Dual-locking medical device and related method

Abstract

The distal end (20) of the medical device (10) may comprise a housing (160) and a stand (126). The stand may include an opening (152) extending from a first surface (154) to a second surface (182). The opening may be configured to receive an attached medical device through the opening, such that the attached medical device extends distally to the most distal end of the housing.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to dual-locking medical devices and related methods. In particular, aspects of the present disclosure relate to the articulation and distal tip features of duodenoscopes, among other aspects.

Background Art

[0002] A duodenoscope can include a handle and a sheath, and the sheath can be insertable into a body lumen of a subject. The sheath can terminate at a distal tip portion that can include features such as optical elements (e.g., a camera, illumination), an air / water outlet, and a working channel opening. The articulation stage can be disposed at the distal tip portion and can be operable to change the orientation of a medical device / tool passed through the working channel. For example, the articulation stage can be rotatable or otherwise movable.

[0003] Elements within the handle can control elements at the distal tip portion. For example, buttons, knobs, levers, etc. can control elements at the distal tip portion. The articulation stage can be controlled via a control mechanism within the handle such as a lever, and this control mechanism can be attached to a control wire coupled to the articulation stage. When an actuator (e.g., a lever) is actuated, the wire can move in a proximal direction and / or a distal direction, thereby raising and / or lowering the articulation stage. The articulation stage can lock an instrument inserted through the working channel of the duodenoscope in a retroflexed configuration of the instrument or other configurations where the instrument extends radially outward, but cannot lock the instrument in other configurations thereof. Accordingly, there is a need for dual-locking medical devices and related methods.

Summary of the Invention

[0004] Each of the aspects disclosed herein can include one or more of the features described in relation to any of the other aspects disclosed. In one example, the distal end of a medical device may comprise a housing and a support base. The support base may include an opening extending from a first surface to a second surface. The opening may be configured to receive an auxiliary medical device through the opening, with the auxiliary medical device extending distally to the most distal end of the housing.

[0005] Any exemplary device or method described herein may include any of the following features: The first surface of the lifting platform may be on the first side of the rotation axis of the lifting platform. The second surface of the lifting platform may be on the second side of the rotation axis. The first side may be opposite to the second side. In the lifting configuration of the lifting platform, the opening may be configured to receive an accessory medical device through the opening. In the lifting configuration of the lifting platform, the first surface may be proximal to the second surface. The housing may include a boss. In the lowering configuration of the lifting platform, the boss may be configured to be received within the opening. The second surface of the lifting platform and the boss may be configured to engage with the accessory medical device in a configuration in which the accessory medical device is received through the opening, thereby holding the accessory medical device in a locking configuration in which the accessory medical device extends substantially parallel to the longitudinal axis of the distal tip. The boss may include a recess. The recess may be configured to receive an accessory medical device. The second surface of the lifting platform may include a recess. In the locking configuration, the auxiliary medical device may be received in a recess of the second surface. The recess may be distal to the opening. The opening may have a completely enclosed perimeter. The opening may be substantially circular. The distal tip may also include a channel. The lifting platform may be received within the channel. The channel may have an open distal end. The housing may define at least one surface of the channel. At least one surface may include a notch at its distal end. The housing may define a locking surface at the proximal end of the channel, which is configured to engage with a first surface of the lifting platform in the lifting platform's raising configuration. In the lifting platform's lowering configuration, the distal tip may be configured to receive the auxiliary medical device such that the device extends from the proximal end of the lifting platform to the distal end of the lifting platform.

[0006] In another example, the lifting platform of a medical device may include an axis. The lifting platform may be rotatable around the axis. The axis of rotation of the lifting platform may extend through the axis. The lifting platform 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 lifting platform between the first surface and the second surface.

[0007] Any of the devices disclosed herein may have an opening with a completely enclosed perimeter. In one embodiment, the method of using the 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 most distal end of the medical device while the lifting platform of the medical device is in an elevated configuration, and using the auxiliary medical device to perform a medical procedure.

[0008] Any embodiment disclosed herein may include any of the following features: The method may include extending the auxiliary medical device distally, and then lowering the lifting platform at least partially to engage the lifting platform between its distal surface and the surface of the 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.

[0009] It should be understood that both the general description above and the detailed description below are illustrative and descriptive only and do not limit the claimed invention. As used herein, the terms “comprises,” “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus including an enumeration of elements may include other elements not expressly enumerated or specific to such process, method, article, or apparatus, rather than including only those elements. The term “diameter” may refer to the width if the element is not circular. The term “distal” refers to the direction away from the operator, and the term “proximal” refers to the direction toward the operator. The term “exemplary” is used to mean “example,” not “ideal.” The term “approximately” or similar terms (e.g., “substantially”) include values ​​within ±10% of the stated values.

[0010] The accompanying drawings incorporated herein and constituting part of herein are illustrative of aspects of this disclosure and serve to illustrate the principles of this disclosure together with the description. [Brief explanation of the drawing]

