JP2016073469A - Dilator and catheter assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a dilator and catheter assembly capable of improving operability when inserting a catheter into a body.SOLUTION: A guiding catheter assembly 10 includes a guiding catheter 11 and a dilator 12. The dilator 12 includes: a dilator shaft 41 that is inserted inside the guiding catheter 11 and formed into a projection part 71, with it inserted therein, where a part thereof is projected from a distal end of the guiding catheter 11; and a connector 43 to be connected to the proximal side of the guiding catheter 11. The connector 43 is configured to change over between a fixed state where the connector is fixed to the dilator shaft 41, and a released state where the connector can be displaced in the axial direction with respect to the dilator shaft 41.SELECTED DRAWING: Figure 7

Description

  The present invention relates to a dilator and a catheter assembly.

  In general, when a device such as a balloon catheter is introduced into a blood vessel, an introduction hole communicating from the body surface into the blood vessel is first formed, and a sheath introducer is introduced into the blood vessel through the hole. In this case, a dilator is mounted inside the sheath introducer. The dilator is mounted in a state in which a part thereof protrudes from the distal end of the sheath introducer to the distal end side. When the sheath introducer is introduced into the blood vessel, the sheath introducer is introduced into the blood vessel while the hole is expanded by the protruding portion of the dilator. After introducing the sheath introducer into the body, a guiding catheter is introduced into the blood vessel through the inside of the sheath introducer, and then a device such as a balloon catheter is introduced into the blood vessel through the inside of the guiding catheter.

  By the way, in the above-described procedure, the introduction hole is expanded by the outer diameter of the sheath introducer. However, considering the burden on the patient, it is desirable to make the size of the hole as small as possible. Therefore, in recent years, a method has been proposed in which a guiding catheter is directly introduced into a blood vessel without using a sheath introducer (that is, without a sheath). According to this method, the size of the hole is only required to be approximately the same as the outer diameter of the guiding catheter, so that the burden on the patient can be reduced.

  Such a sheathless type guiding catheter is equipped with a dilator. Patent Document 1 discloses a guiding catheter assembly including a guiding catheter and a dilator attached to the inside of the guiding catheter. In this guiding catheter assembly, the dilator has a connector at its proximal end, and the connector is connected to the proximal end of the guiding catheter. Further, the dilator has a protruding portion protruding from the distal end of the guiding catheter. When the guiding catheter assembly is introduced into the blood vessel, the guiding catheter assembly is introduced while expanding the introduction hole by the protruding portion.

JP 2013-5963 A

  By the way, unlike a sheath introducer, a guiding catheter is introduced to the vicinity of a treatment target site in a blood vessel. Therefore, when introducing the above-described guiding catheter assembly into a blood vessel, it is conceivable that the guiding catheter assembly passes through the bent blood vessel during the introduction. However, since the guiding catheter assembly has a double structure consisting of a guiding catheter and a dilator, it is considered that the rigidity of the guiding catheter assembly is relatively high. It may be difficult to follow the bent blood vessel.

  In addition, it is conceivable that at least the distal end side of the guiding catheter assembly is formed of a material having low rigidity (high flexibility) to improve the followability with respect to the bent blood vessel. When introducing into the blood vessel while expanding the hole by the protruding portion, there is a possibility that a problem such as kinking of the distal end side may occur. Therefore, in this case, there is a possibility that the introduction work into the blood vessel becomes difficult.

  This invention is made | formed in view of the said situation, and it aims at providing the dilator and catheter assembly which can improve the operativity at the time of introduce | transducing a catheter in a body.

  In order to solve the above-mentioned problem, a dilator according to a first aspect of the present invention is inserted into a catheter, and in the inserted state, a dilator shaft having a part protruding from the distal end of the catheter, and a dilator shaft of the catheter And a connector having a connection portion connected to the base end side, wherein the connection portion is displaceable in an axial direction with respect to the dilator shaft.

  The dilator is attached to the catheter by inserting the dilator shaft into the catheter and connecting the connector to the proximal end side of the catheter. In the catheter assembly in which the dilator is mounted on the catheter in this way, a part of the dilator shaft protrudes from the distal end of the catheter and becomes a protruding portion. The catheter assembly generally has a double structure of a dilator shaft and a catheter, but the protrusion is composed only of the dilator shaft. Therefore, in this protrusion part, the softness | flexibility is high compared with the double structure part of the base end side rather than it.

  Therefore, in the present invention, paying attention to this point, the dilator is provided with an adjusting function capable of adjusting the length of the protruding portion. Specifically, the connecting portion of the connector can be displaced in the axial direction with respect to the dilator shaft, whereby the catheter connected to the connecting portion can be displaced (relatively displaced) in the axial direction with respect to the dilator shaft. In this case, the length of the protrusion protruding from the distal end of the catheter can be adjusted by the relative displacement between the two.

  According to such a configuration, for example, when the catheter assembly is passed through the bent blood vessel, the flexibility of the distal end side of the catheter assembly can be increased by increasing the length of the protruding portion. Thereby, the followable | trackability with respect to a bending blood vessel can be improved. Further, when the catheter assembly is introduced into the blood vessel through the introduction hole, the distal end side of the catheter assembly can be increased in rigidity by shortening the length of the protrusion (reducing flexibility). Is possible). Thereby, malfunctions, such as a tip side kinking, can be controlled. Therefore, in this case, the operability when introducing the catheter into the body can be improved.

  The “connecting portion connected to the proximal end side of the catheter” includes not only a connecting portion directly connected to the proximal end side of the catheter but also a connector (for example, a hemostasis connector) or the like on the proximal end side of the catheter. A connection part connected via a member is also included.

