Patent Abstract:
A torque apparatus for facilitating manipulation of a guidewire includes a handle member dimensioned for engagement by a clinician and defining a longitudinal axis and a torque member mounted to the handle member. The torque member defines a lumen configured for reception and passage of a guidewire and is configured to rotate relative to the handle member to impart rotational movement to the guidewire. A gripper member associated with the torque member is adapted to releasably secure the guidewire relative to the torque member and a trigger member depending from the handle member is actuable to cause the gripper member to release the guidewire to thereby permit the guidewire to be moved within the lumen of the torque member. An actuator is operatively coupled to the torque member and is movable to impart rotational movement to the torque member to thereby cause corresponding rotational movement of the guidewire.

Full Description:
BACKGROUND 
     1. Technical Field 
     The present disclosure generally relates to a torque apparatus, and, in particular, relates to a torque apparatus for gripping a guidewire to facilitate maneuvering of the guidewire during an intravascular procedure. 
     2. Description of Related Art 
     Guidewires are commonly used for a variety of intravascular procedures to guide a catheter to a desired location within the body. In order to position the guidewire at the desired location, a clinician manipulates the guidewire by advancing and torquing the guidewire. Torquing the guidewire changes the orientation of the guidewire tip allowing a clinician to navigate the guidewire through the tortuous vascular system. 
     Guidewires may have a hydrophilic coating to provide lubricity to permit the guidewire to pass more easily through a blood vessel. However, due to the lubricity, sufficient torque cannot be applied by simply rolling or twisting the proximal end of the guidewire by the clinician. Consequently, a torque apparatus is needed to grip the guidewire for adequate torque application. Torque apparatus are well known in the art, however the majority of such apparatus require a two-handed operation in order for the clinician to reposition the torque apparatus along the guidewire. Specifically, when the clinician needs to reposition the torque apparatus along the guidewire, the user grasps one end of the torque apparatus while actuating a mechanism to release the guidewire with the other hand. The torque apparatus is then moved along the guidewire to reposition the torque device along the guidewire. As a result of the two-handed operation required to release the guidewire and reposition the torque apparatus, another clinician is needed to hold the guidewire steady while the torque device is repositioned. 
     SUMMARY 
     Accordingly, the present disclosure is directed to a torque apparatus for manipulation of a guidewire. The torque apparatus includes a handle member dimensioned for engagement by a clinician and defining a longitudinal axis and a torque member mounted to the handle member and defining a lumen configured for reception and passage of a guidewire. The torque member is configured to rotate relative to the handle member to impart rotational movement to the guidewire. A gripper member associated with the torque member is adapted to releasably secure the guidewire relative to the torque member. A trigger member depending from the handle member is actuable to cause the gripper member to release the guidewire to thereby permit the guidewire to move through the lumen of the torque member. The torque apparatus further includes a manual actuator which is operatively coupled to the torque member and is movable to impart rotational movement to the torque member to thereby cause corresponding rotational movement of the guidewire. 
     In disclosed embodiments, the torque apparatus also includes a counter member associated with the torque member. The counter member is dimensioned and adapted to count and/or tally incremental movements of the torque member in the clockwise or counter clockwise direction. 
     In disclosed embodiments, the gripper member is movable between a first engaged position in engagement with the guidewire to substantially prevent movement of the guidewire through the lumen of the torque member and to operatively couple the guidewire to the torque member whereby rotational movement of the torque member causes corresponding rotational movement of the guidewire, and a second release position released from the guidewire to permit movement of the guidewire through the lumen. The gripper member may be normally biased to the first engaged position. 
     In disclosed embodiments, the torque member is adapted to rotate about the longitudinal axis. The trigger member may be adapted for pivotal movement relative to the handle member between an initial position corresponding to the first engaged position of the gripper member and a pivoted position corresponding to the second release position of the gripper member. The trigger member may be normally biased to the initial position. 
