Instrument Wetting Accessories

Abstract

A biopsy cap can be operably connected to a port of a medical device. The biopsy cap seals a working channel configured to allow devices of different diameters to pass through. During endoscopic procedures, the tips of many devices, such as guidewires and catheters, can be moistened before use to avoid excessive drag when inserting the device through the working channel of the endoscope. The cap system comprises a cap for the port of a first medical device and a wetting device connected to a portion of the cap and configured to moisten a second medical device passing through the cap system.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to medical device components, assemblies, and related methods. In particular, aspects of the present disclosure relate, among other things, to devices, systems, and methods for wetting instruments at a biopsy port entry.

Background Art

[0002] A biopsy cap may be operably coupled to a port of a medical device (e.g., an endoscope, a bronchoscope, an endoscopic ultrasound (EUS) scope, etc.). The biopsy cap seals a working channel configured to allow passage of devices of different diameters. The biopsy cap also helps prevent leakage of bioburden. During an endoscopic procedure, the tips of many devices, such as guidewires and catheters, may be wetted prior to use to avoid excessive dragging forces when inserting the device through the working channel of the endoscope. Additionally, wetting the tip of such a device can also prevent the device from snagging on the mucosa.

Summary of the Invention

Means for Solving the Problems

[0003] Each of the aspects disclosed herein may include one or more of the features described with respect to any of the other disclosed aspects. In one example, a cap system can include a cap for a port of a first medical device and a wetting device coupled to a portion of the cap and configured to wet a second medical device passing through the cap system.

[0004] Any of the devices disclosed herein may incidentally or alternatively include, in any combination, any of the following features: The wetting device may include a bottom film at the bottom of the wetting device. The bottom film may be perforated to form an opening in the bottom film. The wetting device may include a top film at the top of the wetting device. The top film may be perforated to form an opening in the top film. The cap system may further include a wetting liquid between the top film and the bottom film of the wetting device. The flange of the wetting device may define a bottom opening configured to receive a portion of the biopsy cap. The flange may be at the bottom of the wetting device, may extend below the bottom film, and the bottom opening may be radially inward of the flange. The flange may fit around the grip of the cap and define a first opening to accommodate it. The flange may fit around a connector connecting the lid of the cap to the base of the cap and define a second opening to accommodate it. The wetting device may include a sponge configured to hold the wetting liquid. The sponge may be positioned on top of a portion of the cap and configured to be bonded to it. The sponge may be centered within the sponge and define a through-hole extending from the top to the bottom of the sponge. The through-hole may have a diameter of approximately 0.05 inches (1.27 mm). The cap may further include a coating on at least one of the outsides of the sponge.

[0005] In another embodiment, the wetting device may comprise a substantially cylindrical tube that receives and retains a liquid and defines an interior for the passage of a first medical device, the tube being configured to restrain the upper part of the base of the cap of the port of the second medical device, and the tube including a bottom locking structure for coupling the tube to the base.

[0006] Any device described herein may include, incidentally or alternatively, any combination of the following features: The tube may further comprise an upper opening configured to receive a cap lid, and an upper locking geometry for connecting the tube to the lid.

[0007] In another embodiment, the wetting device may comprise a sponge defining a through-hole extending within the sponge from the top to the bottom of the sponge, the through-hole opening at the top of the sponge and opening at the bottom of the sponge to allow a first medical device to pass through the through-hole, the sponge comprising a flange at the bottom of the sponge, the flange defining a bottom opening configured to receive a portion of the cap of a port of a second medical device, and the wetting device may further comprise a coating on the outside of the sponge to prevent leakage of the liquid absorbed by the sponge.

[0008] Any of the devices described herein may include, incidentally or alternatively, any combination of the following features: The flange may include a first opening configured to fit around and accommodate the grip of the cap, and a second opening configured to fit around and accommodate the connector connecting the cap lid to the base of the cap. The wetting device may have a substantially cylindrical shape.