[0011] [Figure 1A] An exemplary medical device is shown. [Figure 1B] An exemplary medical device is shown. [Figure 2A] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the lowered position. [Figure 2B] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the lowered position. [Figure 2C] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the lowered position. [Figure 2D] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the lowered position. [Figure 3A] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the raised position. [Figure 3B] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the raised position. [Figure 3C] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the raised position. [Figure 3D] Figures 1A and 1B show the distal tip of the medical device with the lifting platform in the raised position. [Figure 4A] Figures 1A and 1B show the distal end of the medical device, with a smaller diameter attachment device extending through the distal end. [Figure 4B] Figures 1A and 1B show the distal end of the medical device, with a smaller diameter attachment device extending through the distal end. [Figure 4C] Figures 1A and 1B show the distal end of the medical device, with a smaller diameter attachment device extending through the distal end. [Figure 4D] Figures 1A and 1B show the distal end of the medical device, with a smaller diameter attachment device extending through the distal end. [Figure 5A] Figures 1A and 1B show the distal end of the medical device, with a larger diameter attachment device extending through the distal end. [Figure 5B] Figures 1A and 1B show the distal end of the medical device, with a larger diameter attachment device extending through the distal end. [Figure 5C] Figures 1A and 1B show the distal end of the medical device, with a larger diameter attachment device extending through the distal end. [Figure 5D] Figures 1A and 1B show the distal end of the medical device, with a larger diameter attachment device extending through the distal end. [Figure 6A] Figures 1A to 5D show the support structures at the distal tip of the medical devices. [Figure 6B] Figures 1A to 5D show the support structures at the distal tip of the medical devices. [Figure 6C] Figures 1A to 5D show the support structures at the distal tip of the medical devices. [Figure 6D]Figures 1A - 5D show the raised platform of the distal tip of the medical device. [Figure 6E] Figures 1A - 5D show the raised platform of the distal tip of the medical device. [Figure 7A] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 7B] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 8A] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 8B] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 9A] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 9B] Another distal tip is shown with an accessory device extending through the distal tip. [Figure 10A] Figures 7A - 9B show the distal tip without a raised platform. [Figure 10B] Figures 7A - 9B show the distal tip without a raised platform. [Figure 11A] Figures 7A - 9B show the raised platform of the distal tip of the medical device. [Figure 11B] Figures 7A - 9B show the raised platform of the distal tip of the medical device. [Figure 11C] Figures 7A - 9B show the raised platform of the distal tip of the medical device. [Figure 11D] Figures 7A - 9B show the raised platform of the distal tip of the medical device.

DETAILED DESCRIPTION OF THE INVENTION

[0012] Traditionally, operators may utilize different types of scope devices for various medical procedures. For example, upper endoscopy or esophagogastoduodenoscopy ("EGD") may be performed using a forward-looking endoscope. A forward-looking endoscope may include an imaging device and / or working channel opening at its distal tip that is oriented forward (i.e., distally). Other procedures, such as endoscopic retrograde cholangiopancreatography ("ERCP"), may be performed using a lateral-looking duodenoscope. A lateral-looking duodenoscope may include an imaging device and / or working channel opening at its distal tip that is oriented laterally (e.g., radially outward with respect to the central longitudinal axis of the duodenoscope shaft).

[0013] Distal-tip lateral-viewing medical devices, such as duodenoscopes, may include a lifting platform. The lifting platform may be operably connected to an actuator in the handle of the duodenoscope. When the operator acts on the actuator, the lifting platform may be raised / lowered. When the operator inserts an accessory device (e.g., instrument or guidewire) into the working channel of the medical device and advances the instrument through the working channel, the lifting platform may initially be in a lowering configuration. After the accessory device has extended outward from the distal opening of the working channel, the lifting platform may be raised to deflect the distal tip of the accessory device. When deflected, the accessory device may have a retroflexed shape or other shape in which the accessory device protrudes radially outward. The lifting platform may lock the accessory device in a retroflexed configuration or other configuration in which the accessory device extends radially outward. Such deflection may be used to allow the operator to access the bile duct of the target and / or to insert a cannula into the papilla of the target.

[0014] Conventional lateral-viewing medical devices with conventional lifting platforms may only be useful for specific medical procedures. It may be desirable to have medical devices configured to have a device that extends distally from the medical device without deflection. Such medical devices may be useful for both EGD and ECRP procedures. However, conventional lifting platforms can deflect the instrument in a lowered configuration, causing the device to extend radially outward in addition to distally from the working channel. In other words, such a lifting platform can partially articulate / deflect the accessory device, even in a fully open / lowered configuration. Furthermore, the distal tip of a medical device with a lifting platform may be open on one side, which may allow the accessory device to move through the open side without constraint. Such a configuration is in contrast to conventional distally oriented medical devices (e.g., endoscopes) with a working channel open on the distal surface, where such a working channel and distal tip configuration prevents the accessory device from moving over a wide radial range.

[0015] The medical devices disclosed herein may include a lifting platform having a fenestration formed therein. When the lifting platform is in the lowered position, the boss of the housing at the distal tip of the medical device can be received within the fenestration. With the lifting platform in the lowered position, as the accessory device passes through the working channel of the medical device, the accessory device may extend from the distal tip in a manner similar to that of a conventional duodenoscope. The lifting platform may be actuated to deflect the accessory device and lock the accessory device in the raised position. By using the medical device in such a manner, an operator can perform medical procedures such as ERCP on the target pancreatic and bile ducts.

[0016] In procedures where the operator desires to use a medical device more similar to an endoscope oriented forward / distally (i.e., with the accessory device extending distally from the medical device without extension or radial outward extension), the operator may raise the lifting platform to the raised position and then pass the accessory device through the working channel. The accessory device may extend distally from the medical device through the fenestration (similar to how a device extends from the working channel of an endoscope oriented forward). The lifting platform and / or boss may include features that facilitate locking the accessory device in such a position (i.e., a position where the accessory device extends distally with its longitudinal axis substantially parallel or coaxial with the longitudinal axis of the medical device). Thus, a medical device including a lifting platform with a fenestration may allow for dual or bidirectional locking of the accessory device in an articular / extension / radial outward configuration or in a straight / distally extending configuration.

[0017] Figure 1A shows an exemplary medical device 10 having a handle 12 and an insertion portion 14. Figure 1B shows the proximal end of the handle 12. The medical device 10 may also include an umbilical portion 16 for the purpose of connecting the medical device 10 to a source of power, such as air, water, suction, or electricity, and to imaging and / or observation equipment. While duodenoscopes and endoscopes (and combination devices that perform the functions of duodenoscopes and endoscopes) are particularly referred to herein, this disclosure also encompasses other types of devices such as bronchoscopes, gastroscopes, endoscopic ultrasounds ("EUS"), colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cystoscopes, suction scopes, sheaths, catheters, or similar devices. References to duodenoscopes herein should be understood to encompass any of the above medical devices.

