Devices, systems, and methods for providing sealable access to working channel

Abstract

The present invention relates generally to the field of medical devices, such as endoscopes, endoscope assemblies, catheters, introducers, and instrument caps for endoscopes, catheters, and introducers. In particular, the present invention relates to biopsy cap configurations that provide a sealable access for a medical device to a working channel, such as a working channel for an endoscope.

Description

priority

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Serial No. 62 / 755,024, filed on November 2, 2018, and entitled “Attachment for an Endoscope,” U.S. Provisional Patent Application Serial No. 62 / 768,808, filed on November 16, 2018, and entitled “Inner Seal for a Biopsy Cap,” U.S. Provisional Patent Application Serial No. 62 / 834,192, filed on April 15, 2019, and entitled “Biopsy Cap and Biopsy Cap Housing,” and U.S. Provisional Patent Application Serial No. 62 / 834,201, filed on April 15, 2019, and entitled “Device, System, and Method for Providing a Sealable Access to a Working Channel,” the disclosures of which are incorporated herein by reference in their entirety and for all purposes. Technical Field

[0002] The present invention generally relates to the field of medical devices, such as endoscopes, endoscope components, guidewires, catheters, introducers, and instrument caps for endoscopes, guidewires, catheters, and introducers. In particular, the present invention relates to biopsy cap configurations that provide a sealable access for a medical device to a working channel, such as a working channel for an endoscope. Background Art

[0003] In endoscopic surgery, for example, medical professionals are faced with the challenge of accessing a patient's anatomy with a medical instrument through a working channel of an endoscope while preventing undesired fluid exchange through the inlet or proximal port of the working channel and between the patient and the atmosphere. For example, bile, air, or other fluids may undesirably enter or escape the patient. Poor leak prevention may result in an unsanitary environment for the medical professional or patient, thereby increasing the chances of causing health problems, such as infection, and increasing frustration for the medical professional during surgery.

[0004] With these considerations in mind, a variety of beneficial medical outcomes can be achieved through the medical devices, systems, and methods of the present invention. Summary of the invention

[0005] Embodiments of the present invention may generally assist in providing medical instruments with sealable access to a working channel of a medical device, such as a biopsy cap configuration for a working channel of an endoscope, including design, materials, manufacturing methods, and use alternatives for such medical devices.

[0006] In one embodiment, a sealing assembly may include a biopsy cap having an inner chamber therein, a cap hole at a first end in fluid communication with the inner chamber, and a fixing member at a second end. A plurality of sealing members may be disposed within the inner chamber, each sealing member having a sealing hole in fluid communication with the cap hole. A base may be disposed within the fixing member, the base having a base hole therethrough in fluid communication with each of the sealing holes.

[0007] In various embodiments described herein or elsewhere, the base may include a recess configured to engage a fixing member. The recess may be an outer annular recess. The proximal end of the base may have a slope toward the base hole, the slope having a first angle transitioning to a second angle, wherein the second angle is between the first angle and the hole, and wherein the second angle is greater than the first angle. The first angle may be about 30° and the second angle may be about 45°. The base may include at least two extensions, at least two extensions extending distally from the base and configured to engage a port of a working channel. Each of the holes of a plurality of sealing members may be axially aligned with each other, the base hole, and the cap hole. At least one of the plurality of sealing members may include a plurality of surfaces extending radially around the sealing hole in a spiral pattern. At least one of the plurality of sealing members may include a plurality of protrusions extending radially inwardly toward the sealing hole, wherein the plurality of protrusions are layers offset at an angle. A plurality of protrusions may define a sealing hole at the center of the sealing member so that the sealing hole extends axially through the seal.

[0008] In one embodiment, a device can be configured to attach to a port of an endoscope. A hole can be in fluid communication with the port through the device. At least two extensions can extend distally from a base and are configured to engage the port of a working channel. A recess can be disposed around the device, the recess being configured to engage a biopsy cap.

[0009] In various embodiments described herein or elsewhere, the recess can be an outer annular recess. The proximal end of the base can have a ramp toward the hole, the ramp having a first angle transitioning to a second angle, wherein the second angle is between the first angle and the hole, and wherein the second angle is greater than the first angle. The first angle can be about 30° and the second angle can be about 45°. The base can include at least two extensions extending distally from the base and configured to engage a port of the working channel. A ridge can surround the hole, the ridge being configured to compress and seal the port.

[0010] In one embodiment, a sealing system may include an endoscope having a working channel and a port at a proximal end of the working channel. A base may be disposed around the port, the base having a base hole therethrough. A biopsy cap has a cap hole therethrough, and a securing member may be at an end of the biopsy cap, the securing member being disposed around the base such that the cap hole is in fluid communication with the base hole and the port.

[0011] In various embodiments described herein or elsewhere, a medical device can extend through a cap hole, a base hole, and a port. The base can include at least two extensions extending distally from the base and configured to engage a port of a working channel. A sealing member can be disposed within an interior chamber of the biopsy cap, the sealing member having a sealing hole in fluid communication with the cap hole.

[0012] In one embodiment, a medical device may include a seal for use in conjunction with an endoscope. The seal may include a body including a circumferential outer wall surrounding a central cavity. The body may have a top surface and a bottom surface, and a plurality of projections extending radially from the outer wall toward the center of the cavity. The plurality of projections may be arranged in a series of circumferential and angularly offset layers, wherein each layer includes a plurality of projections.

[0013] In various embodiments, a plurality of projections may define an opening at the center of the cavity, the opening extending axially through the seal. A series of angularly offset layers may extend axially along the body so that the projections spiral downward from the top surface of the body around the seal to the bottom surface. Each layer may include the same number of projections. The plurality of projections in each layer may be circumferentially spaced. Each layer may include between three and fifteen projections. The plurality of projections may be arranged in a layer between three and fifteen layers. The projections of each layer may be offset between ten and forty degrees from an adjacent layer. The outer surface of the outer wall may include a plurality of axial slits.

[0014] In one embodiment, a method of manufacturing a seal for use in conjunction with an endoscope may include molding the seal as a single-piece component. The seal may be molded to have a body including a circumferential wall surrounding a central lumen; and a plurality of projections extending radially outward from the wall away from the lumen. The plurality of projections may be molded in a series of circumferentially and angularly offset layers. The molded seal may be turned inside out so that the plurality of projections extend radially inward toward the center of the central lumen.

[0015] In various embodiments, molding the seal may include assembling a multi-piece radially injectable mold around a core element. The core element may define the shape of the wall, and the multi-piece mold defines the shape and orientation of the plurality of protrusions. Molding may include injection molding the seal and subsequently disassembling the multi-piece mold. Molding the seal may include assembling an axially rivet mold including a top and a base and a plurality of plates. Each plate may define the shape and orientation of a layer of protrusions. Molding may include injection molding the seal and subsequently disassembling the axially rivet mold.

[0016] In one embodiment, a seal for use in conjunction with an endoscope may include a body including a circumferential outer wall surrounding a central cavity. The body may have a top surface and a bottom surface, at least one support wall extending radially from the outer wall toward the center of the cavity, and at least one spiral fin extending spirally downward from the support wall along an inner surface of the outer wall. The at least one spiral fin may define an opening at the center of the cavity.

[0017] In various embodiments, at least one spiral wing can extend spirally downward along the inner surface of the outer wall in a first direction, and radially downward toward the center of the inner cavity in a second direction. At least one support wall can be composed of only the first and second support walls, and at least one spiral wing can be composed of only the first and second spiral wing. The first spiral wing can extend from the top surface of the first support wall to the bottom surface of the second support wall. Each spiral wing can have a first end adjacent to the top surface of the body, and a second end extending below the bottom surface of the body. The opening can be partially defined as a space between the first and second support walls, the space having a first diameter adjacent to the top surface of the first and second support walls, and a second diameter adjacent to the bottom surface of the first and second support walls. The first and second support walls can be arranged directly opposite each other. A seal can be arranged in the chamber of the biopsy cap. The biopsy cap can have a base having a fixing member for fixing the biopsy cap to a port on the endoscope. The biopsy cap can have a locking member and a housing defining a chamber.

[0018] In one embodiment, a device for providing an enhanced sealable access to a working channel may include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body may be configured to be removably disposed at the proximal end of the working channel in fluid communication therewith. A substantially linear aperture may be at the proximal end of the body configured to allow one or more medical devices to pass therethrough while substantially sealing fluid from the working channel therethrough. A plurality of reinforcing ribs may be arranged around the aperture to reinforce the aperture to prevent tearing.

[0019] In various embodiments described in addition and elsewhere, the hole can be substantially closed when there is no medical device passing through it. The ribs can extend radially in a plane substantially transverse to the longitudinal axis. Each of the plurality of ribs can have a width dimension in a transverse plane and a thickness dimension in a plane substantially parallel to the longitudinal axis. One or more of the ribs can extend substantially perpendicular to the hole. The ribs extending substantially perpendicular to the hole can have a greater width than any other width of the plurality of ribs. The ribs can have a greater width and thickness when extending radially away from the hole. The ribs can increase continuously in width and thickness as they extend radially away from the hole. One or more of the ribs can have a greater thickness than the thickness of one or more of the other ribs. The tubular body can be hollow. The ribs can be disposed on a surface inside the hollow tubular body. The ribs can be arranged symmetrically in a circular pattern around the hole in the transverse plane. The tubular body can include silicone. The device can be a biopsy cap for a sealable passage of a working channel of an endoscope. The force required to tear a hole in a body having ribs may be greater than the tear force for a hole without ribs.

