Hemostatic valve

Abstract

A hemostatic valve for use with an access device such as a catheter. The hemostatic valve may be connected to a housing to which a catheter can be connected. The hemostatic valve may comprise a deformable elastic tubular member having a passageway. The hemostatic valve is adjustable between a first position in which the passageway is sealed and a second position in which the passageway is unsealed. The passageway may be sealed by one or more cams, and these cams may be biased towards the sealing position such that, in the absence of the application of an active force, the cams return to their original position to seal the passageway.

Description

[Technical Field]

[0001] (Related Applications) This application claims the privilege and priority of U.S. Provisional Application No. 63 / 481,358, entitled Hemostatic Valve, filed January 24, 2023, and U.S. Provisional Application No. 63 / 370,058, entitled Hemostatic Valve, filed August 1, 2022, both of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Valves, such as hemostatic valves, are primarily used to maintain hemostasis (e.g., prevent bleeding and hypotension) while one or more devices have access to a patient's vasculature. For example, hemostatic valves are often provided at the proximal end of introducers outside the patient's body to allow guidewires, catheters, or similar devices to be advanced through the patient's vasculature.

[0003] Typically, when using such valves, it is important for the operator to be aware of the valve's state (e.g., open or closed) at all times during the procedure. Failure to recognize that the valve is open can, for example, cause excessive bleeding and, in some cases, allow air to enter the vascular system. In this regard, it can be useful for such valves to be easy to operate (e.g., open and close) to minimize distractions and interruptions during the medical procedure. Summary of the Invention

[0004] The present invention relates generally to hemostasis valves.

[0005] In some exemplary embodiments, the hemostatic valve is connected to an access device such as an introducer or catheter.

[0006] In some exemplary embodiments, the hemostatic valve is connected to a suction device, such as a suction catheter.

[0007] The hemostatic valve may include a tubular member having a passage, one or more cams for selectively sealing the passage of the tubular member, and an actuator for adjusting the plurality of cams. In this specification, for simplicity, there may be references to a plurality of cams, but any of the embodiments of the present invention may alternatively include only one cam instead.

[0008] In some example embodiments, the tubular member may include a gasket.

[0009] In some example embodiments, the plurality of cams may be adjustable between a first position where the plurality of cams deform the tubular member to seal the passage and a second position where the plurality of cams release the tubular member to at least partially unseal the passage.

[0010] In some example embodiments, the plurality of cams may be biased toward a closed position, a contracted position, or a sealed position.

[0011] In some example embodiments, the plurality of cams may include a first cam and a second cam, and the first cam may not be directly connected to the second cam.

[0012] In some example embodiments, the plurality of cams may include two pairs of cams.

[0013] In some example embodiments, the plurality of cams may be swingable between a sealed position and an open position.

[0014] In some example embodiments, the tubular member may be disposed between the first cam and the second cam.

[0015] In some example embodiments, the tubular member may be sandwiched between the first cam and the second cam when the first cam and the second cam are in the sealed position.

[0016] In some example embodiments, four cams may be arranged radially on the outer periphery of the tubular member.

[0017] In some example embodiments, each of the plurality of cams may be arranged along the same radial plane.

[0018] In some example embodiments, the plurality of cams may be oscillated together such that by oscillating one of the plurality of cams, the remaining ones of the plurality of cams also oscillate.

[0019] In some example embodiments, the plurality of cams may each be oscillatable separately and independently.

[0020] In some example embodiments, one or more biasing members may be connected to the plurality of cams to bias the cams toward the closed position.

[0021] In some example embodiments, a first biasing member may be connected between the first cam and the actuator, and a second biasing member may be connected between the second cam and the actuator.

[0022] In some example embodiments, one or more biasing members may comprise one or more springs such as coil springs.

[0023] In some example embodiments, the actuator may comprise a ring member having a flange for engaging the plurality of cams.

[0024] In some example embodiments, the actuator may be rotatable to adjust the plurality of cams between a closed position and an open position.

[0025] In some example embodiments, each of the plurality of cams may be pivotally connected to a pin such that the cam pivots about the pin or pivots with the pin.

[0026] In some example embodiments, the present invention may comprise a housing having an internal lumen for connection to a catheter, the tubular member may be connected to the housing, and the passage of the tubular member may be fluidly connected to the internal lumen of the housing.

Brief Description of the Drawings

[0027] These and other aspects, features, and advantages made possible by the implementation of the present invention will become clear and understood from the following description of the embodiments of the present invention made with reference to the accompanying drawings.

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Figure 9B

Mode for Carrying Out the Invention

[0042] Hereinafter, specific embodiments of the present invention will be described with reference to the drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the drawings, like numbers refer to like elements.

[0043] Hemostatic valves are generally used at the proximal opening of a device that accesses a patient's vasculature, such as an introducer, catheter, or catheter hub. The hemostatic valve can pass other devices such as guidewires, catheters, implant delivery devices, and devices similar thereto, and occlude or seal around the device. Accordingly, excessive blood leakage from the vasculature is prevented and hemostasis is maintained within the patient's body.

[0044] The present invention generally relates to a hemostatic valve that can be used in connection with any known medical procedure in which a hemostatic valve is currently used, such as guidewire access, catheter access, implant delivery access, and suction catheter access.

[0045] The hemostatic valve of the present invention may include one or more cams, a portion of which moves between a first position for compressing or applying a radial pressure to a tubular gasket and a second position for allowing radial expansion of the tubular gasket. Accordingly, the one or more cams open or seal the tubular gasket against the tubular gasket itself or around a device disposed through the tubular gasket.

