Abstract:
One preferred embodiment includes a guidewire manipulation device for manipulating a guidewire during a procedure. Preferably, the guidewire manipulation device includes a powered motor that drives a tandem roller assembly. The guidewire is passed through a hole positioned lengthwise through the device where the roller assembly engages the guidewire&#39;s outer surface. The interface of the manipulation device includes a power button that directs the internal roller assembly to roll the guidewire in a desired rotational direction. Additional interface controls are also preferable to provide a different roll patterns, depending upon surgeon preference and guidewire placement efficiency.

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application Ser. No. 60/853,731 filed Oct. 21, 2006 entitled Powered Guidewire Torque Device which is hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention generally relates to the maneuvering of a guidewire in surgical procedures where an ‘endovascular’ technique is employed to access vasculature of a patient. Additional background information can be found in U.S. Pat. No. 5,634,475, the contents of which are hereby incorporated by reference. 
     A guidewire is typically a semi-rigid probe used as an initial access point for performing an endovascular procedure. The guidewire is twisted, bent, and otherwise maneuvered through an access vessel in order to position the guidewire tip at a location a surgeon would like to treat. 
     Convention guidewire manipulation methods often involve applying “torque” to the guidewire to aid its passage through tortuous and clogged vessels. This maneuver is performed by quickly and stiffly spinning the wire in one&#39;s fingertips. This torque helps curve or manipulate the guidewire through an obstruction or difficult passageway. This technique is also known as “helicoptering”, alluding to the spinning blades of a helicopter. 
     However, applying torque remains difficult since guidewires are extremely thin in diameter and typically have a low friction surface. Additionally, the gloves of a surgeon are often coated with blood or saline solution, further increasing the slickness of the guidewire. In this respect, helicoptering and similar maneuvers can be time consuming and inefficient. This inefficiency not only frustrates surgeons but also increases procedure times and therefore procedure costs. 
     Present guidewire designs attempt to address these problems by providing a torque handle consisting of a plastic tube that is about 0.5 inches in diameter and three inches long that slips over the proximal end of the guidewire and locks in place. The surgeon manipulates this torque device (Olcott Torque Device) to facilitate rotational motion of the guidewire and grip. 
     These current techniques and practices have several problems. First, the current torque devices require a surgeon to concentrate on spinning the guidewire with the attached torque device. The spinning technique greatly depends on the ability of the user and can be difficult to learn. Thus, these devices remain inefficient and often highly dependent on the operator skill. Since it is highly desirably to place a guidewire quickly and therefore finish a procedure quickly, a more consistently controllable guidewire placement device that overcomes these disadvantages is desired. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     It is therefore an object of the invention to provide a strong, non-slip grip on a guidewire. 
     It is another object of the invention to use a powered motor to spin a guidewire on a surgeon&#39;s command. 
     It is another object of the invention to spin the guidewire using a motorized guidewire spinning mechanism to provide optimal torque and technique that would thus be operator (i.e. surgeon) independent. For example, helicoptering with the spinning mechanism by rapidly twisting the guidewire about 180 degrees to the left and then rapidly spinning the guidewire to the right. In another example, rapidly spinning the guidewire in one direction. 
     It is another object of the invention to use a motorized mechanism to helicopter the guidewire in a number of different patterns dependant on the surgeon&#39;s need. Such patterns include, but are limited to a full clockwise rotation, a full counterclockwise rotation, continuous clockwise or counterclockwise rotations or any combination of the above. 
     It is another object of the invention to provide a vibration mechanism to allow the guidewire to vibrate to help the guidewire travel past a distal obstruction. 
     It is another object of the invention to utilize a roller mechanism to attain efficient traction on a guidewire. These rollers may be rubberized to provide traction in case the wire is slippery from liquids or due to a slick coating provided by the manufacturer. 
     It is another object of the invention to, via a roller system, allow for manual control of guidewire spinning using a large cog-like manual control which would “torque” the guidewire using the surgeon&#39;s finger motion. Gears within the system may also be used to maximize the surgeon&#39;s finger motion efficiency. This manual control can be in addition to, or instead of, a motorized embodiment. 
