WO2005030063A1 - Medical treatment instrument - Google Patents

Abstract

A medical treatment instrument, comprising a rotary cutter (3) rotatably and slidably held by a guide wire (1) and rotatingly cutting a blood vessel stenosed site (2), wherein a large number of cutters are formed integrally with each other on the surface of the rotary cutter (3) independently of each other at proper intervals.

Description

 Description Treatment device Technical field

 The present invention relates to a therapeutic device (catheter device) for performing rotary cutting of a deposit in a coronary artery stenosis or other stenosis in a blood vessel to penetrate or expand the stenosis. Background art

 When treating a disease in which deposits adhere to the inner wall of a blood vessel, it is often necessary to insert a catheter device to the area to be treated in the blood vessel to remove the deposits, or to expand a narrowed portion narrowed by the deposits. Done.

 FIG. 17 is a diagram schematically illustrating a method of cutting a sediment.

 First, the small-diameter guide wire 105 is passed through the blood vessel 101 until it passes over the stenosis 27, and the small-diameter catheter device 125 is passed along the guide wire 105. The catheter device 125 has a grindstone 127 (similar to cutting bars 60, 70 described later) and a drive shaft 125 formed of a coiled wire. Then, the grindstone 127 of the catheter device 125 is rotated at a high speed (about 200,000 rpm in one example) to scrape off the sediment 103. First, the diameter of the entrance of the constriction 27 is reduced to about 1 mm. Spread out the centering stone and then let the whole grindstone 127 pass through.

Next, the catheter device 125 is pulled out while leaving the guide wire 105, and then the catheter device provided with a grindstone having a slightly larger diameter is passed along the guide wire. Rotate to scrape off sediment 103. This operation is performed using a guide wire and a catheter device. This is repeated while gradually increasing the diameter of the grindstone, and finally the diameter of the stenosis part 27 of the blood vessel is expanded to about 2.5 mm.

 Thus, conventional treatment instruments used for this type of treatment consist of so-called rotablators. In other words, the rotary cutting lever (rotary grindstone) is rotatably and slidably held by the guide wire passing through the coronary artery stenosis, and the rotary cutting lever is driven at high speed to cause calcification. The coronary artery stenosis is configured to be resected and treated.

 Next, a specific example of the cutting bar (the above-described grindstone 127) will be described with reference to FIGS. 15 and 16.

 FIG. 15 is a partial cross-sectional view showing a cutting lever of a conventional treatment instrument in relation to an intravascular stenosis.

 The cutting bar 60 shown in FIG. 15 is driven to rotate at high speed around a guide wire (not shown) as a center axis. Diamond abrasive grains 61 are bonded to the surface of the cutting bar 60. The diamond abrasive grains 61 have a mixture of large and small particle diameters, and the surface is covered with a plating layer 62.

 Such a cutting bar 60 is a device capable of performing an effective treatment for rotating and resecting deposits in a vascular stenosis 2 such as a calcified coronary artery. In this case, the cutting force and the size of the cutting powder on the intravascular stenosis 2 correspond to the force pressing the cutting bar 60 against the intravascular stenosis 2.

 FIG. 16 is a cross-sectional view showing different cutting structures of a cutting lever of a conventional treatment instrument.

 In the case of the cutting bar 70 shown in FIG. 16 (A), a cutting blade 71 of normal size is formed on the surface in place of the diamond abrasive grain 61 of FIG. By using the cutting bar 70 having such a cutting blade 71 on the surface, it is possible to remove the deposits in the intravascular stenosis 2.

The conventional treatment device is configured as described above. In the case of shaving par 60, diamond cutting grains 61 fall off due to the cutting reaction force from the hardened calcified sediment when cutting the sediment in the intravascular stenosis 2 and flow downstream in the blood vessel to remove peripheral blood vessels. There was a risk of clogging. In addition, diamond abrasive grains 61 change the size of the cutting powder depending on the force and speed of pressing the cutting surface against the sediment, so that the cutting powder is often quickly and strongly pressed against the sediment. There was a problem of growing and clogging peripheral blood vessels.

 On the other hand, in the case of the cutting bar 70 shown in FIG. 16, when the diameter is further expanded after the initial resection of the intravascular stenosis 2, the cutting bar 70 itself is compressed in the axial direction and plastically deformed in the expanding direction. However, as shown in FIG. 16 (B), there is a problem that a crack 72 is formed on the cutting edge 71 or the cutting edge 71 is deformed, so that the cutting ability is greatly reduced.

 The cutting bars 60 and 70 have a strong structure in which the surface is a ground surface to which abrasive grains are attached, and do not have a diameter expansion mechanism. Therefore, in cases where a calcified intravascular stenosis is to be expanded to a diameter larger than the diameter that originally penetrated it, the rotary cutting bar (grinding wheel 127 in Fig. 17) was driven by a drive shaft (drive shaft 1229). ) Must be completely removed from the guide wire (105) and replaced with a larger diameter wire. In the past, nearly 40% of cases used a cutting bar (grinding wheel 127) and a drive shaft (drive shaft 127), two with a large diameter and one with a small diameter. (The average number used per case is 1.4), but it was necessary to replace it in a clean area in the operating room.

 Here, since the conventional cutting bars 60 and 70 are integrated with the drive shaft (drive shaft), it is necessary to work according to the following steps (1) to (4) to replace them. There was a problem.

① Separate the drive shaft (drive shaft 1 29 in Fig. 17) from the drive control section. The

 ② Pull out the drive controller from the guide wire.