[0046] The hemostatic valve may include one, two, three, four, five, six, or more cams. The cams may be biased to a first position (i.e., the closed position of the valve) via a spring, elastic member, or a component similar thereto. The cams may be connected to an actuator component accessible from outside the valve to enable manual operation of the cams so that the valve can be opened or closed / sealed.

[0047] The cams may be arranged in a radial plane perpendicular to the axis of rotation such that each cam is positioned at the same depth within the valve. However, one or more cams may be arranged such that the one or more cams are not arranged in a radial plane perpendicular to the axis of rotation with the remaining one or more cams, and are positioned at a depth different from that of the remaining one or more cams.

[0048] In the following, examples of specific embodiments will be further described. However, it should be understood that any features of any of the embodiments can be mixed and adapted with each other in any combination. Therefore, the present invention should not be limited to only these embodiments, but should be limited to any broader combination thereof.

[0049] FIG. 1 shows an example of an embodiment of a hemostatic valve 100. In this example, the hemostatic valve 100 is an integral member with the housing 101, but the valve mechanism itself may take the form of a stand-alone valve device that is directly connected to another medical device (e.g., a catheter hub of a catheter). Various types of housings 101 can be employed, and thus the example of the illustrated embodiment should not be construed as limiting with respect to, for example, the shape, size, configuration, number of ports, etc. of the housing 101. The housing 101 may include at least one internal lumen 101A as shown in FIGS. 2A and 5, and through this internal lumen 101A, insertion and removal of a medical device with respect to the housing 101 can be performed. In some embodiments, the housing 101 may further include additional lumens. Also, in some embodiments, the housing 101 may include additional ports such that each port has its own one or more lumens.

[0050] Continuing to refer to FIG. 1, it can be seen that an access device such as catheter 110 may be connected to housing 101. The access device may be fixed to housing 101, removably attached to housing 101, or integrated with housing 101. By removably connecting catheter 110 to housing 101, it may be possible to replace it with various types of catheters 110 as needed.

[0051] In the illustrated exemplary embodiment, it can be seen that housing 101 may include, at its distal end, a connector 101B to which catheter 110 or catheter hub 109 can be attached. Connector 101B may include a threaded portion so that catheter 110, an adapter, or other connection structure can be screwed on and attached. The figure shows an embodiment in which connector 101B includes an outer threaded portion (e.g., male threaded portion) and catheter hub 109 includes an inner threaded portion (e.g., female threaded portion). In some embodiments, the reverse configuration may be employed (e.g., catheter 110 may include an inner threaded portion (e.g., ring with inner threads) and catheter hub 109 may include an outer threaded portion). It should also be noted that in some embodiments, another type of connector 101B to which catheter 110, catheter hub 109, or adapter can be attached may be employed. Further, in another embodiment, as described above, an access device such as catheter 110 may be integral with housing 101.

[0052] A variety of access devices can be connected to or integrated with the housing 101, and the specific configuration of the catheter 110 shown should not be construed as limiting the scope. In one example of an embodiment, the aspiration catheter 110 can be connected to the housing 101, and another catheter (e.g., an implant delivery catheter or a drug balloon catheter) can be advanced through the lumen of the valve. In another example of an embodiment, without limitation, various types of catheters 110 known to those skilled in the art, such as diagnostic catheters, microcatheters, etc., can be connected to the housing 101.

[0053] The hemostatic valve 100 can generally be integral with the housing 101 as shown in FIG. 1. In an example of an embodiment, the hemostatic valve 100 can be connected to the housing 101. In some embodiments, the hemostatic valve 100 can be fixed to the housing 101 or removably connected to the housing 101. The hemostatic valve 100 can be disposed within the housing 101 as shown. In such an embodiment, the housing 101 may include an internal cavity in which the hemostatic valve 100 is disposed.

[0054] Figures 2A - 2B are exploded views showing various components of an example embodiment of the hemostatic valve 100. As shown in Figures 2A - 2B, the hemostatic valve 100 may include a tubular member 102, one or more cams 105A, 105B for selectively sealing the passage 102A of the tubular member, and an actuator 106 for adjusting the cams 105A, 105B between at least two positions (e.g., a sealed / closed position and a seal - released / open position).

[0055] The shape, size, position, orientation, and configuration of the tubular member 102 may vary in different embodiments. In the example of the illustrated embodiment, the tubular member 102 is shown as comprising a cylindrical body having an internal passage 102A. Thus, in the illustrated embodiment, the tubular member 102 may have a circular cross-section. However, in another embodiment, the shape of the tubular member 102 may be different from that shown in the exemplary figures. For example, the tubular member 102 may have a triangular, rectangular, oval, or square cross-section in some embodiments.

[0056] The tubular member 102 may be composed of a flexible or semi-rigid member having a passage 102A extending therethrough. The tubular member 102 may have elasticity. In a preferred embodiment, the tubular member 102 may be configured of a deformable material such that the tubular member 102 can be deformed to seal the passage 102A or the deformation can be released to unseal the passage 102A.

[0057] As an example, without limitation, the tubular member 102 may be composed of various deformable and elastic polymers, rubbers, or other materials such that when no force is applied, the tubular member 102 returns to a shape in which the passage 102A is not blocked (i.e., not sealed). As another method, by configuring the tubular member 102 of a shape memory material, the tubular member 102 may have shape memory such that when not constrained (e.g., by cams 105A, 105B as described herein), the tubular member 102 returns to a tubular shape and the passage 102A is not sealed.

[0058] In an example of an embodiment, the tubular member 102 may function as a gasket for sealing or unsealing the passage 102A. As described herein, the tubular member 102 may be deformed to seal the passage 102A, for example, by applying a force (such as a clamping force) by one or more cams 105A, 105B. When released, the tubular member 102 preferably at least partially returns to its original shape in which the passage 102A is unsealed.

