Patent Publication Number: US-11389191-B2

Title: Device handle for a medical device

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application claims priority to U.S. Patent Application No. 62/513,207 filed on May 31, 2017, the entire content of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally relates to a device handle for a medical device and method for grinding a substance from an inner wall surface of a body lumen. 
     BACKGROUND DISCUSSION 
     Medical devices are used to remove substances from a living body. As an example, an atherectomy device is used to remove arteriosclerosis from a blood vessel. The atherectomy device is typically configured to be positioned in the living body adjacent the substance to be cut and then the treatment part of the device is then rotated to cut the substance. The debris resulting from this cutting procedure is then removed from the living body. The removal of the cut-away debris can be accomplished by way of a gateway lumen passing through the atherectomy device. 
     Experience has shown that these known devices and methods can result in distal embolization. That is, some of the debris can create an obstruction or blockage resulting in slow flow or no flow in the peripheral vessel. When this occurs, physicians must aspirate the peripheral vessel to remove the debris forming the distal embolization. In very severe cases, it may be necessary to perform amputation. 
     Proposals have been made to address concerns about distal embolization. For example, some atherectomy devices are provided with an aspiration function for removing the debris by way of an aspiration port. However, these solutions have not been found to be particularly satisfactory. In some instances, choking of the aspiration port occurs, thus inhibiting or preventing a continuous aspiration of the desired region. 
     The atherectomy procedure for cutting substance from a living body lumen (removing arteriosclerosis from a blood vessel) typically involves the use of two different guidewires. A first coated guidewire is used to deliver the atherectomy device to the stenotic region or treatment area. After the atherectomy device is located at the desired position, the coated guidewire is removed and a second different guidewire is inserted into the atherectomy device. One way in which the second guidewire differs from the first is that the second guidewire is not coated. This second non-coated guidewire is used during operation of the atherectomy device when the treatment part is rotated at a high speed. 
     The reason two different guidewires are used is that the coated first guidewire is a preferred guidewire for guiding and delivering the atherectomy device to the treatment area. However, the coating on this first guidewire tends to become abraded or damaged during rotation of the treatment part. The abrasion of the rotating treatment part against the coated guidewire can produce coating fragments that may cause distal embolization. 
     SUMMARY 
     A method is disclosed for grinding substances inside a living body, the method comprising: introducing a treatment member into the living body and positioning the treatment member adjacent substance in the living body to be ground; moving the treatment member in at least a clockwise direction or a counterclockwise direction about a central axis, which is different from an axis of rotation of the treatment member while the treatment member is positioned adjacent the substance to be ground in the living body to grind the substance; and shearing debris resulting from the grinding of the substance to reduce a size of the debris. 
     A gearing arrangement is disclosed for a medical device, the gearing arrangement comprising: a first sub gear having a first partial tooth gear; and a second sub gear having a second partial tooth gear, the first sub gear having a plurality of teeth on outer circumference, which engage a plurality of teeth on an outer circumference of the second sub gear, and wherein first and second partial tooth gear are configured to engage a toothed main shaft gear in an alternative arrangement, which causes a main shaft of the main shaft gear to rotate a revolution shaft in a wipe or wiper-like action. 
     A method is disclosed for grinding substances inside a living body, the method comprising: introducing a medical device into the living body and advancing the medical device to a substance, the medical device comprising a treatment member and a revolution shaft located near by the treatment member; rotating the revolution shaft toward one direction; reversing the rotation of the revolution shaft before rotating the revolution shaft by 360 degrees to grind the substance; and shearing debris resulting from the grinding of the substance to reduce a size of the debris. 
     In accordance with an exemplary embodiment, a distal portion of the revolution shaft has angles (or is angled with) respect to a central axis of a proximal portion of the revolution shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of the medical device according to one embodiment. 
         FIGS. 2A and 2B  are cross-sectional views of the distal portion of the medical device, including the treatment member having a bending section positioned in a blood vessel to grind-away a substance in the blood vessel. 
         FIG. 3  is a perspective view of one version of the treatment member forming part of the medical device shown in  FIG. 1 . 
         FIG. 4  is a cross-sectional view of the treatment member illustrated in  FIG. 3 . 
         FIG. 5  is a perspective view of an exemplary handle for a medical device in accordance with an exemplary embodiment. 
