JP5936093B2 - Double lumen dilator - Google Patents

Description

  The present invention relates to a dilator used to expand a stab entry point for inserting a catheter into a blood vessel.

  Conventionally, in the field of clinical medicine, catheter treatment is known in which a catheter is inserted into a blood vessel for treatment or examination. For example, a balloon catheter is inserted into a stenosis part in a blood vessel, and the balloon is expanded to push the stenosis part to widen the blood flow. Treatment to be injected into the department

  By the way, when performing catheter treatment, for example, as shown in Japanese Patent Publication No. 3-1026 (Patent Document 1), an indwelling needle composed of an inner needle portion and an outer tube portion, a guide wire, A catheter is inserted into the blood vessel using a sheath and a dilator having a tapered portion.

  However, the blood vessel has several branches, and these branches have various shapes. Therefore, depending on the shape of the branching portion and the branching angle, it may be difficult to allow the guide wire to enter the branching blood vessel on the side where the treatment site exists. In such a case, the catheter could not smoothly reach the treatment site along the guide wire, which caused a problem that an extremely high level of skill was required for the operator.

Japanese Patent Publication No. 3-1026

  The present invention has been made in the background of the above-mentioned circumstances, and the problem to be solved is that a guide wire can be easily placed in a branch blood vessel to be entered from the branch portion regardless of the shape or angle of the branch portion of the blood vessel. It is an object of the present invention to provide a dilator that can be made to enter.

The first aspect of the present invention is provided with a tapered portion that gradually decreases in diameter toward the distal tip, and has a length of 50 to 600 mm. So that the tip is inserted into the blood vessel bifurcation located proximal to the treatment site without passing through the treatment site of the blood vessel, and the insertion port is expanded by the taper portion. In addition, the dilator is removed from the puncture entrance prior to the insertion of the treatment catheter, and the first lumen through which the first guide wire is inserted to be able to advance and retract and the second guide wire are inserted to be able to advance and retract. The first lumen is opened in the axial direction from the tip surface at the distal tip portion, and the second lumen is inclined and opened laterally from the outer peripheral surface. With them The first and second lumens are both of double lumen being a continuous lumen structure to the proximal end face of the proximal dilator is characterized.

  The dilator of this aspect can be pushed into the blood vessel while expanding the diameter of the blood vessel with the tapered portion on the distal side along the first guide wire previously inserted into the blood vessel. When the first guide wire enters the branch blood vessel on the side different from the side where the treatment site is present at the branch portion of the blood vessel, the distal end portion of the distal side is inclined and opened. The second guide wire can be inserted through the second lumen and can be easily entered into the branch vessel where the treatment site exists.

  In addition, the dilator of this aspect can also be used in combination with a sheath, for example. As a specific example, the introducer may be configured by combining the dilator of this aspect so that it can be inserted into the sheath inserted into the blood vessel from the puncture opening provided in the blood vessel wall. If such an introducer realized based on the present invention is used, a sheath extrapolated to the dilator can be percutaneously inserted into the blood vessel together with the dilator. Then, by removing the dilator while leaving the sheath, it becomes possible to introduce a treatment catheter or the like into the blood vessel through the sheath left in the state of being inserted into the blood vessel, thereby making treatment work more efficient. Can be done.

  According to a second aspect of the present invention, there is provided the dilator according to the first aspect, wherein the outer peripheral surface of the tapered portion has a side opening portion that opens obliquely forward, Two lumens are open to the outer peripheral surface through the side openings.

  In the dilator of this aspect, when the second lumen is opened on the outer peripheral surface of the tapered portion inclined with respect to the central axis of the dilator, the inclination angle of the opening portion of the second lumen with respect to the central axis of the dilator is small However, it is possible to satisfactorily form the opening of the second lumen. Even when used as an introducer in combination with the above-described sheath, it is possible to employ a sheath having a length that covers the outer peripheral surface over substantially the entire length excluding the tapered portion of the dilator.