     It is another object of the invention to use a lever-operated system to provide guidewire torque in an alternate embodiment with or without electric motor power. This system provides guidewire torque in a variety of patterns which mimics current surgical technique performed by hand. 
     In one preferred embodiment, the present invention is directed to a guidewire manipulation device for providing a user with guidewire manipulation techniques. Preferably, the guidewire manipulation device includes a lightweight housing (e.g., plastic) in which a powered motor drives a tandem roller assembly. The guidewire is passed through a hole positioned lengthwise through the device where the roller assembly engages the guidewire&#39;s outer surface. 
     The interface of the manipulation device includes a power button that directs the internal roller assembly to roll the guidewire in a desired rotational direction. Additional interface controls are also preferable to provide a different roll patterns, depending upon surgeon preference and guidewire placement efficiency. 
     In an alternate embodiment the roller assembly may be driven by a thumb wheel. Preferably, the roller assembly is spring-loaded, allowing the surgeon to roll the thumb control wheel in one direction and then have the guidewire automatically roll back in the opposite direction. 
     The manipulation device may be reusable or disposable and may include contours to provide an ergonomic grip for the user. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a view of a guidewire manipulation device being used on a patient according to a preferred embodiment of the present invention; 
         FIG. 2A  illustrates a top view of the guidewire manipulation device of  FIG. 1 ; 
         FIG. 2B  illustrates a side view of the guidewire manipulation device of  FIG. 1 ; 
         FIG. 3  illustrates a top open view of the guidewire manipulation device of  FIG. 1 ; 
         FIG. 4  illustrates a bottom open view of the guidewire manipulation device of  FIG. 1 ; 
         FIG. 5  illustrates a cross sectional view of the rollers of the guidewire manipulation device of  FIG. 1 ; 
         FIG. 6  illustrates a side view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 7  illustrates a side view of the guidewire manipulation device of  FIG. 6  with a depressed trigger according to a preferred embodiment of the present invention; 
         FIG. 8  illustrates a side view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 9  illustrates a side view of the guidewire manipulation device of  FIG. 8 ; 
         FIG. 10  illustrates a perspective view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 11  illustrates a side cross sectional view of the guidewire manipulation device of  FIG. 10 ; 
         FIG. 12  illustrates a side cross sectional view of the guidewire manipulation device of  FIG. 10 ; 
         FIG. 13  illustrates a perspective open view of the guidewire manipulation device of  FIG. 10 ; 
         FIG. 14  illustrates a perspective open view of the guidewire manipulation device of  FIG. 10 ; 
         FIG. 15  illustrates a perspective open view of the guidewire manipulation device of  FIG. 10 ; 
         FIG. 16  illustrates a side open view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 17  illustrates a side open view of the guidewire manipulation device of  FIG. 16 ; 
         FIG. 18  illustrates a side view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 19  illustrates a side open view of a guidewire manipulation device according to a preferred embodiment of the present invention; 
         FIG. 20  illustrates a side open view of the guidewire manipulation device of  FIG. 19 ; 
         FIG. 21  illustrates a side open view of a guidewire manipulation device according to a preferred embodiment of the present invention; and 
         FIG. 22  illustrates a side open view of the guidewire manipulation device of  FIG. 21 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  illustrates a preferred embodiment of a guidewire manipulation device  100  which is advanced over a guidewire  102 . As seen in this figure, the guidewire  102  is introduced into the vessel of the patient (e.g., a femoral artery). The manipulation device  100  is slid over the guidewire  102  and selectively locked on to the guidewire  102 . As the guidewire  102  is advance into the patient, the user operates the manipulation device  100  to rotate or vibrate the guidewire  102  as appropriate. 
