The present invention pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present invention pertains to polypectomy snare devices.
A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
The invention provides design, material, manufacturing method, and use alternatives for medical devices including polypectomy snare devices. An example polypectomy snare device may include a hollow shaft. A distal portion of the shaft may have a slit formed therein. The shaft may be shiftable between a first configuration wherein the distal portion is substantially straight and a second configuration wherein the distal portion includes a bend. A snare wire may be disposed within the shaft. A distal section of the snare wire may extend through the slit when the shaft is in the second configuration.
Another example polypectomy snare instrument may include a hollow shaft may extend through and be movable relative to the sheath. The shaft may have a distal portion and may terminate at a distal end. The distal portion of the shaft may be preformed to have a curvature when the distal portion of the shaft is extended distally beyond the distal end of the sheath. The distal portion of the shaft may have a slit formed therein. A flexible wire may be disposed within the shaft. The wire may be controllably extendible through the longitudinal slit.
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.
A hollow shaft 30 may be disposed inside the tubular sheath 20. The hollow shaft 30 may have a distal portion 31 and may terminate at a distal end 32. The shaft 30 may be advanced and retracted with respect to the sheath 20. The shaft 30 may extend from the distal end 32 to a proximal end (not shown), which may also attach to the handle 60 that can alter the position the shaft 30 with respect to the sheath 20. In some cases, the same handle controls the positioning of both the sheath 20 and the shaft 30. In other cases, the sheath 20 and the shaft 30 are positioned by separate handles. In some cases, the handle or handles are hand-operated. In some cases, the sheath 20 may be stiffer than the shaft 30. In some cases, the hollow shaft 30 may have a closed distal end 32, although in other cases, the distal end 32 may be open. In some cases, the hollow shaft 30 may be or otherwise include a hypotube.
All or a portion of the hollow shaft 30 may be pre-formed to have a curvature in its relaxed state. In some cases, only the distal portion 31 of the shaft 30 is pre-formed to have a curvature. Because the hollow shaft 30 may be less stiff than the sheath 20, the hollow shaft 30 may take on the shape of the sheath 20 when the pre-curved portion is inside the sheath 20. If the sheath 20 is essentially straight, then the pre-curved portion of the hollow shaft 30 is essentially straight when inside the sheath 20. When the pre-curved portion of shaft 30 is extended out of the sheath 20, distally beyond the distal end 22 of the sheath 20, the pre-curved portion assumes its relaxed, curved state. In some cases, the curvature has a constant radius of curvature throughout. In other cases, the pre-formed portion has a bend, with less bent portions on one side or on both sides adjacent to the bend. Note that the hollow shaft 30 and/or the snare wire 40 may be pre-curved. These are just examples.
The hollow shaft 30 may have a longitudinal slit or slot 50 on its distal portion 31. The slit 50 may have distal end 52 near the distal end 32 of the shaft 30, and may not extend fully to the distal end 32 of the shaft 30. In other cases, the slit 50 extends fully to the distal end 32 of the shaft 30. In some cases, the slit 50 in the shaft 30 faces an interior of the curvature of the distal portion 31 of the shaft 30.
As seen in
Note that the snare wire 40 may have any suitable cross-section, including round, sharpened, serrated, triangular, multi-angular, square, and so forth. These are just examples.
It may be instructive to examine the snare instrument 10 in various stages of use. For example, prior to deployment, the snare instrument 10 may resemble the stage shown in
Once the snare instrument 10 is positioned near the polyp, the hollow shaft 30 may be distally advanced beyond the distal end 22 of the sheath 20, or, equivalently, the sheath 20 may be proximally retracted to expose the distal portion 31 of the hollow shaft 30. When the distal portion 31 of the hollow shaft 30 is released from the sheath 20, it may assume its pre-formed state and may become curved. This stage is shown in
The longitudinal slit 50 at the distal portion 31 of the hollow shaft 30 may face the interior of the curvature. The snare wire 40, without any additional advancing or retracting, with respect to the hollow shaft 30, may take on the shape shown in
Alternatively, the snare wire 40 may remain inside the hollow shaft 30 for the duration of the longitudinal slit 50. This may occur through careful sizing or orientation of the slit 50, such as making the width of the slit 50 comparable to an outer diameter of the snare wire 40, or by skewing the orientation of the slit 50 so that it does not face directly toward the interior of the curvature but is angled slightly away from the interior of the curvature. In these cases, friction may hold the snare wire 40 inside the hollow shaft 30 for the duration of the longitudinal slit 50.