  When the dilator according to the present invention is used, the second guide wire is inserted into the target branching blood vessel at the branching portion of the blood vessel, in addition to the treatment for facilitating the insertion of the catheter or the like by expanding the puncture opening into the blood vessel Can be easily entered. Therefore, even when there is a treatment site in the branch blood vessel where the first guide wire extending in the axial direction of the dilator is difficult to enter, the catheter can be used without requiring troublesome operations such as inserting and removing the dilator and the catheter. It is possible to quickly and easily insert the second guide wire that guides to the treatment site in the branch blood vessel into the branch blood vessel.

  Moreover, the dilator according to the present invention can also be configured with an introducer in combination with a sheath. In such an introducer, in addition to effectively exhibiting the above-described effects of the dilator, the dilator can be removed and the catheter and the like can be inserted and removed more smoothly by using the lumen of the sheath. It becomes possible.

1 is a front view of an embodiment of a dilator having a structure according to the present invention. FIG. Sectional drawing which expands and shows the longitudinal cross section of the distal end side of the dilator shown by FIG. FIG. 3 is a longitudinal cross-sectional explanatory diagram for explaining a usage state of the dilator shown in FIG. 1. The front view which shows an example of the introducer comprised using the dilator according to this invention.

  Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

  First, FIG. 1 shows a front view of a double lumen dilator 10 as an embodiment of the present invention. In FIG. 1, the distal side having the tip portion inserted into the blood vessel is shown on the left side in the drawing, and the proximal side having the operation portion is shown on the right side in the drawing.

  More specifically, as shown in FIGS. 1 and 2, the dilator 10 of the present embodiment includes a tubular body 12 that is inserted into a blood vessel from a distal end portion. The tubular main body 12 has an elongated and substantially cylindrical shape that can be inserted into a blood vessel as a whole, and is made of a resin tube that can be elastically bent and deformed. The resin material forming the tubular body 12 is not particularly limited, but considering that it is harmless to the human body and has corrosion resistance, appropriate elasticity and strength, and easy processing. For example, urethane resin, polyolefin, fluorine resin, polyamide or the like is employed.

  In addition, the length and thickness of the tubular body 12 are set so that the distal portion of the annular body 12 is inserted into the blood vessel up to the blood vessel bifurcation near the treatment site in consideration of conditions such as the treatment site in the blood vessel. Is set as appropriate. For example, in the case of treatment of peripheral blood vessels, the length is generally about 50 to 600 mm and the outer diameter is about 0.3 to 5 mm.

  Further, a dilator hub 14 is provided at the proximal end of the tubular body 12. The dilator hub 14 is larger in diameter and harder than the tubular body 12 so that it can be easily picked and operated by a fingertip. And the tubular main body 12 has extended from the edge part of the axial direction one side (left side in FIG. 1) of the dilator hub 14. As shown in FIG. On the other hand, a narrow first tube 16 and a second tube 18 made of a soft material such as polyvinyl chloride resin extend from the other axial end of the dilator hub 14 (to the right in FIG. 1). I'm out. Note that a fitting portion 24 to be fitted to a sheath hub 22 of the sheath 20 to be described later may be formed at one end portion in the axial direction of the dilator hub 14 (see FIG. 4).

  The tubular body 12 extending from one end of the dilator hub 14 in the axial direction is formed with a first lumen 26 and a second lumen 28 extending in the axial direction. The first tube 16 is connected to the proximal end side opening of the first lumen 26 and the second tube is connected to the proximal end side opening of the second lumen 28. 18 is connected.

As a result, the first guide wire 30 is inserted into the first lumen 26 from the first tube 16, and the second guide 18 is inserted into the second lumen 28 from the second tube 18. The guide wire 32 is inserted. Guide wire insertion hubs 34 and 36 are attached to the proximal end sides of the first and second tubes 16 and 18, respectively. The first and second guide wires 30 and 32 are operated by a surgeon by grasping the proximal end side extending outward from the guide wire insertion hubs 34 and 36 with fingers. The tubular body 12 is inserted into the first and second lumens 26 and 28 so as to be able to advance and retreat.

  Further, the distal end portion of the tubular body 12 is a tapered portion 38 having a tapered outer peripheral surface that gradually decreases in diameter toward the distal end.