[0020] In another embodiment, a device for providing an enhanced sealable access to a working channel may include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body may be configured to be removably disposed at the proximal end of the working channel in fluid communication therewith. A substantially linear aperture at the proximal end of the body may be configured to allow one or more medical devices to pass therethrough while substantially sealing fluid from the working channel therethrough. A reinforcing ridge may extend around the aperture to reinforce the aperture to prevent tearing.

[0021] In various embodiments described herein or elsewhere, the body can be hollow. The ridges can be disposed on the proximal surface of the body. The ridges can be spaced away from the aperture. The ridges can be tear resistant. The ridges can include an elliptical, circular, or oval peripheral profile around the aperture. The ridges can have a cross-section consisting of a generally half-moon shape in a plane parallel to the longitudinal axis. The aperture can be substantially closed when there is no medical device extending therethrough.

[0022] In yet another embodiment, a device for providing an enhanced sealable access to a working channel may include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body may be configured to be removably disposed at the proximal end of a working channel in fluid communication therewith. The hole may be at the proximal end of a body having a first end and a second end. The hole may be configured to allow one or more medical devices to pass therethrough while substantially sealing the fluid from the working channel therethrough. The hole may include an enhanced pattern extending in a plane substantially transverse to the longitudinal axis in more than one dimension.

[0023] In various embodiments described herein or elsewhere, the hole may include a third end. The hole may extend substantially linearly from the first end to the separation point. The hole may extend substantially linearly from the separation point to the second end. The hole may extend substantially linearly from the separation point to the third end. The hole may extend from the separation point to the second end at the same angle from the separation point to the first end. The length of the hole extending from the first end to the separation point may be less than the length of the hole extending from the separation point to the second end. The length of the hole extending from the separation point to the third end may be substantially the same as the length of the hole extending from the separation point to the second end. The second end and the third end are each configured to receive and substantially fix a guide wire.

[0024] The above summary of embodiments, aspects and / or examples is not intended to describe every embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For clarity, not every component is labeled in every figure, nor is every component of every embodiment shown necessary to allow one skilled in the art to understand the present invention. In the drawings:

[0026] Figure 1 is a perspective view of an example endoscope assembly with a biopsy cap according to one embodiment of the present invention;

[0027] Figure 2 FIG. 1 is a diagram showing a biopsy cap according to an embodiment of the present invention. Figure 1 An exploded view of the example endoscope assembly portion shown in ;

[0028] Figure 3 is a cross-sectional view of a biopsy cap according to one embodiment of the present invention;

[0029] Figure 4 is a top view of a sealing member according to an embodiment of the present invention;

[0030] Figure 5 yes Figure 4 A three-dimensional top view of a sealing member;

[0031] Figure 6 It was taken along line 6-6 Figure 4 and Figure 5 a cross-sectional side view of a sealing member;

[0032] Figure 7It was taken along line 7-7 Figures 4 to 6 a cross-sectional side view of a sealing member;

[0033] Figure 8 is a top view of a sealing member according to an embodiment of the present invention;

[0034] Fig. 9 yes Figure 8 A three-dimensional top view of a sealing member;

[0035] Fig.10 is a medical device inserted therethrough Figure 8 and Fig. 9 A three-dimensional top view of a sealing member;

[0036] Fig.11 is a method for manufacturing or assembling a Figures 8 to 10 A perspective view of a separate disc of a sealing member;

[0037] Fig.12 is a top view of an example sealing member after molding and before being turned inside out according to one embodiment of the present invention;

[0038] Fig.13 yes Fig.12 A three-dimensional view of a sealing member;

[0039] Fig.14 is a perspective view of a sealing member after molding and before being turned inside out according to one embodiment of the present invention;

[0040] Fig.15 is a partial top view of a sealing member after molding and before being turned inside out according to one embodiment of the present invention;

[0041] Fig.16 is a top view of a mold having a sealing member disposed therein according to one embodiment of the present invention;

[0042] Fig.17 is a perspective view of a mold for a sealing member before assembly according to one embodiment of the present invention;

[0043] Fig.18 An isometric view of a biopsy cap is shown;

[0044] Fig.19 Shows Fig.18 A magnified view of the hole of the biopsy cap used;

[0045] Fig. 20A A biopsy cap having two guide wires extending through the biopsy cap is shown;

[0046] Fig. 20B Shows Fig. 20A A top cross-sectional view of a biopsy cap;

[0047] Fig.21A shows a bottom view of a biopsy cap including ribs according to one embodiment of the present invention;

[0048] Fig.21B Shows Fig.21A Side view of the biopsy cap;

[0049] Fig. 21C Shows Fig.21A and Fig. 21B A side view of the biopsy cap which is essentially translucent;

[0050] Fig.21D The invention shows a method for manufacturing a housing according to an embodiment of the present invention. Figures 21A to 21C Isometric view of the biopsy cap;

[0051] Fig.21E Shows Fig.21D A cross-sectional view of

[0052] Fig.21F Shows Fig.21D A cross-sectional view of

[0053] Fig.22A shows an isometric view of a biopsy cap including ridges according to one embodiment of the present invention;

[0054] Fig. 22B Shows Fig.22A Top view of the biopsy cap;

[0055] Fig.23A An isometric view of a biopsy cap including holes extending in more than one dimension is shown according to one embodiment of the present invention;

[0056] Fig. 23B Shows Fig.23A Top view of the biopsy cap;

[0057] Fig.24 A top view of a biopsy cap is shown;

[0058] Fig.25 shows a top view of a biopsy cap including holes extending in more than one dimension according to one embodiment of the present invention;

[0059] Fig.26 shows a top view of a biopsy cap including holes extending in more than one dimension according to one embodiment of the present invention;

[0060] Fig.27AAn enlarged view of a working channel side of a hole of a biopsy cap according to one embodiment of the present invention is shown;

[0061] Fig.27B An enlarged view of the working channel side of the aperture of a biopsy cap used according to one embodiment of the present invention is shown;

[0062] Fig.27C An enlarged view of the working channel side of the aperture of a biopsy cap used according to one embodiment of the present invention is shown;

[0063] Fig.28A shows a perspective view of a base according to one embodiment of the present invention;

[0064] Fig.28B Shows Fig.28A A side view of a base;

[0065] Fig.28C Shows Fig.28A A front view of the base;

[0066] Fig.28D Shows Fig.28A A cross-sectional view of a base;

[0067] Fig.29 A cross-sectional view of an assembly of a biopsy cap including a sealing member and a base is shown according to one embodiment of the present invention.

[0068] Although the various aspects of the present invention are suitable for various modifications and alternative forms, the specific details thereof have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0069] The present invention is not limited to the specific embodiments described. The terms used in this article are only used to describe specific embodiments and are not intended to be limited beyond the scope of the appended claims. Unless otherwise specified, all technical terms used in this article have the same meaning as those commonly understood by ordinary technicians in the field to which the present invention belongs.

[0070] Although embodiments of the present invention are described with reference to endoscopes, it will be appreciated that such devices, systems and methods may be used with a variety of medical and other devices including valves, working channels, ports, holes, passageways, and the like.

[0071] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. When used herein, the terms "include" and / or "comprise" or "include" and / or "comprising" indicate the presence of stated features, regions, steps, elements and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or combinations thereof.

[0072] As used herein, the term "distal" refers to the end of a medical device farthest from a medical professional when the device is introduced into a patient, and the term "proximal" refers to the end of a medical device closest to a medical professional when the device is introduced into a patient.

[0073] As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so connected, individually and in any combination and quantity unless the context clearly indicates otherwise.

[0074] As used herein, the term "valve" may refer alone, in combination with, or integrally with a biopsy cap or assembly to a hole, opening, slit, slot, seal, sealing member having a plurality of radial or axial protrusions, projections, or walls.

[0075] All numerical values ​​are assumed to be modified by the term "about" herein, regardless of whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the quoted value (i.e., having the same function or result). In many cases, the term "about" may include a number rounded to the nearest significant figure. Unless otherwise specified, the term "about" (i.e., in the context other than numerical values) may be assumed to have its common and customary definition, as understood and consistent with the context of this specification. The reference to the numerical range represented by the endpoint includes all numbers within the range, including the endpoint (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4 and 5).

[0076] For the sake of clarity, certain identifying digital nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various descriptions and / or claimed features. It is to be understood that the digital nomenclature is not intended to be limiting and is merely exemplary. In certain embodiments, for the sake of brevity and clarity, the digital nomenclature previously used can be changed and deviated from. That is, the feature identified as a "first" element can be referred to as a "second" element later, a "third" element, etc., or can be completely omitted, and / or different features can be referred to as a "first" element. The meaning and / or name in each case will be apparent to the technician.

