Systems and methods for a hemostasis valve

Abstract

A hemostasis valve includes a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid. The hemostasis valve further includes one or more levers, each of the one or more levers having an engaged state and a released state, and a bias for each of the one or more levers. The bias is configured to impel the respective lever toward the released state. An elastomeric member is configured to seal the valve member when the one or more levers are in the released state. Actuation of the one or more levers to the engaged state reduces a sealing force applied by the elastomeric member to permit insertion of a medical instrument through the lumen

Description

Attorney Docket: INM_005PCTSYSTEMS AND METHODS FOR A HEMOSTASIS VALVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of the U.S Provisional Patent Application No.63 / 789.984 filed on April 16. 2025, the contents of which are incorporated by reference herein.FIELD OF THE INVENTION

[0002] The present disclosure relates to medical devices for facilitating access to a patient’s circulatory system or other bodily lumens. More particularly, it relates to hemostasis valves configured to permit insertion and manipulation of medical instruments while managing fluid flow. The disclosure further relates to systems configured to maintain sealing and controlled access during medical procedures.BACKGROUND

[0003] When patients undergo surgery or other medical procedures, it may be necessary to expose one or more portions of the patient’s vasculature. A vasculature may be defined as a patient’s circulatory system, including all blood vessels that comprise arteries, veins, and capillaries. For example, a medical practitioner may require access to a patient’s vasculature to perform one or more procedures, such as inserting a catheter into a vein or administering various substances to the patient. During such procedures, it is important to maintain sterile conditions, minimize blood loss, and control fluid flow into and out of the vasculature.

[0004] Medical practitioners must therefore attempt to minimize the exposure to the air and contaminants, as well as minimize any blood loss that occurs as a result of exposing the patient’s vasculature to an outside environment. A device that medical practitioners use to control access to an artificially created opening in a patient’s vasculature may be referred to as a hemostasis valve. A hemostasis valve may allow a medical practitioner to open and close access to a patient’s vasculature while maintaining a seal around inserted medical instruments. Accordingly, a medical practitioner may open a hemostasis valve, perform a procedure that requires a flow of fluid to or from (or through) the hemostasis valve, and subsequently close the hemostasis valve.Attorney Docket: INM_005PCT

[0005] The term thrombectomy refers to a medical procedure in which interventional devices are used to access the vascular system to remove clots. The basic steps of the procedure may include: 1) gaining access to the vascular system, 2) navigating a flexible catheter shaft to the target vessel location (typically guided by fluoroscopy (x-ray)), and finally 3) aspirating (applying vacuum suction) or mechanically retrieving the clot from the vessel. The sequence described above requires careful navigation, control, and smooth operation of the catheter system for optimal outcomes. Further, such procedures require repeated insertion, manipulation, and withdrawal of medical instruments through an access point while maintaining hemostasis and minimizing blood loss.

[0006] Conventional hemostasis valves may be difficult to operate, may not provide consistent sealing under varying conditions, and may limit efficient aspiration or fluid management during procedures. Accordingly, there is a need in the art for a hemostasis valve that is easy to use for medical practitioners, effectively seals the patient’s vasculature from outside exposure to pathogens and pathogenic compounds, and facilitates performance of a wide range of procedures, such as a thrombectomy.SUMMARY

[0007] The disclosed subject matter relates to a hemostasis valve configured for use in a medical setting. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid. The hemostasis valve further includes one or more levers, each of the one or more levers having an engaged state and a released state, and a bias for each of the one or more levers. The bias is configured to urge the respective lever toward the released state. An elastomeric member is configured to seal the valve member when the one or more levers are in the released state, wherein actuation of the one or more levers to the engaged state reduces a sealing force applied by the elastomeric member to permit insertion of a medical instrument through the lumen.In some embodiments, the elastomeric member has a disk shape with a hole through a longitudinal axis of the disk shape. The bias may be in mechanical communication with a hollow spool, the hollow spool configured to contact the elastomeric member when the one or more levers are in the released state, and a longitudinal axis of the hollow spool may provide at least a portion of the flow path. TheAttorney Docket: INM_005PCTelastomeric member may be configured to compress the hole when the one or more levers are in the released state.

[0008] In embodiments, the bias comprises a spring. The spring may be configured to apply a force of about 10-40 pounds over a range of motion of about 1 / 4 inch. The spring may further be configured such that the one or more levers are actuated by an operator with a force of less than about 5 pounds to place the one or more levers in the engaged state. In certain embodiments, the elastomeric member is configured to be compressed against a tapered bore of a hub of the hemostasis valve, the tapered bore having an angle of between about 11 and 32 degrees, and the elastomeric member having a durometer in a range of about 0 to 10.

[0009] In one aspect, an aspiration port for a hemostasis valve is provided. The aspiration port may include a female coupling at a terminal end of a fluid flow path of the hemostasis valve and an elastomeric member disposed in the fluid flow path of the female coupling, the elastomeric member comprising a cross-slit seal configured to seal the fluid flow path when not penetrated. The female coupling may be configured to be coupled to a male coupling, the male coupling comprising a hollow bore configured to penetrate the cross-slit seal. In other embodiments, the aspiration port may include a check valve configured to allow a flow of fluid through the fluid flow path when in an open state and to seal the fluid flow path when in a closed state, wherein the check valve is configured to be in the closed state when uncoupled and in the open state when coupled to an aspiration tool.

[0010] In another aspect, a method for aspirating fluid through a hemostasis valve is provided. The method includes navigating a catheter through a fluid flow path of the hemostasis valve into a vascular system of a subject. The method connects an aspiration tool to a terminal end of the hemostasis valve to open the fluid flow path. Further, the method activates the aspiration tool to aspirate fluid through the fluid flow path, and detaches the aspiration tool from the terminal end of the hemostasis valve to cause the terminal end to close the fluid flow path. In some embodiments, the terminal end comprises a check valve configured to allow fluid flow in an open state and to seal the fluid flow path in a closed state.BRIEF DESCRIPTION OF THE DRAWINGSAttorney Docket: INM_005PCT

[0011] FIG. 1 is a schematic that shows an embodiment of the disclosed subject matter, illustrating an aspiration tool connected to a hemostasis valve that establishes a fluid flow path to a catheter, which is used to connect to the vascular system of a subject.

[0012] FIG. 2 is an illustration of an embodiment of an aspiration tool coupled to a disclosed hemostasis valve.

[0013] FIG. 3 are illustrations of the disclosed hemostasis valve from a top view and a side view.

[0014] FIG. 4 is another illustration of an embodiment of the disclosed hemostasis valve from a perspective view.

[0015] FIG. 5 is a cross-sectional illustration of the disclosed hemostasis valve from a side view.

[0016] FIG. 6 is another cross-sectional illustration of the disclosed hemostasis valve from a side view while the actuation levers are in an engaged state.

[0017] FIG. 7 is another cross-sectional illustration of the disclosed hemostasis valve from a side view while the actuation and actuation levers are in an engaged state, and an instrument is inserted into the fluid flow path.

[0018] FIG. 8 is yet another cross-sectional illustration of the disclosed hemostasis valve from a side view while the actuation levers are in a released state and an instrument is inserted into the fluid flow path.

[0019] FIG. 9 is a set of photographs of the disclosed hemostasis valve operated by an operator.

[0020] FIG. 10 is a set of photographs showing a fluid flow path of the disclosed hemostasis valve while the actuation levers are in an engaged state and a released state.