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

[0010] [Figure 1A] An exemplary medical device is shown. [Figure 1B] An exemplary medical device is shown. [Figure 2A] Figures 1A-1B show known biopsy caps that may be used in conjunction with the exemplary medical devices. [Figure 2B] Figures 1A-1B show known biopsy caps that may be used in conjunction with the exemplary medical devices. [Figure 2C] Figures 1A-1B show known biopsy caps that may be used in conjunction with the exemplary medical devices. [Figure 3A] The biopsy cap system of this disclosure is shown. [Figure 3B] The biopsy cap system of this disclosure is shown. [Figure 4A] Another biopsy cap system of this disclosure is shown. [Figure 4B] Another biopsy cap system of this disclosure is shown. [Figure 5A] Another biopsy cap system of this disclosure is shown. [Figure 5B] Another biopsy cap system of this disclosure is shown. [Figure 6] Another biopsy cap system is shown. [Figure 7] Another biopsy cap system of this disclosure is shown. [Modes for carrying out the invention]

[0011] The accompanying drawings incorporated herein and constituting part of herein illustrate aspects of this disclosure and, together with the description, are useful in illustrating the principles of this disclosure. As explained in the background technology, the tips of many devices, such as guidewires and catheters, can be moistened before insertion into the biopsy cap of the medical device to avoid excessive dragging force and prevent the device from getting caught in the mucous membrane. Conventional approaches involve pouring water into a kidney-shaped container, which may be placed in a tower or counter space. However, such approaches create an opportunity for water to spill onto the floor, increasing the risk of the user slipping. In addition, an open water container can also be rapidly contaminated if bioburden accidentally falls into the container. Furthermore, such approaches can complicate the process by adding unnecessary steps to prepare the device (e.g., pouring water into a kidney-shaped container, immersing the device in water, etc.). As a result, improved devices, systems, and methods for moistening devices are needed.

[0012] Figure 1A shows an exemplary duodenoscope 10 having a handle 12 and an insertion section 14. Figure 1B shows the proximal end of the handle 12. The duodenoscope 10 may also include an umbilicus 16 for the purpose of connecting the duodenoscope 10 to a power source such as air, water, suction, or power, as well as to an imaging and / or viewing device. While the term duodenoscope may be used herein, it will be understood that this disclosure also encompasses endoscopes, bronchoscopes, gastrocameras, EUS scopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cystoscopes, suction scopes, sheaths, catheters, or similar devices. References to duodenoscopes herein should be understood to encompass any of the above medical devices.

[0013] The insertion portion 14 may include a sheath or shaft 18 and a distal tip portion 20. The distal tip portion 20 may include an imaging device 22 (e.g., a camera) and a light source 24 (e.g., an LED or optical fiber). The distal tip portion 20 may be side-facing. That is, the imaging device 22 and the light source 24 may face radially outward, perpendicularly, substantially perpendicularly, or otherwise transversely with respect to the longitudinal axis of the shaft 18 and the distal tip portion 20. Incidentally or alternatively, the distal tip portion 20 may include one or more imaging devices 22 facing two or more directions. For example, the first imaging device 22 may face radially outward, and the second imaging device 22 may face distally (subtly parallel to the longitudinal axis of the distal tip portion 20 / shaft 18).

[0014] The distal tip 20 may also include an elevator 26 for changing the orientation of the tool inserted into the working channel of the duodenal endoscope 10. The elevator 26 may alternatively be referred to as a swing stand, pivot stand, raising base, or any other appropriate term. The elevator 26 may be pivotable, for example, via an actuation wire or another control element extending from the handle 12 through the shaft 14 to the elevator 26.

[0015] The distal portion of the shaft 18 connected to the distal tip 20 may have a steerable section 28. The steerable section 28 may be, for example, a joint. The shaft 18 and the steerable section 28 may have various structures known or becoming known in the art.

[0016] The handle 12 may have one or more actuators / control mechanisms 30. The control mechanism 30 can provide control for the steerable section 28, the elevator 26, and / or enable the provision of air, water, suction, etc. For example, the handle 12 may include control knobs 32, 34 for controlling the steerable section 28 in the left, right, up, and / or down directions. For example, one of the knobs 32, 34 can provide left / right control of the steerable section 28, and the other of the knobs 32, 34 can provide up / down control of the steerable section 28. The handle 12 may further include one or more lock mechanisms 36 (e.g., a knob or lever) for preventing steering and / or braking of the steerable section 28 in at least one of the up, down, left, or right directions. The handle 12 can include an elevator control lever 38 (see FIG. 1B). The elevator control lever 38 can raise and / or lower the elevator 26 through a connection between the lever 38 and an actuating wire extending from the lever 38 through the shaft 18 to the elevator 26. The port 40 may enable a tool to enter the working channel of the duodenoscope 10 through the port 40 and reach the distal tip 20 through the sheath 18.

