JP2018117969A - Cracking device and treatment method using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a cracking device that performs treatment for a calcified lesion part by shaving it and giving an impact, and has good passing property in a living body lumen, and a treatment method using the same.SOLUTION: A cracking device 1 comprises: a shaft 10; an elastically-deformable linear crushing part 11 which can be axially moved with respect to the shaft 10 and whose distal end side extends radially outside in a state of being projected more on a distal end side from the distal end of the shaft 10; a ring part 12 provided at the distal end of the shaft 10 and having an opening 12a for making the crushing part 11 be inserted along the axial direction of the shaft 10; and a hand part 13 for holding a proximal end part of the shaft 10. The opening 12a of the ring part 12 is positioned more in the radial direction center side from the inner circumferential surface of the shaft 10. The hand part 13 has an operation part 31 for elastically moving the shaft 10 toward the proximal end side, and the ring part 12 moves from the distal end side of the crushing part 11 to the proximal end side by the operation part 31.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a cracking device in which a linear crushing portion provided at a distal end portion of a device changes its shape elastically in a living body lumen and a treatment method using the same.

  Treatment of vascular lesions using a catheter is widely performed because of less surgical invasion. For example, in percutaneous transluminal coronary angioplasty, a balloon catheter is used to expand the coronary lesion and improve blood flow. A balloon catheter is also used to perform PTA (Percutaneous Transluminal Angioplasty) to treat arteriosclerosis that has occurred in the femoral artery, iliac artery, popliteal artery, inferior arteries, etc. of the lower limbs. Sometimes.

  As arteriosclerosis progresses, the lesion becomes calcified and a hard part is generated. In this case, the calcified lesion cannot be pushed and expanded only by the expansion force of the balloon catheter, and treatment with a normal balloon may be difficult. Further, in the calcified lesion, the balloon to be expanded may slip in the axial direction, which also contributes to the difficulty in treatment with a normal balloon.

  A scoring balloon catheter in which a balloon is provided with a blade is known as a device that can treat even a calcified lesion. The scoring balloon catheter has a blade-like or linear or spiral blade provided in the balloon, and when the calcified site is cracked by this blade and the lumen of the lesion is expanded, As the blade bites into the lesion, balloon slip can be suppressed. An example of a balloon catheter having such a blade is disclosed in Patent Document 1.

Japanese Patent No. 2591573

  Since the scoring balloon catheter has a blade on the surface of the balloon, the outer diameter becomes large. For this reason, the passability at the time of delivering a balloon to a lesioned part becomes lower than a normal balloon. In addition, since the blade is cracked in the calcified lesion, it is formed of a hard material such as metal, and the flexibility is lowered because the blade is fixed to the front and rear of the balloon portion or directly. This is also a factor that reduces the passage of the balloon.

  Furthermore, the scoring device is expected to exhibit a scoring effect (a dividing effect) on a portion calcified with a blade arranged on the balloon as a treatment for a calcified lesion. On the other hand, in fact, the calcified lesion is very hard, and the shape of the lesion is unevenly distributed, and the entire circumference is rare, so the scoring effect on calcification with a scoring device is rare. However, there were cases where it was not possible to perform as expected.

  The present invention has been made in order to solve the above-described problems, and is a device for performing treatment by mainly giving an impact to a hard calcified lesion, and has good permeability in a living body lumen. An object is to provide a simple cracking device and a treatment method using the same.

A cracking device according to the present invention that achieves the above object includes a long tubular shaft,
An elastically deformable linear crushing portion that is movable along the axial direction with respect to the shaft and has a shape in which the distal end side extends radially outward from the distal end of the shaft. ,
A ring portion provided at a tip portion of the shaft and having an opening through which the crushing portion is inserted along the axial direction of the shaft;
A hand portion for holding the base end portion of the shaft,
The opening of the ring portion is located on the radial center side from the inner peripheral surface of the shaft,
The hand portion has an operation portion that elastically moves the shaft toward the proximal end side, and the ring portion moves from the distal end side to the proximal end side of the crushing portion in accordance with the operation of the operation portion. .

