Patent Description:
The present disclosure relates generally to hemostasis valves. More specifically, the present disclosure relates to hemostasis valves configured for passage of two or more elongate medical devices. This disclosure also relates to hemostasis valve systems including a hemostasis valve and a medical device such as a sheath introducer, wherein the hemostasis valve is coupleable to the medical device. Related methods are also disclosed. Document <CIT> describes a flexible access device having one or more lumens capable of receiving a surgical instrument with an elongated shaft. The access device includes a seal anchor member having an hourglass configuration to assist in retention within the body cavity. It is not disclosed that the seal anchor member includes a valve bypass portion that is configured to couple the seal anchor member to a valved medical device as recited in claim <NUM>. Additionally, the document discloses the insertion device as a cannula that is configured to receive an obturator to facilitate advancement of the cannula through a passageway of the seal anchor member. It is not disclosed that the cannula includes an elongate member having a side opening disposed through a sidewall of the elongate member as recited in claim <NUM>. Document <CIT> describes a flexible port seal for insertion through tissue comprising an outer seal having a proximal end and a distal end, a support plate located within a bore of the outer seal; and a throughport attached to the support plate and defining a throughbore for receipt of a surgical instrument, wherein the through port forms a fluid tight seal against a surgical instrument inserted through the throughport. Document <CIT> describes a surgical access device, comprising a flexible retractor having an opening extending therethrough, a housing coupled to a portion of the retractor and a base member disposed within the housing and having a plurality of sealing elements formed therein being configured to allow positioning of surgical instruments therethrough in a sealing arrangement. Document <CIT> describes a surgical access device, comprising a housing having a central axis and a working channel extending therethrough, a seal member disposed in the housing and configured to seal the working channel and a plurality of sealing elements disposed in the seal member including at least one movable sealing element that is movable independent of the other sealing elements within a predetermined path. Document <CIT> describes a sheath introducer system comprising a sheath introducer defining a lumen therethrough and having a proximal valve housing in fluid communication with a distal tubular sheath, an exchangeable valve module coupled to the valve housing, the valve module having at least one entry port for receiving an interventional device therethrough and a locking collar for releasably securing the valve module to the valve housing of the sheath introducer. None of the prior art documents discloses the hemostasis valve system with all features of claim <NUM>.

The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. While various aspects of the embodiments are presented in drawings, the drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:.

The various embodiments disclosed herein generally relate to hemostasis valves and hemostasis valve systems. In some embodiments, the hemostasis valve includes a valve member, wherein the valve member includes a first sealable opening disposed through a first portion of the valve member and a second sealable opening disposed through a second portion of the valve member. The valve member may also include three or more sealable openings. In certain embodiments, a hemostasis valve system may include a hemostasis valve and a first medical device (e.g., a sheath introducer). The hemostasis valve may be releasably coupleable to the first medical device.

Various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.

Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus is not intended to limit the scope of the disclosure, but is merely representative of possible embodiments of the disclosure. In some cases, well-known structures, materials, or operations are not shown or described in detail.

The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

The terms "proximal" and "distal" refer to opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a medical device is the portion nearest a practitioner during use, while the distal portion is the portion at the opposite end. For example, the proximal end of a hemostasis valve is defined as the end closest to the practitioner during utilization of the hemostasis valve. The distal end is the end opposite the proximal end, along the longitudinal direction of the hemostasis valve.

The term "resilient" refers to a component, device, or object having a particular shape that can then be elastically deformed into a different shape, but that may return to the original shape when unconstrained. For example, a wall of a valve member may have a first shape when unconstrained (i.e., when not engaged with an elongate medical device) and, in use, the wall may then be constrained (i.e., temporarily engaged with the elongate medical device) to elastically deform the wall into a second shape (i.e., displaced laterally due to interaction with a portion of the elongate medical device), then unconstrained (i.e., removed from engagement with the elongate medical device) such that the wall returns to its first shape or substantially returns to its first shape.

Various examples of hemostasis valve systems described herein comprise sealable openings configured to allow passage of instruments through a valve while maintaining hemostasis across the valve. Various examples herein reference sealable openings comprising one or more slits in a valve member. Notwithstanding any specific example to slits herein, sealable openings within the scope of this disclosure include single slits, intersecting slits, expandable holes, pin holes, multi-diameter holes, and so forth. Accordingly, any suitable sealable opening may be used in connection with the specific embodiments described herein.

<FIG> is a perspective view of a hemostasis valve system <NUM>, <FIG> is a side view of the hemostasis valve system <NUM>, and <FIG> is an end view of a proximal end portion <NUM> of the hemostasis valve system <NUM>. The hemostasis valve system <NUM> can include a hemostasis valve <NUM> and another medical device such as first medical device <NUM>. The hemostasis valve <NUM> can be releasably coupleable to the first medical device <NUM>. In various embodiments, the first medical device <NUM> may be a valved medical device (e.g., a traditional hemostasis valve, a valved sheath introducer, etc.). Other suitable first medical devices <NUM> are also within the scope of this disclosure. In certain embodiments, the hemostasis valve <NUM> is independent of the hemostasis valve system <NUM>. For example, the hemostasis valve <NUM> may be provided and/or used without the first medical device <NUM> or any other component of the hemostasis valve system <NUM> as provided herein. Furthermore, the hemostasis valve <NUM> may be configured for universal adaption. That is, the hemostasis valve <NUM> may be coupleable to a first medical device <NUM> of any suitable size. For example, the first medical device <NUM> may be an introducer having a size between about <NUM> French and about <NUM> French, and the hemostasis valve <NUM> may be coupleable to the introducer.

In some embodiments, the hemostasis valve <NUM> can include a body <NUM> and a valve member <NUM> (see also <FIG> and <FIG>). The valve member <NUM>, or at least a portion of the valve member <NUM>, may be formed from a resilient material or a stretchable material. For example, the valve member <NUM> may be formed from an elastomeric material. The valve member <NUM> can be coupled to the body <NUM> at a position at or adjacent the proximal end portion <NUM> of the body <NUM>.

In certain embodiments, the hemostasis valve <NUM> can further include a cap <NUM>. The cap <NUM> may be coupled to the body <NUM> such that at least a portion of the valve member <NUM> is disposed between at least a portion of the body <NUM> and at least a portion of the cap <NUM>. For example, the cap <NUM> may secure the valve member <NUM> to the body <NUM>. The cap <NUM> may be releasably coupleable to the body <NUM>. For example, a practitioner may desire to remove the cap <NUM> to access the valve member <NUM>. In various embodiments, the practitioner may desire to access the valve member <NUM>, for example, to replace the valve member <NUM>, to clean the valve member <NUM>, etc. In various embodiments, the cap <NUM> may provide protection to at least a portion of the valve member <NUM>. For example, the cap <NUM> may be formed from a rigid material and the cap <NUM> may limit or prevent at least a portion of the valve member <NUM> from being compromised or damaged (e.g., upon contact with a surface, a body part, another medical device, etc.). In various other embodiments, the hemostasis valve <NUM> may lack the cap <NUM>. The valve member <NUM> may comprise a swabable or cleanable surface with or without the cap <NUM>.

In some embodiments, the hemostasis valve <NUM>, or at least a portion of the hemostasis valve <NUM>, may be formed from a clear or transparent material. Accordingly, a color of a portion (e.g., an end) of an introducer that is coupled to the hemostasis valve <NUM> may be visible (e.g., to a practitioner) through at least a portion of the hemostasis valve <NUM>. In certain embodiments, the color of the end of the introducer may correspond to the size (e.g., the French size) of the introducer.

In various embodiments, the hemostasis valve <NUM>, or at least a portion of the hemostasis valve <NUM>, may include one or more indicia. The indicium may be a color. The one or more indicia of the hemostasis valve <NUM>, or at least a portion of the hemostasis valve <NUM>, may communicate a size of the hemostasis valve <NUM> to a user. For example, the hemostasis valve <NUM>, or at least a portion of the hemostasis valve <NUM>, may be blue and the blue color may correspond to a size of <NUM> French, which may indicate to a user that two or more elongate medical devices may be disposed through the hemostasis valve <NUM> that add up to a total of <NUM> French (e.g., two <NUM> French catheters, a <NUM> French catheter and a <NUM> French catheter, etc.). Other suitable colors and corresponding sizes are also within the scope of this disclosure. In some embodiments, the hemostasis valve <NUM> may be a neutral color, including clear or white.

