Patent ID: 12256895

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

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 numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

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 employed in its sense including “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

The following detailed description should be read with reference to the drawings in which similar elements in different drawings 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.

In various embodiments, features and advantages of providing sealable access to a working channel, e.g., of an endoscope, may be realized in combination with a biopsy cap and biopsy cap housing. Such sealable access to a working channel, which may be reinforced, may be implemented with features throughout the disclosures of U.S. patent application Ser. No. 16/100,960, filed Aug. 10, 2018 and titled “Biopsy Cap For Use With Endoscope,” United States patent application, filed on even date herewith and titled “Devices, Systems, And Methods For A Biopsy Cap And Housing,” United States patent application, filed on even date herewith and titled “Biopsy Cap And Biopsy Cap Housing,” United States patent application filed on even date herewith and titled, “Devices, Systems, And Methods For Providing Sealable Access To A Working Channel,” United States patent application, filed on even date herewith and titled “Internal Seal for Biopsy Cap,” United States patent application, filed on even date herewith and titled “Devices, Systems, and Methods for Providing Sealable Access to a Working Channel,” which are each incorporated by reference in their entirety and for all purposes.

During endoscopic procedures, a medical instrument such as a guidewire, catheter, endoscopic instrument, or the like may be inserted through a working channel of the endoscope. A port (e.g., a “biopsy port”) along the endoscope may provide access to the working channel. During use, it may be desirable to couple a biopsy cap to the biopsy port. The biopsy cap may have one more seals or sealing members. The seals may be designed to seal against the biopsy port and/or against instrument(s) that may be extended through the biopsy cap into the working channel. During some interventions, it may be desirable to secure the position of a medical instrument (e.g., a guidewire) relative to the endoscope. In order to secure the medical instrument, a locking mechanism may be secured to the endoscope and/or the biopsy cap. Disclosed herein are endoscope attachments or biopsy cap assemblies that may include a number of features including a biopsy cap housing, biopsy cap, a locking mechanism, as well as other features.

FIG.1illustrates a portion of a biopsy port10of an example endoscope12. The biopsy port10may include a stem or neck region14and an end or flanged region16. The biopsy port10serves as an access point to a channel (e.g., a working channel) of the endoscope12. The biopsy port10, in general, may be designed to receive a biopsy cap.

FIGS.2-3illustrates an example endoscope attachment18including a housing20coupled to the biopsy port10. In general, the endoscope attachment18is designed to be coupled to (e.g., detachably coupled, attached, secured to, etc.) the biopsy port of an endoscope (e.g., the biopsy port10of the endoscope12). In addition, the endoscope attachment18includes a number of features including the ability to form a seal with a biopsy cap at the biopsy port10, allow for a medical instrument (e.g., a guidewire, catheter, endoscopic device, and/or the like) to pass therethrough and into the working channel of the endoscope12, allow for the medical instrument to be secured relative to the endoscope12, etc., and may be configured to securely receive a biopsy cap.

The endoscope attachment18may include a housing20having a skirt region22, a grip region24, and a locking region26. In some instances, the housing20may be a single piece. In other instances, the housing20may be formed from 2 or more pieces, for example, first housing portion20aand second housing portion20b, which are secured together. InFIG.3, for example, the second housing portion20bis removed and only the first housing portion20ais shown. Forming the housing20from separate pieces may allow for the housing20to be relatively easily molded (e.g., compared to a singular piece) or otherwise formed into a complex shape. When formed from separate pieces, the housing portions20a/20bmay be secured together in a suitable manner such as by pinning (e.g., snap locks that include pins on one portion and holes or openings to receive the pins on the other portion), thermal bonding, adhesive bonding, and/or the like. In various embodiments, the housing20may be substantially rigid. Pinning may result in secure attachment of the portions20a,20band also may enhance the ability of the two portions20a/20bof the housing to “pivot” relative to one another. When doing so, the housing20can open or widen (e.g., adjacent to a lower portion of the endoscope attachment18such as adjacent to the skirt region22) in order to attached/detach the endoscope attachment18to the biopsy port10. A slot or opening28may be formed along a portion of the housing20. The slot(s) may enhance the flexibility and/or pivoting ability of the housing20and may make it easier to secure the endoscope attachment18to the biopsy port10.

