Occlusive guidewire system having an ergonomic handheld control mechanism and torqueable kink-resistant guidewire

Abstract

An occlusive guidewire system having an ergonomic handheld control mechanism and torqueable kink-resistant guidewire having a distally located inflatable balloon. The present invention provides convenient structure and overall mechanism for operation of a torqueable kink-resistant guidewire, including evacuation and inflation control of an occlusive balloon, and sealing and severing of a crimpable inflation tube which is in communication with an occlusive balloon. The torqueable kink-resistant guidewire includes a centrally located shaft which imparts robustness to the torqueable kink-resistant guidewire. An inflation lumen aligns within the torqueable kink-resistant guidewire for inflation of the balloon.

1 . An occlusive guidewire system comprising: 
 a. a handheld control mechanism, the mechanism including: 
 (1) a housing;  
 (2) an inflation syringe carried by the housing;  
 (3) an evacuation syringe carried by the housing;  
 (4) an inline inflation control valve carried by the housing and arranged in communication with the inflation syringe, the inline inflation control valve having an actuator button extending therefrom;  
 (5) an inline evacuation control valve carried by the housing and arranged in communication with the evacuation syringe, the inline evacuation control valve having an actuator button extending therefrom;  
 (6) a compression sealing mechanism for sealing a catheter to be connected to the handheld control mechanism;  
 (7) an inflation tube sealing mechanism for sealing and severing a crimpable inflation tube;  
 (8) a pressure gauge in communication with the inline inflation control valve; and,  
 (9) a four-port infusion “Y”; and,  
   b. a torqueable kink-resistant guidewire having a proximal end and a distal end, the guidewire including: 
 (1) a centrally located shaft extending between the proximal end and the distal end and having a polymer jacket extending along a portion thereof;  
 (2) a proximal crimpable inflation tube;  
 (3) a balloon at the distal end of the shaft in fluid communication with the proximal crimpable inflation tube; and,  
 (4) a distally located flexible tip.  
   
     
     
         2 . The occlusive guidewire system of  claim 1 , wherein the housing is a two-part hollow shell.  
     
     
         3 . The occlusive guidewire system of  claim 1 , wherein the housing has an upper housing half and a lower housing half.  
     
     
         4 . The occlusive guidewire system of  claim 3 , wherein the upper housing half and the lower housing half are joined at a segmented mating edge.  
     
     
         5 . The occlusive guidewire system of  claim 1 , wherein the housing is ergonomically shaped.  
     
     
         6 . The occlusive guidewire system of  claim 1 , wherein the inflation syringe is graduated.  
     
     
         7 . The occlusive guidewire system of  claim 1 , wherein the inflation syringe includes a flange and a plunger with an actuator pad passing through the flange.  
     
     
         8 . The occlusive guidewire system of  claim 7 , wherein the housing includes a syringe support bracket having a laterally oriented channel, and wherein the flange of the inflation syringe is captured in the laterally oriented channel such that at least the actuator pad of the plunger extends from the housing.  
     
     
         9 . The occlusive guidewire system of  claim 1 , wherein the evacuation syringe is graduated.  
     
     
         10 . The occlusive guidewire system of  claim 1 , wherein the evacuation syringe includes a flange and a plunger with an actuator ring.  
     
     
         11 . The occlusive guidewire system of  claim 10 , wherein the housing includes a syringe support bracket having a laterally oriented channel, and wherein the flange of the evacuation syringe is captured in the laterally oriented channel such that at least the actuator ring of the plunger extends from the housing.  
     
     
         12 . The occlusive guidewire system of  claim 1 , wherein the housing includes an arcuate extension, the arcuate extension carrying a syringe support bracket having a laterally oriented channel, and wherein the inflation syringe and the evacuation syringe each has a flange, the flanges being captured in the laterally oriented channel.  
     
     
         13 . The occlusive guidewire system of  claim 12 , wherein at least one of the inflation syringe and the evacuation syringe is graduated; and wherein the syringe support bracket, when the flanges of the inflation syringe and the evacuation syringe are captured in the laterally oriented channel, allows viewing of the at least one graduated syringe.  
     
     
         14 . The occlusive guidewire system of  claim 1 , wherein the inflation syringe is joined to the inline inflation control valve through a Luer fitting.  
     