[0077] The terms "integral" and "unitary" shall generally refer to an element or elements that are made or composed of a single structure or basic unit / element. Integral and / or unitary elements shall exclude structures and / or features that result from assembling or otherwise combining multiple discrete elements.

[0078] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, whether or not explicitly described, it is within the knowledge of those skilled in the art to implement such feature, structure, or characteristic in conjunction with other embodiments, unless explicitly stated to the contrary. That is, even if not explicitly shown in a particular combination, the various individual elements described below are still considered to be combinable or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0079] A variety of endoscope assemblies, biopsy caps, and seals have been developed. Each of the known endoscope assemblies, biopsy caps, and seals has certain advantages and disadvantages. There is a continuing need to provide alternative endoscope assemblies, biopsy caps, and seals, as well as methods of making and using the same.

[0080] In an attempt to achieve controlled fluid exchange, a biopsy cap that is in line with the working channel of an endoscope (e.g., attached to the inlet / proximal port of the working channel) can provide a sealable instrument access to the working channel while restricting the entry or exit of unwanted fluids. These functions can often be inversely related, such that because it is easier for a medical professional to pass an instrument through the biopsy cap, it can be more difficult to prevent fluids from leaking through the biopsy cap. Conversely, a biopsy cap designed for significant leak protection can require additional force from the medical professional to pass the medical device through the biopsy cap, which can be difficult for delicate instruments or instruments with large diameters. Additionally, the biopsy cap can become damaged as the medical device is moved through the biopsy cap and / or locked into place, which can affect leak protection.

[0081] Endoscopic surgery that can include the installation of a biopsy cap is used as a background for the biopsy cap embodiments described herein, which include a valve in line with the working channel of the endoscope, but it should be understood that these and other embodiments within the scope of the present invention can be applied to other criteria, products and surgeries, as described above. Endoscopic surgery can include, for example, attaching a biopsy cap to the entrance or proximal port of the working channel of the endoscope. The endoscope can then be inserted into a body cavity or chamber of the patient. The body cavity can then be insufflated to improve visibility and provide a working space therein. In doing so, positive pressure can be created in the body and in the channel. Pressure can be maintained by the installed biopsy cap. At least one hole in the biopsy cap can be configured to open, clamp one or more medical devices inserted through the biopsy cap and seal around it. In addition to substantially preventing the exchange of fluids across the valve, the sealing member and / or hole (i.e., in and out of the working channel and / or patient) of the cap, the valve can "squeeze" liquid from the outer surface of the instrument when the instrument is inserted or withdrawn. At least one aperture is configured to be substantially or completely closed when not occupied by the instrument to prevent fluid exchange and / or insufflation loss.

[0082] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which similar elements in different figures have the same numbering. The detailed description and drawings are intended to illustrate, not to limit, the invention. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the invention. The detailed description and drawings illustrate example embodiments of the invention. However, for purposes of clarity and ease of understanding, although every feature and / or element may not be shown in every drawing, the features and / or elements are understood to be present anyway unless otherwise noted. Figure 1An example endoscope and / or endoscope assembly 10 is shown in FIG. The endoscope 10 may be any of a variety of types of endoscopes or related medical devices that are generally identified by the particular anatomical structure that it is desired to reach. For example, the endoscope 10 may be a bronchoscope, a colonoscope, a duodenoscope, an esophagoscope, a catheter, an introducer (with or without vision or visualization capabilities), or any other type of endoscope or related medical device. The endoscope 10 may include a handpiece 12 and an elongated shaft 14 extending distally from the handpiece 12 to a distal tip 18. The shaft 14 may include a lumen defining a working channel 16 that extends through the shaft 14 from a distal end 19 proximate the distal tip 18 of the shaft 14 to an access port 20 that may be located in the handpiece 12 or another portion of the endoscope 10. Although the endoscope 10 is depicted as having Figure 1 However, it will be appreciated that in other embodiments, the endoscope 10 may include multiple working channels as desired.

[0083] The handpiece 12 may include one or more controls 22, such as a rotating knob, which may be used to control movement of the distal tip 18 of the shaft 14 during operation. For example, a first rotating knob 22a may control up and down movement or deflection of the distal tip 18 of the shaft 14, while a second rotating knob 22b may control left and right movement or deflection of the distal tip 18 of the shaft 14. The handpiece 12 may also include one or more buttons 24, which may be used to activate suction or delivery of fluids, such as air, saline and / or water, through the lumen of the endoscope 10, or to perform other functions as desired. Additionally, the handpiece 12 may include a fiber optic cable 26 connected to an external light source (not shown).

[0084] refer to Figure 2 , shows an access port 20 of the handpiece 12 providing access to the working channel 16 of the endoscope 10. The access port 20, which may extend from a side of the endoscope 10 or be at another location, may include a coupling portion 28 for coupling a cap 30 to the access port 20. The cap 30, which may be removably attached or permanently attached to the access port 20, may provide a passage for inserting and / or advancing an endoscopic device through the working channel 16 of the endoscope 10.

[0085] Caps like cap 30, which may be referred to as "biopsy caps", are typically designed with several functions in mind. For example, cap 30 may form a fluid / air barrier to working channel 16, which may help control insufflation and the outflow of bile fluid from it, which may then splash onto the physician's hands and / or the floor, thereby interfering with intervention and / or becoming a biohazard. In addition, cap 30 may have an opening 32 extending through it. Opening 32 may be in fluid communication with working channel 16, and it may reduce the size of opening 34 of working channel 16, for example, to accommodate endoscopic devices or instruments. Therefore, a cap like cap 30 may be more like an adapter because it forms a physical transition at opening 34 (or other instrument channel or entry point) of working channel 16, so that it transitions to a size closer to the size of the device to be inserted into working channel 16. Some additional discussion of biopsy caps can be found in U.S. Patent No. 9,149,173, filed on June 20, 2006, and entitled “Medical Device for Use in Endoscopic Surgery,” U.S. patent application serial number 11 / 405,655, filed on April 17, 2006, and entitled “Elongated Medical Device Having Improved Distal Profile for Use with an Endoscope,” and U.S. patent application serial number 11 / 400,806, filed on April 7, 2006, and entitled “Biopsy Port for Facilitating Device Access,” the entire disclosures of which are incorporated herein by reference and for all purposes.

[0086] In various embodiments, the features and advantages of providing a sealable access to, for example, a working channel of an endoscope can be achieved in conjunction with a biopsy cap and a biopsy cap housing. Such sealable access to a working channel that can be enhanced can be used in U.S. patent application Ser. No. 16 / 100,960, filed on Aug. 10, 2018, and entitled “BIOPSY CAP FOR USE WITH ENDOSCOPE,” U.S. patent application Ser. No. 16 / 100,960, filed on Aug. 10, 2018, and entitled “ATTACHMENT FOR ENDOSCOPE,” U.S. patent application Ser. No. 8150.0613, filed on the same date, and entitled “BIOPSY CAP AND BIOPSY CAP HOUSING,” U.S. patent application Ser. No. 8150.0553, filed on the same date, and entitled “BIOPSY CAP AND BIOPSY CAP HOUSING,” U.S. patent application Ser. No. 8150.0613, filed on the same date, and entitled “ATTACHMENT FOR ENDOSCOPE,” The present invention realizes features of U.S. patent application having attorney docket number 8150.0657 entitled "DEVICES, SYSTEMS, AND METHODS FOR A BIOPSY CAP AND HOUSING", U.S. patent application having attorney docket number 8150.0610 filed on the same date thereof and entitled "INTERNAL SEAL FOR BIOPSY CAP", and U.S. patent application having attorney docket number 8150.0555 filed on the same date thereof and entitled "DEVICES, SYSTEMS, AND METHODS FOR PROVIDING A SEALABLE ACCESS TO A WORKING CHANNEL", each of which is incorporated herein by reference in its entirety and for all purposes.

[0087] Although specific reference is made to a device configured to allow for visualization through an endoscope, laparoscope or other visualization system, such as SpyGlass TM Embodiments of the present invention are described with reference to biopsy caps and biopsy cap housings for delivery and / or replacement of various medical devices with biopsy caps and ports of a Direct Visualization System (Boston Scientific Corporation, Marlborough, MA), but it should be understood that such designs may be adapted for assembly and / or use with a variety of medical devices and medical applications that include sealable passageways.

[0088] Additionally, multiple biopsy caps incorporating at least some of the desired features of the biopsy cap and having other desired characteristics are contemplated. The description discloses some of the contemplated cap embodiments. These caps may include passive seals. For purposes of the present invention, the passive seal is at the port 20 (e.g., Figure 1 The seal disclosed herein is a seal that seals the endoscope 10 at the port 20 to prevent leakage of body fluids and / or air. In addition, by being "passive", the seal disclosed herein is configured to close the endoscope 10 at the port 20 without requiring the clinician to perform any so-called "active" process or step.

