JPS59151968A - 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 1. Background of the Invention Technical Field The present invention relates to a catheter. Details i
Specifically, the present invention relates to a catheter in which the distal end portion is more flexible than the main body portion and both are integrally molded.

BACKGROUND ART Conventionally, elastic type catheters have been widely used for medical purposes such as urine catheterization, intraoral suction, rectal use, and angiography. These have the advantage that, because of their elasticity, they can be inserted anywhere within the body. For example, in selective hematopoietic imaging, a catheter inserted into a blood vessel must be guided (pull) by an operation from outside the body so that the tip of the catheter reaches the target area to be imaged. The tip of the catheter is advanced to the target site by pushing, pulling back, or rotating the proximal end of the proximal end of the catheter, so the force applied to the proximal end must be sufficiently transmitted to the distal end. To do this, the body of the catheter must have a relatively high bending modulus. However, the tip of the catheter must be more flexible than the body so as not to damage the vessel wall. In addition, the tip of the force i-pull has a predetermined shape to match the target contrast area, and in order to advance this catheter into the blood vessel, insert the guide into the lumen of the catheter, and This is done by straightening the tip.At this time, if the tip, which has been molded into a certain shape, is hard, the guide Wt7- will lose its grip and will not be able to straighten it completely, so the tip should not be flexible.

Therefore, the conventional catheter has a main body made of a 2i material with a large bending elastic modulus and a flexible moon 131 with a small bending elastic modulus.
The tip of Iζ is joined using the /IJ decyl /ζ. However, since the tip and the main body of the conventional A3 are joined to each other, there is a risk that the tip may come off during use due to a poor connection, and if the tip comes off in the human body. and pose a danger to life.
It turns out. Furthermore, the above-mentioned catheter has a disadvantage in that there is a slight step at the joint due to its manufacture, which requires rotating the catheter to insert it into the human body.

(1) Object of the Invention Therefore, an object of the present invention is to provide a V/I catheter. Another object of the present invention is to provide a catheter in which the distal end portion is more flexible than the main body portion and both are integrally molded.

In various cases, in a catheter made of a flexible synthetic resin made from a flexible synthetic resin in which the distal end and the tube main body are integrally formed, the plasticizer content of the distal end of the catheter is lower than the plasticizer content of the main body. The inclusion is achieved by a catheter characterized in that it is larger and the tip portion is made more flexible than the body portion.

Further, the present invention is a catheter made of a catheter made of the same material as the tube body, which is softened by contacting the softening part with a plasticizer solution to impregnate the catheter with a plasticizer. Furthermore, in the present invention, the difference between the plasticizer content of the softened tip and the plasticizer content of the main body is 3 to 3.
120 PHR (parts per 100 parts of resin), preferably a catheter in which the plasticizer content (6) of the softened tip is 3 to 100 PI (R) more than the plasticizer content of the main body, especially the plasticizer content of the main body. Containing jtl is 0 to 1001) H
R, and the plasticizer content of the softened tip is 3
The catheter is ~220Pl~IR. The present invention also provides a catheter in which the synthetic resin material is one selected from the group consisting of vinyl chloride resin, polyamide resin, polyurethane resin, and saturated polyester resin. The present invention is a plasticizer solution in a solvent that is a poor solvent for synthetic resin materials but a good solvent for plasticizers. Further, in the present invention, when a vinyl chloride resin is used as a synthetic resin material, an alkyl ester of an aromatic or aliphatic polycarboxylic acid is used as a plasticizer, and in particular, a solution of a lower aliphatic alcohol is used. This is a catheter. Furthermore, in the present invention, polyamide resin is preferable as the synthetic resin material, and in that case, the plasticizer is aromatic or aliphatic sulfonamides or aromatic quaternary compounds, particularly lower aliphatic alcohols or halogenated This catheter is made using a hydrocarbon solution.

■0 Detailed Description of the Invention Examples of flexible synthetic resin materials constituting the catheter according to the present invention include vinyl chloride resin, polyamide resin,
Examples include polyurethane resins and saturated polyester resins, with polyamide resins and vinyl chloride resins being particularly preferred.

