HEMOSTASIS VALVE DEVICE

A hemostasis valve device includes a valve body having an open first end and an open second end with a main lumen extending from the open first end to the open second end. The valve includes a valve member disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position and a closed position. An actuator is disposed between the valve member and the open second end. The actuator is configured to move the valve member between the open position and the closed position.

TECHNICAL FIELD

The present disclosure relates to medical devices and instruments and more particularly, the present disclosure relates to hemostasis valve devices with improved actuators and hemostasis cannula units containing hemostasis valves.

BACKGROUND

Current surgical procedures often require temporary and at times repeated introduction of catheters (cannulas device) and/or guidewires and/or other instruments into the neuroendovascular and/or cardiovascular system of a patient. For example, a catheter can be introduced into the body of a patient and be used to deliver fluid, such as a medicament, directly to a predetermined location within the patient's neuroendovascular and/or cardiovascular system. Catheters can also be used for exploratory surgery and for removing tissue samples within a body.

A common catheter design used in performing many procedures includes an elongated, flexible, cylindrical catheter body that has a fluid flow passageway or a lumen extending along the interior of the catheter body. In one exemplary procedure, an end of the catheter is inserted into a vessel within the vasculature of the patient. The catheter is advanced along the internal passageway of the vessel until the end of the catheter is located at a predetermined location within the patient's body. This location is often associated with a point at which a medicament is to be delivered or a therapeutic procedure is to be performed.

In order to position the catheter, a long, cylindrical, and rigid but manipulable guidewire is often used to direct the catheter to a desired location within the body. In other words, the rigid configuration and small diameter of such guidewires are specially configured for directing and advancing the guidewire to a desired location within the cardiovascular system. The end of the guidewire, positioned outside the body of the patient, is then received within the lumen of the catheter. Using the guidewire as a guide, the catheter is advanced along the length of the guidewire so as to properly position the catheter within the body of the patient. The guidewire can then be removed from within the catheter to open the lumen of the catheter.

It will be appreciated that medical procedures which utilize catheters often require the insertion and removal of several different types of catheters and guidewires. One of the issues that is encountered with the insertion and removal of catheters and guidewires is controlling bleeding at the point where the catheters and guidewires are first introduced into the cardiovascular system. One approach which has been utilized to control the bleeding at the catheter insertion point while also facilitating insertion and removal of the catheter and/or guidewire within the cardiovascular system is to utilize an introducer during the insertion procedure. An introducer is a relatively large gauge tube which is inserted into the patient. One end of the introducer is positioned outside the body of the patient and is attached to an adapter. The adapter typically comprises a short, rigid tube having a passageway extending therethrough. The adapter tube includes a valve commonly referred to as a hemostasis valve.

The hemostasis valve, which either closes independently or is compressed around the catheter and/or guidewire, restricts blood from spilling out of the adapter through the lumen of the valve.

A hemostasis valve is routinely used in neuroendovascular procedures to decrease the risk of thromboembolism and more specifically, a hemostasis valve is commonly used for continuous irrigation of guide and microcatheters to decrease the risk of thromboembolism. A conventional hemostasis valve has a rotating seal at the end, which is turned open or closed each time a wire or microcatheter/guidewire is introduced or extracted. Often this results in significant back bleeding. When a rotating seal is adjusted suboptimally during a wire or microcatheter manipulation, leakage of pressurized saline from the end of a hemostasis valve results in stagnation of blood within a guiding catheter, which becomes a potential source of emboli during a procedure.

There are a wide variety of hemostasis valve devices that are commercially available; however, these valves suffer from the main disadvantage that these hemostasis valve devices require two hands to operate in that the surgeon holds the valve body in one end and in the case of a rotatable actuator, the surgeon uses his or her other hand to manipulate the rotatable actuator to effectuate opening and closing of the hemostasis valve. In addition, many hemostasis valve devices have lengths that are too great to permit access into the brain to perform neuroendovascular procedures.