 (3) Pull out the rotary cutting par and drive shaft (grinding wheel 127 and drive shaft 122) completely out of the body once, and also from the guide wire.

 ④Pass the rotary cutting bar with a large diameter and the drive shaft (grinding wheel 127 and drive shaft 122) through the guide wire.

 さ せ る The rotating cutting bar (grinding wheel 127) reaches the affected area of the coronary artery.

 通 Pass the drive controller through the guide wire.

 ⑦ Connect the drive control unit to the large diameter rotary cutting bar and drive shaft (grinding wheel 127 and drive shaft 122).

 The present invention has been made in view of the above-mentioned problems, and has been made to leave a guide wire in a blood vessel when performing further diameter expansion treatment of the intravascular stenosis following the initial treatment of the intravascular stenosis. It is an object of the present invention to provide a treatment instrument that can expand the diameter of a rotary cutter on a guide wire without removing the rotary force cutter from the guide wire.

 Another object of the present invention is to provide a therapeutic instrument capable of easily expanding the diameter of a rotating force cutter drawn out of the body along the guide wire left in the blood vessel.

 Another object of the present invention is to provide a therapeutic instrument capable of rapidly and effectively resecting a stenosis in a blood vessel using a rotary cutter. Disclosure of the invention

 In order to solve the above-mentioned problems, a treatment instrument according to a first aspect of the present invention includes a guide wire that passes through a stenosis in which a deposit is deposited in a blood vessel and extends outside the body.

This guide wire guides freely and slides freely. A rotational force cutter for rotationally cutting the deposit in the intravascular stenosis,

 While connecting to this rotating force

A hollow drive shaft through which the guide wire passes, a fixed sheath through which the drive shaft passes,

 A controller having a rotation drive unit of the drive shaft, a treatment instrument for performing treatment such as penetration of the intravascular stenosis by the rotational force cutter, such as diameter expansion,

 On the surface of the rotating force

A large number of independent minute cutting blades are formed integrally with the base material of the cutter.

 In the treatment instrument according to the first aspect of the present invention, when the rotary cutter further expands the diameter of the intravascular stenosis after cutting treatment of the intravascular stenosis by the cutter, the rotary cutter compresses the intravascular stenosis in the axial direction to expand the stenosis. It can be plastically deformable.

 In this case, the cutting reaction force applied to the surface of the rotary cutter when cutting the affected part becomes small. For this reason, the thickness of the rotary cutter can be reduced, so that even if the rotary cutter is plastically deformed and its diameter is increased, no cracks are generated in the micro cutting blade or the micro cutting blade is not deformed. Therefore, a decrease in cutting ability can be suppressed.

 The therapeutic device according to the second aspect of the present invention includes a guide wire that passes through a stenotic portion where a deposit is deposited in a blood vessel and extends outside the body.

 A rotary force cutter that is rotatably and slideably guided by the guide wire and rotatably cuts deposits in the intravascular stenosis;

 A hollow drive shaft connected to the rotating force meter and through which the guide wire passes;

A fixed sheath through which the drive shaft is passed; A controller having a rotary drive unit of the drive shaft, and another medical treatment rotating force meter having a cutting surface outer diameter larger than a cutting surface maximum outer diameter of the rotary cutter (initial cutting rotary cutter). A large number of independent minute cutting blades are formed integrally with the base material of the cutter, on each surface of the initial cutting rotary power cutter and the treatment rotary power cutter.

 When the intravascular stenosis is further expanded after cutting treatment of the intravascular stenosis by the initial resection rotator, the treatment rescue rotator is attached to the body on the guide wire. At the time of the connection, the cutting blades of the two rotating force meters are configured to be sufficiently small and arranged so as to be linked at appropriate intervals in the direction of resection of the affected part. .

 In the treatment instrument of the present invention, the micro-cutting blade comprises a fine uneven portion formed on the outer peripheral surface of the cutter,

 The height, depth, width, and length of the irregularities are limited to dimensions such that the size of the cutting powder of the sediment cut by the cutter is 10 microns or less. Things.

 In this case, it is possible to eliminate the possibility that peripheral blood vessels are clogged by the cutting powder of the affected part.

 In the treatment device of the present invention, the uneven portion is formed in a shape that is elongated along the rotation direction of the cutter, gradually deepens from a front end to a rear end in the direction, and rises sharply at the deepest portion. It may have an elongated groove portion or a protruding cutting blade portion rising from the cutter surface at the deepest portion of the elongated groove portion.

In the treatment instrument of the present invention, the micro-cutting edge is formed by any one of laser processing, electric discharge processing, etching processing, press processing, pressure welding processing, and cutting processing. In addition, the force cutter may be formed on the surface of the base material.

 In this case, a minute cutting blade can be easily formed.

 In the treatment instrument of the present invention, the cutting surface forming regions of the plurality of minute concave and convex portions forming the minute cutting blade may be arranged so as to overlap each other.

 In this case, each micro-cutting blade can be individually and densely formed on the surface of the rotary force cutter. Therefore, the uncut portion of the stenosis in the blood vessel can be reduced.

 In the treatment instrument of the present invention, the plurality of minute uneven portions forming the minute cutting blades include an uneven portion in which a cutting surface faces a normal cutter rotation direction, and a cutting surface in a direction opposite to a normal cutter rotation direction. And an uneven portion facing the surface.

 In this case, it is possible to change the cutting force between the one-way rotation and the other-direction rotation of the rotary force meter. Therefore, cutting treatment can be performed according to the symptoms of the affected area.