         FIG. 6  is a schematic view of a handle for a medical device in accordance with an exemplary embodiment. 
         FIG. 7  is another schematic view of a handle for a medical device in accordance with an exemplary embodiment. 
         FIG. 8  is a view of an indicator on a revolution shaft indicating a direction of bend in accordance with an exemplary embodiment. 
         FIG. 9  is an illustration of bending section of the medical device and the indicator on the revolution shaft indication the direction of bend in accordance with an exemplary embodiment. 
         FIG. 10  is a flow chart illustrating the functions of the handle with a wiper-like action in accordance with an exemplary embodiment. 
         FIGS. 11A and 11B  are cross-sectional views of the wiper-like action of a treatment member inside a blood vessel in accordance with an exemplary embodiment. 
         FIG. 12  is a cross-sectional view of the wiper-like action of a treatment member inside a blood vessel having an up grind action. 
         FIG. 13  is a cross-sectional view of the wiper-like action of a treatment member inside a blood vessel having a down grind action. 
         FIG. 14  a perspective view of a gearing arrangement for a medical device having a treatment member having a wiper-like action in accordance with an exemplary embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In order to facilitate description, dimensional ratios in the drawings are exaggerated, and thus are different from actual ratios in some cases. 
     Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In order to facilitate description, dimensional ratios in the drawings are exaggerated, and thus are different from actual ratios in some cases. 
       FIG. 1  schematically illustrates one embodiment of the medical device representing an example of the inventive medical device disclosed here. This disclosed medical device is configured to grind a substance in a body lumen such as arteriosclerosis in a blood vessel. The terms “grind” and “grinding” as used here are not limited to any particular operation or manner of acting on the substance, and include operations such as grinding, scraping, abrading, ablating, macerating, grinding and otherwise breaking down desired substance or material into particles or other smaller units of material to facilitate removal from the living body (e.g., blood vessel). 
     The medical device  100  shown in  FIG. 1  can be used to grind a stenosis  30  such as shown in  FIGS. 2A, 2B  from a blood vessel  10 , which stenosis can be constituted by a thrombus, calcified lesion, etc. Referring initially to  FIG. 1 , the medical device  100  may include a treatment member  102  and an operation unit  104  configured to transmit a rotation driving force to the treatment member  102  to rotate the treatment member  102 . The operation unit  104  may be housed in a handle  108 . 
     The operation unit  104  includes a motor  28  that produces a rotational output force. The operation unit  104  also includes a drive mechanism section  122  for transmitting or applying the rotational output shaft of the motor  28  to the drive shaft  114 . The drive mechanism section  122  includes a drive gear  124  and a driven gear  120  that mesh with one another so that rotation of the drive gear  124  results in rotation of the driven gear  120 . The motor  128  serves as a driving source and includes a rotatable motor shaft  130  to which the drive gear  124  is fixed so that the motor shaft  130  and the drive gear  124  rotate together as a unit. Operation of the motor  128  causes rotation of the motor shaft  130 , which in turn results in rotation of the drive gear  124 . The proximal end of the drive shaft  114  may be fixed to the driven gear  120  so that the drive shaft  114  and the driven gear  120  rotate together as a unit. Thus, the operation of the motor  128  and the rotation of the motor shaft  130  are transmitted to the treatment member  102  by way of the drive gear  124 , the driven gear  120  and the drive shaft  114 . A power supply section  106  that includes a battery  126  may be provided in the handle  108  and connected to the motor  128  to supply power to the motor  128 . A power cable  110  may be connected to the battery  126  to supply power.  FIG. 1  also shows that the medical device  100  may be provided with an aspiration tube  112  to remove (i.e., draw-away or suck-away) debris resulting the grinding of the substance  30 . 
     The drive shaft  114  may be comprised of a tubular drive shaft that is hollow so that a central lumen extends throughout the entire axial extent of the drive shaft  114 . The drive shaft  114  may preferably be flexible, but also well suited to transmitting the rotational output of the motor unit from the proximal end of the drive shaft  114  to the distal end  117  of the drive shaft  114  at which the treatment member  102  is located. The drive shaft  114  may be any desired construction. For example, the drive shaft  114  may be constituted by a multi-layer structure. As an example, the drive shaft  114  may be configured as a multi-layered coiled tube made from, for example, a polyolefin such as polyethylene or polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine series such as PTFE Polymer, PEEK, polyimide, or combinations thereof. The tubular drive shaft can also be provided with reinforcement. The size of the drive shaft may be appropriately selected. Examples of an appropriate size include an inner diameter of 0.40 mm to 1.40 mm and an outer diameter of 0.6 mm to 1.6 mm. 
