JP2001095927A - Fitting structure of medical device and method for manufacture thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device that can be simply and reliably connected to a member of any material, does not use an adhesive or a solvent type adhesive that may denature at least an adhered portion or an adhesive, the safeness of which at a biological level is questionable and has less restrictions on the manufacturing process, can be assembled simply and has no particularly complex structure. SOLUTION: A fitting structure for a medical device in which tubular soft and hard members are connected, a large diameter annular projection and a small diameter annular projection are formed in the form of concentric circles at one end of the hard member, an annular clearance is formed between both annular projections, the tubular soft member is inserted into the clearance, a cylindrical insertion member is inserted and fitted into a clearance between the tubular soft member inserted and the large diameter annular projection, and a plurality of projections is formed in the internal cavity of the large diameter projection that the insertion portion butts.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device having a specific fitting structure for connecting synthetic resin assemblies to each other, and more particularly to a member made of different materials, such as a soft member. The present invention relates to a medical device fitted so as to be hardly detached from a hard member and a method for manufacturing the same.

[0002]

2. Description of the Related Art Hitherto, when assembling a medical device composed of a plurality of components, it has been devised to connect them without using an adhesive as much as possible. This is because solvent-based adhesives that are frequently used for connecting synthetic resins have many problems as described below. That is, first
In the adhesive, the part where the medical device was applied deteriorates,
This is because there is a risk of damage. Secondly, sterilization, especially steam sterilization, may reduce the bonding strength at the connection points. Third, there is a concern that the remaining solvent may affect the living body. Fourth, an adhesive must be applied only to the connection part, which is troublesome. Therefore, Japanese Patent Application Laid-Open No. Sho 60-126166
To solve the problems caused by the solvent-based adhesive by using a curable adhesive as disclosed in the above-mentioned publication and by changing the shape of the connecting portion so that the amount of the adhesive to be used can be reduced. Has been done. However, in the above-described method, problems such as a decrease in connection strength due to sterilization and a work burden of applying an adhesive cannot be avoided. Further, the problem is not limited to the curable adhesive, but has a general defect that the bonding strength of the adhesive varies depending on the adherend and the material of the adherend is limited.

In an example in which no adhesive is used, as shown in FIG. 8, a large-diameter annular protrusion 2 provided at the lower part of a drip tube is used.
An annular gap 4 is formed between the small-diameter annular protrusion 3 and a soft tube 5 inserted into the gap 4. In this conventional example, the large-diameter annular protrusion 2 prevents the end of the infusion tube 5 connected to the drip tube from bulging outward, so that the fitting can withstand normal use. The combined strength can be obtained. However, if only this is done, if a tensile force acts on the connection portion between the tube 5 of the infusion set and the drip tube 1 for a long time, there is a possibility that the tube will be detached. This may be due to the influence of the lubricant or the like contained in the soft tube 5 as described above, or may be due to the long-term deformation and followability of the soft tube.

As disclosed in Japanese Patent Application Laid-Open No. 2-80059, a method of caulking by placing another third member on the first and second members to be connected has been studied. However, this method has limitations in the selection of materials and in the manufacturing process, which is troublesome. First, a third member (caulking member) having a lower melting point than each material of the first member (drip tube) and the second member (infusion tube)
And it was necessary to heat and melt the third member at a specific temperature. In addition, before assembling the drip tube and the infusion tube, a cylindrical caulking member had to be loaded into the infusion tube, and the caulking member had to be held near the junction between the drip tube and the infusion tube. However, it is difficult to move the caulking member on the infusion tube and hold the caulking member at a predetermined position unless there is a particular restraining means.

[0005]

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a medical device which solves various conventional problems in connection, and to provide a fitting method or a connection method therefor. . That is, an object of the present invention is to solve the following problems. (1) It is possible to simply and securely connect without being limited to the material of the connecting member. (2) Do not use adhesive. Alternatively, a solvent-type adhesive which may degrade at least the member to be bonded or an adhesive which has a problem in safety to a living body is not used. (3) Those which have few restrictions on the manufacturing process, can be easily assembled, and do not particularly have a complicated structure.

