JP6766934B2 - Multiluminal catheter and its manufacturing method - Google Patents

Description

The present disclosure relates to a multiluminal catheter and a method for manufacturing the same.

Adhesives are used to stop bleeding in blood vessels and block air leaks in the lungs. Adhesives used for such applications are required to act locally on the treatment site. For this reason, it is common to use a two-component adhesive that exhibits adhesiveness by mixing two types of chemicals. By separately supplying each agent of the two-component adhesive to the treatment site and mixing the two agents at the treatment site, the adhesive function can be exerted locally at the treatment site. As a method of separately supplying each drug of the two-component adhesive to the treatment site, there is a method of using a double lumen catheter having two independent cavities. By delivering a different drug to each lumen of the double lumen catheter, the drug can be supplied to the treatment site without mixing.

A double lumen catheter has a tube with two lumens and a hub connected to the rear end of the tube. The hub has two plugs having the same cross-sectional shape as the lumen, and the tube and the hub are connected by inserting the plugs into the lumen (see, for example, Patent Document 1).

Special Table 2005-506133

However, the conventional double lumen catheter has a problem that the lumens communicate with each other at the joint between the tube and the hub. It is very difficult to completely match the cross-sectional shapes of the lumen and the plug, and a gap is likely to occur between the lumen and the plug. Further, since the wall surface between the lumens is thin, it is difficult to improve the adhesion between the end face of the tube and the end face of the hub. For this reason, an unintended fine passage is generated at the joint between the tube and the hub, and the lumens communicate with each other.

Such problems can occur with all catheters that have multiple lumens, not just those that supply the adhesive.

An object of the present disclosure is to solve the above-mentioned problems and to realize a multiluminal catheter in which communication between lumens is unlikely to occur.

The first aspect of the method for manufacturing a multi-lumen catheter is to attach a hub to the rear end of a different diameter tube having a first lumen and a second lumen and having an outer diameter larger than the tip at the rear end. The hub is provided with a step of fixing with an adhesive, and the hub has a cap portion that is externally fitted to a tube having a different diameter, and a tubular first plug and a second plug that protrude from the cap portion toward the tip side, and adheres the hub. In the step of fixing with the agent, the inside of the cap portion is filled with an adhesive, and the first plug is inserted into the first lumen and the second plug is inserted into the second lumen. The cap portion filled with the agent is fitted onto a tube having a different diameter.

A second aspect of the method of manufacturing a multi-lumen catheter is to attach a hub to the posterior end of a different diameter tube that has a first lumen and a second lumen and has a larger outer diameter than the distal end. The hub is provided with a step of fixing with an adhesive, and the hub is bonded through the cap portion that fits the different diameter tube, the tubular first plug and the second plug that protrude from the cap portion toward the tip side, and the cap portion. A cap so that the first plug is inserted into the first lumen and the second plug is inserted into the second lumen in the step of having an agent supply path and fixing the hub with an adhesive. The portion is fitted onto a tube having a different diameter, and then the adhesive is supplied from the adhesive supply path.

In the second aspect of the method for manufacturing a multiluminal catheter, the cap portion has a top plate portion and a collar portion surrounding the top plate portion, and the adhesive supply path is a side surface or the top plate portion of the top plate portion. An opening may be provided on the surface on the rear end side and the surface on the front end side of the top plate portion.

One aspect of a multiluminal catheter is a different diameter tube that has a first lumen and a second lumen and has a larger outer diameter than the tip at the rear end, and an adhesive at the rear end of the different diameter tube. A fixed hub is provided, and the hub has a cap portion that fits into a tube having a different diameter, and a tubular portion that protrudes from the cap portion toward the tip side, and has a first plug and a second plug inserted into a first lumen. It has a second plug inserted into the lumen and the adhesive is between the cap and the rear end face of the different diameter tube, between the cap and the side surface of the different diameter tube, the outer wall of the first plug. It is filled between the inner wall of the first lumen and the outer wall of the second plug and the inner wall of the second lumen.

In one aspect of a multiluminal catheter, the cross-sectional shape at the posterior ends of the first and second lumens may be such that the circle is distorted in at least one direction.

In one aspect of a multiluminal catheter, the inner diameter of the first lumen may be different from the inner diameter of the second lumen.

According to the multi-lumen catheter of the present disclosure and the method for manufacturing the same, it is possible to realize a multi-lumen catheter in which communication between lumens is unlikely to occur.

