Devices, systems and methods for biopsy cap and housing

Abstract

To provide a biopsy cap and a biopsy cap housing that are capable of realizing a variety of advantageous medical outcomes.SOLUTION: A housing attachment for a biopsy port of an endoscope comprises a first center-split half and a second center-split half. The first center-split half comprises a first portion, a second portion, and one or more locking parts configured to engage the biopsy port. The second center-split half comprises a first portion, a second portion, and one or more locking parts configured to engage the biopsy port.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to the field of medical devices, and more particularly to medical devices for use with endoscopes, such as biopsy caps and biopsy cap housings, that have improved stability and stress distribution for secure attachment to endoscope biopsy ports. [Background technology]

[0002] A wide variety of medical devices have been developed for medical use. These devices include guidewires, guide tubes, catheters, endoscopes, endoscopic devices, etc. Such devices may be manufactured by any of a variety of different methods and used according to any of a variety of methods.

[0003] Endoscopic biopsy cap housings and biopsy caps present a variety of challenges, both individually and cumulatively, that can lead to component failure, unnecessarily complex or additional procedure steps, and / or lengthy procedures.

[0004] Various beneficial medical results may be achieved with the biocap and biocap housing according to embodiments of the present invention. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2009 / 143129 Summary of the Invention

[0006] In an embodiment, a housing attachment for a biopsy port of an endoscope includes a first central half having a first portion forming the first half of an upper chamber. A second portion forms the first half of a lower chamber. A first locking portion extends from an inner surface of the first central half and is configured to engage the biopsy port. A second central half includes a first portion forming the second half of the upper chamber. The second portion forms the second half of the lower chamber. A second locking portion extends from an inner surface of the second central half and is configured to engage the biopsy port. Mating surfaces of the first and second central halves are configured to interlock.

[0007] In various embodiments described herein, the upper chamber is configured to receive a biopsy cap, and the lower chamber is configured to receive a biopsy port. The first and second central halves each include a radial ridge configured to engage a corresponding recess formed in the outer wall of the biopsy cap. The base is disposed on the outer periphery of the biopsy port and within the biopsy cap. The first locking hook is attached to the proximal end of the first central half, and the second locking hook is attached to the proximal end of the second central half, such that the first and second locking hooks are substantially adjacent to each other when the first and second central halves are interlocked. The first and second locking portions are each angled radially inward and toward the upper chamber. At least one stabilizing member extends from an inner surface of the first center half or the second center half and is configured to impact with the first locking portion or the second locking portion when the first locking portion or the second locking portion is radially deformed. The at least one stabilizing member includes a vertical surface that is approximately perpendicular to the radial curvature of the first locking portion or the second locking portion. The at least one stabilizing member is positioned so that the first locking portion or the second locking portion can be radially deformed up to about 15 degrees to about 25 degrees. The mating surface of the first center half includes one or more protrusions, and the mating surface of the second center half includes one or more receiving elements, the protrusions being received within the corresponding receiving elements.

[0008] In an embodiment, the biopsy cap assembly includes a first central split housing half including a first portion that forms a first half of the upper chamber. A second portion forms the first half of the lower chamber. A second central split housing half includes a first portion that forms the second half of the upper chamber. The second portion forms the second half of the lower chamber. The mating surfaces of the first and second central split housing halves are configured to interlock to form the upper and lower chambers. The biopsy cap is disposed within the upper chamber.

[0009] In various embodiments described herein, the outer wall of the biopsy cap includes a recess formed therein, and the first and second central halves each include a radial ridge configured to engage a corresponding recess formed in the outer wall of the biopsy cap. The base is disposed on the outer periphery of the biopsy port and is disposed within the biopsy cap. The housing includes a lip extending into the proximal end of the upper chamber, and the biopsy cap includes a wedge extending outward from the top surface of the cap, the lip configured to engage the top surface of the wedge. The housing includes wedges formed within the inner surfaces of the first and second portions of the first and second central housing halves, and the biopsy cap includes a wedge extending outward from the outer wall of the top of the biopsy cap, the wedge of the housing configured to engage the wedge of the biopsy cap.

[0010] In one embodiment, a housing attachment for an endoscopic biopsy port includes a body including an upper chamber configured to receive a biopsy cap. A lower chamber is adjacent the upper chamber and configured to engage the biopsy port. A skirt region is configured to receive a portion of an endoscope. The skirt region includes internal gripping members along an inner surface of the skirt region configured to frictionally fit over a portion of the endoscope. The upper chamber includes radial ridges configured to engage corresponding recesses formed in an outer wall of the biopsy cap. A grip region is an outer circumferential surface of the body at the upper chamber, and the grip region includes external gripping members configured to be grasped by a user. At least two slots extend through the body along the upper chamber and the skirt region, the at least two slots configured to allow the body to flex when the grip region is compressed.

[0011] The present invention provides designs, materials, manufacturing methods, and alternative uses for medical devices. An embodiment of an endoscopic attachment is disclosed. The attachment includes one or more or all of the following elements: a housing; one or more angled locking portions extending from an inner surface of the housing, the angled locking portions designed to engage a biopsy port of an endoscope; one or more stabilizing members extending from an inner surface of the housing; a locking device coupled to the housing; and a biopsy cap disposed within the housing.

[0012] In various embodiments described herein, the one or more angled locking portions may include a first angled locking portion disposed on a first side of the inner surface of the housing and a second angled locking portion disposed on a second side of the inner surface of the housing. The one or more angled locking portions may include a first angled locking portion, and the first angled locking portion may include a bent portion. The one or more angled locking portions may include a first angled locking portion, and the first angled locking portion may be substantially V-shaped. The one or more angled locking portions may include a first angled locking portion, and the first angled locking portion may be substantially rigid. The one or more angled locking portions may include a first angled locking portion, and the first angled locking portion may be resiliently deflectable. The one or more stabilizing members may include a first stabilizing member disposed on a first side of the inner surface of the housing and a second stabilizing member disposed on a second side of the inner surface of the housing. The one or more stabilizing members may include a first stabilizing member extending radially inward from an inner surface of the housing. The housing may include a skirt region. The locking device may include one or more guidewire locks. The biopsy cap may include various sealing members, such as an elastomeric seal.

[0013] In one embodiment, an attachment for an endoscope is disclosed, the attachment comprising: a housing designed to engage a biopsy port of an endoscope, a skirt region formed along a first end region of the housing, a locking region formed along a second end region of the housing, an angled locking portion extending from an inner surface of the housing, a stabilizing member extending from the inner surface of the housing and positioned adjacent the angled locking portion, and one or more or all of the elements disposed on the housing.

