JP4608462B2 - Catheter assembly - Google Patents

Description

  The present invention relates to a catheter assembly that is inserted into a living body and sucks foreign matter in the living body.

  When removing a relatively soft thrombus generated in a blood vessel, that is, an atheroma from the blood vessel, a catheter assembly that sucks the atheroma is used. As this catheter assembly, for example, a suction catheter device described in Patent Document 1 is known.

  This suction catheter device has an outer catheter, an inner catheter (central catheter) inserted through the outer catheter, and a syringe connected to the hub of the inner catheter. In order to suck the atheroma in the blood vessel using the suction catheter device having such a configuration, first, the outer catheter and the inner catheter are inserted into the blood vessel, and the distal end opening of the inner catheter is placed in the atheroma (or in the vicinity thereof (nearest) )). Next, in this state, the syringe is operated, that is, the syringe pusher (plunger) is moved in the proximal direction with respect to the syringe outer cylinder. Thereby, the inside of the inner catheter is decompressed, and the atheroma is sucked from the distal end opening of the inner catheter.

  However, in this suction catheter device, the inner catheter has a long tube shape, and therefore, when the syringe is operated, a relatively large pressure resistance is generated in the inner catheter. For this reason, it is difficult to operate the syringe, that is, it becomes difficult to operate the pusher, and there is a problem that the atheroma cannot be reliably sucked.

  Moreover, since pressure loss occurs in the inner catheter due to the pressure resistance, there is a problem that even if the syringe is operated, atheroma cannot be reliably (sufficiently) sucked.

Japanese Patent No. 2925457

  The objective of this invention is providing the catheter assembly which can attract | suck the foreign material in a biological body reliably.

Such an object is achieved by the present inventions (1) to (17) below.
(1) A catheter assembly that is inserted into a living body and sucks foreign matter in the living body,
An outer catheter having an outer catheter body that is flexible and has a long tubular shape with a lumen opened at the tip;
A long inner linear body that is flexible and is inserted into the outer catheter body, and an inner structural body that is provided at a distal end of the inner linear body and has an elastic head. Prepared,
In a state where the inner structure is inserted into the outer catheter, the head can project from the distal end opening of the outer catheter body, and the inner linear body from the projecting state to the proximal end with respect to the outer catheter by moving operation in the direction of the head is housed in the outer catheter body slides within the outer catheter body is configured to suction the foreign matters from the distal end opening of the outer catheter body,
The catheter assembly according to claim 1, wherein an outer diameter of the inner linear body is smaller than a maximum outer diameter of the head.

(2) The foreign matter is bowl-shaped or jelly-shaped,
The catheter according to (1), which is used to perform a moving operation on the outer catheter body after the head is inserted into the foreign object in a state where the head protrudes from a distal end opening of the outer catheter body. Assembly.

(3) The inner linear body has a first lumen formed along the longitudinal direction thereof,
The catheter assembly according to (1) or (2), wherein the head is formed with a second lumen that communicates with the first lumen and opens at a tip of the head.

  (4) The catheter assembly according to (3), wherein each of the first lumen and the second lumen functions as an insertion passage through which a guide wire is inserted.

  (5) The catheter assembly according to (4), wherein the second lumen is blocked by the guide wire in a state where the guide wire is inserted.

  (6) The catheter assembly according to any one of (3) to (5), wherein a maximum outer diameter of the head in a natural state is substantially equal to or slightly smaller than an inner diameter of the outer catheter body.

  (7) The catheter assembly according to any one of (3) to (5), wherein a maximum outer diameter of the head in a natural state is larger than an inner diameter of the outer catheter body.

  (8) When the head slides in the outer catheter main body, the outer peripheral surface thereof is pressed by the inner peripheral surface of the outer catheter main body, and the second lumen is narrowed or blocked (7) ).

  (9) The said inner structure is joined to the base end part of the said inner linear body, and has the inner hub comprised by the cylindrical body connected to the said 1st lumen | bore (3) thru | or (8). The catheter assembly according to any one of the above.

(10) The inner structure has a cap that is detachably attached to a proximal end opening of the inner hub,
The catheter assembly according to (9), wherein the proximal end side of the first lumen is closed in a state where the cap is attached to the proximal opening.

  (11) The catheter assembly according to any one of (1) to (10), wherein the head has a portion whose outer diameter gradually decreases in the distal direction.

  (12) The catheter assembly according to any one of (1) to (11), wherein the head has a portion whose outer diameter gradually decreases in the proximal direction.

  (13) The catheter assembly according to any one of (1) to (12), wherein the head has an X-ray contrast property.

(14) The catheter assembly according to any one of (1) to (13) , wherein the outer catheter body is substantially transparent.

(15) The catheter assembly according to any one of (1) to (14) , wherein the distal end portion of the outer catheter body has X-ray contrast properties.

(16) on the inner circumferential surface and / or outer peripheral surface of the head portion of the outer catheter body, to friction reducing treatment for reducing the friction between these surfaces to each other above (1) to which are applied (15) The catheter assembly according to any one of the above.

(17) The catheter assembly according to any one of (1) to (16) , further including state maintaining means for maintaining a state where the inner structure is inserted into the outer catheter.