  The dilator according to a second aspect of the present invention is the dilator according to the first aspect, wherein the connector is configured to be switchable between a fixed state in which the connector is fixed to the dilator shaft and a released state in which the fixing is released. Then, it is possible to be displaced in the axial direction with respect to the dilator shaft.

  According to the present invention, since the connector (including the connecting portion) can be displaced in the axial direction with respect to the dilator shaft, the length of the protruding portion can be adjusted by displacing the connector itself in the axial direction. it can. Thereby, compared with the case where the displacement mechanism which displaces a connection part to an axial direction is provided in a connector, simplification of a structure can be achieved.

  A dilator according to a third invention is the dilator shaft according to the second invention, wherein the connector has an insertion portion through which the dilator shaft is inserted, and the connector is inserted into the insertion portion in the released state. It is possible to displace along the axis in the axial direction.

  According to the present invention, the connector can be moved (displaced) in the axial direction along the dilator shaft inserted through the insertion portion. In this case, since the connector can be guided along the dilator shaft, the operation of adjusting the length of the protruding portion by moving the connector can be facilitated.

  Moreover, it is desirable that the insertion portion is an insertion hole portion through which the dilator shaft is inserted. In this case, when the connector is moved in the axial direction along the dilator shaft, the connector does not come off from the dilator shaft, so that the operation of adjusting the length of the protruding portion can be further facilitated.

  A dilator according to a fourth invention is the dilator according to the second or third invention, wherein the dilator shaft has a lumen into which a guide wire can be inserted, and the connector is provided so as to surround an outer periphery of the dilator shaft. An annular elastic member, and a pair of bodies provided so as to be relatively displaceable between a compression position for compressing the elastic member in the axial direction and a compression release position for releasing the compression. Is in the compression position, the compression of the elastic member causes the inner peripheral portion of the elastic member to be pressed against the outer peripheral surface of the dilator shaft, the connector is in the fixed state, and the pair of bodies are released from the compression release. When in the position, the pressing of the inner peripheral portion of the elastic member against the outer peripheral surface is released, and the connector is in the released state. That.

  According to the present invention, the annular elastic member is provided so as to surround the outer periphery of the dilator shaft, and the elastic member is compressed in the axial direction by the relative displacement of the pair of bodies, and the compression is released. Can be switched to the decompressed state. In this case, when the elastic member is in a compressed state, the inner peripheral portion of the elastic member is pressed against the outer peripheral surface of the dilator shaft, and the connector is fixed to the dilator shaft (becomes a fixed state). In such a fixed configuration, the dilator shaft is not easily crushed, so that it is possible to fix the connector to the dilator shaft while suppressing a decrease in the insertability of the guide wire inserted through the lumen therein.

  A dilator according to a fifth invention is used in the guiding catheter as the catheter in any one of the first to fourth inventions.

  A guiding catheter (sheathless guiding catheter) introduced into the body without using a sheath introducer is equipped with a dilator. Since the guiding catheter is introduced to the vicinity of the treatment target site in the body, there is a high possibility that the guiding catheter passes through the bent blood vessel during the introduction. In view of this point, the present invention applies the dilator of the first invention to such a guiding catheter. In this case, when the guiding catheter passes through the bent blood vessel, the length of the protruding portion can be increased to improve the followability to the bent blood vessel, so that the operability when introducing the guiding catheter into the body is improved. Can be increased.

  A catheter assembly of a sixth invention includes the catheter and the dilator of any one of the first to fifth inventions, and the dilator shaft is inserted into the catheter, and in the inserted state. A part of the protruding portion protrudes from the distal end of the catheter, and the connecting portion is connected to a proximal end side of the catheter, and the connecting portion is connected to the catheter along with the catheter in the axial direction. The length of the protruding portion can be adjusted by displacing the projection.

  According to the present invention, the same effects as those of the first to fifth inventions can be obtained as a catheter assembly.

FIG. 3 is a schematic overall side view showing a configuration of a guiding catheter assembly. (A) is a front view which shows the guiding catheter by which the hemostatic connector was connected to the base end side, (b) is a longitudinal cross-sectional view which expands and shows the periphery of the hemostatic connector, (c) is a guiding catheter. It is a longitudinal cross-sectional view which expands and shows the front-end | tip part. (A) is a front view which shows the structure of a dilator, (b) is a longitudinal cross-sectional view which expands and shows the hub periphery of a dilator. (A) is the front view which expands and shows the connector periphery, (b) is the cross-sectional view which expanded the connector periphery and was seen from the base end side. It is the longitudinal cross-sectional view which expands and shows the periphery of a connector, (a) has shown the fixed state with which the connector was fixed to the dilator shaft, (b) has shown the cancellation | release state with which the fixation was cancelled | released. (A) is the longitudinal cross-sectional view which expands and shows the connection part by which the connector of the dilator was connected to the base end side of the guiding catheter, (b) is the front view which expands and shows the connection part. It is a front view which shows a mode that the length of a protrusion part is adjusted. The figure for demonstrating the work content at the time of introduce | transducing a guiding catheter assembly in the blood vessel.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a guiding catheter assembly for peripheral blood vessels is embodied. FIG. 1 is a schematic overall side view showing a configuration of a guiding catheter assembly. 2, (a) is a front view showing a guiding catheter having a hemostatic connector connected to the proximal end side, (b) is an enlarged longitudinal sectional view showing the periphery of the hemostatic connector, (c) FIG. 2 is an enlarged longitudinal sectional view showing a distal end portion of a guiding catheter.

  As shown in FIG. 1, the guiding catheter assembly 10 includes a guiding catheter 11 and a dilator 12 inserted into the guiding catheter 11. The guiding catheter assembly 10 is used when a device such as a balloon catheter is introduced into a treatment target site in a peripheral blood vessel, and has a length of about 500 mm to 1500 mm as a whole. The guiding catheter assembly 10 corresponds to a “catheter assembly”, and the guiding catheter 11 corresponds to a “catheter”.

