Hemostasis valve

Abstract

A hemostasis valve for use with an access device, such as a catheter. The hemostasis valve may be connected to the housing, and the catheter may be connected to the housing. The hemostasis valve may include a deformable, resilient tubular member having a channel. The hemostasis valve is adjustable between a first position in which the channel is sealed and a second position in which the channel is unsealed. The channel may be sealed by one or more cams, where the cams are biased toward a sealing position such that the cams return to an initial position to seal the channel without active application of force.

Description

[0001] Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Application Serial No. 63 / 481,358, entitled "Hemostasis Valve", filed on January 24, 2023, and U.S. Provisional Application Serial No. 63 / 370,058, entitled "Hemostasis Valve", filed on August 1, 2022, both of which are hereby incorporated by reference in their entirety. Background Art

[0003] Valves, such as hemostasis valves, are primarily used to maintain hemostasis (e.g., prevent bleeding and blood pressure drop) when one or more devices enter a patient's vasculature. For example, a hemostasis valve is typically included on the proximal end of an introducer outside the patient's body so that a guide wire, catheter, or similar device can be advanced through and into the patient's vasculature.

[0004] During the use of such valves, it is often important for the operator to be aware of the valve's status (e.g., open or closed) throughout the procedure. For example, failure to recognize that the valve has opened can result in excessive bleeding and potential air entry into the vasculature. In this regard, it may be helpful for such valves to be easy to operate (e.g., open and close) to minimize interference or interruption in a medical procedure. Summary of the Invention

[0005] The present invention generally relates to a hemostasis valve.

[0006] In some exemplary embodiments, the hemostasis valve is connected to an access device (such as a introducer or catheter).

[0007] In some exemplary embodiments, the hemostasis valve is connected to a suction device (such as a suction catheter).

[0008] The hemostasis valve may include a tubular member that includes a channel, one or more cams for selectively sealing the channel of the tubular member, and an actuator for adjusting the plurality of cams. It should be noted that while, for simplicity, this specification may refer to a plurality of cams, any embodiment herein may alternatively include only one cam.

[0009] In some exemplary embodiments, the tubular member may include a gasket.

[0010] In some exemplary embodiments, the plurality of cams can be adjusted between a first position and a second position, in which the plurality of cams deform the tubular member to seal the channel and, in the second position, the plurality of cams release the tubular member to at least partially unseal the channel.

[0011] In some exemplary embodiments, multiple cams may be biased toward a closed, collapsed, or sealed position.

[0012] In some exemplary embodiments, the multiple cams may include a first cam and a second cam, where the first cam is not directly connected to the second cam.

[0013] In some exemplary embodiments, the multiple cams may include two pairs of cams.

[0014] In some exemplary embodiments, the multiple cams can pivot between a sealed position and an open position.

[0015] In some exemplary embodiments, a tubular member may be positioned between the first cam and the second cam.

[0016] In some exemplary embodiments, when the first cam and the second cam are in the sealed position, the tubular member may be clamped between the first cam and the second cam.

[0017] In some exemplary embodiments, four cams may be radially positioned around the circumference of the tubular member.

[0018] In some exemplary embodiments, each of the multiple cams may be aligned along the same radial plane.

[0019] In some exemplary embodiments, the multiple cams may pivot together such that pivoting of one of the multiple cams causes the remaining cams of the multiple cams to also pivot.

[0020] In some exemplary embodiments, the multiple cams may each be independently and individually pivotable.

[0021] In some exemplary embodiments, one or more biasing members may be connected to the multiple cams to bias the cams toward the sealed position.

[0022] In some exemplary 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.

[0023] In some exemplary embodiments, one or more biasing members may include one or more springs, such as helical springs.

[0024] In some exemplary embodiments, the actuator may include a ring member that includes a flange for engaging the multiple cams.

[0025] In some exemplary embodiments, the actuator may be rotatable to adjust the multiple cams between the sealed position and the open position.

[0026] In some exemplary embodiments, each of the plurality of cams may be pivotally connected to a pin to pivot about or with the pin.

[0027] In some exemplary embodiments, the present invention may include a housing that includes an internal lumen for connection to a conduit, wherein a tubular member is connected to the housing and a passage of the tubular member is fluidly connected to the internal lumen of the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] These and other aspects, features, and advantages of embodiments of the present invention will become apparent and be elucidated from the following description of embodiments of the present invention by reference to the accompanying drawings, in which:

[0029] Figure 1 is an isometric view of a hemostatic valve and access device according to an embodiment of the present invention.

[0030] FIG. 2 is an exploded view of a hemostatic valve according to an embodiment of the present invention.

[0031] Figure 3A is an end view of a hemostatic valve in a closed position according to an embodiment of the present invention.

[0032] Figure 3B is an end view of a hemostatic valve in an open position according to an embodiment of the present invention.

[0033] Figure 4A is a cross-sectional view of a hemostatic valve in a closed position according to an embodiment of the present invention.

[0034] Figure 4B is a cross-sectional view of a hemostatic valve in an open position according to an embodiment of the present invention.

[0035] Figure 5 is an end view of a housing according to an embodiment of the present invention.

[0036] Figure 6A is an end view of a hemostatic valve in a closed position according to an embodiment of the present invention.

[0037] Figure 6B is an end view of a hemostatic valve in an open position according to an embodiment of the present invention.

[0038] Figure 7 is an exploded view of a hemostatic valve according to an embodiment of the present invention.

