Patent Description:
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.

See, e.g., <CIT>, <CIT>, <CIT> and <CIT>.

The invention is defined by independent claim <NUM> and subsequent dependent claims <NUM> - <NUM>.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A medical device is disclosed. The medical device comprises: an elongate shaft having a proximal end region and a distal end region; a first lumen defined in the shaft; a second lumen defined in the shaft; wherein the distal end region includes a common lumen region in fluid communication with the first lumen and the second lumen; and a deflectable member disposed within the shaft, the deflectable member being designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Alternatively or additionally to any of the embodiments above, the deflectable member includes a spring ribbon wire.

Alternatively or additionally to any of the embodiments above, the deflectable member includes a one-way valve.

Alternatively or additionally to any of the embodiments above, the first lumen, the second lumen, or both have a constant diameter.

Alternatively or additionally to any of the embodiments above, along at least a portion of the length of the shaft, the first lumen, the second lumen, or both have a variable diameter.

Alternatively or additionally to any of the embodiments above, the deflectable member is biased to be in the first configuration.

Alternatively or additionally to any of the embodiments above, further comprising a trapper balloon disposed within the first lumen.

Alternatively or additionally to any of the embodiments above, the shaft defines a third lumen in fluid communication with the trapper balloon.

Alternatively or additionally to any of the embodiments above, the shaft defines a fourth lumen and wherein a shapeable member is disposed within the fourth lumen.

Alternatively or additionally to any of the embodiments above, further comprising a distal balloon coupled to the distal end region of the shaft.

Alternatively or additionally to any of the embodiments above, the shaft defines a fifth lumen in fluid communication with the distal balloon.

Alternatively or additionally to any of the embodiments above, the distal balloon includes a compliant material.

A dilator is disclosed. The dilator comprises: an elongate shaft having a proximal end region and a distal end region; a guidewire lumen defined in the shaft; a needle lumen defined in the shaft; wherein the guidewire lumen and the needle lumen merge into a common lumen along the distal end region of the shaft; and a deflectable member disposed within the shaft, the deflectable member being designed to shift between a first configuration where the deflectable member is configured to direct a guidewire device from the common lumen into the guidewire lumen and a second configuration where the deflectable member is deflected in order to allows a needle device to move between the common lumen and the needle lumen.

Alternatively or additionally to any of the embodiments above, further comprising a trapper balloon disposed within the guidewire lumen and wherein the shaft defines a third lumen in fluid communication with the trapper balloon.

Alternatively or additionally to any of the embodiments above, further comprising a compliant balloon coupled to the distal end region of the shaft and wherein the shaft defines a fifth lumen in fluid communication with the compliant balloon.

A method for medical treatment, not forming part of the present invention, is disclosed. The method comprises:
advancing a medical device into body lumen, wherein the medical device comprises:
an elongate shaft having a proximal end region and a distal end region, a first lumen defined in the shaft, a second lumen defined in the shaft, wherein the distal end region includes a common lumen region in fluid communication with the first lumen and the second lumen, and a deflectable member disposed within the shaft; wherein a needle is disposed in the second lumen, passes through the common lumen region, and extends distally beyond a distal end of the shaft; proximally retracting the needle into the second lumen; wherein proximally retracting the needle shifts the deflectable member from an open configuration to a closed configuration; and extending a guidewire between the first lumen and the common lumen region.

On the contrary, the intention is to cover all modifications and alternatives falling within the scope of the disclosure.

A number of medical devices may be used in various medical interventions. Some of these interventions may include providing access to the vascular system, providing access to various chambers of the heart, septal crossings, and the like. Typical, such interventions may involve a number of steps such wire/needle exchanges. Disclosed herein are medical devices that may be used for number of different interventions, may help reduce or simplify an intervention (e.g., by reducing or eliminating steps such as wire/needle exchanges), and the like as well as methods for using such devices.