     In disclosed embodiments, the torque member includes a shaft defining a shaft lumen therethrough for reception of the guidewire and the gripper member includes at least one spring member mounted to the shaft. The at least one spring member is arranged to engage the guidewire in general secured frictional relation therewith when the gripper member is the first engaged position and arranged to release the guidewire when the gripper member is in the second release position. The torque apparatus may include a plurality of spring members extending in a general longitudinal direction with respect to the longitudinal axis. 
     In disclosed embodiments, the handle member defines a substantially pistol grip arrangement. 
     Another aspect of the present disclosure is directed to another embodiment of the torque apparatus for facilitating manipulation of a guidewire. The torque apparatus includes a handle member dimensioned for engagement by a clinician and defining a longitudinal axis and a torque member mounted to the handle member and defining a lumen configured for reception and passage of a guidewire. The torque member is configured to rotate relative to the handle member to impart rotational movement to the guidewire. The torque member includes a gripper member associated with the torque member is adapted to releasably secure the guidewire relative to the torque member. The torque member also includes a manual actuator actuable to cause the gripper member to release the guidewire to thereby permit the guidewire to move through the lumen of the torque member. A trigger member depending from the handle member is actuable to prevent the torque member from spinning while the manual actuator is actuated to release the guidewire. The manual actuator is movable to impart rotational movement to the torque member to thereby cause corresponding rotational movement of the guidewire. 
     In disclosed embodiments, the torque apparatus also includes a counter member associated with the torque member. The counter member is dimensioned and adapted to count and/or tally incremental movements of the torque member. 
     In disclosed embodiments, the gripper member is movable between a first engaged position in engagement with the guidewire to substantially prevent movement of the guidewire through the lumen of the torque member and to operatively couple the guidewire to the torque member whereby rotational movement of the torque member causes corresponding rotational movement of the guidewire, and a second release position released from the guidewire to permit movement of the guidewire through the lumen. The gripper member may be normally biased to the second release position. 
     In disclosed embodiments, the torque member is adapted to rotate about the longitudinal axis. The trigger member may be adapted for pivotal movement relative to the handle member between an initial position corresponding to the first release position of the torque member and a pivoted position corresponding to the second secure position of the torque member. The trigger member may be normally biased to the initial position. 
     In disclosed embodiments, the handle member defines a substantially pistol grip arrangement. 
     In disclosed embodiments, a method for torquing a guidewire via a one handed operation of a torque apparatus is provided. In the method, a user actuates a trigger member of the torque apparatus to permit movement of a guidewire within a lumen of the torque apparatus. The trigger member being actuable by a finger on a first hand of a user. The user releases the trigger member to secure the guidewire within the lumen of the torque apparatus. The guidewire is advanced by moving the torque apparatus toward a patient. The guidewire is torqued by rotating a manual actuator of the torque apparatus. The manual actuator being rotatable by a thumb on the first hand of the user. To reposition the guidewire, the user actuates the trigger member to release the guidewire and permit movement of the guidewire within the lumen. The trigger member is released to secure the guidewire within the lumen of the torque apparatus. 
