JPS6063063A - Production of medical device - 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] ■8 Background of the invention Technical field The present invention relates to a method for manufacturing medical instruments.

Specifically, blood bags and infusion bags.

The present invention relates to a method of manufacturing a medical device having a joint structure of tubular members such as a blood circuit.

Prior art blood bags, infusion bags, blood circuit q medical equipment,
Conventionally, it has excellent processability and physiological safety.

Although it is mainly made of vinyl chloride resin from the viewpoint of transparency and low cost, tubular members are arranged in various places, and the tubular members are joined in a U-shape to form the device. There is. For example, taking a blood bag as an example, one blood collection bag is connected to a blood collection tube connected to a hub having a surface collection button fixed to the tip. In addition, as an example of another blood bag, one or more child bags may be provided (pulled) in addition to the blood collection bag by connecting the blood sampling sword, hub J3, and blood collection tube. The blood collection bag and the child bags are connected to each other by a connecting tube via a branch port.

In addition, examples of arterial blood circuits used in dialysis machines include synchronized adapters, mixed ml, T-tubes, negative pressure monitors, and bombduzo connectors.

Each connecting member such as a jacket, port connector, etc. is connected to a jacket made of soft vinyl chloride resin.

Therefore, the blood collection duplex and the branch τ;, the connecting connection-1-branch tube, and the above-mentioned connecting parts and tubes have a core metal inside because the joint members are relatively rough and long tubular members. Therefore, conventionally, these tubular members were bonded together using a solvent, such as a solvent that dissolves the vinyl chloride polymer. ]~Rahydrofuran (T-1-
After applying IF) etc. to the parts to be joined and partially dissolving the parts, one part is attached to the other part.
After inserting one uncoated member into the other member of red-coated A1j, apply the organic solvent to the slight gap between both members, and let it penetrate through the capillary action in the gap. The two parts were then joined by partial dissolution and reassimilation using the organic solvent.

Such a joining method can be used, for example, as shown in FIG.
From the openings at both ends of the central shaft hole 2 of the hub 1 made of moon oil, etc.,
A solvent was applied to the respective end surfaces 3 and 4 to partially dissolve the portions, and a μ-tube 5.6 was inserted as shown in FIG. 1(B) and bonded and fixed.

In addition, as shown in FIG. 2, insert one blood sampling hook 8 into the center shaft hole of the hub 7 made of hard "crystalline vinyl resin, polycarbonate resin, etc." Apply the solvent from the other side to the frontage side surface of the connecting duplex '10 made of soft vinyl chloride resin to the center shaft hole of the hub 7, which has been fixed by applying an adhesive 9 such as a type adhesive. It is made by inserting and fixing a partially melted material.

However, in such an organic solvent coating method, if the gap is too small, the i8 medium will not penetrate sufficiently, resulting in insufficient bonding, and if the gap is too large, excess solvent will leak to areas other than the bonded area. There is also a risk that the liquid may leak out, for example, into a blood bag containing an anticoagulant or an infusion bag containing an infusion solution, and become mixed in with the contents.

In addition, when such organic solvents are used, they not only cause whitening of the joints, stiffness, and deterioration over time, but also deteriorate the work environment due to their volatility, and also cause problems with polyvinyl chloride. The problem was that the cracks in the molded product were covered up. Furthermore, FIG. 1 (A).

In the case of the bonded 4M structure shown in (B), a soft vinyl chloride resin dupe is inserted into the hub part [71], so if the dupe is deformed during or after the welding operation, There was a risk that liquid such as blood flowing through the duplex would leak.

(1) Purpose of the Invention Accordingly, the purpose of the present invention is to provide a new method for manufacturing a stinky medical device. Other objects of the present invention are:
It is an object of the present invention to provide a method for manufacturing a medical device that controls the joining structure of tubular members such as blood bags, infusion bags, blood circuits, etc.

These features include a flexible vinyl chloride resin duplex that is connected to at least one end of the hard cylindrical connecting part I and the medical device part, and a vinyl chloride polymer base material that is blended with a plasticizer. After the connecting portion is filled with resin substantially without any gaps, the medical instruments thus constructed are heat sterilized and bonded together liquid-tightly.
[ζ
(depending on the manufacturing method of the medical device).

