Patent Application
20240374866
The disclosure is directed to an introducer. More particularly, the disclosure is directed to an introducer that keeps OTW tools within a saline flow.
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 disclosure is directed to several alternative designs, materials and methods of manufacturing medical device structures and assemblies, and the use thereof. An example may be found in a medical system including an introducer device including an elongate shaft defining a shaft lumen therethrough, the elongate shaft including a proximal region, and a proximal hub secured relative to the proximal region of the elongate shaft. The proximal hub includes a primary channel extending through the proximal hub and fluidly coupled with the shaft lumen and a secondary channel extending through the proximal hub and fluidly coupled with the shaft lumen. A guide catheter is adapted to be advanced through the secondary channel and into the shaft lumen. A guidewire is adapted to be advanced through the secondary channel. A working catheter is adapted to be advanced through the primary channel and into the shaft lumen when the guide catheter has been withdrawn proximally such that a distal end of the guide catheter remains within the secondary channel, the working catheter including a catheter shaft including a distal region, the distal region of the working catheter adapted to releasably engage the guidewire.
Alternatively or additionally, the medical system may further include a first hemostasis valve fluidly coupled with the primary channel and a second hemostasis valve fluidly coupled with the secondary channel.
Alternatively or additionally, the medical system may further include a third hemostasis valve disposed between the proximal hub and the elongate shaft, thereby providing a fluid tight volume within the primary channel and the secondary channel.
Alternatively or additionally, the guidewire may have a first diameter over the guidewire outside of an engagement region, and a second diameter less than the first diameter within the engagement region.
Alternatively or additionally, the distal end of the working catheter may include a distal body defining a primary engagement feature adapted to releasably engage the guidewire.
Alternatively or additionally, the primary engagement feature may include a body lumen having a body lumen diameter and a channel operably coupled with the body lumen, the channel having a channel width less than the body lumen diameter.
Alternatively or additionally, the channel width may be less than the first diameter of the guidewire and greater than the second diameter of the guidewire, and the body lumen diameter may be greater than the first diameter of the guidewire.
Alternatively or additionally, the engagement feature may further include one or more secondary engagement features disposed proximally of the primary engagement feature.
Alternatively or additionally, each of the one or more secondary engagement features may include C-shaped features having a lumen diameter greater than the first diameter of the guidewire and a channel width that is greater than the second diameter of the guidewire.
Alternatively or additionally, the primary channel may be curved and the secondary channel may be straight and may intersect the primary channel.
Another example may be found in an introducer device for use with a guide catheter and a working catheter. The introducer device includes an elongate shaft defining a shaft lumen therethrough and a hub secured relative to a proximal region of the elongate shaft. The hub includes a first hemostasis valve disposed at a proximal end of the hub, a second hemostasis valve disposed at the proximal end of the hub, the second hemostasis valve parallel with but spaced from the first hemostasis valve, a primary channel extending distally through the hub from the first hemostasis valve to the shaft lumen and a secondary channel extending distally through the hub from the second hemostasis valve and fluidly coupled with the primary channel.
Alternatively or additionally, the primary channel may curve through the hub from the first hemostasis valve towards the shaft lumen.
Alternatively or additionally, the secondary channel may extend linearly through the hub from the second hemostasis valve to an intersection between the primary channel and the secondary channel.
Alternatively or additionally, a diameter of the secondary channel may narrow from proximal to distal.
Alternatively or additionally, the introducer device may further include a third hemostasis valve fluidly coupled between the primary channel and the shaft lumen, thereby providing a fluid-tight volume between the first hemostasis valve, the second hemostasis valve and the third hemostasis valve.
Another example may be found in a working catheter adapted to be used in combination with an introducer device having a bifurcated hub, the bifurcated hub defining a first passageway adapted to accommodate the working catheter and a second passageway adapted to accommodate a guide catheter and a guidewire, the second passageway intersecting the first passageway, the guidewire having a first diameter outside of an engagement region and a second diameter less than the first diameter within the engagement region. The working catheter includes an elongate catheter shaft extending from a proximal region to a distal region and a working member secured within the distal region. The working member includes a primary engagement feature that is adapted to releasably secure the body member to a guidewire and one or more secondary engagement features that are each adapted to releasably secure the body member to the guidewire.
Alternatively or additionally, the working member may further include a working feature.
Alternatively or additionally, the primary engagement feature may include a body lumen having a body lumen diameter that is greater than the first diameter of the guidewire and a channel operably coupled with the body lumen, the channel having a channel width that is less than the first diameter of the guidewire and greater than the second diameter of the guidewire.
Alternatively or additionally, the channel width may be less than a first diameter of the guidewire and greater than a second diameter of the guidewire, and the body lumen diameter may be greater than the first diameter of the guidewire.
