JP6679294B2 - Device for penetrating embolus - Google Patents

Description

  The present invention relates to an embolus portion penetrating device for use in treatment of an occluded site in a body cavity.

  An embolus penetrating device used for treatment of a hardened occlusion site in a blood vessel (for example, chronic total occlusion (Chronic Total Occlusion, CTO) has been proposed. As an example of the embolus penetrating device, a rotablator is known. Patent Document 1 discloses an embolus removal catheter including a rigid head, a rotary drive wire, and a balloon catheter, which has a drill-shaped conical portion at its tip. The rotary drive wire connects the rigid head and the motor, the rotary drive wire is rotated by the motor to rotate the rigid head, and the conical portion of the rigid head rotates to remove the hard thrombus. The rotary drive wire is made of stainless steel, and the balloon catheter surrounds the rotary drive wire. From the tip, rigid head protrudes. The balloon catheter is made of plastic.

JP-A-7-407

  The case where the embolus removal catheter is passed through the blood vessel in order to move the rigid head to the occlusion site in the blood vessel is illustrated. Here, when the blood vessel is bent, the embolus removal catheter cannot be passed through the blood vessel unless the rotary drive wire and the balloon catheter also bend along the blood vessel. In the case of the embolus removal catheter described above, the rotary drive wire may be less flexible than the balloon catheter because the rotary drive wire is made of stainless steel and the balloon catheter is made of plastic. Therefore, in particular, the rotary drive wire may not be able to bend following the blood vessel. In this case, there is a problem that the balloon catheter is caught in the blood vessel and the rigid head cannot be moved to the closed portion.

  An object of the present invention is a device for penetrating an embolus portion that treats an occluded site or the like in a body cavity by using a cutting device, the embolus piercing device being capable of appropriately moving the cutting device to the occluded site or the like in the body cavity. Is to provide a device for use.

The device for penetrating an embolus part of the present invention has a cutting means capable of cutting an occlusion site in a body cavity, has a flexible and elongated shape, and has the cutting means connected to one end and the other end. Drive means is connected to the drive means, the cutting means can be rotated in response to the drive of the drive means, at least a part of which is inserted into the lumen of the catheter and is on one side of the catheter. Rotating means that is movable to both the distal end side and the base end side that is the other side, and is capable of projecting the cutting means from the distal end side end portion of the catheter when moving to the distal end side. with the door, orthogonal hardness of said rotating means, said catheter softness rather than hardness, the ends of the distal side of the cutting means includes a rotating axis when said cutting means is rotated by said rotating means Has a flat part to The flat portion, the occlusion site a possible cutting, characterized by comprising at least one a groove extending linearly along and the plane portion recessed into the proximal end side.

The device for penetrating an embolus has a rotation means that is softer than a catheter. The rotating means rotates in response to the driving of the driving means to rotate the cutting means. The cutting means rotates to cut an occlusion site or the like in the body cavity. Here, in order to cut the occluded portion by the cutting means, it is necessary to bring the cutting means close to the occluded portion through the catheter and the rotating means in the body cavity. In this case, since the rotating means is softer in hardness than the catheter, when the catheter can be bent to follow the bent body cavity, the rotating means can also bend to follow the body cavity. Therefore, the device for penetrating the embolus portion can appropriately move the cutting means connected to one end of the rotating means to a closed site or the like in the body cavity. Further, the cutting means can cut by appropriately bringing the groove portion of the flat portion into contact with the closed portion that gradually closes from the base end side toward the tip end side. Further, by providing the groove portion on the flat surface portion, it is possible to prevent the groove portion of the flat surface portion from contacting the catheter and damaging the catheter when the rotating means moves toward the distal end side or the proximal end side with respect to the catheter. Further, shavings produced when the closing member is cut by the cutting means can be moved to the base end side via the groove. Therefore, the device for penetrating the embolus portion can prevent the cutting by the cutting means from being obstructed by shavings.

  In the present invention, the rotating means is N (where N is an integer of 2 or more) coils wound so that their respective central axes extend in the same direction, and the n-th coil (where n is The "n + 1" th coil is wound along the outer peripheral surface of the coil of any one of 1 to "N-1", and the nth coil and the "n + 1" th coil are It may include N coils wound in opposite directions. In this case, the rotating means can appropriately transmit the driving force of the driving means to the cutting means to rotate the cutting means, and at the same time, can make the hardness of the rotating means softer than the hardness of the catheter. Therefore, the rotating means that is softer than the catheter can be easily manufactured.

  In the present invention, the winding diameters of the N coils may be substantially the same. In this case, for example, the diameter of the rotating means can be minimized by minimizing the diameter of the winding. Therefore, it is possible to easily manufacture a rotating means that can be passed through a narrow body cavity.

  In the present invention, the rotating means may include three coils. In this case, the rotating means can minimize the diameter of the rotating means while appropriately transmitting the driving force of the driving means to the cutting means.