[0021] FIG. 11 is an illustration of an embodiment of the elastomeric seal.Attorney Docket: INM_005PCT

[0022] FIG. 12 is a cross-sectional view of the hemostasis valve showing the elastomeric seal in a closed state.

[0023] FIG. 13 is a cross-sectional view of the hemostasis valve showing movement of the hollow spool as the actuation levers are engaged.

[0024] FIG. 14 is a blown-up view of an embodiment of the hemostasis valve.

[0025] FIG. 15 is an illustration of an aspiration tool that may be coupled to an aspiration port of the disclosed hemostasis valve.

[0026] FIG. 16 is an illustration of the aspiration tool coupled to the aspiration port of the disclosed hemostasis valve.

[0027] FIG. 17 are illustrations of the disclosed hemostasis valve showing a stopcock valve on the aspiration port and a female coupling dry seal on the aspiration port.

[0028] FIG. 18 are photographs of a front side and back side of an embodiment of an elastomeric seal that may be inserted into an aspiration port.

[0029] FIG. 19 shows illustrations of an embodiment of the aspiration port before being coupled to an aspiration tool, being coupled to an aspiration tool, and being decoupled from an aspiration tool.

[0030] FIG. 20 is a partially transparent view of an embodiment of the aspiration tool and aspiration port, showing placement of the elastomeric seal.

[0031] FIG. 21 is a cross-sectional view of an embodiment of the aspiration tool showing elastomeric cross-slit seals.

[0032] FIG. 22 shows illustrations of an embodiment of the aspiration tool with a check valve as it is decoupled and coupled to an aspiration tool.

[0033] FIG. 23 is a transparent view of an embodiment of the check valve.Attorney Docket: INM_005PCT

[0034] FIG. 24 is a blown-up view of an embodiment of the check valve coupled to an aspiration tool.

[0035] FIG. 25 is an illustration of the washer and plunger of the check valve.

[0036] FIG. 26 shows illustrations of an assembly of the check valve.

[0037] FIG. 27 is a flow diagram of a method for aspiration using an embodiment of the disclosed hemostasis valve.DETAILED DESCRIPTION

[0038] The disclosed subject matter is a hemostasis valve and aspiration port designed to provide a fluid flow path to a subject’s vasculature. This fluid flow path may allow a catheter to be inserted into the subject’s vascular tube. The hemostasis valve can be sealed or unsealed by engaging one or more actuation levers, and the aspiration port can be connected to an aspiration tool to aspirate the fluid flow path.

[0039] The disclosed hemostasis valve and aspiration port are designed to streamline the syringe-based aspiration of clot materials from a subject’s vasculature. The syringe-based aspiration may be conducted as described in this document.

[0040] In one aspect, the disclosed subject matter relates to a hemostasis valve configured to control access to a fluid flow path while maintaining a seal during medical procedures. The hemostasis valve may be particularly useful in procedures involving vascular access, where medical instruments such as catheters, guidewires, or other interventional devices are introduced into a patient’s vasculature. The disclosed hemostasis valve enables repeated insertion and manipulation of such instruments while reducing fluid leakage, minimizing blood loss, and limiting ingress of air or contaminants.

[0041] In general, the hemostasis valve includes a valve member defining a lumen that extends between a proximal end and a distal end. The lumen provides a fluid flow path and may accommodate one or more medical instruments. In use, the distal end of the valve member may be coupled to a catheter or other device that interfaces with the patient’ s vasculature, while the proximal end may be accessible to a medical practitioner for instrument insertion and control.Attorney Docket: INM_005PCT

[0042] The hemostasis valve further includes one or more levers that are configured to control sealing within the lumen. Each lever may be movable between an engaged state and a released state. The levers may be positioned to allow intuitive actuation by an operator, and in some embodiments, may be arranged to enable single-handed operation. This configuration may improve ease of use during procedures requiring simultaneous manipulation of multiple devices.

[0043] A bias is associated with each of the one or more levers and is configured to urge the respective lever toward the released state. In some embodiments, the bias includes a spring that provides a relatively high sealing force when the levers are not actuated, while allowing the levers to be actuated with a comparatively low manual force. For example, the spring may be configured to apply a force in a range sufficient to maintain sealing under fluid pressure or vacuum conditions, while requiring less force from the operator to transition the levers to the engaged state. This arrangement may allow the valve to remain normally closed while still being easily actuated when needed.

[0044] An elastomeric member is positioned within the valve member and serves as a primary sealing component. The elastomeric member may be formed from a compliant material capable of deforming under applied force. In some embodiments, the elastomeric member has a generally disk-shaped configuration with a hole extending through its longitudinal axis. The hole may be configured to constrict or close when the elastomeric member is compressed, thereby sealing the lumen when no instrument is present. When an instrument is inserted, the elastomeric member may conform around the instrument to maintain a seal.

[0045] The interaction between the one or more levers, the bias, and the elastomeric member provides controlled modulation of the sealing force. When the levers are in the released state, the bias applies force that compresses the elastomeric member, thereby sealing the lumen. When the levers are actuated to the engaged state, the compression on the elastomeric member is reduced, which decreases the sealing force and allows insertion or manipulation of a medical instrument through the lumen. Upon release of the levers, the bias restores the sealing force, thereby reestablishing a seal.

[0046] In some embodiments, the bias may be mechanically coupled to a hollow spool. The hollow spool may be configured to transmit force from the bias to the elastomeric member andAttorney Docket: INM_005PCTmay move in response to actuation of the levers. The hollow spool may also define at least a portion of the fluid flow path through the valve. Movement of the hollow spool may adjust the degree of compression applied to the elastomeric member, thereby controlling the sealing characteristics of the valve.

[0047] In certain embodiments, the elastomeric member is configured to be compressed against a tapered bore of a hub of the hemostasis valve. The tapered geometry may facilitate uniform compression of the elastomeric member and improve sealing performance. For example, the taper may assist in directing deformation of the elastomeric member inward toward the lumen, thereby enhancing closure of the hole and sealing around an inserted instrument. The material properties of the elastomeric member, such as durometer, may be selected to achieve a desired balance between flexibility and sealing effectiveness.

[0048] In addition to controlling instrument access, the hemostasis valve may facilitate fluid management. In some embodiments, the valve includes an aspiration port located along the fluid flow path. The aspiration port may enable connection to an external device, such as an aspiration tool, to allow fluid to be withdrawn from or introduced into the system.

[0049] In one embodiment, the aspiration port includes a female coupling and an elastomeric member disposed within the coupling. The elastomeric member may include a cross-slit seal that remains closed in the absence of a mating component. When a male coupling having a hollow bore is inserted into the female coupling, the bore may penetrate the cross-slit seal, thereby opening the fluid flow path. This configuration may allow selective access to the flow path while maintaining a normally closed condition.

[0050] In another embodiment, the aspiration port includes a check valve mechanism. The check valve may be configured to remain closed when not coupled to an external device and to open when coupled. The check valve may include an elastomeric washer that is pressed into sealing engagement with a molded fitting to block fluid flow. A plunger may be coupled to the elastomeric washer and may be biased by a spring to maintain the closed state.

[0051] When an aspiration tool is coupled to the check valve, a coupling mechanism may act on the plunger to overcome the spring force and disengage the elastomeric washer from theAttorney Docket: INM_005PCTmolded fitting. This action opens the fluid flow path and allows fluid communication between the valve and the aspiration tool. In some embodiments, the coupling mechanism may be actuated by a twisting motion of the aspiration tool relative to the check valve.

