Patent Description:
The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to hemostasis valves and methods for making and using hemostasis valves.

A wide variety of 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. <CIT> discloses a bleedback control assembly for controlling blood loss during vascular diagnostics. Furthermore, <CIT> discloses a valve apparatus for use with bloodless exchange of elongate instruments into a patient's vasculature. <CIT> discloses a hemostasis valve that includes one or more seals that is able to accommodate both large and small diameter catheters and guidewires.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example hemostasis valve is disclosed, as defined in claim <NUM>. The hemostasis valve comprises: a main body having a distal end region and a proximal end region; a first seal member disposed within the proximal end region of the main body; a cartridge at least partially disposed within the proximal end region of the main body, the cartridge including a second seal member; wherein the cartridge has one or more projections formed thereon; wherein the proximal end region of the main body has one or more recesses formed therein, the one or more recesses being designed to engage the one or more projections; and a plunger coupled to the proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, the one or more recesses comprise one or more grooves formed along an inner surface of the proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, the one or more recesses comprise one or more slots formed along the proximal end region of the main body.

Engagement of the one or more projections with the one or more recesses is designed to limit rotation of the cartridge relative to the proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, further comprising a ring member disposed along an outer surface of the proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, wherein the proximal end region of the main body includes one or more threads.

Alternatively or additionally to any of the embodiments above, further comprising a nut threadably engaged with the one or more threads.

Alternatively or additionally to any of the embodiments above, the cartridge includes two projections positioned along opposing sides of the cartridge.

Alternatively or additionally to any of the embodiments above, the proximal end region of the main body includes two recesses.

A hemostasis valve is disclosed. The hemostasis valve comprises: a main body having a distal end region, a side port, and a proximal end region; a high pressure seal member disposed within the proximal end region of the main body; a cartridge at least partially disposed within the proximal end region of the main body, the cartridge including a low pressure seal member; wherein the cartridge has one or more projections formed thereon; wherein the proximal end region of the main body has one or more recesses formed therein, the one or more recesses being designed to engage the one or more projections so as to limit rotation of the cartridge relative to the proximal end region of the main body; and a plunger coupled to the proximal end region of the main body.

A hemostasis valve is disclosed. The hemostasis valve comprises: a main body having a threaded proximal end region; a nut threadably engaged with the threaded proximal end region; a first seal member disposed within the threaded proximal end region of the main body; a cartridge at least partially disposed within the threaded proximal end region of the main body, the cartridge including a second seal member; wherein the cartridge a pair of opposing projections formed thereon; and wherein the threaded proximal end region of the main body has a pair of opposing recesses formed therein, the recesses being designed to engage the projections so as to limit rotation of the cartridge relative to the threaded proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, the recesses comprise grooves formed along an inner surface of the threaded proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, the recesses comprise slots formed along the threaded proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, further comprising a plunger coupled to the threaded proximal end region of the main body.

Alternatively or additionally to any of the embodiments above, the first seal member comprises a high pressure seal.

Alternatively or additionally to any of the embodiments above, the second seal member comprises a low pressure seal with at least one cut, slit, or slot formed therein.

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

A number of medical procedures, for example intravascular procedures, utilize medical devices within body lumens. For example, some intravascular procedures include the placement of a guidewire, guide catheter, interventional device, or the like in a blood vessel. Because fluid under pressure (e.g., blood) is present within the blood vessel, fluid could travel along or through the medical device and escape or leak from the patient. In some instances, it may be desirable to dispose a hemostasis valve or hemostasis valve assembly at the proximal end of a medical device to reduce or otherwise limit the leaking of fluids/blood from the proximal end of the device.

An example hemostasis valve <NUM> is shown in <FIG>. The hemostasis valve <NUM> includes a main body <NUM>. The main body <NUM> may include a side port <NUM>. The side port <NUM> may be connected to another device such as an infusion device, an inflation device, or the like. An adapter <NUM> may be coupled to the distal end of the main body <NUM>. The adapter <NUM> may be used to couple the hemostasis valve <NUM> to a device such as a catheter. A plunger <NUM> is coupled to the proximal end of the main body <NUM>. The plunger <NUM> may be used to activate or otherwise close a seal (e.g., as discussed herein) within the hemostasis valve <NUM>. These and other features of the hemostasis valve <NUM> are discussed herein.

<FIG> is an exploded view of the hemostasis valve <NUM>. Here, the various components of the hemostasis valve <NUM> can be seen. The hemostasis valve <NUM> includes a cartridge <NUM>. The cartridge <NUM>, which may include two pieces 20a, 20b that are coupled to one another (e.g., press fit, thermally bonded, adhesively bonded, etc.), may be arranged so that at least a portion thereof can be disposed within a proximal end region <NUM> of the main body <NUM>. A first seal member <NUM> is disposed within the cartridge <NUM>. A second seal member <NUM> is disposed within the proximal end region <NUM> of the main body <NUM>. In at least some instances, the second seal member <NUM> may be disposed distally of the cartridge <NUM>. The second seal member <NUM> may include a textured distal surface, grooves or wells formed therein, or the like. In addition or in the alternative, the second seal member <NUM> may include a proximal region with a reduced diameter. A nut <NUM> is coupled to the proximal end region <NUM> of the main body <NUM>, for example at one or more threads <NUM> formed along the proximal end region <NUM>.