[0039] Figure 8A is a cross-sectional view of a hemostatic valve in a closed position according to an embodiment of the present invention.

[0040] Figure 8BCross-sectional view of a hemostatic valve in an open position according to an embodiment of the present invention.

[0041] Figure 9A End view of a hemostatic valve in a closed position according to an embodiment of the present invention.

[0042] Figure 9B End view of a hemostatic valve in an open position according to an embodiment of the present invention. Detailed Description

[0043] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth 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 terminology used in the detailed description of the embodiments illustrated in the drawings is not intended to limit the present invention. In the drawings, like reference numerals denote like elements.

[0044] Hemostatic valves are typically used at the proximal opening of a device (such as a introducer, catheter, or catheter hub) that accesses a patient's vasculature. The hemostatic valve allows other devices (such as guidewires, catheters, implant delivery devices, and the like) to pass through and closes or seals around the perimeter of the device. Thus, excessive blood is prevented from escaping from the vasculature and hemostasis is maintained within the patient.

[0045] The present invention generally relates to a hemostatic valve that can be used in conjunction with any known medical procedure that currently uses a hemostatic valve, such as guidewire access, catheter access, implant delivery access, and aspiration catheter access.

[0046] The hemostatic valve of the present invention may include one or more cams, a portion of which moves between at least a first position and a second position, the first position for compressing a tubular gasket or providing a radial pressure on the tubular gasket, and the second position for allowing a radial expansion of the tubular gasket. Thus, the one or more cams cause the tubular gasket to open or seal by abutting against its own seal or around a device positioned through the tubular gasket.

[0047] The hemostatic valve may include 1, 2, 3, 4, 5, 6, or more cams. The cams may be biased in their first position (i.e., the sealed position of the valve) via a spring, elastic member, or similar component. The cams may be connected to an actuator member that is accessible from the outside of the valve to allow for manual actuation movement of the cams to open or close / seal the valve.

[0048] The cams can be aligned in a radial plane perpendicular to the axis of rotation such that each cam in the cams is positioned at the same depth within the valve. However, one or more of the cams can be positioned at a different depth from one or more of the remaining cams such that one or more of the cams are not aligned with one or more of the remaining cams in a radial plane perpendicular to the axis of rotation.

[0049] Specific exemplary embodiments are described further below. However, it should be understood that any features from any embodiment can be mixed and matched with each other in any combination. Accordingly, the present invention should not be limited to these embodiments, but rather to any broader combination thereof.

[0050] Figure 1 An exemplary embodiment of a hemostatic valve 100 is illustrated. In this example, the hemostatic valve 100 is an integral part of the housing 101, but the valve mechanism itself can alternatively take the form of a stand-alone valve device directly connected to another medical device (e.g., the catheter hub of a catheter). Various types of housings 101 can be used, and thus the exemplary embodiment illustrated in the figures should not be construed as limiting the scope with respect to, for example, the shape, size, configuration, number of ports, etc. of the housing 101. The housing 101 can include at least one internal lumen 101A, such as Figure 2A and Figure 5 as shown, a medical device can be inserted into or removed from the housing 101 through the internal lumen. In some embodiments, the housing 101 can include additional lumens. In some embodiments, the housing 101 can also include additional ports, each port having its own one or more lumens.

[0051] Continuing to refer to Figure 1 , it can be seen that an access device, such as a catheter 110, can be connected to the housing 101. The access device can be fixed to the housing 101, removably attached to the housing 101, or integral with the housing 101. The catheter 110 can be removably connected to the housing 101 such that different types of catheters 110 can be interchanged as needed.

[0052] In the exemplary embodiment shown in the figure, it can be seen that the housing 101 may include a connector 101B at its distal end, to which a catheter 110 or a catheter hub 109 may be attached. The connector 101B may include threads such that the catheter 110, an adapter, or another connection structure may be threadably attached to the connector 101B. An embodiment is illustrated in the figure in which the connector 101B includes external threads (e.g., male threads) and the catheter hub 109 includes internal threads (e.g., female threads). In some embodiments, an opposite configuration may be used (e.g., the catheter 110 may include internal threads (e.g., a ring with internal threads) and the catheter hub 109 may include external threads). It should also be understood that in some embodiments, other types of connectors 101B may be used to which the catheter 110, catheter hub 109, or adapter may be attached. In other embodiments, as described above, an access device (such as the catheter 110) may be integral with the housing 101.

[0053] A wide range of access devices may be connected to or integral with the housing 101, and thus the specific configuration of the catheter 110 illustrated in the figure should not be construed as a limitation on the scope. In one exemplary embodiment, a suction catheter 110 may be connected to the housing 101 to allow other catheters (e.g., an implant delivery catheter or a drug balloon catheter) to advance through the lumen of the valve. In other exemplary embodiments, various types of catheters 110 known in the art (such as but not limited to diagnostic catheters, micro catheters, etc.) may be connected to the housing 101.

[0054] The hemostatic valve 100 may generally be integral with the housing 101, such as Figure 1 as shown. In an exemplary embodiment, the hemostatic valve 100 may be connected to the housing 101. In some embodiments, the hemostatic valve 100 may be fixed to the housing 101 or removably connected to the housing 101. The hemostatic valve 100 may be positioned within the housing 101, as shown in the figure. In this embodiment, the housing 101 may include an internal lumen within which the hemostatic valve 100 is positioned.