[0018] The insertion portion 14 may include a sheath or shaft 18 and a distal tip portion 20. The distal tip portion 20 may include an imaging device 22 (e.g., a camera) and an illumination source 24 (e.g., an LED or optical fiber). The distal tip portion 20 may be oriented laterally. That is, the imaging device 22 and illumination source 24 may be oriented radially outward, perpendicular, substantially perpendicular, or otherwise laterally with respect to the longitudinal axis of the shaft 18 and the distal tip portion 20. Additionally or alternatively, the distal tip portion 20 may include one or more imaging devices 22 oriented in two or more directions. For example, the first imaging device 22 may be oriented radially outward, and the second imaging device 22 may be oriented distally (subtly parallel to the longitudinal axis of the distal tip portion 20 / shaft 18).

[0019] The distal tip 20 may also include a lifting platform 26 for changing the orientation of an accessory device or tool inserted into the working channel of the medical device 10. The lifting platform 26 may alternatively be referred to as a swing platform, swivel platform, lifting platform, or any other preferred term. The lifting platform 26 may be swivelable, for example, via an actuation wire or another control element extending from the handle 12 through the shaft 18 to the lifting platform 26.

[0020] The distal portion of the shaft 18 connected to the distal tip 20 may have a controllable section 28. The controllable section 28 may be, for example, an articular joint. The shaft 18 and the controllable section 28 may include various structures that are or may become known in the art.

[0021] The handle 12 may have one or more actuators / control mechanisms 30. One or more of the control mechanisms 30 may provide control over the controllable section 28. One or more of the control mechanisms 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 controllable section 28. For example, one of the knobs 32, 34 may provide left / right control of the controllable section 28, and the other of the knobs 32, 34 may provide up / down control of the controllable section 28. The handle 12 may further include one or more locking mechanisms 36 (e.g., knobs or levers) for preventing and / or braking the control of the controllable section 28 in at least one of the up, down, left, or right directions. The handle 12 may include a lifting platform control lever 38 (see Figure 1B). The lifting platform control lever 38 can raise and / or lower the lifting platform 26 via a connection between the lever 38 and an actuation wire extending from the lever 38 through the shaft 18 to the lifting platform 26. The port 40 can allow a tool to enter the working channel of the medical device 10 through the port 40 and pass through the shaft 18 to the distal tip 20.

[0022] During use, the operator may insert at least a portion of the shaft 18 into the body lumen of the target. The distal tip 20 may be navigated to the treatment site within the body lumen. The operator may insert an attachment device (not shown) into the port 40 and guide the attachment device through the shaft 18 and through the working channel to the distal tip 20. The attachment device can exit the working channel at the distal tip 20. The user may raise the lifting platform 26 using the lifting platform control lever 38 and angle the attachment device toward the desired location (e.g., the pancreaticobiliary papilla). The user can then use the attachment device to perform a medical procedure.

[0023] Figures 2A to 5D show various configurations of the distal tip 120 for use in the medical device 10. The distal tip 120 may have any of the features of the distal tip 20. Figures 2A, 3A, 4A, and 5A show oblique cross-sections of the distal tip 120 in the various configurations described below. Figures 2C, 3C, 4C, and 5C show cross-sections taken along the lines indicated in Figures 2D, 3D, 4D, and 5D, respectively. Certain elements of the distal tip 120 (e.g., cap, cover, sheath, etc.) may be omitted from Figures 2A to 5D to more clearly illustrate the aspects of this disclosure. Figures 6A to 6E show configurations of the support base 126 of the distal tip 120. Figure 6B shows a cross-section taken along line 6B in Figure 6A. In certain figures, arrows labeled "P" and "D" indicate the proximal and distal directions, respectively. The support base 126 may have any of the features of the support base 26. Where feasible, Figures 2A to 6E indicate corresponding elements from Figures 1A to 1B by adding 100 to the reference numerals of Figures 1A to 1B. For ease of illustration, some reference numerals related to the distal tip 120 or the support base 126 have been omitted from certain figures, but it will be understood that the structures of the distal tip 120 described herein relate to each of Figures 2A to 5B in which those structures are visible, and the embodiments of the support base 126 described herein apply to each of Figures 2A to 6E in which those embodiments are visible.

[0024] The distal tip 120 may include a housing 160 for receiving the components described herein. The housing 160 may be formed from 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 the components of the distal tip 120 in 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 a cap that covers the other elements of the distal tip 120.

[0025] The distal tip 120 may include an imaging device 122 (for example, shown in Figures 2A and 2B). Although the imaging device 122 is shown as a side-viewing type, it will be understood that the distal tip 120 may further or alternatively include one or more forward-facing (i.e., distal-facing) imaging devices. Although light sources such as light source 24 are not shown in Figures 2A to 5D, it will be understood that the distal tip 120 may include one or more light sources having desired features (such as any of the features of light source 24) and pointing in any desired direction. For example, as shown in Figures 2A and 2C, a working channel 142 may extend through the shaft 18 to an opening in the distal tip 120. The working channel 142 may have any suitable dimensions and may be used, for example, to receive one or more accessory devices that have passed through the port 40 of the handle 12.