[0052] The hemostasis valve described herein may be used in various medical procedures, including procedures requiring aspiration. For example, during a thrombectomy procedure, a catheter may be navigated through the lumen of the hemostasis valve into a target location within a vascular system. An aspiration tool may be coupled to the aspiration port, and suction may be applied to remove fluid or debris through the fluid flow path. Upon completion, the aspiration tool may be removed, allowing the valve to automatically return to a sealed state.

[0053] While specific embodiments have been described, it will be understood that various modifications and variations may be made without departing from the scope of the disclosed subject matter. For example, the number and arrangement of levers, the configuration of the elastomeric member, and the design of the aspiration port may be varied. Such modifications are intended to be included within the scope of the claims.

[0054] Referring to FIG. 1, FIG 1 is a schematic 100 depicting an embodiment of the disclosed subject matter. In this figure, an aspiration tool 105 is connected to an aspiration port 110 of a hemostasis valve assembly. The hemostasis valve assembly includes a hub or valve body 115 defining a lumen that establishes a fluid flow path to a catheter 120, which in turn connects to a vascular system 125 of a subject. The hemostasis valve may be actuated (e.g., via one or more levers) to open a fluid flow path, allowing a guide wire to be inserted into the subject’s vasculature. Releasing the valve may cause it to close the fluid flow path around the guide wire or medical instrument, sealing the path from external exposure and maintaining hemostasis. In some embodiments, coupling of the aspiration tool 105 to the aspiration port 110 opens a branch of the fluid flow path to enable aspiration of fluid through the catheter 120.

[0055] The access hub or hub or valve body 115 of the hemostasis valve assembly may be operated by a clinician or medical practitioner and provides the following features. First, it offers a seal that prevents blood loss in patients. Second, it prevents negative pressure generated by a syringe from affecting aspiration suction performance, thereby preventing vacuum leakage. Third, it provides a large-bore access site, enabling the passage of a guide wire and otherAttorney Docket: INM_005PCTcatheter-based tools used during a procedure. This bore should match the inner diameter of the catheter but collapse completely to seal off the catheter when no instrument is present in the bore. It should also seal around the guide wire and catheter-based tools, allowing their axial motion with minimal drag. Fourth, the hub is designed for ease of operation. Ideally, it should be usable with one hand, and it should be operable by the clinician or practitioner without requiring direct visualization. In some embodiments, the hemostasis valve assembly is configured such that the fluid flow path remains sealed when the aspiration tool 105 is decoupled from the aspiration port 110.

[0056] Referring to FIG. 2, FIG. 2 is an illustration 200 of an embodiment of an aspiration tool coupled to a disclosed hemostasis valve. The illustration 200 shows an aspirationl tool 205 (e.g., a syringe) used as the aspiration tool. The aspiration port 210 includes a stopcock valve that may be opened and closed to open and seal a fluid flow path that connects the aspiration tool to the hemostasis valve. In some embodiments, the stopcock valve is configured to selectively allow or restrict fluid communication between the aspiration tool 205 and a lumen of the hemostasis valve. The hemostasis valve includes a hub or valve body 215, and further includes one or more levers (for example, two actuation levers), each of the one or more levers having an engaged state and a released state, that may be engaged by an operator to open a fluid flow path of the hemostasis valve. Actuation of the one or more levers to the engaged state may reduce a sealing force applied by an elastomeric member within the hemostasis valve to permit passage of a medical instrument through the lumen.

[0057] In an example of use shown in the illustration 200, a catheter 225 may be inserted into the fluid flow path of the hemostasis valve when the hemostasis valve is engaged to unseal the fluid flow path. The catheter 225 may extend through the lumen of the hemostasis valve and into a vascular system of a subject. In embodiments, the hemostasis valve may include an infusion port 220 that may allow infusion of one or more medicaments or other fluids to the vasculature of a subject. The infusion port 220 may be in fluid communication with the lumen of the hemostasis valve and may include a valve mechanism to control fluid flow. The coupling mechanisms described for the aspiration port 210 herein may be used for both the aspiration port and the infusion port. In some embodiments, the aspiration port 210 and / or the infusion port 220Attorney Docket: INM_005PCTare configured to maintain the fluid flow path in a sealed condition when not coupled to an external device.

[0058] Referring to FIG. 3, FIG. 3 shows illustration 300 of the disclosed hemostasis valve from a top view and a side view. The hemostasis valve includes one or more levers 305, each of the one or more levers having an engaged state and a released state, that may be engaged to open a fluid flow path. In particular, actuation of the one or more levers 305 to the engaged state may reduce a sealing force applied by an elastomeric member within the hemostasis valve to permit fluid flow and insertion of a medical instrument. In the hemostasis valve, the fluid flow path may connect the vasculature of a subject, such as a human subject or animal subject, to the outside environment while maintaining selective sealing control. In embodiments, a catheter 325 may be inserted through the fluid flow path into the vasculature. The catheter 325 may extend through a lumen of a valve member of the hemostasis valve. In embodiments, the hemostasis valve may include an aspiration port 315. Also, in embodiments, the hemostasis valve may include an infusion port 320. The aspiration port 315 and the infusion port 320 may each be in fluid communication with the lumen of the hemostasis valve. In embodiments, the aspiration port and / or infusion port may include a coupling mechanism that automatically opens the fluid flow path to the aspiration port and infusion port when it is coupled to a tool, such as an aspiration tool or infusion tool, and closes the fluid flow path when uncoupled.

[0059] Referring to FIG. 4, FIG. 4 is another illustration 400 of an embodiment of the disclosed hemostasis valve from a perspective view. In embodiments, the hemostasis valve includes a hub or valve body 215 and one or more levers 305, each of the one or more levers having an engaged state and a released state. The hemostasis valve may allow for one or more medical instruments, such as clot-retrievable instruments to be inserted through the hemostasis valve via a lumen of a valve memberto remove clots from a subject. For example, a catheter 325 may be inserted into the subject while the one or more levers 305 are in an engaged state to reduce a sealing force and open the fluid flow path to the outside environment. When the one or more levers 305 are moved to the released state, the fluid flow path may be sealed around the catheter 325 by an elastomeric member, thus sealing the catheter 325 and maintaining hemostasis while permitting axial movement of the catheter 325 through the lumen.Attorney Docket: INM_005PCT

[0060] Referring to FIG. 5, FIG. 5 is a cross-sectional illustration 500 of the hemostasis valve from a side view. As shown in the side view, the hemostasis valve may include an elastomeric member 505 (alternatively referred to as elastomeric seal), that may be pressed into tapered bore of a hub or valve body of the hemostasis valve by a hollow spool 515. The hollow spool 515 may be pressed into the elastomeric seal by a bias, such as a compression spring 510. In some embodiments, a longitudinal axis of the hollow spool 515 provides at least a portion of a fluid flow path through the hemostasis valve. Actuation of the actuation levers or the one or more levers 305, such as by squeezing the one or more levers 305 by an operator, may push against the hollow spool 515, which in turn compresses the compression spring 510 and reduces a force applied to the elastomeric member 505, thereby reducing compression of the elastomeric member 505 within the tapered bore..