In some embodiments, the valve member <NUM> may include a first sealable opening 132a disposed through a first portion of the valve member <NUM>. As shown, the valve member <NUM> may also include a second sealable opening 132b disposed through a second portion of the valve member <NUM>. The first and second portions of the valve member <NUM> may be adjacent to each other (e.g., as shown in <FIG> and <FIG>), or the first and second portions of the valve member <NUM> may be spaced apart from each other. Other suitable dispositions of the first and second portions of the valve member <NUM> are also within the scope of this disclosure. In some circumstances, a practitioner may desire to access and/or treat two branches of a vessel (e.g., simultaneously or sequentially). As further discussed herein, a hemostasis valve having two or more sealable openings, as disclosed herein, may aid in such access and/or treatment.

Furthermore, the first sealable opening 132a may include a first slit 134a disposed through at least a portion of the first sealable opening 132a and/or along at least a portion of the diameter of the first sealable opening 132a. The first sealable opening 132a may also include a second slit 134b, wherein the second slit 134b may intersect at least a portion of the first slit 134a. Likewise, the second sealable opening 132b may include the first slit 134a' disposed through at least a portion of the second sealable opening 132b and/or along at least a portion of the diameter of the second sealable opening 132b. The second sealable opening 132b may also include a second slit 134b, wherein the second slit 134b may intersect at least a portion of the first slit 134a. As depicted, the first slits 134a, 134a' may be disposed substantially perpendicular to the second slits 134b, 134b'. The first slit 134a may be continuous with the first slit <NUM>' (see <FIG>). Stated another way, the first slit <NUM> can be integral with the first slit <NUM>'. In some other embodiments, the first slit <NUM> and the first slit <NUM>' may be separate or distinct slits. In certain embodiments, the valve member <NUM> may include a third sealable opening, a fourth sealable opening, a fifth sealable opening, a sixth sealable opening, a seventh sealable opening, an eighth sealable opening, or more sealable openings.

The sealable openings (e.g., the first sealable opening 132a and the second sealable opening 132b) may be configured such that an elongate medical device (e.g., a guidewire, a stylet, a catheter, etc.) may be disposed through at least a portion of the slits of the sealable opening, and the sealable opening and/or the slits may form a seal (e.g., a hemostatic seal) around the elongate medical device. In some embodiments, the sealable openings, or at least a portion of each of the sealable openings, may be formed from a resilient or stretchable material such that the sealable opening and/or the slits of the sealable opening may form a seal (e.g., around an outside surface of an elongate medical device). The sealable openings may also be configured such that the sealable openings are substantially sealed when no object (e.g., an elongate medical device) is disposed through the sealable openings. An elongate medical device may be disposed through the first sealable opening 132a and then the elongate medical device may be transitioned along at least a portion of the first slits 134a, 134a' (e.g., when the first slits 134a, 134a' are integral) such that the elongate medical device is disposed through the second sealable opening 132b, or vice versa.

With continued reference to <FIG>, the hemostasis valve <NUM> may further include a sidearm <NUM>. The sidearm <NUM> may include a sidearm lumen <NUM>, the sidearm lumen <NUM> extending through at least a portion of the sidearm <NUM>. In some embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a hemostasis valve lumen <NUM> of the hemostasis valve <NUM> (see also <FIG> and <FIG>). Accordingly, a practitioner may dispose or introduce a fluid through the sidearm lumen <NUM> to flush and/or clean at least a portion of the hemostasis valve lumen <NUM>.

The first medical device <NUM> may also include a sidearm <NUM>. The sidearm <NUM> may include a sidearm lumen <NUM>, the sidearm lumen <NUM> extending through at least a portion of the sidearm <NUM>. In some embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a first medical device lumen <NUM> of the first medical device <NUM> (see also <FIG> and <FIG>). Accordingly, a practitioner may dispose or introduce a fluid through the sidearm lumen <NUM> to flush and/or clean at least a portion of the first medical device lumen <NUM>. The sidearm <NUM> may rotate independent of the sidearm <NUM>, for example, when the hemostasis valve <NUM> is coupled to the first medical device <NUM>. Furthermore, the hemostasis valve <NUM> may be configured such that upon coupling of the hemostasis valve <NUM> to the first medical device <NUM>, the sidearm lumen <NUM> is not blocked by a portion of the hemostasis valve <NUM>. For example, fluid communication through the sidearm lumen <NUM> may be substantially maintained upon coupling of the hemostasis valve <NUM> to the first medical device <NUM>. In various embodiments, each of the sidearm lumens <NUM>, <NUM> may be in fluid communication with each of the first medical device lumen <NUM> and the hemostasis valve lumen <NUM> (e.g., when the first medical device <NUM> is coupled to the hemostasis valve <NUM>).

The hemostasis valve <NUM> may also include a coupling member (not shown) disposed, for example, at or adjacent a distal end portion <NUM> of the hemostasis valve <NUM>. The coupling member may be configured to couple, or releasably couple, the hemostasis valve <NUM> to the first medical device <NUM>. In certain embodiments, the coupling member may be configured to form a snap fit between the hemostasis valve <NUM> and the first medical device <NUM>. In certain other embodiments, the coupling member may be configured to threadably couple the hemostasis valve <NUM> and the first medical device <NUM> to each other (e.g., the coupling member may include one or more threads). Other suitable coupling mechanisms are also within the scope of this disclosure.

<FIG> is an exploded view of the hemostasis valve system <NUM>. As shown, the hemostasis valve system <NUM> can include the hemostasis valve <NUM>. As discussed above, the hemostasis valve <NUM> can include the body <NUM> and the sidearm <NUM> extending radially outward relative to a longitudinal axis L of the hemostasis valve <NUM>.

As shown, the hemostasis valve lumen <NUM> can extend between the proximal end portion <NUM> and the distal end portion <NUM> of the hemostasis valve <NUM>. Accordingly, there may be fluid communication between the proximal end portion <NUM> and the distal end portion <NUM> of the hemostasis valve <NUM>.

The hemostasis valve <NUM> can further include the valve member <NUM>, wherein the valve member <NUM> is configured to be disposed at or adjacent the proximal end portion <NUM> of the hemostasis valve <NUM>. Stated another way, the valve member <NUM> may be coupleable to the hemostasis valve <NUM> at a position at or adjacent the proximal end portion <NUM> of the hemostasis valve <NUM> (e.g., at a valve member coupling portion <NUM>). The valve member coupling portion <NUM> may be configured to limit or prevent movement (e.g., longitudinal movement) of the valve member <NUM> relative to the hemostasis valve <NUM> when the valve member <NUM> is coupled to the hemostasis valve <NUM>. For example, the valve member coupling portion <NUM> may include one or more ridges which engage or interact with at least a portion of the valve member <NUM> such that the valve member <NUM> is secured to the hemostasis valve <NUM>. The valve member coupling portion <NUM> may also be configured to limit or prevent leakage around an edge of the valve member <NUM>. For example, the valve member coupling portion <NUM> may form a seal around at least a portion of the valve member <NUM> (i.e., between the body <NUM> and the valve member <NUM>) when the valve member <NUM> is coupled to the body <NUM>.

As depicted, the valve member <NUM> includes the first sealable opening 132a disposed through a first portion of the valve member <NUM> and the second sealable opening 132b disposed through a second portion of the valve member <NUM>. Additionally, each of the first and second sealable openings 132a, 132b includes the first slits 134a, 134a' and the second slits 134b, 134b', respectively, disposed through at least a portion of the first and second sealable openings 132a, 132b. The valve member <NUM> can further include a wall or a flow divider <NUM> disposed between the first sealable opening 132a and the second sealable opening 132b. As illustrated, the first slits 134a, 134a' can extend through the wall <NUM> between each of the first and second sealable openings 132a, 132b. At least a portion of the wall <NUM> may be resilient or deformable (e.g., at least a portion of the wall <NUM> may be formed from a resilient material). In some embodiments, the wall <NUM> may be resilient such that it may bias away from the first sealable opening 132a toward the second sealable opening 132b, or vice versa. The resilient wall <NUM> may be configured to release pressure on at least a portion of the valve member <NUM>, for example, upon displacement of an elongate medical device through the first and/or the second sealable opening 132a, 132b.

In some embodiments, the wall <NUM> may be displaceable between at least a resting position, a first lateral position, and a second lateral position. As such, the wall <NUM> may be disposed in the resting position (e.g., as depicted in <FIG>) when the wall <NUM> is not engaged with an object such as an elongate medical device disposed through one of the sealable openings 132a, 132b. Interaction between the wall <NUM> and an object may displace (e.g., laterally displace) at least a portion of the wall <NUM>. For example, displacement of an elongate medical device through the first sealable opening 132a may exert a force on the wall <NUM> such that at least a portion of the wall <NUM> is displaced laterally away from the first sealable opening 132a. Stated another way, in such a configuration the wall <NUM> may transition from the resting position to the second lateral position. Analogously, displacement of an elongate medical device through the second sealable opening 132b may exert a force on the wall <NUM> such that at least a portion of the wall <NUM> is displaced laterally away from the second sealable opening 132b. In other words, in such a configuration the wall <NUM> may transition from the resting position to the first lateral position.