It is sectional drawing which shows the multiluminal catheter of this embodiment. It is an end view which shows the tip of the different diameter tube. It is an end view which shows the rear end of the different diameter tube. A plan view shows a hub used in a modified example of a method for manufacturing a multiluminal catheter. FIG. 3 is a cross-sectional view taken along the line IV-IV of FIG. It is a top view which shows the modification of the hub. It is sectional drawing which shows the modification of the multi-lumen catheter of this embodiment.

In the present disclosure, the side that becomes the patient side when using a multiluminal catheter will be described as the distal end, and the opposite side will be described as the posterior end. Matching values means that they can be considered equal within the margin of error, not just if they are exactly equal. For example, in the case of a value related to the size of a molded product by extrusion molding, a difference of about 3% to 10% is allowed. The substantially circular shape means not only a circular shape but also a shape in which the circle is distorted in at least one direction, for example, a semicircular shape, a D-shape, an oval shape, an elliptical shape, and the like. Further, the circular shape includes not only a mathematically perfect circle but also a shape that can be regarded as a circle with normal molding accuracy. The diameter in the case of a non-circular shape is the diameter of a circle having the same area.

As shown in FIGS. 1, 2A and 2B, the multiluminal catheter 100 of the present embodiment includes a different-diameter tube 101 having a larger outer diameter on the rear end side than the distal side and a different-diameter tube, which are the catheter main bodies. A hub 102 fixed by an adhesive 103 is provided at the rear end of the 101. The different diameter tube 101 has a first lumen 111 and a second lumen 112. The hub 102 has a cap portion 125 that is externally fitted to the different diameter tube 101, and a tubular first plug 121 and a second lumen that protrude toward the tip side from the cap portion 125 and are inserted into the first lumen 111. It has a second plug 122 that is inserted into 112.

The inner diameter phi ₂ of the inner diameter phi ₁ and a second lumen 112 of the first lumen 111 corresponds to the outer diameter of the different-diameter tube 101. Therefore, the inner diameters of the first lumen 111 and the second lumen 112 are larger on the rear end side than on the tip side, respectively. The value of the ratio φ _1a / φ _2a of the inner diameter phi _2a of the second lumen 112 to the inner diameter phi _1a of the first lumen 111 at the distal end, to the inner diameter phi _1b of the first lumen 111 in the rear end portion The ratio of the inner diameter φ _2b of the second lumen 112 is in agreement with the value of φ _1b / φ _2b . At any position between the front end and the rear end, the ratio of the inner diameter φ ₂ of the second lumen 112 to the inner diameter φ ₁ of the _first lumen 111 and the value of φ ₁ / φ ₂ are the same. There is. Further, the values of φ _1a / φ _2a and φ _1b / φ _2b are also in agreement with the value of φ _1c / φ _2c , which is the ratio of the inner diameter φ _2c of the second plug 122 to the inner diameter φ _1c of the first plug 121. .. However, a phi ₁ / phi ₂ is 1, the inner diameter phi ₁ of the first lumen 111 and the inner diameter phi ₂ of the second lumen 112 may coincide.

When used for the supply of multi-tube two a lumen catheter 100 different viscosities of the agents of the present embodiment, the ratio of the inner diameter phi ₂ of the inner diameter phi ₁ and a second lumen 112 of the first lumen 111 phi ₁ / φ ₂ may be a value corresponding to the difference in viscosity between the first drug and the second drug. For example, an inner diameter phi ₁ of the first lumen 111 and smaller than the inner diameter phi ₂ of the second lumen 112, a low viscosity agent is supplied by the first lumen 111, a viscosity higher drug second Can be supplied by the lumen 112 of. In this way, two types of agents having different viscosities can be supplied to the treatment site in the same manner. For example, when supplying a fibrin-based adhesive, φ ₁ / φ _{2 is set} to about 0.65, and a drug containing thrombin as a main component, which has a relatively low viscosity, is supplied through a relatively thin first lumen 111. The relatively thick second lumen 112 allows a relatively viscous fibrinogen-based drug to be supplied.

The cap portion 125 of the hub 102 has a top plate portion 125A and a flange portion 125B, and is externally fitted to the rear end portion of the different diameter tube 101. The first plug 121 and the second plug 122 are inserted into the first lumen 111 and the second lumen 112, respectively. An adhesive 103 is filled between the hub 102 and the different diameter tube 101. Specifically, between the flange portion 125B and the side surface of the different diameter tube 101, between the outer wall of the first plug 121 and the inner wall of the first lumen 111, and between the outer wall of the second plug 121 and the second lumen. The adhesive 103 is filled between the inner wall and the 112.

