Patent Description:
In minimally invasive surgery, small incisions are created through a blood vessel which one or several catheters are inserted. Each of these one or several catheters can define a lumen extending longitudinally through that catheter. These catheters are moved to a position proximate to tissue, nerves, or other body structures targeted by the surgery, and then tools for performing the procedure are inserted through the lumens of some or all of these catheters.

To minimize blood loss, prevent delivery of air into the vasculature, and to facilitate maintenance of sterility within the patient's body (e.g., blood vessel), these catheters are equipped with hemostasis valves. These valves seal or selectably seal the lumens of the catheters. In many instances, these valves can seal the lumen of the catheter when a tool extends through the catheter, and specifically through the valve. Additionally the valves can seal the lumen when a tool is removed or does not extend through the catheter.

<CIT> describes selective fluid barrier valve devices and methods of treatment. An example comprises a housing, an actuator, a sleeve, a wire member, and a connector. The sleeve defines a passageway that extends through the sleeve. The actuator is moveable between a first position and a second position. When the actuator is in the first position, the sleeve is in a first configuration such that fluid can pass through the passageway defined by the sleeve. When the actuator is in a second position, the sleeve is in a second configuration such that fluid is prevented from passing through the passageway defined by the sleeve.

<CIT> describes an access valve for a laparoscopic device or a intraluminal deployment device, having a cylindrical diaphragm with a longitudinal aperture. A flexible member is passed circumferentially around the cylindrical diaphragm and an extension arrangement to pull the flexible member radially and/or tangentially to constrict the diaphragm to at least partially close off the longitudinal aperture.

<CIT> is directed to a sealing apparatus for sealing around a medical instrument, the sealing apparatus comprising a housing body; a two-piece cam body disposed inside the housing body; a sealing member disposed inside the cam body and having a channel extending axially of the cam body, the sealing member having at least two protrusions disposed around the channel; a plurality of pins operable to engage with the protrusions of the sealing member for movement relative to the cam body to radially compress the sealing member against and form a seal around the medical instrument; and biasing means for compressing the sealing member. In one aspect of the invention, the biasing means includes a first finger tab fixed to and extending laterally from the housing body, a second finger tab operatively associated with the cam body for movement relative to the housing body, the second finger tab extending laterally from the housing body in apposition to the first finger tab, and a spring being disposed between the first and second finger tabs to normally force the finger tabs apart.

While such traditional hemostasis valves are greatly beneficial for intravascular access, they have some drawbacks. For example, some valves may not seal adequately for all interventional applications or tools, and/or the operation of some valves may be complicated for operator use. The drawbacks of such valve designs may in turn increase the complexity of any surgery performed therewith and/or reduce patient safety (e.g., bleeding, infection, and/or other detrimental complications). Accordingly, new and improved hemostasis valves and methods of use are desired.

The invention is set out in the appended claims, with various examples to illustrate the invention and/or provide context set out below.

The following relates to valves, medical systems incorporating valves, and methods of using the same. The valve can include a tubular member that can be constricted, collapsed, and/or sealed by one or several tensioning mechanisms. The tensioning mechanism can include at least one filament that extends around at least a portion of the tubular member. The filament can interact with the tubular member to constrict, collapse, and/or seal the tubular member via manipulation of the tensioning mechanism(s). A tool can be inserted through the valve to gain access to a patient's body and specifically to gain access to a blood vessel. Through the use of the tensioning mechanism and filament to constrict, collapse, and/or seal the tubular member, the valve can seal around a wide range of tool sizes and shapes, as well as multiple tools of differing sizes simultaneously. Additionally, such a valve creates a robust seal that maintains its seal when a vacuum is applied such as occurs during aspiration.

Aspects of the present disclosure relate to a hemostatic valve for sealing a medical device. The hemostatic valve includes an elongate member having a first end, a second end, and a central lumen extending therebetween. The elongate member is pliable. The hemostatic valve includes a reinforcement structure extending along at least a portion of the elongate member, such that the reinforcement structure is coupled to the elongate member. The hemostatic valve includes an active tensioning mechanism coupled to the elongate member. The tensioning mechanism is moveable between a first configuration in which the central lumen is constricted and sealed and a second configuration in which the central lumen is open. Optionally, the valve may be manually adjusted by the user to intermediate positions between fully open and fully closed. Additionally, an instrument (e.g. catheter) may provide an intermediate position where the valve creates hemostasis without user adjustment.

In some embodiments, the elongate member can be a compliant polymer tube. In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the elongate member. In some embodiments, the reinforcement structure is positioned between the at least one filament and the elongate member. In some embodiments, the reinforcement structure can be a braided mesh. In some embodiments, the reinforcement structure is coupled to the elongate member at a position proximate to the first end of the elongate member and at a position proximate to the second end of the elongate member. In some embodiments, the reinforcement structure is not coupled to the elongate member at a position between the first end of the elongate member and the second end of the elongate member. In some embodiments, the central portion of the compliant polymer tube that is constrained or collapsed by the tensioning mechanism, and at least one filament, is not coupled to the reinforcement structure.

The tensioning mechanism includes an actuator coupled to the at least one filament. In some embodiments there are two tensioning mechanisms coupled to the at least one filament that operate in opposite directions. In some embodiments the two tensioning mechanisms are attached to the same filament. In some embodiments the two tensioning mechanisms are attached to opposing filaments. In some embodiments, the actuator can be moveable to control movement of the at least one filament from a first position in which the central lumen is constricted and sealed to a second position in which the central lumen is open. In some embodiments, the at least one filament is in the first position when the tensioning mechanism is in the first configuration. The actuator is biased towards the first position. In some embodiments, the actuator can be a manual actuator.

In some embodiments, the at least one filament forms a loop around the elongate member. In some embodiments, the at least one filament forms a bight around a portion of the elongate member. In some embodiments, the at least one filament can include a first filament and a second filament. In some embodiments, each of the first filament and the second filament are coupled to the same actuator. In some embodiments, each of the first filament and the second filament are coupled to different actuators. In some embodiments, the first filament and the second filament are moveable from the first position to the second position. In some embodiments, each of the first filament and the second filament form a loop around the elongate member. In some embodiments, the first filament forms a first bight around a first portion of the elongate member, and the second filament forms a second bight around a second portion of the elongate member. In some embodiments, the first bight extends through the second bight.