  According to the present invention, foreign matter in the living body can be reliably sucked into the outer catheter body by sliding the head in the proximal direction in the outer catheter body. Further, since the suction operation can be performed in the vicinity of the foreign matter, it is possible to prevent (suppress) the occurrence of pressure loss in the outer catheter body, and thus more reliably suck the foreign matter into the outer catheter body. be able to. In addition, since pressure loss, that is, pressure resistance is prevented (suppressed), the inner linear body can be easily moved in the proximal direction with respect to the outer catheter body.

  In addition, when the first lumen is formed in the inner linear body and the second lumen is formed in the head, the insertion / non-insertion of the guide wire with respect to these lumens can be selected. it can. As a result, the second lumen can be selected to be closed / opened, so that foreign matter can be sucked when the second lumen is closed.

  Hereinafter, a catheter assembly of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a partial longitudinal sectional view showing a first embodiment of the catheter assembly of the present invention, and FIGS. 2 to 5 are enlarged longitudinal sectional views sequentially showing usage states of the catheter assembly shown in FIG. 6 is a longitudinal sectional view showing a configuration example of the state maintaining means of the catheter assembly shown in FIG. In the following description, for convenience of explanation, the right side in FIGS. 1 to 6 (also in FIGS. 7 to 14) is referred to as “base end”, and the left side is referred to as “tip”.

  A catheter assembly 1A shown in FIG. 1 is inserted into a living body such as a blood vessel and sucks and removes foreign matter in the living body. In the present embodiment, as a foreign substance sucked and removed by the catheter assembly 1A, a relatively soft thrombus (hereinafter referred to as “atheroma”) 200 generated in a blood vessel is taken as an example.

  The catheter assembly 1A includes an outer catheter 2 and an inner catheter (inner structure) 3A, and is used in combination with a guide wire 10. That is, as shown in FIG. 1, the catheter assembly 1A is used in a state where the inner catheter 3A is inserted into the outer catheter 2 and the guide wire 10 is further inserted into the inner catheter 3A (inserted state). In the catheter assembly 1A having such a configuration, the inner catheter 3A and the guide wire 10 are collectively moved in the proximal direction with respect to the outer catheter 2 from the state shown in FIG. 1 (also in FIG. 2). Thereby, as shown in FIGS. 3 to 5, the atheroma 200 is drawn into the outer catheter 2.

  Before describing the catheter assembly 1A of the present invention, the guide wire 10 inserted through the inner catheter 3A will be described.

  The guide wire 10 shown in FIGS. 1-5 is a linear body which has flexibility, As a constituent material, stainless steel, a cobalt-type alloy, an alloy (a superelastic alloy is included) which shows pseudoelasticity, for example And various metal materials such as piano wire.

  The distal end surface 101 of the guide wire 10 is rounded. As a result, the guide wire 10 can be smoothly inserted (moved) in the distal direction in the blood vessel. In addition, when the guide wire 10 moves in the distal direction in the blood vessel, it is possible to reliably prevent the blood vessel wall from being damaged by the distal end surface 101.

Next, each part constituting the catheter assembly 1A will be described.
As shown in FIG. 1, the outer catheter 2 has a long tubular (tubular) outer catheter body 21 and an outer hub 4 connected to the proximal end of the outer catheter body 21. .

  The outer catheter body 21 has a desired flexibility, and examples of the constituent material thereof include polyolefins such as polyethylene and polypropylene, polystyrene, polyamide, polyimide, polyetheretherketone, polyurethane, polyethylene terephthalate, and polybutylene. Polyesters such as terephthalate, fluororesins such as polytetrafluoroethylene, various thermoplastic elastomers such as polyolefins, polystyrenes, polyamides, polyurethanes, polyesters, fluororubbers, chlorinated polyethylenes, etc. The thing (polymer alloy, polymer blend, etc.) which combined 2 or more types of them is mentioned.

  Further, the outer catheter main body 21 may have a multilayer laminated structure made of a plurality of types of materials.

  The outer catheter body 21 is preferably substantially transparent. Thereby, the aspirated atheroma 200 can be visually recognized through the outer catheter body 21.

  The outer catheter body 21 is formed with a lumen (lumen) 23 along the longitudinal direction thereof. The distal end of the lumen 23 is open to the distal end (tip opening) 211 of the outer catheter body 21. The lumen 23 is used not only for insertion of the inner catheter 3A (inner catheter body (inner linear body) 31), but can also be used for supplying a liquid medicine into the blood vessel and sucking the liquid.

  On the surface defining the lumen 23, that is, the inner peripheral surface 212 of the outer catheter main body 21, a coating layer that reduces (reduces) frictional resistance with the outer peripheral surface 51 of the head (tip) 5 </ b> A of the inner catheter 3 </ b> A described later. May be provided, that is, a friction reducing process may be performed. Thereby, insertion / extraction of the inner catheter 3A with respect to the outer catheter 2 can be performed smoothly. Thereby, the suction operation of the atheroma 200 can be performed more reliably, and the atheroma 200 can be more reliably suctioned by the operation. Examples of the coating layer include a coating layer of fluororesin such as polytetrafluoroethylene (Teflon coat (“Teflon” is a registered trademark)), a silicon coat, and a hydrophilic polymer coat having lubricity when wet. It is done.