     For example, as a distal end of the guidewire  102  reaches an angled or curved region of the vessel, the user activates the manipulation device  100  to rotate the guidewire  102  (e.g., in a counter clockwise direction indicated by arrow  103 ), thereby causing the distal end of the guidewire  102  to more easily advance through the angled or curved region. In another example, the distal end of the guidewire  102  reaches an obstruction (e.g., an embolism) but is unable to easily pass. The user then activates the guidewire manipulation device  102  to vibrate (e.g., by rotating between a clockwise and counter clockwise direction quickly), thereby causing the distal end of the guidewire  12  to pass through the obstruction. In another example, the device  100  may include a multiple, preprogrammed rotation patterns appropriate for different vessel configurations (e.g., a 180 degree clockwise rotation followed by 180 degree counter clockwise rotation, a 90 degree clockwise rotation followed by 90 degree counter clockwise rotation or a 30 degree clockwise rotation followed by 180 degree counter clockwise rotation). The device may also include a microprocessor and memory connected to the motor and button  108  for storing and executing the preprogrammed rotation patterns. 
       FIGS. 2A and 2B  illustrate external views of the guidewire manipulation device  100 . As seen in these figures, the guidewire  102  passes through a passage along the length of the device  100 . Preferably, the manipulation device  100  includes a locking assembly in the form of a guidewire lock switch  106  which allows the user to selectively lock the device  100  to the guidewire  102 . In this respect, the device  100  can move relative to the guidewire  102  in an unlocked state, and can move the guidewire  102  in a locked state. 
     The device  100  also preferably includes a power indicator light  104  (e.g., an LED) which indicates if the device  100  is powered on and a rotation button  108  which causes the guidewire  102  to rotate. Optionally, the device  100  may include a button, switch or similar mechanism to toggle the device  100  between rotating in a clockwise direction or a counter clockwise direction. Alternately, the button  108  may include multiple actuation techniques for determining clockwise or counter clockwise rotation (e.g., sliding forward or backward, multiple button presses, etc.). 
     Preferably, an outer container or casing  110  is composed of a light-weight material such as plastic and has an ergonomic shape that at least partially fits in the user&#39;s hand. In this respect, the user can comfortably operate the device  100  during a procedure. 
     Referring to  FIGS. 3 and 4 , an interior view of the device  100  within the outer casing  110  is illustrated according to a preferred embodiment of the present invention. The guidewire  102  is engaged by the device  100  with elongated rollers  120  (also seen in the cross sectional view of  FIG. 5 ). Preferably the device  100  includes at least three rollers, however, any number of rollers  120  are possible (e.g., 1-5 rollers). When the button  108  is pressed, the rollers  120  rotate, thereby rotating the guidewire  102 . Preferably, the lock  106  raises or lowers one or more of the rollers  120  in relation to the guidewire  102 , so as to lock the guidewire  102  with the device  100  when the rollers  120  are pressed against the guidewire  102  and unlock the guidewire  102  from the device  100  when the roller(s)  120  are moved away from the guidewire  102 . 
     One or more of the rollers  120  are preferably driven by a motor  116  which is powered by battery  114  (or alternately by A.C. power such as an outlet). The motor  116  connects to the rollers  120  by a cam  119  made up of a first linkage  118  connected to the motor  116  and a second linkage  112  connected to the roller  120 . In this respect, activation of the motor  116  drives the cam  119  and ultimately rotation of the roller  120 . 
       FIGS. 6 and 7  illustrate another preferred embodiment of a manual manipulation device  130  according to the present invention. The device  130  is generally similar to the previously described device  100 , except that the rollers  120  and therefore rotation of the guidewire  102  is driven by a handle  126 . For example, depressing the handle  126  rotates the guidewire  102  in a clockwise direction (arrow  122 ) and releasing the handle  126  rotates the guidewire  102  in a counter clockwise direction (arrow  124 ). Additionally, switch  124  is included to change a type of rotation caused by the handle  126 . For example, the switch  124  may change a gear ratio and therefore the amount of rotation cause by depressing the handle. In another example, the switch  124  may change directions of rotation caused by depressing the handle  126 . 
