Method and apparatus for percutaneously accessing a pressure activated implanted port

Abstract

Methods and apparatus for percutaneously accessing an implanted port using an access tube which is periodically introduced to the implanted port. The apparatus is preferably an implantable port having a pressure-responsive valve element. It has been found that repeated passage of the access tube through the same tissue tract to the implantable port reduces patient trauma, with minimized bleeding and reduction in sensitivity. The tract may be initially formed by percutaneously placing a penetrating element through intact skin to the port and leaving the element in place for a time sufficient to created the tract.

1 . An implantable port comprising: 
 a body having a flow passage therethrough, said flow passage having an upstream end and a downstream end, wherein at least a portion of the upstream end is adapted to sealingly engage an access tube which is inserted into said upstream end;    a pressure-responsive valve element positioned in the flow passage and integrally formed with the port body downstream from the upstream portion so that an access tube can be fully inserted into said upstream portion without engaging the valve component, wherein the valve component is closed in the absence of a differential pressure above a threshold level; and    a cannula connected at a proximal end of the flow passage and having a distal end adapted to connect to a blood vessel.    
   
   
       2 . An implantable port as in  claim 1 , wherein said port body comprises a housing and a housing insert coupled to said housing.  
   
   
       3 . An implantable port as in  claim 2 , wherein the pressure-responsive valve element is integrally formed in the housing insert.  
   
   
       4 . An implantable port as in  claim 2  wherein said insert comprises a compliant material defining a portion of the flow passage.  
   
   
       5 . An implantable port as in  claim 2  wherein said portion of the upstream end of the housing adapted to sealingly engage the access tube has a radial stiffness greater than a radial stiffness of said access tube.  
   
   
       6 . An implantable port as in  claim 2  wherein said housing comprises stainless steel.  
   
   
       7 . An implantable port as in  claim 2  wherein the housing defines a first portion of the passage and the insert defines a second portion of the passage.  
   
   
       8 . An implantable port as in  claim 7  wherein the first portion of the passage has a distal opening with a diameter smaller than a diameter of the access tube.  
   
   
       9 . An implantable port as in  claim 1 , wherein the downstream end of the flow passage is disclosed at about a 90° angle relative to the upstream end which receives the access tube.  
   
   
       10 . An implantable port as in  claim 1  wherein the passage does not have a needle guide channel coupled to the body and upstream of the upstream end of the passage.  
   
   
       11 . An implantable port as in  claim 1 , wherein said valve element comprises a pressure-responsive slit valve.  
   
   
       12 . An implantable port as in  claim 1 , wherein said valve element comprises an articulating, pressure-responsive leaflet valve.  
   
   
       13 . An implantable port as in  claim 1 , wherein the threshold valve of the differential pressure is between about 0.25 and 25.0 psi.  
   
   
       14 . A kit comprising: 
 a subcutaneously implantable port according to  claim 1;     instructions for implanting the port comprising implanting a port in a subcutaneous tissue pocket, wherein an access cannula-receiving aperture of the port is disposed beneath an intact region of skin, and introducing a penetrating element through the intact region of skin into the aperture, wherein the element remains anchored in the aperture for a time sufficient to create an access tract; and    a package adapted to contain the port and the instructions for use.    
   
   
       15 . A kit as in  claim 14 , further comprising a penetrating element.  
   
   
       16 . A kit as in  claim 15 , wherein the penetrating element comprises a syringe needle.