as a motor and / or gears for rotating the distal tip 100 (see Figures 6A to 7C, which will be described below). As will be further explained with respect to Figures 6A to 6B, the distal tip 100 may also house a motor for raising and lowering the elevator 110.

[0022] The working channel 120 may extend from the proximal end of the distal tip 100. The working channel 120 may define a lumen (e.g., a central lumen) for receiving a tool, for performing suction, and / or for receiving bodily fluids or tissue. The working channel 120 may be detachable from the distal tip 100 or may be permanently coupled to the distal tip 100. The working channel 120 may extend proximal from the distal tip 100 to the handle 12. When the distal tip 100 is attached to the distal end of the duodenal endoscope, the working channel 120 may be backfeed through the shaft 18 to the handle 12. Within the handle 12, the working channel 120 may be fixed to a suitable structure (e.g., among other things, an instrument port 40). As described below, the walls of the work channel 120 may accommodate various components such as the observation element 102, the illumination element 104, and / or wires and / or cables for the motors for the rotation of the distal tip 100 or the operation of the elevator 110. The work channel 120 may also accommodate conduits for fluid communication with air and / or water nozzles and / or control mechanisms (e.g., wires) for the elevator 110.

[0023] The distal end 100 may house either a complementary component integrated with the components of the work channel 120 (for example, if the work channel 120 is fixedly attached to the distal end 100), or a separate complementary component operably connected to / connectable to the components of the work channel 120. Wires and / or cables, conduits, and elevator control elements may be present on the handle 12, the shaft 18, and the distal end 100, and may include a single integrated component or components operably coupled to each other.

[0024] A lumen may extend into the working channel 120, which may allow equipment, suction, and / or body tissue to pass through. The working channel 120 may terminate at or within the proximal end of the distal tip 100. The lumen of the working channel 120 may communicate with the opening 130 of the distal tip. The lumen 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 lumen of the working channel 120. Equipment may pass through the lumen of the working channel 120 and exit through the opening 130. The elevator 110 may be activated by the elevator control lever 28 to raise or lower it to change the orientation of equipment protruding from the opening 130.

[0025] The proximal side of the distal tip 110 may include one or more mating components 140. As shown in Figure 2A, the distal tip 110 may have two mating components 140. The mating components 140 may include various structures, such as those described below with respect to Figures 4A to 4C. As shown in Figure 2A, the mating component 140 may include a projection (e.g., a peg) extending proximal from the proximal surface of the distal tip 100. The mating component 140 may include a column and a head. The mating component 140 may have a shape such as, for example, the head of a screw. The mating component 140 can mate with components of the shaft 18 of the duodenal endoscope, or the distal tip 100 can be fixed to the shaft 18 by other means. For example, the distal surface of the shaft 18 may include a curved slot (not shown) for accommodating the mating component 140. Rotation of the distal end 100 relative to the shaft 18 can cause the mating component 140 to engage with a slot, thereby securing the distal end 100 to the shaft 18. Alternatively, the distal surface of the shaft 18 may include an opening of a round or other shape for accommodating and engaging with the component 140 to secure the distal end 100 to the shaft 18. Further details regarding an exemplary mating mechanism are provided below.

[0026] Figure 3 shows an exemplary configuration of a working channel 220, which may have any of the characteristics of a working channel 120 and may be used with a distal tip such as a distal tip 100. Alternatively, the working channel 220 may be used with another duodenal endoscope. Figure 2A shows a working channel 220 terminating at a proximal end 222. A lumen 224 may extend along 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 feed instruments from a port in the handle of the duodenal endoscope through an opening 130 at the distal tip 110. Body fluids may also be fed proximally into the lumen 224 through the opening 130.

[0027] The proximal end 222 of the work channel 220 may include a mating structure 226 to facilitate mating between the work channel 220 and the handle 12. For example, as shown in Figure 2A, the mating structure 226 may include threads for providing a threaded mating between the work channel 220 and a receiving portion in the handle that can communicate with the port 40.