The present disclosure sets forth hemostasis valves that are configured so that the surgeon can use one hand to both hold and manipulate the actuator to cause opening and closing of the valve.

SUMMARY

A hemostasis valve device, according to one embodiment, includes a valve body having an open first end and an open second end with a main lumen extending from the open first end to the open second end. The valve includes a valve member disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position and a closed position. An actuator is disposed between the valve member and the open second end. The actuator is configured to move the valve member between the open position and the closed position. The actuator is located along a side of the valve body and is configured to translate a force applied to the actuator into opening of the valve member. For example, the actuator is configured to translate an applied force that is perpendicular (normal) to a longitudinal axis of the main lumen into a longitudinal force that causes the valve member to open.

The actuator can include a first portion that is accessible along one or more sides of the valve body and a second portion that is disposed completely within the main lumen, the first portion being configured to translate the applied force into axial translation of the second portion within the main lumen resulting in the valve member being breached and opened by the second portion.

In another embodiment, the actuator comprises a pair of two-bar linkages that are pivotally coupled to the valve body and move between a relaxed position in which the valve member is closed and a compressed position in which the valve member is open.

In yet another embodiment, an actuator is configured to translate axial, longitudinal motion along the exterior of the device into axial movement of another part of the actuator to cause opening and closing of the valve member.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

FIGS.1-6illustrate a hemostasis valve device100that is configured to mate with a cannula device (not shown), such as a catheter or the like, as well as other external devices, such as medical instruments, etc. that are intended to be fed through the hemostasis valve device100. The device100includes a hollow main body (manifold)110that has an open first end112and an opposing open second end114with a main lumen120extending completely from the first end112to the second end114. The main body110thus can be thought of as being a central tubular body. As shown in the figures, the main lumen120can have a non-uniform shape in that one end of the main lumen120can have a diameter (width) that is different than the other end and/or other portions of the main lumen120. In some areas within the body110, the main lumen120can be defined by a tubular structure129.

The main body110can be formed of any number of suitable materials including but not limited to plastics.

A catheter access section130is defined at the second end114of the main body110and is configured to mate with an external device, such as the cannula device, (not shown). As shown, the catheter access section130has an inner surface or face132that can be a threaded section and an external surface of face134. The external surface134can be a ribbed surface as shown. The threaded inner surface132is thus configured to mate with external threads that are part of the cannula device to couple the cannula device to the catheter access section130. For example, the cannula device can be screwed onto the threaded inner surface132of the catheter access section130to couple the cannula device to the device100. The lumen of the cannula device is thus placed in fluid communication with the main lumen120when the cannula device is coupled to the device100.

As shown inFIG.3, the main lumen120, defined by the tubular structure129, extends beyond the end of the access section130.

The main body110also includes a connection branch140that extends radially outward from a first side111of the main body110between the first end112and the second end114. In the industry, this type of arrangement is known as a hemostasis valve Y connector and as mentioned, traditionally, such Y connectors can include a rotating male luer lock and a female luer lock sideport or other types of actuators/locks.

The first side111of the main body110can be considered to be a top side/top surface of the main body110. The connection branch140is a tubular structure that has an exposed, free end142to which an external device (not shown) is attached. A lumen141is formed in the connection branch140. For example, the external device can be a syringe that permits a fluid, such as medication, to be dispensed into the main lumen120since the connection branch140is in fluid communication with the main lumen120. The free end142is configured to permit the external device to be coupled in a sealed manner to the free end142. For example, the free end142can be in the form of a threaded end or it can be in the form of a luer fitting (luer lock sideport).

One feature of the device100is that the connection branch140also serves as a first finger rest in that an inner surface143can be a sloped surface and more particularly, the lower portion of the inner surface143adjacent the main body110can be a sloped surface (concave shaped) to permit resting of a finger thereagainst. In addition, along the connection branch140there is a first finger support145. The first finger support145can be in the form of a curved protrusion (finger) that protrudes outwardly from the first side111in the direction toward the second end114of the main body110. The first finger support145defines the upper end of the curved, sloped inner surface143that receives the finger.

