Dual locking medical devices and related methods

Abstract

A distal tip (20) of a medical device (10) may include a housing (160) and a lifter (126). The lifter may include an opening (152) extending from a first surface (154) of the lifter to a second surface (182) of the lifter. The opening may be configured to receive a secondary medical device therethrough such that the secondary medical device extends distally of the distal-most end of the housing.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 498,294, filed April 26, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The various aspects of this disclosure generally relate to dual-locking medical devices and related methods. Specifically, aspects of this disclosure relate to the lifter and distal tip features of a duodenoscope, etc. Background Technology

[0003] A duodenoscopy may include a handle and a sheath, the latter being inserted into the body cavity of a subject. The sheath may terminate at a distal tip, which may include features such as optical elements (e.g., a camera, illumination device), air / water outlets, and a working channel opening. A lift may be located at the distal tip and may be actuated to change the orientation of medical devices / instruments passing through the working channel. For example, the lift may pivot or otherwise move.

[0004] Components in the handle control components at the distal tip. Examples include buttons, knobs, and levers. The lift can be controlled by a control mechanism (e.g., a lever) in the handle, which connects to a control wire attached to the lift. When the actuator (e.g., the lever) is actuated, the control wire moves proximally and / or distally, thereby raising and / or lowering the lift. The lift can lock instruments inserted through the working channel of a duodenoscope into a posteriorly flexed configuration or another configuration where the instrument extends radially outward, but not into other configurations. Therefore, a dual-locking medical device and related methods are required. Summary of the Invention

[0005] Each aspect disclosed herein may include one or more features described in connection with any other disclosed aspect.

[0006] In one example, the distal tip of the medical device may include a housing and a lifter. The lifter may include an opening extending from a first surface of the lifter to a second surface of the lifter. The opening may be configured to receive an auxiliary medical device passing through it, such that the auxiliary medical device extends distally to the furthest end of the housing.

[0007] Any exemplary apparatus or method described herein may include any of the following features: A first surface of the lifter may be on a first side of the axis of rotation of the lifter. A second surface of the lifter may be on a second side of the axis of rotation. The first side may be opposite to the second side. In a raised configuration of the lifter, an opening may be configured to receive an auxiliary medical device passing through it. In a raised configuration of the lifter, the first surface may be proximal to the second surface. The housing may include a boss. In a lowered configuration of the lifter, the boss may be configured to be received within the opening. The second surface of the lifter and the boss may be configured to engage the auxiliary medical device in a configuration where the auxiliary medical device is received through the opening, thereby holding the auxiliary medical device in a locked configuration in which the auxiliary medical device extends generally parallel to the longitudinal axis of the distal tip. The boss may include a recess. The recess may be configured to receive the auxiliary medical device. The second surface of the lifter may include a groove. In the locked configuration, the auxiliary medical device may be received within the groove of the second surface. The groove may be distal to the opening. The opening may have a fully closed perimeter. The opening may be generally circular. The distal tip may also include a channel. An elevator may be received within a channel. The channel may have an open distal end. A housing may define at least one surface of the channel. At least one surface may include a notch at the distal end. The housing may define a locking surface at the proximal end of the channel, wherein the locking surface is configured to mate with a first surface of the elevator in an elevated configuration of the elevator. In a lowered configuration of the elevator, the distal tip may be configured to receive an assistive medical device such that the assistive medical device extends from the proximal end of the elevator to the distal end of the elevator.

[0008] In another example, the lifter of the medical device may include a shaft. The lifter is rotatable about the shaft. The axis of rotation of the lifter may extend through the shaft. The lifter may also include: a first surface on a first side of the axis of rotation; a second surface on a second side of the axis of rotation; and an opening extending through the lifter between the first and second surfaces.

[0009] Any device disclosed herein may have an opening with a completely enclosed perimeter.

[0010] In one aspect, the method of using a medical device may include: inserting an auxiliary medical device into the working channel of the medical device; extending the auxiliary medical device distally to the farthest end of the medical device when the lifting mechanism of the medical device is in an elevated configuration; and performing a medical procedure using the auxiliary medical device.

[0011] Any aspect disclosed herein may have any of the following features. After extending the assistive medical device distally, the method may include at least partially lowering the lifter to engage the lifter between a distal surface of the lifter and a surface of a distal tip of the medical device. The surface of the distal tip may be the surface of a boss extending from the housing of the distal tip.

[0012] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and do not limit the claimed invention. As used herein, the terms “comprising,” “including,” “containing,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “diameter” may refer to the width of an element when it is not circular. The term “far side” refers to the direction away from the operator, and the term “proximal side” refers to the direction towards the operator. The term “exemplary” is used in the sense of “example” rather than “ideal.” The term “about” or similar terms (e.g., “substantially”) include ±10% of the value. Brief description of the attached figures

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0014] FIG. 1A and FIG. 1B An exemplary medical device is shown.

[0015] FIGS. 2A-2D It shows FIGS. 1A-1B The distal tip of the medical device, in which the lifter is in the lowered position.

[0016] FIGS. 3A-3D It shows FIGS. 1A-1B The distal tip of the medical device, in which the lifter is in the raised position.

[0017] FIGS. 4A-4D It shows FIGS. 1A-1B The distal tip of the medical device, through which a smaller diameter auxiliary device extends.

[0018] FIGS. 5A-5D It shows FIGS. 1A-1B The distal tip of the medical device, through which a larger diameter auxiliary device extends.

[0019] FIGS. 6A-6E It shows FIGS. 1A-5D The lifter at the distal tip of the medical device.

[0020] FIGS. 7A-9B Another distal tip is shown, through which the auxiliary device extends.