     The drive shaft  114  is preferably a tubular drive shaft as mentioned above so that the drive shaft includes a lumen defining a guidewire-receiving passage. The guidewire passes through the lumen in the drive shaft and allows the drive shaft  114  together with the treatment member  102  to be navigated through the living body (e.g., the lumen of a blood vessel) to position the treatment member  102  at the desired place adjacent substance to be ground. 
     The drive shaft  114  may be housed in a tubular outer sheath  116 . The outer sheath  116  may be a tubular body that accommodates the drive shaft  114  so that the drive shaft  114  is rotatable and axially movable relative to the outer sheath  116  and in the outer sheath  116 . The material forming the outer sheath  116  is not limited to a particular material. By way of example, the outer sheath  116  may be made of polyethylene, polypropylene, polyolefin such as polyethylene terephthalate, polyester such as polyamide terephthalate, fluorine-based polymers such as PTFE, PEEK, polyimide, and the like. 
     The operation of the motor  128  can be controlled by way of a switch  132 . Operating or turning on the switch  132  causes the motor  128  to operate and rotate the motor shaft  130 . As a result, the drive gear  124  rotates and in turn rotates the driven gear  120 , which meshes with the drive gear  124 . The rotation of the driven gear  120  results in rotation of the drive shaft  114  and ultimately rotation of the treatment member  102 . 
       FIGS. 2A and 2B  shows a state of grinding a stenosis  30  in a blood vessel  10  using the medical device  100  according to this embodiment. As shown in  FIGS. 2A and 2B , when grinding the stenosis  30  on a vessel wall  20  of the blood vessel  10 . Next, when the drive shaft  114  is rotated, as shown in  FIG. 3 , the rolling structure  101  rotates and the third grinding part  125  and the first grinding part  123  rotate the inside of the living body lumen of the stenosis  30  can be ground. At this time, the diameter of the bottom portion  127  of the constricted portion  126  becomes the first diameter. The diameter of the annular portion  112  (see  FIG. 3 ), and the diameter of the second annular portion  111  (see  FIG. 3 ), it is possible to prevent the first grinding part  123  from coming into contact with the living tissue such as a normal blood vessel, and relatively high safety can be secured. 
     As shown in  FIGS. 2A and 2B , the bending section  118  may be provided in the tubular outer sheath  116  and the drive shaft  114 . This bending section  118  may be provided at an intermediate point along the length of the drive shaft  114  and the outer sheath  116 . In this bending section  118 , the outer sheath  116  and the drive shaft  114  are bent such as illustrated in  FIGS. 2A and 2B . This allows the treatment unit  102  to be manipulated in a way that allows grinding of the stenosis  30  located in a blood vessel  20 . That is, as the drive shaft  114  is rotated by operation of the motor  128 , the treatment member  102  traces a movement path this circular or annular, as opposed to rotating about the central axis of the drive shaft  114 .  FIGS. 2A and 2B  also illustrate that, during operation of the medical device while the treatment member  102  is positioned in the living body (blood vessel) and is being rotated, the distal end portion of the treatment member  102  is positioned distally beyond the distal-most end of the outer sheath  116 . 
       FIGS. 3 and 4  illustrate additional details associated with the treatment member  102  that is connected to the distal end  214  of the drive shaft  114 .  FIGS. 3 and 4  illustrate the centrally located guidewire lumen  115  that may be centrally provided in the drive shaft  114  for receiving a guidewire as discussed above. As mentioned above, during operation of the medical device, the distal end portion of the treatment member  102  is positioned distally beyond the distal-most end of the outer sheath  116 .  FIGS. 3 and 4  show that the treatment member  102  that extends distally beyond the distal-most end of the tubular outer sheath  116  and is thus exposed (for example, the treatment member  102  not covered by the outer sheath  116 ). The treatment member  102  that is exposed distally beyond the distal end of the outer sheath  116  during operation may be comprised of a distal-most end portion  136 , an intermediate portion  138  and a proximal end portion  140 . The intermediate portion  138  is positioned axially between the distal-most end portion  136  and the proximal end portion  140 . The distal-most end portion  136 , the intermediate portion  138  and the proximal end portion  140  may preferably be configured to facilitate grinding of the substance in the body lumen (e.g., stenosis S in a blood vessel BV). One way of accomplishing this result is to provide the distal-most end portion  136 , the intermediate portion  138  and the proximal end portion  140  of the treatment member  102  with a coating that helps facilitate the grinding of the substance in the body lumen. An example of the coating is a diamond grind coating. 
