JPS59151969A - 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 10. Background of the Invention Field The present invention relates to a catheter that can be easily inserted and fixed in the heart accurately, and has good indwelling properties without the risk of blocking side holes. It is something.

PRIOR ART Various types of surgical catheters are currently in use. For example, during surgical operations for heart valvular disease or myocardial infarction, the blood in each part of the heart is drained in advance, and the inlet tubes of the oxygenator and veins are connected to the arteries and veins that connect the heart and lungs. A predetermined surgery is performed after connecting an outlet tube and emptying the heart while exchanging blood with oxygen through the artificial lung. In this case, in order to drain the blood inside the heart, a hole is made in the wall of the ventricle of the heart.
After inserting a cardiac catheter into the hole and fixing it,
It is discharged through the main lumen of the catheter through a side hole drilled in the distal end of the catheter.

Various types of such cardiac catheters have been proposed. For example, U.S. Patent No. 3,788
As disclosed in U.S. Pat. , a fixing ring 4 is provided at a position rearward of the distal end portion 2 provided with side holes 3, and this fixing ring 4
A moving ring 5 is slidably fitted on the outside at a further rear position.

Therefore, in order to use such a cardiac catheter 1 for cardiac surgery, the inlet and outlet tubes of the oxygenator are connected to the artery and vein, respectively, as described above, and then a hole is made in the wall of the ventricle. , insert the distal end 2 of the cardiac catheter 1 into the hole.
, and further insert up to the fixed ring 4 so that it comes into contact with the inner surface of the wall, and then slide the movable ring 5 from the outside toward the ventricular side so that it comes into contact with the outside surface of the wall. The catheter 1 is fixed to the heart by pinching the catheter. Then,
A discharge means such as a pump (not shown) connected to the other end of the catheter 1 is activated to discharge blood in the ventricle from the side hole through the main lumen.

However, in such a catheter 1, if the height and ring width of the fixing ring 4 from the catheter 1 are made small, the diameter of the hole to be drilled in the wall can be made small, but there is a risk that the catheter will come off after fixation. There is sex. On the other hand, if the height of the fixing ring 4 from the catheter 1 is too large (ring width), it will be difficult to insert it, so it is necessary to make the diameter of the hole larger. There is a risk that the catheter may become dislodged later. Furthermore, in such a catheter, since the catheter 1 is fixed only at the walls of the rings 4 and 5, the position of the distal end 2 of the catheter fluctuates, and depending on the position, the blood may There is a risk that the side hole 3 will come into contact with the wall and become clogged during discharge.

■Object of the Invention Accordingly, an object of the present invention is to provide a novel catheter. Another object of the present invention is to provide a catheter that can be easily and accurately inserted, can be fixed within the heart, and has good indwelling properties without the risk of occlusion of side holes.

These various methods include a catheter having a main lumen and a side lumen inside, a curved part formed of a flexible material at the distal end, and at least one side hole bored in the inner surface of the curved distal end. This is achieved by a catheter characterized by the following features:

However, the present invention is a catheter in which the flexible material is a polymeric diostomer. Furthermore, the present invention is a catheter in which the flexible material is a flexible synthetic resin material.

IH, Detailed Description of the Invention Next, one embodiment of the catheter according to the present invention will be described with reference to the drawings. That is, as shown in FIGS. 2 and 3, in a catheter 11 equipped with a main lumen 14 and a side lumen 5, the distal end portion 12 is formed with a curved portion 12 of a flexible material, and the distal end curved portion 12 is made of a flexible material. The catheter f 11 has at least one, preferably a plurality of side holes 13 bored in its inner side. Therefore, the main lumen 14 and the side lumen 15 are connected to the catheter 1.
The distal end of the catheter 1 communicates with the distal end of the catheter 1.
A sealing stopper 17 is fixed to the tip opening J6 of the opening J6 to close the opening 16. The reason why the tip opening 16 was sealed using the sealing stopper F was to take into consideration the fact that when the catheter is indwelled as shown in FIG. 4, the stylet 22 is inserted into the main lumen 14. be. Therefore, the above object can be achieved by making the inner diameter of the tip opening 16 smaller than the outer diameter of the stylet 22 without providing the sealing plug 17. A connector connection port 18 is formed at the other end of the catheter 11 and communicates with the main lumen 14, and a side lumen tube 19 that communicates with the side lumen 15 is located slightly closer to the distal end than the connector connection port 18. are provided as necessary. The side hole 13 is bored on the main lumen side. Therefore, the tip curved portion 12 of the catheter is connected to the main lumen 14.
It is curved so that the side is the inside part. Also, the side hole 13 is used for draining blood accumulated in the ventricle, and it is preferable that the total area of the side hole 13 is large, but if the hole is made large, the stiffness of the tip curved portion 12 will become weak. It is preferable to provide about 3 to 4 holes having an area smaller than the cross-sectional area of the main lumen 12. Tip curved part 120
The radius of curvature is preferably large enough to allow the catheter 11 to be indwelled in the ventricle, and large enough so that it will not be pulled out when the catheter 11 is inserted through a hole in the wall of the ventricle.