[0021] FIGS. 10A-10B Showing no elevator FIGS. 7A-9B The distal tip.

[0022] FIGS. 11A-11D It shows FIGS. 7A-9BThe lifter at the distal tip of the medical device. Detailed Implementation

[0023] Traditionally, operators may use different types of endoscopic devices for different medical procedures. For example, upper gastrointestinal endoscopy or esophagogastric-duodenoscopy (“EGD”) can be performed using a forward-looking endoscope. A forward-looking endoscope may include an anteriorly (i.e., distally) imager and / or working channel opening at its distal tip. Other procedures, such as endoscopic retrograde cholangiopancreatography (“ERCP”), can be performed using a lateral-looking duodenoscope. A lateral-looking duodenoscope may include a laterally (e.g., radially outward relative to the central longitudinal axis of the duodenoscope’s axis) imager and / or working channel opening at its distal tip.

[0024] Distal tip lateral viewing medical devices (such as duodenoscopes) may include a lifter. The lifter is operatively connected to an actuator in the handle of the duodenoscope. When the operator activates the actuator, the lifter can be raised / lowered. The lifter may initially be in a lowered configuration as the operator inserts an auxiliary device (such as an instrument or guidewire) into the working channel of the medical device and advances the instrument through the working channel. After the auxiliary device has extended from the distal opening of the working channel, the lifter may be raised to deflect the distal tip of the auxiliary device. When deflected, the auxiliary device may have a flexed shape or other shapes that project radially outward. The lifter may lock the auxiliary device in a flexed configuration or other configurations that project radially outward. This deflection can be used to allow the operator access to the subject's bile duct and / or the subject's main mastoid process.

[0025] Traditional side-viewing medical devices with conventional lifters may only be useful for certain medical procedures. It is desirable to provide a medical device that is also configured such that the device extends distally without being deflected. Such a device could be used for both EGD and ERCP procedures. However, conventional lifters deflect the instrument in a lowered configuration, causing the device to extend radially outward in addition to extending distally from the working channel. In other words, even in a fully open / lowered configuration, such a lifter can partially articulate / deflect the auxiliary device. Furthermore, the distal tip of the medical device with the lifter can be open on one side, allowing the auxiliary device to move unrestricted through the open side. This arrangement contrasts with conventional distally-facing medical devices (e.g., endoscopes) that have a working channel open on the distal face; this arrangement of the working channel and distal tip prevents extensive radial movement of the auxiliary device.

[0026] The medical device disclosed herein may include a lifter having a window formed therein. When the lifter is in the lowered position, a boss on the housing of the distal tip of the medical device may be received within the window. When an auxiliary device passes through the working channel of the medical device with the lifter in the lowered position, the auxiliary device may extend from the distal tip in a manner similar to a conventional duodenoscope. The lifter may be actuated to deflect the auxiliary device and lock it in the raised position. Using the medical device in this manner, an operator may perform medical procedures, such as ERCP, on the pancreatic and biliary system of a subject, for example.

[0027] For procedures where the operator desires a medical device that more closely resembles a forward-looking / distal-facing endoscope (i.e., the auxiliary device extends distally from the medical device without flexing or radially outward), the operator can raise the lift to the elevated position and then pass the auxiliary device through the working channel. The auxiliary device may pass through a window and extend distally from the medical device (e.g., similar to how a device extends distally from the working channel of a forward-looking endoscope). The lift and / or boss may include features that facilitate locking the auxiliary device in this position (i.e., the distally extended position where the longitudinal axis of the auxiliary device is generally parallel to or coaxial with the longitudinal axis of the medical device). Therefore, a medical device including a lift with a window can allow for dual or double locking—locking the auxiliary device in an articulated / flexed / radially outward configuration or a straight / distally extended configuration.

[0028] FIG. 1A An exemplary medical device 10 with a handle 12 and an insertion portion 14 is shown. FIG. 1B The proximal end of the handle 12 is shown. The medical device 10 may also include a connecting tube 16 for connecting the medical device 10 to a source such as air, water, suction, power, etc., and to an image processing and / or observation device. Although this disclosure specifically refers to duodenoscopy and endoscopy (and combined devices performing duodenoscopy and endoscopy functions), it also covers other types of devices such as bronchoscopes, gastroscopes, endoscopic ultrasound (“EUS”) endoscopes, colonoscopes, ureteroscopes, laparoscopes, cystoscopes, aspiration endoscopes, sheaths, catheters, or similar devices. Reference to duodenoscopy herein should be understood to cover any of the aforementioned medical devices.

[0029] 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 22 (e.g., a camera) and a light source 24 (e.g., an LED or fiber optic cable). The distal tip 20 may be side-viewed. That is, the imaging device 22 and the light source 24 may be radially outward, perpendicular, substantially perpendicular, or otherwise transverse to the longitudinal axis of the shaft 18 and the distal tip 20. Alternatively, the distal tip 20 may include one or more imaging devices 22 facing in multiple directions. For example, a first imaging device 22 may be radially outward, and a second imaging device 22 may be distally oriented (substantially parallel to the longitudinal axis of the distal tip 20 / shaft 18).

[0030] The distal tip 20 may also include a lifter 26 for changing the orientation of an auxiliary device or tool inserted into the working channel of the medical device 10. The lifter 26 may alternatively be referred to as a swing frame, pivot frame, lifting base, or any other suitable term. The lifter 26 may be pivoted, for example, by an actuation line extending from the handle 12 through the shaft 18 to the lifter 26 or by another control element.

[0031] The distal portion of the shaft 18 connected to the distal tip 20 may have a maneuverable portion 28. The maneuverable portion 28 may be, for example, a hinged joint. The shaft 18 and the maneuverable portion 28 may include various structures known or possibly known in the art.

