Medical devices and related methods

By designing an expandable distal cap, the surface area on the distal surface of the medical endoscope is increased, and the problem of limited size of functional components in the prior art is solved, achieving greater lighting and imaging effects.

CN120076752APending Publication Date: 2025-05-30BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202380073133.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-08-19
Filing Date
2023-08-17
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

The external diameter of existing medical endoscopes is limited, resulting in limited size of functional components on the distal surface, limiting the size of accessories and lighting devices available to the doctor during operation.

Method used

A distal cap is designed to include a deployable portion that can be deployed radially outward from the body and retract radially inward from the deployed position, increasing the surface area on the distal surface to accommodate a larger lighting device and imager.

Benefits of technology

By increasing the surface area on the distal surface, a larger lighting device and imager is achieved without changing the outer diameter of the endoscope, thereby improving operational flexibility and effect.

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Abstract

A medical device includes a handle including an actuator, a shaft extending distally from the handle, wherein the shaft includes a lumen, and a distal cap. The distal cap includes a body including a first channel in communication with a distal portion of the lumen; the far end face comprises an opening, and the opening is a far end opening of the channel; and a deployable portion connected to the body, the deployable portion configured to deploy radially outward from the body and retract radially inward to the body from a deployed position. The deployable portion includes at least one lighting device.
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Description

Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 371,916, filed on August 19, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure generally relates to medical devices and related methods. More specifically, at least some embodiments of the present disclosure relate to medical devices, such as endoscopes (scopes), that include a deployable distal portion that enables a larger working channel and / or enhanced illumination, and related methods. Background Art

[0003] Medical endoscopes commonly used in endoscopic surgery, such as duodenoscopes, catheters, etc., generally include an accessory / working channel, a flushing channel, a suction channel, a lighting device, and / or an imager. For various reasons, the outer diameter of such endoscopes may be limited to a certain size, such as 3.5 millimeters, which limits the surface area of the distal end face of the endoscope. Therefore, in order to accommodate various functional components on the distal end face, the diameter or width of these functional components, such as the diameter of the working channel, the size of the lighting device, etc., are necessarily limited. As a result, when operating these medical endoscopes, doctors may be restricted, for example, to using only certain accessories and / or tools that are small enough to pass through the working channel. Similarly, doctors may only be able to use smaller and / or lower-capacity lighting devices, rather than larger lighting devices. Summary of the Invention

[0004] Examples of the present disclosure relate to medical devices and methods, etc. Each example disclosed herein may include one or more features described in relation to any other disclosed example.

[0005] According to one aspect, a medical device may include: a handle including an actuator; a shaft extending distally from the handle, wherein the shaft includes a lumen; and a distal cap. The distal cap includes: a body including a first channel that communicates with a distal portion of the lumen; a distal end face including an opening that is a distal opening of the channel; and a deployable portion connected to the body, wherein the deployable portion is configured to deploy radially outward from the body and retract radially inward to the body, and the deployable portion includes at least one lighting device.

[0006] According to another aspect, the actuator may be engaged with the deployable portion such that the actuator is configured to control the deployment and retraction of the deployable portion.

[0007] According to another aspect, the deployable portion is biased towards a retracted position. In the retracted position, the outer diameter of the distal cap may be substantially the same as the outer diameter of the remainder of the shaft.

[0008] According to another aspect, the distal face may not include any illumination means.

[0009] According to another aspect, the opening diameter of the distal face may be from about 1.5 millimeters to 2.0 millimeters.

[0010] According to another aspect, the deployable portion may be connected to the body by a hinge. The deployable portion may be connected to the distal end of the body such that in the retracted position, the deployable portion covers at least a portion of the opening, and in the deployed position, the deployable portion exposes the entire opening. The deployable portion may be semi-circular such that in the retracted position, a portion of the opening remains exposed. The deployable portion may be transparent. The actuator and the deployable portion may be engaged with each other by an opening wire and a closing wire, wherein a force applied to the opening wire is configured to deploy the deployable portion, and a force applied to the closing wire is configured to retract the deployable portion. The body may further include an outer cylinder and an inner cylinder, wherein the outer cylinder surrounds at least a portion of the inner cylinder, and the inner cylinder may rotate about the central longitudinal axis of the body. The outer cylinder includes a first groove, and the inner cylinder includes a second groove, wherein the first groove and the second groove overlap, and the first groove and the second groove are configured to accommodate the deployable portion in the retracted position. The deployable portion may be connected to the outer cylinder by a hinge and connected to the inner cylinder by a hinge, and a rotational force applied to the rotatable inner cylinder in a first direction is configured to deploy the deployable portion. A rotational force applied to the rotatable inner cylinder in a second direction is configured to retract the deployable portion into the first groove and the second groove.