<FIG> is a partial cross-sectional view that schematically depicts an example medical device <NUM>. In this example, the medical device <NUM> may be considered to be a catheter or dilator. The medical device <NUM> may include an elongate shaft <NUM> having a proximal end region <NUM> and a distal end region <NUM>. One or more lumens may be defined in the shaft <NUM>. For example, the shaft <NUM> may define a first lumen <NUM> and a second lumen <NUM>. A common lumen region <NUM> may be defined in the shaft <NUM> where the first lumen <NUM> and the second lumen <NUM> merge. The common lumen <NUM> may be in fluid communication with both the first lumen <NUM> and the second lumen <NUM>.

A deflectable member <NUM> may be disposed within the shaft <NUM>. The deflectable member <NUM> may be coupled to the shaft <NUM> in a number of different ways. For example, the deflectable member <NUM> may extend along a portion of the first lumen <NUM>, may extend along a portion of the second lumen <NUM>, may be attached to an internal region of the shaft <NUM>, may be embedded in a portion of the shaft <NUM>, or the like. In general, the deflectable member <NUM> may be designed to direct a device passing through the elongate shaft <NUM> into one of the first lumen <NUM> and/or the second lumen <NUM>. For example, <FIG> illustrate the function of the deflectable member <NUM>. For example, a first medical device <NUM> may be disposed in the first lumen <NUM>. In some instances, the first medical device <NUM> may take the form of a guidewire. A second medical device <NUM> may be disposed in the second lumen <NUM>. In some instances, the second medical device <NUM> may take the form of a needle or trocar.

The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). When the deflectable member <NUM> is in the first configuration, at least a portion of the deflectable member <NUM> may obstruct, block, or cover at least a portion of the second lumen <NUM>. This may be desirable for a number of reasons. For example, the deflectable member <NUM> may help to direct a device (e.g., such as the guidewire <NUM>) to enter into the desired lumen (e.g., the first lumen <NUM>) when the guidewire <NUM> is backloaded into the shaft <NUM>. For example, when the deflectable member <NUM> is in the first configuration, the deflectable member <NUM> may direct the guidewire <NUM> (e.g., which may be disposed within the common lumen region <NUM>) into the first lumen <NUM>. When the deflectable member <NUM> is in the second configuration, the deflectable member <NUM> may allow the needle <NUM> to move between the common lumen region <NUM> and the second lumen <NUM>. In addition, the deflectable member <NUM> may also limit distal migration of the needle <NUM> within the second lumen <NUM>, which may help to contain the relatively sharp point of the needle <NUM> within the shaft <NUM>. Other desirable benefits are contemplated.

While the deflectable member <NUM> may be capable of shifting between configurations, in at least some instance the deflectable member <NUM> is biased to be in the first configuration. For the purposes of this disclosure, being "biased" may be understood to mean that the deflectable member <NUM> in its native state or in a state when not subjected to forces that would be capable of shifting the deflectable member <NUM>, the deflectable member <NUM> is in the first configuration. In order to have this bias, the deflectable member <NUM> may be elastically deformable/deflectable between the first configuration and the second configuration. This may include forming at least a portion of the deflectable member <NUM> out of an elastic material, a super-elastic and/or shape memory material, combinations thereof, or the like.

The deflectable member <NUM> may shift to the second configuration when subject to a force. For example, the needle <NUM> may be advanced distally into contact with the deflectable member <NUM> and cause the deflectable member <NUM> to move or "open" the second lumen <NUM> (e.g., as shown in <FIG>). When the needle <NUM> is proximally retracted, the deflectable member <NUM> may shift back to the first configuration (e.g., as shown in <FIG>).

In other instances, rather than the deflectable member <NUM> being deflectable, the deflectable member <NUM> may be replaced by a septum member <NUM>' that makes up part of a medical device <NUM>' similar to other devices disclosed herein. The septum member <NUM>' may extend across the second lumen <NUM> and be secured to the wall of the shaft <NUM>. Advancing the needle <NUM> may include advancing the needle <NUM> through the septum member <NUM>'.

In some instances, the shaft <NUM> may include additional features. For example, an interior portion of the shaft <NUM> (e.g., a wall surface along the first lumen <NUM>, the second lumen <NUM>, or both) may have a ridge or ledge <NUM> that can engage a flange region <NUM> on the needle <NUM>. This may limit how far the needle <NUM> can distally migrate within the shaft <NUM>. Because of the shape difference in the wall along one or both of the lumen <NUM>, <NUM>, the first lumen <NUM>, the second lumen <NUM>, or both may have a variable diameter. In some instances, the first lumen <NUM>, the second lumen <NUM>, or both have a substantially constant diameter.