     
         15 . The occlusive guidewire system of  claim 1 , wherein the evacuation syringe is joined to the inline evacuation control valve through a Luer fitting.  
     
     
         16 . The occlusive guidewire system of  claim 1 , wherein the actuator button of the inline inflation control valve is carried by guided near tangential close spaced support in a sheltered and recessed location on the housing, such that a conscious decision and dedicated effort is required to depress the actuator button and enable passage through the inline inflation control valve, thereby minimizing inadvertent actuation.  
     
     
         17 . The occlusive guidewire system of  claim 1 , wherein the actuator button of the inline evacuation control valve is carried by guided near tangential close spaced support in a sheltered and recessed location on the housing, such that a conscious decision and dedicated effort is required to depress the actuator button and enable passage through the inline evacuation control valve, thereby minimizing inadvertent actuation.  
     
     
         18 . The occlusive guidewire system of  claim 1 , further comprising a configured lock for locking the inflation syringe to prevent inadvertent inflation.  
     
     
         19 . The occlusive guidewire system of  claim 1 , further comprising a Luer “tee” and paired check valves between the evacuation syringe and inline evacuation control valve to enable purging while avoiding undesired return flows from the evacuation syringe through the inline evacuation control valve.  
     
     
         20 . The occlusive guidewire system of  claim 1 , wherein the inflation syringe and the evacuation syringe are oriented in parallel within the housing.  
     
     
         21 . The occlusive guidewire system of  claim 1 , further comprising flexible tubing connecting the inline inflation control valve and the inline evacuation control valve to the four-port infusion “Y”.  
     
     
         22 . The occlusive guidewire system of  claim 1 , further comprising flexible tubing connecting the pressure gauge to the four-port infusion “Y”.  
     
     
         23 . The occlusive guidewire system of  claim 1 , wherein the housing has an orifice to accommodate the pressure gauge.  
     
     
         24 . The occlusive guidewire system of  claim 1 , wherein the compression sealing mechanism is directly linked to the four-port infusion “Y” by a Luer fitting.  
     
     
         25 . The occlusive guidewire system of  claim 24 , wherein the compression sealing mechanism includes a sealing cap.  
     
     
         26 . The occlusive guidewire system of  claim 25 , wherein the compression sealing mechanism includes a puncturable self-sealing seal capable of sealing against the proximal crimpable inflation tube.  
     
     
         27 . The occlusive guidewire system of  claim 26 , wherein the inflation tube sealing mechanism has a generally tubular body including a passageway for mated accommodation of the sealing cap.  
     
     
         28 . The occlusive guidewire system of  claim 27 , wherein the inflation tube sealing mechanism further includes a pivot dowel pin carrying a pivotable handle with an actuator pad accessible in the housing and an actuatable pincer dowel pin arranged such that actuation of the pivotable handle forcefully urges the actuatable pincer dowel pin against the proximal crimpable inflation tube and an underlying stationary pincer dowel pin so as to simultaneously seal and sever the proximal crimpable inflation tube while maintaining inflation of the balloon.  
     
     
         29 . The occlusive guidewire system of  claim 1 , wherein the polymer jacket has an elongated section and a short section, the elongated section and the short section being joiningly connected by connecting means selected from the group consisting of a bond produced by adhesive and a bond produced by heat treatment.  
     
     
         30 . The occlusive guidewire system of  claim 1 , wherein the distally located flexible tip is angled from a centerline of the shaft, and is selected from the group consisting of a preshaped polymer tip, a shapeable polymer tip, a preshaped coil tip, and a shapeable coil tip.  
     
     
         31 . The occlusive guidewire system of  claim 1 , wherein the balloon is formed of a material selected from the group consisting of noncompliant, semi-compliant, and compliant material.  
     
     
         32 . The occlusive guidewire system of  claim 1 , wherein the balloon is formed of a material selected from the group consisting of silicone, Pebax, and polyurethane.  
     
     
         33 . The occlusive guidewire system of  claim 1 , wherein a spiral cut tube of stainless steel allows communication of inflation fluid through gaps or spaces.  
     