[0017] During use, the operator can insert at least a portion of the shaft 18 into the body lumen of the target. The distal tip 20 may be navigated to the treatment site within the body lumen. The operator may insert an attachment device (not shown) into the port 40 and pass the attachment device through the working channel through the shaft 18 to the distal tip 20. The attachment device may be exited from the working channel at the distal tip 20. The user may use the elevator control lever 38 to raise the elevator 26 and angle the attachment device toward the desired location (e.g., the pancreaticobiliary papilla). The user can then use the attachment device to perform a medical procedure.

[0018] Figures 2A and 2C show examples of known biopsy caps 200. Figure 2A shows a perspective view of the biopsy cap 200 in a closed configuration. Figure 2B shows a perspective view of the biopsy cap 200 in an open configuration, and Figure 2C shows a side section view of the biopsy cap 200 mounted on an access port 214. The biopsy cap 200 includes a biopsy cap cover 202 and a biopsy cap base 204 configured to be mounted on an access port 214. The biopsy cap 200 is an example of a cap that may be used in connection with embodiments of the present disclosure, but the scope of the present disclosure extends to other types and configurations of caps mounted on the access port of a scope.

[0019] The biopsy cap 200 includes a biopsy cap lid 202, a biopsy cap base 204, an upper opening 206, a biopsy cap lid connector 208, a middle opening 210, a grip 212, and a lower opening 224. The biopsy cap base 204 is configured to allow an instrument (e.g., a catheter) to pass through the biopsy cap base 204 via the middle opening 210 and enter the access port 214. The biopsy cap base 204 is configured to be disposed over the access port 214 via a lower base fixing region 218. For example, the lower base fixing region 218 includes a flange that fits into a groove of the access port 214 to fix the biopsy cap base 200 to the access port 214. The biopsy cap base 204 includes a middle opening 210 configured to receive the biopsy cap lid 202 via an upper base fixing region 216. The biopsy cap lid 202 is configured to be disposed within the middle opening 210 via a lid fixing region 220. For example, the upper base fixing region 216 has a radially inward-facing lip 217 that is received in a radially outward-facing groove 219 that faces the lid fixing region 220. Also, the lower portion of the lid fixing region 220 includes a flange 221 that is held under the lip 217 of the upper base fixing region 216. Other ways of removably connecting the cap lid to the cap base are within the scope of this disclosure.

[0020] As shown in FIG. 2C, when the biopsy cap lid 202 is coupled to the biopsy cap base 204, the biopsy cap lid 202 is configured to allow an instrument (e.g., a catheter, tool, guide wire, etc.) to pass through the upper opening 206 into the biopsy cap lid 202, through the slit 222 into the middle opening 210, through the lower opening 224, and into the access port 214. The grip 212 is part of the biopsy cap lid 202 and, in the configuration shown in FIGS. 2A and 2C, extends radially outwardly relative to the remainder of the biopsy cap lid 202 at the upper portion of the lid 202. The grip 212 includes a flat surface configured for a user to grasp and manipulate the biopsy cap lid 202.

[0021] The biopsy cap lid connector 208 is configured to connect the biopsy cap lid 202 and the biopsy cap base 204. For example, one end of the biopsy cap lid connector 208 is connected to the biopsy cap lid 202, and the other end of the biopsy cap lid connector 208 is connected to the biopsy cap base 204. The lid connector 208 is flexible and bendable so that the biopsy cap 200 can transition between a closed configuration (Figures 2A and 2C) and an open configuration (Figure 2B).

[0022] Referring to Figures 3A-3B, in one embodiment, the biopsy cap system 300 of the present disclosure includes a biopsy cap 302 having the same (or similar) elements as those outlined in Figures 2A-2C. The biopsy cap system 300 also includes a cup 304 configured to wet an instrument 320 passing through the biopsy cap system 300.

