JP2006075524A - Wire operation implement assembly and wire set for removing endovascular foreign body - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a wire operation implement assembly capable of accurately operating a wire for removing endovascular foreign bodies, and a wire set for removing the endovascular foreign bodies. <P>SOLUTION: The wire operation implement assembly 2 comprises: a fixing implement 3 connected to the proximal end side of a catheter 8 and provided with a fixing implement body 31 into which the wire 1 for removing the endovascular foreign bodies and a guide wire can be respectively inserted and a fixing means 32 capable of fixing the wire 1 for removing the endovascular foreign bodies inserted inside the fixing implement body 31; an operation implement 4 provided with an operation implement body 41 capable of inserting the wire 1 for removing the endovascular foreign bodies and fixing the inserted wire 1 for removing the endovascular foreign bodies and a moving operation means 42 operated so as to move the wire 1 for removing the endovascular foreign bodies fixed to the operation implement body 41 to the catheter 8 along the longitudinal direction; and an attaching means 5 capable of attaching the fixing implement 3 and the operation implement 4 so as to fix their position relation with each other in the longitudinal direction. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a wire operation tool assembly and a wire set for removing foreign matter in a blood vessel.

  According to the Ministry of Health, Labor and Welfare's demographic statistics, the first cause of death in Japan is cancer, the second is heart disease, the third is stroke, and deaths and sequelae are especially urgent. It has become.

  In recent years, thrombolytic therapy using a thrombolytic agent has been developed for treating cerebral infarction in the acute phase in the treatment of stroke, and its therapeutic effect has been raised, but its limitations are also pointed out. In other words, from the experience of doctors, thrombolytic agents require a long time for thrombolysis, smaller thrombi fly further to form new emboli sites, and there are thrombi that do not dissolve with thrombolytic agents. It recognized.

  In the case of cerebral infarction, if the blood flow can be resumed within 3 hours after the onset of the infarction, not only will the survival rate increase, but it has been proved in the United States and Europe that it can be inserted into the cerebral blood vessels and directly takes a thrombus. There is a strong demand for the development of medical devices that can be used. As such a medical instrument, an intravascular foreign matter removing wire in which a foreign matter catching part for catching foreign matter in a blood vessel is provided on the distal end side is used.

  In order to remove the thrombus using the intravascular foreign matter removing wire, first, the thrombus is captured by the foreign matter capturing portion protruding from the distal end opening of the catheter. Next, the foreign body capturing part is moved closer to the distal end of the catheter so that the size of the foreign body capturing part becomes smaller, that is, the intravascular foreign body removing wire is moved in the proximal direction (pulled). Thereafter, the thrombus is removed from within the blood vessel.

  However, for example, when the intravascular foreign matter removing wire is pulled too much, the foreign matter catching portion becomes too small. For this reason, the thrombus may receive excessive pressure from the foreign matter capturing part and may be crushed. Therefore, the operation of the intravascular foreign matter removing wire requires carefulness and delicate force adjustment.

  For such problems, for example, wire operating tools as shown in Patent Document 1 and Patent Document 2 are known. This wire operation tool is configured to hook three fingers on a proximal ring and change the foreign matter catching portion (basket) between a reduced diameter state and an enlarged diameter state by operating (opening / closing) the ring. ing.

  Patent Document 3 discloses a wire operating tool including a slide portion corresponding to an intravascular foreign matter removing wire having a basket formed on the tip side. The wire operating tool is configured to change the basket between a reduced diameter state and an expanded diameter state by moving (sliding) the slide portion in the distal direction or the proximal direction.

  However, even with such a wire operating tool, as described above, in order to capture and remove a relatively soft foreign matter such as a thrombus, a subtle difference with respect to the intravascular foreign matter removing wire when the basket is reduced in diameter is used. Power adjustment is required. For this reason, for example, if an excessive force is applied to the operation of the intravascular foreign matter removing wire, the basket may be excessively reduced in diameter, that is, the thrombus may be crushed.

US Pat. No. 6,015,415 US Pat. No. 6,264,664 US Pat. No. 6,183,482

  An object of the present invention is to provide a wire operating tool assembly and an intravascular foreign matter removing wire set capable of accurately operating an intravascular foreign matter removing wire.

Such an object is achieved by the present inventions (1) to (9) below.
(1) A wire operation tool assembly that is used by being attached to a catheter through which a foreign-matter removing wire provided with a foreign-matter catching part for catching a foreign substance in a blood vessel and a guide wire can be inserted. And
The proximal end side of the catheter is connected, and a fixing tool body through which the intravascular foreign matter removal wire and the guide wire can be inserted, and the intravascular foreign matter removal wire inserted through the fixing body can be fixed. A fixing device having a fixing means,
The intravascular foreign matter removal wire can be inserted, and the operation tool main body capable of fixing the inserted intravascular foreign matter removal wire, and the intravascular foreign matter removal wire fixed to the operation tool main body in its longitudinal direction And an operation tool having a movement operation means for operating the catheter so as to move with respect to the catheter,
A wire operating tool assembly comprising: an attaching means capable of attaching the fixing tool and the operating tool in a longitudinal direction so as to fix the positional relationship therebetween.

(2) In a state where the intravascular foreign matter removing wire is fixed by the operation of the fixing means, the positional relationship between the fixing tool and the operation tool is fixed,
Next, after fixing the intravascular foreign matter removing wire by the operation tool main body, the fixing by the operation of the fixing means is released, and the intravascular foreign matter removing wire is operated. Operation tool assembly.