  In the present invention, the cutting means has a substantially circular cross section when cut along a plane orthogonal to the rotation axis, and the diameter of the flat surface portion is the cross section on the proximal end side with respect to the flat surface portion. The diameter may be greater than or equal to. In this case, it is possible to prevent the portion of the base end side of the flat portion from coming into contact with the catheter. Therefore, the device for penetrating the embolus portion can more appropriately prevent the cutting means from contacting the catheter and damaging the catheter.

  In the present invention, the at least one groove may have two grooves extending linearly and orthogonal to each other. In this case, the two groove portions can be easily formed on the flat surface portion of the cutting means.

  The present invention may further include the catheter, and a connector that is connected to an end portion on the proximal end side of the catheter and that has an injection port capable of injecting a liquid into the lumen of the catheter from the outside. . In this case, the device for penetrating the embolus part can remove gas from the inside of the catheter by injecting the liquid into the catheter through the inlet. Further, when the temperature of the closed portion rises during cutting by the cutting means, it can be cooled by the liquid injected from the injection port.

  In the present invention, the catheter may have a first lumen through which the rotating means is inserted and a second lumen through which a guide wire is inserted. In this case, in the catheter, the first lumen through which the rotating means is inserted and the second lumen through which the guide wire is inserted can be separated. Therefore, in the device for penetrating the embolus portion, the cutting means can be smoothly moved along the guide wire, so that the cutting means can be appropriately brought close to the closed site or the like in the body cavity.

  In the present invention, the catheter has a first catheter having the first lumen and a second lumen and is connected to an outer peripheral surface of the first catheter in the vicinity of an end portion on the distal end side. A second catheter may be included. In this case, the diameter of each of the first catheter and the second catheter can be minimized. Therefore, the device for penetrating the embolus portion can allow the catheter to be inserted even in a narrow body cavity.

In the present invention, the torque transmissibility of the rotating member may be higher than the torque transmissibility of the catheter. In this case, twisting of the rotating means when the rotating means is rotated by the driving means is suppressed. Therefore, the device for penetrating the embolus part can more effectively cut the closed part by rotating the rotating means by the driving means.
In the present invention, the constituent material of the cutting means may be a material having higher radiopacity than the rotating means. Further, in the present invention, the cutting means may have a cylindrical shape having an outer peripheral surface that is an outer side in a radial direction around the rotation axis, and a groove may be formed on the outer peripheral surface.

It is a side view of the device 1 for embolus part penetration. FIG. 3 is an enlarged cross-sectional view of the vicinity of the tip of the catheter 2. It is sectional drawing which looked at the AA line in FIG. 1 from the arrow direction. It is a side view of the rotating member 3 and the cutting member 4. FIG. 5 is an enlarged cross-sectional view of the vicinity of the tip of the rotating member 3 and the cutting member 4. It is the figure which looked at the rotating member 3 from the front end side. It is the figure which looked at cutting member 4 from the tip side. FIG. 6 is a cross-sectional view showing a cutting member 4 inside a blood vessel 8.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. The embolus penetrating device 1 is, for example, a device used for treatment of chronic total occlusion (CTO). As shown in FIG. 1, the embolus penetrating device 1 includes a catheter 2, a rotating member 3, a cutting member 4, a connector 5, a drive mechanism 6, and a lever 7. The rotating member 3 is inserted into a later-described first catheter 21 of the catheter 2. The connector 5 is connected to one end of the first catheter 21. Hereinafter, one of the two ends of the catheter 2 that corresponds to one side of the first catheter 21 is referred to as a “base end”. Of the two ends of the catheter 2, the end corresponding to the other side of the first catheter 21 is referred to as the “tip”. The direction that extends along the catheter 2 is referred to as the “stretching direction”. On the plane orthogonal to the extending direction, in the radial direction with reference to the cross-sectional center of the catheter 2, the side close to the cross-sectional center of the catheter 2 is called "inside", and the side distant from the cross-sectional center of the catheter 2 is ". Outside.

<Catheter 2>
The catheter 2 is a so-called rapid exchange type (RX (Rapid eXchange) type) catheter. As shown in FIGS. 1 to 3, the catheter 2 is a tubular member having flexibility. The catheter 2 extends along the extending direction. The catheter 2 has a first catheter 21 and a second catheter 22. As shown in FIGS. 2 and 3, the first catheter 21 has a first lumen 212 that is a space surrounded by an inner peripheral surface 211 that is an inner surface. The second catheter 22 has a second lumen 222 that is a space surrounded by an inner peripheral surface 221 that is an inner surface. The inner diameters of the first catheter 21 and the second catheter 22 are substantially the same. As shown in FIG. 1, the length of the second catheter 22 in the extending direction is shorter than the length of the first catheter 21 in the extending direction. The second catheter 22 is joined near the end of the first catheter 21 on the tip side. More specifically, as shown in FIG. 2, the outer peripheral surface 223, which is the outer surface of the second catheter 22, is a part of the outer peripheral surface 213 (see FIG. 2), which is the outer surface of the first catheter 21. , Are joined by heat welding. Hereinafter, as shown in FIG. 1, the distal end side and the proximal end side end of the first catheter 21 are referred to as a “distal end 214” and a “proximal end 215”, respectively. The distal end side and the proximal end side end of the second catheter 22 are referred to as “distal end 224” and “proximal end 225”, respectively. The positions of the distal end 214 of the first catheter 21 and the distal end 224 of the second catheter 22 in the extending direction are the same.