[0014] In various embodiments, the housing may further include a second angled locking portion extending from an inner surface of the housing and disposed opposite the angled locking portion. The angled locking portion may include a curved portion. The angled locking portion may be generally V-shaped. The angled locking portion may be generally rigid. The angled locking portion may be resiliently deflectable. A second stabilizing member may extend from an inner surface of the housing and disposed opposite the stabilizing member. The stabilizing member may extend radially inward from the inner surface of the housing.

[0015] In one embodiment, an attachment for an endoscope is disclosed that includes one or more or all of the following elements: a housing designed to engage a biopsy port of an endoscope, an asymmetric skirt region formed along a first end region of the housing, a guidewire locking region formed along a second end region of the housing, a pair of angled locking portions extending from an inner surface of the housing, a pair of stabilizing members extending from the inner surface of the housing and positioned adjacent the pair of angled locking portions, and a biopsy cap positioned within the housing, the biopsy cap including a resilient sealing member.

[0016] In one aspect, the present invention relates to a biopsy cap housing comprising a first central half and a second central half. The first central half includes a first portion forming the first half of the upper chamber and a second portion forming the first half of the lower chamber. A first pivot member is integrally formed with the first central half. A first slit extends through sidewalls of the first and second portions of the first central half in alignment with the first pivot member. The second central half includes a first portion forming the second half of the upper chamber and a second portion forming the second half of the lower chamber. The second pivot member is integrally formed with the first central half. A second slit extends through sidewalls of the first and second portions of the second central half in alignment with the second pivot member. Mating surfaces of the first and second central halves are configured to interlock to form the upper and lower chambers.

[0017] In embodiments described within the scope of the present invention and in other embodiments, the protruding surface of the first pivot member extends into the upper chamber, and the protruding surface of the second pivot member extends into the upper chamber opposite the first pivot member. The upper chamber is configured to receive a biopsy cap. The lower chamber is configured to receive an endoscopic biopsy port. The first and second pivot members include a thickness greater than the thickness of the walls of the first and second central halves. A force applied to the first portions of the first and second central halves can move the second portions of the first and second central halves away from each other. A force applied to the second portions of the first and second central halves can move the first portions of the first and second central halves away from each other. The protruding surfaces of the first and second pivot members are configured to engage corresponding recesses formed in the outer walls of a biopsy cap disposed within the upper chamber. The first locking hook is attached to the proximal end of the first central half, and the second locking hook is attached to the proximal end of the second central half. When the first and second central halves are interlocked, the first and second locking hooks are substantially adjacent to one another. The inner surfaces of the first portions of the first and second central halves include surface elements configured to engage with corresponding surface elements formed in the outer wall or outer wall of a biopsy cap disposed in the upper chamber. The surface element of the housing includes a lip extending into the proximal end of the upper chamber. The surface element of the biopsy cap includes a wedge extending inward from the top surface of the biopsy cap. The lip is configured to engage with the top surface of the wedge of the biopsy cap. The surface element of the housing includes wedge portions formed in the inner surfaces of the first and second portions of the first and second central halves. The surface element of the biopsy cap includes a wedge portion extending outward from the outer wall of the biopsy cap top. The housing wedge is configured to engage the biopsy cap wedge. The mating surface of the first central half includes one or more protrusions, and the mating surface of the second central half includes one or more receiving elements. The protrusions are configured to be received within the corresponding receiving elements. The one or more protrusions can include one or more pins, and the one or more receiving elements can include one or more pin holes.One or more pins and one or more corresponding pin holes are disposed at the proximal end of the first portion of the first and second center halves. One or more pins and one or more corresponding pin holes are disposed at the proximal end of the second portion of the first and second center halves. The one or more protrusions can include one or more pegs, and the one or more receiving elements can include one or more sockets. The one or more pegs and one or more corresponding sockets are disposed at the proximal end of the second portion of the first and second center halves. The one or more protrusions can include one or more snap locks, and the one or more receiving elements can include one or more snap lock receivers. The one or more snap locks and one or more corresponding snap lock receivers are disposed at the proximal end of the first portion of the first and second center halves. The one or more snap locks and one or more corresponding snap lock receivers are disposed at the proximal end of the second portion of the first and second center halves. The one or more snap locks include angled surfaces configured to securely engage corresponding angled surfaces of the one or more snap lock receivers. The inner surfaces of the second portions of the first and second central halves include one or more locking portions configured to extend into the lower chamber and releasably engage the outer surface of an endoscopic biopsy port disposed within the lower chamber. The inner surfaces of the second portions of the first and second central halves include one or more platform portions on opposite sides of the first and second slits and extending into the lower chamber between the one or more locking portions. The ends of the one or more locking portions and the surfaces of the one or more platform portions are spaced apart a predetermined distance within the lower chamber when no force is applied to the first portions of the first and second central halves. The ends of the one or more locking portions and the surfaces of the one or more platform portions come into contact when force is applied to the first portions of the first and second central halves. The force applied to the first portions of the first and second central halves is an inward compressive force that separates the second portions of the first and second central halves from each other. The contact between the one or more locking portions and the surfaces of the one or more platform portions can prevent breakage of at least one locking portion due to excessive extension.

[0018] In one aspect, the present invention relates to a biopsy cap including one or more surface elements formed thereon. The one or more surface elements are configured to frictionally and / or compressively engage corresponding surface elements formed on or within the inner surface of the first portion of the first and second central halves of the biopsy cap housing. The biopsy cap includes a first surface element attached to or integrally formed with the proximal end of the biopsy cap and second and third surface elements attached to or integrally formed with the outer wall of the biopsy cap. The one or more surface elements include first and second recesses integrally formed within the outer wall of the biopsy cap and spaced approximately 90 degrees from the second and third surface elements relative to the outer periphery of the biopsy cap. The biopsy cap may be formed of various compressible materials (e.g., silicone, rubber, etc.) or may include various compressible materials (e.g., silicone, rubber, etc.) formed into a single, integral structure. The surface element may include a substantially continuous lip portion. The surface element may include a substantially continuous wedge portion. The surface element may include a recess portion.

[0019] In one aspect, the present invention relates to a biopsy cap assembly including a first central split housing half and a second central split housing half. The first central split housing half includes a first portion forming the first half of the upper chamber and a second portion forming the first half of the lower chamber. A first pivot member is integrally formed with the first portion of the first central split housing half. The second central split housing half includes a first portion forming the second half of the upper chamber and a second portion forming the second half of the lower chamber. The second pivot member is integrally formed with the first portion of the second central split housing half. Mating surfaces of the first and second central split housing halves are configured to interlock to form upper and lower chambers. A biopsy cap is disposed within the upper chamber.