A second side113of the main body110, which can be considered to be a bottom side/bottom surface, includes a second finger support147. The second finger support147comprises a curved protrusion (finger) that protrudes outwardly from the second side113in the direction toward the second end114of the main body110. The second finger support147can be located slightly closer to the first end112of the main body110compared to the first finger support145. As shown, both of the first finger support145and second finger support147have a concave shape in the direction of the of the second end114.

Based on the foregoing construction, each of the first side111and the second side113is a swept surface that provides an ergonomic design to the main body110that can be grasped and held by the user.

The device100includes a valve member200that moves between an open position and a closed position. In the open position, an external device, such as a surgical instrument and/or guide wire, can be fed through the valve member200. In the closed position, the valve member200is sealed shut. The valve member200is disposed at or proximate to the first end112. The valve member200can take many different forms and in the illustrated embodiment, the valve member200can take the form of an elastic gasket that moves between the open and closed positions when a force is applied.

The valve member200is thus located within main body110and more particularly, the valve member200is located within (along) the main lumen120and thus, in the open position of the valve member200, the main lumen120is open. Conversely, when the valve member200is closed, the main lumen120is occluded.

The valve member200can have a cylindrical shape that has a first end202that is located at or proximate the first end112of the device100and an opposing second end204. The valve member200also includes an inner wall210that extends across a side wall of the valve member200within the hollow interior of the valve member200. The inner wall210has an openable/sealable slit or opening215formed therein (e.g., a single slit or cross-hair shaped slit). The opening of the valve member200is marked by the opening of the opening215and conversely, the closing of the valve member200is marked by the closing/sealing of the opening215. As shown inFIG.2, the inner wall210is at or proximate to the first end202and does not extend completely to the second end204resulting in an open space205being formed in the valve member200at the first end202. In the illustrated embodiment, the open space205has a cylindrical shape.

As shown, the valve member200can be contained in an enlarged interior space within the main body110with the side wall of the valve member200being in contact with the inner wall of the main body110that defines this enlarged interior space. The opening of the main body110at the first end112can have an enlarged size relative to the opening at the first end114. The opening at the first end112serves as an entrance into which an external device (e.g., a surgical instrument and/or guide wire, etc.) can be inserted, while the opening at the second end114serves as an exit through which the external device exits.

The device100also includes an actuator300that is configured to open and close the valve member200. More specifically, the actuator300is accessible to the user (surgeon) and when manipulated by the user, the actuator300opens and closes the valve member200. The present disclosure describes and illustrates several different types of actuators that are configured to perform the intended function described herein, namely, the opening and closing of the valve member200.

FIGS.1-6illustrate actuator300according to one embodiment. The actuator300is designed to translate a user squeezing or pinching action (compressive force) of the actuator300into opening and closing of the valve member200. Within the main body110there is an actuator inner space305.

The actuator300is accessible along at least one of the first side111and the second side113of the main body110. In the illustrated embodiment, the actuator300is accessible along both the first side111and the second side113. For example, the first side111and the second side113can include an opening that is in fluid communication with actuator inner space305and the main lumen120.FIG.5shows the opening in the first side111, with the opening in the second side113being a mirror image thereof. In other words, the openings lead into the actuator inner space305. The openings can be formed to have any number of different shapes including circular or oval. These openings are axially aligned along an axis that passes through the actuator inner space305and the main body110and can define a single through hole that passes from and is open along the first side111and the second side113.

The actuator300can include a first part310that is disposed within the main body110, namely, within the main lumen120, and a second part320that is disposed within the main body110, namely, within the main lumen120. The first part310is a tubular structure and therefore its placement in the main lumen120does not restrict the flow of fluid within the main lumen120and similarly, the second part320is a tubular structure and therefore its placement in the main lumen120does not restrict the flow of fluid within the main lumen120. The first part310and the second part320are spaced apart from one another and more particularly, the first part310is positioned between the actuator300and the first end112and the second part320is positioned between the actuator300and the second end114.