  The rotating member 3 described later is inserted into the first lumen 212 of the first catheter 21 (see FIGS. 2 and 3). A guide wire (not shown) is inserted into the second lumen 222 of the second catheter 22. Examples of constituent materials of the catheter 2 include various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene-based, and the like. It is possible to use one of these or a combination of two or more thereof (polymer alloy, polymer blend, laminate, etc.).

<Rotating member 3>
As shown in FIGS. 4 to 6, the rotating member 3 is a flexible elongated member. The rotating member 3 is inserted into the first lumen 212 of the first catheter 21 of the catheter 2 and the main body portion 51 of the connector 5 described later (see FIG. 1). The rotating member 3 extends along the extending direction. The rotary member 3 is movable with respect to the first catheter 21 and the connector 5 on both sides (distal end side and proximal end side) in the extending direction. The outer diameter of the rotating member 3 is, for example, 0.36 mm. The diameter of the rotating member 3 is slightly smaller than the inner diameter of the first catheter 21 of the catheter 2. The length of the rotating member 3 in the stretching direction is 1500 mm, for example. The length of the rotating member 3 in the extending direction is longer than the length of the first catheter 21 of the catheter 2 in the extending direction.

  As shown in FIG. 5, the rotating member 3 has coils 31, 32, and 33. The coils 31 to 33 are spiral coils. The central axes of the coils 31 to 33 coincide. Hereinafter, the central axes of the coils 31 to 33 are referred to as “central axis 3A”. The central axis 3A extends along the stretching direction. That is, the coils 31 to 33 are wound so as to extend in the extending direction along the same central axis 3A and overlap in the radial direction. The diameter of each winding of the coils 31 to 33 is the same, for example, 0.04 mm.

  The coils 31 to 33 have different inner diameters. Further, the coils 31, 33 and the coil 32 have different winding directions. The details are as follows. The coil 31 is arranged on the innermost side of the coils 31 to 33. The inner peripheral surface 311 which is the inner surface of the coil 31 has a diameter of, for example, 0.1 mm. The inner cavity 312, which is a space surrounded by the inner peripheral surface 311 of the coil 31, corresponds to a through hole that penetrates the rotating member 3 along the extending direction. The coil 31 is wound in a direction that coincides with the clockwise direction when viewed from the base end side along the extending direction. Hereinafter, unless otherwise specified, the winding direction of the coils 31 to 33 is the direction when the coils 31 to 33 are viewed from the base end side along the extending direction. The coil 32 is wound counterclockwise along the outer surface of the coil 31. That is, the winding directions of the coils 31 and 32 are opposite to each other. The coil 33 is wound clockwise along the outer surface of the coil 32. That is, the winding directions of the coils 32 and 33 are opposite to each other. The coil 33 is arranged on the outermost side of the coils 31 to 33. The diameter of the outer peripheral surface 331 of the coil 33 matches the outer diameter of the rotating member 3, and is 0.36 mm as described above. The coils 31 to 33 are arranged concentrically as viewed from the extending direction.

  Examples of the constituent material of the coils 31 to 33 include stainless steel wire, piano steel wire, silicon chrome steel wire, nickel / titanium steel wire, and platinum / iridium steel wire. The constituent material, the diameter of the winding, the winding method of the winding, and the like are adjusted so that the hardness of the rotating member 3 becomes softer than the hardness of the catheter 2. Further, the constituent material, the diameter of the winding, the winding direction of the winding, and the like are adjusted so that the torque transmissibility of the rotating member 3 is higher than that of the catheter 2. Therefore, the rotating member 3 is less likely to be twisted during rotation than the catheter 2. Both ends of the coils 31 to 33 in the extending direction are terminated by brazing. As a result, loosening of the coils 31 to 33 is suppressed.

<Cutting member 4>
As shown in FIGS. 4, 5, and 7, the cutting member 4 is provided at the end of the rotating member 3 on the tip side. The cutting member 4 has a cylindrical shape. A cross section (hereinafter, referred to as “cut surface”) when the cutting member 4 is cut along a plane orthogonal to the central axis 4A of the cutting member 4 is circular. The central axis 4A of the cutting member 4 coincides with the central axis 3A of the rotating member 3. The cutting member 4 extends in the extending direction. The outer diameter of the cutting member 4 is substantially the same as the outer diameter of the rotating member 3. Therefore, the outer peripheral surface 41, which is the outer surface of the cutting member 4, and the outer peripheral surface 331 of the rotating member 3 are smoothly connected without a step. The length of the cutting member 4 in the extending direction is, for example, 1 mm.

