Abstract:
An interventional guidewire assembly with improved guidewire control includes a guidewire and a housing having a first opening that accommodates the guidewire and a second opening. The assembly further includes an actuator that passes through the second opening that is actuated by a finger in a direction substantially perpendicular to an axis of the guidewire. The assembly further includes a clamp operably coupled to the actuator that compresses the guidewire to couple the guidewire to the housing when pressure is applied to the actuator. The assembly further includes a return spring that supplies pressure to remove the clamp from the guidewire.

Description:
TECHNICAL FIELD 
       [0001]    The apparatus described herein generally relates to the field of medical devices. More specifically, the apparatus relates to guidewires for interventional procedures. 
       BACKGROUND 
       [0002]    Maintaining accurate control and placement of a guidewire during a medical interventional procedure is essential. Present torque devices used to accomplish this task require excessive manipulation with more than one hand or excessive force parallel to the guide wire axis in order to correctly position the device. This can divert the attention of the interventionalist during the procedure and increase the chance of unwanted movement of the wire in the patient, which could lead to complications. 
         [0003]    The current devices require release of the secure hand position on the guidewire in order to adjust the positioning of the torque device. These moments of release of the guidewire could result in unexpected advancement or retraction of the guidewire that could lead to problems during the procedure 
         [0004]    As can be seen, there is a need for an improved torque devices for guidewires. This apparatus should permit blind one-handed operation and not require substantial force in a direction parallel to the guidewire axis to manipulate. 
       BRIEF SUMMARY 
       [0005]    An interventional guidewire assembly with improved guidewire control includes a guidewire and a housing having a first opening that accommodates the guidewire and a second opening. The assembly further includes an actuator that passes through the second opening that is actuated by a finger in a direction substantially perpendicular to an axis of the guidewire. The assembly further includes a clamp operably coupled to the actuator that compresses the guidewire to couple the guidewire to the housing when pressure is applied to the actuator. The assembly further includes a return spring that supplies pressure to remove the clamp from the guidewire. 
         [0006]    In some embodiments, the assembly includes a retention spring that supplies pressure to compress the clamp against the guidewire. In some embodiments, the return spring and the retention spring are two layers on a single leaf spring. In some embodiments, the clamp is a collet. In some embodiments, the assembly includes a sleeve that compresses the collet against the guidewire when the actuator is actuated. In some embodiments, the assembly includes a wire guide disposed in the housing in contact with the guidewire opposite the actuator, and the clamp comprises the wire guide and the actuator. In some embodiments, the assembly includes a ratchet that retains the clamp compressed against the guidewire after the actuator has been actuated. In some embodiments, the ratchet rotates relative to the housing. In some embodiments, the assembly further includes a pivot that couples the actuator to the housing and allows relative rotation between the actuator and the housing when pressure is applied to the actuator. In some embodiments, the assembly includes a linkage that transfers motion from the actuator to the clamp and retains the clamp compressed against the guidewire after the actuator has been actuated. 
         [0007]    An apparatus for precise control of a wire in two axes includes a housing having a first opening that accommodates the wire and a second opening. The apparatus further includes an actuator that passes through the second opening that is actuated by a finger in a direction substantially perpendicular to an axis of the wire. The apparatus further includes a clamp operably coupled to the actuator that compresses the wire to couple the wire to the housing when pressure is applied to the actuator. The apparatus further includes a return spring that supplies pressure to uncouple the clamp from the wire. 
