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

Abstract

To provide sealable access for medical instruments to a working channel of a medical device, such as a working channel for an endoscope.SOLUTION: A seal system comprises: an endoscope having a working channel and a port at a proximal end of the working channel; a base disposed about the port, the base having a base aperture therethrough; and a biopsy cap having a cap aperture therethrough and a securing member at an end of the biopsy cap, the securing member disposed about the base such that the cap aperture is in fluid communication with the base aperture and the port; wherein at least two extensions extend distally from the base and beyond the securing member to engage the port.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates generally to the field of medical devices, such as endoscopes, endoscope assemblies, guidewires, guide tubes, introducers, and instrument caps for endoscopes, guidewires, guide tubes, and introducers. In particular, the present invention relates to a biopsy cap arrangement that provides sealable access for a medical instrument to a working channel, such as a working channel for an endoscope. [Background technology]

[0002] In endoscopic procedures, for example, medical personnel face the challenge of accessing a patient's anatomy through a working channel with a medical instrument while preventing undesirable fluid exchange between the patient and the atmosphere through the entrance or proximal port of the working channel of the endoscope. For example, bile, air, or other fluids may inappropriately enter or leak out of the patient's body. Inadequate leak protection can create an unhygienic environment for the medical personnel or patient, increasing the likelihood of health problems such as infection and increasing the frustration of the medical personnel during the procedure. Summary of the Invention

[0003] With these considerations in mind, various beneficial medical outcomes can be achieved by the medical devices, systems and methods of the present invention. Embodiments of the present invention can generally support biopsy cap constructions that provide sealable access for medical instruments to working channels of medical devices, such as working channels for endoscopes, and include designs, materials, manufacturing methods, and use alternatives for such medical devices.

[0004] In one embodiment, the seal assembly can include a biocap having an interior chamber therein, a cap pore at a first end in fluid communication with the interior chamber, and a fixation member at a second end. A plurality of seal members can be disposed within the interior chamber, each seal member having a seal pore in fluid communication with a cap pore. A base arrangement can be disposed within the fixation member, the base having base pores therethrough in fluid communication with each of the seal pores.

[0005] In various embodiments described herein or elsewhere, the base can include a recess configured to engage with the securing member. The recess can be an external annular recess. The proximal end of the base can have a slope toward the base pore, the slope having a first angle transitioning to a second angle, the second angle being between the first angle and the pore and being greater than the first angle. The first angle can be approximately 30°, and the second angle can be approximately 45°. The base can include at least two extensions extending distally from the base and configured to engage with ports of the working channel. Each of the plurality of seal member pores can be axially aligned with each other, the base pore, and the cap pore. At least one of the plurality of seal members can include multiple surfaces extending radially around the seal pore in a helical pattern. At least one of the plurality of seal members can include multiple protrusions extending radially inward toward the seal pore, the multiple protrusions being angularly offset layers. The plurality of projections may define a seal aperture in the center of the seal member such that the seal aperture extends axially through the seal.

[0006] In one embodiment, the device can be configured to attach to a port on an endoscope. A pore can extend through the device in fluid communication with the port. At least two extensions can extend distally from the base and are configured to engage with the port on the working channel. A recess can be disposed around the periphery of the device that is configured to engage with a biopsy cap.

[0007] In various embodiments described herein or elsewhere, the recess can be an external annular recess. The proximal end of the base can have a slope toward the base pore, the slope having a first angle transitioning to a second angle, the second angle being between the first angle and the pore, and the second angle being greater than the first angle. The first angle can be approximately 30°, and the second angle can be approximately 45°. The base can include at least two extensions extending distally from the base and configured to engage with ports in the working channel. There can be a ridge around the pore configured to compressively seal against the port.

[0008] In one embodiment, the sealing system can include an endoscope having a working channel and a port at a proximal end of the working channel. A base can be disposed about the port, with the base having a base pore extending therethrough. There can be a biopsy cap with a cap pore extending therethrough and a fixation member at an end of the biopsy cap. The fixation member is disposed about the base such that the cap pore is in fluid communication with the base pore and the port.

[0009] In various embodiments described herein or elsewhere, a medical instrument can extend through the cap pore, the base pore, and the port. The base can include at least two extensions extending distally from the base and configured to engage the ports of the working channel. A seal member can be disposed within the interior chamber of the biopsy cap, the seal member having a seal pore in fluid communication with the cap pore.

[0010] In one embodiment, a medical device can include a seal for use in combination with an endoscope. The seal can include a body including a peripheral outer wall surrounding a central lumen. The body can have a top surface and a bottom surface and a plurality of protrusions extending radially inward from the outer wall toward the center of the lumen. The plurality of protrusions can be arranged in a series of circumferentially and angularly offset layers, each layer including a plurality of protrusions.

[0011] In various embodiments, the plurality of projections can define an opening in the center of the lumen, the opening extending axially through the seal. A series of angularly offset layers can extend axially along the body such that the projections spiral downward around the seal from the top surface to the bottom surface of the body. Each layer can include the same number of projections. The plurality of projections in each layer can be circumferentially spaced apart. Each layer can include 3 to 15 projections. The plurality of projections can be arranged in 3 to 15 layers. Each layer of projections can be offset from the adjacent layer by 10 to 40 degrees. The outer surface of the outer wall can include a plurality of axial slits.

[0012] In one embodiment, a method of manufacturing a seal for use in combination with an endoscope can include molding the seal as a single-piece element. The seal can be molded to have a body including a peripheral wall surrounding a central lumen and a plurality of projections extending radially outward from the wall, away from the lumen. The plurality of projections can be molded in a series of circumferentially and angularly offset layers. The molded seal can be inverted so that the plurality of projections extend radially inward toward the center of the central lumen.

[0013] In various embodiments, molding the seal can include assembling a multi-piece, radially removable mold around a core element. The core element can define the shape of the wall, and the multi-piece mold defines the shape and orientation of the plurality of protrusions. Molding can include injection molding the seal and then disassembling the multi-piece mold. Molding the seal can include assembling an axially staked mold including a top and a base and a plurality of plates. Each plate can define the shape and orientation of one layer of protrusions. Molding can include injection molding the seal and then disassembling the axially staked mold.

[0014] In one embodiment, a seal for use in combination with an endoscope can include a body including a peripheral outer wall surrounding a central lumen. The body can have top and bottom surfaces, at least one support wall extending radially from the outer wall toward the center of the lumen, and at least one spiral flap extending spirally downward from the support wall along the inner surface of the outer wall. The at least one spiral flap can define an opening in the center of the lumen.

[0015] In various embodiments, at least one spiral flap can extend downward in a first direction spirally along the inner surface of the outer wall and in a second direction radially toward the center of the lumen. The at least one support wall can consist solely of a first support wall and a second support wall, and the at least one spiral flap can consist solely of a first spiral flap and a second spiral flap. The first spiral flap can extend from a top surface of the first support wall to a bottom surface of the second support wall. Each spiral flap can have a first end adjacent the top surface of the body and a second end extending below the bottom surface of the body. The opening can be defined, in part, as a space between the first support wall and the second support wall, the space having a first diameter adjacent the top surfaces of the first support wall and the second support wall and a second diameter adjacent the bottom surfaces of the first support wall and the second support wall. The first support wall and the second support wall can be positioned directly opposite each other. The seal can be disposed within a cavity in a biopsy cap. The biopsy cap can have a base with a securing member that secures the biopsy cap to a port on an endoscope. The biopsy cap can have a locking member and an outer shell that defines a cavity.

[0016] In one embodiment, a device for providing reinforced, sealable access to a working channel can include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body can be configured to be removably positioned at the proximal end of the working channel in fluid communication therewith. The proximal end of the body can have a substantially linear pore. The pore is configured to allow one or more medical instruments to pass therethrough while simultaneously substantially sealing against fluid from the working channel passing therethrough. A plurality of reinforcing ribs can be arranged around the pore to reinforce the pore against tearing.

[0017] In various embodiments described herein or elsewhere, the pores can be substantially closed in the absence of a medical device passing through the pores. The ribs can extend radially in a plane substantially transverse to the longitudinal axis. Each rib of the plurality of ribs can have a width dimension in the 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 pores. A rib extending substantially perpendicular to the pores can have a width greater than the width of any other rib of the plurality of ribs. The ribs can have increasing widths and thicknesses as they extend radially away from the pores. The ribs can continuously increase in width and thickness as they extend radially away from the pores. One or more of the ribs can have a thickness greater than the thickness of one or more of the other ribs. The tubular body can be hollow. The ribs can be disposed on an interior surface of the hollow tubular body. The ribs can be symmetrically disposed in a circular pattern around the pore in the transverse plane. The tubular body can include silicone. The device can be a biopsy cap for sealable access to a working channel of an endoscope.The force required to tear a pore in a body having ribs can be greater than the tear force for a pore without ribs.