[0028] The wall 227 of the work channel 220 may define one or more lumens 228 extending longitudinally within the wall 227. The lumen 228 may be defined by a circular surface. Alternatively, the lumen 228 may have a different shape. For example, the lumen 228 may include a slot extending radially inward from the outer surface of the work channel 220. The lumen 228 may be completely enclosed or may include portions that lead to the outer surface of the work channel 220.

[0029] Lumen 228 may be other than the central lumen for receiving or delivering tools, suction, and bodily fluids / tissues. Lumen 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. Lumen 228 may surround the central lumen. Each lumen 228 may extend from the proximal end 222 to the distal end of the working channel 220. Lumen 228 may open at the proximal end 222 and the distal end of the working channel 220. The wall 227 may define any appropriate number of lumens 228. For example, as shown in Figure 2, the wall 227 may define four lumens 228. Lumen 228 may form passages for wires and / or cables, conduits, and / or elevator control elements extending from the handle through the shaft 18 to the distal tip 110 of the duodenal endoscope. For example, cables and / or wires are used to power and / or control the observation element 102 and the illumination element 104, and / or to receive signals from the observation element 102. Water and / or air can also pass through the lumen 228. A conduit may be passed through the lumen 228 to supply water and / or air from the handle of the duodenal endoscope to the distal tip. Alternatively, water and / or air may move directly within the lumen 228 without an intermediate conduit structure passing through the lumen 228.

[0030] For example, the working channel 220 may include four lumens 228. Of the four lumens 228, the first may be used to supply air or another fluid, the second may be used to supply water or another fluid. The third lumen 228 may be used to carry a signal cable for supply from the observation element 102. The fourth lumen 228 may be used to carry a power cable that can supply power to the observation element 102, the illumination element 104, and the motor of the distal end 100 used to raise and lower the elevator 110 and / or rotate the distal end 100.

[0031] A receiving section within the handle 12 may provide an automatic connection between elements passing through the lumen 228 of the work channel 220 and the corresponding structure within the handle 12. For example, screwing the work channel 220 into a suitable receiving section may provide an electrical connection between a control unit within the handle 12 and the corresponding wire in the lumen 228. In such an example, after the work channel 220 is fed back through the shaft 18, the proximal end 222 of the work channel 220 may seat within the receiving section of the handle 12, providing a single step for forming a connection between elements in the lumen 228 and the corresponding element of the handle 12. Alternatively, elements carried within the lumen 228 may be connected separately to the corresponding element of the handle 12 before or after the proximal end 222 is fixed to the handle 12. For example, wiring carried within the lumen 228 may be proximal to a plug that can be inserted into the receiving section of the handle 12.

[0032] Figures 4A and 4B show alternative distal tip 100' and alternative working channel 220'. Although distal tip 100' and working channel 220' are described together in this specification, the features of distal tip 100' and / or working channel 220' may be combined with other embodiments described herein. For example, the features of distal tip 100 may be used together with the features of working channel 220', and the features of distal tip 100' may be used together with the features of working channel 220. Unless otherwise specified, distal tip 100' and working channel 220' may each have either the features of distal tip 100 or working channel 220.

[0033] Compared to the working channel 220, the working channel 220' may have fewer lumens 228' formed inside it. Some components may pass outside the working channel 220' instead of passing through the lumens 228'. For example, the working channel 220' may define two lumens 228'. The two lumens 228' may carry air (or another fluid) and water (or another fluid), respectively. Cables or wires for providing power and / or receiving image signals from the observation element 102 may pass outside the working channel 220 within the shaft 18. Cables or wires may extend through a port 260 on the proximal surface of the distal end 100'. The port 260 may also be an opening, and cables and / or wires may extend proximal through the opening from electronic elements (e.g., a motor, observation element 102, and / or illumination element 104). When the distal tip 100' is positioned on the shaft 18, the cable and / or wire may be fed back through the shaft 18 and connected to a portion of the handle 12. In such an example, the port 260 may include a sealing element to prevent fluids (such as body fluids) from passing through the port 260. Alternatively, the port 260 may form a receptacle for receiving a connector. For example, a single-use or reusable wire and / or cable may extend distally from the handle 12 toward the distal tip 110'. The wire and / or cable may be fixedly or detachably coupled to an element of the handle 12. The wire and / or cable may be distally terminated in a connector that can be inserted into the port 260 to form an electrical connection with an element of the distal tip 100'.