The treatment method according to the present invention that achieves the above object is a long tubular shaft, and is movable along the axial direction with respect to the shaft, with the distal end side having a diameter protruding from the distal end of the shaft. An elastically deformable linear crushing portion having a shape spreading outward in the direction, a ring portion provided at a tip portion of the shaft and having an opening through which the crushing portion is inserted along the axial direction of the shaft, A proximal portion for holding the proximal end portion of the shaft, and the opening of the ring portion is located on the radial center side from the inner peripheral surface of the shaft, and the proximal portion is located on the proximal end side of the shaft. A treatment method using a cracking device that has an operation part that moves elastically toward the operation part, and the ring part moves from the distal end side to the proximal end side of the crushing part in accordance with the operation of the operation part,
Inserting the tip of the shaft to the position of the lesion in a state where the tip side of the crushing part is inserted through the opening of the ring part;
By operating the operation portion of the hand portion, the shaft is elastically moved toward the proximal end side, and the ring portion moves from the distal end side to the proximal end side of the crushing portion, whereby the crushing portion A step of elastically expanding the diameter;
Moving the shaft toward the distal end, moving the ring portion from the proximal end side of the crushing portion to the distal end side, and reducing the diameter of the crushing portion;
Have

  Since the cracking device configured as described above can constrain the crushing part to the radial center side from the inner peripheral surface of the shaft by the ring part, the crushing part is crushed until it is delivered to the lesioned part. The outer diameter of the part can be kept small, and the permeability in the living body lumen can be improved. On the other hand, in the lesioned part, the shaft moves elastically, the crushing part elastically expands to give an impact to the lesioned part, and the calcified lesioned part can be crushed.

  Since the treatment method configured as described above can be held in a smaller diameter than the shaft by the ring portion until the crushing portion is delivered to the lesioned portion, it can improve the passage in the blood vessel. Moreover, since the crushing part can be expanded and contracted by moving the ring part in the axial direction, the crushing part can be repeatedly expanded in diameter by the lesioned part, and the calcified lesioned part can be reliably crushed. .

  Moreover, if it has a vibration generation part which gives a vibration to the said crushing part, when a crushing part expands, a vibration will be given to the line which forms a crushing part, and the impact with respect to a lesioned part will be transmitted more effectively. be able to.

  The vibration generating unit includes a coil unit provided in the crushing unit and an iron core unit provided in the shaft, and the coil unit is provided on a proximal end side from a portion protruding from the shaft. The iron core portion is arranged to be inserted into the coil portion in a state where the ring portion has moved from the distal end side to the proximal end side of the crushing portion. Thereby, by energizing the crushing part, vibration can be generated in the crushing part with the movement of the shaft, and vibration can be given to the crushing part with a simple structure.

  Moreover, if the said vibration generation part is an ultrasonic vibration part connected with the said crushing part, it can give a vibration with arbitrary timing with respect to the crushing part.

  In addition, if a plurality of crushing portions are provided in the circumferential direction and a plurality of openings are formed in the ring portion corresponding to the crushing portions, a shock is applied to a plurality of circumferential directions with respect to the lesioned portion. And the calcified lesion can be more easily crushed.

  The proximal portion has an elastic member between the shaft and the operation portion, and an engaging portion that engages the shaft against the urging force of the elastic member is provided on the operation portion, and The engagement state of the engagement portion with respect to the shaft is released by operation of the operation portion. Thereby, a mechanism for moving the shaft can be formed with a simple structure of the elastic member and the engaging portion.

  In addition, the proximal portion is provided with a contact surface portion that prevents movement of the shaft moving toward the distal end side, and a plurality of the corresponding contact surface portions are provided at different positions in the axial direction, and the contact portion that contacts the shaft. The face part can be switched. Thereby, the protrusion length of a crushing part and the magnitude | size of a diameter expansion can be changed according to a condition, and an impact can be given with respect to a lesioned part more flexibly.