  In the distal end portion of the tubular body 12, the distal sides of the first and second lumens 26 and 28 are open. In particular, the first lumen 26 extends in the length direction (axial direction) over the entire length of the tubular body 12, and opens through the distal end opening 40 provided on the distal end surface of the tapered portion 38 of the tubular body 12. ing. In other words, the tip opening 40 of the first lumen 26 opens on a straight line extending along the axial direction of the tubular body 12. As a result, the distal end portion of the first guide wire 30 inserted through the first lumen 26 is axially outward from the distal end surface of the tapered portion 38 through the distal end opening 40 on the distal side of the tubular body 12. It is designed to protrude straight toward you.

  On the other hand, the second lumen 28 extends in the axial direction over the entire length of the tubular body 12, but a bent portion 42 is provided near the distal end portion, and the bent portion 42 reaches the opening. A portion having a predetermined length is inclined with respect to the axial direction of the tubular body 12 and extends obliquely to the side. The second lumen 28 opens through a side opening 44 that opens obliquely forward on the outer peripheral surface of the tapered portion 38 of the tubular body 12. As a result, the distal end portion of the second guide wire 32 inserted through the second lumen 28 passes through the side opening 44 on the distal side of the tubular main body 12 and is obliquely out of the outer circumferential surface of the tapered portion 38. It is designed to be inclined and project toward the direction. The side opening 44 does not necessarily have to be provided on the outer peripheral surface of the taper portion 38, and is opened obliquely forward on the outer peripheral surface of the straight portion (a portion extending with a substantially constant outer diameter) of the tubular body 12. May be provided.

  In particular, in the second lumen 28, the guide surface in which the inner peripheral surface of the portion from the bent portion 42 to the side opening 44 extends obliquely at a predetermined angle (β) with the central axis P of the tubular body 12. 45. Thereby, the distal end portion of the second guide wire 32 inserted into the second lumen 28 is inclined from the side opening 44 with an inclination angle substantially equal to the inclination angle (β) set on the guide surface 45. It is designed to protrude outward. The shape of the second lumen 28 from the bent portion 42 to the side opening 44 may be any shape as long as it can guide the protruding direction of the second guide wire 28 obliquely forward. In addition to the curved shape in which the angle changes continuously, various modes such as a linearly inclined shape having a constant inclination angle and a bent inclination shape in which the inclination angle changes stepwise can be adopted.

  In addition, although the magnitude | size of inclination-angle: (beta) which the guide surface 45 and the central axis: P of the tubular main body 12 make is not specifically limited, It is set as the value within the range of 5-45 degrees suitably. . If the angle of inclination: β is smaller than 5 °, it is difficult to project the second guide wire 28 toward the branch blood vessel with a sufficient angle of inclination, while the angle of inclination: β is larger than 45 °. Then, there is a possibility that the insertion resistance of the second guide wire 28 in the bent portion 42 becomes too large.

  Next, a method of using the dilator 10 when performing catheter treatment on a site to be treated generated in a branch blood vessel of a peripheral blood vessel will be described. The following method is merely an example. The method of using the dilator 10 according to the present embodiment, specifically, the dilator 10 is used to dilate the blood vessel, and the second guide wire 32 is placed in a desired branch blood vessel. The method of inserting is not limited to the method described below.

  First, the distal end of the dilator 10 is inserted into a blood vessel such as a peripheral blood vessel, which is performed by a conventionally known method. For example, first, an indwelling needle composed of an inner needle portion and an outer tube portion is punctured percutaneously into a blood vessel to form a puncture opening. Next, after removing the inner needle portion of the indwelling needle from the outer tube portion, the first guide wire 30 is inserted into the blood vessel through the placed outer tube portion. Thereafter, the outer tube portion is removed while leaving the first guide wire 30. Thereafter, the tubular body 12 and the first tube 16 of the dilator 10 are extrapolated to the first guide wire 30, and the distal end of the tubular body 12 is pierced into the blood vessel through the puncture opening formed in the blood vessel wall. Insert like you can. At this time, the puncture opening formed in the subcutaneous tissue or the blood vessel wall by the puncture of the indwelling needle is expanded so as to be expanded by the tapered portion 38 of the dilator 10.

  Next, as shown in FIG. 3, the tubular body 12 of the dilator 10 is pushed into the blood vessel 46 along the first guide wire 30 and further pushed forward.

