A hemostasis valve

Abstract

A hemostasis valve capable of controlling a flow of fluid in a tube or catheter to and from a vasculature of a human patient or animal subject. An exemplary embodiment of the hemostasis valve includes a valve member having a lumen with a proximal end and a distal end for receiving flexible tubing or a catheter. The hemostasis valve includes one or more constricting wires that are tensioned by connections to valve member components. The hemostasis valve includes one or more force receiving contact surfaces connected to at least one of the one or more constricting wires configured to cause the contracting wires to constrict the flexible tube or catheter passing therethrough, when the one or more force receiving contact surfaces are in flow restricting state. The force receiving contact surfaces cause the constricting wires to release the flexible tube or catheter passing therethrough, when the one or more force receiving contact surfaces are in a not is a flow restricting state.

Description

A HEMOSTASIS VALVECROSS REFERENCE TO PRIOR APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 593,237, entitled as “A HEMOSTASIS VALVE”, filed October 26, 2023, which is incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] This disclosure relates to the field of medical devices that facilitate access to the circulatory system of a human or other animal.BACKGROUND

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

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

[0005] The term thrombectomy refers to a medical procedure where interventional devices arc used to access the vascular system to remove clots. The very basic steps of the procedure can beoutlined as follows: 1) gain access to the vascular system, 2) navigate a flexible catheter shaft to the target vessel location (typically guided by fluoroscopy (x-ray)), and finally 3) to aspirate (apply vacuum suction) or mechanically retrieve the clot from the vessel. The sequence described above requires careful navigation, control, and smooth operation of the catheter system for optimal outcomes.

[0006] There is a need in the art for hemostasis valve that is easy to use for medical practitioners, effectively seals the patient’s vasculature from outside exposure to pathogens of pathogenic compounds, and facilitates performance of a wide range of procedures, such as a thrombectomy.SUMMARY

[0007] The disclosed subject matter is a hemostasis valve configured for use in a medical setting. The hemostasis valve includes a fluid flow tube through which fluid, blood, or infusate may flow. It also features a constricting mechanism configured to constrict the fluid flow tube when activated. The constricting mechanism may include one or more inputs that can be operated by the medical practitioner to place the constricting mechanism in a constricting or nonconstricting state.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1A is a pictorial view of an embodiment of the disclosed hemostasis valve.

[0009] FIG. IB is an illustration of a constricting wire of a hemostasis valve showing various constricting wire elongations and the wire end button positions.

[0010] FIG. 2 is a first pictorial partial cross-sectional view of the hemostasis valve of Fig. 1 A.

[0011] FIG. 3 is a second pictorial partial cross-sectional view of the hemostasis valve of Fig. 1A.

[0012] FIG. 4 is a pictorial view of an alternate embodiment of a hemostasis valve.

[0013] FIG. 5 is a first pictorial cross-sectional view of portions of the hemostasis valve of Fig- 4.

[0014] FIG. 6 is a second pictorial cross-sectional view of portions of the hemostasis valve of Fig- 4.

[0015] FIG. 7 is a pictorial cross-sectional exploded view of a second alternate embodiment of portions of a hemostasis valve according to the invention.

[0016] FIGS. 8A-8C, each are front views of three separate embodiments of hemostasis valve s according to the invention the three embodiments each having two constriction control buttons and having various distances (widths) between the opposite surfaces of the complementary buttons.

[0017] FIG. 9 is a pictorial cross-sectional view of portions of the hemostasis valve of Fig. 8B.

[0018] FIG. 10 is a front view of the hemostasis valve of Fig. 8B with tubing attached to the lower three ports of the valve body.

[0019] FIG. 11 is a pictorial view of a hemostasis valve according to the invention, whose activation requires relative rotation between separate portions of the valve body.

[0020] FIG. 12A is a first pictorial cross-sectional view of portions of the embodiment of the hemostasis valve shown in Fig. 11.

[0021] FIG. 12B is a close up view of a spring positioned in the top section of the valve shown in Fig. 12A, the ends of the spring being connected between an outer body and an inner rotating member of the valve shown in Fig. 12A..

[0022] FIG. 13 is a cut away view of portions of the valve shown in Figs. 11, 12A, and 12B.

[0023] FIG. 14A is a second pictorial cross-sectional view of portions of the hemostasis valve shown in Figs. 11, 12A, 12B, and 13.

[0024] FIG. 14B is a close up view of interlocking elements in the core and circumferential portions of the hemostasis valve shown in Fig. 14A.

[0025] FIG. 15 is a pictorial view of central and core portions of the hemostasis valve shown in Figs. 11, 12A, 12B, 13, and 14A.

[0026] FIG. 16 is an illustration of a valve operator hand holding the hemostasis valve shown in Figs. 11, 12A, 12B, 13, and 14A in a "ready to operate" position.

[0027] FIG. 17 is a pictorial view of the hemostasis valve of Figs. 11, 12A, 12B, 13, and 14A with three branches of separate tubing connecting to a lower end of the hemostasis valve.

[0028] FIG. 18 is a pictorial view of another embodiment of a hemostasis valve utilizing a spring clamp.

[0029] FIG. 19 is a pictorial illustration of fingers of a hand of an operator positioned on the actuating handles of the spring clamp of the hemostasis valve of Fig. 18.

[0030] FIG. 20 is an end view of the hemostasis valve of Fig. 18, when the spring clamp is in a relaxed state.

[0031] FIG. 21 is an end view of the hemostasis valve of Fig. 18 when the actuating handles of the spring clamp are squeezed and the spring clamp is in a state deformed from its relaxed state.

[0032] FIG. 22 is a pictorial view of another embodiment of a hemostasis valve picturing a single button actuating surface.

[0033] FIG. 23 is a schematic depiction of pails of a constriction mechanism as used in the hemostasis valve for Fig. 22.

[0034] FIG. 24 is a pictorial illustration of a fingers of the hand of an operator holding the hemostasis valve Fig. 22 as might be held when the valve is operated

[0035] FIG. 25 is a pictorial illustration of the hemostasis valve of Fig. 22, showing a single button actuating surface in a fully depressed state.

[0036] FIG. 26 is a pictorial illustration of the hemostasis valve of Fig. 22, showing the single button actuating surface is in a partially depressed state.

[0037] FIG. 27 is a pictorial illustration of the hemostasis valve of Fig. 22, showing the a single button actuating surface is in a released state.

[0038] FIG. 28 is a pictorial view of an alternate embodiment of a hemostasis valve utilizing a constricting wedge mechanism.

[0039] FIG. 29 is a pictorial illustration of the hemostasis valve of Fig. 28 being held in the fingers of an operator.

[0040] FIG. 30 is a pictorial view of the hemostasis valve of Fig. 28 where the valve activation mechanism (button) is in a relaxed state.

[0041] FIG. 31 is a pictorial view of the hemostasis valve of Fig. 28 where the valve activation mechanism (button) is in an activated state.

[0042] FIG. 32 is a pictorial cross-sectional view of the hemostasis valve of Fig. 28, showing a constricting wedge of the valve where the valve activation mechanism (button) is in its relaxed state.

[0043] FIG. 33 is a pictorial cross-sectional view of the hemostasis valve of Fig. 28, showing a larger fluid flow tube inserted through the valve than the one shown in Fig. 32 where the valve activation mechanism (button) is in its relaxed state.

[0044] FIG. 34 is a pictorial view of another embodiment hemostasis valve having symmetrical levers used to control valve actuation (where the lever arm to valve body core separation springs are not shown).

[0045] FIG. 35 is a pictorial view of the hemostasis valve of Fig. 34, where the levers configured to activate the valve.

[0046] FIG. 36 is a pictorial cross-sectional view of the hemostasis valve of Fig. 34 (where the lever arm to valve body core separation springs are shown, but the fluid flow tube constricting filament, the each of which is attached, one to each lever arm, is not shown).

[0047] FIG. 37A is a schematic diagram of an alternate arrangement of components of a hemostasis valve, similar to the one shown in Fig. 34, where the lever arm pivot axes are not at the end of the lever arms, and the biasing force to pivot the lever arms open is an elastic memberon the opposite side of the pivot axis of the lever arm from the points of attachment of the constricting members.

[0048] FIG. 37B is a schematic diagram of the hemostasis valve depicted in Fig. 37Awhere the lever arms are in a released state, causing the constricting members to constrict that flow tube through the valve.

[0049] FIG. 38A is a general illustration of an example of an elastomeric flow path tube that might act as flow tubes in one or more of the hemostasis valve embodiments described herein. Note that that two constricting wires are shown loosely encircling a constricting location on the outside of the elastomeric flow path tube.

[0050] FIG. 38B is a general illustration of an example of the elastomeric flow path tube of Fig. 38 A show the constricting wires constricting the tube at the constricting location (point) on the outside of the elastomeric flow path tube.

[0051] FIG. 39 is a pictorial illustration of another embodiment of the hemostasis valve utilizing a geared lever mechanism to constrict the flow therethrough.

[0052] FIG. 40 is an illustration of the hemostasis valve of Fig. 39 showing a syringe in position to be attached to a port of the valve, to for example: remove an embolism.

[0053] FIG. 41 is a cut away view showing some parts of the internal mechanism of the hemostasis valve of Fig. 39 as it is being operated by fingers of a human operator.

[0054] FIG. 42 is an illustration of the hemostasis valve of Fig. 39 in a fully closed configuration (where the constricting wires are fully tensioned to constrict the fluid tube therethrough to its maximum - note: that the constricting wires are not pictured).

[0055] FIG. 43 is an illustration of the hemostasis valve of Fig. 39 in a fully open configuration (where the constricting wires are fully relaxed - note: that the constricting wires are not pictured).

[0056] FIG. 44 is a cutaway - isolated parts view of only the lever components and constricting wires of the hemostasis valve of Fig. 39, where the parts arc configured to show a fully closed configuration.

[0057] FIG. 45 is a cutaway - isolated parts view of only the lever components and constricting wires of the hemostasis valve of Fig. 39, where the parts are configured to show a fully open configuration.

[0058] FIG. 46 is a pictorial illustration of an embodiment of the hemostasis valve of Fig. 39 comprising flexible tabs (the flexible tabs are formed from a specifically shaped through cut of the top surface of the valve body thereby providing a nominal axial tab dimension that allows the tabs to bend under the application of force to them more easily (under lower force) than the surrounding top surface of the valve body around the tabs).

[0059] FIG. 47 is a pictorial illustration of a portion of a housing in an embodiment of the hemostasis valve of Fig. 39 comprising flexible tabs (the flexible tabs are formed from a specifically shaped through cut of the bottom surface of the valve body thereby providing a nominal axial tab dimension that allows the tabs to bend under the application of force to them more easily (under lower force) than the surrounding bottom surface of the valve body around the tabs).

[0060] FIG. 48 is another pictorial illustration of the valve outer housing of the hemostasis valve of Figs. 39, 41, 44, and 47 comprising flexible tabs.

[0061] FIG. 49 is a pictorial and schematic illustration of a portion of one lever arm of the valve engaging a lever hinge post and raised detent of a flexible tab of the valve outer housing of the hemostasis valve of Figs. 39, 41, 44, and 47.

[0062] FIG. 50 is a pictorial cross-sectional illustration of a portion of the rotational position locking mechanism for one actuation lever of the hemostasis valve of Figs. 39, 41, 44, and 47.

[0063] FIG. 51 is a cut away illustration showing the inner mechanisms of the bottom portion of the hemostasis valve of Figs. 39, 41, 44, and 47 in a closed configuration.

[0064] FIG. 52 is a cut away illustration showing the inner mechanisms of the bottom portion of the hemostasis valve of Figs. 39, 41, 44, and 47 in an open configuration.

[0065] FIG. 53 is a close-up view of the hemostasis valve of Fig. 52.

[0066] FIG. 54 is a plan view of the hemostasis valve of Figs. 39-53.

[0067] FIG. 55 is a side view of the hemostasis valve of Fig. 54.

[0068] FIG. 56 is a cut away view showing inner parts of the hemostasis valve of Figs. 39-55.

[0069] FIG. 57A is a perspective view of a guillotine embodiment of the hemostasis valve.

[0070] FIG. 57B is a top view of the guillotine embodiment of the hemostasis valve.

[0071] FIG. 58A is a perspective view of the constricting plates of the guillotine embodiment of the hemostasis valve.

[0072] FIG. 58B is a separated view of the constricting plates of the guillotine embodiment of the hemostasis valve.

[0073] FIG. 59A is an illustration of constricting plates of the guillotine embodiment of the hemostasis valve in a non-constricting state.

[0074] FIG. 59B is an illustration of constricting plates of the guillotine embodiment of the hemostasis valve in a partially constricting state.

[0075] FIG. 59C is an illustration of constricting plates of the guillotine embodiment of the hemostasis valve in a constricting state.

[0076] FIG. 60 is an illustration of an embodiment of the fluid flow tube.DETAILED DESCRIPTION

[0077] The disclosed subject matter is a selectively controllable valve or hemostasis valve. The hemostasis valve is configured to open and close flexible tubing providing access to a vasculature. A vasculature, as described herein, refers to a human or animal circulatory systemincluding blood vessels such as arteries, veins, and capillaries. The disclosed hemostasis valve may be used to grant access for a fluid flowing in tubing routed through the valve into any portion of a vasculature. The most likely access point to a vasculature for the tubing controlled by the hemostasis valve would be the veins.

[0078] The hemostasis valve, which may be coupled to a flexible catheter, shall be easily positioned by the clinician or other medical practitioner for any of the following procedural actions including but not limited to smooth passage of a guide wire (typically 0.035” in diameter), smooth passage of large diameter tubular instruments (up to 0.310”), smooth passage and withdrawal of a dilator component, which provides the ability to seal against full vacuum during aspiration.

[0079] Operation of the hemostasis valves disclosed will be intuitive and easily operated by the clinician with fingers of one hand. A pail of this disclosure includes descriptions of the design of a hemostasis valve which is coupled to a flexible catheter shaft with external diameters ranging in size from 0.080” to 0.330” and lengths from 80 cm to 130 cm. The details of construction of the flexible tubular catheter shaft are not described herein.