  As shown in FIG. 2A, the guiding catheter 11 includes a catheter shaft 14 and a hub 15 connected to the proximal end side of the catheter shaft 14. As shown in FIG. 2C, the catheter shaft 14 has a lumen 14a extending in the entire axial direction. The catheter shaft 14 has a three-layer structure, and includes an inner layer 14b and an outer layer 14c made of a resin material, and a metal braid layer 14d (intermediate layer) provided between the layers 14b and 14c. Yes. Moreover, the catheter shaft 14 has a tapered tip so that the insertion into the blood vessel is enhanced.

  As shown in FIG. 2B, the hub 15 is made of a resin material having transparency, and has an internal passage 15a extending over the entire region in the axial direction. The proximal end portion of the catheter shaft 14 is inserted into the inner passage 15a on the distal end side. The proximal end portion of the catheter shaft 14 is joined to the hub 15 in the inserted state. In this case, the internal passage 15 a communicates with the lumen 14 a of the catheter shaft 14. Further, the internal passage 15a is a tapered passage portion 16 having a base end side whose diameter is increased toward the base end of the passage 15a.

  An annular projecting portion 18 is provided on the outer peripheral surface of the base end portion of the hub 15. A male screw portion (not shown) is formed on the protruding portion 18. A rubber cover 19 is attached to the distal end side of the hub 15, and the proximal end side of the catheter shaft 14 is covered with the rubber cover 19.

  A hemostatic connector 21 having a hemostatic function is connected to the proximal end side of the hub 15. The hemostatic connector 21 has a hub connection portion 22 connected to the proximal end side of the hub 15 and a hemostatic portion 23 provided on the proximal end side of the hub connection portion 22.

  The hub connection portion 22 is formed of a resin material having transparency. The hub connecting portion 22 includes a cylindrical tubular portion 25 extending in the axial direction, a disk-shaped inner plate portion 26 provided inside the tubular portion 25, and a circular tube extending from the inner plate portion 26 toward the distal end side. Connecting pipe portion 27. A female thread portion 25 a is formed on the inner peripheral surface of the cylindrical portion 25 on the tip side of the inner plate portion 26. A plurality of ribs 25b extending in the axial direction are provided on the outer peripheral surface of the cylindrical portion 25 at predetermined intervals in the circumferential direction.

  The connecting pipe part 27 has a pipe hole 27a extending in the axial direction therein. The tube hole 27 a is formed across the connecting tube portion 27 and the inner plate portion 26, and penetrates both of them 26 and 27 in the axial direction. The connecting pipe portion 27 is inserted into the internal passage 15a of the hub 15 in detail, from the proximal end side into the tapered passage portion 16, and is fitted into the tapered passage portion 16 in a liquid-tight state by the insertion. In the inserted state of the connecting pipe portion 27, the cylindrical portion 25 is located on the outer peripheral side of the hub 15, and the female screw portion 25 a is fastened to the screw portion of the protruding portion 18 of the hub 15. As a result, the hub connection portion 22 and thus the hemostatic connector 21 are connected to the hub 15.

  The hemostatic part 23 includes a main body part 31, a hemostatic valve 32, and a cap 33. The main body 31 is formed in a cylindrical shape from a resin material having transparency, and has an internal passage 31a extending over the entire region in the axial direction. Further, the main body portion 31 is a reduced diameter portion 31b whose distal end side is reduced in both outer diameter and inner diameter. The reduced diameter portion 31b is inserted into the hub connection portion 22 from the proximal end side, and the distal end portion is in contact with the inner plate portion 26 of the hub connection portion 22 in the inserted state. The reduced diameter portion 31b is joined to the hub connection portion 22 in such an inserted state. In this case, the internal passage 31 a of the main body portion 31 communicates with the tube hole 27 a of the connection tube portion 27.

  The main body part 31 is provided with a branch pipe part 35 protruding from the outer peripheral surface thereof. The branch pipe portion 35 is formed with a pipe hole 35a communicating with the internal passage 31a. A conduit 36 is connected to the branch pipe portion 35, and a liquid agent supplier (not shown) for supplying a liquid agent such as a contrast medium into the body is connected to the conduit 36.

  Further, the main body 31 is provided with a protrusion 37 that protrudes from the outer peripheral surface thereof. The protrusion 37 has a rectangular shape and is provided in a part of the main body 31 in the circumferential direction. Further, the protruding portion 37 is arranged on the proximal end side with respect to the branch pipe portion 35.

  In the present embodiment, the main body 31 is formed separately from the hub connection 22, but the main body 31 may be integrally formed with the hub connection 22.

  A hemostasis valve 32 is provided at the proximal end of the main body 31. The hemostasis valve 32 is formed in a disc shape from an elastic material such as silicon rubber, and is disposed so as to close the proximal end opening of the internal passage 31a. Further, the hemostasis valve 32 is formed with a slit 32a penetrating in the thickness direction.

  The cap 33 is made of the same resin material as that of the main body 31 and has an accommodation recess 33 a for accommodating the hemostasis valve 32. The cap 33 is fixed on the base end portion of the main body 31 in a state where the hemostasis valve 32 is housed in the housing recess 33a. Thereby, the hemostatic valve 32 is built in the hemostatic part 23. In addition, the cap 33 is formed with a hole 33 b that communicates with the slit 32 a of the hemostasis valve 32. The hole 33b, the accommodating recess 33a, the internal passage 31a, and the tube hole 27a constitute a connector passage 39 of the hemostatic connector 21, and the connector passage 39 penetrates the hemostatic connector 21 in the axial direction.