[0061] When the one or more levers 305 are in a released state, as shown in the illustration, the hemostasis valve may be in a sealed state and the flow path may be substantially closed due to compression of the elastomeric member 505. When the one or more levers 305 are in an engaged state, the hemostasis valve is in an open or reduced-sealing state, and the fluid flow path is open as the hollow spool 515 reduces compression of the elastomeric seal. This permits insertion and / or movement of a medical instrument through a lumen of the hemostasis valve.

[0062] Referring to FIG. 6, FIG. 6 is another cross-sectional illustration 600 of the disclosed hemostasis valve from a side view while the actuation levers or the one or more levers 305 are in an engaged state. As shown in the illustration, the one or more levers 305 are actuated toward a hub or valve body 215. In an example of use, an operator may squeeze the one or more levers 305 with a hand to place the one or more levers 305 in the engaged state. Engagement of the one or more levers 305 may press against the hollow spool 515 to release the elastomeric member 505 from a tapered bore of the hemostasis valve hub. In one aspect, the engagement of the one or more levers 305 may press against the hollow spool 515, which in turn compresses the compression spring 510 and reduces a force applied to the elastomeric member 505, thereby reducing compression of the elastomeric member 505 against a tapered bore of the hub or valve body 215.Attorney Docket: INM_005PCT

[0063] The compression spring may exert a force on the hollow spool, which in turn applies force to the elastomeric member. This compression causes the elastomeric member 505 to press against the tapered bore of the hub body, effectively sealing the catheter shaft. In embodiments, this compression seals a lumen of the hemostasis valve when the one or more levers 305 are in the released state. In the engaged state shown in FIG. 6, the force applied by the compression spring 510 to the elastomeric member 505 is reduced, allowing the elastomeric member 505 to expand and increase the opening through the lumen. Actuation of the one or more levers may release the pressure on the elastomeric member 505, permitting the passage of devices such as guide wires, catheters, cable devices, and similar instruments through the lumen of the hemostasis valve.

[0064] Referring to FIG. 7, FIG. 7 is another cross-sectional illustration 700 of the disclosed hemostasis valve from a side view, showing the one or more levers 305 in an engaged state and an instrument 705 inserted into the fluid flow path through a lumen of the hemostasis valve. As shown in the illustration, the elastomeric member 505 can conform to the instrument 705 and maintain a seal around the instrument 705 while permitting movement of the instrument 705 through the lumen. The design allows axial motion of the instrument 705, where the force required to advance or retract the instrument 705 is referred to as the drag force. The hub components’ design and material properties are balanced to ensure the sealing force is sufficient to withstand negative pressure conditions, such as vacuum pressure generated during aspiration, while the drag force remains low enough for axial manipulation of instruments with minimal effort. In embodiments, this minimal force may range from about 5 to 15 newtons. Actuation of the one or more levers 305 to the engaged state reduces compression of the elastomeric member 505, thereby facilitating insertion of the instrument 705 into the lumen. When the one or more levers 305 are returned to the released state, the elastomeric member 505 increases compression around the instrument 705 to maintain a seal.

[0065] The hemostasis valve may further include a side port 710 in fluid communication with the lumen, the side port 710 being configured to function as an aspiration port, an infusion port, or a combination thereof. In some embodiments, the side port 710 may be coupled to an external device, such as an aspiration tool or infusion tool, to provide fluid communication with the fluid flow path while the instrument 705 is positioned within the lumen.Attorney Docket: INM_005PCT

[0066] Referring to FIG. 8, FIG. 8 is yet another cross-sectional illustration 800 of the disclosed hemostasis valve from a side view, showing the one or more levers 305 in a released state and an instrument 705 inserted into the fluid flow path through a lumen of the hemostasis valve. As shown in the illustration, the one or more levers 305 are released, allowing a bias to increase a force applied to the elastomeric member 505, and causing the elastomeric member 505 to conform to the instrument 705 inserted into the fluid flow path and form a seal around the instrument 705. In this released state, compression of the elastomeric member 505 against a tapered bore of a hub or valve body increases, thereby enhancing sealing of the lumen while the instrument 705 is present. The elastomeric member 505 may maintain sealing contact with the instrument 705 while permitting limited axial movement of the instrument 705 through the lumen.

[0067] Referring to FIG. 9, FIG. 9 is a set of photographs 900 of the disclosed hemostasis Valve being operated by an operator. A first photograph 905 shows the hemostasis valve in a released state of one or more levers, while the second photograph 910 shows the hemostasis valve in an engaged state of the one or more levers. As seen in the photographs, the spacing of the one or more levers is ergonomically designed for a typical operator’s hand, thereby facilitating single-handed actuation of the hemostasis valve. In some embodiments, an actuating force of approximately 2 to 4 pounds may be used to move the one or more levers to the engaged state. Furthermore, the valve’s design allows the operator to feel and operate it without the need for direct visual confirmation. This enables tactile feedback during operation and facilitates use in procedures where visual attention is directed elsewhere.

[0068] Referring to FIG. 10, FIG. 10 is a set of photographs 1000 of the disclosed hemostasis valve being operated by an operator. The first photograph 1005 shows the hemostasis valve in a released state of one or more levers. A second photograph 1010 shows the fluid flow path while the hemostasis valve is in the released state. A third photograph 1015 shows the hemostasis valve in an engaged state of the one or more levers. A fourth photograph 1020 shows the fluid flow path in an engaged state.

[0069] As shown in the second photograph 1010 and the fourth photograph 1020, the fluid flow path substantially closed when the one or more levers are in the released state due toAttorney Docket: INM_005PCTcompression of an elastomeric member, and the fluid flow path is opened or enlarged when the one or more levers are in the engaged state due to reduced compression of the elastomeric member. Variables that impact the performance of the hemostasis valve include the elastomeric member 505, the hub body geometry, the compression spring force, and the mechanical advantage provided by the one or more levers 305.

[0070] Referring to FIG. 11, FIG. 11 is an illustration 1100 of an embodiment of the elastomeric member 505. The elastomeric member is designed to be soft or compliant, such that the deformation forces required to seal the hemostasis valve remain relatively low. In some embodiments, a force applied by a bias to compress the elastomeric member 505 may be in a range of about 11 to 40 pounds over a range of motion. The material properties of the elastomeric member are selected so that it can return to an open or uncompressed or less-compressed configuration due to its material resilience. In embodiments, the durometer range of the elastomeric member may be between about 0 and 10 on the Shore A scale. The elastomeric member is disk-shaped with a hole along the longitudinal axis, as shown at the base of the elastomeric member. Additionally, the elastomeric member 505may feature a slight taper from its outer diameter toward its inner diameter to facilitate compression against a tapered bore of a hub or valve body and enhance sealing performance.

[0071] Referring to FIG. 12, FIG. 12 is a cross-sectional view 1200 of the hemostasis valve showing the elastomeric member 505 in a sealed or closed state. As previously discussed, the elastomeric member 505 may seal the fluid flow path in response to compression from the hollow spool 515, which is urged toward the elastomeric member 505 by a bias, such as a compression spring 510, and applies a force to the elastomeric member 505. In embodiments, the compression spring 510 may be configured to apply a force of about 10 to 40 pounds over a range of motion of approximately one quarter inch. The one or more levers 305 mechanical advantage shall be such that the force required by a clinical operator is less than 5 pounds. The mechanical advantage may exceed 8 times.