[0080] The hemostasis valve may be operated by a human operator using one or both hands. In various embodiments, a human operator may press or release one or more buttons or levers to open the hemostasis valve to allow fluid to flow through a fluid path within the hemostasis valve. In various embodiments the human operator may operate the hemostasis valve by a mechanism other than a button or lever. In an exemplary embodiment, the hemostasis valve may be operated by rotating a knob or handle to open a flow path within the hemostasis valve.

[0081] In various embodiments, the hemostasis valve comprises a fluid flow path that traverses the hemostasis valve. The fluid flow path may facilitate flow of a fluid such as blood or other substance that may be infused or otherwise mixed into blood of a human patient or animal subject. The fluid flow path of the hemostasis valve comprises a flow path tube with a compressible lumen that is configured to be opened and closed by a constriction mechanism. The constriction mechanism may include a bias mechanism that causes the constriction mechanism to press on the compressible lumen to restrict or seal the fluid flow area in the tube available for flow.

[0082] In various embodiments, the constriction mechanism may comprise a bias that causes the constriction mechanism to release the compressible lumen and open the fluid flow path tube. In various embodiments, the hemostasis valve may be configured such that the bias acts to constrict the lumen and seal the flow path tube when no outside force is applied to the hemostasis valve. Accordingly, a human practitioner may operate one or more mechanisms on the hemostasis valve to open the fluid flow path tube. As soon as the human practitioner releases the one or more mechanisms, the fluid flow path tube on the hemostasis valve may automatically close.

[0083] In various embodiments, a human practitioner may quickly insert a catheter into a human or animal vasculature by operating the constricting mechanism to open the hemostasis valve and insert the catheter. The human practitioner may then release the hemostasis valve to seal a lumen to an outside surface of the catheter and limit vascular exposure. In various embodiments, infusate may be prepared to be infused into a vasculature by operating the hemostasis valve. For example, infusate comprising one or more substances to be infused into a vasculature may be connected to a flow path of the hemostasis valve. Upon operating the hemostasis valve, the flow path tube may open and infusate may enter the vasculature through the flow path tube of the hemostasis valve.

[0084] The constricting mechanism may comprise various embodiments. In an exemplary embodiment, the constricting mechanism comprises a button affixed to one or more constricting wires. The one or more constricting wires may make contact with the fluid flow path tube and act to constrict the fluid flow path tube when the button is released. The bias that causes the button to be released may cause the constricting wires to constrict the fluid flow path tube and seal it.

[0085] The constricting wires may be arranged in various configurations to effectuate a constriction on the fluid flow path tube. In various embodiments the one or more constricting wires may be looped around the fluid flow path tube. The one or more constricting wires that are looped around the fluid flow path tube may be configured to tighten the fluid flow path tube to seal the lumen when the constricting mechanism is released by a human practitioner.Alternatively, the constricting wires may be configured to release or otherwise unconstrict the fluid flow path tube when a human operator releases the constricting mechanism.

[0086] An exemplary embodiment of the constricting mechanism may comprise a two button constricting mechanism whereby two buttons arc arranged on the same axis oriented 180 degrees relative to one another such that a human operator may depress the two buttons by squeezing the constricting mechanism with a single hand. A bias force may be applied to each of the two buttons. In an implementation of the exemplary embodiments described herein, each of the two buttons may be of various sizes. In an exemplary embodiment, the two buttons comprise between about 2 to 8 cm along an axis of the fluid flow path.

[0087] The bias for each button may comprise two springs that are oriented perpendicular to the fluid flow path in a direction of movement of the button. Each of the two springs may be positioned relative to the other spring along the axis of the fluid flow path. In an exemplary embodiment, one or more constricting wires are affixed to each button at a point in between the two springs.

[0088] In an exemplary embodiment, the constricting mechanism may comprise a single button affixed to one or more constricting wires. Like the two button embodiment, the bias in the constricting mechanism may comprise two springs that force the button into an up state. A human practitioner may press the button into a depressed state. In various embodiments, the constricting mechanism may be configured to seal the lumen of the fluid flow path tube when the button is in a depressed state. Likewise, the constricting mechanism may be configured to open the lumen of the fluid flow path tube when the button is in an up or released state.

[0089] In an exemplary embodiment, the constricting mechanism may comprise a spring clamp that surrounds the fluid flow path tube of the hemostasis valve. The spring clamp may be in a released state or a compressed state. In a released state, the spring clamp may compress the fluid flow path tube and seal the lumen of the hemostasis valve. A human practitioner may compress or squeeze the spring clamp to release constricting pressure on the fluid flow path tube and unseal the lumen. Accordingly, a human practitioner may operate the spring clamp embodiment using a single hand.

[0090] In an exemplary embodiment, the constricting mechanism comprises a rotatable valve member attached to a plurality of constricting members. The bias causes the rotatable valve member to rotate causing the constricting members to wrap around the fluid flow path tube.When the rotatable valve member is released, the bias forces the rotatable valve member to rotate, which causes the constricting members to constrict around the fluid flow path tube and seal the lumen. A human practitioner may rotate or twist the rotatable valve member to unconstrict the constricting members and open the lumen.

[0091] In an exemplary embodiment, the constricting mechanism comprises a button and wedge mechanism. The button, when pushed into an up state by a bias, may press against a wedge that compresses the fluid flow path tube and seals the lumen. A human practitioner may press the button to release compression from the wedge and open the lumen. In various embodiments, the button may be configured instead to seal the lumen when the button is depressed and open the lumen when the button is released by the human practitioner.

[0092] In an exemplary embodiment, the constricting mechanism comprises one or more levers attached to one or more constricting wires. The constricting wires may be wrapped in various configurations around the fluid flow path tube such as a loop (or bight). When the one or more levers are released, the bias force provided by each of the one or more levers may push the lever into an extended position and tension the constricting wires around the fluid flow path tube, which will seal the lumen. A human practitioner may engage the one or more levers to open the lumen and expose the vasculature through the hemostasis valve.

[0093] Vascular catheters arc an important tool for the treatment of systemic defects within human vasculature. This disclosure further describes a catheter system intended for the removal of blood clots from the human vasculature. Blood clots can restrict the flow of oxygenated blood to target organs. It is therefore important to remove these clots to restore optimal profusion.

[0094] Access to the vascular system is typically gained with an access sheath. Access sites commonly include the iliac veins / arteries, radial veins / arteries, saphenous veins / arteries, and jugular veins / arteries. These access sheaths serve as a conduit for the passage of flexible catheters into the human vascular system and are commonplace.

[0095] The flexible catheter shaft shall have the length, diameter, flexibility, and torque- ability needed to safely navigate to the desired location. It is important to get to within a few centimeters of the blood clot to maximize aspiration / retrieval performance. The catheter systemmay include a guide wire component which serves as a track that the catheter shaft can ride over. The catheter system may further include a dilator which fills the ID of the catheter shaft and includes a pointed tip, which greatly improves the ability of the catheter system to track to the target location.

[0096] Referring to Fig. 1 A, Fig. 1A is a pictorial view of an embodiment of the disclosed hemostasis valve 100. The hemostasis valve 100 includes a fluid flow path tube that may be connected to a vasculature of a human being or animal subject. The hemostasis valve 100 is configured to be used by a medical practitioner such as a doctor, nurse, physician’s assistant, veterinarian, or any other medical professional.

[0097] The fluid flow path in the hemostasis valve 100 may be accessed by at least two ends of the hemostasis valve. As shown in Fig. 1A, the hemostasis valve includes a first inlet 102 at one end of the fluid flow path and a junction 106 which is connected to a second inlet 104 of the hemostasis valve 100. Fluid may flow through the hemostasis valve 100 in either direction. The terms distal end and proximal end may designate the two ends of the hemostasis valve such as the first inlet 102 and the second inlet 104. The inlet selected as the distal end or proximal end may be arbitrarily selected. The term proximal end, as used herein, may be the inlet or access opening at a top or left side of images of the hemostasis valve 100. Likewise, the term distal end, as used herein, may refer to the inlet or access opening at a bottom or right side of the hemostasis valve 100. The fluid flow path in the hemostasis valve 100 comprises a compressible flow path tube and a lumen that can be compressed to seal the lumen and shut off a flow of fluid through the fluid flow path tube. The hemostasis valve 100 may comprise a bias that operates a constriction mechanism.Two Button Embodiment

[0098] The hemostasis valve 100 may comprise multiple embodiments such as the two button embodiment shown in Fig. 1A. Other embodiments of the hemostasis valve 100 include a one- button embodiment, a wedge constriction embodiment, a spring clamp embodiment, and a rotary embodiment.

[0099] The bias in the hemostasis valve 100 shown in Fig. 1 A comprises springs that are covered by a housing 120. The bias imparts a force to a button or other mechanical switch. For example, the bias may include a spring that imparts a force to a mechanical switch such as a button, knob, lever, or the like. In an exemplary embodiment, the hemostasis valve 100 may be configured such that the bias causes a constriction mechanism to seal the lumen and shut the fluid How path tube when no outside forces are acting on the hemostasis valve 100. Accordingly, a medical practitioner may seal the hemostasis valve 100 by releasing it or otherwise ceasing operation of the hemostasis valve 100. In various embodiments, each of the springs and the hemostasis valve may have a spring constant of between about 0.15 N per millimeter and about 0.6 N per millimeter.

[0100] Alternatively, the hemostasis valve may be configured to seal the lumen of the fluid flow path tube only upon activation by a human operator such as a medical practitioner. For example, the bias of the hemostasis valve 100 may be configured to impart a force that causes the constriction mechanism to open the lumen of the fluid flow path tube when no outside forces are acting on the hemostasis valve 100. A medical practitioner may operate this alternative embodiment of the hemostasis valve 100 to constrict the fluid flow path tube and seal the lumen from fluid flow.

[0101] In various embodiments, the hemostasis valve 100 includes a junction 106 at one or more of the access points to the fluid flow path. The junction 106 may branch the fluid flow path into two or more flow paths. In the embodiment shown in Fig. 1A, the junction 106 branches the fluid flow path into a first flow path 108, a second flow path 110, and a 3rdflow path 114. In various embodiments, the branching flow paths may include one or more shut-off valves such as the shut-off valve 112 affixed to the first flow path 108.

[0102] The embodiment of the hemostasis valve 100 shown in Fig. 1A comprises a two-button constriction mechanism, comprising a first button 116 and a second button 118, that is configured to be hand-operable by a medical practitioner. When the 2 buttons are in an up or released state, the constriction mechanism constricts the fluid flow path tube within the hemostasis valve 100 to seal the lumen. Accordingly, no fluid may flow through the embodiment of the hemostasis valve 100 shown in Fig. 1A when the buttons are in a released state. Themedical practitioner may squeeze the buttons of the hemostasis valve 100 to operate the constriction mechanism to release the constriction of the fluid flow path tube and open the lumen, which will allow fluid to flow through the hemostasis valve 100. In various embodiments, each of two buttons may have a length along an axis of a fluid flow path, which connects the first inlet 102 to the second inlet 104, of between about 3 cm and about 6 cm.

[0103] In an exemplary embodiment, the buttons of the hemostasis valve 100 include a stabilizing guide 122. The stabilizing guide 122 may comprise a longitudinal rail or track that limits the linear movement of the button on an axis 124 of the longitudinal rail of the stabilizing guide 122. The stabilizing guide 122 provides resistance to a torque force that is inadvertently applied to the buttons by a medical practitioner as they attempt to depress the buttons.

[0104] Referring to Fig. IB, Fig. IB is an illustration 150 of the constricting wires of the hemostasis valve 100 at various button states. The button states that are illustrated in the illustration 150 comprise a fully engaged state 155, a midway state 160, and a released state 165. The buttons are coupled to constricting wires that wrap around a fluid flow tube. In various embodiments, the constricting wires wrap around the fluid flow tube to make a loop. The size of the loop may change based on the state of the button. A larger loop will allow more space for the fluid flow tube. A smaller loop will compress the fluid flow tube.

[0105] The fully engaged state 155 is where both buttons arc fully pressed in by a medical practitioner. By pressing in the buttons the loop 158 made by the constricting wires becomes larger and releases any constriction around the fluid flow tube. In the midway state 160, the buttons are partially pressed which cause the loop 163 to be smaller than the loop 158 where the buttons are fully engaged. Accordingly, there is more constriction in the fluid flow tube in the midway state 160 than in the fully engaged state 155. The released state 165 is where the buttons are fully released and the loop 168 is fully constricted. The fluid flow tube which is wrapped by the loop 168 will be in its most constricted state and may be fully shut off from any fluid flow.

[0106] Referring to Fig. 2, Fig. 2 is a cross-sectional view 200 of the hemostasis valve 100. Some features of the hemostasis valve 100 are not displayed in the cross-sectional view 200 in order to more clearly show some elements of the hemostasis valve 100. The cross-sectional view 200 displays portions of the hemostasis valve 100 inside the housing 120. The cross-sectionalview 200 shows a flow path tube 215 with a lumen 216. The fluid flow path tube includes a first opening 226 and a second opening 229. Fluid may enter or exit the hemostasis valve through either of the first opening 226 and second opening 229. The constricting mechanism of the hemostasis valve 100 shown in Fig. 2 is in a released state causing the constricting wires 210 to constrict the fluid flow tube 215 and seal the lumen 216.

[0107] The constricting mechanism for the embodiment of the hemostasis valve 100 includes four springs 205, whereby two springs provide a bias for the first button 222 and two springs provide a bias for the second button 224. In the embodiment shown in Fig. 2, the constricting wires 210 are attached to the buttons and wrap around the flow path tube 215 at a constriction point 220. The constricting wires 210 may comprise one or more wires that at least partially wrap around the flow path tube 215. In various embodiments the constricting wires 210 loop around the flow path tube 215 whereby each constricting wire 210 wraps completely around the flow path tube 215. In various embodiments, the constricting wire(s) 210 may form a bight around the flow path tube 215 whereby the constricting wire 210 forms a U-shaped bend around the flow path tube 215.

