JPS5925762A - Self-guide type cathetel - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a self-guided catheter that functions as both a guide wire and a catheter for use in inspecting or treating the condition of an affected area within a blood vessel. More specifically, the present invention relates to a self-guided catheter that has excellent operability, reduces patient pain, and is capable of ultra-selective treatment of affected areas within blood vessels.

Conventionally, catheters used to examine the condition of diseased areas within the blood vessels of the human body and to transport medicinal solutions to the affected areas have been introduced by first sending a guide wire into the blood vessel, then swamping the outer wall of the catheter and introducing it into the affected area. It was like that. Guidewires used for this purpose are e.g.
These coiled metal wires are manufactured and sold by companies such as 00K, UMI, and USCI, and consist of stainless steel wire and stainless steel wire coils. On the other hand, catheters - e.g.
These are synthetic resin tubes manufactured and sold by companies such as Ml, ECC, and USCI, and are used in combination with the metal guidewires mentioned above.

``In order to actually insert the metal guide wire and catheter (III), first insert the guide wire and catheter.
Insert 12 into the blood vessel, and when it reaches the target affected area, insert the guide 12 over the core. - [Apply force 1 in such a way as to cover the area; Q. After reaching the affected area, guide 1' pull out the violet 1~, then C the end of the catheter. The treatment liquid should be introduced into the affected area from the injection point. In this series of operations, the metal hood wire is a coiled wire! Due to the unevenness of the irradiation, the face frame adheres to the wire, and the wire is made of metal 4. Therefore, it is extremely difficult to insert the C guidewire into the blood vessel and into the 1st part of the blood vessel. ] Requires manual handling and advanced techniques, takes a long time to operate the guide, and since it is made of metal wire, it is difficult to insert into the blood vessel when advancing the guide. (There were problems such as the -* being lj41hh or getting into the blood vessel.
There are situations in which it is extremely difficult to advance the treatment to the affected area for the purpose of intravenous treatment.Moreover, it can cause pain and negative effects on the patient during treatment. On the other hand, when introducing the catheter, the burden placed on the patient is greater because the catheter itself is thicker than the guide wire. This tendency is more pronounced in peripheral blood vessels. As a whole - [even looking at it].

Operation using this method not only requires many steps such as introducing a guide wire, introducing a catheter, withdrawing the guide wire, and injecting a drug solution, but also involves combining multiple guide wires and catheters with various shapes. There are disadvantages in that the operation requires a long time because of the large number of calls, and it is extremely difficult to superselectively reach the target affected blood vessel with the catheter.

Therefore, with the combination of a conventional metal guide wire V and a catheter, there is a high risk of damaging the peripheral IIL'tl intima including the coronary artery, and it is difficult to insert the metal guide wire into the narrow V or its periphery. Therefore, for example, in cases where coronary artery stenosis Σγ occurs due to myocardial infarction, etc. [+-, 1, if a complete bypass is performed on the aorta and coronary artery during open-heart surgery, The only option is to use advanced surgical methods to treat the condition, but these three treatments place a heavy burden on the patient and result in a great deal of cost and time.

Therefore, the inventors conducted intensive studies to improve all the shortcomings of the catheter technology using guide wires (see above), and found that a synthetic resin monofilament with a hollow structure was used as a base material, and a specific structure was added to it. By combining the roles of a guide wire and a catheter, it is possible to super-selectively insert the peripheral blood vessel into the affected area of the peripheral blood vessel, which was previously impossible to reach, with easy operation. The inventors discovered that an excellent self-guide catheter can be obtained using a simple method, and arrived at this invention.

However, in this invention, the distal end of a hollow monofilament made of synthetic resin is configured in order from the end into a spherical part, a flexible part, and a tapered part, and the part after the tapered part is configured as an operating part, and the spherical part Ill lj k:、Ma/
Koi・■ floating part posterior end injection KL (IE population respectively) L
- At the same time, in the hollow part of the bulb, there is a cutout in the length direction of the monofilament to create a cavity that communicates with the flexible part. A small piece of X-ray opaque metal that has been formed cleanly is cut into a hole, and at least in the remaining part of the hollow part of the operation part, a space necessary for communicating the chemical solution inlet with the space in the taper part is secured. 1. The gist of the catheter is a self-guided catheter characterized in that a cavity communicating with the monofilament over its entire length is used as a drug liquid transport path.