In some embodiments, the hemostatic valve can include a shell defining a first aperture and a second aperture. In some embodiments, the elongate member extends from the first aperture to the second aperture and fluidly couples the first aperture and the second aperture. In some embodiments, the tensioning mechanism is self-adjustable to seal around tools of different sizes extending through the hemostatic valve. In some embodiments, the central lumen can comprise a single lumen, and in some embodiments, the central lumen can comprise a plurality of lumens.

One aspect of the present disclosure relates to a delivery system for intravascular access of a blood vessel within a patient's body. The delivery system includes a catheter having a first end, a second end, and a catheter lumen extending therebetween and a hemostatic valve coupled to the first end of the catheter. The hemostatic valve includes a tubular member having a first end, a second end, and a central lumen extending therebetween. In some embodiments, the central lumen of the tubular member is fluidly coupled with the catheter lumen. The hemostatic valve includes an active tensioning mechanism coupled to the tubular member, the tensioning mechanism can be moveable between a first configuration in which the tensioning mechanism constricts on the central lumen and the central lumen is sealed and a second configuration in which the central lumen is open.

In some embodiments, the hemostatic valve further includes a reinforcement structure extending along at least a portion of the tubular member. In some embodiments, the reinforcement structure is located between the tensioning mechanism and the tubular member. In some embodiments, the reinforcement structure can be a braided mesh. In some embodiments, the reinforcement structure is coupled to the tubular member at a position proximate to the first end of the tubular member and at a position proximate to the second end of the tubular member. In some embodiments, the reinforcement structure is adhered to the tubular member at the first end of the tubular member and at the second end of the tubular member. In some embodiments, the reinforcement structure is uncoupled to the tubular member between the first end of the tubular member and the second end of the tubular member.

In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the tubular member. In some embodiments, the tensioning mechanism can include an actuator coupled to the at least one filament. In some embodiments, moving the tensioning mechanism from the first configuration to the second configuration can include moving the actuator and the thereto coupled at least one filament from a first position to a second position. In some embodiments, the filament constricts and seals the central lumen of the tubular member when the filament is in the first position.

In some embodiments, the actuator can be a manual actuator. In some embodiments, the actuator can include a pair of opposing and depressable buttons, which buttons can be biased towards an undepressed position. In some embodiments, the central lumen is sealed when the buttons are in the undepressed position. In some embodiments, the filament can be a monofilament. In some embodiments, the filament can be at least one of: a polymer filament; or a metallic filament. In some embodiments, the catheter can include a thrombus extraction device.

One aspect of the present disclosure relates to a method of sealing a delivery device accessing a blood vessel of a patient. The method includes inserting the delivery device including a catheter and a hemostatic valve into the blood vessel of the patient. In some embodiments, the catheter can have a first end, a second end, and a catheter lumen extending therethrough. In some embodiments, the hemostatic valve can be coupled to the first end and can have a tubular member defining a central lumen fluidly coupled with the catheter lumen and a tensioning mechanism coupled with the tubular member. In some embodiments, the tensioning mechanism collapses and seals the central lumen in a first configuration and thereby seals access to the blood vessel. The method can include moving the tensioning mechanism of the hemostatic valve to a second configuration. In some embodiments, the central lumen is open and access to the blood vessel is unsealed when the tensioning mechanism is in the second configuration. The method can include advancing a shaft of a tool through the delivery device until a first end of the tool reaches a desired position within the blood vessel of the patient and a portion of the shaft is positioned within the central lumen of the tubular member. The method can include returning the tensioning mechanism of the hemostatic valve to the first configuration such that the tubular member collapses on the shaft of the tool and seals around the shaft of the tool.

In some embodiments, the method includes retracting the shaft of the tool from the delivery device. In some embodiments, the tensioning mechanism is maintained in the first configuration during and after the retracting of the shaft of the tool from the delivery device. In some embodiments, the tensioning mechanism is moved to the second configuration during the retracting of the shaft of the tool from the delivery device, and the tensioning mechanism is returned to the first configuration after the shaft of the tool is retracted from the delivery device.

In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the tubular member. In some embodiments, the at least one filament collapses the tubular member when the tensioning mechanism is in the first configuration. In some embodiments, the at least one filament circumferentially constricts the tubular member to collapse the tubular member when the tensioning mechanism is in the first configuration. In some embodiments, the hemostatic valve can include a reinforcement structure located between the at least one filament and the tubular member.

In some embodiments, the at least one filament forms a loop around the elongate member, and moving the tensioning mechanism from the second configuration to the first configuration reduces a size of the loop to thereby constrict the tubular member within the loop. In some embodiments, the filament forms at least one bight around a portion of the elongate member. In some embodiments, the filament can include a first filament and a second filament. In some embodiments, the at least one bight can include a first bight oriented in a first direction and formed by the first filament and a second bight oriented in a second direction and formed by the second filament. In some embodiments, the first and second bights overlap to encircle a portion of the tubular member within a constricting area.

In some embodiments, moving the tensioning mechanism from the second configuration to the first configuration can include moving the first bight in the first direction and the second bight in the direction to reduce the size of the constricting area and collapse and seal the central lumen of the tubular member. In some embodiments, the tensioning mechanism can include an actuator. In some embodiments, moving the tensioning mechanism to the second configuration can include manipulating the actuator. In some embodiments, the method includes applying a vacuum to the delivery device and/or delivery system to aspirate material through the catheter. In some embodiments, the central lumen remains sealed during the aspiration. In some embodiments, the tool can include a thrombus extraction device.

The present disclosure relates to a valve that can be used a hemostasis valve. This valve, also referred to herein as a garrote valve can seal with or without a tool extending through the valve. The garrote valve provides convenient, single-handed operation for a wide range of medical devices including catheters, wires, embolectomy systems, or the like. This single-handed operation of the garrote valve allows the user to easily and quickly swap different tools being used through the valve without compromising hemostasis and therefore simplifying the procedure. Combined with single-handed operation, the garrote valve provides robust sealing either with or without a tool extending through the valve. This robust sealing minimizes leakage in applications with a pressure differential on different sides of the valve. This pressure differential can arise, for example, during the application of vacuum aspiration in a procedure. Even under such conditions, as well as under other conditions, the garrote valve maintains seal integrity and prevents leakage in one or both directions.

The garrote valve includes a tubular member. The tubular member is a flexible member that defines a central lumen, which can, in some embodiments, define a single lumen, and in some embodiments, defines a plurality of lumens. In some embodiments, each of the plurality of lumens can comprise the same size and shape, and in some embodiments, some or all of the plurality of lumens can comprise different sizes and shapes. In some embodiments, for example, the plurality of lumens can comprise a lumen sized and/or shaped to receive a guide wire and a lumen sized and/or shaped to receive a tool. The tubular member extends at least partially through a constricting mechanism. The constricting mechanism can be moved from a first configuration to a second configuration, and the constricting mechanism can collapse and/or seal the central lumen of the tubular member when the constricting mechanism is in the first configuration. The constricting mechanism creates the above-discussed robust seal of the tubular member and thus of the valve.