[0011] According to another aspect, a medical device end cap may include: a body including a channel; a distal face including an opening that is the distal opening of the channel; a first wing connected to the body; and a second wing connected to the body, wherein the first wing and the second wing are each configured to radially expand outward from the body to a deployed position and radially retract inward from the deployed position to the body, and wherein the first wing and the second wing each include at least one illumination means.

[0012] According to another aspect, the first wing may be configured to radially expand outward in a first radial direction, and the second wing may be configured to radially expand outward in a second radial direction, wherein the first radial direction and the second radial direction are different.

[0013] According to another aspect, the distal face may not include any illumination means.

[0014] According to another aspect, one or more of the first and second wings may further include an imaging device.

[0015] In another aspect, a method of using a medical device including a handle containing an actuator, a shaft, and a distal cap including a deployable portion controllable by the actuator, where the deployable portion includes at least one illumination device, the method may include: delivering the distal end of the shaft and the distal cap into a body cavity; positioning the distal end of the shaft and the distal cap near a target site; actuating the actuator to control the deployable portion of the distal cap to deploy the deployable portion of the distal cap; and activating the at least one illumination device. Brief Description of the Drawings

[0016] The accompanying drawings are incorporated in and constitute a part of this specification, showing various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

[0017] Figure 1 is a perspective view of a medical device according to one embodiment.

[0018] Figure 2A and Figure 2B is Figure 1 perspective views of the distal portion of the medical device in different configurations.

[0019] Figures 3A - 3C is a perspective view of the distal portion of a medical device according to another embodiment. Detailed Description

[0020] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Whenever possible, the same or similar reference numerals are used in the drawings to refer to the same or similar parts. The term "distal" refers to the part that is farthest from the user when the device is introduced into an object (e.g., a patient). In contrast, the term "proximal" refers to the part that is closest to the user when the device is inserted into the object.

[0021] The above general description and the following detailed description are exemplary and explanatory and do not limit the claimed features. As used herein, the terms "comprises", "comprising", "having", "including" or other variants thereof are intended to cover non-exclusive inclusion, such that a process, method, article or apparatus that comprises a series of elements includes not only those elements but also other elements not expressly listed or inherent to such process, method, article or apparatus. In the present disclosure, relative terms such as "about", "substantially", "generally" and "approximately" are used to indicate that the stated value or characteristic may vary by ±10%.

[0022] Embodiments of the present disclosure may address one or more limitations in the prior art. However, the scope of the present disclosure is defined by the appended claims and not by the ability to solve a particular problem. In some embodiments, the present disclosure relates to a medical device, for example, which may be any endoscope (e.g., bronchoscope, duodenoscope, endoscope, colonoscope, ureteroscope, cholangioscope, etc.), including a handle and a shaft extending distally from the handle, such as a catheter. As further discussed below, the shaft may include a distal cap having one or more "deployable" features, such as features configured to open / close, expand radially outward, retract radially inward, etc. in some embodiments. In some embodiments, prior to deployment, these deployable features do not increase the cross-sectional diameter (or otherwise affect the dimensions) of the distal cap or the distal portion of the shaft, such that the shaft may have the same diameter during insertion / delivery. Each deployable feature may include a lighting device, an imager, and / or other endoscope features. Such a distal cap increases the surface area of the distal face of the endoscope relative to an endoscope that includes a lighting device, an imager, and other features on the distal face.

[0023] Figure 1 A medical device 10 (device 10), such as an endoscope, is shown according to one embodiment. Device 10 includes a flexible shaft 15 (e.g., a catheter) connected to a distal cap 150, and a handle 12 connected to the proximal end of shaft 15. As discussed below, distal cap 150 may include one or more deployable / retractable features (structures).

[0024] Handle 12 may be connected to a umbilical portion 11, and handle 12 may include an actuator 14, such as one or more knobs. Umbilical portion 11 extends proximally relative to handle 12. Umbilical portion 11 may be connected to any suitable source, such as a fluid source, a suction source, a power source, etc., a control system, a display, etc.

[0025] The actuator 14 can be connected to the upper (proximal) portion of the handle 12 and can be configured to control at least a portion of the flexible shaft 15 and / or the articulation movement of the joint (articulating joint) at the distal end of the flexible shaft 15 in multiple directions. The actuator 14 can be, for example, one or more rotatable knobs, each knob rotating about its axis to push / pull an actuating element, such as a steering wire (not shown). The actuating element, such as a cable or wire suitable for medical procedures (e.g., medical-grade plastic or metal), extends distally from the proximal end of the device 10 and is connected to the distal portion of the flexible shaft 15 to control its movement. Alternatively, or additionally, the user can operate the actuating element independently of the handle 12, such as through a separate control device. The distal end of the actuating element can extend through the flexible shaft 15 and terminate at the joint of the flexible shaft 15 and / or the distal cap 150. For example, one or more actuating elements can be connected to the joint, and actuation of the actuating element can cause the joint and / or the distal end of the flexible shaft 15 to move in multiple directions.

