JP2016185277A - Introducer Sheath and Introducer Assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an introducer sheath and an introducer assembly that can introduce a catheter and perform treatment while a patient is in a supine position and that do not give stress to the patient even when an introduction blood vessel is a knee back blood vessel of a lower extremity.SOLUTION: An introducer sheath 11 includes a sheath body part 1 and a sheath branching part 4. The sheath body part 1 includes a sheath tube 2, a first body part 3 in which a first opening 3a is formed, and a branching part 8 connecting the sheath tube 2 and the first body part 3. The sheath branching part 4 includes a branching tube 5 that is connected to the branching part 8 and extends, and a second body part 6 in which a second opening 6a is formed. The length from the branching part 8 to the second opening 6a is formed to be longer than the length from the branching part 8 to the first opening 3a. The branching tube 5 extends inclined with respect to the axis line of the sheath body part 1 toward the first opening 3a side, and is formed to be more flexible than the branching part 8.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an introducer sheath and an introducer assembly used to introduce a catheter into a body cavity such as a blood vessel, and in particular, to introduce a catheter into the back of a knee vein of a lower limb.

  In recent years, various forms of treatment have been performed in medicine using catheters. As such a treatment method, by utilizing the longness of the catheter, a drug is directly administered to the vascular lesion from the distal end of the catheter, or a catheter with a balloon that is expanded by pressurization is attached to the distal end. To open and widen the stenosis of the patient, scrape and open the affected area using a catheter with a cutter attached to the tip, and conversely close the aneurysm, bleeding site or feeding vessel using a catheter Etc. In addition, in order to maintain the stenosis in the blood vessel in an open state, there is a method in which a tube-shaped stent having a meshed side surface is embedded in a blood vessel using a catheter and placed.

  In such a treatment method, there is a medical instrument generally referred to as an introducer assembly as an instrument conventionally used for introducing a catheter into a blood vessel or the like. As an introducer assembly, Patent Document 1 proposes an introducer assembly configured as follows. The introducer assembly of Patent Document 1 includes a dilator portion and a sheath portion. A protrusion is formed on the inner peripheral surface of the dilator portion, and the protrusion is engaged with the outer peripheral surface of the sheath portion. Thus, a thread groove is formed.

  In the introducer assembly of Patent Document 1, the dilator portion and the sheath portion are integrated with each other by the engagement between the protrusion and the thread groove portion, and when inserted into the blood vessel, the axial direction and the rotational direction. It corresponds to the movement of Therefore, in the introducer assembly of Patent Document 1, the dilator part and the sheath part are not relatively rotated or displaced in the axial direction, and furthermore, the fitting of both can be released with one hand, so that Easy insertion into the blood vessel.

  As one means for inserting a catheter into a blood vessel using the introducer assembly of Patent Document 1, there is a method for securing a blood vessel called the Seldinger method. In this method, a puncture needle such as an indwelling needle is percutaneously punctured into a blood vessel, and a guide wire is inserted into the inner tube of the puncture needle from the rear end. Next, the puncture needle is withdrawn and the sheath portion of the introducer assembly is percutaneously inserted along the guide wire. At this time, since the dilator part is engaged with the sheath part, the percutaneous insertion opening is widened by inserting the dilator part. The sheath portion is then left inside the blood vessel, the guide wire and dilator portion are withdrawn from the sheath portion, and then the catheter is introduced through the sheath portion into the blood vessel.

JP 07-289645 A

However, when the introducer assembly of Patent Document 1 is used to introduce a catheter into a blood vessel, if the introduced blood vessel is a knee back vessel of the lower limb, the patient is introduced from the time of puncture of the introducer sheath to the time of treatment with the catheter. There is a problem that the patient needs to be prone and contributes to the stress of the patient.
Therefore, the present invention was devised to solve such a problem, and the problem is that even if the introduction blood vessel is the back of the knee, the catheter can be introduced and treated while the patient is in the supine state. It is an object of the present invention to provide an introducer sheath and an introducer assembly that does not stress a patient.

