Safety catheter

Abstract

A device and method for positioning a catheter to establish a fluid access site into the vasculature of a patient includes a luer assembly having a cannula or catheter, a shuttle assembly having a stylet for stiffening the catheter, and a holder assembly having an actuator for providing controlled retraction into a handle. The safety catheter comprises a flash window that allows a clinician to view when the vasculature of a patient has been properly accessed and to confirm that the stylet has been fully retracted into a safe position.

1 . A method for manufacturing an actuator for separating a luer assembly from a shuttle assembly while maintaining a stationary engagement of the shuttle assembly with a handle, and for subsequently retracting the shuttle assembly into a hollow chamber of the handle, the actuator comprising the steps of:
 mounting a base member on the handle for linear movement along a longitudinal axis of the handle between a proximal position and a distal position;   affixing a pair of opposed rails onto the base member, wherein the pair of opposed rails are aligned substantially parallel to each other and extend distally from the base member in an axial direction, wherein, as the actuator is moved from its proximal position to its distal position, the rails urge against the luer assembly to disengage the luer assembly from the shuttle assembly while the base member holds the handle on the shuttle assembly; and   mounting a pair of opposed living hinges on the base member at a radial distance therefrom, wherein the living hinges interact with the handle and are compressed during a distal movement of the actuator to bias the actuator for a return back into its proximal position, and wherein a return of the actuator to its proximal position releases the engagement of the handle with the shuttle assembly for a retraction of the shuttle assembly into the chamber of the handle.   
     
     
         2 . A method as recited in  claim 1  wherein the base member is annular shaped and is centered on the axis to override the resilient fingers of the handle when the actuator is moved from its proximal position to its distal position. 
     
     
         3 . A method as recited in  claim 1  wherein each living hinge is substantially “Y” shaped with a pair of splayed arms, and wherein the bias of the living hinge is created when the arms are forced toward each other by structure on the handle during a movement of the actuator toward its distal position, and further wherein each living hinge is positioned at a radial distance from the axis, and each living hinge has a first arm and a second arm, and wherein the actuator further comprises:
 a first arcuate band interconnecting the respective first ends of each living hinge; and 
 a second arcuate band interconnecting the respective second ends of each living hinge, wherein the first and second arcuate bands move from the radial distance and toward the axis during a movement of the actuator toward its distal position for engagement with respective stops on the handle to prevent further movement of the actuator in a distal direction. 
 
     
     
         4 . A method as recited in  claim 1  further comprising the step of connecting a dorsal pad to the base member for manipulation of the actuator. 
     
     
         5 . A method as recited in  claim 1  further comprising the step of positioning a compressed spring between the shuttle assembly and the handle for retracting the shuttle assembly into the hollow chamber of the handle when the actuator is returned from its distal position to its proximal position. 
     
     
         6 . A method for assembling and operating a safety catheter, wherein the safety catheter comprises an actuator, a handle formed with a chamber and with a plurality of resilient fingers extending distally on the handle away from the chamber, a shuttle assembly with a stylet, and a luer assembly with a cannula, the method comprising the steps of:
 engaging the plurality of resilient fingers of the handle against the shuttle assembly;   positioning the luer assembly over the fingers of the handle, with the fingers between the luer assembly and shuttle assembly, to hold the fingers against the shuttle assembly and to maintain the shuttle assembly in a distal position relative to the chamber in the handle with the stylet of the shuttle assembly inserted into the cannula of the luer assembly to stiffen the cannula; and   locating the actuator in a proximal position on the handle for gripping the luer assembly, to hold the luer assembly in a stationary engagement with the shuttle assembly and with the handle, during an operation of the safety catheter.   
     
     
         7 . A method as recited in  claim 6  wherein the actuator is formed with an annular shaped base member and wherein the locating step requires positioning the base member on the handle with the base member centered on the longitudinal axis of the handle. 
     
     
         8 . A method as recited in  claim 7  wherein the actuator is formed with a pair of opposed rails extending in parallel from the base member in a distal direction. 
     