[0034] As described above with respect to the distal end 100, the elevator 110 can be operated (raised or lowered) by a motor located within the distal end 100. Alternatively, a control wire 214 (Figure 4D) may be connected to an elevator control lever 38 and pass through the shaft 18. Moving the elevator control lever 38 can produce proximal and distal motion of the control wire 214. The control wire 214 may terminate within the distal end 215 shown in Figure 4D. The distal end 215 may include the shaft 216 and the head 218. The head 218 may extend radially outward relative to the shaft 216. One or more projections 220 may extend radially outward from the surface of the head 218. For example, two projections 220 may extend from the head 218, as shown in Figure 4D. The projections 220 may have any suitable shape. For example, as shown in Figure 4D, the projection 220 may have a longitudinal dimension that is larger than its circumferential dimension (it may extend longer in the longitudinal direction of the head 218 than in the circumferential direction of the head 218).

[0035] The control wire 214 may be operably connected to a pin 250 extending proximal to the proximal surface of the distal tip 100'. The pin 250 may form the proximal end of the control wire extending into the distal tip 100', and the pin 250 may be operably connected to the elevator 110 such that the elevator 110 rises when the pin 250 moves proximal and the elevator 110 descends when the pin 250 moves distal. Alternatively, the pin 250 may be operably connected to a separate control wire within the elevator 110 such that the elevator rises and descends when the pin 250 moves proximal and distal. Figure 4C shows a detailed view of the pin 250. The pin 250 may include a shaft 252 and a head 254 having a larger radial dimension than the shaft 252. Alternatively, the pin 250 may have a uniform radial dimension. The head 254 may define a cavity 255, which may open at the proximal end of the head 254. A portion of the pin 250 (e.g., the head 254) may define one or more slots 256. For example, as shown in Figure 4C, the pin 250 may define two slots 256 extending into the wall of the head 254. The slots 256 may be L-shaped. The distal portion of the slot 256 may extend circumferentially, and the proximal portion of the slot 256 may extend longitudinally.

[0036] To enable the operation of connecting the control wire 214 to the pin 250, the distal end 215, including the head 218, can be inserted into the cavity 255 with the projection 220 aligned with the slot 256. The distal end 215 may be moved distally so that the projection 220 advances along the slot 256. The distal end 215 may then be rotated so that the projection 220 continues to advance along the portion of the slot 256 that extends circumferentially around the pin 250.

[0037] While the control wire 214 can be coupled to the pin 250, the peg 140 can be coupled to a feature of the shaft 18 at the same time (or after or before). For example, when the distal tip 100' and the shaft 18 are assembled, the distal end 215 of the control wire 214 can be inserted into the cavity 255 of the pin 250, and the peg 140 can be inserted into a hole, slot, or other feature of the shaft 18. The distal tip 100' can then be rotated relative to the shaft 18. Rotation allows the control wire 214 to be coupled to the pin 250, while coupling the peg 140 to the shaft 18 secures the distal tip 100' to the shaft 18. The distal tip 100 or distal tip 100' can also be attached to the shaft 18 by rotation, even if the pin 250 is not present on the distal tip 100'. A skirt may be positioned around the distal tip 100 / 100' and the shaft 18 to further secure the distal tip 100 / 100' to the shaft 18 and to prevent fluid from entering and leaching between the distal tip 100 / 100' and the shaft 18. After the procedure, the distal tip 100 or distal tip 100' can be removed from the shaft 18 (for example, by turning it in the opposite direction). The distal tip 100 or distal tip 100' may be disposable or reprocessed for further procedures.

