Adaptable devices, systems and methods for providing sealable access to working channel

Abstract

To provide an adapter for allowing a cap assembly to fit securely on two or more medical device ports with different sizes, shapes, and / or dimensions.SOLUTION: A cap assembly has a housing with an interior configuration corresponding with an exterior configuration of first port and surrounding port regions of a medical device. An adapter having an exterior configuration corresponding with the housing interior configuration, and an interior configuration corresponding with second port and port regions may be fitted in the housing. Alternatively, an adapter having a first configuration may be provided in the housing to configure the housing interior to correspond with the exterior configuration of the first port. The adapter may be shiftable into a second configuration with an interior corresponding with the exterior configuration of the second port. The first and second configurations of the housing interiors adapt the housing to fit securely on the corresponding port.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of medical devices and components for use with endoscopes. In particular, the present disclosure relates to a cap assembly including a housing and a cap within the housing for coupling with or mounting over an access port of an endoscope. [Background technology]

[0002] Endoscopes are used during various medical procedures. The proximal end of the endoscope generally remains under the physician's hand control for navigation, irrigation, visualization, insufflation, device management, etc. One or more ports are provided on the proximal end (e.g., handle) of the endoscope. During various medical procedures, various medical devices, tools, and instruments (e.g., for both diagnostic and therapeutic purposes) are inserted through one or more ports and navigated through the endoscope to the treatment site. Devices, tools, and instruments may be removed via the ports and replaced with other devices, tools, or instruments. Caps (also known as biopsy caps) have been introduced to fit over endoscope ports and provide access for endoscopic device passage and exchange, for example, to help maintain insufflation, and to provide a better seal under a wide range of use conditions. Caps are often associated with (e.g., fitted within) a housing configured to couple the cap to the endoscope. One drawback is that such caps and / or housings are typically shaped, sized, and configured to fit into the specific shape and configuration of an endoscope port, which generally has set dimensions. Because ports can vary from endoscope to endoscope, a biopsy cap may provide desirable sealing performance and device stability when used with the port for which the cap was designed, but may not function as well with ports with different shapes, sizes, dimensions, and / or configurations. Summary of the Invention

[0003] This Summary of the disclosure is provided to aid in understanding, and those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be used advantageously separately in some cases, or in combination with other aspects and features of the disclosure in other cases. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0004] According to various principles of the present disclosure, a cap assembly configured to be coupled to a port of a medical device includes a housing having an upper portion configured to receive the cap and a lower portion with an interior having a configuration corresponding to the external configuration of a first port of the medical device, and an adapter securely fitted within the housing and having an internal configuration corresponding to a second port of the medical device.

[0005] In some embodiments, the adapter has an exterior configuration that corresponds to the interior configuration of the lower housing portion. In some embodiments, the exterior of the adapter mates with the interior of the lower housing portion in face-to-face contact to ensure a secure engagement therebetween. In some embodiments, the interior of the lower housing portion includes one or more ribs or grooves, and the exterior of the adapter includes one or more grooves or ribs that mate with the housing ribs or grooves.

[0006] In some embodiments, the housing includes at least one stabilizing shoulder extending inward from an interior of the lower housing section. In some embodiments, the cap assembly further includes a cap disposed within the upper housing section, the cap including a base seated and stabilized on the stabilizing shoulder. In some embodiments, the adapter further includes one or more hooks engaged between an upper surface of the stabilizing shoulder and a lower surface of the base. In some embodiments, the adapter further includes one or more hooks engaged between the upper surfaces of the stabilizing shoulders. In some embodiments, the housing includes a pair of locking tabs extending inward from opposite sides of an interior of the lower housing section, the locking tabs being formed from a flexible, resilient, creep-resistant, dimensionally stable material and configured to securely engage the first port or the second port. In some embodiments, the adapter further includes at least one protrusion positioned to engage one of the locking tabs to at least inhibit lateral shift of the locking tab relative to the second port.

[0007] In some aspects of the present disclosure, the adapter is shiftable between a first configuration, in which the adapter internal configuration is the internal configuration of a lower portion of the housing corresponding to the external configuration of the first port, and a second configuration, in which the adapter internal configuration corresponds to the external configuration of a second port of the medical device. In some embodiments, the adapter includes at least one actuator accessible from the exterior of the housing. In some embodiments, the adapter includes a movable component and a gripping component, the actuator being provided on the movable component, the gripping component including a gripping portion having a gripping surface shaped to correspond to the outer surface of the neck of either the first port or the second port, the actuator being movable relative to the housing to move the movable component to move the gripping components between a first position spaced a first distance from each other and a second position spaced a second distance from each other, the first distance being greater than the second distance, shifting the configuration of the adapter between the first and second configurations. In some embodiments, the movable component and the gripping component have corresponding cam surfaces.

[0008] In some embodiments, the first port is on a first endoscope and the second port is on a second endoscope, and the adapter comprises a housing for coupling to two different endoscopes.