[0020] In the described embodiment and other embodiments within the scope of the present invention, the outer wall of the biopsy cap includes a recess formed therein. The protruding surface of the first pivot member extends into the upper chamber, and the raised surface of the second pivot member extends into the upper chamber generally opposite the first pivot member. The protruding surface can frictionally engage the recess of the biopsy cap. The first and second pivot members include a thickness greater than the wall thickness of the first and second central split housing halves. The housing can include a lip extending into the proximal end of the upper chamber, and the biopsy cap includes a wedge extending outward from the top surface of the cap. The lip is configured to engage the top surface of the wedge. The housing includes wedges formed within the inner surfaces of the first and second portions of the first and second central split housing halves. The biopsy cap includes a wedge extending outward from the outer wall of the top of the biopsy cap. The wedge of the housing is configured to engage the wedge of the biopsy cap.

[0021] The above summary of specific embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments.

[0022] The present invention can be more fully understood from the following detailed description considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is a top view of a portion of an endoscope including a biopsy port in a working channel of the endoscope. [Figure 2] FIG. 1 is a top view of a biopsy cap housing coupled to an endoscope in accordance with one embodiment of the present invention. [Figure 3] FIG. 1 is a side view of a portion of a biopsy cap housing coupled to an endoscope in accordance with an embodiment of the present invention. [Figure 4] FIG. 2 is a perspective view of a portion of a biopsy cap housing according to one embodiment of the present invention. [Figure 5A]FIG. 1 is a perspective view showing the center split half of a biopsy cap housing according to one embodiment of the present invention. [Figure 5B] FIG. 1 is a perspective view showing the center split half of a biopsy cap housing according to one embodiment of the present invention. [Figure 5C] FIG. 1 is a perspective view showing the center split half of a biopsy cap housing according to one embodiment of the present invention. [Figure 6A] FIG. 2 is a perspective view of a biopsy cap housing according to one embodiment of the present invention. [Figure 6B] FIG. 2 is a perspective view of a biopsy cap housing according to one embodiment of the present invention. [Figure 6C] FIG. 2 is a perspective view of a biopsy cap housing according to one embodiment of the present invention. [Figure 7] FIG. 2 is a perspective view of a biopsy cap housing according to one embodiment of the present invention. [Figure 8] FIG. 1 illustrates a biopsy cap housing coupled to an endoscope in accordance with one embodiment of the present invention. [Figure 9] FIG. 1 illustrates a biopsy cap housing coupled to an endoscope in accordance with one embodiment of the present invention. [Figure 10] FIG. 2 is a perspective view of a biopsy cap housing according to one embodiment of the present invention. [Figure 11] FIG. 10 shows a biopsy cap housing coupled to an endoscope. [Figure 12] FIG. 10 shows a biopsy cap housing coupled to an endoscope. [Figure 13] FIG. 1 is a perspective view showing a biopsy cap according to an embodiment of the present invention. [Figure 14] FIG. 1 is a side view of a portion of a biopsy cap housing coupled to an endoscope in accordance with an embodiment of the present invention. [Figure 15A] FIG. 1 is a perspective view showing a biopsy cap disposed within a biopsy cap housing according to one embodiment of the present invention. [Figure 15B] FIG. 1 is a perspective view showing a biopsy cap disposed within a biopsy cap housing according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present invention is not limited to the specific embodiments described herein. The terms used herein are intended only to describe specific embodiments and are not intended to limit 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 the present invention belongs.

[0025] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein, whether expressly stated or not, are assumed to be modified by the term "about." The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" includes multiple numerical values ​​that are rounded to the nearest significant figure.

[0026] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise.

[0027] Although embodiments of the present disclosure are described with particular reference to biopsy caps and biopsy cap housings configured to enable delivery and exchange of various medical devices through biopsy caps and ports of an endoscope, laparoscope, or visualization system such as the SpyGlas® Direct Visualization System (Boston Scientific Corporation, Marlborough, Massachusetts), it should be understood that such designs can be adapted and / or used with a variety of medical devices and medical applications, including sealable access.

[0028] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular elements, structures, and / or characteristics. However, such listing does not necessarily mean that all embodiments include the particular element, structure, and / or characteristic. Furthermore, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated otherwise.

[0029] The following detailed description should be read with reference to the drawings, in which like elements are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0030] Some biopsy cap housings allow axial and rotational movement of the housing and / or cap during device exchange. Furthermore, exchange of larger-diameter medical devices (e.g., catheters, stent introducers, etc.) through the biopsy cap tends to exert radially outward forces that partially or completely separate or separate the two centrally separated halves of the biopsy cap housing. Applying an adhesive to the central halves can minimize such separation, but this can increase assembly time and cost. Locking or unlocking a guidewire to a hook located on one side of the biopsy cap housing exerts a radially outward force on one of the central halves, potentially moving the central halves in either direction and partially or completely separating or separating them from each other. Excessive bending due to lateral forces exerted on one or both central halves, for example, during removal of the biopsy cap housing from the biopsy port, can concentrate stress on the locks securing the biopsy cap housing to the endoscope port, potentially resulting in the failure of one or more of the locks. Component breakage or separation of the central split halves due to these forces can compromise the stability between the biopsy cap housing and the endoscope biopsy port. Furthermore, the cumulative effect of these separating forces can shorten the usable life of the biopsy cap housing.

[0031] In various embodiments, for example, the features and advantages of providing sealable access to a working channel of an endoscope can be achieved by a biopsy cap and biopsy cap housing combination. Such sealable access to a working channel is described in U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Biopsy Cap for Use with an Endoscope," U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Attachment for an Endoscope," U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Biopsy Cap and Biopsy Cap Housing," U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Devices, Systems, and Methods for Providing Sealable Access to a Working Channel," U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Attachment for an Endoscope," U.S. patent application Ser. No. 16 / 100,960, filed Aug. 10, 2018, and entitled "Apparatus, System, and Method for Providing Sealable Access to a Working Channel ... The present invention may be supplemented by and implemented with elements disclosed in U.S. patent application having attorney docket number 8150.0656, entitled "Internal Seal for a Biopsy Cap," filed on the same date and having attorney docket number 8150.0610, entitled "Internal Seal for a Biopsy Cap," and U.S. patent application having attorney docket number 8150.0555, filed on the same date and entitled "Device, System, and Method for Providing Sealable Access to a Working Channel," the disclosures of each of which are incorporated by reference in their entirety and for all purposes.

[0032] During endoscopic procedures, medical instruments such as guidewires, catheters, and endoscopic instruments are inserted through the working channel of an endoscope. A port (e.g., a "biopsy port") along the endoscope provides access to the working channel. During use, it may be desirable to couple a biopsy cap to the biopsy port. The biopsy cap includes one or more seals or sealing members. The seals are designed to seal against the biopsy port and / or against instruments extending through the biopsy cap and into the working channel. During the procedure, it may be desirable to secure the position of a medical instrument (e.g., a guidewire) relative to the endoscope. A locking mechanism is secured to the endoscope and / or biopsy cap to secure the medical instrument. Disclosed herein is an endoscopic attachment or biopsy cap assembly that includes a number of elements, including a biopsy cap housing, a biopsy cap, a locking mechanism, and other elements.

