JP2838707B2 - Medical instruments and methods of making them - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a medical device and a method for manufacturing the same, and in particular, a connecting tube made of a polyvinyl chloride resin is connected to a main body made of an ethylene-vinyl acetate copolymer resin. The present invention relates to a structure of the joining portion of a medical bag and a manufacturing method thereof.

[Prior art] Conventionally, in a medical synthetic resin container, a medical bag used for dispensing a plurality of infusions and medicines in a hospital at the time of use includes polyethylene, polypropylene, polyvinyl chloride and the like. There was something.

However, medical bags made of polyethylene and polypropylene are inflexible, and thus have a drawback that closed-system infusion cannot be performed. Further, the medical bag made of polyvinyl chloride has no problem in flexibility, but has a drawback that a plasticizer or the like added to the polyvinyl chloride resin is eluted into the content liquid.

For this reason, medical bags made of ethylene-vinyl acetate copolymer resin, which do not have these disadvantages, have recently been used. This medical bag is made by using two sheets made of an ethylene-vinyl acetate copolymer resin and fusing the peripheral edge thereof with a high-frequency seal or a heat seal.

[Problems to be Solved by the Invention] By the way, this bag needs a tube for introducing a necessary number of infusion agents for dispensing at the time of use. The functions required for the tube must be able to be closed and cut after the preparation is completed, in addition to passing the liquid. The method of closing and cutting is as follows: (1) A loop is formed, tied up, and then cut.

(2) After closing by caulking with an aluminum ring, cut.

(3) There is a method of cutting after closing by high-frequency fusion or heat sealing.

The tube material that sufficiently satisfies the functions required for these tubes is polyvinyl chloride resin, but the sheet made of ethylene-vinyl acetate copolymer resin and the tube made of polyvinyl chloride resin cannot be fused by high-frequency fusion. For this reason, conventionally, an ethylene-vinyl acetate copolymer resin tube has been used for an ethylene-vinyl acetate copolymer resin sheet.
Here, heat sealing is not suitable as a method of fusing the sheet and the tube. Therefore, conventionally, a medical bag has been manufactured by combining an ethylene-vinyl acetate copolymer resin sheet and an ethylene-vinyl acetate copolymer resin tube and fusing them by high frequency fusion.

However, in the case of the tube made of an ethylene-vinyl acetate copolymer resin, there is a problem that it is difficult to close and cut the tube after the preparation is completed.

Further, as another conventional example, after the above-mentioned tube made of ethylene-vinyl acetate copolymer resin is fused to a sheet made of ethylene-vinyl acetate copolymer resin by high-frequency fusion, the tube is cut into short pieces (cut short beforehand). After that, fusion may be performed by high-frequency fusion), and a tube made of a polyvinyl chloride resin provided with a relay tube is connected to the tube. As the relay pipe, a pipe formed by inserting a relay pipe made of polypropylene, polyethylene, or polycarbonate into a hard polyvinyl chloride resin tube or a soft polyvinyl chloride resin tube was used.

However, in this method, there is almost no problem when the medical bag is empty, but when pressure is applied after the bag is filled with the drug solution, the tube made of ethylene-vinyl acetate copolymer resin and polyvinyl chloride resin becomes a tube. The chemical leaks from the joint,
Alternatively, the two may be disconnected from each other, which has been a problem.

The present invention has been made in view of such a problem, and an object thereof is to provide a first medical device and a second medical device formed of different synthetic resins such as a medical bag and a connecting tube. It is an object of the present invention to provide a medical device and a method for manufacturing the same, which can be integrated by bonding the concrete with sufficient strength and can solve the conventional problems.

[Means for Solving the Problems] In order to solve the above-mentioned conventional problems, a medical device according to the present invention has a first portion to be fused, and at least the portion to be fused is made of a synthetic resin. The first medical device includes a first medical device and a second fused portion corresponding to the fused portion of the first medical device. At least the second fused portion includes the first medical device. A second medical device made of a synthetic resin different from the first portion to be fused and a joined body of the first resin film and the second resin film, wherein the first medical device and the second medical device And a bonding multi-layered film member interposed between the first medical device and the second medical device. The first resin film is fused to the first portion to be fused of the first medical device. And the second resin film is fused to the second portion to be fused of the second medical device, and the first resin film is fused. The film is made of a resin having good fusibility with the first portion to be fused of the first medical device, and the second resin film is formed of a second material to be fused on the second medical device. And a resin having a good fusibility.