 In the treatment instrument of the present invention, the surface of the force cutter may be mirror-finished.

 Alternatively, the powerter surface may be coated.

 In these cases, frictional heat generated between the affected part and the affected part can be suppressed. In the treatment instrument of the present invention, the rotary cutter is axially compressed by a jig arranged in advance on or near the drive shaft so as to be plastically deformed in the radially enlarged direction. It can be said that.

In the treatment instrument of the present invention, the medical treatment rotary cutter is The initial cutting rotary force cutter may be press-fitted or covered with a jig arranged in advance on the same axis as or close to the shaft.

 In the treatment device of the present invention, the jig may have a grasping-operation-type lever mechanism that can be operated with one hand by applying a booster mechanism using a lever or a cam.

 In this case, the initial resection rotator and the treatment rotator can be easily combined.

 In the treatment instrument of the present invention, the controller has a mechanism for pushing out the rotary cutter from a distal end of the fixed sheath to a diseased side in front and a mechanism for pulling back to a near side,

 These mechanisms may be adapted to be operated by a grasping operation lever provided with an automatic return mechanism and a position holding mechanism.

 In this case, it is possible to easily perform the operation of pushing and retracting the rotating force meter from the distal end of the fixed sheath to the front of the affected part.

 In the treatment instrument of the present invention, the controller may include a vibration imparting mechanism that applies a reciprocating vibration motion to the rotary cutter in a direction along the guide wire.

 In this case, the cutting force due to the rotation and the cutting force due to the reciprocating motion can be applied to the rotating cutter in a superimposed manner, so that the cutting force at the stenosis in the blood vessel by the rotating force cutter can be increased or stabilized. In addition, friction when the rotating cutter and the fixed sheath are inserted into the guiding catheter can be reduced to facilitate insertion.

In the treatment instrument of the present invention, the controller includes a drive unit that applies a rotational force to the drive shaft, The drive unit may include a motor having a hollow rotating shaft that can pass through the drive shaft.

 In this case, the drive shaft can be easily pulled out of the body along the guide wire without completely pulling out the drive shaft from the guide wire.

 In the treatment instrument of the present invention, the controller may include a chucking mechanism for the drive shaft and a detachable mechanism for the soft sheath.

 In this case, the rotation driving force can be reliably transmitted to the drive shaft by the chucking mechanism. Furthermore, the fixed sheath can be easily removed from the controller during maintenance inside the controller. Brief Description of Drawings

 FIG. 1 is a perspective view illustrating a use state of a treatment instrument according to a first embodiment of the present invention.

 FIG. 2 is an enlarged perspective view showing a controller of the treatment instrument of FIG. FIG. 3 is a partial perspective view showing the controller of FIG. 2 with a part cut away. FIG. 4 is a perspective view showing a turning force meter of the treatment instrument according to the first embodiment of the present invention.

 FIG. 5 is a radial cross-sectional view partially showing a cutting surface of the rotary cutter of FIG.

 FIG. 6 is an axial sectional view of FIG.

FIG. 7 (A) is a perspective view showing a state before the rotary cutter for initial resection and the rotary cutter for medical treatment are combined, and FIG. 7 (B) is a perspective view showing a state where both cutters of FIG. 7 (A) are combined. . FIG. 8 is a cross-sectional view partially showing a turning force meter of the treatment instrument according to the second embodiment of the present invention.

 FIG. 9 is an explanatory view showing an example of processing a micro-cutting blade of the turning force meter of the treatment instrument according to the present invention.

 FIG. 10 is a partial cross-sectional view showing a cutting portion structure of a turning force meter of a treatment instrument according to a fourth embodiment of the present invention.

 FIG. 11 is a partial cross-sectional side view of a rotary cutter enlarging jig of a treatment instrument according to a fifth embodiment of the present invention.

 FIG. 12 is a side sectional view showing a structure of a controller of a treatment instrument according to a sixth embodiment of the present invention.

 FIG. 13 is an enlarged side sectional view showing the structure of the main part of the controller of the treatment instrument shown in FIG.

 FIG. 14 is a side cross-sectional view showing a state where the sheath connector of the controller of the treatment instrument of FIG. 12 is removed.

 FIG. 15 is a partial cross-sectional view showing a cutting lever of a conventional treatment instrument in relation to an intravascular stenosis.

 FIG. 16 is a cross-sectional view showing different cutting structures of a cutting lever of a conventional treatment instrument.

 FIG. 17 is a diagram schematically illustrating a method of cutting a sediment. BEST MODE FOR CARRYING OUT THE INVENTION

 Hereinafter, description will be made with reference to the drawings.

 FIG. 1 is a perspective view illustrating a use state of a treatment instrument according to a first embodiment of the present invention.

In the lower left part of FIG. 1, an intravascular stenosis 2 which is a target site of the treatment is shown. In the state shown in this figure, the distal end of the treatment instrument is inserted into the part 10. Yes.

 This treatment device has a guide wire 1. The guide wire 11 passes through the intravascular stenosis 2 and extends outside the body. The guide wire 1 holds a rotary cutter (rotary cutter for initial cutting) 3. The rotary cutter 3 for initial resection rotates about the guide wire 11 as a central axis, and can slide freely along the wire 1. The details of the rotary cutter 3 will be described later.

 The rear end of the rotary cutter 3 is connected to the drive shaft 4. The drive shaft 4 is a hollow member made of a soft flexible material. The drive shaft 4 is slidably inserted into a fixed sheath 5 which is a flexible cover tube. The fixed sheath 5 is passed through a guiding catheter 6. A controller 10 is connected to the rear end of the guiding catheter 6. The controller 10 has a built-in drive mechanism for driving the drive shaft 4 to rotate at high speed and reciprocatingly oscillate.

