Soft-grip medical connector

Abstract

A soft grip medical connector comprises a housing with an upstream end, a downstream end and a lumen extending through a central portion thereof. A flexible member comprises a valve portion integrally formed with a sleeve portion. The valve portion is positioned within a section of the housing and is configured to control a flow of fluid through the housing lumen. The sleeve is inverted to envelope at least a portion of the outer surface of the housing. In some embodiments the gripping portion is integrally formed with the valve portion. In some embodiments, the connector is also generally configured to create a positive pressure in a catheter lumen upon removal of a syringe or other medical device from the upstream end of the connector. Methods of making a medical fluid connector generally comprise forming a valve member with a sleeve extending there from, and assembling the valve, sleeve and housing.

1 . A soft grip medical connector comprising: 
 a housing with an upstream end, a downstream end and a lumen extending through a central portion thereof;    a flexible member having a valve portion integrally formed with a gripping portion, the valve portion being positioned within a portion of the housing and configured to control a flow of fluid through the housing lumen, and the gripping portion substantially surrounding at least a portion of an outer surface of the housing.    
   
   
       2 . The connector of  claim 1 , wherein the housing comprises a substantially hourglass-shaped profile  
   
   
       3 . The connector of  claim 1 , wherein the housing comprises an upstream housing portion containing the flexible member and a downstream housing portion configured to be mateably coupled to the upstream housing portion.  
   
   
       4 . The connector of  claim 3 , wherein an end of the gripping portion of the flexible member is retained between the upstream housing portion and the downstream housing portion when the upstream housing portion and the downstream housing portion are coupled.  
   
   
       5 . The connector of  claim 1 , wherein the housing comprises a generally cylindrical member having a pair of slots oriented at about 180° with respect to one another.  
   
   
       6 . The connector of  claim 5 , wherein the housing further comprises a plurality of rings extending radially from an outer surface of the cylindrical portion.  
   
   
       7 . The connector of  claim 6 , wherein the gripping portion comprises structures which engage the rings to limit movement of the gripping portion relative to the housing.  
   
   
       8 . The connector of  claim 1 , wherein the housing comprises protrusions on an upper portion thereof, the protrusions configured to engage internal threads of a Luer connector for securing a medical device to an upstream end of the connector.  
   
   
       9 . The connector of  claim 8 , wherein the gripping portion comprises windows configured to surround the protrusions.  
   
   
       10 . The connector of  claim 1 , wherein the housing is constructed of a polycarbonate material.  
   
   
       11 . The connector of  claim 1 , wherein the housing is constructed of a glass-reinforced thermoplastic polyester resin.  
   
   
       12 . The connector of  claim 1 , wherein the connector comprises a substantially hourglass-shaped profile.  
   
   
       13 . The connector of  claim 1 , wherein the flexible member is made of silicone rubber.  
   
   
       14 . The connector of  claim 1 , wherein the flexible member comprises features arranged to interact with features of the housing in order to limit movement of the flexible member relative to the housing.  
   
   
       15 . The connector of  claim 1 , wherein at least a portion of the housing further comprises at least one vent between an un-stretched state.  
   
   
       16 . The connector of  claim 1 , wherein the housing member further comprises at least one vent between a upper housing cavity and a Luer lock cavity in the housing.  
   
   
       17 . The connector of  claim 1 , wherein a lower surface of the housing comprises at least one vent configured to allow air flow into and out of an interior cavity within the housing when a lower portion of the connector is joined to a medical device.  
   
   
       18 . The connector of  claim 1 , wherein the valve portion comprises a planar surface at the upstream end of the housing, the planar surface having a slit therein.  
   
   
       19 . The connector of  claim 1 , wherein the flexible member is constructed of silicone rubber.  
   
   
       20 . The connector of  claim 1 , wherein the valve portion is configured to force a volume of fluid downwards through the lumen upon removal of a medical device from the upstream end of the connector.  
   
   
       21 . The connector of  claim 20 , wherein the valve portion comprises a seal element made of a flexible material, the seal element having a downstream end, an upstream end suitable for receiving at least a portion of a medical device, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end, and a neck portion positioned in a region near the upstream end, the passage being relatively wide in the region of the upstream end and the passage being relatively narrow in the region of the downstream end, the passage adapted to have a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the medical device into the upstream end of the passage, the passage adapted to retract to define a restricted flow path and a relatively small interior volume upon the withdrawal of the medical device from the seal element, at least a portion of the upstream end adapted to initially press against the inserted portion of the medical device as the medical device is withdrawn, so that a fluid occupying the interior volume is forced toward the downstream end as the passage retracts.  
   