[0033] 1 shows a portion of a biopsy port 10 of an exemplary endoscope 12. The biopsy port 10 includes a stem or neck region 14 and an end or flanged region 16. The biopsy port 10 serves as access to a channel (e.g., a working channel) of the endoscope 12. Typically, the biopsy port 10 is designed to receive a biopsy cap.

[0034] 2-3 show an example of an endoscopic attachment 18 including a housing 20 coupled to a biopsy port 10. In general, the endoscopic attachment 18 is designed to be coupled (e.g., removably coupled, attached, or secured) to a biopsy port of an endoscope (e.g., the biopsy port 10 of an endoscope 12). Additionally, the endoscopic attachment 18 includes a number of elements capable of forming a seal with a biopsy cap at the biopsy port 10, allowing a medical device (e.g., a guidewire, catheter, endoscopic device) to pass therethrough and enter the working channel of the endoscope 12, and configured to secure the medical device relative to the endoscope 12 and securely receive a biopsy cap 300 (e.g., FIG. 13).

[0035] The endoscopic attachment 18 includes a housing 20 having a skirt region 22, a grip region 24, and a locking region 26. In some examples, the housing 20 is a single piece. In other examples, the housing 20 is formed of two or more pieces, such as a first housing portion 20a and a second housing portion 20b, secured together. In FIG. 3, for example, the second housing portion 20b has been removed, showing only the first housing portion 20a. Forming the housing 20 from separate pieces may allow the housing 20 to be relatively easily molded (e.g., compared to a single piece) or formed into complex shapes. When formed from separate pieces, the housing portions 20a, 20b are secured together by a suitable method, such as pinning (e.g., a snap lock including a pin in one portion and a hole or opening in the other portion to receive the pin), thermal bonding, adhesive bonding, or the like. In various embodiments, the housing 20 is substantially rigid. The pinning allows for secure attachment of the portions 20a, 20b and may enhance the ability of the two housing portions 20a, 20b to "pivot" relative to one another. In that case, the housing 20 may be opened or widened (e.g., adjacent a lower portion of the endoscopic attachment 18, such as at the skirt region 22) to attach and detach the endoscopic attachment 18 to the biopsy port 10. A slot, or opening 28, is formed along a portion of the housing 20. The slot may enhance the flexibility and / or pivoting ability of the housing 20, making it easier to secure the endoscopic attachment 18 to the biopsy port 10.

[0036] The skirt region 22 is designed to follow the shape and / or contour of the endoscope 12. More specifically, the skirt region 22 is formed to match the shape of the handle region of the endoscope 12 adjacent the biopsy port 10, thereby enhancing the stability of the endoscopic attachment 18 and ensuring its position relative to the endoscope 12. In at least some examples, the shape of the skirt region 22 is described as asymmetric. For example, the skirt region 22 includes a first portion 30 (e.g., which may or may not correspond to the first housing portion 20a) and a second portion 32 (e.g., which may or may not correspond to the second housing portion 20b).

[0037] The gripping region 24 includes one or more gripping members 34. The gripping members 34 may take the form of a tab or pinch grip that allows a user to grasp the endoscopic attachment 18. In some cases, the gripping members 34 may be pinched together to spread the endoscopic attachment 18 apart (e.g., adjacent the skirt region 22) so that the endoscopic attachment 18 can be attached to or removed from the biopsy port 10. The slots 28 help facilitate bending / curving of the endoscopic attachment 18 when the gripping members 34 are pinched.

[0038] Locking region 26 includes one or more locking devices 36. Locking devices 36 may vary in shape. In some cases, locking devices 36 may take the form of hooks designed to engage and hold a medical device (e.g., a guidewire, a catheter, an endoscopic device, etc.) so that the medical device is held in place relative to endoscopic attachment 18 (and / or endoscope 12).

[0039] As shown in FIGS. 3 and 4 , the housing 20 of the endoscopic attachment 18 includes one or more angled locking portions 38. Generally, the angled locking portions 38 take the form of protrusions extending radially inward from the interior surface of the housing 20 and toward the upper chamber. The angled locking portions 38 include a bend, curve, or bend 40. In at least some examples, the angled locking portions 38 can be described as “V-shaped.” However, other shapes are contemplated. The angled locking portions 38 are resiliently flexible, allowing them to bend or deflect to conform and secure to the flanged region 16 of the biopsy port 10. The number of angled locking portions 38 and / or the arrangement of the angled locking portions 38 may vary. For example, the housing 20 may include two, three, four, five, six, seven, eight, or more angled locking portions 38. In some examples, each center split half 20a, 20b may include a pair of angled locking portions 38 positioned opposite or facing each other. When the housing portions 20a, 20b are brought together, the angled locking portions 38 of each opposing housing portion 20a, 20b are positioned adjacent to each other. Other configurations are contemplated.

[0040] The housing 20 of the endoscopic attachment 18 includes one or more stabilizing members 42. Generally, the stabilizing members 42 take the form of protrusions extending radially inward from the interior surface of the housing 20. The stabilizing members 42 help stabilize the position (e.g., laterally and / or axially) on the biopsy port 10. The number and / or arrangement of the stabilizing members 42 may vary. For example, the housing may include two, three, four, five, six, seven, eight, or more stabilizing members 42. In some examples, each housing portion 20a, 20b includes a pair of stabilizing members 42 positioned adjacent to one another. When the housing portions 20a, 20b are brought together, the pair of stabilizing members 42 in each opposing housing portion 20a, 20b are positioned opposite one another. Other configurations are contemplated.

[0041] 5A and 5B, an embodiment of a biopsy cap housing of the present invention includes first and second central halves 110a, 110b (e.g., first and second housing portions or components) configured to engage or interlock with one another to form a first portion 112a, 112b (e.g., upper chamber, first chamber, top chamber) configured to securely receive a biopsy cap 300 (e.g., FIG. 13) and a second portion 122a, 122b (e.g., lower chamber, second chamber, bottom chamber, etc.) configured to securely and releasably engage the neck 610 of an endoscope port 600.