With reference now to <FIG>, a perspective view of one embodiment of a delivery system <NUM>, also referred to herein as a delivery device <NUM>, is shown. The delivery system <NUM> can include a catheter <NUM> and a garrote valve <NUM>, also referred to herein as valve <NUM>. The catheter <NUM> can comprise a shaft <NUM>, also referred to herein as an elongate sheath <NUM>, having a proximal end <NUM>, also referred to herein as a first end <NUM>, that can connect to the valve <NUM> and a distal end <NUM>, also referred to herein as a second end <NUM>. The shaft <NUM> can define a catheter lumen <NUM> extending from the proximal end <NUM> of the shaft <NUM> to the distal end <NUM> of the shaft <NUM>. The catheter <NUM> and specifically the shaft <NUM> can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the catheter <NUM> can be flexible and/or can be made from a biocompatible material. The elongate sheath <NUM> can have an outer diameter of at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, at least <NUM> French, between <NUM> French and <NUM> French, between <NUM> French and <NUM> French, between <NUM> French and <NUM> French, and/or any other or intermediate size.

The valve <NUM> can include an outer shell <NUM>. The outer shell <NUM> can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the outer shell <NUM> can be made from one or several polymers or composites. The outer shell <NUM> can include features that allow interaction with and/or control of the valve <NUM> to move the valve <NUM> between the first configuration and the second configuration.

The outer shell <NUM> can include a proximal cap <NUM> located at a proximal end <NUM> of the outer shell <NUM> and a distal cap <NUM> located at a distal end <NUM> of the shell <NUM>. The proximal cap <NUM> can include and/or house a proximal aperture <NUM>, also referred to herein as a proximal channel <NUM>, a first channel <NUM>, or a first aperture <NUM>, that extends through the proximal cap <NUM>, and the distal cap <NUM> can include and/or house a distal aperture <NUM>, also referred to herein as a distal channel <NUM>, a second channel <NUM>, or second aperture <NUM>, that extends through the distal cap <NUM>. As seen in <FIG>, the distal cap <NUM> connects to the shaft <NUM> of the catheter <NUM> at the distal end <NUM> of the valve <NUM>.

The proximal cap <NUM> and the distal cap <NUM> are connected via a housing <NUM>. The housing <NUM> can be a one-piece housing <NUM> or a multi-piece housing <NUM>. In the embodiment depicted in <FIG>, the housing comprises a two-piece housing <NUM>. The housing <NUM> can be configured to receive and couple with each of the proximal cap <NUM> and the distal cap <NUM>, and as seen in <FIG>, the housing <NUM> is coupled with each of the proximal cap <NUM> and the distal cap <NUM> to secure the relative position of the proximal cap <NUM> and the distal cap <NUM> with respect to each other.

The housing <NUM> can define an interior channel <NUM> through which an elongate member <NUM>, also referred to herein as a tubular member <NUM>, a septum <NUM>, or a tubular septum <NUM>, can extend and connect the proximal cap <NUM> and the distal cap <NUM>. The elongate member <NUM> can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the elongate member <NUM> can comprise a compliant tubular structure that can be, for example, a thin-walled compliant tubular structure. The thin-walled structure of the elongate member <NUM> can facilitate the collapse, and specifically the uniform collapse of the elongate member <NUM> and the sealing of the elongate member <NUM>. In some embodiments, the elongate member <NUM> is an elastic, resilient material that may comprise a polymer including either a natural or synthetic polymer. In some embodiments, the elongate member can comprise an elastic, resilient material that may comprise silicone, urethane, ethylene-vinyl acetate, natural or synthetic rubber or other elastomers known in the art. In some embodiments, the elongate member <NUM> can comprise a silicone tube.

The elongate member <NUM> can comprise a proximal end <NUM>, also referred to herein as a first end <NUM>, that can couple to the proximal cap <NUM>, and a distal end <NUM>, also referred to herein as a second end <NUM>, that can couple to the distal cap <NUM>. The elongate member <NUM> can define a central lumen <NUM> that can extend from the first end <NUM> to the second end <NUM> of the elongate member <NUM>. The elongate member <NUM> can be coupled to the proximal cap <NUM> such that the central lumen <NUM> is fluidly coupled with the proximal aperture <NUM> of the proximal cap <NUM>, and the elongate member <NUM> can be coupled to the distal cap <NUM> such that the central lumen <NUM>, as seen in <FIG> and in <FIG>, is fluidly coupled with the distal aperture <NUM> of the distal cap <NUM>.

The central lumen <NUM> of the elongate member <NUM> can be defined by a wall of the elongate member <NUM> that can have a thickness that is uniform along the length of the elongate member <NUM> between the first end <NUM> and the second end <NUM>, or that is non-uniform along the length of the elongate member <NUM> between the first end <NUM> and the second end <NUM>. In some embodiments, the wall can have a thickness that is approximately between <NUM> inches and <NUM> inches, and/or approximately between <NUM> inches and <NUM> inches (<NUM> inch = <NUM>). As used anywhere herein, "approximately" refers to a range of +/- <NUM>% of the value and/or range of values for which "approximately" is used.

In some embodiments, the elongate member <NUM> can be cylindrically shaped, and specifically can be circular-cylindrically shaped. In some embodiments, the elongate member <NUM> can be dog-bone shaped to facilitate, for example, connection to each of the proximal cap <NUM> and the distal cap <NUM>. In some embodiments, the elongate member <NUM> can include one or several outward-extending protuberances that engage with all or portions of a constricting mechanism <NUM>, also referred to herein as a tensioning mechanism <NUM>, of the valve <NUM> to secure a position of all or portions of the constricting mechanism <NUM> with respect to the elongate member <NUM>. In some embodiments, the constricting mechanism <NUM> can be self-adjusting to seal around tools of different sizes extending through the valve <NUM>.

The constricting mechanism <NUM> can, in some embodiments, collapse and seal the elongate member <NUM> via compression and/or constriction, and specifically via constriction with at least one filament <NUM>. The constricting mechanism <NUM> can comprise: an actuator <NUM> which can be a manual actuator such as one or several buttons <NUM>; and the at least one filament <NUM> that can extend at least partially around the elongate member <NUM>. In some embodiments, the use of the constricting mechanism <NUM> can facilitate sealing of the valve around tools or instruments of a wide range of sizes and/or diameters, and particularly around tools or instruments that fit through the elongate member <NUM>.