[0023] The cup 304 includes an upper film 306, a wetting liquid 308, a bottom film 310, and a flange 316. The cup 304 has a substantially cylindrical shape that defines an interior for receiving and holding the wetting liquid 308. The cup 304 is configured to be positioned on top of the upper part 312 of the biopsy cap 302. For example, the cup 304 may include a bottom opening configured to receive the lid of the biopsy cap 302 via the flange 316. The flange 316 is the bottom portion of the cup 304 that extends beyond the bottom film 310 and defines the bottom opening radially inward and within the flange. When fitted onto the biopsy cap 302, the flange 316 is positioned proximal to the biopsy cap 302. The flange 316 includes two openings / slots: a first opening for fitting around and accommodating the grip 314, and a second opening for fitting around and accommodating the biopsy cap lid connector 328. The flange 316 has dimensions and flexibility to friction fit onto the lid of the biopsy cap 302. When connected to the lid of the biopsy cap 302, the flange 316 can flex slightly radially outward to provide a friction fit. The cup 304 may be removable from the lid of the biopsy cap 312. In other embodiments, the cup 304 may be molded integrally with the biopsy cap 302, or otherwise manufactured as a single piece with the biopsy cap 302 (in which case the cup 304 and the biopsy cap 310 are a single integrated structure).

[0024] The bottom film 310 may be made of a thin plastic and / or silicone material so that the instrument 320 (e.g., a catheter, guidewire, etc.) can pass through the bottom film 310, but it may have sufficient rigidity to hold the wetting fluid 308 prior to the insertion of the instrument 320. The bottom film 310 is attached to the bottom of the cup 304 just above the flange 316 and extends across the top 312 of the biopsy cap 302 when the cup 304 is fitted into the biopsy cap 302. The bottom film 310 prevents the wetting fluid 308 from being discharged into the biopsy cap 302 before the instrument 320 is inserted into the biopsy cap system 300. When the instrument 320 is inserted into the biopsy cap system 300 and penetrates the bottom film 310, the bottom film 310 includes an opening 324, which allows the instrument 320 to pass through the bottom film 310, enter the opening 326 of the biopsy cap 302, and pass through the access port 318. In some embodiments, the bottom film 310 may be made of a material and / or have a structure that allows the instrument 320 to pass through the opening 324, but the opening 324 is sealed to the outside of the instrument 320 to prevent leakage of the wetting fluid 308 into the biopsy cap 302.

[0025] The upper film 306 may be made of a thin plastic and / or silicone material so that the instrument 320 (e.g., catheter, guidewire, etc.) can pass through the upper film 306, but may have sufficient rigidity to hold the wetting fluid 308 prior to the insertion of the instrument 320. The upper film 306 is attached to the top of the cup 304. The upper film 306 prevents the wetting fluid 308 from spilling out of the cup 304 before the instrument 320 is inserted into the biopsy cap system 300. Once the instrument 320 is inserted into the biopsy cap system 300 and passes through the upper film 306, the upper film 306 will include an opening 322, allowing the instrument 320 to pass through the upper film 306, enter the opening 324 of the bottom film 310, enter the opening 326 of the biopsy cap 302, and pass through the access port 318. In some embodiments, the upper film 306 may be made of a material and / or have a structure that allows the instrument 320 to pass through the opening 322, but the opening 322 is sealed to the outside of the instrument 320 to prevent leakage of the wetting fluid to the outside of the biopsy cap 302.

[0026] The wetting solution 308 is placed between the upper film 306 and the bottom film 310 of the cup 304. For example, the wetting solution 308 may include a water-like substance, thick water (e.g., a substance intended for hydration in patients with dysphagia), or a hydrogel-like product. The wetting solution 308 moistens the outer surface of the instrument 320 as it passes through the opening 322 of the upper film 306, then through the wetting solution 308, the opening 324 of the bottom film 310, the opening 326 of the biopsy cap 302, and into the access port 318. The instrument 320 may be removed from the biopsy cap system 300, and another instrument 320 may be inserted into the same biopsy cap system 300. Alternatively, the cup 304 may be removed from the biopsy cap 302, and another cup 304 may be attached to the biopsy cap 302 prior to the insertion of the next instrument 320.

[0027] Referring to Figures 4A-4B, in one embodiment, the biopsy cap system 400 of the present disclosure includes a biopsy cap 402 having the same (or similar) elements as those outlined in Figures 2A-2C. The biopsy cap system 400 also includes a sponge 404 configured to moisten the instrument 406 as it passes through the biopsy cap system 400. Figure 4A is a cross-sectional view of the biopsy cap system 400 in a plane passing through the center of the biopsy cap system 400.