[0059] Figures 3A - 4B and 5A - 5B show a pair of cams 105A, 105B disposed sandwiching the tubular member 102. The cams 105A, 105B may generally be operable to deform the tubular member 102 (e.g., by clamping or compressing) to seal the passage 102A. The shape, size, orientation, position, and number of the cams 105A, 105B may vary in different embodiments and thus should not be construed as limited to the specific configuration shown in the illustrative figures.

[0060] In an example of an embodiment, the cams 105A, 105B may be disposed at opposing positions sandwiching the tubular member 102. For example, in a cylindrical embodiment of the tubular member 102, the cams 105A, 105B may be 180 degrees apart along the outer periphery of the tubular member 102. However, it should be understood that various other positions may be employed (e.g., in some embodiments, the cams 105A, 105B may be disposed adjacent to each other).

[0061] Cams 105A and 105B are best shown in FIGS. 4A and 4B. As shown, in an example of an embodiment, cams 105A and 105B may have the same shape and size but opposite orientations. However, in some embodiments, cams 105A and 105B may have different shapes or sizes. Each of cams 105A and 105B may include an opening through which pins 103A and 103B can pass, as will be described in more detail below. In another embodiment, cams 105A and 105B may be configured to move or swing around pins 103A and 103B, or both cams 105A and 105B and pins 103A and 103B may be configured to rotate integrally with respect to the remaining portion of valve 100.

[0062] Continuing to refer to FIGS. 4A and 4B, each of cams 105A and 105B may include a curved outer surface and a flat inner surface. That is, the first cam 105A may include a first curved outer surface 105C and a first flat inner surface 105D, and the second cam 105B may include a second curved outer surface 105E and a second flat inner surface 105F. However, it should be understood that in some embodiments, the inner surfaces of cams 105A and 105B may be convex, concave, or curved.

[0063] In embodiments having flat inner surfaces, the flat inner surfaces 105D and 105F of each of cams 105A and 105B may be configured to contact tubular member 102 and, when engaged, may deform tubular member 102 to seal passageway 102A. The inner peripheral portions of actuator 106, as will be described in more detail below, may include flat surfaces 106A and 106B that are useful for pressing cams 105A and 105B toward each other and maintaining the seal even when no force is applied. For example, as shown in FIG. 4A, the first flat surface 106A of actuator 106 may engage the first curved outer surface 105C of the first cam 105A, and the second flat surface 106B of actuator 106 may engage the second curved outer surface 105E of the second cam 105B.

[0064] As best shown in FIGS. 4A and 5A, the cams 105A, 105B function together as a vise with a tubular member 102 disposed therebetween, and the flat surfaces 105D, 105F of the cams 105A, 105B are brought close to each other to seal the passage 102A as shown in FIGS. 4A and 6A, and may be separated from each other to unseal the passage 102A as shown in FIGS. 4B and 6B.

[0065] It should be understood that the number of cams 105A, 105B may vary in different embodiments. FIGS. 2A-4B and 6A-6B show a pair of cams 105A, 105B consisting of a first cam 105A and a second cam 105B. However, in some embodiments, only a single cam 105A may be employed. In another embodiment, three or more cams 105A, 105B may be employed. FIGS. 7-9B show a first pair of cams 110A, 110B consisting of a first cam 110A and a second cam 110B, and a second pair of cams 111A, 111B consisting of a third cam 111A and a fourth cam 111B.

[0066] The cams 105A, 105B are generally operable to move between a first position where the cams 105A, 105B apply sufficient force to the tubular member 102 to deform the tubular member 102 and seal the passage 102A, and a second position where the cams 105A, 105B do not apply sufficient force to the tubular member 102 and the passage 102A is unsealed, opened, radially expanded, and / or unconstricted. When sealed, the passage 102A is generally sufficiently constricted, closed, blocked, sealed, or crushed to prevent fluid (e.g., liquid and / or gas) from flowing through the passage 102A.

[0067] When passage 102A is sealed, the distance between respective cams 105A, 105B depends on the diameter of tubular member 102. When releasing the seal of passage 102A, cams 105A, 105B may, in some embodiments, completely release (e.g., not contact) tubular member 102, or in another embodiment, may still contact tubular member 102 but be deformed enough not to have the force to seal it. Thus, in some embodiments, cams 105A, 105B may be in contact with the outer surface of tubular member 102 even when in the unsealed position. In some embodiments, passage 102A may be partially closed but not fully sealed when in the unsealed position.

[0068] Cams 105A, 105B may each have a separate and independent structure as shown. In such embodiments, cams 105A, 105B may not be connected (e.g., directly connected) to each other or may not contact each other. In another embodiment, cams 105A, 105B may be coordinated with each other in various ways.

[0069] The method of adjusting cams 105A, 105B between multiple positions may vary in different embodiments. In the example of the illustrated embodiment, cams 105A, 105B are shown as being swingable between respective positions such that each of cams 105A, 105B swings between a sealed position and an unsealed position. However, in some embodiments, cams 105A, 105B may be adjustable in various non-swinging ways, for example, by sliding or other movement inwardly towards each other or outwardly away from each other.

[0070] In an embodiment where the cams 105A and 105B swing between a plurality of positions, the first cam 105A swings around a first pivot point, and the second cam 105B swings around a second pivot point, such that the first and second pivot points may be spaced apart in the centrifugal direction with respect to each other. Further, the first cam 105A may swing in a first direction, and the second cam 105B may swing in a second direction, such that the first direction is opposite to the second direction.