It is a whole front view of the cracking device of this embodiment. It is the figure which looked at the ring part in the axial direction. It is the whole cracking device front view in the state where the crushing part was exposed to the tip side of a shaft. It is an expanded sectional view of a hand part. It is an expanded sectional view of a hand part in the state where the operation part was operated. It is the figure which looked at the rotation operation part to the axial direction. FIG. 7 is a cross-sectional view taken along the line AA in FIG. 6 (FIG. 7A), a cross-sectional view taken along the line BB (FIG. 7B), and a cross-sectional view taken along the line CC (FIG. 7C). The figure (FIG. 8 (a)) showing the protrusion state of the crushing part when the circumferential direction position of a rotation operation part is set so that a 1st contact surface part may oppose the contact part of an inner cylinder part, FIG. The figure (FIG. 8 (b)) showing the protruding state of the crushing part when the circumferential position of the rotation operation part is set so that the contact surface part faces the contact part of the inner cylinder part, the third contact surface part is It is the figure (FIG.8 (c)) showing the protrusion state of the crushing part at the time of setting the circumferential direction position of a rotation operation part so as to oppose the contact part of an inner cylinder part. It is the elements on larger scale of the shaft showing the composition of the vibration generating part. FIG. 10 is a partially enlarged view of the shaft showing a state in which the crushing portion is exposed to the tip end side of the shaft from the state of FIG. 9. It is a figure showing the state which inserted the guiding catheter to the lesioned part vicinity. It is a figure showing the state which made the guiding catheter penetrate the guiding catheter, and has arrange | positioned the front-end | tip part of the shaft containing a crushing part in a lesioned part. It is a figure showing the state which operated the operation part from the state of FIG. 12, moved the shaft to the base end side, and expanded the crushing part in diameter. It is a figure showing the state which removes a cracking device after treatment of a lesioned part. It is an enlarged view of the vicinity of the tip of the shaft when a plurality of crushing portions are provided in the circumferential direction. It is the figure which looked at the ring part of FIG. 15 in the axial direction. It is an enlarged view of the vicinity of the tip of the shaft when the tip of the crushing part is cut.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. Further, in this specification, the side of the cracking device 1 that is inserted into the living body lumen is referred to as “tip” or “tip side”, and the proximal side that is operated is referred to as “base end” or “base end side”.

  As shown in FIG. 1, the cracking device 1 of the present embodiment has a long tubular shaft 10 and a hand portion 13 provided at a proximal end portion of the shaft 10. A ring portion 12 is provided at the tip of the shaft 10. As shown in FIG. 2, the ring portion 12 has an opening 12 a that communicates the inside and the outside of the shaft 10. Two openings 12 a are located in the radial direction center side from the inner peripheral surface of the shaft 10, and two openings 12 a are provided in the ring portion 12. The ring portion 12 has a guide wire opening 12b through which the guide wire 55 is inserted at the center.

  As shown in FIG. 1, the distal end portion of the linear crushing portion 11 is exposed from the ring portion 12 toward the distal end side. The crushing part 11 for crushing the lesioned part is made of metal and can be elastically deformed. The front end portion of the crushing portion 11 has a shape that expands in the radial direction, but in the shaft 10, the tip portion is housed within the range of the inner diameter of the shaft 10. The aforementioned ring portion 12 is made of metal and has a function of holding the crushing portion 11 in a small diameter against the force of the crushing portion 11 trying to return to a shape that expands in the radial direction. The ring portion 12 may be formed of a material other than metal such as resin.

  The shaft 10 is preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, Examples thereof include fluororesins such as polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polytetrafluoroethylene, silicone rubber, and latex rubber.

  The hand portion 13 has a main body portion 30 having an inner diameter that can accommodate the shaft 10, an operation portion 31 that can be pressed on the outer peripheral surface, and a rotation operation portion 32 that can be rotated on the base end portion. Provided. From the base end part of the main body part 30, the inner cylinder part 33 protrudes toward the base end side, and a pressing operation part 34 having an outer diameter larger than the inner cylinder part 33 is provided at the base end. Although the material of the main-body part 30 is not specifically limited, For example, hard resin, such as a polycarbonate, polyethylene, a polypropylene, etc. can be used.

  As shown in FIG. 3, the inner cylinder portion 33 is connected to the shaft 10. As shown in FIG. 3, the inner cylinder portion 33 moves toward the proximal end side in the axial direction with respect to the main body portion 30. It moves to the base end side in the axial direction with respect to the portion 30. At this time, since the crushing part 11 does not move in the axial direction with respect to the main body part 30, the tip of the crushing part 11 is exposed to the tip side of the shaft 10. Thereby, since the position holding the crushing part 11 of the ring part 12 provided in the shaft 10 moves to the base end side of the crushing part 11, the restriction | limiting by the ring part 12 is cancelled | released by the front-end | tip part of the crushing part 11. It becomes a shape spreading in the original radial direction.

  Next, a mechanism for moving the shaft 10 with respect to the main body 30 will be described. As shown in FIG. 4, the main body 30 has a protruding elastic body holding part 30 a on the inner peripheral surface, and the inner cylinder part 33 has a pocket-like elastic body holding part 33 a on the outer peripheral surface. Between these, the elastic member 35 urged in the extending direction is held. The inner cylinder part 33 has a guide wire lumen 33d for inserting the guide wire 55 in the center.