Likewise, the sealable openings (e.g., the first and second sealable openings 132a, 132b) may have a resting configuration and a non-resting configuration. That is, a sealable opening may be in the resting configuration when the sealable opening is not biased or stretched (e.g., due to an interaction with an object such as an elongate medical device). The first and second sealable openings 132a, 132b, as illustrated in <FIG>, are in the resting configuration. Upon interaction with an object, however, the sealable openings may transition from the resting configuration to the non-resting configuration. In the non-resting configuration the sealable openings may be biased, deformed, and/or stretched.

Upon displacement of the wall <NUM> a size of the first sealable opening 132a can decrease as a size of the second sealable opening 132b increases, or vice versa. Such a configuration may aid in the displacement of elongate medical devices having different profiles or sizes (e.g., larger profiles relative to the size of the first or second sealable opening 132a, 132b in the resting configuration) through the first and second sealable openings 132a, 132b. For example, a practitioner may desire to displace a first elongate medical device having a first profile through the first sealable opening 132a. The first profile, however, may be greater than a size of the first sealable opening 132a when the first sealable opening 132a is in the resting configuration. Accordingly, the practitioner may displace the wall <NUM> from the resting position to the second lateral position such that the size of the first sealable opening 132a increases and displacement of the first elongate medical device through the first sealable opening 132a is allowed or permitted.

Also depicted in <FIG> is the cap <NUM>. The cap <NUM> can include a first cap opening 142a and a second cap opening 142b. The first cap opening 142a may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the first cap opening 142a is in substantial alignment with the first sealable opening 132a. Likewise, the second cap opening 142b may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the second cap opening 142b is in substantial alignment with the second sealable opening 132b. As noted above, the valve member <NUM> may include more than two sealable openings. Accordingly, in some embodiments, the cap <NUM> may include three, four, five, or more cap openings. A wall <NUM> can be disposed between the first and second cap openings 142a, 142b. In some embodiments, at least a portion of the wall <NUM> may be resilient or deformable. The wall <NUM> may be resilient such that it may bias away from the first cap opening 142a toward the second cap opening 142b, or vice versa. An elongate medical device may be disposed through the first cap opening 142a and the first sealable opening 132a and then the elongate medical device may be transitioned along at least a portion of the first slits 134a, 134a' such that the elongate medical device is disposed through the second sealable opening 132b, or vice versa. In such a configuration, the resilient wall <NUM> may bias such that the elongate medical device may transition between at least a portion of the each of the first and second sealable openings 132a, 132b. In some other embodiments, the hemostasis valve <NUM> may lack the cap <NUM> such that an elongate medical device may transition between the first and second sealable openings 132a, 132b without interacting with the wall <NUM>.

At least a portion of an edge surrounding the first and/or the second cap opening 142a, 142b may be chamfered or sloped. Such a configuration may aid in guiding an elongate medical device through the first and/or the second cap opening 142a, 142b and through the first and/or the second sealable opening 132a, 132b.

The first and second sealable openings 132a, 132b can provide communication between the hemostasis valve lumen <NUM> and a position proximal of the hemostasis valve <NUM> (e.g., via the first slits 134a, 134a' and the second slits 134b, 134b'). For example, as discussed above, an elongate medical device may be disposed through at least a portion of the slits of the sealable opening such that access is provided to the hemostasis valve lumen <NUM> from a position outside of the hemostasis valve <NUM> (e.g., from a position proximal of the hemostasis valve <NUM>).

The hemostasis valve system <NUM> may also include the first medical device <NUM>. As illustrated, the distal end portion <NUM> of the hemostasis valve <NUM> may be shaped (e.g., skirt-shaped or otherwise shaped) such that upon coupling of the hemostasis valve <NUM> and the first medical device <NUM> at least a portion of the distal end portion <NUM> extends around at least a portion of a proximal end portion <NUM> of the first medical device <NUM>. In certain embodiments, the first medical device <NUM> may include a valve <NUM>; for example, the first medical device <NUM> may be a valved medical device. Furthermore, the hemostasis valve <NUM> may include a valve bypass portion <NUM>, wherein the valve bypass portion <NUM> extends distally from the distal end portion <NUM> of the hemostasis valve <NUM>. In some embodiments, the hemostasis valve lumen <NUM> may extend through at least a portion of the valve bypass portion <NUM>.

The valve bypass portion <NUM> may be configured to bypass or override the valve <NUM> of the valved medical device <NUM> when at least a portion of the valve bypass portion <NUM> is disposed through at least a portion of the valve <NUM> of the valved medical device <NUM>. For example, at least a portion of the valve bypass portion <NUM> may be configured to be displaced through the valve <NUM> (e.g., via slits 109a, 109b of the valve <NUM>) and the valve <NUM> may be configured to form a seal (e.g., a hemostatic seal) around the valve bypass portion <NUM>. Accordingly, the valve bypass portion <NUM> may be configured to couple the hemostasis valve <NUM> to the first medical device or valved medical device <NUM>. Upon coupling of the hemostasis valve <NUM> and the valved medical device <NUM>, the hemostasis valve <NUM> may be in fluid communication with the valved medical device <NUM> (e.g., via the hemostasis valve lumen <NUM>).

<FIG> is a cross-sectional view of the hemostasis valve system <NUM> through line 1E-1E of <FIG>. The hemostasis valve system <NUM> can include the hemostasis valve <NUM> and the first medical device <NUM>. As discussed above, the hemostasis valve <NUM> can include the body <NUM> and the valve member <NUM>. The valve member <NUM> can be coupled to the body <NUM> at a position at or adjacent the proximal end portion <NUM> of the body <NUM>. The hemostasis valve <NUM> can further include the cap <NUM>. The cap <NUM> may be coupled to the body <NUM> such that at least a portion of the valve member <NUM> is disposed between at least a portion of the body <NUM> and at least a portion of the cap <NUM>.

As illustrated, the valve member <NUM> can include the first sealable opening 132a disposed through a first portion of the valve member <NUM> and the second sealable opening 132b disposed through a second portion of the valve member <NUM>. The hemostasis valve <NUM> can further include the sidearm <NUM> (see <FIG>). The sidearm <NUM> may include the sidearm lumen <NUM>, wherein the sidearm lumen <NUM> can extend through at least a portion of the sidearm <NUM>. As depicted, the sidearm lumen <NUM> may be in fluid communication with at least a portion of the hemostasis valve lumen <NUM> of the hemostasis valve <NUM>. The hemostasis valve lumen <NUM> can be shaped such that upon displacement of a first elongate medical device through the first sealable opening 132a, the first elongate medical device may be directed from a proximal end of the hemostasis valve lumen <NUM> toward a distal end of the hemostasis valve lumen <NUM>. For example, as shown, the sides or inner surfaces of at least a portion of the hemostasis valve lumen <NUM> are sloped from a first, wider diameter D<NUM> at or adjacent the proximal end of the hemostasis valve lumen <NUM> to a second, narrower diameter D<NUM> at or adjacent the distal end of the hemostasis valve lumen <NUM>. Likewise, the shape of the hemostasis valve lumen <NUM> can aid in the displacement of a second elongate medical device through the second sealable opening 132b from the proximal end of the hemostasis valve lumen <NUM> to the distal end of the hemostasis valve lumen <NUM>.

As discussed above, the distal end portion <NUM> of the hemostasis valve <NUM> may be shaped such that upon coupling the hemostasis valve <NUM> and the first medical device <NUM> at least a portion of the distal end portion <NUM> extends around at least a portion of the proximal end portion <NUM> of the first medical device <NUM>. In the illustrated embodiment, at least a portion of the distal end portion <NUM> is skirt-shaped. In some other embodiments, at least a portion of the distal end portion <NUM> may be conical, cap-shaped, or otherwise suitably shaped. Furthermore, the hemostasis valve <NUM> may include the valve bypass portion <NUM> extending distally from the distal end portion <NUM> of the hemostasis valve <NUM>. As illustrated, the hemostasis valve lumen <NUM> can extend through at least a portion of the valve bypass portion <NUM>.

With continued reference to <FIG>, at least a portion of the valve bypass portion <NUM> may be configured to be displaced through the valve <NUM> of the first medical device <NUM>. As such, the valve bypass portion <NUM> may couple the hemostasis valve <NUM> to the first medical device or valved medical device <NUM>. Upon coupling of the hemostasis valve <NUM> and the valved medical device <NUM>, the hemostasis valve <NUM> may be in fluid communication with the valved medical device <NUM>. In some embodiments, a distal end of the valve bypass portion <NUM> may be rounded such that the distal end of the valve bypass portion <NUM> is atraumatic (e.g., the distal end of the valve bypass portion <NUM> may be configured to avoid or limit damaging or traumatizing the valve <NUM> of the first medical device <NUM>).