 Hereinafter, the controller 10 will be described in detail with reference to FIGS.

FIG. 2 is an enlarged perspective view showing a controller of the treatment device shown in FIG. 1. FIG. 3 is a partial perspective view showing the controller shown in FIG. 2 with a part cut away. As shown in FIG. 2 and FIG. The controller 10 is provided with a rotational force cutter (a rotary cutter for treatment) 7. The rotary cutter 7 is a rotary power cutter different from the above-described rotary power cutter 3 for initial cutting. The turning torque meter 7 for treatment has an outer diameter of the cutting face which is larger than the maximum diameter of the cutting face of the turning torque meter 3 for initial resection. The treatment rotary cutter 7 is a drive shaft. It is rotatably and freely slidably held by the extracorporeal part 4. The rotary cutter 7 is detachably fitted and held in a pedestal hole 12 provided in the front end wall of the housing 11 of the controller 10.

 A jig 13 is slidably attached to the front end of the housing 11 of the controller 10. The jig 13 is a jig for fitting the rotary cutter 3 for initial resection and the rotary force cutter 7 for treatment by fitting. The jig 13 has a bent end piece 13a. The bent end piece 13a is bent at the end of the jig 13 (a portion extending forward from the front end of the housing 11). A notched slit 13b is formed in the bent end piece 13a. On the other hand, a cam engaging piece 13c (see FIG. 3) is bent at the rear end of the jig 13 (a portion located in the housing 11). Although not shown in FIG. 2 and FIG. 3, the front bent piece 13a is formed with a force turret fitting portion facing the pedestal hole 12.

 A jig operation lever 14 is pivotally supported on the housing 11 of the controller 10. A cam 15 is connected to the rotation shaft of the operation lever 14. The cam 15 is engaged with a cam engaging piece 13 c at the rear end of the jig 13. The engagement between the cam 15 and the cam engaging piece 13c enables the jig 13 to move forward and backward with the operation of the jig operating lever 14.

 Next, the rotary cutter 3 for initial resection and the rotary power cutter 7 for medical treatment will be described in detail with reference to FIGS.

 FIG. 4 is a perspective view showing a turning force meter of the treatment instrument according to the first embodiment of the present invention.

 FIG. 5 is a radial cross-sectional view partially showing a cutting surface of the rotary force meter of FIG.

 FIG. 6 is an axial sectional view of FIG.

Figure 7 (A) shows the state before the rotary cutter for initial resection and the rotary cutter for medical treatment are combined. 7 (B) is a perspective view showing a state in which both cutters in FIG. 7 (A) are connected.

 The rotational force cutter 3 for initial resection shown in these figures has a large number of minute cutting blades 300 on the surface. These cutting blades 300 are formed integrally with the cutter base material so as to be independent of each other at appropriate intervals. On the other hand, the treatment rotary force cutter 7 also has a large number of minute cutting edges 700 formed on the surface. These cutting edges 700 are also formed integrally with the power base material so as to be independent of each other at appropriate intervals. As shown in FIG. 5, the cutting blades 300, 700 are formed by minute concave portions 301, 701, and convex portions 302, formed on the respective surfaces of the cutters 3, 7, respectively. 7 0 2 and power.

 More specifically, the concave portions 301 and 0.701 are formed by elongated grooves along the rotation direction of the cutters 3 and 7, respectively. The elongated grooves 301 and 701 are elongated along the rotation direction of the cutters 3 and 7, and have a shape that gradually becomes deeper from the front end to the rear end in the rotation direction and rises sharply at the deepest part. It has been. On the other hand, the protruding portions 302 and 702 form a protruding cutting blade portion rising from the surface of the force cutter at the deepest portion of the elongated groove portions 301 and 701. These cutting blade portions 302 and 720 are formed in a front circular shape (see FIG. 6) in the rotation direction of the cutters 3 and 7. In addition, the back wall portion which gradually lowers from the rising edge of each cutting blade portion (convex portion) 302, 702 in the direction opposite to the rotation direction of each cutter 3, 7 3 are formed.

 The width W of the elongated grooves 301 and 701 and the cutting blades 302 and 702 and the height H of the cutting blades 302 and 702 from the surface of the power meter are The size of the cutting powder of the sediment in the intravascular stenosis part 2 due to the high-speed rotation of 1 and 7 is set to be 10 microns or less.

Next, the endovascular stenosis 2 was resected using the treatment device of the first embodiment. The operation will be described.

 First, in the initial resection treatment, the guide wire 1 is inserted into a blood vessel, and the tip of the guide wire 1 is passed over the intravascular stenosis 2. Then, the initial resection rotator 3 is advanced to the intravascular stenosis 2 along the guide wire 1 while rotating at a low speed. When the rotary power cutter 3 reaches the intravascular stenosis 2, the power rotary cutter 3 is rotated at a high speed upon arrival. Then, the intravascular stenosis 2 is initially resected with a large number of minute cutting blades 300 of the rotating force cutter 3.

 To continue the initial resection and further expand the diameter of the intravascular stenosis 2, keep the guide wire 1 inside the body (inside the blood vessel) and dry-shaft the rotating force cutter 3 along the wire 1. Pull it out together with 4 and sheath 5 once. The rotary cutter 3 pulled out of the body is not pulled out of the guide wire 1 but is fitted into the medical treatment rotary force cutter 7 fitted in the pedestal hole 12 of the controller 10 as shown in FIG.