[0038] While light-emitting diodes have been described for the distal tips 100 and 100', it will be understood that optical fibers may be used as an alternative or additional measure. The optical fibers may extend within the shaft 18 and the distal tip 100 or distal tip 100'. The optical fibers in the shaft 18 and the optical fibers in the distal tip 100 or distal tip 100' may be in contact at the junction between the shaft 18 and the distal tip 100 or distal tip 100'. The optical fibers may be flush with the proximal surface of the distal tip 100 or distal tip 100' and the distal surface of the shaft 18. By making the optical fibers flush, cleaning of components such as the shaft 18 may be easier because fluid cannot leak into gaps or adhere to the outer surface of the optical fibers.

[0039] Figures 5A to 5C show alternative mounting mechanisms for connecting a portion of the control wire in the shaft 18 to a portion of the control wire in the distal end, such as distal end 100 or distal end 100'. While the mounting mechanisms described in Figures 5A to 5C may be explained in relation to control wires for raising and lowering an elevator, it will be understood that additionally or alternatively, the mounting mechanisms may be used to fix the distal end (such as distal end 100 or distal end 100') to the shaft 18.

[0040] Figures 5A and 5B show a fixing mechanism 300 that can function as a finger trap. A distal tip control wire 312 may be connected to an elevator (e.g., elevator 110) and may extend proximal toward the shaft 18 within the distal tip. A shaft control wire 314 that may extend into the shaft 18 may have a sleeve 316 mounted around the shaft control wire 314. The sleeve 316 may define a lumen and may extend circumferentially around the distal portion of the shaft control wire 314 which may be positioned within the lumen.

[0041] One or more projections 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 wire 312. A single projection 318 may extend inward to the sleeve 316, and a single notch 319 may extend around the distal tip control wire 312. Alternatively, there may be multiple distinct projections on the sleeve 316 and multiple distinct notches on the distal tip control wire 312.

[0042] The projection 318 and the notch 319 may have the same or complementary shape so that when the distal tip control wire 312 is inserted into the sleeve 316 and the projection 318 is aligned with the notch 319, the projection 318 can engage with the notch 319 and hold the distal tip control wire 312 within the sleeve 316. For example, the proximal sides of the projection 318 and the notch 319 may be substantially perpendicular to the longitudinal axis of the shaft control wire 314, the sleeve 316, and / or the distal tip control wire 312. The distal sides of the projection 318 and the notch 319 may be angled radially outward and / or tapered toward the first side. The projection 318 and the notch 319 may be triangular or wedge-shaped.

[0043] Figure 5A shows the distal tip control wire 312 and the shaft control wire 314 before the distal tip control wire 312 is fully inserted into the sleeve 316. To connect the distal tip control wire 312 to the shaft control wire 314, the proximal end of the distal tip control wire 312 can be inserted into the sleeve 316. The distal tip control wire 312 can be moved proximal. The distal tip control wire 312 can contact the projection 318 and deflect the projection 318 radially outward. The sleeve 316 and / or projection 318 may be formed of an elastic, flexible, and / or shape-memory material that can be bent so that the proximal end of the distal tip control wire 312 passes through the projection 318. As shown in Figure 5B, the projection 318 can engage with a notch 319 to hold the distal tip control wire 312 within the sleeve 316. By pulling the distal tip control wire 312 distally with sufficient force, the distal tip control wire 312 can be engaged with and disengaged from the sleeve 316 without damaging the sleeve 316.

[0044] While a sleeve 316 mounted around the shaft control wire 314 has been described, alternatively, the sleeve 316 may be mounted around the distal tip control wire 312, and the shaft control wire 314 may include one or more notches similar to the notch 319. While a projection 318 extending radially inward from the sleeve 316 has been described, it will be understood that the projection 318 may extend radially outward from the distal tip control wire 312 (or shaft control wire 314). Notches (similar to the notch 319) may be formed in the wall of the sleeve 316.