[0042] 5A, in one embodiment, a first central half 110a (e.g., first side, locking side, etc.) of a biopsy cap housing (e.g., housing 20 of FIGS. 2-4) includes a first portion 112a (e.g., upper, upper portion) that forms a first half of an upper chamber (e.g., a generally semi-cylindrical half), and a second portion 122a (e.g., lower, lower portion) that forms a first half of a lower chamber (e.g., a generally semi-cylindrical half). A first locking hook 123a (e.g., guidewire locking hook) and guide 130 are attached to or integrally formed with the proximal end of first portion 112a. A first pivot member 114a (e.g., a first pivot button, a first pivot element, etc.) is integrally formed at approximately the midpoint of the first portion 112a, and a first slit 126a (e.g., an opening, a slot, etc.) extends through the sidewalls of the first and second portions 112a, 122a generally aligned with (e.g., on the same side, directly below, etc.) the first pivot member 114a. The first pivot member 114a includes a radially protruding or raised surface (e.g., an enlarged portion, a protrusion) that extends into the first half of the upper chamber to engage, for example, a corresponding recess 312a formed in the outer wall of the biocap 300 (see FIG. 13 herein).

[0043] In one embodiment, the inner surface of the first portion 112a of the first central half 110a includes a surface element configured to press and / or frictionally engage a corresponding surface element on the biopsy cap. In some embodiments, the surface element includes a lip 117a (e.g., a step element, etc.) integrally formed on the inner wall of the first central half 110a and extending into the first half of the upper chamber at or near the proximal end of the first portion 112a. In various embodiments, the surface element includes a pair of wedges 116a (e.g., recesses, indentations) in the inner wall of the first portion 112a distal to the lip 117a and on opposite sides of the first half of the first portion 112a (e.g., spaced approximately 180 degrees apart).

[0044] In one embodiment, one or more locking portions 124a (e.g., V-locks, etc.) are attached to or integrally formed with the interior wall of the first central half 110a at or near the proximal end of the second portion 122a and on either side of the first half of the second portion 122a (e.g., spaced approximately 180 degrees apart). The locking portions 124a are configured to releasably engage with a biopsy port 600 (e.g., neck 610) located within the second portion 122a (e.g., FIG. 6A herein). For example, the ends of the locking portions 124a include a pair of substantially vertical surfaces 125a, 127a configured to engage (e.g., contact, fit within) a substantially 90-degree surface (e.g., a bottom or underside of a lip) of the neck 610 of the biopsy port 600 when radially deformed in the absence of the biopsy port 600 (described below with respect to FIGS. 6A-6C). Additionally, one or more platform portions (eg, stops) are attached to or integrally formed with the interior wall of the first center half 110a on either side of the first slit 126a and between the locking portions 124a.

[0045] In one embodiment, one or more protrusions are attached to or integrally formed with mating surfaces 111 a of first and second sections 112 a, 122 a of first center half 110 a. In various embodiments, the protrusions include one or more pins 118 a (e.g., posts, rods, etc.) having generally spherical or cylindrical outer dimensions. In various additional embodiments, the protrusions include one or more pegs 119 a (e.g., blocks, etc.) having generally square or rectangular outer dimensions. In various additional embodiments, the protrusions include one or more snap locks 120 a (e.g., arms, etc.) with generally curved or hooked ends.

[0046] As a non-limiting example, in one embodiment, two pins 118a extend from mating surface 111a at or near the proximal end of first portion 112a, and two pins 118a extend from mating surface 111a adjacent locking portion 124a. Two snap locks 120a extend from mating surface 111a at or near the proximal end of first portion 112a and proximal to pins 118a, and two snap locks extend from mating surface 111a at or near the distal end of second portion 122a. Two pegs 119a extend from mating surface 111a adjacent locking portion 124a, distal to pins 118a and proximal to pegs 119a.

[0047] 5B, in one embodiment, the second central split half 110b (e.g., second side, groove side, etc.) of the biopsy cap housing (e.g., housing 20 of FIGS. 2-4) includes a first (e.g., upper) portion 110b that forms the second half of the upper chamber (e.g., the generally semi-cylindrical half) and a second (e.g., lower) portion 122b that forms the second half of the lower chamber (e.g., the generally semi-cylindrical half). A second locking hook 123b (e.g., a guidewire locking hook) is attached to or integrally formed with the proximal end of the first portion 112b. A second pivot member 114b (e.g., a second pivot button, a second pivot feature) is integrally formed at approximately the midpoint of the first portion 112b, and a second slit 126b (e.g., an opening, a slot, etc.) extends through the sidewalls of the first and second portions 112b, 122b and generally aligned (e.g., on the same side, directly below) with the second pivot member 114b. The second pivot member 114b includes a protruding or raised surface (e.g., an enlarged portion) that extends into the first half of the upper chamber to engage a corresponding recess 312a (e.g., a groove, a depression) formed in the outer wall of, for example, the biocap 300 (e.g., FIG. 13 herein).

[0048] In one embodiment, the inner surface of the first portion 112b of the second central half 110b includes a surface element configured to press and / or frictionally engage a corresponding surface element on the biopsy cap. In one embodiment, the surface element includes a lip 117b (e.g., a step element, etc.) integrally formed on the inner wall of the second central half 110b and extending into the first half of the upper chamber at or near the proximal end of the first portion 112b. In one embodiment, the surface element includes a pair of wedges 116b (e.g., recesses, indentations) formed in the inner wall of the second portion 112b distal to the lip 117b and on opposite sides of the first half of the first portion 112b (e.g., spaced approximately 180 degrees apart).

[0049] In one embodiment, one or more locking portions 124b (e.g., V-locks, etc.) are attached to or integrally formed with second portion 122b at or near the proximal end thereof and on opposite sides of the second half of the lower chamber (e.g., spaced approximately 180 degrees apart). Locking portions 124b are configured to releasably engage the neck 610 of a biopsy port 600 disposed within the lower chamber (see FIG. 6A). For example, the ends of locking portions 124b comprise a pair of substantially vertical surfaces 125a, 127a configured to engage a substantially 90-degree surface (e.g., the bottom or underside of the lip) of the neck 610 of the biopsy port 600, or alternatively, a stabilizing member 128b, when radially deformed in the absence of the biopsy port 600. Additionally, one or more platform portions 128b (eg, stops, etc.) are attached to or integrally formed with the inner wall of the second center half 110b on either side of the second slit 126b and between the locking portions 124a.