     The distal-most end portion  136  of the treatment member  102  is comprised of a distally tapering portion  142  and a proximally tapering portion  144 . The proximally tapering portion  144  is positioned proximal of the distally tapering portion  142 . The distally tapering portion  142  constantly tapers in a narrowing manner towards the distal-most end of the treatment member  102  while the proximally tapering portion  144  constantly tapers in a narrowing manner towards the proximal-most end of the treatment member  102 . The distal-most end portion  136  of the treatment member  102  also comprises a constant outer diameter intermediate portion  143  positioned between the distally tapering portion  142  and the proximally tapering portion  144 . In the illustrated embodiment, the coating that helps facilitate the grinding of the substance in the body lumen is not provided on the constant outer diameter intermediate portion  143 . Of course, the coating applied to the outer surface of the remainder of the treatment member  102  may also be provided on the outer surface of the constant outer diameter intermediate portion  143 . 
     The intermediate portion  138  may be a tapering portion as illustrated in  FIGS. 3 and 4  in which the intermediate portion tapers in a constant manner along its entire extent from the proximal-most end of the intermediate portion  138  to the distal-most end of the intermediate portion  138 . The intermediate portion  138  tapers towards the distal-most end of the treatment member  102  so that the outer diameter of the intermediate portion  138  gradually narrows in the distal direction. The proximal end portion  140  may possess a constant outer diameter along its entire axial extent as shown in  FIGS. 3 and 4 . 
     The treatment member  102  is also provided with at least one window or through opening  150  that communicates with the hollow interior or lumen inside the treatment member  102 . The treatment member  102  may include a plurality of circumferentially spaced-apart windows or through openings  150 . As mentioned above, each of the windows or through openings  150  opens into and communicates with the hollow interior or lumen (gateway lumen) in the treatment member  102 . The lumen or hollow interior of the treatment member  102  is in communication with the lumen  117  in the outer sheath  116  as shown in  FIG. 4 . The aspiration tube  112  shown in  FIG. 1  is connected to or fluidly communicates with the lumen  117  in the outer sheath  116 . The aspiration tube  112  is connected to an aspiration source or suction device  111  schematically illustrated in  FIG. 1 . 
     During operation of the medical device  100 , the treatment member  102  is rotated by operation of the motor  128  to grind the substance  30  in the body lumen  10  (e.g., stenosis in the blood vessel). While the treatment member  102  is grinding the substance in the body lumen, the suction source  111  is operated to draw debris resulting from the grinding operation through the windows or through openings  150  in the treatment member  102 , into the lumen or hollow interior in the treatment member  102 , and into the lumen  117  in the outer sheath  116 . The debris is then drawn out of or removed from the body lumen by way of the suction device  111 . 
     As illustrated in  FIG. 4 , the proximal end portion of the treatment member  102  includes a reduced outer diameter portion defining a shaft portion  152  of the treatment member  102 . This reduced-outer diameter shaft portion  152  of the treatment member  102  represents a seating region for receiving an outer tubular member  160  representing a shaft bearing or bush member. A lumen extends throughout the entire axial extent of the outer tubular member  160  (i.e., passes through the outer tubular member  160 ), and the reduced-outer diameter shaft portion  152  of the treatment member is positioned in the lumen that extends throughout the entire axial extent of the outer tubular member  160 . The tubular member  160  is rotatable relative to the treatment member  102 . That is, as described above, the treatment member  102  is rotatably driven by way of the drive shaft  114 , and the treatment member  102  rotates relative to the tubular member  160 . 