         [0008]    In some embodiments, the apparatus includes a retention spring that supplies pressure to compress the clamp against the wire. In some embodiments, the return spring and the retention spring are two layers on a single leaf spring. In some embodiments, the clamp is a collet. In some embodiments, the apparatus further includes a sleeve that compresses the collet against the wire when the actuator is actuated. In some embodiments, the apparatus further includes a wire guide disposed in the housing in contact with the wire opposite the actuator. In some embodiments, the clamp comprises the wire guide and the actuator. In some embodiments, the apparatus further includes a ratchet that retains the clamp compressed against the wire after the actuator has been actuated. In some embodiments, the ratchet rotates relative to the housing. In some embodiments, the apparatus further includes a pivot that couples the actuator to the housing and allows relative rotation between the actuator and the housing when pressure is applied to the actuator. In some embodiments, the apparatus further includes a linkage that transfers motion from the actuator to the clamp and retains the clamp compressed against the wire after the actuator has been actuated. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a perspective view of one embodiment of the apparatus in use. 
           [0010]      FIG. 2  is a detail longitudinal sectional view taken on line  2 - 2  of  FIG. 1 , showing the apparatus in an uncoupled configuration. 
           [0011]      FIG. 3  is a cross-sectional view taken on line  3 - 3  of  FIG. 2 . 
           [0012]      FIG. 4  is a detail longitudinal sectional view similar to  FIG. 2 , showing the embodiment of  FIG. 1  in a coupled configuration. 
           [0013]      FIG. 5  is a cross-sectional view taken on line  5 - 5  of  FIG. 4 . 
           [0014]      FIG. 6  is a detail longitudinal sectional view of one embodiment of the apparatus. 
           [0015]      FIG. 7  is a detail longitudinal sectional view similar to  FIG. 6  in a clamped configuration. 
           [0016]      FIG. 8  is a detail longitudinal sectional view of one embodiment of the apparatus. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    In several embodiments, the apparatus described herein is a compression torque device with compression activation and release. The apparatus described herein allows for single action of the finger to immediately secure the torque device to the guidewire. A subsequent finger manipulation causes immediate release of the torque device from the guidewire for adjustment to the next position. When secured, the apparatus facilitates single-handed rotational manipulation of the guidewire allowing for precise placement of the guidewire tip. This will allow single hand repositioning and manipulation of the torque device on the guidewire to allow the interventionalist to maintain precise control of the wire, with a single hand, without diverting attention away from the procedure image or the patient. 
         [0018]    The apparatus described herein enables the interventionalist to maintain single hand position without eye to hand visual cues to secure and release the torque device for positioning. The apparatus described herein also enables the interventionalist to be able to continuously maintain secure control of the guidewire during all repositioning. The downward force required to secure and release the embodiments described herein is perpendicular to the guidewire and therefore decreases potential for unexpected advancement or retraction. In other words, the device can be operated using only one-handed blind operation. 
         [0019]      FIG. 1  shows the apparatus in use during an operation. An operator compresses actuator  16  using finger  11 . In this embodiment, finger  11  is an index finger. This action allows the user to toggle between a coupled mode where manipulation of apparatus  10  will translate into guidewire  12 , and an uncoupled mode where apparatus  10  moves independently of guidewire  12 . The user can move guidewire  12  in two axes (longitudinal and rotational) by applying corresponding force to housing  14  of apparatus  10 . In coupled mode, the user can move the guidewire in an axial direction  13  or a rotation direction  12  using apparatus  10 . In uncoupled mode, the user can move apparatus  10  in those directions while not moving guidewire  12 . 
         [0020]      FIGS. 2 and 3  show the apparatus in an uncoupled configuration. In an uncoupled mode, the torque device  10  may travel either backwards or forwards  13  on wire  12 , or rotate relative to wire  12 . Apparatus  10  comprises a clamping mechanism, in this case a collet unit  20  (consisting of clamping fingers  22 ) and tapered sleeve  24 . Actuator  16  transfers motion to collet unit  20  via linkage  18 . Compression of actuator  16  thereby results in a movement of collet unit  20  in a proximal axial direction, resulting in the compression of collet fingers  22  by tapered sleeve  24  against guidewire  12 . Clamping fingers  22  have a surface that comes in contact with and secures guidewire  12 . Return spring  26  applies a force in the distal axial direction against collet unit  20 , which separates collet fingers  22  from guidewire  12 . Pivot  28  couples actuator  16  to housing  14  and permits a rotational movement between actuator  16  and housing  14 . As a result, actuator  16  is compressed in a direction perpendicular to an axis  13  of guidewire  12 , giving a user greater control over guidewire  12 . 