[0006]

According to the present invention, a tubular soft member and a hard member are connected, and a large-diameter annular protrusion and a small-diameter annular protrusion are formed concentrically at one end of the hard member. An annular gap is formed between the two annular projections, and a tubular soft member is inserted into the gap. A cylindrical insertion member is inserted into a gap between the inserted tubular soft member and the large-diameter annular projection. The above object has been solved by a fitting structure for a medical device, wherein a plurality of projections are formed in a lumen of a large-diameter annular projection that is inserted and abuts with the insertion member.

Further, when connecting the tubular soft member and the hard member, an annular gap formed between a large-diameter annular protrusion and a small-diameter annular protrusion provided concentrically at one end of the hard member. After the tubular soft member is inserted into the gap, the cylindrical insert member is inserted into the gap between the inserted tubular soft member and the large-diameter annular protrusion, and the lumen of the large-diameter annular protrusion that the insertion member is in contact with. The object has been solved by a method for manufacturing a medical device, wherein a plurality of outer surface portions of a large-diameter annular projection corresponding to the above are treated by a melting means.

The present inventors have sought and studied various methods for preventing the above-mentioned detachment, but inserted a tubular soft member into the annular gap between the large-diameter annular projection and the small-diameter annular projection. By forming a plurality of projections in the large-diameter annular projection in this state, it has been found that simple and effective (reproducible) long-term prevention of detachment can be obtained. In order to easily form the convex portion in the bore of the large-diameter annular protrusion, a method of partially melting the outer surface of the large-diameter annular protrusion (a plurality of locations) using a heating and melting means can be used.

[0009] It has been confirmed that the desorption preventing effect can be obtained by the above method. However, the present inventors have further found that the desorption preventing effect can be further improved by the following method. That is, the tubular soft member is inserted into the annular gap between the large-diameter annular protrusion and the small-diameter annular protrusion, and the cylindrical soft member is inserted into the gap formed between the outer surface of the inserted tubular soft member and the lumen surface of the large-diameter annular member. The insertion member is inserted (meaning that it is inserted and loaded). The contact portion (the insertion member abuts in the large-diameter annular protrusion lumen) so that a plurality of convex portions are formed in the lumen portion of the large-diameter annular protrusion that the cylindrical insertion member contacts. The outer surface portion of the large-diameter annular projection corresponding to the above is processed at a plurality of locations by the melting means. By taking the above configuration, or by the above manufacturing method, in addition to the adhesion effect between the soft member and the hard member by the cylindrical insertion member, a convex portion for pressing the cylindrical insertion member or the soft member into the large-diameter annular protrusion inner cavity. Are formed, and the effect of preventing desorption is further enhanced.

[0010]

BRIEF DESCRIPTION OF THE DRAWINGS Various embodiments of the present invention are described in more detail below with reference to the drawings. FIG. 1 is a partially enlarged view of the lower part of a drip tube of an infusion set connected by the fitting structure of the present invention. An annular projection 2 having a large diameter and an annular projection 3 having a small diameter are formed concentrically below the drip tube 1, and an annular gap 4 is formed between the annular projections. As shown in FIG. 1, the small-diameter annular protrusion 3 extends downward longer than the large-diameter annular protrusion 2. The infusion set soft tube 5 is inserted into the gap 4. More precisely, as shown in FIG. 1, the infusion tube 5 is pressed into the small-diameter annular projection 3. In this state, the outer surface of the infusion tube 5 is not in contact with the large-diameter annular protrusion inner cavity (not shown). The infusion tube 5 of this example is made of a vinyl chloride resin, and the infusion tube 1 is made of a polyolefin copolymer, but may be made of a vinyl chloride resin. The stop ring 10 of the cylindrical insertion member is made of polypropylene in this example, but may be other polyolefin, vinyl chloride resin, or a general-purpose synthetic resin.

Next, the stop ring 10 is attached to the infusion tube 5. As shown in FIGS. 2 and 3, the retaining ring 10 is formed with a single slot 13 that connects both ends 11 and 12, and the retaining ring 10 is attached to the infusion tube 5 by expanding the slot 13. Can be retrofitted).
If the stop ring is not formed with a slot, the stop ring must be inserted through the tube before assembling the drip tube and the infusion tube, but the stop ring 10 of this embodiment can be retrofitted. . The stop ring 10 inserted through the infusion tube 5 is inserted into the gap 14 formed between the outer surface of the infusion tube 5 inserted into the annular gap 4 and the inner cavity of the large-diameter annular protrusion 2. Refill. As shown in FIG. 4, the distal end portion 12 of the retaining ring 10 is formed in a tapered shape so that it can be easily inserted into the narrow gap 14. The proximal end 11 of the retaining ring is formed with a step, and defines the insertion depth of the retaining ring 10 into the gap 14.

