JP2002035122A - Medical implement and its manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical implement for rigidly connecting a plurality of members in a short time and a method for manufacturing the same. SOLUTION: The medical implement comprises a liquid flow passage obtained by caulking a plurality of members formed of materials having different characteristics by ultrasonic swaging treatment and connecting the members. The method for manufacturing the same is provided.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device using ultrasonic bonding technology, in which ultrasonic vibrations are applied to superposed members made of different materials such as metal or resin to join the members together. Which belongs to the technical field that enables the production of

[0002]

2. Description of the Related Art Conventionally, as this type of liquid introduction needle, for example, one disclosed in Japanese Utility Model Registration No. 3012310 (known example) is known.

[0003] The feature of this device is that a spiral portion is provided at the base of the needle tube main body, and is screwed and connected to a rubber stopper of the infusion bottle by a wing body.

[0004] A technique of bonding members having different required characteristics with an adhesive or fitting them together to integrate them is widely known (known technique).

[0005]

In the above-mentioned known example, the connection between the infusion bottle and the needle tube main body is made by screw means. There was a risk of causing leakage.

Further, in the above-mentioned prior art, the bonding process takes a long time, and it is difficult to ensure a stable bonding state, and there is a possibility that the bonding strength becomes insufficient.

[0007] Even in the case of the fitting means, the connection strength is weak,
There was a risk that both would be separated.

The present invention has the following object.

A first problem to be solved by the present invention is to provide a medical device in which a plurality of members made of materials having different characteristics are firmly connected.

A second problem to be solved by the present invention is to provide a medical device in which a plurality of members formed of materials having different characteristics are relatively rotatably connected by swaging.

A third problem to be solved by the present invention is to manufacture a medical device which can surely join medical devices made of a combination of a plurality of materials having different characteristics without being separated in a short time. Is to provide a way.

A fourth problem to be solved by the present invention is to provide a method for manufacturing a medical device by joining materials having different characteristics in a short time by caulking using ultrasonic vibration energy. It is to be.

[0013]

Means for solving the above problems are as follows.

(1) A medical device provided with a liquid flow passage capable of being used for blood transfusion, transfusion, or the like, including at least a plurality of members made of materials having different characteristics, wherein the members are formed by swaging or the like. A medical device characterized by being bonded by an ultrasonic bonding process.

(2) The medical device according to (1), wherein the plurality of members are relatively non-rotatably coupled.

(3) The medical device according to (2), wherein a roughened surface is formed in an ultrasonic bonding region of at least one of the plurality of members.

Therefore, it is possible to obtain a highly reliable medical device in which members having different characteristics and having liquid flow passages are securely joined.

(4) The medical device according to (1), wherein the plurality of members are relatively rotatably connected.

(5) The unevenness means capable of engaging and disengaging with each other is formed on both of the plurality of members, and the plurality of members can be locked to each other in a required turning area. Medical tools.

Therefore, the different members are joined so as to be relatively pivotable without being separated carelessly,
Even if a twisting force is applied, the members are not dissociated from each other, and a highly safe medical device can be provided.

(6) A method of manufacturing a medical device having a liquid flow path capable of providing blood transfusion, transfusion, or the like, wherein a first member of at least a plurality of members made of materials having different characteristics is replaced with a second member. The first member is swaged by an ultrasonic bonding process such as a swaging process so that the first member is swaged.
A method for producing a medical device, characterized in that the medical device is bonded to a member.

(7) The medical treatment according to (6), wherein the caulking region in the second member is formed in a rough surface in advance, and the ultrasonic bonding process is performed as in (6). Tool making method.

The function is the same as the above (1) to (3).

(8) The medical device according to (6), wherein the crimping region of the second member is formed with an uneven portion in advance, and the ultrasonic bonding process is performed as in (6). Recipe.

The function is the same as the above (4) and (5).

(9) The method of manufacturing a medical device according to (6), wherein the ultrasonic bonding is performed using a torsional vibration horn.

[0027]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The contents of the present invention will be described below based on the illustrated embodiments.

(Embodiment 1) 1. Means of use of a medical needle 100 which is a kind of the medical device of the first embodiment shown in FIGS. 1 to 3 is as shown in FIG. 4, and an ultrasonic bonding apparatus 1 for manufacturing the medical needle 100 is shown in FIG.
000 and its manufacturing process are shown in FIGS.

Hereinafter, the medical needle 100 and the manufacturing apparatus and method thereof will be described in order.

(1) Configuration of Medical Needle 100 As shown in FIG. 4, the medical needle 100 according to this embodiment includes a blood transfusion set 200 such as a blood transfusion or a drug to be injected into a patient's body, and a transfusion container (transfusion container). The needle tube 110 and the cover member 120 are integrally connected as shown in FIGS. 1 and 2.