[0108] The springs 205 may be braced against a platform 228 that surrounds the flow path tube 215. In an exemplary embodiment, the platform 228 is solid and does not bend or move relative to the hemostasis valve 100. The platform 228 includes one or more apertures 230 that allow the constricting wires 210 to pass through the platform 228 and wrap around the flow path tube 215.

[0109] In various embodiments, the hemostasis valve 100 may be configured to receive a catheter through the first opening 226. For example, a medical practitioner may engage the first button 222 and the second button 224 to relax the constricting wires 210 and open the flow path tube 215 to allow for the catheter to be inserted into the flow path tube 215. Once the catheter is inserted past the constriction point 220, the medical practitioner may release the first button 222 and the second button to 224 to cause the constricting wires 210 to tighten around the constriction point 220 and cause the flow path tube 215 to seal around the catheter.

[0110] In various embodiments, the flow path tube 215 may comprise an elastomeric material such as medical grade silicone or polyurethane that is capable of forming seals or capable of shutting off a flow of fluid. The flow path tube 215 may comprise any material that is capable offorming a seal around a catheter to shut off the flow of fluid around the periphery of the catheter. The material of the fluid flow tube 215 may be further configured to be constrictablc such that it may form a seal without any object inside the flow path tube 215 upon sufficient constriction of the flow path tube 215.

[0111] Referring to Fig. 3, Fig. 3 is a cross-sectional view 300 of portions of the hemostasis valve 100. The hemostasis valve 100 shown in Fig. 3 includes a spring housing 305 for each bias in the hemostasis valve 100. The two button embodiment of the hemostasis valve 100 shown in Fig. 3 includes four spring housings 305 to accommodate four springs. Each button 310 is acted upon by a spring-generated bias wherein the bias comprises two springs for each button 310.

[0112] The two spring housings 305 for each button stabilize the springs to lock one end of the springs in place as the hemostasis valve 100 is operated. The constricting wires that connect an end of the button to the flow path tube may be coupled to an end of the button and drawn between the two spring housings 305 before being wound around the flow path tube 215. The two spring housings 305 may be separated by a space to make way for the constricting wires. The aperture 230 may be positioned in the space in between the two spring housings 305.

[0113] Referring to Fig. 4, Fig. 4 is a pictorial view 400 of an embodiment of the disclosed hemostasis valve 100. The buttons of the embodiment of the hemostasis valve 100 shown in Fig. 4 include a longitudinal rail 405. The longitudinal rail 405 limits rotational movement of the buttons.

[0114] A medical practitioner that applies a force to the buttons at a radial distance away from a center point 420 of each button creates a torque force as well as a translational force on the button. The height of the longitudinal rail 405 shown in Fig. 4 is measured all along the height axis 430. The height plane 435, indicated by the shaded area of the longitudinal rail 405 makes contact with the guardrail of the housing and prevents rotation of the button on the height axis 430.

[0115] The housing 415 of the hemostasis valve 100 may include one or more guardrails to receive the one or more longitudinal rails on the one or more buttons of the hemostasis valve100. Accordingly, a medical practitioner that applies a force some distance along an axis 425 some distance away from a center point 420 will apply a torque to the button which is resisted by one or more longitudinal rails 405.

[0116] Referring to Fig. 5, Fig. 5 is a cross-sectional view 500 of portions of the hemostasis valve 100. Fig. 5 shows an image of a two button embodiment of the hemostasis valve 100 wherein a significant portion of each of the two buttons are exposed from the housing 415. The two buttons may comprise a stop 505 that makes contact with the housing when the buttons are at full extension. Accordingly, contact of the housing with the stop 505 prevents the buttons from extending beyond a set distance. The springs or other bias provide a force that pushes the buttons into an up or released position. At full extension, the springs or other bias will press the stop 505 of the buttons against the housing 415 of the hemostasis valve 100.

[0117] In the exemplary embodiment of the hemostasis valve 100 shown in Fig. 5, the stop may extend the same distance on the height axis 430 as the longitudinal rail 405. This may allow for ease in manufacturing as the same parts that are used for the longitudinal rail 405 may be used for the stop 505.

[0118] Referring to Fig. 6, Fig. 6 is a cross-sectional view 600 of portions of the hemostasis valve. The cross-sectional view 600 shows a bottom portion of the hemostasis valve 100. As shown in the cross-sectional view 600, the stop 505 of the button may make contact with a portion of the housing 605 that prevents the button from being pushed from the hemostasis valve 100 by the one or more springs.

[0119] The buttons of the hemostasis valve 100 may include one or more holes 610 that may facilitate coupling of the constricting wires to the buttons. In an exemplary embodiment, one constricting wire may be coupled to a first button 625 via the holes 610 and drawn through a first aperture 620 wrap around the flow path tube 615 and drawn through the second aperture 622 to couple to the second button 627 at the holes 612. In various embodiments where each constricting wire is only attached to a single button, a first constricting wire may be coupled to the first button 625 at the holes 610 and drawn through the first aperture 620 to wrap around the flow path tube 615 and a second constricting wire may be coupled to the second button 627 at the holes 612 and drawn through the second aperture 622 to wraparound the flow path tube 615.

[0120] As shown in the cross-sectional view 600, the second button 627 is fully depressed. Accordingly, the stop 505 for the second button 627 makes contact with the cross panel 630 of the housing. The cross panel 630 may also serve as a support for the flow path tube 615.

[0121] Referring to Fig. 7, Fig. 7 is a cross-sectional exploded view 700 of portions of the hemostasis valve 100. The cross-sectional exploded view 700 shows one of the buttons 705 of the hemostasis valve 100 separated from the housing of the hemostasis valve 100. In the exemplary embodiment shown in Fig. 7, the button 705 may be constructed as one solid piece. The embodiment of the button 705 shown in the cross-sectional exploded view 700 includes the stop 505, but not the longitudinal rail 405. The stop 505 may make contact with the central panel 710 of the housing when the button 705 is fully depressed. Further, the button may make contact with an outside edge 715 of the housing when the button is in an up or released position.

[0122] Referring to Figs. 8A-8C, Figs. 8A-8C are front views of a two button embodiment of typical hemostasis valves of various widths. Embodiments of the hemostasis valve 100 may have various dimensions. For example, as shown in Fig. 8 A, the housing ### of the hemostasis valve 800 may have a width of between about 10 and 12 cm. A greater width hemostasis valve 100 can provide larger buttons with a greater activation travel distance. Accordingly, the activation travel distance for the buttons of the hemostasis valve 800 may be between about 1 cm and 4 cm.

[0123] The housing of the hemostasis valve 820 may have a width of between about 7 cm and 10 cm. The buttons of the hemostasis valve 820 may have an activation distance between about 1 cm and about 3 cm. The housing of the hemostasis valve 840 may have a width between about 5 cm and about 7 cm. The buttons of the hemostasis valve 840 may have an activation distance between about 1 cm and about 2 cm. The various widths of the hemostasis valves may be modified based on space limitations, physical size and strength of the medical practitioners who use the hemostasis valve 100, and any other variables or limitations in a medical setting.

[0124] Referring to Fig. 9, Fig. 9 is a cross-sectional view 900 of portions of the hemostasis valve 840. The hemostasis valve 840 with the shorter width than other variations of the hemostasis valve 100 may accommodate size limitations or allow a medical practitioner to applymore force to the hemostasis valve 840 based on the mechanical advantage of squeezing a small hemostasis valve versus a larger hemostasis valve with a human hand.

[0125] The hemostasis valve 840 includes a first button 905 and a second button 910. The first button 905 is coupled to a first constriction wire 915. The first constriction wire 915 wraps around the flow path tube 925 to form a bight or U-shaped bend. Likewise, the second constriction button 910 is coupled to the second constriction wire 920. The second constriction wire wraps around the flow path tube 925 to also form a bight or u-shaped bend.

[0126] The first button 905 and second button 910 are in a fully depressed state whereby both buttons are pressed all the way down. Accordingly, the first constriction wire 915 and the second constriction wire 920 provide the lowest level of constriction around the flow path tube 925 causing it to be open which allows fluid to flow through the lumen 930. When the buttons are released, they will pull the first constriction wire 915 and the second constriction wire 920 causing them to constrict around the flow path tube 925. When the buttons are fully released, the first constriction wire 915 and second constriction wire 920 will have compressed the flow path tube 925 enough to seal it and shut off fluid flow through the lumen 930.

[0127] Referring to Fig. 10, Fig. 10 is a front view 1000 of a hemostasis valve 100. The hemostasis valve 100 shown in the front view 1000 is a two button embodiment of the hemostasis valve. The hemostasis valve 100 may be in a closed state when both the first button 1010 and second button 1015 arc in a released state. The buttons are held in place by contact between a stop on the button and portions of the housing 1005. A longitudinal rail 1020 on each of the buttons prevents rotation of the button on an axis when a torque force is inadvertently applied to the button.

[0128] The flow path tube 215 of the hemostasis valve includes two access points, a first access point 1035 and a second access point 1040. Alternatively, the first access point 1035 may be referred to as an inlet and the second access point 1040 may be referred to as an outlet. In various embodiments, the second access point 1040 may be coupled to a junction 1045 that has multiple outlets. In the embodiment shown in the front view 1000, the junction is coupled to a first outlet 1030, a second outlet 1025, and a 3rdoutlet 1050.Rotary Embodiment

[0129] The hemostasis valve 100 may have multiple embodiments including but not limited to a two button embodiment, one button embodiment, a rotary embodiment, a spring clamp embodiment, and a hand lever embodiment. The multiple embodiments may have various advantages and disadvantages based on the medical procedure, space allocated for the hemostasis valve, personal preference of the medical practitioner, manufacturing cost, reliability, and performance of the device.

[0130] Referring to Fig. 11, Fig. 11 is a pictorial view of a rotary embodiment of the hemostasis valve 1100. The hemostasis valve 1100 may be utilized by a medical practitioner to open and shut off access into a vasculature of a human patient or animal subject. In various embodiments, the medical practitioner may rotate the hemostasis valve 1100 to shut off or open a flow path tube 215 and allow fluid such as blood or medicament to flow through the lumen 216.

[0131] The hemostasis valve 1100 includes a bias that causes a rotary portion 1120 to rotate relative to the rest of the hemostasis valve 1100. The bias may cause a multitude of constriction members to wrap around the flow path tube 215 and constrict the flow path tube. In an exemplary embodiment, the bias causes the constriction members to rotate around and constrict the flow path tube 215 when no outside force is applied to the hemostasis valve 1100. The bias may cause a multitude of constriction members to wrap around the flow path tube 215 and constrict the flow path tube 215. While under no outside force, the constriction members may constrict the flow path tube 215 enough to shut off a flow of fluid through the hemostasis valve 1100.

[0132] The hemostasis valve 1100 may include a first access opening 1105 and a second access opening 1110. Fluids such as medicaments, circulatory fluids, infusate, and the like may flow in either direction through the hemostasis valve 1100. A medical practitioner may twist the rotary portion 1120 to open or close the constriction mechanism around the flow path tube 215. The embodiment of the hemostasis valve 1100 shown in Fig. 11 includes a handle with a multitude of handgrips 1125. A medical practitioner may twist the rotary portion 1120 at the handgrips 1125 to operate the hemostasis valve 1100.

[0133] Referring to Fig. 12A and Fig. 12B, Fig. 12A is a cross-sectional view 1200 of portions of the rotary embodiment of the hemostasis valve 1100. Fig. 12B is a magnified view 1250 of the spring 1215. The Hemostasis valve 1100 may include a flow path tube 1225 that comprises a lumen that is capable of facilitating a flow of fluid through the hemostasis valve. The flow path tube 1225 is compressible by constriction members 1220 that wrap around the flow path tube 1225.

[0134] The hemostasis valve 1100 includes a bias that produces a torque force on the rotary portion 1210. In the exemplary embodiment shown in Fig. 12A, the bias comprises a spring 1215 that surrounds the flow path tube 1225. An end 1255 of the spring 1215 is coupled to the rotary portion 1210. Accordingly, the spring 1215 will coil and uncoil based on rotation of the rotary portion 1210. The spring 1215 may be partially uncoiled at the end 1255 to cause the rotary portion to be under a rotational bias that causes a torque force to be exerted on the rotary portion 1210.

[0135] The torque force may cause the rotary portion to rotate in a direction that causes the constriction members 1220 to wrap around and constrict the flow path tube 1225. In an exemplary embodiment, the rotary portion 1210 of the hemostasis valve 1100 will rotate enough under no outside force to cause the constriction members 1220 to constrict the flow path tube 1225 such that the flow path tube 1225 is sealed.

[0136] A constriction portion of the hemostasis valve may include the rotary portion 1210, the constriction members 1220, and a non-rotating portion 1230. In various embodiments the constriction portion may translate linearly in an up-and-down direction 1245 when the rotary portion 1210 rotates. A gap 1235 in the non-rotating portion 1230 may allow for the constriction portion to translate linearly while remaining bonded to the rest of the hemostasis valve 1100.

[0137] Referring to Fig. 13, Fig. 13 is a cross-sectional view 1300 of portions of the rotary embodiment of the hemostasis valve 1100. In various versions of the rotary embodiment of the hemostasis valve 1100, the rotary portion may include a multitude of inner teeth 1320 that couple the upper end of the constriction mechanism to the rest of the hemostasis valve 1100.

[0138] Referring to Fig. 14A and Fig. 14B, Fig. 14A is a cross-sectional view 1400 of portions of the hemostasis valve 1100. Fig. 14B is a magnified portion 1450 of an interlocking section of the hemostasis valve 1100. When the rotary portion 1210 rotates, the constriction portion of the hemostasis valve 1100 may move in an up-and-down direction 1245. Interlocking teeth between a bottom end of the constriction portion and the rest of the hemostasis valve 1100 allow for the constriction portion to move linearly while remaining sealed to the hemostasis valve 1100.

[0139] In various embodiments, a bottom end of the constriction portion may include one or more rectangular gaps 1415 that are aligned with rectangular teeth 1420 of the hemostasis valve 1100. A length of the rectangular gaps 1415 and rectangular teeth 1420 in an up-and-down direction 1245 may correspond to a length that the constriction portion moves when the rotary portion 1210 is rotated.

