The present invention pertains to endoscopes, endoscope assemblies, guidetubes, introducers, and instrument caps for endoscopes, guidetubes, and introducers. More particularly, the present invention pertains to biopsy caps for an access port of an endoscope.
A wide variety of endoscope assemblies and biopsy caps have been developed. Of the known endoscope assemblies and biopsy caps, each has certain advantages and disadvantages. There is an ongoing need to provide alternative endoscope assemblies and biopsy caps as well as methods for making and using the same.
The invention provides design, material, and manufacturing method alternatives for endoscope assemblies and biopsy caps as well as provides methods for making and using endoscope assemblies and biopsy caps.
An example endoscope assembly may include an endoscope having a channel formed therein and a port that provides access to the channel. A cap may be coupled to the port. The cap may include a base having a securing member for securing the cap to the port. The cap may also include an outer shell, a locking member coupled to the shell, an inner seal member disposed within the shell, and one or more openings extending through the cap and into the channel. A fluid control region may be defined within the shell.
An example endoscope biopsy cap may include an outer shell having an opening formed therein and a base. A fluid control region may be defined within the shell. A securing member may be disposed on the base for securing the base to a port on an endoscope. A locking member may be coupled to the shell for securing the position of a medical device disposed in the opening. A seal member may be disposed within the shell.
Another example endoscope biopsy cap may include an outer shell, a securing member coupled to the shell, a locking member coupled to the shell, a seal member disposed within the shell, and means for controlling fluid disposed within the shell.
An example method for using an endoscope may include providing an endoscope having a channel formed therein and a port that provides access to the channel, disposing the endoscope within a body lumen of a patient, and disposing a cap on the port. The cap may include an outer shell having an opening formed therein and a base, a securing member disposed on the base for securing the base to a port on an endoscope, a locking member coupled to the shell for securing the position of a medical device disposed in the opening, and a seal member disposed within the shell. A fluid control region may be defined within the shell.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention 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 invention.
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 (i.e., 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.
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.
An example endoscope and/or endoscope assembly 10 is illustrated in
Handpiece 12 may include one or a plurality of controls 22, such as rotating knobs, which may be used to control movement of distal tip 18 of shaft 14 during operation. For example, a first rotating knob 22a may control up and down movement or deflection of distal tip 18 of shaft 14, while a second rotating knob 22b may control side-to-side movement or deflection of distal tip 18 of shaft 14. Handpiece 12 may also include one or a plurality of buttons 24, which may be used to activate suction or deliver fluid such as air, saline and/or water, etc. through a lumen of the endoscope 10 or perform other functions as desired. Additionally, handpiece 12 may include an optical cable 26 connected to an external light source (not shown).
Turning now to
Caps like cap 30, which may be termed “biopsy caps”, are often designed with several functions in mind. For example, cap 30 may form a fluid/air barrier to working channel 16 that may help control insufflation and bile fluid egress therefrom that later have the potential to spill onto the clinician's hands and/or the floor thereby interfering with the intervention and/or become a biohazard. In addition, cap 30 may have an opening 32 extending therethrough. Opening 32 may be in fluid communication with working channel 16 and it may reduce the size of the opening 34 of working channel 16, for example, to accommodate an endoscopic device or instrument. Thus, caps like cap 30 may be much like an adapter in that it forms a physical transition at opening 34 of working channel 16 (or other instrument channels or access points) so that it transitions to a size more closely to that of the device to be inserted into working channel 16. Some additional discussion regarding biopsy caps can be found in U.S. Patent Application Pub. Nos. US20070293719A1, US20070244356A1, and US20070238928A1, the entire disclosures of which are herein incorporated by reference.
A number of additional biopsy caps are contemplated that incorporate at least some of the desirable features of biopsy caps as well as have other desirable characteristics. The forgoing discussion discloses some of the embodiments of caps that are contemplated. These caps may include an active seal. For the purposes of this disclosure, an active seal is a seal that when actuated by a user seals endoscope 10 at port 20 so as to prevent the leakage of bodily fluids and/or air. In addition, by virtue of being “active”, the caps disclosed herein are configured to be selectively activated so as to seal off endoscope 10 at port 20 at any appropriate time during an intervention and, conversely, may also be configured to be “unlocked” or “unsealed” at the desired time by a clinician.
Turning now to the remaining figures,
Shell 136 may have one or more apertures 152 formed therein. Aperture 152, for example, may be disposed on a top surface or surface that is opposite securing member 140 and may extend all the way through cap 130 including, for example, through seal member 144 and securing member 140. Although aperture 152 is illustrated on the top of shell 136, it can be appreciate that essentially any other suitable portion of shell 136 may include apertures 152 including the sides or side surfaces of shell 136. Aperture 152 may be the entrance point or otherwise define one or more openings that extend through cap 130 into channel 16 when cap 130 is seated on port 20. Thus, aperture 152 may form the exterior opening in cap 130 where other medical devices (e.g., guidewires, catheters, etc.) can be passed through so as to gain access to working channel 16.