[0009] In one aspect of the present disclosure, the adapter is configured to fit within the interior of the lower part of the housing of the cap assembly, the interior of the lower part of the housing having a configuration corresponding to the outer configuration of the first port of the medical device and the first port area of ​​the medical device surrounding the first port, to securely engage the cap assembly with the first port without the adapter being fitted, the adapter has an outer configuration corresponding to the configuration of the interior of the lower part of the housing to establish face-to-face contact with the interior of the lower part of the housing to securely fit within the interior of the lower part of the housing, and an inner configuration corresponding to the outer configuration of the second port and the second port area of ​​the medical device surrounding the second port, to securely engage the cap assembly with the adapter fitter therein with the second port, the second port area being narrower than the first port area.

[0010] In some embodiments, the adapter further includes one or more hooks configured to fit between an upper surface of a stabilizing shoulder in the cap assembly housing and a lower surface of a base of the cap seated in the upper portion of the cap assembly housing and on the stabilizing shoulder.

[0011] In another aspect of the present disclosure, an adapter is configured to fit within a lower portion of a housing of a cap assembly to shift an internal configuration of the lower portion of the housing between a first configuration for securely engaging a first port of a medical device and a second configuration for securely engaging a second port of the medical device, the adapter including a gripping component including gripping portions having gripping surfaces shaped to securely engage a neck of the port of the medical device, and at least one movable component, the movable component being movable relative to the gripping component to move at least one of the gripping portions relative to another of the gripping portions.

[0012] In some embodiments, the at least one movable component is shifted via an actuator accessible through a window in the bottom of the housing. In some embodiments, the at least one movable component has a cam actuator with a cam surface, and the at least one gripping portion has a cam surface corresponding to the cam actuator cam surface, and movement of the movable component relative to the gripping component causes the cam actuator cam surface and the at least one gripping portion cam surface to slide relative to each other, moving the at least one gripping portion relative to another gripping portion.

[0013] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawings]

[0014] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the relative dimensions, positions, order, and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in scale with respect to fitting within, for example, a working channel of a delivery catheter or endoscope. In the various figures, identical, substantially identical, or equivalent elements may generally be labeled with the same reference numerals, and similar elements may generally be labeled with similar reference numerals that differ by 100, and redundant description will be omitted. For purposes of clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure.

[0015] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference numerals indicate like elements, as follows: [Figure 1] FIG. 1 is an exploded perspective view of a cap assembly according to aspects of the present disclosure shown positioned relative to a port of a medical device handle. [Figure 2] 2 is a cross-sectional view of a cap assembly as in FIG. 1 taken along line II-II of FIG. 1 in an assembled configuration on a medical device port. [Figure 3] 3 is a cross-sectional view of a cap assembly as in FIG. 1 taken along line III-III of FIG. 1 in an assembled configuration on a medical device port. [Figure 4] 4 is a cross-sectional perspective view of a cap assembly as in FIG. 1 taken along line IV-IV of FIG. 1 in an assembled configuration on a medical device port. [Figure 5] 1 is an isolated elevational view of an example of a port of a medical device to which a cap assembly formed in accordance with the principles of the present disclosure may be attached; [Figure 6] FIG. 10 is a bottom view of a cap housing and adapter formed in accordance with the principles of the present disclosure. [Figure 7] 1 is a top perspective view of an adapter formed in accordance with the principles of the present disclosure; [Figure 8] FIG. 10 is a side view of another example embodiment of a cap assembly formed in accordance with various principles of the present disclosure. [Figure 9] 9 is a perspective view of an example of a cap housing and adapter for the cap assembly shown in FIG. 8, with half of the cap housing shown in exploded view and the adapter in a first configuration. [Figure 10] 10 is a bottom perspective view of an example cap housing and adapter half for the cap assembly shown in FIG. 9. FIG. [Figure 11] 10 is a perspective view of the cap housing and adapter of FIG. 9, with half of the cap housing shown in an exploded view and the adapter in a second configuration; FIG. [Figure 12] 12 is a bottom perspective view of an example cap housing and adapter half for the cap assembly shown in FIG. 11. FIG. [Figure 13] 13 is a bottom perspective view of the example cap housing and adapter of FIGS. 8-12 in a second configuration shown secured to the neck of the example medical device port. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0016] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, as such may vary. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Thus, references to elements, structures, or features in the drawings should be recognized as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Accordingly, the present subject matter is intended to cover such modifications and variations as come within the scope of the appended claims and their equivalents.

[0017] It will be understood that the present disclosure is described in this application at various levels of detail. In certain instances, details that are not necessary for those skilled in the art to understand the present disclosure or that would make it difficult for those skilled in the art to appreciate other details may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0018] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician or endoscopist, such terms are used interchangeably herein without limitation and include automated controller systems, etc.) such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery), and "distal" refers to a direction or location furthest from a user such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least generally bisecting the center point, and "central axis," with respect to an opening, means a line at least generally bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, channel, cavity, or bore.