The housing <NUM> can further include one or several retention features <NUM>. The one or several retention features <NUM> of the housing can engage with and retain all or portions of the constricting mechanism <NUM> of the valve <NUM>. In some embodiments, the one or several retention features <NUM> of the housing <NUM> can retain the actuator <NUM> and/or can couple the actuator <NUM> to the housing <NUM>. The actuator <NUM> can comprise any desired type of actuator including, for example, a manual actuator and/or an automated actuator such as, for example, an electromechanical actuator including a solenoid-based actuator. In some embodiments, the actuator can comprise one or several buttons <NUM>, and specifically, as depicted in <FIG>, the actuator <NUM> can comprise a first button <NUM>-A and a second button <NUM>-B. Alternatively, and as depicted in <FIG>, the actuator <NUM> can comprise a single button <NUM>. In such an embodiment, the filament <NUM> can be coupled to the single button <NUM> and to a portion of the housing <NUM> such as, for example, to grip portion <NUM> of the housing <NUM> such that the movement of the single button <NUM> causes the sealing and/or opening of the elongate member <NUM> and of the valve <NUM>.

The actuator <NUM> can be biased towards a configuration such as, for example, biased towards the first configuration or biased towards the second configuration. As depicted in <FIG>, which shows the constricting mechanism <NUM> in the first configuration, the actuator <NUM> can be biased towards the first configuration wherein the elongate member <NUM> is collapsed and/or sealed by a bias feature <NUM>. In this first configuration, the buttons <NUM> can be in a first position, also referred to herein as an undepressed position. This bias feature <NUM> can, as shown in <FIG>, include a first spring <NUM>-A configured to bias the first button <NUM>-A towards the first position corresponding to the first configuration of the constricting mechanism <NUM>, and a second spring <NUM>-B configured to bias the second button <NUM>-B towards a first position corresponding to the first configuration of the constricting mechanism <NUM>. One or both of the first spring <NUM>-A and the second spring <NUM>-B can comprise a tension spring, compression spring, a torsion spring, a coil spring, or any other desired type of spring.

In some embodiments, one or both of the first spring <NUM>-A and the second spring <NUM>-B can generate sufficient force so as to allow actuation of the actuator <NUM> with a single hand and so as to collapse and seal the elongate member <NUM> when the constricting mechanism <NUM> is in the first configuration. In some embodiments, one or both of the first spring <NUM>-A and the second spring <NUM>-B can generate a force of: at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pound, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, at least <NUM> pounds, and/or at least <NUM> pounds and in some embodiments one or both of the first spring <NUM>-A and the second spring <NUM>-B can generate a force approximately between: <NUM> and <NUM> pounds, <NUM> and <NUM> pounds, <NUM> and <NUM> pounds, <NUM> and <NUM> pounds, and/or <NUM> and <NUM> pounds (<NUM> pound = <NUM>).

The constricting mechanism <NUM> can include at least one filament <NUM> that extends at least partially around the elongate member <NUM>. In some embodiments, the at least one filament <NUM> can circumferentially constrict the elongate member <NUM> to collapse and seal the elongate member <NUM> when the constricting mechanism <NUM> is in the first configuration. The filament can be made from a variety of materials including, for example, a polymer, a synthetic, and/or a metal. In some embodiments, the filament <NUM> can be nylon, stainless steel, nitinol, silicone, or the like. In some embodiments, the filament can comprise a single strand such as, for example, a monofilament, and in some embodiments, the filament can comprise a plurality of strands that can be, for example, twisted, woven, grouped, and/or fused to form the filament. In some embodiments, the filament <NUM> can comprise one or several threads, lines, cords, rope, ribbon, flat wire, sheet, or tape.

The filament <NUM> can be coupled to the actuator <NUM> such that the filament <NUM> selectively constricts, collapses, and/or seals the elongate member <NUM>, and specifically the central lumen <NUM> of the elongate member <NUM> based on the movement and/or position of the actuator <NUM>. In some embodiments, the filament <NUM> can be connected to one or both of the buttons <NUM>-A, <NUM>-B such that the filament <NUM> collapses, constricts, and/or seals the elongate member <NUM> and specifically the central lumen <NUM> of the elongate member <NUM> when the buttons <NUM>-A, <NUM>-B are in the first position, and the filament <NUM> can be connected to one or both of the buttons <NUM>-A, <NUM>-B such that the elongate member <NUM> and specifically the central lumen <NUM> of the elongate member <NUM> is open and uncollapsed when the buttons <NUM>-A, <NUM>-B are in the second position. In some embodiments in which the actuator <NUM> comprises a single button <NUM>, as depicted in <FIG>, the filament <NUM> can be connected to the button <NUM> and to the housing <NUM> such that the filament <NUM> is tightened when the button <NUM> moves to the first position.

In some embodiments, the at least one filament <NUM> can extend along an axis <NUM> that can be perpendicular to a central axis <NUM> of the elongate member <NUM> and/or of the apertures <NUM>, <NUM>. In some embodiments, the axis <NUM> of the at least one filament <NUM> can intersect and be perpendicular to the central axis <NUM> of the elongate member <NUM> and/or of the apertures <NUM>, <NUM>. In some embodiments, the actuator <NUM>, and specifically the buttons <NUM>-A, <NUM>-B can move along this axis <NUM> when moved from the first position to the second position.

In <FIG>, an embodiment of the valve <NUM> with the constricting mechanism <NUM> in the second configuration is shown. As specifically shown, both of the first and second buttons <NUM>-A, <NUM>-B are in the second position, depressed into the retention features <NUM> of the housing <NUM>. In this second position, the filament <NUM> is loosened, thereby allowing the expansion of the elongate member <NUM> and the unsealing of the central lumen <NUM> of the elongate member <NUM>.