  Next, the configuration of the dilator 12 will be described with reference to FIG. 3A is a front view showing the configuration of the dilator 12, and FIG. 3B is a longitudinal sectional view showing the periphery of the hub of the dilator 12 in an enlarged manner.

  As shown in FIG. 3A, the dilator 12 includes a dilator shaft 41, a hub 42 connected to the proximal end side of the dilator shaft 41, and a connector 43 that can be connected to the hemostatic connector 21.

  The dilator shaft 41 is formed in a tubular shape with a flexible resin material. The dilator shaft 41 is made of, for example, a fluororesin. However, the dilator shaft 41 is not necessarily formed of a fluororesin, and may be formed of other resin materials such as polyethylene, polypropylene, polyester, nylon, nylon elastomer, and the like.

  As shown in FIG. 3B, the dilator shaft 41 has a lumen 41 a that extends over the entire area in the axial direction. The lumen 41a functions as a guide wire lumen (corresponding to a lumen) through which the guide wire is inserted. Further, the dilator shaft 41 has a tapered tip, and the insertion property into the blood vessel is enhanced.

  The hub 42 is formed in a tubular shape from a resin material having transparency. The hub 42 has an internal passage 42a extending in the entire axial direction inside thereof. The proximal end portion of the dilator shaft 41 is inserted into the distal end side of the internal passage 42a. The base end portion of the dilator shaft 41 is joined to the hub 42 in the inserted state. In this case, the internal passage 42 a of the hub 42 communicates with the lumen 41 a of the dilator shaft 41. An opening on the proximal end side in the internal passage 42a of the hub 42 serves as a connection port 46 to which a medicine supply device (not shown) that supplies medicine into the body through the inner cavity 41a of the dilator shaft 41 is connected. Reference numeral 47 in FIG. 3B denotes a rubber cover 47 that is attached to the distal end side of the hub 42 and covers the proximal end side of the dilator shaft 41.

  Next, the connector 43 will be described with reference to FIGS. 4A is an enlarged front view showing the periphery of the connector 43, and FIG. 4B is a cross-sectional view of the periphery of the connector 43 viewed from the base end side. FIG. 5 is an enlarged vertical sectional view showing the periphery of the connector 43. FIG. 5A shows a fixed state in which the connector 43 is fixed to the dilator shaft 41, and FIG. 5B shows that the fixing is released. Indicates the release state.

  As shown in FIGS. 4A and 5A, the connector 43 includes a first body 51 and a second body 52 provided on the proximal end side of the first body 51. The first body 51 is made of a resin material, for example, polyacetal. The first body 51 is formed in a cylindrical shape extending in the axial direction as a whole. The first body 51 has a large-diameter portion 51a on the distal end side, and a small-diameter portion 51b having a smaller outer diameter than the large-diameter portion 51a on the proximal end side.

  The large-diameter portion 51a is formed with a recess that opens toward the tip side. As will be described later, the concave portion serves as an accommodating concave portion 53 that accommodates the hemostatic portion 23 of the hemostatic connector 21. A guide passage 56 for guiding the protruding portion 37 of the hemostatic portion 23 is formed in the peripheral wall portion 54 surrounding the accommodating recess 53 in the large diameter portion 51a. The guide passage 56 penetrates the peripheral wall portion 54 in the thickness direction, and extends from the distal end of the peripheral wall portion 54 toward the proximal end side, and a proximal end side (proximal end portion) of the first passage portion 56a. And a second passage portion 56b extending in the circumferential direction.

  The first body 51 (mainly the small diameter portion 51b) is formed with a hole 58 extending from the housing recess 53 toward the base end side. The hole 58 is formed in the central portion of the first body 51 and opens to the outside of the first body 51 at the base end portion (of the small diameter portion 51b). The hole 58 includes a small-diameter hole 58a extending from the accommodation recess 53 toward the base end side, and a large-diameter hole 58b extending from the base end side to the base end opening of the hole 58 with respect to the small-diameter hole 58a. Each of these holes 58a, 58b is formed on the same axis. In the small diameter hole portion 58a, the hole diameter is the same as or slightly larger than the outer diameter of the dilator shaft 41. Further, the large diameter hole portion 58b has a larger hole diameter than the small diameter hole portion 58a, and a female screw 59 is formed on the inner peripheral surface thereof. In this case, the large-diameter hole 58b functions as a screw hole (hereinafter also referred to as a screw hole 58b).

  In the hole 58, a step surface 62 is formed at the boundary between the small diameter hole 58a and the large diameter hole 58b to connect the inner peripheral surfaces of the holes 58a and 58b. The stepped surface 62 is an inclined surface (tapered surface) that inclines radially outward from the distal end side (small diameter hole portion 58a side) toward the proximal end side (large diameter hole portion 58b side).

  A plurality of ribs 61 extending in the axial direction are provided on the outer peripheral surface of the small diameter portion 51b at predetermined intervals (equal intervals) in the circumferential direction. These ribs 61 are used as anti-skids to prevent the hand from slipping when the external thread part 63 (to be described later) is tightened or loosened in the screw hole part 58b while holding the outer peripheral surface of the small diameter part 51b by hand. Function.

  The second body 52 is made of a resin material, for example, ABS. The second body 52 is formed in a cylindrical shape extending in the axial direction as a whole. The second body 52 has a male screw portion 63 that is screwed into the screw hole 58 b of the first body 51 at the tip side. On the outer peripheral surface of the male screw portion 63, a male screw 63a that is screwed into the female screw 59 of the screw hole portion 58b is formed. The second body 52 is integrated with the first body 51 by screwing the male screw portion 63 into the screw hole portion 58b.