[0071] Continuing the description of the embodiment where the cams 105A and 105B swing between a plurality of positions, each of the cams 105A and 105B may be connected to pins 103A and 103B. That is, the first cam 105A may be connected to the first pin 103A, and the second cam 105B may be connected to the second pin 103B. In an embodiment employing additional cams 105A and 105b, additional pins 103A and 103B may be employed. Therefore, although only a pair of pins 103A and 103B are shown in the figure, it should be understood that in some embodiments, three or more pins 103A and 103B may be employed.

[0072] Further, in an example of the embodiment, only one pin 103A may be employed (for example, in an embodiment employing only a single cam 105A, or in an embodiment where a plurality of cams 105A and 105B are at least partially overlapped with each other, such as an embodiment where a plurality of cams 105A and 105B are connected to a single pin 103A). Therefore, in an embodiment using only a single cam 105A, only one pin 103A may be employed, and in an embodiment using three or more cams 105A and 105B, three or more pins 103A and 103B may be employed.

[0073] Pins 103A and 103B may function as rocking shaft members for rocking cams 105A and 105B. Each of cams 105A and 105B may rock with the corresponding pins 103A and 103B as fulcrums, or in another embodiment, cams 105A and 105B may be fixed to the corresponding pins 103A and 103B so that cams 105A and 105B rock integrally with the corresponding pins 103A and 103B. Accordingly, each of pins 103A and 103B may be constituted by an elongated member such as a rod. Pins 103A and 103B may be constituted by various types of materials such as, but not limited to, metal, alloy, and polymer.

[0074] In the embodiments shown in FIGS. 4A, 4B, 6A, and 6B, it can be seen that in an example of the embodiment, one or more pins 103A and 103B may be arranged sandwiching the tubular member 102. In the example of the illustrated embodiment, the first pin 103A is shown arranged along the first side of the tubular member 102, and the second pin 103B is shown arranged along the second side of the tubular member 102. In an embodiment where the tubular member 102 is cylindrical, pins 103A and 103B may be 180 degrees apart along the outer periphery of the tubular member 102. However, it should be understood that various other positions may be adopted (for example, in some embodiments, pins 103A and 103B may be arranged adjacent to each other).

[0075] In the embodiments best shown in FIGS. 4A, 4B, 6A, and 6B, it can be seen that each of the pins 103A, 103B may extend through the corresponding cams 105A, 105B. Accordingly, each of the cams 105A, 105B may be provided with an opening through which the pins 103A, 103B can extend. As described above, each of the cams 105A, 105B may be fixed to the pins 103A, 103B such that the cams 105A, 105B swing integrally with the pins 103A, 103B, or each of the cams 105A, 105B may be swingably connected to the pins 103A, 103B such that the cams 105A, 105B swing about the pins 103A, 103B as a fulcrum.

[0076] Each of the pins 103A, 103B may be attached to or fixed to the housing 101 as shown in FIGS. 2A and 2B. In such embodiments, each of the pins 103A, 103B may be fixed within the opening of the housing 101. The method of fixing the pins 103A, 103B to the housing 101 may vary in different embodiments. For example, the pins 103A, 103B may be fixed to the housing 101 by frictional engagement, an adhesive, or the like. In some embodiments, the pins 103A, 103B may be removable from the housing 101. The pins 103A, 103B may be rotatable within the above-described opening of the housing 101 in embodiments where the cams 105A, 105B are fixed to the pins 103A, 103B, or may be fixed within the above-described opening of the housing 101 in embodiments where the cams 105A, 105B swing about the pins 103A, 103B as a fulcrum.

[0077] The cams 105A and 105B may be biased toward a closed or sealed position so that the cams 105A and 105B seal the passage 102A when no force is applied. Since the cams 105A and 105B are biased in a direction to seal the passage 102A, an operator such as a physician can be confident that the passage 102A is sealed when no positive force is applied. This is useful for preventing an error such that the operator may think that the passage is sealed when the passage 102A is not sealed (for example, an un-biased valve, etc.).

[0078] The method of biasing the cams 105A and 105B may vary in different embodiments. In an example of an embodiment, the cams 105A and 105B may be biased by one or more biasing members 104A and 104B. In an example of an embodiment, a single biasing member 104A and 104B may bias a plurality of cams 105A and 105B, such as a pair of cams 105A and 105B, alone. In another embodiment, each of the cams 105A and 105B may be individually biased by one or more biasing members 104A and 104B.

[0079] In an example of the illustrated embodiment, the first cam 105A may be biased by the first biasing member 104A, and the second cam 105B may be biased by the second biasing member 104B. In different embodiments, various types of biasing members 104A and 104B may be employed. In an example of the illustrated embodiment, each of the biasing members 104A and 104B may be configured as a spring. Various types of springs such as a compression spring, a tension spring, a torsion spring, and a constant force spring may be employed. The figure shows an embodiment where each of the biasing members 104A and 104B is configured as a coil spring.

[0080] One or more biasing members 104A, 104B may be such that the first end is attached to the cams 105A, 105B and the second end is attached to the actuator 106. However, it should be understood that in some embodiments, the biasing members 104A, 104B may be attached to various other components. In an example of some embodiments, the first end of each biasing member 104A, 104B may be attached to the corresponding pins 103A, 103B, and the second end of each biasing member 104A, 104B may be attached to the actuator 106.

[0081] In the embodiments shown in FIGS. 6A and 6B, it can be seen that the first end of each biasing member 104A, 104B may include an eyelet having an opening through which the pins 103A, 103B pass. The second end, which is the opposite end of each biasing member 104A, 104B, may optionally include an eyelet having an opening for attaching (e.g., fixing) to the actuator 106.