     
         9 . A method as recited in  claim 8  further comprising the steps of:
 inserting the stiffened cannula into a target tissue; and 
 pressing the actuator to move the actuator in a distal direction from its proximal position to a distal position. 
 
     
     
         10 . A method as recited in  claim 9  wherein the pressing step simultaneously accomplishes the steps of:
 further advancing the stiffened cannula into the target tissue; 
 urging the rails of the actuator against the luer assembly to separate the luer assembly from the shuttle assembly; and 
 moving the base member over the fingers of the handle to maintain the hold of the handle fingers against the shuttle assembly. 
 
     
     
         11 . A method as recited in  claim 9  wherein the actuator includes a pair of opposed living hinges mounted at a radial distance outwardly from the base member, and wherein the pressing step further accomplishes the steps of:
 compressing the living hinges through an interaction of the living hinges with the handle during a distal movement of the actuator on the handle; and 
 biasing the actuator during the compressing step for a subsequent proximal movement of the actuator. 
 
     
     
         12 . A method as recited in  claim 11  further comprising the step of releasing the actuator for a return of the actuator back into its proximal position. 
     
     
         13 . A method as recited in  claim 12  wherein the releasing step simultaneously accomplishes the steps of:
 removing the hold of the base member on the fingers of the handle to separate the shuttle assembly from the handle; and 
 allowing the shuttle assembly to be retracted into the chamber of the handle with a consequent withdrawal of the stylet from the cannula. 
 
     
     
         14 . A method as recited in  claim 13  wherein the retraction of the shuttle assembly into the chamber of the handle is accomplished by a spring, wherein the spring is compressed between the handle and the shuttle assembly during the assembly of the safety catheter. 
     
     
         15 . A method for using a safety catheter which comprises the steps of:
 inserting a stiffened cannula of a luer assembly into target tissue, wherein the cannula is stiffened by a stylet of a shuttle assembly, and wherein the shuttle assembly is mounted on a handle;   pressing an actuator to further move the actuator in a distal direction, wherein the distal movement of the actuator separates the luer assembly from the shuttle assembly while holding the shuttle assembly stationary on the handle and maintaining the stylet in the cannula; and   selectively releasing the actuator after the pressing step to remove the hold of the handle on the shuttle assembly to allow a retraction of the shuttle assembly into a hollow chamber of the handle while leaving the cannula with the luer assembly in contact with the target tissue.   
     
     
         16 . A method as recited in  claim 15  wherein the actuator comprises an annular shaped base member, a pair of opposed rails extending in parallel from the base member in a distal direction, and a pair of opposed living hinges mounted at a radial distance outwardly from the base member, and wherein the handle is formed with a hollow chamber and comprises a plurality of resilient fingers extending distally on the handle away from the chamber, and further wherein the pressing step is accomplished manually to move the actuator in a distal direction on the handle from a proximal position to a distal position. 
     
     
         17 . A method as recited in  claim 16  wherein the pressing step simultaneously accomplishes the steps of:
 further advancing the stiffened cannula into the target tissue; 
 urging the rails of the actuator against the luer assembly to separate the luer assembly from the shuttle assembly; and 
 moving the base member over the fingers of the handle to maintain the hold of the handle fingers against the shuttle assembly. 
 
     
     
         18 . A method as recited in  claim 17  wherein the actuator includes a pair of opposed living hinges mounted at a radial distance outwardly from the base member, and wherein the pressing step further accomplishes the steps of:
 compressing the living hinges through an interaction of the living hinges with the handle during a distal movement of the actuator on the handle; and 
 biasing the actuator during the compressing step for a subsequent proximal movement of the actuator. 
 
     
     
         19 . A method as recited in  claim 18  further comprising the step of releasing the actuator for a return of the actuator back into its proximal position. 
     
     
         20 . A method as recited in  claim 19  wherein the releasing step simultaneously accomplishes the steps of:
 removing the hold of the base member on the fingers of the handle to separate the shuttle assembly from the handle; and 
 allowing the shuttle assembly to be retracted into the chamber of the handle with a consequent withdrawal of the stylet from the cannula.