As further seen in <FIG>, the proximal cap <NUM> has a proximal end <NUM> and a distal end <NUM>. The proximal cap <NUM> can include a funnel portion <NUM> of the proximal aperture <NUM>, which funnel portion <NUM> can facilitate insertion of a tool into the proximal aperture <NUM>. The distal end <NUM> of the proximal cap <NUM> can partially extend into the interior channel <NUM> of the housing <NUM>. The proximal cap <NUM> can include a mating feature <NUM> that can mate with the proximal end <NUM> of the elongate member <NUM>. In some embodiments, the proximal end <NUM> of the elongate member <NUM> can fit over the mating feature <NUM> of the proximal cap <NUM>. The proximal end <NUM> of the elongate member <NUM> can be compressed between the mating feature <NUM> of the elongate member <NUM> and a portion of the interior channel <NUM> of the housing <NUM> into which the mating feature <NUM> is inserted to thereby secure the proximal end <NUM> of the elongate member <NUM> on the mating feature <NUM>. In some embodiments, the proximal end <NUM> of the elongate member <NUM> can be further secured on the mating feature <NUM> by a proximal O-ring <NUM> that can be compressed between the housing <NUM> and the mating feature <NUM> of the proximal cap <NUM> to sealingly couple the elongate member <NUM> to the proximal cap <NUM>.

The distal cap <NUM> has a proximal end <NUM> and a distal end <NUM>. The distal cap can include a mating feature <NUM> located on the proximal end <NUM> of the distal cap <NUM>, which mating feature <NUM> can mate with the distal end <NUM> of the elongate member <NUM>. In some embodiments, the distal end <NUM> of the elongate member <NUM> can fit over the mating feature <NUM> of the distal cap <NUM>. The distal end <NUM> of the elongate member <NUM> can be compressed between the mating feature <NUM> of the elongate member <NUM> and a portion of the interior channel <NUM> of the housing <NUM> into which the mating feature <NUM> is inserted to thereby secure the distal end <NUM> of the elongate member <NUM> on the mating feature <NUM>. In some embodiments, the distal end <NUM> of the elongate member <NUM> can be further secured on the mating feature <NUM> by a distal O-ring <NUM> that can be compressed between the housing <NUM> and the mating feature <NUM> of the proximal cap <NUM> to sealingly couple the elongate member <NUM> to the distal cap <NUM>.

The distal cap <NUM> can, in some embodiments, further include a side port barb <NUM> that can extend laterally away from the distal cap <NUM> and specifically away from the distal aperture <NUM> of the distal cap <NUM>. The side port barb <NUM> can define a side port channel <NUM> that can extend through the side port barb <NUM> and fluidly connect to the distal aperture <NUM>. In some embodiments, the side port barb <NUM> can include a securement feature <NUM> such as a barb that can secure coupling of a hose or tube to the side port barb <NUM>.

In some embodiments, the side barb <NUM> can be used to apply a vacuum to the portions of the delivery device <NUM>, and particularly to portions of the delivery device <NUM> that are distal of the axis <NUM> along which the elongate member <NUM> seals. This vacuum can be applied to aspirate a material through the delivery device <NUM>, and specifically through the catheter <NUM> of the delivery device. This aspirated material can be a biological material including, for example, bodily fluids, multi-phase bodily materials that can include, for example, a fluidic portion and at least one solid portion, or the like.

In some embodiments, due to the narrowing shape of the elongate member <NUM> when the constricting mechanism <NUM> is in the first configuration, a vacuum applied to the portions of the delivery device <NUM> distal to the axis <NUM> draws the elongate member <NUM> towards the first configuration and can, in some embodiments, increase the strength, robustness, and/or strength of the seal of the valve <NUM>. This attribute of the valve <NUM> can provide benefits over other valve designs in which a vacuum can compromise the seal of the valve, and thus the ability to draw a vacuum and aspirate can be limited.

In some embodiments, the valve <NUM> can further include a reinforcement structure <NUM> that can extend along all or portions of the elongate member <NUM>. The reinforcement structure <NUM> can facilitate the uniform collapse of the elongate member <NUM>, can prevent the at least one filament <NUM> from cutting through and/or tearing the elongate member <NUM>, and can assist in guiding one or several tools through the elongate member <NUM>. The reinforcement structure <NUM> can be tubular, can extend along and around the elongate member <NUM>, and can be positioned so as to be between the elongate member <NUM> and the at least one filament <NUM>.

The reinforcement structure <NUM> can include a proximal end <NUM> and a distal end <NUM>. In some embodiments, the reinforcement structure <NUM> extends along and around the elongate member <NUM>, and is positioned such that the proximal end <NUM> of the reinforcement structure <NUM> is proximate to the first end <NUM> of the elongate member <NUM> and the distal end <NUM> of the reinforcement structure <NUM> is proximate to the second end <NUM> of the elongate member <NUM>.

The reinforcement structure <NUM> can be coupled to the elongate member <NUM>. In some embodiments, the reinforcement structure <NUM> is coupled to the elongate member <NUM> along the length of the reinforcement structure <NUM>, and in some embodiments, the reinforcement structure <NUM> is coupled to the elongate member <NUM> and distinct positions along the length of the elongate member <NUM> and/or the reinforcement structure <NUM>. In one embodiment, for example, the reinforcement structure <NUM> can be coupled to the elongate member <NUM> at one or both of the proximal end <NUM> of the reinforcement structure <NUM> and the distal end <NUM> of the reinforcement structure <NUM> and/or at one or both of the first end <NUM> and the second end <NUM> of the elongate member <NUM>. In some embodiments, the reinforcement structure <NUM> can be coupled to the elongate member <NUM> via one or several other components of the valve <NUM>. In some embodiments, the reinforcement structure <NUM> can be coupled to the elongate member <NUM> via the compression of the reinforcement structure <NUM> and the elongate member <NUM> between the housing <NUM> and one or both of the proximal <NUM> and the distal <NUM>.

In some embodiments, the reinforcement structure <NUM> can be adhered to the elongate member <NUM> via, for example, an adhesive such as silicone adhesive. In some embodiments, the adhesive can be circumferentially applied to the reinforcement structure <NUM> and/or the elongate member <NUM> in an adhesive ring that can, for example, a have a length approximately between: <NUM> inches and <NUM> inches; <NUM> and <NUM> inches; <NUM> inches and <NUM> inches, or any other or intermediate range (<NUM> inch = <NUM>).

In one embodiment, each of the proximal end <NUM> and the distal end <NUM> of the reinforcement structure <NUM> can be adhered via an adhesive to the elongate member <NUM>. In such an embodiment, the reinforcement structure <NUM> may be uncoupled to the elongate member <NUM> at positions other than the coupling at one or both of the proximal end <NUM> and the distal end <NUM> of the reinforcement structure <NUM>, and thus the reinforcement structure <NUM> is uncoupled to the elongate member <NUM> at a position between the first end <NUM> and the second end <NUM> of the elongate member <NUM> and/or between the proximal end <NUM> and the distal end <NUM> of the reinforcement structure <NUM>.