  The second body 52 has a hole 64 that penetrates the body 52 in the axial direction. The hole 64 is formed at the center of the second body 52. The hole portion 64 includes a small diameter hole portion 64a extending from the distal end opening toward the proximal end side, and a large diameter hole portion 64b extending from the proximal end of the small diameter hole portion 64a toward the proximal end side. In the small-diameter hole portion 64a, the hole diameter is the same as or larger than the outer diameter of the dilator shaft 41. Further, the large-diameter hole portion 64b has a larger hole diameter than the small-diameter hole portion 64a. Specifically, the hole diameter gradually increases from the distal end side toward the proximal end side. Thereby, the hole diameter is sufficiently larger than the outer diameter of the dilator shaft 41 at the base end opening of the large-diameter hole 64b (and consequently the hole 64).

  The hole 64 of the second body 52 communicates with the hole 58 of the first body 51. In this case, an internal passage 65 that penetrates the connector 43 in the axial direction is formed by each of the holes 58 and 64 and the housing recess 53 of the first body 51, and the dilator shaft 41 is inserted into the internal passage 65. ing. Therefore, in this case, the internal passage 65 corresponds to the insertion portion and the insertion hole portion.

  A distal end surface 66 surrounding the distal end opening of the hole 64 in the external thread portion 63 is a tapered surface formed so that the outer diameter increases from the distal end side toward the proximal end side. The front end surface 66 is opposed to the step surface 62 of the first body 51 in the axial direction, and is specifically a surface parallel to the step surface 62. In this case, the stepped surface 62 and the front end surface 66 are a pair of facing surfaces facing each other in the axial direction, but the pair of facing surfaces do not necessarily need to be tapered surfaces, for example, orthogonal to the axial direction. It may be a surface to be used.

  As shown in FIG. 4B, a plurality (specifically, two) of handle portions 68 projecting from the outer peripheral surface of the second body 52 are provided on the base end side of the external thread portion 63. Yes. These handle portions 68 are provided at equal intervals (specifically, 180 ° intervals) around the axis. When the male screw part 63 is screwed into the screw hole part 58b of the first body 51 or loosened, it is possible to perform this operation by placing a finger on the handle part 68.

  As shown in FIGS. 5A and 5B, an O-ring 69 is interposed between the step surface 62 of the first body 51 and the tip surface 66 of the second body 52. The O-ring 69 is an elastic member formed in an annular shape from a resin material having elasticity, and is provided so as to surround the outer peripheral surface of the dilator shaft 41. The inner diameter of the O-ring 69 is the same as or slightly larger than the outer diameter of the dilator shaft 41. However, the inner diameter of the O-ring 69 may be slightly smaller than the outer diameter of the dilator shaft 41.

  As shown in FIG. 5A, the O-ring 69 is configured such that the male thread 63 of the second body 52 is tightened (screwed) into the screw hole 58 b of the first body 51. Between the step surface 62 and the front end surface 66 of the second body 52, it is compressed in the axial direction. In this case, the O-ring 69 is expanded toward both sides in the radial direction, that is, the inner peripheral side and the outer peripheral side based on the compression in the axial direction. As the O-ring 69 expands, the inner peripheral portion, specifically, the entire inner peripheral portion is pressed against the outer peripheral surface of the dilator shaft 41. Thereby, the O-ring 69 is fixed to the dilator shaft 41 by the pressing, and as a result, the connector 43 is fixed to the dilator shaft 41. The relative positions of the bodies 51 and 52 at this time correspond to “compression positions”.

  On the other hand, as shown in FIG. 5B, when the male thread portion 63 of the second body 52 is loosened with respect to the screw hole portion 58 b of the first body 51, the second body 52 is separated from the first body 51. The O-ring 69 is released from compression in the axial direction between the stepped surface 62 of the first body 51 and the distal end surface 66 of the second body 52. As a result, the O-ring 69 returns to the natural state, and the pressing of the inner peripheral portion of the O-ring 69 against the outer peripheral surface of the dilator shaft 41 is released. As a result, the fixing of the O-ring 69 to the dilator shaft 41 is released, and consequently the fixing of the connector 43 to the dilator shaft 41 is released. The relative positions of the bodies 51 and 52 at this time correspond to “compression release positions”.

  As described above, the connector 43 is fixed to the dilator shaft 41 (state shown in FIG. 5A), and is released from the fixed state (state shown in FIG. 5B). It can be switched to. In the released state of the connector 43, the connector 43 can be moved (displaced) along the dilator shaft 41 in the axial direction. In this case, since the dilator shaft 41 is inserted into the internal passage 65 of the connector 43, the connector 43 can be moved (displaced) in the axial direction along the inserted dilator shaft 41.

  Next, a configuration in a state where the dilator 12 is mounted in the guiding catheter 11 will be described based on FIGS. 1 and 6. 6A is an enlarged longitudinal sectional view showing a connection portion where the connector 43 of the dilator 12 is connected to the proximal end side of the guiding catheter 11, and FIG. 6B is an enlarged view showing the connection portion. It is a front view.

  As shown in FIG. 6 (a), the dilator 12 has a dilator shaft 41 straddling the lumen 14a of the catheter shaft 14 of the guiding catheter 11, the internal passage 15a of the hub 15, and the connector passage 39 of the hemostatic connector 21. It is inserted. In this inserted state, as shown in FIG. 1, a part of the dilator shaft 41 protrudes from the distal end of the catheter shaft 14 toward the distal end side to form a protruding portion 71.

  The dilator shaft 41 is inserted through a slit 32 a of a hemostasis valve 32 provided in the hemostasis connector 21. In this inserted state, the outer peripheral surface of the dilator shaft 41 and the inner peripheral surface of the slit 32a are in close contact with each other, thereby preventing blood leakage between them.