  On the outer peripheral surface of the inner cylinder portion 33, there is a recess 33e on the base end side from the elastic body holding portion 33a, and an engaged portion 33b is formed in the recess 33e. The operation part 31 provided in the main body part 30 has an engaging part 31a that can be engaged with the engaged part 33b. The inner cylinder portion 33 receives a biasing force toward the proximal end side of the main body portion 30 by the elastic member 35. Since the engaging portion 31 a is engaged with the engaged portion 33 b, the inner cylinder portion 33 is stationary with respect to the main body portion 30 against the urging force of the elastic member 35.

  A contact portion 33c facing the base end side is formed on the outer peripheral surface of the inner cylinder portion 33 at a position closer to the base end side than the engaged portion 33b. The contact portion 33 c is formed on a part of the outer peripheral surface of the inner cylinder portion 33 in the circumferential direction. The rotation operation part 32 provided at the base end part of the main body part 30 has a first contact surface part 32a that faces the contact part 33c of the inner cylinder part 33 in the axial direction.

  The operation part 31 is rotatable with respect to the main body part 30 around the rotation shaft part 31b. In the rotary shaft portion 31b, the operation portion 31 is urged in a direction to rotate clockwise in the drawing and is supported by the main body portion 30 so as not to rotate clockwise in the drawing from the horizontal position shown in FIG. ing. By pressing the outer surface proximal end side portion of the operation portion 31, the operation portion 31 rotates counterclockwise in the figure against the urging force in the rotating shaft portion 31b, and the engagement portion 31a is engaged. The engaged state with respect to the portion 33b is released.

  When the operating portion 31 is pressed to release the engaged state of the engaging portion 31a from the engaged portion 33b, the inner cylinder portion 33 is moved to the proximal end by the urging force of the elastic member 35 as shown in FIG. It moves elastically toward the side. The inner cylinder part 33 moves to the proximal end side, and the contact part 33c contacts the first contact surface part 32a of the rotation operation part 32, so that further movement of the inner cylinder part 33 is prevented. The cylinder part 33 stops. As the inner cylinder portion 33 moves, the shaft 10 connected to the inner cylinder portion 33 also moves elastically toward the proximal end side.

  In a state where the inner cylinder portion 33 has moved to the proximal end side, the inner cylinder portion 33 is operated by pressing the pressing operation portion 34 provided at the proximal end portion of the inner cylinder portion 33 toward the distal end side. It moves toward the tip side against the urging force. When the engaged portion 33b of the inner cylinder portion 33 moves to the position of the engaging portion 31a of the operation portion 31, the operation portion 31 is rotated clockwise in the figure by the urging force applied to the rotating shaft portion 31b. The engaging part 31a enters the recessed part 33e having the engaged part 33b. As described above, since the operation unit 31 stops at the horizontal position, the wall surface of the recess 33e comes into contact with the engagement unit 31a, and stops the movement of the inner cylinder unit 33 toward the distal end side. Therefore, when the pressing operation on the pressing operation portion 34 is stopped, the inner cylinder portion 33 is slightly returned to the proximal end side by the urging force of the elastic member 35, and the engaging portion 31a is engaged with the engaged portion 33b. As described above, by repeating the operation of the operation unit 31 and the operation of the pressing operation unit 34, the inner cylinder part 33 and the shaft 10 connected thereto can be reciprocated in the axial direction.

  As shown in FIG. 6, the rotation operation unit 32 has a first contact surface portion 32a, a second contact surface portion 32b, and a third contact surface portion 32c at different positions in the circumferential direction. As shown in FIG. 7, the first contact surface portion 32a, the second contact surface portion 32b, and the third contact surface portion 32c are disposed at different positions in the axial direction. The second contact surface portion 32b is located on the distal end side with respect to the first contact surface portion 32a, and the third contact surface portion 32c is located on the distal end side with respect to the second contact surface portion 32b. By rotating the rotation operation part 32, any one contact surface part of the rotation operation part 32 can be made to face the contact part 33 c of the inner cylinder part 33.

  When the contact part 33c of the inner cylinder part 33 is opposed to the first contact surface part 32a of FIG. 7A, when the operation part 31 is operated, the position shown in FIG. The inner cylinder portion 33 moves to the proximal end side. In this case, at the distal end portion of the shaft 10, as shown in FIG. 8A, the ring portion 12 moves to the proximal end side of the crushing portion 11, and the crushing portion 11 is exposed to the distal end side of the shaft 10. The shape is greatly expanded radially outward.