[0028] The sponge 404 includes a flange 408, a through hole 410, and a coating 418. The sponge 404 has a substantially cylindrical shape (although other shapes are also within the scope of this disclosure) and is made from a material configured to hold a wetting liquid 422. The material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The material may be an open-cell foam. Suitable materials include polyurethanes, polymers having ester and / or ether functional groups, and composite materials.

[0029] The sponge 404 is configured to cover the top of the biopsy cap 402. For example, the sponge 404 may include a bottom opening configured to receive the lid 412 of the biopsy cap 402 via a flange 408. The flange 408 is the bottom portion of the sponge 404 located proximal to the biopsy cap 402 when fitted onto the biopsy cap 402. The flange 408 has a first opening that fits around and receives the grip 414 and a second opening that fits around and receives the biopsy cap lid connector 412. The flange 408 has dimensions and flexibility such that it friction fits onto the lid 412 of the biopsy cap 402. When connected to the lid 412 of the biopsy cap 402, the flange 408 can flex slightly radially outward to provide a friction fit. The sponge 404 may be removable from the lid 412 of the biopsy cap 402.

[0030] The through-hole 410 is located in the center of the sponge 404 and has a cylindrical shape with a diameter smaller than the diameter of the sponge 404. The cylindrical shape extends from the top to the bottom of the sponge 404 so as to allow an instrument 406 (e.g., a catheter, guidewire, etc.) to pass through the through-hole 410 of the sponge 404. For example, when an instrument 406 is inserted into the through-hole 410, the through-hole 410 allows the instrument 406 to enter the opening 420 of the biopsy cap 402 and pass through the access port 416. The through-hole 410 may have a diameter of about 0.05 inches (1.27 mm), but the sponge 404 may be sufficiently flexible so that the through-hole 410 can accommodate instruments with a diameter larger than 0.05 inches (1.27 mm).

[0031] In some embodiments, the wetting solution 422 is absorbed by the sponge 404 before the sponge 404 is placed on the biopsy cap 402. Alternatively, the wetting solution 422 is placed on the sponge 404 after the sponge 404 is placed on the biopsy cap 402. The wetting solution 422 includes substances such as water, concentrated water (e.g., substances intended for hydration in patients with dysphagia), and hydrogel-like products. The wetting solution 422 wets the instrument 406 as it passes through the upper opening of the through-hole 410, then through the through-hole to come into contact with the wetting solution 422 in the sponge 404, through the bottom opening of the through-hole 410, and through the opening of the biopsy cap 420 to enter the access port 416. The instrument 406 may be removed from the biopsy cap system 400, and another instrument 406 may be inserted into the same biopsy cap system 400. Alternatively, sponge 404 may be removed from biopsy cap 402, and another sponge 404 may be attached to biopsy cap 402 prior to the insertion of the next instrument 406.

[0032] The coating 418 is affixed to the outside (outer circumference) of the sponge 404. In some embodiments, the coating 418 is not affixed to the ends (top and bottom) of the sponge 404 where the through holes 410 begin or end. In other embodiments, the coating 418 is affixed to the ends of the sponge 404 so that the coating covers the entire outer surface of the sponge 404. The coating 418 may be made from and / or have a structure that prevents the wetting liquid 422 from leaking out of the sponge 404. Suitable coating materials include, for example, plastics, laminated paper, caulking foam, and silica-based gels.

[0033] Referring to Figures 5A-5B, in one embodiment, the biopsy cap system 500 of the present disclosure includes a biopsy cap 524 having the same (or similar) elements as those outlined in Figures 2A-2C. The biopsy cap system 500 also includes a wetting tube 508 configured to wet instruments passing through the biopsy cap system 500.

[0034] The wetting tube 508 includes a substantially cylindrical shape that defines an interior for receiving and holding the wetting fluid. The wetting tube 508 is positioned to cover the upper part 514 of the biopsy cap base 502 and is configured to connect to the biopsy cap base 502 via locking geometry. For example, the wetting tube 508 includes a connecting groove 510 and flange 512, similar to the groove 219 and flange 221 shown in Figure 2C. The wetting tube 508 may include a bottom opening configured to receive the upper part 514 of the biopsy cap base 502 via the flange 512. The flange 512, much like in the embodiments described above, can bend slightly radially inward when inserted into the biopsy cap base 502, and then return to its unbent position to fit under the lip of the biopsy cap base 502. The flange 512 is the bottom of the wetting tube 508 defining the bottom opening within the flange 512. When the flange 512 is fitted into the biopsy cap base 502, it is positioned within the biopsy cap base 502.