[0140] For example, when the rotary portion 1210 is rotated, the constriction members 1410 may move to obstruct or leave open the lumen of the flow path tube 1405 depending on the direction that the rotary portion 1210 is rotated. In one direction of rotation, the constriction members 1410 will interfere with the positioning of the outer surface of the flow path tube 1405 causing the lumen of the flow path tube to be constricted thereby reducing area of the lumen inside for fluid to flow. At a maximum amount of constriction, the lumen of the flow path tube 1405 will seal such that no fluid can flow through the lumen. Rotating in the other direction will cause the constriction members 1410 to release their interference and open the flow path tube 1405. The rotating the rotary portion 1210 in either direction will cause the constricting portion to move up and down. The interlocking section shown in Fig. 14B allows for the constricting portion to move linearly while remaining sealed to the hemostasis valve 1100.

[0141] Referring to Fig. 15, Fig. 15 is a pictorial view 1500 of portions of the hemostasis valve 1100. A medical practitioner may operate the hemostasis valve by rotating the rotatable portion 1510 around a longitudinal axis of the hemostasis valve 1100. A direction of rotation is indicated by the arrow 1505. The rotatable portion 1510 may be rotated in either direction along the longitudinal axis.

[0142] Referring to Fig 16, Fig. 16 is an illustration 1600 of a medical practitioner operating the hemostasis valve 1100. Various embodiments of the hemostasis valve 1100 may include amultitude of handgrips 1610 on an outside of the rotary portion 1210 of the hemostasis valve 1100. A medical practitioner may hold or press against the handgrips 1610 to rotate the rotary portion 1210 of the hemostasis valve 1100.

[0143] In the exemplary embodiment of the hemostasis valve 1100 shown in Fig 16, the hemostasis valve 1100 may be configured to be operated with one hand. A body 1605 of the hemostasis valve 1100 may be configured to be held in the palm of the hand while the rotary portion is configured to be rotated with the thumb and forefinger as the thumb and forefinger push against the handgrips 1610.

[0144] In various embodiments, the rotary portion 1210 of the hemostasis valve 1100 may include a notch 1615 that holds the end 1255 of the spring 1215. The notch 1615 transmits a force of coiling and uncoiling of the spring 1215 to the rotary portion 1210. In various embodiments, the end 1255 of the spring 1215 may be coupled to the rotary portion 1210 by other means.

[0145] Referring to Fig 17, Fig. 17 is a pictorial view 1700 of a hemostasis valve 1100 with a junction of 3 branches of separate tubing at one end of the hemostasis valve 1100. In the exemplary embodiment of the hemostasis valve 1100 shown in Fig 17, an access opening 1110 is attached to a junction that branches into 3 separate tubing branches.

[0146] A medical practitioner may utilize the junction to quickly infuse various medicaments or other infusate to a vasculature. For example, a first infusate may be prepared at a first junction 1710 and a second infusate may be prepared at a second junction 1715. By opening and closing the stopcocks for each of the junctions and medical practitioner may quickly infuse the first infusate by opening the stopcock attached to the first junction 1710 and twisting the hemostasis valve 1100 to open the flow path tube 1225 to allow fluid to flow through the hemostasis valve. The medical practitioner may then close the stopcock at the first junction 1710 and open the stopcock at the second junction 1715 to add the second infusate by twisting the rotary portion of the hemostasis valve 1100. A third junction 1720 may be opened to add a third infusate to the vasculature.Spring Clamp Embodiment

[0147] Referring to Fig. 18, Fig. 18 is a pictorial view of a spring clamp embodiment of the hemostasis valve 1800. The spring clamp embodiment of the hemostasis valve 1800 may allow a medical practitioner to operate the hemostasis valve by squeezing handles 1820 of a spring clamp with two fingers such as a thumb and forefinger. The hemostasis valve 1800 may include a first access opening 1805 and a second access opening 1825. The access openings are connected by the flow path tube 215.

[0148] The spring clamp comprises a spring 1810 that wraps around a fluid flow tube 1835. When no external forces are operating on the spring clamp, the spring 1810 may tighten around the fluid flow tube 1835 to constrict the fluid flow tube 1835. In various embodiments, the spring clamp may be configured to tighten sufficiently to fully constrict the fluid flow tube 1835 enough to seal the fluid flow tube 1835 when no external force is applied to the spring clamp.

[0149] Fluid may flow through the flow path tube 215 in either direction. For example, fluid may flow into the hemostasis valve 1800 through the first access opening 1805 and out of the hemostasis valve 1800 through the second access opening 1825. Additionally, the hemostasis valve 1800 may include a junction with one or more junction openings such as the first junction opening 1830.

[0150] In an exemplary embodiment, the spring may be enveloped by a compressible material 1815. In various embodiments, the compressible material 1815 comprises flexible silicone. The compressible material 1815 may transmit constriction forces of the spring 1810 to the fluid flow tube 1835.

[0151] Referring to Fig. 19, Fig. 19 is an illustration 1900 of a medical practitioner utilizing the spring clamp of the hemostasis valve 1800. Portions of the illustration 1900 of the hemostasis valve 1800 that are dashed are obscured by the medical practitioner. As shown in Fig. 19, the medical practitioner may operate the spring clamp by squeezing the handles 1905 of the spring clamp with a forefinger and a thumb. Squeezing the spring clamp may release tension on the spring 1810 and open the fluid flow tube 1835 to allow fluid to flow through the hemostasis valve 1800.

[0152] Referring to Fig. 20, Fig. 20 is a front view 2000 of the spring clamp embodiment of the hemostasis valve 1800 when the spring clamp is in a released state. A released state refers to a state of the spring clamp wherein no force is applied to the handles 2005 and handles are allowed to separate under the bias exerted by the spring 1810. While in a release date, the spring 2010 of the spring clamp will tighten around the fluid flow tube 2015. In an exemplary embodiment, the spring clamp may be configured to completely shut off a flow of fluid through the fluid flow tube 2015 when the spring clamp is in a released state.

[0153] Referring to Fig. 21, Fig. 21 is a front view 2100 of the spring clamp embodiment of the hemostasis valve 1800 when the spring clamp is in a squeezed state. The squeezed state of the spring clamp relaxes the spring 2110 and unconstricts the fluid flow tube 2115. A medical practitioner may press the handles 2105 of the spring clamp together to put the spring clamp in a squeezed state. In an example of use, a medical practitioner may squeeze the handles 2105 to open the fluid flow tube 2115 to allow a flow of medicament, blood, infusate, or the like to flow through the hemostasis valve 1800.Single Button Embodiment

[0154] Referring to Fig. 22, Fig. 22 is a pictorial view of a single button embodiment of a hemostasis valve 2200. The single button embodiment of the hemostasis valve 2200 may include a first access opening 2205 and a second access opening 2230. The first access opening 2205 and second access opening 2230 may be connected by a fluid flow tube through which fluid may flow through a path that is connected to a vasculature of a human patient or animal subject.

[0155] Like the two button embodiment of the hemostasis valve 100, the one button embodiment of the hemostasis valve 2200 comprises a button 2210 that is under a potential force that is provided by a bias. In various embodiments, the bias comprises a spring 2215. The button 2210 is coupled to one or more constricting wires that wrap around the fluid flow tube of the hemostasis valve 2200.

[0156] A medical practitioner may utilize the single button embodiment of the hemostasis valve 2200 by pressing the button to open the fluid flow tube and allow fluid to flow through thehemostasis valve 2200. By releasing the button, the medical practitioner may constrict the fluid flow tube of the hemostasis valve 2200 and stop fluid flow through the hemostasis valve 2200.

[0157] Referring to Fig. 23, Fig. 23 is a schematic 2300 of a constriction mechanism for the single button embodiment of the hemostasis valve 2200. The constriction mechanism may comprise one or more constricting wires 2320 coupled to a button 2305. The button is under a potential provided by a spring 2315. The one or more constricting wires 2320 wrap around a fluid flow tube to form a loop 2310 around the fluid flow tube.

[0158] Releasing the button 2305 allows the potential provided by the spring 2315 to fully extend the button 2305 and constrict the loop 2310 and thus constrict the fluid flow within the loop 2310. Pressing the button 2305 exerts force against the potential provided by the spring 2315 and releases the constricting wires 2320, causing the loop to expand, which will cause the fluid flow tube to expand and allow fluid to flow through the hemostasis valve 2200.

[0159] Referring to Fig. 24, Fig. 24 is an illustration 2400 of a medical practitioner utilizing the single button embodiment of the hemostasis valve 2200. A medical practitioner may use the single button embodiment of the hemostasis valve 2200 using one hand. As shown in the illustration 2400, a medical practitioner may grip the hemostasis valve 2200 with a thumb and forefinger by placing the thumb on the button 2405 and wrapping the forefinger around the back of the hemostasis valve 2200.

[0160] The medical practitioner may open the hemostasis valve by pressing the button 2405. For example, the hemostasis valve 2200 may be set up by the medical practitioner to release a medicament into a patient when the fluid flow tube of the hemostasis valve is opened. The medical practitioner may open the fluid flow tube by pressing the button 2405. The medical practitioner may then close the hemostasis valve and stop the release of the medicament by releasing the button 2405.

[0161] Referring to Fig. 25, Fig. 25 is an illustration 2500 of the single button embodiment of the hemostasis valve 2200 when the button is in a fully depressed state. The single button embodiment is in a fully depressed state when the button 2505 is pressed all the way down. The button 2505 in the released state creates slack in the constricting wire and increases the size ofthe loop that surrounds the fluid flow tube 2510. Accordingly, the fluid flow tube 2510 is in its most expanded state when the button is fully depressed as shown in Fig. 25. The button 2505 may include a stabilizing guide 2515 that locks the button into a path of movement of the button 2505.

[0162] Referring to Fig. 26, Fig. 26 is an illustration 2600 of the single button embodiment of the hemostasis valve when the button 2605 is in a partially depressed state. The partially depressed state refers to the button 2605 being partially pressed and in between fully extended and fully depressed. The loop that surrounds the fluid flow tube 2610 is constricted relative to the fully depressed state. Accordingly, the fluid flow tube 2610 is constricted relative to the fluid flow tube 2510 as shown in Fig. 25 and fluid will flow more slowly through the hemostasis valve 2200 when the button is in a partially depressed state than when the hemostasis valve is in a fully depressed state.

[0163] Referring to Fig. 27, Fig. 27 is an illustration 2700 of the single button embodiment of the hemostasis valve when the button 2705 is in a released state. The button 2705 in the fully released state refers to the button 2705 being fully extended without any outside force acting on the button 2705. In the fully released state, the potential force from the spring 2215 presses on the button 2705, whereby the forces are transferred to the constricting wire to constrict the fluid flow tube 2710. In the fully released state, the fluid flow tube 2710 may be fully constricted and shut off.

[0164] In various embodiments, the potential force delivered by the spring 2215 is dependent on a spring constant of between about 0.15 N per millimeter and about 0.6 N per millimeter. In various embodiments the force produced by the spring is a combined force from two or more springs. The button 2705 may have various dimensions. In an exemplary embodiment, the button has a length, as measured along an axis of the fluid flow to 2710 of between about 3 cm and about 6 cm.

[0165] Constricting Wedge Embodiment

[0166] Referring to Fig. 28, Fig. 28 is a pictorial view of a constricting wedge embodiment of the hemostasis valve 2800. The constricting wedge embodiment of the hemostasis valve 2800includes a first access opening 2805 and a second access opening 2825 for a fluid flow tube 2830. The fluid flow tube 2830 of the hemostasis valve 2800 may be connected to a vasculature of a human patient or animal subject.

[0167] The hemostasis valve 2800 may include a bias that exerts a potential force against a pressable button 2835 or platform. In an exemplary embodiment, the bias of the hemostasis valve 2800 may comprise a spring 2810 that presses against the button 2835 or platform. A medical practitioner may press the button 2835 or platform to operate the constricting mechanism 2820 to start or stop a flow of fluid through the fluid flow tube 2830. In various embodiments, the hemostasis valve 2800 may include a junction 2815 with one or more branching tubes attached to the junction 2815.

[0168] Referring to Fig. 29, Fig. 29 is an illustration 2900 of a medical practitioner utilizing the constricting wedge embodiment of the hemostasis valve 2800. As shown in the illustration 2900, a medical practitioner may grip the hemostasis valve 2800 by an upper and lower portion of the button 2905. For example, the medical practitioner may grip the button 2905 with a forefinger on top and a thumb underneath. The medical practitioner may then squeeze the button 2905 to operate the hemostasis valve 2800. In various embodiments, the hemostasis valve 2800 may be configured to open the fluid flow tube 2830 responsive to the medical practitioner squeezing the button 2905. Accordingly, the hemostasis valve would likewise be configured to close or seal the fluid flow tube 2830 responsive to the medical practitioner releasing the button 2905.

[0169] In an alternative embodiment of the hemostasis valve 2800, the hemostasis valve may be configured to close the fluid flow tube 2830 when a medical practitioner squeezes the button 2905. The hemostasis valve 2800 may be configured to open the fluid flow tube 2830 when the medical practitioner releases the button 2905.

[0170] Referring to Fig. 30, Fig. 30 is a pictorial view of the hemostasis valve 2800 when the button 3015 is in a released state. When the button 3015 is in a released state, the constricting mechanism of the hemostasis valve 2800 may restrict the fluid flow path 3005 and stop all fluid from flowing through the hemostasis valve 3000.

[0171] Referring to Fig. 31 , Fig 31 is a pictorial view 3100 of the hemostasis valve 2800 when the button 3120 is in a depressed state. A medical practitioner may fully engage or depress the button 3120 to operate the hemostasis valve 2800. By pressing the button 3120, the constricting mechanism 3125 may release constriction on the fluid flow tube and allow the fluid flow tube to expand.

[0172] The pictorial view 3100 shows various expansions of the fluid flow tube that may result from different actuation states of the button. For example, the fluid flow tube 3115 in the most expanded state may correlate to the fully depressed state of the button 3120 that is shown in the pictorial view 3100. The fluid flow tube 3110 is a partially constricted fluid flow tube and may be the result of a button that is partially pressed. And the fluid flow tube 3105 is a fully constricted fluid flow tube, which may be the result of a button that is fully released.