     An axially extending lumen extends throughout the entire length of the reduced-outer diameter shaft portion  152  (for example, passes through the reduced-outer diameter shaft portion  152 ). This lumen in the reduced-outer diameter shaft portion  152  communicates with and is coaxial with the lumen  115  in the drive shaft  114 . The lumen in the reduced-outer diameter shaft portion  152  is also coaxial with the open end  119  at the distal-most end of the treatment member  102  shown in  FIG. 3  and opens into and communicates with the lumen in the treatment member  102 . 
     A bearing may be positioned between the outer surface of the reduced outer diameter shaft portion  152  and the inner surface of the outer tubular member  160  to facilitate the relative rotation between the reduced outer diameter shaft portion  152  and the outer tubular member  160 . The bearing may be of any desired configuration, including a plurality of roller bearings  162  as shown in  FIG. 4 . The roller bearings  162  help facilitate relative rotation between the treatment member  102  and the outer tubular member  160 . 
     As illustrated in  FIG. 4 , the outer peripheral surface of the outer tubular member  160  may be recessed to define a radially inwardly recessed portion defining a recess  164 . The recess  164  is of limited circumferential extent (i.e., the recess  164  does not extend around the entire circumferential extent of the outer tubular member  160 ) so that the recess  164  possesses a circumferential extent less than 360°, preferably less than 180°. The recess  164  extends from the proximal-most end of the outer tubular member  160  towards the distal end of the outer tubular member  160 . The recess  164  thus opens to the proximal-most end of the outer tubular member  160  and extends less than the entire axial extend of the outer tubular member  160  so that the distal-most end of the recess  164  is defined by a wall  166 .  FIG. 4  illustrates that the recess  164  in the outer surface of the outer tubular member  160  receives a distally extending projection at the distal end portion of the outer sheath  116 . The engagement between the distally extending projection  168  of the outer sheath  116  and the recess  166  in the outer tubular member  160  rotationally fixes the outer sheath  116  and the outer tubular member  160  so that the outer sheath  116  and the outer tubular member  160  do not rotate relative to each other. Thus, when the treatment member  102  is rotated by operation of the motor  128 , the treatment member  102  rotates relative to both the outer sheath  116  and the outer tubular member  160 . The outer tubular member  160  may also include at least one radially inwardly directed protrusion  170 . 
       FIG. 5  is a perspective view of an exemplary handle  200  for a medical device  100  in accordance with an exemplary embodiment. As shown in  FIG. 5 , the handle  200  includes a high-speed drive source (rotational)  210 , a drive shaft  212 , an infusion port  220 , an aspiration port  230 , a seal  240 , a low-speed drive source (‘revolutional”)  250 , gearing arrangement  252 , and an indicator  260  to show a bending direction of the bending section  118 , and a revolution shaft  262 . The revolution shaft  262  has a proximal portion  266 , a distal portion  268 , and a central axis of rotation  267  of the distal portion  268 . In accordance with an exemplary embodiment, the handle  200  also includes a first activation switch  270  and a second activation switch  280 . Although not shown, the handle  200  preferably also houses a power supply section, which can include source of power, for example, a battery, or a connection to a power source to operate the motor and other related electrical components in connection with the high-speed drive source  210  and the low-speed drive source  250 . In addition, the handle  200  can include a microprocessor and/or a microcontroller, an optional memory unit, and electrical circuitry. Alternatively, the motors can be powered and controlled by a separate console. 
     In accordance with an exemplary embodiment, the high-speed drive source  210  is configured to provide a lower torque property than revolution, and can include a motor and a gearing arrangement comprising one or more gears. The high-speed drive source  210  is connected to the drive shaft  212 , which ultimately rotates the treatment member  102  about an axis of the treatment member. The gearing arrangement allows using low speed motors to reduce manufacturing cost. Instead of using the gearing arrangement, the motor can be a motor with a hollow shaft, to which the drive shaft  212  is directly connected to rotate the treatment member  102 . In accordance with an exemplary embodiment, the second activation switch  280  activates the high-speed drive source. The activation switch is activated only when the second activation switch  280  is pressed to rotate the drive shaft until pressed again, which simplifies procedure and shorten the procedure time. Alternatively, in accordance with an exemplary embodiment, the activation switch can have a first position (i.e., “OFF”) and a second position (i.e., “ON”). The drive shaft  212  rotates in the “ON” position until the activation switch  280  is placed in the “OFF” position (i.e., until the rotation button is pressed again or switch to the “OFF” position), which will prevent unintended operation by differentiating the interface of control to the first activation switch  270 . 