[0032] Handle 12 may have one or more actuator / control mechanisms 30. One or more control mechanisms 30 may provide control over the operable portion 28. One or more control mechanisms may allow the supply of air, water, suction, etc. For example, handle 12 may include control knobs 32, 34 for left, right, up, and / or down control of the operable portion 28. For example, one of knobs 32, 34 may provide left / right control of the operable portion 28, and another of knobs 32, 34 may provide up / down control of the operable portion 28. Handle 12 may further include one or more locking mechanisms 36 (e.g., knobs or levers) for preventing the operable portion 28 from turning and / or braking in at least one of the upward, downward, leftward, or rightward directions. Handle 12 may include a lift control lever 38 (see [link to relevant documentation]). FIG. 1B The lifter control lever 38 can raise and / or lower the lifter 26 via a connection between the control lever 38 and an actuation line extending from the control lever 38 through the shaft 18 to the lifter 26. Port 40 allows tools to pass through the port 40 into the working channel of the medical device 10, through the shaft 18 to the distal tip 20.

[0033] 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 an auxiliary device (not shown) into port 40 and pass it through the working channel from shaft 18 to the distal tip 20. The auxiliary device can extend out of the working channel at the distal tip 20. The user can raise the lift 26 using lift control lever 38 and angle the auxiliary device toward a desired location (e.g., a mastoid process of the pancreatic or biliary system). The user can use the auxiliary device to perform medical procedures.

[0034] FIGS. 2A-5D Various configurations of the distal tip 120 for the medical device 10 are shown. The distal tip 120 may have any of the features of the distal tip 20. FIG. 2A , 3A Figures 4A and 5A show perspective cross-sections of the distal tip 120 in various configurations, as follows. FIG. 2C , 3C 4C and 5C show the respective directions along FIG. 2D , 3D Cross-sections taken from lines marked accordingly in 4D and 5D. To illustrate aspects of this disclosure more clearly, see [the provided text]. FIGS. 2A-5D Some components (such as caps, covers, sheaths, etc.) at the distal tip 120 are omitted. FIGS. 6A-6E Various aspects of the lift 126 of the distal tip 120 are shown. FIG. 6B It shows along FIG. 6A The cross-section is taken by line 6B. In some figures, arrows labeled "P" and "D" indicate the proximal and distal directions, respectively. Lifter 126 may have any of the features of lifter 26. Where feasible, FIGS. 2A-6E Through FIGS. 1A-1B Add 100 to the reference number to indicate that it comes from FIGS. 1A-1B The corresponding components. Although some reference numerals associated with the distal tip 120 or the lifter 126 have been omitted in some figures for ease of illustration, it should be understood that the structure of the distal tip 120 described herein is applicable to... FIGS. 2A-5B Each diagram shows the structure, and the aspects of the elevator 126 described herein are applicable to... FIGS. 2A-6E Every diagram visible from all aspects.

[0035] The distal tip 120 may include a housing 160 for receiving components of the document. The housing 160 may be formed of any suitable material (e.g., metal or plastic) and may have any suitable shape. In some examples, the housing 160 may be hollow and may receive components of the distal tip 120 therein or on it. The housing 160 may be constructed according to any suitable process (e.g., molding or additive manufacturing). The housing 160 may include caps fitted onto other elements of the distal tip 120.

[0036] The distal tip 120 may include an imaging device 122 (e.g., in...) FIG. 2A and FIG. 2B (As shown in the figure). Although the imaging device 122 is depicted as side-viewing, it should be understood that the distal tip 120 may also or alternatively include one or more forward-viewing (i.e., distally-facing) imaging devices. FIGS. 2A-5D A light source such as light source 24 is not shown, but it should be understood that the distal tip 120 may include one or more light sources having desired characteristics (such as any characteristics of light source 24) and pointing in any desired direction. For example, as FIG. 2A and FIG. 2C As shown, the working channel 142 extends through the shaft 18 to an opening in the distal tip 120. The working channel 142 can have any suitable size and can be used to receive one or more auxiliary devices, for example, through the port 40 of the handle 12.

[0037] The lift 126 can be received within the channel 162 of the distal tip 120 (see, for example) FIG. 2B , 2D (3B, 4B, and 5B). Channel 162 may extend generally parallel to the central longitudinal axis of the distal tip 120 / axis 18. Channel 162 may communicate with working channel 142. Channel 162 may be open on both sides (e.g., the top and distal sides adjacent to imaging device 122) and also communicate with the distal opening of working channel 142. As used herein, the terms "top," "upward," "facing upward," etc., refer to... FIGS. 2C-2D The upward direction of 3C-3D, 4C-4D, and 5C-5D. The terms "bottom," "downward," and "facing down" refer to... FIGS. 2C-2D The downward directions of 3C-3D, 4C-4D, and 5C-5D. Compared to a conventional duodenoscope, channel 162 can be extended in a proximal / distal direction and opens distally to channel 162.

[0038] The lift 126 can be connected to the control wire 150 via its arm 151. The arm 151 is merely an exemplary configuration for connecting the control wire 150 to the lift 126, and the control wire 150 can be connected to the lift 126 in any suitable manner. The control wire 150 can be directly or indirectly connected to the control lever 38 (see above description). FIG. 1B When the control lever 38 is rotated or otherwise actuated, the control wire 150 can move proximally or distally. When the control lever 38 is rotated in the first direction, the control wire 150 can move proximally, thereby raising the lift 126 to a raised configuration (e.g., FIGS. 3A-3DThe fully raised configuration of the lift 126 shown is described in further detail below. When the control lever 38 is rotated in the second direction (i.e., the direction opposite to the first direction), the control wire 150 can be moved distally, thereby lowering the lift 126 to a lowered configuration (e.g., FIGS. 2A-2D The fully lowered configuration shown is described in further detail below. The lifter 126 is rotatable about a shaft 180 located near its proximal end. The axis of rotation of the lifter 126 extends through the shaft 180.

