Medical devices and related methods

Abstract

A medical device comprising: a handle including an actuator; a shaft extending distally from the handle, the shaft including a lumen; and a distal cap. The distal cap includes a body including a first channel, the first channel communicating with a distal portion of the lumen, a distal surface including an opening, the opening being a distal opening of the channel, an expandable portion coupled to the body and configured to radially expand outward from the body from an expanded position and radially retract into the body. The expandable portion includes at least one illumination device.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical devices and related methods of use. More particularly, at least some embodiments of the present disclosure relate to medical devices, such as scopes, that include an expandable distal end to allow for a larger working channel and / or enhanced illumination, and related methods. [Background technology]

[0002] Medical scopes, such as duodenoscopes, catheters, and the like, often used in endoscopic procedures typically include accessory / working channel(s), irrigation channel(s), suction channel(s), multiple illumination devices, and / or imaging devices. For various reasons, the outer diameter of these scopes may be limited to a certain size, e.g., 3.5 mm, thereby limiting the surface area of the distal face of the scope. Therefore, to accommodate various features disposed on the distal face of the scope, the diameter or width of these features, e.g., the diameter of the working channel and the size of the illumination device, are necessarily limited. As a result, when operating these medical scopes, physicians may be limited to certain accessories and / or tools that are small enough to be inserted into the working channel. Similarly, physicians may be limited to smaller and / or less powerful illumination devices than larger illumination devices. Summary of the Invention

[0003] Examples of the present disclosure relate to, among other things, medical devices and methods. Each embodiment disclosed by this disclosure may include one or more of the features described in connection with any of the other disclosed embodiments.

[0004] According to one aspect, the medical device may include a handle including an actuator and a shaft extending distally from the handle, the shaft including a lumen, and the medical device may further include a distal cap. The distal cap includes a body, the body including a first channel, the first channel communicating with a distal portion of the lumen. The medical device includes a distal surface, the distal surface including an opening, the opening being a distal opening of the channel. The medical device includes an expandable portion, the expandable portion coupled to the body. The expandable portion is configured to radially expand from an expanded position outward from the body and to radially retract into the body, and the expandable portion further includes at least one lighting device.

[0005] According to another aspect, an actuator can be engaged with the expandable portion such that the actuator is configured to control the expansion and retraction of the expandable portion. According to another aspect, the expandable portion can be biased to a retracted position. According to another aspect, in the retracted position, the outer diameter of the distal cap can be approximately equal to the outer diameter of the remainder of the shaft.

[0006] According to another aspect, the distal face may not include an illumination device. According to another embodiment, the diameter of the opening in the distal face can be from about 1.5 mm to 2.0 mm.

[0007] According to another aspect, the expandable portion can be biased to a retracted position. The expandable portion can be coupled to a distal end of the body such that in the retracted position, the expandable portion covers at least a portion of the opening and in the expanded position, the entire opening is exposed. The expandable portion can be semi-annular so that a portion of the opening remains exposed in the retracted position. The expandable portion can be biased to the retracted position. The actuator and the expandable portion can engage with each other via an opening wire and a closing wire. A force acting on the opening wire is configured to expand the expandable portion, and a force acting on the closing wire is configured to retract the expandable portion. The body can further include an outer cylinder and an inner cylinder. The outer cylinder surrounds at least a portion of the inner cylinder, and the inner cylinder is rotatable about a central axis of the body. The outer cylinder can include a first slot. The inner cylinder can include a second slot. The first slot and the second slot overlap, and the first slot and the second slot are configured to receive the expandable portion in the retracted position. The expandable portion can be hingedly coupled to the outer cylinder and hingedly coupled to the inner cylinder, a rotational force acting on the rotatable inner cylinder in a first direction configured to expand the expandable portion, and a rotational force acting on the rotatable inner cylinder in a second direction configured to retract the expandable portion into the first slot and the second slot.

[0008] According to another aspect, a medical device end cap can include a body including a channel and a distal face including an opening. The opening is a distal opening of the channel. The medical device end cap can include a first wing coupled to the body and a second wing coupled to the body. The first wing and the second wing are each configured to extend radially outward from the body to an extended position and retract radially inward from the extended position, and each of the first wing and the second wing includes at least one illumination device.

[0009] According to another aspect, the first wing can be configured to expand radially outward in a first radial direction, and the second wing can be configured to expand radially outward in a second radial direction, the first radial direction and the second radial direction being different.