<FIG> is a partial exploded view of the hemostasis valve system <NUM> showing a distal end of the cap <NUM>. As depicted, the cap <NUM> may include two recessed portions 144a, 144b and the proximal end portion <NUM> of the body <NUM> may include a single raised portion <NUM>. Caps with more or fewer recessed portions and raised portions are likewise within the scope of this disclosure. In the illustrated embodiment, the raised portion <NUM> extends radially outward from the proximal end portion <NUM> of the body <NUM>. The recessed portion 144a may be disposed about <NUM>° from the recessed portion 144b along the circumference of the cap <NUM>, though other relative positions are within the scope of this disclosure. For example, in some other embodiments, the recessed portions 144a, 144b may be disposed about <NUM>°, about <NUM>°, about <NUM>°, or another suitable number of degrees relative to each other and the cap <NUM> may comprise additional recessed portions, spaced equally or irregularly about the circumference of the cap <NUM>.

The raised portion <NUM> may be configured to receive one of the recessed portions 144a, 144b. Upon coupling the cap <NUM> to the body <NUM>, the recessed portion 144a or the recessed portion 144b may engage or interact with the raised portion <NUM>. The engagement of the raised portion <NUM> with one of the recessed portions 144a, 144b can form a key/lock mechanism, such that when the cap <NUM> is coupled to the body <NUM>, the cap <NUM> cannot be rotated relative to the body <NUM>, or vice versa. Stated another way, the key/lock mechanism may "lock" the rotational position of the cap <NUM> in relation to the body <NUM>. In some embodiments, the cap <NUM> may include one, three, four, five or another suitable number of recessed portions and the proximal end portion <NUM> of the body <NUM> may include two, three, four, five, or another suitable number of raised portions <NUM>.

<FIG> illustrates a hemostasis valve <NUM> that can, in certain respects, resemble components of the hemostasis valve <NUM> described in connection with <FIG>. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " For instance, the cap is designated as "<NUM>" in <FIG>, and an analogous cap is designated as "<NUM>" in <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the hemostasis valve <NUM> and related components shown in <FIG> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the hemostasis valve <NUM> of <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the hemostasis valve <NUM> and components illustrated in <FIG> can be employed with the hemostasis valve <NUM> and components of <FIG>, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

<FIG> is an end view of a proximal end of a hemostasis valve <NUM>. The hemostasis valve <NUM> can include a valve member <NUM>. As depicted, the valve member <NUM> may include a first sealable opening 232a disposed through a first portion of the valve member <NUM>. The valve member <NUM> may also include a second sealable opening 232b disposed through a second portion of the valve member <NUM>. A first slit 234a and a second slit 234b may be disposed through at least a portion of the first sealable opening 232a, and a first slit 234a' and a second slit 234b' may be disposed through at least a portion of the second sealable opening 232b. As depicted, the first sealable opening 232a may be substantially the same size as the second sealable opening 232b. In some other embodiments, the first sealable opening 232a may be larger than the second sealable opening 232b, or vice versa.

The valve member <NUM> may also include a third sealable opening 232c disposed through a third portion of the valve member <NUM>. Furthermore, a first slit 234a" and a second slit 234b" may be disposed through at least a portion of the third sealable opening 232c. As depicted, the third sealable opening 232c may be larger than each of the first sealable opening 232a and the second sealable opening 232b. In various embodiments, a practitioner may displace a first guidewire through the first sealable opening 232a and a second guidewire through the second sealable opening 232b. The practitioner may also displace an elongate medical device having a larger profile than either of the first or second guidewire through the third sealable opening 232c (e.g., such as a balloon catheter).

In some embodiments, the hemostasis valve <NUM> may include one or more exchange slits (not shown) and may lack a cap. For example, the exchange slit can be disposed through a portion of the valve member <NUM> and extend between the first sealable opening 232a and the third sealable opening 232c. As such, the practitioner may dispose the first guidewire through the first sealable opening 232a, through the hemostasis valve <NUM>, and then into at least a portion of a vessel of a patient. The practitioner may then displace the first guidewire from the first sealable opening 232a to the third sealable opening 232c via the exchange slit. Upon displacement of the first guidewire to the third sealable opening 232c, the practitioner may then dispose an elongate medical device such as a balloon catheter over and along the first guidewire and through the third sealable opening 232c of the hemostasis valve <NUM>. The hemostasis valve <NUM> may include one, two, three, or more exchange slits. For example, a second exchange slit may be disposed between the second sealable opening 232b and the third sealable opening 232c.

Other relative sizes of the each of the first, second, and third sealable openings 232a, 232b, 232c are also within the scope of this disclosure. For example, in some other embodiments, each of the first, second, and third sealable openings 232a, 232b, 232c may be a different size (e.g., the first sealable opening 232a may be a first size, the second sealable opening 232b may be a second size, and the third sealable opening 232c may be a third size).

The sealable openings (e.g., the first sealable opening 232a, the second sealable opening 232b, the third sealable opening 232c) may be configured such that an elongate medical device (e.g., a guidewire, a stylet, a catheter, etc.) may be disposed through at least a portion of the slits of the sealable opening and the sealable opening and/or the slits may form a seal (e.g., a hemostatic seal) around the elongate medical device.

In some embodiments, a first balloon catheter may be disposed through the first sealable opening 232a and a second balloon catheter may be disposed through the second sealable opening 232b. Furthermore, a contrast agent (e.g., for an angiogram) may be introduced through the third sealable opening 232c (e.g., via a catheter). For example, the first and second sealable openings 232a, 232b may be configured to seal around at least a portion of <NUM> French first and second balloon catheters and the third sealable opening 232c may be configured to seal around at least a portion of a <NUM> French contrast agent catheter.

The hemostasis valve <NUM> may also include the cap <NUM>. The cap <NUM> may be coupleable to a proximal end portion of the hemostasis valve <NUM> such that at least a portion of the valve member <NUM> is disposed between the cap <NUM> and a body of the hemostasis valve <NUM>. As stated above, in some other embodiments, the hemostasis valve <NUM> may lack a cap. The cap <NUM> can include a first cap opening 242a and a second cap opening 242b. The first cap opening 242a may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the first cap opening 242a is in substantial alignment with the first sealable opening 232a. The second cap opening 242b may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the second cap opening 242b is in substantial alignment with the second sealable opening 232b. The cap <NUM> may also include a third cap opening 242c. The third cap opening 242c may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the third cap opening 242c is in substantial alignment with the third sealable opening 232c.

<FIG> is an end view of a proximal end of a hemostasis valve <NUM>. The hemostasis valve <NUM> can include a valve member <NUM>. As depicted, the valve member <NUM> may include a first sealable opening 332a disposed through a first portion of the valve member <NUM> and a second sealable opening 332b disposed through a second portion of the valve member <NUM>. A first slit 334a may be disposed through at least a portion of the first sealable opening 332a, and a second slit 334b may be disposed through at least a portion of the second sealable opening 332b. Furthermore, an elongate slit <NUM> may be disposed through a portion of the valve member <NUM>. The first sealable opening 332a and the second sealable opening 332b may be coupled via the elongate slit <NUM>. In such a configuration, a first elongate medical device may be disposed through the first sealable opening 332a and then displaced from the first sealable opening 332a to the second sealable opening 332b via the elongate slit <NUM>. Likewise, a second elongate medical device may be disposed through the second sealable opening 332b and then displaced from the second sealable opening 332b to the first sealable opening 332a via the elongate slit <NUM>.

The hemostasis valve <NUM> may also include a cap <NUM>. The cap <NUM> can include a cap opening <NUM>. The cap opening <NUM> may be disposed through the cap <NUM> such that upon coupling of the cap <NUM> to the hemostasis valve <NUM>, the cap opening <NUM> is disposed around each of the first and second sealable openings 332a, 332b and/or provides access (e.g., to a practitioner) to each of the first and second sealable openings 332a, 332b.

<FIG> is a side view of a hemostasis valve <NUM>, <FIG> is a cross-sectional view of the hemostasis valve <NUM> through line 4B-4B of <FIG>, and <FIG> is an end view of a proximal end of the hemostasis valve <NUM>. The hemostasis valve <NUM> can include a body <NUM> extending between a proximal end portion <NUM> and a distal end portion <NUM>. The hemostasis valve <NUM> can also include a valve member <NUM>, wherein the valve member <NUM> may be coupled to the body <NUM> at a position at or adjacent the proximal end portion <NUM>. The hemostasis valve <NUM> can further include a cap <NUM>, wherein the cap <NUM> may be coupled to the body <NUM> such that at least a portion of the valve member <NUM> is disposed between at least a portion of the body <NUM> and at least a portion of the cap <NUM>. In some embodiments, the hemostasis valve <NUM> may lack a cap.