The adhesive 103 is also filled between the top plate portion 125A and the rear end surface of the different diameter tube 101. In particular, the adhesive 103 is also filled between the rear end surface of the boundary wall 115 between the first lumen 111 and the second lumen 112 and the top plate portion 125A. As a result, it is possible to make it difficult to create a fine passage that communicates between the first lumen 111 and the second lumen 112.

The configuration in which the adhesive 103 is filled between the different diameter tube 101 and the cap portion 125 can be formed as follows. First, the adhesive 103 is filled inside the cap portion 125. Specifically, the adhesive 103 is filled in the recess formed by the flange portion 125B. Next, the first lumen 111 is aligned with the position of the first plug 121, the second lumen 112 is aligned with the position of the second plug 122, and the different diameter tube 101 is fitted into the cap portion 125. The adhesive 103 filled in the recess is not only between the end of the different diameter tube 101 and the top plate 125A, but also between the inner wall of the first lumen 111 and the outer wall of the first plug 121, and the first It is also filled between the inner wall of the lumen 112 of 2 and the outer wall of the second plug 122. After that, the adhesive 103 may be cured under predetermined conditions.

The collar portion 125B preferably has a sufficient depth from the viewpoint of improving the adhesiveness with the different diameter tube 101. The height of the first plug 121 and the second plug 122 is preferably higher than the height of the flange portion 125B from the viewpoint of preventing the adhesive 103 from adhering to the tip end side of the plug. From the viewpoint of preventing communication of the lumen, it is preferable that the position where the adhesive 103 reaches is about 30% or more of the height of the flange portion 125B. From the viewpoint of preventing the adhesive from adhering to the tip end side of the plug, it is preferable that the position where the adhesive 103 reaches is about 70% or less of the height of the flange portion 125B.

An example is shown in which the recess is filled with the adhesive 103 in advance and then the different diameter tube 101 is fitted into the cap portion 125. However, it is also possible to pour the adhesive 103 after fitting the different diameter tube 101 into the cap portion 125. is there. In this case, the adhesive supply path 125C for supplying the adhesive 103 may be provided inside the cap portion 125.

The adhesive supply path 125C may have any configuration as long as the adhesive 103 can be supplied from the outside of the cap portion 125 into the recess formed by the top plate portion 125A and the flange portion 125B. For example, as shown in FIGS. 3 and 4, the adhesive supply path 125C can be provided on the top plate portion 125A. In FIGS. 3 and 4, an opening serving as an adhesive injection port is provided on the side surface of the top plate portion 125A and adhered to a position between the first plug 121 and the second plug 122 on the top plate portion 125A. The adhesive supply path 125C is a through passage provided with an opening that serves as an outlet for the agent. The position of the opening serving as the outlet of the adhesive is not particularly limited as long as the adhesive can be supplied to the recess. Further, as shown in FIG. 5, a plurality of openings serving as outlets for the adhesive may be provided. Further, an opening serving as an injection port for the adhesive may be provided on the rear end side of the top plate portion 125A.

After fitting the different diameter tube 101 into the cap portion 125, the adhesive 103 is supplied from the adhesive supply path 125C, so that the diameter of the different diameter tube 101 is different from that of the flange portion 125B between the rear end surface of the different diameter tube 101 and the top plate portion 125A. Adhesive 103 is applied between the side surface of the tube 101, between the outer wall of the first plug 121 and the inner wall of the first cavity 111, and between the outer wall of the second plug 121 and the inner wall of the second cavity 112. Can be filled.

In FIG. 1 and the like, between the top plate portion 125A and the rear end surface of the different diameter tube 101, between the outer wall of the first plug 121 and the inner wall of the first lumen 111, and the outer wall and the second of the second plug 121. It is described that the thickness of the adhesive 103 is constant with respect to the inner wall of the lumen 112. However, since the thickness of the adhesive 103 is determined by the dimensions of each part and the like, the thickness of the adhesive 103 does not have to be constant.

In the multiluminal catheter of the present embodiment, the adhesive 103 is sufficiently distributed between the different diameter tube 101 and the cap portion 125, so that the inner diameter of the cap portion 125 is slightly larger than the outer diameter of the different diameter tube 101. Well, high dimensional accuracy is not required. Further, the outer diameter of the first plug 121 may be slightly smaller than the inner diameter of the first lumen 111, and the outer diameter of the second plug 122 may be slightly smaller than the inner diameter of the second lumen 112. Good. Depending on the materials of the different diameter tube 101 and the hub 102, the outer diameter of the plug may be slightly larger than the inner diameter of the lumen so that it can be pushed in.

