JPS61265149A - Production of medical tubular body - 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 Field of the Invention The present invention relates to methods of manufacturing various medical tubular bodies used in medical instruments.

Prior art and its problems There are many types of medical instruments that are constructed by appropriately combining and connecting tubular bodies such as tubes, hubs, and connectors, and bag bodies such as bags. These tubular bodies are usually bonded together using an adhesive, and the adhesive generally contains a solvent. There is a risk that this solvent will be eluted when medical instruments are used. In addition, it is not desirable for the solvent to flow into the human body. An example of a catheter connected to a conduit using a solvent is an AVF catheter (dialysis indwelling catheter).

AVF catheters that use solvent-based conduit connections use a solvent such as tetrahydrofuran to connect the conduit and wing hub, and the conduit and connector, by melting and welding the contact surfaces of the conduit, wing hub, and connector. In the assembly process, delicate control is required as the solvent directly affects the bonding strength and airtightness.
Solvents cause contamination of conduits, wing hubs, and connectors. Further, the use of a large amount of solvent is not preferable because it increases the amount of substances eluted from the solvent and increases the amount flowing into the human body.

From this point of view, it is best to connect only the constituent materials of the parts to be connected, and it is a simple method for medical
There is a strong need for the development of a method for manufacturing safe medical tubular bodies.

mm OBJECT OF THE INVENTION Accordingly, an object of the present invention is to solve the above-mentioned problems of the prior art and to provide a method for manufacturing a medical tubular body by a simple method without using solvents or adhesives.

■Specific structure of the invention According to the first aspect of the invention, two tubular bodies, at least one of which is made of thermoplastic resin, are formed, and at least one of the tubular bodies is in contact with the other. Either one of the tubular bodies is rotated, or at least one of the tubular bodies is brought into contact while being rotated, and the contact portion of the thermoplastic resin tubular body generates heat to bring the tubular body into a liquid-tight state. A method for manufacturing a medical tubular body characterized by fusion bonding is provided.

According to the second aspect of the present invention, two tubular bodies, at least one of which is made of thermoplastic resin, are formed, and a lubricant is applied or applied to one or both of the parts to be joined of the tubular bodies. The thermoplastic resin Provided is a method for manufacturing a medical tubular body, which is characterized in that the contacting portions of the tubular bodies are heated to fuse the tubular bodies in a liquid-tight state.

During exothermic fusion due to the rotation of the tubular body, the rotation speed is 5
00~110000rp, insertion speed is 20~100m5
/SeC is preferable. It is preferable to apply a lubricant to the joints of the tubular bodies before rotational fusing, and the lubricant is most preferably water or alcohol.

Although there are various types of tubular bodies, soft vinyl chloride resin tubes are often used in medical devices. Therefore, at least one of the tubular bodies is often a soft vinyl chloride resin tube.

Next, a method for joining tubular bodies according to the present invention will be described in detail with reference to the drawings.

First, the thermoplastic synthetic resin used in the method of the present invention includes vinyl chloride, polycarbonate, and the like.

The tubular body made of thermoplastic resin is manufactured by a known method, for example,
Molded by extrusion molding, injection molding, etc.

Tubular bodies used in medical devices include tubes,
There are various types such as hubs and connectors, and the present invention is a manufacturing method that includes a step of joining two such tubular bodies. In the explanation below.

Although the wing hub, tube, and connector of an intravenous nailed catheter are typically connected, the present invention is not limited thereto, and can of course be applied to connections of various tubular bodies. Further, although most tubular bodies generally have a uniform diameter, they may have portions with different diameters, and it is preferable that the tubular bodies to be joined have a difference in inner and outer diameters. Furthermore, a tubular body with a taper on one or both sides may be used. The joining portion of the tubular body is not limited to the end portion thereof, but may be an enlarged diameter portion of the tubular body to be fitted.

FIG. 1 shows the state of the intravenous nailed catheter 1 before connection.

In the figure, 2 is a tube, 3 is a hub having a needle 4 and wings 5, and 6 is a connector. Wing hub 3 has a polymerization degree of 700 to 3000 and a plasticizer of 10 to 110p.
The outer diameter of the fitting part for connection is preferably 0.2 to 1.0 mm larger than the inner diameter of the tube 2.
2 ■Large, the length of the mating part is 3.0 to 20.0 m11
There is.

Tube 2 has a degree of polymerization of 700 to 3000 and a plasticizer of 1O to
Made of 110 phr polyvinyl chloride resin.

Connector 6 has a polymerization degree of 700 to 3000 and a plasticizer of 10
It is made of ~110 phr vinyl chloride resin, polypropylene, ABS resin, or polycarbonate resin, and the outer diameter of the fitting part for connection is 0.2 to 1.2 + am larger than the inner diameter of the tube 2, and the length of the fitting part is is 3.0
~20.0mm.