[0018] In another embodiment, a device for providing reinforced, sealable access to a working channel can include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body can be configured to be removably positioned at the proximal end of the working channel in fluid communication therewith. A substantially linear pore at the proximal end of the body can be configured to allow one or more medical instruments to pass therethrough while simultaneously substantially sealing against fluid from the working channel passing therethrough. A reinforcing ridge can extend around the pore to reinforce the pore against tearing.

[0019] In various embodiments described herein or elsewhere, the body can be hollow. The ridge can be located on a proximal surface of the body. The ridge can be spaced from the pore. The ridge can be tear-resistant. The ridge can include a peripheral contour around the pore that is elliptical, circular, or oval. The ridge can have a cross-section in a plane parallel to the longitudinal axis that includes a substantially half-moon shape. The pore can be substantially closed in the absence of a medical device extending therethrough.

[0020] In yet another embodiment, a device for providing reinforced, sealable access to a working channel can include a tubular body having a proximal end, a distal end, and a longitudinal axis. The distal end of the tubular body can be configured to be removably positioned at the proximal end of the working channel in fluid communication therewith. At the proximal end of the body, there can be a pore having a first end and a second end. The pore can be configured to allow one or more medical instruments to pass therethrough while simultaneously substantially sealing against fluid from the working channel passing therethrough. The pore can include a reinforcing pattern extending in two or more dimensions in a plane substantially transverse to the longitudinal axis.

[0021] In various embodiments described herein or elsewhere, the pore can include a third end. The pore can extend substantially linearly from the first end to the division point. The pore can extend substantially linearly from the division point to the second end. The pore can extend substantially linearly from the division point to the third end. The pore can extend from the division point to the second end at an angle relative to the division point to the first end. The pore can extend from the division point to the third end at the same angle as the division point to the first end. The length of the pore extending from the first end to the division point can be less than the length of the pore extending from the division point to the second end. The length of the pore extending from the division point to the third end can be substantially the same as the length of the pore extending from the division point to the second end. The second end and the third end can each be configured to receive and substantially secure a guidewire.

[0022] The above summary of embodiments, aspects and / or examples is not intended to describe each embodiment or every implementation of the present invention. The figures and the detailed description that follow more particularly exemplify these embodiments.

[0023] Non-limiting embodiments of the present invention will now be described, by way of example, with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every drawing, and not every component of every embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the invention. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a perspective view of an example endoscope assembly with a biopsy cap, in accordance with one embodiment of the present invention. [Figure 2] 2 is an exploded view of a portion of the example endoscope assembly shown in FIG. 1 showing a biopsy cap, in accordance with one embodiment of the present invention. [Figure 3]1 is a cross-sectional view of a biopsy cap according to one embodiment of the present invention. [Figure 4] FIG. 2 is a top view of a seal member according to one embodiment of the present invention. [Figure 5] FIG. 5 is a top perspective view of the seal member of FIG. 4. [Figure 6] 6 is a cross-sectional side view of the seal member of FIGS. 4 and 5 taken along line 6-6. [Figure 7] 7 is a cross-sectional side view of the seal member of FIGS. 4 to 6 taken along line 7-7. [Figure 8] FIG. 2 is a top view of a seal member according to one embodiment of the present invention. [Figure 9] FIG. 9 is a top perspective view of the seal member of FIG. 8. [Figure 10] 10 is a top perspective view of the seal member of FIGS. 8 and 9 with a medical device inserted therein; FIG. [Figure 11] FIG. 11 is a perspective view of a separate disk used to manufacture or assemble the seal member of FIGS. 8-10, according to one embodiment of the present invention. [Figure 12] 1 is a top view of an example seal member after molding and before being inverted, according to one embodiment of the present invention. [Figure 13] FIG. 13 is a perspective view of the seal member of FIG. 12. [Figure 14] 1 is a perspective view of an example seal member after molding and before being inverted, according to one embodiment of the present invention. [Figure 15] 1 is a partial top view of an example seal member after molding and before being inverted, according to one embodiment of the present invention. [Figure 16] FIG. 2 is a top view of a mold having a seal member disposed therein, according to one embodiment of the present invention. [Figure 17] 2 is a perspective view of a mold for a seal member prior to assembly, according to one embodiment of the present invention; FIG. [Figure 18] Isometric view of a biopsy cap. [Figure 19] FIG. 19 is a close-up of the pores of the biopsy cap used in FIG. 18. [Figure 20A] Diagram of a biopsy cap with two guidewires extending through it. [Figure 20B] 20B is a top cross-sectional view of the biopsy cap of FIG. 20A. [Figure 21A] FIG. 10 is a bottom view of a biopsy cap including ribs, according to one embodiment of the present invention. [Figure 21B] FIG. 21B is a side view of the biopsy cap of FIG. 21A. [Figure 21C] 21A and 21B are semi-transparent, substantially side views of the biopsy cap of FIG. 21A and FIG. 21B. [Figure 21D] FIG. 21B is an isometric view of the biopsy cap of FIGS. 21A-21C within a housing, according to one embodiment of the present invention. [Figure 21E] Cross section of Figure 21D. [Figure 21F] Cross section of Figure 21D. [Figure 22A] 1 is an isometric view of a biopsy cap including ridges, according to one embodiment of the present invention. [Figure 22B] FIG. 22B is a top view of the biopsy cap of FIG. 22A. [Figure 23A] 1 is an isometric view of a biopsy cap including pores extending in more than one dimension, according to one embodiment of the present invention. [Figure 23B] FIG. 23B is a top view of the biopsy cap of FIG. 23A. [Figure 24] Top view of the biopsy cap. [Figure 25] 1 is a top view of a biopsy cap including pores extending in more than one dimension, according to one embodiment of the present invention. [Figure 26] 1 is a top view of a biopsy cap including pores extending in more than one dimension, according to one embodiment of the present invention. [Figure 27A] FIG. 10 is a close-up view of the working channel side of the pores of the biopsy cap, according to one embodiment of the present invention. [Figure 27B] FIG. 10 is a close-up view of the working channel side of the pores of a used biopsy cap, according to one embodiment of the present invention. [Figure 27C] FIG. 10 is a close-up view of the working channel side of the pores of a used biopsy cap, according to one embodiment of the present invention. [Figure 28A] FIG. 2 is a perspective view of a base according to one embodiment of the present invention. [Figure 28B] 28B is a side view of the base of FIG. 28A. [Figure 28C] FIG. 28B is a front view of the base of FIG. 28A. [Figure 28D]28B is a cross-sectional view of the base of FIG. 28A. [Figure 29] 1 is a cross-sectional view of a biopsy cap assembly including a sealing member and a base, according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0025] While aspects of the invention are susceptible to various modifications and alternative forms, certain of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that it is not intended to limit aspects of the invention to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0026] The present invention is not limited to the specific embodiments described. The terms used herein are for the purpose of describing specific embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs.

[0027] Although embodiments of the present invention are described with respect to endoscopes, it should be understood that such devices, systems and methods may be used with a variety of medical or other devices, including valves, working channels, ports, pores, channels, etc.

[0028] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The terms "comprises" and / or "comprising" or "includes" and / or "including," as used herein, specify 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 groups thereof.

[0029] As used herein, the term "distal" refers to the end along a medical device that is furthest from the medical professional when the medical device is introduced into a patient's body, and the term "proximal" refers to the end along a medical device that is closest to the medical professional when the medical device is introduced into a patient's body.

[0030] As used herein, the conjunction "and" includes each of the structures, components, features, etc. so combined, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so combined, separately and in any combination and number, unless the context clearly dictates otherwise.

[0031] The term "valve" as used herein may refer alone, together with or integrally with a biopsy cap or assembly, to a pore, opening, slit, slot, seal, or sealing member having multiple radial or axial protrusions, projections, or walls.

[0032] All numerical values ​​herein are deemed to be modified by the term "about," whether explicitly stated or not. The term "about," in the context of numerical values, generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) can be deemed to have its ordinary and accustomed definition as understood from and consistent with the context of this specification, unless otherwise specified. The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0033] For clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or claims to list and / or identify various described and / or claimed features. It should be understood that such numerical nomenclature is not intended to be limiting and is merely exemplary. In some embodiments, for brevity and clarity, modifications may be made to and departures from previously used numerical nomenclature. That is, an element identified as a "first" element may later be referred to as a "second," "third," etc. element, or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or designation in each instance will be apparent to those of ordinary skill in the art.

[0034] The terms "unitary" and "unitary" shall generally refer to one element or multiple elements made or constructed from a single structure or base unit / element. Unitary and / or unitary element shall exclude structures and / or features made by assembling or otherwise joining together multiple separate elements.