Other features of the hemostasis valve <NUM> that can be seen in <FIG> include a spring member <NUM> and an O-ring <NUM>. The spring member <NUM> may be coupled to the plunger <NUM>. In at least some instances, the spring member <NUM> may be designed to exert a proximally directed force on the plunger <NUM>. The O-ring <NUM> may be positioned adjacent to the adapter <NUM>. In addition, a ring member or "snap ring" <NUM> may be disposed along the proximal end region <NUM> of the main body <NUM>.

<FIG> is a cross-sectional view the hemostasis valve <NUM>. Here some of the structural features of the hemostasis valve <NUM> can be seen. For example, the hemostasis valve <NUM> may include a central lumen <NUM>. In general, the central lumen <NUM> is designed to be placed into fluid communication with one or more lumens of a device coupled to the adapter <NUM>. A second or infusion lumen <NUM> may be defined adjacent to the side port <NUM>. The second lumen <NUM> may be in fluid communication with the central lumen <NUM>.

As indicated above, the hemostasis valve <NUM> is designed so that it may be coupled to another device. For example, the adapter <NUM>, which may take the form of a Tuohy-Borst or other type of connector, may be engaged with the proximal end of the other device. When connected (and with the plunger <NUM> in the configuration shown in <FIG>), the second seal member <NUM> may be in an open state or configuration. Conversely, the first seal member <NUM> may be in a closed or sealed configuration when the hemostasis valve <NUM> is connected to the other device (and with the plunger <NUM> in the configuration shown in <FIG>).

Collectively, when the hemostasis valve <NUM> is connected to another device and in the configuration shown in <FIG>, the hemostasis valve <NUM> is able to substantially hold a fluid-tight seal that substantially prevents the backflow and/or leakage of body fluids (e.g., blood). At some point during a medical intervention, it may be desirable to infuse additional fluids such as contrast media through the hemostasis valve <NUM>. This may include attaching an infusion device to the side port <NUM>. Because the first seal member <NUM> may be designed to substantially prevent the backflow and/or leakage of relatively-low pressure fluids, if the infusion device infuses fluids at a relatively high pressure, it is possible that the infusion fluid may be able to flow through the first seal member <NUM>.

In order to prevent backflow of relatively high pressure fluids, the hemostasis valve <NUM> can be actuated to close or "seal" the second seal member <NUM>. To do so, the plunger <NUM> may initially be urged distally until a distally-facing, proximal end surface or cap <NUM> of the plunger <NUM> is disposed adjacent to a proximal end region <NUM> of the nut <NUM> as shown in <FIG>. When doing so, a tubular region <NUM> of the plunger <NUM> may extend through (and open) the first seal member <NUM>. In addition, a portion of the plunger <NUM> may move distally beyond the ring member <NUM>. With the cap <NUM> of the plunger <NUM> disposed adjacent to the nut <NUM>, the plunger <NUM> can be rotated (e.g., in a clockwise direction) to close the second seal member <NUM> as shown in <FIG>. This rotation may cause the nut <NUM> to rotate and move distally. Because the distal end region of the nut <NUM> may be engaged with the cartridge <NUM>, distal movement of the nut <NUM> urges the cartridge <NUM> distally within the proximal end region <NUM> of the main body <NUM> such that the cartridge <NUM> engages and deforms the second seal member <NUM>, thereby shifting the second seal member <NUM> to the closed or sealed configuration. The plunger <NUM> may be released or otherwise allowed to move proximally, as shown in <FIG>, which may reclose the first seal member <NUM> (while the second seal member <NUM> remains closed).

Rotational movement of the nut <NUM> causes the nut <NUM> to translate and engage the cartridge <NUM>, which in turn engages and closes the second seal member <NUM>. Typically, the axial movement of the cartridge applies an axial force onto the second seal member <NUM>, which closes or "seals" the second seal member <NUM>. If the rotational movement of the nut <NUM> causes the cartridge <NUM> to rotate, this could lead to rotational forces begin applied to the second seal member <NUM>. If this happens, the second seal member <NUM> could become distorted/twisted in such a manner that the second seal member <NUM> may not completely close off or seal the main lumen <NUM>. It may be desirable to limit rotational forces being applied to the cartridge <NUM> and/or the second seal member <NUM>. Disclosed herein are hemostasis valves that are designed to limit such forces.