  (3) The wire operating tool assembly according to (1) or (2), wherein the guide wire is operated in a state of being movably inserted through the fixing tool.

  (4) The wire operation tool assembly according to any one of (1) to (3), wherein the guide wire cannot be inserted into the operation tool main body.

  (5) The moving operation means includes a handle that rotates while being screwed to the operation tool main body, and a conversion unit that converts the rotational motion of the handle into a linear motion in which the intravascular foreign matter removing wire moves. The wire operating tool assembly according to any one of (1) to (4).

  (6) The wire operating tool assembly according to (5), wherein when the handle is rotated, the mounting means can be fixed to the mounting means with such a strength that the operating tool does not rotate.

  (7) The wire operation tool assembly according to any one of (1) to (6), wherein the operation tool includes a restriction unit that restricts a maximum movement amount of the intravascular foreign matter removal wire.

  (8) The wire operating tool assembly according to any one of (1) to (7), wherein the operating tool is provided with a scale indicating the amount of movement of the intravascular foreign matter removing wire.

(9) The wire operation tool assembly according to any one of (1) to (8),
A wire for removing foreign matter in a blood vessel in which a foreign matter catching portion for catching foreign matter in a blood vessel is provided on the distal end side;
A wire set for removing intravascular foreign matter, comprising: a catheter through which the intravascular foreign matter removing wire and guide wire can be inserted.

  According to the present invention, by providing the moving operation means, the intravascular foreign matter removing wire can be accurately moved (operated), so that the foreign matter in the blood vessel can be reliably captured and removed.

  In addition, the fixing tool, the operating tool, and the attachment means can be used individually for each of the intravascular foreign matter removal wire and the guide wire, and therefore, excellent operability for the intravascular foreign matter removal wire and the guide wire. Can be obtained.

  Hereinafter, a wire operation tool assembly and a wire set for removing foreign matter in a blood vessel of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  1 is a perspective view of an intravascular foreign matter removing wire set according to the present invention, FIG. 2 is a perspective view of a wire operating tool assembly fixing tool provided in the intravascular foreign matter removing wire set shown in FIG. 1, and FIG. 2 is a longitudinal sectional view of the fixing means of the fixing tool shown in FIG. 2, FIG. 4 is a perspective view of the operating tool of the wire operating tool assembly provided in the intravascular foreign matter removing wire set shown in FIG. 1, and FIG. FIG. 6 is a perspective view of the intravascular foreign matter removing wire included in the intravascular foreign matter removing wire set shown in FIG. 1, and FIGS. 7 to 12 are diagrams respectively. FIG. 2 is a diagram for explaining step by step how to use the intravascular foreign matter removing wire set shown in FIG.

  In the following description, the left side in FIGS. 1 to 12 is referred to as “tip”, and the right side is referred to as “base end”. Further, the intravascular foreign matter removing wire and the blood vessel are exaggerated with respect to the wire operation tool assembly.

  An intravascular foreign matter removing wire set (hereinafter simply referred to as “wire set”) 9 shown in FIG. 1 includes an intravascular foreign matter removing wire 1, a catheter 8, and a wire operation tool assembly 2. Hereinafter, the configuration of each unit will be described.

First, the wire operation tool assembly 2 will be described.
As shown in FIG. 1, the wire operation tool assembly 2 is used by being attached to a catheter 8. The wire operating tool assembly 2 includes a fixing tool 3, an operating tool 4, and attachment means 5 for attaching the fixing tool 3 and the operating tool 4.

  As shown in FIG. 2, the fixture 3 includes a fixture body 31 into which the intravascular foreign matter removal wire 1 and the guide wire 10 can be inserted, a supply port 33 provided in the fixture body 31, and an intravascular foreign matter. And fixing means 32 capable of fixing the removal wire 1.

  The fixture main body 31 has a tubular shape, and the inner diameter thereof is larger than the outer diameter (wire diameter) of the intravascular foreign matter removing wire 1 or the guide wire 10. As a result, the intravascular foreign matter removing wire 1 and the guide wire 10 can be smoothly (smoothly) inserted through the fixture main body 31, respectively.

  Further, the hub 84 (base end side) of the catheter 8 is connected to the distal end portion 311 of the fixture main body 31 so as to be connectable / detachable.

  As shown in FIG. 3, the base end portion 312 of the fixture main body 31 is provided with a columnar recess 35 formed along the longitudinal direction of the fixture main body 31. On the outer periphery of the base end portion 312, a male screw portion 34 that is screwed with a pressing member 37 described later is formed.

  As shown in FIG. 3, the fixing means 32 includes a ring-shaped member 36 housed in the recess 35 of the fixture main body 31 and a pressing member 37 that presses the link-shaped member 36.

  The ring-shaped member 36 is made of an elastic material. In the natural state, the ring-shaped member 36 has an inner diameter that is substantially equal to the inner diameter of the fixture body 31 and an outer diameter that is approximately equal to the inner diameter of the recess 35. Here, the “natural state” means a state in which no external force is applied to the ring-shaped member 36.

  The pressing member 37 includes a disk-shaped disk-shaped part 371, a cylindrical-shaped cylindrical part 372 provided concentrically with the disk-shaped part 371, and the disk-shaped part 371 as well as the cylindrical part 372. And a cylindrical columnar portion 373 provided concentrically.