Next, the structure of the self-guide catheter according to the present invention will be explained by giving examples. FIG. 1G) is a longitudinal cross-sectional view showing the basic structure of the self-guided catheter according to the embodiment, and FIG. 1(b) is a cross-sectional view taken along line A--A in FIG. 1(a). The catheter is made of a synthetic Itlli monofilament LK material with a hollow part 2 communicating over its entire length, with a distal end ranging from 1M to 1M.
V (is configured in the ball part 3, flexible 7 pull part 4 and taper part 5, and the entire operation part 6 from the Qi/Z part 5 onwards.The tip of the ball part 3 has a chemical liquid outlet. The lower part opens L1, and the part between the rear ends of the v1 working part 6 is the chemical liquid inlet 8.

In this embodiment, the spherical portion 3 has a cylindrical shape with a spherical tip, but it may also be spherical or elongated. It is said that the chemical solution lead-out Ll 7 It is provided on the side surface of the bulb part 3. In order to reduce the accumulation of liquid, it is preferable that the chemical liquid guide 11-17 is opened in a tapered shape extending outward. In the hollow part of the bulb part 3, 1-
As shown in FIG. 2, a small cylindrical piece 9 made of an X-ray opaque metal is built-in σf'.

Formed within the small piece 9, along the length of the monofilament l? The 15 holes, that is, the long holes 1o with a circular cross section, fill the voids 1.1 in the f1/-X-shuffle part 4 with 71i'G liquid>
It is connected to the lower part of the q output. The bulb 3 is shown in FIG. t') small piece 12 may be internally molded. This small piece 12 has three walls extending in the radial direction from the center, and between the walls, a defect extending in the length direction of the monofilament 1, that is, the length rM 13 of the cross-sectional bead angle j, is formed. There is Sanoshioto. The long groove 13 communicates with the void 11 in the saily flexible 76B4. If the upper small piece 12 is built-in, a chemical solution outlet 7 can be provided on the side surface of the small ball part 3 as shown in FIG. The shape of the small piece to be built into the bulb part 3, as long as it allows the chemical solution outlet 1] to be communicated with the cavity in the flexible gel part,
The structure does not have to be as described above. For example, it may be porous with a large number of communicating holes, or it may be a book made of bundled ultra-thin wires. However, the hollow structure parallel to the sphere 3 and /-! The ball part 3 as illustrated in Figure 3.4
A small piece 1 which has an outer hard grooved structure parallel to the .
This is more preferable in terms of ensuring smooth delivery of the drug solution. The small piece of X-ray opaque metal must have sufficient X-ray opacity to monitor and confirm from outside the body that the bulb has superselectively reached the affected area of the peripheral blood vessel. Gold is a must-have, especially since it is radiopaque.

Preferably used are tungsten, platinum, platinum hexagon 1, and stainless steel.

Flexinople part 4Vi has a hollow (++ narrow and flexible part C') and has sufficient strength.

Depah, ・5 to II, 1 - its IG diameter is (・ψ floating part 6
□, I was alone and when I reached the floating part 6, it had the same diameter as the operating part 6. <tmaso hollow part σ)−・
It is ε-, which has a built-in X-ray metal f'til permetallic p'41 strip in the part.

”・”φ made ii Rh il,, inside, the structure of ゛Konanonoiramenoto l is also G) as a no GA structure - C holding 1
), -soL/)yl, has a large hollow part 2K over its entire length and a built-in X-ray opaque metal filament 14, but the diameter of this metal filament 14 is the hollow diameter (inner diameter) of the hollow part 2. It is preferable to have a diameter smaller than that, especially a diameter of 20 to 80 mm in the hollow part. Since the metal wire 14 thus has a cross section with diameter f smaller than the hollow diameter of the operating portion 6,
A 91 ft space 16 is ensured in the operation part 6 to communicate with the space 15 in the tapered part 5 of the drug injection hole 8 and to discharge it.

KOBI)↓゛)RO: The striations with a structure that secures a void space include a medium-beam-like striation, a porous striation with a communicating hole, or an east-shaped body of a polar #llll wire, etc. It is fine if it is adopted.

The X-ray opaque metal filament used here is
These metal strips, such as stainless steel and tungsten, have excellent contrast properties when irradiated with X-rays, and in consideration of their reactivity with the chemical solutions used,
Usually, it is preferable to use it by coating it with a resin such as polyethylene, polyethylene terephthalate, and fluorine 1]ffJII.