[0026] The handle 12 can also include one or more additional controls 17, such as buttons. Although not shown, the controls 17 can also include one or more levers, rotating components, etc., which can be configured to actuate the deployment and / or retraction of the deployable features of the distal cap 150, which will be discussed in more detail below. For example, the control 17 can be actuated by pressing a button (as Figure 1 shown) to cause the deployable feature to deploy from the retracted state and can also cause the deployable feature to retract from the deployed state. In other embodiments, the control 17 includes a lever and / or a rotating component, and the lever and / or the rotating component can be rotated in a first direction to cause the deployable feature to deploy from the retracted state and rotated in a second direction to cause the deployable feature to retract from the deployed state. The control 17 can engage the deployable features of the distal cap 150 through any additional actuating elements extending between the control 17 and the distal cap 150, such as push-pull actuating elements, rotating elements, etc. The position of the control 17 along the handle 12 and its relative position to the actuator 14 are not particularly limited and can be ergonomically arranged. For example, the control 17 can be arranged in the proximal portion of the handle 12, which is configured to be operated by the finger, such as the index finger, of the operator / user / doctor.

[0027] The handle 12 may further include one or more ports 13, 18 for introducing and / or removing tools, fluids, or other materials from the patient's body. For example, the port 13 may be used to introduce an attachment device (not shown), which can be any tool or device suitable for medical use. The port 13 may be in fluid communication with a working channel, such as the lumen (not shown) of the shaft 15. Although not shown, the port 13 may be a Y-shaped port. The port 13 may receive any suitable attachment device (such as a snare, basket, stone retrieval basket, forceps, grasper, scissors, clip, stapler, needle, knife, electrode, electrocautery ring, etc.), which may extend distally along the shaft 15 and toward the distal end of the device 10. The port 18 may be connected to the umbilical portion 11, for example, for introducing fluids, performing aspiration (suction), and / or connecting wiring for electronic components.

[0028] In addition, one or more cables (not shown) may extend from the proximal end of the device 10 (such as from the handle 12 and / or the umbilical portion 11), pass through the flexible shaft 15, and reach the distal cap 150. One or more cables may provide power and / or electrical signals for imaging, illumination, and / or other electrical devices at the distal cap 150, and may transmit imaging signals from one or more imaging devices at the distal cap 150 proximally for processing and / or display on a monitor. The handle 12 is not particularly limited and may be any endoscope handle suitable for operation by an operator (such as a doctor).

[0029] The shaft 15 may include at least one lumen (not shown) for accommodating any number of additional devices, such as endoscopes, tools, instruments, cables, etc., for delivering fluids, performing aspiration, etc. The shaft 15 extends between the proximal end connected to the handle 12 and the distal end connected to the distal cap 150. The shaft 15 is not particularly limited and may be any flexible shaft suitable for passing through a body cavity during a surgical procedure.

[0030] Figure 2A and Figure 2BAn embodiment of a distal cap 150 for a medical device, including but not limited to device 10, is shown. The distal cap 150 may be connected to the distal end of the shaft 15 and may include one or more components that communicate (communicate) with the handle 12 and / or the control system or display, for example, via the umbilical cord portion 11. The distal cap 150 includes a body 151, which may include a main channel 161, one or more secondary channels 165 (e.g., a pair of secondary channels 165), one or more third channels 163 (e.g., a pair of third channels 163), and an imager slot 167. The main channel 161 may communicate with the central lumen (i.e., the working channel) of the shaft 15 such that one or more instruments, tools, and accessories may pass through the working channel and the main channel 161 and extend distally from the distal opening of the main channel 161. The diameter of the main channel 161 may be substantially the same as the diameter of the working channel of the shaft 15. For example, the diameter of the main channel 161 may be between about 0.5 mm and about 4.0 mm, and in other examples, between about 1.5 mm and about 2.0 mm. However, the diameter of the main channel 161 is not particularly limited and may be any suitable diameter that can accommodate one or more instruments, tools, and accessories that can be used for various medical procedures (e.g., endoscopy).