On the inner peripheral surface of the cylindrical portion 372, a female screw portion 374 that is screwed with the male screw portion 34 of the fixture main body 31 (base end portion 312) is formed. Thereby, the pressing member 37 can be rotated while being screwed to the fixture main body 31.
The cylindrical portion 373 has an outer diameter that is substantially equal to the inner diameter of the recess 35.

  The pressing member 37 having such a structure is formed with a through hole 375 penetrating the pressing member 37 in the longitudinal direction. The diameter of the through hole 375 is substantially the same as the inner diameter of the fixture body 31. As a result, the intravascular foreign matter removing wire 1 and the guide wire 10 inserted through the fixture main body 31 can protrude toward the proximal end side of the fixture 3.

  As the pressing member 37 and the fixture main body 31 are screwed together, the ring-shaped member 36 is pressed against the distal end surface of the columnar portion 373 of the pressing member 37. Due to this pressing, the ring-shaped member 36 is elastically deformed to increase the outer diameter, but the outer peripheral surface 361 of the ring-shaped member 36 is restricted by the inner peripheral surface 351 of the recess 35, and the ring-shaped member 36. The outer diameter cannot be expanded. Therefore, the inner diameter of the ring-shaped member 36 is surely reduced (see the ring-shaped member 36 ′ in FIG. 3). Thereby, the inner peripheral surface 362 of the ring-shaped member 36 presses (crimps) the intravascular foreign matter removing wire 1 inserted through the fixture main body 31, so that the intravascular foreign matter removing wire 1 is securely fixed. can do.

  Further, the fixing means 32 can also reliably fix the guide wire 10 inserted through the fixture main body 31.

  A supply port 33 that is inclined with respect to the fixture body 31 is provided in the middle of the fixture body 31.

  The supply port 33 is formed of a tubular body and communicates with the inside of the fixture main body 31. Thereby, the liquid (for example, contrast agent) supplied from the supply port 33 can be reliably supplied into the catheter 8 via the inside of the fixture main body 31.

  In addition, although it does not specifically limit as a constituent material of the fixing tool 3 (except the ring-shaped member 36), For example, various metal materials, various plastics, etc. can be used individually or in combination.

  The elastic material constituting the ring-shaped member 36 is not particularly limited. For example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber , Various rubber materials such as hydrin rubber, urethane rubber, silicone rubber, fluoro rubber (especially those vulcanized), styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, Various thermoplastic elastomers such as transpolyisoprene, fluororubber, and chlorinated polyethylene can be used, and one or more of these can be used in combination.

Next, the operation tool 4 will be described.
As shown in FIG. 4, the operation tool 4 includes an operation tool body 41 through which the intravascular foreign matter removal wire 1 can be inserted, a scale 44 attached to the operation tool main body 41, and the intravascular foreign matter removal wire 1. 8 is provided with a movement operation means 42 that operates so as to move with respect to 8, and a regulation means 43 that regulates the maximum movement amount of the intravascular foreign matter removal wire 1.

  The operation tool main body 41 includes an outer cylinder 415, an inner cylinder 411, and a cap 412 that is screwed (attached) to the distal end portion of the inner cylinder 411.

  Now, in general, the outer diameter of the intravascular foreign matter removing wire 1 is smaller (thinner) than the outer diameter of the guide wire 10.

  Therefore, the inner diameter of the inner cylinder 411 is larger than the outer diameter of the intravascular foreign matter removing wire 1 and smaller than the outer diameter of the guide wire 10. That is, in the inner cylinder 411 (the operation tool main body 41), the intravascular foreign matter removing wire 1 can be inserted, but the guide wire 10 cannot be inserted. Thereby, it is possible to prevent the guide wire 10 from being erroneously inserted into the operation tool main body 41 (operation tool 4).

  In addition, a plurality of (for example, four) claws 413 projecting in the distal direction are formed at the distal end of the inner cylinder 411. Each claw 413 has a triangular cross-sectional shape, and one apex faces the central axis 414 side of the inner cylinder 411.

  By tightening the cap 412 against the inner cylinder 411, each claw 413 is pressed against the inner peripheral surface of the cap 412. Thereby, each nail | claw 413 is displaced toward the central axis 414, and the space | interval of each vertex toward the central axis 414 becomes small.

  By such an action of the cap 412 and the claw 413, the intravascular foreign matter removing wire 1 inserted between the apexes can be fixed. Therefore, the cap 412 and the claw 413 have a function as a chuck for fixing the intravascular foreign matter removing wire 1.

  The force (chucking force) for fixing the intravascular foreign matter removing wire 1 is such that when the intravascular foreign matter removing wire 1 is operated, the intravascular foreign matter removing wire 1 is pulled from the operating tool body 41 (the operating tool 4). It is strong enough to prevent slipping. Thereby, the intravascular foreign matter removing wire 1 can be more reliably fixed.

  On the inner peripheral surface of the outer cylinder 415, a female screw portion 416 that is screwed with a handle 421 described later is formed. Further, a reduced diameter portion 417 having a diameter smaller than the outer diameter of the outer cylinder 415 is formed on the outer peripheral surface of the outer cylinder 415.

  As shown in FIG. 5, the movement operation means 42 includes a handle 421 that rotates while being screwed to the outer cylinder 415 (operation tool main body 41), and a conversion unit 422 that converts the rotational motion of the handle 421 into a linear motion. have.