[0089] refer to Figure 3 , shows an embodiment of a biopsy cap 130 according to the present invention. The biopsy cap 130 includes a housing 136 defining an interior chamber 132, which can help secure the cap 130 to the port 20 (e.g., Figure 1 136, one or more locking members 142 connected to the shell 136, and an internal sealing member 100 disposed within the shell 136. The shell 136 can take a number of different shapes and forms. However, in general, the shell 136 can be made of a relatively rigid or hard polymer / plastic, a metal or metal alloy, a ceramic, or the like, or a combination thereof, and can take the form of an exoskeleton or protective covering over a more sophisticated interior (e.g., the sealing member 100). In addition, since the shell 136 is formed of a relatively rigid material, multiple accessories and / or structural components of the cap 130 can be fixed to the shell 136 or formed integrally therewith. For example, the fixing member 140 and / or the locking member 142 can be fixed to the shell 136 or formed integrally therewith.

[0090] The housing 136 can have one or more apertures 146 formed therein. For example, the apertures 146 can be disposed on a top surface or surface opposite the securing member 140, however any other suitable portion of the housing 136 can include the apertures 146, including a side or side surface. The apertures 146 can be entry points, or otherwise define one or more openings, that extend through the interior chamber 132 of the cap 130 and into the working channel 16 (e.g., Figure 1146). For example, the hole 146 can extend through the housing 136 and provide access to the sealing member 100. Thus, the hole 146 can form an external opening in the cap 130, through which other medical devices (e.g., guide wires, catheters, etc.) can pass to obtain access to the working channel 16 via the sealing member 100. The cap 130 may include a flange 138 extending into the interior chamber 132. The sealing member 100 may be seated on the flange 138. The sealing member 100 may have an opening 105 in its top and bottom surfaces, which may be longitudinally aligned with the hole 146 in the cap 130. The hole 146 can guide the medical device into the opening 105 and through the sealing member 100.

[0091] In various embodiments, the aperture 146 can have chamfered or beveled edges that can act like a funnel to guide the medical device into the aperture 146 and can facilitate the user's ability to pass the medical device through the aperture 146. In addition to the funnel function that can be achieved by including the beveled aperture 146, the aperture 146 can also provide a number of additional desirable characteristics to the cap 130. For example, because the aperture 146 is formed in the relatively rigid housing 136 and because the aperture 146 is substantially positioned at a distance from the port 20 (e.g., at Figure 1 ), the hole 146 and / or the housing 136 can also act as a strain relief, which can eliminate stress that might otherwise be applied to the endoscope 10 (e.g., at the port 20), for example, during a device exchange or transfer. Thus, shear stress that may be generated during a device exchange can be moved away from the endoscope 10, which can improve the ability of the cap 130 to retain the seal at the port 20.

[0092] In various embodiments, the fixing member 140 can be disposed on the bottom surface of the cap 130. The fixing member 140 can take any number of forms, including those disclosed herein. For example, the fixing member 140 can include a pair of lugs 150a, 150b that can snap onto the port 20 (e.g., Figure 1) or otherwise secured to the port 20. Securing the lugs 150a, 150b to the port 20 may include, for example, snapping the lugs 150a, 150b onto a narrowed ring or portion of the port 20. This may include snapping the lugs 150a, 150b onto the port from a peripheral or side region of the port 20. In addition, a portion of the shell 136 may include a cutout or notch (not shown) that may provide some structural release for the securing member 140 and may allow the lugs 150a, 150b to have greater flexibility than without release when securing the cap 130 to the port 20. The precise form of the securing member 140 and / or lugs 150a, 150b may vary. For example, a different number of lugs may be utilized, lugs of different shapes may be utilized, and / or different securing systems may be used together to secure the cap 130 to the port 20. Furthermore, if such a connection cannot be easily made using the tabs 150a, 150b or another suitable securing member 140, various adapters may be provided to create a suitable connection between the cap 130 and the port 20.

[0093] The locking member 142 can be generally disposed adjacent to the top surface of the cap 130, and it can be used to fix and / or maintain the position of a device (e.g., a guide wire, a catheter, etc.) extending through the cap 130 into the working channel 16. However, the locking member 142 can be disposed on any suitable surface of the cap 130 and / or the shell 136. The locking member 142 can also be formed integrally with the shell 136. In addition to maintaining the position of the device, the locking member 142 can also tend to guide these devices away from the center of the cap 130 so that other devices can obtain access to the working channel 16 via the cap 130. In at least some embodiments, the locking member 142 may include one or more bends, hooks, or channels 144 formed therein, and the medical device can be wrapped or squeezed therein to maintain its position. The number of locking members 142 can vary. In some embodiments, one locking member 142 is utilized. In other embodiments, two, three, four, five, six or more locking members 142 are utilized. In addition, the precise form of the locking member 142 can also vary. For example, locking member 142 may or may not include wings or tabs that may tend to direct the device toward locking member 142 .

[0094] Figure 4 Can be set in Figure 3 1 is a top view of a sealing member 200 according to one embodiment of the present invention within a cap 130. The sealing member 200 may include a body 205 defined by a circumferential outer wall 210 surrounding a central cavity 215. At least one axial support wall 230 may extend radially from the outer wall 210 into the central cavity 215. Figure 5As shown, at least one spiral wing 220 can spirally extend from the top surface 232 of the support wall 230 along the inner surface of the outer wall 210 downward to the bottom surface 234 of the support wall 230. The spiral wing 220 and the support wall 230 do not extend all the way to the center of the cavity 215, but leave an opening 240 that extends completely through the sealing member 200. Therefore, the medical device can be inserted through Figure 3 The hole 146 in the cap 130 is shown advanced into the cavity 150 in the sealing member 200, through the opening 240, and into the working channel 16 for use as part of the medical intervention. Alternatively, the spiral fins 220 and the support wall 230 can extend to the center of the cavity 215 while allowing instruments to pass through the cavity 215 (e.g., by flexing and / or tearing the spiral fins 220 and / or the support wall 230).

[0095] exist Figure 4 In the illustrated embodiment, the sealing member 200 includes only two support walls 230 disposed opposite to each other, and only two spiral fins 220, each of which spirally extends from one of the two support walls 230. Each spiral fin 220 may spirally extend downward from a first end 222 at a top surface 232 of a support wall 230 to a second end 224 at a bottom surface 234 of the opposing support wall 230, as shown in FIG. Figure 5 214. The downward direction can be defined as extending from the top surface 212 of the body 205 to the bottom surface 214. Each spiral fin 220 can extend downward in two directions: spirally extending along the outer wall 210 in the direction indicated by the first arrow 226, and radially extending toward the opening 240 in the direction indicated by the second arrow 228. The downwardly inclined spiral fin 220 can help guide or inject the device through the opening 240. The support wall 230 can extend vertically along the longitudinal axis extending through the opening 240. The two support walls 230 can be arranged opposite to each other, wherein the spiral fins 220 each define approximately half of the circular sealing member 200.

[0096] exist Figure 4 and Figure 5In the illustrated embodiment, a sealing member 200 having only two support walls 230 and only two spiral fins 220 can provide advantages over sealing members having more than two support walls and spiral fins. For example, including only two support walls 230 and two spiral fins 220 can allow the fin to increase its thickness by 10 to 20% along its cross-section, which can improve sealing performance. In addition, the number of possible pockets formed at the bottom of the fins and support walls is reduced. These pockets may become deeper when the angle between the fins and the support walls is low. Reducing the number of support walls and fins to only two results in a reduction in pocket depth because the angle between the fins and the support walls is increased, which significantly reduces the occurrence of device blockage and improves the passability of the device, or the ability of the device to translate through the sealing member 200.

[0097] In various embodiments, the outer wall 210 of the sealing member 200 may include a series of alternating grooves 250 and legs 260 in both the top surface and the bottom surface. The grooves 250 and legs 260 allow two or more sealing members 200 to be stacked (e.g., axially stacked on each other). In some embodiments, the grooves 250 and legs 260 may be of uniform size and equally spaced around the outer wall 210 (not shown), thereby allowing two sealing members 200 to be stacked in any of four 90 degree offset orientations. For example, wherein the two opposing support walls 230 of each sealing member 200 are stacked above each other (the same "+" or dash configuration when one sealing member is rotated 180 degrees), and the two opposing support walls 230 of one sealing member 100 are oriented perpendicular to the support walls 230 of the second sealing member 200 (the same "+" or cross symbol configuration when one sealing member is rotated 90 degrees). In other embodiments, the grooves 250 and legs 260 may be unequally spaced (see Figure 5 ) and are sized so that two sealing members 200 can be stacked in only two 180 degree offset orientations. The grooves 250 and legs 260 are sized and spaced so that two sealing members 200 can only be stacked in a "+" configuration, providing a better seal than the "-" configuration with similar performance (e.g., passability) of a medical device that can pass through the sealing member 200.

[0098] refer to Figure 6 , showing Figure 4 and Figure 5 200, wherein the spiral fin 220 spirally extends downward from a first end 222 at the top surface 212 of the body 205 to a second end 224 adjacent to a bottom surface 234 of an opposing support wall 230. The bottom surface 234 of each support wall 230 extends below the bottom surface 214 of the sealing member 200. Figure 7A view taken through each of the opposing support walls 230 is shown. Figure 6 A cross-sectional view rotated 90 degrees. Figure 7 , a variable diameter of an opening 240 adjacent to a support wall 230 is shown. The support wall 230 can be angled downward from a base 233 connected to the outer wall 210 to an inner edge 235 that partially defines the opening 240. The opening 240 increases from a first diameter D1 between facing support walls 230 at a top surface 232 adjacent to the support wall 230 to a second diameter D2 at a bottom surface 234 of the support wall 230. The increased hole diameter at the bottom of the sealing member 200 prevents the formation of a pocket that could hinder the introduction of a curved top medical device. The reduced diameter D1 at the top compensates for the larger bottom diameter D2 of the opening 240, thereby maintaining the sealing properties of the sealing member 200.