Alternatively or additionally, each of the one or more secondary engagement features may include C-shaped features having a lumen diameter greater than the first diameter of the guidewire and a channel width that is greater than the second diameter of the guidewire.
The preceding summary is provided to facilitate an understanding of some of the innovative features unique to the present disclosure and is not intended to be a full description. A full appreciation of the disclosure can be gained by taking the entire specification, claims, figures, and abstract as a whole.
The disclosure may be more completely understood in consideration of the following description of various examples in connection with the accompanying drawings, in which:
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 disclosure to the particular examples described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
The following description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict examples that are not intended to limit the scope of the disclosure. Although examples are illustrated for the various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that may be utilized.
All numbers are herein assumed to be modified by the term “about”, unless the content clearly dictates otherwise. The recitation of numerical ranges by endpoints includes all numbers subsumed 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 the 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 a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is contemplated that the feature, structure, or characteristic may be applied to other embodiments whether or not explicitly described unless clearly stated to the contrary.
A number of medical procedures may utilize a plurality of medical devices such as catheters. A guide catheter may be used to access a particular treatment area, for example. In some instances, the guide catheter may be used to guide a guidewire to the particular treatment area. In some instances, the guidewire may be advanced through the vasculature prior to the guide catheter and perhaps subsequent working catheters being advanced over the guidewire. In some instances, multiple working catheters may be advanced over the guidewire. In some instances, there may be benefits in being able to exchange multiple devices such as catheters by removing one catheter and subsequently advancing another catheter over the guidewire. In some instances, there may be benefits in making this exchange within a saline environment in order to reduce or even eliminate the possibility of air bubbles being dragged into a patient as a medical device such as a catheter is advanced through the vasculature.
An illustrative but non-limiting example of such a procedure is a cardiac valve repair process in which a plurality of working catheters may be used to deliver and deploy repair elements close to the cardiac valve being repaired. A guide catheter may be advanced to a position proximate the cardiac valve in order to guide a guidewire to an appropriate location within the vasculature. Once the guidewire has been appropriately deployed, a series of working catheters may be used to deliver and deploy the repair elements.
The introducer device 12 includes a first hemostasis valve 26 and a second hemostasis valve 28. In some instances, as shown, the introducer device 12 may include a third hemostasis valve 30. It will be appreciated that inclusion of the first hemostasis valve 26, the second hemostasis valve 28 and the third hemostasis valve 30 may provide a fluid-tight volume between the first hemostasis valve 26, the second hemostasis valve 28 and the third hemostasis valve 30. Each of the first hemostasis valve 26, the second hemostasis valve 28 and the third hemostasis valve 30 (if included) may be adapted to provide a fluid-tight seal when no devices extend through the hemostasis valve, and to provide a fluid-tight seal against any devices extending through the hemostasis valve.
As shown, a working catheter 32 is extending through the first hemostasis valve 26 and at least partially through the hub 22. A guide catheter 34 is extending through the second hemostasis valve 28 and at least partially through the hub 22. A guidewire 36 is shown within the guide catheter 34, and extends through the hub 22 and through the elongate shaft 14. In some instances, the guide catheter 34 may be steerable, and thus may be used to accurately position the guidewire 36.
In some instances, the guidewire 36 and the guide catheter 34 may each be independently adapted to be advanced through the second hemostasis valve 28 and through the secondary channel 40 until reaching the primary channel 38 at the intersection point 42. From there, the guidewire 36 and the guide catheter 34 may each be independently adapted to be advanced through the third hemostasis valve 30 (if present) and into the shaft lumen 16 of the elongate shaft 14. The working catheter 32 may be adapted to be advanced through the first hemostasis valve 26 and through the primary channel 38 to a point at which the working catheter 32 is able to releasably engage with the guidewire 36. In some instances, a reduced diameter region 44 of the secondary channel 40 may be dimensioned to have an inner diameter that is about the same or just larger than an outer diameter of the guide catheter 34.
In some instances, D1 and D2 are equal to each other, and are defined at least in part upon an overall size of the guidewire 36. As an example, the guidewire 36 may be referred to as an 0.035 inch guidewire, meaning that both D1 and D2 are equal to 0.035 inches. In some instances, D1 and D2 may vary, depending on the particular guidewire, but are equal to each other. Various size guidewires may be used, depending at least in part upon the dimensions of the vasculature through which the guidewire will be expected to pass and the dimensions and other requirements of the guide catheter and working catheters to be advanced over the guidewire. In some instances, it is contemplated that D1 and D2 may vary from each other. As an example, D1 may be smaller than D2 in situations in which having a smaller diameter distal region 52 may be beneficial.