[0050] In one embodiment, one or more receiving elements (e.g., receiving features, etc.) are integrally formed within the mating surfaces 111b of the first and second portions 112b, 122b of the second central split half 110b and configured to receive / engage one or more corresponding protrusions on the first central split half 110a, such as by a friction fit or an interference fit, e.g., the first and second central split halves 110a, 110b interlocking in a snap-fit ​​configuration to form the assembled biocap housing. In various embodiments, the receiving element includes one or more pin holes 118b (e.g., posts, rods, etc.) having a generally spherical or cylindrical inner dimension configured to frictionally receive a corresponding generally spherical or cylindrical outer dimension of the pin 118a. In various additional embodiments, the receiving element includes one or more sockets 119b having a generally square or rectangular inner dimension configured to frictionally receive a corresponding generally square or rectangular outer dimension of the peg 119a. In various additional embodiments, the receiving element includes one or more snap lock receivers 120b having a generally curved or hook-shaped interior dimension configured to receive a corresponding generally curved or hook-shaped end of the snap lock 120a. Referring to FIG. 5C, in one embodiment, one or more snap locks 120a of the present invention include a recessed angled surface 121a configured to frictionally and / or compressively contact / engage a corresponding angled surface 121b of the one or more snap lock receivers 120b. In various embodiments, the interface between these opposing angled surfaces can provide a "positive locking" interaction with a greater locking force / interaction than between corresponding non-angled surfaces.

[0051] As a non-limiting example, in one embodiment, two pin holes 118b are formed in mating surface 111b at or near the proximal end of first portion 112b, and two pin holes 118b are formed in mating surface 111b adjacent locking portion 124b. Two snap-lock receivers 120b are formed in mating surface 111b at or near the proximal end of first portion 112b and proximal to pin holes 118b, and two snap-lock receivers 120b are formed in mating surface 111b at or near the distal end of second portion 122b. Two sockets 119b are formed in mating surface 111b adjacent locking portion 124b, distal to pin holes 118b and proximal to snap-lock receivers 120b.

[0052] In one embodiment, the biopsy cap housing of the present disclosure is assembled by aligning the mating surfaces 111 a, 111 b of the first and second central halves 110 a, 110 b such that one or more protrusions (e.g., pin 118 a, peg 119, snap lock 120 a) are aligned with one or more corresponding receiving elements (e.g., pin hole 118 b, socket 119 b, snap lock receiving portion 120 b), respectively, to compress or press the first and second central halves 110 a, 110 b together in a snap-fit ​​configuration. In various embodiments, the first and second locking hooks 123 a, 123 b are substantially adjacent to one another when the biopsy cap housing is assembled and configured to securely engage the proximal portion of a guidewire. Additionally, the surface elements of the first portions 112a, 112b of the first and second central halves 110a, 110b are substantially aligned to form a continuous surface element that prevents or limits axial and / or rotational movement of the biopsy cap 300 (e.g., FIG. 13 herein) disposed within the upper chamber and prevents fluid flow (e.g., leakage) along the exterior surface of the biopsy cap 300. For example, the lips 117a, 117b of the first and second portions 112a, 112b are aligned to form a substantially continuous lip that extends into the upper chamber at or near the proximal end of the biopsy cap housing, and the wedges 116a, 116b are aligned to form continuous wedges on either side of the upper chamber.

[0053] Referring to FIG. 6A, in one embodiment, locking portion 124a (e.g., a V-lock) releasably engages neck 610 of biopsy port 600 disposed within the lower chamber, for example, when second portions 122a and 122b of biopsy cap housing 120 (e.g., second portions 122a and 122b of FIGS. 5A and 5B) are compressed inward toward one another. Locking portion 124a may be locking portion 38 of FIGS. 3 and 4, locking portions 124a and 124b of FIGS. 5A and 5B, or a locking portion of another embodiment of the housing. Referring to FIG. 6B, in a resting state and without biopsy port 600, locking portion 124a is spaced a fixed distance from platform surface 129a (e.g., an enlarged or thickened surface) of each substantially vertical stabilizing member 128a. 6C , when the locking portions are radially compressed toward one another without the biopsy port 600 present (e.g., when the biopsy cap housing first portions 112a, 112b are compressed inward toward one another), the ends of the locking portions 124a contact the surfaces 129a of the respective stabilizing members 128a, preventing the locking portions 124a from overstretching to the point of failure. For example, the surfaces 129a prevent the locking portions 124a from extending beyond the respective platform portions 128a to the point where one or both of the locking portions 124a may break or fracture (e.g., the surfaces 129a are approximately perpendicular to the radial curvature of the first or second locking portion). By way of non-limiting example, the platform portions 128a are configured or arranged to allow the locking portions 124a to bend or flex at multiple angles (e.g., approximately 15 degrees and less than or equal to approximately 25 degrees).

[0054] As will be appreciated by those skilled in the art, a nearly equal distribution of forces throughout the biopsy cap housing, including radial forces from device exchange or guidewire locking and high stresses at the pivot points from attachment / detachment to the biopsy port, can reduce the cumulative effects of wear from incremental and continuous actuation between the interlocking protrusions and receiving elements and can prevent partial or complete disengagement of the lower housing from the neck 610 of the endoscopic biopsy port 600.

[0055] 7, in one embodiment, the skirt region 22 has one or more gripping members or ribs 46 disposed along an interior surface (e.g., the interior surface of the housing 20 at or along the skirt region 22). The ribs 46 form or define a surface along the inside of the endoscopic attachment 18 that allows the endoscopic attachment 18 to "grip" and / or frictionally engage the endoscope 12, helping to secure the endoscopic attachment 18 to the endoscope 12.

[0056] 8 and 9 show an embodiment of an endoscopic attachment 18 having a housing 20 attached to a biopsy port 10. For example, the endoscopic attachment 18 is positioned adjacent to the biopsy port 10. When so positioned, the angled locking portion 38 is adjacent to the flange region 16 of the biopsy port, as shown in FIG. 8. To open or spread the housing 20 (e.g., adjacent the skirt region 22), a user applies force (e.g., a pinching force) along a gripping region (e.g., gripping region 24 in FIG. 2) of the attachment 18, bending or pivoting it outward. The user also applies a downward force to the endoscopic attachment 18 to engage and secure the endoscopic attachment to the biopsy port 10. When so positioned, the angled locking portion 38 resiliently deflects so that the angled locking portion 38 seats below the flange region 16, as shown in FIG. 9. When secured, the stabilizing member 42 engages the neck region 14 and / or flange region 16 of the biopsy port 10. Securing the endoscopic attachment 18 to the biopsy port 10 engages the opening 48 or base portion 45 of the seal member with the biopsy port 10, allowing the seal member 48 to press or seal against a channel 50 of the endoscope 12 (e.g., a channel 50 accessible through the biopsy port 10). When the endoscopic attachment 18 is secured to the biopsy port 10, the endoscopic attachment 18 may provide tactile feedback, such as a “snap” or “click” sound and / or sensation. A user can remove the endoscopic attachment 18 by simply pinching the gripping portion region 24 to flex / pivot / extend the housing 20 (and extend / open the angled locking portion 38) and pulling the endoscopic attachment 18 from the biopsy port 10.