[0019] According to various principles of the present disclosure, a cap assembly, including a cap and a cap housing, is configured to securely fit onto two or more ports of a medical device. More specifically, the cap housing may be configured to securely fit onto two or more ports of a medical device to couple the cap to the ports (such terms and variations thereof are used interchangeably herein with mounted, secured, fitted, etc., without limitation). The medical device may be an endoscope (including, without limitation, a gastroscope, bronchoscope, colonoscope, ureteroscope, etc.), the ports of which allow access to the working channel of the endoscope by one or more medical tools, instruments, or devices (such terms may be used interchangeably herein, without limitation). The ports may be provided on the handle of the endoscope, which may provide various navigation functions to medical professionals. While various endoscopes are sterilizable, infection prevention control in clinical settings creates a demand for single-use scopes that reduce the risk of patient infection and related adverse events without requiring sterile equipment and processes. Various ports on an endoscope or various ports of different endoscopes may have different dimensions, such as height (e.g., between the bottom of a flange typically provided around the port opening and a peripheral portion of the medical device, such as a shoulder or other handle surface surrounding the port) and / or diameter (e.g., of the neck of the port). Cap assemblies are often configured to securely engage the port region of a medical device (a portion or surface of the medical device, e.g., an endoscope handle, that surrounds or is adjacent to the port). Variations in the materials used to manufacture the medical device (e.g., materials used for reusable medical devices may differ from materials used for single-use or disposable medical devices) may result in different sizes, shapes, configurations, and / or dimensions of the port (or portions thereof) and / or port region.

[0020] The port cap provides a reliable (e.g., tight) fluid / air barrier to the working channel of the medical device, which can help control air insufflation and / or fluid (e.g., bile) outflow therefrom without undesired leakage, seepage, or outflow from the port. The port cap (referred to herein as a "cap" for convenience and without limitation) is generally provided within a cap housing that couples the cap to the port. The cap may include various components (e.g., sealing components) to prevent leakage of bodily fluids and / or air.

[0021] The housing holds the cap in place to ensure proper function of the cap. In some embodiments, the cap housing includes a first portion with an interior configuration sized, shaped, configured, and dimensioned to fit over and secure (to couple the cap to) a first port of a medical device, and a second portion in which the cap is disposed. For convenience and without intent to be limiting, the first portion of the cap housing may be referred to herein as a lower portion, and the second portion of the cap housing may be referred to herein as an upper portion. Optionally, the housing includes an instrument engagement structure configured to engage and hold in place a medical instrument (e.g., a guidewire, a catheter, an endoscopic device, and / or the like) relative to an endoscope.

[0022] The cap assembly (and its various components) may have openings (such terms are used interchangeably herein with openings, channels, lumens, holes, and bores, without intending to be limiting, and such features are not limited to circular cross-sections) through which communicate with the ports and / or working channels of the medical device. The diameter of the openings (or at least the openings through one or more components of the cap assembly) may be smaller than the diameter of the working channel to form a transition to a size that more closely matches the size of the device extending through the working channel.

[0023] In view of the above, the cap and / or cap housing and / or cap assembly helps prevent undesirable leaks, seeps, spills, etc. from the port that may cause biological fluids (or treatment fluids) to come into contact with the user's hands and / or medical devices holding the endoscope and / or other objects and / or other persons nearby on the floor. The secure engagement of the cap assembly, and particularly the housing and cap, minimizes or prevents such undesirable occurrences.

[0024] It will be understood that, for convenience, reference herein will be made generally to one or more of a cap, cap housing, or cap assembly without intending to be limiting unless otherwise indicated.

[0025] Generally, the lower portion of the cap housing has an internal configuration corresponding to the external configuration of the first port of the medical device. The internal configuration of the lower portion of the cap housing is preferably shaped, sized, and dimensioned to securely engage the exterior of the first port, and optionally also the first port area, to securely and stably couple the cap to the first port. Such configurations that facilitate a secure coupling may be described herein as "corresponding" configurations that match, closely match, fit, or otherwise mate with one another. It should be understood that, unless expressly excluded, reference to a port is generally intended to include reference to a similarly associated or corresponding port area.

[0026] In accordance with various principles of the present disclosure, an adapter is provided within a portion of the cap housing (generally referred to herein as a lower portion for convenience and without limitation) to modify the internal configuration of the cap housing to accommodate the external configuration of a second port of a medical device having a different size, shape, configuration, and / or one or more dimensions than the first port. The adapter has an external configuration that corresponds to the internal configuration of the portion of the cap housing so that it can fit securely therein. Alternatively or additionally, the adapter may include various locking or engaging structures (e.g., tabs, ribs, shoulders, etc.) configured to engage with the cap housing to securely hold the adapter in place relative to the cap housing. The adapter may shape or otherwise contribute to the internal configuration of the cap housing to accommodate the first port of the medical device. Alternatively, the internal configuration of the cap housing may correspond to the first port of the medical device when the adapter is not disposed therein.