In addition to vinyl chloride homopolymers, vinyl chloride resins include polyvinylidene chloride, vinyl chloride, and other copolymers.
There are copolymers with single exciters, and the average degree of polymerization is 70.
0-3,000. Preferably 1.000 to 2,700
It is. Comonomers for vinyl chloride include vinylidene chloride, ethylene, propylene, vinyl acetate, vinyl bromide, vinyl fluoride, styrene, vinyltoluene, vinylpyridine, acrylic acid, and alkyl acrylates (eg, methyl acrylate, ethyl acrylate).

Examples include isopropylnoacrylate, n-butyl acrylate, 2-ethylhexyl acrylate, etc.), methacrylic acid, alkyl methacrylates (eg, methyl methacrylate, ethyl methacrylate, 2-ethylhexyl methacrylate, etc.), acrylonitrile, methacrylonitrile, and the like. Further, the vinyl chloride resin can also be blended with polymers such as dylene-acrylonitrile copolymer and subbourene-methyl methacrylate copolymer.

Polyamide resins include nylon 6, nylon 66,
Nylon 610, nylon 11, nylon 12, N-alkoxymethyl modified nylon, nylon 12 and poly[
There are polyamide elastomers made of copolymers of Stell.

The polyurethane resin is based on linear 27j-Lüsdel, polyneedle or polynisderamide, which is reacted with a diisocyanate to form a prepolymer, polymerized with a chain extender, and cured with heat or a suitable crosslinking agent. So-called prepolymer method, or polyol, diisocyanate 1~. There are those manufactured by a one-shot method in which a chain extender and a crosslinking agent are simultaneously mixed to obtain a lastomer, and segmented polyurethanes. Saturated polynisfuls include thermoplastic polyethylene terephthalate, polybutylene terephthalate, and the like.

If the synthetic resin material constituting the catheter is an elastic resin, it is not necessary to add a plasticizer, but other resins usually contain 10 to 100 P to give them some flexibility.
A plasticizer having a HR, preferably about 20 to 70 PHR is blended.

Note that the vinyl chloride resin contains calcium.

Metals such as zinc and barium and stearic acid, lauric acid,
Stabilizers such as metal soaps such as ricinoleic acid, naphthenic acid, 2-ethylhexoic acid, etc., and if necessary, epoxidized animal and vegetable compounds and lubricants such as epoxidized soybean oil and epoxidized linseed oil, and other antioxidants. is blended.

A flexible tip sheathed catheter according to the present invention is fabricated as follows. That is, the part of the distal end of a catheter whose distal end and main body are integrally molded is immersed in a plasticizer solution, and the plasticizer is added to the vinyl chloride resin constituting the catheter distal end. By impregnating with a solution of and then drying to evaporate the dissolved Is, a predetermined amount of plasticizer is not contained in the contact area and the contact area is softened.

The plasticizer is a poor solvent for synthetic resin materials,
It is generally used as a solution in a solvent that is a good solvent for the plasticizer used.

The tip and main body before making the tip soft v1.
When the synthetic resin material is vinyl chloride resin, dibutyl phthalate, plasticizer J3, which is optionally blended into the body-molded catheter, and the plasticizer impregnated into the OIM part that softens the OIM part, are used. Phthalates such as dihexyl phthalate, dihebdylphthalate-1-, di-2-■purhexyl phthalate, di-1)-A-cutyl phthalate [・, diiso-A-cutyl phthalate, dinonyl phthalate, didecyl phthalate, didodecyl tsthalate, butylbenzyl phthalate, etc. Acid nisderates, trimellitic acid esters such as [Libupur 1-limellidate, trioctyl trimellitate, etc., aliphatic polybasic acid nisderates such as dioctyl adipate, diA ctyl azelate, diA ctyl sebacate, tricresyl phosphene] 7) Phosphate esters such as ctyl diphenylbosphate, monobutyldiosylekyl phosphate, 1 to ctyl phosphate, tributyl acetyl citrate, trioxylenyl phosphate, etc. citrate, citric acid esters such as tributyl citrate, epoxidized soybean oil.