  When the contact part 33c of the inner cylinder part 33 is facing the 2nd contact surface part 32b of FIG.7 (b), when the operation part 31 is operated, the inner cylinder part 33 is more than the 1st contact surface part 32a. Since it abuts on the second abutment surface portion 32b located on the distal end side, it stops at a position closer to the distal end than in FIG. In this case, as shown in FIG. 8 (b), the position of the ring portion 12 is located closer to the tip than in the case of FIG. 8 (a) at the tip of the shaft 10, and the crushing portion 11 on the tip side further than that. Is exposed on the tip side of the shaft 10. For this reason, the magnitude | size which spreads to the radial direction outer side of the crushing part 11 becomes smaller than the case of Fig.8 (a).

  When the contact part 33c of the inner cylinder part 33 is facing the 3rd contact surface part 32c of FIG.7 (c), when operating the operation part 31, the inner cylinder part 33 is more than the 2nd contact surface part 32b. Since it abuts on the third abutment surface portion 32c located on the distal end side, it stops at a position closer to the distal end than when it abuts on the second abutment surface portion 32b. In this case, as shown in FIG. 8 (c), the position of the ring portion 12 is located closer to the tip than in the case of FIG. 8 (b) at the tip of the shaft 10, and the crushing portion 11 on the tip side further than that. Is exposed on the tip side of the shaft 10. For this reason, the magnitude | size which spreads to the radial direction outer side of the crushing part 11 becomes still smaller than the case of FIG.8 (b).

  Thus, by rotating the rotation operation part 32 and selecting the contact surface part to be opposed to the contact part 33c of the inner cylinder part 33, the protruding length of the crushing part 11 when operating the operation part 31 is selected. And the magnitude | size expanded radially can be changed in steps.

  The shaft 10 is provided with a mechanism for imparting vibration when the crushing portion 11 is exposed to increase the diameter. As shown in FIG. 9, the crushing part 11 has a coil part 21 wound in a coil shape in the shaft 10. Further, the crushing portion 11 is connected to an external power source (not shown) on the proximal end side of the shaft 10, and is energized from the external power source when the crushing portion 11 is vibrated. In the shaft 10, an iron core portion 40 is disposed on the tip side of the coil portion 21. A magnet member 41 is also disposed in the vicinity of the coil portion 21. These coil part 21, iron core part 40 and magnet member 41 form a vibration generating part.

  When the operating portion 31 is operated and the shaft 10 moves to the proximal end side, the iron core portion 40 of the shaft 10 enters the inside of the coil portion 21 as shown in FIG. When the coil unit 21 is energized from an external power source in this state, the coil unit 21 becomes an electromagnet. The coil portion 21 is periodically magnetized by passing a direct current in a pulsed manner or an alternating current to the coil portion 21, and periodically between the magnet member 41 provided on the shaft 10. Power works. Thereby, the coil part 21 vibrates and the vibration is transmitted also to the part protruded to the front end side of the shaft 10. The distal end portion of the crushing portion 11 is elastically expanded by moving the shaft 10 toward the proximal end side and gives an impact to the calcified lesion, but in addition to this, it is vibrated by the vibration generating portion. Thus, a further impact can be given to the lesion. Thereby, the calcified lesion can be effectively crushed.

  Next, a treatment method using the cracking device 1 of the present embodiment will be described. First, a catheter introducer (not shown) is percutaneously punctured into a blood vessel 60 that is a living body lumen by the Seldinger method or the like. Next, the guiding catheter 50 having the guide wire 55 inserted therein is inserted into the catheter introducer, and the guide wire 55 is protruded from the distal end. Insert into. Thereafter, the guiding catheter 50 is gradually pushed forward to the vicinity of the stenotic lesion 61, which is the target site, with the guide wire 55 being advanced.

  Next, the end of the guide wire 55 is inserted into the guide wire opening 12 b of the ring portion 12, and the guide wire 55 is taken out from the end of the hand portion 13. Next, as shown in FIG. 11, the shaft 10 is inserted into the guiding catheter 50 inserted into the blood vessel 60 from the tip, and the shaft 10 is pushed along the guide wire 55. As shown in FIG. 12, the shaft 10 is inserted until the crushing portion 11 at the distal end portion is located at the lesioned portion 61.

  A filter device (not shown) is arranged on the distal end side of the lesioned part 61 before the lesioned part 61 is crushed by the crushing part 11. By the filter device, it is possible to prevent the fragments of the crushed lesion 61 from flowing to the downstream side of the blood vessel.