The valve member <NUM> can include a first sealable opening 432a disposed through a first portion of the valve member <NUM> and a second sealable opening 432b disposed through a second portion of the valve member <NUM>. The hemostasis valve <NUM> can further include a sidearm <NUM>. The sidearm <NUM> can include a sidearm lumen <NUM>, wherein the sidearm lumen <NUM> can extend through at least a portion of the sidearm <NUM>. As depicted, the sidearm lumen <NUM> may be in fluid communication with at least a portion of a hemostasis valve lumen <NUM> of the hemostasis valve <NUM>. Furthermore, the hemostasis valve lumen <NUM> can extend through at least a portion of the hemostasis valve <NUM>. As illustrated, the hemostasis valve lumen <NUM> extends between the proximal end portion <NUM> and the distal end portion <NUM> of the hemostasis valve <NUM>. As discussed above regarding the hemostasis valve lumen <NUM>, the shape of the hemostasis valve lumen <NUM> can aid in the displacement of an elongate medical device through the hemostasis valve <NUM>.

The distal end portion <NUM> of the hemostasis valve <NUM> may be configured such that the hemostasis valve <NUM> can be coupled to another medical device. For example, a coupling mechanism may be coupled to or disposed at or adjacent the distal end portion <NUM> (e.g., a luer connector, a snap fit mechanism, a plurality of threads). In some embodiments, another medical device may extend distally from the distal end portion <NUM> of the hemostasis valve <NUM>. For example, a sheath introducer may be integral with the hemostasis valve <NUM> and the sheath introducer may extend distally from the distal end portion <NUM>. Other suitable medical devices may also be coupled to or integral with the hemostasis valve <NUM> (e.g., a catheter, medical tubing, etc.). <FIG> is a side view of the hemostasis valve <NUM> coupled to an introducer sheath <NUM> adjacent the distal end portion <NUM> of the body <NUM>.

Analogous to the introducer sheath <NUM> of <FIG>, any of the hemostasis valves described herein may be coupled to a variety of elongate medical devices, including introducer sheaths, catheters, conduits, and so forth. As noted above, in some instances the hemostasis valve may snap onto the hub of an elongate device, including hubs that include an existing hemostasis valve. In other embodiments, the hemostasis valves described herein may be configured to attach to an elongate medical instrument via a luer lock. For instances, a hemostasis valve within the scope of this disclosure may comprise a luer lock at the distal end portion <NUM> which may be configured to couple to a catheter; in some embodiments the catheter may be a standard catheter with a luer fitting on its proximal end. Similarly, hemostasis valves described herein may be coupled to a variety of devices through use of a variety of connectors, including snap fits, luer fittings, barb fittings, adhesives, and so forth.

<FIG> is an exploded view of a hemostasis valve <NUM> including a valve dividing member <NUM>. As illustrated, the valve dividing member <NUM> can include a first elongate portion <NUM> that extends between an actuator <NUM> and a hinge portion <NUM>. Furthermore, the first elongate portion <NUM> can extend through a slot <NUM>, wherein the slot <NUM> is disposed through a proximal end portion <NUM> of the hemostasis valve <NUM>. The valve dividing member <NUM> can further include a second elongate portion <NUM>, wherein the second elongate portion <NUM> is coupled to the first elongate portion <NUM> and/or the actuator <NUM> via a transverse portion <NUM>.

Upon coupling of the hemostasis valve <NUM> to a valve member <NUM>, the first elongate portion <NUM> and the second elongate portion <NUM> may be configured to couple, engage with, and/or interact with the valve member <NUM>. The first elongate portion <NUM> and the second elongate portion <NUM> may be configured as a divider displaceable along a sealable opening <NUM> of the valve member <NUM>. The divider may allow a practitioner to divide the sealable opening <NUM> into a first side and a second side, for example to separate two guidewires positioned in different points of a patient's anatomy. Displacement of the valve dividing member <NUM> in one direction may increase the available space to advance a larger therapy (such as a balloon) over one guidewire. At the conclusion of the initial therapy, the valve dividing member <NUM> could be displaced in the other direction to provide more space for treatment via a wire on the other side of the valve dividing member <NUM>. This embodiment may allow a practitioner to separate two guidewires and accommodate larger therapies when needed, while minimizing the overall size of the hemostasis valve <NUM>.

The first elongate portion <NUM> and the second elongate portion <NUM> may provide structure and support above and below the valve member <NUM> such that a practitioner may displace the first elongate portion <NUM> and the second elongate portion <NUM> to change the effective length of the sealable opening <NUM> on other side of the first elongate portion <NUM> and the second elongate portion <NUM>. This support structure may allow the sealable opening <NUM> to remain sealed on a guidewire on one side of the valve dividing member <NUM> while a large therapy such as a balloon is inserted through the sealable opening <NUM> on the other side of the valve dividing member <NUM>. The support structure may facilitate simultaneous sealing of the sealable opening <NUM> on both the balloon on one side and a guidewire on the other side of the valve dividing member <NUM>.

The valve dividing member <NUM> may be configured to be displaceable between at least a resting position, a first lateral position, and a second lateral position. The resting position may correlate to a central position when the valve dividing member <NUM> is disposed in a middle portion of the valve member <NUM> (e.g., as depicted in <FIG>). Displacement of the valve dividing member <NUM> (e.g., via the actuator <NUM>) in a first direction as indicated by the arrow D<NUM> may displace the first elongate portion <NUM> and the second elongate portion <NUM> in the first direction (i.e., to the first lateral position). In the first lateral position, the sealable opening <NUM> has a longer effective or usable length on the side of the first elongate portion <NUM> and the second elongate portion <NUM> associated with the second direction (indicated by arrow D<NUM>). Thus, in this position a practitioner may be able to advance larger therapies (such as a balloon) through the sealable opening <NUM> on the side of the valve dividing member <NUM> associated with the second direction. Again, the sealable opening <NUM> may simultaneously seal against a guidewire on the first side of the valve dividing member <NUM> and a larger device on the second side of the valve dividing member <NUM>.

Likewise, displacement of valve dividing member <NUM> in a second direction as indicated by the arrow D<NUM> may displace at least a portion of the first elongate portion <NUM> and the second elongate portion <NUM> in the second direction (i.e., to the second lateral position). This displacement may provide a greater effective length of the sealable opening <NUM> on the side of the valve dividing member <NUM> associated with the first direction.

In some other embodiments, a first iris-like support member may provide structure and support above a valve member and/or a second iris-like support member may provide structure and support below the valve member. At least a portion of the iris-support member may be analogous to a camera aperture. The first and/or second iris-like support members may be configured to transition from a first diameter to a second diameter, wherein the first diameter is greater than the second diameter. The first and/or second iris-like support members may be disposed around a sealable opening, as provided herein, having a first slit and a second slit wherein the intersecting first and second slits form at least four leaflets in the valve member at the sealable opening.

When the first and/or second iris-like support members are in the first diameter, a first elongate medical device having a first diameter may be disposed through the sealable opening and the leaflets can form a seal around the first elongate medical device. When a second elongate medical device having a second, smaller diameter is disposed through the sealable opening, a practitioner may transition the first and/or second iris-like support members to the second smaller diameter such that the leaflets are supported (i.e., by the first and/or second iris-like support members) and can form a seal around the second elongate medical device having the second, smaller diameter.

<FIG> illustrates a valve member <NUM>. <FIG> is a cross-sectional view of the valve member <NUM> taken through line 6A-6A and <FIG> is a cross-sectional view of the valve member <NUM> taken through line 6B-6B. As shown, the valve member <NUM> can include a first sealable opening 632a having a first slit 634a disposed through at least a portion of the first sealable opening 632a and/or along at least a portion of the diameter of the first sealable opening 632a. The first sealable opening 632a may also include a second slit 634b, wherein the second slit 634b may intersect at least a portion of the first slit 634a. Likewise, the first slit 634a may be disposed through at least a portion of a second sealable opening 632b and/or along at least a portion of the diameter of the second sealable opening 632b. The second sealable opening 632b may also include a second slit 634b', wherein the second slit 634b' may intersect at least a portion of the first slit 634a. As depicted, the first slit 634a may be disposed substantially perpendicular to the second slits 634b, 634b'.

The valve member <NUM> can further include a wall <NUM> disposed between the first sealable opening 632a and the second sealable opening 632b. As illustrated, the first slit 634a can extend through the wall <NUM> between each of the first and second sealable openings 632a, 632b. As discussed above, at least a portion of the wall <NUM> may be resilient or deformable. At least a portion of a first edge 639a surrounding the first sealable opening 632a and/or at least a portion of a second edge 639b surrounding the second sealable opening 632b may be chamfered or sloped. Such a configuration may aid in guiding an elongate medical device through the first and/or the second sealable openings 632a, 632b.