[0082] As best shown in FIGS. 3A, 3B, 6A, and 6B, additional pins 103C, 103D may be such that the first end is connected to the actuator 106 and the second end is connected to the biasing members 104A, 104B. More specifically, it can be seen that each of the pair of pins 103C, 103D may be fixed within a receiving portion formed in the body of the actuator 106 as best shown in FIGS. 3A and 3B. The second pair of pins 103C, 103D may be the same size as the first pair of pins 103A, 103B or may be of a different size.

[0083] Each of the second pair of pins 103C, 103D may function to fix one of the biasing members 104A, 104B to the actuator 106. In the example of the illustrated embodiment, it can be seen that the third pin 103C may fix the first biasing member 104A to the actuator 106 at the first radial position, and the fourth pin 103D may fix the second biasing member 104B to the actuator 106 at the second radial position.

[0084] Accordingly, in the example of the illustrated embodiment, the first biasing member 104A may be such that the first end is fixed to the first cam 105A by the first pin 103A and the second end is fixed to the actuator 106 by the third pin 103C. Similarly, the second biasing member 104B may be such that the first end is fixed to the second cam 105B by the second pin 103B and the second end is fixed to the actuator 106 by the fourth pin 103D.

[0085] When each of the cams 105A, 105B moves toward the open position or the unsealing position, for example, by the operation (e.g., rotation) of the actuator 106, each of the biasing members 104A, 104B extends, i.e., becomes longer, as shown in FIGS. 6A and 6B. When the actuator 106 is released, each of the biasing members 104A, 104B naturally contracts back to its original state, and the cams 105A, 105B are adjusted to return to the stationary position where the tubular member 102 is sealed.

[0086] Various types of actuators 106 can be employed to unseal the passage 102A. In the example of the embodiment best shown in the figure, an actuator 106 is shown, and this actuator 106 may include a circular ring member configured to unseal the passage 102A by rotating to adjust the cams 105A, 105B. However, it should be understood that the shape, size, and configuration of the actuator 106 may vary in different embodiments. Accordingly, the scope of the present invention should not be construed as being limited to the circular ring-shaped actuator 106 as illustratively shown in the figures.

[0087] An example of an embodiment of the illustrated actuator 106 may include an outer edge (e.g., an outer circumference) and an inner edge (e.g., an inner circumference) that defines a central opening. The outer edge of the actuator 106 may include grooves, ribs, protrusions, etc. to improve the grip. The inner edge of the actuator 106 may include one or more flat surfaces 106A, 106B for engaging the cams 105A, 105B when in the sealed position, as shown in FIGS. 4A and 6A. More specifically, it can be seen that when in the sealed position, the first flat surface 106A of the inner edge of the central opening of the actuator 106 engages the first cam 105A, and the second flat surface 106B of the inner edge of the central opening of the actuator 106 engages the second cam 105B. In some embodiments, the inner edge of the actuator 106 may include one or more flanges to assist in holding and engaging the cams 105A, 105B.

[0088] In some embodiments, the actuator 106 may not include a circular ring member, or may include additional features connected to the circular ring member. In such embodiments, the actuator 106 may include, for example, one or more levers, one or more buttons, etc., or may further include them. For example, a handle, lever, button, or actuator, etc. may be connected to the ring member or formed integrally with the ring member to assist in adjusting the ring member. The actuator 106 may have a shape other than the illustrated circular shape. As an example, in some embodiments, the actuator 106 may be square.

[0089] The method of adjusting the actuator 106 to release the seal of the passage 102A may vary in different embodiments. In the illustrated embodiment, it can be seen that the actuator 106 rotates in a first direction to release the seal of the passage 102A and rotates in a second direction to seal the passage 102A. More specifically, it can be seen that the actuator 106 may rotate in the counterclockwise direction to release the seal of the passage 102A and rotate in the clockwise direction to seal the passage 102A.

[0090] However, it should be understood that in some embodiments, clockwise rotation may be alternatively employed to release the seal of the passage 102A, and counterclockwise rotation may be alternatively employed to seal the passage 102A. In either case, the actuator 106 is actively rotated to release the seal of the passage 102A and, when released, may passively return to its original position (e.g., without applying any input or force) to seal the passage 102A, for example, by the action of the biasing members 104A, 104B.

[0091] Referring to FIGS. 1 to 2B, it can be seen that a cap 107 may be connected to the end of the actuator 106. The cap 107 functions to surround the tubular member 102, the pins 103A, 103B, the biasing members 104A, 104B, and the cams 105A, 105B, and may prevent the intrusion of fine particles such as dust that may impair the operation of the biasing members 104A, 104B or the cams 105A, 105B, and / or prevent contact of these members with fluids such as blood or other body fluids. The figure shows an embodiment where the cap 107 is circular, but it should be understood that in certain embodiments, the cap 107 may have various other shapes.

[0092] The cap 107 may be removably attached to the actuator 106 so that the cap 107 can be removed to access the inside of the hemostatic valve 100, or the cap 107 may be fixed to the actuator 106. The cap 107 may include a cap inlet 107A such as a central opening as shown in the figure, whereby various medical devices may be inserted into the passage 102A or fluidly connected to the passage 102A when not sealed. In an exemplary embodiment, the pins 103A, 103B may be fixed to the cap 107. In such an embodiment, the cap 107 may include an opening through which the pins 103A, 103B extend or an opening to which the pins 103A, 103B are attached.

