JPH10165510A - Medical implement introducing device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical implement introducing device whereby an inserting operation is facilitated to shorten a work time, the enlargement of an inserting port is reduced to easily stop bleeding after an operation and insertion is enabled even in a comparatively narrow part. SOLUTION: The medical implement introducing device 10 is constituted of a sheath 11 where a synthetic resin tube 12 having an inner diameter which enables inserting medical implement such as a catheter is adopted as a mainbody and an inserting port part 12a having a seal means for preventing the flow-out of body fluids is provided in the base end part and of a dilator 15 where a shape memory alloy tube 16 having an outer diameter to be inserted into the sheath 11, its tip 18 is formed to be a piercing possible shape and also length is the one to be projected from the tip of the sheath 11 is adopted as the mainbody. A slit 19 can be provided in the tip part of the shape memory alloy tube 16 so as to have flexibility.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device introduction device for facilitating the insertion of a medical device such as a guidewire or a catheter into a tubular organ such as a blood vessel. .

[0002]

2. Description of the Related Art In general, a catheter is inserted into a tubular organ such as a blood vessel by being guided by a guide wire, and the tip of the catheter reaches a target portion. It is used for performing, removing tissue of an affected part through forceps or the like, or inserting and placing a member such as a stent.

Conventionally, to insert a catheter or the like into a tubular organ such as a blood vessel, as shown in FIG. 4, a mantle tube 1 mainly composed of a synthetic resin tube and a metal tube inserted into the mantle tube 1 are used. An introduction device including an introduction needle 2, an introduction guide wire 3, a sheath 5 mainly composed of a synthetic resin tube, and a dilator 6 inserted into the sheath 5 and also composed mainly of a synthetic resin tube is used. , FIG.
The procedure was as described in (h).

That is, as shown in FIG. 1A, an introduction needle 2 is inserted into a mantle tube 1, and is inserted into a blood vessel A in a state in which the tip of the introduction needle 2 protrudes from the tip of the mantle tube 1. At this time, the tip of the mantle tube 1 covered on the outside of the introduction needle 2 is also guided by the introduction needle 2 and inserted into the blood vessel A.

[0005] Next, as shown in FIG. 1 (b), the introduction needle 2 is pulled out in the direction of the arrow P while the mantle tube 1 is pierced into the blood vessel A. As a result, only the mantle tube 1 is inserted and held in the blood vessel A.

Next, as shown in FIG. 1C, an introduction guide wire 3 is inserted into the mantle tube 1. The elongated introduction guide wire 3 penetrates the mantle tube 1 and its distal end reaches a position where it is inserted to some extent in the axial direction of the blood vessel A.

Next, as shown in FIG. 1D, only the mantle tube 1 is pulled out from the inside of the blood vessel A in the direction of arrow P while leaving the guide wire 3 for introduction.

Next, as shown in FIGS. 1 (e) and 1 (f),
The sheath tube assembly 4 in which the dilator 6 is inserted into the sheath 5 is inserted into the blood vessel A via the introduction guide wire 3 held in the blood vessel A. The dilator 6
The tip is thin, and it is easy to guide the sheath 5 into the blood vessel A.

Next, as shown in FIG. 1G, the introduction guide wire 3 and the dilator 6 are sequentially pulled out from the sheath tube assembly 4 inserted into the blood vessel A, and only the sheath 5 is inserted into the blood vessel A. Leave.

Finally, as shown in FIG. 1 (h), a catheter 7 is inserted through the sheath 5 along the arrow P, and is pushed to reach a target site in the blood vessel A. To give prescribed treatment. Before inserting the catheter 7, a guide wire (not shown) may be inserted so that the distal end of the guide wire reaches a target site, and then the catheter 7 may be inserted along the guide wire.

[0011]

However, in the above-mentioned technical technique, there is a problem that a lot of operations are required until the catheter 7 is inserted, so that a long working time is required.

In addition, since various instruments are inserted and removed many times, the puncture opening of the blood vessel is widened and bleeding is increased, and it takes time to stop the bleeding after the operation.

Further, the dilator is required to have a certain thickness in order to provide the required rigidity, so that there is a limit in reducing the diameter of the dilator and the sheath.
There has been a problem that insertion cannot be performed unless the portion is relatively thick such as a blood vessel.

The present invention has been made to solve the above-mentioned problems of the prior art, and its object is to provide a guide wire,
It simplifies the insertion operation of medical devices such as catheters, shortens the working time, reduces the size of the insertion port as much as possible, simplifies hemostasis after surgery, and enables insertion into relatively thin parts such as blood vessels. Another object of the present invention is to provide a medical device introduction device.