After the infusion tube 5 is inserted, a soldering iron-shaped heating means (so that the pressed portion has a small area of a specific shape) is pressed against the outer surface of the large-diameter annular protrusion 2, as shown in FIG. Such a partially concave melting portion 6 is formed. As the formation part of the melting part 6, in the lumen of the large-diameter annular projecting part,
The effect is small unless it is on the outer surface side of the large-diameter annular projection corresponding to the point 15 in contact with the retaining ring 10. Various means for heating may be used, but a preferable one may be selected from the viewpoints of use, cost, etc., such as high frequency, ultrasonic wave, and electric heating.

In the case of heat treatment, the temperature is 100 to 1
The temperature is preferably in the range of 50 ° C., and the contact (pressing) time is preferably 1.0 to 4.0 seconds. If the heating temperature is too high,
It is difficult to adjust the melting portion 6, and if the temperature is too low, it becomes difficult to melt, and the desorption preventing effect is reduced. On the other hand, if the contact time is too long, the melting portion of the large-diameter annular protrusion becomes large. If the contact time is short, melting becomes difficult.

As a result of forming the above-described melting portion 6 on the outer surface of the large-diameter annular projection 2, a convex portion 7 or a deformed portion which is pressed against the retaining ring 10 on the inner cavity side of the large-diameter annular projection 2. Is formed. The state is shown in FIG. In FIG. 1, the convex portion 7 is exaggeratedly drawn. However, in actuality, the deformation may not always be visually recognized. The shape, size and number of the melted portions 6 formed on the outer surface of the large-diameter annular protrusion 2 for forming the convex portions 7 are not particularly limited, but are preferable and ranges from the following points. Exists.

The preferred shape of the partial melting part 6 is as follows.
Diameter D is 1.0-2.0mm, maximum part depth DP1 is 0.8
~ 1.5 mm circular recess (FIG. 7) or length L of 1.0
It is a linear or square concave (FIGS. 5 and 6) having a width W of 0.3 to 2.0 mm and a maximum depth DP2 of 0.8 to 1.5 mm. If the melting portion 6 is too large, the normal function of the connection portion is impaired, and if it is severe, there is a possibility that breakage or liquid leakage may occur. Conversely, if it is too small, an effective desorption preventing action cannot be exhibited.

The number of the partially melted portions 6 is 2 to 4
Location is preferred, more than it takes time and effort,
Below this, an effective desorption preventing action cannot be exhibited. In order to form the partial melting part 6, specifically, 100 to 15
The heating means heated to about 0 ° C. is pressed against the outer surface of the large-diameter annular protrusion 2 for 1.0 to 4.0 seconds.

As for the shape and arrangement of the partial melting portion 6, there are various embodiments other than those described above, as shown in FIGS . FIG. 6 shows a configuration in which four linear or square concaves 6 are formed on the front side and the rear side, two in each column, a total of four. Thereby, the detachment prevention effect is further reinforced. FIG. 7 shows a linear or square concave of FIG.
Is replaced with Similar effects can be obtained with less melting.

In order to increase the connection strength, it is effective to roughen the outer surface of the small-diameter annular protrusion, a part of the inner cavity of the soft tube, or both. As the degree of the rough surface, the average surface roughness Ra is 0.4 to
The range of 0.6 μm is appropriate, and if it is 0.3 μm or less, the effect of preventing desorption is small, and if it is 0.7 μm or more, it causes liquid leakage.

[0019]

The following advantages can be obtained by the fitting structure of the present invention or the manufacturing method of the present invention. (1) It is possible to simply and securely connect without being limited to the material of the connecting member. (2) It is not necessary to use an adhesive. Alternatively, there is no need to use a solvent-type adhesive that may modify the adhesive member, or an adhesive that has a problem in safety for living bodies. (3) Depending on manufacturing processes such as sterilization and long time
The connection strength is not easily reduced. (4) As a means for obtaining the effect of preventing desorption, it can be carried out quickly and simply, without any trouble.