Examples include epoxidized animal and vegetable oils such as ebony (linseed oil). Among these, alkyl esters of aromatic or aliphatic polycarboxylic acids are preferred, and phthalate esters are particularly preferred.

The solvent used in the case of the vinyl chloride resin is as follows:
Meknol, ethanol, n-propanol, ilobanol, n-butanol, isobutanol, 5ec-
Alkanols such as butanol, tert-butanol, hexanols, heptatools, Δphtanols, hydrocarbons such as 0-hexane, n-heptane, n-octane, ligroin, kerosene, benzene, triene, xylene, methyl chloride .

Halogenated hydrocarbons such as methylene dichloride, chloroform, carbon tetrachloride, methane dichloride difluoride, ethane tetrafluoride,
Examples include dimethyl needle, carbon disulfide, etc., but lower aliphatic alcohols such as methanol, ethanol, and isopropanol are preferred, and methanol is most preferred.

Plasticizers used in polyamide resins include:
1) - Edylhexyl oxybenzoate, dioxybenzoic acid] Nisdel, aromatic oxycarboxylic acid needles, phenols, aromatic IMA xy compounds such as aromatic A xaldehyde, N-methylbenzenesulfonamide, N
-butylbenzenesulfonamide, p-toluenesulfonamide, N-ethyl-p-toluenesulfonamide, N-cyclohexyl-p-toluenesulfonamide, etc. afPA sulfonamides, N-alkyl aliphatic sulfonamides.

Orthophosphoric acid esters such as 7-A quartzyl diphenyl sulfate, cresyl phenyl phosphonate, xylenyl diphenyl phosphate, dioctyl abire-1~, di-A
Fatty acid nitrides such as cutyl rebacut, lactams, lactones, cyclic ketones, adducts of oxycarboxylic acids and alkylene oxides, amylcyclohegisanol, carbonic acid esters of detrahydrofurfuryl alcohol, chlorinated aromatic hydrocarbons, and J-tyl , adducts of polyamide and ethylene oxide, condensates of urethane and formaldehyde,
These include composites of isocyanate and polyoxy compounds, non-quality low-crystalline polyamides, etc. In addition, plasticizers used in polyurethane resins and saturated polyester resins include dibutyl diglycol adipate, monoocdyldiphenyl phosphonoate, etc., and solvents include trichlorethylene, toluene, acetone, etc. There is.

Next, the present invention will be explained with reference to the drawings. 1st
The figure shows one embodiment of the present invention, and the catheter 1 includes:
The hub 2 and the tube 3 are made up of a tube body 4 and a tube tip 5, which are integrally molded from flexible synthetic resin. The tube tip 5 is
The catheter shown is a Bigzol type catheter, which is shaped in a predetermined shape according to the purpose and the insertion site to be covered, and is inserted into the ventricle of the heart and used for imaging the heart. Tube 3 is plasticizer-free or walking 1
It is made of a flexible synthetic resin containing a plasticizer, and is made by impregnating the tip portion 5 of the dupe with a predetermined amount of plasticizer to soften the portion.

Figure M2 is a state diagram when the guide wire A-hoo 16 is inserted into the big sole type force gauge manufactured according to the present invention. In conventional catheters (although they are integrally molded), the duplex distal end 15 is as hard as the duplex main body 1/1, so when the guide wire V-16 is inserted during use, the rigidity of the guide wire 17-16 becomes stiffer. The force is negative to the bending force of the tube tip 15 and it does not become straight.For this reason,
If the distal end portion 15 is curved, it is difficult to insert the tube into the blood vessel, and it is difficult to selectively advance the tube inside the blood vessel.
It also has the disadvantage of easily damaging blood vessel walls. However, in the catheter according to the present invention, the tube distal end 1
5 is Eisen, so the guide wire ψ−16 as shown in the figure.
When inserted, the tube tip 15 becomes straight, providing good operability.