  In order to solve the above problems, an introducer sheath according to the present invention includes a sheath main body portion and a sheath branch portion, and the sheath main body portion is disposed on the proximal end side of the sheath tube and the sheath tube, and is a dilator. A first main body part in which a first opening is formed, and a branch part connecting the sheath tube and the first main body part, the sheath branch part being connected to the branch part A branch tube extending in a direction different from the axis of the sheath main body, and a second main body disposed on the proximal end side of the branch tube and having a second opening into which a catheter is inserted, A length from the branching portion to the second opening is formed to be longer than a length from the branching portion to the first opening, and the branching tube is directed toward the first opening side. Body part Inclined relative to the axis extends, and characterized in that it is flexibly formed than the bifurcation. In the introducer sheath of the present invention, it is preferable that a valve body is disposed in the first opening and the second opening. In the introducer sheath of the present invention, it is preferable that the branch portion is integrally connected to the first main body portion. Furthermore, in the introducer sheath of the present invention, the length from the branch portion to the second opening is preferably 5 to 40 cm.

  According to the above configuration, the sheath main body portion having the first opening into which the dilator is inserted and the sheath branch portion having the second opening into which the catheter is inserted are arranged in different directions via the branch portion. . Further, the sheath branch portion has a long and flexible branch tube. Therefore, even when the patient is supine after puncturing a dilator into the back of the knee with the patient lying down, the operator can bend the branch tube so that the position of the second opening into which the catheter is inserted is the patient's position. Can move to the front or side. Therefore, the catheter can be introduced and treated with the patient lying on his / her back.

The introducer assembly which concerns on this invention is equipped with the said introducer sheath and the dilator inserted in the said introducer sheath, It is characterized by the above-mentioned.
According to the above configuration, by using the introducer sheath, the position of the second opening into which the catheter is inserted is placed on the front or side of the patient even when the patient is supine after puncturing a dilator into the back of the knee. I can move. Therefore, the catheter can be introduced and treated with the patient lying on his / her back.

  According to the introducer sheath and the introducer assembly according to the present invention, even if the introduction blood vessel is a knee lining blood vessel of the lower limb, the catheter can be introduced and treated in a state where the patient is supine, and the patient is stressed. There is nothing.

It is the front view which fractured | ruptured one part which shows typically the embodiment of the introducer sheath and introducer assembly which concern on this invention. It is a front view which shows typically other embodiment of a sheath main-body part. It is a figure which shows typically the use condition at the time of puncture the knee back blood vessel with the introducer assembly which concerns on this invention.

  An embodiment of an introducer sheath according to the present invention will be described with reference to the drawings. In the present invention, the distal end side refers to the blood vessel insertion side of the introducer sheath, and the proximal end side refers to the side on which the operator or the like operates the introducer sheath.

  As shown in FIG. 1, an introducer sheath (hereinafter referred to as a sheath) 11 includes a sheath main body 1 and a sheath branching portion 4.

<Sheath body>
The sheath body 1 has a sheath tube 2, a first body 3, and a branch portion 8.

(Sheath tube)
The sheath tube 2 is introduced into the blood vessel percutaneously. The sheath tube 2 is a long and tubular member having a lumen through which a dilator 23 and a catheter (not shown) can be inserted during use. The length and outer diameter of the sheath tube 2 are not particularly limited. For example, the length is 70 to 400 mm and the outer diameter is 2 to 4 mm.

  The constituent material of the sheath tube 2 is made of a resin material such as polyolefin, polyamide, polyurethane, polyester, or fluorine resin, and it is preferable to use a resin material having relatively high rigidity. The outer surface of the sheath tube 2 is preferably subjected to a hydrophilization treatment that exhibits lubricity when it comes into contact with blood, physiological saline, or the like.

(First body part)
The first main body 3 is a tubular member that is disposed on the proximal end side of the sheath tube 2 and whose lumen communicates with the lumen of the sheath tube 2. The first main body 3 constitutes a first opening 3a into which the proximal end side of the lumen opens and the dilator 23 is inserted, and the distal end side of the lumen enters the lumen of the sheath tube 2 via the branching portion 8. Communicate. Thereby, in use, the dilator 23 inserted from the first opening 3 a is inserted into the lumen of the sheath tube 2 via the branch portion 8 and protrudes from the distal end side of the sheath tube 2.

  The constituent material of the 1st main-body part 3 is not specifically limited, For example, it is preferable to consist of a resin material used with the sheath tube 2. FIG. The constituent material of the first main body 3 may be the same as or different from that of the sheath tube 2.

  The first main body 3 has a disc-shaped valve body 9a in which a slit that opens and closes as the dilator 23 is inserted and removed is fixed to the first opening 3a. The valve body 9a is a hemostasis valve, and is preferably made of an elastic material such as silicone rubber that prevents the ejection of blood when securing a blood vessel.