     The torque apparatus described herein permit a clinician to reposition a torque device along a guidewire using a one-handed operation. The guidewire is torqued independently of manipulating the handle thereby enabling a clinician to maintain the handle stationary on a flat surface for support while torquing the guidewire. Additionally, the torque apparatus allow a clinician to easily judge the torque applied to the guidewire through the use of visual indicators. The pistol grip arrangement of the torque apparatus has an ergonomic design to minimize physical effort and discomfort. Further, the pistol grip arrangement is intuitive thereby permitting a clinician to easily comprehend the correct operation of the torque apparatus. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the present disclosure will be readily appreciated by reference to the drawings wherein: 
         FIG. 1  is a perspective view of a torque apparatus in accordance with an embodiment of the present disclosure; 
         FIG. 2  is an exploded view of the torque apparatus of  FIG. 1 ; 
         FIG. 3  is a perspective view of a manual actuator in accordance with an embodiment of the present disclosure 
         FIG. 4A  is a perspective view of a torque and gripper assembly in accordance with an embodiment of the present disclosure; 
         FIG. 4B  is a perspective view of a leaf spring of the torque and gripper assembly in accordance with an embodiment of the present disclosure; 
         FIG. 4C  is a side view of the torque and gripper assembly of  FIG. 4A ; 
         FIG. 5A  is a perspective view of a trigger member in accordance with an embodiment of the present disclosure; 
         FIG. 5B  is a perspective view of a spring strap of  FIG. 5A ; 
         FIG. 6A  is a perspective view of the torque and gripper assembly and trigger member assembly in accordance with an embodiment of the present disclosure; 
         FIG. 6B  is a cross-section view of the torque and gripper assembly and trigger member in an engaged position in accordance with an embodiment of the present disclosure; 
         FIG. 6C  is a cross-section view of the torque and gripper assembly and the trigger member in a released position in accordance with an embodiment of the present disclosure; 
         FIG. 7  is a perspective view of the torque and gripper assembly, trigger member, and the proximal handle segment in accordance with an embodiment of the present disclosure; 
         FIG. 8  is a perspective view of the torque member and the counter member in accordance with an embodiment of the present disclosure 
         FIG. 9  is a perspective view of a torque apparatus in accordance with another embodiment of the present disclosure; 
         FIG. 10  is an exploded view of the torque apparatus of  FIG. 9 ; 
         FIG. 11A  is a side view of a torque and gripper assembly in accordance with an embodiment of the present disclosure; 
         FIG. 11B  is a cross-section view of the torque and gripper assembly of  FIG. 11A  taken along the lines  11 B- 11 B; 
         FIG. 12A  is a rear view of the torque and gripper assembly of  FIG. 11A  in a released position; and 
         FIG. 12B  is a rear view of the torque and gripper assembly of  FIG. 11A  in an engaged position. 
     
    
    
     DETAILED DESCRIPTION 
     Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Well known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures. The term “clinician” refers to any medical professional (i.e., doctor, surgeon, nurse, or the like) performing a medical procedure involving the use of embodiments described herein. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” or “trailing” refers to the end of the apparatus which is closer to the clinician and the term “distal” or “leading” refers to the end of the apparatus which is further away from the clinician. 
     In the embodiments described herein, the torque apparatus is a handheld implement used to facilitate gripping and torquing of a guidewire. The torque apparatus permits a clinician to release, re-attach, and/or torque or spin a guidewire using only a single hand. 
     During use of the torque apparatus, the clinician grasps the torque apparatus  100  of  FIG. 1  with a single hand. The clinician then actuates a trigger with his/her index finger in order to introduce a guidewire through a proximal end of the torque apparatus. The trigger is released and the guidewire is secured within the torque apparatus. Then the clinician advances the guidewire in to a vessel by moving the torque apparatus distally. While navigating the guidewire through the vessel, the clinician rotates a manual actuator with his/her thumb to orient the tip of the guidewire toward the appropriate path. When the clinician needs to reposition the torque apparatus along the guidewire to increase the length of the guidewire available to be inserted into the vessel, the clinician actuates trigger and moves the torque apparatus proximally before releasing the trigger to secure the guidewire in place. Once again, the torque apparatus is moved distally to navigate the guidewire through the vessel. This procedure is repeated until the guidewire is located in the correct position within the vessel. After the guidewire is located in the correct position, the clinician actuates trigger and moves the torque apparatus proximally over the guidewire until the guidewire is extricated. 
     Referring now to  FIGS. 1 and 2 , the torque apparatus  100  in accordance with an embodiment of the present disclosure is illustrated. The torque apparatus  100  generally includes a handle member  102 , an actuator  104  mounted to the handle member  102 , a torque and gripper assembly  106  positioned within the handle member  102  and a counter member  108  also disposed within the handle member  102 . The torque apparatus  100  further includes a trigger member  110  depending from the handle member  102  and couplable to the torque and gripper assembly  106 . The handle member  102  may be in the form of a pistol grip and defines a longitudinal axis “X”. The handle member  102  has a substantially planar lower surface dimensioned to be positioned on a support or table in the upright orientation shown in  FIG. 1 . 