[0026] The lifting platform 126 can be received within a channel 162 of the distal tip 120 (see, for example, Figures 2B, 2D, 3B, 4B, and 5B). The channel 162 may extend substantially parallel to the central longitudinal axis of the distal tip 120 / shaft 18. The channel 162 may communicate with the working channel 142. In addition to communicating with the distal opening of the working channel 142, the channel 162 may be open on two sides (e.g., the upper and distal sides adjacent to the imaging device 122). As used herein, terms such as “up,” “upwards,” and “upward” refer to the upward direction in Figures 2C–2D, 3C–3D, 4C–4D, and 5C–5D. Terms such as "bottom," "downward," and "downward" refer to the downward direction in Figures 2C-2D, 3C-3D, 4C-4D, and 5C-5D. Compared to conventional duodenoscopes, channel 162 may be elongated along the proximal / distal direction and may be open on the distal side of channel 162.

[0027] The lifting platform 126 may be coupled to a control wire 150 via an arm 151 of the lifting platform 126. The arm 151 is merely an exemplary structure for coupling the control wire 150 to the lifting platform 126, and the control wire 150 may be coupled to the lifting platform 126 in any preferred manner. The control wire 150 may be coupled directly or indirectly to a lever 38 (see Figure 1B above). As the lever 38 is rotated or otherwise actuated, the control wire 150 may move in a proximal or distal direction. As the lever 38 is rotated in a first direction, the control wire 150 moves in a proximal direction, thereby raising the lifting platform 126 to an elevated configuration (such as the fully elevated configuration of the lifting platform 126 as shown in Figures 3A to 3D and described in more detail below). When the lever 38 is rotated in a second direction (i.e., opposite to the first direction), the control wire 150 moves distally, thereby allowing the lifting platform 126 to be lowered to a lowered configuration (for example, to a fully lowered configuration as shown in Figures 2A to 2D and described in more detail below). The lifting platform 126 may have various intermediate positions between the fully raised configuration and the fully lowered configuration. The lifting platform 126 may rotate around an axis 180 at its proximal end. The axis of rotation of the lifting platform 126 may extend through the axis 180.

[0028] The lifting base 126 may include a first guide surface 154 (see, for example, Figures 2A and 2B), which extends between the axis 180 of the lifting base 126 and the distal end 181 (for example, the most distal end) of the lifting base 126 (see Figures 2C and 3C). The lifting base 126 may also include a second back surface 182 on the opposite side of the lifting base 126 from the guide surface 154, which extends between the axis 180 and the distal end 181. The guide surface 154 may be on the first side of the rotation axis of the lifting base 126, and the back surface 182 may be on the second side of the rotation axis of the lifting base 126 (opposite the first side). When the lifting base 126 is in a lowering configuration (see Figures 2A to 2D), the guide surface 154 may face the open side of the channel 162. In the lowering configurations shown in Figures 2A to 2D, the back surface 182 may face the surface of the housing 160. When the lifting platform 126 is in the fully raised configuration (see Figures 3A to 3D), the guide surface 154 may be on the proximal side of the lifting platform 126, and the back surface 182 may be on the distal side of the lifting platform 126.

[0029] For example, as shown in Figures 2B, 2C, 3A, 3C, 3D, 4C, 4B, 5A, 5C, 5D, and 6A-6E, the lifting base 126 may include an opening 152. The opening 152 may extend through the entire thickness of the lifting base 126 between the guide surface 154 and the back surface 182. The opening 152 may have any preferred shape. For example, the opening 152 may define a substantially circular opening, as shown particularly in Figures 6A and 6C. The diameter / width of the opening defined by the opening 152 may be any preferred size (e.g., approximately the same size as or larger than the diameter / width of the largest accessory device used in device 10). In some examples, the opening 152 may have a diameter / width less than or equal to the diameter / width of the working channel 142. The size of the opening 152 may depend on the width of the lifting base 126. The lifting base 126 must have sufficient wall strength on at least one side of the opening 152 to apply frictional force when the lifting base 126 is fully raised or fully lowered. For example, the opening 152 may be about 3.5 mm (which may be smaller than the size of the working channel 142, which may be about 4.2 mm), or it may have any preferred size (e.g., any size of about 6.35 mm (0.25 inches) or less), and the working channel 142 may have a similar size, e.g., about 6.35 mm (or 0.25 inches) or less. The opening 152 may be configured to receive an accessory device through the opening 152. Although the opening 152 is shown as a hole, it will be understood that the opening 152 may alternatively be any type of slot, notch, gap, recess, or other type of opening. The opening 152 may be completely enclosed around the periphery of the opening 152 (i.e., the hole), as shown in the figure. Alternatively, the opening 152 may include one or more open sides so that the opening 152 forms a slot or notch.

[0030] The guide surface 154 and / or the back surface 182 may be contoured adjacent to the opening 152. For example, as shown in Figure 6C, the back surface 182 may include a contoured recess 184 distal to and adjacent to the opening 152. As will be described in detail below, the contoured recess 184 may have a shape and size that interfaces with an accessory device (e.g., a small-diameter accessory device). As shown in Figure 6C, the contoured recess 184 may taper distally in width (horizontal in Figure 6C) and depth (in the direction of entering / exiting in Figure 6C) such that the contoured recess 184 becomes narrower and shallower along the distal direction.

[0031] The bottom wall 161 of the housing 160 (see, for example, Figures 2C, 3A, and 3B) may define the bottom surface of the channel 162. The bottom wall 161 may have a boss 166 positioned thereon. The boss 166 may be formed integrally with the bottom wall 161 (i.e., monolithically from the same piece of material), or it may be formed separately from the bottom wall 161 and attached to the bottom wall 161. In particular, as shown in Figure 2B, the boss 166 may have a substantially circular cross-sectional shape. Alternatively, the boss 166 may have any preferred shape. The shape and size of the opening 152 may be complementary to the shape and size of the boss 166 so that the boss 166 can fit into / fit with the opening 152. To allow the boss 166 and the lifting base 126 to move freely relative to each other as the lifting base 126 is raised / lowered, the opening 152 may have a diameter / width slightly larger than that of the boss 166. In particular, as shown in Figure 3A, the boss 166 may include two ridges 168 on either side thereof, with a recess 170 between them. The recess 170 may extend substantially parallel to the central longitudinal axis of the distal tip 120 / shaft 18.