The skirt region22may generally be designed to follow the shape and/or contour of the endoscope12. More particularly, the skirt region22may be shaped so as to conform to the shape of the handle region of the endoscope12adjacent to the biopsy port10. This may increase the stability of the endoscope attachment18and assist with securing hold the position of the endoscope attachment18relative to the endoscope12. In at least some instances, the shape of the skirt region22may be described as being asymmetrical. For example, the skirt region22may include a first portion30(e.g., which may or may not correspond to the first housing portion20a) and a second portion32(e.g., which may or may not correspond to the second housing portion20b).

The grip region24may include one or more gripping members34. The gripping members34may take the form of finger or pinch grips that allow a user to grasp the endoscope attachment18. In some instances, pinching together the gripping members34may widen the endoscope attachment18(e.g., adjacent to the skirt region22) and allow for the endoscope attachment18to be more attached to/detached from the biopsy port10. The slot28may help to facilitate the flexing/bending of the endoscope attachment18when the gripping members34are pinched.

The locking region26may include one or more locking apparatuses36. The locking apparatuses36may vary in form. In some instances, the locking apparatuses36may take the form of hooks designed to engage and hold a medical instrument (e.g., a guidewire, catheter, endoscopic device, and/or the like). When doing so, the medical instrument can be held in place relative to the endoscope attachment18(and/or the endoscope12).

As shown inFIGS.3and4, housing20of the endoscope attachment18may include one or more angled locking members38. In general, the angled locking members38take the form of projections that extend radially inward and in a direction toward an upper chamber from the inner surface of the housing20. The angled locking members38may include a bend, jogged, or bent region40. In at least some instances, the angled locking members38may be described as being “V-shaped”. However, other shapes are contemplated. The angled locking members38may be resiliently flexible such that the angled locking members38can bend or deflect in order to fit over and secure to the flanged region16of the biopsy port10. The number of angled locking members38and/or the arrangement of the angled locking members38may vary. For example, the housing20may include two, three, four, five, six, seven, eight, or more angled locking members38. In some instances, each center-split halves20a,20bincludes a pair of angled locking members38that are arranged across from or opposite one another. When the housing portions d20a,20bare brought together, one of the angled locking members38from each of the opposing housing portions20a,20bmay be disposed adjacent to one another. Other arrangements are contemplated.

The endoscope attachment18may include one more stabilizing members42. In general, the stabilizing members42may take the form of take the form of projections that extend radially inward from the inner surface of the housing20. The stabilizing members42may help to stabilize the position (e.g., laterally and/or axially) on the biopsy port10. The number of stabilizing members42and/or the arrangement of the stabilizing members42may vary. For example, the endoscope attachment18may include two, three, four, five, six, seven, eight, or more stabilizing members42. In some instances, each housing portion20a/20bincludes a pair of stabilizing members42that are disposed adjacent to one another. When the housing portions20a/20bare brought together, the pairs of stabilizing members42from each of the opposing housing portions20a/20bmay be disposed opposite to one another. Other arrangements are contemplated.

A biopsy cap44may be disposed within the housing20of the endoscope attachment18as shown inFIG.5. It is noted that for clarity purposes, the biopsy cap44is not shown inFIGS.3-4. The biopsy cap44may vary in form. In at least some instances, the biopsy cap44may include one or more seals or sealing members (not depicted inFIG.5). The seal(s) may be designed to seal against the biopsy port10and thereby prevent fluid from leaking from the biopsy port10. In addition, the seal(s) may be designed to seal against a medical instrument (e.g., a guidewire, catheter, endoscopic device, and/or the like) passing through the endoscope attachment18and/or the biopsy cap44. In at least some instances, the biopsy cap44may be disposed adjacent to and/or otherwise seated on the stabilizing members42.