  The connector 43 of the dilator 12 is connected to the proximal end side of the hemostatic connector 21 (specifically, the hemostatic portion 23). In the connector 43, the hemostatic part 23 of the hemostatic connector 21 is accommodated in the accommodating recess 53 of the first body 51. In the accommodated state of the hemostatic part 23, the projection 37 of the hemostatic part 23 (main body part 31) enters the second passage part 56 b of the guide passage 56 of the first body 51, as shown in FIG. . In this case, the protruding portion 37 is engaged with the second passage portion 56b, and the first body 51 and thus the connector 43 are connected to the hemostatic connector 21 by the engagement. In this case, the first body 51 corresponds to the connection portion.

  Here, a procedure for connecting the connector 43 to the proximal end side of the hemostatic connector 21 will be briefly described. At the time of connection, first, the proximal end side of the hemostatic part 23 of the hemostatic connector 21 is inserted into the accommodating recess 53 of the connector 43, and the hemostatic part 23 is pushed into the inner side of the accommodating recess 53 in this state. At this time, the protrusion 37 passes through the first passage portion 56 a of the guide passage 56. When the hemostatic part 23 is pushed to the back side of the housing recess 53, the connector 43 is rotated around the axis with respect to the hemostatic connector 21, and the protruding part 37 enters the second passage part 56 b of the guide passage 56. Thereby, the projection part 37 will be in the state engaged with the 2nd channel | path part 56b, and the connection of the connector 43 with respect to the hemostatic connector 21 is completed.

  As described above, the connector 43 of the dilator 12 is connected to the proximal end side of the hemostatic connector 21, in other words, connected to the proximal end side of the guiding catheter 11 via the hemostatic connector 21. By this connection, the dilator 12 is integrated with the guiding catheter 11, and the guiding catheter assembly 10 including both of them is configured.

  Here, in the present guiding catheter assembly 10, the dilator 12 is provided with an adjusting function for adjusting the length of the protruding portion 71 of the dilator shaft 41. Hereinafter, such an adjustment function will be described with reference to FIG. FIG. 7 is a front view showing how the length of the protrusion 71 is adjusted.

  As described above, the connector 43 of the dilator 12 can be displaced in the axial direction with respect to the dilator shaft 41 in the released state (the state shown in FIG. 5B) in which the fixing to the dilator shaft 41 is released. . In this case, by displacing the connector 43 in the axial direction with respect to the dilator shaft 41, the guiding catheter 11 connected to the connector 43 (via the hemostatic connector 21) is displaced in the axial direction with respect to the dilator shaft 41 ( Relative displacement). Therefore, the length of the protruding portion 71 protruding from the distal end of the guiding catheter 11 (specifically, the catheter shaft 14) can be adjusted by the relative displacement between the both 11 and 41. Specifically, as shown in FIG. 7A, the length of the protruding portion 71 can be increased by displacing the connector 43 toward the proximal end side with respect to the dilator shaft 41. On the other hand, as shown in FIG. 7B, the length of the protruding portion 71 can be shortened by displacing the connector 43 toward the distal end side with respect to the dilator shaft 41.

  Thus, the length of the protrusion 71 can be adjusted in the released state of the connector 43. After adjusting the length of the protrusion 71, the connector 43 is fixed to the dilator shaft 41 to be in a fixed state (the state shown in FIG. 5A).

  Next, the work content when introducing the above-described guiding catheter assembly 10 into a blood vessel will be described. FIG. 8 is a diagram for explaining such work contents. In the following, it is assumed that the guiding catheter assembly 10 is introduced to the treatment target site in the peripheral blood vessel of the leg. Here, the guiding catheter assembly 10 is introduced into the blood vessel from the thigh of the leg opposite to the leg to be treated.

  As shown in FIG. 8A, an introductory hole 75 that leads from the body surface into the blood vessel 74 (femoral artery) is formed in advance in the patient's thigh. A guide wire G is introduced into the blood vessel 74 through the hole 75 in advance. The tip of this guide wire G reaches the treatment target location in the peripheral blood vessel.

  When introducing the guiding catheter assembly 10 into the blood vessel 74, first, the guide wire G is inserted into the lumen 41 a of the dilator shaft 41, and the guiding catheter assembly 10 is inserted into the blood vessel 74 through the hole 75 in the inserted state. Introduce into. At this time, the length L1 of the protruding portion 71 is shortened, for example, set to a length of about 5 mm to 10 mm. The guiding catheter assembly 10 is introduced into the blood vessel 74 while expanding the hole 75 by the protrusion 71. In this case, since the length of the protrusion 71 is shortened, the rigidity of the distal end side of the guiding catheter assembly 10 is increased. Therefore, when introducing into the blood vessel 74, it is possible to suppress problems such as kinking of the distal end side, and to facilitate the introduction work.

  Here, when the guiding catheter assembly 10 is introduced into the peripheral blood vessel, as shown in FIG. 8B, the guiding catheter assembly 10 may pass through the bent blood vessel 77 during the introduction thereof. . In such a case, the length of the protrusion 71 is set to a length L2 longer than L1, for example, a length L2 of about 5 mm to 200 mm. In this case, since the flexibility on the distal end side of the guiding catheter assembly 10 can be increased, the followability to the bent blood vessel 77 can be improved. Therefore, it is possible to facilitate the operation of passing the bent blood vessel 77.

  In addition, when guiding catheter assembly 10 is introduced into a peripheral blood vessel, as shown in FIG. 8C, it may be considered that guiding catheter assembly 10 passes through stenotic region 81 during the introduction thereof. . In FIG. 8C, the lesioned part 79 is fixed to the inner wall of the blood vessel 78, and the lesioned part 79 causes a stenosis site 81 in the blood vessel 78. When passing the guiding catheter assembly 10 through such a stenosis part 81, the length of the protrusion 71 is set to a length L3 shorter than L2, for example, the same length L3 as L1. In this case, since the rigidity on the distal end side of the guiding catheter assembly 10 can be increased, the pushing force when the guiding catheter assembly 10 is pushed into the stenosis part 81 can be suitably transmitted to the distal end of the protrusion 71. . Therefore, it is possible to facilitate the operation of passing the stenosis region 81.