Moreover, in the present invention, the hard cylindrical connecting member is hard? This is a method for manufacturing a medical device made of T vinyl chloride (H resin, lc is polycarbonate 1).Furthermore, the present invention provides a method for manufacturing a medical device in which at least one end of the rigid cylindrical connecting portion 4Δ forms a parallel portion with the same external shape. There is a medical device that is inserted into a tube made of soft vinyl chloride resin (with the inner diameter of the joint being right).
III! The outside of at least one end of the in-shaped connecting member forms an AJU-shaped tapered part, and the connecting part of the soft Jnn-formed vinyl N15 L-bub is expanded in diameter so that the inner diameter part to be joined is on the right side. This is a manufacturing method. In addition, the inner surface of at least one end of the hard cylindrical member forms an m-shaped part with a light length, and a dupe made of soft vinyl chloride resin (an outer part whose diameter is reduced and sticks together) is formed. This is a method for manufacturing medical equipment.

Furthermore, the present invention is a method j) for manufacturing medical instruments in which the heat sterilization is d-1 to crepe sterilization. ,,1. The present invention is a method for manufacturing a medical device whose medical device member is a container for storing liquid. J7. J3 to this invention
Medical equipment members refer to members that constitute medical equipment other than chicoves and connecting parts, such as blood bags, infusion bags, blood circuit bags, pumps, etc.

(9) Specific structure of the invention Next, an embodiment of the invention will be described with reference to the drawings. That is, FIG. 3 shows a blood bag, which is a blood collection bag 133 made of soft vinyl chloride resin and equipped with a plurality of beer tabs, a JJI outlet 11, and a connecting outlet 12.
The peripheral edge 14 of the J3 is sealed by frequency heating.
A blood collection duplex 116 made of soft vinyl chloride resin is connected to the internal space 15 of the blood collection bag. In the internal space 15 of this blood collection bag, an anticoagulant (△C
v-Δ solution (e.g., citric acid in 100 nz2 aqueous solution), 2.20 Q of citric acid, 0.80 g of citric acid/acid J3J: 2.20 Q of 7-dose), CP +) solution (e.g.,
In 100 m of aqueous solution, 0.327 q of citric acid, 1 to 2.63 ml of citric acid, 0.251 u of phosphoric acid.

Contains glucose 2.32 (+), etc.

J. At the tip of the blood sampling dicove 1G, there is a blood sampling side 17.
A key 17 and a knob 18 are attached to this blood collection side 17 (=i 4).

In addition, when connecting a child bag to the reservoir of the blood collection bag 3, a beer tab is provided with a peripheral portion 20 made of a soft 12-molecular vinyl resin. !
A first child bag 23, which is sealed by i-frequency heating and is equipped with a connection dupe 22 made of soft vinyl chloride resin that communicates with its internal space 21, is connected to the blood collection bag 13 via a branch pipe 24. It is connected by a connecting nail 25 at the tip and connected to a C-connecting duplex 26. In addition, the second child bag 32 is equipped with a peel tab holder JJI outlet 27, a peripheral portion 28 is sealed, and a connection dup 31 made of soft vinyl chloride resin is connected to the internal space 1i1129. It is connected to the connecting duplexes 22, 2G via a branch pipe 27I.

Therefore, the branch pipe 24 and the connecting pipe, S-b 22, 26.3
1. In order to join the tubular members made of soft JAa vinyl small aggregates such as the B-tie tube 1G and the hub 33 which is a hard 1r1-shaped connecting member, the following steps are performed.

However, g8PI such as anticoagulants and infusions is passed through the connecting tube 16! 1. For example, in order to join the connecting duplex 1G and the hub 33, etc., the fourth
As shown in the figure, the hub 3 is made of soft vinyl chloride polymer.
Fit and insert the blood collection side 17 into the center 11111 hole of
A hub formed by forming an ljE-shaped arbor part that is formed coaxially with the central axis hole of 133 and tapering outward, and an annular vortex on the outside of the arbor part. Insert the J-bar part of 33 into the connecting joint 1-b 16, and expand the diameter of the connecting joint J-116 to 1iiJ Ili'J.
The JN vinyl polymer base resin 35 is fixed to the bobber part of the rehab 33 due to the contraction force of the connecting tube 16, and a plasticizer is added to the gap between the hub 33 and the connecting tube 1G. The resulting medical instruments are sterilized by filling them with substantially no gaps and heat sterilizing them, preferably by heating them in a crepe in the presence of high pressure steam. The base-like paste resin is trapped and liquid-tight with each other.

In addition, in the tree M, connection refers to connecting with a connecting member by expanding or contracting the diameter of the duplex using the elasticity of the tube. In addition, filling with substantially no gaps means that the base resin is present so that the connecting portion is liquid-tight.