  The first main body 3 is fitted to the dilator hub 22 of the dilator 23 in the axial direction and the rotational direction. An engaging portion (not shown) that engages with an engaged portion (not shown) formed on the inner peripheral surface of the dilator hub 22 is provided on the outer peripheral surface on the proximal end side of the first main body portion 3. Preferably it is formed. Examples of the engaged portion or the engaging portion include a concave portion or a convex portion, a male tapered surface or a female tapered surface, a male screw groove portion or a female screw groove portion. The first main body 3 may be formed with an injection port (not shown) or the like on the outer peripheral surface thereof in order to inject physiological saline or the like into the lumen.

(Branch part)
The branch portion 8 connects the sheath tube 2 and the first main body portion 3, connects to the distal end side of the sheath branch portion 4 (branch tube 5), and communicates the sheath main body portion 1 and the sheath branch portion 4. It is a member. The branch part 8 has a straight straight pipe part 8a and a side pipe part 8b extending from the middle of the straight pipe part 8a. The distal end side of the straight tube portion 8 a is connected to the sheath tube 2, and the proximal end side of the straight tube portion 8 a is connected to the first main body portion 3. The side tube portion 8 b is connected to the branch tube 5. Moreover, the side pipe part 8b is branched in the direction inclined with respect to the axial direction of the straight pipe part 8a toward the first opening 3a side (base end side). Thereby, the sheath branch part 4 (branch tube 5) extends in a direction different from the axial direction of the sheath body part 1. Note that the lumen of the straight tube portion 8a communicates with the lumen of the sheath tube 2 and the first main body portion 3, and the lumen of the side tube portion 8b communicates with the sheath branch portion 4 (the branch tube 5). Moreover, it does not specifically limit as a connection method in the branch part 8, Fusion, adhesion | attachment, fitting, etc. can be used.

  In addition, it is preferable that the side pipe part 8b of the branch part 8 inclines toward the sheath main-body part 1 side with respect to the axial direction of the straight pipe part 8a. Thereby, the 2nd main-body part 6 can be arrange | positioned at the operator's hand side only by arrange | positioning the branch tube 5 to the side pipe part 8b. In addition, a medical device such as a catheter inserted from the second main body 6 can be guided to the distal end side of the sheath tube 2.

  The constituent material of the branch part 8 is not specifically limited, For example, it is preferable to consist of the resin material used with the 1st main-body part 3. FIG. The constituent material of the branch portion 8 may be the same as or different from the sheath tube 2 and the first main body portion 3.

  In the sheath main body 1, it is preferable that the branch portion 8 is integrally connected to the first main body portion 3 as shown in FIG. 1, but the branch portion 8 is flexible resin material or the like as shown in FIG. 2. It may be connected to the 1st main part 3 via the connection tube 10 which consists of.

  The constituent material of the connection tube 10 is not particularly limited, and is preferably made of a resin material used in the sheath tube 2. The constituent material of the connection tube 10 may be the same as or different from that of the branch portion 8 and the first main body portion 3. As a constituent material of the connection tube 10, it is preferable to select a resin material that does not hinder the insertion of the dilator 23 into the first main body 3 due to a kink (bending) or the like of the connection tube 10.

<Sheath branch>
The sheath branch portion 4 includes a branch tube 5 and a second main body portion 6.

(Branch tube)
The distal end side of the branch tube 5 is connected to the branch portion 8 (side tube portion 8b) and is different from the axis of the sheath body portion 1, that is, the sheath body portion 1 toward the first opening 3a side (base end side). This is a long and tubular member extending obliquely with respect to the axis. The branch tube 5 has a lumen through which a catheter (not shown) can be inserted during use. The outer diameter of the branch tube 5 is not specifically limited, For example, it is 3-8 mm.

  The distal end side of the branch tube 5 is connected to a branch part 8 (a side pipe part 8b of the branch pipe) via a connection connector 7. The proximal end side of the branch tube 5 is connected to the proximal end side of the second main body portion 6. The connection connector 7 is a tubular member having a lumen through which a catheter (not shown) can be inserted. As a result, the lumen of the second main body portion 6 communicates with the lumen of the sheath main body portion 1 (sheath tube 2) via the lumen of the branch tube 5. The branch tube 5 may be connected to the branch portion 8 without using the connection connector 7. Moreover, it does not specifically limit as a connection method in the branch tube 5, Fusion, adhesion | attachment, fitting, etc. can be used.