 In this state, the jig 13 is moved to the housing 11 side by the jig operation lever 14. Then, the rotary cutter 3 for initial resection is pressed into the rotary cutter 7 for medical treatment. As a result, the two cutters 3 and 7 are combined and integrated, and the initial cutting rotational force cutter 3 is expanded in diameter by the treatment rotational force cutter 7.

After the cutters 3 and 7 have been integrated in this way, open the jig 13 to remove the integrated cutters 3 and 7 (unit cutter), and fix the unit cutter on the guide wire 1. It moves to the patient side from the bent end piece 13a of the tool 13. In this state, while rotating the unit cutter at a low speed, the device is inserted along the guide wire 1 that has been inserted into the blood vessel to the intravascular stenosis 2 after the initial resection. Then, the unit cutter is rotated at a high speed. Then, the remaining blood vessel 內 stenosis is cut with the cutting blade portion 70 2).

 According to the first embodiment described above, the initial cutting of the intravascular stenosis portion 2 by the initial resection rotational force cutter 3 and the intravascular stenosis portion by the unit cutters of the two rotary cutters 3 and 7 are performed. At the time of diameter-enlarged cutting, it does not fall off like diamond abrasive grains of conventional cutting bars, and the affected area can be efficiently and safely cut. In addition, the small cutting edges 300, 700 of the cutters 3, 7 are arranged such that the cutting blade portions 302, 720 are sufficiently small and are arranged at appropriate intervals. It is also unlikely that sections 302 and 7.02 will be deformed by the cutting reaction force. Therefore, sufficient cutting force can be secured.

 Further, the treatment instrument of the first embodiment has a configuration in which the elongated groove portions 301 and 701, and the cutting blade portions 302 and 702 of each of the minute cutting blades 300 and 700 are set. As a result, the size of the cutting powder of the sediment in the intravascular stenosis part 2 cut by the cutters 3 and 7 becomes 10 μm or less, so that there is no possibility that peripheral blood vessels are clogged by the cutting powder of the affected part.

 Furthermore, in the treatment device of the first embodiment, the small cutting blades 300 and 700 have sufficiently small sizes and are arranged at appropriate intervals. Even if integrated, the connection of each cutting surface (micro cutting edge 300, 700) becomes smooth. In addition, since the minute cutting edges 300 and 700 can be arranged at the extremely end portions of the cutters 3 and 7, the minute cutting edges 300 and 700 are also located in the vicinity of the joint surface between the cutting surfaces of the cutters 3 and 7. Blades 300 and 700 can be arranged. Therefore, the minute cutting edges 300 and 700 can be prevented from being greatly interrupted between the cutters 3 and 7.

Further, according to the treatment device of the first embodiment, when the diameter expansion treatment is performed again after the resection treatment of the intravascular stenosis 2, the controller 10, the rotary cutter 3, the drive shaft 4, and the like are conventionally used. Pull out all of the fixed sheath 5 completely _{6 It} is not necessary to replace the rotary cutter 3 with a new one. The treatment instrument according to the first embodiment can easily expand the cutting surface of the power cutter by simply attaching another medical power rotary cutter 7 to the rotary power cutter 3 on the guide wire 1 extending outside the body. Can be diameter. For this reason, the stepwise resection treatment of the intravascular stenosis can be performed promptly and efficiently.

 FIG. 8 is a cross-sectional view partially showing a turning force meter of the treatment instrument according to the second embodiment of the present invention.

 In the rotary cutters 3 and 7 of the second embodiment, the cutting surface forming regions of the plurality of minute concave and convex portions forming the minute cutting edges 300 and 700 are arranged so as to overlap each other. ing.

 According to the rotary cutters 3 and 7, the minute cutting blades 300 and 700 can have a cutting section structure in which the micro cutters 300 and 700 are individually and individually densely arranged on the surfaces of the rotary cutters 3 and 7. Therefore, the uncut portion of the affected part can be reduced.

 FIG. 9 is an explanatory view showing an example of processing a micro-cutting blade of the turning force meter of the treatment instrument according to the present invention.

 FIG. 9 (A) shows an example of machining the micro cutting blade 300 of the rotary cutter 3 for initial cutting. In this figure, the rear outer peripheral surface (larger outer peripheral surface) of the rotary cutter 3 is chucked by the chuck claw 100. The center fixed shaft 101 is pressed against the shaft center of the small diameter end of the rotary cutter 3. Then, the minute cutting blade 300 of the rotary cutter 3 is cut with a diamond needle 102. That is, this diamond needle 102 is pierced into the surface of the base material of the rotary force cutter 3 to a certain depth to cut the minute cutting blade 300.

FIG. 9 (B) shows an example of processing of the micro cutting edge 700 of the treatment rotary cutter 7. In this figure, one end of the ring-shaped rotary cutter 7 is fitted It is fitted into the holder 1 shaft 1 ◦3. The other end of the rotary force cutter 7 is fixed to a fixing screw 104. In this case as well, as in FIG. 9 (A), a diamond-dollar 102 is pierced into a predetermined position on the surface of the base material of the rotary cutter 7 to a certain depth, and the micro cutting blade 700 is cut. You.

 With such a processing method, minute and independent cutting edges 300 and 700 can be easily formed on the respective surfaces of the cutters 3 and 7 at appropriate intervals.