[0035] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, it is within the knowledge of one skilled in the art to apply that feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary. That is, various individual elements described below, even if not explicitly shown in specific combinations, are nevertheless contemplated as being combinable or configurable to form other or additional embodiments, or to supplement and / or enhance the described embodiments, as would be understood by one skilled in the art.

[0036] A wide variety of endoscope assemblies, biopsy caps, and seals have been developed. Known endoscope assemblies, biopsy caps, and seals each have certain advantages and disadvantages. There remains a need to provide alternative endoscope assemblies, biopsy caps, and seals, as well as methods of making and using them.

[0037] In an effort to achieve controlled fluid exchange, a biopsy cap collinear with an endoscope's working channel (e.g., attached to the inlet / proximal port of the working channel) can provide sealable instrument access to the working channel while restricting unwanted fluids from entering or exiting. These features may generally be inversely related; the easier it is for a medical professional to thread an instrument through the biopsy cap, the more difficult it may be to prevent fluids from leaking through the biopsy cap. Conversely, a biopsy cap designed for significant leak protection may require the medical professional to use additional force to thread a medical instrument through the biopsy cap, which may be difficult for delicate instruments or instruments with large diameters. Furthermore, the biopsy cap may be damaged as a medical instrument is moved through and / or locked into place, which may compromise leak protection.

[0038] While an endoscopic procedure that can include placing a valved biopsy cap collinear with an endoscope's working channel is used in the context of the biopsy cap embodiments described herein, it should be understood that these and other embodiments within the scope of the present invention may be applicable in other fields, products, and procedures, as discussed above. An endoscopic procedure can include, for example, attaching a biopsy cap to an inlet or proximal port of an endoscope working channel. The endoscope can then be inserted into a patient's body cavity or lumen. Gas can then be insufflated into the body cavity or lumen to enhance visualization and provide a working space therein. In doing so, positive pressure can be created within the body and within the channel. The pressure can be maintained by the installed biopsy cap. At least one pore in the biopsy cap can be configured to open and grip and seal around one or more medical instruments inserted through the biopsy cap. In addition to substantially preventing fluid exchange across the pores of the valve, seal member, and / or cap (i.e., into or out of the working channel and / or the patient's body), the valve can "squeegee" liquid from the exterior of the instrument as it is inserted or withdrawn. At least one pore is configured to substantially or completely close when not obstructed by the instrument to prevent fluid exchange and / or insufflation loss.

[0039] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which similar elements in different drawings are numbered the same. The detailed description and drawings are intended to illustrate, rather than limit, the present invention. Those skilled in the art will understand that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description and drawings illustrate example embodiments of the present invention. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, but they can be understood to be present independently unless otherwise specified. FIG. 1 illustrates an example endoscope and / or endoscope assembly 10. The endoscope 10 can be any of many types of endoscopes or related medical devices, typically identified by the particular anatomical structure desired to be reached. For example, the endoscope 10 can be a bronchoscope, colonoscope, duodenoscope, esophagoscope, guide tube, introducer (with or without visual or visualization capabilities), or any other type of endoscope or related medical device. Endoscope 10 may include a handpiece 12 and an elongate shaft 14 extending distally from handpiece 12 to a distal tip 18. Shaft 14 may include a lumen that defines a working channel 16 that extends through shaft 14 from a distal end 19 near the distal tip 18 of shaft 14 to an access port 20 that may be positioned on handpiece 12 or another portion of endoscope 10. Although endoscope 10 is shown in FIG. 1 as having a single working channel, it can be understood that in other embodiments, endoscope 10 may include multiple working channels as desired.

[0040] The handpiece 12 may include one or more controls 22, such as rotary knobs, that can be used to control the movement of the distal tip 18 of the shaft 14 during operation. For example, a first rotary knob 22a may control the up and down movement or deflection of the distal tip 18 of the shaft 14, and a second rotary knob 22b may control the lateral movement or deflection of the distal tip 18 of the shaft 14. The handpiece 12 may also include one or more buttons 24 that can be used to activate the aspiration 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 an optical cable 26 connected to an external light source (not shown).

[0041] 2 , an access port 20 of the handpiece 12 is shown providing access to the working channel 16 of the endoscope 10. The access port 20, which may extend from the side of the endoscope 10 or at another location, may include a coupling portion 28 that couples a cap 30 to the access port 20. The cap 30, which may be removably or permanently attached to the access port 20, may provide access for inserting and / or advancing an endoscopic device through the working channel 16 of the endoscope 10.

[0042] Caps, such as cap 30, which may be referred to as a "biopsy cap," are often designed with several functions in mind. For example, cap 30 can form a fluid / air barrier for working channel 16, which can help control insufflation and leakage of bile fluid from the working channel, which could subsequently spill onto the clinician's hands and / or the floor, thereby hindering the intervention and / or posing a potential biohazard. Additionally, cap 30 can have an opening 32 extending therethrough. Opening 32 can be in fluid communication with working channel 16 and can reduce the size of opening 34 of working channel 16, for example, to accommodate an endoscopic device or instrument. Thus, caps, such as cap 30, can be adapter-like in that they create a physical transition at opening 34 of working channel 16 (or other instrument channel or access point) to more closely match 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 June 20, 2006, entitled "Medical Device For Use In Endoscopic Procedure," U.S. Patent Application No. 11 / 405,655, filed April 17, 2006, entitled "Elongate Medical Devices Having An Improved Distal Profile For Use With An Endocsope," and U.S. Patent Application No. 11 / 405,655, filed April 7, 2006, entitled "Biopsy port for easy device passage." No. 11 / 400,806, entitled "Passage," the disclosures of which are incorporated herein by reference in their entirety and for all purposes.

[0043] In various embodiments, the features and advantages of providing sealable access to a working channel, for example, of an endoscope, may be embodied in combination with a biopsy cap and biopsy cap housing. Such sealable access to the working channel, which can be reinforced, is described in U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, entitled "Biopsy Cap For Use With Endoscope," U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Attachments For Endoscopes," Attorney Docket No. 8150.0613, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Biopsy Cap And Biopsy Cap Housing," Attorney Docket No. 8150.0553, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Devices, Systems, And Methods For A Biopsy Cap And Housing," Attorney Docket No. 8150.0657, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Internal Seal for Biopsy Cap," Attorney Docket No. 8150.0658, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Attachments For Endoscopes," Attorney Docket No. 8150.0659, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Devices, Systems, And Methods For A Biopsy Cap And Housing," Attorney Docket No. 8150.0659, U.S. patent application Ser. No. 16 / 100,960, filed on even date herewith, entitled "Internal Seal for Biopsy Cap," Attorney Docket No. 8150.0659, U.S. patent application Ser. No. 16 / 10 U.S. patent application having attorney docket number 8150.0610 entitled "Biopsy Cap," filed on even date herewith, entitled "Devices, Systems, and Methods for Providing Sealable Access to a Working Channel," No. 6,250,555, entitled "Ultra-High Performance In-Vehicle System with Integrated Circuits," which has attorney docket number 8150.0555 and which is incorporated herein by reference in its entirety for all purposes.

[0044] Although embodiments of the present invention are described specifically with respect to biopsy caps and biopsy cap housings that are configured to enable delivery and / or exchange of various medical devices through the biopsy cap and ports of an endoscope, laparoscope, or other visualization system, such as the Spy Glass® Direct Visualization System (Boston Scientific Corp., Marlborough, Massachusetts), it should be understood that such designs can be adapted to accommodate and / or be used with various medical devices and applications that include sealable access.

[0045] Additionally, multiple biopsy caps are contemplated that incorporate at least some of the desirable features of the biopsy cap and have other desirable features. This specification discloses several of the contemplated cap embodiments. These caps may include a passive seal. For purposes of the present invention, a passive seal is a seal that seals the endoscope 10 at the port 20 (e.g., of FIG. 1 ) to prevent leakage of bodily fluids and / or air. Furthermore, by "passive," the seals disclosed herein are configured to seal the endoscope 10 at the port 20 without the need for any so-called "active" processes or steps by the clinician.

[0046] Referring to FIG. 3 , one embodiment of a biopsy cap 130 according to the present invention is shown. The biopsy cap 130 includes an outer shell 136 defining an interior chamber 132, a securing member 140 that can help secure the cap 130 to the port 20 (e.g., of FIG. 1 ), one or more locking members 142 bonded to the shell 136, and an interior seal member 100 disposed within the outer shell 136. The outer shell 136 can take on a number of different shapes and forms. Generally, however, the outer shell 136 can be fabricated from a relatively rigid or hard polymer / plastic, a metal or metal alloy, a ceramic, or the like, or a combination thereof, and can take on a form resembling an exoskeleton or protective covering over a more detailed interior portion (e.g., the seal member 100). Furthermore, because the outer shell 136 is formed from a relatively rigid material, several accessories and / or structural components of the cap 130 can be secured to or integrally formed with the shell 136. For example, the securing member 140 and / or the locking member 142 may be secured to or integrally formed with the outer shell 136 .