[0015]

In order to achieve the above object, the present invention has the following arrangement. That is, the first of the present invention is a guidewire, a medical device introduction device for inserting a medical device such as a catheter into a tubular organ of a human body, mainly comprising a synthetic resin tube having an inner diameter capable of inserting the medical device, A first tubular body provided with an insertion opening having a sealing means for preventing outflow of bodily fluid at a base end thereof, and an outer diameter capable of being inserted into the first tubular body and having a pointed tip. And a second tubular body mainly composed of a shape memory alloy tube having a length protruding from the distal end of the first tubular body.

According to a second aspect of the present invention, there is provided a medical device introduction device in which a slit is formed at a position protruding from the first tubular body in the vicinity of the tip of the second tubular body.

A third aspect of the present invention is the medical device introduction device according to claim 1 or 2, wherein a medical solution administration tube with a valve is connected to a side wall of the insertion opening of the first tubular body.

According to a fourth aspect of the present invention, the second tubular body includes the shape memory alloy tube and a grip portion having an insertion hole such as a guide wire attached to a base end of the shape memory alloy tube. It is a medical device introduction device provided.

According to a fifth aspect of the present invention, the second tubular body comprises a shape memory alloy tube and a resin tube inserted into the shape memory alloy tube, and the tip of the resin tube has the shape. This is a medical device introduction device that can be protruded and retracted from the distal end of a memory alloy tube.

According to a sixth aspect of the present invention, a driving means for moving the resin tube forward and backward with respect to the shape memory alloy tube is provided between a base end of the shape memory alloy tube and a base end of the resin tube. It is a medical device introduction device provided.

According to the first aspect of the present invention, the first tubular body corresponds to the sheath of the conventional device, and the second tubular body corresponds to the dilator of the conventional device. The second tubular body has an outer diameter that can be inserted into the first tubular body, has a sharpened tip, and has a length that can project from the tip of the first tubular body. Since it is mainly composed of a tube, the second tubular body is inserted into the first tubular body without using a mantle tube or an introducer needle as in a conventional device, and the distal end of the second tubular body is inserted. In a state in which is protruded from the first tubular body, it can be directly pierced and inserted into a tubular organ such as a blood vessel due to sufficient rigidity by metal and small piercing resistance due to a thin and sharp tip. Then, since the second tubular body is pulled out while leaving the first tubular body and a guide wire or a catheter can be inserted through the first tubular body, the operation is extremely simplified as compared with the method using the conventional device. , Work time can be reduced.

Also, the operation of piercing the introduction device into a tubular organ such as a blood vessel before inserting the catheter is only required once when piercing the second tubular body inserted into the first tubular body. In addition, the insertion opening does not widen, and the hemostatic work after the operation becomes easy.

Further, since the second tubular body is a shape memory alloy tube, sufficient rigidity can be maintained even if the thickness of the second tubular body is reduced, whereby the second tubular body, and hence the first tubular body, can be maintained. The diameter of the tubular body can be reduced, and the tubular body can be inserted into a relatively thin site such as a blood vessel.

According to the second aspect of the present invention, the distal end of the second tubular body made of a shape memory alloy tube can be given flexibility to facilitate insertion along a path such as a blood vessel.

According to the third aspect of the present invention, since the drug solution administration tube with the valve is connected to the side wall of the insertion port, and the insertion port has a sealing means for preventing outflow of body fluid. During the operation, a medical solution such as an antithrombotic agent can be prepared within a short time by using the already inserted first tubular body without the need for difficult work or working time for inserting a special catheter or the like. Can be administered.

According to the fourth aspect of the present invention, since the grip portion is provided at the base end of the second tubular body, the operation of inserting and removing the second tubular body can be easily performed. In addition, since a guide wire or the like can be inserted from an insertion hole provided in the grip portion, for example, the tip of the second tubular body inserted into the first tubular body is slightly pierced into a blood vessel or the like, and then inserted into the second tubular body. It is also possible to insert a guide wire so that the distal end of the guide wire reaches a predetermined position in a blood vessel, and pierce the second tubular body further deeply along the guide wire.

According to the fifth aspect of the present invention, after the distal end of the shape memory alloy tube of the second tubular body is pierced into the tubular organ, the resin tube is projected from the distal end of the shape memory alloy tube so that the resin tube comes into contact with the inner wall of the tubular organ. The second tubular body can be safely inserted deeply along the inner wall of the tubular organ by abutting and pushing the resin tube further while sliding along the inner wall.