FIG. 3 is a balloon catheter according to another embodiment of the invention. This balloon catheter 21 is composed of a connector side 22 and a tube 23, and the tube 23 is composed of a duplex main body 24, a duplex distal end 25, etc., and is integrally molded from flexible synthetic resin. A balloon 27 is attached to the duplex tip 25 as shown in FIG.
] This balloon catheter 21 has a main lumen 28 and a side lumen 29 through which fluid for inflating the balloon 27 passes, and a side hole 3o is bored on the distal side of the balloon 27. The balloon 27 is made of rubber or the like, and its volume is close to zero.
9, and the side lumen 29 communicates with a balloon inflation fluid injection path 32 having a built-in check valve (not shown). The tip end portion 25 of the duplex is made soft by impregnating it with a predetermined amount of plasticizer.

Next, the present invention will be explained in more detail by giving Examples.

Example 1 100 parts by weight of polyvinyl chloride having an average degree of polymerization of about 1,300, 40 parts by weight of di-2-I derhexyl tstalate,
[Poxidized human oil (8.0 parts by weight, Ca-Zl), 1 carton of light stabilizer, part M, J3J: 1 part of lubricant, vinyl chloride resin (= bu as shown in Figure 3). -1 Main body part 24
J5 and Bulb L - Barusica 1 with the tip of the bulb 25 on the right
The tube 23 of the tube 21 is integrally molded.Furthermore, a rubber balloon 27 is attached to the tip end 25 of the duplex and communicates with the idle lumen 29. The rigidity is 400 k(+,/cm2
Then, attach the tube tip 25 to G2.
- 60% methanol with 1 syl tthalate to the nibble?
After soaking IJ13 in 8 liquid for 4 hours, pull it up and dry it.
]However, the content of the G2-nibblehexyl ivy 1 note at the tip 25 of the 82-metered pipe is 60 Pt-I
R, and the rigidity was 4.1150 kg/Cm2.

Example 2 A tube 3 of a pigtail-type power tail 1 having a tube main body 4 and a tube tip 5 as shown in FIG. Molded in one piece. The rigidity of this tube 3 is 950 kg/cm2
Met. Next, the tube tip 5 was immersed in a monooctyl diphenyl phosphate 50% by weight methanol/trichlorethylene <1/1) solution for 4 hours, and then pulled to dry. The content of diphenyl phosphate is 6 P
HR and rigidity coefficient Ha5 E50 kg/cm2
There was a time.

Example 3 A pigtail type force j-chill tube having a main body 4 (13) and a tube tip 5 as shown in FIG. The tube 3 of No. 1 was integrally molded.The rigidity of this tube 3 was 950 kg/
It was cm2. Next, the tube tip 5 was immersed in a solution of 50% by weight ethanol/tricomeniburene (1/1) of benzenesulfone butyramide for 4 hours, and then dried. The content of ben L'sulfone butyramide at the tip of the tube is 18P.
HR, and the rigidity modulus was 350 kg/Cm2r.

■9 Specific Effects of the Invention As described above, the catheter according to the present invention has a distal end portion and a tube body portion integrally formed, and is made of a rigid resin material that has flexibility. J5, the plasticizer-containing Δl at the distal end of the catheter is replaced by the plasticizer-containing -
(2) Since the distal end is made larger and more flexible than the main body, there is no connection between the distal end and the main body, so the inner and outer surfaces of the tube are smooth. Furthermore, since the C1 is integrally molded, there is no risk of the tip being separated from the main body due to poor connection. In general, since the tube is integrally molded, there is no need for difficult processing to connect the main body and the distal end, making it easy to manufacture the catheter. Furthermore, since the tube body is hard and the tube tip is flexible, the catheter has extremely good operability.