[0047] The outer shell 136 can have one or more pores 146 formed therein. The pores 146 can be located, for example, on the top surface, i.e., the surface opposite the fixation member 140, although any other suitable portion of the outer shell 136, including a side or flank, can include the pores 146. The pores 146 can be entry points or otherwise define one or more openings that extend through the internal chamber 132 of the cap 130 and into the working channel 16 (e.g., of FIG. 1) when the cap 130 is positioned over the port 20. For example, the pores 146 can extend through the outer shell 136 and provide access to the seal member 100. The pores 146 can thus form an external opening in the cap 130 through which other medical devices (e.g., guidewires, catheters, etc.) can pass to access the working channel 16 via the seal member 100. The cap 130 can include a flange 138 extending into the internal chamber 132. Seal member 100 can be seated on flange 138. Seal member 100 can have openings 105 on its top and bottom surfaces, which can be longitudinally aligned with slots 146 in cap 130. Slots 146 can guide a medical device into openings 105 and through seal member 100.

[0048] In various embodiments, the slot 146 can have a chamfered or beveled edge, which can act like a funnel to guide the medical device into the slot 146 and aid the surgeon's ability to pass the medical device through the slot 146. In addition to the funneling function that can be realized by the inclusion of a beveled slot 146, the slot 146 can also impart several additional desirable features to the cap 130. For example, because the slot 146 is formed in the relatively rigid outer shell 136 and because the slot 146 is generally positioned a distance from the port 20 (e.g., in FIG. 1 ), the slot 146 and / or the outer shell 136 can also function as a strain relief mechanism that can relieve strain that might otherwise be imposed on the endoscope 10 (e.g., at the port 20), for example, during device exchange or movement. Thus, shear stresses that might occur during device exchange can be shifted away from the endoscope 10, thereby improving the ability of the cap 130 to maintain a seal at the port 20.

[0049] In various embodiments, the securing member 140 can be disposed on a bottom surface of the cap 130. The securing member 140 can take any number of wide forms, including those disclosed herein. For example, the securing member 140 can include a pair of tabs 150 a, 150 b, which can snap or otherwise secure to the port 20 (e.g., FIG. 1 ). Securing the tabs 150 a, 150 b onto the port 20 can include, for example, snapping the tabs 150 a, 150 b onto a narrow ring or portion of the port 20. This can include snapping the tabs 150 a, 150 b onto the port 20 from a peripheral or side region of the port 20. Additionally, a portion of the shell 136 can include a cutout or notch (not shown), which can provide some structural relief for the securing member 140 and allow the tabs 150 a, 150 b to have greater flexibility when securing the cap 130 to the port 20 than would be possible without the relief mechanism. The exact form of the securing member 140 and / or tabs 150a, 150b can be varied. For example, a different number of tabs can be utilized, different shapes of tabs can be utilized, and / or different securing systems can be utilized in conjunction to secure the cap 130 to the port 20. For example, if the tabs 150a, 150b or another suitable securing member 140 do not readily allow for a suitable connection between the cap 130 and the port 20, various adapters can be provided to effect such a connection.

[0050] The locking member 142 may generally be positioned adjacent the top surface of the cap 130 and may be used to secure and / or retain a portion of a device (e.g., a guidewire, catheter, etc.) extending through the cap 130 and into the working channel 16. However, the locking member 142 may be positioned on any suitable surface of the cap 130 and / or shell 136. The locking member 142 may also be integrally formed with the shell 136. In addition to retaining the position of the device, the locking member 142 may also tend to guide other devices away from the center of the cap 130 so that these devices can access the working channel 16 through the cap 130. In at least some embodiments, the locking member 142 may include one or more bends, hooks, or channels 144 formed therein that a medical device can wrap or compress around to hold the medical device in place. The number of locking members 142 may vary. In some embodiments, one locking member 142 is utilized. Other embodiments utilize two, three, four, five, six, or more locking members 142. Additionally, the exact form of the locking members 142 can vary. For example, the locking members 142 may or may not include wings or flaps that may tend to point the device toward the locking members 142.

[0051] Figure 4 is a top view of a seal member 200 according to one embodiment of the present invention, which may be disposed within the cap 130 shown in Figure 3. The seal member 200 may include a body 205 defined by a peripheral outer wall 210 surrounding a central lumen 215. At least one axial support wall 230 may extend radially from the outer wall 210 into the central lumen 215. As shown in Figure 5, at least one spiral flap 220 may extend from a top surface 232 of the support wall 230, spiraling downward along the inner surface of the outer wall 210 to a bottom surface 234 of the support wall 230. The spiral flap 220 and the support wall 230 do not extend to the center of the lumen 215, leaving an opening 240 extending completely through the seal member 200. 3 into lumen 150 of seal member 200 and through opening 240 into working channel 16 for use as part of a medical intervention. Alternatively, spiral flap 220 and support wall 230 can extend to the center of lumen 215 while still allowing an instrument to pass through lumen 215 (e.g., by spiral flap 220 and / or support wall 230 bending and / or tearing).

[0052] In the embodiment shown in Figure 4, the seal member 200 includes only two support walls 230 disposed opposite one another and only two spiral flaps 220, each spiral flap extending spirally from one of the two support walls 230. As shown in Figure 5, each spiral flap 220 may extend spirally downward from a first end 222 at a top surface 232 of the support wall 230 to a second end 224 at a bottom surface 234 of the opposite support wall 230. The downward direction may be defined as extending from the top surface 212 to the bottom surface 214 of the body 205. Each spiral flap 220 may extend downward in two directions: spirally along the outer wall 210 in the direction indicated by a first arrow 226, and radially toward the opening 240 in the direction indicated by a second arrow 228. The downwardly sloping spiral flap 220 can help guide or feed a device through the opening 240. The support wall 230 can extend perpendicularly along a longitudinal axis extending through the opening 240. Two support walls 230 can be positioned opposite each other, with the spiral flaps 220 each defining substantially one half of the circular seal member 200.

[0053] In the embodiment shown in FIGS. 4 and 5, the seal member 200 includes only two support walls 230 and two spiral flaps 220, which may provide advantages over seal members with three or more support walls and spiral flaps. For example, by including only two support walls 230 and two spiral flaps 220, the thickness of the flaps along their cross-sections can be increased by 10-20%, thereby improving sealing performance. Furthermore, the number of pockets that may form at the bottom of the flaps and support walls is reduced. These pockets can become deeper when the angle between the flaps and support walls is reduced. By reducing the number of support walls and flaps to only two, the angle between the flaps and support walls is increased, thereby reducing pocket depth, thereby significantly reducing the occurrence of device blockage and improving device passability, i.e., the ability of devices to move through the seal member 200.

[0054] In various embodiments, the outer wall 210 of the seal member 200 can include a series of alternating grooves 250 and legs 260 on both the top and bottom surfaces. The grooves 250 and legs 260 allow two or more seal members 200 to be stacked (e.g., axially relative to one another). In some embodiments, the grooves 250 and legs 260 can be the same size and equally spaced around the circumference (not shown) of the outer wall 210, allowing two seal members 200 to be stacked in any of four 90-degree angular orientations. For example, the two opposing support walls 230 of each seal member 200 can be stacked on top of one another (a "minus" or dash symbol configuration, which is the same as if one seal member were rotated 180 degrees), or the two opposing support walls 230 of one seal member 100 can be oriented perpendicular to the support walls 230 of the second seal member 200 (a "plus" or cross symbol configuration, which is the same as if one seal member were rotated 90 degrees). In other embodiments, grooves 250 and legs 260 can be spaced non-equally (see FIG. 5) and sized to allow two seal members 200 to be stacked only in two 180 degree angular orientations. Sizing and spacing grooves 250 and legs 260 to allow two seal members 200 to be stacked only in a "plus" configuration provides a better seal with similar ability (e.g., passability) for a medical device to pass through seal member 200 compared to a "minus" configuration.

[0055] Referring to Figure 6, a cross-sectional view of the seal member of Figures 4 and 5 is shown, showing a spiral flap 220 extending spirally downward from a first end 222 at the top surface 212 of the body 205 to a second end 224 adjacent the 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 seal member 200. Figure 7 shows a cross-sectional view rotated 90 degrees from Figure 6 through each of the opposing support walls 230. Figure 7 illustrates the variable diameter of the opening 240 adjacent the support wall 230. The support wall 230 can angle downward from a base 233 connected to the outer wall 210 to an inner edge 235 that partially defines the opening 240. Opening 240 increases from a first diameter D1 between opposing support walls 230 adjacent top surfaces 232 of support walls 230 to a second diameter D2 at bottom surfaces 234 of support walls 230. The increased diameter at the bottom of seal member 200 prevents the formation of pockets that could impede the introduction of curved-tip medical devices. The reduced diameter D1 at the top compensates for the larger bottom diameter D2 of opening 240, thus maintaining the sealing properties of seal member 200.