Therefore, the filling can be done before or after the time. Ma IC%
Liquid tightness means that when a liquid flows inside the medical device of the present invention,
This means that no liquid leaks from the connection. moreover,
FIG. 4 shows the connecting duplex 22.・26.31 and branch pipe 2
4 shows the state of connection with the connecting tube 24. By inserting each connecting L knee 122, 26, 31 into the branch 24 from the open end of the branch tube 24, each connecting tube is connected. After reducing the diameter of the insertion end and filling the gap between the branch pipe 24 and each connecting duplex with the base resin 35 containing the plasticizer, heat sterilization is performed.
- By heating in the presence of high-pressure steam in a crepe, the medical instruments to be prepared are sterilized and the paste-like paste is solidified and adhesively bonded to each other in a fluid-tight manner. So, there it is.

FIG. 6 shows another embodiment of the present invention.

In other words, the figure shows an example of an arterial blood circuit, which is equipped with a plasminic 4-nidotube 51. seat adapter 52, mixed t1 port 5:3, clove tube 54.55,
Negative pressure monitor 56 and pump tube connector 57.5
8, 11 members 559, and boat 21 connectors 60, respectively, with duplexes 61 and 62 made of soft vinyl chloride resin.
．． They are connected at 63.6/1.65, 66°67. Taking the Pump Due 1 connector 58 as an example, the 9-(tube connection structure is explained below).
Figure (△).

As shown in (B), hard cylindrical 3+1! The central shaft hole of the pump duvet 1 connector 58 made of hard vinyl chloride resin or Borea J-Bone 1 to resin, which is the connection part, has an Mt-shaped tapered part 68 on one side of the diameter end, and the other open end side. Similarly, a tapered string-shaped tapered portion 69 is formed, and the string-shaped tapered portions (38 and 69 are respectively inserted into a soft vinyl chloride resin duplex 70.66 and connected to the duplex 70.66 and the pump tube. The gap between the connectors 58 is filled with vinyl chloride polymer paste 1 Helenzin mixed with a plasticizer, and the LC is heat sterilized, preferably by heating in the presence of water vapor in a t-1 crepe. , Ya1
This is made by liquid-tightly adhering the medical instruments to be used together with the sterilization tube to the phase U. In this case, the base resin is
, - After fitting the part into the connecting part l, apply IJ to the gap.
It is desirable to completely seal the liquid-tight 19 by applying the coating to the surface of the connecting part of the connecting member before fitting the duplex! But that's fine. In this case, the base resin may be applied to the outer surface of the end of the connecting dup 16 in advance, and then the connecting dup 16 and the hub 33 are connected, and then the same sterilization process is performed.

Note that A-clape sterilization is usually carried out in an autoclave under a pressure of 1.0 to 3.7 kg/cm2, preferably 1.7 to 2,4 klJ/Cl, and sterilized at 100 to 140°C, preferably. J, Siku is 115
at a temperature of ~126°C for 5 to 12:0 minutes, preferably 4
It is heated for 5 to 70 minutes.

The vinyl chloride polymer base resin blended with the plasticizer used in the present invention and lJl, particle size 0.02r~2. O
ttm, preferably 0.1 to 10 μIll Jfj.

It is made by uniformly dispersing and suspending fine powder of vinyl chloride polymer in a plasticizer. Finely powdered vinyl chloride polymers include small vinyl chloride polymers, as well as copolymers of vinyl chloride and vinyl chloride, vinyl acetate, vinyl alcohol, etc.; The amount of comonomer forming the bond J' is not less than 15 mol%.
1. Preferably it is 3 to 7 mol%. The average degree of polymerization of these small monopolymers and copolymers is 900-120
0, RiYJ.

It is preferably 960-1130.

The base resin is this J: Finely powdered vinyl chloride polymer mixed into a plasticizer! The solid content is from 25 to 50% by weight, preferably from 30 to 50% by weight. As a plasticizer to avoid such vinyl chloride coalescence, di-2-ethylhexyl phthalate-1
・, G n-J Kujirufutare 1~. Diiso A quidylphthale-1, dihebdylphthale-1, didecyl phthalate, diisodecyl phthalate, A quidylphthalate 1-, butylbenzyl phthalate 1-Kasa's notaric acid J Nisdels, 1 to ribdeltrimerizo-1 -, Trioctyl 1 to Limerite 1-M esters such as Trioctyl 1 to Limerite 1-, Dioctyl azelate,
l1t111/j /A such as diAcutyl seba//-1~
Polybasic acids] Nisdels, 1 to licresyl small snoate,
1-dixylenylphosphate-1~, Mono A
Nil small sulfate, seven-knob fluoride 4: Silenylbosph U-1-, 1-lioctylphosph 1-1 phosphoric acid:
L sprues, tributyl acetate 1-1-11-
Examples include lactyl acetyl citrate, butyl phthalyl butyl glycolate, and the like.