[0072] In embodiments, the hub body geometry may feature a tapered bore having an angle between about 11 and 32 degrees. This taper helps the elastomeric member 505 deform inwardly to close a lumen and form a seal when compressed, and to return toward an uncompressedAttorney Docket: INM_005PCTconfiguration when compression is reduced. As depicted in the illustration, the hub body 1210 is tapered where it interfaces 1205 with the elastomeric member 505, such that compression of the elastomeric member 505 against the tapered bore enhances sealing of the fluid flow path.

[0073] Referring to FIG. 13, FIG. 13 is a cross-sectional view 1300 of the hemostasis valve, showing movement of the hollow spool 515 as the one or more levers 305 are moved to the engaged state. As indicated by the arrows in the cross-sectional view, an actuation force is applied to the one or more levers, causing the hollow spool 515 to move relative to the elastomeric member 505. This movement compresses a bias, such as a compression spring, and reduces a force applied to the elastomeric member 505, thereby reducing compression of the elastomeric member 505 against a tapered bore of a hub or valve body. As compression of the elastomeric member 505 is reduced, an opening through a lumen increases, allowing passage of one or more instruments through the fluid flow path.

[0074] In some embodiments, the hollow spool 515 and / or associated components may function similarly to a plunger that translates actuation force from the one or more levers 305 to the elastomeric member 505. In such embodiments, movement of the plunger relative to the elastomeric member 505 reduces compression of the elastomeric member 505 to facilitate device passage. Upon release of the one or more levers 305, the bias urges the hollow spool 515 toward the elastomeric member 505 to increase compression and re-establish sealing of the lumen.

[0075] Referring to FIG. 14, FIG. 14 is a blown-up view 1400 of an embodiment of the hemostasis valve. As shown in the blown-up view 1400, the hemostasis valve includes a hub body 1210, one or more levers 305 (e.g., actuation levers), an elastomeric member 505 (or an elastomeric seal), a plunger 520, a compression spring 510, clamshell housings 1405, and alignment pins 1410.

[0076] In some embodiments, the plunger 520 may correspond to or function as a hollow spool that is configured to transmit force from the one or more levers 305 to the elastomeric member 505. The clamshell housings 1405 may be configured to enclose and support internal components of the hemostasis valve, including the compression spring 510 and the plunger 520, and may be secured using the alignment pins 1410. The hub body 1210 may define a lumen extending through the hemostasis valve to provide a fluid flow path.Attorney Docket: INM_005PCT

[0077] Tn operation, actuation of the one or more levers 305 may cause movement of the plunger 520 (or hollow spool), which interacts with the compression spring 510 to control a force applied to the elastomeric member 505, thereby selectively sealing or opening the fluid flow path.Syringe Attachment Port

[0078] In embodiments, the disclosed hemostasis valve may include one or more ports that may be referred to as dry seal couplers. The dry seal coupler may allow easy coupling of one or more tools to the dry seal coupler to open a fluid flow path to the hemostasis valve to the tool. In some embodiments, the dry seal coupler may include a valve mechanism configured to maintain a sealed condition when not coupled to a tool and to open upon coupling to the tool. The one or more ports may include an aspiration port and / or an infusion port, each of which may be in fluid communication with the lumen of the hemostasis valve. In some embodiments, coupling of a tool, such as a syringe, to the dry seal coupler may establish fluid communication with the fluid flow path while maintaining hemostasis.

[0079] Referring to FIG. 15, FIG. 15 is an illustration 1500 of the aspiration tool coupled to the aspiration port 1505 of the disclosed hemostasis valve. The aspiration port 1505 may enable users to easily couple and decouple the aspiration tool from the hemostasis valve. Additionally, the aspiration port 1505 may minimize blood leakage or drips during coupling and decoupling. The aspiration port 1505 may also allow for syringe aspiration without the need to actuate a valve, such as a stopcock valve. In some embodiments, the aspiration port 1505 includes a female coupling at a terminal end of a fluid flow path of the hemostasis valve. The aspiration tool 205 (e.g„ syringe) may include or be coupled to a male coupling having a hollow bore configured to interface with the female coupling.

[0080] In some embodiments, an elastomeric member may be disposed within the aspiration port 1505, the elastomeric member comprising a cross-slit seal configured to seal the fluid flow path when not penetrated by the male coupling. Upon coupling of the aspiration tool to the aspiration port 1505, the hollow bore of the male coupling may penetrate the cross-slit seal to open the fluid flow path and enable aspiration.Attorney Docket: INM_005PCT

[0081] The aspiration port 1505 may include dry-seal coupling fittings configured to maintain a sealed condition when the aspiration tool is decoupled and to automatically open upon coupling. In some embodiments, the aspiration port 1505 may be configured to prevent ingress of air and egress of fluid during both coupled and decoupled states.

[0082] Referring to FIG. 16, FIG. 16 is an illustration 1600 of the aspiration tool coupled to the aspiration port of the disclosed hemostasis valve. The illustration 1600 shows a traditional aspiration tool configuration that may be replaced by the disclosed dry-seal device method or dry-seal coupling approach. The traditional aspiration port 1615 is coupled to an aspiration tool 205 through a stopcock 1610. In such traditional configurations, the stopcock 1610 is manually actuated to selectively open or close fluid communication between the aspiration tool 205 and a fluid flow path of the hemostasis valve.

[0083] The stopcock 1610 may introduce additional steps during operation, including manual manipulation to establish or interrupt fluid communication, and may present potential leakage paths during coupling and decoupling. In contrast, the disclosed aspiration port (e.g., aspiration port 1505 described with respect to FIG. 15) may eliminate the need for a stopcock by providing a coupling mechanism that automatically opens a fluid flow path upon coupling to the aspiration tool and seals the fluid flow path upon decoupling.

[0084] In some embodiments, the traditional aspiration port 1615 may be replaced with a dryseal coupling including a female coupling and an elastomeric member having a cross-slit seal, such that coupling of the aspiration tool establishes fluid communication without manual actuation of a valve. This configuration may reduce procedural complexity and minimize fluid leakage and air ingress.

[0085] Referring to FIG. 17, FIG. 17 shows illustrations 1700 of a disclosed hemostasis valve, including a stopcock valve 1705 on the aspiration port and a female coupling dry seal 1710 on the aspiration port. The illustrations 1700 may represent alternative embodiments or configurations of an aspiration port of the hemostasis valve. The stopcock valve 1705 may be manipulated by hand to open and close the fluid flow path to the hemostasis valve. In such embodiments, the stopcock valve 1705 provides selective manual control of fluid communication between an aspiration tool and a lumen of the hemostasis valve. The female coupling dry sealAttorney Docket: INM_005PCT1710 may automatically open when coupled to an aspiration tool or infusion tool, and automatically close when the tool is removed. In some embodiments, the female coupling dry seal 1710 includes a coupling interface configured to receive a corresponding male coupling of the aspiration tool.

[0086] The female coupling of the dry seal may include a cross-slit elastomeric member to maintain a secure seal. The cross-slit elastomeric member may be configured to remain closed in the absence of a penetrating component and to open upon insertion of a hollow bore of a male coupling associated with the aspiration tool. When decoupled from the tool, the female coupling of the dry seal may prevent any fluid leakage. In some embodiments, the female coupling dry seal 1710 may further prevent ingress of air into the fluid flow path when uncoupled. FIG. 18 below displays photographs of embodiments of the elastomeric cross-slit seal.