In use, the medical device <NUM> may be used to provide access to a vascular region. For example, the first lumen <NUM> may contain the guidewire <NUM> and the second lumen <NUM> may contain the needle <NUM>. The needle <NUM> may be advanced distally to shift the deflectable member <NUM> to the second configuration (e.g., as shown in <FIG>). When doing so, the distal end of the needle <NUM> may extend out from the end of the shaft <NUM>. When so arranged, the needle <NUM> can be used to puncture the skin of a patient and gain access to a vascular region. The medical device <NUM> (which may function as a dilator) can also be advanced into the vascular region. When the medical device <NUM> is positioned in the vascular region in the desired manner, the needle <NUM> can be proximally retracted into the second lumen <NUM>, thereby allowing the deflectable member <NUM> to shift to the first configuration (e.g., as shown in <FIG>). When so arranged, the guidewire <NUM> can be advanced out from the shaft <NUM>, into the vascular region, and along the vascular region to a target site.

In other used, the medical device <NUM> (either loaded with the needle <NUM> or not loaded with the needle <NUM>) can be backloaded with the guidewire <NUM>. In other words, the proximal end of the guidewire <NUM> can be pushed through the distal end of the shaft <NUM> and into the first lumen <NUM>. The deflectable member <NUM> may help to guide or steer the guidewire <NUM> into the first lumen <NUM>. This use may allow the medical device <NUM> to be loaded with the guidewire <NUM> either for packaging or as part of preparing the medical device for an intervention.

The form, arrangement, and design of the deflectable member <NUM> may vary. <FIG> to <FIG> illustrate some of the alternative deflectable members contemplated. For example, <FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, the deflectable member <NUM> may take the form of a valve or a "squish valve". The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). For example, the deflectable member <NUM> may be designed to be in the first configuration in a native state and when subjected to forces, the deflectable member <NUM> may be deform into a flattened second configuration.

<FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, the deflectable member <NUM> may take the form of a one-way valve. The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). <FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, the deflectable member <NUM> may take the form of a deflectable valve or arm. The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). <FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, the deflectable member <NUM> may take the form of a collapsible spring wire. The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). <FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, the deflectable member <NUM> may take the form of a coil spring or coil spring wire. The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>). <FIG> illustrates an example deflectable member <NUM> disposed within a shaft <NUM>. In this example, an interior portion of the shaft <NUM> may make up or define the deflectable member <NUM>. The deflectable member <NUM> may be designed to shift between a first configuration (e.g., as shown in <FIG>) and a second configuration (e.g., as shown in <FIG>).

<FIG> illustrates another example medical device <NUM> that may be similar in form and function to other medical devices disclosed herein. The medical device <NUM> may include an elongate shaft <NUM> having a proximal end region <NUM> and a distal end region <NUM>. One or more lumens may be defined in the shaft <NUM>. For example, the shaft <NUM> may define a first lumen <NUM> and a second lumen <NUM>. A common lumen region <NUM> may be defined in the shaft <NUM> where the first lumen <NUM> and the second lumen <NUM> merge. A deflectable member <NUM> may be disposed within the shaft <NUM>.

The medical device <NUM> may include an expandable member or trapper balloon <NUM>. The trapper balloon <NUM> may be disposed within the first lumen <NUM>, within the second lumen <NUM>, may span both lumens (<NUM>, <NUM>), or both lumens (<NUM>, <NUM>) may include a separate trapper balloon <NUM>. The trapper balloon <NUM> may be designed to be expanded or otherwise inflated in order to secure a device within a lumen of the shaft <NUM>. For example, the trapper balloon <NUM> may be inflated in order to secure a guidewire (e.g., the guidewire <NUM>) within the first lumen <NUM>. Other arrangements are contemplated. It should be understood that the trapper balloon <NUM> may be used with any of the devices disclosed herein, in combination with any of the deflectable members disclosed herein, and in any of the lumens of the shafts disclosed herein, as appropriate.