     In accordance with an exemplary embodiment, the low-speed drive source  250 , which provides a revolution motion (or revolving action) to the treatment member  102 , and preferably has a higher torque than the high-speed drive source  210 , and is configured to revolve the revolution shaft  262  within the blood vessel  10 , which causes the treatment member  102  to revolve in a circular or rotate, for example, in a wiper-like motion about a central axis, which is different than an axis of rotation of the treatment member  102 . The higher torque revolution provides better transmission of revolution motion to the treatment member, which makes grinding more effective and safe. For example, the central axis can be an axis formed by the outer sheath  116  proximally to the bending section  118 . As set forth above, the operation of the motor (not shown) of the high-speed drive source  210  is controlled by the first activation switch  270 , which causes the revolution shaft  262  to rotate in combination with the gearing arrangement  252 . In accordance with an exemplary embodiment, the gearing arrangement  252  is a pair of gears. In accordance with an exemplary embodiment, the low-speed drive source  250  is only activated upon the pressing of the first activation switch  270  or application of pressure, which simplifies the procedure in combination with the second activation switch  280  and can shorten the procedure time. Upon releasing the first activation switch  270  (or releasing the pressure), the low-speed drive source  250  is no longer activated. Thus, the first activation switch  270  causes a revolution type action, for example, continuous rotation, intermittent rotation, or wiper-like action of the treatment member or flushing, aspiration, or sealing of the medical device  100 . As a result, the treatment member  102  can touch more of the stenosis (or stenosed portion)  30  and make larger luminal gain of the target vessel to provide better blood flow. 
     In accordance with an exemplary embodiment, the rotational speeds of the treatment member  102  and the drive shaft  114 ,  212  are equal and can be, for example, 5,000 revolutions per minute (rpm) to 200,000 rpm. On the other hand, the rotational speed of the revolution shaft  262  can be, for example, 5 rpm to 5,000 rpm. By rotating the drive shaft at a higher speed and the revolution shaft at a slower speed (or lower speed), the luminal gain of the target vessel can be maximized with less vessel injuries. If the revolution shaft is rotated at a higher speed, as it touches to the vessel all over the outer surface of the catheter, the revolution shaft can cause trauma or spasm of the target vessel. The first activation switch  270  may only be activated while the second activation switch  280  is activated, which can help prevent unexpected injury to the vessel wall due to unintentionally touching the first activation switch  270 . 
     In accordance with an exemplary embodiment, rather than a first activation switch  270 , a manual knob (not shown) can be used to rotate the treatment member  102 , for example, in a wiper-like action, which can be useful for operators who prefer manual operations. The manual knob can be connected to a locking and releasing mechanism, which can help prevent the treatment member  102  from rotating when the manual knob is not is use. 
     As shown in  FIG. 5 , the handle  200  includes a housing  202 , which houses the high-speed drive source  210 , the drive shaft  212 , the seal  240 , the low-speed drive source  250 , and the gearing arrangement  252 . The housing  202  is preferably made of a plastic or plastic like material, for example, from an organic polymer. In accordance with an exemplary embodiment, the housing  202  has a generally rectangular shape and can be configured to fit within a hand of a user or operator. 
     In accordance with an exemplary embodiment, the first activation switch  270  and the second activation switch  280  can be located on a distal portion of the housing  202 . In accordance with an exemplary embodiment, the first activation switch  270  and the second activation switch  280  can be operated by thumb holding the handle  200 , which provides single-hand operation. In accordance with an exemplary embodiment, the switches  270 ,  280  can be operated by two or more fingers, for example, the index finger on the first activation switch  270  and the middle finger on the second activation switch  280 . However, depending on the operator, any of the fingers of the operator can be used to operate the first activation switch  270  and/or the second activation switch  280 . 
     The handle  200  can also include an infusion port  220  configured to be in fluid communication with a liquid supply unit, which supplies a lubricant liquid like a saline solution (or physiological salt solution) or the like into the outer sheath  116  to reduce heat generation caused by physical frictions between static and rotating components. In addition, an aspiration port  230  is provided, which is in communication with the aspiration tube  112  to remove (for example, draw-away or suck-away) debris resulting from the grinding of the stenosis  30  (i.e., substance). 