     The handle member  102  may include a proximal handle segment  102   a  and a distal handle segment  102   b  which are connected to each other by conventional means. The proximal handle segment  102   a  defines an internal recess  112  which at least partially accommodates the trigger member  110  and a central aperture  114  in general alignment with the longitudinal axis “X”. The central aperture  114  at least partially accommodates the torque and gripper assembly  106 . The distal handle segment  102   b  includes a central aperture  116  for passage of the guidewire “G”. The distal handle segment  102   b  may further include a window  118 , which may be an opening in the wall of the distal handle segment  102   b  to permit viewing of the orientation of the counter member  108  as will be discussed. The proximal handle segment  102   a  and the distal handle segment  102   b  may be fabricated from any suitable material including polymeric materials formed by injection molding techniques, metallic materials such as stainless steel or any other suitable material. The handle segments  102   a ,  102   b  may be connected to each other by any conventional means such as adhesives, sonic welding techniques, and fasteners. 
     With reference to  FIG. 3 , in conjunction with  FIGS. 1-2 , the actuator  104  is illustrated. In the embodiments described below, the actuator  104  is shown as having a circular configuration that is manually operated. Other devices may be used to torque the torque member  132 , such as, but not limited to, a crank or an electric motor. The actuator  104  may also have a smooth continuous movement or the actuator  104  may include a ratchet mechanism for incremental movements. The ratchet mechanism may provide an audible click noise to indicate the number of torques applied to the guidewire “G”. 
     The actuator  104  is adapted for rotational movement relative to the handle member  102  about longitudinal axis “X”, which effects rotation or torquing of the guidewire “G”. The actuator  104  may define a general circular configuration having an outer ring  120  with a surface irregularity in the form of notches or ridges  122  to facilitate engagement and manipulation of the actuator  104  by the clinician. The actuator  104  has a central aperture  124  in general alignment with the longitudinal axis “X” to permit passage of the guidewire “G”. Within the interior of the actuator  104  is an annular ring  126  coaxially disposed about the aperture  124  and defining an internal cavity  128 . The internal cavity  128  is dimensioned to at least partially accommodate the torque and gripper assembly  106 . A protrusion or detent  130  extends within the internal cavity  128  and is couplable with the torque and gripper assembly  106 . The relationship of the detent  130  with the torque and gripper assembly  106  will be discussed in further detail hereinbelow. 
     Referring now to  FIGS. 4A-4C , the torque and gripper assembly  106  will be discussed. The torque and gripper assembly  106  includes a torque member  132  and a gripper member  134  couplable to the torque member  132 . The torque member  132  includes a shaft  136  having or defining a lumen  138  that extends from the proximal end of the shaft  136  to the distal end of the shaft  136 . The lumen  138  is aligned with longitudinal axis “X” of handle  102  and is configured to receive the guidewire “G”. The torque member  132  includes a groove  140  within the shaft  136 . The groove  140  is dimensioned to receive the detent  130  of the actuator  104  to couple the torque member  132  and the manual actuator  104 . 
     The shaft  136  further includes at least one pair of apertures  142   a ,  142   b  which are spaced along the longitudinal axis “x”, and separated by a central shaft segment  143 . In embodiments, the shaft  136  includes four pairs of apertures  142   a ,  142   b . The pairs of apertures  142   a ,  142   b  may be arranged equidistantly about the circumference of the shaft  136 , e.g., at 90 degree intervals relative to the longitudinal axis “X”. 