In addition, the tip direction V of the X-ray opaque metal filament is
As shown in the figure, it is preferable that the catheter be tapered into a sharp point, which further improves the operability of the catheter and the ability to supply the drug solution.

The metal wire 14 is preferably fixed in the following manner, for example. That is, the rear end of the metal wire 14 is bent outward at the 1'' portion between the rear ends of the operating section 6, and then covered with a tube 17 or the like as shown in FIG. 1 and fixed. If the metal wire 14 is not fixed redundantly, the metal wire 14 will shift toward the distal end during injection of the chemical solution, which is undesirable because the introduction of the chemical solution will be cut off. In addition, chemical injection, l
A pass cap is placed on H, and a cover 18 is provided in addition to the cap shown in FIG.

- As shown in the figure - C+i in the C2 catheter, drug l night injection [18 to drug n1 delivery lower - empty space 16 in the operating section 6. Vacant space 15 in the taber section 5. flexible! IL
Vacant space 11 in A and void space in bulb 3 (missing space 1° + #
&:1. '13) or over the entire length of the monofilament (il 扛j(＞-f)), this communicating space becomes the drug delivery and transport route for this self-guided catheter. , usually subjected to a sterilizing treatment.

Regarding the dimensions of each part of the cabootel, please refer to the age of the patient being treated,
1 to the left and right from the affected area person + e1, etc.,
Examples of the dimensions of each part of the normal replacement and shadow are as follows.

Note that the diameter of the tapered portion gradually becomes thicker from the flexible portion to the operating portion, so even V is not shown as a specific value. In addition, the lengths of the flexible part and the tapered part may not always be clearly distinguishable;
The total length of the flexible part and tapered part is 200 mm.
It is appropriate to keep it within the range. The larger the inner diameter of the hollow portion of the monofilament, the better.

The synthetic resin material constituting the self-guided catheter of the present invention must be a material that can be molded by one-bath melt extrusion, and preferably includes, but not limited to, polyamide, polyester, polyolefin, and fluorine tIJ resin.

To manufacture the self-guided force Tedel of this invention,
First, a hollow monofilament is spun by a one-way melt spinning method using a hollow spinneret, and if desired, it is appropriately stretched and cut into a suitable length. Next, the tip part of the hollow monofilament cut 17 above is subjected to local high-magnification stretching, leaving the part where the spherical part 3 will be formed, to create the flexible part 4 and the tapered part 5 at once (after 7) The hollow part of the part forming part 1/notogen pure impermeability] (The small piece of metal 9.12 is fully inserted 17, and the chemical solution lead-out lower part is semi-melted and sealed to form a sphere i1'+ 3 RF shadow form.Then,
An X-ray opaque metal is bent from the rear end of the operating part 6 to the hollow part 2 in the direction of the tapered part 5 and fixed at a point C near 4; I≦e injection 1.18. , Incidentally, when doing this, the end of the non-transparent metal filament in the direction of the tip is processed into a bobber shape.1. It is preferable to leave it in place for a long time, as this provides further flexibility and elasticity, further improving operability. In addition, if the bulb is completely melt-sealed 17, V''1, from the outside of the bulb 3 to the hollow part, +
1@4+1 It is possible to drill a small hole with a drill etc. to form the chemical solution lead-out lower. Next, if necessary, connect the connection end J' of a ghee Y-tubuma connector etc. to the chemical injection 118.
l 8i・Can be formed or inspected. Koha, Niichi Riichiko (
Hakoming's self-guided power Dadel is completed.

7) It is more preferable to apply an antithrombotic coating such as a silicone coated Teflon coating to the outer surface of the catheter, which improves antithrombotic properties and operability represented by slippage due to stiffness. j
The menu will be improved.

When using the self-guided catheter of the present invention having the above-mentioned configuration, it is inserted into a blood vessel, and while monitoring contrast enhancement by X-ray projection, its tip is super-selectively targeted to the affected area of the peripheral blood vessel. - Then introduce the medicinal solution to the affected area.