  The handle 421 includes a disk-shaped disk-shaped part 424 and a columnar part 425 provided concentrically with the disk-shaped part 424.

  On the outer peripheral surface of the columnar portion 425, a male screw portion 423 that is screwed with the female screw portion 416 of the outer cylinder 415 is formed. Further, a claw portion 426 that is rotatably connected to the inner cylinder 411 of the operation tool main body 41 is formed on the distal end surface of the columnar portion 425.

  In the state shown in FIG. 5, when the disk-shaped portion 424 is rotated, for example, counterclockwise, the handle 421 moves in the proximal direction. Accordingly, the inner tube 411 of the operation tool body 41 moves in the proximal direction, that is, the intravascular foreign matter removing wire 1 fixed to the operation tool body 41 moves in the proximal direction (along the longitudinal direction). To do. Thus, the conversion part 422 is comprised by the internal thread part 416 of the outer cylinder 415, and the external thread part 423 of the handle 421. FIG.

  Here, as described above, since the columnar portion 425 of the handle 421 and the inner cylinder 411 of the operation tool main body 41 are rotatably connected, the rotation of the handle 421 is prevented from being transmitted to the inner cylinder 411. ing. As a result, the intravascular foreign matter removing wire 1 is prevented from being twisted (rotated), and the operability of the intravascular foreign matter removing wire 1 is further improved.

  With the moving operation means 42 having such a configuration, the intravascular foreign matter removing wire 1 can be operated accurately and easily (stopped at an arbitrary position). In addition, the amount of movement of the intravascular foreign matter removing wire 1 relative to the amount of rotation of the handle 421 can be changed by appropriately setting the size of the screw pitch of the male screw portion 423 and the female screw portion 416. Thereby, delicate adjustment in the operation of the intravascular foreign matter removing wire 1 becomes possible.

  Further, the moving amount of the intravascular foreign matter removing wire 1 relative to the rotation amount of the handle 421 is not particularly limited, and is preferably 0.1 to 4 mm per rotation of the handle 421, for example, 0.2 to 2 mm. It is more preferable that

  Further, as shown in FIG. 5, an enlarged diameter portion 418 that is larger than the outer diameter of the inner cylinder 411 is provided on the outer peripheral surface of the inner cylinder 411. Since the proximal end surface 418a of the enlarged diameter portion 418 and the distal end surface 415a of the outer cylinder 415 are in contact with each other, it is possible to reliably prevent the intravascular foreign matter removing wire 1 from moving excessively. The maximum amount of movement of the internal foreign matter removal wire 1 can be reliably regulated. Accordingly, the restricting means 43 is constituted by the enlarged diameter portion 418 and the outer cylinder 415.

  Moreover, the maximum movement amount of the intravascular foreign matter removing wire 1 is not particularly limited, but is preferably 5 to 40 mm, and more preferably 10 to 20 mm, for example.

  Further, as shown in FIG. 4, a scale 44 indicating the amount of movement of the intravascular foreign matter removing wire 1 is provided (applied) on the outer peripheral surface of the inner cylinder 411. Thereby, it is possible to operate the intravascular foreign matter removal wire 1 while confirming (viewing) the movement amount of the intravascular foreign matter removal wire 1, that is, the operation of the wire set 9 (wire operating tool assembly 2). Improves.

  Moreover, although the magnitude | size of the space | interval of the scale 44 is not specifically limited, For example, it is preferable that it is 0.1-4 mm, and it is more preferable that it is 0.1-1 mm.

  In addition, the constituent material of the operation tool 4 is not particularly limited, but for example, the constituent material described in the description of the fixing tool 3 can be used.

Next, the attachment means 5 will be described.
As shown in FIG. 1, the mounting means (mounting base) 5 includes a mounting base body 51, fixing tool nails 52 and 53, and an operating tool pawl 54.

  The mounting base body 51 is composed of a long plate-like body. On one surface of the mounting base body 51, fixing tool claws 52 and 53 and an operation tool claw 54 are provided.

  The fixing tool claws 52 and 53 are for fixing the fixing tool 3. The fixing tool claw 52 is formed at the distal end portion of the mounting base body 51, and the fixing tool claw 53 is formed on the proximal side from the fixing tool claw 52.

  The distal end side and the proximal end side of the fixture main body 31 are engaged (fitted) with the fixture claws 52 and 53, respectively.

  The operation tool claw 54 is for fixing the operation tool 4. The operation tool claw 54 is formed at the proximal end portion of the mounting base body 51. The reduced diameter portion 417 of the outer cylinder 415 of the operation tool main body 41 is engaged with the operation tool claw 54.

  When the fixture 3 and the operation tool 4 are attached to the attachment means 5 having such a configuration, the positional relationship between the fixture 3 and the operation tool 4 in the longitudinal direction is fixed (see FIG. 1).

  Further, when the pressing member 37 of the fixing tool 3 is rotated with the fixing tool 3 attached to the fixing tool claws 52 and 53, the fixing tool 3 is attached to the fixing tool claws 52 and 53 (attachment means 5). It is preferable that it can be fixed with a strength that does not rotate with respect to the means 5. Thereby, even if the user of the fixture 5 does not press (press) the fixture 3 against the attachment means 5, the pressing member 37 can be easily rotated, that is, the fixture 3 (wire operation). The operability of the tool assembly 2) is improved.