Here, it is preferable that the first medical device is a medical bag and the second medical device is a connecting tube, and the fused portion of the medical bag is a cylindrical connecting device. Part, it is preferable that the distal end of the connecting tube is inserted into the connecting portion, and the joining multilayer film member is a connecting portion of the medical bag and one end of the connecting tube. Preferably, the medical bag inner side end of each of the connecting multilayer film member and the connecting tube on the inner wall surface of the connecting portion, An annular inflow prevention member formed of the same synthetic resin as the connection tube with a thickness corresponding to at least the sum of the thickness of the bonding multilayer film member and the thickness of the connection tube is joined to the portion. It is preferable that the are.

In addition, the method for manufacturing a medical device according to the present invention is a method for manufacturing a medical device by integrating a first medical device specific material and a second medical device specific material made of a synthetic resin at least in which the parts to be fused are made of different materials. A method for manufacturing, comprising: a first resin film having good fusion-bonding property with a first fusion-bonded portion of the first medical device, and a second fusion-bonded portion of the second medical device. Forming a bonding multilayer film member by bonding the first medical device and the second medical device to each other. A first film to be fused and the first resin film of the first medical device, a second film to be fused of the second medical device and the second film to be fused are interposed with a multilayer film member. And a step of fusing the resin films to each other. Here, the first medical device and the first fused portion are formed of an ethylene-vinyl acetate copolymer, and the second medical device and the second fused portion are formed of polyvinyl chloride. Preferably, the first resin film is formed of an ethylene-vinyl acetate copolymer, and the second resin film is formed of a polyvinyl chloride resin. Preferably, the first medical device is a medical bag and the second medical device is a connecting tube, and the first medical device is a medical bag, and the first medical device is a medical bag. At each of the first medical device specific inside end portions of the multilayer film member and the connecting tube, a thickness corresponding to the sum of the thickness of the joining multilayer film member and the thickness of the connecting tube is used. And ethylene-vinegar Vinyl copolymer made of the resin inflow prevention member preferably formed by fusing mounted annularly.

[Operation] In the present invention having the above configuration, the first medical device specific first fusion-bonded portion and the first resin film, the second medical device specific second fusion-bonded portion and the second medical device specific second medical device specific second medical device specific. Are firmly adhered to each other, so that the substantial adhesive strength between the first medical device embodiment and the second medical device embodiment is between the first resin film and the second resin film. Adhesive strength, the first
The adhesive strength is greatly improved as compared with the case where the medical device specific and the second medical device specific are directly fused.

Embodiment An embodiment of the present invention will be described below with reference to the drawings.

FIG. 1 shows the overall structure of a medical bag according to one embodiment of the present invention. In the drawing, reference numeral 1 denotes a medical bag main body as a first medical device specific example, and a connecting tube 3 as a second medical device specific example is connected to a cylindrical connecting portion 2 provided in the medical bag main body 1. One end is fused. From the connection tube 3, a medical solution or the like is introduced into the medical bag main body 1.

The medical bag main body 1 is formed of an ethylene-vinyl acetate copolymer resin which has excellent flexibility and does not elute a plasticizer together with the connecting portion 2. On the other hand, the connection tube 3 is formed of a polyvinyl chloride resin which is easy to close and cut after passing the liquid.

As described above, it is difficult to bond the ethylene-vinyl acetate copolymer resin and the polyvinyl chloride resin by high-frequency fusion, and even if fused, they are easily peeled off when pulled.

Therefore, in this embodiment, as shown in FIG. 2, the connecting portion 2 and the connecting tube 3 of the medical bag body 1 are taken out.
And an annular laminated film 4 is interposed therebetween. The laminated film 4 is used for the medical bag body 1.
Has a two-layer structure including a first resin film 4a fused to the connecting portion 2 and a second resin film 4b fused to the connecting tube 3, and the first resin film 4a and the second resin The film 4b is adhered by an adhesive.

The first resin film 4a is formed of a resin having good adhesion to the ethylene-vinyl acetate copolymer resin, for example, the same ethylene-vinyl acetate copolymer resin.
Is formed of a resin having good adhesion to polyvinyl chloride resin, for example, the same polyvinyl chloride resin. The connecting portion 2 of the medical bag body 1 and the first resin film 4a, the connecting tube 3 and the second resin The films 4b are firmly bonded to each other by high-frequency fusion.