     The gripper member  134  includes at least one, and in some embodiments, four leaf springs  144 . Each leaf spring  144  may be composed of a suitable resilient material such as stainless steel, a shape memory alloy, or a polymeric material. In a normal unstressed condition thereof, each leaf spring  144  defines a generally arcuate profile having a central arc segment  146  disposed between two end segments  148   a ,  148   b . The central arc segment  146  is radially offset relative to the two end segments  148   a ,  148   b  a predetermined distance “d” ( FIG. 4B ). The end segments  148   a ,  148   b  of each leaf spring  144  are configured and dimensioned to be disposed in the apertures  142   a  and  142   b , respectively, of the shaft  136  with the central arc segment  146  straddling the central shaft segment  143  of the shaft  136  as best depicted in  FIG. 4C . Further details of the leaf springs  144  and their functioning in gripping and releasing the guidewire “g” will be discussed in greater detail hereinbelow. 
     Referring now to  FIGS. 5A and 5B , in conjunction with  FIG. 2 , the trigger member  110  will be discussed. The trigger member  110  includes a lever  150  which is pivotally mounted to the proximal handle segment  102   a  about pivot pin  152 . In some embodiments, pivot pin  152  is inserted into aperture  154  of lever  150  and aperture  155  of proximal handle segment  102   a  to mount lever  150  to proximal handle segment  102   a . The lever  150  is fabricated from any suitable material including polymeric materials formed by any conventional material processing techniques. The trigger member  110  further includes a resilient strap  156  having a first end  158  couplable to the proximal handle segment  102   a . The lever  150  is coupled to a second end  160  of the resilient strap  156 . The resilient strap  156  has a generally circular configuration and may be fabricated from stainless steel, a shape memory alloy, or a polymeric material. Actuation through pivotal movement of the lever  150  from an initial position to a pivoted position about the pivot pin  152  causes the resilient strap  156  to transition from a first larger diameter to a second smaller diameter. For example, as a clinician actuates the lever  150 , the lever  150  pivots about the pin  152  causing the second end  160  to move radially away from the longitudinal axis “X” while the first end  158  remains secured to the proximal handle segment  102   a . This action causes the effective circumference of the resilient strap  156  to decrease. Upon release of the lever  150 , the resilient strap  156  returns to the first larger diameter. 
       FIGS. 6A-6C  illustrate the torque and gripper assembly  106  positioned within the resilient strap  156  of the trigger member  110 . The resilient strap  156  is concentrically disposed about the central are segments  146  of the leaf springs  144 . As shown in  FIG. 6B , the leaf springs  144  of the gripper member  134  are normally biased to an engaged position such that the ends  148   a ,  148   b  are positioned radially toward the lumen  138  and will prevent entry of a guidewire or engage the guidewire. When a clinician actuates the trigger member  110  by pressing the lever  150 , the resilient strap  156  moves from the first larger diameter to the second smaller diameter thereby causing the midpoint  146  of the leaf springs  144  to move radially towards the central shaft segment  143 . ( FIG. 6C ) Moving the central arc segment  146  of the leaf springs  144  toward the central shaft segment  143  causes the ends  148   a ,  148   b  of the leaf springs  144  to move radially away from the lumen  138  within the respective apertures  142   a ,  142   b  thereby permitting a guidewire to be positioned or repositioned within the lumen  138 . Releasing the lever  150  causes the  148   a ,  148   b  of the leaf springs  144  to move radially toward the lumen  138  thereby securing a guidewire within the lumen  138 . In other words, when the leaf springs  144  are in the engaged position, the leaf springs  144  have a first radius of curvature that causes ends  148   a ,  148   b  to engage the lumen  138  and any guidewire positioned therein. Upon actuation of the lever  150 , the radius of curvature of the leaf springs  144  transition to a second radius of curvature that is greater than the first radius of curvature thereby moving ends  148   a ,  148   b  away from the lumen  138  and permitting a guidewire to be positioned or repositioned in the lumen  138 . ( FIG. 6C ) 
       FIG. 7  illustrates the torque and gripper assembly  106  positioned within the resilient strap  156  of the trigger member  110  and the proximal handle segment  102   a . As shown in  FIG. 7 , the first end  158  of resilient strap  156  is secured to the proximal handle segment  102   a  by inserting rod  158   a  ( FIG. 5B ) at the first end  158  into an aperture  162  of the proximal handle segment  102   a . In the normal unstressed condition of the resilient strap  156 , i.e., when the resilient strap  156  has the first larger diameter configuration, the resilient strap  156  biases the trigger in the initial position as shown in  FIG. 7 . 