Once the distal portion 31 of the hollow shaft 30 is exposed and assumes its pre-curved state, the snare wire 40 may be forced distally from its proximal end, and may bow outward through the longitudinal slit 50. This stage is shown in
Note that there may be several ways of achieving the bowed state. In one case, the excess snare wire 40 may be pushed forward, so that it forces a bend that exits the shaft 30. In another case, the snare wire 40 may be pulled backwards to force the shaft 30 to bend. In still another case, the shaft 30 may be bent separately, forcing the snare wire 40 out. The above cases may be combined in any suitable manner, as well.
In the deployed stage, the practitioner places the loop over the polyp. The combination of the rounded distal portion 32 of the shaft 30 and the pre-formed curvature in the shaft 30 may aid in positioning the loop about the polyp. In addition, one or more of the surfaces of the shaft 30 and/or the wire 40 may be roughened or otherwise altered so as to improve the ability of the instrument 10 to “grip” the polyp. When properly positioned, the clinician may proximally retract the snare wire 40 and/or proximally retract the shaft 30 to sever the polyp and detach it from the anatomy. In some embodiments, cautery current may be passed down one or more of the shaft 30 and the snare wire 40 to cauterize the treatment site.
Once the polyp has been detached, the hollow shaft 30 and snare wire 40 may be retracted proximally into the distal portion 21 of the sheath 20. In some cases, such a retraction may be done all at once, going from the stage of
It may be beneficial to refer to particular configurations for the snare instrument 10. A first configuration may be shown in
In this second configuration, the snare wire 40 may be generally relaxed or forced proximally, as in the generally straight shape of
In general, various handles may be used to actuate the device. For example, the device may use one or more spools that slide on a shaft, and so forth.
The materials that can be used for the various components of the snare instrument 10 (and/or other sheaths, shafts or wires disclosed herein) may include those commonly associated with medical devices including metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. 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: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 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; titanium; 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 (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-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. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP. In addition, the device handle may optionally include one or soft grip portions, which may include a polymer such as TPE that may be molded onto the handle.
In at least some embodiments, portions or instruments 10 disclosed herein or the various components thereof 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 snare instrument 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, other radiopaque marker bands and/or coils may also be incorporated into the design of snare instrument 10 to achieve the same result.
In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into snare instrument 10. For example, the instruments 10 and/or components thereof may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Snare wire 40 and/or the tubular members, or portions thereof, 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 some embodiments, the exterior surface of the snare instrument 10 (including, for example, the exterior surface of snare wire 40 and/or the exterior surface of hollow shaft 30) may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc. In these as well as in some other embodiments, a coating, for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the sheath, or in embodiments without a sheath over portion of snare wire 40 and/or tubular member, or other portions of snare instrument 10. Alternatively, the sheath may comprise a lubricious, hydrophilic, protective, or other type of coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves guidewire handling and device exchanges. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility. Some other examples of such coatings and materials and methods used to create such coatings can be found in U.S. Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.
The coating and/or sheath may be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), gradient extrusion, or fusing several segments end-to-end. The layer may have a uniform stiffness or a gradual reduction in stiffness from the proximal end to the distal end thereof. The gradual reduction in stiffness may be continuous as by ILC or may be stepped as by fusing together separate extruded tubular segments. The outer layer may be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without deviating from the scope of the present invention.
It should be noted that although a sheath 20 is illustrated in the figures, the sheath 20 itself may not be necessary. In some cases, the snare wire 40 may be delivered through a small diameter lumen, such as inside a needle or a small catheter, without a sheath. For instance, the snare wire 40 may be delivered through an endoscopic ultrasound-guided fine needle aspiration system. Alternatively, the snare wire 40 may be delivered through one of several commercially available small visualization catheters, such as SPYGLASS® direct visualization catheters commercially available from Boston Scientific.
Note that the oval-shaped bow of the snare wire 40 is not the only shape available. Other example shapes are shown in
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 priority under 35 U.S.C. §119 to U.S. Provisional Application Ser. No. 61/506,433, filed Jul. 11, 2011, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
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61506433 | Jul 2011 | US |