  The cutting member 4 has a through hole extending in the extending direction along the central axis 4A. The through hole corresponds to the inner cavity 431 that is a space surrounded by the inner peripheral surface 43 that is the inner surface of the cutting member 4. The cross-sectional shape of the inner peripheral surface 43 is circular. The diameter of the inner peripheral surface 43 of the cutting member 4 matches the diameter of the inner peripheral surface 311 of the rotating member 3, and is 0.1 mm as described above. Therefore, the inner peripheral surface 43 of the cutting member 4 and the inner peripheral surface 311 of the rotating member are smoothly connected without a step.

  The plane of the tip end side of the cutting member 4 is orthogonal to the central axis 4A of the cutting member 4. Hereinafter, the flat surface on the tip side of the cutting member 4 is referred to as a "flat surface portion 42". The diameter of the flat surface portion 42 is the same as the diameter of the cut surface in the portion of the cutting member 4 closer to the base end than the flat surface portion 42.

  As shown in FIG. 7, the groove portion 45 is formed in the flat surface portion 42. The groove portion 45 is a groove-shaped portion that is recessed from the flat surface portion 42 toward the base end side. The groove portion 45 has a first groove portion 451 and a second groove portion 452. The first groove portion 451 and the second groove portion 452 extend linearly along the flat surface portion 42. Both the first groove portion 451 and the second groove portion 452 pass through the position of the central axis 4A. Both ends of each of the first groove portion 451 and the second groove portion 452 extend to the outer ends of the flat surface portion 42. That is, the first groove portion 451 and the second groove portion 452 cross the flat surface portion 42. The first groove portion 451 and the second groove portion 452 intersect at the position of the central axis 4A. The extending directions of the first groove portion 451 and the second groove portion 452 are orthogonal to each other. The inner cavity 431 of the cutting member 4 communicates with a portion where the first groove portion 451 and the second groove portion 452 intersect. The width of each of the first groove portion 451 and the second groove portion 452 is, for example, 0.05 to 0.07 mm. The length (depth) in the extending direction of each of the first groove portion 451 and the second groove portion 452 is 0.1 to 0.15 mm.

  The cutting member 4 is joined to the rotary member 3 at the same time when the end of the rotary member 3 on the tip side is terminated by brazing. As a constituent material of the cutting member 4, it is preferable to use a material having higher radiopacity than that of the rotating member 3, and for example, tungsten can be used. Further, the surface of the cutting member 4 may be subjected to, for example, DLC (diamond-like carbon). The groove portion 45 is formed in the flat portion 42 by laser processing.

<Connector 5>
As shown in FIG. 1, the connector 5 is connected to the proximal end of the catheter 2. The connector 5 has a main body portion 51, a connecting portion 52, and an injection port 53. The main body 51 extends linearly along the extending direction. The main body 51 is a tubular member having a circular cross section. An inner cavity (not shown) of the main body 51 extends in the extending direction. The rotating member 3 communicates with the inner cavity of the main body 51. The inner diameter of the main body portion 51 is larger than the outer diameter of the rotating member 3. The rotating member 3 is movable in the extending direction along the inner cavity of the main body 51.

  The connecting portion 52 is provided at the end on the tip side of the main body portion 51. A connecting member 216 provided at the proximal end of the first catheter 21 of the catheter 2 is detachably connected to the distal end of the connecting portion 52. In the state where the main body 51 and the first catheter 21 are connected via the connecting portion 52, the lumen of the main body 51 and the first lumen 212 of the first catheter 21 (see FIG. 2) communicate with each other. A backflow prevention valve (not shown) for preventing backflow of the liquid is provided on the proximal end side of the inner cavity of the main body 51.

  The injection port 53 extends from the main body 51 in an oblique direction with respect to the extending direction. The inlet 53 is a tubular member having a circular cross section. An internal cavity (not shown) of the injection port 53 communicates with an internal cavity (not shown) of the main body 51. It is possible to connect a supply device (not shown) capable of supplying a liquid to the end of the injection port 53 opposite to the side communicating with the inner cavity of the main body 51. The liquid injected from the supply device toward the injection port 53 flows into the internal cavity of the main body 51 via the internal cavity of the injection port 53. The liquid that has flowed into the main body portion 51 further flows into the first lumen 212 of the first catheter 21 via the connecting portion 52.

<Drive mechanism 6>
As shown in FIG. 1, the drive mechanism 6 is provided on the base end side of the connector 5. The drive mechanism 6 is connected to the end of the rotating member 3 which projects from the inner cavity of the main body 51 of the connector 5 toward the base end side. The drive mechanism 6 has a motor (not shown) inside. The drive mechanism 6 can rotate the rotating member 3 and the cutting member 4 about the central axes 3A and 4A.