[0087] Referring to FIG. 18, FIG. 18 shows photographs 1800 of a front and backside of an embodiment of a cross-slit elastomeric seal that may be inserted into an aspiration port. The cross-slit 1815 elastomeric seal 1805 may also be inserted into an aspiration port. The photograph 1800 shows a bottom view of the elastomeric cross-slit seal. In some embodiments, the cross-slit elastomeric seal 1805 may correspond to the cross-slit elastomeric member described with respect to the aspiration port. The cross-slit 1815 may be arranged to form intersecting slits that remain closed in an unstressed condition.

[0088] The photograph 1810 shows a top view of the elastomeric cross-slit 1820 seal. The elastomeric cross-slit seal features two crosswise slits that open when a hollow bore penetrates the seal. Thus, a syringe with a male coupling designed for the dry seal coupling can directly connect the fluid flow path of an aspiration catheter to the aspiration port and the syringe. In some embodiments, the crosswise slits may be configured to elastically deform to accommodate insertion of the hollow bore and to return to a closed configuration upon removal of the hollow bore. The geometry and thickness of the elastomeric cross-slit seal may be selected to balance sealing performance with ease of penetration by the male coupling.

[0089] Referring to Fig. 19, FIG. 19 shows illustrations 1900 of an embodiment of the aspiration port before 1905 being coupled to an aspiration tool, while 1910 illustrates the aspiration port being coupled to an aspiration tool, and 1915 illustrates the aspiration port afterAttorney Docket: INM_005PCTbeing decoupled from an aspiration tool. As shown in the illustrations 1900, the hemostasis valve includes an aspiration port with a female coupling and a dry seal. In some embodiments, the dry seal includes a cross-slit elastomeric member. When the female coupling is in a decoupled state, the fluid flow path remains sealed because the elastomeric cross-slit seal is not penetrated by the hollow bore.

[0090] A tool inserted into the female coupling contains the hollow bore that penetrates the elastomeric cross-slit seal. In some embodiments, the tool includes a male coupling having the hollow bore configured to interface with the female coupling. When the aspiration tool or infusion tool is inserted into the female coupling, the hollow bore penetrates the elastomeric seal, thereby opening a fluid flow path at the aspiration port. Upon decoupling the tool from the aspiration port, the elastomeric seal closes, effectively sealing the fluid flow path again. The cross-slit elastomeric member may elastically return to a closed configuration upon removal of the hollow bore, thereby maintaining a sealed condition. In embodiments, the aspiration port may feature a tab that can be depressed to decouple the aspiration or infusion tool from the port. In some embodiments, the tab may form part of a release mechanism configured to disengage the male coupling from the female coupling.

[0091] Referring to FIG. 20, FIG. 20 is a partially transparent view 2000 of an embodiment of the aspiration tool and aspiration port, showing the placement of the elastomeric cross-slit seal 2010. In some embodiments, the elastomeric cross-slit seal 2010 corresponds to a cross-slit elastomeric member disposed within a female coupling of the aspiration port. The aspiration tool 2005 can be inserted into the female coupling, the aspiration tool 2005 including or being coupled to a male coupling having a hollow bore, penetrating the elastomeric cross-slit seal. Once penetrated, the elastomeric cross-slit seal opens a fluid flow path.

[0092] The hollow bore of the male coupling may provide fluid communication between the aspiration tool 2005 and the fluid flow path of the hemostasis valve. In some embodiments, the male coupling 2005 may include an elongated or tapered tip configured to facilitate penetration of the elastomeric cross-slit seal 2010 while minimizing damage to the elastomeric material. Upon removal of the male coupling from the female coupling, the elastomeric cross-slit seal 2010 may return to a closed configuration to reseal the fluid flow path.Attorney Docket: INM_005PCT

[0093] Referring to FIG. 21, FIG. 1 is a cross-sectional view 2100 of an embodiment of the aspiration tool coupled to an aspiration port. The male fitting of the aspiration tool crosses the elastomeric cross-slit seal, the male fitting including or being coupled to a male coupling having a hollow bore, enabling interaction between the aspiration port and aspiration tool to form a seal. In some embodiments, the elastomeric cross-slit seal corresponds to a cross-slit elastomeric member disposed within a female coupling of the aspiration port. The elastomeric cross-slit seal provides an O-ring seal 2105 between the couplings, effectively resisting leakage under aspiration pressures of 1 atm vacuum.

[0094] In some embodiments, the elastomeric cross-slit seal may provide both a primary seal via the cross-slit interface and a secondary sealing function via compression against surrounding surfaces, similar to an O-ring configuration. The hollow bore of the male coupling may establish fluid communication through the elastomeric cross-slit seal and into a fluid flow path of the hemostasis valve. In some embodiments, the sealing configuration may be configured to resist negative pressure conditions generated during aspiration while maintaining minimal leakage and preventing ingress of air.

[0095] Referring to FIG. 22, FIG. 22 shows illustrations 2200 of an embodiment of an aspiration tool 2215 with a check valve 2205, both in a decoupled state and a coupled state 2210. The illustrations 2200 depict the check valve 2205 in a closed state when the aspiration tool 2215 is decoupled (no fluid flow), and in an open state when the aspiration tool 2215 is coupled. In FIG. 22, the illustrations 2200 depict an alternative to the dry seal coupler. The check valve can be twisted into the aspiration tool 2215 to open a fluid flow path between the aspiration port and the aspiration tool.

[0096] In some embodiments, the check valve 2205 includes a coupling mechanism configured to cause the check valve 2205 to be in a closed state when uncoupled and to transition to an open state when coupled to the aspiration tool 2215. In some embodiments, the coupling mechanism includes a threaded or twist-lock interface that causes axial movement of internal components of the check valve 2205 upon rotation of the aspiration tool 2215.

[0097] In some embodiments, the check valve 2205 may include an elastomeric washer and a plunger, the plunger being configured to press the elastomeric washer into a molded fitting toAttorney Docket: INM_005PCTseal a fluid flow path when in the closed state. Upon coupling and twisting of the aspiration tool 2215, the plunger may be displaced to disengage the elastomeric washer from the molded fitting, thereby opening the fluid flow path.

[0098] In some embodiments, a spring may be provided to bias the plunger toward the closed state, such that the check valve 2205 automatically returns to the closed state upon decoupling of the aspiration tool 2215.

[0099] Referring to FIG. 23, FIG. 23 is a transparent view 2300 of an embodiment of the check valve. The check valve includes a plunger 2310 mechanically connected to a spring 2305. The spring and plunger press against a washer 2315. which in turn presses against a molded fitting to seal the aspiration port. In some embodiments, the washer 2315 comprises an elastomeric washer configured to deform against the molded fitting to block a fluid flow path when the check valve is in a closed state. As shown in the transparent view 2300, the check valve can be disengaged from the molded fitting by twisting the check valve into an aspiration tool equipped with the appropriate coupling 2320.

[0100] In some embodiments, twisting engagement of the check valve with the aspiration tool via the coupling 2320 causes axial displacement of the plunger 2310 relative to the elastomeric washer 2315, thereby disengaging the elastomeric washer 2315 from the molded fitting and opening the fluid flow path. The fluid flow path may extend through the coupling 2320 and through the check valve, as illustrated by arrows in the transparent view 2300.

[0101] In some embodiments, the spring 2305 biases the plunger 2310 toward the elastomeric washer 2315 to maintain the check valve in the closed state when uncoupled, and to automatically return the check valve to the closed state upon decoupling. The configuration may be adapted to allow fluid flow in both directions when in the open state while preventing unintended leakage when in the closed state.