  The constituent material of the branch tube 5 is made of a resin material such as polyolefin, polyamide, polyurethane, polyester, or fluorine resin, and it is necessary to use a resin material having rigidity lower than that of the branch portion 8 of the sheath body 1. Thereby, since the branch tube 5 is formed more flexibly than the branch portion 8, the branch tube 5 as a member for inserting the catheter is moved by the operator or the like to the front or side of the patient who is supine in use. It becomes possible to do. For this reason, it is possible to insert the catheter into the branch tube 5 and the sheath tube 2 and introduce the catheter into the blood vessel while the patient is lying on the back without moving the patient. As a constituent material of the branch tube 5, it is preferable to select a resin material that does not prevent insertion of the catheter by a kink (bend) of the branch tube 5 or the like.

  When the introducer sheath 11 is placed in a blood vessel, the sheath tube 2 is fixed to the patient's skin. Therefore, the branch portion 8 is most loaded when the branch tube 5 is moved. In the present invention, the constituent material of the branch portion 8 of the sheath body 1 is higher in rigidity than the constituent material of the branch tube 5. Thereby, the branching portion 8 prevents kinking, and a medical device such as a catheter inserted from the second main body portion 6 can be satisfactorily guided to the distal end side of the sheath tube 2.

  The constituent material of the connection connector 7 is not particularly limited, and is preferably made of a resin material used in the branch portion 8. The constituent material of the connection connector 7 may be the same as or different from that of the branch portion 8 and the branch tube 5.

(Second body part)
The second main body portion 6 is disposed on the proximal end side of the branch tube 5 and is connected to the branch tube 5, and is a tubular member whose lumen communicates with the lumen of the branch tube 5. The second main body portion 6 constitutes a second opening 6a into which the proximal end side of the lumen is opened and a catheter (not shown) is inserted, and the distal end side of the lumen communicates with the lumen of the branch tube 5. ing. Thereby, in use, the catheter inserted from the second opening 6 a is inserted into the lumen of the sheath tube 2 via the branch tube 5 and the branch portion 8, and protrudes from the distal end side of the sheath tube 2. Further, as a connection method in the second main body 6, fusion, adhesion, fitting, or the like is used.

  The constituent material of the 2nd main-body part 6 is not specifically limited, For example, it is preferable that it consists of the resin material used with the branch tube 5. FIG. The constituent material of the second main body 6 may be the same as or different from that of the branch tube 5.

  The second body 6 preferably has a disc-shaped valve body 9b in which a slit that opens and closes with insertion and removal of a catheter (not shown) is fixed to the second opening 6a. The valve body 9b is a hemostasis valve, and is preferably made of an elastic material such as silicone rubber that prevents the ejection of blood when securing a blood vessel. Further, the second main body 6 may be formed with an injection port (not shown) or the like on its outer peripheral surface in order to inject physiological saline or the like into the lumen.

  The sheath branch portion 4 is formed such that the length from the branch portion 8 to the second opening 6a, preferably the length of the branch tube 5 is longer than the length from the branch portion 8 to the first opening 3a. Need to be. And it is preferable that the length from the branch part 8 to the 2nd opening 6a is 5-40 cm. Thereby, in use, the second opening 6a (branch tube 5) serving as a catheter insertion port can be moved by the operator or the like to the front or side of the patient who is supine. Thereby, it is possible to insert the catheter into the branch tube 5 and the sheath tube 2 and introduce the catheter into the blood vessel while the patient is in the supine position.

  Next, an embodiment of an introducer assembly according to the present invention will be described with reference to the drawings.

  As shown in FIG. 1, the introducer assembly 100 includes the sheath 11 and a dilator 23 inserted into the sheath 11. Since the sheath 11 is the same as described above, only the dilator 23 will be described below.

<Dilator>
The dilator 23 includes a dilator tube 21 and a dilator hub 22.

(Dilator tube)
The dilator tube 21 is a long and tubular member having a lumen through which a guide wire (not shown) can be inserted during use. Further, the distal end portion of the dilator tube 21 has a tapered shape whose outer diameter gradually decreases in the distal direction. The length of the dilator tube 21 is not particularly limited, and is such that the distal end portion of the dilator tube 21 protrudes from the distal end portion of the sheath tube 2 in an assembled state with the sheath 11 in use. The outer diameter of the dilator tube 21 is not particularly limited, and is set to an outer diameter that can be inserted into the lumen of the sheath tube 2.