[0039] The lifter 126 may include a first guide surface 154 (see example...) FIG. 2A and FIG. 2B It extends between the shaft 180 of the elevator 126 and the distal end 181 (e.g., the furthest end) of the elevator 126 (see [link]). FIG. 2C and FIG. 3C The lifter 126 may also include a second rear surface 182 extending between the shaft 180 and the distal end 181, located on the side of the lifter 126 opposite to the guide surface 154. The guide surface 154 may be on a first side of the axis of rotation of the lifter 126, and the rear surface 182 may be on a second side (opposite to the first side) of the axis of rotation of the lifter 126. When the lifter 126 is in a lowered configuration (see...), FIGS. 2A-2D The guide surface 154 may face the open side of the channel 162. FIGS. 2A-2D In the lowered configuration, the rear surface 182 may face the surface of the housing 160. When the elevator 126 is in the fully raised configuration (see...), FIGS. 3A-3D The guide surface 154 may be the proximal side of the elevator 126, and the rear surface 182 may be the distal side of the elevator 126.

[0040] For example, such as FIG. 2B , 2C As shown in 3A, 3C, 3D, 4C, 4B, 5A, 5C, 5D, and 6A-6E, the lifter 126 may include a window 152. The window 152 may extend through the entire thickness of the lifter 126 between the guide surface 154 and the rear surface 182. The window 152 may have any suitable shape. For example, the window 152 may define a generally circular opening, such as... FIG. 6A and FIG. 6CAs specifically shown in the diagram. The diameter / width of the opening defined by the aperture 152 can be any suitable size (e.g., approximately the same as or larger than the diameter / width of the largest auxiliary device to be used with device 10). In some examples, the diameter / width of the aperture 152 can be equal to or smaller than the diameter / width of the working channel 142. The size of the aperture 152 may depend on the width of the lift 126. The lift 126 needs to have sufficient wall strength on at least one side of the aperture 152 to apply friction when the lift 126 is fully raised or fully lowered. For example, the aperture 152 can be approximately 3.5 mm (which can be smaller than the size of the working channel 142, which can be approximately 4.2 mm), or it can have any suitable size (e.g., any size less than or equal to approximately 6.35 mm (0.25 inches), and the working channel 142 can have a similar size, e.g., less than or equal to approximately 6.35 mm (or 0.25 inches)). The aperture 152 can be configured to receive an auxiliary device through it. Although the window opening 152 is depicted as a hole, it should be understood that the window opening 152 may alternatively be any type of slot, notch, gap, groove, or other type of opening. As shown, the window opening 152 may be completely closed (i.e., a hole) around its perimeter / circumference. Alternatively, the window opening 152 may include one or more open sides, such that the window opening 152 forms a slot or notch.

[0041] The guide surface 154 and / or the rear surface 182 adjacent to the window opening 152 are configured as curved surfaces. For example, as FIG. 6C As shown, the rear surface 182 may include a curved groove 184 on the distal side of and adjacent to the window opening 152. As described in detail below, the shape and size of the curved groove 184 may be configured to engage with an auxiliary device (e.g., a small-diameter auxiliary device). FIG. 6C As shown, the width of the curved groove 184 ( FIG. 6C (horizontal direction) and depth (entry and exit) FIG. 6C The direction of the groove 184 can gradually narrow towards the distal side, making the curved groove 184 narrower and shallower in the distal direction.

[0042] The bottom wall 161 of the housing 160 (see example) FIG. 2C , 3A (and 3B) may define the bottom surface of channel 162. A boss 166 may be provided on the bottom wall 161. The boss 166 may be integrally formed with the bottom wall 161 (i.e., formed entirely from the same piece of material), or it may be separately formed from and attached to the bottom wall 161. For example... FIG. 2BAs specifically shown, boss 166 may have a generally circular cross-sectional shape. Boss 166 may alternatively have any suitable shape. The shape and size of window opening 152 may complement the shape and size of boss 166, such that boss 166 can be fitted into / fitted into window opening 152. The diameter / width of window opening 152 may be slightly larger than the diameter / width of boss 166 to allow boss 166 and lifter 126 to move freely relative to each other when lifter 126 is raised / lowered. FIG. 3A As specifically shown, the boss 166 may include two ridges 168 on its two sides, with a recess 170 between the two ridges 168. The recess 170 may extend generally parallel to the central longitudinal axis of the distal tip 120 / axis 18.

[0043] Various configurations and uses of the distal tip 120, as well as methods of using the distal tip 120, will now be described. In one example, the device 10 and the distal tip 120 can be used as a typical lateral medical device (e.g., for ERCP surgery). The lifter 126 may have a first lowering configuration, such as... FIGS. 2A-2D As shown. The boss 166 can be received within the window opening 152. The boss 166 can be used to block the window opening 152. For example... FIG. 2C As shown, the boss 166 can protrude from the bottom wall 161 to a height approximately the same as the thickness of the lift 126 between the guide surface 154 and the rear surface 182. The top surface of the boss 166 can be approximately aligned with the guide surface 154. During ERCP or other procedures that utilize the lateral viewing feature of the device 10, an auxiliary device (e.g., a guidewire) can pass through the working channel 142 with the lift 126 in a lowered configuration. With the boss 166 received within the window 152, the auxiliary device can pass along the guide surface 154 as with conventional lifts for lateral viewing endoscopes until the distal tip of the auxiliary device is distal to the distal end 181 of the lift 126.