The first part310and the second part320can thus be in the form of a hollow pin. As shown, the first part310can have a stepped construction with a distal section312being configured to be sealingly fitted within the main lumen120, while a proximal section314is received within the actuator inner space305. The proximal section314can thus be in the form of an annular flange.

The second part320preferably comprises a frustoconical shaped hollow pin that has an inward taper in the direction of the distal end of the second part320. As shown, the second part320can have a stepped construction with a distal section322and a proximal section324is received within the actuator inner space305. The proximal section324can thus be in the form of an annular flange. The frustoconical shaped second part320is sized such that the proximal section324has a greater width (diameter) than the distal section322. When the proximal section324is thus inserted into the main lumen120, the proximal section324is sealingly fitted to the main lumen120.

As discussed herein, the first part310can be fixedly attached to the main body110within the main lumen120, while the second part320is movable within main body110and more particularly, the second part320moves axially (along a longitudinal axis) within the main lumen120to contact the valve member200and move it from the closed (sealed) position to the open position.

The actuator300includes a biasing mechanism that is configured to move the second part320between an extended position in which the second part320is driven into contact with and through the valve member200to cause opening of the valve member200and a retracted position in which the second part320is spaced from the valve member200which remains closed. The biasing mechanism is configured such that when a force is applied to the actuator300, the second part320is driven in the direction toward the first end112of the main body110. The driving of the second part320causes the second part320to contact and pierce the inner wall210by passing through the opening215to cause opening of the valve member200as shown inFIG.6. Since the second part320is a tubular structure, when the second part320opens and passes through the valve member200, the main lumen120is open from the first end112to the second end114, thereby allowing the external device to enter the first end112and exit the second end114and enter into the other external device (e.g., catheter) attached to the second end114. As shown inFIG.6, in the fully extended position, the second part320passes completely through the valve member200(through the opening formed therein) and the distal end of the second part320is open to the enlarged opening of the main body110at the first end112.

The biasing mechanism is also configured such that when the applied force is removed, the biasing mechanism reverts back to its at rest position which is a position in which the second part320is retracted and is withdrawn from the opening215of the valve member200resulting in the closing (sealing) of the valve member200.

In the illustrated embodiment, the biasing mechanism can be in the form of first and second leaf springs330,340. The first leaf spring330is disposed along the first side111and the second leaf spring340is disposed along the second side113. The first leaf spring330at least partially extends through the opening formed in the first side111and is coupled to both the first part310and the second part320. A first end of the first leaf spring330is attached to the first part310and an opposite second end is attached to the movable second part320. Similarly, the second leaf spring340at least partially extends through the opening formed in the second side113and is coupled to both the first part310and the second part320. A first end of the second leaf spring340is attached to the first part310and an opposite second end is attached to the movable second part320. As shown, each of the first leaf spring330and the second leaf spring340can have a U-shape.

In the at rest position, the distal end of the second part320is received within the open space205but does not pierce the inner wall of the valve member200.

When the first and second leaf springs330,340are compressed by applied forces against the respective leaf springs330,340in the direction that is perpendicular to the main body110(i.e., perpendicular to the longitudinal axis of the device100), the actuator operates on the valve member200. The actuator300is thus configured to translate an applied force in a first direction (direction perpendicular to the main body110) into movement of the actuator300in a second different direction (an axial direction along the longitudinal axis of the device). In other words, the compression of the leaf springs330,340is translated into axial movement of the second part320in a direction toward the first end112resulting in the second part320being driven into contact with and through the valve member200as described herein for the opening thereof.FIG.6shows this position in which the valve member200is in the open position. It will be seen that in this position, the first part310has not moved and remains stationary as it is fixed to the main body110; however, the second part320has moved axially toward the first end112.

The actuator300also includes an actuator cover that is sealingly coupled to the main body110and covers the actuator300. More specifically, the actuator cover can be in the form of a first actuator cover350that is disposed over the first leaf spring330and is disposed over the opening in the first side111. The first actuator cover350thus seals the opening in the first side111and prevents any fluid within the main lumen from existing the first side111. At the same time, the first actuator cover350permits contact with and compression of the first leaf spring330.