[0035] In addition, the moist tube 508 may include an upper opening configured to receive the biopsy cap cover 504 via a locking geometry, as shown in Figure 5B. The upper part of the moist tube 508 may include a geometry such as the upper part of the biopsy cap base 204 / 502 (as described above) so that the moist tube 508 can receive and connect to the biopsy cap cover 504.

[0036] The through-hole passing through the moist tube 508 has a cylindrical shape with a diameter smaller than the diameter of the moist tube 508. The through-hole extends from the top to the bottom of the moist tube 508, allowing an instrument (e.g., a catheter, guidewire, etc.) to pass through the moist tube 508. For example, when an instrument is inserted into the through-hole, the through-hole allows the instrument to enter the upper part 514 of the biopsy cap base 502 and pass through the access port 516.

[0037] The moist tube 508 may be removable from the biopsy cap base 502. In other embodiments, the moist tube 508 may be molded integrally with the biopsy cap base 502, or otherwise manufactured together with the biopsy cap base 502 as a single component (the moist tube 508 and the biopsy cap base 502 are a single structure).

[0038] A wetting solution is placed inside the wetting tube 508. For example, the wetting solution may include a water-like substance, concentrated water (e.g., a substance intended for hydration in patients with dysphagia), or a hydrogel-like product. As shown in Figure 5A, the wetting tube 508 may wet the instrument when the upper opening is not receiving the biopsy cap cover 504. For example, the wetting solution wets the instrument as it passes through the wetting tube 508, and then sequentially through the biopsy cap base 502 and access port 516. Alternatively, as shown in Figure 5B, the wetting tube 508 may wet the instrument after the upper opening has received the biopsy cap cover 504 via a locking geometry. For example, the wetting solution wets the instrument as it passes through the biopsy cap cover 504, and then sequentially through the wetting tube 508, biopsy cap base 502, and access port 516. The instrument may be removed from the biopsy cap system 500, and another instrument may be inserted into the same biopsy cap system 500. Alternatively, the moist tube 508 may be removed from the biopsy cap base 502, and another moist tube 508 may be attached to the biopsy cap base 502 prior to the insertion of the next instrument.

[0039] Referring to Figure 6, in one embodiment, the biopsy cap system 600 of the present disclosure includes a biopsy cap 622 having the same (or similar) elements as outlined in Figures 2A–2C. The biopsy cap system 600 also includes a cup 604 configured to moisten instruments (indicated by arrow 616) passing through the biopsy cap system 600.

[0040] The cup 604 includes a slit 606, a connecting groove 608, a flange 610, a wetting fluid 612, and a main opening 614. The cup 604 includes a substantially cylindrical shape that defines an interior for receiving and holding the wetting fluid 612. The cup 604 is configured to be placed on a biopsy cap base 620. For example, the cup 604 may include a bottom opening configured to fit into the opening of the biopsy cap base 620 via the connecting groove 608 and the flange 610. The connecting groove 608 is the middle portion of the cup 604, connecting the top of the cup 604 to the flange 610. The connecting groove 608 and the flange 610 have dimensions and flexibility to friction fit into the opening of the biopsy cap base 620. The flange 610, substantially as in the embodiments described above, can bend slightly radially inward when inserted into the biopsy cap base 620, and then return to its unbend position to fit under the lip of the biopsy cap base 620. The flange 610 is the bottom of the cup 604, defining a bottom opening within the flange 610. When the flange 610 is fitted into the biopsy cap base 620, it is positioned within the biopsy cap base 620. The cup 604 may be removable from the biopsy cap base 620. In other embodiments, the cup 604 may be molded integrally with the biopsy cap 622, or otherwise manufactured as a single piece with the biopsy cap 622 (the cup 604 and biopsy cap 622 are a single structure).