     Turning to  FIG. 8 , the counter member  108  circumscribes the shaft  136  near the distal end of the shaft  136 . The counter member  108  is fabricated from any suitable material including polymeric materials formed by any conventional fabrication techniques known in the art. The counter number  108  includes indicia, in the form of, e.g., the numbers  164 , that may indicate an incremental degree or number of rotations of the actuator  104  and the guidewire through a predetermined arc of rotation about the longitudinal axis “X”. The numbers  164  may be any real number, e.g., integers ranging from . . . , −2, −1, 0, 1, 2, . . . where a negative number may indicate a counter clockwise direction and a positive number may indicate a clockwise direction or vice versa. The radius of the counter member  108  may be set to a predetermined length by the manufacturer. In other embodiments, the counter member  108  may be adjusted by a clinician to adjust the predetermined arc of rotation that is indicated by the numbers  164  by changing the radius of the counter member  108 . The counter member may be frictionally fit over the shaft  136 . Other methods of securing the counter member  108  to the shaft  136  are also contemplated that include, but are not limited to, a tongue and groove configuration, welding, etc. 
     In another embodiment, the shaft  136  may include a pair of ribs (not shown) at the distal end that are configured to secure the counter member  108  in the correct location so that the numbers  164  appear in the window  118 . 
     In the embodiments described hereinabove, the actuator  104 , the torque member  132  and the counter member  108  are described as being separate components. It is also contemplated that the actuator  104  and the torque member  132  may be formed as a unitary component, the torque member  132  and the counter member  108  may be formed as a unitary component, or that the actuator  104 , the torque member  132 , and the counter member  108  may be formed as a unitary component. Further, the handle member  102  was described hereinabove as being composed of two components (the proximal handle segment  102   a  and the distal handle segment  102   b ) that are separated along a plane that is transverse to the longitudinal axis “X”. In other embodiments, the handle member  102  may be composed of two components that are separated along a plane that is aligned with the longitudinal axis “X”. Also, the various components of the torque apparatus  100  may be assembled by a clinician or they may be preassembled by a manufacturer where the proximal handle segment  102   a  and the distal handle segment  110  may be welded together after assembly of the torque apparatus  100 . Any of the components described herein may be disposable single use components or reposable. 
     Referring again to  FIGS. 2 and 3 , during use of the torque apparatus  100 , the clinician grasps the torque apparatus  100  with a single hand. The clinician then actuates lever  150  with his/her index finger in order to introduce a guidewire through aperture  124 , lumen  138 , and aperture  116 . The lever  150  is released and the guidewire is secured within the torque apparatus  100  by leaf springs  144 , e.g., the ends  148   a ,  148   b  of the leaf springs  144 . Then the clinician advances the guidewire in to a vessel by moving the torque apparatus  100  distally. While navigating the guidewire through the vessel, the clinician rotates actuator  104  with his/her thumb to orient the tip of the guidewire through the vasculature. When the clinician needs to reposition the torque apparatus  100  along the guidewire to increase the length of the guidewire available to be inserted into the vessel, the clinician actuates lever  150  and moves the torque apparatus  100  proximally before releasing the lever  150  to secure the guidewire in place. Once again, the torque apparatus  100  is moved distally to navigate the guidewire through the vessel. This procedure is repeated until the guidewire is located in the correct position within the vessel. After the guidewire is located in the correct position, the clinician actuates lever  150  and moves the torque apparatus  100  proximally over the guidewire until the guidewire is extricated. 