[0057] FIG. 10 illustrates an embodiment of an endoscopic attachment 918 similar in form and function to another endoscopic attachment disclosed herein. The endoscopic attachment 918 includes a housing 920. The housing 920 is generally more flexible than the housing 20 of FIG. 2 or FIGS. 5A-5C. A slot 928 is formed within the housing to further enhance the housing's flexibility. One or more locking features 952 extend from the housing 920. In some examples, the locking features 952 take the form of a generally rigid protrusion extending radially inward from the housing 920. In at least some examples, the locking features 952 are configured to form a generally circular (e.g., and / or broken-circle) lock designed to extend around the periphery of a biopsy port (e.g., biopsy port 10).

[0058] 11 and 12 show the endoscopic attachment 918 of FIG. 10 attached to the biopsy port 10. For example, the endoscopic attachment 918 may be positioned adjacent to the biopsy port 10. When so done, the locking portion 952 is adjacent to the flange region 16 of the biopsy port, as shown in FIG. 11. A user may apply a downward force to the endoscopic attachment 918 to secure the endoscopic attachment 918 to the biopsy port 10. When so done, the housing 920 resiliently deflects so that the locking portion 952 seats below the flange region, as shown in FIG. 12. Securing the endoscopic attachment 918 to the biopsy port 10 engages the opening 948 of the seal member or base portion 945 with the biopsy port 10, such that the base portion 945 presses against or seals against the channel 50 of the endoscope 12 (the channel 50 accessible through the biopsy port). When the endoscopic attachment 918 is secured to the biopsy port 10, the endoscopic attachment 918 may generate tactile feedback, such as a "snap" or "click" sound.

[0059] 13, in one embodiment, a biopsy cap 300 of the present invention includes surface elements formed on or within the biopsy cap 300 and configured to frictionally engage and / or press against corresponding surface elements formed on or within the inner surfaces of the first portions of the first and second central halves (e.g., first and second central halves 110a, 110b in FIGS. 5A and 5B). In one embodiment, the biopsy cap 300 includes a first surface element 314a attached to or integrally formed with a proximal end (e.g., top surface) of the biopsy cap 300, and second and third surface elements 314b, 314c attached to or integrally formed with an outer wall of the biopsy cap 300. Additionally or alternatively, the surface elements include first and second recessed portions 312a, 312b integrally formed within the outer wall of the biopsy cap 300 and spaced apart from the second and third surface elements 314b, 314c at approximately 90 degrees relative to the outer periphery of the biopsy cap 300. In various embodiments, the biopsy cap 300 of the present invention is formed from or includes various compressible materials (e.g., silicone, rubber, etc.) formed as one unitary structure using, for example, co-extrusion or co-extrusion techniques known in the art.

[0060] Referring to FIG. 14 , an embodiment of a biopsy cap 44 is positioned within the housing 20 of the endoscopic attachment 18 (e.g., FIGS. 2, 5A-5C). Note that for clarity, the biopsy cap 44 is not shown in FIGS. 2-5C. The shape of the biopsy cap 44 may vary. In at least some examples, the biopsy cap 44 includes one or more seals or sealing members (not shown in FIG. 14 ). The seals are designed to seal against the biopsy port 10, thereby preventing fluid from leaking from the biopsy port 10. Additionally, the seals are designed to seal against a medical device (e.g., a guidewire, catheter, endoscopic device) that passes through the biopsy cap 44 of the endoscopic attachment 18. In at least some examples, the biopsy cap 44 is positioned adjacent to and / or seated against the stabilizing member 42.

[0061] In various embodiments, various advantages may be realized by the biopsy cap housing 20 and / or biopsy cap 300 of the present invention. For example, with reference to FIG. 15A , in one embodiment, a substantially continuous lip extending at or near the proximal end of the biopsy cap housing 100 (e.g., formed by lip portions 117a, 117b of respective halves 110a, 110b of housing 100) frictionally engages and / or presses against the substantially flat upper surface of first surface element 314a of biopsy cap 300. Additionally or alternatively, continuous wedge portions on either side of the first portion (e.g., formed by respective wedge portions 116a, 116b) frictionally engage and / or press against the upper surfaces and / or angled sides of respective corresponding second and third surface elements 314b, 314c, and base portion 45 of biopsy cap 300. 15B, additionally or alternatively, the protruding surfaces of the first and second pivot members 114a, 114b frictionally engage and / or press against corresponding recessed portions 312a, 312b formed in the outer wall of the biopsy cap 300. These features may be similarly implemented with the housing 20 of the endoscopic attachment embodiment of FIGS. 2-4, and with the base portions 45, 945 of FIGS. 8, 9, 11, and 12.

[0062] In various embodiments, the cumulative effect of these frictional and / or compressive forces along various opposing surfaces and sides of biopsy cap 300 limits or prevents axial and / or rotational movement of biopsy cap 300 within the first portion (upper chamber) of biopsy cap housing 100 and / or prevents fluid flow (e.g., leakage) around the outer periphery of biopsy cap 300, for example, during device exchange through lumen 310 of biopsy cap 300.

[0063] Additionally or alternatively to the above advantages, various additional advantages may be realized by the interlocking projections and receiving elements of the respective first and second central halves 110 a, 110 b. For example, the interlocking pins 118 a / pin holes 118 b and snap locks 120 a / snap lock receiving portions 120 b may provide structural support, minimize movement, and evenly distribute radially outward forces imparted to the biopsy cap housing across and / or between the first and second central halves 110 a, 110 b. For example, radially outward forces imparted to the biopsy cap housing 100 during exchange of a large (e.g., 16 French) medical instrument through the flexible biopsy cap 300 are substantially evenly distributed along the entire length of the biopsy cap housing 100 (e.g., between / along the mating surfaces 111 a / 111 b) rather than being concentrated within the upper chamber. Furthermore, radially outward forces applied unevenly to one side of the biopsy cap housing 100, for example, by a guidewire secured to the first and / or second locking hooks 123a, 123b, are redistributed substantially evenly along the entire length of the biopsy cap housing 100. Additionally or alternatively, the larger surface area of ​​the interlocking pegs 119a / sockets 119b at or near the locking portions 124a, 124b (compared to, for example, the pins 118a / pin holes 118b) may provide additional structural support to minimize movement and distribute forces evenly at or near the bottom of the biopsy cap housing 100, for example, adjacent the locking portions 124a, 124b that reversibly engage the neck 410 of the endoscopic biopsy port 400.