[0099] Figures 4 to 7 The sealing member 200 shown in FIG. 2 may be a single unitary piece formed by injection molding or other suitable molding techniques. The sealing member 200 may be made of an elastomeric material, such as a flexible silicone.

[0100] Figure 8 Shows that it can be set Figure 3 130 according to an embodiment of the present invention. The sealing member 300 may include a body 305 defined by a circumferential outer wall 310 surrounding a central cavity 315. A plurality of projections 320 may extend radially inward from the outer wall 310 toward the center of the cavity 315. The projections 320 may extend from a base 322 attached to the outer wall 310 to a tip 324. The tips 324 of the projections 320 do not intersect at the center of the cavity 315, but leave an opening 340 that extends completely through the sealing member 300. Thus, a medical device may be inserted through the sealing member 300. Figure 3 The hole 146 in the cap 130 is shown advanced, through the opening 340, and into the working channel 16 for use as part of a medical intervention. Alternatively, the helical projection 320 can extend to the center of the cavity 315 while allowing instruments to pass through the cavity 315 (e.g., by flexing and / or tearing the projection 320).

[0101] In various embodiments, the plurality of projections 320 may be oriented in a series of circumferential and angularly offset layers such that they spiral downwardly from the top surface 312 of the outer wall 310 to the bottom surface 314 in a stair-like manner around the sealing member 300, as shown in FIG. Fig. 9As shown. Each layer may include a plurality of circumferentially spaced apart protrusions 320. A series of offset layers may extend axially along the body 305, wherein a first layer 321 defines a portion of the top surface 312 of the body, a second layer 323 is disposed below the first layer 321 and circumferentially offset from the first layer 321, a third layer 325 is disposed below the second layer 323 and circumferentially offset from the second layer 323, a fourth layer 327 is disposed below the third layer 325 and circumferentially offset from the third layer 325, a fifth layer 329 is disposed below the fourth layer 327 and circumferentially offset from the fourth layer 327, and so on. The bottom layer may define a portion of the bottom surface 314 of the body 305.

[0102] The sealing member 300 may include any number of protrusions 320. In some embodiments, the sealing member 300 may include multiple layers, each of which includes, for example, three to fifteen circumferentially spaced protrusions 320, which are arranged equidistantly around the circumference of the body 305. The sealing member 300 may include, for example, three to fifteen layers of protrusions. Fig. 9 In the example shown, the body 305 includes seven layers, each having five protruding portions.

[0103] The medical device can be inserted through the opening 340 in the sealing member 300, and the top 324 of the protrusion 320 can engage the medical device to form a seal. The sealing member 300 can provide an improved seal for catheters or other medical devices having a longitudinal slit or channel, particularly a C-shaped longitudinal channel. When a device 400 having a C-shaped channel 410 is inserted through the opening in the sealing member 300, the top 324 of the protrusion 320 can enter the channel 410 of the device 400, thereby providing an enhanced seal, such as Fig.10 As shown. Regardless of the rotation direction of the device 400, the plurality of projections 320 disposed circumferentially around the outer wall 310 and extending radially inwardly can provide the advantage of engaging the channel 410. Moreover, when the device 400 is rotated and disposed in the sealing member 300, the channel 410 will remain sealed because when the device 400 is rotated, the top ends 324 of some projections will slide out of the channel 410, and the top ends 324 of adjacent projections will enter and seal the channel 410. In some embodiments, the size and shape of the top ends 324 of the projections can be set to match the size of the channel 410 of a particular device 400.

[0104] The sealing member 300 can be manufactured and / or assembled using a variety of methods. In one example, the sealing member 300 can be molded as Fig.11Multiple individual disks 370 shown. In various embodiments, each disk 370 can be molded with, for example, 5 projections 320 (however, other number of projections 320 can also be envisioned, as discussed above), each having a top 324, and the top 324 has a size that is set to engage the size of the C channel. The disk 370 can be stacked one on top of another, wherein each disk is stacked into a clock shape at an angle to cover the entire 360 ​​° of peripheries around the opening 340. The stacked disks can then be combined together to form the sealing member 300. Although the stacking process has produced a sealing member 300 with desired sealing properties, it may be time-consuming to mold each disk separately and then assemble it to the method in the sealing member 300, because it is not feasible to assemble manually, and the method requires an expensive assembly automation process. Additionally, controlling the angled orientation of each disk during assembly may be expensive and challenging. All these factors may increase assembly costs and reduce production.

[0105] However, molding the sealing member 300 with all of the inwardly facing projections 320 in a single molded assembly may be difficult due to the many required undercuts and limitations on tool movement. Additionally, the decomposing core molding process may increase costs and affect the quality of the assembly.

[0106] In one embodiment, the entire sealing member 300 can be molded in a single unitary piece in a simple, cost-effective process. Fig.12 As shown, the sealing member 300 may be molded with bases 322 of all protrusions 320 disposed on the periphery of the outer wall 310 and tops 324 of the protrusions 320 extending radially outward. The protrusions 320 may be arranged in a series of circumferentially offset layers. Fig.13 In the example shown, each layer has five protrusions 320 and there are seven layers of protrusions, with each layer circumferentially offset from the layers above and below. This orientation forms a staircase of protrusions 320. After demolding, the sealing member 300 is turned inside out, thereby turning the protrusions 320 to the center, as shown by arrow 390. The resulting structure is as shown in FIG. Fig. 9 As shown in . Multiple layers of protrusions 320 can be offset in various patterns. In some embodiments, the protrusions of each layer can be circumferentially offset from the adjacent layers by between 5 degrees and 40 degrees. Fig.13 In the example shown in , multiple layers of protrusions may be circumferentially offset by 11 degrees from the adjacent layers above and / or below. Fig.14 In another example shown in FIG. 5 , a seal member 500 may have seven layers of protruding portions 520 that are circumferentially offset by 22 degrees from the adjacent layers above and / or below.

[0107] In one embodiment, the outer wall 310 of the sealing member may include one or more axial grooves or slits 395 formed on the inner surface during molding, such as Fig.15 The slits 395 are located on the outer surface of the outer wall 310 after the sealing member 300 is turned inside out and can provide stress relief for the completed sealing member 300. The slits 395 can prevent or help reduce warping of the sealing member 300 after the sealing member 300 is turned inside out.

[0108] The inside-out sealing member 300 with the protruding portion 320 in any orientation can be manufactured by an injection molding process. In one embodiment, the sealing member 300 can be formed using a radially injectable mold 600, such as Fig.16 6. The radially ejectable mold 600 may include a plurality of radially movable segments and a core element 650. The desired number and orientation of projections are formed in the mold segment, which is radially removed to demold the sealing member 300, as indicated by arrows 660. The size of the core element 650 determines the size of the outer wall 310 of the sealing member 300. In various embodiments, the sealing member may be formed using an axially staking mold 700, as shown in FIG. Fig.17 The axial staking die 700 may include a top 710 and a base 720 and a series of staking protrusion orientation plates 730 , each plate 730 defining the shape and orientation of a layer of protrusions 320 .

[0109] In various embodiments, sealing member 100,200,300 may include soft materials, such as plastics, foam, silicone, rubber or elastomer, which may be suitable for sealing around the medical device extending through it. The precise form and material for sealing member 100,200,300 can be changed. For example, sealing member 100,200,300 may include a flexible or formable material, which may or may not be absorbable. In some embodiments, sealing member 100,200,300 may include those materials of similar structures disclosed in U.S. Patent No. 6,663,598, filed on May 17, 2000 and entitled "Fluid Seal for Endoscope", which is incorporated herein by reference in its entirety and for all purposes. In at least some embodiments, sealing member 100,200,300 may extend laterally to the edge (and / or top) of shell 136, thereby substantially filling inner chamber 132. This can help prevent or reduce the amount of fluid that may move in and out of cap 130. Alternatively, a gap may be formed between the top of the sealing member 100, 200, 300 and the top of the interior chamber 132 of the shell 136 and may be used, for example, to retain body fluids that may escape from the sealing member 100, 200, 300 and that might otherwise "splash" during, for example, device removal or replacement. In further embodiments, a portion of the sealing member 100, 200, 300 may extend from the shell 136 and it may define or otherwise serve as a strain relief.

[0110] In addition to being disposed in a biopsy cap 130 for an endoscope, the sealing members 100, 200, 300 may also be used in other similar applications where leakage protection is required along a device inserted through the sealing members 100, 200, 300. Additionally, with the downwardly oriented flaps, the sealing member 200 may also be used as a one-way valve to seal a fluid inside the sealing member 200.