[0055] Figures 2A - 2B is an exploded view of the different components of an exemplary embodiment of the hemostatic valve 100. As Figures 2A - 2B shown, the hemostatic valve 100 may include a tubular member 102, one or more cams 105A, 105B for selectively sealing the channel 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 an unsealed / open position).

[0056] The shape, size, location, orientation, and configuration of the tubular member 102 can vary in different embodiments. In the exemplary embodiment shown in the figures, the tubular member 102 is illustrated as including a cylindrical body having an internal passageway 102A. Thus, in the illustrated embodiment, the tubular member 102 can include a circular cross-section. However, in other embodiments, the shape of the tubular member 102 can be different from that shown in the exemplary figures. For example, in some embodiments, the tubular member 102 can have a triangular, rectangular, oval, or square-shaped cross-section.

[0057] The tubular member 102 can include a flexible or semi-rigid member having a passageway 102A extending therethrough. The tubular member 102 can be elastic. In a preferred embodiment, the tubular member 102 can include a deformable material such that the tubular member 102 can be deformed to seal the passageway 102A or released to unseal the passageway 102A.

[0058] By way of example and not limitation, the tubular member 102 can include various polymers, rubbers, or other deformable and elastic materials such that, in the absence of an applied force, the tubular member 102 returns to a shape in which the passageway 102A is unblocked (i.e., unsealed). In other words, the tubular member 102 can include a shape memory material so as to have shape memory such that when unconstrained (e.g., by cams 105A, 105B as described herein), the tubular member 102 returns to its tubular shape in which the passageway 102A is unsealed.

[0059] In an exemplary embodiment, the tubular member 102 can be used as a gasket to seal or unseal the passageway 102A. The tubular member 102 can be deformed to seal the passageway 102A, such as by applying a force (e.g., a clamping force) by one or more of the cams 105A, 105B discussed herein. When released, the tubular member 102 will preferably at least partially return to its initial shape in which the passageway 102A is unsealed.

[0060] Figures 3A - 4B and Figure 5 A- Figure 5 FIG. B illustrates a pair of cams 105A, 105B positioned on either side of the tubular member 102. The cams 105A, 105B can generally be operable to deform the tubular member 102 (e.g., by clamping or squeezing) to seal the passageway 102A. The shape, size, orientation, location, and number of the cams 105A, 105B can vary in different embodiments and should not, therefore, be construed as limited to the specific configuration shown in the exemplary figures.

[0061] In an exemplary embodiment, cams 105A, 105B may be positioned on opposite sides of the tubular member 102. For example, in an embodiment where the tubular member 102 is cylindrical, cams 105A, 105B may be separated by 180 degrees along the outer circumference of the tubular member 102. However, it should be understood that various other positions may be used (e.g., in some embodiments, cams 105A, 105B may be positioned adjacent to each other).

[0062] In Figure 4A and Figure 4B the cams 105A, 105B can be seen best. As shown, in an exemplary embodiment, cams 105A, 105B may each include the same shape and size, but opposite orientations. However, in some embodiments, cams 105A, 105B may have different shapes or sizes relative to each other. Each cam 105A, 105B may include an opening through which pins 103A, 103B may extend, as discussed in more detail below. In different embodiments, cams 105A, 105B may move or pivot about pins 103A, 103B, or both cams 105A, 105B and pins 103A, 103B may rotate together relative to the remainder of the valve 100.

[0063] Continuing to refer Figure 4A and Figure 4B , each of the cams 105A, 105B may include a curved outer surface and a flat inner surface. Thus, 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, 105B may be convex, concave, or curved.

[0064] In embodiments having flat inner surfaces, the flat inner surfaces 105D, 105F of the respective cams 105A, 105B may abut the tubular member 102 and deform the tubular member 102 upon engagement to seal the passage 102A. The inner edges of the actuator 106 (to be discussed in more detail below) may include flat surfaces 106A, 106B that help to force cams 105A, 105B toward each other and maintain the seal without the application of force. As Figure 4A shown, for example, the first flat surface 106A of the actuator 106 may engage the first curved outer surface 105C of the first cam 105A, and the second flat surface 106B of the actuator 106 may engage the second curved outer surface 105E of the second cam 105B.

[0065] As in Figure 4A andFigure 5 As best shown in Figure 4A and Figure 6A and Figure 4B and Figure 6B , the cams 105A, 105B can be used together as a vise, with the tubular member 102 positioned between the vises, where the flat surfaces 105D, 105F of the cams 105A, 105B are brought closer together to seal the passage 102A (as

[0066] It should be understood that the number of cams 105A, 105B can vary in different embodiments. Figures 2A - 4B and Figures 6A - 6B illustrates a pair of cams 105A, 105B including a first cam 105A and a second cam 105B. However, in some embodiments, only a single cam 105A can be used. In other embodiments, three or more cams 105A, 105B can be used. Figures 7 - 9B illustrates a first pair of cams 110A, 110B including a first cam 110A and a second cam 110B and a second pair of cams 111A, 111B including a third cam 111A and a fourth cam 111B.

[0067] The cams 105A, 105B can generally be operable to move between a first position and a second position. In the first position, the cams 105A, 105B apply sufficient force against the tubular member 102 to deform the tubular member 102 to seal the passage 102A. In the second position, the cams 105A, 105B do not apply sufficient force against the tubular member 102 to seal the passage 102A, such that the passage 102A is unsealed, opened, radially expanded, and / or unrestricted. When sealed, the passage 102A will generally be sufficiently contracted, closed, blocked, plugged, or adhered to prevent fluid (e.g., liquid and / or gas) from flowing through the passage 102A.