[0045] Figure 5C shows an alternative mechanism for attaching a shaft 618 (having the characteristics of either shaft 18) to a distal tip 600 (having the characteristics of either distal tip 100 or 100'). The distal tip 600 may include an observation element 602 (which may have the characteristics of either observation element 102) and an illumination source 604 (which may have the characteristics of either illumination source 104). The distal tip 600 may also include an elevator 610 which may have the characteristics of either elevator 110. A shaft control wire 614 may extend into a shaft 618 of a certain length and may have the characteristics of either shaft control wire 314. The shaft control wire 614 may be operably connected to an actuator within a duodenal endoscope handle (such as handle 12) to move the shaft control wire 614 proximal and distal. The distal tip control wire 612 may extend longitudinally within the distal tip 600 and may be operably connected to the elevator 110 so that the elevator 110 can be raised and / or lowered by the proximal and distal movement of the distal tip control wire 612.

[0046] The distal tip control wire 612 may be terminated proximal within the magnetic element 640. The magnetic element 640 may be formed from the same material as the rest of the distal tip control wire 612, or it may be a separate component from the distal tip control wire 612, securely fixed to the distal tip control wire 612. The shaft control wire 614 may be terminated distally within the magnetic element 642. The magnetic element 642 may be formed from the same material as the rest of the shaft control wire 614, or it may be a separate component from the shaft wire 614, securely fixed to the shaft control wire 614. Opposite portions of the magnetic element 640 and magnetic element 642 may have opposite polarities so that the magnetic elements 640 and 642 attract each other. The magnetic force between the magnetic elements 640 and 642 may be calibrated so that the magnetic elements 640 and 642 secure the distal tip control wire 612 to the shaft control wire 614. After use, the magnetic element 640 can be separated from the magnetic element 642 by sufficient force applied by the user. Alternatively, at least one of the magnetic elements 640 and 642 may be an electromagnet and may be able to be switched off to release the magnetic element 640 from the magnetic element 642. Alternatively, after use, a key or other device may be configured to release the magnetic elements 640 and 642.

[0047] Figures 6A and 6B show transparent views of an exemplary distal tip 600 that may have any of the distal tip features described above. The distal tip 600 may define a lumen 624 that passes longitudinally through the distal tip 600. The lumen 624 may extend from a proximal opening on the proximal surface of the distal tip 600 to a distal opening. The distal opening of the lumen 624 may lead to an elevator 610. The elevator 610 may have any of the elevator features described above. The elevator 610 may be configured to rise and fall to change the orientation of equipment passing through the lumen 624 and exiting from the distal end of the lumen 624. As shown in Figure 6B, a work channel 620 may be housed within the lumen 624. The work channel 620 may have any of the characteristics of the work channels 120, 220, and 220' described above. For example, the work channel 620 may have the characteristics of the work channel 220.

[0048] The distal tip 600 may include a rotary motor 660. The rotary motor 660 may be powered, for example, by an internal power source (e.g., a lithium-ion battery), by a wire or cable passing through the lumen of the work channel 620 as described above with respect to the work channel 220. The rotary motor 660 may power a gear 662. The rotary motor 660 may rotate the gear 662 in a first or second direction. The gear 662 may have teeth formed around at least a portion of its circumference.

[0049] Gear 662 may engage with teeth 664 that may extend radially from the internal circumferential surface of the distal tip 600. The teeth 664 may function similarly to a rack gear but may be curved to correspond to the circumference of the distal tip 600. As gear 662 rotates, it engages with the teeth 664, causing rotation of the rotatable portion 670 of the distal tip 600 relative to the fixed portion 672 of the distal tip 600. The rotatable portion 670 may be distal to the fixed portion 672. As shown, the rotary motor 660 and gear 662 may be positioned on the rotatable portion 670 such that the operation of the rotary motor 660 causes the rotatable portion 670 to rotate together with the rotary motor 660 around the longitudinal axis of the distal tip 600 and / or lumen 624 (since the teeth 664 are arranged radially around that axis), and the teeth 664 may be fixed (not rotating). Alternatively, the rotary motor 660 and gear 662 may be positioned on the stationary portion 672, and the teeth 664 on the rotatable portion 670, such that the rotation of the teeth 664 causes the rotation of the rotatable portion 670.