According to the sixth aspect of the present invention, the resin tube can be quickly and easily moved relative to the shape memory alloy tube by the driving means provided between the base end of the shape memory alloy tube and the base end of the resin tube. Can protrude.

[0029]

1 and 2 show an embodiment of a medical device introducing apparatus 10 according to the present invention. FIG. 1 is an explanatory view showing a first tubular body 11 and a second tubular body 15 that constitute the above-described apparatus 10. FIG. 2 is a view showing a shape memory alloy tube 16 of the second tubular body 15. It is a perspective view which shows the example of the shape of a front-end | tip part.

As shown in FIG. 1, the first tubular body 11 is
An insertion opening 1 having a thin and long synthetic resin tube 12 as a main body and a sealing means (not shown) built in at a base end thereof.
2a is attached. As the sealing means, for example, a rubber stopper having a small hole for inserting the second tubular body 15 or the like is used. Further, the outer periphery of the second tubular body 15 is held by the sealing means, and the second tubular body 15 is prevented from rotating. In addition, one end of a drug solution administration tube 13 is connected to a side wall of the insertion opening portion 12a, and a valve body 14 formed of a three-way plug is attached to the other end of the drug solution administration tube 13 in this embodiment. . A cylinder (not shown) or the like is connected to the valve body 14 so that a drug solution such as an antithrombotic agent can be injected. This medicinal solution is administered from the medicinal solution administration tube 13 through the synthetic resin tube 12 into a tubular organ such as a blood vessel.

The synthetic resin tube 12 of the first tubular body 11
The inner diameter of the second tubular body 15 and the catheter 2
0 is inserted, and the size is usually preferably 1.5 to 5 mm. In addition, the length of the synthetic resin tube 12 is set to a length that can guide sufficiently when the catheter 20 or the like is inserted, and is usually preferably 15 to 30 cm.

The second tubular body 15 is composed of a shape memory alloy tube 16 and a grip 17 attached to a base end thereof. The grip 17 has an insertion hole (not shown) for inserting a guide wire or the like. Further, the shape memory alloy tube 16 has an outer diameter that can be inserted into the synthetic resin tube 12 of the first tubular body 11,
The length is preferably 1 to 5 mm, and the length thereof is such that the tip can protrude from the tip of the synthetic resin tube 12, preferably 1.5 to 3 cm. Further, the wall thickness of the shape memory alloy tube 16 is 0.05 to 0.
It is preferably 5 mm. Shape memory alloy tube 1
As the material of No. 6, for example, a known shape memory alloy such as Ti—Ni can be used, and its transformation point is preferably 35 to 38 ° C. in order to impart flexibility when inserted into the body.

Referring also to FIG. 2, the distal end 18 of the shape memory alloy tube 16 has a pointed shape so as to be able to pierce a tubular organ such as a blood vessel. That is, in the embodiment of FIGS. 2A to 2D, the tip 18 is cut obliquely. However, the shape may be sharpened by gradually reducing the diameter of the tip.

The distal end of the shape memory alloy tube 16 may have a shape simply sharpened as shown in FIG. 2A, but is shown in FIGS. 2B to 2D. As described above, the slits 19, 19a, and 19b may be provided in a portion slightly before the tip 18 over a predetermined length to impart flexibility. (B) shows a slit 19 along the axial direction.
(C) is an example in which annular (arc-shaped) slits 19a are provided at predetermined intervals, and (d) is a spiral as a whole. This is an example in which a slit 19c is provided.

The width and the interval of the slits 19, 19a, 19b may be changed toward the tip of the shape memory alloy tube so that the flexibility increases toward the tip of the shape memory alloy tube. it can. Further, the outer periphery of the shape memory alloy tube 16 may be coated with a synthetic resin film or a synthetic resin tube for imparting slipperiness or the like.

Next, a method of using the medical device introducing apparatus 10 according to the above embodiment will be described with reference to FIG. First, as shown in FIG. 1A, the second tubular body 15 is inserted into the first tubular body 11, and the distal end 18 of the shape memory alloy tube 16 of the second tubular body 15 is moved to the first tubular body 11. It protrudes from the tip of the tubular body 11.

Next, as shown in FIG. 2B, the distal end 18 of the shape memory alloy tube 16 of the second tubular body 15 protruding from the first tubular body 11 is inserted into the blood vessel A through the skin. Then, the distal end of the first tubular body 11 is inserted into the blood vessel A together with the second tubular body 15.

At this time, since the shape memory alloy tube 16 of the second tubular body 15 has appropriate rigidity and flexibility due to the properties of the shape memory alloy, it can be pierced into the blood vessel A, Further, after being inserted into the blood vessel A, the blood vessel A
Can be inserted while bending flexibly along the path.