[0027] According to one aspect of the present disclosure, the adapter is in the form of an insert fitted into the interior of the cap housing, such as the lower portion of the cap housing, to engage with the inner surface of the lower portion of the cap housing. In some embodiments, the adapter exterior and the cap housing interior surface engage via surface-to-surface (as opposed to point-to-point) contact. More specifically, the adapter is sized, shaped, configured, and dimensioned such that, when inserted into a portion of the cap housing, a majority of the adapter's exterior surface contacts the inner surface of the lower portion of the cap housing. In some embodiments, at least the exterior of the adapter's sidewall is sized, shaped, configured, and dimensioned to substantially match (e.g., be substantially a three-dimensional mirror image of) the interior of the portion of the cap housing in which the adapter is disposed, such as the sidewall of the lower portion of the cap housing. The lower sidewall of the cap housing can be considered a skirt that surrounds the medical device port and port area, and optionally additional portions of the medical device (e.g., its handle). The surface-to-surface contact between the adapter exterior surface and the inner surface of the lower portion of the cap housing inhibits or prevents relative movement therebetween. Optionally, further engagement structure may be provided to engage with additional internal structure within the cap housing. Such engagement structure may also interact with the cap (seated within the cap housing, such as on top of the cap housing) to secure the adapter in place within the cap housing. It will be appreciated that greater interference may cause improper assembly, while greater clearance may result in a more unstable design. More specifically, greater interference may result in an improper fit between the cap or cap housing and the scope to which it is mounted, due to the locking element not properly engaging or locking under the biopsy port flange. Greater clearance may allow the cap or cap housing to become unstable on the scope or may not provide a sufficient connection to the biopsy port flange and therefore not function as intended.Thus, the adapter is designed to have a small or slight interference, such as about 0.005 inches (0.127 mm), and a small clearance, such as about 0.010 inches (0.254 mm), allowing a total range of about 0.015 inches (0.381 mm).

[0028] According to another aspect of the present disclosure, an adapter is provided within the cap housing (e.g., a lower portion of the cap housing) and is shiftable between one or more configurations. In a first configuration, the adapter is sized, shaped, configured, and dimensioned to securely engage a first port of a medical device to securely couple the cap housing thereto. Such a first configuration may be considered to be a first configuration of an interior of the cap housing in which the adapter is disposed. In a second configuration, the adapter is sized, shaped, configured, and dimensioned to securely engage a second port of a medical device to securely couple the cap housing thereto. In some embodiments, the adapter includes at least first and second locking features, such as cam mechanisms, movable relative to one another to shift an interior of the cam housing between at least the first and second configurations.

[0029] Upon secure engagement with the ports, the cap housing and / or adapter ensure a desirable seal and secure mounting of the cap to two or more different ports on the medical device. The ports may be on the same or different medical devices. In some embodiments, at least one of the adapter configurations allows mounting of the cap assembly to a port on a medical instrument independent of the height of the port.

[0030] Various embodiments of a cap assembly for coupling with a port of a medical device and its associated components will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in connection with an embodiment. However, such references do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic, or that an embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Furthermore, references to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. in various places herein do not necessarily all refer to the same embodiment, nor are they necessarily mutually exclusive separate or alternative embodiments from other embodiments. It should be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly stated, unless expressly stated to the contrary. Furthermore, it is understood that such features, structures, and / or characteristics may be used or presented alone or in various combinations with each other to create alternative embodiments that are considered part of this disclosure, as it would be excessive to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be features, structures, and / or characteristics or requirements of some embodiments but may not be features, structures, and / or characteristics or requirements of other embodiments. Accordingly, the present invention is not limited to only the embodiments specifically described herein.

[0031] It will be understood that in the following description and accompanying drawings, similar elements or components among the various illustrated embodiments are generally designated by similar reference numerals increased by 100, and redundant description will be omitted. Common features are identified by common reference elements, and for brevity, descriptions of common features will generally not be repeated. For clarity, not all components having the same reference numerals have been renumbered.

[0032] Turning now to the drawings and referring to FIG. 1 , a cap assembly 100 formed in accordance with various principles of the present disclosure is shown exploded along its central axis CA and positioned relative to a medical device 1000. While a “central” axis may be referenced, it will be understood that such reference is intended to include an axis that generally extends along the central axis CA (e.g., parallel to or within a minimal angle relative to the central axis CA). More specifically, in the illustrated example, the cap assembly 100 is shown positioned adjacent a first port 1010 on a handle 1020 of the medical device 1000. The cap assembly 100 includes a cap housing 110, a cap 120 configured to fit within an upper portion 112 of the cap housing 110, and an adapter 130 configured to fit within a lower portion 114 of the cap housing 110. The lower portion 114 of the cap housing 110 is configured to engage a portion or region of the medical device 1000, such as surrounding the port 1010. The components of the cap assembly 100 are shown in assembled configuration in cross section along line II-II in FIG. 2 and along line III-III in FIG.

[0033] 2 and 4 , the cap housing 110 includes one or more locking tabs 116 extending radially inward from the interior 111 of the cap housing 110 toward the central axis CA of the cap assembly 100. As used herein, the term “tab” should be understood as not limited to a particular shape or configuration and may alternatively be referred to herein as a finger, flange, protrusion, shoulder, element, member, etc., without any intended limitation. When assembled onto the port 1010 of the medical device 1000 (shown in isolated view in FIG. 5 ), the locking tabs 116 fit between the underside or surface of the flange 1012 at the top of the port 1010, the periphery of the neck 1014 of the port 1010 (e.g., on a different side, such as the opposite side thereof), and above the port area 1016 around the periphery of the port 1010, as shown in FIG. 2 . The locking tabs 116 are configured to engage the port 1010 and secure the cap housing 110, and thus the cap 120, relative to the port 1010. In the embodiment shown, the locking tab 116 is bent upwardly or otherwise (e.g., in a "V" configuration) such that the middle section 116m of the locking tab 116 rests on the port area 1016 and the upper end 116u contacts the underside of the flange 1012. It will be understood that alternative configurations are within the scope and spirit of the present disclosure. The port height P H and port diameter P DBecause the external dimensions of medical device ports such as (FIG. 5) can vary from port to port and device to device, locking tab 116 is preferably formed from a material that is sufficiently flexible and resilient, yet resists deformation and has sufficient dimensional stability (a material with an appropriately selected tensile modulus, flexural modulus, and / or tensile strain at yield point) to securely engage cap housing 110, and thus cap 120 therein, with port 1010. In some embodiments, locking tab 116 mates with port 1010 with an interference fit. The locking tab 116 (and optionally the cap housing 110) may be formed from any of a variety of suitable biocompatible materials having the properties as described above with respect to the locking tab 116, such as metals, alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or other materials as disclosed in U.S. Patent Application Publication No. 2020 / 0138272, published May 7, 2020, entitled "Devices, Systems, And Methods For A Biopsy Cap And Housing," U.S. Patent Application Publication No. 2020 / 0138274, published May 7, 2020, entitled "Attachments For Endoscopes," or U.S. Patent Application Publication No. 2020 / 0138419, published May 7, 2020, entitled "Biopsy Cap And Biopsy Cap Housing," which are incorporated herein by reference in their entireties for all purposes.