[0173] Referring to Fig. 32, Fig. 32 is a cross-sectional view 3200 of the constricting wedge embodiment of the hemostasis valve 2800 when the button is in a released state. As shown in the cross-sectional view 3200, the constricting mechanism may comprise a wedge 3220 that is coupled to an upper end 3205 of the button. The upper end 3205 is movable relative to the hemostasis valve 2800 and is acted upon by a potential created by the spring 3230.

[0174] The lower end 3210 of the button is solid and does not move relative to the rest of the hemostasis valve 2800. The hemostasis valve 2800 includes a constricting wall 3235 that makes contact with the wedge 3220. When the upper end 3205 of the button rises, contact with the constricting wall 3235 causes the wedge to constrict the fluid flow tube 3225.

[0175] Alternatively, when the upper end 3205 of the button is pressed down, the base of the wedge is lowered below the constricting wall 3235 where there is more space between the base of the wedge and the fluid flow tube 3225. Consequently, the wedge 3220 may separate away from the fluid flow tube 3225 and allow the fluid flow tube 3225 to expand.

[0176] The constricting wall 3235 may be positioned a distance from the fluid flow tube 3225 that is less than a length of the base of the wedge 3220. The base of the wedge 3220 may be the length that the bottom of the wedge 3220, as viewed in Fig. 32, extends from the fluid flow tube 3225 as indicated by the dashed line 3245.

[0177] Referring to Fig. 33, Fig 33 is a cross-sectional view 3300 of the constricting wedge embodiment of the hemostasis valve 2800 when the button is in a depressed or partially depressed state. In the depressed state, the upper end 3305 of the button of the hemostasis valve 2800 pushes down on the wedge 3315 which allows more space for the wedge within the constricting mechanism and allows the fluid flow tube 3325 to expand relative to an expansion of the fluid flow tube 3325 in the released state of the button.

[0178] In various embodiments, the constricting wall 3320 of the constricting mechanism may be coupled to the lower end 3310 of the button. In the embodiment shown in the cross-sectional view 3300, the lower end 3310 of the button and the wall form a contiguous piece that form an L-shape in the surface of the cross-sectional view 3300.Lever Embodiment

[0179] Referring to Fig 34, Fig 34 is a pictorial view of a lever embodiment of the hemostasis valve 3400. The lever embodiment includes a first access opening 3405 and a second access opening 3420. A medical practitioner may control a constriction of a fluid flow tube that connects the first access opening 3405 and second access opening 3420 within the hemostasis valve 3400.

[0180] In an exemplary embodiment, the hemostasis valve 3400 may be configured to constrict the fluid flow tube when levers, including a left lever 3410 and a right lever 3415, are released. Likewise, the hemostasis valve 3400 may be configured to open the fluid flow tube when the levers are engaged by a medical practitioner. The lever embodiment of the hemostasis valve 3400 shown in Fig. 34 includes two levers. In various embodiments, the hemostasis valve 3400 may comprise a multitude of levers including variations where the hemostasis valve 3400 comprises more than two levers or only one lever.

[0181] Referring to Fig 35, Fig 35 is a pictorial view 3500 of the lever embodiment of the hemostasis valve 3400 when the levers are in an engaged state. The left lever 3510 and right lever 3505 are in an engaged state when both levers are pressed toward the fluid flow tube 3525. An upper end 3515 of the right lever and an upper end 3520 of the left lever may each be coupled to one or more constriction wires that wrap around the fluid flow tube 3525.

[0182] When the left lever 3510 and right lever 3505 are in a released state, as shown in the pictorial view 3500, the upper ends of the levers arc drawn closer to the fluid flow tube 3525, which creates more slack in the constriction wires that wrap around the fluid flow tube 3525, and allows the fluid flow tube to expand. Accordingly, a medical practitioner may squeeze the lever embodiment of the hemostasis valve 3400 to expand the fluid flow tube 3525 and allow fluid to flow through the hemostasis valve 3400.

[0183] Referring to Fig.36, Fig. 36 is a cross-sectional view 3600 of the lever embodiment of the hemostasis valve 3400. As shown in the cross-sectional view 3600, the upper ends of the left lever and the right lever include a bias that exerts a potential force on the levers. The biases in the version of the lever embodiment shown in the cross-sectional view 3600 comprise springs. A left spring 3610 exerts a potential force on the left lever 3510. A right spring 3605 exerts a potential force on the right lever 3505. Although not shown, the constricting wires may be coupled to the right lever at point 3615 and coupled to the left lever at point 3620 and drawn through the springs to wrap around the fluid flow tube 3625. For example, a constriction wire may be coupled to the right lever at point 3615 and drawn through the right spring 3605 to wrap around the fluid flow to 3625. Likewise, a constriction wire may be coupled to the left lever at point 3620 and drawn through the left spring 36102 wrap around the fluid flow tube 3625.

[0184] Referring to Fig. 37A, Fig. 37A is a schematic of an alternate version 3700 of the lever embodiment of the hemostasis valve 3400. As shown in the schematic, the alternate version 3700 comprises a left lever 3725 and a right lever 3720. The upper ends of the left lever 3725 and right lever 3720 are coupled to constricting wires that wrap around the fluid flow tube 3730.

[0185] The hemostasis valve 3400 includes a fulcrum for each of the levers. Accordingly, the left lever 3725 is coupled to a left fulcrum 3715. The right lever 3720 is coupled to a right fulcrum 3717. The hemostasis valve 3400 includes a bias 3710 that acts to draw the lower ends of the left lever 3725 and right lever 3720 toward each other. Accordingly, the action of the lower ends of the lever being drawn toward each other causes the upper ends of the levers to be drawn away from each other and tightens the constricting wires 3705 around the fluid flow tube 3730.

[0186] A medical practitioner may operate the alternate version 3700 of the hemostasis valve 3400 shown in the schematic by squeezing the upper ends of the levers to draw the upper ends toward each other to loosen the constricting wires 3705 around the fluid flow tube 3730. The act of squeezing the upper ends of the levers will cause the fluid flow tube 3730 to expand and allow fluid to flow through the tube.

[0187] Referring to Fig. 37B, Fig. 37B is a schematic 3750 of the alternate version 3700 of the lever embodiment of the hemostasis valve 3400 in a released state. The term “released state” refers to the state of the hemostasis valve that is not acted upon by any external forces. Thus, the schematic 3750 shows the alternate version 3700 of the hemostasis valve 3400 as it is released by a medical practitioner. The upper ends of the left lever 3775 and right lever 3770 are drawn away from each other because the bias 3760 draws the bottom of the left lever 3775 and right lever 3770 toward each other. In various embodiments, the bias may comprise a spring or band.

[0188] The left fulcrum 3765 and right fulcrum 3768 cause the upper ends of the levers to draw away from the fluid flow tube 3780 when the lower ends are drawn toward the fluid flow tube by the bias 3760. Accordingly, the constricting wires 3705 constrict the fluid flow tube 3780 and slow or stop fluid flow through the fluid flow tube.

[0189] Referring to Figs. 38A and 38B, Fig. 38A is an illustration of an elastomeric flow path tube 3800 in an embodiment of the disclosed subject matter. Fig. 38B is an illustration 3850 of the elastomeric flow path tube 3855 as it is being constricted by a first constricting wire 3860 and a second constricting wire 3865. In various embodiments, one or more constricting wires may be wrapped around the elastomeric flow path tube 3800. The elastomeric flow path tube 3800 may be configured to remain in an open state such that fluid may freely flow between a first opening 3820 and a second opening 3825 when the elastomeric flow path tube 3800 is not actively constricted.

[0190] In the exemplary embodiment shown in Fig. 38A, a first constricting wire 3810 and a second constricting wire 3815 are wrapped around the elastomeric flow path tube 3800. The two constricting wires may be coupled to a constricting mechanism that, when activated, causes the constricting wires to constrict around the elastomeric flow path tube 3800, as shown in the illustration 3850.

[0191] When the constricting wires are relaxed, as shown in Fig. 38A, the elastomeric flow path tube 3800 automatically opens. When the constricting wires arc tightened, as shown in the illustration 3850, the elastomeric flow path tube 3855 collapses at a constriction point 3870. The elastomeric flow path tube 3855 may fully collapse, stopping a flow of fluid through the elastomeric flow path tube 3855. The elastomeric flow path tube 3855 may be further configured to partially collapse, which would slow a flow of fluid through the elastomeric flow path tube 3855.

[0192] In various embodiments, the elastomeric flow path tube 3800 may be configured to be coupled with a flexible vascular catheter, which is not shown in the figure. A medical practitioner may insert the flexible vascular catheter through the elastomeric flow path tube 3800 and operate the constricting mechanism to collapse the elastomeric flow path tube 3800 to form a seal around the flexible vascular catheter. In various embodiments, the elastomeric flow path tube 3800 may have a diameter of up to about 0.330 inches. In various embodiments, the elastomeric flow path tube 3800 may have a length between about 1.5 and 2.5 inches.

[0193] Referring to Fig. 39, Fig. 39 is an illustration of another lever embodiment of a hemostasis valve 3900. The compact hemostasis valve 3900 includes a fluid flow tube through which fluid such as infusate, medicament, blood, or the like may flow. The hemostasis valve 3900 includes two levers, a first lever 3905 and a second lever 3910, that may be operated to constrict the fluid flow tube.

[0194] The two levers are coupled to each other and one or more constricting wires that act to constrict the fluid flow tube when a complimentary end of each one of the two coupled levers is pressed, rotated, or otherwise operated in a valve closing direction. Operating the levers in the valve opening direction may act to unconstrict the fluid flow tube. The two levers each have a set of gear teeth engaged with the gear teeth of the other lever. The engaged sets of gear teeth cause the levers to move in concert and simultaneously with one another.

[0195] In the exemplary embodiment shown in Fig. 39, the hemostasis valve includes an aspiration port 3915 through which aspiration of a fluid within the fluid flow tube may be accomplished. For example, an aspiration syringe may be affixed to the aspiration port 3915. Although not shown, the aspiration port 3915 may include a shut off valve to close the aspirationport 3915. The hemostasis valve 3900 may also include an infusion port 3920 for infusing various fluids into the fluid flow tube.

[0196] The hemostasis valve 3900 may be configured to have a catheter shaft (e.g., 3925) inserted into one or both ends of the hemostasis valve 3900. A medical practitioner may operate the first lever 3905 and / or second lever 3910 (as movement of one causes the other to move simultaneously in concert with the one being moved) or both the first lever 3905 and second lever 3910, simultaneously, to open the fluid flow tube in the hemostasis valve 3900 in order to insert the catheter shaft 3925 into the fluid flow tube. The medical practitioner may then operate one or both levers to seal the fluid flow tube around a tube inserted therethrough, such as the catheter shaft 3925.

[0197] Referring to Fig., Fig. 40 is an illustration 4000 of the hemostasis valve 3900 of Fig. 39 that is prepared to perform a thrombectomy. A thrombectomy is a procedure to remove an embolism 4005, which is a blood clot that forms in the human body. An embolism can result in a variety of life-threatening conditions. A potential use of the hemostasis valve 3900 is to aid in removal of embolisms from human patients.

[0198] An example of a process to perform a thrombectomy comprises (1) advancing a catheter shaft 4015 through an access sheath over a guidewire 4025 or dilator into a blood vessel. The catheter may be advanced to a target location. (2) Fully close the hemostasis valve 4020 and attach an aspiration syringe 4010. (3) Aspirate to pull the blood clot from the blood vessel. (4) Open the hemostasis valve 4020 to allow passage of a device used to navigate the catheter shaft 4015 to an alternate location.

[0199] The various lever positions of the first and second levers (the lever assembly) contained in a valve body of the hemostasis valve 3900 may include causing the hemostasis valve to have one of the following configurations, but are not limited to (1) hemostasis valve 3900 in an urged close (low drag) configuration such that a guidewire and dilator can be advanced / retracted into and through the valve constricting location of the valve; (2) hemostasis valve 3900 in a fully urged closed configuration with a guidewire extending through it, in place; (3) hemostasis valve 3900 in a fully urged closed configuration; and (4) hemostasis valve 3900 in a fully unconstrained open configuration. In the (1) position, the constricting location of the hemostasisvalve is urged closed to seal around an object such as a guidewire or dilator, but the frictional force exerted between the object and the valve when there is an axial differential force applied between the object and the valve along the fluid flow axis of the valve, is such that the object can be advanced or retracted through the sealed hemostasis valve without damaging the object or the valve and without losing a fluid seal between the outside surface of the object and the inside of the urged closed constricting location of the valve.

[0200] In the (2) position, the constricting location of the hemostasis valve 3900 is configured to be urged to seal around an object, such as a guidewire or dilator, where the object cannot be advanced or retracted, without damaging one or the other. In the (3) position, the constricting location of the hemostasis valve 3900 is urged to a fully closed (sealed) configuration with no object inside. In the (4) position, the constricting location of the hemostasis valve 3900 is fully open and is not urged closed and not sealed around any object.

[0201] Referring to Fig., Fig. 41 is a cut away view 4100 showing some parts of the internal mechanism of the hemostasis valve 3900 of Fig. 39 as a lever assembly contained therein is operated by fingers of a human operator. The hemostasis valve includes a first lever 4105 and a second lever 4110. The lever assembly includes the first and second levers, the valve body portions (such a rotation hubs and detent mechanism components that that couple and interact with the levers. The hemostasis valve includes one or more constriction wires 4120 extending radially and / or tangentially, whose ends are fixed to respective ends of the first lever 4105 and the second lever 4110, that when urged into tension, tighten around a fluid flow tube 4150, to act to constrict the fluid flowing therethrough when the human operator initiates urging the one or more constriction wires 4120 to tighten around a constriction location of the fluid flow tube 4150.