[0050] The teeth 664 may extend around the entire circumference of the distal tip 600 to allow for nearly 360-degree rotation of the rotatable portion 670. Alternatively, as shown, the teeth 664 may extend only to a portion of the circumference of the distal end 600 to allow for rotation of less than 360 degrees (e.g., nearly 90 degrees, nearly 180 degrees, or nearly 270 degrees). To limit the rotation to the above amounts, a stopper may be located at the rotating end (e.g., on the inner circumference of the distal tip 600). The rotatable portion 670 may be coupled to the stationary portion 672 via a bearing unit, such as a polymer bearing unit.

[0051] The distal tip 600 may also include an elevator motor 680 (see Figure 6B). The elevator motor 680 can cause the elevator 610 to move up and down. The elevator motor may be powered by a wire, cord, or cable that extends into the lumen of the work channel 620 (for example, as described with respect to the work channel 220).

[0052] The rotary motor 660, gear 662, teeth 664, and elevator motor 680 are described in particular with respect to disposable distal tips such as those described above, but it will be understood that these elements may be used with various distal tips of duodenal endoscopes or other types of endoscopes.

[0053] Figures 7A and 7B show components that may be used to facilitate the rotation of the distal tip of the duodenal endoscope 10 relative to the shaft 18 of the duodenal endoscope 10. The components of Figures 7A and 7B may be used with the distal tip described herein or another distal tip.

[0054] Figure 7A shows an anti-tangle component 860 that may be used to help prevent twisting and entanglement of components such as wires or cables extending between the rotating part (e.g., distal tip) and the non-rotating part (e.g., shaft) of a duodenal endoscope or other endoscope.

[0055] For example, cable 804 may extend into a shaft such as shaft 18. Cable 804 may extend through or be fixed to plate 812. Alternatively, plate 812 may be omitted. Plate 812 may be a portion of the distal end of the shaft (e.g., the distal surface of the shaft). The distal portion 808 of cable 804 may extend distal to plate 812. As shown in Figure 7A, cable 804 may be a Bowden cable. If cable 804 is a Bowden cable, the distal portion 808 of cable 804 may lack the outer cover or sheath of the more proximal portion of cable 804. Alternatively, cable 804 may be another type of cable or wire, and the distal portion 808 may be uniform with the rest of cable 804. Although two cables 804 are shown, it will be understood that other numbers of cables 804 (e.g., four) may be used.

[0056] The distal end of the cable 804 may be coupled to an anti-tangle element 820. The anti-tangle element 820 may include a plate 830 and a ring 822. The ring 822 may be housed within an opening in the plate 830 and may be rotatable relative to the plate 830. The edge of the ring 822 may be on the distal side surface of the plate 830. To facilitate rotation between the ring 822 and the plate 830, a ball bearing may be positioned between the ring 822 and the plate 830. The ring 822 may have an arm 824 extending proximally through the opening in the plate 830. The arm 824 may define a slot for housing the cable 804 (e.g., for housing the distal portion 808). The distal end of the cable 804 may include a cap 826 (e.g., a rounded, protruding end of the cable 804) for holding each cable 804 within the slot of the arm 824.

[0057] Cable 802 may extend into the distal tip of a duodenal endoscope or other endoscope (such as any of the distal tips described herein). Cable 802 may extend into or be attached to plate 810. Alternatively, plate 810 may be omitted. Plate 810 may be a portion of the distal tip (e.g., the proximal surface of the distal tip). The proximal portion 806 of cable 802 may extend proximal to plate 810. As shown in Figure 7A, the proximal cable 802 may be a Bowden cable, and the proximal portion 806 may include wires or cables of a Bowden cable without an outer sheath / cover. Although two cables 802 are shown, it will be understood that a different number (e.g., four) of cables may be used.

[0058] The plate 830 of the anti-tangle element 820 may define slots 832 for accommodating cables 802 (such as proximal ends 806). The proximal ends of the cables 802 may include caps (for example, rounded, protruding ends of the cables 802 that may have any of the characteristics of cap 826) for holding each cable 802 within the slots of the plate 830.