     Referring now to  FIGS. 9 and 10 , a torque apparatus  200  in accordance with another embodiment of the present disclosure is illustrated. The torque apparatus  200  generally includes a handle member  202  and a torque and gripper assembly  204  positioned within the handle member  202 . The torque apparatus  200  further includes a trigger member  206  depending from the handle member  202  and couplable to the torque and gripper assembly  204 . The handle member  202  may be in the form of a pistol grip and defines a longitudinal axis “X”. The handle member  202  has a substantially planar lower surface dimensioned to be positioned on a support or table in the upright orientation shown in  FIG. 9 . 
     The handle member  202  may include a proximal handle segment  202   a  and a distal handle segment  202   b  which are connected to each other by conventional means. The proximal handle segment  202   a  defines an internal recess  208  which at least partially accommodates the trigger member  206  and a recess  210  in general alignment with the longitudinal axis “X”. The recess  210  at least partially accommodates a proximal end  211  of the torque and gripper assembly  204 . The torque and gripper assembly  204  rotates freely about the longitudinal axis “X” within recess  210   
     The trigger member  206  includes a lever  212  which is pivotally mounted to the proximal handle segment  202   a  about pivot pin  214 . In some embodiments, pivot pin  214  is inserted into aperture  216  of lever  212  and aperture  218  of proximal handle segment  202   a  to mount lever  212  to proximal handle segment  202   a . The lever  212  is fabricated from any suitable material including polymeric materials formed by injection molding techniques. 
     The trigger member  206  further includes a resilient strap  218  having a first end  220  couplable to the proximal handle segment  202   a . Specifically, the first end  220  is secured to the proximal handle segment  202   a  by inserting rod  222  at the first end  220  into an aperture  224  of the proximal handle segment  202   a . The lever  212  is coupled to a second end  226  of the resilient strap  218 . The resilient strap  218  has a generally circular configuration and may be fabricated from stainless steel, a shape memory alloy, or a polymeric material. Actuation through pivotal movement of the lever  212  from an initial position to a pivoted position about the pivot pin  214  causes the resilient strap  218  to transition from a first larger diameter to a second smaller diameter. For example, as a clinician actuates the lever  212 , the lever  212  pivots about the pin  214  causing the second end  226  to move radially away from the longitudinal axis “X” while the first end  220  remains secured to the proximal handle segment  202   a . This action causes the effective circumference of the resilient strap  218  to decrease. Upon release of the lever  212 , the resilient strap  218  returns to the first larger diameter. 
     The distal handle segment  202   b  includes a central aperture  228  configured to receive a distal end  230  of the torque and gripper assembly  204 . The distal end  230  of the torque and gripper assembly  204  is couplable to a cap  232  that is disposed distally of the distal handle segment  202   b . The distal handle segment  202   b  may include an indicator, e.g., an arrow  234 , which, in conjunction with the cap  232 , indicates the number of torque increments applied to a guidewire inserted into the torque apparatus  200 . Specifically, the cap  232  may have indicia, e.g., numbers  236 , that are arranged circumferentially around the cap  232 . The number  236  that is aligned with arrow  234  indicates the number of torque increments applied to the guidewire. 
     The proximal handle segment  202   a  and the distal handle segment  202   b  may be fabricated from any suitable material including polymeric materials formed by injection molding techniques, metallic materials such as stainless steel or any other suitable material. The handle segments  202   a ,  202   b  may be connected to each other by conventional means including adhesives, sonic welding techniques, fasteners or the like. 