[0041] In some embodiments, the cup 604 includes an upper film. The upper film may be made of a thin plastic and / or silicone material so that an instrument 616 (e.g., a catheter, guidewire, etc.) can pass through the upper film, but may have sufficient rigidity to hold the wetting fluid 612 prior to the insertion of the instrument 616. The upper film is attached to the top of the cup 604. The upper film prevents the wetting fluid 612 from spilling out of the cup 604 before the instrument 616 is inserted into the biopsy cap system 600. Once the instrument 616 is inserted into the biopsy cap system 600 and passes through the upper film, the upper film includes an opening that allows the instrument 616 to pass through the upper film and enter the slit 606 and biopsy cap opening 626 of the cup 604 and pass through the access port 624. In some embodiments, the upper film may be made of a material that allows the instrument 616 to pass through and / or have a structure thereof, but the upper film may have an opening that seals against the outside of the instrument 616 and prevents the wetting liquid from leaking out of the cup 604.

[0042] The wetting solution 612 is placed inside the cup 604. For example, the wetting solution 612 may include a water-like substance, concentrated water (e.g., a substance intended for hydration in patients with dysphagia), or a hydrogel-like product. The wetting solution 612 wets the instrument 616 as it passes through the main opening 614, then through the wetting solution 612, the slit 606, and the biopsy cap base 620 in sequence, and into the access port 624. The instrument 616 may be removed from the biopsy cap system 600, and another instrument may be inserted into the same biopsy cap system 600. Alternatively, the cup 604 may be removed from the biopsy cap base 620, and another cup 604 may be attached to the biopsy cap base 620 prior to the insertion of the next instrument.

[0043] Referring to Figure 7, in one embodiment, the wetting system 700 of the present disclosure includes a biopsy cap 708 having the same (or similar) elements as those outlined in Figures 2A-2C. The wetting system 700 includes a biopsy cap base 702 configured to house a wetting gel 704.

[0044] The moist gel 704 is placed into the opening of the biopsy cap base 702 by an administration device 710 (e.g., a syringe). In some embodiments, the moist gel 704 is administered through a slit in the biopsy cap 708. The moist gel 704 may contain a hydrogel-like product. The moist gel 704 moistens the instrument as it passes through the moist gel 704 in the biopsy cap base 702 and then through the access port 706. The instrument may be removed from the biopsy cap system 700, and another instrument may be inserted into the same biopsy cap system 700.

[0045] The principles of this disclosure are described herein with reference to exemplary examples for specific applications, but it should be understood that this disclosure is not limited thereto. Those skilled in the art and those with access to the teachings provided herein will recognize that further modifications, applications, and substitutions of equivalents are all within the scope of the examples described herein. In addition, various elements from each of the presented embodiments can be combined to achieve the same or similar results as one or more of the disclosed embodiments. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. It is a cap system: With a cap for the port of the first medical device; A wetting device, which is coupled to a part of the cap and configured to wet a second medical device passing through the cap system, A cap system equipped with this feature.

2. The cap system according to claim 1, wherein the wetting device includes a bottom film at the bottom of the wetting device.

3. The cap system according to any one of claims 1 to 2, wherein the bottom film can be perforated in order to form an opening in the bottom film.

4. The cap system according to any one of claims 1 to 3, wherein the wetting device includes an upper film on the upper part of the wetting device.

5. The cap system according to claim 4, wherein the upper film can be perforated in order to form an opening in the upper film.

6. A cap system according to any one of claims 1 to 5, A cap system further comprising a wetting liquid between the upper film and the bottom film of the wetting device.

7. The cap system according to any one of claims 1 to 6, wherein the flange of the wetting device defines a bottom opening configured to receive the portion of the biopsy cap.

8. The cap system according to claim 7, wherein the flange is the bottom of the wetting device and extends beneath the bottom film, and the bottom opening is radially inward of the flange.

9. The cap system according to claim 8, wherein the flange fits around the grip of the cap and defines a first opening for housing the grip.

10. The cap system according to claim 9, wherein the flange fits around a connector that connects the lid of the cap to the base of the cap, and defines a second opening for housing it.

11. The cap according to any one of claims 1 to 10, wherein the wetting device comprises a sponge configured to hold a wetting liquid.

12. The cap according to claim 11, wherein the sponge is positioned on a part of the cap and is configured to be coupled to the part of the cap.

13. The cap according to claim 12, wherein the sponge is located in the center of the sponge and defines a through hole extending from the top of the sponge to the bottom of the sponge.

14. The cap according to claim 13, wherein the through hole has a diameter of approximately 0.05 inches (1.27 mm).

15. The cap according to claim 12, further comprising a coating on the outside of at least one of the sponges.

Images