The actuator cover can be in the form of a second actuator cover360that is disposed over the second leaf spring340and is disposed over the opening in the second side113. The second actuator cover360thus seals the opening in the second side113and prevents any fluid within the main lumen from existing the second side113. At the same time, the second actuator cover360permits contact with and compression of the second leaf spring340.

The first and second actuator covers350,360are thus formed of a flexible material (e.g., polymeric material (e.g., silicone)) that can easily compress under application of a force. As illustrated, the first and second actuator covers350,360can be flexible dome shaped structures.

By placing two biasing mechanisms along the two opposing sides111,113, the device100can be considered to be a dual sided actuator that allows the user (surgeon) to hold the main body110and operate the actuator300along both sides111,113of the main body110. However, it will be appreciated that while two biasing mechanisms are shown in the figures, the device100can include a single actuator in that the device100can include only one biasing mechanism located along one of the sides111,113.

FIGS.7-8illustrate an actuator according to a second embodiment. This second embodiment is similar to the first embodiment in that it includes an actuator that is configured to translate a squeezing action (compressive force) into axial movement for purposes of opening and closing the valve member200.

The second embodiment includes an actuator301that is very similar to the actuator300and therefore, like parts are numbered alike. The main difference between the actuator301and the actuator300is that the first and second biasing mechanisms are different. More particularly, each of the first biasing mechanism and the second biasing mechanism comprises a two-bar linkage311,321, respectively, and therefore, the actuator301can be characterized as being a four-bar linkage. The first two-bar linkage311is located along the side111and the second two-bar linkage321is located along the side113.

One end of the first two-bar linkage311is attached to the first part310, while the other end of the first two-bar linkage321is attached to the second part320and similarly, the second two-bar linkage321is attached to the first part310, while the other end of the second two-bar linkage321is attached to the second part320. Much like the leaf springs330,340, the first and second two-bar linkages311,321are configured to compress (collapse) when a force (e.g., squeezing action) is applied in a direction normal to the longitudinal axis of the main body110. This compression drives the second part320through the valve member200for opening thereof as described herein with respect to actuator300. When the applied force is removed, the first and second two-bar linkages311,321return to their fully retracted at rest positions.

The actuators300,301thus operate in a similar manner.

As with the first embodiment, it will be appreciated that the actuator of the second embodiment can include only a single two-bar linkage as opposed to using two two-bar linkages as shown in the figure.

Location of Actuator300to the Valve Member200

In accordance with one feature of the present device100and in direct contrast to conventional hemostasis valve constructions, the actuator300is spatially separated from the valve member200. More specifically, the actuator300is located between the valve member200and the second end114and more particularly, the actuator300is between the connection branch140and the second end114. As shown, the actuator300is located on one side of a center axis that passes through the connection branch140, while the valve member200is located on an opposite side of the center axis. In other words, the actuator300is located on one side of the connection branch140, while the valve member200is located on the other side of the connection branch140.

As mentioned previously, conventional hemostasis valve constructions are such that the actuator (such as a knob) is an integral part of the valve member. By spatially separating the actuator and moving the actuator300to an intermediate location along the main body110, the user can hold the device100with one hand along this intermediate location and at the same time operate the actuator300with the same time. To hold the device100, the user places his or her finger against the first finger support145, while the thumb is placed against the second finger support147. From this holding position, the user can then press down (squeeze or pinch) the first biasing mechanism and the second biasing mechanism. When these two biasing mechanisms are compressed, the second part320is driven toward and through the valve member200, thereby opening the valve member200. Once the valve member200is open, the external device can be fed through the opening215in the valve member200and pass through the main lumen120. Once use of the external device is completed, the user removes the external device and then releases the actuator causing the automatic retraction of the second part320and the return of the first and second biasing mechanisms to the at rest position.