 Although FIG. 9 shows a method of forming the convex portion by plastic working, other methods that can form the convex portion, for example, a processing method such as laser, electric discharge, etching, press, pressure welding, and cutting may be used. Good. With laser or electric discharge, the rim is formed in a convex shape around the processing point like a crater without evaporating the workpiece. In the etching, for example, the powder is discretely attached and then etched, and the powder is melted so that the back surface of the powder remains as a projection. In addition, press and cutting are dug up to make a paris, and make a convex part. In pressure welding, the powder is crushed so that it sticks to the surface as a projection.

 FIG. 10 is a partial cross-sectional view showing a cutting portion structure of a turning force meter of a treatment instrument according to a fourth embodiment of the present invention.

 The rotating force cutter 3 according to the fourth embodiment is formed so as to be plastically deformable, and has a plurality of minute cutting blades 300 independent of each other at appropriate intervals on the surface. Such a rotary cutter 3 performs an initial cutting treatment of a stenosis in a blood vessel in a state before plastic deformation shown in FIG. 10 (A). Then, when the stenosis in the blood vessel is further expanded after the initial cutting treatment, as shown in FIG. 10 (B), the stenosis is axially compressed and plastically deformed in the expanding direction.

According to the rotational force cutter 3 of the fourth embodiment, the cutting reaction force applied to the surface of the rotational force cutter 3 at the time of cutting the affected part is reduced. Because in Figure 15 ₍₁ ) In the diamond cutting blade shown in the figure, diamond grains that point in one direction act as cutting blades because the individual directions are random, but other than that, they simply act as obstructive protrusions that increase friction Because. On the other hand, as shown in FIG. 5, the cutting blade of this embodiment has the blades aligned only in the direction of the piece, so that the cutting reaction force is small. In addition, the concave part around the convex part acts as a friction surface during cutting, but if that surface is made a mirror surface, the cutting reaction force will be reduced. In addition, the cutting edge may be worn after cutting. For example, in Fig. 9, the surface may be coated with a hard plating layer. By reducing the cutting reaction force in this manner, the thickness of the rotary cutter 3 can be reduced, so that even if the rotary force cutter 3 is plastically deformed and its diameter is increased, a crack is generated in the micro cutting blade 300, The micro cutting edge 300 does not deform. Therefore, a decrease in cutting ability can be suppressed.

 FIG. 11 is a partial cross-sectional side view of a rotary cutter enlarging jig of a treatment instrument according to a fifth embodiment of the present invention.

 The jig 16 shown in FIG. 11 has a lever mechanism that can be operated with one hand. The jig 16 is a pair of lever-operated operating levers 1 rotatably connected by an axis P.

6 A and 16 B are provided. At the end of one operating lever 16 A, a pedestal

17 are linked together. The pedestal 17 has a hole 17 a, a pedestal hole 17 b for fitting and holding the medical treatment rotary power meter 7, and a notched slit for fitting the fixing case 5. G 17c is formed.

 A pressure member 18 is slidably inserted into the hole 17 a of the pedestal 17. The pressure member 18 has a substantially L-shaped cross section, and includes an engagement piece 18a that engages with the tip of the other operation lever 16B. In addition, the pressing member 18 has a power cutter one-fitting recess 18 b for fitting the rotational force cutter 3 for initial resection, and a notch slit for fitting the guide wire 1.

18 c is formed. When using the jig of the fifth embodiment, as shown in FIG. 11 (A), the medical treatment rotary force cutter 7 is previously fitted and held in the pedestal hole 17 b of the pedestal 17. In advance, the rotational force cutter 3 for initial resection is fitted into the cutter 1 fitting concave portion 18 b of the pressing member 18. In this state, when the operation levers 16A and 16B are gripped, the middle shaft portion 3b of the initial cutting rotational force cutter 3 is pressed into the annular medical treatment rotary cutter 7. As a result, both cutters 3 and 7 are integrally connected as shown in FIG. 11 (B), and the cutter cutting surface is enlarged.

 FIG. 12 is a side sectional view showing a structure of a controller of a treatment instrument according to a fifth embodiment of the present invention.

 FIG. 13 is an enlarged side sectional view showing the structure of the main part of the controller of the treatment instrument shown in FIG.

 FIG. 14 is a side sectional view showing a state where the sheath connector of the controller of the treatment instrument in FIG. 12 is removed.

 As shown in FIG. 12, the controller 10 has a housing 11. The housing 11 is integrally formed so that the grip 11 A stands up. A grip lever 30 is attached to the grip 11A. The grip lever 30 incorporates a lever core 31, and the lever core 31 is pivotally supported by the grip 11 A via the shaft P 1.

A lock lever 32 is connected to the shaft P1. A motor holder 33 is attached to a lower portion 31 a of the lever core 31 in the housing 11 at a position separated from the shaft P 1 below. A guide slit 34 is formed on a mounting piece of the motor holder 33 to the lever core 31. A guide bin 35 protruding from the lower end of the lever core 31 is slidably fitted into the guide slit 34. Motor holder 3 to 3 ^ Motor 36 is held. An eccentric cam 37 is fitted on the output shaft of the motor 36. A bearing holder 39 is fitted on the outer periphery of the eccentric cam 37 via a bearing 38. Bearing holder

At the center of the bottom of 39, a hanging shaft 39a is provided on the body.