[0202] In Fig. 41, each of the levers of the hemostasis valve includes two finger contact surfaces. The first lever 4105 includes a valve closing finger contact surface 4130 and a valve opening finger contact surface 4135. Likewise, the second lever 4110 includes a valve closing finger contact surface 4140 and a valve opening finger contact surface 4145. A human operator may apply an operating force to any of the valve opening or valve closing contact surfaces with their fingers 4115. For example, the human operator may apply force on the valve closingcontact surfaces to engage the constricting mechanism to seal the fluid flow tube 4150 at the constriction location 4125.

[0203] Alternatively, the human operator may press on the valve opening contact surfaces to release tension from the one or more constricting wires 4120, to allow the fluid flow tube 4150 to elastically expand to allow fluid to flow through the valve. The human operator may apply force on one or the other contact surfaces on the hemostasis valve levers to engage or disengage tensioning of the constricting wires.

[0204] Referring to Fig. 42, Fig. 42 is an illustration 4200 of the hemostasis valve of Fig. 39 in a fully closed configuration (where the constricting wires are fully tensioned to constrict the fluid tube therethrough to its maximum - note: that the constricting wires are not pictured). The hemostasis valve in in Fig. 42, includes a closing contact surface 4205 on the first lever and a closing contact surface 4210 on the second lever. A human operator may engage the closing contact surfaces to move them in the direction shown by the arrows in the illustration to urge tensioning of the one or more constriction wires in the hemostasis valve. The positions of the first lever and second lever in the hemostasis valve shown in Fig. 42, indicate that the one or more constriction wired are being urged into tension to urge the hemostasis valve toward a fully closed configuration.

[0205] Referring to Fig. 43, Fig. 43 is an illustration 4300 of the hemostasis valve of Fig. 39 in a fully open configuration (where the constricting wires are fully relaxed - note: that the constricting wires are not pictured). The hemostasis valve includes an opening contact surface 4305 on the first lever and an opening contact surface 4310 on the second lever. A human operator may press on the opening contact surfaces in the direction indicated by the arrows shown in Fig. 43, to disengage the constriction mechanism in the hemostasis valve. Accordingly, a human operator may open and close the hemostasis valve by pressing on the opening contact surfaces or the closing contact surfaces.

[0206] Referring to Fig. 44, Fig. 44 is a cutaway - isolated parts view 4400 of the lever components of the hemostasis valve of Fig. 39, where the parts are configured to show a fully closed configuration. The hemostasis valve includes a first lever 4420 and a second lever 4425, each having an axis of rotation at the circular holes pictured. The first lever 4420 and secondlever 4425 are coupled (enmeshed) by gear teeth configured on opposing facing edges of the levers 4420, 4425 along a gear teeth engagement section 4415. The first lever and said second lever each have a gear teeth outer edge portion having a fixed radius from respectively said first lever axis of rotation and said second lever axis of rotation such that gear teeth configured on the respective gear teeth outer edge portions of the first lever and the gear teeth outer edge portion of the second lever complementarily workably mesh with one another, such that a rotary motion of one lever around its axis of rotation forces the complimentary rotary motion of the other lever around its axis of rotation. Accordingly, the movement (rotation) of the levers 4420, 4425, will mirror one another. A constricting end of the first lever 4420 is coupled to the one or more constriction wires 4405 at a coupling location 4430. A constricting end of the second lever 4425 is coupled to the one or more constriction wires 4405 at a coupling location 4435.

[0207] The constriction wires are configured to loop (partially or fully wrap) around the fluid flow tube at the constriction location 4410. When a closing force is applied to the closing contact surfaces of the levers 4420, 4425, in the direction shown by the arrows, the coupling location 4430 and the coupling location 4435 separate causing the constriction wires looped around the constriction point to tighten and move to constrict the opening of the fluid flow tube at the constriction location 4410.

[0208] Referring to Fig. 45, Fig. 45 is a cutaway - isolated parts view 4500 of only the lever components and constricting wires of the hemostasis valve of Fig. 39, where the parts are configured to show a fully open configuration. The hemostasis valve includes a first lever 4515 and a second lever 4520. The first lever includes an opening contact surface 4505 and the second lever includes an opening contact surface 4510. As indicated by the arrows, a human operator may press on the opening contact surfaces to cause the constriction mechanism to disengage the fluid flow tube and allow it to open.

[0209] Pressing on the opening contact surfaces in the directions of the arrows causes the coupling location 4540 of the first lever 4515 to move in the right direction as seen in Fig. 45. The coupling location 4545 of the right lever 4520 will move in the left direction as seen in Fig. 45. This will cause the one or more construction wires 4525 to release tension (give more slack) in the constricting wires at the constriction location 4530.

[0210] Referring to Fig. 46, Fig. 46 is a pictorial illustration 4600 of an embodiment of the hemostasis valve of Fig. 39 comprising flexible tabs 4605 (the flexible tabs arc formed from a specifically shaped through cut of the top surface of the valve body thereby providing a nominal axial tab dimension that allows the tabs to bend under the application of force to them more easily (under lower force) than the surrounding top surface of the valve body around the tabs). The flexible tabs 4605 are a part of a detent (locking) mechanism that can lock the levers in place at various intermediate positions as well as its position at its extremes of travel. In various embodiments, an inwardly projection nib near the end of the left flexible tab may engage a pail of the first lever 4610 and an inwardly projection nib near the end of the right flexible tab may engage a part of the second lever 4615 to lock them in place. Additional details of the locking mechanism will be described in the following figures.

[0211] Referring to Fig. 47, Fig. 47 is a pictorial illustration 4700 of a portion of a housing in an embodiment of the hemostasis valve of Fig. 39 comprising flexible tabs (the flexible tabs are formed from a specifically shaped through cut of the bottom surface of the valve body thereby providing a nominal axial tab dimension that allows the tabs to bend under the application of force to them more easily (under lower force) than the surrounding bottom surface of the valve body around the tabs). The embodiment of the hemostasis valve shown includes a first flexible tab 4705 and a second flexible tab 4710. Each of the flexible tabs includes one or more raised nibs that are shaped to engage complementary depressions or hole locations of the levers to form a detent mechanism when the levers are rotated to various positions between their extremes of travel. In the illustration, the first flexible tab 4705 includes a raised nib 4715. The second flexible tab 4710 includes a raised nib 4720.

[0212] The housing shown includes two lever hinge posts. A first lever hinge post 4725 is configured act as an axis of rotation for the first lever when it is engaged thereon. A second lever hinge post 4730 is configured act as an axis of rotation for the second lever when it is engaged thereon.

[0213] Referring to Fig. 48, Fig. 48 is another pictorial illustration 4800 of the valve outer housing of the hemostasis valve of Figs. 39, 41, 44, and 47 comprising flexible tabs. The embodiment of the hemostasis valve shown includes a first flexible tab 4805 and a secondflexible tab 4810. Each of the flexible tabs includes one or more raised nibs. The first flexible tab 4805 includes a first raised nib 4815 and the second flexible tab 4810 includes a second raised nib 4820.

[0214] As shown by the double ended arrows, the first flexible tab 4805 and second flexible tab 4810 are configured to have greater flexibility in the vertical direction as indicated by the arrow heads. The raised nibs are configured to fit into one or more complementarily locations slots (or depressions or holes) on the levers, when the levers are in a configured to be various positions such as the fully open or fully closed position or discreet intermediate (partially closed or open) positions therebetween. The movement, as indicated by the arrows of the flexible tabs allows the raised nibs to slip in and out of the slots on the levers, and thereby provide engagement and disengagement of the detent mechanism created by the raised nibs on the flexible tabs and the slots or depressions or holes located complementarily on the levers.

[0215] Referring to Fig. 49, Fig. 49 is a pictorial and schematic illustration 4900 of a portion of one lever arm of the valve engaging a lever hinge post and raised detent of a flexible tab of the valve outer housing of the hemostasis valve of Figs. 39, 41, 44, and 47. The first lever 4905 is drawn in dashed lines to indicate that it is transparent. The first lever 4905 rotates around the hinge lever post 4910. As the first lever 4905 rotates, it causes a multitude of slots (or holes) 4935 to come into alignment with the raised nib 4925 of the first flexible tab 4915.

[0216] Every time one of the slots of the first lever 4905 is aligned with the raised nib4925, the raised nib 4925 may be pushed into the slot (to act as a detent mechanism), which will releasably lock the first lever 4905 into a particular rotational location or place. Placing a rotational force on the first lever, such as by a human practitioner pushing on the opening contact surface or a closing contact surface on the first lever 4905 introduces a torque onto the first lever which will cause the walls of the slot that are aligned with the raised nib 4925 to push against the raised nib 4925 and cause the first flexible tab 4915 to move and release the raised nib 4925 from the slot. The first lever (and correspondingly, the second lever) will be release from the slot after a threshold release force is applied and allowed to rotate when the raised nib 4925 is released from the slot it was engaged with.

[0217] The slots and raised nibs in the hemostasis valve may be configured to require a minimum amount of force to be applied to rotate the levers once they arc rclcasably locked. In an exemplary embodiment, the hemostasis valve may be configured such that 6 pounds of force are required to move a lever that is locked by having a raised nib aligned with one of the slots.

[0218] Referring to Fig. 50, Fig. 50 is a pictorial cross-sectional illustration 5000 of a portion of the rotational position locking mechanism for one actuation lever of the hemostasis valve of Fig. 39, 41, 44, and 47. The first lever 5015 of the hemostasis valve includes a multitude of slots. A slot 5005 (of the multitude of slots) is aligned with the raised nib 5010 of the first flexible tab 5020. The raised nib 5010 is positioned inside the slot 5005, which prevents the first lever 5015 from rotating. Accordingly, the first lever 5015 is in a reliably locked or static state. The second lever, which is not shown, will also be releasably locked because it is coupled to the first lever 5015 via the complementarily meshing gear, including gear tooth 5025.

[0219] Referring to Fig. 51, Fig. 51 is cut away illustration 5100 showing the inner mechanisms of the bottom portion of the hemostasis valve of Figs. 39, 41, 44, and 47 in a closed configuration. A first lever 5105 includes a closing contact surface 5115 and an opening contact surface 5125. The second lever 5110 includes a closing contact surface 5120 and an opening contact surface 5130.

[0220] A human practitioner may press or squeeze the closing contact surfaces to cause the levers to rotate and separate the first coupling location 5145 on the first lever 5105 from the second coupling location 5150 on the second lever 5110. As the two coupling locations separate, the one or more constricting wires 5135 tighten around the fluid flow tube 5155 (having a longitudinal aperture therethrough) at the constriction location 5140 to narrow, restrict, or seal the fluid flow tube 5155. Fig 51 shows the components of the hemostasis valve in positions matching a fully closed configuration of the valve, where the fluid flow tube 5155 and the longitudinal aperture passing therethrough is sealed.

[0221] Referring to Fig. 52, Fig. 52 is a cut away illustration 5200 showing the inner mechanisms of the bottom portion of the hemostasis valve of Figs. 39, 41, 44, and 47 in an open configuration. The fluid flow tube 5235 is supported in a valve body of the hemostasis valve in which the fluid flow tube is received. The hemostasis valve includes a first lever 5205 and asecond lever 5210. A human practitioner may press on the opening contact surfaces of the first lever 5205 and second lever 5210 to disengage the constricting mechanism and allow the fluid flow tube 5235 to open. By pressing on the opening contact surfaces, the first coupling location 5225 and second coupling location 5230 are pushed closer to one another allowing the constricting wires 5215 to relax and reduce restriction at the constriction location 5220.

[0222] The components of the hemostasis valve shown in Fig. 52, are shown in positions corresponding to a valve open position where the constricting wires 5215 are not under tension. Accordingly, the fluid flow tube 5235 is allowed to expand and fluid may flow through it.

[0223] Referring to Fig. 53, Fig. 53 is a close-up view 5300 of the hemostasis valve of Fig. 52. The first lever 5305 rotates at the lever hinge post 5320 when a torque force is applied to the first lever 5305. A length (closing lever length) between the lever hinge post 5320 and a reference point on the closing contact surface 5310 is labeled LI. A length (opening lever length) between the lever hinge post 5320 and a reference point on the coupling contact surface 5315 of the first lever 5305 is labeled as L2. A ratio between LI and L2 may determine a mechanical advantage when a force is applied at reference point on the closing contact surface 5310 is pressed to engage the constricting mechanism. The dimensions of the lever arms and the position of the axes of rotation can be adjusted to provide a mechanical advantage ratio of 1.5 or greater, as desired by the valve designer.

[0224] In various embodiments, 5 pounds of tensioning force may be required to be applied to the constricting wires 5325 to seal the fluid flow tube 5330. A mechanical advantage, as determined by the ratio between LI and L2 may allow for less force to be applied to the reference point on the closing contact surface 5310 to engage the constricting mechanism and seal the fluid flow tube 5330. As pictured in Fig. 53, LI is greater than L2 which gives a mechanical advantage of greater than one and lowers the amount of force required to be applied to the reference point on the closing contact surface 5310 to seal the fluid flow tube 5330 when a human practitioner is pressing on the closing contact surface 5310.

[0225] Referring to Fig. 54, Fig. 54 is a plan view 5400 of the hemostasis valve of Figs. 39-53.As shown, a distance between a first end of the fluid flow tube 5425 and a second end of the fluid flow tube 5430 is denoted by L3. And a distance between an end of the closing contactsurface 5405 of the first lever 5415 and an end of the closing contact surface 5410 of the second lever is denoted by L4. In various embodiments, L3 may be about 2.4 inches and L4 may be about 1.8 inches. In various embodiments, L3 may be between about 1.9 inches and 2.9 inches. In various embodiments L4 may be between about 1.4 inches and 2.2 inches.

[0226] Referring to Fig. 55, Fig. 55 is a side view 5500 of the hemostasis valve of Fig. 54. A distance between a top side 5505 and a bottom side 5510 of the hemostasis valve, is denoted by L5. In various embodiments L5 may be about 0.9 inches. In various embodiments L5 may be between about 0.6 and 1.2 inches.