This self-guided catheter exhibits the following effects when used. In other words, the most advanced bulb part 3 can move freely within the blood vessel, relying on the blood vessel, and does not damage the intima or penetrate into the intima F, which is different from the conventional metal guide wire e. Compared to a pushing operation, it can be introduced into a blood vessel by free movement along the blood vessel, and can be delivered to the target affected area with a natural and natural operation without damaging the vascular intima. In addition, since the bulb part 3d has built-in small pieces of metal 9 and 12 that are opaque to X-ray radiation, it is possible to project the rays and position them when working while viewing the X-ray beam. You can easily check the medicine/l only to the intended affected area! 5f: It is possible to do ft people. Since the flexible part 4 is designed to be thin and flexible, the free movement of the bulb part 3 within the blood vessel is effective. Since the tapered part 5Q1 is processed into a tapered shape, it can prevent abnormal 1" IW retention of blood, and also prevent subtle movements such as advancement and regression during the process of introducing the blood vessel aimed at the bulbous part 3. The operation can be easily performed.The tip portion consisting of the ball portion 3.) 1/gimple portion 4 and the tapered portion 5 at the side end has flexibility 9 elasticity to the extent that it does not pierce even tofu, for example. C11r1 [can significantly reduce the destruction of the intima and the pain to the patient.
°VJ Constructed from resin monofilament, it has a smooth surface and high elasticity, making it easy to operate.
do. In addition, it has a built-in X-ray opaque gold line 14 over its entire length, and is projected through the monitor)1. Makes the image extremely clear.

<L7-U, the self-guided catheter of this invention,
1. If + t 'iN (D Pi sufficiently follows rough driving and delicate operations, and introduces it with natural movements.)
It can be easily inserted into meandering parts of blood vessels and super-selective peripheral blood vessels. After the tip of the catheter reaches the target affected area, the drug solution is injected and pumped from the drug injection [] 8, and the drug solution is led out [the core may also be directed to the affected area] through the drug transport path consisting of a communicating cavity. and is effectively supplied to achieve excellent therapeutic effects. According to this catheter, the medicinal solution is selectively introduced only to the affected area, so treatment can be achieved with just a few stitches of the medicinal solution, and there is no risk of side effects. For example, anticancer drugs often have side effects on normal areas, and it is not only impossible to administer a large amount at once, but also to be administered from a site far from the affected area, so conventional catheters However, if it is diluted, its efficacy will not reach its full potential and the therapeutic effect will inevitably be low.

On the other hand, according to the catheter of the present invention, since the medicinal solution can be administered directly to the affected area, it is possible to minimize the test force t' to the necessary minimum and obtain a large therapeutic effect, with no fear of side effects.

In addition, this invention can be applied to superselective imaging of the coronary arteries of the heart (self-guided type)
．． It can be expected to be applied as so-called coronaries and catheters.

Invention (1) Since the self-guided catheter functions as both a guide wire and a catheter, it is possible to achieve labor-saving treatment equipment, and Treatment time can be significantly shortened. Also, since there is a self-mori 1 < + RPV, the operability is extremely improved and C is improved 2, and I couldn't reach C at this point.
t4-selective intravascular insertion into the affected area becomes H'iJ' function.

However, since it is composed of a monofilamate made of volatile oil, it has a smooth texture and antithrombotic properties, and is suitable for blood vessels. (
If you add -1 and rub -, you get 'l' fit: C. According to the invention, the catheter is a conventional intravenous catheter (11'i Okikawa catheter).
'(Comparing the two, C is also thin enough kj e, and its built-in metal WJII gives a suitable f: r waist, so blood r + Ii, l K, ' JHyt row L -U
1fll'? ′? When indwelling the tube, its position is good 1: (JI, JI, there is no chance of it falling out of the target blood vessel. -9 However, for continuous intra-arterial drug injection +... It also has properties that allow it to be used as a Yl''i cube.

The present invention will be explained in more detail with reference to specific examples below.

〔Example〕

Polyethylene terephthalate (Type 9) manufactured by Toshiku Co., Ltd.
00) was used as a material, and a diameter of 1. Otnm, and the hollow pore diameter is 0.
An undrawn hollow monofilament with a 7 mm hollow portion was spun and cut into 1.3 m lengths. At one end of this monofilament, a sphere-forming part of approximately 3 mm was left and stretched approximately 3 times using a local stretching device to form a flexible part with a diameter of 0.4 mm, a length of 20 mm, and a tapered part with a length of 110 mm. were created in one go. Next, the outer diameter t) from the tip end is 65 mm + hollow diameter 0.
A gold hollow dip having a diameter of 4 mm and a length of 2 mm was inserted and heated and semi-melt sealed to create a distal bulb having a chemical solution outlet 11. On the other hand, from the rear end of the operating part to the hollow part, the tip diameter Q, 15
mm, rear end diameter 0.255mm, length 1.3m
Insert the stainless steel H with a tapered tip and the '404 metal wire, and insert the end of the metal wire that protrudes from the rear end by l.
One ThTh external wall was bent by approximately 2 nm.