  At this time, the first guide wire 30 inserted in advance in the blood vessel 46 is inserted into the second branch blood vessel 54 that is different from the first branch blood vessel 52 where the treatment site 50 exists in the branch portion 48 of the blood vessel 46. If so, the tubular body 12 follows the first guide wire 30 and is pushed into the second branch vessel 54. That is, it is inserted into the second branch blood vessel 54 which is originally different from the first branch blood vessel 52 to be inserted.

  In that case, as shown in FIG. 3, the tubular body 12 is stopped in the blood vessel 46 at a position where the tapered portion 38 and the side opening 44 are disposed at the branch portion 48.

  Thereafter, the second guide wire 32 is inserted into the second lumen 28 via the second tube 18 from the guide wire insertion hub 36 attached to the proximal end of the second tube 18. Then, the distal end of the second guide wire 32 is guided by the guide surface 45 while the second guide wire 32 is advanced in the second lumen 28, and the side from the side opening 44. Protruding toward. As a result, the distal end of the second guide wire 32 is advanced into the first branch blood vessel 52.

When the opening direction of the side opening 44 of the second lumen 28 is different from the position of the first branch blood vessel 52 around the central axis of the tubular body 12, the tubular body 12 is rotated in the circumferential direction. Thus, the second guide wire 32 can be inserted into the first branch blood vessel 52.

In addition, since the shape of the branch portion 48 of the blood vessel 46 is difficult to insert the first guide wire 30 into the first branch blood vessel 52 where the treatment site 50 exists, Even if the guide wire 30 has been inserted into a second branch blood vessel 54 different from the first branch blood vessel 52, the first wire 30 is provided through the side opening 44 provided at the distal end of the tubular body 12. A second guide wire 32 other than the guide wire 30 can be easily and reliably entered into the first branch blood vessel 52.

  Therefore, when the dilator 10 of this embodiment is used, when the treatment site 50 exists in one branch blood vessel (first branch blood vessel 52) divided by the branch portion 48, the branch portion 48 Regardless of the shape, the catheter for treatment of the treatment site 50 can reach the treatment site 50 along the second guide wire 32 very smoothly and quickly. Accordingly, the procedure for the catheter treatment of the treatment site 50 is greatly simplified without being limited to the location where the treatment site 50 exists in the blood vessel 46, and such a procedure can be performed. A reduction in the time required is realized.

  More specifically, for example, when the site to be treated 50 exists in the superficial femoral artery (first branch blood vessel 52) in the terminal region of the lower limb, the guide wire 50 is connected to the deep femoral artery (second branch blood vessel 54). ) And enter the superficial femoral artery (first branch blood vessel 52). At that time, according to the dilator 10 according to the present invention, the guide wire 50 can reach the superficial femoral artery (first branch blood vessel 52) very smoothly and quickly.

  It is also possible to attach a contrast marker that can be contrasted by fluoroscopy or the like to the distal end portion of the tubular body 12. In particular, by providing a contrast marker at the position of the side opening 44 in the second lumen 28, the protruding direction of the second guide wire 32 can be predicted. Specifically, for example, by using a double lumen tube, filling the X-ray opaque material at the tip of one lumen and closing it, and then processing the tip of the double lumen tube into a tapered shape It is possible to provide a contrast marker made of a radiopaque material only at the tip of the second lumen 28 (position close to the side opening 44). The side opening 44 of the second lumen 28 is formed with a guide surface 45 by punching or cutting the tip of the second lumen closed with a radiopaque material. can do.

  Next, FIG. 4 shows an embodiment of an introducer having a structure according to the present invention. As apparent from FIG. 4, the introducer 56 of the present embodiment includes the dilator 10 and the sheath 20 through which the dilator 10 is inserted. The dilator 10 included in the introducer 56 has the same structure as that of the dilator 10 according to the above-described embodiment having the structure according to the present invention described in detail above, and therefore redundant description is omitted.