With reference to <FIG>, the first slit 634a may extend inward from a first surface <NUM> of the valve member <NUM> and through at least a portion of the each of the first and second sealable openings 632a, 632b. As illustrated, the first slit 634a may form a substantially arc-shaped cut or slit in at least a portion of the valve member <NUM>. Other shapes of the first slit 634a (e.g., linear, wavy, etc.) are also within the scope of this disclosure. Furthermore, the second slits 634b, 634b' may extend inward from a second or opposite surface <NUM> of the valve member <NUM>. Each of the second slits 634b, 634b' may intersect with at least a portion of the first slit 634a to form the first and second sealable openings 632a, 632b.

With reference to <FIG>, the first slit 634a may extend inward from the first surface <NUM> of the valve member <NUM> and through at least a portion of the first sealable opening 632a. Furthermore, the second slit 634b may extend inward from the second surface <NUM> of the valve member <NUM>. The second slit 634b may intersect with at least a portion of the first slit 634a to form the first sealable opening 632a. As illustrated, the second slit 634b may form a substantially arc-shaped cut or slit in at least a portion of the valve member <NUM>. Other shapes of the second slit 634b (e.g., linear, wavy, etc.) are also within the scope of this disclosure. The second slit 634b', which is not shown in <FIG>, may be configured in a similar manner to that of the second slit 634b.

<FIG> illustrates a valve member <NUM>. <FIG> is a cross-sectional view of the valve member <NUM> taken through line 7A-7A and <FIG> is a cross-sectional view of the valve member <NUM> taken through line 7B-7B. As shown, the valve member <NUM> can include a first sealable opening 732a and a second sealable opening 732b. A first slit 734a can be disposed through at least a portion of the first and second sealable openings 732a, 732b. The first sealable opening 732a may also include a second slit 734b, wherein the second slit 734b may intersect at least a portion of the first slit 734a. Likewise, the second sealable opening 732b may also include a second slit 734b', wherein the second slit 734b' may intersect at least a portion of the first slit 734a. As depicted, the first slit 734a may be disposed substantially perpendicular to the second slits 734b, 734b'.

With reference to <FIG>, the first slit 734a may extend inward from a first surface <NUM> of the valve member <NUM> and through at least a portion of each of the first and second sealable openings 732a, 732b. As illustrated, the first slit 734a may form a substantially arc-shaped cut or slit in at least a portion of the valve member <NUM>. Other shapes of the first slit 734a (e.g., linear, wavy, etc.) are also within the scope of this disclosure. Furthermore, the second slits 734b, 734b' may extend inward from a second or opposite surface <NUM> of the valve member <NUM>. Each of the second slits 734b, 734b' may intersect with at least a portion of the first slit 734a to form the first and second sealable openings 732a, 732b.

With reference to <FIG>, the first slit 734a may extend inward from the first surface <NUM> of the valve member <NUM> and through at least a portion of the first sealable opening 732a. Furthermore, the second slit 734b may extend inward from the second surface <NUM> of the valve member <NUM>. The second slit 734b may intersect with at least a portion of the first slit 734a to form the first sealable opening 732a. As illustrated, the second slit 734b may form a substantially arc-shaped cut or slit in at least a portion of the valve member <NUM>. Other shapes of the second slit 734b (e.g., linear, wavy, etc.) are also within the scope of this disclosure. The second slit 734b', which is not shown in <FIG>, may be configured in a similar manner to the second slit 734b.

<FIG> illustrates a valve member <NUM>. As shown, the valve member <NUM> can include a first sealable opening <NUM> having a first slit 834a disposed through at least a portion of the first sealable opening <NUM> and/or along at least a portion of the diameter of the first sealable opening <NUM>. The first sealable opening <NUM> may also include a second slit 834b, wherein the second slit 834b may intersect at least a portion of the first slit 834a. Likewise, a first slit 834a' may be disposed through at least a portion of a second sealable opening <NUM>' and/or along at least a portion of the diameter of the second sealable opening <NUM>'. The second sealable opening <NUM>' may also include a second slit 834b', wherein the second slit 834b' may intersect at least a portion of the first slit 834a'. As depicted, the first and second slits 834a, 834b may be disposed such that they form an X shape. The first and second slits 834a', 834b' may also be disposed such that they form an X shape. The slits forming the X shape may intersect at various angles and are not necessarily perpendicular to each other.

<FIG> illustrates a valve member <NUM>. As shown, the valve member <NUM> can include a first sealable opening <NUM> having a single slit <NUM> disposed through at least a portion of the first sealable opening <NUM> and/or along at least a portion of the diameter of the first sealable opening <NUM>. Likewise, a single slit <NUM>' may be disposed through at least a portion of a second sealable opening <NUM>' and/or along at least a portion of the diameter of the second sealable opening <NUM>'. Any of the sealable openings and/or slits depicted in <FIG> may be formed in manner analogous to any of the sealable openings and/or slits depicted in <FIG>.

<FIG> is an exploded view of a hemostasis valve <NUM>. The hemostasis valve <NUM> can include a body <NUM>. The hemostasis valve <NUM> can further include a first valve member 1030a and a second valve member 1030b, wherein the first and second valve members 1030a, 1030b are configured to be disposed at or adjacent a proximal end portion <NUM> of the hemostasis valve <NUM>. Stated another way, the first and second valve members 1030a, 1030b may be coupleable to the hemostasis valve <NUM> at a position at or adjacent the proximal end portion <NUM> of the hemostasis valve <NUM> (e.g., at a first and second valve member coupling portion 1022a, 1022b, respectively). The first and second valve member coupling portions 1022a, 1022b may be configured to limit or prevent movement (e.g., longitudinal movement) of the first and second valve members 1030a, 1030b relative to the hemostasis valve <NUM> when the first and second valve members 1030a, 1030b are coupled to the hemostasis valve <NUM>.

As depicted, the first valve member 1030a includes a first sealable opening 1032a disposed through a first portion of the first valve member 1030a and a second sealable opening 1032b disposed through the second valve member 1030b. As discussed above, each of the first and second sealable openings 1032a, 1032b can include one or more slits disposed through at least a portion of the first and second valve members 1030a, 1030b. In some embodiments, the hemostasis valve <NUM> may include three, four, five, or more valve members.

Any of the valve members depicted in <FIG> or <FIG> may be formed in a manner analogous to the valve members depicted in <FIG>. In other words, the valve member may include a single piece or member including two or more sealable openings or the valve member may include multiple pieces or members. Additionally, any of the hemostasis valves provided herein may be stand-alone hemostasis valves for use with a hemostasis valve system or the hemostasis valves may be configured such that they may retrofit a standard (e.g., off-the-shelf) hemostasis valve system.

<FIG> is a perspective view of a hemostasis valve system <NUM>. The hemostasis valve system <NUM> can include a hemostasis valve <NUM> and another medical device such as a first medical device <NUM>. The hemostasis valve <NUM> can be releasably coupleable to the first medical device <NUM>. The first medical device <NUM> may comprise or be releasably coupleable to a first elongate member <NUM> including, for example, a length of tubing <NUM> coupled to a stopcock <NUM>. The hemostasis valve <NUM> may also comprise or be releasably coupleable to a second elongate member <NUM> including, for example, a length of tubing <NUM> coupled to a stopcock <NUM>. In certain embodiments, the first medical device <NUM> may be independent of the first elongate member <NUM> and/or the hemostasis valve <NUM> may be independent of the second elongate member <NUM>. For example, the first medical device <NUM> may be provided and/or used without the first elongate member <NUM>. Likewise, the hemostasis valve <NUM> may be provided and/or used without the second elongate member <NUM>.