[0064] Additionally or alternatively to any of the above advantages, various additional advantages may be realized by the first and second pivot members 114a, 114b of the first and second central halves 110a, 110b. For example, in addition to providing protruding surfaces for frictionally and / or compressively engaging corresponding recessed portions 312a, 312b formed in the outer wall of the biopsy cap 300, the first and second pivot members 114a, 114b may comprise an increased thickness (e.g., compared to the remaining wall thickness of the first portions 112a, 112b of the first and second central halves 110a, 110b) to provide a strengthened or enhanced region of the biopsy cap housing 100 at the pivot location (e.g., a high stress area) between the upper and lower chambers. For example, when a user compresses the second portions 122a, 122b of the biopsy cap housing 100 inward, the first portions 112a, 112b of the first and second central halves 110a, 110b move away from each other and the second portions 122a, 122b of the first and second central halves 110a, 110b move toward each other, engaging the locking portions 124a, 124b of the lower chamber with the neck 610 of the endoscopic biopsy port 600 (FIG. 6A). Similarly, when a user compresses the first portions 112a, 112b of the biopsy cap housing 100 inward, the first portions 112a, 112b of the first and second central halves 110a, 110b move toward each other and the second portions 122a, 122b of the first and second central halves 110a, 110b move away from each other, disengaging the locking portions 124a, 124b from the neck 610 of the endoscopic biopsy port 600. In various embodiments, the shape, position, and / or thickness of the first and second pivot members 114a, 114b may provide increased strength and / or flexibility compared to the corresponding pivot points of the biopsy cap housing 100 without increasing the total amount of material in the first and second pivot members 114a, 114b. These features may similarly be implemented with the housing 20 of the endoscopic attachment embodiment of FIGS. 2-4.

[0065] In addition to or alternative to any of the above advantages, the ability of the platform portion of the stabilizing member 128a to prevent overextension of the locking portions 124a, 124b can further prevent or minimize the cumulative effects of wear caused by gradual, continuous overextension of the locking portions 124a, 124b before or after repeated engagement and disengagement with the neck 610 of the endoscopic biopsy port 600.

[0066] In various embodiments, the first and second central halves 110a, 110b are integrally formed (co-molded, co-extruded, injection molded, etc.) from a variety of high-quality polymers (e.g., acetyl, etc.) capable of providing the necessary yield stress and force modulus to withstand the various radial and loading forces applied to the biopsy cap housing, while maintaining sufficient flexibility to be opened and closed using force applied by the user's fingers. These features can also be implemented with the housing 20 of the endoscopic attachment embodiment of Figures 2-4.

[0067] The present invention is not limited to embodiments in which one or more protrusions are disposed only on the mating surface of the first center split half and one or more corresponding receiving elements are disposed only on the mating surface of the second center split half. In various embodiments, one or more protrusions may be disposed on the mating surface of the second center split half and one or more corresponding receiving elements may be disposed on the mating surface of the first center split half. In various additional embodiments, the mating surface of the first center split half may include both protrusions and receiving elements configured to receive and / or be received within corresponding receiving elements and protrusions on the mating surface of the second center split half.

[0068] Materials that can be used for the various components of endoscopic attachment 18 (and / or other endoscopic attachments disclosed herein) can include those generally corresponding to medical devices. For example, endoscopic attachment 18 can be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc., or another suitable material. Examples of suitable polymers include acrylonitrile butadiene styrene, acrylonitrile butadiene styrene, and polycarbonate, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (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® or Elmer® available from Bayer). CRISTAMID® available from Phatochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available for example 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 (such as REXELL®), polyesters, 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 (for example KEVLAR®), polysulfone, nylon,These may include nylon-6, nylon-12 (such as GRILAMID® available from EMS American Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or blends, combinations, copolymers thereof, polymer / metal composites, etc.

[0069] It should be understood that this disclosure 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, substituting any element used in one example in another embodiment. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of this specification. While the devices and methods of the present invention have been described in terms of preferred embodiments, those skilled in the art will recognize that changes can be made in the devices and / or methods, and in the steps or sequence of steps, disclosed 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 within the spirit, scope, and concept of the invention as defined by the appended claims.

Claims

1. A biopsy cap assembly comprising: A housing defining an upper chamber and a lower chamber configured to receive a biopsy port of an endoscope, the housing comprising: a first housing portion, a first portion defining the upper chamber; a second portion defining the lower chamber; a first housing portion comprising: a second housing portion, a first portion defining the upper chamber; a second portion defining the lower chamber; and a second housing portion comprising: a housing, wherein mating surfaces of the first housing portion and the second housing portion are configured to engage to define the upper chamber and the lower chamber; a biopsy cap disposed within the upper chamber; A biopsy cap assembly comprising:

2. A biopsy cap assembly as described in claim 1, wherein the biopsy cap is positioned above the lower chamber.

3. A biopsy cap assembly as described in claim 1 or 2, further comprising a base portion positioned within the biopsy cap at the outer periphery of the biopsy port.

4. A biopsy cap assembly as described in claim 3, wherein the base portion is positioned at the bottom of the biopsy cap.

5. A biopsy cap assembly as described in claim 3, wherein the base portion is positioned within the upper chamber.

6. A biopsy cap assembly as described in claim 3, wherein the base portion is positioned above the lower chamber.

7. A biopsy cap assembly as described in claim 1 or 2, wherein the first housing portion, the second housing portion, and the biopsy cap define mating surfaces configured to prevent axial and / or rotational movement of the biopsy cap within the housing.

8. A biopsy cap assembly as described in claim 1 or 2, wherein the outer wall of the biopsy cap includes a recess formed therein, and the first housing portion and the second housing portion each include a substantial radial ridge configured to engage with a corresponding recess formed in the outer wall of the biopsy cap.

9. A biopsy cap assembly as described in claim 1 or 2, wherein the housing includes a lip portion extending into the proximal end of the upper chamber, the lip portion configured to engage with the biopsy cap within the housing.

10. A biopsy cap assembly as described in claim 9, wherein the biopsy cap includes a wedge portion extending outward from an upper surface of the biopsy cap, and the lip portion is configured to engage with the upper surface of the wedge portion.

11. A biopsy cap assembly as described in claim 9, wherein the lip portion extends into the first housing portion at or near the proximal end of the biopsy cap.

12. A biopsy cap assembly as described in claim 9, wherein the lip portion is positioned to engage with the top and / or side surfaces of the biopsy cap.

13. A biopsy cap assembly as described in claim 1 or 2, wherein the housing includes wedge portions formed within the inner surfaces of the first housing portion and the second housing portion, the wedge portions configured to engage with the biopsy cap within the housing.

14. A biopsy cap assembly as described in claim 13, wherein the biopsy cap includes a wedge portion extending outward from an outer wall of the upper portion of the biopsy cap, and the wedge portion of the housing is configured to engage with the wedge portion of the biopsy cap.

15. The biopsy cap assembly of claim 13, wherein the biopsy cap includes a surface element along an outer wall of the biopsy cap, and the wedge portion of the housing is configured to engage with the surface element of the biopsy cap.

Images