[0010] According to another aspect, the distal face may not include an illumination device. According to another aspect, at least one of the first wing and the second wing may further include an imaging device.

[0011] According to another aspect, a method of using a medical device includes a handle including an actuator, a shaft, and a distal cap including an expandable portion controllable by the actuator. The expandable 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 lumen, positioning the distal end of the shaft and the distal cap near a target site, activating the actuator to control the expandable portion of the distal cap to expand the expandable portion, and activating the at least one illumination device. [Brief explanation of the drawings]

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] 1 is a perspective view of a medical device according to one embodiment. [Figure 2A] 2 is a perspective view of the distal face of the medical device according to FIG. 1. [Figure 2B] 2B is a perspective view of the distal face of the medical device according to FIG. 1, shown in a different configuration than in FIG. 2A. [Figure 3A] FIG. 10 is a perspective view of a distal face of a medical device according to another embodiment. [Figure 3B] FIG. 10 is a perspective view of a distal face of a medical device according to another embodiment. [Figure 3C] FIG. 10 is a perspective view of a distal face of a medical device according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0013] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers are used in the drawings to refer to the same or like parts. The term "distal" refers to the portion of the device that is furthest from the user when introducing the device into a subject (e.g., a patient). Conversely, the term "proximal" refers to the portion of the device that is closest to the user when placing the device in a patient.

[0014] Both the general description above and the detailed description below are exemplary and explanatory and are not limited to the features set forth in the claims. As used herein, "comprises / consists," "comprising / consisting of," or any other variation thereof, is intended to imply a non-exclusive inclusion. That is, a process, method, article, or apparatus consisting of a list of elements does not include only those elements, but may include other elements not expressly listed or elements inherent in such process, method, article, or apparatus. In this disclosure, relative terms such as "about," "generally," "generally," and "approximately" are used to indicate a possible variation of ±10% in a stated numerical value or range.

[0015] Embodiments of the present disclosure may solve these problems or one or more limitations of the art. However, the scope of the disclosure is defined by the appended claims, not by the ability to solve a particular problem. The present disclosure, in certain embodiments, relates to medical devices, including any scope (e.g., bronchoscope, duodenoscope, endoscope, colonoscope, ureteroscope, cholangioscope, etc.). These scopes include a handle and a shaft, e.g., a catheter, extending distally from the handle. As described further below, the shaft may include a distal cap that includes one or more "deployable" features. For example, features configured to open and close, features configured to expand radially outward, and features configured to retract radially inward. In some embodiments, the deployable features do not increase the cross-sectional diameter (or affect other dimensions) of the distal cap or distal portion of the shaft until deployed. This allows the shaft to have the same diameter during insertion / delivery. Each of the deployable features may include an illumination feature, an imaging feature, and / or additional scope features. Such a distal cap increases the surface area of the distal face relative to a scope that includes illumination, imaging, and / or other features located on the distal face of the scope.

[0016] 1 illustrates a medical device 10 (device 10), such as a scope, according to one embodiment. Device 10 includes a flexible shaft (e.g., a catheter) 15 coupled to a distal cap 150 and a handle 12 coupled to the proximal end of shaft 15. As described below, distal cap 150 may include one or more deployable / retractable features.

[0017] Handle 12 may be coupled to umbilicus 11, and handle 12 may include actuators 14, including, for example, one or more knobs. Umbilicus 11 extends proximally relative to handle 12. Umbilicus 11 may be coupled to suitable sources of, for example, fluid, suction, electricity, etc., a control system, a display, etc.

[0018] The actuator 14 may be coupled to an upper (proximal) portion of the handle 12 and may be configured to control movement of at least some of the articulations of the flexible shaft 15 and / or an articulation joint located at the distal end of the flexible shaft 15 in multiple directions. The actuator 14 may be, for example, one or more rotatable knobs, each of which rotates about its axis to push / pull an actuation element, such as a steering wire (not shown). An actuation element, such as a medically compatible cable or wire (e.g., made of 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, a user may operate the actuation element independently of the handle 12, for example, via a separate control device. The distal end of the actuation element may pass through the flexible shaft 15 and terminate in an articulation joint and / or distal cap 150 of the flexible shaft 15. For example, one or more actuation elements may be coupled to the articulation joint. Actuation of the actuation element may cause the articulation joint and / or the distal end of the flexible shaft 15 to move in multiple directions.