     
         34 . An ergonomic handheld control mechanism for use with a guidewire having a crimpable proximal end, the mechanism comprising: 
 a. a housing;    b. an inflation syringe carried by the housing;    c. an evacuation syringe carried by the housing;    d. an inline inflation control valve carried by the housing and arranged in communication with the inflation syringe, the inline inflation control valve having an actuator button extending therefrom;    e. an inline evacuation control valve carried by the housing and arranged in communication with the evacuation syringe, the inline evacuation control valve having an actuator button extending therefrom;    f. a compression sealing mechanism for sealing a catheter to be connected to the handheld control mechanism;    g. an inflation tube sealing mechanism for sealing and severing a crimpable inflation tube;    h. a pressure gauge in communication with the inline inflation control valve; and,    i. a four-port infusion “Y”.    
     
     
         35 . A guidewire, with a proximal end and a distal end, the guidewire comprising: 
 a. a centrally located shaft extending between the proximal end and the distal end and having a polymer jacket extending along a portion thereof;    b. a proximal crimpable inflation tube;    c. a balloon at the distal end of the shaft in fluid communication with the proximal crimpable inflation tube; and,    d. a distally located flexible tip.    
     
     
         36 . The guidewire of  claim 35 , wherein the guidewire is torqueable and kink-resistant.  
     
     
         37 . The guidewire of  claim 35 , wherein the shaft is made of a super-elastic material.  
     
     
         38 . The guidewire of  claim 37 , wherein the super-elastic material is nitinol.  
     
     
         39 . The guidewire of  claim 35 , wherein the polymer jacket is coated with a hydrophilic material.  
     
     
         40 . A method of installing an occlusive guidewire, the method comprising the steps of: 
 a. providing a handheld control mechanism including: 
 (1) a housing;  
 (2) an inflation syringe carried by the housing;  
 (3) an evacuation syringe carried by the housing;  
 (4) an inline inflation control valve carried by the housing and arranged in communication with the inflation syringe, the inline inflation control valve having an actuator button extending therefrom;  
 (5) an inline evacuation control valve carried by the housing and arranged in communication with the evacuation syringe, the inline evacuation control valve having an actuator button extending therefrom;  
 (6) a compression sealing mechanism for sealing a catheter to be connected to the handheld control mechanism;  
 (7) an inflation tube sealing mechanism for sealing and severing a crimpable inflation tube;  
 (8) a pressure gauge in communication with the inline inflation control valve; and,  
 (9) a four-port infusion “Y”; and,  
   b. providing a sealable occlusive guidewire including: 
 (1) a centrally located shaft extending between the proximal end and the distal end and having a polymer jacket extending along a portion thereof;  
 (2) a proximal crimpable inflation tube;  
 (3) a balloon at the distal end of the shaft in fluid communication with the proximal crimpable inflation tube; and,  
 (4) a distally located flexible tip;  
   c. joining the handheld control mechanism to the sealable occlusive guidewire;    d. advancing the sealable occlusive guidewire along vasculature to position the balloon past a desired region;    e. inflating the balloon;    f. actuating the inflation tube sealing mechanism to crimp and sever the proximal crimpable inflation tube; and,    g. separating the handheld control mechanism from the sealed occlusive guidewire.    
     
     
         41 . The method of  claim 40 , wherein the handheld control mechanism and the sealable occlusive guidewire are joined prior to advancing the sealable occlusive guidewire along vasculature.  
     
     
         42 . The method of  claim 40 , wherein the handheld control mechanism and the sealable occlusive guidewire are joined subsequent to advancing the sealable occlusive guidewire along vasculature.  
     
     
         43 . The method of  claim 40 , wherein the handheld control mechanism is leak tested prior to joining it to the sealable occlusive guidewire.  
     
     
         44 . The method of  claim 40 , further comprising the step of: 
 h. cutting the proximal region of the sealed occlusive guidewire to cause deflation of the balloon.    
     
     
         45 . The method of  claim 44 , further comprising the step of: 
 i. removing the sealable occlusive guidewire and deflated balloon from the vasculature.    
     
     
         46 . The method of  claim 45 , wherein the sealable occlusive guidewire is repositioned within vasculature for repeated inflation of the balloon.  
     
     
         47 . The method of  claim 44 , wherein the handheld control mechanism is used to generate vacuum for quicker deflation of the balloon.