[0059] Since the ring 822 may be rotatable relative to the plate 830, cable 802 can rotate around the axis of the anti-tangle element 820 without rotating cable 804, thereby avoiding entanglement of cable 804 (or cable 802) due to cable twisting. The anti-tangle element 820 may have properties (e.g., conductivity) or features (e.g., traceability) that allow communication between cables 804 and 802 through the anti-tangle element 820. Alternatively, cables 802, 804 may be articulated wires / cables that allow steering of the distal end of the shaft. If cables 802, 804 are articulated wires, it will be understood that additional cables may also be used to provide up / down / left / right articulation. The additional cables may have properties similar to those of cables 802, 804 and may be connected in a manner similar to that of the anti-tangle element 820.

[0060] The anti-tangle section 860 may also include ring 814 (on the sheath side of the anti-tangle element 820) and ring 816 (on the distal end side of the anti-tangle element 820), which can facilitate the installation of the anti-tangle section 860 and can be fitted with the duodenal endoscope and / or elements of the anti-tangle section 860. For example, ring 814 may be fitted into the central opening of ring 822 and fixed to plate 812. In such a configuration, ring 814 can facilitate the positioning of plate 812 relative to the anti-tangle element 820. Additionally or alternatively, ring 814 may form a seal.

[0061] Only certain embodiments of the anti-tangle section 860 may be used with a duodenal endoscope or other endoscopes. For example, an anti-tangle element 820 (or a similar structure having the same or similar function) may be used, but plates 812 and 810 may be omitted. The anti-tangle section 860 may be used with other embodiments described herein (for example, with the motor of the distal tip 600 in Figures 6A and 6B).

[0062] Figures 7B and 7C show embodiments of the duodenal endoscope 900 which may have a rotating mechanism that can be used together with the anti-tangle section 860 or the distal tip 600 or with other elements described herein. Figure 7C shows an exploded view of the apparatus of Figure 7B. The duodenal endoscope 900 may include a shaft 918 which may have any of the characteristics of the shafts (e.g., shaft 18) described herein. The duodenal endoscope 900 may have a distal tip 901 which may have any of the characteristics of the distal tip described herein. The distal tip 901 may have an observation element 902 and an illumination element 904 which may have any of the characteristics of the other observation and illumination elements described herein. The distal tip 901 may also have an elevator 910 which may have any of the elevator features described herein.

[0063] The distal tip 901 may be joined to the shaft 918 via a rotating bearing 960. The rotating bearing 960 may include a fixed plate 962 and a rotating plate 964 that are detachable from each other. The rotating plate 964 may rotate 360 ​​degrees (or less than 360 degrees) relative to the fixed plate 962. The rotating bearing 960 may be used with any of the exemplary distal tips described herein to facilitate the rotation of the distal tip relative to the duodenal endoscope shaft or vice versa. The rotating bearing 960 may be, for example, a turntable type bearing. The rotating bearing 960 may have any of the characteristics of the anti-tangle element 820 described above, which also includes two components (plate 830 and ring 822) that are rotatable relative to each other. Cables may be secured to the rotating bearing 960 in a manner similar to that of the anti-tangle element 860 described above. For example, the cable of the shaft 918 may be secured to the fixed plate 962, and the cable of the distal tip 901 may be secured to the rotating plate 964.

[0064] The principles of this disclosure are described herein with reference to examples of specific uses, but it should be understood that this disclosure is not limited thereto. Anyone with ordinary skill in the art and access to the teachings provided herein will recognize that all additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. It is a medical device, The medical device is equipped with a distal tip, and the distal tip is Observation elements, Lighting elements, At least one mechanism configured to detachably connect the distal tip to the shaft, The distal tip is configured to be rotatable relative to the shaft, The medical device comprises a working channel, which is coupled to the distal end and defines a central lumen configured to house a tool, the walls of the working channel define at least one additional lumen, and the working channel is configured to be removably inserted into the shaft. The medical device comprises at least one of a wire, cable, or conduit passing through the at least one additional lumen, The medical device comprises a first plate connected to the shaft, a first pair of steering cables connected to the first plate, and A medical device comprising: a second plate coupled to the distal end thereof, wherein the first plate is rotatable relative to the second plate, and a second pair of steering cables are coupled to the second plate.