In some embodiments, the first medical device <NUM> may be a traditional hemostasis valve, a valved sheath introducer, or another valved medical device. The first medical device <NUM> may be an off-the-shelf medical device such that the tubing <NUM> has a standard length. For example, the tubing <NUM> of an off-the-shelf first medical device <NUM> may be about <NUM> inches in length or another suitable length. In certain embodiments, the length of the tubing <NUM> of the hemostasis valve <NUM> may be greater than the length of the tubing <NUM> of the first medical device <NUM>. For example, if the length of the tubing <NUM> of the first medical device <NUM> is <NUM> inches, the length of the tubing <NUM> of the hemostasis valve <NUM> may be between about <NUM> inches and about <NUM> inches, about <NUM> inches, between about <NUM> inches and about <NUM> inches, about <NUM> inches, between about <NUM> inches and about <NUM> inches, about <NUM> inches, or another suitable length. In certain other embodiments, the length of the tubing <NUM> of the hemostasis valve <NUM> may be less than the length of the tubing <NUM> of the first medical device <NUM>. For example, if the length of the tubing <NUM> of the first medical device <NUM> is <NUM> inches, the length of the tubing <NUM> of the hemostasis valve <NUM> may be between about <NUM> inches and about <NUM> inches, about <NUM> inches, between about <NUM> inches and about <NUM> inches, about <NUM> inches, between about <NUM> inches and about <NUM> inches, about <NUM> inches, or another suitable length. Accordingly, the length of the tubing <NUM> of the hemostasis valve <NUM> may be an indicium. Stated another way, the length of the tubing <NUM> of the hemostasis valve <NUM> may be an indicium that communicates to a user which tubing is coupled to the hemostasis valve and which tubing is coupled to the first medical device <NUM>. The first and second lengths of the tubings <NUM>, <NUM> can distinguish the tubings <NUM>, <NUM> (and/or the first medical device <NUM> and the hemostasis valve <NUM>) from each other. Other suitable indicia may also be used. For example, while the tubing <NUM> of the first medical device may be clear or transparent, the tubing <NUM> of the hemostasis valve <NUM> may have a color or tint (e.g., the tubing <NUM> may be green). Likewise, the stopcocks <NUM>, <NUM> may be color coded to correspond with a portion of the hemostasis valve <NUM>, <NUM> to which they are directly coupled.

The hemostasis valve <NUM> can include a body <NUM> and a valve member <NUM>. The valve member <NUM> can be coupled to the body <NUM> at a position at or adjacent a proximal end portion <NUM> of the body <NUM>. The valve member <NUM> may include a first sealable opening 1132a disposed through a first portion of the valve member <NUM>. The valve member <NUM> may also include a second sealable opening 1132b disposed through a second portion of the valve member <NUM>. As discussed herein, a hemostasis valve having two or more sealable openings may aid in access and/or treatment. In certain embodiments, the valve member <NUM> may include a third sealable opening, a fourth sealable opening, a fifth sealable opening, a sixth sealable opening, a seventh sealable opening, an eighth sealable opening, or more sealable openings.

With continued reference to <FIG>, the hemostasis valve <NUM> may further include a sidearm <NUM>. The sidearm <NUM> may include a sidearm lumen <NUM>, the sidearm lumen <NUM> extending through at least a portion of the sidearm <NUM>. In some embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a hemostasis valve lumen <NUM> of the hemostasis valve <NUM>. In various embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a second elongate member lumen <NUM> of the second elongate member <NUM>.

The first medical device <NUM> may also include a sidearm <NUM>. The sidearm <NUM> may include a sidearm lumen <NUM>, the sidearm lumen <NUM> extending through at least a portion of the sidearm <NUM>. In some embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a first medical device lumen <NUM> of the first medical device <NUM>. In certain embodiments, the sidearm lumen <NUM> may be in fluid communication with a lumen or a first elongate member lumen <NUM> of the first elongate member <NUM>. As shown, the first elongate member <NUM> may be coupled or releasably coupled to the sidearm <NUM> and the second elongate member <NUM> may be coupled or releasably coupled to the sidearm <NUM>.

As discussed above, the sidearm <NUM> may rotate independent of the sidearm <NUM>, for example, when the hemostasis valve <NUM> is coupled to the first medical device <NUM>. The hemostasis valve <NUM> may also be configured such that upon coupling of the hemostasis valve <NUM> to the first medical device <NUM>, the sidearm lumen <NUM> is not blocked by a portion of the hemostasis valve <NUM>. In various embodiments, each of the first and second elongate member lumens <NUM>, <NUM> may be in fluid communication with each of the first medical device lumen <NUM> and the hemostasis valve lumen <NUM> (e.g., when the first medical device <NUM> comprising the first elongate member <NUM> is coupled to the hemostasis valve <NUM> comprising the second elongate member <NUM>).

Methods of using the hemostasis valve systems and hemostasis valves are also disclosed herein. In some embodiments, a method of using a hemostasis valve system or hemostasis valve as disclosed herein may include displacing a first elongate medical device (e.g., a first guidewire) through a first sealable opening of the hemostasis valve. The method may further include displacing a second elongate medical device (e.g., a second guidewire) through a second sealable opening of the hemostasis valve.

In certain embodiments, the method of using the hemostasis valve system or hemostasis valve may include coupling the hemostasis valve to a valved medical device (e.g., another hemostasis valve) such that a lumen of the hemostasis valve is in fluid communication with a lumen of the valved medical device, and such that the hemostasis valve bypasses the valve of the valved medical device. In various embodiments, the hemostasis valve may be sealably coupled to the valved medical device.

Procedures wherein a hemostasis device having multiple sealable openings is coupled to a valved medical device during use of the valved medical device are within the scope of this disclosure. For instance, during a procedure wherein a single guidewire or other device is disposed within a single sealable opening valved medical device, a practitioner may desire placement of a second guidewire or medical device. Simply inserting a second guidewire or medical device through a standard sealable opening may cause blood loss, as the sealable opening is not configured to seal around two devices. Rather, such sealable openings may be configured to seal about the outside diameter of one medical device. <FIG> illustrate an exemplary procedure wherein a hemostasis valve having multiple sealable openings can be coupled to a valved medical device, without removing a device disposed within the valved medical device, while minimizing blood loss by only presenting one device outside diameter for the valved medical device to seal against.

<FIG> is view of a guidewire <NUM> and a valved medical device <NUM> (also referred to herein as a first medical device). As depicted, the valved medical device <NUM> can be a valved sheath introducer. Other valved medical devices are also within the scope of the present disclosure, for example, the valved medical device <NUM> may be a traditional hemostasis valve. As illustrated in <FIG>, the guidewire <NUM> may be introduced into the valved medical device <NUM> (e.g., through an opening and/or a valve of the valved medical device <NUM>). In some embodiments, the guidewire <NUM> may be introduced into the valved medical device <NUM> at a proximal end portion <NUM> of the valved medical device <NUM>. The guidewire <NUM> may then be displaced through the valved medical device <NUM> such that at least a portion of the guidewire <NUM> extends distal of a distal end portion <NUM> of the valved medical device <NUM>. In various embodiments, the guidewire <NUM> may be introduced through the valved medical device <NUM> from the distal end portion <NUM> to the proximal end portion <NUM>.

Upon disposition of the guidewire <NUM> within the valved medical device <NUM>, a distal end of the guidewire <NUM> may be disposed distal of the distal end portion <NUM> of the valved medical device <NUM> and a proximal end of the guidewire <NUM> may be disposed proximal of the proximal end portion <NUM> of the valved medical device <NUM>. In certain embodiments, at least the distal end of the guidewire <NUM> may be disposed within a patient (e.g., within a vasculature of the patient).

The valved medical device <NUM> may have a single sealable opening. However, as noted above, in some embodiments, a practitioner may desire to dispose more than one elongate medical device through the valved medical device <NUM>. Stated another way, the practitioner may desire to introduce two or more medical devices into a patient via the valved medical device <NUM>. Accordingly, the practitioner can use a hemostasis valve as provided herein. For example, the practitioner may use a hemostasis valve as discussed above, such as, but not limited to, hemostasis valves <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>.

<FIG> illustrates a hemostasis valve <NUM> and an insertion device <NUM>. In certain embodiments, the insertion device <NUM> may include an elongate member <NUM>, wherein a lumen <NUM> extends through at least a portion of the elongate member <NUM>. The insertion device <NUM> may also include a handle <NUM> disposed at a proximal end of the insertion device <NUM> and an opening <NUM> disposed at a distal end of the insertion device <NUM>. The handle <NUM>, as illustrated, may include one or more ridges or protrusions <NUM>. The handle <NUM> and/or the protrusions <NUM> can aide a practitioner in grasping the insertion device <NUM> (e.g., during use of the insertion device <NUM>).

The insertion device <NUM> can also include a side opening <NUM> disposed through a sidewall of the insertion device <NUM>. The side opening <NUM> can provide fluid communication between the lumen <NUM> and an exterior of the insertion device <NUM>. As depicted, the insertion <NUM> may also include a bend or curve portion <NUM>. The side opening <NUM> can be disposed at or adjacent the bend portion <NUM> such that at least a portion of an elongate medical device such as the guidewire <NUM> can be displaced from within the lumen <NUM>, through the side opening <NUM>, and to the exterior of the insertion device <NUM>. In certain embodiments, the insertion device <NUM> may also include a slit (not shown) extending through at least a portion of the side wall of the insertion device <NUM>, for example, between the opening <NUM> and the side opening <NUM>. The slit may be configured such that at least a portion of an elongate medical device such as the guidewire <NUM> can be displaced from within the lumen <NUM>, through the slit, and to the exterior of the insertion device <NUM>.