[0044] During ERCP surgery, the user can raise the lift 126 to the elevated position / configuration, such as... FIGS. 3A-3D As shown, this hinges the auxiliary device (e.g., a rearward-bending configuration to the auxiliary device, or other configurations where the auxiliary device extends radially outward (e.g., approximately 90 degrees outward)). For clarity, the features of the distal tip 120 are illustrated. FIGS. 2A-3DThe auxiliary device is not depicted. In some aspects, the auxiliary device (e.g., a guidewire) may be locked (held in a desired position / configuration) between a portion of the guide surface 154 (e.g., distal end 181) and the locking surface 164 of the housing 160. The locking surface 164 may be proximal to the channel 162. The locking surface 164 may have a shape complementary to the guide surface 154, such that the guide surface 154 can mate with the locking surface 164. Alternatively, the locking surface may have a generally “V” shape. The locking surface 164 may have any features known in the art. In the raised configuration, although the boss 166 is no longer located within the window 152, the distal end of the auxiliary device has extended beyond the distal end 181. Therefore, the window 152 does not interfere with the hinge of the auxiliary device or the locking of the auxiliary device between the guide surface 154 and the locking surface 164. Thus, the distal tip 120 allows the user to perform procedures such as ERCP, as is routinely performed using a side-viewing device.

[0045] In another example, the user can pass the auxiliary device through the lift 126 when the lift 126 is in the lowered configuration / position described above. The user can perform surgery without raising the lift 126. For example, the user can use the medical device 10 as a forward-looking device, such as for EGD surgery. In this configuration, the auxiliary device can move freely (e.g., floatingly) up and down through the channel 162, including through the open top side of the channel 162.

[0046] Alternatively, the user may expect to perform procedures such as EGD surgery with the assistive device in a locked position (not able to move freely up and down). To do this, the user can raise the lift 126 to the elevated position before fully traversing the working channel 142, such as... FIGS. 3A-3D As shown. The user can then extend the auxiliary device through the working channel 142 and through the window opening 152 of the lift 126. The working channel 142 may communicate with the window opening 152. For example, the window opening 152 may be generally aligned with the working channel 142. Features of the guide surface 154 guide the auxiliary device through the window opening 152. When the lift 126 is in... FIGS. 3A-3D In the fully raised configuration shown, window 152 can resemble the distal opening of working channel 142. The auxiliary device can extend to the distal end 163 of housing 160 (see...). FIG. 4B and FIG. 4C ) and the far-end extension of the farthest end of channel 162.

[0047] The distal tip 120 is operable to retain (i.e. lock) both the small-diameter and large-diameter auxiliary devices, such that the auxiliary devices extend to the distal side of the distal tip 120 (e.g., generally parallel to the longitudinal axis of the distal tip 120 and / or the shaft 18). FIGS. 4A-4DA small-diameter auxiliary device 190, such as a guidewire, is shown in a locked configuration. For example, the diameter of the small-diameter auxiliary device may be greater than or equal to 0.020 inches (e.g., greater than or equal to 0.025 inches). FIG. 4A In the middle, a portion of the small-diameter auxiliary device near the lift 126 is partially obscured by the control wire 150. As described above, the small-diameter auxiliary device 190 can pass through the window opening 152 when the lift 126 is in the raised position. To lock the small-diameter auxiliary device 190, the user can partially lower the lift 126 such that the rear surface 182 of the lift 126 and the boss 166 engage the small-diameter auxiliary device 190, as shown. FIGS. 4A-4D As shown. This engagement holds the small-diameter auxiliary device 190 such that it extends substantially parallel to the longitudinal axis of the distal tip 120 / axis 18 (i.e., locking the small-diameter auxiliary device 190). The amount or extent to which the lifter 126 is lowered to lock the small-diameter auxiliary device 190 may depend on one or more dimensions or other characteristics of the distal tip 120 and / or the diameter / width of the small-diameter auxiliary device 190. In the locking configuration, the small-diameter auxiliary device 190 may extend through the recess 170. The curved groove 184 may have a shape that mates with / interacts with the small-diameter auxiliary device 190 to engage the small-diameter auxiliary device 190 between the curved groove 184 and a portion of the boss 166 (e.g., the recess 170).

[0048] like FIG. 3B and FIG. 4B As shown, the distal end of the bottom wall 161 of the housing 160 may have a notch 172 at the distal end of the channel 162. The notch 172 may be generally triangular in shape, having a proximal vertex 173 ( FIG. 3B When the small-diameter auxiliary device 190 is in FIGS. 4A-4D In the shown locking configuration, the small-diameter auxiliary device 190 can be received within the recess 172 at the apex 173. The apex 173 can further help constrain the small-diameter auxiliary device 190 such that it extends distally, generally parallel to the longitudinal axis of the distal tip 120 and / or shaft 18. Alternatively, the housing 160 may include a protrusion (not shown) similar to the locking surface 164 to constrain the small-diameter auxiliary device 190. This protrusion may be between the recess 172 and the recess 170 and may have a shape complementary to the curved groove 184. To unlock the small-diameter auxiliary device 190, the lift 126 can be raised. The small-diameter auxiliary device 190 can then be removed (e.g., retracted proximally) or repositioned.