[0032] The following describes various configurations and uses of the distal tip 120, along with methods for using the distal tip 120. In one example, the device 10 and the distal tip 120 may be used as a typical lateral-view medical device (e.g., for ERCP procedures). The lifting base 126 may have a first, downward configuration, as shown in Figures 2A to 2D. The boss 166 may be received within the window 152. The boss 166 may serve to close the window 152. As shown in Figure 2C, the boss 166 may protrude from the bottom wall 161 to a height approximately equal to the thickness of the lifting base 126 between the guide surface 154 and the back surface 182. The upper surface of the boss 166 may be substantially aligned with the guide surface 154. During an ERCP procedure or other procedure in which the lateral-view function of the device 10 is utilized, an accessory device (e.g., a guidewire) may pass through the working channel 142 with the lifting base 126 in the downward configuration. With the boss 166 received within the opening 152, the accessory device can move along the guide surface 154, similar to the stand of a conventional lateral-viewing endoscope, until the distal tip of the accessory device is distal to the distal end 181 of the stand 126.

[0033] During an ERCP procedure, the user can raise the lifting platform 126 to an elevated position / configuration, as shown in Figures 3A–3D, thereby articulating the accessory device (e.g., to an extension configuration of the accessory device, or to another configuration in which the accessory device extends radially outward (e.g., about 90 degrees outward)). To facilitate the characterization of the distal tip 120, the accessory device is not shown in Figures 2A–3D. In some embodiments, the accessory device (e.g., a guidewire) may be locked (held in a desired position / configuration) between a portion of the guide surface 154 (e.g., the distal end 181) and a locking surface 164 of the housing 160. The locking surface 164 may be located proximal to the channel 162. The locking surface 164 may have a shape complementary to the guide surface 154 so that the guide surface 154 can engage with the locking surface 164. Additionally or alternatively, the locking surface may have a substantially "V" shape. The locking surface 164 may have any features known in the art. In the raised configuration, the boss 166 is no longer positioned within the opening 152, but the distal end of the accessory device has already extended beyond the distal end 181. Therefore, the opening 152 does not interfere with the articulation of the accessory device or with the locking of the accessory device between the guide surface 154 and the locking surface 164. Thus, the distal tip 120 allows the user to perform procedures such as ECRP, as is conventionally done with a side-viewing device.

[0034] In another example, the user may pass the attached device over the lifting platform 126 while the lifting platform 126 is in the lowered configuration / position, as described above. The user may perform the procedure without raising the lifting platform 126. For example, the user may use the medical device 10 as a forward-looking device for, for example, an EGD procedure. In such a configuration, the attached device may move freely up / down (e.g., float) through the channel 162, including passing through the open upper side of the channel 162.

[0035] Alternatively, the user may wish to perform procedures such as EGD while the attached device is locked and cannot move freely upward or downward. To do so, the user may raise the lifting platform 126 to the raised position, as shown in Figures 3A to 3D, before fully passing the attached device through the work channel 142. The user may then extend the attached device through the work channel 142 and through the opening 152 of the lifting platform 126. The work channel 142 may communicate with the opening 152. For example, the opening 152 may be substantially aligned with the work channel 142. Features of the guide surface 154 may guide the attached device through the opening 152. The opening 152 may resemble the distal opening of the work channel 142 when the lifting platform 126 is in the fully raised configuration, as shown in Figures 3A to 3D. The attached device may extend distally from the most distal end 163 of the housing 160 (see Figures 4B and 4C) and the most distal end of the channel 162.

[0036] The distal tip 120 may operate to hold (i.e., lock) both small-diameter and large-diameter attachments so that the attachments extend distally to the distal tip 120 (for example, substantially parallel to the longitudinal axis of the distal tip 120 and / or the shaft 18). Figures 4A to 4D show small-diameter attachments 190, such as guide wires, in a locking configuration. For example, small-diameter attachments may have a diameter of 0.020 inches or more (e.g., 0.025 inches or more). In Figure 4A, a portion of the small-diameter attachment proximal to the lifting platform 126 is partially obscured by the control wire 150. As described above, the small-diameter attachments 190 may pass through the opening 152 when the lifting platform 126 is in the raised position. To lock the small-diameter attachment device 190, the user may partially lower the lifting base 126 so that the back surface 182 and boss 166 of the lifting base 126 engage with the small-diameter attachment device 190, as shown in Figures 4A to 4D. This engagement can hold the small-diameter attachment device 190 so that it extends substantially parallel to the longitudinal axis of the distal tip 120 / shaft 18 (i.e., lock the small-diameter attachment device 190). The amount or extent to which the lifting base 126 is lowered to lock the small-diameter attachment 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 attachment device 190. The small-diameter attachment device 190 may extend through the recess 170 in the locking configuration. The contoured recess 184 may have a shape that engages with / interacts with the small-diameter accessory device 190 so as to engage with the small-diameter accessory device 190 between the contoured recess 184 and a portion of the boss 166 such as a recess 170.

[0037] As shown in Figures 3B and 4B, 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 in the shape of a substantially triangular shape with a proximal vertex 173 (Figure 3B). As shown in Figures 4A to 4D, when the small diameter attachment device 190 is in a locking configuration, the small diameter attachment device 190 can be received within the notch 172 at the vertex 173. The vertex 173 may further help to restrain the small diameter attachment device 190 so that it extends distally substantially parallel to the longitudinal axis of the distal tip portion 120 and / or the shaft 18. Additionally or alternatively, the housing 160 may include projections (not shown) similar to the locking surface 164 to restrain the small diameter attachment device 190. Such protrusions may be located between the notch 172 and the recess 170 and may have a shape that complements the shape of the contoured recess 184. The lifting platform 126 can be raised to release the small-diameter attachment device 190. The small-diameter attachment device 190 can then be removed (for example, retracted in the proximal direction) or repositioned.