<Lever 7>
The lever 7 projects outward from the base end side portion of the main body 51. The lever 7 is connected to the rotating member 3 in the inner cavity of the main body 51. The lever 7 is movable in the stretching direction. As the lever 7 moves in the extending direction, the rotating member 3 and the cutting member 4 also move in the extending direction. Specifically, it is as follows. When the lever 7 moves to the tip side, the rotating member 3 and the cutting member 4 also move to the tip side. In this case, as shown in FIG. 1 and FIG. 2, a part of the distal end portion of the rotating member 3 is exposed from the first lumen 212 of the first catheter 21 to the distal end side. In this state, the cutting member 4 provided at the tip end side of the rotating member 3 projects from the tip end 214 of the first catheter 21 to the tip end side. Hereinafter, the state in which the cutting member 4 projects from the tip 214 of the first catheter 21 is referred to as a “projected state”. On the other hand, when the lever 7 moves to the base end side, the rotating member 3 and the cutting member 4 also move to the base end side. In this case, the end portion of the rotating member 3 on the distal end side enters the inside of the first lumen 212 of the first catheter 21. In this state, the cutting member 4 provided at the tip end side of the rotating member 3 does not project from the tip end 214 of the first catheter 21 to the tip end side. Hereinafter, a state in which the cutting member 4 does not project from the tip 214 of the first catheter 21 is referred to as a “non-projecting state”.

<How to use>
An example of a method of using the embolus penetrating device 1 will be described. First, a guiding sheath is inserted into the blood vessel. Next, the guide wire is inserted into the guiding sheath. A guide wire is delivered into the blood vessel through the opening at the tip of the guiding sheath. The tip of the guide wire is guided near the intravascular CTO.

  The embolus penetrating device 1 in the non-protruding state and in which the rotation of the rotating member 3 by the drive mechanism 6 is stopped is prepared. The saline solution is injected into the main body 51 from the injection port 53 of the connector 5. The saline solution flows into the first catheter 21 from the connector 5. As a result, the air in the first lumen 212 of the first catheter 21 is discharged to the outside. The inside of the first lumen 212 is filled with sanitary saline.

  The guide wire is passed from the tip 224 of the second catheter 22 of the embolus penetrating device 1 toward the second lumen 222. The catheter 2 and the rotating member 3 move in the blood vessel along the guide wire toward the CTO in response to the movement of the second catheter 22 in the blood vessel along the guide wire. The tip 214 of the first catheter 21 is arranged near the CTO. After that, the guide wire is removed from the blood vessel. The operation for starting the rotation of the rotating member 3 by the drive mechanism 6 is performed by the user. The rotation of the rotating member 3 and the cutting member 4 is started.

  The lever 7 is moved to the tip side by the user. The embolus penetrating device 1 is in a protruding state. The cutting member 4 projects from the tip 214 of the first catheter 21 to the tip side. CTO exists near the tip 214 of the first catheter 21. As the cutting member 4 projects toward the tip side, the flat surface portion 42 of the cutting member 4 contacts the CTO. The rotating member 3 and the cutting member 4 are in a state of being rotated by the drive mechanism 6. Therefore, the groove portion 45 provided in the flat surface portion 42 of the cutting member 4 excavates the CTO. The user repeatedly moves the lever 7 back and forth toward the distal end side and the proximal end side. As a result, the cutting member 4 gradually moves toward the tip side while excavating the CTO.

  In the process in which the cutting member 4 gradually moves toward the tip side while excavating the CTO, physiological saline is injected from the injection port 53 of the connector 5 as necessary. The injected physiological saline flows through the inner cavity 312 of the rotary member 3 and the inner cavity 431 of the cutting member 4 to the tip side and is discharged to the tip side of the cutting member 4. A part of the discharged physiological saline flows outward along the groove portion 45 of the flat portion 42. As a result, the CTO shavings clogged in the groove portion 45 are flushed out. In addition, part of the discharged physiological saline flows to the tip side. As a result, the shavings accumulated on the tip side of the cutting member 4 are flushed to the tip side. Furthermore, the physiological saline flowing to the tip side cools the CTO heated by cutting. Finally, the cutting member 4 forms a through hole in the CTO. As a result, the narrowing of the blood vessel due to CTO is eliminated.

<Main actions and effects of the present invention>
The embolus penetrating device 1 has a rotating member 3 that is softer than the catheter 2. The rotating member 3 rotates according to the drive of the drive mechanism 6 to rotate the cutting member 4. The cutting member 4 rotates to cut an occlusion site (for example, CTO) in the blood vessel. Here, in order to cut the occluded portion with the cutting member 4, it is necessary to pass the catheter 2 and the rotating member 3 into the blood vessel to bring the cutting member 4 close to the occluded portion. Here, as described above, since the rotating member 3 is softer in hardness than the catheter 2, when the catheter 2 is bendable by following the bent blood vessel, the rotating member 3 is also bendable by following the blood vessel. Therefore, the embolus penetrating device 1 can appropriately move the cutting member 4 connected to the end of the rotating member 3 on the distal end side to the occlusion site in the blood vessel.

  The rotating member 3 has coils 31 to 33. The coils 31 to 33 are wound so as to overlap each other in the radial direction. The winding directions of the coils 31 and 32 and the winding directions of the coils 32 and 33 are opposite to each other. In this case, the rotating member 3 can appropriately transmit the rotational driving force of the drive mechanism 6 to the cutting member 4 and rotate the cutting member 4. Further, with such a configuration, the hardness of the rotating member 3 can be made easier than the hardness of the catheter 2. Therefore, the rotating member 3 having a hardness lower than that of the catheter 2 can be easily manufactured.

