Patent Description:
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> is related to a valve assembly including an enlarged compression chamber having a shoulder leading to a smaller passage. A tubular seal is housed within the compression chamber and has a distal end face with an annular tongue distally projecting therefrom and interlocking with a receiving groove on the shoulder of the compression chamber. The tubular seal also has a proximal end face with an annular second tongue proximally projecting therefrom and interlocking with a second receiving groove positioned at the distal end of a tubular shaft. The tubular shaft advances within the compression chamber to compress the seal so as to selectively constrict and block the passage through the seal.

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 seal member is designed to shift between an open configuration and a sealed configuration; a plunger coupled to the proximal end region of the main body, the plunger having an inner tubular region having a distal end; wherein the distal end of the inner tubular region is spaced a clearance distance from a proximal end of the seal member so that when the seal member is in the sealed configuration and exposed to pressures of <NUM>-<NUM> kPa (<NUM>-<NUM> pounds per square inch), the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

The clearance distance may have an axial dimension of <NUM> to <NUM> millimeters.

The clearance distance may be designed so that when the seal member is in the sealed configuration and exposed to pressures of <NUM>-<NUM> kPa (<NUM>-<NUM> pounds per square inch), the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

The proximal end region of the main body may include a retaining protrusion.

The plunger may have a distal retaining flange designed to engage the retaining protrusion.

A spring member may be disposed within the plunger and engaged with a proximal end of the plunger.

The hemostasis valve may further comprise a nut threadably engaged with one or more threads along the proximal end region of the main body.

The inner tubular region may have a wall thickness that varies along the length thereof.

The inner tubular region may have an inner diameter that varies along the length thereof.

A 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 seal member is designed to shift between an open configuration and a sealed configuration; a plunger coupled to the proximal end region of the main body, the plunger having an inner tubular region having a distal end; wherein the seal member and the plunger are arranged so that there is a clearance distance between a proximal face of the seal member and the distal end of the inner tubular region such that when the seal member is in the sealed configuration and exposed to pressures of <NUM>-<NUM> pounds per square inch, the proximal face of the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

The proximal end region of the main body may include a retaining protrusion, wherein the plunger may have a distal retaining flange designed to engage the retaining protrusion.

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 cartridge at least partially disposed within the threaded proximal end region, the cartridge including a seal member; wherein the seal member is designed to shift between an open configuration and a sealed configuration; a plunger coupled to the threaded proximal end region of the main body, the plunger having an inner tubular region having a distal end; wherein the seal member and the plunger are arranged so that there is a clearance distance between a proximal face of the seal member and the distal end of the inner tubular region such that when the seal member is in the sealed configuration and exposed to pressures of <NUM>-<NUM> pounds per square inch, the proximal face of the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

The clearance distance may have an axial dimension of <NUM> to <NUM> millimeters, wherein the clearance distance may be designed so that when the seal member is in the sealed configuration and exposed to pressures of <NUM>-<NUM> kPa (<NUM>-<NUM> pounds per square inch), the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

On the contrary, the intention is to cover all modifications, equivalents, and 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> 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 Tuchy-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. For example, the first seal member <NUM> may be designed to withstand pressures on the order of about <NUM>-<NUM> kPa (<NUM>-<NUM> pounds per square inch (psi)). While this performance is considered to be acceptable, it may desirable to further 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 a portion of another example hemostasis valve <NUM> that may be similar in form and function to other hemostasis valve 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 hemostasis valve <NUM> includes a main body <NUM> having a proximal end region <NUM>. A cartridge <NUM> may be disposed at least partially within the proximal end region <NUM>. The cartridge <NUM> may include a first seal member <NUM>. A second seal member <NUM> may also be at least partially disposed within the proximal end region <NUM>. A plunger <NUM> may be coupled to the proximal end region <NUM> and a nut <NUM> may be threadably engaged with the proximal end region <NUM>.

The plunger <NUM> may include an inner tubular region <NUM>. The inner tubular region <NUM> may have a distal end <NUM>. When the plunger <NUM> is positioned in the manner depicted in <FIG>, the distal end <NUM> of the inner tubular region <NUM> is designed to be arranged such that a clearance distance <NUM> is defined between the distal end <NUM> of the inner tubular region <NUM> and a proximal end or surface <NUM> of the first seal member <NUM>. In at least some instances, the clearance distance <NUM> is sufficiently small (e.g., on the order of about <NUM> to <NUM> or about <NUM> to <NUM>) so that when the first seal member <NUM> is exposed to elevated pressures, the proximal surface <NUM> of the first seal member <NUM> may slightly deform or shift into engagement with the distal end <NUM> of the inner tubular region <NUM> as shown in <FIG>. When doing so, the distal end <NUM> of the inner tubular region <NUM> may provide additional structural support such that the first seal member <NUM> is able to substantially remain sealed at higher pressures. For example, the first seal member <NUM> may begin to deflect into engagement with the distal end <NUM> of the inner tubular region <NUM> when exposed to pressures of about <NUM>-<NUM> kPa (<NUM>-<NUM> pounds per square inch (psi)), or about <NUM>-<NUM> kPa (<NUM>-<NUM> psi), or about <NUM>-<NUM> kPa (<NUM>-<NUM> psi). Such a deflection can be understood as a partial deflection or modification, which is different from a modification where the first seal member <NUM> is opened or otherwise permits the flow of fluids therethrough. Because of the ability of the first seal member <NUM> to partially deflect into contact with the inner tubular region <NUM>, the inner tubular region <NUM> may provide additional structural support to the first seal member <NUM> such that the first seal member <NUM> may be able to withstand pressures of about <NUM>-<NUM> kPa (<NUM>-<NUM> psi) or more, or about <NUM>-<NUM> kPa (<NUM>-<NUM> psi) or more, or about <NUM>-<NUM> kPa (<NUM>-<NUM> psi) or more.

