Gamma-stable high pressure stopcock

Abstract

A medical stopcock is provided that is constructed and arranged to withstand high pressures and gamma irradiation. The stopcock generally includes a housing and a valve member. The valve member is trapped within the housing so that, when subjected to relatively high pressures, the valve member is unlikely to become separated from the housing. A handle member is attached to the valve member and allows the valve member to be rotated from open to closed positions. In some preferred embodiments, the handle member locks the valve member within the housing, when attached. All of the components are constructed of gamma-stable materials so that the stopcock may be sterilized, in its package, using gamma irradiation.

1 - 39 . (canceled)  
   
   
       40 . A stopcock, comprising: 
 a housing constructed from gamma-susceptible material defining an inlet port, at least one outlet port, and an interior cavity having an inner diameter and open at two opposing ends;    a valve member constructed from gamma-stable material rotatably contained within said interior cavity, defining a passage alignable with said ports, and having:    an outer diameter less than said inner diameter; and    a handle member, attached to an opposite end of said valve member, constructed and arranged to allow rotation of said valve member and to prevent said valve member from becoming separated from said housing;    wherein said housing forms a seal with said valve member and said valve member is retained within said housing after exposure of said housing to gamma radiation.    
   
   
       41 . The stopcock of  claim 40  further comprising a weld connecting said handle member to said valve member.  
   
   
       42 . The stopcock of  claim 40  further comprising a pin connecting said handle member to said valve member.  
   
   
       43 . The stopcock of  claim 41  wherein said weld comprises an ultrasonic weld.  
   
   
       44 . The stopcock of  claim 40  further comprising an adhesive connecting said handle member to said valve member.  
   
   
       45 . The stopcock of  claim 40  wherein said housing comprises a material selected from the group: acetal and ABS.  
   
   
       46 . The stopcock of  claim 40  wherein said handle member comprises a material selected from the group: acetal and ABS.  
   
   
       47 . The stopcock of  claim 40 , further comprising a stop at an end of said valve member extending radially therefrom; wherein said stop is rendered unable to pass through said interior cavity after exposure of said housing to gamma radiation.  
   
   
       48 . The stopcock of  claim 40  wherein said valve member comprises a material selected from the group: polyesters, PETG, polycarbonate, polycarbonate alloys, polysulfone, polyurethane, PEKK, PEEK, PAEK, polyetherimide, thermosets, polyamides, and flouroplastics other than PTFE and FEP.  
   
   
       49 . The stopcock of  claim 48  wherein said thermosets comprise the group: polyimides, polyurethanes, and polyesters.  
   
   
       50 . The stopcock of  claim 40  wherein said handle member and said valve member are made of the same material.  
   
   
       51 . The stopcock of  claim 47  wherein said handle member and said valve member are made of the same material.  
   
   
       52 . The stopcock of  claim 40  further comprising a flange, extending from the housing, providing a gripping area.  
   
   
       53 . The stopcock of  claim 47  further comprising a flange, extending from the housing, providing a gripping area.  
   
   
       54 . The stopcock of  claim 52  wherein said flange is integral with the housing.  
   
   
       55 . The stopcock of  claim 53  wherein said flange is integral with the housing.  
   
   
       56 . The stopcock of  claim 40  wherein said seal is formed by shrinkage of said housing member.  
   
   
       57 . The stopcock of  claim 47  wherein said valve member is rendered unable to pass due to shrinkage of said housing after exposure of said housing to gamma radiation.  
   
   
       58 . The stopcock of  claim 40  wherein said seal is formed when said inner diameter is substantially equal to said outer diameter.  
   
   
       59 . The stopcock of  claim 47  wherein said valve member is rendered unable to pass when said stop extends beyond the dimension of said inner diameter.  
   
   
       60 . A stopcock comprising: 
 a housing constructed from gamma-susceptible material and defining an inlet port, at least one outlet port, and an interior cavity having an inner diameter and open at two opposing ends; and    a valve member constructed from gamma-stable material, said valve member rotatably contained within said cavity and defining a passage alignable with said ports;    wherein said housing assumes at least one desired final dimension after exposure to gamma radiation.    
   
   
       61 . The stopcock of  claim 60 , further comprising a stop operably attached to an end of said valve member, constructed and arranged to prevent said valve member from passing completely through the said cavity of said housing.  
   