[0034] 3, 4, and 6, the cap housing 110 may also include one or more stabilizing tabs 118 extending radially inward from the interior 111 of the lower portion 114 of the cap housing 110 toward the central axis CA of the cap assembly 100. The stabilizing tabs 118 may be configured to help stabilize the position (lateral and / or axial) of the cap assembly 100 relative to the port 1010. The stabilizing tabs 118 may also be configured to help stabilize the cap 120 relative to the cap housing 110 and / or relative to the port 1010 to which the cap assembly 100 is coupled.

[0035] The cap 120 may include various components that contribute to the sealing function of the cap assembly 100. In the example embodiment shown in Figure 1, the cap 120 includes an outer shell 122, a foam section 124, a brush section 126, a disc shutter section 128 (optionally having multiple fins), and a base 140. The various internal components of the cap 120 (the foam section 124, the brush section 126, the disc shutter section 128, and / or other components) are not critical to the spirit of the present disclosure and will not be described in detail herein. For details regarding example components of cap 120, reference is made to the above-referenced patent applications incorporated herein by reference, as well as U.S. Patent Application Publication No. 2019 / 0046016, published February 14, 2019, entitled "Biopsy Cap For Use With Endoscope," U.S. Patent Application Publication No. 2020 / 0138273, published May 7, 2020, entitled "Internal Seal For Biopsy Cap," U.S. Patent Application Publication No. 2020 / 0138276, published May 7, 2020, entitled "Devices, Systems, And Methods For Providing Sealable Access To A Working Channel," and U.S. Patent Application Publication No. 2020 / 0138277, published May 7, 2020, entitled "Devices, Systems, And Methods For Providing Sealable Access To A Working Channel," each of which is incorporated herein by reference in its entirety for all purposes. The base 140 is preferably formed from a suitable biocompatible material that can seal against and around the port 1010 of the medical device 1000. Examples of suitable materials (for sealing, etc.) include, but are not limited to, silicone materials such as liquid silicone rubber (LSR) such as ELASTOSIL © sold by Wacker, which may have a Shore A hardness of 40 or 50.Alternative materials include Wacker SILPURAN®-640050-AB, Wacker ELASTOSIL® LR 3043 / 50 A / B, NuSil® SIL 5950, NuSil® MED-4950, Dow Q7-7850, Dow Q7 4850, or Dow C6-750. Base 140 may rest on top of stabilizing tabs 118 such that stabilizing tabs 118 stabilize cap 120 against port 1010.

[0036] The interior 111 of the lower portion 114 of the cap housing 110 may include one or more ribs 115 and / or grooves 117, as can be understood with reference to Figure 6. The ribs 115 and / or grooves 117 may be configured and arranged to form or otherwise define surfaces along the interior of the cap housing 110 that allow the lower portion 114 of the cap housing 110 to "grip" and / or otherwise frictionally engage the medical device 1000 (e.g., around the port 1010) to assist in securing the cap assembly 100 to the medical device 1000.

[0037] As shown above, the port height P H and port diameter P D The exterior dimensions of medical device ports, such as (shown in FIG. 5), may vary from port to port and / or device to device. Thus, the interior 111 of the cap housing 110 may be sized, shaped, configured, and dimensioned to securely engage with a first port, but not necessarily with a second port having different exterior dimensions.

[0038] In accordance with various principles of the present disclosure, an adapter 130, as shown in FIG. 7 , is provided to fit within the lower portion 114 of the cap housing 110 to adapt the cap housing 110 to securely mate with a second port and / or port area having exterior dimensions that do not correspond to the interior configuration of the cap housing 110. The example embodiment of the adapter 130 shown in FIG. 7 has one or more hooks 132 along its top surface. As shown in FIG. 4 (and may also be seen in FIGS. 2 and 3 ), the hooks 132 are configured to engage with stabilizing tabs 118 of the cap housing 110 to hold the adapter 130 in place relative to the cap housing 110 within the interior 111 of the cap housing 110. It should be understood that the term “hook” is not limited to a particular shape or configuration and may alternatively be referred to herein as a finger, flange, protrusion, shoulder, latch, element, member, etc., without any intended limitation. Hooks 132 may be provided extending on an upper surface of one or more of the stabilizing tabs 118, such as on both sides of the stabilizing tabs 118, as shown in Figure 4. As can be seen with reference to Figure 3, hooks 132 may fit between the upper surface of the stabilizing tabs 118 and the lower surface of the base 140, further contributing to holding the adapter 130 in place relative to the cap housing 110. Although only one half of the adapter 130 fitted within the cap housing 110 is shown in Figure 4, the other half of the adapter 130 and the cap housing 110 may have similar interior configurations.