2. The medical device according to claim 1, wherein the at least one of the wire, the cable, or the conduit includes the wire or the cable, and the wire or the cable is configured to operate at least one of the distal end lifter, the observation element, or the illumination element.

3. The medical device according to claim 2, wherein the distal tip further includes a motor that functions to raise or lower the elevator.

4. The medical device according to claim 3, wherein at least one of the wire, cable, or conduit includes the wire or cable, and the wire or cable is configured to supply power to the motor.

5. The medical device according to any one of claims 1 to 4, wherein the wall of the work channel defines at least two additional lumens.

6. It is a medical device, The medical device is equipped with a distal tip, and the distal tip is Observation elements, Lighting elements, At least one mechanism configured to detachably connect the distal tip to the shaft, It has, The medical device comprises a working channel, which is coupled to the distal end and defines a central lumen configured to house a tool, the walls of the working channel define at least one additional lumen, and the working channel is configured to be removably inserted into the shaft. The medical device comprises at least one of a wire, cable, or conduit passing through the at least one additional lumen, A medical device wherein the distal tip has a column extending from the proximal surface of the distal tip, and the column is configured to be detachably connected to a control wire extending through the shaft.

7. The medical device according to claim 6, wherein the column defines at least one slot, and the control wire includes at least one projection configured to be received by the at least one slot.

8. It is a medical device, The medical device is equipped with a distal tip, and the distal tip is Observation elements, Lighting elements, At least one mechanism configured to detachably connect the distal tip to the shaft, It has, The medical device comprises a working channel, which is coupled to the distal end and defines a central lumen configured to house a tool, the walls of the working channel define at least one additional lumen, and the working channel is configured to be removably inserted into the shaft. The medical device comprises at least one of a wire, cable, or conduit passing through the at least one additional lumen, A medical device wherein the distal tip has at least one peg extending from the proximal surface of the distal tip, the peg being configured to connect the distal tip to the shaft.

9. It is a medical device, The medical device is equipped with a distal tip, and the distal tip is Observation elements, Lighting elements, At least one mechanism configured to detachably connect the distal tip to the shaft, It has, The medical device comprises a working channel, which is coupled to the distal end and defines a central lumen configured to house a tool, the walls of the working channel define at least one additional lumen, and the working channel is configured to be removably inserted into the shaft. The medical device comprises at least one of a wire, cable, or conduit passing through the at least one additional lumen, A medical device comprising a motor configured to rotate the distal tip relative to the shaft.

10. The medical device according to claim 9, wherein the motor is configured to rotate a gear, and the distal tip includes teeth configured to mesh with the gear.

11. The medical device according to any one of claims 1 to 5 and 8 to 10, wherein the distal tip includes a magnet for connecting the elements of the distal tip to the elements of the shaft.

12. A medical device, The medical device is equipped with a distal tip, and the distal tip is Observation elements, Lighting elements, At least one mechanism configured to detachably connect the distal tip to the shaft, It has, The medical device comprises a working channel, which is coupled to the distal end and defines a central lumen configured to house a tool, the walls of the working channel define at least one additional lumen, and the working channel is configured to be removably inserted into the shaft. The medical device comprises at least one of a wire, cable, or conduit passing through the at least one additional lumen, A medical device wherein the distal tip further comprises a distal tip lifter control wire for raising and lowering the lifter of the endoscope, and the proximal end of the distal tip lifter control wire includes a notch configured to fit into a slot of a shaft lifter control wire.

13. The medical device according to any one of claims 1 to 12, wherein the proximal end of the working channel includes a plurality of threads for securing the proximal end to a handle located at the proximal end of the shaft.

14. The medical device according to any one of claims 1 to 13, wherein the proximal end of the distal tip defines a port for operably connecting the electronic element of the distal tip to a shaft cable or wire extending within the shaft.

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