  In addition, at least near the distal end 211 (tip portion) of the outer catheter body 21, a member (for example, platinum, gold, tungsten, etc.) made of a material having radiopacity (X-ray contrast property) (for example, platinum, gold, tungsten, etc.) A ring-shaped (tubular) or coil-shaped member) may be installed. Thereby, the tip 211 of the outer catheter main body 21 can be reliably confirmed under X-ray fluoroscopy.

  Further, a covering member (anti-kink protector) 24 having a reinforcing function is provided at a proximal end portion of the outer catheter body 21, that is, a portion connected to the outer hub 4 of the outer catheter body 21. Thereby, the bending (kink) of the said part can be prevented more effectively. The constituent material of the covering member 24 is not particularly limited. For example, polyester such as polyolefin, polyamide, polyethylene terephthalate, and polybutylene terephthalate, fluorine such as polyurethane, polyvinyl chloride, ABS resin, AS resin, and polytetrafluoroethylene. Various thermoplastic elastomers such as resin, polyamide elastomer, polyester elastomer, and polyurethane elastomer are listed.

  Moreover, the length of the outer catheter main body 21 is not specifically limited, For example, it is preferable that it is 300-1800 mm, and it is more preferable that it is 600-1400 mm.

  Moreover, the outer diameter of the outer catheter main body 21 is not specifically limited, For example, it is preferable that it is 1.0-6.0 mm, and it is more preferable that it is 1.5-4.5 mm.

  Further, the inner diameter (φD2) of the outer catheter body 21 is not particularly limited, and is preferably 1.0 to 4.0 mm, and more preferably 1.2 to 3.5 mm, for example.

  The outer hub 4 is fluid-tightly connected to the proximal end portion of the outer catheter body 21. The outer hub 4 presses the tubular outer hub body 41, a branching portion 47 branched from the middle of the outer hub body 41, a ring-shaped member 42 accommodated in the outer hub body 41, and the ring-shaped member 42. And a pressing member 43 (see FIGS. 1 and 6).

  The outer space of the outer hub body 41 communicates with the lumen 23 of the outer catheter body 21.

  The branching portion 47 has a tubular shape like the outer hub body 41 and communicates with the outer hub body 41. For example, a drug can be injected into the outer catheter 2 or the aspirated atheroma 200 can be removed via the branch portion 47.

  The base end portion 411 of the outer hub main body 41 is provided with a columnar recess 44 formed along the longitudinal direction of the outer hub main body 41. The recess 44 is larger in diameter than the inner diameter of the outer hub body 41. Further, a male screw portion 45 that is screwed into the pressing member 43 is formed on the outer periphery of the base end portion 411 of the outer hub main body 41.

  A ring-shaped member 42 is accommodated in the recess 44 of the outer hub body 41. The ring-shaped member 42 is made of an elastic material. In the natural state, the ring-shaped member 42 has an inner diameter substantially equal to the inner diameter of the outer hub body 41 and an outer diameter substantially equal to the inner diameter of the recess 44. Here, the “natural state” means a state in which no external force is applied to the ring-shaped member 42.

  The pressing member 43 includes a disk-shaped disk-shaped portion 431, a cylindrical tube-shaped portion 432 provided concentrically with the disk-shaped portion 431, and the disk-shaped portion 431, similar to the tube-shaped portion 432. And a columnar columnar portion 433 provided concentrically.

  On the inner peripheral surface of the cylindrical portion 432, a female screw portion 434 that is screwed with the male screw portion 45 of the outer hub main body 41 (base end portion 411) is formed. As a result, the pressing member 43 can rotate while being screwed to the outer hub body 41.

The cylindrical portion 433 has an outer diameter that is substantially equal to the inner diameter of the recess 44.
A through hole 435 that penetrates the pressing member 43 in the longitudinal direction is formed in the pressing member 43 having such a configuration. The diameter of the through hole 435 is substantially equal to the inner diameter of the outer hub body 41.

  As the pressing member 43 and the outer hub main body 41 are screwed together, the ring-shaped member 42 is pressed by the distal end surface of the columnar portion 433 of the pressing member 43. Due to this pressing, the ring-shaped member 42 is elastically deformed and tends to expand its outer diameter, but the outer peripheral surface 421 of the ring-shaped member 42 is restricted by the inner peripheral surface 441 of the recess 44, and the ring-shaped member 42. The outer diameter cannot be expanded. Therefore, the inner diameter of the ring-shaped member 42 is surely reduced (see the ring-shaped member 42 'in FIG. 6). Thereby, the inner peripheral surface 422 of the ring-shaped member 42 presses (compresses) the inner catheter main body 31 inserted through the outer hub main body 41, so that the inner catheter main body 31 can be reliably fixed.

  Thus, in the catheter assembly 1A, the fixing means (state maintaining means) for fixing the inner catheter 3A (the inner catheter body 31) by the recess 44 of the outer hub body 41, the ring-shaped member 42, and the pressing member 43. Is configured. By this fixing means, the assembled state, that is, the state where the inner catheter 3A is inserted into the outer catheter 2 can be reliably maintained. In this assembled state, the head 5A of the inner catheter 3A protrudes from the outer catheter 2 as shown in FIG. 1, and the head 5A as shown in FIG. 5 (also in FIGS. 3 and 4). It is in a state of being housed (positioned) in the outer catheter 2. In the catheter assembly 1A, the state shown in FIG. 1 and the state shown in FIG. 5 can be maintained by the fixing means. The fixing means can also reliably fix the guide wire 10 inserted through the inner catheter 3 </ b> A depending on the degree of fixing, that is, the pressing amount of the pressing member 43.