[0039] The adapter 130 may also include a plurality of protrusions 134 along the top surface of the adapter 130, as shown in FIG. 7. When the adapter 130 is placed within the cap housing 110, the protrusions 134 may extend on either side of the locking tab 116 within the cap housing 110 to hold the locking tab 116 in place relative to the port 1010, as can be understood with reference to FIG. 4. Thus, the protrusions 134 may inhibit or prevent lateral shifting of the cap assembly 100 relative to the port 1010. Although only one half of the adapter 130 fitted within the cap housing 110 is shown in FIG. 4, the other half of the adapter 130 and the cap housing 110 may have similar interior configurations.

[0040] The exterior 133 of the adapter 130 is preferably sized, shaped, configured, and dimensioned to correspond to the size, shape, form, and dimensions of the interior 111 of the cap housing 110. As can be seen with reference to FIGS. 6 and 7 , the adapter 130 may include one or more ribs 135 and / or grooves 137 that correspond to one or more ribs 115 and / or grooves 117 on the interior 111 of the cap housing 110. The engagement of the grooves 137 of the adapter 130 with the ribs 115 of the cap housing 110 and / or the engagement of the grooves 117 of the cap housing 110 with the ribs 135 of the adapter 130 further enhances the secure engagement of the adapter 130 to the cap housing 110, thereby providing a stronger, more stable connection of the cap assembly 100 to the medical device 1000. Such engagement may be considered to provide surface-to-surface contact (extending surface contact) as opposed to point-to-point contact (limited area contact).

[0041] As described above, with the adapter 130 secured in place within the lower portion 114 of the cap housing 110, the cap housing 110 may be securely mounted to a second port that is sized, shaped, configured, and dimensioned differently from a first port that is sized, shaped, configured, and dimensioned to correspond to the interior configuration of the cap housing 110. Thus, the cap housing 110 may be securely connected to ports of at least two different sizes, shapes, configurations, and dimensions. For example, the adapter 130 effectively reduces the inner diameter of the cap housing 110, allowing the cap housing 110 to securely fit into a second port area that is narrower than the first port area that the interior 111 of the cap housing 110 is dimensioned to securely fit into. The adapter 130 also effectively increases the height that the locking tab 116 can extend around the neck of the port. Thus, the cap housing 110 can fit securely around a first neck region around the neck of the first port and between the top flange of the first port and its corresponding or associated port region, and around a second neck region around the neck of the second port and between the top flange of the second port and its corresponding or associated port region, the second neck region being larger than the first neck region.

[0042] In accordance with various principles of the present disclosure, another embodiment of the cap assembly 200 may include an adapter 230 that can shift between at least two configurations to enable the cap assembly 200 to securely engage at least two ports of different sizes, shapes, configurations, and / or dimensions, as shown in FIG. 8 . The cap assembly 200 of FIG. 8 is shown in position relative to a medical device 1000 similar to the medical device 1000 shown in FIG. 1 . Like the cap housing 110 of the embodiment of FIG. 1 , the cap housing 210 of the embodiment of FIG. 8 has an upper portion 212 onto which a cap (such as the cap 120 shown in FIG. 1 ) can be positioned. Also like the cap housing 110 of the embodiment of FIG. 1 , the cap housing 210 of the embodiment of FIG. 8 has a lower portion 214 configured to engage a portion of the medical device 1000, such as surrounding the port 1010. The cap housing 210 may be formed from two mating cap housing halves 210 a, 210 b, as shown, for example, in FIGS. 9 and 11 , to facilitate manufacturing and assembly of the cap assembly 200. The cap housing halves 210a, 210b may be coupled together in any known or previously known manner (e.g., using mating locking tabs 219 as shown), the details of which may be readily understood by those skilled in the art (see, e.g., the above-incorporated U.S. Patent Application Publication No. 2020 / 0138272) and are not provided herein because they are not necessary for an understanding of the principles disclosed herein with respect to the cap assembly, or cap, or cap housing, or adapter. As can be understood with reference to FIGS. 9, 10, and 12, the interior of the cap housing 210 may include a stabilizing tab 218. The base 140 of the cap 120, as shown in FIGS. 1-3, may be seated and stabilized on the stabilizing tab 218. The adapter 230 may be securely fitted into a position within the cap housing 210 corresponding to the position of the locking tab 116 of the cap housing 110 in FIGS. 1-7. For reasons that will become apparent later, the locking tab 116 provided on the cap housing 110 of FIGS. 1-7 need not be provided on the cap housing 110 of FIGS.

