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.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example hemostasis valve is disclosed. The hemostasis valve comprises: a main body having a proximal end region; a cartridge at least partially disposed within the proximal end region, the cartridge including a seal member; wherein the cartridge has a proximal member, a distal member, and defines a seal holding region; wherein the seal member has an axial thickness of <NUM>-<NUM> (<NUM>-<NUM> inches); and wherein the seal member is secured within the seal holding region by a mechanical bond.

Alternatively or additionally to any of the embodiments above, the mechanical bond includes a crimp.

Alternatively or additionally to any of the embodiments above, the seal member has an axial thickness of <NUM>-<NUM> (<NUM>-<NUM> inches).

Alternatively or additionally to any of the embodiments above, the seal member has a distal face with a distal slit, wherein the seal member has a proximal face with a proximal slit; and wherein the distal slit and the proximal slit are axially spaced <NUM>-<NUM> (<NUM>-<NUM> inches).

Alternatively or additionally to any of the embodiments above, the distal slit is arranged orthogonally with the proximal slit.

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

Alternatively or additionally to any of the embodiments above, the seal member has a seal body and a peripheral region designed to engage the seal holding region of the cartridge.

Alternatively or additionally to any of the embodiments above, the peripheral leg region has a radial thickness of <NUM>-<NUM> (<NUM>-<NUM> inches).

Alternatively or additionally to any of the embodiments above, the central seal region has a width that is at least twice as large as a radial thickness of the peripheral leg region.

Alternatively or additionally to any of the embodiments above, the proximal end region of the main body includes one or more threads and further comprising a nut threadably engaged with the one or more threads.

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 plunger coupled to the threaded proximal end region; a cartridge at least partially disposed within the threaded proximal end region, the cartridge including a seal member; wherein the seal member is secured within a seal holding region of the cartridge by a mechanical bond; and wherein the seal member has an axial thickness of <NUM>-<NUM> (<NUM>-<NUM> inches).

Alternatively or additionally to any of the embodiments above, the seal member has a central seal region and a peripheral leg region designed to engage the seal holding region of the cartridge.

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 plunger coupled to the threaded proximal end region; a cartridge at least partially disposed within the threaded proximal end region, the cartridge including a seal member; wherein the seal member is secured within a seal holding region of the cartridge by a crimp bond; wherein the seal member has a central seal region and a peripheral leg region designed to engage the seal holding region of the cartridge; and wherein the central seal region has a width that is at least twice as large as a radial thickness of the peripheral leg region.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the independent claim(s).

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> may include 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> may be 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. For example, the hemostasis valve <NUM> may include 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> may be disposed within the cartridge <NUM>. A second seal member <NUM> may be 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> may be 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).

As indicated above, the first seal member <NUM> may be described as a "low pressure" seal, designed to prevent the flow of fluids at a relatively low pressure. It may desirable to enhance the performance of the first seal member <NUM>. Disclosed herein are hemostasis valves where the performance of the first seal member <NUM> is enhanced.

<FIG> illustrates an example seal member <NUM> that may be similar in form and function to other seal members disclosed herein (e.g., such as the first seal member <NUM>) and may be used with the hemostasis valve <NUM> and/or other hemostasis valves. The seal member <NUM> may include a seal body <NUM> and a peripheral region <NUM>. Because of its shape from a side view or in cross-section, the peripheral region <NUM> may be thought of as having "legs" or pairs of legs. A shoulder region <NUM> may be defined between the peripheral region <NUM> and the seal body <NUM>.

The structural arrangement of the seal member <NUM> may be sized and shaped to provide a number of desired features. Some of the structural features may include a thickness or width <NUM> of the peripheral region <NUM>, a thickness or width <NUM> of the shoulder region <NUM>, a width <NUM> of the seal body <NUM>, and a thickness <NUM> of the seal body <NUM>. The thickness <NUM> of the seal body <NUM> may be in the range of about <NUM>-<NUM> (<NUM>-<NUM> inches), or about <NUM>-<NUM> (<NUM>-<NUM> inches) or so, or about <NUM>-<NUM> (<NUM>-<NUM> inches). For example, the thickness <NUM> of the seal body <NUM> may be about <NUM> (<NUM> inches), or about <NUM> (<NUM> inches), or about <NUM> (<NUM> inches), or about <NUM> (<NUM> inches).

In some instances, the width/thickness <NUM> of the peripheral region <NUM> may be relatively thin. For the purposes of this disclosure, "relatively thin" may be understood with respect to the dimensions of other structures of the seal member <NUM>. For example, the width <NUM> of the peripheral region <NUM> may be smaller or thinner than the width <NUM> of the shoulder region <NUM> and/or thinner than the width <NUM> of the seal body <NUM>. In some instances, the width <NUM> of the shoulder region <NUM> may be about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>. In some of these and in other instances, the width <NUM> of the seal body <NUM> may be about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the peripheral region <NUM>. In some of these and in other instances, the width <NUM> of the seal body <NUM> may be about <NUM>-<NUM> times the width <NUM> of the shoulder region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the shoulder region <NUM>, or about <NUM>-<NUM> times the width <NUM> of the shoulder region <NUM>.