[0049] The distal tip 120 can also be used to position and hold the large-diameter auxiliary device 192, such as FIGS. 5A-5DAs shown. For example, the diameter / width of the large-diameter auxiliary device 192 may be less than or equal to approximately 6.35 mm (0.25 inches) or less than or equal to approximately 4.2 mm. As above, the large-diameter auxiliary device 192 can pass through the working channel 142 when the lift 126 is in the raised configuration. Like the small-diameter auxiliary device 190, the large-diameter auxiliary device 192 can extend through the recess 170 of the boss 166. FIGS. 5A-5D As shown, the width / diameter of the large-diameter auxiliary device may be similar to the width / diameter of the window 152. Therefore, it may not be necessary or required to lower the lift 126 to lock / hold the large-diameter auxiliary device 192 in a configuration where the large-diameter auxiliary device 192 extends generally parallel to the longitudinal axis of the distal tip 120 / axis 18. The window 152 may be similar to the working channel opening of a conventional distally facing medical device to constrain the large-diameter auxiliary device 192. The periphery of the window 152 prevents the large-diameter auxiliary device 192 from moving upward through the top open side of the channel 162. The large-diameter auxiliary device 192 may extend generally parallel to the longitudinal axis of the distal tip 120 and / or axis 18. Features of the guide surface 154 may facilitate guiding the large-diameter auxiliary device 192 through the window 152.

[0050] It should be understood that the elevator 126 can be moved to FIGS. 4A-4D and FIGS. 5A-5D Intermediate configurations between the shown configurations are used to lock auxiliary devices of various sizes. Alternatively, the lift 126 can be held... FIGS. 3A-3D In the fully raised configuration, the auxiliary device is allowed to move freely to the proximal / far side (e.g., longitudinally) while being at least partially constrained by the periphery / circumference of the window 152.

[0051] Although the auxiliary devices 190, 192 are described as extending generally parallel to the longitudinal axis of the distal tip 120 and / or shaft 18, it should be understood that the axis of the auxiliary devices 190, 192 may be flexible, and therefore these devices may be passively or actively bent (especially if these devices extend a considerable distance distal to the distal tip 120). The description of the auxiliary devices 190, 192 extending generally parallel to the longitudinal axis of the distal tip 120 and / or shaft 18 is intended to be particularly applicable to configurations of the auxiliary devices 190, 192 at or near the distal tip 120.

[0052] Therefore, the features of the lift 126 and / or channel 162 (including the bottom wall 161 defining a portion of the channel 162) can facilitate the use of the medical device 10 as both a forward-looking and a lateral-looking medical device. The same medical device 10 can be used for both EGD and ERCP procedures. For a particular procedure, the medical device 10 can be used as a forward-looking device only or a lateral-looking device only. Alternatively, the medical device 10 can be used in both ways in a single procedure. As described above, the distal tip 120 can facilitate dual locking; the assist device can be locked in a flexed position (or another position where the assist device extends radially outward) or in a position where the assist device extends distally.

[0053] FIGS. 7A-10B Various aspects of the alternative distal tip 220 for the medical device 10 are shown. Unless described below, the distal tip 220 may have any of the features of the distal tips 20 and 120. The features of the distal tips 120 and 220 may be combined in any suitable manner. FIG. 7A , 8A Figures 9A and 10A show perspective cross-sections of the distal tip 220. FIG. 7B , 8B 9B and 10B show the following along FIG. 7A , 8A Side views of cross-sections taken from the same plane of 9A and 10A. To illustrate aspects of this disclosure more clearly, see [the provided text]. FIGS. 7A-10B Some components (such as caps, covers, sheaths, etc.) at the distal tip 220 are omitted. FIGS. 11A-11D Various aspects of the lifter 226 at the distal tip 220 are shown. Where feasible, FIGS. 7A-11D The reference number is in FIGS. 2A-6E Add 100 to the reference number to indicate a similar structure.

[0054] The distal tip 220 may include a housing 260, which, unless otherwise stated, has any of the features of housing 160. Housing 260 may define a channel 262, which, unless otherwise stated, has any of the features of channel 162. The distal tip 220 may include an imaging device 222, which has any of the features of imaging device 122.

[0055] The distal tip 220 may also include a lifter 226. FIGS. 11A-11DAspects of the lift 226, separated from the distal tip 220, are shown. Like lift 126, lift 226 may include a window 252. However, while lift 126 pivots about an axis 180 below the working channel 142 (i.e., closer to the bottom wall 161 than the working channel 142), lift 226 may be connected to housing 260 such that it pivots about an axis 280 above the working channel 242. In other words, the axis 280 about which lift 226 rotates may be located on the side of the working channel 242 closer to the imaging device 222, rather than on the bottom wall 261 of housing 260 (see, for example...). FIG. 8A ).

[0056] The lift 226 may include a body 227 connected to the arm 251. For example, as FIG. 11A and FIG. 11C As shown, a first end of arm 251 may be connected to shaft 280, which in turn may be connected to body 227. Shaft 280 may have a generally cylindrical shape. Body 227 may include two legs 227a, 227b extending from shaft 280 toward a distal end 281 of lifter 226. Distal portion 227c of body 227 may extend between legs 227a and 227b. Distal portion 227c may have a first guide surface 254 having any of the characteristics of guide surface 154. Guide surface 254 may be configured to receive and guide an auxiliary device along lifter 226. Distal portion 227c may also have a second rear surface 282. Rear surface 282 and guide surface 254 may form opposite sides of lifter 226. Guide surface 254 and rear surface 282 may be on opposite sides of shaft 280, about which lifter 226 rotates.

[0057] like FIG. 11A As specifically shown, the proximal side of window 252 may be defined by the distal surface of shaft 280. Legs 227a and 227b may define the lateral side of window 252. The proximal and lateral sides of window 252 may be generally straight / linear. The proximal edge of the distal portion 227c may define the distal side of window 252. The distal side of window 252 may be curved (e.g., generally semi-circular).