That is, in the medical bag of the present embodiment, the connection portion 2 of the medical bag main body 1 and the first resin film 4a, and the connection tube 3 and the second resin film 4b are substantially integrated. It is in a state. Therefore, the substantial adhesive strength between the medical bag main body 1 and the connecting tube 3 is the strength of the adhesive between the first resin film 4a and the second resin film 4b. Therefore, the bonding strength is greatly improved as compared with the case where the connecting portion 2 of the medical bag main body 1 and the connecting tube 3 are directly bonded by high-frequency fusion, and pressure is applied after the medical bag is filled with the drug solution. Also,
There is no leakage of the chemical solution and no separation of the joint as in the conventional case.

Next, a method for manufacturing the medical bag will be described. First, a sheet made of an ethylene-vinyl acetate copolymer resin and a connecting tube made of a polyvinyl chloride resin to be the medical bag main body 1 are prepared, respectively, and a laminate film is prepared as a joining member of the two.

The laminate film is formed into two layers by multilayer extrusion of an ethylene-vinyl acetate copolymer resin and polyvinyl chloride. In this laminated film, ethylene-
The content of vinyl acetate in the vinyl acetate copolymer resin is 1 to 40%,
Preferably it is 5 to 30%, more preferably 10 to 20%.
The plasticizer content of the polyvinyl chloride resin is 5 to 80 parts by weight, preferably 15 to 70 parts by weight, more preferably 30 to 60 parts by weight. The thickness of the laminate film is 20 to 30μ, preferably 50 to 200μ, more preferably 100 to 150μ. The ratio between the ethylene-vinyl acetate copolymer resin layer and the polyvinyl chloride resin layer in the laminate film is as follows: ethylene-vinyl acetate copolymer resin: polyvinyl chloride resin = 10: 90 to 90:10, preferably 30:70 It is ~ 70: 30. As the adhesive used for bonding the ethylene-vinyl acetate copolymer resin layer and the polyvinyl chloride resin layer, a two-part curable adhesive such as an epoxy-based or urethane-based adhesive is preferable.

Next, the laminated film is bent with the polyvinyl chloride resin layer surface inside, and a part to be partially overlapped is line-sealed, and unnecessary parts are cut into a cylindrical shape. The inner diameter of the tubular laminated film needs to be set to be substantially the same as the outer diameter of the tube so that the tube can be covered with the polyvinyl chloride resin tube. Subsequently, this cylindrical laminated film is cut into a length that falls within the area to be fused between the ethylene-vinyl acetate copolymer resin sheet and the polyvinyl chloride resin tube.

Next, as shown in FIG. 3, the cut tubular laminated film 4 is put on the fusion bonding position of the connecting tube 3 made of polyvinyl chloride resin, and in this state, the tube is put on two sheets of ethylene-vinyl acetate. It is interposed between the polymer resin sheets 5a and 5b. Thereafter, sheets 5a and 5b made of ethylene-vinyl acetate copolymer resin and laminated film 4 are formed by high frequency fusion.
Between the ethylene-vinyl acetate copolymer resin layer, the connecting tube 3 made of polyvinyl chloride resin and the polyvinyl chloride resin layer on the laminate film 4 side, and a sheet 5a made of ethylene-vinyl acetate copolymer resin. , 5b are adhered to each other to produce a medical bag.

Next, the present inventors conducted the following experiments in order to confirm the effects of the present invention.

(Example 1) A sheet made of an ethylene-vinyl acetate copolymer resin having a thickness of 0.4 mm, a polyvinyl chloride resin tube having an inner diameter of 5.0 mm, an inner diameter of 7.0 mm, and a length of 800 mm, and a laminated film having a thickness of 0.14 mm were used. The medical bag shown in FIG. 1 was produced by the method. The cylindrical laminate film was cut so that the folding diameter was 12 mm and the length of the cylinder was 10 mm. Further, when this cylindrical laminated film was covered with a polyvinyl chloride resin tube, the end of the tube was set so as to protrude from the end of the laminated film tube by 2 to 3 mm.