  As described above, according to the guiding catheter assembly 10, when the guiding catheter assembly 10 is introduced into the blood vessel 74 through the introduction hole 75, the guiding catheter assembly 10 passes through the stenotic region 81 when passing through the bent blood vessel 77. The length of the projecting portion 71 can be adjusted according to each introduction situation such as when performing the operation. Therefore, the flexibility (or rigidity) on the distal end side of the guiding catheter assembly 10 can be adjusted according to each introduction situation, and as a result, the operability when the guiding catheter assembly 10 is introduced into the peripheral blood vessel. Can be increased.

  After introducing the guiding catheter assembly 10 to the peripheral blood vessel, the connector 43 is removed from the hemostatic connector 21 and the dilator 12 is removed from the guiding catheter 11. Thereafter, a device such as a balloon catheter is introduced into the treatment target site in the peripheral blood vessel through the inside of the guiding catheter 11 to treat the site.

  As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.

  In the released state (fixed released state) of the connector 43, the connector 43 can be displaced in the axial direction with respect to the dilator shaft 41. In this case, since the length of the protrusion 71 can be adjusted by displacing the connector 43 itself in the axial direction, a displacement mechanism for displacing the connecting portion (connected to the hemostatic connector 21) to the connector 43 in the axial direction. Compared with the case of providing the configuration, the configuration can be simplified.

  An internal passage 65 through which the dilator shaft 41 is inserted is provided in the connector 43, and the connector 43 can be displaced in the axial direction along the dilator shaft 41 inserted through the internal passage 65. In this case, since the connector 43 can be guided along the dilator shaft 41, the work of adjusting the length of the protrusion 71 by moving the connector 43 can be facilitated.

  Further, since the internal passage 65 has a hole shape, the connector 43 is not detached from the dilator shaft 41 when the connector 43 is moved in the axial direction along the dilator shaft 41. Therefore, the operation of adjusting the length of the protruding portion 71 can be further facilitated.

  The connector 43 can be relatively displaced in the axial direction between an O-ring 69 provided around the outer periphery of the dilator shaft 41, and a compression position for compressing the O-ring 69 in the axial direction and a compression releasing position for releasing the compression. It was set as the structure provided with a pair of body 51,52 made. When the pair of bodies 51 and 52 are in the compression position, the compression of the O-ring 69 causes the inner peripheral portion of the O-ring 69 to be pressed against the outer peripheral surface of the dilator shaft 41 so that the connector 43 is in a fixed state. , 52 are in the compression release position, the pressing of the inner peripheral portion of the O-ring 69 against the outer peripheral surface of the dilator shaft 41 is released, and the connector 43 is released. In the configuration in which the connector 43 is fixed to the dilator shaft 41 in this way, the dilator shaft 41 is not easily crushed. Therefore, the connector 43 is connected to the dilator while suppressing a decrease in the insertion property of the guide wire G inserted into the inner cavity 41a. It can be fixed to the shaft 41.

  Further, by providing the connector 43 with an O-ring 69 (elastic member) disposed on the outer periphery of the dilator shaft 41, the connector 43 and thus the guiding catheter 11 are not intended along the dilator shaft 41 when the connector 43 is released. Can be prevented from sliding.

  The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

  (1) In the above embodiment, the connector 43 is displaceable (movable) in the axial direction with respect to the dilator shaft 41, but the connector 43 may be fixed to the dilator shaft 41. In this case, for example, the connector includes a fixed portion fixed to the dilator shaft 41 and a movable portion that can be displaced in the axial direction with respect to the fixed portion, and the movable portion is configured based on the guiding catheter 11. It is conceivable to connect to the end side (via the hemostatic connector 21). Even in such a configuration, by moving the movable portion (corresponding to the connection portion) in the axial direction with respect to the dilator shaft 41, the guiding catheter 11 connected to the movable portion can be moved in the axial direction with respect to the dilator shaft 41. Since it can be displaced, the length of the protrusion 71 can be adjusted.

  (2) In the above embodiment, the connector 43 is provided with the hole-like internal passage 65 as the insertion portion for inserting the dilator shaft 41. However, the insertion portion does not necessarily need to be a hole shape, and may be a groove shape, for example. . Even in that case, since the connector 43 can be guided in the axial direction along the dilator shaft 41 inserted through the insertion portion, the operation of adjusting the length of the protruding portion 71 by moving the connector 43 is facilitated. be able to. Further, the connector 43 may not be provided with an insertion portion.

  (3) In the above embodiment, the O-ring 69 is compressed in the axial direction by the pair of bodies 51, 52 and the inner periphery of the O-ring 69 is pressed against the outer peripheral surface of the dilator shaft 41. The connector 43 is released (fixed release state) by releasing the compression of the O-ring 69 by the body 51, 52 and stopping the pressing of the inner peripheral portion of the O-ring 69. The configuration for switching to the release state is not necessarily limited to this. For example, the connector is provided with a pair of holding parts for holding the dilator shaft 41, the connector 43 is fixed by holding the dilator shaft 41 by the holding parts, and the connector 43 is released by releasing the holding by the holding part. A configuration is possible.

  (4) In the above embodiment, the O-ring 69 is used as the annular elastic member, but an annular elastic member other than the O-ring may be used.

  (5) In the procedure described in the above embodiment (FIG. 8), the guide wire G is introduced in advance to the treatment target site in the peripheral blood vessel, and the guiding catheter assembly 10 is placed in the blood vessel along the introduced guide wire G. In some cases, the guide wire G and the guiding catheter assembly 10 may be alternately introduced toward the treatment target site. In this case, both guide wires G are alternately introduced while leading the guiding catheter assembly 10.