[0038] The distal tip 120 can also be used to position and hold a large-diameter attachment device 192, as shown in Figures 5A to 5D. For example, the large-diameter attachment device 192 may have a diameter / width of approximately 6.35 mm (0.25 inches) or less, or approximately 4.2 mm or less. As described above, the large-diameter attachment device 192 may pass through the working channel 142 when the lifting platform 126 is in the raised configuration. Similar to the small-diameter attachment device 190, the large-diameter attachment device 192 may extend through the recess 170 of the boss 166. As shown in Figures 5A to 5D, the large-diameter attachment device may have a width / diameter similar to the width / diameter of the opening 152. Therefore, it may not be possible or necessary to lower the lifting platform 126 to lock / hold the large-diameter attachment device 192 in a configuration in which the large-diameter attachment device 192 extends substantially parallel to the longitudinal axis of the distal tip 120 / shaft 18. The opening 152 may function similarly to the working channel opening of a conventional distal-view medical device to restrain the large-diameter attachment device 192. The area around the opening 152 may prevent the large-diameter attachment device 192 from moving upward through the upper open side of the channel 162. The large-diameter attachment device 192 may extend substantially parallel to the longitudinal axis of the distal tip 120 and / or shaft 18. Features of the guide surface 154 may assist in guiding the large-diameter attachment device 192 through the opening 152.

[0039] It will be understood that the lifting platform 126 can be moved to an intermediate configuration between the configurations shown in Figures 4A-4D and 5A-5D in order to secure accessory devices of various sizes. Alternatively, the lifting platform 126 may be held in the fully raised configuration shown in Figures 3A-3D, thereby allowing the accessory device to move freely in the proximal / distal direction (e.g., longitudinal direction) while being at least partially constrained by the periphery of the opening 152.

[0040] Although the accessory devices 190 and 192 are described as extending substantially parallel to the longitudinal axis of the distal tip 120 and / or shaft 18, it should be understood that the shafts of the accessory devices 190 and 192 may be flexible, and therefore, these devices may bend passively or actively (especially when the devices extend a long distance distal to the distal tip 120). The description of the accessory devices 190 and 192 extending substantially parallel to the longitudinal axis of the distal tip 120 and / or shaft 18 is intended to apply in particular to the configuration of the accessory devices 190 and 192 at or near the distal tip 120.

[0041] Therefore, the features of the lifting platform 126 and / or channel 162 (including the bottom wall 161 defining part of 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 EGD and ERCP procedures. In certain procedures, the medical device 10 may be used only as a forward-looking device or as a lateral-looking device. Alternatively, the medical device 10 may be used in both ways in a single procedure. As described above, the distal tip 120 can facilitate dual locking, and the attachment device can be locked in a retracted position (or another position in which the attachment device extends radially outward) or in a position in which the attachment device extends distally.

[0042] Figures 7A to 10B show embodiments of an alternative distal tip 220 for use with the medical device 10. The distal tip 220 may have any of the features of the distal tips 20 and 120, except as described below. The features of the distal tips 120 and 220 may be combined in any preferred manner. Figures 7A, 8A, 9A, and 10A show oblique cross-sections of the distal tip 220. Figures 7B, 8B, 9B, and 10B show side views consisting of cross-sections taken along the same plane as Figures 7A, 8A, 9A, and 10A. Certain elements of the distal tip 220 (e.g., caps, covers, sheaths, etc.) may be omitted from Figures 7A to 10B to more clearly illustrate embodiments of this disclosure. Figures 11A to 11D show embodiments of a support 226 for the distal tip 220. If feasible, the reference numbers in Figures 7A to 11D will be the same as those in Figures 2A to 6E, but with 100 added to indicate a similar structure.

[0043] The distal tip 220 may include a housing 260 having any of the features of the housing 160 unless otherwise specified. The housing 260 may define a channel 262 having any of the features of the channel 162 unless otherwise specified. The distal tip 220 may include an imaging device 222 having any of the features of the imaging device 122.

[0044] The distal tip 220 may also include a lifting platform 226. Figures 11A–11D show an embodiment of the lifting platform 226 separated from the distal tip 220. Similar to the lifting platform 126, the lifting platform 226 may include an opening 252. However, while the lifting platform 126 pivots around an axis 180 below the work channel 142 (i.e., closer to the bottom wall 161 than the work channel 142), the lifting platform 226 may be coupled to the housing 260 to pivot around an axis 280 above the work channel 242. In other words, the axis 280 around which the lifting platform 226 pivots may be positioned on the side of the work channel 242 that is closer to the imaging device 222 than to the bottom wall 261 of the housing 260 (see, for example, Figure 8A).

[0045] The lifting platform 226 may include a body 227 coupled to an arm 251. For example, as shown in Figures 11A and 11C, the first end of the arm 251 may be coupled to a shaft 280, and the shaft 280 may be coupled to the body 227. The shaft 280 may have a substantially cylindrical shape. The body 227 may include two legs 227a, 227b extending from the shaft 280 toward the distal end 281 of the lifting platform 226. A distal portion 227c of the body 227 may extend between the legs 227a and 227b. The distal portion 227c may have a first guide surface 254 having any of the characteristics of a guide surface 154. The guide surface 254 may be configured to receive and guide accessory devices along the lifting platform 226. The distal portion 227c may also have a second back surface 282. The back surface 282 and the guide surface 254 may form both sides of the lifting base 226. The guide surface 254 and the back surface 282 may be on both sides of the axis 280, and the lifting base 226 rotates around the axis 280.