For example, as shown by arrow 7, the wing hub 5 is connected to the tube 2 and the wing hub 3 by fitting each other for a predetermined length.
While rotating, contact the tube 2, or
Rotate the wing hub 5 with the two in contact,
The frictional heat generated between each member melts and fuses the contact parts. Further, the tube 2 and the connector 6 can be fused together in the same manner. The contact between the connecting members is preferably such that one fits into the other. The contact is
In addition to this insertion, the ends of the members to be joined may come into contact with each other. The following will explain the case where it is inserted. In FIG. 1, the wing hub 3 and the connector 6, which have a short overall length and are easy to fix and rotate, are rotated, but it is also possible to rotate both of the members to be joined. Hereinafter, applying rotation to one or both of the members to be joined will be referred to as relative rotation. The following steps are briefly described in the following two ways, and each step will be explained below.

(1) Relative rotation of each member → Fitting of joints (e.g. ends) of each member → Fusion (2) Applying lubricant to the end of each member → Relative rotation → Fitting → Fusion or corner parts Relative rotation→Applying lubricant to the end portion→Fitting→Fusing As shown in FIG. 1, lubricant is applied to the outer end portion of the tube 2, the hub 3, and the inner end portion of the connector 6. The coating may be applied either before or during rotation of the hub 3 (as long as it is before fitting). Lubricant can be applied to either or both of the connections. Further, if the members to be connected have good smoothness during rotation, it is not necessarily necessary to apply lubricant.

It is preferable that the lubricant used does not interfere with thermal fusion and is harmless to the human body. Examples of such lubricants include water and lower alcohols.

Next, in the example shown in FIG. 1 in which each joint member with or without lubricant is relatively rotated, relative rotation is applied between the tube 2, the hub 3, and the connector 6.

The relative rotational speed during relative rotation is a function of many factors such as the constituent materials of the tubular bodies to be joined, the difference in inner and outer diameters, and the presence or absence of lubricant, but it is preferably in the range of 500 to 11,000 Orp. This is because if the rotation speed is less than 50 Orpm, it will be difficult to fit in, and if it exceeds +000 Orpm, the connecting surface will become rough.

Furthermore, the hub 3 and connector 6 are fitted into the tube 2 over a required length. The fitted long screws will be the length of the final joint. Therefore, the length of the fitting portion is appropriately selected so that the required bonding force and liquid tightness, which will be described later, can be obtained for the finished product.

The insertion speed of the tubular bodies is 20 to Inmm/s.
It is better to use ec. If the insertion speed is less than 20 am/sec, the connecting surface will become rough, and if it exceeds 100 mm/see, the tube will buckle, making insertion difficult.

Due to the relative rotation of the tubular bodies as described above, the fitting portions are heated by friction due to the rotation, and the tube 2 and hub 3 shown in FIG.
And the fitting part of the connector 6 is partially melted. When the rotation is stopped, the molten parts of the tube 2, hub 3, and connector 6 cool down, and the fitting parts of the two become integrated, resulting in a complete joint. This state is shown in FIG. 2 as a partial sectional view.

As shown in FIG. 2, the end of the tube 2 is fused onto the hub 3, and the end of the tube 2 is fused onto the connector 6L. The joint between the tubular bodies fused together in this way must have sufficient joining force and liquid (air) tightness against the fluid flowing inside the tubular body during use.

The required level of bonding strength and watertightness of a joint differs depending on the type of medical device. An example of this is shown in Table 1 below.

Table 1 Note that the bonding force and airtightness were measured as follows.

(1) Bonding strength A weight of the required level depending on the product type is hung below the joint, and after 2 hours it is checked to see if it has come loose. (The required weight depending on the product type is approximately I kg for a dialysis blood circuit, and approximately 4 kg-t' for an AVF catheter.) Alternatively, use a strograph at a pulling speed of 100 mm/s.
Measure in ee.

(2) Apply internal pressure to the airtight joint at the required level depending on the product type and check for leaks after 5 seconds.

(2) Specific Effects of the Invention The effects of the present invention will be specifically explained with respect to the method of joining the wing hub, tube, and connector of the intravenous needle catheter shown in FIG.

First, wing hub 3 and tube 2 of the intravenous needle catheter.
and the connector 6 is arranged as shown in FIG. Next, relative rotation is applied to the wing hub 3 and the connector 6.

Prior to this relative rotation operation between the wing hub 3 and the connector 6, if lubricant is applied to at least one of the joints between the tube 2 and the hub 3, and between the tube 2 and the connector 6, it is possible to continue the relative rotation operation. The insertion operation becomes easier.

As the lubricant, it is preferable to use water or lower alcohol, which does not pose a medical problem.

The hub 3' and connector 6 are inserted into the tube 2 while applying relative rotation between the tube 2, the hub 3, and the connector 6. As a result, heat is generated due to friction between the fitting portions of the tube 2, hub 3, and connector 6, and melting occurs at the joint portions.

When the melting of the joint has progressed to a certain extent, the relative rotation is stopped. This causes the molten part of the joint to cool and solidify,
be integrated. In this way, as shown in Figure 2,
The tube 2, the hub 3, and the connector 6 are integrally joined by a simple method without using a solvent, and sufficient joining strength and airtightness can be obtained at the joint.

■　Example Next, the present invention will be specifically explained using examples.