  Specifically, the guide wire G is first introduced to a predetermined location in the blood vessel, and then the guiding catheter assembly 10 is introduced until the distal end of the protruding portion 71 reaches the vicinity of the distal end of the guide wire G. . Then, the guide wire G is introduced again toward the back side in the blood vessel, and then the guiding catheter assembly 10 is introduced again until the distal end reaches the distal end of the guide wire G. Then, the guiding catheter assembly 10 is introduced to the treatment target site while repeating such alternate introduction work.

  Here, in such a procedure, when the guide wire G is introduced to the back side, if the rigidity on the distal end side of the guiding catheter assembly 10 is reduced, the guide wire G is pushed to the back side. The distal end side of the guiding catheter assembly 10 may be deformed and it may be difficult to suitably introduce the guide wire G. In that respect, according to the guiding catheter assembly 10 described above, the rigidity of the distal end side of the guiding catheter assembly 10 can be increased by setting the length of the protrusion 71 short when the guide wire G is introduced. The guide wire G can be suitably introduced to the back side while suppressing the deformation on the tip side.

  (6) The catheter shaft 14 of the guiding catheter 11 and the dilator shaft 41 of the dilator 12 do not necessarily have a linear shape. For example, a bent portion is provided on the distal end side of at least one of the shafts 14 and 41. (Bending part) may be provided. In that case, it is possible to improve the followability to the bent blood vessel.

  Further, the hardness of the tip side portion of the dilator shaft 41 may be changed in the axial direction. For example, it is conceivable to increase the hardness of the tip side portion of the dilator shaft 41 stepwise or continuously from the tip side toward the base end side. In this case, it is possible to improve force transmission and kink resistance at the protrusion 71 of the dilator shaft 41.

  Moreover, as a range (tip side part) to which hardness is changed, for example, a range from the tip of the dilator shaft 41 to a position on the base end side of 200 mm is considered. In that case, it is conceivable that the range is divided into three regions in the axial direction, and the hardness of these three regions is increased stepwise from the distal end side toward the proximal end side. Such hardness distribution can be realized, for example, by configuring the three regions with tubes having different hardnesses. In this case, of the above three regions, the distal region is a region extending from the distal end of the dilator shaft 41 to a position 80 mm proximal, and the intermediate region is 60 mm proximal from the proximal end of the distal region. It is considered that the range is to the position, and the base end side region is set to a range from the base end of the intermediate region to a position 60 mm base end side.

  (7) In the above embodiment, the connector 43 is connected to the proximal end side of the guiding catheter 11 via the hemostatic connector 21 (connecting member), but a connecting member other than the hemostatic connector 21 (for example, a connector having no hemostatic function). The connector 43 may be connected via Further, the connector 43 may be connected to the proximal end side of the guiding catheter 11 via a plurality of connecting members. Further, the connector 43 may be directly connected to the proximal end side of the guiding catheter 11 without using a connecting member.

  (8) In the above embodiment, the dilator of the present invention is used for a guiding catheter for peripheral blood vessels. However, the dilator of the present invention may be used for a guiding catheter used for other blood vessels such as a heart blood vessel. Further, the dilator of the present invention is not necessarily used for a guiding catheter, and may be used for a sheath introducer, for example.

  DESCRIPTION OF SYMBOLS 10 ... Guiding catheter assembly as a catheter assembly, 11 ... Guiding catheter as a catheter, 12 ... Dilator, 21 ... Hemostatic connector, 41 ... Dilator shaft, 41 ... Lumen as lumen, 43 ... Connector, 51 ... A first body as a connection part, 52 ... a second body, 65 ... an internal passage as an insertion part, 69 ... an O-ring as an elastic member, 71 ... a protruding part.

Claims (6)

A dilator shaft that is inserted into the inside of the catheter and that is a protruding portion that partially protrudes from the distal end of the catheter in the inserted state;
A connector having a connecting portion connected to the proximal end side of the catheter;
A dilator comprising:
The dilator according to claim 1, wherein the connecting portion is displaceable in an axial direction with respect to the dilator shaft.   The connector is configured to be switchable between a fixed state in which the connector is fixed to the dilator shaft and a released state in which the fixing is released. In the released state, the connector can be displaced in the axial direction with respect to the dilator shaft. The dilator according to claim 1, wherein: The connector has an insertion part for inserting the dilator shaft,
3. The dilator according to claim 2, wherein in the released state, the connector can be displaced in an axial direction along the dilator shaft inserted through the insertion portion. The dilator shaft has a lumen through which a guide wire can be inserted,
The connector is
An annular elastic member provided to surround the outer periphery of the dilator shaft;
A pair of bodies provided so as to be relatively displaceable between a compression position for compressing the elastic member in the axial direction and a compression release position for releasing the compression;
When the pair of bodies are in the compression position, the compression of the elastic member causes the inner peripheral portion of the elastic member to be pressed against the outer peripheral surface of the dilator shaft so that the connector is in the fixed state. 4. The dilator according to claim 2, wherein when the elastic member is in the compression release position, pressing of the inner peripheral portion of the elastic member against the outer peripheral surface is released, and the connector is in the released state.   The dilator according to claim 1, wherein the dilator is used for a guiding catheter as the catheter. The catheter;
A dilator according to any one of claims 1 to 5,
A catheter assembly comprising:
The dilator shaft is inserted into the catheter, and in the inserted state, a part of the dilator shaft protrudes from the distal end of the catheter,
The connecting portion is connected to the proximal end of the catheter;
A length of the protruding portion can be adjusted by displacing the connecting portion together with the catheter in the axial direction with respect to the dilator shaft.

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