The medical bag manufactured in this manner was subjected to a tensile test using a medical bag manufactured without a laminated film as a comparative example, and the tensile breaking load (kgf) was examined. The pulling speed is 100 mm / min. Table 1 shows the results.

In the tensile fracture state, in Example 1, the polyvinyl chloride resin tube was broken, whereas in Comparative Example 1, the polyvinyl chloride resin tube came off from the medical bag body.

(Example 2) A 0.14 mm thick laminated film was sandwiched between a 0.4 mm thick ethylene-vinyl acetate copolymer resin sheet and a 0.4 mm thick polyvinyl chloride resin sheet, and the width was 5 mm.
Then, the bar seal was subjected to high frequency welding to produce a No. 1 type test piece such that the high frequency welding portion was located at the center. Then, a tensile peel test of this test piece was carried out as a comparative example in which a laminate film was not inserted. The pulling speed is 200 mm / min. The results are shown in Table 2 (unit: kgf).

In the peeling state, the adhesive surface of the laminate film was broken in Example 2, whereas the peeling state was in Comparative Example 2 from the fused surface.

According to Experimental Examples 1 and 2, when no laminate film was used, the polyvinyl chloride resin tube was pulled out or the fused surface was peeled off. The fact that the tube and sheet are broken or broken before the adhesive surface of the film is peeled off, which means that the substantial adhesive force between the medical bag body 1 and the connecting tube 3 shown in FIG. 1 can be sufficiently ensured. Can be.

FIG. 4 shows another embodiment of the present invention. As described above, in the present invention, the connecting tube 3 made of polyvinyl chloride resin can be firmly integrated with the medical bag main body 1 made of ethylene-vinyl acetate copolymer resin. There is such a problem.

That is, the connecting tube 3 is connected to the laminate film 4.
When the high-frequency fusion is performed to the medical bag main body 1 through the
It is necessary to simultaneously fuse two drug mixing tubes 5 and outlet tubes 6 made of a vinyl acetate copolymer resin. At this time, as the polyvinyl chloride resin, the ethylene-vinyl acetate copolymer resin has better high frequency characteristics, so that if the fusion conditions are adjusted to the ethylene-vinyl acetate copolymer resin, the polyvinyl chloride resin melts out. The melted resin flows into the medical bag main body 1 as a dango-like mass. If this dango-shaped mass is present, when a sheet of an ethylene-vinyl acetate copolymer resin is pressure-bonded with a mold to produce the medical bag main body 1, the sheet becomes thin in the mass portion, There is a risk that a pinhole will be formed in that part, making it unusable.

Therefore, in the present embodiment, in order to prevent the polyvinyl chloride resin from flowing into the medical bag main body 1, the end portions of the laminate film 4 and the connecting tube 3 on the inner side of the medical bag main body 1 are provided with ethylene. -An annular resin inflow prevention member 7 made of vinyl acetate copolymer resin is interposed. That is, by simultaneously fusing the connecting tube 3 and the connecting portion 2 with the connecting tube 3 and the connecting portion 2, the resin inflow prevention member 7 is also fused. It prevents the inflow of lumps.

As for the diameter of the resin inflow prevention member 7, the inner diameter is the same as the inner diameter of the connecting tube 3, and the outer diameter is the same as the inner diameter of the connecting portion 2, that is, it corresponds to the sum of the thickness of the laminate film 4 and the connecting tube 3. It is sufficient to set the thickness to the size that
In order to reliably prevent the inflow of the polyvinyl chloride resin, it is preferable to set the wall thickness to be slightly larger. Specifically, for example, the connecting tube 3 has an inner diameter of 5 mm and an outer diameter of 7 mm,
When the thickness of the laminate film 4 is 0.14 mm, the resin inflow prevention member 7 has an inner diameter of 5.0 mm and an outer diameter of 7.5 mm. The length of the resin inflow prevention member 7 is approximately 5 to 7 m when the length of the fusion portion between the connection tube 3 and the connection portion 2 is 10 to 12 mm.
m.

[Effects of the Invention] As described above, according to the present invention, at least a medical device obtained by integrating a first medical device specific example and a second medical specific example made of synthetic resin whose fusion parts are different from each other, Between the first medical device concrete and the second medical device concrete, a bonding multilayer film member made of a resin film having a fusion-bonding property and each of the fused parts of each medical device concrete is interposed, Since the resins having good fusion bondability are bonded by high-frequency fusion, the substantial adhesive strength between the first medical device specific and the second medical specific device is reduced between the resin films constituting the bonding film member. , And the bonding strength is greatly improved as compared with the related art, so that there is no possibility that the bonding portion is damaged.