As shown in FIG. 6, the tip curved portion has a sealing plug 17.
Preferably, it is curved to such an extent that it points toward the rear end of the main body of the catheter. This is because it does not easily come out of the ventricle where it is placed. Furthermore, as shown in FIG. 7, it is preferable that the sealing plug 17 is curved to such an extent that it contacts the outer wall of the catheter.

The tip does not hit the inner wall of the heart, thereby reducing pressure on the inner wall of the heart and reducing tissue damage. Further, the material of this tip curved portion 12 may be the same as or different from that of the main body of the catheter, but it is necessary that the tip curved portion is made of a flexible material, for example, a material made of a flexible material. Constructed of molecular elastomer, flexible synthetic resin material. Therefore, it is usually desirable that the tip portion 12 and the main body portion be integrally molded from the same material.

As will be described later, when inserting the tip curved portion 12 into the ventricle of the heart, the stylet is inserted into the main lumen, the curved portion is stretched, and then the stylet is pulled out again after insertion. Since it is curved, it stretches almost straight due to the rigidity of the stylet, and has the necessary and sufficient flexibility to return to its original shape and form a curved part when the stylet is pulled out and removed. It is desirable that Further, it is preferable that the sealing plug 17 of the distal end opening 16 of the catheter has a shape (for example, hemispherical) so as not to damage the tissue of the heart wall.

Flexible materials suitable for achieving the above purpose include polymeric nidistomer materials, flexible synthetic resin materials, and the like.

Examples of polymeric elastomer materials include natural rubber and synthetic rubber, such as styrene-butadiene rubber, chloroprene rubber, butyl rubber, nitrile rubber, ethylene-propylene rubber, urethane rubber, silicone rubber, and the like. Also,
Examples of flexible synthetic resin materials include soft vinyl chloride resin, polyamide resin, polyurethane resin, and saturated polyester resin. Among the polymer elastomers, silicone rubber is preferred, and flexible synthetic resin materials include soft vinyl chloride resin and polyamide resin.

In addition to vinyl chloride homopolymers, vinyl chloride resins include polyvinylidene chloride, copolymers with other copolymerizable monomers containing vinyl chloride of 907 or more, preferably 95 or more. etc., and the average degree of polymerization is 700-3
000, preferably 1000-2700. Comonomers for vinyl chloride include vinylidene chloride, ethylene, propylene, vinyl acetate, vinyl bromide, vinyl fluoride, styrene, vinyltoluene, vinylpyridine, acrylic acid, alkyl acrylates (for example, methyl acrylate, ethyl acrylate, Examples include isopropyl acrylate, roofyl acrylate, 2-ethylhexyl acrylate, etc.), methacrylic acid, alkyl methacrylates (eg, methyl methacrylate, ethyl methacrylate, 2-ethylhexyl methacrylate, etc.), acrylonitrile, methacrylonitrile, and the like. Moreover, polymers such as styrene-acrylonitrile copolymer and styrene-methyl methacrylate copolymer can also be blended with the vinyl chloride resin.

Polyamide resins include nylon 6, nylon 66,
Examples include nylon 610, nylon 11, nylon 12, and N-alkoxymethyl modified nylon. Polyurethane resins are based on linear polyester, polyether, or polyester amide, which is reacted with diisocyanate to form a prepolymer, which is then polymerized with a chain extender and cured with heat or a suitable crosslinking agent. There are those manufactured by the so-called prepolymer method, or the one-shot method in which a polyol, diisocyanate, chain extender, and crosslinking agent are simultaneously mixed to obtain a diistomer, and segmented polyurethanes. Examples of the saturated polyester include thermoplastic polyethylene terephthalate and polybutylene terephthalate.