[0102] Referring to FIG. 24, FIG. 24 is a blown-up view 2400 of an embodiment of the check valve coupled to an aspiration tool. The check valve in this embodiment includes a molded barb 2405, a spring 2410, a plunger 2415, a silicone washer 2420, a molded component 2425, an O-ring 2430, a molded sleeve 2435. and a connection between the molded sleeve and an aspirationAttorney Docket: INM_005PCTtool. Tn some embodiments, the silicone washer 2420 may comprise an elastomeric washer configured to deform against a molded fitting to seal a fluid flow path when the check valve is in a closed state.

[0103] In some embodiments, the plunger 2415 may be configured to translate relative to the molded component 2425 and the elastomeric washer 2420 in response to coupling of the aspiration tool, thereby selectively opening and closing the fluid flow path. The spring 2410 may be configured to bias the plunger 2415 toward a position in which the elastomeric washer 2420 is pressed against the molded component 2425 to maintain a sealed condition.

[0104] These components are straightforward to mold with standard, unmodified syringes, such as those featuring a large bore greater than 0.35 inches. In some embodiments, dimensions of the components may be selected based on desired flow rates and sealing performance. Additionally, the components may be purchased and bonded using simple fixture and adhesive. In some embodiments, alternative materials and manufacturing techniques, including injection molding, overmolding, or machining may be used to form one or more of the components.

[0105] The O-ring 2430 may provide an additional sealing interface between adjacent components, and the molded sleeve 2435 may provide structural support and alignment for the plunger 2415 and spring 2410. In some embodiments, the check valve may be configured to be integrated with or removably coupled to the aspiration tool via the molded sleeve 2435.

[0106] Referring to FIG. 25, FIG. 25 is an illustration 2500 of a washer 2505 and plunger 2510 of the check valve. The washer 2505 is inserted onto the plunger 2510 within the check valve. In some embodiments, the washer 2505 comprises a silicone washer or an elastomeric washer configured to deform under applied force. The plunger 2510 presses through the washer 2505 by means of a spring, applying force to the molded fitting to seal the check valve when it is in a closed position. In some embodiments, the spring biases the plunger 2510 toward the washer 2505 such that the washer 2505 is compressed against the molded fitting to block a fluid flow path.

[0107] When the check valve is coupled to a tool, the washer 2515 is pushed away from the molded fitting. In some embodiments, coupling of the tool causes axial displacement of theAttorney Docket: INM_005PCTplunger 2510 relative to the washer 2505, thereby reducing compression of the washer 2505 and permitting fluid flow through the check valve. The washer 2505 may elastically return to its sealing position upon decoupling of the tool.

[0108] Referring to FIG. 26, FIG. 26 shows illustration 2600 of a check valve assembly. The first illustration 2610 presents a blown-up view of the check valve with its components separated. These parts can be assembled using a common adhesive 2605. In some embodiments, the adhesive 2605 may comprise a medical-grade adhesive configured to provide a fluid-tight seal between components. In some embodiments, the components may alternatively or additionally be secured using mechanical fastening, interference fits, ultrasonic welding, or overmolding techniques.

[0109] The second illustration 2615 depicts the assembled check valve components, showing the molded barb connected to the spring, which contacts the plunger, the plunger contacting the silicone washer, and the washer pressing against the molded fitting. In some embodiments, the silicone washer comprises an elastomeric washer configured to deform against the molded fitting to seal a fluid flow path when the check valve is in a closed state. The spring may bias the plunger toward the silicone washer to maintain compression of the washer against the molded fitting.

[0110] In operation, displacement of the plunger relative to the molded fitting, such as during coupling of an aspiration tool, may reduce compression of the silicone washer and permit fluid flow through the check valve. Upon removal of the aspiration tool, the spring may return the plunger to a position that re-establishes compression of the silicone washer to seal the fluid flow path.

[0111] Referring to FIG. 27, FIG. 27 is a flow diagram 2700 of a method for aspiration using an embodiment of the disclosed hemostasis valve and aspiration port. The method is designed to enable a medical practitioner, or similar operator, to efficiently operate the hemostasis valve and utilize its coupling mechanisms, reducing the need for complex, multi-hand manipulation. In some embodiments, the method may be performed using one or more of a dry-seal coupling or a check valve coupling as described herein.Attorney Docket: INM_005PCT

[0112] At step 2705 of the process, the medical practitioner navigates an intravascular catheter to a treatment site. The catheter is guided through an embodiment of the disclosed hemostasis valve. For example, the practitioner uses one hand to engage the hemostasis valve, opening a fluid flow path, and another hand to insert the intravascular catheter through this path and into the treatment site. In some embodiments, the hemostasis valve includes an elastomeric member configured to seal around the catheter when the hemostasis valve is in a released state.

[0113] At step 2710 of the process, the practitioner attaches a syringe to the intravascular catheter using a dry seal coupler. The syringe is connected to the aspiration port of the hemostasis valve, which is integrated with the valve’s fluid flow path. The fluid flow path opens automatically upon coupling the syringe to the aspiration port. In some embodiments, the aspiration port includes a female coupling and an elastomeric member comprising a cross-slit seal that is penetrated by a hollow bore of a male coupling of the syringe. In alternative embodiments, the aspiration port includes a check valve configured to open upon coupling of the syringe.

[0114] At step 2715 of the process, the medical practitioner draws the syringe plunger to aspirate materials from the catheter. Since the syringe is coupled to the fluid flow path of the hemostasis valve and to the catheter, this allows materials from the intravascular catheter to be aspirated directly into the syringe. The disclosed hemostasis valve and aspiration port facilitate this aspiration procedure without exposing the materials to the outside environment. In some embodiments, the aspiration port maintains a seal around the coupling during aspiration to prevent leakage and ingress of air.

[0115] At step 2720 of the process, the medical practitioner detaches the syringe containing the aspirated materials. This can be done using one hand and one of the coupling and decoupling mechanisms described in the disclosed subject matter. For example, the practitioner may twist off the syringe utilizing the check valve described herein, or press a release tab to detach the syringe from the aspiration port. Once the syringe is decoupled, the aspiration port automatically seals, closing the fluid flow path and preventing exposure to the outside environment. In some embodiments, the aspiration port returns to a closed state via an elastomeric member or an elastomeric washer biased by a spring, depending on the embodiment.Attorney Docket: INM_005PCT

[0116] A hemostasis valve includes a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; one or more levers, each of the one or more levers having an engaged state and a released state; a bias for each of the one or more levers, where the bias configured to impel the lever toward the released state; and an elastomeric member configured to seal the valve member when the one or more levers are in the released state. The elastomeric member may have a disk shape with a hole through a longitudinal axis of the disk shape. The bias is in mechanical communication with a hollow spool, and the hollow spool is configured to contact the elastomeric member when the one or more levers are in the released state. A longitudinal axis of the hollow spool provides a part of the flow path. The disk shape of the elastomeric member is configured to compress the hole in the disk shape when one or more levers are in the released state. The bias comprises a spring. The spring may be configured to apply a force of about 10-40 pounds over a range of motion of about 1 / 4 inch. The spring may be configured to require the one or more levers to be actuated by an operator by a force of less than about 5 pounds to place the one or more levers in the engaged state. The elastomeric member may be configured to be compressed against a tapered bore of a hub of the hemostasis valve when the one or more levers are in the released state. The tapered bore may have an angle of between about 11 and 32 degrees. The elastomeric member may have a durometer range of about 0 to 10.