For the engagement region 56, the diameter D3 may be considered as being a fraction of either D1 or D2. As an example, D3 may be in a range of about 20 to 80 percent of either D1 or D2. As another example, D3 may be in a range of about 30 to 70 percent of either D1 or D2, or perhaps a range of about 40 to 60 percent of either D1 or D2. In some instances, the guidewire 36 may be a constant diameter guidewire in which the engagement region 56 has been ground down to achieve the diameter D3. As will be discussed, the engagement region 56 allows the working catheter 32 to releasably engage and disengage the guidewire 36.
In some instances, the distal body 64 may include a working feature 74. As shown, the working feature 74 includes a pair of pincers labeled 74a and 74b. This is merely an example, as the working catheter 32 may include any of a variety of different working features 74. In some instances, the pincers 74a and 74b may be used for holding and delivering elements useful in repairing a cardiac valve, for example.
Once the guidewire 36 has been advanced through the vasculature to a desired treatment location, the guide catheter 34 may be withdrawn proximally to a position in which the distal end 46 of the guide catheter 34 is proximate the intersection point 42 between the primary channel 38 and the secondary channel 40, a working catheter such as the working catheter 32 may be advanced distally through the primary channel 38 until the primary engagement feature 66 (and secondary engagement features 72, if present) engage the engagement region 56 of the guidewire 36. In some instances, this may include translating the guidewire 36 distally or proximally in order to properly position the engagement region 56 of the guidewire 36. Once engaged, the working catheter 32 may be moved distally (or the guidewire 36 may be moved proximally) in order to dispose the distal region 52 of the guidewire 36 within the primary engagement feature 66 (and optionally within the secondary engagement features 72, if present).
Once the working catheter 32 is no longer needed, the working catheter 32 may be withdrawn proximally until the distal body 64 is positioned within the primary channel 38. The guidewire 36 may be translated to position the engagement region 56 of the guidewire 36 within the primary engagement feature 66 (and optionally within the secondary engagement features 72, if present). With the guide catheter 34 positioned with its distal end 46 proximate the intersection point 42), continuing to withdraw the working catheter 32 proximally will cause the engagement region 56 of the guidewire 36 to disengage from the primary engagement feature 66 and optionally the secondary engagement features 72, if present.
In some instances, there may be a desire to use one or more additional working catheters. It will be appreciated that each of the one or more additional working catheters may be advanced through the introducer device 12 in a manner similar to that described with respect to the working catheter 32. Because of the hemostasis valves 26, 28 and 30, each additional working catheter will enter the hub 22 via the first hemostasis valve 26 into a saline field prior to engaging and following the guidewire 36 into the patient. This allows any air bubbles entrained within the working catheter being introduced to escape into the saline within the saline field.
The materials that can be used for the various components of the medical devices described herein may include those commonly associated with medical devices. The medical devices described herein, as well as individual components thereof, 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 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.
In at least some embodiments, portions or all of the medical devices described 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 in determining a location of a medical device that includes a radiopaque material. 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 various medical devices to achieve the same result.
The medical devices described herein, as well as portions and components thereof, may be made of the same material along its length, or in some embodiments, can include portions or sections made of different materials. In some embodiments, materials may be chosen to impart varying flexibility and stiffness characteristics to different portions. For example, different portions of a component, such as a proximal section and a distal section, may be formed of different materials, for example, materials having different moduli of elasticity, resulting in a difference in flexibility. In some embodiments, the material used to construct a proximal section may be relatively stiff for pushability and torqueability, and the material used to construct a distal section may be relatively flexible by comparison for better lateral trackability and steerability. For example, a proximal section may be formed of straightened 304v stainless steel wire or ribbon and a distal section may be formed of a straightened super elastic or linear elastic alloy, for example a nickel-titanium alloy wire or ribbon.
In embodiments where different portions of the medical devices described herein are made of different materials, the different portions can be connected using a suitable connecting technique and/or with a connector. For example, the different portions may be connected using welding (including laser welding), soldering, brazing, adhesive, or the like, or combinations thereof. These techniques can be utilized regardless of whether or not a connector is utilized. An example of a connector is a structure such as a hypotube or a coiled wire which has an inside diameter sized appropriately to receive and connect to the ends of the proximal portion and the distal portion.
A sheath or covering (not shown) may be disposed over portions or all of the medical devices described herein. In other embodiments, however, such a sheath or covering may be absent. The sheath may be made from a polymer or 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 some embodiments, the exterior surface of the medical devices described herein 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 medical devices described herein. Alternatively, a sheath may include 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), polytetrafluorocthylene (PTFE), polyarylene oxides, polyvinylpyrrolidones, 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.
Having thus described several illustrative embodiments of the present disclosure, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, arrangement of parts, and exclusion and order of steps, without exceeding the scope of the disclosure. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 63/464,751, filed May 8, 2023, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63464751 | May 2023 | US |