[0093] Figures 7 to 9B show examples of embodiments of the hemostatic valve 100 including two pairs of cams 110A, 110B, 111A, 111B. The first pair of cams 110A, 110B composed of the first cam 110A and the second cam 110B may be arranged along a first radial plane. The second pair of cams 111A, 111B composed of the third cam 111A and the fourth cam 111B may be arranged along a second radial plane. Both the first and second radial planes may be orthogonal to the swing axis of the cams 110A, 110B, 111A, 111B.

[0094] As shown in FIG. 7, the cams 110A, 110B, 111A, 111B may be connected to the housing 101 by one or more pins 103A, 103B, 103C, 103D. Each of the pins 103A, 103B, 103C, 103D may be attached to the housing 101. In some exemplary embodiments, the housing 101 includes a number of openings corresponding to the number of pins 103A, 103B, 103C, 103D, and each of the pins 103A, 103B, 103C, 103D may be disposed or fixed within the corresponding opening.

[0095] The opening and the connected pins 103A, 103B, 103C, 103D may be arranged at equal intervals from each other such that each of the pins 103A, 103B, 103C, 103D is equidistant from the remaining pins 103A, 103B, 103C, 103D. As shown in FIG. 7, the first cam 110A is attached so as to swing about the first pin 103A, the second cam 110B is attached so as to swing about the second pin 103B, the third cam 111A is attached so as to swing about the third pin 103C, and the fourth cam 111B may be attached so as to swing about the fourth pin 103D.

[0096] Alternatively, in an example of another embodiment, the pins 103A, 103B, 103C, 103D may themselves be rotatably connected to the housing 101, and each of the pins 103A, 103B, 103C, 103D may be rotatable with respect to the housing 101. In an example of such an embodiment, the cams 110A, 110B, 111A, 111B may be fixed to the respective pins 103A, 103B, 103C, 103D, and when the respective pins 103A, 103B, 103C, 103D rotate, the corresponding cams 110A, 110B, 111A, 111B may swing.

[0097] As described above, the figure shows an example of an embodiment in which the pins 103A, 103B, 103C, 103D are provided on the cams 110A, 110B, 111A, 111B, respectively. However, in some example embodiments, a plurality of cams 110A, 110B, 111A, 111B may share the pins 103A, 103B, 103C, 103D.

[0098] Continuing to refer to FIG. 7, it can be seen that a pair of biasing members 104A and 104B, such as springs, may be employed to bias each of the cams 110A, 110B, 111A, and 111B toward a desired position. In the example of the embodiment shown in FIG. 7, it can be seen that a pair of biasing members 104A and 104B may function to bias all of the four cams 110A, 110B, 111A, and 111B. In an example of another embodiment, each of the cams 110A, 110B, 111A, and 111B may have its own biasing member 104A and 104B.

[0099] Each of the biasing members 104A and 104B may have its first end connected to one of the pins 103A, 103B, 103C, and 103D. In the example of the embodiment shown in FIGS. 7 to 9B, it can be seen that the first biasing member 104A may be attached to the first pin 103A and the second biasing member 104B may be attached to the second pin 103B. However, the number, position, and orientation of the biasing members 104A and 104B may vary in different embodiments.

[0100] As described above, the second end of each of the biasing members 104A and 104B may be attached to the actuator 106. The rotation of the actuator 106 may be made operable to swing the cams 110A, 110B, 111A, and 111B as described herein. Generally, the rotation of the actuator 106 in the first direction may swing all or part of the cams 110A, 110B, 111A, and 111B in the first direction, and the rotation of the actuator 106 in the second direction may swing all or part of the cams 110A, 110B, 111A, and 111B in the second direction.

[0101] As described above, the cap 107 may be attached to the actuator 106. In the example of the embodiment shown in FIG. 7, the cap 107 includes one or more protrusions, and the one or more protrusions are engaged with corresponding depressions such as grooves or slits on the outer periphery of the actuator 106, and by coupling the cap 107 to the actuator 106, it can be seen that the cams 110A, 110B, 111A, 111B may be substantially surrounded.

[0102] The cams 110A, 110B, 111A, 111B are arranged radially around the tubular member 102, and when engaged for sealing or the like, the cams 110A, 110B, 111A, 111B may deform the tubular member 102, for example, by pinching, thereby sealing the passage 102A passing through the tubular member 102. By using four cams 110A, 110B, 111A, 111B, the tubular member 102 can be sealed more effectively than in examples of embodiments using a smaller number of cams, and furthermore, redundancy can be obtained in the case where one or more of the cams 110A, 110B, 111A, 111B do not function.

[0103] As shown in FIGS. 7 to 9B, the actuator 106 may include one or more protrusions 115A, 115B, 115C, 115D that can function to guide and / or drive the cams 110A, 110B, 111A, 111B between their respective swingable positions. Each of the protrusions 115A, 115B, 115C, 115D may include a semi-circular protrusion extending inward from the actuator 106 as shown.

[0104] The number, position, spacing, and orientation of the protrusions 115A, 115B, 115C, 115D may vary in different embodiments. Generally, the protrusions 115A, 115B, 115C, 115D may be arranged radially and equidistantly around the inner diameter of the actuator 106, as best shown in FIGS. 8A to 8B.

[0105] In the example of the embodiment shown in FIGS. 7 to 9B, it can be seen that the first protrusion 115A may engage with the first cam 110A, the second protrusion 115B may engage with the second cam 110B, the third protrusion 115C may engage with the third cam 111A, and the fourth protrusion 115D may engage with the fourth cam 111B.