         [0021]    The end of the housing  14  may be various shapes to accept the wire  12 , and comprise a first opening  21  to thread guidewire  12 . In this embodiment, the actuator  16  is a button that fits within a second opening  23  in housing  14  with variable degrees of rise from the surface in order to provide a distance to compress in order to engage or disengage the compression mechanism  20 . Actuator  16  may be located on one or more sides of the device  10  along its longitudinal body. In this embodiment, the housing  14  has a cylindrical shape in order to easily rotate or hold between the tips of fingers  11 . The housing  14  may provide a slot  23  for the compression button  16  to extend through and enough space within the housing  14  for the compression mechanism  20  and a slot  21  to pass the wire  12  the length of the device  10 . 
         [0022]    Tapered sleeve  24  may be designed with variable slotted and angled edges that communicate with collet unit  20  to allow for the rotation of tapered sleeve  24  relative to collet unit  20  that enables the clamping fingers  22  to be engaged and/or disengaged at alternating depths/distances. The collet unit  20  may be designed with angles leading to variable communication points with the external slotted and angled edges of the tapered sleeve  24 . The collet unit  20  may remain fixed in housing  14 . The spring  26  may be of variable spring types and may apply perpendicular force to the passed wire  12  by connection to the slotted tapered sleeve  24  and the clamping fingers  22 . 
         [0023]    The cylindrical housing  14  may be shaped in order to be held by one hand between tips of fingers  11  in order to maintain precise longitudinal and rotational control. The housing  14  surface may have a variable texture to help maintain control. The center of the housing  14  may be slotted in order to pass a wire  12  of various diameters through the torque device  10 . There may be one or more compression buttons  16  at various angles along the cylindrical housing  14  that may provide an external means to compress and hold a wire  12  passed through the torque device  10 . The fixed and compressed position allows the pressed wire  12  to be maintained in a fixed position. Once the clamping fingers  22  and spring  26  are disengaged by pressing the compression button  16  again, the housing  14  may be freely moved in a longitudinal or rotational fashion along the wire  12 . The apparatus described herein may allow for single hand manipulation of the torque device  10  along the wire  12  in order to reposition the device with minimal unintentional movement of the wire  12 . 
         [0024]      FIGS. 4 and 5  show apparatus  10  in a coupled configuration. In the coupled configuration, linkage  18 , the outer surface of actuator  16 , and the edge of second opening  23  of housing  14  are aligned, and the shape of the contact surfaces of collet fingers  22  are configured so that apparatus  10  remains in a coupled configuration after actuator  16  is pressed. Apparatus  10  returns to an uncoupled configuration when actuator  16  is pressed in the coupled configuration. 
         [0025]      FIGS. 6 and 7  show is a detail longitudinal sectional view of one embodiment of the apparatus in an uncoupled and coupled configuration, respectively. In this embodiment, actuator  16  comprises a clamping portion  35 , combined with wire guide  38 , compress either side of guidewire  12  to couple it to apparatus  10 . A leaf spring  36  is coupled to actuator  16  and wire guide  38 . In this embodiment, leaf spring  36  comprises two layers that apply force in opposite directions. Therefore, leaf spring  36  applies outward force until it reaches an equilibrium point, and applies inward force beyond that point. Therefore, in the position shown in  FIG. 6 , leaf spring  36  applies an outward force, resisting compression of actuator  16 . In the position shown in  FIG. 7 , leaf spring  36  applies an inward force that compresses clamping portion  35  against guidewire  12  and maintains apparatus  10  in a coupled configuration until actuator  16  is compressed again. 