[0019] The handle 12 may further include one or more additional controls 17, such as buttons. While not shown, the additional controls 17 may additionally or alternatively include one or more levers, rotating mechanisms, etc., which may be configured to drive the deployment and / or retraction of a deployable mechanism of the distal cap 150, as described in further detail below. For example, the additional controls 17 may be actuated by depressing a button (shown in FIG. 1 ) to extend a deployable mechanism from a retracted state to a deployed state and to return the deployable mechanism from the extended state to the retracted state. In another embodiment in which the additional controls 17 include a lever and / or rotating mechanism, the lever or rotating mechanism may be configured to rotate in a first direction to deploy a deployable mechanism from a retracted state and to rotate in a second direction to return a deployable mechanism from a deployed state to the retracted state. The additional controls 17 may engage the deployable mechanism of the distal cap 150 via an additional actuating element, such as a push / pull actuating element, a rotating element, or the like, extending between the additional controls 17 and the distal cap 150. The location of additional controls 17 along handle 12 and relative to actuator 14 is not particularly limited and may be ergonomically positioned. For example, additional controls 17 may be located along a proximal portion of handle 12 configured to accommodate operation by a user's finger, such as an index finger.

[0020] The handle 12 may also include one or more ports 13, 18 for introducing and / or removing tools, fluids, or other substances from a patient. For example, the port 13 may be used to introduce an accessory device (not shown). The accessory device may be any tool or device suitable for medical purposes. The port 13 may be in fluid communication with a working channel, such as a lumen (not shown) of the shaft 15. Although not shown, the port 13 may be a Y-port. The port 13 may accept any suitable accessory device (e.g., a snare, net, basket, forceps, grasper, scissors, clips, stapler, needle, knife, electrode, electrocoagulation loop, etc.). The accessory device may extend distally throughout the shaft 15 toward the distal end of the device 10. The port 18 may connect to the umbilicus 11, for example, to introduce fluids, apply suction, and / or connect wiring for electronic components.

[0021] Additionally, one or more electrical cables (not shown) may extend from the proximal end of device 10 (e.g., from handle 12 and / or umbilicus 11), through flexible shaft 15, and to distal cap 150. The one or more electrical cables may provide power and / or electrical signals to imaging devices, illumination devices, and / or other electrical devices in distal cap 150, and may propagate image signals from one or more imaging devices in distal cap 150 proximally for processing and / or display on a display. Handle 12 is not limited to, and may be, any suitable scope handle configured for manipulation by an operator, such as a physician.

[0022] Shaft 15 may include one or more lumens (not shown) for receiving any number of additional devices, such as a scope, tools, instruments, cables, etc., for conveying fluids, applying suction, etc. Shaft 15 may extend between a proximal end coupled to handle 12 and a distal end coupled to distal cap 150. Shaft 15 is not limited to, and may be any suitable flexible shaft configured to pass through a body lumen during a procedure.

[0023] 2A and 2B illustrate an embodiment of a distal cap 150 for a medical device, including but not limited to device 10. Distal cap 150 may couple to the distal end of shaft 15 and may include one or more components that communicate with handle 12 and / or a control system or display, for example, via umbilicus 11. Distal cap 150 may include body 151. Body 151 may include a primary channel 161, one or more secondary channels 165 (e.g., a pair of secondary channels 165), one or more tertiary channels 163 (e.g., a pair of tertiary channels 163), and an imaging socket 167. Primary channel 161 may communicate with a central lumen, i.e., a working channel, of shaft 15. Thus, one or more instruments, tools, and accessories may pass through the working channel and primary channel 161 and extend distally from a distal opening of primary channel 161. The diameter of primary channel 161 may be approximately the same as the diameter of the working channel of shaft 15. For example, the diameter of primary channel 161 may be between approximately 0.5 mm and approximately 4.0 mm. In other examples, the diameter may be between approximately 1.5 mm and approximately 2.0 mm. However, the diameter of primary channel 161 is not particularly limited and may be any suitable diameter capable of accommodating one or more instruments, tools, and accessories that may be used in various medical procedures, such as endoscopy.

[0024] The secondary channels 165 may communicate with each lumen of the shaft 15 and may be used for various purposes. For example, as shown in FIG. 2B (one of the secondary channels 165 is covered by the wing 182 shown in FIG. 2A ), each of the secondary channels 165 (and each lumen of the shaft 15) may provide a passage for one of the pair of wires 322 and any other additional cables, wires, etc. that may be connected to the lighting device 354. The diameter of the secondary channels 165 is not particularly limited and may be any appropriate 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 shown in FIGS. 2A and 2B . Each of the secondary channels 165 may be adjacent to the primary channel 161. Furthermore, each of the secondary channels 165 may be located on diametrically opposite sides of the primary channel 161, as shown in FIG. 2B .