[0056] 4-7 may be a single, integral part formed by injection molding or other suitable molding technique. The seal member 200 may be made from an elastomeric material such as flexible silicone.

[0057] FIG. 8 illustrates a top view of a seal member 300 according to one embodiment of the present invention, which may be disposed within the cap 130 shown in FIG. 3 . The seal member 300 may include a body 305 defined by a peripheral outer wall 310 surrounding a central lumen 315. A plurality of protrusions 320 may extend radially inward from the outer wall 310 toward the center of the lumen 315. The protrusions 320 may extend radially inward from bases 322 attached to the outer wall 310 to tips 324. The tips 324 of the protrusions 320 do not meet at the center of the lumen 315, leaving openings 340 that extend completely through the seal member 300. Thus, a medical device may be advanced through the pores 146 of the cap 130 shown in FIG. 3 , through the openings 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 lumen 315 while still allowing an instrument to pass through the lumen 315 (eg, by the projection 320 bending and / or splitting).

[0058] In various embodiments, the plurality of protrusions 320 can be oriented in a series of circumferentially angularly offset layers that spiral downward around the seal member 300 from the top surface 312 to the bottom surface 314 of the outer wall 310 in a stepped manner as shown in Figure 9. Each layer can include a plurality of circumferentially spaced protrusions 320. The series of offset layers may extend axially along the body 305, with a first layer 321 defining a portion of the top surface 312 of the body, a second layer 323 disposed below and circumferentially offset from the first layer 321, a third layer 325 disposed below and circumferentially offset from the second layer 323, a fourth layer 327 disposed below and circumferentially offset from the third layer 325, a fifth layer 329 disposed below and circumferentially offset from the fourth layer 327, etc. The bottom layer may define a portion of the bottom surface 314 of the body 305.

[0059] The seal member 300 can include any number of protrusions 320. In some embodiments, the seal member 300 can include multiple layers, each layer including, for example, 3 to 15 circumferentially spaced protrusions 320 evenly spaced around the body 305. The seal member 300 can include, for example, 3 to 15 layers of protrusions. In the example shown in Figure 9, the body 305 includes seven layers, each having five protrusions.

[0060] A medical device can be inserted through the opening 340 of the seal member 300, and the tips 324 of the protrusions 320 can engage with the medical device to form a seal. The seal member 300 can provide an improved seal for catheters or other medical devices having longitudinal slits or grooves, particularly C-shaped longitudinal grooves. As shown in FIG. 10 , when a device 400 having a C-shaped groove 410 is inserted through the opening of the seal member 300, the tips 324 of the protrusions 320 can enter the groove 410 of the device 400, providing an enhanced seal. The multiple protrusions 320 circumferentially disposed about the outer wall 310 and extending radially inward can provide the advantage of engaging the groove 410 regardless of the rotational orientation of the device 400. Additionally, when the device 400 is rotated while disposed within the seal member 300, some of the protruding tips 324 slide out of the groove 410 as the device 400 rotates, while adjacent protruding tips 324 enter and seal the groove 410, thereby keeping the groove 410 sealed. In some embodiments, the protruding tips 324 can be sized and shaped to match the dimensions of the groove 410 of a particular device 400.

[0061] Various methods can be used to manufacture and / or assemble the seal member 300. In one example, the seal member 300 can be molded as a plurality of separate disks 370, as shown in FIG. 11 . In various embodiments, each disk 370 can be molded with, for example, five protrusions 320 (although, as noted above, other numbers of protrusions 320 are contemplated), each having a tip 324 sized to engage with a C-shaped groove. The disks 370 can be stacked together, circumferentially offset at an angle such that each disk spans the entire 360° circumference of the opening 340. The stacked disks can then be joined together to form the seal member 300. While this stacking process provides the seal member 300 with the desired sealing properties, molding each disk individually and then assembling them into the seal member 300 can be time-consuming and, further, requires expensive automated assembly processes because manual assembly is not feasible. Furthermore, controlling the angular orientation of each disk during assembly can be costly and challenging. All of these factors can increase assembly costs and reduce yields.

[0062] However, molding the seal member 300 with all of the protrusions 320 facing inward in a single molded component can be difficult due to the large number of undercuts required and limited tool travel. Additionally, the fused core molding process can increase costs and affect component quality.

[0063] In one embodiment, the entire seal member 300 can be molded in a single, monolithic piece in a simple, cost-effective manner. As shown in FIG. 12, the seal member 300 can be molded with the bases 322 of all of the projections 320 positioned at the periphery of the outer wall 310 and the tips 324 of the projections 320 extending radially outward. The projections 320 can be arranged in a series of circumferentially offset layers. In the example shown in FIG. 13, each layer has five projections 320, resulting in seven layers of projections, each circumferentially offset from the layer above and below. This orientation forms a staircase of projections 320. After demolding, the seal member 300 is flipped over, as indicated by arrow 390, so that the projections 320 are oriented toward the center. The resulting structure is similar to that shown in FIG. 9. The layers of projections 320 can be offset in various patterns. In some embodiments, each layer of projections can be circumferentially offset from the adjacent layer by 5 to 40 degrees. In the example shown in Figure 13, a layer of protrusions can be circumferentially offset by 11 degrees from the adjacent layer above and / or below. In another example shown in Figure 14, the seal member 500 can have seven layers of protrusions 520 that are circumferentially offset by 22 degrees from the adjacent layer above and / or below.

[0064] In one embodiment, the outer wall 310 of the seal member may include one or more axial grooves or slits 395 formed in the interior surface during molding, as shown in Figure 15. The slits 395 are in the exterior surface of the outer wall 310 after the seal member 300 is everted and may provide a stress relief mechanism for the finished seal member 300. The slits 395 may help prevent or reduce distortion of the seal member 300 after it is everted.

[0065] An inside-out seal member 300 with any orientation of the protrusions 320 can be manufactured by an injection molding process. In one embodiment, the seal member 300 can be formed using a radially removable mold 600, as shown in FIG. 16 . The radially removable mold 600 can include multiple radially movable segments and a core element 650. The desired number and orientation of protrusions are formed in the mold segments, which are radially removed to release the seal member 300, as indicated by arrows 660. The size of the core element 650 determines the dimensions of the outer wall 310 of the seal member 300. In various embodiments, the seal member can be formed using an axially fixed mold 700, as shown in FIG. 17 . The axially fixed mold 700 can include a top 710 and a base 720 and a series of fixed protrusion orientation plates 730, with each plate 730 defining the shape and orientation of one layer of protrusions 320.

[0066] In various embodiments, the seal members 100, 200, 300 can comprise soft materials such as plastic, foam, silicone, rubber, or elastomers that may be suitable for sealing around a medical device extending therethrough. The exact configuration and materials for the seal members 100, 200, 300 can vary. For example, the seal members 100, 200, 300 can comprise flexible or moldable materials that may or may not be absorbent. In some embodiments, the seal members 100, 200, 300 can comprise materials used in constructions similar to those disclosed in U.S. Patent No. 6,663,598, filed May 17, 2000, entitled "Fluid Seal For Endoscope," the disclosure of which is incorporated herein by reference in its entirety for all purposes. In at least some embodiments, the seal member 100, 200, 300 can extend laterally to the edge (and / or top) of the shell 136, thereby substantially filling the interior chamber 132. This can help prevent or reduce the amount of fluid that may migrate into and out of the cap 130. Alternatively, a gap can be formed between the top of the seal member 100, 200, 300 and the top of the interior chamber 132 of the shell 136, which can be used to retain bodily fluids that may leak and otherwise splash out of the seal member 100, 200, 300, for example, during device removal or replacement. In further embodiments, a portion of the seal member 100, 200, 300 can extend from the shell 136 and define or otherwise function as a strain relief feature.

[0067] In addition to being placed within a biopsy cap 130 for an endoscope, the seal members 100, 200, 300 may be similarly adapted for other similar applications where leak protection is required along with a device inserted through the seal member 100, 200, 300. Additionally, by having a downwardly directed flap, the seal member 200 can also act as a one-way valve to seal fluid within the seal member 200.

[0068] Referring to Figure 18, an isometric view of a biopsy cap 1800 is shown. The biopsy cap 1800 can be placed collinearly with the entrance to a working channel (e.g., as shown in Figures 1 and 2). The biopsy cap 1800 includes a pore 1802, which is a substantially linear, one-dimensional slit. The pore 1802 is in a substantially closed configuration without any open space between the walls of the pore 1802. The pore 1802 is ready to allow one or more medical instruments to be passed therethrough.