  Further, when the handle 421 of the operation tool 4 is rotated while the operation tool 4 is attached to the operation tool claw 54, the operation tool 4 is attached to the attachment means 5 by the operation tool 4. It is preferable that it can be fixed at such a strength that it does not rotate. Thereby, even if the user of the operation tool 4 does not press the operation tool 4 against the attachment means 5, the handle 421 can be easily rotated, that is, the operation tool 4 (wire operation tool assembly 2). Improved operability.

  Further, when the fixture 3 and the operation tool 4 are attached to the attachment means 5, the distance between the fixture 3 and the operation tool 4, that is, the distance between the base end of the fixture 3 and the tip of the operation tool 4. The length indicated by L in FIG. 10 is not particularly limited, but is preferably 5 to 50 mm, and more preferably 5 to 20 mm, for example.

  Moreover, it is preferable that the fixing tool 3 and the operation tool 4 are detachable with respect to the attachment means 5, respectively.

  In addition, the constituent material of the attachment means 5 is not particularly limited, but for example, the constituent materials described in the description of the fixture 3 can be used.

Next, the intravascular foreign matter removing wire 1 will be described.
The intravascular foreign matter removing wire 1 shown in FIGS. 1 and 6 captures and removes foreign matter (hereinafter referred to as “emboli”) that causes embolization such as thrombus and blood clot in the blood vessel. .

  The intravascular foreign matter removing wire 1 is provided at a long wire main body 11 and a distal end (front end side) of the wire main body 11, and a capturing portion (foreign matter capturing portion) 12 capable of capturing an embolus 200 in the blood vessel 100. And have. Hereinafter, the configuration of each unit will be described.

  The wire body 11 has moderate rigidity and elasticity (flexibility) over the entire length. The structure of the wire body 11 is not particularly limited. For example, the wire body 11 includes a single wire, a bundle of a plurality of wires, a hollow structure, a multilayer structure, a core and a coil wound around the outer periphery thereof. It may have what it has, what combined these, etc.

  Moreover, it does not specifically limit as a constituent material of the wire main body 11, Various metal materials, various plastics, etc. can be used individually or in combination.

  Although the preferable value of the length of the wire body 11 varies depending on the case of the position and thickness of the blood vessel to be applied, it is usually preferably about 500 to 4000 mm, more preferably about 1500 to 2200 mm.

  Further, the wire body 11 is located on the proximal end side, the relatively hard first part, the distal part, the relatively flexible third part, the first part, and the third part. And a second portion where the flexibility changes. In other words, the wire body 11 is preferably such that the rigidity (bending rigidity, torsional rigidity, etc.) gradually decreases from the proximal end toward the distal end. As a result, the operation at hand is reliably transmitted to the distal end, and the traveling performance in the blood vessel and the operability at the bent portion are excellent, and the flexibility of the distal end can be improved and the blood vessel can be prevented from being damaged. . That is, it is possible to ensure higher safety while maintaining the torque transmission performance, pushability (pushability), and kink resistance (bending resistance) of the wire body 11.

  The preferable value of the outer diameter (thickness) of the wire body 11 varies depending on the position of the blood vessel to be applied, the thickness, and the like, but it is usually preferable that the average outer diameter is 0.1 to 2.0 mm. 0.25 to 0.9 mm is more preferable.

  In particular, in the case of the intravascular foreign matter removing wire 1 used by being inserted into a microcatheter, the average outer diameter of the wire body 11 is about 0.1 to 0.53 mm (0.004 to 0.021 inch). It is preferably about 0.25 to 0.46 mm (0.010 to 0.018 inch).

  Here, the microcatheter means an outer diameter of 4 Fr. (French) refers to a catheter for intravascular treatment diagnosis. It is clearly distinguished from the above angiographic catheters, guiding catheters and the like. 4Fr. = About 1.33 mm.

  Needless to say, the present invention is not limited to the one adapted to the microcatheter, but can be applied to a foreign body collecting unit for collecting a large blood vessel adapted to a contrast catheter or a guiding catheter, for example.

  A coating layer that reduces frictional resistance with the inner surface of the catheter 8 may be provided on the outer surface (surface) of the wire body 11. Thereby, insertion / extraction with respect to the catheter 8 can be performed more smoothly. Examples of the coating layer include a coating layer (Teflon coat) of fluororesin such as polytetrafluoroethylene (“Teflon” is a registered trademark) and a hydrophilic polymer coat having lubricity when wet.

  A capturing portion 12 is provided on the distal end side of the wire main body 11. In the natural state, the capture unit 12 is in an expanded (open) state (this state is hereinafter referred to as an “expanded state”) as shown in FIG. In this expanded state, a foreign substance capturing space 121 capable of capturing the embolus 200 in the blood vessel 100 is formed inside the capturing unit 12.

  The capturing part 12 can be deformed from the expanded state to a state in which it is folded to a size (width) that can be accommodated in the catheter 8 (this state is hereinafter referred to as a “reduced diameter state”). ing.

  Such a capturing part 12 can be deformed (restored) from the reduced diameter state to the expanded diameter state by its own elasticity.

  In the following, unless otherwise specified, the description of the shape and size of the capturing portion 12 is in the expanded diameter state (natural state).

  As shown in FIG. 6, the capture unit 12 includes two branch wire portions 13 a and 13 b extending so as to branch from the tip of the wire body 11 (so as to be separated from each other), and the branch wire portion 13 a and the branch portion. It consists of three filament parts 14a, 14b, 14c installed between the wire part 13b.