       FIGS. 8 and 9  illustrate another preferred embodiment of a manual guidewire manipulation device  132  which is generally similar to the previously described devices  100  and  130 . However, the device  132  includes a selectively locking thumb roller  133  on a distal end of the device  132 . The thumb roller  132  includes a locked mode, seen in  FIG. 8 , in which the roller  134  is engaged with the guidewire  102 , thereby allowing the user to roll the roller  134  and thus the guidewire  102 . The thumb roller  132  also includes an unlocked mode, seen in  FIG. 9 , in which the roller  134  is pulled distally from the casing  136 , exposing space  138  and disengaging the roller  134  from the guidewire  102 . Thus, in the unlocked mode, the device  132  can be moved along the length of the guidewire  102 . 
       FIGS. 10-15  illustrate another preferred embodiment of a guidewire manipulation device  140  according to a preferred embodiment of the present invention. The device  140  is generally similar to the previously described device  100 . For example, the device  140  includes a hand-held (e.g., sized to be held within a users hand), ergonomic, outer case  142  and a manipulation button  144 . As best seen in  FIGS. 11 and 12 , the device  140  also includes a motor  152  powered by a battery  154  and a guidewire passage  158 .
         Preferably, the device  140  includes a locking assembly in the form of a locking hub  146  (similar to the device  132 ) which allows the user to selectively lock the guidewire  102  with the device  140 . The locking hub  146  allows free movement of the guidewire  102  when positioned near the case  142  ( FIG. 17 ) and locks the guidewire  102  when the hub is pulled away from the case  142  ( FIG. 12 ). The hub  146  includes an interior cavity with a top surface angled downward towards the case  142 . Within the interior cavity is a locking wedge  150  which is located within a window  149  of a tube  148  that exposes the guidewire  102 . In the unlocked position of  FIG. 11 , the hub  146  restrains the wedge  150  but does not press down on the wedge  150 , thereby allowing the guidewire  102  to slide underneath the wedge  150 . In the locked position of  FIG. 12 , the angled interior surface of the hub  146  forces the wedge downward against the guidewire  102 , preventing the guidewire from movement relative to the device  140 . A perspective view of the wedge  150  can also be seen in  FIG. 15 .       

     As seen in  FIGS. 11-15 , the motor  152  includes a worm gear  155  that engages a first gear section  156 B of shaft  156 . A second gear section  156 A of shaft  156  engages gearing  158 A on the outer surface of tube  148 . In this respect, when the motor  152  is activated, it ultimately rotates the roller assembly, or tube  148 . Thus, the hub  146  must be in a slid-out, locked position to cause the guidewire  102  to rotate. 
     As with all motorized embodiments described in this specification, the device  140  may also include a microprocessor and memory for storing and executing different rotation sequences (i.e., rotation directions and rotation speeds). 
       FIGS. 16 and 17  illustrate a guidewire manipulation device  170  according to yet another preferred embodiment according to the present invention. The device  170  is generally similar to previously described embodiments, including an outer case  184  having an actuation button  176  that is coupled to a battery  186  and a motor  178 . The gear  180  of the motor  178  is engaged with a gear  182  that is also engaged with a geared section  181  on wedge tube  174 . 
     A hub  174  includes an interior, angled passage that increases in diameter in a distal direction. The wedge tube  174  is partially positioned within the hub  174 . In the unlocked position of  FIG. 16 , the angled passage of the hub  172  complements a distally expanding shape of the wedge tube  174 , thereby preventing the wedge tube  172  from clamping or providing force on the guidewire  102  and thus allowing the guidewire  102  to slide and rotate relative to the device  170 . In the locked position of  FIG. 17 , the hub  172  is moved distally from the case  184 , causing the smaller diameter of the interior passage of the hub  172  to wedge or clamp on to the expanded distal end of the wedge tube  174 . Thus, the wedge tube  174  (preferably composed of a compressible, semi-compressible or deformable material) closes around the guidewire  102 , maintaining the position of the guidewire  102  relative to the device  170  and further allowing rotation of the guidewire  102 . 