The lack of coupling of the reinforcement structure <NUM> to the elongate member <NUM> can facilitate and improve the collapse of the elongate member <NUM> around a tool <NUM>, also referred to herein as instrument <NUM> or device <NUM>, inserted through the valve <NUM> as shown in <FIG>. The tool <NUM> can be any device inserted through the valve <NUM> including, for example, one or several additional catheters, lines, wires, grippers, punches, cutters, or the like. As seen in <FIG>, the tool <NUM> is inserted through the valve <NUM> and specifically through the elongate member <NUM> of the valve. As shown, the constricting mechanism <NUM> is in the first configuration and the elongate member <NUM> and the central lumen <NUM> of the elongate member <NUM> is collapsed around the tool <NUM>, and specifically around a shaft <NUM> of the tool <NUM> to thereby seal the valve <NUM> around the tool <NUM> and specifically around the shaft <NUM> of the tool <NUM>. The constricting mechanism <NUM> can seal around tools <NUM> that fit through the elongate member <NUM>, regardless of the size of the tool <NUM>. Thus, the valve can be used with a wide variety of tools.

The reinforcement structure <NUM> can comprise a variety of designs, shapes, sizes, and materials. In some embodiments, the reinforcement structure <NUM> can be sized and shaped so as to receive elongate member <NUM> and to be positioned between the elongate member <NUM> and the at least one filament <NUM>. In some embodiments, the reinforcement structure <NUM> can be made from a material sufficiently strong to prevent the cutting of the at least one filament <NUM> through the elongate member <NUM>.

In some embodiments, the reinforcement structure can comprise a coil or a mesh sheath. The mesh sheath can, in some embodiments, comprise a braided mesh. The braided mesh can be made from any desired number of wires in any desired configuration. In some embodiments, the braided mesh can comprise a <NUM> wire braided mesh, an <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, a <NUM> wire braided mesh, an <NUM> wire braided mesh, a <NUM> wire braided mesh, or any other or intermediate braided mesh. In some embodiments, the braided mesh can comprise: a 1x1 configuration. In some embodiments, the wire in the braided mesh can be any desired material including, for example, a metal wire such as a nitinol wire or a stainless steel wire, a polymer wire, or a natural wire. In one embodiment, the braided mesh can comprise a <NUM> wire mesh in a 1x1 configuration made with a nitinol wire having a diameter of <NUM> inches.

With reference now to <FIG>, different embodiments and/or configurations of the filament <NUM> are shown. The filament <NUM> can comprise a single filament <NUM> having a first end <NUM> and a second end <NUM> as shown in <FIG>. The filament <NUM>, and specifically which first and second ends <NUM>, <NUM> can be coupled to the actuator <NUM> to move the filament <NUM> between the first and second configurations or positions and/or from the first configuration or position to the second configuration or position. In some embodiments, both of the first end <NUM> and the second end <NUM> can be coupled to a single button <NUM>, in some embodiments, each of the first end <NUM> and the second end <NUM> can be coupled to different buttons <NUM>, and in some embodiments, one of the first end <NUM> and the second end <NUM> can be coupled to a button <NUM> and the other of the first end <NUM> and the second end <NUM> can be coupled to the housing <NUM> or other portion of the valve <NUM>.

In some embodiments, the filament <NUM> can comprise multiple filaments, and specifically, as shown in <FIG>, the filament <NUM> can comprise a first filament <NUM>-A and a second filament <NUM>-B. In embodiments in which the filament <NUM> comprises multiple filaments, each of the multiple filaments can have a first end <NUM> and a second end <NUM>. The first and second filaments <NUM>-A, <NUM>-B can be coupled to the actuator <NUM>. In such embodiments, the first and second ends <NUM>, <NUM> can be coupled to the actuator <NUM> to move the filaments <NUM>-A, <NUM>-B between the first and second configurations and/or from the first configuration to the second configuration. In some embodiments, both of the first end <NUM> and the second end <NUM> of one or more of the multiple filaments <NUM> can be coupled to a single button <NUM>, in some embodiments, each of the first end <NUM> and the second end <NUM> of one or more of the multiple filaments <NUM> can be coupled to different buttons <NUM>, and in some embodiments, one of the first end <NUM> and the second end <NUM> of one or more of the multiple filaments <NUM> can be coupled to one button <NUM> and the other of the first end <NUM> and the second end <NUM> of those one or more filaments <NUM> can be coupled to the housing <NUM> or other portion of the valve <NUM>.

The filament <NUM> can be arranged in a variety of configurations. In some embodiments, the filament <NUM> can be configured to form a single loop <NUM> that can extend around the elongate member <NUM> and/or through which the elongate member <NUM> can be received as shown in <FIG>, and in some embodiments, the filament <NUM> can be configured to form multiple loops, and specifically a first loop <NUM> and a second loop <NUM> as shown in <FIG>. The first and second loops <NUM>, <NUM> can each receive the elongate member <NUM>. In some embodiments, a diameter or size of the loop <NUM>, or of the loops <NUM>, <NUM> can decrease when the constricting mechanism <NUM> is moved from the second configuration to the first configuration.

In some embodiments, the filament <NUM> can be configured to form a bight <NUM>, which bight <NUM> can be a single bight or multiple bights. As used herein, a "bight" refers to a U-shaped section between the two ends of the filament <NUM>. As depicted in <FIG>, the bight <NUM> can comprise multiple bights, and specifically a first bight <NUM>-A and a second bight <NUM>-B. In some embodiments, the first bight <NUM>-A can extend through the second bight <NUM>-B such that the first and second bights <NUM>-A, <NUM>-B interlock, whereas in other embodiments, the first and second bights <NUM>-A, <NUM>-B can be non-interlocking. Similarly, in embodiments containing the filament <NUM> having multiple loops, one or several of the multiple loops can be interlocking.

In some embodiments, the bight <NUM>, and specifically one or both of the first bight <NUM>-A and the second bight <NUM>-B can be formed around a portion of the elongate member <NUM> and/or can extend around a portion of the elongate member <NUM>. Each bight <NUM> can define a partially enclosed receiving area <NUM> wherein the elongate member <NUM> can be received. Thus, the first bight <NUM>-A can define a first receiving area <NUM>-A and the second bight <NUM>-B can define a second receiving area <NUM>-B.