     In accordance with an exemplary embodiment, the handle  200  can also include the wire fixation unit  290 , which is configured to fix, for example, the guidewire  115  during grinding operations of the stenosis  30 , such that that guidewire  115  does not move and is secured during the operation and/or procedure. 
       FIGS. 6 and 7  are schematic views of the handle  200  for a medical device as shown in  FIG. 5  in accordance with an exemplary embodiment. As shown, for example, in  FIG. 6 , the seal  240  is preferably a bearing with a rubber seal, a PTFE O-ring, a silicone ring, or a rubber O-ring, which is configured to prevent air from entering into the aspiration port  230  so that the aspiration can create high negative pressure by liquid tight seal. The seal  240  contacts the outer surface of the revolution shaft  262  and prevents air ingress to the aspiration port  230  even when the revolution shaft  262  rotates during the first activation switch  270  is pressed. As a result, the seal  240  can continuously allow fluids or debris from the stenosis  30  to be aspirated inside the outer sheath  116 , and subsequently removed from handle  200  via the aspiration port  230  even when the revolution shaft is rotating. 
       FIGS. 8 and 9  are views of an indicator  260  on the revolution shaft  262  indicating a direction of the bending section  118  and corresponding treatment member  102  in accordance with an exemplary embodiment. As shown in  FIG. 8 , on a proximal end  264  of the revolution shaft  262 , an indicator  260 , for example, in shape of a triangle or other shape, can be arranged to give an operator a visual indicator of the direction in which a tip  103  of the treatment member  102  and the bending section  118  of the medical device  100  are arranged or positioned within the blood vessel  10  to help the operator with the removal of the stenosis  30 . For example, as shown in  FIG. 8 , the indicator  260  preferably corresponds to a relative position of the tip  103  of the treatment member, for example, as shown in  FIG. 9 . 
       FIG. 10  is a flow chart  300  illustrating the functions of the handle  200  with a wiper-like action in accordance with an exemplary embodiment. In accordance with an exemplary embodiment, the low-speed drive source  250  can be configured to revolve the treatment member  102  in a wiper-like motion, i.e., pivoting of the treatment member  102  in a radial type motion from side to side about the central axis, which is different from the axis of the treatment member  102 . 
     In accordance with an exemplary embodiment, in step  310 , the first activation switch (or button)  270  can be pressed, which causes in step  320 , the voltage within the low-speed drive source  250  to become activated. The activation of the low-speed drive source  250  causes the revolution shaft to rotate in a clockwise direction  332  for a defined period of time (for example, X milliseconds (msec)), which in turn cause the treatment member  102  and bending section  118  to revolve or pivot, for example, in a clockwise direction. After the defined period of time, the revolution shaft  262  rotates in a counterclockwise direction  324  causing the treatment member  102  and bending section  118  to rotate in the same counterclockwise direction for a predefined period of time (for example, Y msec). In accordance with an exemplary embodiment, X msec and Y msec are preferably equal to help ensure that the grinding direction of the treatment member  102  are equal, and which can help lead to a safe and an effective procedure. In accordance with an exemplary embodiment, upon releasing the first activation switch (or button)  270  in step  330 , the voltage is turned off  340  to deactivate the low-speed drive source  250 . 
       FIGS. 11A and 11B  are cross-sectional views of the wiper-like action of a treatment member  102  inside a blood vessel  10  in accordance with an exemplary embodiment. As shown in  FIG. 11A , the blood vessel  10  can have a non-stenosed portion, for example, a healthy vessel without calcification, and a stenosed portion (i.e., stenosis)  30 . 
     As shown in  FIG. 11B , with the wiper-like action of the treatment member  102  as disclosed herein, the treatment member  102  can be directed in wiper-like motion into the stenosed portion (i.e., stenosis)  30 , for example, by rotating the handle  200 . In accordance with an exemplary embodiment, an operator, for example, a physician can direct the wiper direction by rotating the handle  200  to define the grinding side, for example, by observing an angiogram. The wiper (or wiper-like) action or wiper grinding is activated by depressing or pressing the first activation switch  270  as disclosed above. In accordance with an exemplary embodiment, for example, the wiper action can be slower than rotational drive. For example, the speed of the wiper action can be, for example, 5 rpm to 500 rpm (equivalent speed when rotated in one way). In addition, the range of angles can be, for example, 5 degrees to 180 degrees, and preferably 10 degrees to 120 degrees. In accordance with an exemplary embodiment, the time of the wiper action is rather the function of (what should be determined based on) the rotation speed and rotation angle. 