[Brief description of the drawings]

FIG. 1 is a front view showing the overall structure of a medical bag according to one embodiment of the present invention, FIG. 2 is a cross-sectional view showing an enlarged main part of FIG. 1, and FIG. 3 is the structure shown in FIG. FIG. 4 is an exploded perspective view for explaining a manufacturing method of the blood bag, and FIG. 4 is a sectional view showing a main part of a blood bag according to another embodiment of the present invention. DESCRIPTION OF SYMBOLS 1 ... Medical bag 2 ... Connection part 3 ... Connection tube 4 ... Laminated film 4a ... First resin film 4b ... Second resin film 7 ... Resin inflow prevention member

──────────────────────────────────────────────────続 き Continued on the front page (58) Fields surveyed (Int. Cl. ⁶ , DB name) A61J 1/00 331 A A61J 1/00 335 A A61J 1/00 330 B

Claims (10)

(57) [Claims] 1. A first medical device having a first portion to be fused and at least the portion to be fused made of synthetic resin, and a first portion to be fused of the first medical device. A second medical device made of a synthetic resin having a corresponding second fused portion and at least the second fused portion being different from the first fused portion of the first medical device. A joined body of a first resin film and a second resin film, wherein the first medical device and the second medical device are interposed between and joined to each other. And a first medical device of the first medical device.
The first resin film is fused to the portion to be fused of the second medical device, and the second resin film is fused to the second portion to be fused of the second medical device. The resin film of the first medical device is made of a resin having good fusibility with the first portion to be fused of the first medical device, and the second resin film is formed of the second material of the second medical device. A medical device comprising a fusion-bonded portion and a resin having good fusion-bonding properties. 2. The medical device according to claim 1, wherein the first medical device is a medical bag, and the second medical device is a connection tube. 3. The medical device according to claim 2, wherein the portion to be fused of the medical bag is a cylindrical connecting portion, and the distal end of the connecting tube is inserted into the connecting portion. 4. The medical device according to claim 3, wherein the joining multilayer film member is annularly interposed between the connecting portion of the medical bag and one end of the connecting tube. 5. At least the thickness of the joining multilayer film member on the inner wall surface of the connecting portion and at the inside end of the medical bag of each of the joining multilayer film member and the joining tube. 5. The medical device according to claim 4, wherein an annular inflow prevention member formed of the same synthetic resin as the connection tube has a thickness corresponding to a sum of a thickness of the connection tube and a thickness of the connection tube. 6. A method of manufacturing a medical device by integrating a first medical device specific material and a second medical device specific material made of synthetic resin at least in which the parts to be fused are made of different materials,
A first resin film having a good fusion-bonding property with the first fused portion of the first medical device and the second resin film of the second medical device;
Forming a multilayer film member for bonding by bonding the portion to be fused and the second resin film having good fusion bonding property to each other, and the first medical device specific and the second medical device specific. The multilayer film member for joining is interposed between the first medical device and the first fusion-bonded portion of the first medical device, the first resin film, and the second fusion device of the second medical device. A step of fusing the portion and the second resin film to each other, respectively. 7. The first medical device and the first portion to be fused are formed of an ethylene-vinyl acetate copolymer.
7. The method for manufacturing a medical device according to claim 6, wherein the second medical device and the second portion to be fused are formed of polyvinyl chloride resin. 8. The method for manufacturing a medical device according to claim 7, wherein said first resin film is formed of an ethylene-vinyl acetate copolymer, and said second resin film is formed of a polyvinyl chloride resin. 9. The method for manufacturing a medical device according to claim 6, wherein the first medical device is a medical bag, and the second medical device is a connection tube. . 10. The bonding multilayer on the first fusion-bonded portion and at the first medical device specific inner side end of each of the bonding multilayer film member and the connecting tube. 10. A resin inflow prevention member made of an ethylene-vinyl acetate copolymer and having a thickness corresponding to the sum of the thickness of the film member and the thickness of the connecting tube, and fused. A method for producing the medical device according to the above.