  More specifically, the sheath 20 of the introducer 56 includes a cylindrical sheath tube 57 that can be inserted into the blood vessel 46, and a sheath hub 22 that is fixed to the proximal end of the sheath tube 57. The sheath tube 57 is shorter than the tubular body 12 of the dilator 10, and the tapered portion 38 on the distal end side of the tubular body 12 inserted through the sheath tube 57 protrudes from the sheath tube 57 in the axial direction. As a result, even when the sheath tube 57 is extrapolated with respect to the tubular body 12, the tip opening 40 and the side opening 44 of the dilator 10 are opened without being covered with the sheath tube 57.

The sheath hub 22 provided at the proximal end of the sheath tube 57 is formed of a hard material so that it can be easily picked with fingers, and has a lumen through which the tubular body 12 can be inserted. A side port 58 that communicates the lumen with the outside is provided in the axially intermediate portion of the sheath hub 22 so as to protrude laterally. A tube 60 is connected to the side port 58, and a three-way cock 62 is attached to the outer end of the tube 60.

  Then, the fitting portion 24 of the dilator hub 14 is fitted to the distal end portion of the sheath hub 22 in a state where the sheath tube 57 is extrapolated to the tubular main body 12 of the dilator 10, whereby the dilator 10 and The introducer 56 is assembled with the sheath 20.

  When the introducer 56 having such a structure is used, the distal end of the sheath tube 57 is located near the branch portion 48 of the blood vessel 46 shown in FIG. A side opening can be located. Therefore, by removing the dilator 10 from the blood vessel while leaving the sheath tube 57 in the blood vessel, an operation for subsequent insertion into the blood vessel 46 such as a catheter using the remaining sheath tube 17 is performed. Can be performed more easily.

  As mentioned above, although embodiment of this invention was explained in full detail, this invention is not limited by the specific description. For example, the outer peripheral surface of the tapered portion 38 with respect to the tubular body 12 of the dilator 10 does not need to have a constant inclination angle in the axial direction, and has a curved convex shape or a curved concave outer peripheral surface whose inclination angle changes in the axial direction. A tapered portion or the like can also be employed.

  The side opening 44 may also be provided at the distal end portion of the tubular body 12 of the dilator 10, and the formation position is not necessarily the outer peripheral surface of the illustrated tapered portion 38. Absent. For example, depending on the axial length of the tapered portion 38 and the inclination angle of the side opening 44, the side opening 44 is opened to the cylindrical outer peripheral surface that does not reach the tip surface of the tapered portion 38 or the tapered portion 38. It is also possible to form.

  Furthermore, in the said embodiment, the whole tubular main body 12 of the dilator 10 was integrally formed using the same resin material. However, the distal tip portion where the tapered portion 38 is provided may be made of another material that is more flexible than the other portions. Thereby, damage of the blood vessel 46 when pushing the tubular body 12 into the blood vessel 46 can be prevented more effectively.

  Furthermore, the guide surface 45 provided in the side opening 44 does not necessarily extend linearly and may extend in a curved manner.

  In addition, the present invention can be similarly applied to dilators and introducers for blood vessels other than peripheral blood vessels such as cardiovascular in addition to peripheral blood vessel dilators and introducers. It is not something.

10: Dilator, 20: Sheath, 26: First lumen, 28: Second lumen, 30: First guide wire, 32: Second guide wire, 38: Tapered portion, 45: Guide surface, 46: Blood vessel, 56: Introducer

Claims (2)

A tapered portion that gradually decreases in diameter toward the distal tip is provided, and the length is set to 50 to 600 mm so that the tip is inserted into the blood vessel from the puncture opening provided in the blood vessel wall. The length is such that it can be inserted into the blood vessel bifurcation located proximal to the treatment site without exceeding the treatment site, and the piercing site is expanded by the taper portion, and prior to insertion of the treatment catheter. A dilator removed from the entrance
A first lumen through which the first guide wire is inserted so as to be able to advance and retract, and a second lumen through which the second guide wire is inserted so as to be able to advance and retract;
In the distal tip portion, the first lumen is opened in the axial direction from the tip surface, while the second lumen is opened obliquely from the outer peripheral surface to the side,
A double lumen dilator characterized in that both the first and second lumens have a lumen structure that continues to the proximal end face on the proximal side.   2. The double according to claim 1, wherein the outer peripheral surface of the tapered portion has a side opening that opens obliquely forward, and the second lumen opens to the outer peripheral surface through the side opening. Lumen dilator.

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