[0068] When the passage 102A is sealed, the distance between the corresponding cams 105A, 105B will depend on the diameter of the tubular member 102. When the passage 102A is unsealed, in some embodiments, the cams 105A, 105B can be fully released (e.g., not in contact) with the tubular member 102, or in other embodiments, they can still contact the tubular member 102, but without sufficient force to deform sufficiently to seal. Thus, in some embodiments, even when in the unsealed position, the cams 105A, 105B can rest on the outer surface of the tubular member 102. In some embodiments, when in the unsealed position, the passage 102A can be partially closed but not fully sealed.

[0069] Cams 105A, 105B may each include different, independent structures, as shown in the figures. In such an embodiment, cams 105A, 105B may not be connected to (e.g., directly connected to) or in contact with each other. In other embodiments, cams 105A, 105B may be connected together in various ways.

[0070] The manner in which cams 105A, 105B are adjusted between positions may vary in different embodiments. In the exemplary embodiment shown in the figures, cams 105A, 105B are illustrated as being pivotable between positions such that each cam 105A, 105B pivots between a sealed position and an unsealed position. However, in some embodiments, cams 105A, 105B may be adjusted in various non-pivotable ways, e.g., by sliding inwardly towards each other or outwardly away from each other or otherwise moving.

[0071] In embodiments where cams 105A, 105B pivot between positions, a first cam 105A may pivot about a first pivot point and a second cam 105B may pivot about a second pivot point, where the first pivot point and the second pivot point are spaced distally from each other. Further, the first cam 105A may pivot in a first direction and the second cam 105B may pivot in a second direction, where the first direction is opposite to the second direction.

[0072] Continuing to refer to embodiments where cams 105A, 105B pivot between positions, each of cams 105A, 105B may be connected to pins 103A, 103B. Thus, a first cam 105A may be connected to a first pin 103A and a second cam 105B may be connected to a second pin 103B. In embodiments using additional cams 105A, 105b, additional pins 103A, 103B may also be used. Thus, it should be understood that although only a pair of pins 103A, 103B are illustrated in the figures, three or more pins 103A, 103B may be used in some embodiments.

[0073] Further, in an exemplary embodiment, only one pin 103A may be used (e.g., in an embodiment using only a single cam 105A, or in an embodiment where multiple cams 105A, 105B are connected to a single pin 103A, such as an embodiment where multiple cams 105A, 105B at least partially overlap each other). Thus, only one pin 103A may be used in an embodiment using only a single cam 105A, and three or more pins 103A, 103B may be used in an embodiment using three or more cams 105A, 105B.

[0074] The pins 103A and 103B can be used as pivot members that function to pivot the cams 105A and 105B. The cams 105A and 105B can each pivot about a respective pin 103A and 103B, or in other embodiments, the cams 105A and 105B can be fixed to each pin 103A and 103B such that the cams 105A and 105B pivot together with the respective pins 103A and 103B. Accordingly, each pin 103A and 103B can include an elongated member such as a rod. The pins 103A and 103B can include various types of materials such as, but not limited to, metals, alloys, polymers, etc.

[0075] In Figure 4A , Figure 4B , Figure 6A and Figure 6B the embodiments shown, it can be seen that in an exemplary embodiment, one or more pins 103A and 103B can be positioned on either side of the tubular member 102. In the exemplary embodiment shown in the figures, the first pin 103A is shown positioned along the first side of the tubular member 102, and the second pin 103B is shown positioned along the second side of the tubular member 102. In an embodiment where the tubular member 102 is cylindrical, the pins 103A and 103B can be separated 180 degrees along the outer circumference of the tubular member 102. However, it should be understood that different other positions can be used (e.g., in some embodiments, the pins 103A and 103B can be positioned adjacent to each other).

[0076] In Figure 4A , Figure 4B , Figure 6A and Figure 6B the embodiment best shown, it can be seen that each pin 103A and 103B can extend through a corresponding cam 105A and 105B. Accordingly, each cam 105A and 105B can include an opening through which the pins 103A and 103B can extend. As previously described, each cam 105A and 105B can be fixed to the pins 103A and 103B such that the cams 105A and 105B pivot together with the pins 103A and 103B, or each cam 105A and 105B can be pivotally connected to the pins 103A and 103B such that the cams 105A and 105B pivot about the pins 103A and 103B.

[0077] Each pin 103A and 103B can be attached or fixed to the housing 101, such as Figure 2A and Figure 2BAs shown. In such an embodiment, each of the pins 103A, 103B can be fixed within an opening in the housing 101. The manner in which the pins 103A, 103B are fixed to the housing 101 can vary in different embodiments. For example, the pins 103A, 103B can be fixed to the housing 101 by friction engagement, adhesives, etc. In some embodiments, the pins 103A, 103B can be removed from the housing 101. In embodiments where the cams 105A, 105B are fixed to the pins 103A, 103B, each of the pins 103A, 103B can rotate within such an opening in the housing 101, or the pins 103A, 103B can be fixed within such an opening in the housing 101 in embodiments where the cams 105A, 105B pivot about the pins 103A, 103B.

[0078] The cams 105A, 105B can be biased toward a closed or sealed position such that, without the application of a force, the cams 105A, 105B seal the passage 102A. Because the cams 105A, 105B are biased toward sealing the passage 102A, an operator (such as a physician) can ensure that the passage 102A is sealed without the active application of a force. This can help prevent the operator from making the mistake of thinking that the passage 102A is sealed when it is not (e.g., with an unbiased valve).