  In addition, although it does not specifically limit as a constituent material of the outer side hub 4 (except the ring-shaped member 42), For example, various metal materials, various plastics, etc. can be used individually or in combination.

  Moreover, it does not specifically limit as an elastic material which comprises the ring-shaped member 42, 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 inner catheter 3A will be described.
As shown in FIG. 1, the inner catheter 3 </ b> A includes a long tubular inner catheter body 31, a head 5 </ b> A as a suction body provided at the distal end of the inner catheter body 31, and a base of the inner catheter body 31. And an inner hub 6 connected to the end.

  The inner catheter body 31 has a desired flexibility and is inserted into the outer catheter body 21. As a constituent material of the inner catheter main body 31, for example, the same material as that of the outer catheter main body 21 described above can be used, and among them, polyimide and polyether ether ketone are preferable from the viewpoint of hardness and elastic modulus.

  Further, the inner catheter body 31 may have a multilayer laminated structure made of a plurality of types of materials.

  A first lumen 311 is formed in the inner catheter body 31 along the longitudinal direction thereof. The first lumen 311 functions not only as an insertion path through which the guide wire 10 is inserted, but also as a supply path for supplying a chemical solution or the like into the blood vessel.

  The outer diameter of the inner catheter body 31 is set smaller than the inner diameter of the outer catheter body 21, that is, between the outer peripheral surface 312 of the inner catheter main body 31 and the inner peripheral surface of the outer catheter main body 21 in the assembled state. A gap occurs. Thereby, the insertion / removal of the inner catheter 3A with respect to the outer catheter 2 can be performed smoothly, and therefore, the suction operation of the atheroma 200 can be performed more reliably. The outer diameter of the inner catheter body 31 is not particularly limited, and is preferably 0.7 to 3.5 mm, for example, and more preferably 0.8 to 3.3 mm.

  Moreover, the internal diameter of the inner catheter main body 31 is not specifically limited, For example, it is preferable that it is 0.5-3.0 mm, and it is more preferable that it is 0.6-2.7 mm.

  Moreover, the length of the inner catheter main body 31 is not specifically limited, For example, it is preferable that it is 350-1850 mm, and it is more preferable that it is 650-1450 mm.

As shown in FIGS. 1 to 5, an elastic head portion 5 </ b> A is joined to the distal end portion of the inner catheter body 31. The bonding method is not particularly limited, and examples thereof include a method using adhesion (adhesion with an adhesive or a solvent), a method using fusion (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.), and the like.
The head 5A has a cylindrical outer shape.

  A second lumen 52 is formed along the longitudinal direction of the head 5A. The second lumen 52 communicates with the first lumen 311. Further, the second lumen 52 opens at the tip 53 of the head 5A. Similar to the first lumen 311, such a second lumen 52 functions as an insertion passage through which the guide wire 10 is inserted, and also has a chemical solution or the like into the blood vessel via the tip 53 of the head 5 </ b> A. It can also be used for supply.

  In the natural state, the head 5A has an inner diameter that is substantially equal to or slightly smaller than the outer diameter of the guide wire 10. Thereby, as shown in FIG. 1 (the same applies to FIGS. 2 to 4), in the state in which the guide wire 10 is inserted through the inner catheter 3 </ b> A, the second inner cavity 52 has an inner peripheral surface 521 that is the outer periphery of the guide wire 10. It is in close contact with the surface 102, that is, is blocked by the guide wire 10.

  Further, the head 5A is positioned on the proximal side with respect to the first taper portion 54 whose outer diameter gradually decreases in the distal direction, and the outer diameter gradually decreases in the proximal direction. And a second tapered portion 55. As a result, in the head portion 5A, a maximum outer diameter portion 56 having the maximum outer diameter is formed in the middle, that is, at the boundary portion between the first taper portion 54 and the second taper portion 55. In the head 5A, the outer diameter (maximum outer diameter) φD1 (see FIG. 2) of the maximum outer diameter portion 56 is set to be substantially equal to or slightly smaller than the inner diameter φD2 (see FIG. 2) of the outer catheter body 21 in the natural state. Has been. Thereby, the head 5A can slide within the outer catheter body 21 (see FIGS. 3 to 5).

  Further, the outer diameter φD1 of the maximum outer diameter portion 56 of the head 5A is set larger than the outer diameter of the inner catheter body 31.

  Such a head portion 5A has the inner catheter body 31 and the guide wire 10 on the outer side from the state shown in FIG. 2, that is, the head portion 5A protruding from the distal end 211 of the outer catheter body 21 in the atheroma 200 in the assembled state. By moving the catheter 2 in the proximal direction, the state shown in FIGS. 3 to 5 is obtained, that is, the catheter 2 is drawn into the outer catheter 2 and slides in the outer catheter 2. Accordingly, the space 231 defined by the distal end side of the maximum outer diameter portion 56 of the outer catheter body 21, that is, the inner peripheral surface 212 and the first tapered portion 54 (outer peripheral surface 51) is decompressed. The atheroma 200 is reliably sucked (stored) in the decompressed space 231.