[0111] refer to Fig.18 , showing an isometric view of a biopsy cap 1800. The biopsy cap 1800 can be installed in line with the entrance of the working channel (e.g., as shown in FIG. Figure 1 and Figure 2 ). Biopsy cap 1800 includes hole 1802, which is a substantially linear one-dimensional slit. Hole 1802 is in a substantially closed configuration without any open space between the walls of hole 1802. Hole 1802 is prepared to allow one or more medical instruments to pass through hole 1802.

[0112] refer to Fig.19 , showing Fig.181800 is an enlarged view of the hole 1802 of the biopsy cap 1800 in use. The hole 1802 of the biopsy cap 1800 extends substantially linearly through a portion of the biopsy cap 1800. After being used in a procedure, the hole 1802 has a length 1906 that is greater than the original length 1904. During use of the biopsy cap 1800, one or more medical instruments may have been inserted into the linear end of the hole 1802, thereby causing the hole 1802 to tear further along the biopsy cap 1800, such that the length of the hole 1802 extends from the original length 1904 to the expanded length 1906, thereby reducing the sealing strength of the biopsy cap 1800 and increasing the ease of passage through the hole 1802 compared to the hole 1802 before tearing.

[0113] refer to Fig. 20A and Fig. 20B , shows a biopsy cap 2000 according to one embodiment of the present invention, which includes two guide wires 2024 extending through the hole 2002. The guide wires 2024 extend away from the hole 2002 and are guided by the guide member 2022. Fig. 20B 2024 is pressed against the wall of the hole 2002 in the direction of the vectors 2026 shown in . Because these vectors 2026 extend in a direction multiple degrees α away from the axis r of the hole 2002, the hole 2002 is pulled open with the guide wire 2024 at least at the end of the hole 2002. Fig. 20B It is shown that the guidewire 2024 has torn the hole 2002 in multiple directions, thereby opening the first portion 2004 of the hole 2002 and opening the second portion 2006 with a widened tear. The first portion 2004 of the hole 2002 is undesirably opened, thereby allowing possible fluid exchange through the hole 2002, while the second portion 2006 is torn into a wider opening than the first portion 2004, thereby allowing even more fluid to be exchanged through the hole 2002.

[0114] In various embodiments, a longer linear length of the aperture may be desired so that the axial force required to insert and remove a medical device through the aperture is reduced compared to a shorter linear length of the aperture. However, since a longer linear length of the aperture may be less able to prevent fluid exchange through the aperture than a shorter linear length of the aperture, a shorter linear aperture may be enhanced to achieve two purposes, for example, to help allow a sealable passage for an instrument while enhancing the aperture to resist tearing to inhibit or prevent fluid exchange. For example, the aperture may have a certain amount of resistance to the insertion of a medical device such that there is typically a seal that prevents fluid exchange through the aperture and / or such that fluid on the medical device can be wiped off when the medical device is removed from the working channel and through the aperture. In the context of a biopsy cap used with a working channel in endoscopic surgery, an example amount of force applied by a medical professional to pass one or more medical devices through the aperture may be about 0.5 lbf to about 3.5 lbf.

[0115] refer to FIG. 21A to FIG. 21F , shows an embodiment of a device for providing an enhanced sealable access to a working channel, comprising a biopsy cap 2100 having a tubular body 2104 having a proximal end 2106, a distal end 2108 and extending along a longitudinal axis. The distal end 2108 is configured to be mounted in line with the working channel at the proximal end or inlet port of the working channel. The biopsy cap 2100 includes a substantially linear hole 2102 at the proximal end 2106 of the body 2104. The hole 2102 extends along a centerline axis r perpendicular to the longitudinal axis of the tubular body 2104 and is configured to allow one or more medical devices to pass therethrough while substantially sealing fluid passing through the working channel. Six reinforcing ribs 2110 are arranged around the hole 2102. From Fig.21AThe bottom view of the biopsy cap 2100 in FIG. 2 shows ribs 2110 disposed on a surface 2118 inside the tubular body 2104 and extending distally from the surface 2118 along the longitudinal axis. The ribs 2110 may extend in a plane substantially perpendicular to the longitudinal axis. The ribs 2110 farthest from the normal axis n may be arranged at about 15° to about 75° or about 45° from the normal axis n or the axis r. The ribs 2110 are used to reinforce the hole 2102 in the closed position, thereby helping the hole 2102 resist fluid pressure and exchange through the hole 2102. The arrangement and number of ribs 2110 closer to the axis n increase the stiffness of the biopsy cap 2100 along the axis n relative to the stiffness of the biopsy cap 2100 along the axis r. This increased stiffness along the axis n (compared to the stiffness along the r axis) also helps provide a resistance f along the axis n. The resistance force f can be described as a force vector acting in a direction perpendicular to the axis r. The resistance force f can resist the force created by an object (e.g., a guide wire or another instrument passing through the hole 2102). There are also no ribs 2110 arranged and extending substantially along the axis r. This also substantially improves the stiffness and closure of the hole 2102 of the biopsy cap 2100 along the axis n direction relative to the stiffness and closure of the hole 2102 along the axis r. Any force substantially along the axis n that may cause the hole 2102 to open and / or tear (e.g., as applied by a guide wire or instrument) will engage a portion of the biopsy cap 2100 having a greater stiffness than the portion of the biopsy cap 2100 that the force may engage substantially along the axis r. As the rib 2110 extends radially away from the hole 2102 from the first end 2112 to the second end 2114, it becomes wider and thicker (i.e., the rib 2110 is wider and thicker at the second end 2114 than it is at the first end 2112). The wider and thicker second end 2114 of the rib 2110 extending toward the hole 2102 to the narrower and thinner first end 2112 contributes to the concentrated drag vector f directed toward the center of the hole 2102 when compared to the rib 2110 having a uniform width and thickness. Additionally, a particular rib 2116 of the group of ribs 2110 extending perpendicular to the r axis and along the normal axis n is wider than the remaining ribs 2110 that are offset from the normal axis n. Because the rib 2116 is wider than the remaining ribs 2110, it has a greater volume of material to contribute to the drag vector f in the direction perpendicular to the axis r to improve the stiffness and closure of the hole 2102. For example, increasing the combined volume of material of the ribs 2110 by increasing the width, thickness, or length of one or more ribs 2110, or increasing the number and / or arrangement of ribs 2110 relative to axis n, can assist in the resistance vector f by providing the mass of the additional ribs 2110 in an opposite direction to the force of the instrument in the hole 2102.These characteristics of the ribs 2110 can be adjusted to "tune" the biopsy cap 2100 to a desired level of tear resistance, improved closure of the aperture 2102, amount of fluid exchange, and force of the instrument required to pass the instrument through the aperture 2102. A rib 2110 extending along the axis n can contribute more to the resistance vector f than another rib that is offset from the axis n, such as a rib 2110 that is angled from about 15° to about 75° or about 45° to the axis n around the longitudinal axis of the biopsy cap 2100. The force required to tear the aperture 2102 of the biopsy cap 2100 having the ribs 2110 is greater than the tear force for the same aperture without the ribs 2110. Although. Fig.21A and Fig. 21C Six ribs 2110 are shown, but any number of ribs may be included (e.g., 1, 2, 3, 4, 5, 7, 8, 9, 10, 12, 20, 50, 100, etc.). Although these figures show variable width and thickness between the ribs 2110, the ribs 2110 may also have a uniform width and thickness. The ribs 2110 are arranged substantially symmetrically about the axis r so that the resistance vector f acting on the hole 2102 is substantially symmetrical. In some embodiments, the arrangement may be asymmetrical. Ridges 2120 are also included, as will be described below, to help strengthen and resist tearing. The ridges 2120 can be combined with the biopsy cap 2100, or the biopsy cap 2100 may not include the ridges 2120. The ridges 2120 can be disposed radially outward from the ribs 2110, or the ridges can extend through the ribs 2110 (e.g., as discussed below). Fig.10 The ridges 2120 and / or ribs 2110 may alternatively or additionally be disposed on the proximal and / or distal surfaces of the biopsy cap 2100.

[0116] refer to FIG. 21D to FIG. 21F, shows a biopsy cap 2100 in an exemplary housing 2120 according to one embodiment of the present invention. The housing 2120 includes a variable-size locking channel 2122 for accommodating one or more medical devices (e.g., a guide wire). The medical device may also be assisted by a guide arm 2126. The biopsy cap 2100 also includes a first surface feature 2114a attached to the proximal end of the biopsy cap 2100 or formed integrally therewith and a second and third surface features 2114b, 2114c attached to the tubular body 2104 of the biopsy cap 2100 or formed integrally therewith. These surface features 2114a, 2114b, and 2114c compress and / or frictionally engage corresponding surface features 2116a, 2116b, 2116c of the housing 2120, which may be a lip, a step feature, etc. formed integrally with the inner wall of the housing 2120. The recessed portions 2112a, 2112b are integrally formed within the tubular body 2104 of the biopsy cap 2100 and are offset from the surface features 2114b, 2114c by approximately 90 degrees relative to the outer circumference of the biopsy cap 2100. The pivot members 2114a, 2114b (e.g., a first pivot button, a first pivot feature, etc.) are integrally formed within the housing 2120 and compressively and / or frictionally engage the corresponding recessed portions 2112a, 2112b.

