Sealing valve assembly for medical products

Abstract

A sealing valve assembly is provided for medical products. The valve assembly includes a valve member mountable within a passageway of a medical product body element, the valve member defining a peripheral portion spaced from a central axis and including two walls extending from the peripheral portion toward the central axis. The walls include ends that contact each other to preclude flow through the passageway. The valve member may be formed of a material having a durometer of less than about 20 Shore A. The valve member may also have a higher durometer material with other wall configurations, or may have a wall member having a varying durometer.

1 . A medical product defining a fluid path, the medical product comprising a valve assembly disposed in the path, the valve assembly comprising: 
 a valve housing defining an opening having a central axis, the opening extending through the valve housing such that the opening forms part of the fluid path through the medical product;    a valve member disposed within the opening, the valve member having a single seal interface defined by at least two opposing flexible walls biased towards each other to a sealing position, the valve member having a peripheral portion with the opposing flexible walls extending from the peripheral portion toward the central axis, the opposing flexible walls including ends that contact each other along the single seal interface; and    at least one of the flexible walls defining a cross-section that tapers to a thickness at its respective end of about 10% to about 30% of its thickness extending from the peripheral portion.    
   
   
       2 . The medical product as in  claim 1 , wherein the valve member is formed of a material having a durometer of about 50 Shore A or less.  
   
   
       3 . The medical product as in  claim 1 , wherein the valve member is formed of a material having a durometer of less than about 20 Shore A.  
   
   
       4 . The medical product as in  claim 1 , wherein the at least one wall tapers continuously in a direction towards its respective end.  
   
   
       5 . The medical product as in  claim 1 , wherein the at least one wall changes thickness discontinuously in a direction towards its respective end.  
   
   
       6 . The medical product as in  claim 1 , wherein the at least one flexible wall tapers in thickness from about 0.005 to about 0.010 inches at its respective end to about 0.040 inches at a location spaced from the respective end.  
   
   
       7 . The medical product as in  claim 1 , wherein the medical product is a gastrostomy catheter, the fluid path defined between a patient's body cavity and an exterior of the body.  
   
   
       8 . A medical product defining a fluid path, the medical product comprising a valve assembly disposed in the path, the valve assembly comprising: 
 a valve housing defining an opening having a central axis, the opening extending through the valve housing such that the opening forms part of the fluid path through the medical product;    a valve member disposed within the opening, the valve member having a single seal interface defined by at least two opposing flexible walls biased towards each other to a sealing position, the valve member having a peripheral portion with the opposing flexible walls extending from the peripheral portion toward the central axis, the opposing flexible walls including ends that contact each other along the single seal interface; and    at least one of the flexible opposing walls defining an overlapping portion extending at an angle to the at least one wall for overlapping a portion of another wall adjacent its respective end.    
   
   
       9 . The medical product as in  claim 8 , wherein the valve member is formed of a material having a durometer of about 50 Shore A or less.  
   
   
       10 . The medical product as in  claim 8 , wherein the valve member is formed of a material having a durometer of less than about 20 Shore A.  
   
   
       11 . The medical product as in  claim 8 , wherein the overlapping portion of the at least one wall extends substantially parallel to the other wall.  
   
   
       12 . The medical product as in  claim 8 , wherein the walls have a thickness of about 0.040 inches.  
   
   
       13 . The medical product as in  claim 8 , wherein the medical product is a gastrostomy catheter, the fluid path defined between a patient's body cavity and an exterior of the body.  
   
   
       14 . A medical product defining a fluid path, the medical product comprising a valve assembly disposed in the path, the valve assembly comprising: 
 a valve housing defining an opening having a central axis, the opening extending through the valve housing such that the opening forms part of the fluid path through the medical product;    a valve member disposed within the opening, the valve member having a single seal interface defined by at least two opposing flexible walls, the valve member having a peripheral portion with the opposing flexible walls extending from the peripheral portion toward the central axis, the opposing flexible walls including ends that contact each other along the single seal interface; and    a stiffening member located on one of the opposing flexible walls, wherein the stiffening member remains free from contact with the valve housing when the valve member is in the closed position, and wherein the stiffening member remains free from contact with the valve housing when the valve member is in the open position.    
   
   
       15 . The medical product as in  claim 14 , wherein a pair of stiffening members are present on the valve member such that one stiffening member is located on one of the opposing flexible walls and the other stiffening member is located on the other one of the opposing flexible walls, wherein the stiffening members remain free from contact with the valve housing when the valve member is in the closed position, and wherein the stiffening members remain free from contact with the valve housing when the valve member is in the open position.  
   
   
       16 . The medical product as in  claim 14 , wherein the valve member and the stiffening member are integrally formed with one another.  
   
   
       17 . The medical product as in  claim 14 , wherein the stiffening member has an arcuate surface.  
   
   
       18 . The medical product as in  claim 14 , wherein the valve member is at least partially made from a material that has a durometer value of less than 10 Shore A.  
   
   
       19 . The medical product as in  claim 18 , wherein the valve member is at least partially made from a material that has a durometer value between about 8 Shore A to less than 10 Shore A.  
   
   
       20 . The medical product as in  claim 14 , wherein the medical product is a gastrostomy catheter, the fluid path defined between a patient's body cavity and an exterior of the body.