  Conventionally, in a debulking device such as a rotablator, the diameter of a member (a wire or the like) for rotating a cutting member becomes large, and it may be impossible to pass a thin blood vessel. On the other hand, in the device 1 for penetrating the embolus part, by setting the number of coils forming the rotating member 3 to 3, the rotating member 3 appropriately transmits the driving force of the driving mechanism 6 to the cutting member 4, The outer diameter of the rotating member 3 can be minimized. The diameter of each winding of the coils 31 to 33 is the same. In this case, the outer diameter of the rotating member 3 can be minimized by minimizing the diameter of each winding. For example, by setting the outer diameter of the rotating member 3 to 0.36 mm as exemplified above, the catheter 2 and the rotating member 3 are inserted into a blood vessel using a catheter introducer sheath having a lumen diameter of 3F (1 mm). can do. Therefore, the rotating member 3 that can pass through a thin blood vessel can be easily manufactured.

  In the device 1 for penetrating an embolus part, the cutting member 4 has a flat surface part 42 at the end on the tip side. The plane portion 42 is orthogonal to the central axis 4A. Here, as shown in FIG. 8, a case where a closed portion 8A that gradually closes from the proximal side toward the distal side is formed in the blood vessel 8 will be exemplified. When the end on the tip side of the cutting member is curved in a convex shape toward the tip side as in the conventional debulking device, a force cannot be locally applied to the closed portion 8A, and the closed portion 8A is cut. May not be able to be done efficiently. On the other hand, in the embolus penetrating device 1, when the cutting member 4 approaches the closed portion 8A from the base end side, the outer end of the flat portion 42 of the cutting member 4 contacts the closed portion 8A. Therefore, by rotating the cutting member 4 in this state, the force of the cutting member 4 moving toward the tip side can be locally applied to the closed portion 8A. Therefore, the groove portion 45 of the flat portion 42 can appropriately cut the closed portion 8A. Further, the groove portion 45 is provided only on the flat surface portion 42 and is not provided on the outer peripheral surface 41. Therefore, when the rotating member 3 reciprocates the first catheter 21 on both sides (base end side and distal end side) in the extending direction, the outer peripheral surface 41 of the cutting member 4 contacts the inner peripheral surface 211 of the first catheter 21. However, it does not damage the inner peripheral surface 211.

  The cutting member 4 has a cylindrical shape, and the diameter of the cutting surface is the same regardless of the position in the stretching direction. In this case, as shown in FIG. 8, when the rotating member 3 moves in the first lumen 212 of the first catheter 21, the entire outer peripheral surface 41 of the cutting member 4 becomes the inner peripheral surface 211 of the first catheter 21. You will come into contact. Therefore, the embolus portion penetrating device 1 can prevent the outer peripheral surface 41 of the cutting member 4 from locally contacting the inner peripheral surface 211 of the first catheter 21 and damaging the inner peripheral surface 211.

  The groove portion 45 provided in the flat surface portion 42 of the cutting member 4 extends linearly along the flat surface portion 42 to the outer end. In this case, shavings when the closing member is cut by the cutting member 4 is moved to the outer end of the flat surface portion 42 by passing through the groove portion 45, and further to the base end side of the flat surface portion 42. You can Therefore, the device 1 for penetrating the embolus portion can prevent the cutting by the cutting member 4 from being obstructed by shavings.

  It is preferable that the number of the groove portions 45 is large, but the larger the number of the groove portions 45, the higher the difficulty of forming the groove portions 45 on the cutting member 4 in the manufacturing process. On the other hand, in the embolus portion penetrating device 1, the groove portion 45 has two groove portions (first groove portion 451 and second groove portion 452). As a result, the embolus portion penetrating device 1 can efficiently perform the cutting operation by forming the groove portion 45 in the flat surface portion 42 of the cutting member 4, and at the same time, easily form the groove portion 45 in the flat surface portion 42. be able to. Further, by making the first groove portion 451 and the second groove portion 452 orthogonal to each other, the load acting on the first groove portion 451 and the second groove portion 452 during cutting can be made uniform, so that the deterioration of the groove portion 45 can be suppressed.

  In conventional debulking devices, measures may be taken to prevent air from being drawn in when inserted into a blood vessel. On the other hand, the connector 5 has an injection port 53. The liquid injected from the inlet 53 flows through the first lumen 212 of the first catheter 21 to the tip side and is discharged to the tip side of the cutting member 4. Therefore, the embolus penetrating device 1 can discharge the air in the first lumen 212 of the first catheter 21 with a liquid.