The needle tube 110 has a liquid guide hole 111 formed in the longitudinal direction thereof, and a needle tip portion 112 penetrated by a stopper 320 fitted to the supply port 310 of the infusion container 300 at the distal end side.
, And the liquid guide hole 111 is opened in the radial direction near the needle tip 112.

A support disk 114 is integrally formed at a substantially central portion of the needle tip portion 112 and the needle base portion 113 of the needle tube 110 so as to expand in the transverse direction. Can be connected to the infusion set 200.

The cover member 120 integrally connected to the needle tube body 110 penetrates the needle point portion 112 through a through hole 123 formed in a bottom portion 122 following a thin-walled, elastically deformable cylindrical portion 121. Then, the support disk 114 is connected to the outside of the bottom 122 by an ultrasonic bonding apparatus 1000.

A notch 125 is formed in the opening 124 facing the bottom 122 of the cover member 120, and the needle tip 1 is so protected that the needle tip 112 can be sufficiently protected.
It is formed to have a dimension longer than twelve.

Further, the cylindrical portion 121 has an infusion container 3
An engagement hole 126 for safe engagement with the 00 is provided, and its function will be described later.

The constituent material of the needle tube 110 is, for example, a metal such as stainless steel, polypropylene, ABS or the like.
Resin, polyethylene, polyamide, polycarbonate,
Examples of the resin include polyester and the like. In the case of using a resin, a needle tube body is used if glass fiber, carbon fiber, talc, kaolin, calcium carbonate, rock wool, alumina fiber, metal whisker, or the like is contained. An improvement in hardness and strength of 110 can be expected.

The cover member 130 made of a material different from the needle tube 110 is made of a resin such as polypropylene, polyethylene, ABS resin, polyacetal, polyester, polyamide, polycarbonate, etc. , Polyethylene, AB
It is preferable that the resin is easily elastically deformable, such as S resin and polyacetal.

(2) How to Use the Medical Needle 100 Next, how to use the medical needle 100 will be described with reference to FIG.

The infusion set 200 includes a tube 20
1. Drip tube 202, roll clamp 203, stopper rubber 2
04, an octopus tube 205, and an infusion needle 206. The tube 201 is firmly connected to the needle base 113 of the needle tube 110 of the medical needle 100 by an adapter rubber tube 207.

When using this infusion set 200,
The needle tip 112 of the needle tube 110 is connected to the mouth 3 of the infusion container 300.
10, the cylindrical part 121 of the cover member 120 is loosely fitted into the mouth 310, and the engagement hole 126 is provided with an outwardly projecting engagement with the mouth 310. The infusion set 200 is connected to the infusion container 300 by engaging the projection 311.

Thereafter, the infusion needle 206 is punctured into the blood vessel of the patient by carefully operating so that air does not enter, and is appropriately fixed with a tape or the like, and the infusion W is administered into the blood vessel of the patient.

If it becomes necessary to remove the needle tube 110 from the rubber stopper 320 during or after use, the mouth 3
When the operator grips the cylindrical portion 121 of the cover member 120 loosely fitted to the outside of the cover 10 and presses the cylindrical portion 121 in a direction perpendicular to the plane of FIG. 2, the cylindrical portion 121 is deformed into an elliptical shape, and a pair of engagement holes is formed. The distance between the contact points 121 becomes large, and the engaging projection 311 is detached from the engaging hole 121. The medical needle 100 can be pulled out from the rubber stopper 320, and the infusion set 200 can be removed from the infusion container 300. is there.

(3) Apparatus for Manufacturing Medical Needle 100 Next, an ultrasonic wave for forming the medical needle 100 by integrally forming the needle tube body 110 and the cover member 120 formed in advance by using a different material is used. The joining device 1000 will be described.

In this case, the ultrasonic bonding apparatus 100
Swaging by 0 (ULTRASONIC SW
In the AGING) process, as shown in FIGS. 6 to 8, the plastic part is melted from the contact portion by pressurization and ultrasonic energy from the tip of the horn 1019, and the melted plastic is formed into the shape of the horn 1019, and the metal is formed. Alternatively, this is a processing method of mechanically locking resin materials of different materials, as shown in FIG. 5, by connecting a horizontal frame 1012 to a vertical frame 1011 provided on a base 1010, and moving up and down on the horizontal frame 1012. The resonating means 1014 is carried on an elevating frame 1013 which is disposed so as to be capable of being provided. The cover member 12 is fixed on a support 1016 fixed on a base 1010.
An anvil 1017 on which 0 can be placed is fixed.