The adhesive used in the present invention is preferably 100 to 300 parts by weight, preferably 150 to 250 parts by weight, most preferably 200 parts by weight, based on 100 parts by weight of such base resin.
It is made by further blending 1 part of Hjff with a plasticizer, and the above-mentioned plasticizers are used as the plasticizer. That is, plasticizer M per 100 parts by weight of base [resin]
If it is less than 100 parts by weight, the viscosity suitability of the welding agent solution used will be insufficient, while if it exceeds 300 parts by weight, the adhesive will be insufficient.

The formulation of such vinyl chloride polymer paste resins and plasticizers requires lead, cadmium, barium,
Metal soaps with zinc, calcium q- metals and stearic acid, lauric acid, ricinoleic acid, naphdic acid, 2-edylhexoin W1'8, dibdeltin dilaure-1
・Organic tins such as dibdeltin mercaptide, dibdeltin mercaptide, etc. can be blended as a stabilizer.

In addition, the vinyl chloride resin that constitutes medical instruments is as follows:
In addition to homopolymers of vinyl chloride, there are copolymers of vinylidene chloride, vinyl acetate, vinyl alcohol, vinyl bromide, etc., with vinyl chloride, and in the case of these copolymers, the amount of comonomers bonded to vinyl chloride is 15 mol%. below,
Preferably it is 3-7%.

In addition, as the soft vinyl chloride resin that forms the duplex, the resin containing the above-mentioned plasticizers in the pre-vinyl chloride resin can be used.
10 to 100 parts by weight per 100 mm part, preferably 4. It is made by blending 0 to 80 parts by weight.

Next, Instinct IllJ will be explained in more detail by giving examples.

Practical Example 1 In a blood bag like 1 shown in Figs. 3 and 4, after injecting an anticoagulant into the connecting bag 16J: Rebag 13, a hard vinyl chloride resin is used to collect blood ε117 as shown in Fig. 4. A flexible polyvinyl chloride resin (average degree of polymerization: 1) is placed in an annular groove around the tapered ML type taper portion at one end of the hub made of soft polyvinyl chloride resin (average degree of polymerization: 1,000).

Insert the connecting tube 16 (outer diameter 5++un, inner diameter 3mm) made of a mixture of 1 part of 300 polyvinyl chloride 100 weight ff and 1 part of di-2-ethylhexyl phthalate 1-62 ffl ff (outer diameter 5++ un, inner diameter 3 mm), μ fitted in the part,
In the gap, a polyvinyl chloride base with an average degree of polymerization of i,ooo is placed. 0□o1. After filling tLT9-2-1 with 1 to 200 parts by weight of Delhexisiftale, it was stored in A-1 to crepe and heated in the presence of hot water at a pressure of 1.7 ka/am2 at 1'15°C. ) 65 due to heat epidemic
Sterilization J3 and adhesion were performed by heating for a minute.

Tests were conducted on the thus obtained @ medical equipment, and the joint strength was 33.8 ko, and the airtightness and pressure resistance were 2. It was 0 kg/clT12.

The joint strength test was performed using a testing machine (Strogbuf P type, manufactured by Toyo Seisakusho Co., Ltd.), and the tensile strength was 200+n.
It was run at Ill/min. In the airtightness durability and pressure test, a part of the connecting tube was closed and air was blown into the tube for 15 minutes through the open end of the connecting tube for 4 consecutive tests. The pressure of the compressed air at that time was measured at a pressure r11.

Example 2 tJ shown in Fig. 6, 43 in the urinary blood circuit, Fig. 7 (A
＞、To the pump connector 58 made of polycarbonate #j resin, which can be used in (13), one finger of soft vinyl chloride resin (100 mm of polyvinyl chloride resin with an average degree of hardness of 1,300 is attached to the pump connector 58). 62 parts) made of main ji: L-Zoro 6 and Pumpji'', -bu 7
0 was concatenated. J3, one female taper part 68 of the pump connector 58 used has a glue line of 8.4 yen at its tip.
mm, 8.6 mm at the distal end, and the outer diameter of the other 1-type taper portion 69 is 5.2 mm at its distal end, r5. mm at the distal end.
/4Inm Teatsuta. The main duplex 6G has an inner diameter of 4.7 mm and an outer diameter (3.7 mm T" ant, Hong 7'
Chew 770 GJ inner diameter 7°8mm, outer diameter 12. l
It was lnm. Next, from the gap between the connection portion between the pump connector 58 and each duplex 66.70,
After filling the polyvinyl chloride base resin containing dihexyl phthale-1, it was placed in an A-1 crepe and heated to 1.7 k(]/Cm2 in the presence of water vapor.
Sterilize by heating at a temperature of 116°C for 65 minutes.
3 J, was bonded and measured in the same manner as in Example 1, and the bonding strength was /I3 on the pump tube side.
, 8ko, main chain: L-b side is 35, 3 kgr, airtight pressure resistance is 3, OK / am2"C
there were.