[0079] The manner in which the cams 105A, 105B are biased can vary in different embodiments. In an exemplary embodiment, the cams 105A, 105B can be biased by one or more biasing members 104A, 104B. In one exemplary embodiment, a single biasing member 104A, 104B can bias multiple cams 105A, 105B by itself, such as a pair of cams 105A, 105B. In other embodiments, each of the cams 105A, 105B can be biased individually by one or more biasing members 104A, 104B.

[0080] In the exemplary embodiment shown in the figure, the first cam 105A can be biased by the first biasing member 104A, and the second cam 105B can be biased by the second biasing member 104B. In different embodiments, various types of biasing members 104A, 104B can be used. In the exemplary embodiment shown in the figure, each of the biasing members 104A, 104B can include a spring. Various types of springs can be used, such as compression springs, tension springs, torsion springs, constant force springs, etc. An embodiment is shown in the figure in which each of the biasing members 104A, 104B can include a helical spring.

[0081] One or more biasing members 104A, 104B may be attached at a first end to cams 105A, 105B and at a second end to an actuator 106. However, it should be understood that in some embodiments, the biasing members 104A, 104B may be attached to various other components. In some exemplary embodiments, the first end of each biasing member 104A, 104B may be attached to a corresponding pin 103A, 103B, and the second end of each biasing member 104A, 104B may be attached to the actuator 106.

[0082] In Figure 6A and Figure 6B the illustrated embodiment, 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 extend. The opposite second end of each biasing member 104A, 104B may also optionally include an eyelet having an opening for attachment (e.g., fixedly) to the actuator 106.

[0083] As Figure 3A , Figure 3B , Figure 6A and Figure 6B best shown in, additional pins 103C, 103D may be connected at a first end to the actuator 106 and at a second end to the biasing members 104A, 104B. More specifically, it can be seen that each pin in a pair of pins 103C, 103D may be fixed within a receiver formed in the body of the actuator 106, such as Figure 3A and Figure 3B best shown in. 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.

[0084] Each pin in the second pair of pins 103C, 103D may be used to anchor one of the biasing members 104A, 104B to the actuator 106. In the exemplary embodiment shown in the figures, it can be seen that a third pin 103C may anchor the first biasing member 104A to the actuator 106 at a first radial position, and a fourth pin 103D may anchor the second biasing member 104B to the actuator 106 at a second radial position.

[0085] Thus, in the exemplary embodiment shown in the figures, the first biasing member 104A may be fixed to the first cam 105A at a first end by a first pin 103A and to the actuator 106 at a second end by a third pin 103C. Similarly, the second biasing member 104B may be fixed to the second cam 105B at a first end by a second pin 103B and to the actuator 106 at a second end by a fourth pin 103D.

[0086] When each of the cams 105A, 105B is moved toward the open or unsealed position, such as by actuation (e.g., rotation) of the actuator 106, each of the biasing members 104A, 104B will stretch or elongate, such as Figure 6A and Figure 6B as shown. When the actuator 106 is released, each of the biasing members 104A, 104B will naturally compress to its initial state, thereby adjusting the cams 105A, 105B back to their rest positions, in which the cams 105A, 105B seal the tubular member 102.

[0087] Various types of actuators 106 can be used to unseal the channel 102A. In the exemplary embodiment best shown in the figures, an actuator 106 is illustrated that can include an annular member configured to be rotated to adjust the cams 105A, 105B and thus unseal the channel 102A. However, it should be understood that the shape, size, and configuration of the actuator 106 can vary in different embodiments. Thus, the scope of the present invention should not be construed as limited to the annular-shaped actuator 106 shown in the exemplary figures.

[0088] The illustrated exemplary embodiment of the actuator 106 can include an outer edge (e.g., outer circumference) and an inner edge (e.g., inner circumference) defining a central opening. The outer edge of the actuator 106 can include grooves, ribs, protrusions, etc. to improve gripping. The inner edge of the actuator 106 can include one or more flat surfaces 106A, 106B for engaging the cams 105A, 105B when in the sealed position as shown in Figure 4A and Figure 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 can engage the first cam 105A, and the second flat surface 106B of the inner edge of the central opening of the actuator 106 can engage the second cam 105B. In some embodiments, the inner edge of the actuator 106 can include one or more flanges to help grip and engage the cams 105A, 105B.

[0089] In some embodiments, the actuator 106 may not include an annular member or may include additional features connected to the annular member. In such embodiments, the actuator 106 can include or further include, for example, one or more levers, one or more buttons, etc. For example, a handle, lever, button, actuator, etc. can be connected to or integrally formed with the ring member to assist in adjusting the ring member. The actuator 106 can include a shape other than the circular shape shown in the figures. For example, in some embodiments, the actuator 106 can be square.

[0090] The manner in which the actuator 106 is adjusted to unseal the channel 102A can vary in different embodiments. In the embodiment shown in the figures, it can be seen that the actuator 106 rotates in a first direction to unseal the channel 102A and rotates in a second direction to seal the channel 102A. More specifically, it can be seen that the actuator 106 can rotate counterclockwise to unseal the channel 102A and can rotate clockwise to seal the channel 102A.