In an embodiment, a skirt region22may have one or more gripping members or ribs46disposed along an inner surface (e.g., an inner surface of the housing20at or along the skirt region22) as shown inFIG.6. The ribs46may help to form or otherwise define a surface along the interior of the endoscope attachment18that allows the endoscope attachment18to “grip” onto and/or otherwise frictionally engage the endoscope12and, thus, help to secure the endoscope attachment18to the endoscope12.

FIGS.7and8depict an embodiment of an endoscope attachment18with housing20being attached to a biopsy port10. For example, the endoscope attachment18may be disposed adjacent to the biopsy port10. When doing so, the angled locking members38may be brought adjacent to the flanged region16of the biopsy port as shown inFIG.7. A user may apply a force (e.g., a pinching force) along a grip region (e.g., the grip region24ofFIG.2) of the attachment18to outwardly flex or otherwise pivot in order to open or widen the housing20(e.g., adjacent to the skirt region22). The user may also apply a downward force onto the endoscope attachment18to bring the endoscope attachment into engagement with and secure the endoscope attachment18to the biopsy port10. When doing so, the angled locking members38may resiliently deflect so that the angled locking members38are seated underneath the flanged region as shown inFIG.8. When secured, the stabilizing members42may engage the neck region14and/or the flanged region16of the biopsy port10. Securing the endoscope attachment18to the biopsy port10may also bring an aperture48of seal member44or a base45into engagement with the biopsy port10so that the seal member48may press against or otherwise seal a channel50of the endoscope12(e.g., a channel50accessible via the biopsy port10). When the endoscope attachment18is secured to the biopsy port10, the endoscope attachment18may provide haptic feedback such as a “snap” or “click” sound and/or sensation, and/or the like. A user may remove the endoscope attachment18by simply pinching the grip region24in order to flex/pivot/widen the housing20(as well as widen/open the angled locking members38) and pulling the endoscope attachment18from the biopsy port10.

FIG.9illustrates an embodiment of an endoscope attachment118that may be similar in form and function to other endoscope attachments disclosed herein. The endoscope attachment118may include a housing120. The housing120may be generally more flexible than the housing20. A slot128may be formed in the housing to further enhance the flexibility of the housing. One or more locking members152may extend from the housing120. In some instances, the locking members152may take the form of substantially rigid projections that extend radially inward from the housing120. In at least some instances, the locking members152may be arranged to form a generally circular (e.g., and/or a broken circle) lock designed to extend around a biopsy port (e.g., such as a biopsy port10.

FIGS.10and11depict the endoscope attachment118being attached to a biopsy port10. For example, the endoscope attachment118may be disposed adjacent to the biopsy port10. When doing so, the locking members152may be brought adjacent to the flanged region16of the biopsy port as shown inFIG.10. A user may apply a downward force onto the endoscope attachment118to secure the endoscope attachment118to the biopsy port10. When doing so, the housing120may resiliently deflect so that the locking members152may be seated underneath the flanged region as shown inFIG.11. Securing the endoscope attachment118to the biopsy port10may also bring an aperture148of the seal member144or a base145into engagement with the biopsy port10so that the base145may press against or otherwise seal a channel50of the endoscope12(e.g., a channel50accessible via the biopsy port10). When the endoscope attachment118is secured to the biopsy port10, the endoscope attachment118may provide haptic feedback such as a “snap” or “click” sound.

The materials that can be used for the various components of the endoscope attachment18(and/or other endoscope attachments disclosed herein) may include those commonly associated with medical instruments. For example, the endoscope attachment18may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include acrylonitrile butadiene styrene, acrylonitrile butadiene styrene and polycarbonate, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example 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 (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-6, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.