A distal expandable anchor or balloon <NUM> may be coupled to the distal end region <NUM> of the shaft <NUM>. In at least some instance, the distal balloon <NUM> may be a compliant balloon that is formed from a relatively soft material such as a silicone material. Other materials are contemplated. The shape of the distal balloon <NUM> may also vary. For example, in some instance, the distal balloon <NUM> may be designed to expand to a shape that is substantially spherical. In other instances, the balloon <NUM> may be designed to expand to a shape that may be described as "dumbbell" or "dog bone" shaped. Other shapes are contemplated. It should be understood that the distal balloon <NUM> may be used with any of the devices disclosed herein, in combination with any of the deflectable members disclosed herein, and in any of the lumens of the shafts disclosed herein, as appropriate.

The distal balloon <NUM> may provide a number of desirable features. For example, distal balloon <NUM> may help the medical device <NUM> navigate or cross portions of the anatomy. For example, the medical device <NUM> may be used to cross interatrial septum (e.g., at or near the fossa ovalis) and into the left atrium (e.g., in an intervention where access to the left atrium, left atrial appendage, or the like is desired). When doing so, inflating or partially inflating the distal balloon <NUM> while crossing the septum may help to urge or pull the medical device <NUM> through septum. Furthermore, after crossing the septum, the distal balloon <NUM> (e.g., when inflated) may function as an anchor that helps secure the positon of the medical device <NUM> within the left atrium.

<FIG> is a cross-sectional view of the shaft <NUM> about line <NUM>-<NUM> in <FIG>. Here it can be seen that a third lumen <NUM> and/or a fourth lumen <NUM> may be defined in the shaft <NUM>. The third lumen <NUM> may be in fluid communication with either the trapper balloon <NUM> or the distal balloon <NUM>. Likewise, the fourth lumen <NUM> may be in fluid communication with either the trapper balloon <NUM> or the distal balloon <NUM>. In some instances, the shaft <NUM> may also include a fifth lumen <NUM>. A shaping member <NUM> may be disposed within the fifth lumen <NUM>. The shaping member <NUM> may take the form of an elastically deformable wire or ribbon that is embedded within or otherwise disposed within the fifth lumen <NUM>. The shaping member <NUM> allows a user to alter the shape of the shaft <NUM>. For example, a user may bend the shaft <NUM> so that it has a curved distal portion, which may help with navigation and or use of the medical device <NUM>. It should be understood that the shaping member <NUM> may be used with any of the devices disclosed herein, in combination with any of the deflectable members disclosed herein, and in any of the lumens of the shafts disclosed herein, as appropriate.

The materials that can be used for the various components of the medical device <NUM> (and/or other medical devices disclosed herein) and the various components thereof may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the shaft <NUM> of the medical device <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other catheter shaft and/or components of any of the medical devices disclosed herein.

The shaft <NUM> may 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 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-<NUM> (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 <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, 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® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, 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 shaft <NUM> 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 the shaft <NUM> 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 the shaft <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the shaft <NUM>. For example, the shaft <NUM>, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The shaft <NUM>, 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.

Claim 1:
A medical device (<NUM>), comprising:
an elongate shaft (<NUM>) having a proximal end region (<NUM>) and a distal end region (<NUM>);
a first lumen (<NUM>) defined in the shaft (<NUM>);
a second lumen (<NUM>) defined in the shaft (<NUM>);
wherein the distal end region (<NUM>) includes a common lumen region (<NUM>) in fluid communication with the first lumen (<NUM>) and the second lumen (<NUM>); and
a deflectable member (<NUM>) disposed within the shaft (<NUM>), the deflectable member (<NUM>) being designed to shift between a first configuration where the deflectable member (<NUM>) directs a first medical device (<NUM>) disposed within the common lumen region (<NUM>) into the first lumen (<NUM>) and a second configuration where the deflectable member (<NUM>) allows a second medical device (<NUM>) to move between the common lumen region (<NUM>) and the second lumen (<NUM>),
wherein the second medical device (<NUM>) takes the form of a needle or trocar,
wherein a wall surface along the first lumen (<NUM>), the second lumen (<NUM>), or both has a ridge or ledge (<NUM>) that can engage a flange region (<NUM>) of the needle or trocar.