[0031] The secondary channels 165 may communicate with corresponding lumens of the shaft 15 and may be used for various purposes. For example, as Figure 2B shown (in Figure 2A which one of the secondary channels 165 is covered by a flank (wing, fin) 182), the secondary channels 165 (and the corresponding lumens of the shaft 15) may each provide a passage for a pair of wires 322 and other additional cables, wires, etc., which may be connected to the lighting device 354. The diameter of the secondary channels 165 is not particularly limited and may be any suitable diameter that can accommodate one or more wires, cables, etc. The shape and / or size of the secondary channels 165 are also not particularly limited and may be cylindrical, for example, as Figure 2A and Figure 2B shown. Each secondary channel 165 may be adjacent to the main channel 161, and each secondary channel 165 may be located on the diametrically opposite side of the main channel 161, as Figure 2B shown.

[0032] The third channels 163 may communicate with corresponding flushing or suction lumens of the shaft 15. The diameter of the third channels 163 is not particularly limited and may be any suitable diameter for flushing or suction purposes. The shape and / or size of the third channels 163 are also not particularly limited and may be cylindrical, for example, as Figure 2A and Figure 2B shown. The position of the third channels 163 within the body 151 is not particularly limited and may be any suitable position for flushing or suction purposes.

[0033] The imager slot 167 is not particularly limited and can be of any shape and size to accommodate any suitable imaging device, such as the camera 351 ( Figure 1 shown in). The imager slot 167 can communicate with a corresponding lumen of the shaft 15, which is configured to accommodate wires, cables, optical fibers, etc. that can be connected to an imager (such as the camera 351). The position of the imager slot 167 is not particularly limited and can be positioned, for example, relative to the main channel 161, the secondary channel 165, and the third channel 163, as Figure 2A and Figure 2B shown.

[0034] The main body 151 and the distal end face 157 of the main body 151 are not provided with a lighting device. Instead, as Figure 2B shown and further discussed below, the lighting device 354 can be connected to different parts of the distal cap 150, such as the wing portion 182. Given that the lighting device 354 is connected to the wing portion 182 and not on the distal end face 157, the wing portion 182 can provide additional surface area on the distal end face 157 to accommodate additional openings / channels, a larger imager, and / or a larger main channel 161 (and working channel) compared to a shaft that also has a lighting device on the distal face.

[0035] The main body 151 can be defined by a proximal portion 153 and a distal portion 155. As Figure 2A and Figure 2B shown, the diameter of the proximal portion 153 can be smaller than the diameter of the distal portion 155, but the present disclosure is not limited thereto. The proximal portion 153 can be covered by the distal portion of the conduit / tube of the shaft 15 such that the distal end of the conduit can be flush with the proximal surface of the distal portion 155 (e.g., at the transition between the proximal portion 153 and the distal portion 155 of the main body 151). The manner in which the proximal portion 153 adheres to the conduit of the shaft 15 is not particularly limited and can include using an adhesive, etc. The diameter of the distal portion 155 can be substantially the same as the outer diameter of the conduit of the shaft 15, but the present disclosure is not necessarily limited thereto.

[0036] The distal portion 155 includes a distal end face 157, which houses various openings related to each of the above channels 161, 163, 165, and the imager slot 167. As Figure 2B shown, the distal end face 157 can be layered such that a first portion 1572 of the distal end face 157 protrudes or extends distally relative to a second portion 1574 of the distal end face 157. Additionally, the first portion 1572 of the distal end face 157 can protrude at least partially in a dome shape, thereby defining a partially circular surface. However, the distal end face 157 is not necessarily limited to this configuration, and in some examples, its entire surface can be flat and / or have a uniform degree of protrusion. The second portion 1574 can be flat, but is also not necessarily limited to this configuration.

[0037] The distal portion 155 may also include a pair of wings 182, for example, pivotally connected to the second portion 1574. The wings 182 may be semi-circular and convex, so that when the wings 182 are in the closed, retracted position (as Figure 2A shown), the wings 182 and the first portion 1572 of the distal face 157 define an opening 169, which opening 169 may be at least partially aligned with the main channel 161. The size of the opening 169 is not particularly limited and may be any suitable diameter to allow various tools, accessories, instruments (such as guide wires) to pass therethrough, as well as through the main channel 161 and the working channel of the shaft 15. The wings 182 may be made of any suitable material, such as medical-grade plastic, and may also be transparent, but the present disclosure is not limited thereto.

[0038] Each wing 182 includes an outer surface 1823 and an inner surface 1821. A lighting component, such as the lighting device 354, may be connected to the inner surface 1821. The lighting component is not particularly limited and may be any suitable lighting device, including but not limited to light-emitting diodes (LEDs), optical fibers, etc. The connection manner of the lighting device 354 (such as adhesive connection) is not particularly limited and may be connected in any suitable manner. In addition, the connection manner of the lighting device 354 may be such that when the wings 182 are in the open, deployed position (expanded position) ( Figure 2B ), the light emitted by the lighting device 354 is emitted distally, and when the wings 182 are in the retracted position ( Figure 2A ), the light is emitted proximally. Since the wings 182 may be transparent, the light emitted proximally can still illuminate the body cavity to a certain extent through the transparent wings 182. The second portion 1574 may be at least partially reflective to achieve such a lighting effect.