As seen in <FIG>, multiple bights, and specifically the first and the second bights <NUM>-A, <NUM>-B can be positioned and oriented such that the first bight <NUM>-A has a first orientation or first direction as indicated by arrow <NUM>, and the second bight has a second orientation or second direction as indicated by the arrow <NUM>. In some embodiments, the first orientation is different from the second orientation such that the first and second receiving areas <NUM>-A, <NUM>-B overlap and define an encircled area <NUM>, also referred to herein as a constricting area <NUM>. The elongate member <NUM> can be received within the encircled area <NUM>. In embodiments in which bights <NUM>-A, <NUM>-B overlap to define the encircled area <NUM>, the movement of the constricting mechanism <NUM> to the first configuration can result in and/or include the first bight <NUM>-A moving in the direction indicated by the arrow <NUM> and/or the second bight <NUM>-B moving in the direction indicated by the arrow <NUM>, which movement of the bights <NUM>-A, <NUM>-B decreases the size of the encircled area <NUM> and constricts, collapses, and/or seals the elongate member <NUM> extending through the encircled area <NUM>.

The filament(s) <NUM> forming the bights <NUM> can each apply an arcuate line or narrow longitudinal zone of pressure to the elongate member <NUM>. If the filament(s) are circular in cross-section, the zone of pressure can be very small, and can, in some embodiments, be less than the diameter or thickness of the filament. In some embodiments, the filaments have a diameter or width less than about <NUM>, less than about <NUM>, less than about <NUM>, less than about <NUM>, less than about <NUM>, less than about <NUM>, less than about <NUM>, and/or less than about <NUM>. In some embodiments, the filaments can have a diameter or width of between about <NUM> and <NUM>, between about <NUM> and <NUM>, between about <NUM> and <NUM>, and/or between about <NUM> and <NUM>. In some embodiments, the arcuate line or zone of pressure may form two opposing arcs and in other embodiments, the arcuate line of pressure may be a singular substantially circular line or zone that encircles the elongate member at least once. The longitudinal length of the of the line or zone of pressure may be very short compared to other valves known in the art. In some embodiments, the longitudinal length of the zone of pressure applied to the elongate member <NUM> by the filament(s) <NUM> may be less than about <NUM> and in some embodiments less than about <NUM>. In some embodiments, the filament(s) <NUM> can have any desired cross-sectional shape including, for example, a circular cross-section, a rectangular cross-section, an oval cross-section, a square cross-section, a polygonal cross-section, a triangular cross-section, or any other desired shape of cross-section.

With reference now to <FIG>, a flowchart illustrating one embodiment of a process <NUM> for sealing a valve <NUM> and/or catheter <NUM> accessing a body of a patient is shown. The process <NUM> can be performed using the valve <NUM> and/or the delivery system <NUM>. The process <NUM> begins at block <NUM>, wherein the delivery device <NUM>, and specifically the catheter <NUM> of the delivery device <NUM> is inserted into the body of the patient. In some embodiments, this can include inserting the catheter <NUM> into a portion of the circulator system of the patient such as, for example, a blood vessel including an artery or a venous vessel. In some embodiments, the delivery device <NUM> can be inserted into the body of the patient directly through an aperture or incision in the patient, and in some embodiments, the delivery device <NUM> can be inserted into the body of the patient via another catheter or device. In some embodiments, the constricting mechanism <NUM> can be in the first configuration while the delivery device <NUM> and/or the catheter <NUM> is inserted into the patient's body.

After the delivery device <NUM> is inserted into the body of the patient, the process <NUM> proceeds to block <NUM>, wherein the constricting mechanism <NUM> is moved from the first configuration to the second configuration. As described above, the central lumen <NUM> of the elongate member <NUM> is unsealed when the constricting mechanism <NUM> is in the second configuration. In some embodiments, the moving of the constricting mechanism <NUM> from the first configuration to the second configuration can include the manipulation of the actuator <NUM> and/or the control of the actuator <NUM>, and specifically the depressing of the one or several buttons <NUM> to move the filament <NUM> from the first position to the second position to allow the expansion and opening of the central lumen <NUM> of the elongate member <NUM>.

After the constricting mechanism <NUM> is moved from the first configuration to the second configuration, the process <NUM> proceeds to block <NUM>, wherein the tool <NUM>, and specifically the shaft <NUM> of the tool <NUM> is advanced through the delivery device <NUM> and specifically through the valve <NUM> until a first end of the tool reaches a desired position within the body of the patient. In some embodiments, a portion of the shaft <NUM> can be positioned within the central lumen <NUM> of the elongate member <NUM> after the advancing of the tool <NUM> through the delivery device <NUM>. In some embodiments, after the tool <NUM> is advanced through the delivery device <NUM>, the desired procedure can be performed with the tool.

After the tool <NUM> is advanced through the delivery device <NUM>, or while the tool <NUM> is being advanced through the delivery device <NUM>, the process <NUM> proceeds to block <NUM>, wherein the constricting mechanism <NUM> is returned to the first configuration. In some embodiments, the returning of the constricting mechanism <NUM> to the first configuration can include the release of the one or several buttons <NUM> and/or the control of the actuator <NUM> to reconfigure the constricting mechanism <NUM> to the first configuration. In some embodiments, the return of the constricting mechanism <NUM> to the first configuration can result in the collapse and/or sealing of the elongate member <NUM> and specifically the central lumen <NUM> of the elongate member <NUM> around the tool <NUM> and specifically around the shaft <NUM> of the tool <NUM>. The return of the constricting mechanism <NUM> to the first configuration, or the movement of the constricting mechanism <NUM> to the first configuration can include the decreasing of the size and/or diameter of one or several loops formed by the filament <NUM> and/or the movement of one or several bights <NUM> such as, for example, the movement of the first bight <NUM>-A in the first direction indicated by arrow <NUM> and the movement of the second bight <NUM>-B in the second direction indicated by arrow <NUM> to reduce the size of the constricting area <NUM>. In some embodiments, after the constricting mechanism is returned to the first configuration, the desired procedure can be performed with the tool.

After the constricting mechanism is returned to the first configuration, the process <NUM> proceeds to block <NUM>, wherein the tool <NUM>, and specifically the shaft <NUM> of the tool <NUM> is retracted from the delivery device <NUM>, and more specifically from the valve <NUM>. In some embodiments, the valve <NUM> can remain sealed during the retracing of the tool <NUM> and/or the shaft <NUM> of the tool. In some embodiments, the valve <NUM> remains sealed during the retracting of the tool <NUM> and/or the retracting of the shaft <NUM> of the tool <NUM> as the constricting mechanism <NUM> can remain in the first configuration during the retracing of the tool <NUM> and/or the shaft <NUM> of the tool <NUM>.