[0117] In various embodiments described herein and elsewhere, the ribs of the device may extend radially in a plane substantially transverse to the longitudinal axis of the device. Each of the plurality of ribs may have a width dimension in a transverse plane and a thickness dimension in a plane substantially parallel to the longitudinal axis. One or more of the ribs may extend substantially perpendicular to the hole of the device. Some ribs may extend substantially perpendicular to the hole, having a greater width than the width of any other rib. The ribs may have a greater width and thickness when extending radially away from the hole. The ribs may increase continuously in width and thickness as they extend radially away from the hole. One or more of the ribs may have a greater thickness than the thickness of one or more of the other ribs, as described above. The body may be hollow, and the ribs may be disposed on a surface inside the tubular body. The ribs may be arranged only on the top surface, only on the bottom surface, or on both the top surface and the bottom surface. As described above, the ribs may be arranged symmetrically in a circular pattern around the hole in a plane transverse to the longitudinal axis of the device. The ribs may be combined with other enhancement features described herein, such as, for example, ridges.

[0118] refer to Fig.22A and Fig. 22B, shows an embodiment of a device for providing enhanced sealable access to a working channel, comprising a biopsy cap 2200 having a tubular body 2204 having a closed substantially linear aperture 2202 at a proximal end 206 of the body 2204, the aperture 2202 being configured to allow one or more medical devices to pass therethrough while substantially sealing fluid passing through the working channel. The distal end of the body 2202 (opposite the proximal end 2206) is configured to be mounted in line with the working channel at the proximal end or inlet port of the working channel. A ridge 2210 is disposed on the proximal end 2206 of the body 2204, extending around the aperture 2202. The ridge 2210 has a peripheral contour around the aperture 2202, and is circular in shape, but may be any shape, such as elliptical, oval, a combination of shapes, etc., to surround the aperture 2202. The ridge 2210 has a cross-sectional thickness in a plane parallel to the longitudinal axis of the device 2200 that is thicker than the inner portion 2208 centered within the ridge 2210 of the tubular body 2204. The thickness of the ridge 2210 can be a variety of thicknesses, for example, the thickness of the ridge 2210 can be at least 25% greater than the thickness of the wall of the proximal end 2206 of the body 2204 through which the hole 2202 extends. For example, the ridge 2210 can have a peak thickness of about 0.071 inches (about 1.80 millimeters), and the thickness of the wall of the proximal end 2206 of the biopsy cap 2200 through which the hole 2202 extends can be about 0.038 inches (about 0.97 millimeters). The thickness of the ridge 2210 provides resistance to forces from a medical device against the wall of the hole 2202, which could otherwise tear the hole 2202. The cross-section of the ridge 2210 is substantially semicircular or half-moon shaped, although a variety of other shapes may be employed, such as parabolic, curved, rectangular, conical, combinations thereof, etc. The hole 2202 does not extend to the ridge 2210, thereby allowing a minimum amount of tearing before the torn hole 2202 propagates to the ridge 2210. The spacing between the hole 2202 and the end of the ridge 2210 may allow a medical device that is nearly as large as or larger than the hole 2202 to be inserted and passed through the hole 2202 without undesirable resistance. Additionally, the spacing between the hole 2202 and the end of the ridge 2210 may help prevent the propagation of a tear in the hole 2202.

[0119] refer to Fig.23A and Fig. 23B, an embodiment of a device for providing an enhanced sealable access to a working channel is shown, comprising a biopsy cap 2300 having a tubular body having a longitudinal axis and a hole 2302 at a proximal end 2306 of the body. The biopsy cap 2300 is configured to be mounted in line with the working channel. The hole 2302 can be configured to allow one or more medical devices to pass therethrough while substantially sealing fluid passing through the working channel. The hole 2302 has an enhanced pattern extending in a plane substantially transverse to the longitudinal axis in more than one dimension. The hole 2302 has a first end 2310, a second end 2312, and a third end 2314. The hole 2302 extends substantially linearly from the first end 2312 to a separation point 2316, and continues to extend from the separation point 2316 to each of the second and third ends 2312, 2314 individually and substantially linearly. The aperture 2302 allows multiple medical devices to be received and secured into the ends 2310, 312, 2314 of the aperture 2302 without having multiple devices occupy the same ends 2310, 312, 2314, which can reduce tearing of the aperture 2302, as will be described below with reference to Fig.24 and Fig.25 And the above reference Figures 18 to 20BAs discussed. Although the portion of the hole 2302 extending from the separation point 2316 to each of the second and third ends 2312, 2314 has substantially the same length and extends substantially at the same angle from the separation point 2315 to the first end and from the axis r of the hole 2302, these angles and lengths can be variable, or some combination of uniform and variable between the ends. The angle can be such that the portion of the hole 2302 extending from the separation point 2316 to each of the second and third ends 2312, 2314 is oriented toward a locking channel configured to secure a medical device within the hole 2302. Additionally, although three ends 2310, 2312, and 2314 are shown, any number of ends may be employed, for example, a number of ends equal to a number of medical devices for securing in place. Although the part of hole 2302 extending from separation point 2316 to second and third ends 2312,2314 is longer than the part extending from first end 2310 to separation point 2316 of hole 2302, the lengths of these parts can be variable relative to each other or can be substantially equal. Second and third ends 2312,2314 can be configured to accommodate a single guide wire separately, and there is substantially no tearing. The exemplary diameter of guide wire can be in the range of about 0.025 inch (about 0.635 mm) to about 0.038 inch (about 0.965 mm), and the exemplary length of hole 2302 from first end 2310 along axis r to separation point 2316 can be about 0.040 inch (1.016 mm), and a larger length can be used to accommodate a plurality of guide wires, a plurality of instruments and / or a larger instrument through hole 2302. An exemplary length of the hole 2302 from the separation point 2316 to the second end 2312 or to the third end 2314 can be about 0.040 inches (1.016 mm) and can be less than about 0.050 inches (1.27 mm). The length of the hole 2302 from the first end 2310 along the axis r to a point between the second end 2312 and the third end 2314 can be about 0.080 inches (2.032 mm) to about 0.140 inches (3.556 mm). Although the ridge 2318 is shown as surrounding the hole 2302, it is similar to the ridge 2318 associated with Fig.22A and Fig. 22B Ridge 2210 is discussed, but various embodiments may or may not include ridge 2318.

[0120] refer to Fig.24, shows a top view of a biopsy cap 2400 including a substantially linear aperture 2402 extending from a first end 2404 to a second end 2406. Two medical devices 2420 (e.g., guidewires) extend through the aperture 2402 at the second end 2406 and are pressed against the walls of the aperture 2402 in the general direction of the vector 2422 (e.g., during and after securing the medical devices 2420 into the locking channel). The substantially linear aperture 2402 is opened at a first portion 2410 near the first end 2404 and is torn at a second portion 2412 near the second end. Fig.24 This tearing and opening has opened the hole 2402 to a size greater than Fig.19 Any gap space shown is a larger gap space that is along Fig.19 The hole 1902 extends substantially linearly. Similar to the above reference Fig. 20A and Fig. 20B As described in the similar biopsy cap 2000, the hole 2402 is torn.

[0121] refer to Fig.25 , shows a top view of an embodiment of a device for providing enhanced sealable access to a working channel, the device comprising a biopsy cap 2500 having a hole 2502 having a reinforcement pattern extending in one or more dimensions in a plane substantially transverse to the longitudinal axis of the device. Similar to the above Fig.23A and Fig. 23B As shown and discussed above, hole 2502 extends from first end 2504 to a separation point and then to each of second end 2506 and third end 2508. Two medical devices 2520 (e.g., guidewires) extend through hole 2502, one at each of second end 2506 and third end 2508. Medical devices 2520 are pressed against a wall of hole 2502 in the general direction of vector 2522 (e.g., during and after securing medical device 2520 into a locking channel).

[0122] Compare Fig.24 and Fig.25 The force vectors 2422, 2522 and tearing in the hole 2402, 2502 have opened the hole 2402, 2502 to a greater Fig.19 shown to a greater extent, which is essentially along the Fig.19 The hole 1902 extends along the linear tear. Fig.24 and Fig.25 The substantially linear holes 2402, 2502 are torn and / or opened at first portions 2410, 2510 near the first ends 2404, 2504 and second portions 2412, 2512 near the opposite ends (second ends 2406, 2506 and third ends 2508). Fig.25 The hole 2502 with the reinforcement pattern includes a separate second and third end 2506, 2508 for each of the medical devices 2520, and the hole 2502 can be substantially linearly torn along the direction of the second end 2503 and the third end 2508, thereby producing Fig.25 The open areas of the first portion 2510 and the second portion 2512 are respectively smaller than Fig.24 The first portion 2410 and the second portion 2412 have open areas where there is no enhancement pattern for the hole. Fig.24 When compared with the open areas of parts 2410 and 2412, Fig.25 These smaller open areas of portions 2510, 2512 allow for a better seal to prevent fluid exchange across aperture 2502 when an instrument is passed therethrough.