  The constituent material of the dilator tube 21 is made of a resin material such as polyolefin, polyamide, polyurethane, polyester, or fluorine resin, and it is preferable to use a resin material having relatively high rigidity.

(Dilator hub)
The dilator hub 22 is disposed on the proximal end side of the dilator tube 21 and is connected to the dilator tube 21. The dilator hub 22 is a tubular member having a lumen through which a guide wire can be inserted during use. In the dilator hub 22, the proximal end side of the lumen opens to form a third opening 22 a, and the distal end side of the lumen communicates with the lumen of the dilator tube 21. Thereby, in use, the guide wire inserted from the distal end side of the dilator tube 21 protrudes from the third opening 22a. Further, as a connection method in the dilator hub 22, fusion, adhesion, fitting, or the like is used.

  The constituent material of the dilator hub 22 is not particularly limited, and is preferably made of, for example, a resin material used in the dilator tube 21. The constituent material of the second main body portion 6 may be the same as or different from that of the dilator tube 21.

  The introducer assembly 100 of the present invention includes the sheath 11 so that, in use, the second opening 6a (branch tube 5) serving as a catheter insertion port is operated on the front or side of the patient who is supine. It can be moved by a person or the like. Thereby, it is possible to insert the catheter into the sheath 11 and introduce the catheter into the blood vessel while the patient is in the supine position.

  Next, a method for using the introducer sheath (sheath) and the introducer assembly according to the present invention will be described with reference to an example of introducing a catheter into the posterior knee vein.

(1) An introducer assembly 100 in an assembled state shown in FIG. 1 is prepared. Next, with the patient lying down, a puncture needle (not shown) such as an indwelling needle is percutaneously punctured into the patient's knee vein.

(2) A guide wire (not shown) is inserted into the puncture needle placed in the blood vessel from the proximal end side. After inserting the guide wire, remove the puncture needle. As a result, the guide wire is placed in the blood vessel.

(3) With the introducer assembly 100 in the assembled state, that is, with the dilator 23 inserted into the sheath 11, the guide wire placed in the lumen of the dilator 23 is inserted and inserted into the blood vessel along the guide wire. Push forward. As a result, the percutaneous insertion opening is pushed wide at the tip of the dilator 23, and the dilator tube 21 is inserted into the blood vessel. Thereafter, the sheath tube 2 is inserted into the blood vessel while being guided by the dilator tube 21.

(4) Next, as shown in FIG. 3, the guide wire and the dilator 23 are extracted from the sheath 11. And the branch tube 5 is curved and the 2nd main-body part 6 is moved to a patient's front or side surface.

(5) Next, a catheter (not shown) is inserted from the second main body 6 into the lumen of the sheath 11 (sheath tube 2). Thereby, the catheter is introduced into the blood vessel.

DESCRIPTION OF SYMBOLS 1 Sheath main-body part 2 Sheath tube 3 1st main-body part 3a 1st opening 4 Sheath branching part 5 Branching tube 6 2nd main-body part 6a 2nd opening 8 Branching part 11 Introducer sheath (sheath)
21 Dilator tube 22 Dilator hub 22a 3rd opening 23 Dilator 100 Introducer assembly

Claims (5)

An introducer sheath comprising a sheath body and a sheath branch,
The sheath body portion includes a sheath tube, a first body portion disposed on a proximal end side of the sheath tube and having a first opening into which a dilator is inserted, the sheath tube and the first body portion. A branch part to be connected,
The sheath branch portion includes a branch tube connected to the branch portion and extending in a direction different from the axis of the sheath main body portion, a second opening that is disposed on the proximal end side of the branch tube and into which the catheter is inserted. A second main body formed,
The length from the branch portion to the second opening is formed to be longer than the length from the branch portion to the first opening,
The introductory tube is inclined and extends toward the first opening side with respect to the axis of the sheath main body, and is formed more flexibly than the bifurcated portion. Deucer sheath.   The introducer sheath according to claim 1, wherein a valve body is disposed in the first opening and the second opening.   The introducer sheath according to claim 1 or 2, wherein the branch portion is integrally connected to the first main body portion.   The length from the said branch part to the said 2nd opening is 5-40 cm, The introducer sheath as described in any one of Claims 1-3 characterized by the above-mentioned.   An introducer assembly comprising: the introducer sheath according to any one of claims 1 to 4; and a dilator inserted into the introducer sheath.

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