The lifting frame 1013 is connected to the air cylinder 10.
18 can be driven up and down, and the resonance means 1
The horn 1019 connected to 014 can be urged toward the anvil 1017.

Further, in the ultrasonic bonding apparatus 1000, in order to control the energization of the resonance means 1014 and the operation of the air cylinder 1018, control means 110 such as a microcomputer operated by a control panel (not shown) is used.
0 is provided.

Next, regarding the anvil 1017,
As shown in FIG. 6, the cover member 120 has a columnar external shape so that the cover member 120 can be fitted and supported, and a through hole 1017a capable of receiving the needle tip 112 of the needle tube body 110 is formed at the center thereof.

In the horn 1019, a joining rib 122a, which will be described later, is fitted on the outer periphery of the support disk 114 provided on the needle tube 110 placed outside the bottom 122 of the cover member 120 during the swaging process. The lower end of the cylindrical portion 1019a is formed in a concave arc-shaped portion 1019b so that the lower end can be attached to the cylinder.

(4) Manufacturing Process of Medical Needle 100 As shown in FIG.
Anvil 1017
The needle tube 1 is fitted so as to hold the support disk 114 of the needle tube 110 in the joining rib 122a, and the needle tip 112 is inserted into the through hole 123.
10 and the cover member 120 are combined.

Next, as shown in FIG.
0, the air cylinder 1018 is operated and the horn 1
While lowering 019, the resonance means 1014 is started to oscillate the ultrasonic vibration in the horn 1019 to press the bonding rib 122a.

Here, the joining rib 122a is softened by the ultrasonic vibration energy to form the concave arc-shaped portion 1019b.
Is deformed so as to follow the shape of.

Next, as shown in FIG. 8, at the end of the joining process, the lowering of the horn 1019 is temporarily stopped, and the operation of the resonance means 1014 is also stopped in this state.

During this time, when about 1 second has passed, the joining rib 1
The temperature of 22a gradually decreases, and is solidified, and a caulked portion 122b is formed.

In this state, the horn 1019 is raised by the air cylinder 1018, and the swaged portion 122b
Dissociate from

Thus, the support disk 114 is clamped by the caulking portion 112b so that the anvil 1017 is held.
Since the medical needle 100 is completed by integrally forming the needle tube 110 and the cover member 120 thereon, if this is removed from the anvil 1017 with a required jig, this processing is completed. is there.

(5) Features of the medical needle 100 The medical needle 1 formed as described in the above (4).
In 00, the support disk 114 of the needle tube 110 is fixed on the bottom 122 of the cover member 120 by the swaged portion 112b formed by the swaging process, and the needle tube 110 and the cover member 120 are not fixed. Since the needle tube 110 and the cover member 120 are made of different materials, the support disk 114 is fixed to the bottom 122 without being detached easily. However, since they are merely connected in frictional engagement with each other, they are relatively rotatable relative to each other in the circumferential direction, and are liquid-tight so that leakage of the infusion is prevented. I have.

Therefore, when this medical needle 100 is connected to the tube 201 by the adapter rubber tube 207 as shown in FIG. It can be prevented from being swiveled and damaged even if it does work, and high reliability has been verified.

[0058]

EXAMPLES Specific examples in the first embodiment are as follows, and good results were obtained.

1. Medical needle 100 (1) Needle tube 110 ◎ Materials used… Polycarbonate ◎ Thickness and outer diameter of support disk… Thickness 1.5 m
m, outer diameter φ20mm (2) Cover member 120 ◎ Materials used ・ ・ ・ Polypropylene ◎ Thickness and height of joining ribs ・ ・ ・ Thickness 1mm, height
2-3.5 mm 2. Joining process (1) Ultrasonic vibration frequency of horn… Approx.
z (2) Ultrasonic vibration application period… About 0.5 seconds (3) Horn up and down stop period… About 1 second

(Embodiment 2) The difference between the needle tube 110A shown in FIG. 9 and FIG.
10A and the cover member 120A are relatively intermittently rotatably connected.

That is, the support disk 11 of the needle tube 110A
A recess 114Aa is formed in advance on the outer periphery of 4A, and ultrasonic bonding is performed by the same process as in the first embodiment. In this case, the bonding rib 122Aa softened by the ultrasonic vibration is partially formed. Is invaded into the recessed portion 114Aa and solidified, and as a result, a temporary detent function is achieved.

The needle tube 110A and the cover member 120A
Is that the function can be turned relative to each other by a required angle, so that the function is improved.

As another design example, if the support disk 114A is made non-circular instead of the recess 114Aa, or if the top surface is formed with an uneven portion such as a rough surface, the needle tube 110 and the cover member 120 are formed. Can be relatively unrotatably connected.