[0091] However, it should be understood that in some embodiments, clockwise rotation can alternatively be used to unseal the channel 102A, and counterclockwise rotation can alternatively be used to seal the channel 102A. In either case, the actuator 106 can be actively rotated to unseal the channel 102A and, when released, can passively (e.g., without any input or force) return to its original position to seal the channel 102A, for example, by the action of the biasing members 104A, 104B.

[0092] Referring Figures 1 to 2B , it can be seen that the cap 107 can be connected to one end of the actuator 106. The cap 107 can be used to enclose the tubular member 102, the pins 103A, 103B, the biasing members 104A, 104B, and the cams 105A, 105B in order to prevent the intrusion of particles (such as dust, etc.) that may impair the operation of the biasing members 104A, 104B or the cams 105A, 105B and / or prevent these parts from coming into contact with fluids (such as blood or other body fluids). Although the embodiment in the figures illustrates where the cap 107 is circular, it should be understood that the cap 107 can include various other shapes in certain embodiments.

[0093] The cap 107 can be removably attached to the actuator 106 such that the cap 107 can be removed to access the interior of the hemostatic valve 100, or the cap 107 can be fixed to the actuator 106. The cap 107 can include a cap inlet 107A, such as a central opening as shown in the figures, through which various medical devices can be inserted through the channel 102A or fluidly connected to the channel 102A when unsealed. In an exemplary embodiment, the pins 103A, 103B can be fixed to the cap 107. In such an embodiment, the cap 107 can include an opening through which the pins 103A, 103B extend, or the pins 103A, 103B are attached within the opening.

[0094] Figures 7 - 9BIllustrated is an exemplary embodiment of a hemostatic valve 100 including two pairs of cams 110A, 110B, 111A, 111B. A first pair of cams 110A, 110B including a first cam 110A and a second cam 110B may be aligned along a first radial plane. A second pair of cams 111A, 111B including a third cam 111A and a fourth cam 111B may be aligned along a second radial plane. The first radial plane and the second radial plane may be perpendicular to the rotation axes of the cams 110A, 110B, 111A, 111B.

[0095] As Figure 7 shown, the cams 110A, 110B, 111A, 111B may be connected to a 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 may include a plurality of openings corresponding to the plurality of pins 103A, 103B, 103C, 103D such that each of the pins 103A, 103B, 103C, 103D may be received or fixed within its own opening.

[0096] The openings and the pins 103A, 103B, 103C, 103D when connected may be positioned at a preset interval from each other such that each of the pins 103A, 103B, 103C, 103D is equidistant from the remaining pins 103A, 103B, 103C, 103D. As Figure 7 shown, the first cam 110A may be attached to pivot about a first pin 103A, the second cam 110B may be attached to pivot about a second pin 103B, the third cam 111A may be attached to pivot about a third pin 103C, and the fourth cam 111B may be attached to pivot about a fourth pin 103D.

[0097] Alternatively, in other exemplary embodiments, the pins 103A, 103B, 103C, 103D themselves may be rotatably connected to the housing 101 such that each of the pins 103A, 103B, 103C, 103D may rotate relative to the housing 101. In such exemplary embodiments, the cams 110A, 110B, 111A, 111B may be fixed to their respective pins 103A, 103B, 103C, 103D such that each of the cams 110A, 110B, 111A, 111B pivots when its respective pin 103A, 103B, 103C, 103D rotates.

[0098] As described above, although the exemplary embodiments illustrated in the figures show pins 103A, 103B, 103C, 103D provided for each of the cams 110A, 110B, 111A, 111B, in some exemplary embodiments, the multiple cams 110A, 110B, 111A, 111B may share the pins 103A, 103B, 103C, 103D.

[0099] Continuing to refer Figure 7 , it can be seen that a pair of biasing members 104A, 104B (such as springs) can be used to bias each of the cams 110A, 110B, 111A, 111B toward a desired position. In the Figure 7 exemplary embodiment shown, it can be seen that a pair of biasing members 104A, 104B can be used to bias all four cams 110A, 110B, 111A, 111B. In other exemplary embodiments, each of the cams 110A, 110B, 111A, 111B may have its own biasing members 104A, 104B.

[0100] Each of the biasing members 104A, 104B can be connected at a first end to one of the pins 103A, 103B, 103C, 103D. In the Figures 7 to 9B exemplary embodiment shown, it can be seen that the first biasing member 104A can be attached to the first pin 103A and the second biasing member 104B can be attached to the second pin 103B. However, in different embodiments, the number, positioning, and orientation of the biasing members 104A, 104B can vary.

[0101] The second end of each of the biasing members 104A, 104B can be attached to the actuator 106, as previously discussed. Rotation of the actuator 106 can operably pivot the cams 110A, 110B, 111A, 111B, as discussed herein. Generally, rotation of the actuator 106 in a first direction can cause all or some of the cams 110A, 110B, 111A, 111B to pivot in the first direction, and rotation of the actuator 106 in a second direction can cause all or some of the cams 110A, 110B, 111A, 111B to pivot in the second direction.

[0102] As previously described, the cover 107 can be attached to the actuator 106. In the Figure 7 exemplary embodiment shown, it can be seen that the cover 107 can include one or more protrusions that can engage corresponding notches (such as grooves or slits) in the outer circumference of the actuator 106 to couple the cover 107 to the actuator 106 and thus substantially enclose the cams 110A, 110B, 111A, 111B.