[0058] Arm 251 may extend at approximately a 90-degree angle relative to the longitudinal axes of legs 227a, 227b (which may be substantially parallel to each other) and relative to the longitudinal axis of shaft 280. The end of arm 251 opposite to shaft 280 may include an opening 253. The opening 253 may have any suitable shape and may be, for example, circular. As described below, the opening 253 may receive control elements for rotating the lift 226.

[0059] like FIG. 11B As specifically shown, the body 227 may have a curved shape. The side profile of the distal portion 227c of the body (as shown in the diagram)FIG. 11B (As shown) It can extend at an angle relative to the longitudinal axis of legs 227a, 227b. In general, by including arm 251, the lift 226 can have an improved "C" shape or an improved "U" shape when viewed from the side.

[0060] For example, such as FIG. 7B As shown, the control wire 250 can be connected to the arm 251 of the lift 226 through the opening 253. The proximal portion of the control wire 250 can pass through the sheath 249a and the coil 249b, such that the assembly of the control wire 250, the sheath 249a and / or the coil 249b is Bowden wire or similar. FIG. 10A and FIG. 10B The distal tip 220 without the lifter 226 is shown. (See image) FIG. 10A and FIG. 10B As shown, the control wire 250 may have a distal projection 279. The distal projection 279 may be generally spherical or may have any other suitable shape. The distal projection 279 may be connected to the lift 226 through the opening 253.

[0061] like FIG. 10B As shown, a hole 277 may be formed in the housing 260. The shaft 280 of the lift 226 may be received in the hole 277 to connect the lift 226 to the housing 260. The lift 226 may rotate about the shaft 280 when the control wire 250 is moved proximally or distally. Moving the control wire 250 distally lowers the lift 226, and moving the control wire 250 proximally raises the lift 226.

[0062] like FIGS. 8A-8B As specifically shown in 10A-10B, the bottom wall 261 of housing 260 may have a boss 266. Unless otherwise stated, boss 266 may have any of the characteristics of boss 166. Boss 266 may have a shape complementary to the shape of window 252. For example, boss 266 may have generally straight sides and a curved distal end. Boss 266 may have a recess 270 (similar to recess 170) extending longitudinally along boss 266 for receiving auxiliary device 292 and / or with auxiliary device 292 (see...) FIG. 9A and FIG. 9B )interaction.

[0063] Various configurations and uses of the distal tip 220, as well as methods of using the distal tip 220, will now be described. In one example, the device 10 and the distal tip 220 can be used as a typical lateral medical device (e.g., for ERCP surgery). The lifter 226 may have a first lowering configuration, such as... FIG. 7A and FIG. 7B As shown. FIG. 7A and FIG. 7BAs shown, during ERCP or other surgeries where the side-view features of device 10 are to be utilized, the auxiliary device 292 can pass through the working channel 242 with the lift 226 in a lowered configuration. Although a large-diameter auxiliary device 292 is depicted, the auxiliary device 292 can alternatively be a small-diameter auxiliary device 292.

[0064] A boss 266 (e.g., the distal portion of boss 266) may be received within a window opening 252 (e.g., within the distal portion of window opening 252). Boss 266 may be used to provide a smooth transition between channel 262 and lifter 226, such that auxiliary device 292 is guided onto guide surface 254, rather than applying force to lifter 226 and thus causing lifter 226 to rotate. FIG. 2C As shown, the auxiliary device 292 can rest on the proximal portion of the boss 266 and the guide surface 254. The distal top surface of the boss 266 can be substantially aligned with the guide surface 254. With the boss 266 received within the window opening 252, the auxiliary device 292 can pass along the guide surface 254 like a conventional lifter for a side-viewing endoscope until the distal tip of the auxiliary device 292 is distal to the distal end 281 of the lifter 226.

[0065] During ERCP surgery, the user can raise the lift 226 to the elevated position / configuration, such as... FIG. 8A and FIG. 8B As shown, this allows for the hinged connection of the auxiliary device 292 (e.g., to a rear-bend configuration of the auxiliary device or other configurations where the auxiliary device extends radially outward (e.g., approximately 90 degrees outward)). In some aspects, the auxiliary device 292 can be locked (held in a desired position / configuration) on a portion of the guide surface 254 (e.g., distal end 281) and the locking surface 264 of the housing 260 (see [link]). FIG. 8B and FIG. 10B Between the guide surface 254 and the window 252. Locking surface 264 may be proximal to the channel 262. Locking surface 264 may have a shape complementary to guide surface 254, such that guide surface 254 can mate with locking surface 264. Alternatively, locking surface may have a generally “V” shape. Locking surface 264 may have any features known in the art. In the raised configuration, although boss 266 is no longer located within window 252, the distal end of auxiliary device 292 has extended beyond distal end 281. Therefore, window 252 does not interfere with the hinge of auxiliary device 292 or the locking of auxiliary device 292 between guide surface 254 and locking surface 264. Therefore, distal tip 220 allows the user to perform procedures such as ERCP, as routinely performed using a side-viewing device.

[0066] In another example, with the lift 226 in the aforementioned lowered configuration / position, the user can pass the auxiliary device 292 through the lift 226, such as... FIG. 7A andFIG. 7B As shown. The user can perform surgery without raising the lift 226. For example, the user can use the medical device 10 as a forward-looking device, such as for EGD surgery. In this configuration, the auxiliary device 292 can move freely (e.g., floatingly) up and down through the channel 262. FIG. 7A (in the direction of), including the open top side passing through channel 262.