[0117] An aspiration port for a hemostasis valve includes a female coupling at a terminal end of a fluid flow path of the hemostasis valve; an elastomeric member disposed in the fluid flow path of the female coupling, where the elastomeric member comprises a cross-slit seal that is configured to seal the fluid flow path when the cross-slit seal is not penetrated; and where the female coupling is configured to be coupled to a male coupling, and the male coupling comprises a hollow bore that is configured to penetrate the cross-slit seal. The aspiration port may further include a release tab on the female coupling, and the release tab may be configured to release the male coupling from the female coupling.

[0118] An alternative aspiration port for a hemostasis valve includes a check valve at a terminal end of a fluid flow path of the hemostasis valve, where the check valve is configured to allow a flow of fluid through the fluid flow path when the check valve is in an open state and to seal the fluid flow path when the check valve is in a closed state; the check valve is configured toAttorney Docket: INM_005PCTcouple to an aspiration tool; and the check valve comprises a coupling mechanism that causes the check valve to be in a closed state when uncoupled and in an open state when the check valve is coupled to the aspiration tool. The check valve may include an elastomeric washer and a plunger coupled to the elastomeric washer, where the plunger is configured to press the elastomeric washer into a molded fitting when the check valve is in a closed state to seal the fluid flow path. The plunger may be pressed into the elastomeric washer by a spring. The aspiration port may further comprise a mechanism that presses against the spring to disengage the plunger and the elastomeric washer from the molded fitting to open the fluid flow path when the check valve is coupled. The mechanism may be engaged by twisting the aspiration tool onto the check valve.

[0119] A method for aspirating a hemostasis valve includes navigating a catheter through a fluid flow path of a hemostasis valve into a vascular system of a subject; connecting an aspiration tool to a terminal end of the hemostasis valve, where the terminal end comprises a branch of the fluid flow path of the hemostasis valve, and where connecting the terminal end opens the fluid flow path to the aspiration tool; activating the aspiration tool to aspirate the fluid flow path; and detaching the aspiration tool from the terminal end of the hemostasis valve, where the detaching causes the terminal end to close the fluid flow path . The terminal end of the hemostasis valve may include a check valve, where the check valve is configured to allow a flow of fluid through the fluid flow path when the check valve is in an open state and to seal the fluid flow path when the check valve is in a closed state; the check valve may be configured to couple to the aspiration tool; and the check valve may comprise a coupling mechanism that causes the check valve to be in a closed state when the check valve is coupled to the aspiration tool.

[0120] Many variations may be made to the embodiments described herein. All variations, including combinations of embodiments, are intended to be included within the scope of this disclosure. The description of the embodiments herein can be practiced in many ways. Any terminology used herein should not be construed as restricting the features or aspects of the disclosed subject matter. The scope should instead be construed in accordance with the appended claims.

Claims

Attorney Docket: INM_005PCTCLAIMS:

1. A hemostasis valve, the hemostasis valve comprising:a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid;one or more levers, each of the one or more levers having an engaged state and a released state;a bias for each of the one or more levers, the bias configured to impel the lever toward the released state; andan elastomeric member configured to seal the valve member when the one or more levers are in the released state.

2. The hemostasis valve of claim 1, wherein the elastomeric member has a disk shape with a hole through a longitudinal axis of the disk shape.

3. The hemostasis valve of claim 1, wherein the bias is in mechanical communication with a hollow spool, the hollow spool is configured to contact the elastomeric member when the one or more levers are in the released state.

4. The hemostasis valve of claim 3, wherein a longitudinal axis of the hollow spool provides a part of the flow path.

5. The hemostasis valve of claim 4, wherein a disk shape of the elastomeric member is configured to compress a hole in the disk shape when the one or more levers are in the released state.

6. The hemostasis valve of claim 5, wherein the bias comprises a spring.

7. The hemostasis valve of claim 6, wherein the spring is configured to apply a force of about 10-40 pounds over a range of motion of about 1 / 4 inch.

8. The hemostasis valve of claim 7, wherein the spring is configured to require the one or more levers to be actuated by an operator by a force of less than about 5 pounds to place the one or more levers in the engaged state.Attorney Docket: INM_005PCT9. The hemostasis valve of claim 5, where in the elastomeric member is configured to be compressed against a tapered bore of a hub of the hemostasis valve when the one or more levers are in the released state.

10. The hemostasis valve of claim 9, wherein the tapered bore has an angle of between about 11 and 32 degrees.

11. The hemostasis valve of claim 9, wherein the elastomeric member has a durometer in a range of about 0 to 10.

12. An aspiration port for a hemostasis valve, the aspiration port comprising:a female coupling at a terminal end of a fluid flow path of the hemostasis valve; an elastomeric member disposed in the fluid flow path of the female coupling, the elastomeric member comprising a cross-slit seal configured to seal the fluid flow path when the cross-slit seal is not penetrated; andwherein the female coupling is configured to be coupled to a male coupling, the male coupling comprising a hollow bore configured to penetrate the cross-slit seal.

13. The aspiration port of claim 12, further comprising a release tab on the female coupling, the release tab configured to release the male coupling from the female coupling.

14. An aspiration port for a hemostasis valve, the aspiration port comprising:a check valve at a terminal end of a fluid flow path of the hemostasis valve, the check valve configured to allow a flow of fluid through the fluid flow path when the check valve is in an open state and to seal the fluid flow path when the check valve is in a closed state;wherein the check valve is configured to couple to an aspiration tool; and the check valve comprising a coupling mechanism configured to cause the check valve to be in the closed state when the check valve is uncoupled, and in the open state when the check valve is coupled to the aspiration tool.

15. The aspiration port of claim 14, wherein the check valve comprises:an elastomeric washer; andAttorney Docket: INM_005PCTa plunger coupled to the elastomeric washer, the plunger configured to press the elastomeric washer into a molded fitting when the check valve is in the closed state to seal the fluid flow path.

16. The aspiration port of claim 15, wherein the plunger is pressed into the elastomeric washer by a spring.

17. The aspiration port of claim 16, further comprising a mechanism configured to press against the spring to disengage the plunger and the elastomeric washer from the molded fitting to open the fluid flow path when the check valve is coupled.

18. The aspiration port of claim 17, wherein in the mechanism is engaged by twisting the aspiration tool onto the check valve.

19. A method for aspirating fluid through a hemostasis valve, the method comprising:navigating a catheter through a fluid flow path of the hemostasis valve into a vascular system of a subject;connecting an aspiration tool to a terminal end of the hemostasis valve, the terminal end comprising a branch of the fluid flow path, connecting the terminal end to open the fluid flow path to the aspiration tool;activating the aspiration tool to aspirate fluid through the fluid flow path; and detaching the aspiration tool from the terminal end of the hemostasis valve, the detaching causing the terminal end to close the fluid flow path.

20. The method of claim 19, wherein the terminal end of the hemostasis valve comprises a check valve, the check valve configured to allow a flow of fluid through the fluid flow path when the check valve is in an open state and to seal the fluid flow path when the check valve is in a closed state;wherein the check valve is configured to couple to the aspiration tool; and wherein the check valve comprising a coupling mechanism that causes the check valve to be in the closed state when the check valve is coupled to the aspiration tool.

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