In order to impart flexibility to the synthetic resin material, a plasticizer is usually blended in an amount of about 40 to 120 parts by weight, preferably about 50 to 100 parts by weight, per 100 parts by weight of the vinyl chloride resin.

Note that the vinyl chloride resin contains calcium, zinc,
Metal soaps containing metals such as barium and stearic acid, lauric acid, ricinoleic acid, naphthenic acid, 2-ethylhequinic acid, etc., stabilizers such as organic tins such as diptyltin dilaurate, diptyltin simalate, etc. Epoxidized animal and vegetable oils such as epoxidized soybean oil and epoxidized linseed oil, lubricants, and other antioxidants are blended.

As a plasticizer, in the case of vinyl chloride resin, dibutyl phthalate, didecyl phthalate, didecyl phthalate,
Heptalic acid esters such as di-2-ethylhexyl phthalate, di-n-octyl phthalate, diyneoctyl phthalate, dinonyl phthalate, didecyl phthalate, dzidodecyl phthalate, butylbenzyl phthalate,
Trimellitic acid esters such as tributyl trimellitate and trioctyl trimellitate, aliphatic polybasic acid esters such as dioctyl adipate, dioctyl azelate, and dioctyl sebacate, tricresyl phosphate, tricylenyl phosphate, monooctyl Phosphate esters such as diphenyl phosphate, monobutyldiosilekyl phosphate, trioctyl phosphate, citric acid esters such as tributyl acetyl citrate, trioctyl acetyl citrate, tributyl citrate, epoxidized soybean oil, epoxidized linseed There are epoxidized animal and vegetable oils such as oil. Among these, alkyl esters of aromatic or aliphatic polycarboxylic acids are preferred, and phthalate esters are particularly preferred. Examples of plasticizers used in polyamide resins include benzenesulfonebutyramide, monooctyldiphenyl phosphate, and dioctyl azelate; examples of plasticizers used in polyurethane resins and saturated polyester resins include diptyldiglycol. Examples include acyhate and monooctyldiphenyl phosphate.

(9) Specific Effects of the Invention The following is an explanation of the case in which the catheter constructed as described above is used in heart surgery. First, the inlet tube and outlet tube of the oxygenator are connected to the pulmonary artery and vein (not shown), and the oxygenator is operated. Drill hole 21. Next, as shown in FIG. 4, by inserting the stylet 22 into the main lumen 14 of the catheter 11, the distal end curved portion 12 of the catheter 11 is stretched out to be approximately straight or gently curved, and the hole 21 is Insert the catheter 11 further. When the stylet 22 is pulled out after inserting the catheter so that the distal end is slightly longer than the part forming the curved section 12, the distal end section 12 of the catheter 11 returns to its original state and returns to the curved section as shown in FIG. form 12. Then, when the catheter is pulled to the other end, the distal end of the curved tip portion 12 comes into contact with the inner surface of the wall, so the catheter is pulled to the other end.
It is locked by. Further, in the case shown in FIG. 7, the curved portion of the distal end curved portion 12 contacts the inner surface of the wall portion, and the catheter is locked.

Next, a tube (not shown) is connected to the catheter 11 to communicate with the main lumen 14, and a suction means (not shown), such as a rotary pump, is attached to this tube.
By activating the suction means, the blood in the ventricle is discharged to the outside of the body through the side hole 13 and the main lumen 14, and the air sucked through the side lumen tube 19 is supplied into the ventricle through the side lumen 15 to drain the blood. will be replaced with On the other hand, after the surgery is completed, blood is returned to the ventricle through the main lumen 14, and air within the ventricle is exhausted to the outside of the body through the side lumen 15. Next, the tube is removed from the catheter 11, the stylet 22 is inserted into the main lumen 14 to stretch the tip curved part 12, and then the catheter 11 is pulled out from the hole 21 in the wall 20. Since blood is present in the heart, it is preferable to make the stylet 22 hollow so that the blood will not be pumped into the heart. The hole 21 is closed by suturing.

Claims (1)

[Scope of Claims] (Li) A catheter having a main lumen and a side lumen inside, the distal end of which is formed with a curved part made of a flexible material, and at least one side hole formed inside the curved distal end. (2) The catheter according to claim 1, wherein the flexible material is a polymer elastomer. (3) The flexible material is a flexible synthetic resin material. A catheter according to claim 1.