  In addition, since the second lumen 52 is closed by the guide wire 10 in the head 5A, the decompressed state of the space 231 is reliably maintained when the head 5A is drawn into the outer catheter 2.

  Further, in the catheter assembly 1A, since a suction operation is performed in the vicinity of the atheroma 200, it is possible to prevent (suppress) the occurrence of pressure loss in the space 231. Therefore, the atheroma 200 can be reliably placed in the space 231. Can be aspirated. Further, since the pressure loss, that is, the pressure resistance is prevented (suppressed), the inner catheter body 31 can be easily operated.

  Further, when the inner catheter 3A is operated, in the inner catheter 3A, the largest outer diameter portion 56 mainly slides in the outer catheter body 21, and the first taper portion 54, the second taper portion 55, and the inner catheter body. The sliding of the outer peripheral surface 312 of 31 is suppressed. Thereby, the operation of the inner catheter 3A, that is, the suction operation can be easily performed, and thus the atheroma 200 can be reliably sucked.

  As described above, the first taper portion 54 is formed in the head portion 5A. Thereby, the head 5A can be easily inserted into the atheroma 200 with the head 5A protruding from the distal end 211 of the outer catheter body 21.

  As described above, the second taper portion 55 is formed in the head portion 5A. Thus, when the head 5A protruding from the distal end 211 of the outer catheter body 21 enters the outer catheter body 21, the operation is smoothly performed.

  An introduction portion 522 whose inner diameter gradually increases in the proximal direction is formed at the proximal end portion of the inner peripheral surface 521 of the head portion 5A. The guide wire 10 inserted from the proximal opening 611 of the inner hub 6 of the inner catheter 3A is inserted into the second lumen 52 along the introduction portion 522 through the first lumen 311.

  The head 5A is made of an elastic material. Examples of this material include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, and the like. And various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.

  In the head 5A, a material having radiopacity (for example, platinum, gold, tungsten, etc.) may be contained in the elastic material. Thereby, the head 5A can be reliably confirmed under X-ray fluoroscopy.

  Further, the outer peripheral surface 51 of the head 5A may be subjected to a friction reducing process in the same manner as the inner peripheral surface 212 of the outer catheter main body 21.

  Moreover, the length of the head 5A is not particularly limited, but is preferably 5 to 15 mm, and more preferably 8 to 12 mm, for example.

  In addition, the outer diameter φD1 of the maximum outer diameter portion 56 of the head 5A is not particularly limited, but is preferably 1.0 to 3.5 mm, and more preferably 1.3 to 3.3 mm, for example. .

  Moreover, the inner diameter of the head 5A is not particularly limited, but is preferably 0.5 to 1.5 mm, and more preferably 0.7 to 1.3 mm, for example.

  The head 5A and the inner catheter body 31 are each hollow (having a lumen), but are not limited thereto, and may be solid, for example.

  The inner hub 6 is fluid-tightly connected to the proximal end portion of the inner catheter body 31. The inner hub 6 has a tubular (tubular) inner hub main body 61 and a pair of wing portions 621 and 622 protruding from the outer peripheral surface of the inner hub main body 61.

  The inner hub body 61 has an inner space communicating with the first lumen 311 of the inner catheter body 31.

  Wings 621 and 622 are formed integrally with the inner hub body 61 on the upper side and the lower side in FIG. Each of the wing portions 621 and 622 is composed of small pieces. When the inner catheter 3A is moved with respect to the outer catheter 2, the operation can be easily performed by gripping the wing portions 621 and 622.

  In addition, although it does not specifically limit as a constituent material of the inner side hub 6, For example, similarly to the outer side hub 4 mentioned above, various metal materials, various plastics, etc. can be used individually or in combination. When such a material is used, the inner hub 6 becomes relatively hard, and thus, for example, the guide wire 10 can be easily inserted into the inner catheter body 31 via the inner hub 6.

Next, an example of how to use the catheter assembly 1A will be described in detail.
[1] First, the position of the atheroma 200 with respect to the blood vessel is confirmed in advance under fluoroscopy. In addition, the catheter assembly 1A is in a state in which the head 5A protrudes from the distal end 211 of the outer catheter body 2 in advance (a protruding state), and the guide wire 10 is inserted into the inner catheter 3A while maintaining this state. Note that the protruding state is reliably maintained by the fixing means.

  [2] Next, only the guide wire 10 is inserted into the blood vessel via a sheath (not shown), and the distal end portion of the guide wire 10 is pierced (inserted) into the atheroma 200. In this state, the catheter assembly 1 </ b> A is advanced along the guide wire 10. Further, the state shown in FIG. 2 is set, that is, the head 5 </ b> A is inserted into the atheroma 200. This operation can be easily performed under fluoroscopy.

  [3] Next, the fixed state by the fixing means is released, and the inner catheter 3A is pulled in the proximal direction with respect to the outer catheter 2 while keeping the position of the outer catheter 2 constant. Thereby, as described above, the atheroma 200 is gradually sucked into the outer catheter 2 (see FIGS. 3 and 4). Finally, the atheroma 200 is housed in the outer catheter 2 (see FIG. 5).