With continued reference to <FIG>, a distal end portion <NUM> of the insertion device <NUM> can be tapered. The tapered shape of the distal end portion <NUM> of the insertion device <NUM> may aide in or ease the introduction of the insertion device <NUM> into the hemostasis valve <NUM> and/or the valved medical device <NUM>. In some other embodiments, a distal end portion of an insertion device may not be tapered. In such an embodiment, an opening at a distal end of the insertion device may be larger than the opening <NUM> in the insertion device <NUM>, which includes a taper. Such larger openings may ease the insertion of the guidewire <NUM> through the opening and into the lumen of the insertion device.

The insertion device <NUM> can be configured to be disposed through at least a portion of the hemostasis valve <NUM>. In some embodiments, the hemostasis valve <NUM> may include two or more sealable openings (see, e.g., <FIG> depicting the hemostasis valve <NUM> including the first sealable opening 1132a and the second sealable opening 1132b). The practitioner may dispose the insertion device <NUM> through a desired sealable opening of the hemostasis valve <NUM>. For example, with reference to <FIG>, the practitioner may dispose the insertion device <NUM> through either one of the first or second sealable openings 1132a, 1132b.

In <FIG>, the insertion device <NUM> has been disposed through at least a portion of the hemostasis valve <NUM> such that the handle <NUM> is disposed proximal of the hemostasis valve <NUM> and the opening <NUM> is disposed distal of the hemostasis valve <NUM>. <FIG> also depicts the guidewire <NUM> that has been displaced through at least a portion of the valved medical device <NUM>.

As illustrated in <FIG>, the practitioner may dispose a proximal end of the guidewire <NUM> through the opening <NUM> and into the lumen <NUM> of the insertion device <NUM>. At least a portion of the guidewire <NUM> may then be displaced through the lumen <NUM> and may exit the lumen <NUM> at the side opening <NUM> of the insertion device <NUM>. The insertion device <NUM> can ease the displacement of the guidewire <NUM> through the hemostasis valve <NUM>. For example, it may be difficult to dispose the guidewire <NUM> through at least a portion of the hemostasis valve <NUM> (e.g., through a sealable opening, a lumen, or another portion of the hemostasis valve <NUM>) without a device such as the insertion device <NUM>. The distal and/or the proximal end portions of the guidewire <NUM> may be configured to be atraumatic, for example, the distal and/or the proximal end portions of the guidewire <NUM> may be easily bendable (e.g., flexible or not rigid).

<FIG> illustrates that the hemostasis valve <NUM> may be coupled to the valved medical device <NUM>, for example, when the guidewire <NUM> and/or the insertion device <NUM> are disposed through the hemostasis valve <NUM> and the valved medical device <NUM>. As shown in the <FIG>, the insertion device <NUM> may be displaced from within the hemostasis valve <NUM> and/or the valved medical device <NUM>, for example, as indicated by the arrow. Furthermore, the guidewire <NUM> may remain disposed within each of the hemostasis valve <NUM> and the valved medical device <NUM> as the insertion device is removed from the around the guidewire <NUM> and from within each of the hemostasis valve <NUM> and the valved medical device <NUM>. In some embodiments, the insertion device <NUM> may be removed from the around the guidewire <NUM> prior to the coupling of the hemostasis valve <NUM> and the valved medical device <NUM>.

With continued reference to <FIG>, methods of disposing elongate medical devices, such as the guidewire <NUM>, through a hemostasis valve may include, introducing at least a portion of the insertion device <NUM> through a first sealable opening of the hemostasis valve <NUM>. The methods may also include, obtaining the guidewire <NUM>, wherein at least a portion of the guidewire <NUM> is disposed through the valved medical device <NUM>. As noted above, the procedure depicted in <FIG> resulting in coupling of the hemostasis valve <NUM> to the valved medical device <NUM>, without removing the guidewire <NUM> from the valved medical device <NUM> and while only presenting one outside diameter (either the guidewire <NUM> or the insertion device <NUM>) at a time to any sealable opening (either in the valved medical device <NUM> or the hemostasis valve <NUM>).

In some embodiments, the methods may include inserting the proximal end of the guidewire <NUM> through the opening <NUM> at the distal end of the insertion device <NUM>. Furthermore, at least a portion of the guidewire <NUM> may be displaced through at least a portion of the insertion device <NUM> such that the proximal end of the guidewire <NUM> is disposed proximal of each of the hemostasis valve <NUM> and the valved medical device <NUM>. The hemostasis valve <NUM> may also be coupled to the valved medical device <NUM>, or vice versa. In various embodiments, when the hemostasis valve <NUM> is coupled to the valved medical device <NUM> a lumen of the hemostasis valve <NUM> may be in fluid communication with a lumen of the valved medical device <NUM> and the hemostasis valve <NUM> may bypass a valve of the valved medical device <NUM>.

In certain embodiments, methods of disposing the guidewire <NUM> through the hemostasis valve <NUM> may include displacing the proximal end of the guidewire <NUM> through the side opening <NUM> disposed adjacent a proximal portion of the insertion device <NUM>. Additionally, the insertion device <NUM> can be removed or retrieved from within the hemostasis valve <NUM> such that the guidewire <NUM> remains disposed through each of the hemostasis valve <NUM> and the valved medical device <NUM>. In some embodiments, the methods may also include inserting a second guidewire through a second sealable opening of the hemostasis valve <NUM> and displacing the second guidewire through each of the hemostasis valve <NUM> and the valved medical device <NUM>.

In various embodiments, a practitioner may dispose the insertion device <NUM> through a first sealable opening or a second sealable opening of the hemostasis valve <NUM>. The practitioner may displace the insertion device <NUM> along a proximal portion of a first guidewire that is disposed through the valved medical device <NUM>. The practitioner may then remove or retrieve the insertion device <NUM> from within the hemostasis valve <NUM> when the first guidewire is disposed through each of the hemostasis valve <NUM> and the valved medical device <NUM>.

In some embodiments, the practitioner may couple (e.g., sealably couple) the hemostasis valve <NUM> to the valved medical device <NUM>. Furthermore, the practitioner may dispose a second guidewire through the second sealable opening when the first guidewire is disposed through the first sealable opening or dispose the second guidewire through the first sealable opening when the first guidewire is disposed through the second sealable opening. In some embodiments, the hemostasis valve <NUM> may include three or more sealable openings, as discussed above. In such a configuration, the practitioner may dispose three or more elongate medical devices, such as guidewires, through the hemostasis valve.

<FIG> depicts a use of a hemostasis valve system. The hemostasis valve system may include the hemostasis valve <NUM> and the insertion device <NUM>. As depicted, the hemostasis valve <NUM> can be coupled to the valved medical device <NUM>. The insertion device <NUM> can be disposed through each of the hemostasis valve <NUM> and the valved medical device <NUM>. As such, the insertion device <NUM> can aide in the disposition of the guidewire <NUM>, or another suitable elongate medical device, through at least a portion of each of the hemostasis valve <NUM> and the valved medical device <NUM>.

Additional methods and/or method steps can be derived from <FIG> and the corresponding disclosure. Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification, such as by use of the term "substantially. " For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as "about" and "substantially" are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term "substantially sealed" is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely sealed configuration.

Similarly, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.

Claim 1:
A hemostasis valve system (<NUM>; <NUM>) comprising:
a hemostasis valve (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) including:
a body (<NUM>; <NUM>; <NUM>; <NUM>) including a valve bypass portion (<NUM>), wherein the valve bypass portion (<NUM>) is configured to couple the hemostasis valve to a valved medical device (<NUM>; <NUM>; <NUM>);
a valve member (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) coupled to the body, the valve member including:
a first sealable opening (132a; 232a; 332a; 432a; 632a; 732a; <NUM>; <NUM>; 1032a; 1132a) disposed through a first portion of the valve member; and
a second sealable opening (132b; 232b; 332b; 432b; 632b; 732b; <NUM>'; <NUM>'; 1032b; 1132b) disposed through a second portion of the valve member; and
a hemostasis valve lumen (<NUM>: <NUM>; <NUM>) extending between a proximal end portion (<NUM>; <NUM>; <NUM>) and a distal end portion (<NUM>; <NUM>; <NUM>) of the hemostasis valve; and
an insertion device (<NUM>) including:
an elongate member (<NUM>);
a side opening (<NUM>) disposed through a sidewall of the elongate member; and
a lumen (<NUM>) extending from a distal end of the elongate member and through a portion of the elongate member, wherein the insertion device (<NUM>) is configured to be disposed through the first and second sealable openings of the hemostasis valve.