The effect of the medical needle 100 is as follows.

[0065] Even if a twisting force acts on the infusion set, there is no possibility that the infusion set will be detached from the infusion container.

A fluid-tight connection can be made to the infusion container.

The attachment / detachment to / from the infusion liquid container is easy.

The needle member is protected by the cover member, and there is no possibility of contamination.

The effects on the manufacturing method are as follows.

It is possible to quickly and reliably connect different members.

[0071] Dissimilar members can be connected to be relatively pivotable.

(Embodiment 2) A medical device shown in FIG. 11 has a three-way cock 2000 with a switchable liquid flow passage.
And the main body 2010 has a connection portion 2011 with a lock.
And a plurality of liquid supply pipes 2012 and 2013 are communicated with each other, and the cock body 2020 pivotally mounted on the main body 2010 can be turned by the handle 2021 to be switched to the liquid supply pipe 2012 or 2013. 2010 and cock body 2 formed of different materials
020 and an ultrasonic bonding apparatus 1000 to form a secure connection by caulking.

In this type of medical device, for example, when the drip tube 202, the roll clamp 203, the infusion needle 206 and the like in the infusion set 200 shown in FIG. Medical instruments such as liquid needles, syringes, dialysers, cardiopulmonary bypass, various catheters, various connectors, blood collection needles, indwelling needles, various filters, thermometers, etc. can be manufactured in the same way by ultrasonic swaging, and their functions are also the same. Needless to say, what can be expected.

[0074]

The specific effects provided by the present invention described above are as follows.

A medical device in which members formed of different materials are joined in a liquid-tight manner can be obtained.

It is possible to obtain a medical device in which members formed of different materials are pivotally joined to each other.

[Brief description of the drawings]

FIG. 1 is an assembled perspective view of a medical needle according to a first embodiment of the present invention.

FIG. 2 is an explanatory view when using FIG. 1;

FIG. 3 is a cross-sectional view of FIG.

FIG. 4 is an explanatory diagram of a use state of FIG. 1;

FIG. 5 is a schematic side view of the ultrasonic bonding apparatus according to the embodiment of the present invention.

FIG. 6 is an explanatory view of the manufacturing process in FIG. 1;

FIG. 7 is an explanatory view of the next step of FIG. 6;

FIG. 8 is an explanatory view of a step subsequent to FIG. 7;

FIG. 9 is a perspective view of a needle tube according to a second embodiment of the present invention.

FIG. 10 is a sectional view taken along line (B)-(B) of FIG. 9;

FIG. 11 is a perspective view of a three-way cock according to the second embodiment.

[Explanation of symbols]

 Reference Signs List 100 medical needle 110 needle tube 120 cover member 200 infusion set 300 infusion container 1000 ultrasonic bonding apparatus

 ────────────────────────────────────────────────── ─── Continuation of front page (72) Inventor Masaru Saiki 1727, Tsukiji Arai, Showa-cho, Nakakoma-gun, Yamanashi Prefecture 1 Termo Co., Ltd. F-term (reference) 4C066 AA07 BB02 CC01 DD01 EE12 FF07 JJ07 KK06 PP01

Claims (9)

[Claims] 1. A medical device provided with a liquid flow passage capable of providing blood transfusion, transfusion, or the like, including at least a plurality of members made of materials having different characteristics, wherein the members are connected to each other by a swaging process or the like. A medical device characterized by being joined by sonic bonding. 2. The medical device according to claim 1, wherein the plurality of members are relatively non-rotatably coupled. 3. The medical device according to claim 2, wherein a rough surface portion is formed in an ultrasonic bonding region of at least one of the plurality of members. 4. The medical device according to claim 1, wherein the plurality of members are relatively rotatably connected. 5. The medical system according to claim 4, wherein the plurality of members are provided with concave / convex means which can be engaged and disengaged from each other, and the plurality of members can be locked to each other in a required turning area. Tools. 6. A method of manufacturing a medical device having a liquid flow passage capable of providing blood transfusion, transfusion, or the like, wherein a first member of at least a plurality of members made of materials having different characteristics is replaced with a second member. A method for manufacturing a medical device, comprising: contacting a first member with a second member by caulking the first member by ultrasonic bonding such as swaging. 7. The method for manufacturing a medical device according to claim 6, wherein the caulking region in the second member is formed in a rough surface in advance, and ultrasonic bonding is performed as in claim 6. . 8. The method for manufacturing a medical device according to claim 6, wherein an uneven portion is formed in advance in a caulking region of the second member, and the ultrasonic bonding process is performed as in claim 6. 9. The method for manufacturing a medical device according to claim 6, wherein the ultrasonic bonding is performed using a torsional vibration horn.