  When the shaft 10 is inserted to the lesioned part, the operation part 31 is pressed at the hand part 13. When the operation unit 31 is operated, the shaft 10 is elastically moved toward the base end side as described above, and accordingly, the crushing unit 11 is exposed from the shaft 10. Since the crushing part 11 is linear with elasticity, it is elastically expanded by the movement of the shaft 10. At this time, the crushing portion 11 is vibrated by the vibration generating portion in the shaft 10. Due to these movements of the crushing part 11, the lesioned part 61 that has been calcified and hardened is impacted, causing cracks and crushing.

  When it is difficult to crush the lesioned part 61 at a time, the protruding operation of the crushing part 11 is repeated. For that purpose, in the state where the crushing part 11 protrudes, first, the pressing operation part 34 is pressed, the shaft 10 is moved to the distal end side, and the crushing part 11 is temporarily stored in the shaft 10. Then, the operation unit 31 is operated again to expose the crushing unit 11 and operate the vibration generating unit to give an impact to the lesioned part 61. By repeating this operation a plurality of times, the hardened lesioned part 61 can be crushed.

  In addition, by rotating the rotation operation unit 32 of the hand portion 13 and changing the protruding length and the diameter expansion size of the crushing portion 11, the contact position and angle of the crushing portion 11 with respect to the lesioned portion 61 change. Therefore, the lesioned part 61 can be crushed more effectively by repeating the protruding operation of the crushing part 11 after appropriately operating the rotary operation part 32.

  When the treatment of the lesioned part 61 by the crushing part 11 is completed, the cracking part 11 is accommodated in the shaft 10 as shown in FIG. When the cracking device 1 is removed, the guide wire 55 is also removed. Note that the guide wire 55 may be left when another treatment is performed subsequently. When the cracking device 1 is removed, the guiding catheter 50 is removed from the catheter introducer, and the catheter introducer is also removed from the living body to complete the procedure.

  Thus, since the crushing part 11 is held by the ring part 12 in a smaller diameter than the shaft 10 until the crushing part 11 is delivered to the lesioned part 61, it is possible to improve the permeability of the device in the blood vessel 60. Moreover, since the crushing part 11 expands elastically in the lesioned part 61 and vibrates by the vibration generating part, the calcified lesioned part 61 can be effectively impacted and crushed. Furthermore, while the diameter of the crushing part 11 and the diameter reduction of the crushing part 11 can be repeatedly operated with the hand part 13, the protruding length and the size of the diameter expansion of the crushing part 11 can be changed. Flexible treatment can be performed according to the state.

  In the present embodiment, one linear crushing portion 11 has a loop shape on the tip side of the shaft 10, but may have a plurality of crushing portions. As shown in FIG. 15, the some crushing part 15 can be arrange | positioned in a different position in the circumferential direction. In this case, as shown in FIG. 16, the ring portion 12 has a plurality of openings 12 a in the circumferential direction corresponding to the number of crushing portions 15. In this way, by providing a plurality of crushing portions 15 in the circumferential direction, it is possible to give an impact to a plurality of locations in the circumferential direction with respect to the lesioned portion 61, and to make it easier to crush the calcified lesioned portion 61.

  Further, the crushing portion does not necessarily have to be a loop shape on the tip side of the shaft 10. As shown in FIG. 17, the tip of the crushing part 16 may be cut off. In this case, the distal end portion of the crushing portion 16 is likely to expand in the radial direction, and the impact on the lesioned portion 61 at the distal end portion of the crushing portion 16 can be further increased.

  In the present embodiment, the vibration generating part is formed by the iron core part 40 in the shaft 10 and the coil part 21 of the crushing part 11, but an ultrasonic vibration part is connected to the proximal end side of the crushing part 11. The vibration may be transmitted to the front end side of the crushing portion 11.

  In the treatment method of the present embodiment, the shaft 10 of the cracking device 1 is inserted into the guiding catheter 50 inserted into the blood vessel 60. However, instead of the guiding catheter 50, the penetrating catheter is used as the blood vessel. The shaft 10 of the cracking device 1 may be inserted into the penetrating catheter. Furthermore, the shaft 10 of the cracking device 1 may be inserted through other types of catheters.