[0043] In the example embodiment shown in FIG. 8 , the adapter actuator 250 extends through a window 213 in the lower portion 214 of the cap housing 210, making it accessible from the exterior of the cap housing 210. As can be seen with reference to FIGS. 9-13 , one or more adapter actuators 250 (with respective windows 213) may be provided, one on each side of the cap housing 210. For simplicity, reference will be made to the components associated with one adapter actuator 250, but it will be understood that similar descriptions may apply to the components associated with another adapter actuator 250 that may be used with the adapter 230 of FIGS. 8-13 . The adapter actuator 250 is positioned relative to the cap housing 210 to be moved between a first position P1 and a second position P2 to shift the adapter 230 between at least two adapter configurations. In the embodiment shown in FIGS. 8 , 9 , and 11 , the adapter actuator 250 has first and second legs 252 a, 252 b that are biased away from each other to fit within corresponding locking regions 213L in the windows 213. In some embodiments, the ends of the first and second legs 252 a, 252 b are enlarged to fit into corresponding enlarged locking regions 213L in the window 213 (one or more locking regions 213L may be provided). When the ends of the first and second legs 252 a, 252 b are within the locking regions 213L of the window 213 in the cap housing 210, the adapter actuator 250 is inhibited or prevented from moving from its position relative to the cap housing 210, thereby securely holding the adapter 230 relative to the medical device 1000 (and port 1010) to which the adapter 230 and cap assembly 200 are mounted. The first and second legs 252 a, 252 b of the adapter actuator 250 can be squeezed together to release the adapter actuator 250 from one locking region 213L and shift the adapter actuator 250 to another position (such as into another locking region 213L) to shift or adjust the configuration of the adapter 230.

[0044] 9-12, one embodiment of an adapter 230 formed in accordance with various principles of the present disclosure is shown having at least two gripping portions 260 configured to grip a port 1010 of a medical device 1000. For example, gripping portions 260 may include opposing gripping surfaces 262 that may be curved or otherwise shaped to correspond to the generally curved (or otherwise shaped or contoured) outer surface of the neck of the medical device port. Gripping portions 260 are shiftable by moving adapter actuator 250 from a first position P1 to a second position P2. When gripping portions 260 are in the first position, adapter 230 is in a first adapter configuration shown in FIGS. 9 and 10. When gripping portions 260 are in the second position, adapter 230 is in a second adapter configuration shown in FIGS. 11 and 12. More specifically, when adapter actuator 250 is in first position P1, gripping portions 260 are at a first position spaced apart by a first distance D1, as shown in FIGS. 9 and 10. When adapter actuator 250 is in second position P2, gripping portions 260 are at a second position spaced apart by a second distance D2, as shown in FIGS. 11 and 12. First distance D1 and second distance D2 are measured from the same opposing points on opposing gripping surfaces 262 of gripping portions 260 and may correlate, for example, to the diameter of the neck of a medical device port that gripping portions 260 grip. In other words, the opposing points may be on either end of the diameter of the neck of a medical device port gripped between gripping surfaces 262. In the embodiment shown in FIGS. 9-12, first distance D1 is greater than second distance D2. Thus, adapter 230 grips around medical device ports with wider necks when in the first configuration than when in the second configuration (where adapter 230 grips around ports with relatively narrower necks). Gripping portion 260 may be formed from a slip-resistant material such that the secure grip of gripping portion 260 against the neck of the medical device port inhibits or prevents movement of cap assembly 200 relative to port 1010 (e.g., along central axis CA of port 1010, as shown in FIGS. 8 and 13 ).Suitable materials include polymers such as elastomers or resins that have a coefficient of friction relative to the material of the medical device port that resists sliding therebetween. One example of a suitable material is Delrin® acetyl resin sold by DuPont deNemours. Alternative materials include Delrin® PC650 NCO010, HOSTAFORM MT® SlideX. TM 1203, HOSTAFORM MT® SlideX TM Examples of suitable materials include polyoxymethylene (POM) such as 2404, acrylonitrile butadiene (ABS) materials such as Cycolac HMG47MD, Cycolac HMG94MD, acrylonitrile butadiene + polycarbonate (ABS+PC) materials such as Cycoloy HC1204HF, PC materials such as Sabic Lexan HP4, polybutylene terephthalate (PBT) materials such as Sabic Valox HX215HP, or polyetherimide (PEI) materials such as Sabic Ultern HU1010.

[0045] In the example embodiment of the reconfigurable adapter 230 shown in Figures 9-12, the adapter 230 has at least one movable component 270 that interacts with a gripping component 280 to shift the adapter 230 between a first configuration and a second configuration. The movable component 270 includes the adapter actuator 250 described above (e.g., one end of the movable component 270) and a cam actuator 272 coupled to the adapter actuator 250 via, e.g., an L-shaped leg 274. The adapter actuator 250, the cam actuator 272, and the L-shaped leg 274 may be formed as an integral unit or from separate components coupled to one another. The gripping component 280 includes one of the gripping portions 260 described above and a mounting leg 264 that mounts the gripping portion 260 to the interior 111 of the cap housing 110. The movable component 270 and / or the gripping component 280 (in whole or in part) may be manufactured within the mold (e.g., of the cap housing 210) itself, or may be UV-bonded after production of the cap housing 210, either of which provides sufficient strength. It will be understood that, in general, a gripping component 280 may be associated with each gripping portion 260 of the pair of gripping portions 260, and a movable component 270 may be associated with each gripping component 280. However, for simplicity and without limitation, one movable component 270 and one gripping component 280 are described herein. As the movable component 270 moves relative to the gripping component 280, the cam actuator 272 moves relative to the gripping portion 260, moving the gripping portion 260 toward or away from the opposing gripping portion 260. In some embodiments, the cam actuator 272 and the gripping portion 260 may have corresponding cam surfaces 266, 276. Movement of the cam actuator 272 relative to the gripping portion 260 (e.g., toward or away from the gripping portion 260) causes the respective cam surfaces 266, 276 to move or slide relative to and along each other, camming the gripping portion 260 in the desired direction to achieve the desired adapter 230 configuration.Although a pair of movable components 270 and a pair of gripping components 280 are shown, it will be understood that a single movable component 270 may be provided to move a corresponding gripping portion 260 relative to another gripping portion 260. A single movable component 270 may move one or more gripping components 280 to move one or more gripping portions 260 relative to one or more gripping portions 280 that may not be moved by the corresponding movable component 270.