 A cylindrical slider 40 is built in the housing 11. The slider 40 is connected to the hanging shaft 39 a of the bearing honoreda 39 such that the slider 40 can reciprocate in the axial direction of the drive shaft 4. The slider 40 is biased by the spring 41 in the retreating direction (the direction in which the drive shaft 3 is pulled out from the body). On the inner circumference of slider 40, an armature iron core

4 2 are arranged. A rotor magnet 44 is arranged inside the armature iron core 42 via an armature coil 43. The slider 40 incorporates a Hall sensor 45. Here, the slider 40, the armature iron core 42, the armature coil 43, the rotor magnet 44, and the hole sensor 45 are provided in the housing 11 with a brushless motor part 46 for rotationally driving the drive shaft. Is composed.

Inside the rotor magnet 44, a sleeve-shaped hollow rotary shaft 47 is rotatably arranged. A sleeve-shaped check member 48 is inserted into the hollow rotary shaft 47 so as to be movable in the axial direction. At one end (front end) of the chuck member 48 in the axial direction, a chuck claw 48 a for chucking the drive shaft 4 is integrally formed. The chuck claw 48 a is reduced in diameter by engaging with one end of the hollow rotary shaft 47 in the axial direction, and chucks the drive shaft 4. Also, the drive shaft 4 is released from the chucking by moving in a direction away from the engagement position with the one end of the hollow rotary shaft 47 in the axial direction. A chuck jaw assembly 49 is screwed to the other end (rear end) of the chuck member 48 in the axial direction. The chuck member 48 and the chuck jaw assembly 49 are formed by the spring 50 so that the chuck jaws 48 a Is biased in the direction to drive the drive shaft 4. With such a structure, the hollow rotary shaft 47, the chuck member 48, the chuck jaw assembly 49 and the spring 50 constitute a chucking mechanism of the drive shaft 4. The chuck member 48 and the chuck pawl assembly 49 are formed of a single sleeve having a chuck pawl 48 a formed at one end in the axial direction, and can be passed through the drive shaft 4. Good.

 A cylinder knob 51 for releasing the chucking is disposed behind the chuck jaw assembly 49. The cylinder knob 51 is held in the housing 11 so as to be movable in the axial direction by a cylinder holder 52, and can abut on the rear end of the chuck claw assembly 49. The cylinder knob 51 is urged by the spring 53 in a direction away from the chuck claw assembly 49.

 A sheath connector 54 is detachably attached to the front end of the housing 11 so as to surround the drive shaft 4. A soft fixed sheath 5 is fitted to the sheath connector 54. A mechanical seal 55 is fitted in the sheath connector 54, and the mechanical seal 55 comes into sliding contact with the drive shaft 4. A saline solution supply tube 56 communicates with the sheath connector 54.

 Next, the operation of the controller 10 will be described.

As shown in FIG. 1, the brushless motor 46 for driving the drive shaft is operated in a state in which the rotating force cutter 3 is moved along the guide wire 1 to the intravascular stenosis 2. As a result, the chuck jaws 48 a for chucking the drive shaft 4 and the drive shaft 4 and the chuck jaw assembly 49 connected to the rear end of the chuck member 48 become integrated with the rotor magnet 44. Rotate. Thereby, the rotary cutter 3 at the tip of the drive shaft 4 rotates to cut off the intravascular stenosis 2. ₀ _ When the motor 36 is operated in the rotating state of the rotary force meter 3, the eccentric cam 37 rotates, and the bearing holder 39 rotates eccentrically with the eccentric cam 37. Then, the slider 40 connected to the hanging shaft 39a of the bearing holder 39 reciprocates in the axial direction. Thus, the drive shaft 4 reciprocates in the axial direction via the drive shaft driving motor unit 46 and the chuck member 48 provided integrally with the slider 40. Therefore, the rotary cutter 3 at the tip of the drive shaft 4 is reciprocated in the direction along the guide wire 1 along with the rotational force. Therefore, the cutting force of the intravascular stenosis 2 by the rotary cutter 3 can be increased or stabilized.

 After the initial resection of the intravascular stenosis 2 by the rotational force cutter 3, when the intravascular stenosis 2 is to be further expanded in diameter, the rotational force cutter 3 and the drive shaft 4 are once pulled out of the body along the guide wire 1. . At this time, the chucking of the drive shaft 4 by the chuck claws 48 a is released. In this case, when the cylinder knob 51 for releasing the chucking is pushed and moved in the direction against the spring 53, the chuck jaw assembly 49 and the chuck member 48 are moved forward against the spring 50 by the cylinder knob 51. The chuck pawl 48 a opens apart from the front end of the hollow rotary shaft 47. As a result, the chuck of the dry shaft 4 by the chuck claws 48 a is released, and the drive shaft 4 can be easily pulled out of the body along the guide wire 1. At the time of resection of the intravascular stenosis 2 by a unit with the medical treatment rotary power meter 7, physiological saline is supplied from the tube 56 into the sheath connector 54. Physiological saline flows through the fixed sheath 5 and is ejected in the direction of the rotating force heater 3.

According to this method, a vibration motor 36 having an eccentric force 37 is provided. ₀ The mechanical drive unit of the controller 10 is configured by combining with the brushless motor 46 for live shaft rotation drive, so that the rotating force meter 3 combines the cutting force by rotation and the cutting force by reciprocation. You can have. For this reason, the cutting force of the stenosis part 2 in the blood vessel by the rotary cutter 3 can be increased or stabilized. Further, friction when inserting the rotary cutter 3 and the sheath 5 into the guiding catheter 6 can be reduced to make the rotation easier. Industrial applicability

 As is clear from the above description, according to the present invention, when cutting a stenosis part in a blood vessel, it does not fall off like diamond abrasive grains of a conventional cutting bar, and the affected part is efficiently and safely cut. When it is possible to treat or to further expand the diameter after the initial cutting of the stenosis in the blood vessel, there is no need to completely remove the rotating force cutter including the controller from the guide wire and replace the rotating cutter itself. This has the effect that the large diameter cutting can be performed quickly.