       FIG. 18  illustrates another preferred embodiment of a device  190  according to the present invention. The device  190  is generally similar to the previously described devices. However, the device  190  includes a locking assembly in the form of a guidewire lock activated by depressing a trigger  196 . In this respect, the user can rotate hub  192 , either clockwise or counter clockwise to respectively rotate the guidewire  102 . 
       FIGS. 19 and 20  illustrate another preferred embodiment of a guidewire manipulation device  190  according to the present invention. The device  190  is generally similar to the previously described embodiments, including a motor  210  powered by a battery, a gear  214  coupled to an output gear  212  of the motor  210  and to a geared portion  200 B of a wedge tube  200  and a case  194  to contain the components. The motor  210  is controlled by a rocker switch  192  that is connected to a first circuit board  202  which sends the position of the rocker switch  192  to the second circuit board  206 . The second circuit board  206  includes a microprocessor and memory for executing a plurality of rotation programs. These rotation programs direct the motor  210  to make predetermined rotation movements such as in a single direction, exponentially increasing rotational speed, quick rotation to cause vibration or a predetermined series of rotational movements. Thus, more complicated movements can be performed by the user. 
     The device  190  locks on to the guidewire  102  when the user releases trigger  196  (see  FIG. 19 ) and unlocks the guidewire  102  when the user depresses trigger  196 . The trigger  196  moves an outer tubing  198  which is biased in a distal direction by a spring  204 . The interior passage of the outer tubing  198  increases in diameter in a distal direction forming an inverted cone shape. An inner wedge tube  200  is positioned within the passage of the outer tubing  198  and includes a wedge  200 A that increases in size in a distal direction of the device  190 . The guidewire  102  is located within a passage of the wedge tube  200 . 
     When the trigger  196  is released, as in  FIG. 19 , the outer tubing  198  is moved distally by the spring  204 , causing the smaller diameter region of the inner passage of the outer tubing  198  to press against the wedge  200 A of wedge tube  200 . The wedge  200  then compresses around the guidewire  102 , locking the guidewire  102  in place relative to the device  190 . When the trigger  196  is depressed, a portion of the trigger  196  pushes the outer tubing  198  in a proximal direction, against the bias of the spring  204 . The angled portions of the inner passage of the outer tubing  198  move away from the wedge  200   a , allowing the inner passage of the wedge tube  200  to release the guidewire  102 . Thus, the user can selectively lock on to and rotate the guidewire  102  (with the roller assembly, including wedge tube  200 ) by releasing the trigger  196  and pressing the actuation button  192 . 
       FIGS. 21 and 22  illustrate another preferred embodiment of a guidewire manipulation device  220  according to the present invention. The device  220  is generally similar to the previously described embodiments, including a battery  234  powering a motor  236  which drives a wedge tube  224  (via a gear  240  connected to geared region  224 B and output gear  238 ) and an actuation button  228 . 
     The device  220  further includes a locking mechanism assembly that locks the lateral position of the guidewire  102 . As seen in  FIG. 21 , when the user releases the trigger  232 , the device remains in a locked position, allowing the user to rotate the guidewire  102 . As seen in  FIG. 22 , when the user depresses the trigger  232 , the device remains in an unlocked position, allowing the user to slide the device  220  along the guidewire  102  and preventing guidewire rotation. 
     In the locked position, the trigger  232  maintains an outer tube  222  in a proximal position, proximally biased by a spring  226 . The outer tube includes an inner passage that generally decreases in diameter in a distal direction. The inner surface of the outer tube  222  presses against a wedge portion  224 A of a wedge tube  224 , causing the wedge tube  224  to press against and lock onto the guidewire  102 . 
     In the unlocked position, the trigger  232  pushes the outer tube  222  distally, against the bias of the spring  226 . The surface of the inner passage of the outer tube  222  moves away from the wedge  224 A, releasing the wedge tube  224  from the guidewire  102 . 
     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.