[0025] The tertiary channel 163 may communicate with each of the irrigation or suction lumens of the shaft 15. The diameter of the tertiary channel 163 is not particularly limited and may be any diameter suitable for irrigation or suction purposes. The shape and / or size of the tertiary channel 163 is not particularly limited and may be, for example, cylindrical, as shown in FIGS. 2A and 2B. The location of the tertiary channel 163 within the body 151 is not particularly limited and may be any location suitable for irrigation or suction purposes.

[0026] Imaging socket 167 is not particularly limited and may be of any shape and size to accommodate any suitable imaging device, such as camera 351 (shown in FIG. 1). Imaging socket 167 may be in communication with each lumen of shaft 15 configured to accommodate wires, cables, fibers, etc. that may be coupled to an imaging device, such as camera 351. The location of imaging socket 167 is not particularly limited and may be located relative to primary channel 161, secondary channel 165, and tertiary channel 163, for example, as shown in FIGS. 2A and 2B.

[0027] Body 151 and distal face 157 of body 151 do not house an illumination mechanism. Rather, as shown in FIG. 2B and described below, illumination device 354 may be coupled to a separate side of distal cap 150, such as wings 182. Assuming illumination device 354 is coupled to wings 182 and not present on distal face 157, wings 182 may provide additional surface area on distal face 157 to accommodate additional openings / channels, a larger imaging device, and / or a larger primary channel 161 (as well as a working channel) compared to a shaft that houses an illumination mechanism on distal face 157.

[0028] The main body 151 may be defined by a proximal portion 153 and a distal portion 155. As shown in FIGS. 2A and 2B , the proximal portion 153 may have a smaller diameter than the distal portion 155, although the present disclosure is not limited thereto. For example, the proximal portion 153 may be covered by the distal portion of the catheter / tube of the shaft 15 at the transition between the proximal portion 153 and the distal portion 155 of the main body 151, such that the distal end of the catheter may be in surface contact with the proximal surface of the distal portion 155. The method by which the proximal portion 153 is adhered to the catheter of the shaft 15 is not particularly limited and may include the use of an adhesive or the like. The distal portion 155 may have a diameter generally the same as the outer diameter of the catheter of the shaft 15, although the present disclosure is not necessarily limited thereto.

[0029] The distal portion 155 includes a distal surface 157, which may include various openings associated with the primary channel 161, the tertiary channel 163, the secondary channel 165, and the imaging socket 167. As shown in FIG. 2B , the distal surface 157 may be stepped such that a first portion 1572 of the distal surface 157 may protrude or extend distally relative to a second portion 1574 of the distal surface 157. Furthermore, the first portion 1572 of the distal surface 157 may be at least partially domed, thereby defining a partially rounded surface. However, the distal surface 157 is not necessarily limited to such a configuration and may, in some cases, be flat and / or have a uniform degree of protrusion across its entire surface. The second portion 1574 may be flat, but is not necessarily limited to such a configuration.

[0030] Distal portion 155 may further include a pair of wings 182 that may be pivotally coupled to second portion 1574, for example. Wings 182 may be semi-circular and convex. This shape allows wings 182 and first portion 1572 of distal surface 157 to form opening 169 that is at least partially aligned with primary channel 161 when wings 182 are in the closed, retracted position, as shown in FIG. 2A . The size of opening 169 is not particularly limited and may be of any suitable diameter to allow various tools, accessories, and instruments, such as guidewires, to extend through the opening, as well as through primary channel 161 and the working channel of shaft 15. Wings 182 may be made of any suitable material, such as medical-grade plastic, and may be transparent, although the disclosure is not limited in this respect.

[0031] Each of the wings 182 may include an outer surface 1823 and an inner surface 1821. An illumination mechanism, such as an illumination device 354, may be coupled to the inner surface 1821. The illumination mechanism may be any suitable illumination device, including, but not limited to, an LED, an optical fiber, or the like. The means by which the illumination device 354 is coupled, such as by adhesive, may be any suitable means. Furthermore, the illumination device 354 may be coupled such that when the wings 182 are in the open, extended position ( FIG. 2B ), the illumination device 354 emits light distally, and when the wings 182 are in the retracted position ( FIG. 2A ), the illumination device 354 emits light proximally. Because the wings 182 may be transparent, light emitted proximally may be able to illuminate the body lumen to some extent through the transparent wings 182. The second portion 1574 may be at least partially reflective to allow such illumination.