[0046] In particular, as shown in Figure 11A, the window portion 252 may have a proximal side defined by the distal plane of the axis 280. The legs 227a and 227b may define the lateral sides of the window portion 252. The proximal and lateral sides of the window portion 252 may be approximately straight / linear. The proximal edge of the distal portion 227c may define the distal side of the window portion 252. The distal side of the window portion 252 may be curved (for example, approximately semicircular in shape).

[0047] The arm 251 may extend at an angle of approximately 90 degrees with respect to the longitudinal axes of the legs 227a and 227b (these longitudinal axes may be substantially parallel to each other) and with respect to the longitudinal axis of the axis 280. The end of the arm 251 opposite to the axis 280 may include an opening 253. The opening 253 may have any preferred shape, for example, it may be circular. As described below, the opening 253 may receive a control element for rotating the lifting platform 226.

[0048] In particular, as shown in Figure 11B, the main body 227 may have a curved shape. The lateral shape of the distal portion 227c of the main body (shown in Figure 11B) may extend at an angle with respect to the longitudinal axis of the legs 227a and 227b. The entire lifting platform 226, including the arm 251, may have a modified "C" shape or a modified "U" shape when viewed from the side.

[0049] For example, as shown in Figure 7B, the control wire 250 may be coupled to the arm 251 of the lifting base 226 via an opening 253. The proximal portion of the control wire 250 may pass through the sheath 249a and coil 249b so that the assembly consisting of the control wire 250, sheath 249a, and / or coil 249b is a Bowden cable or similar. Figures 10A and 10B show the distal tip 220 without the lifting base 226. As shown in Figures 10A and 10B, the control wire 250 may have a distal projection 279. The distal projection 279 may be substantially spherical or have any other preferred shape. The distal projection 279 may be coupled to the lifting base 226 via an opening 253.

[0050] As shown in Figure 10B, a hole 277 may be formed in the housing 260. The shaft 280 of the lifting platform 226 may be received in the hole 277 to connect the lifting platform 226 to the housing 260. The lifting platform 226 may be rotatable around the shaft 280 as the control wire 250 moves in the proximal or distal direction. Moving the control wire 250 distally may lower the lifting platform 226, and moving the control wire 250 proximal may raise the lifting platform 226.

[0051] In particular, as shown in Figures 8A-8B and 10A-10B, the bottom wall 261 of the housing 260 may have a boss 266. Unless otherwise specified, the boss 266 may have any of the characteristics of the boss 166. The boss 266 may have a shape that complements the shape of the opening 252. For example, the boss 266 may have a substantially straight side and a curved distal end. The boss 266 may have a recess 270 (similar to the recess 170) that extends longitudinally along the boss 266 to receive and / or interact with the accessory device 292 (see Figures 9A and 9B).

[0052] The following describes various configurations and uses of the distal tip 220, along with methods for using the distal tip 220. In one example, the device 10 and the distal tip 220 may be used as a typical lateral-viewing medical device (e.g., for ERCP procedures). The lifting platform 226 may have a first, lowering configuration, as shown in Figures 7A and 7B. As shown in Figures 7A and 7B, during an ERCP procedure or other procedure in which the lateral-viewing function of the device 10 is utilized, the accessory device 292 may pass through the working channel 242 with the lifting platform 226 in the lowering configuration. Although a large-diameter accessory device 292 is shown, the accessory device 292 may alternatively be a small-diameter accessory device 292.

[0053] The boss 266 (for example, the distal portion of the boss 266) can be received within the fenestration 252 (for example, within the distal portion of the fenestration 252). The boss 266 may serve to provide a smooth transition between the channel 262 and the lifting platform 226, so that instead of exerting force on the lifting platform 226 and thereby rotating it, the accessory device 292 is guided onto the guide surface 254. As shown in Figure 2C, the accessory device 292 can be placed on the proximal portion of the boss 266 and on the guide surface 254. The distal upper surface of the boss 266 may be substantially aligned with the guide surface 254. With the boss 266 received within the fenestration 252, the accessory device 292 may move along the guide surface 254, similar to a conventional lifting platform of a lateral-viewing endoscope, until the distal tip of the accessory device 292 is distal to the distal end 281 of the lifting platform 226.

[0054] During an ERCP procedure, the user can raise the lifting platform 226 to an elevated position / configuration, as shown in Figures 8A and 8B, thereby articulating the accessory device 292 (for example, to a retracted configuration of the accessory device, or to another configuration in which the accessory device extends radially outward (e.g., about 90 degrees outward)). In some embodiments, the accessory device 292 may be locked (held in a desired position / configuration) between a portion of the guide surface 254 (e.g., the distal end 281) and a locking surface 264 of the housing 260 (see Figures 8B and 10B). The locking surface 264 may be located proximal to the channel 262. The locking surface 264 may have a shape complementary to the guide surface 254 so that the guide surface 254 can engage with the locking surface 264. Additionally or alternatively, the locking surface may have a substantially "V" shape. The locking surface 264 may have any features known in the art. In the raised configuration, the boss 266 is no longer positioned within the opening 252, but the distal end of the accessory device 292 already extends beyond the distal end 281. Therefore, the opening 252 does not interfere with the articulation of the accessory device 292 or with the locking of the accessory device 292 between the guide surface 254 and the locking surface 264. Thus, the distal tip 220 allows the user to perform procedures such as ECRP, as is conventionally done with lateral-viewing devices.

[0055] In another example, the user may pass the accessory device 292 over the lifting platform 226 while the lifting platform 226 is in the lowered configuration / position, as described above and shown in Figures 7A and 7B. The user may perform the procedure without raising the lifting platform 226. For example, the user may use the medical device 10 as a forward-looking device for, for example, an EGD procedure. In such a configuration, the accessory device 292 may move freely up / down (in the direction of Figure 7A) through the channel 262, including passing through the open upper side of the channel 262 (e.g., floating).