         [0026]      FIG. 8  is a detail longitudinal sectional view of one embodiment of the apparatus. In this embodiment, the clamping mechanism comprises ratchet  80 . Ratchet  80  retains clamping mechanism in a coupled position once actuator  16  has been pressed. Ratchet  80  retains clamping mechanism in a coupled position until actuator  16  is pressed in the coupled position, at which point ratchet  80  toggles the clamping mechanism into an uncoupled position. In this embodiment, ratchet  80  rotates and moves axially relative to housing  14  to couple and uncouple apparatus  10  to wire  12 . Ratchet  80  comprises teeth and flanges that engage teeth and grooves on housing  14 . 
         [0027]    In certain embodiments, the apparatus  10  described herein may include a hollow chamber of various materials such as plastic with a tapered tip. The surface of the housing  14  may be designed to have a minimal slip surface. The center of the device  10  may allow for various sizes of interventional wires  12  to pass freely through the device  10 . Once the wire  12  has been passed through the device  10 , securing the wire  12  in position may be the next step. The center chamber of the torque device  10  may include compressible material that surrounds the guidewire  12 . Housing  14  of the device  10  may include one or multiple compression components at various angles that allow for single downward force to secure and hold wire  12  within the compressible central core. When the torque device  10  needs to be repositioned, actuator  16  can be released with a single handed motion without releasing or repositioning the hand. 
         [0028]    As such, apparatus  10  is operated as follows. The user grasps apparatus  10  with one hand and the wire  12  with the other hand. The user advances the torque device  10  over the wire  12  by threading the wire  12  through first opening  21  of the torque device  10  to the desired position along the wire  12 . Once the torque device  10  is at the selected position on the wire  12 , use the tip of index finger  17  of the hand grasping apparatus  10  to compress the actuator  16 . This will engage the compression mechanism to secure the torque device  10  at the desired position along the wire  12 . At this point, the torque device  10  can be used while it is secured to the wire  12  to be able to assist in advancing the wire  12  and or rotating the wire  12  to desired positions. The same hand holding the torque device  10 , that secured it to the wire  12 , can now be used to advance, retract and rotate the secure wire  12  to any position without having to use a second hand, release the wire  12  or depend on visualization of the apparatus  10  for manipulation. When necessary to reposition or remove the torque device  10 , actuator  16  is pressed again which disengages the device  10  from wire  12 . This allows the user to freely reposition the torque device  10  along the wire  12  in a longitudinal or rotational position or remove it from the wire  12  completely without the use of a second hand or dependence of visual cues. This process may be repeated as many times as necessary to position the wire  12 . At all times this device can be used with single hand manipulation which is a significant advancement over previous technology. The force used to engage or disengage this device  10  is perpendicular to the passed wire  12  and therefore a significant advancement over previous technology that often applies force parallel to the passed wire  12  which could lead to unexpected advancement or retraction of the passed wire  12 . 
         [0029]    Elements that could be added to improve the apparatus  10  described herein may include variations of the shape of the housing  14 , variations of the number of actuators  16 , variations of the color and the surface texture of the housing  10 , variations of the shape of the proximal and distal end of the housing  14 , variations of shape and size of the first opening  21  and second opening  23  of housing  14 , variations of the actuator  16  in size, shape and texture, spring mechanisms  26 ,  36  may be of any shape that may allow the compression mechanism to engage and hold the wire  12  and then release when necessary by a second compression of actuator  16  and the housing  14  could be made to glow in the dark for higher visibility. 
         [0030]    The present torque device  10  can be enlarged or minimized to any scale in order to accommodate any size wire  12  or structure needing to be advanced, retracted or rotated. Within any field of technology where a flexible structure would need to be positioned at its distal tip, this device may enable a more proximal fixed position that would allow for rotational and longitudinal movement of the distal end. 
         [0031]    Although the invention has been described with reference to embodiments herein, those embodiments do not limit the invention. Modifications to those embodiments or other embodiments may fall within the scope of the invention.