[0046] In use, the configuration of the adapter 230 of the embodiment of FIGS. 9-13 is easily adjusted by moving the adapter actuator 250 between a first position P1 and a second position P2. The adapter 230 is thereby easily shifted between a first configuration in which the cap assembly 200 can be securely mounted onto a first port of a medical device and a second configuration in which the cap assembly 200 can be securely mounted onto a second port of a medical device. In the first configuration, the gripping portions 260 are spaced apart a first distance (shown in FIGS. 9 and 10 ), and in the second configuration, the gripping portions 260 are spaced apart a second distance (shown in FIGS. 11 and 12 ), the first distance being greater than the second distance. Thus, the cap housing 210 of the embodiment shown in FIGS. 8-12 can be securely mounted onto a first port having a neck with a first diameter and a second port having a neck with a second diameter smaller than the first diameter. Secure engagement of the cap housing 210 with the example adapter 230 shown in Figures 9-13 is shown in Figure 12 for a port having a second, smaller diameter. As can be seen, the cam actuator 272 engages the gripping portion 260 to hold the gripping portion 260 against the neck 1014 of the port 1010. It will be appreciated that the first port and the second port may be on the same medical device or on different medical devices.

[0047] As can be appreciated, various components and structures may be provided on or associated with an adapter formed according to various principles of the present disclosure to enable the cap assembly to have at least two different configurations corresponding to at least two different medical device ports. Thus, a cap assembly having desirable characteristics need not be limited to use with only one particular port. Accordingly, the present disclosure provides cap devices and related systems and methods that are adaptable for use with two or more configurations of ports on devices, such as endoscopes, and are therefore compatible with different ports and different devices. A common configuration of devices and systems providing sealable access to the working channel of a port may be easily modified for use with different ports on a device, or ports on different devices (e.g., from different manufacturers, or different sizes and / or types of devices from one or more manufacturers). Users of such adaptable devices and systems need not change their usage methods or general familiarity with the devices and systems, since compatibility does not affect the form or function presented to the user. Furthermore, a single type of device and system may be compatible with and used across different devices (with minor modifications to adapt the device and system to the port with which it is associated).

[0048] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or forms for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or form of the present disclosure may be combined in alternative aspects, embodiments, or forms. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desirable properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many modifications or variations in the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure, particularly adapted to particular environments and operating requirements, without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise changed, and sizes or dimensions of elements may be changed. Similarly, although operations or acts or procedures are described in a particular order, this should not be construed as requiring such a particular order to achieve desirable results, or that all operations or acts or procedures should be performed. Furthermore, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or to the specific embodiments or configurations described or shown herein. In view of the foregoing, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0049] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the phrases "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a," "an," "the," "first," "second," etc. do not preclude a plurality. For example, the term "a" or "an" entity, as used herein, denotes one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between and relative movement between collections of elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0050] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although individual features may be included in different claims, these may in some cases be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. 1. An adapter for adaptably connecting one or more different ports to a cap assembly, comprising: an exterior form connectable to an interior of a cap housing configured to be connectable to a first port of a medical device; an internal configuration connectable to a second port having a different configuration than the first port; An adapter comprising:

2. 2. The adapter of claim 1, wherein the exterior configuration of the adapter is configured to correspond to the interior configuration of the cap housing, and the interior of the cap housing has a configuration that corresponds to the exterior configuration of the first port of the medical device and a first port region of the medical device surrounding the first port, so as to securely engage the cap assembly with the first port without the adapter being mated.

3. The adapter of claim 1 or 2, wherein an exterior configuration of the adapter establishes face-to-face contact with an interior of the cap housing to securely fit within the cap housing.

4. 4. The adapter of claim 1, wherein the internal configuration of the adapter corresponds to the external configuration of the second port and a second port area surrounding the second port, the second port area being different from the first port area, so as to securely engage the cap assembly with the adapter fitter therein with the second port.

5. 5. The adapter according to claim 1, wherein the adapter has an external configuration corresponding to an internal configuration of the lower portion of the cap housing. adapter.

6. 6. The adapter of claim 1, wherein the exterior of the adapter includes one or more grooves or ribs that mate with ribs or grooves along the interior of the cap housing.

7. 7. The adapter of claim 1, wherein the first port is on a first endoscope and the second port is on a second endoscope, the adapter being configured to couple to two different endoscopes.

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