  [4] Next, after confirming that the atheroma 200 is housed in the outer catheter 2, the guide wire 10 is removed from the second lumen 52 (see FIG. 5). Thereby, the suction function by the catheter assembly 1 </ b> A disappears or attenuates, and for example, blood can be prevented from being sucked into the outer catheter 2. After the guide wire 10 is removed, the entire catheter assembly 1A is removed from the blood vessel while maintaining the stored state of the atheroma 200. Thereby, the atheroma 200 is collected (removed) from the blood vessel.

  [5] It should be noted that the atheroma 200 is sucked up to the outer hub 4 without performing the operation [4], and the atheroma 200 is removed (sucked) from the branch portion 47 connected to the suction means such as a syringe. Also good.

  By such an operation, the atheroma 200 in the blood vessel can be reliably sucked and removed.

  In addition, after the operation [4], when the catheter assembly 1 </ b> A exhibits the suction function again, the guide wire 10 positioned in the first lumen 311 is inserted into the second lumen 52 again. In this state, the suction function is reliably exhibited by pulling the inner catheter 3A.

  In the inner catheter 3A, the inner diameter of the inner catheter body 31 (first lumen 311) is set larger than the inner diameter of the head 5A (second lumen 52). As a result, the guide wire 10 inserted through the first lumen 311 and the second lumen 52 may be removed from the second lumen 52 without being completely removed from these lumens. The suction function by the assembly 1A disappears or attenuates.

  As described above, in the catheter assembly 1 </ b> A, it is possible to select insertion / non-insertion of the guide wire 10 with respect to the second lumen 52. Accordingly, the second lumen 52 can be selected to be closed / opened, so that the atheroma 200 can be aspirated when the second lumen 52 is closed, and the second lumen 52 can be sucked. The suction function can be suppressed when the is opened.

<Second Embodiment>
FIG. 7 to FIG. 9 are enlarged longitudinal sectional views sequentially showing the usage states of the catheter assembly (second embodiment) of the present invention.

Hereinafter, the second embodiment of the catheter assembly of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the size of the head is different.

  As shown in FIG. 7, in the catheter assembly 1B, the head 5B of the inner catheter 3B is set such that the outer diameter φD1 of the maximum outer diameter portion 56 is larger than the inner diameter φD2 of the outer catheter body 21 in the natural state. .

  Further, the inner diameter of the head 5B is gradually reduced toward the distal end in a natural state. The minimum inner diameter φD3 of the head 5B is set to be approximately equal to or slightly smaller than the outer diameter of the guide wire 10. Thereby, when the guide wire 10 is inserted through the second lumen 52 (head 5B), the second lumen 52 can be closed by the guide wire 10.

  As shown in FIGS. 7 to 9, in this embodiment, when performing a suction operation, the guide wire 10 may be removed from the catheter assembly 1B (second lumen 52). The reason is described below.

  In the catheter assembly 1B, by moving the inner catheter 3B in the proximal direction relative to the outer catheter 2 from the state shown in FIG. 7, first, as shown in FIG. 55 is pressed by the inner edge 213 of the distal end 211 of the outer catheter body 21.

  When the inner catheter 3B is further moved in the proximal direction, the edge portion 213 sequentially passes over (presses) the second tapered portion 55 and the maximum outer diameter portion 56, and the maximum outer diameter portion 56 slides in the outer catheter body 21. Move. At this time, as shown in FIG. 9, the maximum outer diameter portion 56 (outer peripheral surface 51) is pressed by the inner peripheral surface 212 of the outer catheter body 21, and different portions of the inner peripheral surface 521 of the head 5B are brought into close contact with each other. That is, the second lumen 52 is occluded (self-occlusion).

  By pulling the inner catheter 3B while the second lumen 52 is closed, the space 231 is decompressed. The atheroma 200 is reliably sucked (stored) in the decompressed space 231.

  As described above, in the catheter assembly 1B, the second lumen 52 is self-occluded (has self-occlusion), so that the guide wire 10 is inserted into the second lumen 52 and the second lumen 52 is inserted. The effect (suction effect) almost the same as that in the state in which is closed is obtained.

<Third Embodiment>
10 to 12 are enlarged longitudinal sectional views sequentially showing the use state of the catheter assembly (third embodiment) of the present invention, and FIG. 13 is the vicinity of the inner hub of the catheter assembly shown in FIGS. 10 to 12. FIG.

  Hereinafter, the third embodiment of the catheter assembly of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the second embodiment except that the inner diameter of the head is different and the structure of the inner hub is different.

  As shown in FIG. 10, in the catheter assembly 1C, the minimum inner diameter φD3 of the head 5C of the inner catheter 3C is set to be larger than the outer diameter of the guide wire 10 in a natural state. That is, in a state where the guide wire 10 is inserted through the head portion 5C (second lumen 52) in the natural state, the head portion 5C and the guide wire 10 are loosely fitted.

  As shown in FIG. 13, in the catheter assembly 1 </ b> C, the inner hub 6 has a tubular inner hub body 61 and a branch portion 623 branched from the middle of the inner hub body 61.