[0039] The wings 182 may be connected to the second portion 1574 by a hinge or a component with similar function, which allows the wings 182 to be converted between the retracted position as Figure 2A shown and the deployed position as Figure 2B shown. In the deployed position, the distal opening of the main channel 161 may be completely exposed. In the retracted position, the distal opening of the main channel 161 may be partially exposed. The conversion between these two configurations may be achieved by any suitable actuator. For example, the control 17 ( Figure 1 shown) may be connected by one or more suitable actuating elements (such as the closing wire 322 and / or the opening wire 324, as Figure 2Bshown) engages with the wing portion 182. The closing lines 322 and the opening lines 324 are not particularly limited and can be, for example, nitinol wires. Each closing line 322 can pass through one of the sub-channels 165, and the distal end of each closing line 322 can be connected to the inner surface 1821 of the wing portion 182. Thus, a pulling force applied to the closing lines 322 (i.e., pulling these lines 322 proximally) can cause the wing portion 182 to transition from the deployed position to the retracted position. In some embodiments, each closing line 322 can be two separate strands, each strand connected to a separate control 17, such that each wing portion 182 can be closed independently of the other. In other embodiments, each closing line 322 can extend from a single drive strand connected to the control 17, or can be connected to a single actuating wire, such that the two wing portions 182 can be closed simultaneously. The distal cap 150 can be configured such that its default state is the retracted position (retracted state) as shown in Figure 2A shown. The retracted position can be maintained by one or more biasing elements. For example, the control 17 and / or another feature of the handle 12 or the distal cap 150 (such as a ratchet and / or a lever) can be configured to hold each closing line 322 (or, in other embodiments, a single drive wire) in a taut, fixed position unless the user actively operates it. Thus, the retracted position can be the default configuration of the distal cap 150.

[0040] Each opening line 324 can extend along the exterior of the distal cap 150 (or through a side channel of the distal cap 150, not shown) and through the conduit of the shaft 15. The distal end of each opening line 324 can be connected to the outer surface 1823 of the wing portion 182. Thus, a pulling force applied to the opening lines 324 (i.e., pulling these lines 324 proximally) can cause the wing portion 182 to transition to the deployed position. In some embodiments, each opening line 324 can be two separate strands, each strand connected to a separate control 17, such that each wing portion 182 can be opened independently of the other. In other embodiments, each opening line 324 can be a single strand from a single actuator connected to the control 17, or can be connected to a single drive wire, such that the two wing portions 182 can be opened simultaneously. The deployed position can also be maintained by one or more biasing elements. For example, the control 17 and / or another feature of the handle 12 or the distal cap 150 (such as a ratchet and / or a lever) can be configured to hold each opening line 324 (or, in other embodiments, a single drive wire) in a taut, fixed position.

[0041] In other embodiments, the distal cap 150 may include only a pair of wires, such as wire 322. These wires may extend from a single drive strand (not shown) connected to an actuator of the control 17. In such an embodiment, the default configuration of the distal cap 150 may be the retracted position, and the single drive wire may be held in the default position by any suitable biasing / locking structure. Starting from the default position, the single drive wire may be translated distally by a first force applied by the actuator, causing the wire 322 to extend against the wing 182 and causing the distal cap 150 to transition to the deployed position. The single drive wire may also be translated proximally back to its default position by a second force applied by the actuator, causing the wire 322 and the wing 182 to retract and causing the distal cap 150 to transition to the retracted position. Alternatively, the above biasing structure (or a different biasing structure), such as a spring, may return the single drive wire to its default position, causing the distal cap 150 to return to the retracted position.