[0069] Referring to FIG. 19 , an enlarged view of the pore 1802 of a used biopsy cap 1800 of FIG. 18 is shown. The pore 1802 of the biopsy cap 1800 extends substantially linearly across a portion of the biopsy cap 1800. After the pore 1802 has been used in a procedure, it has a length 1906 that is greater than its original length 1904. During use of the biopsy cap 1800, one or more medical instruments may be inserted into the linear end of the pore 1802, causing the pore 1802 to tear further along the biopsy cap 1800 such that the length of the pore 1802 extends from the original length 1904 to the enlarged length 1906, reducing the sealing strength of the biopsy cap 1800 and increasing the ease of passage through the pore 1802 compared to the pore 1802 prior to tearing.

[0070] 20A and 20B, a biopsy cap 2000 is shown including two guidewires 2024 extending through a pore 2002, according to one embodiment of the present invention. The guidewires 2024 extend away from the pore 2002 and are guided by a guide member 2022. The guidewires 2024 are pressed against the walls of the pore 2002 generally in the direction of vectors 2026 shown in FIG. 20B. These vectors 2026 diverge away from the axis of the pore 2002 at some angle α, causing the pore 2002 to be pushed open at least at the ends of the pore 2002 by the guidewires 2024. FIG. 20B shows that the guidewires 2024 tear the pore 2002 in multiple directions, opening a first portion 2004 of the pore 2002 and opening a second portion 2006 with the widened tear. A first portion 2004 of pore 2002 opens inadequately, allowing possible exchange of fluid through pore 2002, and a second portion 2006 tears to open wider than first portion 2004, allowing even more fluid to be exchanged through pore 2002.

[0071] In various embodiments, a longer linear pore length may be desirable to reduce the axial force required to insert and remove a medical device through the pore, compared to a shorter linear pore length. However, since a longer linear pore length may be less able to prevent fluid exchange through the pore, compared to a shorter linear pore length, a relatively short linear pore can be reinforced to accomplish both goals, e.g., to reinforce the pore against tearing to inhibit or prevent fluid exchange, while also helping to provide sealable access for instruments. For example, the pore can simultaneously have an amount of resistance to insertion of a medical device such that there is generally a seal against fluid exchange across the pore and / or such that fluids can be wiped off the medical device as it is removed from the working channel through the pore. In the context of a biopsy cap used in a working channel in an endoscopic procedure, an exemplary amount of force applied by a medical professional to pass one or more medical devices through the aperture can be from about 2.224 N (about 0.5 lbf) to about 15.569 N (about 3.5 lbf).

[0072] 21A-21F, an embodiment of a device for providing reinforced, sealable access to a working channel is shown, including a biopsy cap 2100 with a tubular body 2104 having a proximal end 2106 and a distal end 2108 and extending along a longitudinal axis. The distal end 2108 is configured to be collinear with the working channel at the proximal end or inlet port of the working channel. The biopsy cap 2100 includes a substantially linear pore 2102 at the proximal end 2106 of the body 2104. The pore 2102 extends along a centerline axis r that is perpendicular to the longitudinal axis of the tubular body 2104 and is configured to allow one or more medical instruments to pass through the pore 2102 while simultaneously providing a substantial seal against fluids from the working channel passing through the pore 2102. Six reinforcing ribs 2110 are arranged about the pore 2102. The ribs 2110, shown from the bottom view of the biopsy cap 2100 in FIG. 21A, are disposed on a surface 2118 on the interior of the tubular body 2104 and extend distally from the surface 2118 along the longitudinal axis. The ribs 2110 extend in a plane substantially perpendicular to the longitudinal axis. The ribs 2110 furthest from the normal axis n can be disposed at about 15° to about 75°, or about 45°, from the normal axis n or from the axis r. The ribs 2110 act to stiffen the pores 2102 in the closed position, helping the pores 2102 resist fluid pressure and exchange across the pores 2102. The placement and number of ribs 2110 closer to the axis n increases 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 axis r) also helps provide a resistive force 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. This resistance force f can resist a force exerted by an object (e.g., a guidewire or another instrument passing through the pore 2102). Additionally, the ribs 2110 are not disposed or extend substantially along the axis r. This is done to further promote stiffening and closure of the pore 2102 of the biopsy cap 2100 substantially along the direction of the axis n compared to stiffening and closure of the pore 2102 along the axis r.Any force substantially along axis n (e.g., applied by a guidewire or instrument) that may cause the pore 2102 to open and / or tear will act on a portion of the biopsy cap 2100 that has a higher stiffness when compared to a portion of the biopsy cap 2100 where the force may act substantially along axis r. The ribs 2110 become wider and thicker as they extend radially away from the pore 2102 from the first end 2112 to the second end 2114 (i.e., the ribs 2110 are wider and thicker at the second end 2114 than at the first end 2112). The wider and thicker second end 2114 of the ribs 2110 that extend toward the pore 2102 to the narrower and thinner first end 2112 contributes a focused resistance force vector f that is directed toward the center of the pore 2102 when compared to a rib 2110 of uniform width and thickness. Additionally, a given rib 2116 of a group of ribs 2110 that are perpendicular to the r axis and extend 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 contributing to the resistance force vector f in a direction perpendicular to the axis r to promote stiffening and closure of the pore 2102. Increasing the combined volume of material of the ribs 2110, for example, by increasing the width, thickness, or length of one or more ribs 2110 or by increasing the number and / or placement of the ribs 2110 with respect to the axis n, can contribute to the resistance force vector f by providing additional rib 2110 mass to resist the force of an instrument within the pore 2102. These characteristics of the ribs 2110 can be adjusted to "tune" the biopsy cap 2100 for the desired level of resistance to tearing, facilitated closure of the pores 2102, amount of fluid exchange, and instrument force required to pass an instrument through the pores 2102. A rib 2110 extending along axis n can contribute more to the force vector f than another rib that is offset from axis n, for example, a rib 2110 that is angled from axis n at about 15° to about 75°, or about 45° about the longitudinal axis of the biopsy cap 2100.The force required to tear a pore 2102 of a biopsy cap 2100 with ribs 2110 is greater than the tear force for the same pore without ribs 2110. While FIGS. 21A and 21C show six ribs 2110, any number of ribs (e.g., 1, 2, 3, 4, 5, 7, 8, 9, 10, 12, 20, 50, 100, etc.) can be included. While these figures show variable widths and thicknesses between the ribs 2110, the ribs 2110 can be of uniform width and thickness. The ribs 2110 are arranged substantially symmetrically about axis r so that the resistance force vector f acting on the pore 2102 is substantially symmetric. In some embodiments, the arrangement can be asymmetric. Ridges 2120, as described below, are also included to aid in reinforcement and tear resistance. The ridges 2120 may be combined with the biopsy cap 2100, or the biopsy cap 2100 may not include the ridges 2120. The ridges 2120 may be located radially outward of the ribs 2110, or the ridges may extend through the ribs 2110 (e.g., as shown in FIG. 10, described below). The ridges 2120 and / or ribs 2110 may alternatively or additionally be located on the proximal and / or distal surfaces of the biopsy cap 2100.

[0073] 21D-21F, a biopsy cap 2100 is shown within an exemplary housing 2120, according to one embodiment of the present invention. The housing 2120 includes a variably sized locking groove 2122 that accommodates one or more medical instruments (e.g., guidewires). The medical instruments may also be assisted by a guide arm 2126. The biopsy cap 2100 also includes a first surface feature 2114a attached to or integrally formed with the proximal end of the biopsy cap 2100, as well as second and third surface features 2114b and 2114c attached to or integrally formed with the tubular body 2104 of the biopsy cap 2100. These surface features 2114a, 2114b, and 2114c compressively and / or frictionally engage corresponding surface features 2116a, 2116b, 2116c of the housing 2120, which may be lips, step features, etc., integrally formed with the inner wall of the housing 2120. 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 periphery of the biopsy cap 2100. Pivot members 2114a, 2114b (e.g., first pivot buttons, first pivot features, etc.) are integrally formed within the housing 2120 and compressively and / or frictionally engage corresponding recessed portions 2112a, 2112b.

[0074] In various embodiments described herein and elsewhere, the ribs of the device can extend radially in a plane substantially transverse to the longitudinal axis of the device. Each rib of the plurality of ribs can have a width dimension in the 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 pore of the device. Some ribs can extend substantially perpendicular to the pore, with widths greater than the widths of any other ribs. The ribs can have increasing widths and thicknesses as they extend radially away from the pore. The ribs can continuously increase in width and thickness as they extend radially away from the pore. One or more of the ribs can have a thickness greater than the thickness of one or more of the other ribs, as described above. The body can be hollow, and the ribs can be disposed on the interior surface of the tubular body. The ribs can be disposed only on the top surface, only on the bottom surface, or on both the top and bottom surfaces. The ribs, as described above, can be arranged symmetrically in a circular pattern around the pores in a plane transverse to the longitudinal axis of the device. Ribs can be combined with other reinforcing features described herein, such as ridges.