  The proximal end portions of the branch wire portions 13a and 13b are fixed (fixed) to the distal end portion of the wire body 11, respectively. The fixing method is not particularly limited. For example, the base end portions of the branch wire portions 13a and 13b are respectively knitted (wrapped) to the distal end portion of the wire main body 11, brazed, welded, and bonded with an adhesive. Can be fixed.

  Three filament portions 14a, 14b, and 14c having a linear shape are provided between the distal end portion of the branch wire portion 13a and the distal end portion of the branch wire portion 13b. These filament parts 14a, 14b, and 14c are respectively curved so that the center part protrudes to the tip side, and connects the tip part of the branch wire part 13a and the tip part of the branch wire part 13b. In other words, the branch wire portions 13a and 13b and the filament portions 14a, 14b, and 14c are arranged so as to draw an ellipse (oval) in a plan view shown in FIG. In the present embodiment, since the tip portions of the filament portions 14a, 14b, and 14c are smoothly curved, damage to the inner wall of the blood vessel 100 can be prevented, and higher safety can be obtained. It is done.

  In the capturing part 12, a foreign substance capturing space 121 for capturing the embolus 200 is formed so as to be surrounded by the branch wire parts 13a, 13b and the filament parts 14a, 14b, 14c. In other words, a hook-shaped foreign matter holding part is formed by the filament parts 14a, 14b, and 14c. As shown in FIG. 7, the intravascular foreign matter removing wire 1 captures the embolus 200 in the foreign matter capturing space 121.

As a constituent material (raw material) of such a capturing part 12, for example, stainless steel (SUS304, etc.), β titanium steel, Co—Cr alloy, piano wire, platinum-iridium alloy (Pt ₉₀ / Ir ₁₀ , Pt ₈₀ / Ir ₂₀ etc.) Other metal materials such as other noble metal spring alloys, alloys having spring properties such as nickel titanium alloys, and mono-multi fibers made of resin are preferable.

  In addition, the outer diameter of the branch wire portions 13a and 13b is not particularly limited, but is preferably 0.05 to 0.9 mm, and more preferably 0.1 to 0.5 mm. Here, the outer diameter of the branch wire portions 13a and 13b refers to the entire outer diameter of the stranded wire portion.

  Moreover, the outer diameter (wire diameter) of filament part 14a, 14b, 14c is although it does not specifically limit, It is preferable that it is 0.025-0.2 mm, and it is more preferable that it is 0.05-0.1 mm.

  When the wire body 11 is moved forward relative to the catheter 8 from the state in which the capture part 12 is housed in the catheter 8, and the capture part 12 protrudes (exposes) from the distal end opening 81 of the catheter 8, the capture part 12. Is restored from the reduced diameter state to the expanded diameter state by its own elasticity.

  When the wire body 11 is pulled in the proximal direction with respect to the catheter 8 from this state, the proximal ends of the branch wire portions 13a and 13b enter the catheter 8 while abutting against the distal end opening 81 (the edge thereof). As a result, the distance between the branch wire portions 13a and 13b is reduced.

  When the wire body 11 is further pulled in the proximal direction with respect to the catheter 8, the capturing unit 12 is automatically reduced in diameter and stored again in the catheter 8 while narrowing the interval between the branch wire portions 13 a and 13 b. .

  As described above, the capture unit 12 can be automatically deformed (displaced) into a diameter-expanded state and a diameter-reduced state as it enters and exits from the distal end opening 81 of the catheter 8.

Next, the catheter 8 will be described.
As shown in FIG. 1, the catheter 8 includes a catheter body 83 and a hub 84.

  The catheter body 83 is composed of a flexible tube. In the catheter body 83 (lumen 85), the intravascular foreign matter removing wire 1 and the guide wire 10 can be inserted.

A hub 84 is attached (fixed) to the proximal end of the catheter body 83. A lumen that communicates with the lumen 85 is formed in the hub 4. The lumen preferably has an inner diameter substantially equal to the inner diameter of the lumen 85 and is continuous with the inner surface of the proximal end portion of the lumen 85 without causing a step or the like.
Such a hub 84 is detachably attached to the distal end portion 311 of the fixture 3.

  Next, an example of how to use the wire set 9 (wire operating tool assembly 2) of the present invention will be described in detail.

  [1] FIG. 7 shows a state where an embolus 200 such as a thrombus is clogged in the blood vessel 100 and the blood flow is inhibited. The embolus 200 is pressed against the inner wall of the blood vessel 100 by blood pressure and is not easily moved.

  The guide wire 10 is inserted (inserted) into the fixture 3 from the proximal end side of the fixture 3 and is inserted into the lumen 85 of the catheter (microcatheter) 8. In this state, the catheter 8 and the guide wire 10 are inserted into the blood vessel 100, and the distal end portion 101 of the guide wire 10 projected from the distal end opening 81 of the catheter 8 is inserted deeper (peripheral side) than the embolus 200. To do. In other words, the distal end portion 101 of the guide wire 10 passes through the gap between the embolus 200 and the inner wall of the blood vessel 100 and exceeds the embolus 200.

  The operation of the guide wire 10 is performed in a state where the guide wire 10 is movably inserted into the fixture 3, that is, in a state where the fixing means 32 of the fixture 3 is not operated. As a result, the guide wire 10 can move with respect to the catheter 8, and hence the operation of the guide wire 10 becomes easier, that is, the operability of the guide wire 10 (wire operating tool assembly 2) is further improved.