  As described above, the cracking device 1 according to the present embodiment is movable in the axial direction with respect to the long tubular shaft 10 and the shaft 10, and protrudes from the distal end of the shaft 10 to the distal end side. An elastically deformable linear crushing portion 11 having a shape in which the distal end side expands radially outward, and an opening 12a provided at the distal end portion of the shaft 10 through which the crushing portion 11 is inserted along the axial direction of the shaft 10. The ring portion 12 and a hand portion 13 that holds the proximal end portion of the shaft 10, and the opening 12 a of the ring portion 12 is located on the radial center side from the inner peripheral surface of the shaft 10, and the hand portion 13. Has an operation portion 31 that elastically moves the shaft 10 toward the proximal end side, and the ring portion 12 moves from the distal end side to the proximal end side of the crushing portion 11 as the operation portion 31 is operated. Since the cracking device 1 configured in this manner can constrain the crushing portion 11 in the range on the radial center side from the inner peripheral surface of the shaft 10 by the ring portion 12, the crushing portion 11 is delivered to the lesioned portion. Until this, the outer diameter of the crushing part 11 can be made small, and the permeability in a living body lumen can be made favorable. On the other hand, in the lesioned part, the shaft 10 moves elastically, the crushing part 11 elastically expands in diameter and can give an impact to the lesioned part, and the calcified lesioned part can be crushed.

  Moreover, if it has a vibration generation part which gives vibration to the crushing part 11, when the crushing part 11 expands in diameter, a vibration will be given to the line which forms the crushing part 11, and the impact with respect to a lesioned part will be more effective. Can communicate.

  The vibration generating unit includes a coil unit 21 provided in the crushing unit 11 and an iron core unit 40 provided in the shaft 10, and the coil unit 21 is provided on the proximal end side from a portion protruding from the shaft 10. At the same time, it is possible to energize from the base end side, and the iron core portion 40 is disposed so as to be inserted into the coil portion 21 in a state where the ring portion 12 has moved from the tip end side to the base end side of the crushing portion 11. Thereby, by energizing the crushing part 11, the crushing part 11 can be vibrated with the movement of the shaft 10, and the crushing part 11 can be vibrated with a simple structure.

  Further, if the vibration generating unit is an ultrasonic vibration unit coupled to the crushing unit 11, vibration can be applied to the crushing unit 11 at an arbitrary timing.

  Further, if a plurality of crushing portions 11 are provided in the circumferential direction and a plurality of openings 12a are formed in the ring portion 12 corresponding to the crushing portions 11, impacts are applied to a plurality of locations in the circumferential direction with respect to the lesioned portion. It can be given and the calcified lesion can be more easily crushed.

  Further, the hand portion 13 has an elastic member 35 between the shaft 10 and the operation portion 31 is provided with an engaging portion 31 a that engages the shaft 10 against the urging force of the elastic member 35. The engagement state of the engagement portion 31a is released by the operation of the operation portion 31. Thereby, a mechanism for moving the shaft 10 can be formed with a simple structure of the elastic member 35 and the engaging portion 31a.

  Further, the proximal portion 13 is provided with a contact surface portion that prevents the movement of the shaft 10 that moves toward the distal end side, and a plurality of contact surface portions are provided at different positions in the axial direction, and the contact portion that contacts the shaft 10 is provided. The contact part can be switched. Thereby, the protrusion length of the crushing part 11 and the magnitude | size of a diameter expansion can be changed according to a condition, and an impact can be given with respect to a lesioned part more flexibly.

  In addition, the treatment method according to the present embodiment is a long tubular shaft 10 and is movable along the axial direction with respect to the shaft 10, with the distal end side having a diameter protruding from the distal end of the shaft 10 toward the distal end side. An elastically deformable linear crushing portion 11 having a shape that spreads outward in the direction, and a ring portion 12 having an opening 12a that is provided at the tip of the shaft 10 and passes through the crushing portion 11 along the axial direction of the shaft 10. And the hand portion 13 that holds the proximal end portion of the shaft 10, the opening 12 a of the ring portion 12 is positioned on the radial center side from the inner peripheral surface of the shaft 10, and the hand portion 13 is The cracking device 1 is used in which the operation unit 31 is elastically moved toward the proximal end side, and the ring unit 12 moves from the distal end side to the proximal end side of the crushing portion 11 as the operation unit 31 is operated. treatment A step of inserting the distal end portion of the shaft 10 to the position of the lesioned portion in a state where the distal end side portion of the crushing portion 11 is inserted into the opening 12a of the ring portion 12, and operating the operation portion 31 of the hand portion 13 Thus, the shaft 10 is elastically moved toward the proximal end side, and the crushing portion 11 is elastically expanded in diameter by the ring portion 12 moving from the distal end side to the proximal end side of the crushing portion 11. And moving the shaft 10 toward the distal end side, moving the ring portion 12 from the proximal end side to the distal end side of the crushing portion 11, and reducing the diameter of the crushing portion 11. Since the treatment method configured in this manner can be held in a smaller diameter than the shaft 10 by the ring portion 12 until the crushing portion 11 is delivered to the lesioned portion, it can improve the passage in the blood vessel. . Moreover, since the crushing part 11 can be expanded and reduced in diameter by the movement of the ring part 12 in the axial direction, the crushing part 11 is repeatedly expanded in diameter at the lesioned part, and the calcified lesioned part is reliably fractured. be able to.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention.