The frustoconical shape of the second part also promotes opening of the valve member200as the second part320is progressively driven into and through the second part320.

Use of Connection Branch140

In addition, the construction of the actuator300is such that fluid that flows through the connection branch140is not obstructed by the actuator300and instead flows directly into the main lumen120. The fluid thus flows around and/or through the actuator300and into the main lumen120. As shown, the lower end of the connection branch140can have a curved shape to channel and direct fluid into the main lumen120and toward the second end114. In the fully retracted (at rest) position of the actuator300, the connection branch140is located above the second part320. However, as mentioned, the second part320does not obstruct the flow of fluid through the connection branch140into the main lumen120. Thus, fluid can flow around the second part320into the main lumen120. The second part320can also include one or more holes (not shown) that are formed in the side wall of the second part320to allow for flow from a location outside the second part320to a location inside the second part310. The one or more holes can be in the form of a series of pin holes that are arranged in sets that are formed circumferentially about the second part320. For example, each set can include three pin holes that are formed in a line. The sets are spaced apart from one another in the circumferential direction.

FIGS.9-13illustrate another hemostasis valve device500that is similar to the hemostasis valve device100and therefore like parts are numbered alike.

The hemostasis valve device500include a main body510that includes the catheter access section130defined at the distal end of the main body510. The main body510, like main body110, is a hollow structure that includes main lumen120. As shown inFIGS.9and11, inside of the main body510there is an actuator tube520. Unlike the device100, the actuator tube520is fixedly attached to the main body510and thus there is no relative movement between the actuator tube520and the main body510. The inside of the actuator tube520at one end is in fluid communication with the catheter access section130. The actuator tube520terminates in a free end522. As shown inFIG.11, the actuator tube520can include a set of openings formed therein and circumferentially thereabout similar to the openings described above with respect to the actuator300.

The main body510also includes the connection branch140which is in fluid communication with the main lumen120and as described herein, allows for injection of fluid into the main lumen120.

The main body510also includes a first finger support530formed along the top of the main body510and a second finger support540formed along the bottom of the main body510. These two finger supports can thus be oriented 180 degrees apart as illustrated. Each finger support530,540has a curved surface against a thumb or finger can rest to hold the main body510similar to the use of the finger supports145,147. The finger supports530,540are curved towards the catheter access section130.

Unlike the device100, the device500includes a slider part550that moves axially relative to the main body510and more particularly, the slider part550is sealingly coupled to the main body510and slides thereover. The slider part550has a pair of arcuate shaped side walls552,554that are complementary to the main body510to allow the side walls552,554to seat against the outer surface of the main body510and slide thereover. The slider part550has a third finger support560that extends downwardly form the slider part550and has a curved finger support surface. This curved surface faces away from the main body510. Between the side walls552,554, there is a top slot557and an opposite bottom slot559.

The slider part550is thus slidingly coupled to the main body510such that when a compressive force is applied to either of these parts causing these two parts to be drawn together, the side walls552,554slide over the outer surface of the main body510. The slider part550is biased relative to the main body510in that a spring565is provided and seats between an inner surface of the main body510and an inner surface of the slider part550, thereby causing the two parts to be biased relative to one another.FIGS.10and11show an at rest position prior to actuation and in this state, the spring565is in an at rest, extended position and is not storing energy. This results in the slider part550being in a fully extended position relative to the main body510.

As shown inFIG.11, the valve200is disposed and contained within the slider part550. The valve200is thus carried by the slider part550and therefore, when the slider part550slides relative to the main body510, the position of the valve200relative to the main body510likewise changes. Much like the device100, the slider part550is open at both of its ends and therefore, the valve200is positioned adjacent an end opening of the slider part550(similar to end112of device100). The valve200in device500can have the same characteristics as the valve200in device100and thus moves between an open and closed position. In the at rest position prior to actuation, the valve200is closed as shown inFIG.11with the distal free end522of the actuator tube520being adjacent but not breaching the valve200.