[0042] Reference Figure 1 , Figure 2A and Figure 2B , the following further discusses an example of the use of the medical device 10. The user may insert the distal end of the shaft of the mother scope (such as an endoscope) into the subject's body through a natural orifice (such as the oral cavity or anus) and pass through the subject's curved natural body cavity (such as the esophagus, stomach, colon, etc.) towards the intended target site. Then, the user may deliver a guide wire through the channel of the shaft of the mother scope to a position adjacent to or aligned with the intended target site. Next, the user may pass the proximal end of the guide wire through the opening 169 of the distal cap 150 in the retracted position and deliver the distal end of the shaft 15 of the device 10 over the guide wire and through the channel of the shaft of the mother scope. Once the distal end of the shaft 15 is delivered to the intended target site via the guide wire, the user may actuate the control 17 to cause the distal cap 150 to transition from the retracted position ( Figure 2A ) to the deployed position ( Figure 2B)。The user can hold the distal cap 150 in the deployed position by a locking mechanism actuatable by the control 17. Then, the user can activate the lighting device 354 in any suitable manner to emit light distally. Next, the user can withdraw the guide wire from the working channel. The user can irrigate the target site through an actuator or control on the handle 12 or a separate control device. The user can image the intended target site through the camera 351, which can be controlled by another actuator or control on the handle 12 or a separate control device. The user can also introduce additional tools or instruments through the working channel of the shaft 15. Before retracting the distal end of the shaft 15 of the device 10 from the subject's body, or before deflecting the axis of the deflecting mother mirror to image / treat the target site at different positions / directions, the user can also actuate the control 17 to convert the distal cap 150 from the deployed position to the retracted position. Alternatively, the distal cap 150 can be biased towards the retracted position, and the user can allow the distal cap 150 to return to its biased retracted position. The user can actuate the control 17 again for any reason to deploy the wings 182 and convert the distal cap 150 to the deployed position.

[0043] Figures 3A - 3C An embodiment of another medical device 20 according to aspects of the present disclosure and a distal cap 250 connected to the distal portion of the shaft 25 is shown. Like reference numerals refer to like parts. The distal cap 250 includes a body 251, and the body 251 includes an outer cylinder 253, and the outer cylinder 253 can wrap or otherwise surround at least a portion of the rotatable inner cylinder 255. The outer cylinder 253 and the inner cylinder 255 thus form a binocular overlapping structure, and a pair of wings 282 connected to the body.

[0044] The outer cylinder 253 includes a lumen (not shown, see Figure 3B ) extending between its proximal and distal portions. This lumen houses and at least partially wraps the inner cylinder 255. The size and / or shape of the lumen is not particularly limited, and its diameter can allow the inner cylinder 255 to rotate about the central longitudinal axis. The proximal end is not particularly limited and can be any suitable end configured to be flush with and connected to the distal end of the catheter / tube of the shaft 25 of the device 20 and can also house at least a portion of the inner cylinder 255. The distal end is not particularly limited and can include a distal opening having a diameter substantially the same as the outer diameter of the inner cylinder 255. The size of the outer cylinder 253 is not particularly limited. In some examples, the diameter of the outer cylinder 253 can be substantially the same as the outer diameter of the shaft 25. In addition, the material of the outer cylinder 253 is not particularly limited and can be any suitable flexible, biocompatible plastic.

[0045] The outer cylinder 253 includes a first groove 2532 and a second groove 2534. As Figure 3A and Figure 3BAs shown, slots 2532, 2534 extend around a partial circumference of outer tube 253. The dimensions of slots 2532, 2534 are not particularly limited and can be any suitable width to accommodate deployable wings 282. Additionally, slots 2532, 2534 can have any suitable depth such that when wings 282 are retracted and distal cap 250 is in the retracted position, the outer diameter of body 251 is uniform or substantially uniform along its entire length. Slots 2532, 2534 are spaced apart from each other along the length of outer tube 253. Slots 2532, 2534 can also be staggered. For example, slot 2532 can extend around a first portion of the circumference of outer tube 253 and slot 2534 can extend around a second portion of the circumference of outer tube 253. Although the first portion and the second portion can overlap on the circumference of outer tube 253, the first portion and the second portion do not span the same circumferential portion of outer tube 253. This staggering can enable wings 282 to deploy in different radial directions.

[0046] As Figures 3A - 3C As shown, inner tube 255 includes a lumen extending between a proximal end and a distal end. The diameter of the lumen of inner tube 255 is not particularly limited and can be a diameter capable of accommodating instruments, tools, and accessories used in various medical procedures (such as endoscopy). The proximal end is not particularly limited and can be any suitable end configured to connect to or engage with the distal end of a catheter / tube of shaft 25 of device 20. The distal end is also not particularly limited and can include a distal opening 2552. Thus, distal opening 2552 of inner tube 255 and the lumen of inner tube 255 can define a main passage 2554 extending between the proximal and distal ends of body 251 of distal cap 250. Main passage 2554 can communicate with the working passage of shaft 25 such that instruments, tools, and accessories can pass through the working passage of shaft 25 and main passage 2554 of distal cap 250 and extend distally from distal opening 2552. The diameter of main passage 2554 is not particularly limited and can be any suitable diameter capable of accommodating instruments, tools, and accessories used in various medical procedures. When wings 282 are retracted and distal cap 250 is in the retracted position, the alignment between main passage 2554 and the working passage of shaft 25 can be maintained. Additionally, when wings 282 are deployed and distal cap 250 is in the deployed position, wings 282 do not interfere with the distal delivery of instruments, tools, and / or accessories. The diameter of main passage 2554 can be substantially the same as the diameter of the working passage of shaft 25. For example, the diameter of main passage 2554 can be between about 0.5 millimeters and about 4.0 millimeters, and in other examples, can be between about 1.5 millimeters and about 2.0 millimeters. However, the diameter of main passage 2554 is not particularly limited and can be any suitable diameter capable of accommodating one or more instruments, tools, and accessories that can be used in various medical procedures (such as endoscopy).