[0032] The wings 182 may be coupled to the second portion 1574 via a hinge or similar mechanism. The mechanism may allow the wings 182 to transition between a retracted position, shown in FIG. 2A , and an extended position, shown in FIG. 2B . In the extended position, the entire distal opening of the primary channel 161 may be exposed. In the retracted position, only a portion of the distal opening of the primary channel 161 may be exposed. The transition between the two positions may be actuated via any suitable actuator. For example, the control unit 17 (shown in FIG. 1 ) may act on the wings 182 via one or more suitable actuating elements, such as the closing wire 322 and / or the opening wire 324 shown in FIG. 2B . The closing wire 322 and the opening wire 324 may be, but are not limited to, nitinol wires. Each closing wire 322 may extend through one of the secondary channels 165, and the distal end of each closing wire 322 may be coupled to the inner surface 1821 of the wing 182. In this manner, tension applied to the closure wires 322 (i.e., pulling the wires 322 proximally) can transition the wings 182 from the extended position to the retracted position. In some embodiments, each closure wire 322 is comprised of two independent wire strands, which can be coupled to separate controls 17 so that each wing 182 can close independently of the other. In other embodiments, each closure wire 322 can extend from a single drive wire strand coupled to a single actuator of the control 17, or can be coupled to a single drive wire, so that both wings 182 can close simultaneously. The distal cap 150 can be configured such that the retracted position shown in FIG. 2A is its default state. The retracted position can be maintained via one or more biasing elements. For example, the control 17 and / or another mechanism (e.g., a detent and / or lever) on the handle 12 or distal cap 150 may be configured to maintain each closure wire 322 (or in other embodiments, a single drive wire) in a rigid, retained position unless actively manipulated by the user. In this manner, the retracted position may be the default configuration for the distal cap 150.

[0033] Each opening wire 324 may extend along the exterior of the distal cap 150 (or through a side channel (not shown) in the distal cap 150) and through the catheter of the shaft 15. The distal end of each opening wire 324 may be coupled to the outer surface 1823 of a wing 182. In this manner, applying a pulling force to the opening wire 324 (i.e., pulling the wire 324 proximally) may transition the wings 182 to an extended position. In some embodiments, each opening wire 324 is comprised of two independent wire strands, each of which may be coupled to a separate control 17 so that each wing 182 may be opened independently of the other. In other embodiments, each opening wire 324 may extend from a single wire strand coupled to a single actuator of the control 17 or may be coupled to a single drive wire so that both wings 182 may be opened simultaneously. The extended position may also be maintained via one or more biasing elements. For example, the control section 17 and / or another mechanism (e.g., a detent and / or lever) on the handle 12 or distal cap 150 may be configured to maintain each opening wire 324 (or in other embodiments, a single drive wire) in a securely held position.

[0034] In other embodiments, the distal cap 150 may include only a single pair of wires, such as wire 322. These wires may extend from a single drive wire strand (not shown) that is coupled to an actuator of the control unit 17. In such embodiments, the default configuration of the distal cap 150 may be the retracted position. The single drive wire may be held in the default position by any suitable biasing / locking structure. From the default position, the single drive wire may be moved distally via a first force applied, for example, by an actuator. This may cause the wire 322 to extend against the wings 182, transitioning the distal cap 150 to the extended position. The single drive wire may also be moved proximally toward its default position via a second force applied by the actuator. This may retract the wire 322 and wings 182, transitioning the distal cap 150 to the retracted position. Alternatively, the aforementioned biasing structure (or another biasing structure), such as a spring, may return the single drive wire to its default position. This may return the distal cap 150 to the retracted position.