[0106] In some example embodiments, the number of the protrusions 115A, 115B, 115C, 115D may be the same as the number of the cams 110A, 110B, 111A, 111A, 111B, and each of the cams 110A, 110B, 111A, 111B may be actuated by a dedicated individual protrusion 115A, 115B, 115C, 115D, respectively. In another embodiment, fewer protrusions 115A, 115B, 115C, 115D than the cams 110A, 110B, 111A, 111B may be provided, and two or more of the cams 110A, 110B, 111A, 111B may share the protrusions 115A, 115B, 115C, 115D.

[0107] Each of the cams 110A, 110B, 111A, 111B may be provided with an inwardly curved portion at its outer edge, and the respective protrusions 115A, 115B, 115C, 115D may engage with this inwardly curved portion to adjust the cams 110A, 110B, 111A, 111B. However, various other configurations and shapes may be adopted in different embodiments as long as sufficient force is applied by the rotational movement of the actuator 106 to cause the rocking movement of the cams 110A, 110B, 111A, 111B.

[0108] In embodiments where the catheter 110 or access device is not integral with or pre - fixed to the housing 101 during use, the catheter 110 or other access device may first be attached to the distal end of the housing 101. Next, the catheter 110 may be inserted into the patient's body by an operator and fed to a desired position to perform its function (e.g., aspiration). Alternatively, these procedures may be reversed, first inserting an access device such as the catheter 110 into the patient's body, feeding it to a desired position, and then attaching the access device such as the catheter 110 to the housing 101.

[0109] When no force is applied, when the catheter 110 or other access device is fed through the body to a desired position, the passage 102A remains sealed. Thus, the operator can be assured that there is no intrusion of fluid, air, etc. into the body, except when necessary. When the catheter 110 or other access device reaches the target position, the hemostatic valve 100 may be operated.

[0110] Figures 3A, 4A, 6A, 8A, and 9A show examples of embodiments of the hemostatic valve 100 in the sealed position, and Figures 3B, 4B, 6B, 8B, and 9B show examples of embodiments of the hemostatic valve 100 in the unsealed position. In one example of an embodiment, the hemostatic valve 100 can be unsealed by rotating the actuator 106. However, as described above, it should be understood that various other types of actuators 106 may be employed and the hemostatic valve 100 may be unsealed using a motion other than rotational motion. For example, in some embodiments, instead, the actuator 106 may be tightened to unseal the hemostatic valve 100.

[0111] Continuing to refer to the illustrated embodiment, it can be seen that the actuator 106 may be rotated in a first direction to at least partially release the cams 105A, 105B from the tubular member 102 and unseal the passage 102A. When the actuator 106 is rotated in the first direction, the biasing members 104A, 104B are pulled by the actuator 106, both of the biasing members 104A, 104B are extended, and the cams 105A, 105B may be adjusted toward the unsealed position.

[0112] Figures 4A and 4B show an example of an embodiment in which the first direction for unsealing the passage 102A may be counterclockwise. Figures 6A and 6B show an example of another embodiment in which the first direction for unsealing the passage 102A may be clockwise. Therefore, it should be understood that the direction in which the actuator 106 is adjusted to open and close the passage 102A may vary in different embodiments.

[0113] In the example of the embodiment shown in FIGS. 1 to 6B, it can be seen that the biasing members 104A, 104B may be attached to the pins 103A, 103B, and the cams 105A, 105B may be attached to the pins 103A, 103B. More specifically, the first biasing member 104A may be attached to the first pin 103A attached to the first cam 105A, and the second biasing member 104B may be attached to the second pin 103B attached to the second cam 105B. Therefore, in such an embodiment, the biasing members 104A, 104B may pull the pins 103A, 103B, and the pins 103A, 103B may move the cams 105A, 105B away from the tubular member 102 to function to unseal the passage 102A. In addition to or instead of this, the flange of the actuator 106 may move the cams 105A, 105B away from the tubular member 102 to unseal the passage 102A.

[0114] In the example of the embodiment shown in FIGS. 7 to 9B, each of the four cams 110A, 110B, 111A, 111B is connected to a respective individual pin 103A, 103B, 103C, 103D, but it can be seen that only the pins 103A and 103B may be connected to the biasing members 104A, 104B respectively. As described above, in some embodiments, each of the cams 110A, 110B, 111A, 111B may have a respective individual spring. However, in the embodiment shown in FIGS. 7 to 9B, instead, providing the biasing force towards the sealing position or the closed position depends only on a pair of biasing members 104A, 104B, and assisting in moving the cams 110A, 110B, 111A, 111B between their respective positions depends individually on the aforementioned protrusions 115A, 115B, 115C, 115D.

[0115] The amount of rotational movement (e.g., rotational angle) of the actuator 106 required to unseal the passage 102A may vary in different embodiments. Preferably, a minimum amount of rotational movement is required such that the effort required by the operator to unseal the passage 102A is minimized. For example, the actuator 106 may be rotated approximately 45 degrees in a first direction to unseal the passage 102A. However, in some embodiments, a rotational movement of less than 45 degrees may be employed to unseal the passage 102A. In yet another embodiment, a rotational movement greater than 45 degrees (e.g., 60 degrees, 90 degrees, 120 degrees, 180 degrees, or more) may be employed to unseal the passage 102A.

[0116] It is preferable that a certain force (for example, a rotational force) is applied to the actuator 106 so that the cams 105A, 105B, 110A, 110B, 111A, and 111B do not return to their original positions where they seal the passage 102A. With such a configuration, it is ensured that the passage 102A is not unsealed unless necessary. In this way, the operator can be confident that the passage 102A is always sealed, except when the operator manually adjusts the actuator 106 to unseal the passage 102A. This prevents errors that can occur in a valve that is not biased towards the sealing position (for example, a situation where the operator forgets to manually adjust and return the actuator 106 to seal the passage 102A).