Claims

The scope of the claims 1. A guide wire that passes through the stenosis where sediment has accumulated in the blood vessel and extends outside the body  A rotary force cutter that is rotatably and slideably guided by the guide wire and rotatably cuts deposits in the intravascular stenosis;  A hollow drive shaft connected to the rotating force meter and through which the guide wire passes;  A fixed sheath through which the drive shaft is passed;  A controller having a rotation drive unit of the drive shaft, wherein the treatment device performs treatment such as penetration of the intravascular stenosis by the rotational force cutter, such as diameter expansion.  A therapeutic instrument, wherein a large number of independent fine cutting blades are formed integrally with a base material of the cutter on a surface of the rotary cutter. 2. When the rotating cutter further expands the diameter of the vascular stenosis after the cutting treatment of the intravascular stenosis by the cutter, the rotary cutter compresses in the axial direction to be plastically deformable in the expanding direction. The medical treatment device according to claim 1, characterized in that: 3. A guide wire that passes through the stenosis where the sediment is deposited in the blood vessel and extends outside the body.  A rotary force cutter that is rotatably and slideably guided by the guide wire and rotatably cuts deposits in the intravascular stenosis; A hollow drive shaft connected to the rotating force meter and through which the guide wire passes; A fixed sheath through which the dryshaft is passed;  A controller having a rotary drive unit for the drive shaft, another medical treatment rotating force cutter having a cutting surface outer diameter larger than a cutting surface maximum outer diameter of the rotary cutter (initial cutting rotary cutter), A large number of independent minute cutting blades are formed integrally with the base material of the cutter on the surfaces of the initial resection rotary power meter and the treatment rotary power meter, respectively,  When the diameter of the intravascular stenosis is further expanded after the cutting treatment of the intravascular stenosis by the initial resection rotator, the medical treatment rotator is extended on the guide wire by the initial resection rotary cutter. The treatment is characterized in that, at the time of the connection, the respective cutting blades of the two rotating force meters are arranged so as to be sufficiently small and arranged at appropriate intervals in the direction of resection of the affected part. Appliances. 4. The minute cutting edge comprises a minute concave and convex portion formed on the outer peripheral surface of the cutter,  The height and depth of the concave and convex portions ■ The width and the length are configured so that the size of the cutting powder of the sediment cut by the force cutter is limited to 10 microns or less. The therapeutic device according to claim 1 or 3, wherein 5. The uneven portion is An elongated groove portion that is elongated along the rotation direction of the cutter, and is formed in a shape that gradually becomes deeper from the front end to the rear end in the direction and rises sharply at the deepest portion, or the cutter surface at the deepest portion of the elongated groove portion Get up from 5. The treatment instrument according to claim 4, comprising a protruding cutting blade. 6. The micro-cutting blade is formed on the surface of the base material of the cutter by any one of laser processing, electric discharge processing, etching processing, press processing, pressure welding processing, and cutting processing. The therapeutic device described in paragraph 1 or 3. 7. The cutting surface forming region of each of the plurality of minute concave and convex portions forming the minute cutting blade is arranged so as to overlap each other. Treatment equipment. 8. The plurality of minute irregularities forming the minute cutting edge are as follows: the irregularities whose cutting surface is oriented in the normal rotation direction of the power cutter, and the irregularities whose cutting surface is opposite to the normal rotation direction of the force cutter. 6. The therapeutic instrument according to claim 5, wherein the therapeutic instrument comprises a facing uneven portion. 9. The therapeutic instrument according to any one of claims 1 to 3, wherein the surface of the force-tetter is mirror-finished. 10. The therapeutic device according to any one of claims 1 to 3, wherein the surface of the force-gutter is coated. 11. The rotational force meter is characterized in that it is compressed in the axial direction by a jig arranged in advance on or near the side of the drive shaft and is plastically deformed in the radially expanding direction. Claims 1 or 2 治療 treatment equipment. 12. The medical treatment rotary power meter is press-fitted or covered with the initial cutting rotary power meter by a jig arranged in advance on the same axis as or near the drive shaft. 4. The therapeutic device according to claim 3, wherein the therapeutic device is characterized in that: 13. The treatment according to claim 11, wherein the jig has a grasping-operation-type lever mechanism that can be operated with one hand by applying a leverage or cam booster mechanism. 13. Appliances. 14. The controller has a mechanism for pushing out the rotary cutter from the distal end of the fixed sheath to the affected part in the front and a mechanism for pulling it back to the near side, and these mechanisms are an automatic return mechanism and a position holding mechanism. The therapeutic device according to claim 1, wherein the therapeutic device is operated by a grasping operation lever provided with: 15. The controller according to claim 1, wherein the controller is provided with a vibration imparting mechanism for applying a reciprocating vibration motion to the rotating force meter in a direction along the guide wire. The therapeutic device as described. 16. The controller has a built-in drive unit for applying a rotational force to the drive shaft, 16. The therapeutic instrument according to claim 1, wherein the drive section has a motor having a hollow rotary shaft that can pass through the drive shaft. 17. The controller according to claim 1, wherein the controller has a mechanism for chucking the drive shaft and a mechanism for attaching and detaching the soft sheath. The therapeutic device described in the item.