     Referring now to  FIGS. 11A-11B , the torque and gripper assembly  204  will be discussed. The torque and gripper assembly  204  includes a manual actuator  238  in the form of a wheel. The manual actuator  238  is disposed about a proximal washer  240  that is internally threaded. The distal end  230  of the torque and gripper assembly  204  includes a distal washer  242  having a washer  244  that extends proximally. The outer surface of the washer  244  is threaded and is configured to cooperate with the internal threads of proximal washer  240 . As shown in  FIG. 11B , the proximal washer  240  includes an annular chamber  246  configured and dimensioned to receive the washer  244  such that the proximal washer  240  may be positioned anywhere along the longitudinal length of the washer  244 . 
     A gripper member  248  is disposed in a chamber  250  defined by the proximal washer  240 , the distal washer  242  and the washer  244 . Gripper member  248  acts as a valve and moves from a first engaged position in order to grip a guidewire inserted therein to a second release position to permit entry of or repositioning of a guidewire inserted therein. The gripper member  248  is a resilient material such as silicone, which is shapeable when subjected to compressive or tensive forces. The gripper member  248  maintains a constant volume. Thus, when one dimension of the gripper member changes, e.g., axial length, another dimension of the gripper member  248  changes, e.g., radial thickness, to maintain the volume of the gripper member  248 . For example, in some embodiments, when the axial length of the gripper member  248  increases that radial thickness decreases and when the axial length of the gripper member decreases, the radial thickness of the gripper member  248  increases. A lumen  252  is aligned with longitudinal axis “X” of the handle  202  and is configured to receive the guidewire “G”. Further details of the torque and gripper assembly  204  and their functioning in gripping and releasing the guidewire “g” will be discussed in greater detail hereinbelow. 
     During use of the torque apparatus  200 , the clinician grasps the torque apparatus  200  with a single hand. The clinician then actuates lever  212  with his/her index finger causing resilient strap  218  to transition from a first larger diameter to a second smaller diameter. When the resilient strap  218  is in the second smaller diameter configuration, the resilient strap  218  frictionally engages the distal washer  242  of the torque and gripper assembly  204  preventing the torque and gripper assembly  204  from spinning. The clinician then rotates the manual actuator  238  in a first rotational direction causing the proximal washer  240  to move proximally. This action increases the axial length of the chamber  250  thereby permitting the gripper member  248  to assume its natural state having a first reduced thickness “t 1 ” as shown in  FIG. 12A . After a guidewire is inserted into lumen  252  or repositioned within lumen  252 , the manual actuator  238  is rotated in a second rotational direction opposite the first rotational direction thereby moving the proximal washer  240  distally along the longitudinal axis. This action reduces the axial length of the chamber  250  which applies a compressive force to the gripper member  248  in the axial direction thereby reducing the axial length of the gripper member  248 . Reducing the axial length of the gripper member  248  increases the radial thickness of the gripper member to a second larger thickness “t 2 ” as shown in  FIG. 12B . In the configuration shown in  FIG. 12B , when the gripper member  248  assumes the configuration having the second larger thickness “t 2 ”, the gripper member  248  frictionally engages the guidewire “G” inserted therein thereby preventing guidewire “G” from moving along the longitudinal axis “X”. The clinician releases the lever  212  and advances the guidewire in to a vessel by moving the torque apparatus  200  distally. While navigating the guidewire through the vessel, the clinician rotates the manual actuator  238  with his/her thumb to orient the tip of the guidewire toward the appropriate path. When the clinician needs to reposition the torque apparatus  200  along the guidewire to increase the length of the guidewire available to be inserted into the vessel, the clinician actuates lever  212  and moves the manual actuator  238  in the first radial direction to release the guidewire before the torque apparatus  200  is moved proximally. After the guidewire is secured, the torque apparatus  200  is moved distally to navigate the guidewire through the vessel. This procedure is repeated until the guidewire is located in the correct position within the vessel. After the guidewire is located in the correct position, the clinician releases the guidewire and moves the torque apparatus  200  proximally over the guidewire until the guidewire is extricated. 
     The above description and the drawings are provided for the purpose of describing embodiments of the present disclosure and are not intended to limit the scope of the disclosure in any way. It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.

Technology Classification (CPC): 0