[0075] 22A and 22B, one embodiment of a device for providing reinforced, sealable access to a working channel is shown, comprising a biopsy cap 2200 with a tubular body 2204 having a closed, substantially straight pore 2202 at a proximal end 206 of the body 2204 configured to allow one or more medical instruments to pass through the pore 2202 while substantially sealing against fluids from the working channel passing through the pore 2202. A distal end of the body 2204 (opposite the proximal end 2206) is configured to be positioned collinear with the working channel at the proximal end or entry port of the working channel. A ridge 2210 is disposed on the proximal end 2206 of the body 2204, extending about the pore 2202. The ridge 2210 has a peripheral contour that is circular in shape but can be any shape, such as elliptical, oval, a combination of shapes, etc., centered about the pore 2202. The ridge 2210 has a cross-sectional thickness in a plane parallel to the longitudinal direction of the device 2200 that is thicker than an inner portion 2208 of the tubular body 2204 that is centered within the ridge 2210. The thickness of the ridge 2210 can vary, 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 pore 2202 extends. For example, the ridges 2210 can have a peak thickness of about 0.071 inches (about 1.80 millimeters), and the wall thickness of the proximal end 2206 of the biopsy cap 2200 through which the pores 2202 extend can be about 0.038 inches (about 0.97 millimeters). The thickness of the ridges 2210 provides resistance to forces from a medical instrument against the walls of the pores 2202 that could otherwise tear the pores 2202. The cross section of the ridges 2210 is substantially semicircular or half-moon shaped, although numerous other shapes can be employed, such as, for example, parabolic, curved, rectangular, tapered, combinations thereof, etc. The pores 2202 do not extend all the way to the ridges 2210, allowing a minimal amount of tearing before the torn pores 2202 propagate to the ridges 2210.The spacing between the ends of pores 2202 and ridges 2210 can allow a medical device about the same size as or larger than pore 2202 to be inserted and threaded through pore 2202 without undue resistance. Additionally, the spacing between the ends of pores 2202 and ridges 2210 can help prevent the propagation of tears in pores 2202.

[0076] 23A and 23B, one embodiment of a device for providing reinforced, sealable access to a working channel is shown, comprising a biopsy cap 2300 with a tubular body having a longitudinal axis and a pore 2302 at a proximal end 2306 of the body. The biopsy cap 2300 is configured to be placed collinearly with the working channel. The pore 2302 is configured to allow one or more medical instruments to pass through the pore 2302 while simultaneously substantially sealing against fluids from the working channel passing through the pore 2302. The pore 2302 has a reinforcement pattern that extends in two or more dimensions in a plane substantially transverse to the longitudinal axis. The pore 2302 has a first end 2310, a second end 2312, and a third end 2314. Aperture 2302 extends substantially linearly from first end 2312 to division point 2316 and continues to extend separately and substantially linearly from division point 2316 to each of second end 2312 and third end 2314. Aperture 2302 allows multiple medical devices to be received and secured within ends 2310, 2312, 2314 of pore 2302 without multiple medical devices occupying the same end 2310, 2312, 2314, thereby reducing tearing of pore 2302, as described below with reference to Figures 24 and 25 and above with reference to Figures 18-20B. The portions of pore 2302 extending from division point 2316 to each of second end 2312 and third end 2314 are substantially the same length and extend at substantially the same angle from division point 2316 to the first end and from axis r of pore 2302, although these angles and lengths may vary or may be some combination of uniform and variable between the ends. The angle may be such that the portions of pore 2302 extending from division point 2316 to each of second end 2312 and third end 2314 are oriented toward a locking groove configured to secure a medical device within pore 2302. Furthermore, although three ends 2310, 2312, and 2314 are shown, any number of ends may be employed, for example, a number equivalent to the number of medical devices to be secured in place.The portion of pore 2302 extending from division point 2316 to second end 2312 and third end 2314 is longer than the portion of pore 2302 extending from first end 2310 to division point 2316, although these portions may be variable in length or substantially equivalent relative to one another. Second end 2312 and third end 2314 can each be configured to accommodate a single guidewire without substantially splitting. Exemplary diameters of guidewires can range from about 0.025 inches (about 0.635 mm) to about 0.038 inches (about 0.965 mm), and an exemplary length of pore 2302 from first end 2310 to division point 2316 along axis r can be about 0.040 inches (1.016 mm), although longer lengths can be used to accommodate multiple guidewires, multiple instruments, and / or larger instruments through pore 2302. An exemplary length of pore 2302 from division point 2316 to second end 2312 or third end 2314 can be about 0.040 inches (1.016 millimeters) and can be less than about 0.050 inches (1.27 millimeters). The length of pore 2302 from first end 2310 along axis r to a point between second end 2312 and third end 2314 can be about 0.080 inches (2.032 millimeters) to about 0.140 inches (3.556 millimeters). A ridge 2318 similar to ridge 2210 discussed with reference to FIGS. 22A and 22B is shown around pore 2302, although various embodiments may include or exclude ridge 2318.

[0077] Referring to FIG. 24 , a top view of a biopsy cap 2400 is shown, which includes a substantially straight pore 2402 extending from a first end 2404 to a second end 2406. Two medical devices 2420 (e.g., guidewires) extend through the pore 2402 at the second end 2406 and are pressed against the pore 2402 wall in the general direction of vector 2422 (e.g., during and after securing the medical devices 2420 within the locking grooves). The substantially straight pore 2402 is open at a first portion 2410 near the first end 2404 and tears open at a second portion 2412 near the second end. This tearing and opening in FIG. 24 opens the pore 2402 to a larger gap space than any gap space shown in FIG. 19 , which is a substantially straight tear extending along the pore 1902 in FIG. 19 . The pores 2402 are torn in a manner similar to that described with respect to the similar biopsy cap 2000 in Figures 20A and 20B above.

[0078] 25, a top view of one embodiment of a device for providing reinforced, sealable access to a working channel is shown, including a biopsy cap 2500 with pores 2502 having a reinforcing pattern that extends in two or more dimensions in a plane substantially transverse to the longitudinal axis of the device. Similar to the illustration and discussion of FIGS. 23A and 23B above, pores 2502 extend from a first end 2504 to a division point and then to each of second end 2506 and third end 2508. Two medical instruments 2520 (e.g., guidewires) extend through pores 2502, one at each of second end 2506 and third end 2508. The medical instruments 2520 are pressed against the walls of pores 2502 in the general direction of vector 2522 (e.g., during and after securing medical instruments 2520 within locking grooves).

[0079] Comparing the force vectors 2422, 2522 and tearing in Figures 24 and 25, the tearing opens the pores 2402, 2502 more than that shown in Figure 19, which is a substantially linear tear extending along the pore 1902 of Figure 19. The substantially linear pores 2402, 2502 of Figures 24 and 25 tear and / or open at both the first portion 2410, 2510 near the first end 2404, 2504 and the second portion 2412, 2512 near the opposite end (second end 2406, 2506 and third end 2508). Because the reinforcement pattern pore 2502 of Figure 25, according to one embodiment of the present invention, includes separate second and third ends 2506, 2508 for each of the medical devices 2520, the pore 2502 can tear substantially linearly along the direction of the second and third ends 2506, 2508, resulting in open areas of the first and second portions 2510, 2512 of Figure 25 that are smaller than the open areas of the first and second portions 2410, 2412, respectively, of Figure 24, which lack the reinforcement pattern for the pore. These smaller open areas of the portions 2510, 2512 of Figure 25, as compared to the open areas of the portions 2410, 2412 of Figure 24, allow for a better seal against fluid exchange across the pore 2502 when an instrument is passed through it.

[0080] Figure 26 shows a top view of a biopsy cap 2600 including a pore 2602 that extends in more than one dimension, according to one embodiment of the present invention. The embodiment of Figure 26 is the same as Figures 23A and 23B, with the pore 2602 also including a fourth end 2620. The fourth end 2620 extends opposite the first end 2610, extending from the division point 2616 and substantially along the axis r, between the second end 2612 and the third end 2614. The fourth end 2620 can accommodate an additional guidewire and / or aid in the passability of a medical device.