To actuate the device500, as shown inFIGS.12and13, the user pulls the slider part550toward the main body510and this causes the compression of the spring (not shown for ease of illustration) (resulting in the spring storing energy) and the sliding of the slider part550over the main body510causes the actuator tube520to be driven through the valve200(similar to the opening of the valve200of device100). The actuator tube520thus opens the valve200and is placed in fluid communication with the end opening of the slider part550to allow insertion of a tool through the slider part550into and through the actuator tube520to and through the catheter access section130. The slot557accommodates the connector branch140and the first finger support530, while the slot559accommodates the second finger support540when the slider part550slides over the main body510.

To return the valve200to the closed position, the user simply releases the slider part550and the spring565releases its stored energy causing the extension of the slider part550relative to the main body510. This action in effect causes the actuator tube520to slide out of engagement with the valve200and the valve200automatically closes.

Unlike conventional hemostasis valve devices, the actuator is designed to operate from the inside out in that an external element that is outside the valve devices is moved from the outside to the inside of the device to open the valve. The devices100,500disclosed herein have the direct opposite constructions and functionality in that the valve is opened by moving an internal part from the inside out.

Exemplary Method of Use

One exemplary method of use of the device100includes the performance of the following steps. The distal end114of the device100is connected to the proximal end of a primary guiding catheter (not shown). The valve (gasket)200is opened by the actuator300with the application of external perpendicular (pressing) force upon the external (exposed) arc shaped sections (leaf springs330,340) of the actuator300. The internal lumen of the device100is flushed with normal saline to remove air bubbles by connecting the top wall end of the bifurcated proximal component device (identified at140) to a syringe full of saline. The entire device100can be filled with saline.

The valve200closes when the perpendicular pressing force upon the leaf springs330,340of the actuator300is released.

Perpendicular force upon the arch mechanism (leaf springs330,340) is used to open the valve200and a secondary (internal) guiding catheter is introduced through the proximal end112of the device100. While maintaining perpendicular force, the entire secondary guiding catheter is fed through the device100until reaching the area of therapeutic benefit. Perpendicular force is removed, closing the valve200around the secondary guiding catheter as needed.

At the end of the procedure, the hemostatic valve200is opened by including perpendicular force upon the leaf springs330,340, and all guiding catheters are removed.

It will be appreciated that when pushing in the arch mechanism (leaf springs330,340) completely, blood and other fluids leak from the patient. Minimizing blood loss during endovascular procedures is important. With multiple insertions, extractions, and exchanges of catheters and wires, small blood loss in each step can be significant. The present system and device100are designed to minimize blood loss by reducing valve opening/closing time while providing a continuous flush system.

The quick access system also reduces the possibility of blood stagnation within the guide catheter, reducing the risk of thromboembolism. One of the problems with some conventional hemostasis valve is that they are cumbersome to operate, taking a long time to open and close due to hand position during the compression of the mechanism. The present device100allows a natural perpendicular (to the device100) pushing in and out of a mechanism (actuator300) instead of an inadequate parallel (to the device100) pushing move. The present disclosure thus describes an ergonomic method for hemostasis valve actuation and catheter manipulation which requires a singular hand grip and no changes to hand position during the entirety of a procedure.

The physician holds the device100with one hand between the thumb and index finger at the main body110. The required holding position facilitates two functions. A first function is the actuation of the luminal valve200via a squeezing force at350orthogonal to the longitudinal axis of the device100. The second function is to advance or rotate the catheter. Previous technologies require frequent shifts in hand position in order to perform each of these tasks. The present method and device100facilitate each task without any hand shift or movement between them.

Actuation opens the lumen which allows either fluid or a catheter to freely move along the axis of the device100. The present system (device100) provides a novel method of use that reduces the amount of time the device100remains in the open actuated position during a procedure, thereby minimizing blood loss. With multiple insertions, extractions, and exchanges of catheters and wires, small blood loss in each step can be significant. The quick access system also reduces the possibility of blood stagnation within the guide catheter, reducing the risk of thromboembolism.