[0067] Alternatively, the user may expect to perform procedures such as EGD surgery with the assistive device 292 in a locked position (not able to move freely up and down). To do this, the user can raise the lift 226 to an elevated position (similar to) before fully extending the assistive device 292 through the working channel 242. FIG. 8A and FIG. 8B The auxiliary device 292 is located at the position shown, but without the auxiliary device 292. The user can then extend the auxiliary device through the working channel 242 and through the window opening 252 of the lifter 226. The working channel 242 may communicate with the window opening 252. For example, the window opening 252 may be generally aligned with the working channel 242. When the lifter 226 is in its fully raised configuration, the window opening 252 may resemble the distal opening of the working channel 242. The auxiliary device 292 may extend to the distal end 263 of the housing 260 (see...). FIG. 8B ) and the far-end extension of the farthest end of channel 262.

[0068] like FIG. 9A and FIG. 9B As shown, the distal tip 220 is operable to hold the auxiliary device 292 (large-diameter or small-diameter auxiliary device) such that the auxiliary device 292 extends to the distal side of the distal tip 220 (e.g., substantially parallel to the distal tip 220 and / or axis 18). FIG. 1A (The longitudinal axis of )). To lock the small-diameter auxiliary device 290, the user can partially lower the lifter 226 so that the rear surface 282 of the lifter 226 and the boss 266 engage the auxiliary device 290, as shown. FIGS. 9A-9B As shown. This engagement allows the auxiliary device 292 to extend generally parallel to the longitudinal axis of the distal tip 220 / axis 18 (i.e., locking the auxiliary device 292). The amount or extent to which the lifter 226 is lowered to lock the auxiliary device 292 may depend on one or more dimensions or other characteristics of the distal tip 220, and / or the diameter / width of the auxiliary device 292. In the locking configuration, the auxiliary device 292 may extend through the recess 270. The rear surface 282 may have a shaped groove 284 that may have a shape that engages / interacts with the auxiliary device 292 to engage the auxiliary device 292 between the shaped groove 284 and a portion of the boss 266 (e.g., the recess 270).

[0069] Although the auxiliary device 292 is described as extending generally parallel to the longitudinal axis of the distal tip 220 and / or shaft 18, it should be understood that the axis of the auxiliary device 292 may be flexible, and therefore the device may be passively or actively bent (especially if these devices extend a large distance distal to the distal tip 220). The description of the auxiliary device 292 extending generally parallel to the longitudinal axis of the distal tip 220 and / or shaft 18 is intended to be particularly applicable to configurations of the auxiliary device 292 at or near the distal tip 220.

[0070] Therefore, the features of the lift 226 and / or channel 262 (including the bottom wall 261 defining a portion of the channel 262) can facilitate the use of the medical device 10 as both a forward-looking and a lateral-looking medical device. The same medical device 10 can be used for both EGD and ERCP procedures. For a particular procedure, the medical device 10 can be used as a forward-looking device only or a lateral-looking device only. Alternatively, the medical device 10 can be used in both ways in a single procedure. As described above, the distal tip 220 can facilitate dual locking; the assist device can be locked in a flexed position (or another position where the assist device extends radially outward) or in a position where the assist device extends distally.

[0071] While the principles of this disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art and able to access the teachings provided herein will recognize that additional modifications, applications, and equivalent substitutions fall within the scope of the examples herein. Furthermore, various elements of each of the presented embodiments can be combined to achieve the same or similar results as one or more of the disclosed embodiments. Therefore, the invention should not be considered as limited by the foregoing description.

Claims

1. The distal tip of a medical device, comprising: case; as well as A lifter, wherein the lifter includes an opening extending from a first surface of the lifter to a second surface of the lifter; The opening is configured to receive an assistive medical device passing through it, such that the assistive medical device extends distally to the furthest end of the housing.

2. The distal tip of claim 1, wherein the first surface of the lifter is on a first side of the rotation axis of the lifter, wherein the second surface of the lifter is on a second side of the rotation axis, and wherein the first side is opposite to the second side.

3. The distal tip according to any of the preceding claims, wherein in the raised configuration of the lifter, the opening is configured to receive the auxiliary medical device passing through it, and wherein in the raised configuration of the lifter, the first surface is proximal to the second surface.

4. The distal tip according to any of the preceding claims, wherein the housing includes a boss, and wherein, in the lowering configuration of the lifter, the boss is configured to be received within the opening.

5. The distal tip of claim 4, wherein the second surface of the lifter and the boss are configured to engage the auxiliary medical device in a configuration in which the auxiliary medical device is received through the opening, thereby holding the auxiliary medical device in a locking configuration in which the auxiliary medical device extends substantially parallel to the longitudinal axis of the distal tip.

6. The distal tip of claim 4, wherein the boss includes a recess, wherein the recess is configured to receive the auxiliary medical device.

7. The distal tip according to any one of claims 5 or 6, wherein the second surface of the lifter includes a groove, wherein in the locking configuration, the assistive medical device is received within the groove of the second surface.

8. The distal tip of claim 7, wherein the groove is distal to the opening.

9. The distal tip according to any of the preceding claims, wherein the opening has a completely closed periphery.

10. The distal tip of claim 9, wherein the opening is generally circular.

11. The distal tip according to any of the preceding claims, wherein the distal tip further comprises a channel, wherein the lifter is received within the channel.

12. The distal tip of claim 11, wherein the channel has an open distal end.

13. The distal tip of any one of claims 11 or 12, wherein the housing defines at least one surface of the channel, and wherein the at least one surface includes a notch at the distal end.

14. The distal tip of any one of claims 11-13, wherein the housing defines a locking surface at the proximal end of the channel, wherein the locking surface is configured to engage with the first surface of the lifter in the lifting configuration of the lifter.

15. The distal tip according to any of the preceding claims, wherein in the lowering configuration of the lifter, the distal tip is configured to receive the auxiliary medical device such that the auxiliary medical device extends from the proximal end of the lifter to the distal end of the lifter.

Images