[0103] The cams 110A, 110B, 111A, 111B can be radially positioned about a tubular member 102 (such as a seal) such that the cams 110A, 110B, 111A, 111B deform the tubular member 102 (such as by clamping) upon engagement and thus seal a passage 102A extending through the tubular member 102. Using four cams 110A, 110B, 111A, 111B can seal the tubular member 102 more effectively than exemplary embodiments using fewer cams and further can provide redundancy in the event that one or more of the cams 110A, 110B, 111A, 111B fails to function.

[0104] As Figures 7 - 9B shown, the actuator 106 can include one or more protrusions 115A, 115B, 115C, 115D that can be used to guide and / or force the cams 110A, 110B, 111A, 111B between their respective pivotable positions. Each of the protrusions 115A, 115B, 115C, 115D can include a semi-circular bump or the like that extends inwardly from the actuator 106 as shown.

[0105] The number, positioning, spacing, and orientation of the protrusions 115A, 115B, 115C, 115D can vary in different embodiments. Generally, the protrusions 115A, 115B, 115C, 115D can be radially equally spaced about the inner diameter of the actuator 106, such as best shown in Figures 8A - 8B shown.

[0106] In Figures 7 - 9B the exemplary embodiment shown, it can be seen that the first protrusion 115A can engage the first cam 110A, the second protrusion 115B can engage the second cam 110B, the third protrusion 115C can engage the third cam 111A, and the fourth protrusion 115D can engage the fourth cam 111B.

[0107] In some exemplary embodiments, the number of protrusions 115A, 115B, 115C, 115D may be the same as the number of cams 110A, 110B, 111A, 111B, such that each cam 110A, 110B, 111A, 111B may be actuated by its own separate protrusion 115A, 115B, 115C, 115D. In other embodiments, two or more cams 110A, 110B, 111A, 111B may share protrusions 115A, 115B, 115C, 115D, such that there are fewer protrusions 115A, 115B, 115C, 115D than cams 110A, 110B, 111A, 111B.

[0108] Each of the cams 110A, 110B, 111A, 111B may include an inwardly curved portion on its outer edge into which a corresponding protrusion 115A, 115B, 115C, 115D may engage in order to adjust the cams 110A, 110B, 111A, 111B. However, in different embodiments, other configurations and shapes may be used as long as the rotational movement of the actuator 106 imparts sufficient force to cause the pivotable movement of the cams 110A, 110B, 111A, 111B.

[0109] In use, in embodiments where the catheter 110 or access device is not integral with the housing 101 or previously fixed to the housing 101, the catheter 110 or other access device may first be attached to the distal end of the housing 101. The operator may then insert the catheter 110 into the patient's body and route it to the desired location to perform its function (e.g., suction). Alternatively, these steps may be reversed by first inserting an access device (such as the catheter 110) into the patient's body and routing it to the desired location and then attaching the access device (such as the catheter 110) to the housing 101.

[0110] In the absence of any applied force, channel 102A will remain sealed as catheter 110 or other access device is routed through the body to its desired location. Thus, the operator can ensure that no fluid, air, etc. will intrude into the body except when needed. When catheter 110 or other access device reaches its target location, hemostasis valve 100 can be operated.

[0111] Figure 3A , Figure 4A , Figure 6A , Figure 8A and Figure 9A An exemplary embodiment of a hemostatic valve 100 is illustrated in a sealed position, and Figure 3B , Figure 4B , Figure 6B , Figure 8B and Figure 9BIllustrated is an exemplary embodiment of the hemostatic valve 100 in an unsealed position. In one exemplary embodiment, the hemostatic valve 100 can be unsealed by rotating the actuator 106. However, it should be understood that, as previously described, various other types of actuators 106 can be used such that movements other than rotational movement can be used to unseal the hemostatic valve 100. For example, in some embodiments, the actuator 106 can alternatively be squeezed to unseal the hemostatic valve 100.

[0112] Continuing to refer to the embodiment shown in the accompanying drawings, it can be seen that the actuator 106 can be rotated in a first direction to at least partially release the cams 105A, 105B from the tubular member 102, thereby unsealing the channel 102A. When the actuator 106 is rotated in the first direction, the attached biasing members 104A, 104B can be pulled by the actuator 106 such that both biasing members 104A, 104B are stretched and adjust the cams 105A, 105B towards the unsealed position.

[0113] Figure 4A and Figure 4B Illustrated is an exemplary embodiment in which the first direction for unsealing the channel 102A can include a counterclockwise direction. Figure 6A and Figure 6B Illustrated is another exemplary embodiment in which the first direction for unsealing the channel 102A can include a clockwise direction. Therefore, it should be understood that the direction in which the actuator 106 is adjusted to open or close the channel 102A can vary in different embodiments.

[0114] In Figures 1 - 6B the exemplary embodiment shown, it can be seen that the biasing members 104A, 104B can be attached to the pins 103A, 103B; wherein the cams 105A, 105B are attached to the pins 103A, 103B. More specifically, the first biasing member 104A can be attached to the first pin 103A, the first pin 103A is attached to the first cam 105A, and the second biasing member 104B can be attached to the second pin 103B, the second pin 103B is attached to the second cam 105B. Thus, in such an embodiment, the biasing members 104A, 104B can pull the pins 103A, 103B, which are used to move the cams 105A, 105B away from the tubular member 102 to unseal the channel 102A. Additionally or alternatively, the flange of the actuator 106 can force the cams 105A, 105B to move away from the tubular member 102 to unseal the channel 102A.