When the slits 19, 19a, and 19b are provided as shown in FIGS. 2B to 2D, the distal end of the shape memory alloy tube 16 becomes more flexible.
It becomes easier to insert the second tubular body 15 along the path of the blood vessel A.

Next, as shown in FIG. 3C, with the first tubular body 11 inserted into the blood vessel A, the second tubular body 1 is inserted.
Pull out only 5 As a result, only the first tubular body 11 remains in the blood vessel A.

Finally, a catheter 20 is inserted into the blood vessel A through the first tubular body 11, as shown in FIG. Then, the distal end of the catheter 20 is introduced into a predetermined position in the blood vessel A, and an examination or treatment such as administration of a contrast agent can be performed. It is also possible to insert a guide wire (not shown) through the first tubular body 11 before inserting the catheter 20, and insert the catheter via the guide wire.

FIGS. 5 to 11 show another embodiment of the medical device introducing apparatus of the present invention. FIG. 5 is a sectional view showing the structure of the second tubular body, FIG. 6 is a side sectional view showing the distal end of the second tubular body protruding from the leading end of the first tubular body, and FIGS. It is explanatory drawing which shows the operation | movement which inserts a 1st tubular body into a blood vessel using an apparatus. It is to be noted that the same reference numerals are given to substantially the same portions as those in the above-described embodiment, and the description thereof will be omitted.

As shown in FIGS. 5 and 6, the second tubular body 21 used in the medical device introduction device 20 has a shape memory alloy tube 22. Shape memory alloy tube 2
A grip portion 23 having an enlarged diameter is formed at a base end of the ring 2, and a ring-shaped nut 24 is rotatably attached to the grip portion 23. Also, the tip 2 of the shape memory alloy tube 22
5 is obliquely cut and sharpened so that it can pierce the tubular organ.

The feature of this embodiment is that the second tubular body 21 is not only the shape memory alloy tube 22 but also
It has a resin tube 26 inserted therein. The resin tube 26 has a length such that the distal end thereof can protrude from the shape memory alloy tube 22, and has a male screw 27 formed at the base end thereof.
Are screwed into the nut 24.

In FIG. 5, (a) shows the resin tube 2
6 shows a state in which the nut 24 is screwed to the front end of the male screw 27, and the tip of the resin tube 26 does not protrude from the tip of the shape memory alloy tube 22. FIG.
The nut 24 is turned from the state shown in FIG.
7 shows a state in which the resin tube 26 is moved to the rear end, and the tip of the resin tube 26 is projected from the tip of the shape memory alloy tube 22.

FIG. 6 shows a tip shape when the second tubular body 21 is completely inserted into the first tubular body 11, and the tip of the second tubular body 21 is the first tubular body. It protrudes from the tip of the synthetic resin tube 12 with a length X.
In addition, a portion of the slit 1 extending over the axial length Z similar to the above is provided at a portion from the distal end of the second tubular body 21 by a length Y from the base end.
9 is formed to impart flexibility to the distal end of the second tubular body 21. In the above, the length of X is preferably 15 to 30 mm, the length of Y is preferably 3 to 10 mm, and the length of Z is preferably 2 to 7 mm. The structure of the first tubular body 11 is the same as that of the above-described embodiment, and the description thereof will be omitted.

Next, a method of using the medical device introduction device 20 will be described with reference to FIGS. As shown in FIG. 7, the second tubular body 21 is inserted into the first tubular body 11, and the shape memory alloy tube 22 of the second tubular body 21 is inserted.
The distal end 25 of the shape memory alloy tube 22 of the second tubular body 21 is pierced into the blood vessel A in a state where the distal end of the tubular body is projected from the first tubular body 11.

In this state, the nut 24 is turned to advance the resin tube 26 through the male screw 27 of the resin tube 26, and the distal end of the resin tube 26 is connected to the distal end 25 of the shape memory alloy tube 22 as shown in FIG. From a predetermined length.

Then, as shown in FIG. 9, when the medical device introducing device 20 is inserted deeper into the blood vessel A, the tip of the resin tube 26 comes into contact with the inner wall of the blood vessel A, and slides on the inner wall to pass the path of the blood vessel A. Introduced along. Therefore, it is possible to reliably prevent the distal end 25 of the shape memory alloy tube 22 from breaking through the opposing inner wall of the blood vessel A, and to enhance safety. At this time, the shape memory alloy tube 22 is bent flexibly by the slit 19 and inserted into the blood vessel A.