  In the conventional debulking device, shavings at the time of cutting may be clogged in the cutting member to hinder the cutting work, or the temperature of the closed portion may rise during cutting. On the other hand, in the device 1 for penetrating an embolus part, the shavings of the closed part clogged in the groove 45 of the flat part 42 of the cutting member 4 can be flown out by the liquid injected from the injection port 53. Further, the embolus portion penetrating device 1 can flush the shavings accumulated on the tip side of the cutting member 4 to the tip side by the liquid injected from the injection port 53. Further, in the device 1 for penetrating the embolus part, the closed part heated by cutting can be cooled by the liquid injected from the injection port 53.

  The catheter 2 has a first catheter 21 and a second catheter 22. The rotating member 3 is inserted into the first lumen 212 of the first catheter 21. A guide wire is inserted into the second lumen 222 of the second catheter 22. In this manner, the embolus penetrating device 1 has the first inner cavity 212 through which the rotating member 3 passes and the second inner cavity 222 through which the guide wire passes, so that the cutting member 4 can be smoothly moved along the guide wire. Can be moved to. Therefore, in the device 1 for penetrating an embolus portion, the cutting member 4 can be appropriately brought close to the closed portion in the blood vessel.

  In the conventional debulking device, the diameter of the catheter becomes large, and it may not be possible to pass a thin blood vessel. On the other hand, the embolus portion penetrating device 1 separately has the first catheter 21 into which the rotating member 3 is inserted and the second catheter 22 into which the guide wire is inserted. In this case, the embolus penetrating device 1 can minimize the inner diameters of the first catheter 21 and the second catheter 22. Therefore, the embolus penetrating device 1 can allow the catheter 2 to be inserted even in a thin blood vessel.

  When the torque transmissibility of the rotating member 3 is lower than the torque transmissibility of the catheter 2, when the rotating member 3 is rotated by the drive mechanism 6, the rotating member 3 is likely to be twisted. In contrast, in the embolus penetrating device 1, the torque transmissibility of the rotating member 3 is higher than that of the catheter 2. Therefore, when the cutting member 4 cuts the occluded portion in response to the rotation of the rotating member 3 by the drive mechanism 6, the cutting member is directly connected to the catheter to rotate the catheter to cut the occluded portion. Twisting of the rotating member 3 is suppressed as compared with the case where it is performed. Therefore, in the device 1 for penetrating the embolus portion, the closed portion can be efficiently cut by the cutting member 4. Therefore, the device 1 for penetrating the embolus portion can more effectively cut the closed portion by the cutting member 4.

<Modification>
The present invention is not limited to the above embodiment, and various modifications can be made. The embolus penetrating device 1 described above had the catheter 2 and the drive mechanism 6. On the other hand, the embolus portion penetrating device 1 may not include at least one of the catheter 2 and the drive mechanism 6. That is, the embolus penetrating device 1 may be configured to include at least the catheter 2, the rotating member 3, and the cutting member 4.

  The rotating member 3 may be composed of a member other than the coils 31 to 33. For example, the rotating member 3 may be an elongated rod-shaped member. Then, the cutting member 4 may be provided at the end on the tip end side of the rod-shaped member.

  The constituent material of the catheter 2 can be changed to a material different from the above example, within the range of satisfying the condition that it is harder than the coils 31 to 33 of the rotating member 3. The number of coils included in the rotating member 3, the constituent material of the windings of the coils 31 to 33, and the winding method are different from the above examples within the range of satisfying the condition of being harder than the catheter 2. The constituent material of the winding and the winding method can be changed. For example: In the above embodiment, the rotating member 3 has three coils (coils 31, 32, 33). The number of coils included in the rotating member 3 is not limited to three. For example, the number of coils may be one or two, or may be four or more. Here, a case where the rotating member 3 has N coils (where N is an integer of 2 or more) will be exemplified. In this case, the n-th coil from the inner side (where n is any integer from 1 to "N-1") and the "n + 1" -th coil are wound in the same direction. Alternatively, they may be wound in different directions.

  The plane portion 42 of the cutting member 4 may be inclined with respect to the direction orthogonal to the central axis 4A. A groove may be formed on the outer peripheral surface 41 of the cutting member 4. The tip side of the cutting member 4 may have, for example, a conical shape that protrudes toward the tip side from the outer end toward the central axis 4A. The cutting member 4 may be a so-called drill. In this case, the type of drill is not particularly limited. For example, the cutting member 4 may be a twist drill, a core drill, a half-moon drill, a gun drill, a step drill, or the like. The shape of the cutting member 4 is not limited to a cylindrical shape, and may be another shape. For example, the cutting member 4 may have a prismatic shape, a truncated cone shape, or the like. The cutting member 4 may have a smaller outer diameter toward the tip, or conversely may have a larger outer diameter toward the tip. That is, the diameter of the flat portion 42 may be equal to or larger than the diameter of the cut surface on the base end side of the flat portion 42. Instead of the groove portion 45, the flat surface portion 42 may be provided with a protruding portion that projects from the flat surface portion 42 toward the tip side. Further, both the groove portion 45 and the protruding portion may be provided in the flat surface portion 42. The groove portion 45 may have three or more groove portions that linearly extend through the central axis 4A. The shape of each groove is not limited to a linear shape, and may be a curved shape, a spiral shape, a circular shape, or the like.