DESCRIPTION OF SYMBOLS 1 Cracking device 10 Shaft 11 Crushing part 12 Ring part 12a Opening 13 Hand part 20 Tip part 21 Coil part 30 Main body part 30a Elastic body holding part 31 Operation part 32 Rotating operation part 33 Inner cylinder part 33a Elastic body holding part 33b Engaged Part 33c Abutting part 33d Guide wire lumen 33e Concave part 34 Pressing operation part 35 Elastic member 40 Iron core part 41 Magnet member 50 Guiding catheter 55 Guide wire

Claims (8)

A long tubular shaft;
An elastically deformable linear crushing portion that is movable along the axial direction with respect to the shaft and has a shape in which the distal end side extends radially outward from the distal end of the shaft. ,
A ring portion provided at a tip portion of the shaft and having an opening through which the crushing portion is inserted along the axial direction of the shaft;
A hand portion for holding the base end portion of the shaft,
The opening of the ring portion is located on the radial center side from the inner peripheral surface of the shaft,
The hand portion has an operation portion that elastically moves the shaft toward the proximal end side, and the ring portion moves from the distal end side to the proximal end side of the crushing portion in accordance with the operation of the operation portion. Cracking device.   The cracking device according to claim 1, further comprising a vibration generating unit that applies vibration to the crushing unit. The vibration generating unit has a coil unit provided in the crushing unit and an iron core unit provided in the shaft,
The coil portion is provided on the base end side from the portion protruding from the shaft, and can be energized from the base end side,
3. The cracking device according to claim 2, wherein the iron core portion is disposed so as to be inserted into the coil portion in a state where the ring portion is moved from the distal end side to the proximal end side of the crushing portion.   The cracking device according to claim 2, wherein the vibration generation unit is an ultrasonic vibration unit coupled to the crushing unit.   The cracking device according to any one of claims 1 to 4, wherein a plurality of crushing parts are provided in a circumferential direction, and a plurality of openings are formed in the ring part corresponding to the crushing parts. The hand portion has an elastic member between the shaft and
The operating portion is provided with an engaging portion that engages the shaft against the urging force of the elastic member, and the engaged state of the engaging portion with respect to the shaft is released by operation of the operating portion. The cracking device according to any one of claims 1 to 5.   The proximal portion is provided with a contact surface portion that prevents movement of the shaft that moves toward the distal end side, and a plurality of the corresponding contact surface portions are provided at different positions in the axial direction, and the contact surface portion that contacts the shaft is provided. The cracking device according to claim 6, which is switchable. An elongated tubular shaft, movable in the axial direction with respect to the shaft, and elastically deformable with a shape in which the tip side expands radially outward while protruding from the tip of the shaft to the tip side A linear crushing portion, a ring portion provided at a distal end portion of the shaft and having an opening through which the crushing portion is inserted along the axial direction of the shaft, and a proximal portion that holds the proximal end portion of the shaft. The opening of the ring part is located on the radial center side from the inner peripheral surface of the shaft, the proximal part has an operation part for elastically moving the shaft toward the base end side, In accordance with the operation of the operation unit, the ring unit is a treatment method using a cracking device in which the crushing unit moves from the distal end side to the proximal end side,
Inserting the tip of the shaft to the position of the lesion in a state where the tip side of the crushing part is inserted through the opening of the ring part;
By operating the operation portion of the hand portion, the shaft is elastically moved toward the proximal end side, and the ring portion moves from the distal end side to the proximal end side of the crushing portion, whereby the crushing portion A step of elastically expanding the diameter;
Moving the shaft toward the distal end, moving the ring portion from the proximal end side of the crushing portion to the distal end side, and reducing the diameter of the crushing portion;
A treatment method comprising:

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