[Brief description of the drawings]

FIG. 1 is a sectional view schematically showing an embodiment of a fitting structure according to the present invention.

FIG. 2 is a front view schematically showing an embodiment of a cylindrical insertion member according to the present invention.

3 is a plan view of the cylindrical insertion member of FIG. 2 as viewed from above.

FIG. 4 is a sectional view of the cylindrical insertion member of FIG. 2 taken along a central axis.

FIG. 5 is a perspective view schematically showing another embodiment of the present invention.

FIG. 6 is a perspective view schematically showing another embodiment of the present invention.

FIG. 7 is a perspective view schematically showing another embodiment of the present invention.

FIG. 8 is a cross-sectional view schematically showing a conventional fitting structure.

[Explanation of symbols]

1. Infusion tube 2. 2. Large-diameter annular projection 3. small-diameter annular projection Annular gap 5. 5. Flexible (infusion) tube 6. Melting part (concave) Convex part 10. Stop ring 11. Stop ring end (proximal end) 12. 12. Stop ring end (tip) Slot 14. Gap 15. Abutting portion (with large-diameter annular protrusion) [portion corresponding to protrusion forming portion] Melt length W. Melt width D. (Circular) melting part diameter DP1. (Circular) Maximum depth of the melted part DP2. (Square) Maximum depth of the melting part

Claims (12)

[Claims] 1. A tubular soft member and a hard member are connected, and a large-diameter annular protrusion and a small-diameter annular protrusion are formed concentrically at one end of the hard member. An annular gap is formed therebetween, and a tubular soft member is inserted into the gap. A cylindrical insertion member is inserted into a gap between the inserted tubular soft member and the large-diameter annular projection, and the insertion member is brought into contact therewith. A fitting structure for a medical device, wherein a plurality of projections are formed in a bore of a large-diameter annular projection that comes into contact with the projection. 2. The fitting structure for a medical device according to claim 1, wherein said cylindrical insertion member has a slot connecting both ends thereof. 3. The medical device fitting structure according to claim 1, wherein the small-diameter annular protrusion extends longer than the large-diameter annular protrusion. 4. The fitting structure for a medical device according to claim 1, wherein the soft member is a tube for transfusion or blood transfusion, and the hard member is a drip tube for transfusion or blood transfusion. 5. The fitting structure for a medical device according to claim 1, wherein the tube for transfusion / blood transfusion is made of a vinyl chloride resin, and the drip tube is made of a polyolefin copolymer. 6. A large-diameter annular projection corresponding to a lumen of the large-diameter annular projection in contact with the cylindrical insertion member so that a projection is formed in the lumen of the large-diameter annular projection. The fitting structure for a medical device according to claim 1, wherein a plurality of partial melting portions are formed on an outer surface. 7. The partial melting part has a diameter of 1.0 to 2.0 m.
m, a circular concave with a maximum depth of 0.8 to 1.5 mm, or a length of 1.0 to 3.0 mm, a width of 0.3 to 2.0 mm, and a maximum depth of 0.8 to 1.5 mm 7. The fitting structure for a medical device according to claim 6, wherein the fitting structure is a linear concave. 8. The fitting structure for a medical device according to claim 6, wherein said partially melted portion is formed at two to four places. 9. The fitting of the medical device according to claim 1, wherein either the outer surface of the small-diameter annular protrusion or the inner surface of the tubular soft member or both of them are roughened. Construction. 10. An annular gap formed between a large-diameter annular projection and a small-diameter annular projection provided concentrically at one end of a hard member when connecting a tubular soft member and a hard member. After the tubular soft member is inserted into the gap, the cylindrical insert member is inserted into the gap between the inserted tubular soft member and the large-diameter annular protrusion, and the lumen of the large-diameter annular protrusion that the insertion member is in contact with. A method for producing a medical device, comprising: treating an outer surface portion of a large-diameter annular protrusion corresponding to a plurality of portions by melting means. 11. The method for manufacturing a medical device according to claim 10, wherein the treatment by the melting means is by heating and melting. 12. The heat treatment is performed at a temperature of 100 to 150 ° C.
The method for producing a medical device according to claim 11, wherein the contact time is 1.0 to 4.0 seconds.