[0047] The inner cylinder 255 further includes actuation elements (not shown), such as a rotating wire, a gear, a knob, etc., which are configured to rotate the inner cylinder 255 when actuated by an actuator (such as the control 17) on the handle 12, while the outer cylinder 253 remains stationary. Thus, the actuation elements can be engaged with and extend between the inner cylinder 255 and the control 17 in any suitable manner, such as deploying and / or retracting one or more wings 282 relative to the body 251 of the distal cap 250. Another feature of the control 17 and / or the handle 12 (such as a ratchet and a rotating knob) can be configured to lock / hold the distal cap 250 in the deployed position or the retracted position.

[0048] The inner cylinder 255 includes a first slot 2556 and a second slot 2558. The slots 2556, 2558 extend around a partial circumference of the inner cylinder 255. The dimensions of the slots 2556, 2558 are not particularly limited and can be of any suitable width to accommodate the deployable wings 282. Thus, the slots 2532, 2534 of the outer cylinder 253 and the slots 2556, 2558 of the inner cylinder 255 can overlap. The slots 2556, 2558 are also spaced apart from each other along the length of the inner cylinder 255, and the slots 2556, 2558 are also staggered from each other to be consistent with the staggered slots 2532, 2534 of the outer cylinder 253. For example, the slot 2556 can extend around a first portion of the circumference of the inner cylinder 255, and the slot 2558 can extend around a second portion of the circumference of the inner cylinder 255. Although the first portion and the second portion can overlap on the circumference of the inner cylinder 255, the first portion and the second portion do not span the same circumferential portion of the inner cylinder 255. The inner cylinder 255 is not particularly limited and can be formed of a flexible but torque-transmitting material, such as a nitinol tube or a hollow drive cable.

[0049] The wings 282 are respectively mounted in the slots 2532, 2556 and the slots 2534, 2558, and the wings 282 are configured to deploy and retract from the above slots, which will be discussed in further detail below. Although Figures 3A - 3C two wings 282 are shown, the number of wings is not limited thereto and can vary from one wing to more than two wings.

[0050] Each wing 282 includes a first portion 2822 and a second portion 2824. When the wing 282 is in the retracted position, the first portion 2822 can be configured to be mounted in one of the slots 2556, 2558 of the inner cylinder 255 and the corresponding slot of the outer cylinder 253. In some examples, the first portion 2822 can be partially cylindrical, but the present disclosure is not limited thereto. The first portion 2822 can include a first slot 2821. The first slot 2821 is not particularly limited and can be of any shape and size to accommodate and fix any suitable imaging device, such as a camera 351 ( Figure 1) When the wing portion 282 is in the retracted position, the second portion 2824 can also be configured to be installed in one of the slots 2556, 2558 of the inner cylinder 255 and the corresponding slot of the outer cylinder 253. In some examples, the second portion 2824 can be partially cylindrical, but the present disclosure is not limited thereto. The second portion 2824 can include a second slot 2823. The second slot 2823 is not particularly limited and can be of any shape and size to accommodate and fix any suitable lighting component, such as one or more lighting devices 354( Figure 2B as shown). The cables extending from the camera and the lighting components can pass through the outer cylinder 253, and the outer cylinder 253 can also include additional lumens for accommodating and wrapping these cables.