  Accordingly, even when the guide wire 10 is inserted through the head 5C as shown in FIG. 10, for example, the drug solution enters the blood vessel from the branch portion 623 via the inner catheter 3C (from the distal end 53 of the head 5C). (Medicine) can be supplied (administered).

  In the catheter assembly 1C, by moving the inner catheter 3C in the proximal direction relative to the outer catheter 2 from the state shown in FIG. 10, first, as shown in FIG. 55 is pressed by the inner edge 213 of the distal end 211 of the outer catheter body 21. At this time, in the head 5C, the inner peripheral surface 521 approaches (or abuts) the outer peripheral surface 102 of the guide wire 10, that is, the second lumen 52 starts to narrow.

  When the inner catheter 3C is further moved in the proximal direction, the edge portion 213 sequentially passes over (presses) the second tapered portion 55 and the maximum outer diameter portion 56, and the maximum outer diameter portion 56 slides inside the outer catheter body 21. Move. At this time, as shown in FIG. 12, the maximum outer diameter portion 56 (outer peripheral surface 51) is pressed by the inner peripheral surface 212 of the outer catheter body 21, and the second lumen 52 is narrowed. In the narrowed second lumen 52, the inner peripheral surface 521 is in close contact with the outer peripheral surface 102 of the guide wire 10. As a result, the second lumen 52 is closed.

  The space 231 is depressurized by pulling the inner catheter 3C while the second lumen 52 is closed. The atheroma 200 is reliably sucked (stored) in the decompressed space 231.

<Fourth embodiment>
FIG. 14 is a partial longitudinal sectional view showing the vicinity of the inner hub of the catheter assembly (fourth embodiment) of the present invention.

  Hereinafter, a fourth embodiment of the catheter assembly of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the inner catheter further has a cap.

  In the catheter assembly 1 </ b> D shown in FIG. 14, the inner catheter 3 </ b> D has a cap 63. The cap 63 is detachably attached to the proximal end opening 611 of the inner hub 6.

  The cap 63 includes a cap main body 631 having a bottomed cylindrical shape, and a packing (sealing member) 632 installed on the bottom 633 of the cap main body 631.

  A female screw 634 is formed on the inner peripheral surface of the cap body 631. A male screw 612 formed on the outer periphery of the base end portion of the inner hub 6 is screwed into the female screw 634. The cap 63 is attached to the inner hub 6 by screwing these screws.

  In addition, although it does not specifically limit as a constituent material of the cap main body 631, For example, various metal materials, various plastics, etc. can be used individually or in combination.

The packing 632 is a plate-like body made of, for example, various rubber materials.
With the cap 63 having such a configuration attached to the base end opening 611, the packing 632 is sandwiched between the bottom 633 of the cap body 631 and the base end opening 611 of the inner hub 6. Thereby, the proximal end opening 611 (the proximal end side of the first lumen 311) is sealed, that is, closed.

  In the present embodiment, even when the guide wire 10 is removed from the catheter assembly 1D (second lumen 52) during the suction operation, the proximal end opening 611 is sealed by the cap 63, so that the atheroma 200 is reliably aspirated into the outer catheter 2.

  As described above, in the catheter assembly 1D, the cap 63 is attached to the inner hub 6 so that the guide wire 10 is inserted into the second lumen 52 and the second lumen 52 is closed. Similar effects can be obtained.

  As described above, as described in the first to fourth embodiments, in the catheter assembly of the present invention, only the head (with the head itself) functions as a suction body, and the head. The guide wire inserted into the head can take a form in which they function as a suction body.

  As a form in which only the head functions as a suction body, there is a catheter assembly in which the head is self-occluded as in the second embodiment.

  Further, as a form in which the head and the guide wire operate integrally and function as a suction body, the second lumen of the head is naturally closed (usually) with the guide wire as in the first embodiment. The natural catheter head and the guide wire are loosely fitted as in the third embodiment, but the loosely fitted state is obtained when the head is pressed against the inner peripheral surface of the outer catheter. And a catheter assembly in which the second lumen is occluded.

  Further, although the illustrated embodiment of the catheter assembly of the present invention has been described, the present invention is not limited to this, and each component constituting the catheter assembly can have any configuration that can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  Further, the catheter assembly of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  For example, the inner hub of the second embodiment and the third embodiment may be configured so that a cap substantially the same as that of the fourth embodiment can be attached.

It is a fragmentary longitudinal cross-section which shows 1st Embodiment of the catheter assembly of this invention. FIG. 2 is an enlarged vertical cross-sectional view sequentially illustrating usage states of the catheter assembly illustrated in FIG. 1. FIG. 2 is an enlarged vertical cross-sectional view sequentially illustrating usage states of the catheter assembly illustrated in FIG. 1. FIG. 2 is an enlarged vertical cross-sectional view sequentially illustrating usage states of the catheter assembly illustrated in FIG. 1. FIG. 2 is an enlarged vertical cross-sectional view sequentially illustrating usage states of the catheter assembly illustrated in FIG. 1. It is a longitudinal cross-sectional view which shows the structural example of the state maintenance means of the catheter assembly shown in FIG. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (2nd Embodiment) of this invention in order. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (2nd Embodiment) of this invention in order. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (2nd Embodiment) of this invention in order. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (3rd Embodiment) of this invention in order. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (3rd Embodiment) of this invention in order. It is an enlarged vertical sectional view which shows the use condition of the catheter assembly (3rd Embodiment) of this invention in order. FIG. 13 is an enlarged view showing the vicinity of the inner hub of the catheter assembly shown in FIGS. 10 to 12. It is a fragmentary longitudinal cross-section which shows the inner hub vicinity of the catheter assembly (4th Embodiment) of this invention.