   
       22 . The connector of  claim 21 , wherein the passage is substantially planar in the undisturbed state and the seal element further comprises at least one rib on an outer surface of the seal element, the rib extending transversely relative to the plane defined by the passage and spanning longitudinally from the region near the upstream end to the region near the downstream end.  
   
   
       23 . The connector of  claim 1 , wherein the valve portion comprises a seal element made of a flexible material, the seal element having a downstream end, an upstream end suitable for receiving at least a portion of a medical device, and a normally closed passage in fluid communication with the downstream end and the upstream end, the passage having a height being defined by a first interior wall and a second interior wall, the first interior wall and the interior wall being in sealable contact in a region near the upstream end such that the height of the passage is zero and the passage is substantially closed in an undisturbed state, and the first interior wall and the second interior wall diverging towards a region near the downstream end such that the passage has an increasing nonzero height towards the region near the downstream end.  
   
   
       24 . The connector of  claim 23 , wherein the passage has a width tapering from a maximum width at the upstream end to a minimum width at the downstream end.  
   
   
       25 . The connector of  claim 1 , wherein the flexible member comprises features arranged to interact with features of the housing in order to limit movement of the flexible member relative to the housing.  
   
   
       26 . The connector of  claim 25 , wherein the flexible member comprises windows arranged to interact with tabs on the housing.  
   
   
       27 . The connector of  claim 1 , wherein the flexible member is adhered to the housing in order to limit movement of the flexible member relative to the housing.  
   
   
       28 . The connector of  claim 1 , wherein at least a portion of the housing comprises a dimension that is larger than a corresponding dimension of the flexible member in an un-stretched state.  
   
   
       29 . A medical fluid connector comprising: 
 a cylindrical body having an outer wall with a plurality of flanges extending radially therefrom and a lumen extending through a portion thereof; and    a valve portion providing a closable seal between a first end and a second end of the cylindrical body; and    a sleeve portion unitarily formed with the valve portion and surrounding a substantial portion of an outer surface of the cylindrical body.    
   
   
       30 . The medical connector of  claim 29 , wherein the valve portion comprises wings extending through slots in the cylindrical body.  
   
   
       31 . The connector of  claim 29 , wherein the valve portion comprises a slit of substantially zero internal volume in a relaxed position.  
   
   
       32 . The connector of  claim 31 , wherein the slit is sized and configured to open upon insertion of a medical device cannula therein.  
   
   
       33 . The connector of  claim 29 , wherein the valve portion comprises a passage having an upstream end, a downstream end, a height, and a width, and wherein with the valve in an undisturbed position, the height of the passage tapers from substantially zero at the upstream end to a non-zero value at the downstream end such that the passage has a nonzero interior volume with the valve in an undisturbed position.  
   
   
       34 . A method of forming a medical device, the method comprising: 
 injecting an uncured material into a preform mold, thereby molding a first preform from a substantially flexible material;    removing the preform from the preform mold;    molding a second preform;    inserting the first preform and the second preform into a final mold; and    injecting an uncured material into the final mold, and overmolding the first and second pre-forms into a final structure having a valve portion and a sleeve portion extending there from.    
   
   
       35 . The method of  claim 33 , wherein said overmolding further comprises inserting the valve portion into a housing and inverting the sleeve portion to surround at least a portion of an outer surface of the housing.  
   
   
       36 . The method of  claim 33 , further comprising inserting a blade between the first and second preforms after said overmolding step.  
   
   
       37 . A method of making a medical fluid connector comprising: 
 forming a valve member with a sleeve extending there from, the valve and sleeve being integrally formed of a substantially flexible material;    forming a relatively rigid housing;    inserting a portion of the valve member into a cavity of the housing such that the sleeve extends from the housing member; and    inverting the sleeve to surround an outer surface of the housing member.    
   
   
       38 . The method of  claim 37 , wherein inverting the sleeve further comprises aligning features on the sleeve with features on the housing, whereby said aligned features prevent unwanted movement of the sleeve relative to the housing.  
   
   
       39 . The method of  claim 37 , wherein inverting the sleeve further comprises adhering the sleeve to the housing.  
   
   
       40 . The method of  claim 37 , wherein forming the relatively rigid housing comprises the steps of forming a first housing portion; forming a second housing portion configured to be coupled with the first housing portion; and coupling the first housing portion with the second housing portion.  
   
   
       41 . The method of  claim 37 , further comprising joining a downstream end of the housing in fluid communication with a catheter.  
   
   
       42 . The method of  claim 37 , further comprising inserting a rigid cannula into an upstream end of the valve member, thereby joining the rigid cannula and the catheter in fluid communication.