[0051] The first portion 2822 and the second portion 2824 each include a first end 2826, 2828 and a second end (not shown). The first ends 2826 of the first portion 2822 and 2828 of the second portion 2824 can each have features forming a hinge such that the first end 2826 and the first end 2828 can be joined to each other by a hinge relationship. The second end of the first portion 2822 can also be joined to the inner surface of the outer cylinder 253 defining the slots 2532, 2534, so that the first portion 2822 can be hingedly joined relative to the outer cylinder 253. The second end of the second portion 2824 can also be joined to the inner surface of the inner cylinder 255 defining the slots 2556, 2558, such that the second portion 2824 can be hingedly joined relative to the inner cylinder 255. Therefore, in view of such a configuration, by rotating the inner cylinder 255 by an actuator (such as the control 17 of the handle 12), the deployment and retraction of the wing portion 282 can be controlled. When viewed from the proximal end of the cap 250, as the inner cylinder 255 rotates in a first direction (e.g., clockwise), the first portion 2822 and the second portion 2824 can be hinged towards each other and hinged away from the inner cylinder 255 (the first portion 2822 and the second portion 2824 are hingedly close to each other and hingedly away from the inner cylinder 255), thereby transitioning to the open, deployed position as shown in Figure 3B . Alternatively, when viewed from the proximal end of the cap 250, as the inner cylinder 255 rotates in a second direction (e.g., counterclockwise), the first portion 2822 and the second portion 2824 are hinged away from each other and hinged towards the inner cylinder 255, thereby transitioning to the closed, retracted configuration as shown in Figure 3A . In other embodiments, when viewed from the proximal end of the cap 250, the first direction can be counterclockwise and the second direction can be clockwise. The distal cap 250 can default to the closed, retracted configuration. Therefore, the device 20 can be used in a manner similar to the above-described device 10.

[0052] Accordingly, the illumination device and the imaging device can be connected to different parts of the distal cap 250, such as the wings 282, rather than the distal face of the distal cap 250, which provides additional surface area at the distal face to accommodate a larger main channel 2554 (and working channel) and / or additional channels or features (not shown) as compared to a device that also has the illumination device and the imaging device disposed at the distal face. Additionally, in view of the illumination device and the imaging device being connectable to the wings 282, the illumination device and / or the imaging device can also be larger. This can provide stronger illumination and / or better imaging as compared to a device that also has the illumination device and the imaging device disposed at the distal face.

[0053] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices without departing from the scope of the present disclosure. By considering this specification and practicing the invention disclosed herein, other embodiments of the present disclosure will be apparent to those skilled in the art. It is intended that this specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical device, comprising: a handle containing an actuator; a shaft extending distally from the handle, wherein the shaft includes a lumen; and a distal cap, wherein the distal cap includes: a body containing a first channel that communicates with a distal portion of the lumen; a distal face containing an opening, wherein the opening is a distal opening of the channel; and a deployable portion connected to the body, wherein the deployable portion is configured to deploy radially outward from the body and retract radially inward toward the body from a deployed position, and wherein the deployable portion includes at least one lighting device.

2. The medical device according to claim 1, wherein the actuator engages the deployable portion such that the actuator is configured to control the deployment and retraction of the deployable portion.

3. The medical device according to claim 2 or 3, wherein the deployable portion is biased toward a retracted position.

4. The medical device according to claim 3, wherein in the retracted position, the outer diameter of the distal cap is substantially the same as the outer diameter of the remainder of the shaft.

5. The medical device according to any one of the preceding claims, wherein the distal face does not include any lighting devices.

6. The medical device according to any one of the preceding claims, wherein the diameter of the opening is about 1.5 millimeters to 2.0 millimeters.

7. The medical device according to any one of the preceding claims, wherein the deployable portion is connected to the body by a hinge.

8. The medical device according to any one of the preceding claims, wherein the deployable portion is connected to the distal end of the body such that in the retracted position, the deployable portion covers at least a portion of the opening, and in the deployed position, the deployable portion exposes all of the opening.

9. The medical device according to claim 8, wherein the deployable portion is semi-circular such that in the retracted position, a portion of the opening remains exposed.

10. The medical device according to claim 8 or 9, wherein the deployable portion is transparent.

11. The medical device according to any one of claims 8 - 10, wherein the actuator and the deployable portion are engaged with each other by an opening line and a closing line, wherein a force applied to the opening line is configured to deploy the deployable portion, and wherein a force applied to the closing line is configured to retract the deployable portion.

12. The medical device according to claim 7, wherein the body further includes an outer cylinder and an inner cylinder, wherein the outer cylinder surrounds at least a portion of the inner cylinder, and the inner cylinder is rotatable about a central longitudinal axis of the body.

13. The medical device according to claim 12, wherein the outer cylinder includes a first groove, and the inner cylinder includes a second groove, wherein the first groove and the second groove overlap, and the first groove and the second groove are configured to accommodate the deployable portion in the retracted position.

14. The medical device according to claim 13, wherein the deployable portion is connected to the outer cylinder by a hinge and is connected to the inner cylinder by a hinge, and a rotational force in a first direction applied to the rotatable inner cylinder is configured to deploy the deployable portion.

15. The medical device according to claim 14, wherein a rotational force in a second direction applied to the rotatable inner cylinder is configured to retract the deployable portion into the first groove and the second groove.