[0056] Alternatively, the user may wish to perform a procedure such as an EGD procedure while the accessory device 292 is locked and cannot move freely upward or downward. To do so, the user may raise the lifting platform 226 to the raised position (similar to the raised position shown in Figures 8A and 8B, but without the accessory device 292) before fully passing the accessory device 292 through the work channel 242. The user may then extend the accessory device through the work channel 242 and through the opening 252 of the lifting platform 226. The work channel 242 may communicate with the opening 252. For example, the opening 252 may be substantially aligned with the work channel 242. The opening 252 may resemble the distal opening of the work channel 242 when the lifting platform 226 is in the fully raised configuration. The attached device 292 may extend distally from the most distal end 263 of the housing 260 (see Figure 8B) and the most distal end of the channel 262.

[0057] As shown in Figures 9A and 9B, the distal tip 220 may operate to hold the attachment device 292 (either a large-diameter or small-diameter attachment) such that the attachment device 292 extends distally to the distal tip 220 (for example, substantially parallel to the longitudinal axis of the distal tip 220 and / or the shaft 18 (Figure 1A)). To lock the small-diameter attachment device 290, the user may partially lower the lifting base 226 so that the back surface 282 and boss 266 of the lifting base 226 engage the attachment device 290, as shown in Figures 9A and 9B. This engagement may be such that the attachment device 292 extends substantially parallel to the longitudinal axis of the distal tip 220 / shaft 18 (i.e., locks the attachment device 292). The amount or extent to which the lifting platform 226 is lowered to lock the attachment device 292 may depend on one or more dimensions or other characteristics of the distal tip portion 220 and / or the diameter / width of the attachment device 292. The attachment device 292 may extend through a recess 270 in the locking configuration. The back surface 282 may have a contoured recess 284, which may have a shape that engages with / interacts with the attachment device 292 so as to engage the attachment device 292 between the contoured recess 284 and a portion of the boss 266 such as the recess 270.

[0058] Although the accessory device 292 is described as extending substantially parallel to the longitudinal axis of the distal tip 220 and / or shaft 18, it will be understood that the shaft of the accessory device 292 may be flexible, and therefore the device may bend passively or actively (especially when the device extends a long distance distal to the distal tip 220). The description that the accessory device 292 extends substantially parallel to the longitudinal axis of the distal tip 220 and / or shaft 18 is intended to apply in particular to the configuration of the accessory device 292 at or near the distal tip 220.

[0059] Therefore, the features of the lifting platform 226 and / or channel 262 (including the bottom wall 261 defining part of channel 262) can facilitate the use of medical device 10 as both a forward-viewing and a lateral-viewing medical device. The same medical device 10 can be used for EGD and ERCP procedures. In certain procedures, medical device 10 may be used only as a forward-viewing device or as a lateral-viewing device. Alternatively, medical device 10 may be used in both ways in a single procedure. As described above, the distal tip 220 can facilitate dual locking, and the attachment device can be locked in a retracted position (or another position in which the attachment device extends radially outward) or in a position in which the attachment device extends distally.

[0060] The principles of this disclosure are described herein with reference to exemplary examples of certain applications, but it should be understood that this disclosure is not limited thereto. Those skilled in the art and those with access to the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the embodiments described herein. Furthermore, various elements from 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 present invention should not be considered limited by the foregoing description.

Claims

1. The distal tip of a medical device, Housing and A lifting platform comprising a lifting platform including an opening extending from a first surface of the lifting platform to a second surface of the lifting platform, A distal tip portion wherein the opening is configured to receive an attached medical device through the opening, and the attached medical device extends distally to the most distal end of the housing.

2. The distal tip portion according to claim 1, wherein the first surface of the lifting platform is on the first side of the rotation axis of the lifting platform, the second surface of the lifting platform is on the second side of the rotation axis, and the first side is on the opposite side of the second side.

3. The distal tip portion according to claim 1 or 2, wherein, in the raising configuration of the lifting platform, the opening is configured to receive the attached medical device through the opening, and in the raising configuration of the lifting platform, the first surface is located proximal to the second surface.

4. The distal tip portion according to any one of claims 1 to 3, wherein the housing includes a boss, and in the lowering configuration of the lifting platform, the boss is configured to be received within the opening.

5. The distal tip portion according to claim 4, wherein the second surface of the lifting platform and the boss engage with the attached medical device in such a configuration that the attached medical device is received through the opening, thereby holding the attached medical device in a locking configuration in which the attached medical device extends substantially parallel to the longitudinal axis of the distal tip portion.

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

7. The distal tip portion according to claim 5 or 6, wherein the second surface of the lifting platform includes a recess, and in the locking configuration, the attached medical device is received in the recess of the second surface.

8. The distal tip portion according to claim 7, wherein the recess is located distal to the opening.

9. The distal tip portion according to any one of claims 1 to 8, wherein the opening has a periphery that is completely enclosed.

10. The distal tip portion according to claim 9, wherein the opening is substantially circular.

11. The distal tip portion according to any one of claims 1 to 10, wherein the distal tip portion also includes a channel, and the lifting platform is received within the channel.

12. The distal tip portion according to claim 11, wherein the channel has an open distal end.

13. The distal tip portion according to claim 11 or 12, wherein the housing defines at least one surface of the channel, and the at least one surface includes a notch at its distal end.

14. The distal tip portion according to any one of claims 11 to 13, wherein the housing defines a locking surface at the proximal end of the channel, and the locking surface is configured to fit with the first surface of the lifting platform in the lifting configuration of the lifting platform.

15. The distal tip portion according to any one of claims 1 to 14, wherein, in the lowering configuration of the lifting platform, the distal tip portion is configured to receive the attached medical device such that the attached medical device extends from the proximal end of the lifting platform to the distal end of the lifting platform.

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