Explanation of symbols

1A, 1B, 1C, 1D Catheter assembly 2 Outer catheter 21 Outer catheter body 211 Tip (tip opening)
212 inner peripheral surface 213 edge 23 lumen (lumen)
231 Space 24 Covering member (anti-kink protector)
3A, 3B, 3C, 3D inner catheter (inner structure)
31 Inner catheter body (inner linear body)
311 1st lumen 312 Outer peripheral surface 4 Outer hub 41 Outer hub main body 411 Base end portion 42, 42 ′ Ring-shaped member 421 Outer peripheral surface 422 Inner peripheral surface 43 Press member 431 Disc-shaped portion 432 Cylindrical portion 433 Columnar portion 434 Female thread part 435 Through hole 44 Recessed part 441 Inner peripheral surface 45 Male thread part 47 Branch part 5A, 5B, 5C Head (chip)
51 outer peripheral surface 52 second lumen 521 inner peripheral surface 522 introduction portion 53 distal end 54 first taper portion 55 second taper portion 56 maximum outer diameter portion 6 inner hub 61 inner hub body 611 proximal end opening 612 male screw 621 , 622 Wings 623 Branch 63 Cap 631 Cap body 632 Packing (sealing member)
633 bottom 634 female screw 10 guide wire 101 distal end surface 102 outer peripheral surface 200 atheroma (thrombosis)
φD1 outer diameter (maximum outer diameter)
φD2 ID φD3 Minimum ID

Claims (17)

A catheter assembly that is inserted into a living body and sucks foreign matter in the living body,
An outer catheter having an outer catheter body that is flexible and has a long tubular shape with a lumen opened at the tip;
A long inner linear body that is flexible and is inserted into the outer catheter body, and an inner structural body that is provided at a distal end of the inner linear body and has an elastic head. Prepared,
In a state where the inner structure is inserted into the outer catheter, the head can project from the distal end opening of the outer catheter body, and the inner linear body from the projecting state to the proximal end with respect to the outer catheter by moving operation in the direction, the head is housed in the outer catheter body slides within the outer catheter body is configured to suction the foreign matters from the distal end opening of the outer catheter body,
The catheter assembly according to claim 1, wherein an outer diameter of the inner linear body is smaller than a maximum outer diameter of the head. The foreign material is bowl-shaped or jelly-shaped,
2. The catheter set according to claim 1, wherein the head is protruded from a distal end opening of the outer catheter body, and the head is inserted into the foreign substance and then used to perform a moving operation on the outer catheter body. Solid. A first lumen is formed along the longitudinal direction of the inner linear body,
3. The catheter assembly according to claim 1, wherein the head is formed with a second lumen that communicates with the first lumen and opens at a tip of the head.   The catheter assembly according to claim 3, wherein each of the first lumen and the second lumen functions as an insertion passage through which a guide wire is inserted.   The catheter assembly according to claim 4, wherein the second lumen is blocked by the guide wire in a state where the guide wire is inserted.   The catheter assembly according to any one of claims 3 to 5, wherein a maximum outer diameter of the head in a natural state is substantially equal to or slightly smaller than an inner diameter of the outer catheter body.   The catheter assembly according to any one of claims 3 to 5, wherein a maximum outer diameter of the head in a natural state is larger than an inner diameter of the outer catheter body.   8. The head according to claim 7, wherein when the head slides within the outer catheter body, an outer peripheral surface thereof is pressed by an inner peripheral surface of the outer catheter body, and the second lumen is narrowed or occluded. Catheter assembly.   The said inner structure is joined to the base end part of the said inner side linear body, and has an inner side hub comprised with the cylindrical body connected to a said 1st lumen | bore. Catheter assembly. The inner structure has a cap that is detachably attached to a proximal end opening of the inner hub,
The catheter assembly according to claim 9, wherein a proximal end side of the first lumen is closed in a state where the cap is attached to the proximal opening.   The catheter assembly according to any one of claims 1 to 10, wherein the head has a portion whose outer diameter gradually decreases in a distal direction.   The catheter assembly according to any one of claims 1 to 11, wherein the head has a portion whose outer diameter gradually decreases in the proximal direction.   The catheter assembly according to claim 1, wherein the head has an X-ray contrast property.   The catheter assembly according to any one of claims 1 to 13, wherein the outer catheter body is substantially transparent.   The catheter assembly according to any one of claims 1 to 14, wherein a distal end portion of the outer catheter body has X-ray contrast properties.   The catheter according to any one of claims 1 to 15, wherein the inner peripheral surface of the outer catheter body and / or the outer peripheral surface of the head is subjected to a friction reducing process for reducing friction between these surfaces. Assembly.   The catheter assembly according to any one of claims 1 to 16, further comprising state maintaining means for maintaining a state in which the inner structure is inserted into the outer catheter.

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