[0081] 27A-27C show close-up views of a biopsy cap according to an embodiment of the present invention. A pore 2702 in the biopsy cap extends substantially linearly across a portion of the biopsy cap. The pore 2702 has a length between its ends 2704. During use of the biopsy cap, one or more medical instruments can be inserted through the pore 2702, potentially resulting in tearing. Ribs 2710 and / or ridges 2720, as described herein, can limit tearing or reduce tear propagation. Referring to FIG. 27A, the pore 2702 of the biopsy cap, including the ribs 2710 and ridges 2720, has not experienced any tearing after use. Referring to FIG. 27B, the original length of the pore 2702 between the ends 2704 has torn to a larger pore between the torn ends 2706, but the tear has not propagated in a manner that affects the function of the biopsy cap. The length of original pore 2702 (between ends 2704) in Figure 27B can be from about 1.5 mm to about 4 mm, while the length of torn pore 2702 (between torn ends 2706) can be at least 5 mm. Referring to Figure 27C, pore 2702 can tear toward torn ends 2706 having a tear path that is substantially non-linear with pore 2702 (i.e., along a line between original ends 1004). The non-linear torn ends 2706 are maintained radially within ridges 2720 and also radially within ribs 2710.

[0082] 28A-28D, a base 2830 according to one embodiment of the present invention is shown, which includes a recessed annular portion 2832. It will be appreciated that the recessed annular portion 2832 can be complementary to the fixation member 140 formed as part of the biopsy cap 130, 2900 (e.g., FIG. 3 above and FIG. 29 below), such that the biopsy cap 130 can be secured to the base 2830 via a friction fit. The base 2830 and / or biopsy cap can be formed from a material that is sufficiently flexible to allow the biopsy cap to be snap-fit ​​into place on the base 2830. The base 2830 also defines a fixation region 2840 that can be configured to frictionally engage the port 20 (e.g., FIG. 2). Extensions 2844 extend distally from the base 2830 on either side of the fixation region 2840. The extensions 2844 can assist the operator in orienting the fixation region 2840 onto the port 20 so that at least one of the extensions 2844 can contact and engage a mating surface of the port 20. The extensions 2844 can also assist the operator as a handle for removing the base 2830 from the port 20. A pore 2842 extends through the base 2830 to accommodate an elongate member extending through the biopsy cap 130, 2900 and the base 2830. The proximal end 2834 of the base 2830, which forms the pore 2842, has a funnel-like shape that can direct fluids and / or instruments distally into the pore 2842. The sloping funnel-like shape of the proximal end 2834 tapers at a first angle α that transitions distally to a second angle β. Angle α can be less than angle β such that proximal end 2834 transitions (i.e., tapers) from a thicker angle α portion to a thinner angle β portion toward slot 2842, thereby allowing for greater passage (i.e., less axial force to move an instrument) closer to slot 2842 than away from slot 2842. The α and β angles can be any angle between 0 and 360 degrees; for example, angle α can be approximately 30° and angle β can be approximately 45°.A fixed area 2840 located around the periphery of the port 20 can act as a primary seal, and a ridge 2846 extending around the periphery of the fixed area 2840 that compressively engages with the upper surface of the port 20 can act as a secondary seal.

[0083] 29 shows a cross-sectional view of an assembly of biopsy cap 2900, base 2902, and sealing members 2910, 2912, 2914, 2916, according to one embodiment of the present invention. Sealing members 2910, 2912, 2914, 2916 are disposed within biopsy cap 2900, which is disposed over base 2902. The entire assembly can be coupled to the port by securing securement region 2904 to the port such that biopsy cap 2900, base 2902, sealing members 2910, 2912, 2914, 2916, and port pores are all substantially axially aligned along longitudinal axis 1. Any of the sealing members discussed throughout this invention are suitable for assembly within biopsy cap 2900.

[0084] In various embodiments, the pores in the biopsy cap may not extend completely through the wall of the biopsy cap. The pores may terminate at a certain distance within the thickness of the wall of the biopsy cap, allowing a medical instrument to puncture the remaining thickness of the wall at the pore in use. Alternatively, the pores may be covered by a membrane, which may be affixed to the wall of the biopsy cap so that the membrane is positioned across the pore before being punctured by a medical instrument in use.

[0085] In various embodiments, the length of the pore or a portion of the length can range from about 2 mm to about 5 mm, about 1.5 mm to about 4 mm, about 3 mm, etc. The length of the portion with the end of the "Y-shaped" pore can be about 3 mm. The length of a tear propagating from the pore can compromise the function of the biopsy cap depending on the length of the pore. For example, a medical device causing a tear having a length of about 10% of the length of the pore can be significant enough to affect the performance of the biopsy cap.

[0086] In various embodiments, the biopsy cap can comprise a flexible material such as silicone, liquid silicone rubber, rubber, a polymer, an elastomer, a thermoplastic elastomer (TPE), a soft plastic, or a combination thereof. Variable thicknesses across the cap can be employed for various functions, such as a thicker body for secure placement collinear with the working channel, a thinner wall around the pore for passage of a medical device, a thicker ridge around the pore to prevent tear propagation, a thicker ribbed portion to help maintain the pore in a closed position, etc.

[0087] In various embodiments, the biopsy cup can be molded into a tubular body to form a structure or shape that is configured or customized to be placed within a particular housing and / or compatible with a particular working channel, and patterned pores according to the present invention and according to embodiments described herein or elsewhere can be cut into that structure.

[0088] The various biopsy caps, sealing members, and molds, as well as their various components, can be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. Additionally, the various structures can 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 can include transparent or translucent materials to aid in visualization during procedures. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N1027, such as HASTELLOY® C276®). 6, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N®, etc.), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY B2, etc.), Other nickel alloys, such as UNS:N10665, such as B2)®, 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; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steels; combinations thereof, etc.; or any other suitable material.

[0089] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer or Elf Atochem®). CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyethylene ster, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American Grillon Co., Ltd.)Examples of suitable materials include GRILAMID® available from Grilon, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or blends, combinations, copolymers thereof, polymer / metal composites, and the like.

[0090] Additionally, portions or components of the structures disclosed herein (including various securing 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, such as ridges, textures, bumps, grooves, protrusions, etc., that can improve grip.

[0091] Additionally, the various structures disclosed herein can be designed for single use or can be designed for repeated use. Accordingly, the structures disclosed herein can be fabricated from materials that can withstand multiple sterilizations and / or cleanings. This can apply to the entire cap as disclosed herein, or to any of the various features of any of the caps.

[0092] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size and arrangement of steps, without exceeding the scope of the invention. This includes, to the extent appropriate, the use of any of the features of one example embodiment in other embodiments.

[0093] All of the apparatus and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present invention. While the apparatus and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that changes can be made to the apparatus and / or methods and in the steps or sequence of steps of the methods described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

Claims

1. 1. A device configured to be attached to a port of an endoscope having a working channel and a port at a proximal end of the working channel, the device comprising: the device comprises a base disposed about the port, the base having a base slot extending therethrough and a fastening region configured to engage a side of the port; the device comprises a biopsy cap having a first end with a cap aperture extending therethrough and a second end with a fixation member at the end of the biopsy cap, the fixation member being disposed about the base such that the cap aperture is in fluid communication with the base aperture and the port; the base engages the second end of the biopsy cap via the fixation member, and at least two circumferentially spaced extensions extend distally from the base beyond the fixation region of the base to engage the port and beyond the second end of the biopsy cap; The at least two circumferentially spaced extensions are configured to also serve as handles to assist a surgeon in removing the base from the port. Device.

2. The device of claim 1 , further comprising a medical implement extending through the cap pore, the base pore, and the port.

3. The device of claim 1 , further comprising at least one seal member disposed within the interior chamber of the biopsy cap, the seal member having a seal pore in fluid communication with the cap pore.

4. The device of claim 1 , wherein the base further comprises a recess configured to frictionally engage the biopsy cap.

5. The device of claim 4 , wherein the recess is an external annular recess.

6. 6. The device of claim 1, wherein a proximal end of the base has a slope toward the base aperture, the slope having a first angle, the first angle transitioning to a second angle, the slope having the second angle being between the slope having the first angle and the base aperture, and the second angle being greater than the first angle.

7. 7. The apparatus of claim 6, wherein the first angle is 30 degrees and the second angle is 45 degrees.

8. the biopsy cap defining an interior chamber within the biopsy cap; The device of claim 1 , further comprising a plurality of sealing members disposed within the interior chamber of the biopsy cap.

9. The device of claim 8 , wherein each of the plurality of seal members has an opening in fluid communication with the cap pore.

10. The apparatus of claim 9 , wherein the openings of the plurality of seal members are axially aligned with each other, with the base aperture, and with the cap aperture.

11. 11. The apparatus of claim 9 or claim 10, wherein at least one sealing member comprises a plurality of surfaces extending radially around the opening in a spiral pattern.

12. 11. The apparatus of claim 9 or claim 10, wherein at least one seal member comprises a series of circumferentially angularly offset layers comprising a plurality of projections extending radially inwardly towards the opening.

13. The apparatus of claim 12 , wherein the plurality of projections define the opening in a center of the seal member such that the opening extends axially through the seal member.

14. 10. The device of claim 1, wherein the biopsy cap has an interior chamber defined therein between the first end and the second end and within which the base is disposed.

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