In some embodiments, the constricting mechanism <NUM> can be moved to the second configuration to allow the retraction of the tool <NUM> and/or the shaft <NUM> of the tool <NUM> from the valve <NUM>, and the constricting mechanism <NUM> can be returned to the first configuration when the tool <NUM> and/or the shaft <NUM> of the tool <NUM> is removed from the valve <NUM>. In some embodiments, the retraction of the tool <NUM> and/or shaft <NUM> of the tool <NUM> from the valve <NUM> can be performed with the constricting mechanism <NUM> left in the first configuration. In some embodiments, the constricting mechanism <NUM> can be moved to the second configuration, and then returned to the first configuration via the manipulation and/or control of the actuator <NUM>, which manipulation and/or control of the actuator <NUM> can include the depressing of the one or several buttons <NUM> to move the constricting mechanism <NUM> to the second configuration, and the release of the one or several buttons <NUM> to return the constricting mechanism <NUM> to the first configuration. In some embodiments, if the procedure is complete, the delivery device <NUM> can then be removed from the body of the patient, and any incision created for the procedure can be closed.

With reference now to <FIG>, a side view of one embodiment of a thrombectomy system <NUM> including the delivery device <NUM> and a thrombus extraction device <NUM> is shown. In some embodiments, the thrombectomy system <NUM> can be used to access a blood vessel <NUM> to treat and/or extract a thrombus <NUM> from the blood vessel <NUM>. The thrombus extraction device <NUM> can include a self-expanding coring element <NUM> and expandable cylindrical portion <NUM>. In some embodiments, and as shown in <FIG>, the thrombus extraction device <NUM> can be the tool <NUM> that can extend through the valve <NUM>, and in some embodiments, the valve <NUM> can be a part of the thrombus extraction device <NUM>. Further details of thrombectomy systems, thrombus extraction devices, and methods of using the same are disclosed in: <CIT>, and entitled "INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS"; <CIT>, and entitled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION"; and <CIT>, and entitled "DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION".

With reference now to <FIG>, a side-section view of another embodiment of the hemostasis valve <NUM> having two piece caps <NUM>, <NUM> is shown. The valve <NUM> can include a housing <NUM> defining an interior channel <NUM> through which the tubular member <NUM> can extend. The valve <NUM> can include the proximal cap <NUM> and the distal cap <NUM>. In some embodiments, the proximal cap <NUM> can comprise a two piece cap and can include a proximal exterior member <NUM> and a proximal channel member <NUM>. In some embodiments, the distal cap <NUM> can comprise a two-piece cap and can include a distal exterior member <NUM> and a distal channel member <NUM>. In some embodiments, this coupling between the proximal exterior member <NUM> and the proximal channel member <NUM> and/or the coupling between the distal exterior member <NUM> and the distal channel member <NUM> can be a sealed coupling so as to prevent the leakage of material including fluid or gas between the respective ones of the proximal exterior member <NUM> and the proximal channel member <NUM> and/or the distal exterior member <NUM> and the distal channel member <NUM>. In some embodiments, this sealing coupling can be achieved and/or maintained via a seal such as an O-ring <NUM> that can be positioned between the proximal exterior member <NUM> and the proximal channel member <NUM> and/or between the distal exterior member <NUM> and the distal channel member <NUM>.

In some embodiments, the proximal exterior member <NUM> can be coupled, and in some embodiments, rotatingly coupled to the proximal channel member <NUM> in a manner to allow the rotation of the proximal exterior member <NUM> without rotating the proximal channel member <NUM>. Similarly, in some embodiments, the distal exterior member <NUM> can be rotatingly coupled to the distal channel member <NUM> in a manner to allow the rotation of the distal exterior member <NUM> without the rotating of the distal channel member <NUM>. In some such embodiments, the channel members <NUM>, <NUM> can be non-rotatable with respect to the housing <NUM> and/or the tubular member <NUM>, and one or both of the exterior members <NUM>, <NUM> can be rotatable with respect to the housing <NUM> and/or the tubular member <NUM>. In such an embodiment, the maintaining of the rotational position of the channel members <NUM>, <NUM> with respect to the housing <NUM> and/or the tubular member <NUM> can prevent the twisting of the tubular member <NUM> which can result in the sealing of the tubular member <NUM> regardless of the configuration of the constructing mechanism <NUM>.

The exterior members <NUM>, <NUM> can comprise a variety of shapes and sizes and can include a variety of features. In some embodiments, one or both of the exterior members <NUM>, <NUM> can be coupled to, for example, a shaft similar to the shaft <NUM> shown in <FIG>. In some embodiments, for example, the distal exterior member <NUM> can be coupled to a shaft <NUM>, including, for example, can be non-detachably coupled to the shaft <NUM>. In some embodiments, one or both of the exterior members can include one or several features configured to facilitate coupling with the valve <NUM>. These one or several features can include, for example, one or several male or female: connectors; couplers; attachment mechanisms; or the like. In some embodiments, these one or several features can facilitate use of the valve with other existing components, instruments, tools, or the like. In some embodiments, for example, one or both of the exterior members <NUM>, <NUM> can comprise either a male or female luer fitting, and specifically as shown in <FIG>, the distal exterior member <NUM> can comprise a male luer fitting <NUM>.

Other variations are within the scope of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention, as defined in the appended claims.

In the previous description, various embodiments of the present invention are described. However, it will also be apparent to one skilled in the art that the present invention which is defined by the appended claims may be practiced without the specific details.

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The term "connected" is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed.

Claim 1:
A hemostatic valve (<NUM>) for sealing a medical device, the hemostatic valve (<NUM>) comprising:
an elongate member (<NUM>) having a first end (<NUM>), a second end (<NUM>), and a central lumen (<NUM>) extending therebetween, wherein the elongate member (<NUM>) is pliable; and
an active tensioning mechanism (<NUM>) including an actuator (<NUM>) coupled to the elongate member (<NUM>), wherein the actuator (<NUM>) is moveable between (a) a first position wherein the central lumen (<NUM>) is constricted and sealed and (b) a second position wherein the central lumen (<NUM>) is open; and
a biasing member configured to bias the actuator (<NUM>) to the first position;
characterized in that
the hemostatic valve (<NUM>) further comprises a reinforcement structure (<NUM>) extending along at least a portion of the elongate member (<NUM>), wherein the reinforcement structure (<NUM>) is coupled to the elongate member (<NUM>).