To ease the ability of a user to pass a medical device through aperture 152, apertures 152 may have a chamfered or beveled edge, which may function like a funnel to guide the medical device into aperture. In addition to the funneling function that may be realized by the inclusion of beveled aperture 152, aperture 152 may also provide cap 130 with a number of additional desired characteristics. For example, because aperture 152 is formed in the relatively rigid shell 136 and because they are generally positioned a distance away from port 20, aperture 152 and/or shell 136 may also function as a strain relief that may relieve strain that might otherwise be applied to endoscope 10 (e.g., at port 20), for example, during device exchanges or transfers. Thus, the shear stress that may be generated during device exchanges can be shifted away from endoscope 10 (and sealing member 144), which may improve the ability of cap 130 to maintain a good seal at port 20.
Securing member 140 may be disposed on a bottom surface of cap 130 as illustrated in
Locking members 142 may be generally disposed adjacent the top surface of cap 130 and they may be used to secure and/or hold the position of a device (e.g., a guidewire, catheter, etc.) extending through cap 130 into channel 16. However, locking members 142 may be disposed on any suitable surface of cap 130 and/or shell 136. Locking members 142 may also be integrally formed with shell 136. In addition to holding the position of a device, locking members 142 may also tend to guide these devices away from the center of cap 130 so that other device may gain access to channel 16 via cap 130. Locking members 142 may include one or more bends or “hooks” formed therein that a medical device may be wrapped around or pressed against to hold its position. The number of locking members 142 may vary. In some embodiments, one locking member 142 is utilized. In other embodiments, two, three, four, five, six, or more locking members 142 are utilized. In addition, the precise form of locking members 142 may also vary. Examples of some of the various alternative locking members 142 contemplated can be found below.
Seal member 144 may include an outer portion 148 and an inner portion 150. In at least some embodiments, outer portion 148 may be made from a sealing material such as, for example, an elastomer. Other materials, of course, are contemplated. The elastomeric outer portion 148 may be chamfered adjacent aperture 152 so as to guide or funnel devices therethrough. Outer portion 148 may extend laterally to the edges of shell 136. This may help to prevent or reduce the amount of fluids that may migrate into and out from cap 130. Outer portion 148 may also extend to the top of shell 136 and may form a strain relief. Alternatively, a gap 153 may be formed between the top of outer portion 148 and the top of the interior of shell 136. Gap 153 may provide an area for fluids to collect that may escape seal member 144 and that may otherwise “splash” during, for example, device removal or exchange.
Inner portion 150 may comprise a soft material such as a plastic or foam that may be suitable for sealing about a medical device extending therethrough. The precise form and materials for inner portion 150 may vary. For example, inner portion 150 may include a pliable or formable polymer that may be absorbent. In some embodiments, inner portion 150 may include those materials used for similar structures disclosed in U.S. Pat. No. 6,663,598, the entire disclosure of which is herein incorporated by reference. In at least some embodiments, inner portion 150 may substantially fill the interior of outer portion 148. Alternatively, a portion of the interior of outer portion 148 may lack inner portion 150 and may be used, for example, to hold bodily fluids that may escape from port 20.
In some embodiments, inner portion 150 may include a fluid, gel or gel-like material that is capable of both sealing around devices extending therethrough and absorbing fluids. For example, inner portion 150 may include a petroleum jelly or similar substance such as VASELINE® petroleum jelly and/or KY® jelly. Alternatively, inner portion 150 may include a hygroscopic material that may expand upon absorption of fluids and may place additional sealing force on devices extending therethrough. Accordingly, inner portion 150 may help control bodily or other fluids that may be disposed in cap 130 and thus may be understood to be a fluid control region or portion of cap 130.
Securing member 240 may include a slidable button lock 254 that may be actuated to lock or unlock cap 230 from port 220. To facilitate locking, port 220 may include a flange 255 that button lock 254 may catch upon when locking securing member 240. Furthermore, because the position of button lock 254 may be readily viewed by a user, button lock 254 may provide visual confirmation of whether or not cap 230 is satisfactorily locked onto port 220. Other securing members, including any of those disclosed herein, may be substituted for securing member 240 without departing from the spirit of the invention.