Collectively, in at least some instances, the peripheral region <NUM> may be considered to be relatively thin and the width <NUM> of the seal body <NUM> may be considered to be relatively wide. While not wishing to be bound by theory, it is believed that utilizing the relatively thin peripheral region <NUM> and a relatively wide seal body <NUM> allows the seal body <NUM> to have a greater surface area for opening. This may reduce the deformation forces such that actuating the plunger (e.g., the plunger <NUM> as described above) may require less force (e.g., when compared with seal members with a smaller surface area and/or when compared with seal members where the ratio the size of the seal body to the size of the peripheral region is reduced). In addition, the structure/arrangement of the seal member <NUM> may allow the seal member <NUM> to accommodate larger devices therein/therethrough without becoming damaged.

The seal member <NUM> may be formed from a suitable material. For example, the seal member <NUM> may be formed from a silicone and/or silicone rubber material such as LSR6030, commercially available from Shenzhen SQUARE Silicone Co. In some instances, the seal member <NUM> may be formed from an elastomeric material such as Q7-<NUM>, Q7-<NUM>, GUMSTOCK, or the like, which are commercially available from DOW CORNING.

The seal member <NUM> may have one or more slits such as a first slit 152a and a second slit 152b. The first slit 152a and the second slit 152b may come together at a slit interface <NUM>. For the purposes of this disclosure, the slit interface <NUM> may be understood as the distance that the first slit 152a and the second slit 152b overlap. In some instances, the slit interface <NUM> may be about <NUM>-<NUM> (<NUM>-<NUM> inches), or about <NUM>-<NUM> (<NUM>-<NUM> inches), or about <NUM>-<NUM> (<NUM>-<NUM> inches), or about <NUM> (<NUM> inches).

The number and arrangement of the slits (e.g., the first slit 152a and the second slit 152b) may vary. In some instances, only a single slit may be utilized. The single slit may be disposed along the proximal face or the distal face of the seal body <NUM>. In other instances, two or more slits may be arranged on the same side/face of the seal body <NUM>. For example, two slits may be arranged orthogonally on the same side/face of the seal body <NUM>. The opposing side/face may include zero, one, two, three, or more slit in a suitable arrangement. In some instances, one or more of the sides/faces of the seal body <NUM> may include slits that form a pattern such as a "star pattern". In at least some instances, the first slit 152a and the second slit 152b (shown in phantom line) may be arranged orthogonally and originate from opposite sides of the seal body <NUM>, as depicted in <FIG>. The first slit 152a, the second slit 152b or both may be cuts, perforations, or the like. Other arrangements are contemplated.

<FIG> illustrates an example cartridge <NUM>. In this example, the cartridge <NUM> may include a first section 120a and a second section 120b. The seal member <NUM> may be coupled to the cartridge <NUM>. This may include disposing the peripheral region <NUM> along a seal holding region of the cartridge <NUM> that may be defined by a pair of flanged regions 156a/156b and a top or outer region <NUM>. In at least some instances, the seal member <NUM> may be mechanically secured to the cartridge <NUM> at the seal holding region. Mechanically securing the seal member <NUM> to the cartridge <NUM> may help hold the seal member <NUM> more securely so that the seal member <NUM> is less likely to shift or move when exposed to elevated pressures. Because of this, the seal member <NUM> is able to withstand higher pressures (e.g., on the order of about <NUM>-<NUM> psi, or more). In some instances, the peripheral region <NUM> of the seal member <NUM> may be crimped to the cartridge <NUM>. This may include crimping the peripheral region <NUM> between the flanged regions 156a/156b, crimping the peripheral region <NUM> between the flanged region 156a and the outer region <NUM>, crimping the peripheral region <NUM> between the flanged region 156b and the outer region <NUM>, crimping the flanged region 156a to the shoulder region <NUM>, crimping the flanged region 156b to the shoulder region <NUM>, or combinations thereof. Other mechanical bonds are contemplated including mechanical press fitting, ultrasonic welding, adhesive bonding, or the like.

The first section 120a of the cartridge <NUM> may have enlarged internal section <NUM>. In at least some instances, the enlarged internal section <NUM> has a rounded or partially spherical shape. The rounded shape of the enlarged internal section <NUM> may provide additional space for the seal member <NUM> to open up into when a device is passed there through. Thus, the enlarged internal section <NUM> may allow the seal member <NUM> to accommodate larger devices without become deformed or damaged.

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, DURETIIAN® 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 (<NUM>), comprising:
a main body (<NUM>) having a proximal end region (<NUM>);
a cartridge (<NUM>) at least partially disposed within the proximal end region, the cartridge including a seal member (<NUM>, <NUM>);
wherein the cartridge has a proximal member, a distal member, and defines a seal holding region;
wherein the seal member (<NUM>) includes a seal body (<NUM>), a peripheral region (<NUM>), and a shoulder region (<NUM>) therebetween, the peripheral region being designed to engage the seal holding region of the cartridge;
wherein the seal body has an axial thickness (<NUM>) of about <NUM> to about <NUM> (about <NUM> to about <NUM> inches);
wherein a width (<NUM>) of the peripheral region (<NUM>) is thinner than a width (<NUM>) of the shoulder region (<NUM>) and thinner than a width (<NUM>) of the seal body (<NUM>); and
wherein the seal member is secured within the seal holding region by a mechanical bond.