  In the above, the injection ports 53 of the five connectors may not be provided. In this case, for example, the liquid may be directly injected from the proximal end of the inner cavity of the main body 51 of the connector 5.

  The first catheter 21 and the second catheter 22 may have substantially the same length in the extending direction. Further, the catheter 2 may have only the first catheter 21. A guide wire may be inserted through the first lumen 212 of the first catheter 21, the lumen 312 of the rotating member 3, and the lumen 431 of the cutting member 4. Further, the first catheter 21 may be provided with a so-called guide wire lumen. In this case, the lumen of the guide wire lumen may function as the second lumen 222 in the above embodiment.

  In the embolus penetrating device 1, the hardness of the rotating member 3 is softer than the hardness of the catheter 2, and the torque transmissibility of the rotating member 3 is higher than the torque transmissibility of the catheter 2. On the other hand, in the embolus penetrating device 1, the torque transmissibility of the rotating member 3 may be lower than that of the catheter 2. If the torque transmissibility of the rotating member 3 is higher than the torque transmissibility of the catheter 2, the hardness of the rotating member 3 may be harder than the hardness of the catheter 2.

  In the above embodiment, the embolus penetrating device 1 was described as an example of cutting an occlusion site (for example, CTO) in a blood vessel. However, the embolus penetrating device 1 may be used in a body cavity in the fields of gastroenterology, urology and plastic surgery. For example, the embolus penetrating device 1 may be used to crush gallstones.

<Other>
The cutting member 4 is an example of the “cutting means” in the present invention. The drive mechanism 6 is an example of the “drive means” in the present invention. The rotating member 3 is an example of the "rotating means" in the present invention.

1: Device for penetrating embolus part 2: Catheter 3: Rotating members 3A, 4A: Central axis 4: Cutting member 5: Connector 6: Drive mechanism 7: Lever 31, 32, 33: Coil 42: Plane part 45: Groove part 53: Inlet 451: first groove 452: second groove

Claims (12)

A cutting means capable of cutting an occlusion site in the body cavity,
It has flexibility and an elongated shape,
The cutting means is connected to one end, and the driving means is connected to the other end,
It is possible to rotate the cutting means according to the drive of the drive means,
At least a portion is inserted into the lumen of the catheter, and with respect to the catheter, is movable to both sides of the distal side which is one side and the proximal side which is the other side,
A rotating means capable of projecting the cutting means from the end portion on the distal end side of the catheter when moved to the distal end side,
The hardness of the rotating means, softer rather than the hardness of the catheter,
Of the cutting means, the end portion on the tip end side has a flat surface portion orthogonal to the rotation axis when the cutting means is rotated by the rotating means,
The flat portion is
A device for penetrating an embolus part , which is capable of cutting the closed part, and is provided with at least one groove part which is recessed on the proximal end side and linearly extends along the plane part . The rotating means is N coils (where N is an integer of 2 or more) wound so that their respective central axes extend in the same direction,
The "n + 1" th coil is wound along the outer peripheral surface of the nth coil (where n is any integer from 1 to "N-1"), and
The embolus penetrating device according to claim 1, wherein the nth coil and the “n + 1” th coil are provided with N coils wound in opposite directions.   The embolus penetrating device according to claim 2, wherein the winding diameters of the N coils are substantially the same.   The embolus penetrating device according to claim 2 or 3, wherein the rotating means includes three coils. The cutting means is
The cross section when cut along a plane orthogonal to the rotation axis is substantially circular, and
The embolus penetrating device according to any one of claims 1 to 4 , wherein a diameter of the flat portion is equal to or larger than a diameter of the cross section on the proximal end side with respect to the flat portion. Wherein said at least one groove, embolization section through a device according to any one of claims 1 to 5, characterized in that it comprises two grooves to and orthogonal to each other extend in a straight line. The catheter,
It connected to an end portion of the proximal side of the catheter, from claim 1, further comprising a connector having a lumen inlet capable of injecting the liquid from the outside of the catheter 6 The device for penetrating an embolus part according to any one of 1. The catheter is
The embolus penetrating device according to claim 7 , wherein the device has a first lumen through which the rotating means is inserted and a second lumen through which a guide wire is inserted. The catheter is
A first catheter having the first lumen;
The embolus part according to claim 8 , further comprising a second catheter having the second lumen and connected to the outer peripheral surface of the first catheter in the vicinity of the end portion on the distal end side. Penetration device. The embolus penetrating device according to any one of claims 1 to 9 , wherein the torque transmissibility of the rotating unit is higher than the torque transmissibility of the catheter. The constituent material of the cutting means, embolization section through a device according to any of claims 1 1 0 wherein said a material high X-ray opacity than the rotation means. The cutting means is
Having a cylindrical shape having an outer peripheral surface that is an outer side in the radial direction around the rotation axis,
The embolus penetrating device according to any one of claims 1 to 11 , wherein a groove is formed on the outer peripheral surface.

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