Seal member 244 may be seated within shell 236 and secured to shell 236 (e.g., along the interior wall of shell 236) at a plurality of points. However, gaps may be left between seal member 244 and shell including, for example, gap 258. This arrangement may be desirable because it may allow fluid that might otherwise migrate up through seal member 244 to flow into gap 258 and onto a valve or gasket portion 256 of seal member 244. Accordingly, when suction is applied through the endoscope (e.g., via another aspiration tube or lumen so as to create suction on the working channel of the endoscope), valve portion 256 may deform downward (e.g., toward port 220), allowing any fluids collected thereon to flow back into port 220. Thus, gap 258 may define a fluid control region where bodily or other fluids can be housed until a clinician can remove it (e.g., via aspiration, suction, etc.) or otherwise deal appropriately with it.
Cap 230 may also include one or more additional fluid control regions. These regions may also help to collect and/or hold bodily fluids that may accumulate within cap 230. For example, a fluid control chamber 260 may be defined within seal member 244. Chamber 260 may take the form of an opening or widening of seal member 244 that is generally disposed within seal member 244. Thus, fluids that may escape from around a device that extends through seal member 244 may be collected in chamber 260. Another fluid control chamber 262 may be disposed within shell 236, for example, above seal member 244. Chamber 262 may collect fluids that escape from seal member 244 altogether. Chambers 260/262 may be designed to hold a volume of fluid until the time when it might be convenient for a clinician to dispose of the fluid. For example, aspiration and/or suction may be applied to the endoscope (e.g., on the working channel) so that suction pulls downward on cap 230. This may allow fluids that are collected in cap 230 to simply migrate back into the endoscope.
In addition to the fluid control regions illustrated in
An alternative biopsy cap design and details thereof are depicted in
The upper portion 320 of shell 310 preferably has integrally formed thereon one or more locking members 322. As with other embodiments disclosed herein, locking members 322 are used to secure a guidewire, catheter or other instrument at a fixed longitudinal position relative to the endoscope during a procedure. As better illustrated in
The lower portion 330 of shell 310 preferably has integrally formed thereon a base incorporating a securing member 332. As with other embodiments disclosed herein, securing member 332 functions to secure the biopsy cap to the entrance or port of the working channel of the endoscope. The features of this exemplary securing member 332 are better illustrated in
The function of the seal member 350 and its structural details are best shown in
The foam insert member 356 is depicted in perspective view in
The seal member 350 also includes an upper portion 355 which lies over and is attached to the upper surface of the lower portion 351 of seal member 350. The upper portion 355 encloses the top of the cavity 359. The upper portion 355 also includes a slit type seal 361 formed there through in an indented portion 362 of its surface. The indented portion 362 provides a thin layer which stretches when an instrument is inserted through the slit type seal 361. The seal member 350 in this exemplary embodiment therefore includes three seals including an uppers slit type seal, a foam insert seal and a lower seal. Further, a fluid control cavity is formed between the upper and lower seals.
In at least some embodiments, fingers 976 are made from a deformable material that allows them to shift between the first and second positions and hold the desired shape/position. Leaf-like fingers 976 may be utilized alone as a securing member 940, as shown, or as a secondary attachment means by combining them with other securing members 940.
In addition to those securing members disclosed herein, any of the caps disclosed herein may alternatively include other suitable securing members without departing from the spirit of the invention. For example, other securing members may include, but are not intended to be limited to, lock and key designs, slidable or depressible button locks that may catch or otherwise secure onto the port, long sleeves that are disposed over the port, fasteners that includes adhesives including pressure-sensitive adhesives (e.g., that may be analogous to those used on canning lids), and the like. The same may also be true of the various locking members disclosed below.
Although not shown, locking member 1342 may be attached to a biopsy cap at any suitable location using any suitable means. For example, a portion of arms 1386 and/or ring 1388 may be directly attached to a cap. Alternatively, an arm or member may extend from the cap that attaches to locking member 1342. In still other embodiments, locking member 1342 may include an additional structure such as a clip to removably secure locking member 1342 to a cap. These later embodiments of locking member 1342 and other locking members may be desirable because they may allow different types of locking members to be “mixed and matched” based on their particular applicability to a given intervention.
As illustrated in
As illustrated in
A number of different configurations are contemplated for locking member 1642. For example, locking member 1642 may have a barrel-like or cylindrical shape rather than the more squared or rectangular shape as shown. In addition, locking member 1642 may include a lock that can reversibly hold button 1696 in the desired position such as, for example, the locked position.