  [2] When the distal end portion 101 of the guide wire 10 exceeds the embolus 200, the catheter 8 is advanced with respect to the guide wire 10, and the distal end portion of the catheter 8 is inserted into the embolus 200 and the inner wall of the blood vessel 100 as shown in FIG. 8. Get into the gap. At this time, since the distal end portion of the catheter 8 smoothly enters the gap along the guide wire 10, this operation can be easily performed.

  As a conventional treatment, a thrombolytic agent is flowed retrogradely through the catheter 8 in this state to speed up the thrombolysis. Long hours are often experienced by physicians. The present invention is also useful in such a case.

  [3] From the state shown in FIG. 8, the guide wire 10 is removed, and the intravascular foreign matter removing wire 1 is inserted into the lumen 85 of the catheter 8 via the fixture 3. As shown in FIG. 9, when the capturing part 12 protrudes from the distal end opening 81 of the catheter 8, the capturing part 12 in the catheter 8 in the reduced diameter state automatically expands by its own elasticity and expands in diameter. It becomes a state. When the capturing part 12 is in an expanded state, a foreign matter capturing space 121 for capturing the embolus 200 is formed.

  The intravascular foreign matter removing wire 1 protruding from the proximal end of the fixing tool 3 is inserted into the operating tool 4, and the cap 412 of the operating tool 4 is tightened and attached to the intravascular foreign matter removing wire 1. The catheter 8 is moved slightly in the proximal direction, and the distal end portion of the catheter 8 is pulled back to the front of the embolus 200. The operation tool 4 is operated to advance, retract or rotate the intravascular foreign matter removing wire 1 with respect to the catheter 8 so as to scoop the embolus 200 in the foreign matter capturing space 121 of the capturing portion 12 as shown in FIG. And capture (storing). That is, the embolus 200 enters the foreign substance capturing space 121.

  After the embolus 200 is captured, the pressing member 37 of the fixture 3 is rotated, that is, the fixing means 32 of the fixture 3 is operated to fix the intravascular foreign matter removing wire 1 to the fixture 3. Thereby, the positional relationship between the distal end opening 81 of the catheter 8 and the capturing unit 12 is maintained.

  [4] Next, in a state where the positional relationship between the distal end opening 81 of the catheter 8 and the capturing portion 12 is maintained, that is, in a state where the intravascular foreign matter removing wire 1 is fixed by the operation of the fixing means 32. The cap 412 of the operating tool 4 attached to the intravascular foreign matter removing wire 1 protruding from the proximal end of the tool 3 is loosened so that it can move freely with respect to the intravascular foreign matter removing wire 1. At this time, since the intravascular foreign matter removing wire 1 is securely fixed to the fixture 3, even if the operation tool 4 presses the intravascular foreign matter removing wire 1 in the distal direction, Unintentional movement is prevented.

  [5] Next, as shown in FIG. 11, the fixture 3 and the operation tool 4 through which the intravascular foreign matter removing wire 1 is inserted are attached (attached) to the mount 5. Thereby, the positional relationship of the fixing tool 3 and the operation tool 4 in the longitudinal direction is fixed.

  [6] Then, the cap 412 of the operation tool 4 is tightened (see arrow 1 in FIG. 11), and the intravascular foreign matter removing wire 1 is fixed to the operation tool body 41. Thereafter, the pressing member 37 of the fixture 3 is loosened (see arrow 2 in FIG. 11), and the fixation of the intravascular foreign matter removing wire 1 by the pressure bonding of the ring-shaped member 36 (operation of the fixing means 32) is released.

  [7] As shown in FIG. 12, the handle 421 of the operation tool 4 is rotated, and the wire body 11 (intravascular foreign matter removing wire 1) is pulled in the proximal direction with respect to the catheter 8 while checking the scale 44 ( Moving. As a result, the proximal end portions of the branch wire portions 13a and 13b are brought into contact with the distal end opening portion 81 (the edge portion thereof) and are drawn into the catheter 8 while narrowing each other, and the capturing portion 12 (foreign matter capturing space 121) is drawn. Get smaller. Therefore, the embolus 200 is fastened by the branch wire portions 13a and 13b and the filament portions 14a, 14b and 14c. By this tightening force, it can be more reliably held by the capture unit 12 and can be reliably recovered while being prevented from dropping (detaching) from the capture unit 12.

  When the intravascular foreign matter removing wire 1 is continuously pulled, the enlarged diameter portion 418 of the operation tool 4 and the outer cylinder 415 come into contact with each other, so that the intravascular foreign matter removing wire 1 is excessively pulled. Is prevented.

  [8] The intravascular foreign matter removing wire 1 is removed together with the catheter 8 while maintaining the tightened state. As a result, the embolus 200 is recovered (removed) in the parent guiding catheter or sheath introducer (not shown).

As described above, in the wire set 9 (wire operating tool assembly 2), the fixture for the intravascular foreign matter removing wire 1 and the guide wire 10 in each of the usage states [1] to [8]. 3. The operation tool 4 and the attachment means 5 can be used individually. Thereby, the outstanding operativity with respect to the intravascular foreign matter removal wire and the guide wire can be obtained.
One of the fixing tool 3 and the operation tool 4 may be attached to the attachment means 5 in advance.