[0035] An example of a method of using the device 10 is further described below with reference to Figures 1, 2A, and 2B. A user can introduce the distal end of a motherscope shaft, e.g., the distal end of an endoscope, toward a desired target site, for example, through a natural orifice (e.g., the mouth or anus) and further through a tortuous natural body lumen, such as the subject's esophagus, stomach, or colon. The user can then introduce a guidewire through a channel in the motherscope shaft near or toward the desired target site. The user can then pass the proximal end of the guidewire through the opening 169 in the distal cap 150 in the retracted position, and introduce the distal end of the shaft 15 of the device 10 through the channel in the motherscope shaft while covering the guidewire. Once the distal end of shaft 15 has been introduced over the guidewire to the desired target site, the user may actuate control 17 to transition distal cap 150 from the retracted position (FIG. 2A) to the extended position (FIG. 2B). The user may retain distal cap 150 in the extended position with a locking mechanism actuable via control 17. The user may then actuate illumination device 354 via any suitable means, thereby shining light distally. The user may then remove the guidewire from the working channel. The user may irrigate the target site via an actuator or control on handle 12 or another control. The user may image the desired target site via camera 351, which may be controlled via another actuator or control on handle 12 or another control. The user may introduce additional tools or instruments through the working channel of shaft 15. The user may also actuate the control unit 17 to transition the distal cap 150 from the extended position to the retracted position before withdrawing the distal end of the shaft 15 of the device 10 from the subject's body or before deflecting the motherscope shaft to image / treat the target site from a different position / orientation. Alternatively, the distal cap 150 may be biased toward the retracted position, and the user may allow the distal cap 150 to return to the biased retracted position.If the user wishes to do so for any reason, they may again actuate the control 17 to expand the wings 182 and transition the distal cap 150 to the expanded position.

[0036] 3A-3C illustrate another embodiment of a medical device 20 and a distal cap 250 coupled to a distal portion of a shaft 25, according to aspects of the present disclosure. Like reference numerals refer to like parts. The distal cap 250 includes a body 251 with an outer cylinder 253. The outer cylinder 253 may cover or otherwise surround at least a portion of a rotatable inner cylinder 255. In this manner, the outer cylinder 253 and the inner cylinder 255 may form a dual-cylinder structure, and a pair of wings 282 may be coupled to the body.

[0037] The outer cylinder 253 includes a lumen (not shown). The lumen extends between the proximal end and the distal portion of the outer cylinder 253 (FIG. 3B). The lumen can receive and at least partially cover the inner cylinder 255. The size and / or shape of the lumen are not particularly limited and may have a diameter that allows the inner cylinder 255 to rotate about its central axis. The proximal end is not particularly limited and may be any suitable end that can be configured to be attached to or flush with the distal end of the catheter / tube of the shaft 25 of the device 20 and that can accommodate at least a portion of the inner cylinder 255. The distal end is also not limited and may include a distal opening having a diameter approximately equal to the outer diameter of the inner cylinder 255. The dimensions of the outer cylinder 253 are not particularly limited. In some examples, the diameter of the outer cylinder 253 may be approximately equal to the outer diameter of the shaft 25. Furthermore, the material of the outer cylinder 253 is not particularly limited and may be any suitable flexible biocompatible plastic.

[0038] The outer cylinder 253 includes a first slot 2532 and a second slot 2534. As shown in FIGS. 3A and 3B , the slots 2532 and 2534 extend along a portion of the circumference of the outer cylinder 253. The dimensions of the slots 2532 and 2534 are not particularly limited and may have any suitable width capable of accommodating the expandable wings 282. Furthermore, the slots 2532 and 2534 may have any suitable depth such that the outer diameter of the body 251 is consistent or generally consistent along its entire length when the wings 282 are retracted and the distal cap 250 is in the retracted position. The slots 2532 and 2534 are spaced apart from one another along the length of the outer cylinder 253. The slots 2532 and 2534 may be offset from one another. For example, slot 2532 may extend along a first circumferential portion of outer cylinder 253, and slot 2534 may extend along a second circumferential portion of outer cylinder 253. The first and second circumferential portions may overlap around the circumference of outer cylinder 253, but the first and second circumferential portions are not identical across the entire circumference of outer cylinder 253. Such bias may cause wings 282 to expand in different radial directions.

[0039] As shown in FIGS. 3A-3C , the inner cylinder 255 includes a lumen extending between its proximal and distal ends. The diameter of the lumen of the inner cylinder 255 is not particularly limited and may be a diameter capable of accommodating instruments, tools, and accessories that may be used in various medical procedures, such as endoscopy. The proximal end is not particularly limited and may be any suitable end configured to couple or engage with the distal end of a catheter / tube of the shaft 25 of the device 20. The distal end is also not limited and may include a distal opening 2552. Thus, the distal opening 2552 of the inner cylinder 255 and the lumen of the inner cylinder 255 may define a primary channel 2554 extending between the proximal and distal ends of the body 251 of the distal cap 250. The primary channel 2554 may be in communication with the working channel of the shaft 25. Thus, instruments, tools, and accessories may pass through the working channel of shaft 25 and primary channel 2554 of distal cap 250 and extend distally from distal opening 2552. The diameter of primary channel 2554 is not particularly limited and may be any suitable diameter capable of accommodating instruments, tools, and accessories used in various medical procedures, such as endoscopy. While wings 282 are retracted and distal cap 250 is in the retracted position, primary channel 2554 may maintain alignment with the working channel of shaft 25. Furthermore, wings 282 are expanded and do not impede distal introduction of instruments, tools, and / or accessories when distal cap 250 is in the expanded position. The diameter of primary channel 2554 may be approximately the same as the diameter of the working channel of shaft 25. For example, primary channel 2554 may include a diameter ranging from approximately 0.5 mm to approximately 4.0 mm, and in other examples, from approximately 1.5 mm to approximately 2.0 mm, however, the diameter of primary channel 2554 is not particularly limited and may be any suitable diameter capable of accommodating one or more instruments, tools, and accessories that may be used in various medical procedures, such as endoscopy.