[0117] With the passage 102A unsealed, the operator may advance a desired access device, for example, but not limited to, a guidewire, an implant delivery catheter, a balloon catheter, a suction catheter, a thrombus retrieval catheter, or any type of known catheter or endovascular medical device, a delivery catheter, a balloon catheter, a suction catheter, a clot retrieval catheter, any type of known catheter, or an endovascular medical device, etc., through the passage 102A.

[0118] For example, various medical devices may be inserted through the cap inlet 107A, the unsealed passage 102A, and the housing lumen 101A, advanced into the catheter 110, and advanced to a desired position within the patient's vasculature. Once the device reaches the desired position, the operator may release the actuator 106. While the medical device is being inserted through the passage 102A of the valve 100, the biasing forces from the biasing members 104A, 104B may cause the tubular member 102 to contact the medical device so that the passage 102A seals around the medical device. That is, when the medical device is inserted, the valve 100 may be configured to assume a third position where the tubular member 102 is deformed around the medical device. Generally, this third position is between the positions described above as the unsealed position and the sealed position.

[0119] When the use of the medical device is completed, the operator may readjust the actuator 106, for example, by rotating it, release the tubular member 102 from around the medical device, and unseal the passage 102A so that the medical device can be removed. Next, the operator may release the actuator 106, at which time the biasing members 104A, 104B return the cams 105A, 105B, 110A, 110B, 111A, 111B, and the actuator 106 to their original sealed positions where the passage 102A is sealed. During the medical procedure, the same procedure may be repeated as necessary.

[0120] Although the invention has been described with respect to specific embodiments and applications, those skilled in the art can, in light of this teaching, generate additional embodiments and modifications without departing from the spirit of the invention claimed in the claims or exceeding its scope. Accordingly, it should be understood that the drawings and description herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting its scope.

Claims

1. A tubular member having a passageway, a plurality of cams, the plurality of cams being adjustable between a first position in which the plurality of cams deform the tubular member to seal the passageway and a second position in which the plurality of cams release the tubular member to at least partially unseal the passageway, an actuator connected to the plurality of cams for adjusting the plurality of cams between the first position and the second position, wherein the plurality of cams are biased toward the first position, a hemostatic valve.

2. The hemostatic valve according to claim 1, wherein the plurality of cams comprise a first cam and a second cam.

3. The hemostatic valve according to claim 2, wherein the first cam is not directly connected to the second cam.

4. The hemostatic valve according to claim 2, wherein the first cam swings around a first pivot point and the second cam swings around a second pivot point.

5. The hemostatic valve according to claim 4, wherein the first cam is swingable in a direction opposite to that of the second cam.

6. The hemostatic valve according to claim 2, wherein the tubular member is disposed between the first cam and the second cam.

7. The hemostatic valve according to claim 6, wherein the tubular member is sandwiched between the first cam and the second cam when the first cam and the second cam are in the first position.

8. The hemostatic valve according to claim 2, further comprising a first biasing member connected to the first cam and a second biasing member connected to the second cam.

9. The hemostatic valve according to claim 8, wherein the first biasing member is connected between the first cam and the actuator, and the second biasing member is connected between the second cam and the actuator.

10. The hemostatic valve according to claim 8, wherein the first biasing member comprises a first spring and the second biasing member comprises a second spring.

11. The hemostatic valve according to claim 10, wherein the first spring and the second spring each comprise a coil spring.

12. The hemostatic valve according to claim 1, wherein the tubular member further comprises a gasket.

13. The hemostatic valve according to claim 1, wherein the actuator comprises a ring member.

14. The hemostatic valve according to claim 13, wherein the ring member has a flange for engaging the plurality of cams.

15. The hemostatic valve according to claim 1, wherein the actuator is rotatable to adjust the plurality of cams between the first position and the second position.

16. The hemostatic valve according to claim 15, wherein the plurality of cams are swingable between the first position and the second position.

17. The hemostatic valve according to claim 1, further comprising one or more pins, wherein the plurality of cams are swingably connected to the one or more pins.

18. The hemostatic valve according to claim 1, further comprising a housing having an internal lumen for connection to a catheter, wherein the tubular member is connected to the housing and the passage is fluidly connected to the internal lumen.

19. The hemostatic valve according to claim 18, further comprising one or more pins connected to the housing, wherein the plurality of cams are connected to the one or more pins.

20. The hemostatic valve according to claim 1, wherein the plurality of cams comprise a first pair of cams and a second pair of cams.

21. The hemostatic valve according to claim 20, wherein the first pair of cams is composed of a first cam and a second cam, and the second pair of cams is composed of a third cam and a fourth cam.

22. The hemostatic valve according to claim 21, wherein the first cam and the second cam are arranged along a first radial plane, and the third cam and the fourth cam are arranged along a second radial plane.

23. The hemostatic valve according to claim 22, wherein the first radial plane is disposed outside the second radial plane.

24. The hemostatic valve according to claim 20, wherein the first pair of cams is at a different depth position from the second pair of cams.

25. The hemostatic valve according to claim 1, wherein each of the plurality of cams has a curved outer surface, and further comprises a plurality of protrusions extending inwardly from the actuator for engaging with the curved outer surface of each of the plurality of cams.

26. A tubular member having a passage; Sealing means for closing the passage, the sealing means being adjustable between a first position in which the sealing means deforms the tubular member to seal the passage and a second position in which the sealing means releases the tubular member to at least partially unseal the passage; Actuating means for adjusting the sealing means between the first position and the second position, the actuating means being connected to the sealing means; Biasing means for biasing the sealing means toward the first position, and A hemostatic valve comprising the same.

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