   
       62 . The stopcock of  claim 60 , further comprising a handle member, operably attached to an end of said valve member, constructed and arranged to allow rotation of said valve member and to prevent said valve member from becoming separated from said housing.  
   
   
       63 . The stopcock of  claim 60  wherein the at least one outlet port comprises one outlet port.  
   
   
       64 . The stopcock of  claim 60  wherein the at least one outlet port comprises two outlet ports.  
   
   
       65 . The stopcock of  claim 61  wherein said stop extends radially from the valve member.  
   
   
       66 . The stopcock of  claim 60  wherein said desired final dimension of said housing is the diameter of said cavity.  
   
   
       67 . The stopcock of  claim 62 , wherein said desired final dimension of said housing is the diameter of said cavity, and wherein said diameter is smaller than the corresponding dimension of said stop.  
   
   
       68 . The stopcock of  claim 60  wherein the interior cavity of said housing dimension is substantially equal to the outer dimension of said valve member.  
   
   
       69 . The stopcock of  claim 61  wherein the interior cavity of said housing dimension is substantially equal to the outer dimension of said valve member.  
   
   
       70 . The stopcock of  claim 62  wherein the interior cavity of said housing dimension is substantially equal to the outer dimension of said valve member.  
   
   
       71 . The stopcock of  claim 60  wherein said final dimension of said housing forms a seal with said valve member.  
   
   
       72 . The stopcock of  claim 61  wherein said housing having said final dimension housing forms a seal with said valve member.  
   
   
       73 . The stopcock of  claim 62  wherein said final dimension of said housing forms a seal with said valve member.  
   
   
       74 . The stopcock of  claim 60  wherein said valve member comprises a material selected from the group: polyesters, PETG, polycarbonate, polycarbonate alloys, polysulfone, polyurethane, PEKK, PEEK, PAEK, polyetherimide, thermosets, polyamides, and flouroplastics other than PTFE and FEP.  
   
   
       75 . The stopcock of  claim 61  wherein said valve member comprises a material selected from the group: polyesters, PETG, polycarbonate, polycarbonate alloys, polysulfone, polyurethane, PEKK, PEEK, PAEK, polyetherimide, thermosets, polyamides, and flouroplastics other than PTFE and FEP.  
   
   
       76 . The stopcock of  claim 62  wherein said valve member comprises a material selected from the group: polyesters, PETG, polycarbonate, polycarbonate alloys, polysulfone, polyurethane, PEKK, PEEK, PAEK, polyetherimide, thermosets, polyamides, and flouroplastics other than PTFE and FEP.  
   
   
       77 . A stopcock comprising: 
 a valve member of a first gamma-stable material having a longitudinal axis and a passage therethrough transverse to said longitudinal axis;    a housing of a gamma-susceptible material defining an inner cavity for the valve member, the housing having at least one open end and defining at least one inlet port and at least one outlet port, the ports alignable with said passage;    wherein the valve member has varying circular cross-sectional areas measured in planes perpendicular to the longitudinal axis, cross-sectional areas toward a middle of the valve member being greater than the cross-sectional areas toward ends of the valve member, and said inner cavity is sized to accept passage of the valve member during assembly; and    wherein the inner cavity assumes a shape that conforms to the valve member through exposure to gamma radiation such that the housing and the valve member are shaped to allow rotation of the valve member around the longitudinal axis, relative to the housing, and to prevent movement in either direction along the longitudinal axis, relative to the housing.    
   
   
       78 . The stopcock of  claim 77  wherein said housing further comprises a closed end, wherein the open end defines an opening having a cross-sectional area substantially equal to the cross-sectional areas toward the middle of the valve member before gamma irradiation and a cross-sectional area smaller than the cross-sectional areas toward the middle of the valve member after gamma irradiation.  
   
   
       79 . A stopcock, comprising: 
 a valve housing; and    a valve member placed inside the valve housing, such that when the stopcock is exposed to gamma irradiation, the valve housing assumes a final dimension relative to the valve member.    
   
   
       80 . The stopcock of  claim 79 , wherein the valve housing is constructed from gamma-susceptible material.  
   
   
       81 . The stopcock of  claim 79 , wherein the valve member is constructed from gamma-stable material.  
   
   
       82 . The stopcock of  claim 79 , wherein the valve housing shrinks to form a seal with the valve member upon exposure of the stopcock to gamma irradiation.  
   
   
       83 . The stopcock of  claim 79 , wherein the valve housing defines an inlet port, at least one outlet port, and an interior cavity.