(Example 1) A wing hub made of polyvinyl chloride with a degree of polymerization of 1000 and a plasticizer of 40 phr, and a wing hub made of polyvinyl chloride with a degree of polymerization of 2300 and a plasticizer of 75 phr.
A polyvinyl chloride tube of 300 hr was used. The outer diameter of the fitting portion of the wing hub was 4.2 mmφ, the inner diameter of the fitting portion of the tube was 3.5 mmφ, the length of the joint portion was 8 mm, and the hub was fitted into the tube while rotating at a rotational speed of 2500 to 5000 rpm. The insertion speed is 15+++m/sec
I went there.

The joining force between the tube and the hub of the obtained medical tubular body was 4 kg/+am2 or more, and the airtightness against internal pressure was 1.4 kg/cm2 or more.

(Example 2) A tube made of polyvinyl chloride with a degree of polymerization of 2300 and a plasticizer of 75 phr and a connector made of polycarbonate resin were coated with isopropyl alcohol on the inner surface of the tube fitting portion in advance. The outer diameter of the fitting part of the connector is 4.2+omφ,
The inner diameter of the fitting part of the tube was 3.5 mmφ, the length of the joint part was 10 mm, and the connector was fitted into the tube while rotating at a speed of 1000 to 3000 rpm. The insertion speed was 301 cm/see.

The bonding force between the tube and the connector of the obtained medical tubular body was 4 kg/mm2 or more, and the airtightness against internal pressure was 1.4 kg/cm2 or more.

■Specific Effects of the Invention In the present invention, when joining tubular bodies, both tubular bodies are fitted while being given relative rotation, and the fitting portion of the tubular bodies is heated by friction and melted, and the rotation is stopped. Secure the mating part.

In the present invention, since no solvent is used, the solvent does not elute when the medical device is used, so a medical tubular body that is safe as a medical device can be easily manufactured. Further, no time for curing or drying of a solvent is required. There is no need to delicately control the amount of solvent, it is easy to manufacture, and a medical tubular body with reliable bonding strength and airtightness can be manufactured.

Furthermore, if the rotation speed is 50 Orpm - 11,000 Orp, the component itself will pick up the center of the conduit due to rotation and insertion will be easily performed without requiring highly accurate positioning during insertion. Bonding force of 4Kg or more 1.4Kg/C
Airtightness against internal pressures of 112 or more can be obtained. insert,
The connection is secure.

Moreover, if the insertion speed of the tubular body is 20 to 100 mm/sec, insertion and connection will become easier.

Applying a harmless lubricant such as water or alcohol to one or both of the tubular bodies before inserting them into each other will ensure smooth insertion and ensure that the materials of the tubular bodies are comparable. Buckling of the tubular body does not occur even when the tubular body is soft.

Furthermore, it is possible to prevent the occurrence of scratches or cracks on the tube, wing hub, or connector during insertion.

[Brief explanation of drawings]

FIG. 1 is a side view showing the state before the wing hub, tube, and connector are joined. FIG. 2 is a partial sectional view showing the state after the members shown in FIG. 1 are joined. Explanation of symbols

Claims (11)

[Claims] (1) Forming two tubular bodies, at least one of which is made of thermoplastic resin, and applying rotation to at least one of the tubular bodies with one of the tubular bodies in contact with the other, or at least Production of a medical tubular body, characterized in that the tubular body is brought into contact with one of the tubular bodies while being rotated, and the contact portion of the thermoplastic resin tubular body is heated to fuse the tubular bodies in a liquid-tight state. Method. (2) The method for manufacturing a medical tubular body according to claim 1, wherein the contact is insertion. (3) The method for manufacturing a medical tubular body according to claim 1 or 2, wherein at least one of the tubular bodies is made of soft vinyl chloride resin. (4) The rotation speed of the rotation is 500 to 10,000 rpm
The method for manufacturing a medical tubular body according to any one of claims 1 to 3, wherein the method is m. (5) The insertion speed of the tubular body is 20 to 100 mm/se
The method for manufacturing a medical tubular body according to any one of claims 1 to 4, which is: c. (6) Two tubular bodies, at least one of which is made of thermoplastic resin, are formed, and a lubricant is applied to one or both of the parts to be joined of the tubular bodies, or while the lubricant is applied, one of the tubular bodies is At least one of the tubular bodies is rotated while one of them is in contact with the other, or at least one of the tubular bodies is brought into contact while being rotated, and the contact portion of the thermoplastic resin tubular body is 1. A method for producing a medical tubular body, which comprises generating heat to fuse the tubular body in a liquid-tight state. (7) The method for manufacturing a medical tubular body according to claim 6, wherein the contact is insertion. (8) The method for manufacturing a medical tubular body according to claim 6 or 7, wherein at least one of the tubular bodies is made of soft vinyl chloride resin. (9) The rotational speed of the rotation is 500 to 10,000 rpm
The method for manufacturing a medical tubular body according to claim 6 or 7, wherein the method is m. (10) The insertion speed of the tubular body is 20 to 100 mm/s
The method for manufacturing a medical tubular body according to any one of claims 6 to 9, which is ec. (11) The method for manufacturing a medical tubular body according to any one of claims 6 to 10, wherein the lubricant is water or an alcohol solution.