Next, at the rear end of the C1 operation part, an outer diameter of 1.2 nHl (and an inner diameter of 1.2 nHl) was attached.
Omm + length 1. Omm polyvinyl chloride 111J
Connect the Naup and Acrylic Bet V H type Lua lock connectors, attach them all at once via I agent (Sankyo Co., Ltd.?'J acrylic hard lock E510K), and fix the ends of the filaments to the gold.

By the above operations, a self-guided L' type catheter having the components shown in FIG. 1 was completed.

(Clinical Example 1) Implementation The prepared self-guided catheter was percutaneously inserted into the major artery, and the tip of the catheter was advanced into the coronary artery via the aorta for a clinical trial.

While confirming the position of the bulb on the X-ray monitor/TV monitor F, advance the bulb C to the distal end of the coronary artery, and administer the drug solution r- at the posterior end to person 1.
The drug solution meter connected to 1;a J'# was used to selectively supply the drug solution to the affected area by pressing with a tight pump and using a filter.

This self-guiding catheter has a blunt bulb and an extremely
It consists of a flexible part and has the function of a super-selective guide wire, so it is easy to insert it into the target affected area. Furthermore, it was extremely safe to insert into the coronary artery, which is an important blood vessel that nourishes the heart itself, and did not cause arrhythmia or damage the inner wall of the blood vessel.

Therefore, it is clear that this self-guided catheter can be applied to selective intravenous administration of coronary iMb, especially continuous administration, of drugs for peripheral coronary arteries or occlusive diseases.

Furthermore, this self-guided catheter Q, x Ht2
Since the monitor and television display a clear image by projection, a series of operations can be carried out reliably and safely.

In addition, it was easy to remove the catheter after treatment.

(Clinical Example 2) The self-guided catheter prepared in Example was superselectively inserted into the hepatic artery of a patient with hepatocellular carcinoma, and 11 injections were performed.

In other words, after inserting a self-guided catheter to the periphery of the hepatic artery, which has been identified in advance using superselective angiography, a continuous infusion pump (Kronoff User -), a mitomycin solution, an anticancer drug, was injected at a rate of 1 me per hour for 1 week. This catheter has a blunt tip and an extremely flexible portion, which itself functions as a super-selective guide wire, making it easy to super-selectively insert the catheter into the distal hepatic artery.

[Brief explanation of drawings]

Fig. 1(a) is a vertical cross-sectional view showing the basic structure of the self-guided catheter of the present invention, Fig. 1(b) & 11th part view (
There is a cross-sectional view C taken along line A-A of 3). Figure 2 is an enlarged perspective view of the bulbar liver ↓ and its vicinity in Figure 1, Figures 3 and 4.
Figure Q is an enlarged perspective view showing another embodiment of the bulb. ■...No breaks (hollow monofilament) 2...Hollow part 3...Spherical part 4...Flexible part 5...
8 parts 6...Operation part 7...Medical solution delivery 11
8...Medicine fl ¥? lE person 119.12...small piece 1
()...Elongated hole (defect) 11...Vacancy in the I/Xi pull part 13...Groove (defect) 14...Metal wire 15...Vacancy in the tapered part 16.・Empty space in the operation section

Claims (1)

[Claims] (1) The distal end of the synthetic resin hollow monofilament is formed into a spherical part, a flexible part, and a tapered part in order from the end, and the part after the tapered part is formed into an operating part,
A chemical liquid outlet is provided in the bulb and a chemical liquid inlet is provided at the rear end of the operation part, and a hollow part is provided in the hollow part of the bulb to create a cavity that connects the cavity in the flexible part to the chemical liquid outlet. A small piece of X-ray opaque metal is formed in the length direction VCf5 of the monofilament, and behind the remaining part, at least in the hollow part of the operating part, it is necessary to communicate the chemical solution inlet to the cavity in the taber part. A self-guide catheter characterized in that each of the X-ray opaque metal filaments with a cross section sufficient to secure a space is built-in, and the space communicating over the entire length of the monofilament is used as a drug liquid transport path.