IV. Specific Effects of the Invention As described above, the method for manufacturing a medical device according to the present invention connects at least one end of the hard cylindrical connecting portion with a soft vinyl chloride resin tube, and also incorporates a plasticizer. After substantially filling the connecting portion with a vinyl chloride polymer base resin, the gap devices thus formed are heat sterilized and bonded together in a fluid-tight manner. Since this is done by avoiding the assimilation of the base resin, it is not necessary to use a solvent that is compatible with the chlorinated beer resin as in the past (because of this, excess solvent may be applied to the joints). There is no need to worry about the solvent getting mixed into the medical solution through the gap (V- inside the medical device, especially in a device used to store a medical solution such as a blood bag or an infusion bag).
As mentioned above, since no solvent is used, there is no risk of material deterioration or cracking.41. The working environment of I/O will not deteriorate.

Additionally, when the base resin is combined with > 1J, compared to the case of only blocking adhesion, the operation of pressing the tube toward the connecting member (generating a force that causes the tube to expand or contract in diameter) and then pulling it (the tube This has the effect of making it difficult for the duplex to peel off when it is connected to other medical instruments by supporting it in a specific manner. Furthermore, if the base resin is filled into the gap before sterilization, blocking adhesion can be performed as the base resin solidifies during the sterilization process. Furthermore, since paste resin is used, the liquid tightness is perfect even if there is a hole in the bare surface of the tube or the like. Further, when the medical device member is a container containing a liquid such as a blood bag or an infusion bag, since no solvent is used, there is no fear of contamination with the liquid.

[Brief explanation of drawings]

Figures 1(△), (13)
The figure is a schematic front view showing an example of a medical device according to the present invention;
Fig. 4 is a sectional view showing an example of a coupling structure between a cylindrical connecting member and a tube, Fig. 5 is a sectional view showing another coupling structure, and Fig. 6 is another example of a medical device according to the present invention. FIG. 7 is a schematic side view showing (△), a (SZ-containing 11)-shaped connecting member and a block. FIG. 7 is a sectional view illustrating another example of a joint structure with a J-bu. 16, 66.70... Soft vinyl chloride {n resin dicove, 33.58... Hard cylindrical connection part {4, 68, 69
...Theba Department. Patent Applicant Dell Shi Co., Ltd. Procedural Amendment October 20, 1980 Commissioner of the Patent Office Kazuo Wakasugi 1, Indication of the Case 1988 Patent Y [Application No. 170,986 2, Name of Invention Medical Use Manufacturing method of appliances Representative director Mizo Tozawa k, 1 Voluntary correction

Claims (7)

[Claims] (1) A vinyl chloride polymer paste resin that connects at least the b-end of a hard cylindrical connecting member and a soft vinyl chloride resin duplex that is connected to a medical device member, and also contains a plasticizer. The connecting portion is substantially KI
After filling without rEJ, the medical instruments constructed in this way are heat sterilized and bonded together liquid-tightly, and with nrJ
A method for producing a medical device, characterized by assimilating the base resin. (2) The rigid cylindrical connecting member is made of hard γr vinyl chloride resin or polycarbonate resin [! A method for manufacturing a medical device according to II No. 1 Jff. (3) At least one end of the hard cylindrical connecting member forms a parallel part with the same outer diameter, and has an inner diameter part that is inserted into and connected to the soft vinyl chloride resin duplex. Method for manufacturing utensils (4) The outer surface of at least one end of the hard cylindrical connecting member is tapered to form a female taper portion, and the connecting portion of the soft vinyl chloride resin dupe is enlarged in diameter so that the inner diameter portion to be connected is right-angled. The method for manufacturing the medical device described in Section 1. (5) The inner surface of at least one end of the IF quality commercial connection member forms a female tapered portion, and the soft vinyl chloride resin tube has an outer diameter portion that is reduced in diameter and connected. The method for manufacturing the medical device described in Section 1. (6) The method for manufacturing a medical device according to claim 1, wherein the heat sterilization is A-tocrepe sterilization. (7) The method for manufacturing a medical device according to claim 1, wherein the medical device member is a container containing a liquid.