  The embodiment of the wire operating tool assembly and the intravascular foreign matter removing wire set according to the present invention has been described above. However, the present invention is not limited thereto, and the wire operating tool assembly and the intravascular foreign matter are not limited thereto. Each part constituting the wire set for removal can be replaced with one having any structure that can exhibit the same function. Moreover, arbitrary components may be added.

  In addition, the capture part of the intravascular foreign matter removing wire is not limited to one constituted by two branch wire parts and a plurality of filament parts laid between these branch wire parts. It may be configured by a loop wire portion and a plurality of filament portions installed at two different locations in the loop wire portion.

It is a perspective view of the wire set for removing a foreign substance in a blood vessel of the present invention. It is a perspective view of the fixture of the wire operation tool assembly with which the wire set for intravascular foreign substance removal shown in FIG. It is a longitudinal cross-sectional view of the fixing means of the fixing tool shown in FIG. It is a perspective view of the operation tool of the wire operation tool assembly with which the wire set for intravascular foreign matter removal shown in FIG. It is a longitudinal cross-sectional view of the movement operation means of the operating tool shown in FIG. FIG. 2 is a perspective view of an intravascular foreign matter removing wire included in the intravascular foreign matter removing wire set shown in FIG. 1. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step. It is a figure for explaining the usage method of the intravascular foreign matter removal wire set shown in FIG. 1 step by step.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Wire for removing foreign body 11 Wire body 12 Trapping part 121 Foreign body trapping space 13a, 13b Branch wire part 14a, 14b, 14c Filament part 2 Wire operation tool assembly 3 Fixing tool 31 Fixing tool body 311 Tip part 312 Base end part 32 Fixing means 33 Supply port 34 Male thread part 35 Recessed part 351 Inner peripheral surface 36, 36 'Ring-shaped member 361 Outer peripheral surface 362 Inner peripheral surface 37 Press member 371 Disk-shaped part 372 Cylindrical part 373 Columnar part 374 Female thread part 375 Through-hole 4 Operation tool 41 Operation tool main body 411 Inner cylinder 412 Cap 413 Claw 414 Center shaft 415 Outer cylinder 415a Front end surface 416 Female thread portion 417 Reduced diameter portion 418 Expanded diameter portion 418a Base end surface 42 Moving operation means 421 Handle 422 Conversion portion 423 Male thread portion 424 Disc-shaped portion 425 Column-shaped portion 426 Claw portion 43 Restricting means 44 Scale 5 Mounting means (mounting base)
51 Mounting base body 52, 53 Fixing claw 54 Operating tool claw 8 Catheter 81 Tip opening 83 Catheter body 84 Hub 85 Lumen 9 Wire set (wire set for removing foreign matter in blood vessel)
10 guide wire 101 tip 100 blood vessel 200 embolus

Claims (9)

A wire operating tool assembly that is used by being attached to a catheter through which a foreign-matter removing wire provided on the distal end side for capturing a foreign-matter in a blood vessel and a guide wire can be inserted.
The proximal end side of the catheter is connected, and a fixing tool body through which the intravascular foreign matter removal wire and the guide wire can be inserted, and the intravascular foreign matter removal wire inserted through the fixing body can be fixed. A fixing device having a fixing means,
The intravascular foreign matter removal wire can be inserted, and the operation tool main body capable of fixing the inserted intravascular foreign matter removal wire, and the intravascular foreign matter removal wire fixed to the operation tool main body in its longitudinal direction And an operation tool having a movement operation means for operating the catheter so as to move with respect to the catheter,
A wire operating tool assembly comprising: an attaching means capable of attaching the fixing tool and the operating tool in a longitudinal direction so as to fix the positional relationship therebetween. In a state in which the intravascular foreign matter removing wire is fixed by the operation of the fixing means, the positional relationship between the fixing tool and the operation tool is fixed,
The wire operation according to claim 1, wherein after fixing the intravascular foreign matter removing wire by the operation tool main body, the fixing by the operation of the fixing means is released and the intravascular foreign matter removing wire is operated. Tool assembly.   The wire operation tool assembly according to claim 1 or 2, wherein the guide wire is operated in a state where the guide wire is movably inserted into the fixing tool.   The wire operation tool assembly according to any one of claims 1 to 3, wherein the guide wire cannot be inserted into the operation tool main body.   The said movement operation means has a handle | steering-wheel which rotates while screwing with respect to the said operation tool main body, and the conversion part which converts the rotational motion of this handle into the linear motion to which the said wire for foreign body foreign body removal moves. The wire operation tool assembly according to any one of 1 to 4.   6. The wire operation tool assembly according to claim 5, wherein when the handle is rotated, the attachment means can be fixed with such a strength that the operation tool does not rotate with respect to the attachment means.   The wire operating tool assembly according to any one of claims 1 to 6, wherein the operating tool has a restricting means for restricting a maximum movement amount of the intravascular foreign matter removing wire.   The wire operation tool assembly according to any one of claims 1 to 7, wherein the operation tool is provided with a scale indicating the amount of movement of the intravascular foreign matter removal wire. A wire operation tool assembly according to any one of claims 1 to 8,
A wire for removing foreign matter in a blood vessel in which a foreign matter catching portion for catching foreign matter in a blood vessel is provided on the distal end side;
A wire set for removing intravascular foreign matter, comprising: a catheter through which the intravascular foreign matter removing wire and guide wire can be inserted.

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