[0040] The inner cylinder 255 further includes an actuation element (not shown), such as a rotating wire, gear, knob, etc., that, when actuated via an actuator on the handle 12, such as the control 17, rotates the inner cylinder 255 while keeping the outer cylinder 253 stationary. As such, the actuation element may engage and extend both the inner cylinder 255 and the control 17 via any suitable means. For example, the actuation element may extend and / or retract one or more wings 282 relative to the body 251 of the distal cap 250. Another feature on the control 17 and / or handle 12 (e.g., a detent and rotation knob) may be configured to lock / retain the distal cap 250 in the extended or retracted position.

[0041] Inner cylinder 255 includes first slot 2556 and second slot 2558. Slots 2556 and 2558 extend along a portion of the circumference of outer cylinder 255. The dimensions of slots 2556 and 2558 are not particularly limited and may have any appropriate width capable of accommodating expandable wings 282. As such, slots 2532 and 2534 of outer cylinder 253 and slots 2556 and 2558 of inner cylinder 255 may overlap. Slots 2556 and 2558 are also spaced apart from one another along the length of inner cylinder 255, and slots 2556 and 2558 are also offset from one another to correspond to offset slots 2532 and 2534 of outer cylinder 253. For example, slot 2556 may extend along a first circumferential portion of inner cylinder 255, and slot 2558 may extend along a second circumferential portion of inner cylinder 255. The first circumferential portion and the second circumferential portion may overlap around the circumference of inner cylinder 255, but the first circumferential portion and the second circumferential portion are not identical along the entire circumference of inner cylinder 255. Inner cylinder 255 is not particularly limited and may be formed from a flexible material capable of transmitting torque, such as a nitinol tube or a hollow drive cable.

[0042] Wings 282 fit within slots 2532 and 2556, and slots 2534 and 2558, respectively, and are configured to extend and retract from the slots, as described in more detail below. While two wings 282 are shown in Figures 3A-3C, the number of wings is not limited thereto and can range from one wing to two or more wings.

[0043] Each wing 282 includes a first portion 2822 and a second portion 2824. The first portion 2822 may be configured to fit within one of the slots 2556 or 2558 of the inner cylinder 255 and a corresponding slot of the outer cylinder 253 when the wing 282 is in the retracted position. In some embodiments, the first portion 2822 may be partially cylindrical, although the disclosure is not limited thereto. The first portion 2822 may include a first socket 2821. The first socket 2821 is not particularly limited and may be any shape and size capable of receiving and holding any suitable imaging device, such as, for example, a camera 351 (FIG. 1). The second portion 2824 may also be configured to fit within one of the slots 2556 or 2558 of the inner cylinder 255 and a corresponding slot of the outer cylinder 253 when the wing 282 is in the retracted position. In some embodiments, the second portion 2824 may be partially cylindrical, although the disclosure is not limited thereto. The second portion 2824 may include a second socket 2823. The second socket 2823 is not particularly limited and may be any shape and size that can receive and hold any suitable lighting device, such as, for example, one or more lighting devices 354 (shown in FIG. 2B ). Cables extending from the camera and lighting mechanism may extend through the outer cylinder 253. The outer cylinder 253 may further include additional lumen(s) configured to receive and cover these cables.