       FIG. 12  is a cross-sectional view of the wiper-like action of a treatment member  102  inside a blood vessel  10  having an up grind action. As shown in  FIG. 12 , an up grind action combining rotation of the treatment member  102  in a clockwise motion and revolution of the treatment member  102  in a the clockwise direction can help provide a better surface finish and can help lessen the impact on the tip  103  of the treatment member  102 . For example, in accordance with an exemplary embodiment, the up grind action can be used for smaller debris (or substances) within the blood vessel, and which can reduce embolization risks. The up grind action can also be obtained by rotating the treatment member  102  and revolution of the treatment device  102  in the same direction. 
       FIG. 13  is a cross-sectional view of the wiper-like action of a treatment member  102  inside a blood vessel  10  having a down grind action. As shown in  FIG. 12 , the down grind action includes rotation of the treatment member  102  in a clockwise direction and revolution of the treatment member  102  in a counterclockwise motion into the stenosed portion (i.e., stenosis)  30 . For example, the down grind action can be performed with tools having for example, a diamond coating, which are durable and exhibit stable grinding performance. The down grind action can also be obtained by rotating the treatment member  102  and revolution of the treatment device  102  in opposite directions. In accordance with an exemplary embodiment, for example, both an up grind and a down grind can be used, which can provide for both durability and better surface finish for better blood flow. This effect is not limited for the wiper-like action but also can be applied to continuous or intermittent revolution actions where the revolution shaft is rotated continuously or intermittently. 
       FIG. 14  a perspective view of a gearing arrangement  400  for a medical device having a treatment member  102  having a wiper-like action in accordance with an exemplary embodiment. As shown in  FIG. 14 , the gearing arrangement  400  can be used in place of a microcontroller to control the clockwise and counterclockwise motion of the treatment member  102  via the revolution shaft  262  about the central axis, which is different from the rotational axis of the treatment member  102 . As shown in  FIG. 14 , the gearing arrangement can include a motor  440 , for example, a revolution motor, which rotates, for example, a first sub gear  420  having a first partial tooth gear  430 . The first sub gear  420  has a plurality of teeth  421  on outer circumference, which engage a plurality of teeth  423  on an outer circumference of a second sub gear  422 . The second sub gear has a second partial tooth gear  432 . The first and second partial tooth gears  430 ,  432  are configured to engage a toothed main shaft gear  410  in an alternative arrangement, which causes a main shaft  412  of the main shaft gear  412  to rotate the revolution shaft  262  in a wiper action (or wiper-like action), that is, in back and forth motion. 
     In accordance with an exemplary embodiment, the first and the second partial tooth gears  430 ,  432  have a series of teeth  431 ,  433  on approximately half the circumference or 180 degrees around the circumference of the gears  430 ,  432 . In addition, one of the first and the second partial tooth gears  430 ,  432  will rotate clockwise, and the other of the first and second partial tooth gears  430 ,  432  will rotate in a counterclockwise direction such that a series of teeth  411  on the main shaft gear  410  will essentially be in contact with one of the first and second partial tooth gears  430 ,  432  continuously, and upon reach an end of the series of teeth of one of the first and the second partial tooth gears  430 ,  432 , the engagement with the other of the first and second partial tooth gears  430 ,  432 , will cause the main shaft gear  410  to rotate in an opposite direction. Thus, with the gearing arrangement  400  as shown in  FIG. 14 , the electrical control of the handle  200  can be simplified and the wiper action can be relatively free from electrical failure. In accordance with an alternative embodiment, the wiper action can be controlled by a microprocessor, which electronically changes the direction of the revolution shaft  262 . 
     In accordance with an exemplary embodiment, the gear arrangements can be replaced any power-transmitting component like pulley, belts, and clutches. 
     The detailed description above describes a device handle for a medical device and treatment method. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.