[0115] In Figures 7 - 9BIn the exemplary embodiment shown, it can be seen that each of the four cams 110A, 110B, 111A, 111B can be connected to its own separate pin 103A, 103B, 103C, 103D, but only pins 103A and 103B are respectively connected to the biasing members 104A, 104B. As previously described, in some embodiments, each of the cams 110A, 110B, 111A, 111B can have its own separate spring. However, Figures 7 - 9B the exemplary embodiment shown instead relies only on a pair of biasing members 104A, 104B to provide a biasing force toward the sealed or closed position, and separately relies on the above-mentioned protrusions 115A, 115B, 115C, 115D to help force the cams 110A, 110B, 111A, 111B into their respective positions.

[0116] The amount (e.g., degrees) of rotational movement of the actuator 106 necessary to unseal the access channel 102A can vary in different embodiments. Preferably, the minimum rotational movement will be required such that the operator requires the least amount of effort to unseal the access channel 102A. By way of example, the actuator 106 can be rotated approximately 45 degrees in a first direction to unseal the access channel 102A. However, in some embodiments, a rotational movement of less than 45 degrees can be used to unseal the access channel 102A. In other embodiments, a rotational movement of more than 45 degrees (e.g., 60 degrees, 90 degrees, 120 degrees, 180 degrees or greater) can be used to unseal the access channel 102A.

[0117] Preferably, a constant force (e.g., rotational force) needs to be applied to the actuator 106 to prevent the cams 105A, 105B, 110A, 110B, 111A, 111B from returning to their initial positions that seal the access channel 102A. This configuration ensures that the access channel 102A is never unsealed unless needed. In this way, it can be ensured to the operator that the access channel 102A is always sealed unless the actuator 106 is manually adjusted to unseal the access channel 102A. This prevents errors that can occur in valves that are not biased toward the sealed position (e.g., a situation where the operator may forget to manually adjust the actuator 106 back to seal the access channel 102A).

[0118] In the case where the access channel 102A is unsealed, the operator can advance a desired access device through the access channel 102A, such as but not limited to a guide wire, an implant delivery catheter, a balloon catheter, a suction catheter, a clot retrieval catheter, or any type of known catheter or intravascular medical device. A delivery catheter, a balloon catheter, a suction catheter, a clot retrieval catheter, any type of known catheter or intravascular medical device.

[0119] For example, various medical devices can be inserted through the cap inlet 107A, the unsealed passage 102A, and the housing lumen 101A to enter the catheter 110 and be advanced to a desired location within a patient's vasculature. When the device reaches the desired position, the operator can release the actuator 106. When a medical device is inserted to extend through the passage 102A of the valve 100, the biasing forces from the biasing members 104A, 104B can force the tubular member 102 into contact with the medical device such that the passage 102A seals around the medical device. Thus, when a medical device is inserted therethrough, the valve 100 can be in a third position in which the tubular member 102 deforms around the medical device. Generally, the third position will be located between what was previously referred to as the unsealed position and the sealed position.

[0120] When use of the medical device is complete, the operator can again adjust the actuator 106 (such as by rotation) to release the tubular member 102 around the medical device and unseal the passage 102A such that the medical device can be removed therefrom. The operator can then release the actuator 106, at which time the biasing members 104A, 104B will naturally return the cams 105A, 105B, 110A, 110B, 111A, 111B, and the actuator 106 to their initial sealed position in which the passage 102A is sealed. During a medical procedure, the same steps can be repeated as needed.

[0121] Although the invention has been described in terms of specific embodiments and applications, those of ordinary skill in the art can generate additional embodiments and modifications based on this teaching without departing from the spirit of the claimed invention or exceeding the scope of the claimed invention. Thus, it should be understood that the figures and description herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.

Claims

1. A hemostatic valve, comprising: A tubular member, the tubular member including a channel; A plurality of cams, wherein the plurality of cams are adjustable between a first position and a second position, in the first position the plurality of cams deform the tubular member to seal the channel, and in the second position the plurality of cams release the tubular member to at least partially unseal the channel; and An actuator connected to the plurality of cams, the actuator for adjusting the plurality of cams between the first position and the second position; and, Wherein the plurality of cams are biased towards the first position.

2. The hemostatic valve according to claim 1, wherein, The plurality of cams include 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 pivots about a first pivot point, and wherein the second cam pivots about a second pivot point.

5. The hemostatic valve according to claim 4, wherein, The first cam can pivot in a direction opposite to the second cam.

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

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

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 wherein 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 includes a first spring, and wherein the second biasing member includes a second spring.

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

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

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

14. The hemostatic valve according to claim 13, wherein, The ring member includes a flange for engaging with 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 can pivot between the first position and the second position.

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

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

19. The hemostatic valve according to claim 18 further includes one or more pins connected to the housing, and 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 include 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 includes a first cam and a second cam, and wherein the second pair of cams includes a third cam and a fourth cam.

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

23. The hemostatic valve according to claim 22, wherein, The first radial plane is positioned outwardly relative to the second radial plane.

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

25. The hemostatic valve according to claim 1, wherein, Each of the plurality of cams includes a curved outer surface, and the hemostatic valve further includes 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 hemostatic valve, comprising: A tubular member, the tubular member including a channel; A sealing device for closing the passage, the sealing device being adjustable between a first position and a second position, in the first position the sealing device deforming the tubular member to seal the passage, and in the second position the sealing device releasing the tubular member to at least partially unseal the passage; and an actuating device for adjusting the sealing device between the first position and the second position, the actuating device being connected to the sealing device; and, a biasing device for biasing the sealing device towards the first position.

Images