[0044] Each of first portion 2822 and second portion 2824 includes a first end 2826, 2828 and a second end (not shown). First end 2826 of first portion 2822 and first end 2828 of second portion 2824 may each have a hinge-forming mechanism such that first end 2826 and first end 2828 may be hingedly engaged with one another. The second end of first portion 2822 may also engage with an inner surface of outer cylinder 253 defining slots 2532 and 2534 such that first portion 2822 may be hingedly coupled to outer cylinder 253. The second end of second portion 2824 may also engage with an inner surface of inner cylinder 255 defining slots 2556 and 2558 such that second portion 2824 may be hingedly coupled to inner cylinder 255. Thus, based on this configuration, rotation of the inner cylinder 255, e.g., via an actuator such as the control 17 of the handle 12, can control the extension and retraction of the wings 282. When the inner cylinder 255 is rotated in a first direction, e.g., clockwise as viewed from the proximal end of the distal cap 250, the first portion 2822 and the second portion 2824 can pivot toward each other and away from the inner cylinder 255, thereby transitioning to the open, extended position shown in FIG. 3B. On the other hand, when the inner cylinder 255 is rotated in a second direction, e.g., counterclockwise as viewed from the proximal end of the distal cap 250, the first portion 2822 and the second portion 2824 can pivot away from each other and toward the inner cylinder 255, thereby transitioning to the closed, retracted configuration shown in FIG. 3A. In other embodiments, the first direction can be counterclockwise as viewed from the proximal end of the distal cap 250, and the second direction can be clockwise as viewed from the proximal end of the distal cap 250. Distal cap 250 defaults to a closed, stored configuration. Device 20 can be used in a manner similar to device 10, as described above.

[0045] In this manner, the illumination and imaging devices may be coupled to another portion of the distal cap 250, such as the wings 282, other than the distal face of the distal cap 250. This provides additional surface area on the distal face to accommodate a larger primary channel 2554 (and working channel) and / or additional channels or features (not shown) compared to devices that place the illumination and imaging devices on the distal face. Furthermore, given that the illumination and imaging devices may be coupled to the wings 282, the illumination and / or imaging devices may also be larger. This may allow for more intense illumination and / or more accurate imaging compared to devices that place the illumination and imaging devices on the distal face.

[0046] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical device comprising: the medical device comprises a handle including an actuator; the medical device comprises a shaft extending distally from the handle, the shaft including a lumen; The medical device comprises a distal cap, the distal cap comprising: a body including a first channel, the first channel communicating with a distal portion of the lumen; a distal surface including an opening, the opening being a distal opening of the channel; an expandable portion coupled to the body, the expandable portion configured to expand radially outward from the body and to retract radially inward toward the body from an expanded position, the expandable portion including at least one lighting device; and 2. A medical device comprising:

2. The medical device of claim 1 , wherein the actuator is engaged with the expandable portion such that the actuator is configured to control expansion and retraction of the expandable portion.

3. The medical device of claim 2 or 3, wherein the expandable portion is biased toward the retracted position.

4. The medical device of claim 3 , wherein in the retracted position, the outer diameter of the distal cap is approximately equal to the outer diameter of the remainder of the shaft.

5. The medical device of any one of claims 1 to 4, wherein the distal face does not include an illumination device.

6. The medical device of any one of claims 1 to 5, wherein the opening has a diameter of about 1.5 mm to 2.0 mm.

7. The medical device of any one of claims 1 to 6, wherein the expandable portion is coupled to the body via a hinge.

8. 8. The medical device of claim 1, wherein the expandable portion is coupled to a distal end of the body such that in the retracted position, the expandable portion covers at least a portion of the opening and in the expanded position, the expandable portion exposes the entire opening.

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

10. The medical device of claim 8 or 9, wherein the expandable portion is transparent.

11. 11. The medical device of claim 8, wherein the actuator and the expandable portion are engaged with each other via an opening wire and a closing wire, wherein a force acting on the opening wire is configured to expand the expandable portion and a force acting on the closing wire is configured to retract the expandable portion.

12. The medical device of claim 7 , wherein the body further includes an outer cylinder and an inner cylinder, the outer cylinder surrounding at least a portion of the inner cylinder, and the inner cylinder being rotatable about a central axis of the body.

13. 13. The medical device of claim 12, wherein the outer cylinder includes a first slot and the inner cylinder includes a second slot, the first slot and the second slot overlapping, and the first slot and the second slot configured to receive the expandable portion in the retracted position.

14. 14. The medical device of claim 13, wherein the expandable portion is hingedly coupled to the outer cylinder and hingedly coupled to the inner cylinder, and wherein a rotational force acting on the rotatable inner cylinder in a first direction is configured to expand the expandable portion.

15. 15. The medical device of claim 14, wherein a rotational force acting on the rotatable inner cylinder in a second direction is configured to retract the expandable portion into the first slot and the second slot.

Images