[0123] Fig.26 A top view of a biopsy cap 2600 including a hole 2602 extending in more than one dimension is shown in accordance with one embodiment of the present invention. Fig.26 Examples and Fig.23A and Fig. 23B The embodiment of the present invention is the same as that of the embodiment of the present invention, which has a hole 2602, which also includes a fourth end 2620. The fourth end 2620 extends opposite the first end 2610 and extends from the separation point 2616 and substantially along the axis r, and is located between the second and third ends 2612, 2614. The fourth end 2620 can accommodate an additional guide wire and / or can assist in the passability of a medical device.

[0124] FIG. 27A to FIG. 27C An enlarged view of a biopsy cap according to one embodiment of the present invention is shown. A hole 2702 of the biopsy cap extends substantially linearly through a portion of the biopsy cap. The hole 2702 has a length between ends 2704 of the hole 2702. During use of the biopsy cap, one or more medical instruments may be inserted through the hole 2702, which may cause a tear. As described herein, the tear may be limited or the tear propagation reduced by the ribs 2710 and / or ridges 2720. Reference Fig.27A , the hole 2702 of the biopsy cap including the ribs 2710 and the ridges 2720 does not experience any tearing after use. Fig.27B , the original length of hole 2702 between ends 2704 has been torn into a larger sized hole between torn ends 2706, but the tear has not propagated in a manner that would affect the function of the biopsy cap. Fig.27B The original hole 2702 length (between the torn ends 2704) can be about 1.5 mm to about 4 mm, while the torn hole 2702 length (between the torn ends 2706) can be at least about 5 mm. Fig.27C, the hole 2702 can tear toward the tear end 2706, which has a tear path that is substantially non-linear with the hole 2702 (i.e., along the line between the original ends 1004). The non-linear tear end 2706 is radially retained within the ridge 2720 and is also radially retained within the rib 2710.

[0125] refer to FIG. 28A to FIG. 28D , shows a base 2830 according to one embodiment of the present invention, which includes a recessed annular portion 2832. It will be understood that the recessed annular portion 2832 can be complementary to the fixing member 140 formed as part of the biopsy cap 130, 2900 (e.g., the upper Figure 3 and below Fig.29 ), and thus the biopsy cap 130 can be secured to the base 2830 via a friction fit. The base 2830 and / or the biopsy cap can be formed of a material having sufficient flexibility to enable the biopsy cap to snap fit into position on the base 2830. The base 2830 also defines a securing region 2840, which can be configured to frictionally engage the port 20 (e.g., Figure 2 ). Extensions 2844 extend distally from the base 2830 on either side of the securing region 2840. The extensions 2844 can assist a user in orienting the securing region 2840 onto the port 20 so that at least one of the extensions 2844 contacts and can engage with a mating surface of the port 20. The extensions 2844 can also serve as a handle to assist a user in removing the base 2830 from the port 20. A hole 2842 extends through the base 2830 to accommodate an elongated member extending through the biopsy cap 130, 2900 and the base 2830. The proximal end 2834 of the base 2830 forming the hole 2842 has a funnel-like shape that allows fluids and / or instruments to be injected distally into the hole 2842. The inclined funnel-like shape of the proximal end 2834 has a slope at a first angle α that transitions distally to a second angle β. Angle α can be less than angle β, so that the proximal end 2834 transitions (i.e., tapers) from a coarser angle α portion to a finer angle β portion toward the hole 2842, thereby allowing greater accessibility (i.e., less axial force to translate the instrument) closer to the hole 2842 than farther away from the hole 2842. The α and β angles can be any angle between 0 and 360 degrees, for example, angle α can be about 30° and angle β can be about 45°. The fixed area 2840 installed around the port 20 can serve as a primary seal, while the ridge 2846 extending around the fixed area 2840 of the top surface of the compression engagement port 20 can serve as a secondary seal.

[0126] Fig.29A cross-sectional view of an assembly of a biopsy cap 2900, a base 2902, and sealing members 2910, 2912, 2914, 2916 according to one embodiment of the present invention is shown. Sealing members 2910, 2912, 2914, 2916 are disposed within the biopsy cap 2900, and the cap 2900 is disposed on the base 2902. The entire assembly can be coupled to a port by securing the securing region 2904 to the port such that the biopsy cap 2900, the base 2902, the sealing members 2910, 2912, 2914, 2916, and the aperture of the port are all substantially axially aligned along the longitudinal axis 1. Any sealing member discussed throughout the present invention is suitable for assembly in the biopsy cap 2900.

[0127] In various embodiments, the hole of the biopsy cap may not extend completely through the wall of the biopsy cap. The hole may terminate at a distance within the thickness of the wall of the biopsy cap so that the remaining thickness of the wall at the hole can be pierced by a medical device in use. Alternatively, the hole may be covered by a film that can be adhered to the wall of the biopsy cap so that the film is disposed across the hole before the film is pierced by a medical device in use.

[0128] In various embodiments, the length of the hole or a portion of the length can be in the range of about 2 mm to about 5 mm, about 1.5 mm to about 4 mm, about 3 mm, etc. The length of a portion of the end having a "Y-shaped" hole can be about 3 mm. The propagation length of a tear from the hole may impair the function of the biopsy cap, depending on the length of the hole. For example, a medical device that causes a tear having a length of about 10% of the length of the hole may be significant enough to affect the performance of the biopsy cap.

[0129] In various embodiments, the biopsy cap can include a flexible material such as silicone, liquid silicone rubber, rubber, polymer, elastomer, thermoplastic elastomer (TPE), flexible plastic, or a combination thereof. Variable thickness across the cap can be employed for various functions, for example, a thicker body for securely mounting in line with the working channel, a thinner wall around the hole for passage of a medical device, a thicker ridge around the hole for preventing extended tearing, a thicker rib portion for helping to maintain a closed position of the hole, etc.

[0130] In various embodiments, the biopsy cap can be molded into a tubular body to form a configuration or shape that is configured or customized to fit into a specific housing and / or be compatible with a specific working channel. The patterned holes according to embodiments described herein or elsewhere of the present invention can be cut into this configuration.

[0131] The various biopsy caps, sealing members and molds, and their various components can be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, etc. or any other suitable technique. In addition, the various structures may include materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc. or any other suitable material. These materials may include transparent or translucent materials to facilitate visualization during surgery. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; combinations thereof; etc.; or any other suitable material.

[0132] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those commercially available from DuPont ), polyamide (e.g., available from Bayer Or available from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, available under the trade name commercially available), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS)), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc.

[0133] Additionally, portions or components of the structures disclosed herein (including various fixing members, locking members, etc.) can be coated with a relatively soft material, such as a thermoplastic elastomer, that can improve grip. The coating may or may not include additional features that can improve grip, such as ridges, surface textures, protrusions, grooves, projections, etc.

[0134] In addition, the various structures disclosed herein can be designed for single use or can be designed for repeated use. Therefore, the structures disclosed herein can be made of materials that can withstand multiple sterilizations and / or cleanings. This may be correct for any of the various features of the entire cap or any of the caps as disclosed herein.

[0135] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments.

[0136] According to the present invention, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation. Although the devices and methods of the present invention have been described in preferred embodiments, it is obvious to those skilled in the art that changes can be applied to the devices and / or methods and the steps of the methods described herein or in the sequence of steps without departing from the concept, spirit and scope of the present invention. All such similar substitutions and modifications obvious to those skilled in the art are considered to be within the spirit, scope and concept of the present invention as defined by the appended claims.

Claims

1. A sealing assembly comprising: a biopsy cap having a first end and a second end, an inner chamber defined therein between the first end and the second end, and a cap hole in fluid communication with the inner chamber at the first end; a plurality of sealing members disposed in the inner chamber, each sealing member having a sealing hole in fluid communication with the cap hole; and a base disposed within the interior chamber, the base having a base aperture therethrough, the base aperture being in fluid communication with each of the sealing apertures; in: The sealing member is disposed between the base and the first end of the biopsy cap; and The biopsy cap and the base are configured to be frictionally secured together.

2. The assembly according to claim 1, wherein The base also includes a recess configured to frictionally engage the biopsy cap.

3. The assembly according to claim 2, wherein: The recess is an outer annular recess.

4. The assembly according to claim 1, wherein: The proximal end of the base has a sloped surface toward the base hole, the sloped surface having a first angle transitioning to a second angle, wherein the second angle is between the first angle and the hole, and wherein the second angle is greater than the first angle.

5. The assembly according to claim 4, wherein: The first angle is about 30° and the second angle is about 45°.

6. The assembly according to claim 1, wherein: The base also includes at least two extensions extending distally from the base and configured to engage the ports of the working channel.

7. The assembly according to claim 1, wherein: Each of the apertures of the plurality of sealing members are axially aligned with each other, the base aperture, and the cap aperture.

8. The assembly of claim 1, wherein: At least one of the plurality of sealing members includes a plurality of surfaces extending radially in a spiral pattern around the sealing aperture.

9. The assembly of claim 1, wherein: At least one of the plurality of sealing members includes a plurality of projections extending radially inwardly toward the sealing aperture, wherein the plurality of projections are angularly offset layers.

10. The assembly according to claim 9, wherein: The plurality of projections define the sealing bore at a center of the sealing member such that the sealing bore extends axially through the sealing member.

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