In some embodiments, bases 1999 and/or 2099 may be generally planar. In other embodiments, bases 1999 and/or 2099 may be curved so as to be convex, concave, or have another shape. Moreover, bases 1999 and/or 2099 may change from one shape to another upon actuation of fingers 1998a/1999b and/or 2098a/2098b. For example, bases 1999 and/or 2099 may be generally planar when fingers 1998a/1999b and/or 2098a/2098b are in the open position and bases 1999 and/or 2099 may shift to a concave shape when fingers 1998a/1999b and/or 2098a/2098b shift to the flat configuration. Alternatively, bases 1999 and/or 2099 may shift from concave to planar, convex to planar, planar to convex, etc.
A number of alternatives are also contemplated for fingers 1998a/1999b and/or 2098a/2098b. For example, fingers 1998a/1999b and/or 2098a/2098b may be interconnected so that the shifting of one finger results in the shifting of all the fingers. Alternatively, flaps may be used instead of or in addition to fingers 1998a/1999b and/or 2098a/2098b that extend down at least a portion of the length of bases 1999 and/or 2099 and that are configured to shift between an open and a closed configuration.
Base 1999/2099 of locking members 1942/2042 may desirably add a surface substrate that may allow these devices to be attached to a biopsy cap. In some embodiments, base 1999/2099 may include a strip of polymer or plastic that can be bonded to a biopsy cap with a permanent adhesive. In other embodiments, base 1999/2099 may be configured to be removably attached to the biopsy cap. For example, a removable or temporary adhesive may be used, base 1999/2099 may be “velcroed” onto the cap, etc.
In some embodiments, one or more additional locking members may be added to a cap. The additional locking member may take any suitable form including any of those disclosed herein. Adding the locking members may include fastening, snapping on, or hingedly connecting an external locking member assembly onto the cap. Some additional discussion of wire or other locking devices which may be suitable for use with a biopsy cap may include U.S. Patent Application Pub Nos. US20060229496A1, US20050148820A1, and US20040106852A1 as well as U.S. Pat. Nos. 7,060,052, 7,037,293, 6,893,393, 6,663,597, and 6,096,009, the entire disclosures of which are herein incorporated by reference.
The various caps as well as the various components thereof may be manufactured according to essentially any suitable manufacturing technique including molding, casting, mechanical working, and the like, or any other suitable technique. Furthermore, the various structures may include materials commonly associated with medical devices such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or any other suitable material. These materials may include transparent or translucent materials to aid in visualization during the procedure. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: NO6625 such as INCONEL® 625, UNS: NO6022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: NO4400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; combinations thereof; and the like; or any other suitable material.
Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane, 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-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.
In at least some embodiments, portions or all of the structures disclosed herein may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of endoscope 10 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, radiopaque marker bands and/or coils may be incorporated into the design of endoscope 10 or the various components thereof to achieve the same result.
In some embodiments, a degree of MRI compatibility may be imparted into the structures disclosed herein. For example, to enhance compatibility with Magnetic Resonance Imaging (MRI) machines, it may be desirable to make a portion of endoscope 10 in a manner that would impart a degree of MRI compatibility. For example, a portion of endoscope 10 may be made of a material that does not substantially distort the image and create substantial artifacts (artifacts are gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. A portion of endoscope 10 may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
In addition, portions or components of the structures (including the various securing members, locking members, etc.) disclosed herein may be coated with a relatively soft material that may improve grip such as a thermoplastic elastomer. The coating may or may not include additional features that may improve grip such as ridges, surface textures, bumps, grooves, projections, etc.
Furthermore, the various structures disclosed herein may be designed for single use or may be designed for repeated uses. Thus, the structures disclosed herein may be manufactured from materials that can withstand multiple sterilizations and/or cleanings. This may be true of entire caps, as disclosed herein, or any of the various features of any of the caps.
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 invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/054,413, filed May 19, 2008, the entire disclosure of which is incorporated herein by reference. This application is related to U.S. patent application Ser. No. ______ (atty. docket number 1001.2134101), filed on even date herewith and entitled “Integrated Locking Device with Passive Sealing”, which claims the benefit of U.S. Provisional Application Ser. No. 61/054,407, filed May 19, 2008; U.S. patent application Ser. No. ______ (atty. docket number 1001.2133101), filed on even date herewith and entitled “Integrated Locking Device with Active Sealing”, which claims the benefit of U.S. Provisional Application Ser. No. 61/054,393, filed May 19, 2008; and U.S. patent application Ser. No. ______ (atty. docket number 1001.2091101), filed on even date herewith and entitled “Biopsy Cap Attachment and Integrated Locking Device”, which claims the benefit of U.S. Provisional Application Ser. No. 61/054,294, filed May 19, 2008, which disclosures are all hereby incorporated herein by reference. This application is also related to U.S. patent application Ser. No. 12/029,148, filed Feb. 11, 2008, the disclosure of which is hereby incorporated herein by reference.
Number | Date | Country | |
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61054413 | May 2008 | US |