Further, as shown in FIG. 10, the medical instrument introduction device 20 is inserted further deeply into the blood vessel A, and the first tubular body 11 is inserted into the blood vessel A. The first tubular body 11 is
Inserted while being bent along the inner wall of the blood vessel A while being guided by the second tubular body 21.

Then, as shown in FIG. 11, when the first tubular body 11 is sufficiently inserted into the blood vessel A, the second tubular body 21 is pulled out from the first tubular body 11. Thereafter, the catheter is inserted into the blood vessel A through the first tubular body 11 as described in the above embodiment.

[0052]

As described above, according to the medical device introduction device of the present invention, compared with the method using the conventional device,
The operation of introducing a catheter or the like into a tubular organ such as a blood vessel is greatly simplified, and the operation time can be reduced. In addition, since the operation of piercing the device for introduction only needs to be performed once before the insertion of the catheter, the insertion port is not widened, and the hemostatic work after the operation is facilitated. Furthermore, since the thickness of the second tubular body can be reduced and the diameter of the second tubular body, and thus the first tubular body, can be reduced, it is possible to insert the second tubular body into a relatively thin site such as a blood vessel.

[Brief description of the drawings]

FIG. 1 is an exploded view of a medical device introduction device according to an embodiment of the present invention.

FIG. 2 is a partially enlarged perspective view showing different examples of the distal end shape of a second tubular body in the medical device introduction device of the present invention.

FIG. 3 is a process diagram showing an operation of inserting a catheter using the medical device introduction device of the above embodiment.

FIG. 4 is a process chart showing an operation of inserting a catheter using a conventional device.

FIG. 5 is a cross-sectional view showing a structure of a second tubular body in another embodiment of the medical device introduction device of the present invention.

FIG. 6 is a side sectional view showing a shape of a distal end portion of the medical device introduction device of the embodiment.

FIG. 7 is an explanatory diagram showing a state where the distal end of the second tubular body is pierced when the medical device introduction device of the embodiment is inserted into a blood vessel.

FIG. 8 is an explanatory diagram showing a state in which the distal end of the resin tube projects from the distal end of the second tubular body when inserting the medical device introduction device of the embodiment into a blood vessel.

FIG. 9 is an explanatory diagram showing a state where the second tubular body is inserted further deeply when the medical device introduction device of the embodiment is inserted into a blood vessel.

FIG. 10 is an explanatory diagram showing a state where the first tubular body is inserted into a blood vessel when the medical device introduction device of the embodiment is inserted into the blood vessel.

FIG. 11 is an explanatory view showing a state in which the first tubular body is inserted deeper into the blood vessel and then the second tubular body is extracted when the medical device introduction device of the embodiment is inserted into the blood vessel. .

[Explanation of symbols]

 10, 20 Medical device introduction device 11 First tubular body 12 Synthetic resin tube 12a Insertion port 13 Chemical solution administration tube 14 Valve body 15 Second tubular body 16 Shape memory alloy tube 17 Gripping portion 18 Tip 19, 19a, 19b Slit Reference Signs List 21 second tubular body 22 shape memory alloy tube 23 gripping part 24 nut 25 tip 26 resin tube 27 male screw

Claims (6)

[Claims] 1. A medical device introduction device for inserting a medical device such as a guide wire or a catheter into a tubular organ of a human body, the device mainly comprising a synthetic resin tube having an inside diameter into which the medical device can be inserted, and a base end thereof. A first tubular body provided with an insertion opening having a sealing means for preventing bodily fluid outflow, and having an outer diameter capable of being inserted into the first tubular body, having a pointed tip, and A medical instrument introduction device, comprising: a second tubular body mainly composed of a shape memory alloy tube having a length protruding from a distal end of the first tubular body. 2. The medical device introduction device according to claim 1, wherein a slit is formed at a position protruding from the first tubular body in the vicinity of a distal end portion of the second tubular body. 3. A side wall of an insertion opening of the first tubular body,
3. The medical device introduction device according to claim 1, wherein a medical solution administration tube with a valve body is connected. 4. The second tubular body includes the shape memory alloy tube and a grip portion having a through hole such as a guide wire attached to a base end of the shape memory alloy tube. The medical device introduction device according to any one of claims 1 to 3. 5. The second tubular body includes a shape memory alloy tube and a resin tube inserted into the shape memory alloy tube, and a tip of the resin tube has a tip of the shape memory alloy tube. The medical device introduction device according to claim 1, wherein the medical device introduction device is capable of appearing and retracting from the medical device. 6. A base end of the shape memory alloy tube,
6. The medical device introduction device according to claim 5, wherein a driving unit for moving the resin tube forward and backward with respect to the shape memory alloy tube is provided between the resin tube and the base end of the resin tube.