[0227] Referring to Fig. 56, Fig. 56 is a cut away view 5600 showing inner parts of the hemostasis valve of Figs. 39-55. A distance between an end 5610 of the fluid flow tube 5605 and the constriction point 5615 is denoted by L6. A distance between the constriction point 5615 and the other end 5620 of the fluid flow tube 5605 is denoted by L7. In various embodiments, L6 may be about 1.5 inches and L7 may be about 0.6 inches. In various embodiments, L6 may be between about 1 inch and 2 inches. In various embodiments, L7 may be between about 0.4 inches and 0.8 inches.

[0228] Referring to Figs. 57A and Fig. 57B, Fig. 57A is a perspective view 5700 of a guillotine embodiment of the hemostasis valve. Fig. 57B is a top view 5750 of the guillotine embodiment of the hemostasis valve. The guillotine embodiment of the fluid flow tube includes constricting plates that are configured to slide against one another to constrict an aperture that is traversed by the fluid flow tube 5705.

[0229] The guillotine embodiment of the hemostasis valve includes a first constricting plate 5710 and a second constricting plate 5715. Each of the constricting plates includes a teardropshaped aperture. The fluid flow tube 5705 is positioned through the teardrop-shaped aperture of each of the constricting plates. Engaging the levers of the hemostasis valve or other activating mechanism may move the constricting plates to either move them into a constricting state or non-constricting state.

[0230] The hemostasis valve shown in Figs. 57A and 57B has a lever-based constricting mechanism. The constricting mechanism shown includes a first lever 5720 and a second lever5725. The first lever 5720 and second lever 5725 are configured to be activated by the hand of a medical practitioner. In an example of use, the fluid flow tube 5705 is directed through the teardrop-shaped aperture of each constricting plate.

[0231] The teardrop- shaped aperture has a large radius section and a small radius section. The large radius section is configured to allow full fluid flow through the fluid flow tube 5705. The small radius section of the teardrop- shaped aperture is configured to constrict fluid flow through the fluid flow tube 5705. Accordingly, when the first constricting plate 5710 and second constricting plate 5715 are engaged to position the small radius section of their teardrop-shaped apertures around the fluid flow tube 5705, the constricting plates act to restrict fluid flow through the fluid flow tube 5705.

[0232] Referring to Figs. 58A and 58B, Fig. 58A is perspective view 5800 of the constricting plates of the guillotine embodiment of the hemostasis valve. Fig. 58B is a separated view 5850 of the constricting plates of the guillotine embodiment of the hemostasis valve. The perspective view 5800 includes a first constricting plate 5810 and a second constricting plate 5815. Each constricting plate includes a teardrop- shaped aperture. The apertures of the two constricting plates may be aligned to allow the fluid flow tube to traverse the apertures. As shown in Fig.58B, the first constricting plate 5810 includes a teardrop-shaped aperture 5820. The second constricting plate 5815 also includes a teardrop-shaped aperture 5835.

[0233] The teardrop- shaped aperture 5820 includes a large radius section 5825 and a small radius section 5830. Likewise, the teardrop-shaped aperture 5835 includes a large radius section 5845 and a small radius section 5840. As shown in Fig. 58A, the first constricting plate 5810 and second constricting plate 5815 are placed next to each other such that the large radius sections of the two apertures are aligned. Accordingly, the alignment of the two teardrop- shaped apertures, which are oppositely aligned, may allow the largest combined aperture for the fluid flow tube to traverse the two apertures in this state. This is the non-constricting state.

[0234] Likewise, when the first constricting plate 5810 and second constricting plate 5815 are separated, the small radius sections of the two apertures may be aligned such that the fluid flow tube would traverse the small radius sections. This is the constricting state. In the constrictingstate, the small radius apertures may constrict the fluid flow tube and prevent fluid from flowing through the fluid flow tube.

[0235] Referring to Figs. 59A-59C, Fig; 59A is an illustration 5900 of constricting plates of the guillotine embodiment of the hemostasis valve in a non-constricting state. Fig. 59B is an illustration 5910 of constricting plates of the guillotine embodiment of the hemostasis valve in a partially constricting state. Fig. 59C is an illustration 5920 of constricting plates of the guillotine embodiment of the hemostasis valve in a constricting state.

[0236] The two constricting plates, when place flat against each other, have a combined aperture that changes shape based on how the two teardrop shapes align with each other. As shown in the illustration 5900, the combined aperture 5905, when the first constricting plate and second constricting plate are aligned to be in the non-constricting state, the combined aperture has the largest area.

[0237] The illustration 5910 shows the combined aperture in a partially constricted state. This is when the first constricting plate and second constricting plate are separated along an axis that aligns with the large radius section and small radius section of the teardrop shape. When the constricting plates are separated, the combined aperture shrinks, thus partially constricting the combined aperture. This in turn constricts the fluid flow tube, which traverses the combined aperture 5915. The flow of fluid through the fluid flow tube may be similarly constricted.

[0238] In the illustration 5920, the constricting plates are in a constricted state. The first constricting plate and second constricting plate are separated such that the small radius sections of the two constricting plates are aligned to form the combined aperture. Here, the combined aperture 5925 is small enough to constrict a flow of all fluid in the fluid flow tube. Accordingly, fluid flow through the fluid flow tube may be stopped by separating the first constricting plate and second constricting plate, and fluid flow may be initiated by pushing the two constricting plates together. The movement of the two constricting plates may be activated by various mechanisms such as levers, buttons, or the like.

[0239] Referring to Fig. 60, Fig. 60 is an illustration 6000 of an embodiment of the fluid flow tube. The illustration shows an embodiment of a fluid flow tube for the hemostasis valve. The fluidflow tube presented in the illustration 6000 may be combined with any of the disclosed embodiments of the hemostasis valve. The fluid flow tube may include multiple layers. As shown in Fig. 60, the fluid flow tube may include a reinforcement layer 6015, a lubricious layer 6010, and a soft tube layer 6005. Fluid may flow through the inter lumen of the soft tube layer 6005 as indicated by the fluid flow area 6020.

[0240] The reinforcement layer 6015 may provide rigidity and resiliency to the fluid flow tube. In embodiments, the reinforcement layer may comprise a braided tube. The lubricious layer 6010 may allow for the reinforcement layer and soft tube layer to slide relative to one another. In embodiments, the lubricious layer causes the reinforcement layer and soft tube layer to be decoupled, allowing them to slide relative to one another. This may allow for the soft tube layer to fold or seal more effectively when in a compressed state. The lubricious layer also allows for the reinforcement layer to protect the soft tube layer from damage from being compressed.

[0241] The disclosed subject matter includes a hemostasis valve having a fluid flow tube with a longitudinal aperture therethrough, with a constriction wire passed circumferentially around the fluid flow tube and extending substantially radially and / or tangentially therefrom; a lever assembly to pull the constriction wire radially and / or tangentially to constrict the fluid flow tube to at least partially close off the longitudinal aperture, where the lever assembly includes a valve body having a first lever pivot axis and a second lever pivot axis, where a first lever having an axis of rotation is coupled to the valve body such that the first lever can selectively rotate around a first lever axis of rotation in the valve body, where a second lever having an axis of rotation is coupled to the valve body such that the second lever can selectively rotate around a second lever axis of rotation in the valve body, where the first lever and the second lever each have a gear teeth outer edge portion having a fixed radius from respectively the first lever axis of rotation and the second lever axis of rotation such that gear teeth configured on the gear teeth outer edge portion of the first lever and the gear teeth outer edge portion of the second lever complementarity workably mesh with one another, such that a rotary motion of one lever around its axis of rotation forces the complimentary rotary motion of the other lever around its axis of rotation, where the first lever and the second lever each have a constriction wire coupling end, each constriction wire coupling end is operably coupled to an end of the constriction wire such that rotation of the first and second levers around their respective axes of rotation in a closing direction, causes the constriction wireto be tensioned to constrict the fluid flow tube to at least partially close off the longitudinal aperture, while rotation of the first and second levers around their respective axes of rotation in a opening direction, causes the constriction wire tension to be released to allow fluid to flow through the fluid flow tube to open the longitudinal aperture. The fluid flow tube is supported in valve body housing into which the fluid flow tube is received.

[0242] The first lever and the second lever have a closing lever length between a reference point on a closing contact surface and the lever arm's axis of rotation, where the first lever and the second lever have an opening lever length between a reference point on a coupling contact surface and the lever arm's axis of rotation, where the ratio of the lengths of the closing lever length and the opening lever length are dimensioned to provide a force multiplier advantage to the valve operator when exerting a closing force on one or more of the two closing contact surfaces of the valve. The ratio of the lengths of the closing lever length and the opening lever length is at least 1.5. The fluid flow tube is formed from a resilient material. The fluid flow tube is constructed from a silicone rubber. The constriction wire is a string, suture, band or other suitable material.

[0243] The hemostasis valve may further include a detent mechanism whereby the position of the lever assembly can be releasably locked and the extremes of its travel as well as one or more rotational positions intermediate the extremes of it travel, is provided. The valve may be mounted onto an access location of a laparoscopic device or a prosthesis delivery device.

[0244] Another general aspect is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The lumen provides a flow path for a liquid. The hemostasis valve includes two levers that have an engaged state and a released state. The hemostasis valve further includes a constriction mechanism that constricts the valve member when the one or more levers are in a released state. The two levelers may be coupled by gears. The hemostasis valve may further include a locking mechanism that is configured to hold the two levers in a static state. The locking mechanism may include one or more flexible taps. The one or more flexible tabs may include a detent where at least one of the two levers include holes that arc configured to latch with a detent of at least one of the one or more flexible tabs to lock the lever into the static state. The hemostasis valve may further include a fulcrum for each of the two levers. Each of the two levers may include a closing contact point that is configured totransmit a pressing force to constrict the valve member. Each of the two levers may further include an opening contact point that is configured to transmit a pressing force to unconstrict the valve member.

[0245] The disclosed subject matter comprises embodiments of a hemostasis valves capable of controlling a flow of fluid to and from a vasculature of a human patient or animal subject. An exemplary embodiment is a hemostasis valve, including a fluid flow tube with a longitudinal aperture therethrough and a constricting mechanism. The constricting mechanism includes a first constriction plate oriented about perpendicular to the fluid flow tube, the first constriction plate having a first teardrop aperture with a large radius end and a small radius end. A second constriction plate is also oriented perpendicular to the fluid flow tube and has a second teardrop aperture with a large radius end and a small radius end oppositely aligned with the first. The constricting mechanism transitions between open and closed positions, with the closed position constricting the fluid flow tube at the small radius ends of both teardrop apertures. The hemostasis valve includes a first bias acting against the first constriction plate in a direction toward the large radius end and a second bias acting against the second constriction plate toward the large radius end. Engagement mechanisms such as levers move the constricting mechanism from a closed position into an open position.

[0246] Another general aspect is a hemostasis valve, including a fluid flow tube with a longitudinal aperture therethrough, an inner layer comprising a pliable tube, an outer layer comprising a reinforced tube that is not coupled to the inner layer, and a lubricious layer situated between the inner and outer layers. The hemostasis valve includes a constricting mechanism configured to constrict the flow of fluid through the fluid flow tube when in a constricted state, with a bias that acts to place the constricting mechanism in the constricted state. The bias is activated by an engagement mechanism, which may include a lever or one or more push buttons.

[0247] An exemplary embodiment of the hemostasis valve includes a valve member having a lumen with a proximal end and a distal end for a liquid. The hemostasis valve includes one or more constricting wires that are in contact with the valve member. The hemostasis valve includes one or more buttons connected to at least one of the one or more constricting wires where the one or more buttons cause the constricting wires to constrict the valve member when the one or morebuttons are in an up state. The buttons cause the constricting wires to release the valve member when the one or more buttons arc in a depressed state. The hemostasis valve further includes a bias that pushes up each of the one or more buttons where each of the one or more buttons are engaged to a stabilizing guide that extends along a path of movement of the button. The bias for each of the one or more buttons may include two springs. Each end of the one or more constricting wires may be positioned between the two springs as the constricting wire extends from the contact with the valve member to the end. Each button may have a length along an axis of the flow path of between about 3 cm and about 6 cm. Each of the two springs may have a spring constant of between about 0.15 N per millimeter and about 0.6 N per millimeter. The two springs may be oriented along an axis of the lumen.

[0248] Another general aspect is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The hemostasis valve includes a plurality of constricting members that are arranged to surround the valve member. Each of the plurality of constricting members is attached to a constricting mechanism at a distal end and a proximal end of the constricting members. The hemostasis valve includes a spring that provides a rotational bias to the proximal end of the constricting mechanism. The hemostasis valve may further comprise a linear slide at a distal end of the constricting mechanism. The hemostasis valve may further include a handgrip attached to the proximal end. The constricting mechanism may be configured to move along the linear slide when the handgrip is turned. The constricting members may wrap around the valve member. The rotational bias may cause the constricting members to constrict the lumen. A force to turn the handgrip opposite the rotational bias may act to unconstrict the lumen. The constricting mechanism may be configured to fully constrict the lumen when no force is applied to the hand grip.

[0249] An exemplary embodiment is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The lumen provides a flow path for a liquid and a spring clamp is positioned around the valve member. The spring clamp may comprise two handles that are configured to release tension in the spring clamp when the handles arc pressed toward one another. The spring clamp may be configured to constrict the lumen when no force is applied to the handles. The spring clamp may be configured to unconstrict the lumen when the handles are pressed toward one another. The hemostasis valvemay further include flexible silicone that envelops a portion of the spring clamp and the hemostasis valve. The lumen may constrict to shut the flow path from a flow of liquid when no force is applied to the handles.

[0250] Another general aspect is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The lumen provides a flow path for a liquid. The hemostasis valve includes one or more constricting wires that are in contact with the valve member. The hemostasis valve includes a button connected to at least one end of the one or more constricting wires where the button causes the constricting wires to constrict the valve member when the button is in an up state. The button further causes the constricting wires to release the valve member when the button is in a depressed state. The hemostasis valve further includes a bias that pushes up on each of the one or more buttons. The button may engage a stabilizing guide that extends along a path of movement of the button. The bias for the button may include two springs. Each end of the one or more constricting wires may be positioned between the two springs as a constricting wire extends from the contact with the valve member to the end. The button may have a length along an axis of the flow path of between about 3 cm and about 6 cm. Each of the two springs may have a spring constant of between about 0.15 N per millimeter and about 0.6 N per millimeter. The two springs may be oriented along an axis of the valve member.