<FIG> illustrates a portion of an example hemostasis valve <NUM> that is similar in form and function to other hemostasis valves disclosed herein. While only a portion of the hemostasis valve <NUM> is shown, it can be appreciated that the reminder of the hemostasis valve <NUM> may include structures similar to or the same as those in the hemostasis valve <NUM> described above. The proximal end region <NUM> of the main body <NUM> includes one or more slots or recesses <NUM>. In addition, the cartridge <NUM> includes one or more wings or projections <NUM>. When the cartridge <NUM> is disposed within the proximal end region <NUM> of the main body <NUM>, the wings <NUM> may fit within the recesses <NUM>. When axial forces are applied to the cartridge <NUM> (e.g., by the nut <NUM>), the cartridge <NUM> will begin to translate relative to the main body <NUM>. When doing so, the projections <NUM> will translate along the recesses <NUM> as shown in <FIG>. Because of structural relationship between the projections <NUM> and the recesses <NUM>, rotation of the cartridge <NUM> is reduced or otherwise eliminated as the cartridge moves distally within the proximal end region <NUM>.

It can be appreciated that a number of variations are contemplated for the hemostasis valve <NUM>. For example, in some instances, the proximal end region <NUM> may include a single recess <NUM>, two recesses <NUM>, three recesses <NUM>, four recesses <NUM>, or more. The recesses <NUM> may be arranged in a number of suitable manners. In some instances, the recesses <NUM> may be evenly spaced about the proximal end region <NUM>. Alternatively, the recesses <NUM> may be unevenly spaced. Similarly, the cartridge <NUM> may include a suitable number of projections <NUM> such as one, two, three, four, five, six, or more. The projections <NUM> may be evenly spaced or unevenly spaced about the cartridge <NUM>. In some instances, the number of projections <NUM> and the number of recesses <NUM> may be the same. Alternatively, the number of projections <NUM> may differ from the number of recesses <NUM>.

<FIG> illustrates a portion of an example hemostasis valve <NUM> that is similar in form and function to other hemostasis valves disclosed herein. In this example, the proximal end region <NUM> of the main body <NUM> may include one or more internal grooves <NUM>. In addition, the cartridge <NUM> may include one or more wings or projections <NUM>. The projections <NUM> may extend along a portion of the length of the cartridge <NUM> or a portion of the length. When the cartridge <NUM> is disposed within the proximal end region <NUM> of the main body <NUM>, the wings <NUM> may fit within the grooves <NUM>. Because of this, rotation of the cartridge <NUM> is reduced or otherwise eliminated as the cartridge moves distally within the proximal end region <NUM> as shown in <FIG>.

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

The main body <NUM> and/or other components of the hemostasis valve <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.

Claim 1:
A hemostasis valve, comprising:
a main body (<NUM>; <NUM>) having a distal end region and a proximal end region (<NUM>; <NUM>);
a plunger (<NUM>) coupled to the proximal end region (<NUM>; <NUM>) of the main body (<NUM>; <NUM>),
a cartridge (<NUM>; <NUM>) at least partially disposed within the proximal end region (<NUM>; <NUM>) of the main body (<NUM>; <NUM>), the cartridge (<NUM>; <NUM>) including a first seal member (<NUM>);
a second seal member (<NUM>) disposed within the proximal end region (<NUM>; <NUM>) of the main body (<NUM>; <NUM>);
a nut (<NUM>) coupled to the proximal end region (<NUM>) of the main body (<NUM>);
wherein the plunger (<NUM>) is configured to be rotated to cause the nut (<NUM>) to rotate and move distally which urges the cartridge (<NUM>) distally within the proximal end region (<NUM>) of the main body (<NUM>) such that the cartridge (<NUM>) engages and deforms the second seal member (<NUM>), thereby shifting the second seal member (<NUM>) to a closed configuration;
wherein the plunger (<NUM>) is configured to be released or otherwise allowed to move proximally which closes the first seal member (<NUM>) while the second seal member (<NUM>) remains closed;
characterised in that the cartridge (<NUM>; <NUM>) has one or more projections (<NUM>; <NUM>) formed thereon; and
wherein the proximal end region (<NUM>; <NUM>) of the main body (<NUM>; <NUM>) has one or more recesses (<NUM>, <NUM>) formed therein, the one or more recesses (<NUM>, <NUM>) being designed to engage the one or more projections (<NUM>; <NUM>) to limit rotation of the cartridge (<NUM>; <NUM>) relative to the proximal end region (<NUM>; <NUM>) of the main body (<NUM>; <NUM>) as the cartridge (<NUM>; <NUM>) moves distally within the proximal end region (<NUM>; <NUM>), wherein the one or more projections (<NUM>; <NUM>) are fitted within the one or more recesses (<NUM>, <NUM>) and translate along the one or more recesses (<NUM>, <NUM>), when axial forces are applied to the cartridge (<NUM>; <NUM>) by the nut (<NUM>).