It can be appreciated that a number of differing designs may be utilized for the hemostasis valve <NUM> that result in the desired clearance distance <NUM>. For example, in some instances, the inner tubular region <NUM> of the plunger <NUM> may be sized so as to bring the inner tubular region <NUM> into the desired proximity of the first seal member <NUM>. This may include the inner tubular region <NUM> extending distally beyond the distal end of the plunger <NUM>, the inner tubular region <NUM> extending to the distal end of the plunger, the inner tubular region <NUM> extending to a position that is proximal of the distal end of the plunger <NUM>. Likewise, the first seal member <NUM> may also be designed with structural features that provide the desired clearance distance <NUM>. This may include the first seal member <NUM> having an increased thickness, a reduced thickness, etc. Furthermore, the cartridge <NUM> may also be designed with structural features that provide the desired clearance distance <NUM>. For example, the cartridge <NUM> may be designed so that the position of the first seal member <NUM> therein may be shifted proximally or distally. Numerous other variations are contemplated.

The disclosure may be further clarified by reference to the following Examples, which serve to exemplify some embodiments, and not to limit the disclosure.

A number of hemostasis valves similar to hemostasis valve <NUM> were manufactured without the plunger assembly attached. Tests were run to determine the amount of fluid pressure that could be applied until the first seal member began to leak fluid. It was determined that the average fluid pressure where leakage was observed for sample sterilized hemostasis valves at a time right after sterilization was <NUM> kPa (<NUM> psi). It was also determined that the average fluid pressure where leakage was observed for sample sterilized hemostasis valves six months after sterilization was <NUM> kPa (<NUM> psi).

A number of hemostasis valves similar to hemostasis valve <NUM> were manufactured. Tests were run to determine the amount of fluid pressure that could be applied until the first seal member began to leak fluid. No leakage was observed at pressures of <NUM> kPa (<NUM> psi), and leakage was not observed until pressures of <NUM> kPa (<NUM> psi) were applied.

A number of hemostasis valves similar to hemostasis valve <NUM> were manufactured. Tests were run to determine the amount of fluid pressure that could be applied until the first seal member began to leak fluid under differing conditions. It was determined that the average fluid pressure where leakage was observed for sample sterilized hemostasis valves after a single "plunge" (e.g., which can be understood to be a single actuation of the plunger where the plunger is moved distally, rotated clockwise in order to close the second seal member, rotated counter-clockwise to open the second seal member, and the moved proximally) was <NUM> kPa (<NUM> psi). It was also determined that after <NUM> "plunges", the average fluid pressure where leakage was observed was <NUM> kPa (<NUM> psi).

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.

The first seal member <NUM> (and/or other seal members disclosed herein) 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.

Claim 1:
A hemostasis valve (<NUM>, <NUM>), comprising:
a main body (<NUM>, <NUM>) having a proximal end region (<NUM>, <NUM>);
a cartridge (<NUM>, <NUM>) at least partially disposed within the proximal end region (<NUM>, <NUM>), the cartridge (<NUM>, <NUM>) including a seal member (<NUM>, <NUM>);
wherein the seal member (<NUM>, <NUM>) is designed to shift between an open configuration and a sealed configuration;
a plunger (<NUM>, <NUM>) coupled to the proximal end region (<NUM>, <NUM>) of the main body (<NUM>, <NUM>), the plunger (<NUM>, <NUM>) having an inner tubular region (<NUM>, <NUM>) having a distal end (<NUM>);
wherein the distal end (<NUM>) of the inner tubular region (<NUM>, <NUM>) is spaced a clearance distance (<NUM>) from a proximal end (<NUM>) of the seal member (<NUM>, <NUM>) so that when the seal member (<NUM>, <NUM>) is in the sealed configuration and exposed to pressures of about <NUM> kPa to about <NUM> kPa (about <NUM> to about <NUM> pounds per square inch), the seal member (<NUM>, <NUM>) deflects into contact with the distal end (<NUM>) of the inner tubular region (<NUM>, <NUM>) and remains in the sealed configuration.