US2023321421A1PendingUtilityA1

Hemostasis valve device

Assignee: MERIT MEDICAL SYSTEMS INCPriority: Dec 14, 2020Filed: Jun 12, 2023Published: Oct 12, 2023
Est. expiryDec 14, 2040(~14.4 yrs left)· nominal 20-yr term from priority
A61M 39/0613A61M 2039/064A61M 39/0693A61M 2039/062A61M 2039/0673
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
1 . A hemostasis valve device comprising:
 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;   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; and   an actuator disposed between the valve member and the open second end, the actuator being configured to move the valve member between the open position and the closed position.   
     
     
         2 . The hemostasis valve device of  claim 1 , wherein the valve body further includes a hollow side port that extends radially outward from the valve body so as to define a Y-shaped structure, the hollow side port having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member. 
     
     
         3 . (canceled) 
     
     
         4 . The hemostasis valve device of  claim 2 , wherein a portion of the actuator that is accessible by a user is located between the hollow side port and the open second end of the valve body. 
     
     
         5 . The hemostasis valve device of  claim 1 , wherein 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, and
 wherein the force that is applied is perpendicular a longitudinal axis of the valve body.   
     
     
         6 . (canceled) 
     
     
         7 . The hemostasis valve device of  claim 5 , wherein the actuator includes a first portion that is exposed along the side of the valve body and a second portion that contacts the valve member to open the valve member, and
 wherein the first portion of the actuator comprises a biased part that moves between an extended position and a collapsed position and the second portion comprises an elongated hollow driven pin that upon actuation of the actuator is driven into contact with the valve member to cause an opening thereof, thereby fluidly connecting the open first end and the open second end of the valve body and upon retraction of the elongated hollow driven pin, the valve member seals and returns to the closed position.   
     
     
         8 . (canceled) 
     
     
         9 . The hemostasis valve device of  claim 7 , wherein the first portion includes a first spring and a second spring, the first and second springs being radially positioned around and symmetric about the longitudinal axis of the valve body. 
     
     
         10 . The hemostasis valve device of  claim 9 , wherein the first spring and the second spring comprise leaf springs. 
     
     
         11 . The hemostasis valve device of  claim 1 , wherein the valve body has one or more side openings through which at least a first portion of the actuator extends to allow the actuator to be accessible and contactable along a side of the valve body, the one or more side openings being in fluid communication with the main lumen and therefore the actuator is fluidly sealed relative to the valve body and about the one or more side openings,
 wherein the one or more side openings comprises a pair of opposing side openings and the first portion of the actuator comprises a first biased element and a second biased element that are operatively coupled to the valve member such that when the first biased element and the second biased element are relaxed to a relaxed position, the valve member is closed and when the first biased element and the second biased element are compressed to a compressed position and store energy, the valve member is in the open position,   wherein the first biased element and the second biased element are coupled to an elongated hollow driven pin that is driven into contact with the valve member to cause an opening thereof when the first biased element and the second biased element move from the relaxed position to the compressed position and conversely, when the first biased element and the second biased element return to the relaxed position, the elongated hollow driven pin retracts relative to the valve member for closing thereof.   
     
     
         12 - 14 . (canceled) 
     
     
         15 . The hemostasis valve device of  claim 11 , wherein a first end of each of the first biased element and the second biased element is fixedly coupled to the valve body and an opposite second end of each of the first biased element and the second biased element is fixedly coupled to the elongated hollow driven pin. 
     
     
         16 . The hemostasis valve device of  claim 1 , wherein the actuator comprises a dual sided actuator that is accessible along opposite sides of the valve body. 
     
     
         17 . The hemostasis valve device of  claim 1 , wherein the actuator comprises a first portion that moves in a first direction and a second portion that moves in a second direction, the second direction being a direction that is different than the first direction and is along a longitudinal direction along the main lumen. 
     
     
         18 . The hemostasis valve device of  claim 17 , wherein the first direction is perpendicular to the second direction. 
     
     
         19 . (canceled) 
     
     
         20 . The hemostasis valve device of  claim 1 , wherein the valve member comprises an elastomeric gasket,
 wherein the elastomeric gasket has a side wall and a membrane extending between the side wall, the membrane having a slit formed therein, wherein in the open position, the slit is open and in the closed position, the slit is closed, and   wherein the side wall of the gasket is sealingly fixed to an inner surface of the valve body.   
     
     
         21 - 22 . (canceled) 
     
     
         23 . The hemostasis valve device of  claim 1 , further including an elastomeric cover that surrounds the actuator and is fluidly sealed to the valve body. 
     
     
         24 . The hemostasis valve device of  claim 1 , wherein 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. 
     
     
         25 . The hemostasis valve device of  claim 1 , wherein the valve body includes a first finger support along a side of the valve body and a second finger support along an opposite side of the valve body,
 wherein the actuator is disposed between: (1) the first finger support and second finger support and (2) the open second end of the valve body, and   wherein the valve body further includes a hollow side port that extends radially outward from the valve body, the hollow side port having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member, wherein the first finger support is integrally formed as part of the hollow side port.   
     
     
         26 - 27 . (canceled) 
     
     
         28 . A hemostasis valve device comprising:
 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;   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 disposed between the valve member and the open second end, the actuator being movable between a first position in which the valve member is in the closed position and a second position in which the valve member is in the open position; and a cover that surrounds the actuator and is fluidly sealed to the valve body.   
     
     
         29 . The hemostasis valve device of  claim 28 , wherein the valve body has one or more side openings through which at least a first portion of the actuator extends to allow the actuator to be accessible along a side of the valve body, the one or more side openings being in fluid communication with the main lumen, the cover being fluidly sealed to the valve body such that the one or more side openings lie within the cover, and
 wherein the one or more side openings comprises a pair of opposing side openings and the first portion of the actuator comprises a first biased element and a second biased element that are operatively coupled to the valve member such that when the first biased element and the second biased element are relaxed in the first position of the actuator, the valve member is closed and when the first biased element and the second biased element are compressed in the second position of the actuator, the valve member is in the open position.   
     
     
         30 . (canceled) 
     
     
         31 . A hemostasis valve device comprising:
 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;   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 disposed between the valve member and the open second end, the actuator being movable between a first position in which the valve member is in the closed position and a second position in which the valve member is in the open position, the actuator being configured to translate an applied force that is perpendicular to a longitudinal axis of the main lumen into a longitudinal force that causes the valve member to open.   
     
     
         32 . The hemostasis valve device of  claim 31 , wherein the actuator includes 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. 
     
     
         33 - 34 . (canceled)

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