In addition, the power digit is made soft by impregnating a portion of a catheter whose distal end is made of the same material as the duplex main body with a plasticizer while avoiding contact with a plasticizer solution. Therefore, it is possible to soften a predetermined portion using an extremely simple method. Furthermore, t between the plasticizer content of the softened tip and the plasticizer content of the main body is 3 to 120 PI-IR, especially when the plasticizer content of the softened tip is the same as the plasticizer content of the main body. 3~100P from the amount
When there are many HRs, insertion into a predetermined location becomes extremely easy. In particular, the plasticizer content of the main body is O~100P)-
+ R, and the plasticizer content of the softened tip is 3 to 220 P HR, the tube body has a suitable hardness, so it is easy to operate to selectively advance inside the blood vessel. Since the distal end is more flexible than the main body of the tube, it can be easily inserted into a predetermined location, and in the case of a balloon catheter, for example, it can be easily carried along in the bloodstream. Furthermore, as a synthetic resin material, vinyl chloride resin, polyamide resin, polyurethane resin, or saturated polyamide resin, especially vinyl chloride resin or (J polyamide resin), is inexpensive and safe.Also, ii) as a plastic agent, synthetic resin If you use a plasticizer solution with a solvent that is a poor solvent for the material but a good solvent for the plasticizer,
The required amount of plasticizer can be soaked into the tip of the tube without adversely affecting the catheter itself, thereby providing the necessary flexibility at a given location.

[Brief explanation of drawings]

FIG. 1 is a side view showing one embodiment of the cuff-chill according to the present invention, and FIG. 2 is a side view of the catheter of FIG.
FIG. 3 is a side view showing the state when inserted, FIG. 3 is a side view showing other embodiments, and FIG. 1.11.21... Catheter, 2.12... Hub, 3.13.23... Tube, 4. ．． 14.24・
...Tube body, 5,15.25...Tube tip.

Claims (1)

[Claims] (1) In a table made of a flexible synthetic resin material in which the distal end portion and the BooUso main body portion are integrally formed, the plasticizer content of the distal end portion of the catheter is determined in the main body. A catheter characterized in that the distal end portion is made larger than the plasticizer-containing portion and is made more flexible than the main body portion. (2) The distal end portion is made soft by contacting the portion of the catheter to be softened, which is made of the same material as the main body portion with a plasticizer solution, to impregnate it with the plasticizer. The catheter according to claim 1. (3) The difference between the plasticizer content of the softened tip and the plasticizer content of the main body is 3 to 120 PHR. (4) The catheter according to claim 1 or 2, wherein the plasticizer-containing IB of the softened tip portion is 3 to 100 P + -I R higher than the plasticizer content of the main body portion. The catheter described above. (5) The main body has a plasticizer content of 0 to 100 P HR, and the softened tip has a plasticizer content of 3 to 2.
The catheter according to any one of claims 1 to 4, which is 20 P 1-I R. (6) Claim 1, wherein the monthly synthetic resin is one selected from the group consisting of vinyl chloride resin, polyamide resin, polyurethane resin, and saturated polyester resin.
The catheter according to any one of Items 5 to 5. (7) The plasticizer solution is a plasticizer solution of a solvent that is a poor solvent for the synthetic resin but a good solvent for the plasticizer. A catheter according to any one of the above. (8) The catheter according to claim 6, wherein the synthetic resin is vinyl chloride resin. (9) The catheter according to claim 8, wherein the plasticizer is an alkylnisdel of aromatic or aliphatic polycarboxylic acid. (10) The cadaver according to claim 8 or 9, wherein the plasticizer solution is a solution of a lower aliphatic alcohol. (11) The catheter according to claim 6, wherein the synthetic resin material is a polyamide resin. (12) Claim 1 in which the plasticizer is an aromatic or aliphatic nulfonamide or an aromatic A-oxy compound.
The catheter according to item 1. (13) Claim 1, wherein the plasticizer solution is a solution of lower aliphatic alcohol or halogenated hydrocarbons.
The catheter according to item 1 or item 12. (14) The catheter according to claim 6, wherein the synthetic resin is a polyurethane resin. (15) The catheter according to claim 6, wherein the synthetic resin material 1 is a saturated polyurethane resin.