[0251] An exemplary embodiment is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The lumen provides a flow path for a liquid. The hemostasis valve includes a button with a depressed state and a released state with a path that is aligned with an axis of the valve member. The hemostasis valve includes a bias that pushes up on the button toward the released state. The hemostasis valve further includes a constriction mechanism that constricts the valve member when the button is in a release state. The bias for the button may include a spring that is aligned with the valve member. The constriction mechanism may include one or more constricting wedges that are configured to constrict the valve member when the button is in a released state. The one or more constricting wedges may be further configured to unconstrict the valve member when the button is in a depressed state. The hemostasis valve may further include a constricting wall that is configured to maintain a contact with the one or more constricting wedges. The constructing wall may bepositioned a distance from the valve member that is less than a width of a base of the one or more constricting wedges. The one or more constricting wedges may be configured to close the flow path to prevent the flow of liquid when the button is in a released state.

[0252] An exemplary embodiment is a hemostasis valve. The hemostasis valve includes a valve member having a lumen with a proximal end and a distal end. The lumen provides a flow path for a liquid. The hemostasis valve includes one or more levers where the one or more levers have engaged state and a released state. The hemostasis valve further includes a bias for each of the one or more levers where the bias is configured to impel the lever toward the released state. The hemostasis valve includes a constriction mechanism that constricts the valve member when the one or more levers are in a released state. The constricting mechanism may include one or more constricting wires that constrict the valve member when the one or more levers are in a released state. The one or more constricting wires may unconstrict the valve member when the one or more levers are in an engaged state. The bias may include a spring. The distance between the released state and the engaged state for each of the one or more levers may be between about 3 cm and about 6 cm. The spring may have a spring constant of between about 0.15 N per millimeter and about 0.6 N per millimeter. The hemostasis valve may further include a fulcrum where the bias is on an opposite side of the fulcrum relative to the constricting wires.

[0253] Many variations may be made to the embodiments described herein. All variations, including combinations of variations, are intended to be included within the scope of this disclosure. The description of the embodiments herein can be practiced in many ways. Any terminology used herein should not be construed as restricting the features or aspects of the disclosed subject matter. The scope should instead be construed in accordance with the appended claims.

Claims

CLAIMS:

1. A hemostasis valve having a fluid flow tube with a longitudinal aperture therethrough, a constriction wire passed circumferentially around the fluid flow tube and extending substantially radially and / or tangentially therefrom; a lever assembly to pull the constriction wire radially and / or tangentially to constrict the fluid flow tube to at least partially close off the longitudinal aperture, wherein the lever assembly includes: a valve body having a first lever pivot axis and a second lever pivot axis, where a first lever having an axis of rotation is coupled to said valve body such that said first lever can selectively rotate around a first lever axis of rotation in said valve body, where a second lever having an axis of rotation is coupled to said valve body such that said second lever can selectively rotate around a second lever axis of rotation in said valve body, where said first lever and said second lever each have a gear teeth outer edge portion having a fixed radius from respectively said first lever axis of rotation and said second lever axis of rotation such that gear teeth configured on said gear teeth outer edge portion of said first lever and said gear teeth outer edge portion of said second lever complementarily workably mesh with one another, such that a rotary motion of one lever around its axis of rotation forces a complimentary rotary motion of an other lever around its axis of rotation, where said first lever and said second lever each have a constriction wire coupling end, each constriction wire coupling end is operably coupled to an end of said constriction wire such that rotation of said first and second levers around their respective axes of rotation in a closing direction, causes said constriction wire to be tensioned to constrict the fluid flow tube to at least partially close off the longitudinal aperture, while rotation of said first and second levers around their respective axes of rotation in an opening direction, causes said constriction wire tension to be released to allow fluid to flow through said fluid flow tube to open the longitudinal aperture.

2. The hemostasis valve as in Claim 1 wherein said fluid flow tube is supported in valve body housing into which the fluid flow tube is received.

3. The hemostasis valve as in Claim 1 wherein said first lever and said second lever have a closing lever length between a reference point on a closing contact surface and a lever arm's axis of rotation, where said first lever and said second lever have an opening lever length between a reference point on a coupling contact surface and the lever arm's axis of rotation, where a ratio of the lengths of the closing lever length and the opening lever length are dimensioned to provide a force multiplier advantage to the valve operator when exerting a closing force on one or more of the two closing contact surfaces of the valve.

4. The hemostasis valve as in Claim 3, where the ratio of the lengths of the closing lever length and the opening lever length is at least 1.5.

5. The hemostasis valve as in Claim 1 wherein the fluid flow tube is formed from a resilient material.

6. The hemostasis valve as in Claim 1 wherein the fluid flow tube is constructed from a silicone rubber.

7. The hemostasis valve as in Claim 1 wherein the constriction wire is a string, suture, band or other suitable material.

8. The hemostasis valve as in Claim 6 further including a detent mechanism whereby a position of the lever assembly can be releasably locked and extremes of its travel as well as one or more rotational positions intermediate the extremes of it travel, is provided.

9. The hemostasis valve as in Claim 1 mounted onto an access location of a laparoscopic device.

10. The hemostasis valve as in Claim 1 mounted onto a prosthesis delivery device.

11. A hemostasis valve, the hemostasis valve comprising:a fluid flow tube with a longitudinal aperture therethrough; a constricting mechanism, the constricting mechanism comprising: a first constriction plate oriented about perpendicular to the fluid flow tube, the first constriction plate having a first teardrop aperture; the first teardrop aperture having a large radius end and a small radius end; a second constriction plate oriented about perpendicular to the fluid flow tube, the second constriction plate having a second teardrop aperture; the second teardrop aperture having a large radius end and a small radius end oppositely aligned to the large radius end and the small radius end of first teardrop aperture; the constricting mechanism having a closed position and an open position, the closed position comprising the first constriction plate and second constriction plate positioned to constrict the fluid flow tube in the small radius end of the first teardrop aperture and the small radius end of the second teardrop aperture.

12. The hemostasis valve of claim 11, further comprising: a first bias that acts against the first constriction plate in a direction toward the large radius end of the first teardrop aperture; and a second bias that acts against the second constriction plate in a direction toward the large radius end of the second teardrop aperture.

13. The hemostasis valve of claim 12, wherein the first bias and second bias comprise springs.

14. The hemostasis valve of claim 12, further comprising: a first lever connected to the first bias; a second lever connected to the second bias; wherein an engagement action on the first lever and the second lever cause the constricting mechanism to go from a closed state into a open state.

15. A hemostasis valve, the hemostasis valve comprising: a fluid flow tube comprising: a longitudinal aperture therethrough; an inner layer comprising a pliable tube;an outer layer comprising a reinforced tube, the outer layer not coupled to the inner layer; and a lubricious layer comprising a tube in between the inner layer and outer layer; a constricting mechanism configured to constrict a flow of fluid through the fluid flow tube when the constricting mechanism is in a constricted state.

16. The hemostasis valve of claim 15, further comprising a bias that acts to put the constricting mechanism in the constricted state.

17. The hemostasis valve of claim 16, wherein the bias is activated by an engagement mechanism.

18. The hemostasis valve of claim 17, wherein the engagement mechanism comprises a lever.

19. The hemostasis valve of claim 17, wherein the engagement mechanism comprises one or more push buttons.

20. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; one or more constricting wires that are in contact with the valve member; one or more buttons connected to at least one end of one of the one or more constricting wires, the one or more buttons causing the one or more constricting wires to constrict the valve member when the one or more buttons are in an up state, and the buttons causing the one or more constricting wires to release the valve member when the one or more buttons are in a depressed state; a bias that pushes up each of the one or more buttons; and each of the one or more buttons engaged to a stabilizing guide that extends along a path of movement of the button.

21. The hemostasis valve of claim 20, wherein the bias for each of the one or more buttons comprises two springs.

22. The hemostasis valve of claim 21 , wherein an end of the one or more constricting wires is positioned between the two springs as the constricting wire extends from the contact with the valve member to the end.

23. The hemostasis valve of claim 21, wherein each button has a length along an axis of the flow path of between about 3 cm and about 6 cm.

24. The hemostasis valve of claim 21, wherein each of the two springs has a spring constant of between about 0.15 N / mm and about 0.6 N / mm.

25. The hemostasis valve of claim 21, where in the two springs are oriented along an axis of the lumen.

26. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end; a plurality of constricting members, arranged to surround the valve member, each of the plurality of constricting members attached to a constricting mechanism at a distal end and a proximal end of the constricting members; and a spring that provides a rotational bias to the proximal end of the constricting mechanism.

27. The hemostasis valve of claim 26, further comprising a linear slide at the distal end of the constricting mechanism.

28. The hemostasis valve of claim 27, further comprising a hand grip attached to the proximal end.

29. The hemostasis valve of claim 28, wherein the constricting mechanism is configured to move along the linear slide when the hand grip is turned.

30. The hemostasis valve of claim 29, wherein the constricting members wrap around the valve member.

31. The hemostasis valve of claim 30, wherein the rotational bias causes the constricting members to constrict the lumen.

32. The hemostasis valve of claim 31 , wherein a force to turn the hand grip opposite the rotational bias acts to unconstrict the lumen.

33. The hemostasis valve of claim 32, wherein the constricting mechanism is configured to fully constrict the lumen when no force is applied to the hand grip.

34. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; and a spring clamp positioned around the valve member.

35. The hemostasis valve of claim 34, wherein the spring clamp comprises two handles that are configured to release tension in the spring clamp when the handles are pressed toward one another.

36. The hemostasis valve of claim 35, wherein the spring clamp is configured to constrict the lumen when no force is applied to the handles.

37. The hemostasis valve of claim 36, wherein the spring clamp is configured to unconstrict the lumen when the handles are pressed toward one another.

38. The hemostasis valve of claim 37, further comprising flexible silicone that envelops of portion of the spring clamp and the hemostasis valve.

39. The hemostasis valve of claim 38, wherein the handles are not enveloped by the flexible silicone.

40. The hemostasis valve of claim 39, wherein the lumen constricts to shut the flow path from a flow of liquid when no force is applied to the handles.

41. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; one or more constricting wires, that are in contact with the valve member; a button connected to at least one end of one of the one or more constricting wires, the button causing the constricting wires to constrict the valve member when thebutton is in an up state, and the button causing the constricting wires to release the valve member when the button is in a depressed state; a bias that pushes up each of the one or more buttons; and the button is engaged to a stabilizing guide that extends along a path of movement of the button.

42. The hemostasis valve of claim 41, wherein the bias for the button comprises two springs.

43. The hemostasis valve of claim 42, wherein each of the ends of the one or more constricting wires is positioned between the two springs as the constricting wire extends from the contact with the valve member to the button.

44. The hemostasis valve of claim 42, wherein the button has a length along an axis of the flow path of between about 3 cm and about 6 cm.

45. The hemostasis valve of claim 42, wherein each of the two springs has a spring constant of between about 0.15 N / mm and about 0.6 N / mm.

46. The hemostasis valve of claim 42, where in the two springs are oriented along an axis of the valve member.

47. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; a button, with a depressed state and a released state with path that is aligned with an axis of the valve member; a bias that pushes up on the button toward the released state; and a constriction mechanism that constricts the valve member when the button is in the released state.

48. The hemostasis valve of claim 47, wherein the bias for the button comprises a spring that is aligned with the valve member.

49. The hemostasis valve of claim 47, wherein the constriction mechanism comprises one or more constricting wedges that arc configured to constrict the valve member when the button is in the released state.

50. The hemostasis valve of claim 49, wherein the one or more constricting wedges are further configured to unconstrict the valve member when the button is in the depressed state.

51. The hemostasis valve of claim 50, further comprising a constricting wall that is configured to maintain a contact with the one or more constricting wedges.

52. The hemostasis valve of claim 51, wherein the constricting wall is positioned a distance from the valve member that is less than a width of a base of the one or more constricting wedges.

53. The hemostasis valve of claim 52, wherein the one or more constricting wedges are configured to close the flow path to prevent a flow of liquid when the button is in the released state.

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

55. The hemostasis valve of claim 54, wherein the constriction mechanism comprises one or more constricting wires that constrict the valve member when the one or more levers are in the released state.

56. The hemostasis valve of claim 55, wherein the one or more constricting wires unconstrict the valve member when the one or more levers arc in the engaged state.

57. The hemostasis valve of claim 56, wherein the bias comprises a spring.

58. The hemostasis valve of claim 57, wherein a distance between the released state and the engaged state for each of the one or more levers is between about 3 cm and about 6 cm.

59. The hemostasis valve of claim 57, the spring has a spring constant of between about 0.15 N / mm and about 0.6 N / mm.

60. The hemostasis valve of claim 54, further comprising a fulcrum for each of the one or more levers.

61. The hemostasis valve of claim 54, further comprising a fulcrum for each of the one or more levers; and wherein an opposing bias is on an opposite side the fulcrum relative to the bias of each of the one or more levers.

62. A hemostasis valve, the hemostasis valve comprising: a valve member having a lumen with a proximal end and a distal end, the lumen providing a flow path for a liquid; two levers, the two levers having an engaged state and a released state; and a constriction mechanism that constricts the valve member when the two levers are in the released state.

63. The hemostasis valve of claim 62, wherein the two levers are coupled by gears.

64. The hemostasis valve of claim 63, further comprising a locking mechanism that is configured to hold the two levers in a static state.

65. The hemostasis valve of claim 64, wherein the locking mechanism comprises one or more flexible tabs, the one or more flexible tabs comprising a detent; andwherein at least one of the two levers comprise holes that are configured to latch with the detent of at least one of the one or more flexible tabs to lock the lever into the static state.

66. The hemostasis valve of claim 65, further comprising a fulcrum for each of the two levers.

67. The hemostasis valve of claim 65, wherein each of the two levers comprise a closing contact point that is configured to transmit a pressing force to constrict the valve member.

68. The hemostasis valve of claim 67, wherein each of the two levers further comprise an opening contact point that is configured to transmit the pressing force to unconstrict the valve member.

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