The different diameter tube 101 is a flexible tube, and is not particularly limited, but is preferably made of a soft resin. For example, it may be polyurethane, polysilicon, polyamide or the like. The different diameter tube 101 is not particularly limited, but can be manufactured by extrusion molding. In the case of extrusion molding, the value of φ _1a / φ _{2a and} the value of φ _1b / φ _2b can be easily matched in the range of several% to 10%. In the case of extrusion molding, the value of the ratio of the outer diameter on the rear end side to the outer diameter on the front end side can be about 2 to 4.

The cross-sectional shape of the different diameter tube 101 is not particularly limited, but may be a substantially circular shape. The cross-sectional shape of the rear end portion of the different diameter tube 101 may not completely match the cross-sectional shape of the cap portion 125 of the hub 102. For example, the cross-sectional shape of the rear end portion of the different diameter tube 101 may be distorted, and the cross-sectional shape of the cap portion 125 may be circular. When the different diameter tube 101 is formed by extrusion molding or the like, the cross-sectional shape may not be circular but a circular shape may be distorted. In the present embodiment, since the adhesive is filled between the side surface of the different diameter tube 101 and the cap portion 125, the cross-sectional shape of the rear end portion of the different diameter tube 101 and the cross-sectional shape of the cap portion 125 match. Sufficient sealing performance can be obtained without it. However, the cross-sectional shape of the rear end portion of the different diameter tube 101 and the cross-sectional shape of the cap portion 125 may be the same.

The cross-sectional shape at the rear ends of the first lumen 111 and the second lumen 112 may be any shape as long as the first plug 121 and the second plug 122 can be inserted, respectively. For example, it can be substantially circular. The cross-sectional shape of the lumen and the plug do not have to match. For example, the cross-sectional shape of the lumen may be a D-shaped or other distorted circle, and the cross-sectional shape of the plug may be circular. When the different diameter tube 101 is formed by extrusion molding or the like, the cross-sectional shape of the lumen may not be circular, and the circle may be distorted into a D shape or an elliptical shape. In addition, the cross-sectional shape may be positively distorted in order to form a plurality of lumens. On the other hand, the cross section of the plug can be made circular relatively easily. However, when the cross-sectional shape of the lumen is not circular, it is difficult to obtain a cross-sectional shape that matches it. In the present embodiment, since the adhesive is filled between the outer wall of the plug and the inner wall of the lumen, sufficient sealing property can be obtained even if the cross-sectional shape of the lumen and the cross-sectional shape of the plug do not match. .. However, the cross-sectional shape of the lumen and the cross-sectional shape of the plug may be the same. Further, the cross-sectional shapes of the first lumen 111 and the second lumen 112 may or may not be the same.

The outer diameter of the different diameter tube 101 is not particularly limited, but may be about 1.5 mm to 3 mm at the front end and about 5 mm to 10 mm at the rear end. The inner diameters of the first lumen 111 and the second lumen 112 are not particularly limited, but may be about 0.5 mm to 1.5 mm at the front end and about 1 mm to 5 mm at the rear end.

The length of the different diameter tube 101 is not particularly limited, but can be about several tens of cm to several m. Further, when supplying the bioadhesive, as shown in FIG. 6, a short different diameter tube 101A of about several cm to 10 cm can be used.

The hub 102 is not particularly limited, but is preferably made of a relatively hard resin. For example, it can be polycarbonate, acrylonitrile-butadiene-styrene (ABS), or the like.

The cross-sectional shape of the first plug 121 and the second plug 122 is not particularly limited, but may be a substantially circular shape. As described above, the plug and the lumen may or may not have the same cross-sectional shape. Further, the first plug 121 and the second plug 122 may have different cross-sectional shapes. The first plug 121 and the second plug 122 may have a tapered shape that tapers toward the tip end side. If the cross-sectional shapes of the first plug 121 and the second plug 122 are circular, there is an advantage that the tapered shape can be easily formed.

A connector portion 126 for connecting a medical device such as a tube may be provided on the rear end side of the cap portion 125. In the present embodiment, the connector portion 126 is a tubular protrusion to which the tube 104 is directly connected. With such a configuration, the hub 102 can be made smaller. However, the connector portion 126 may have any configuration depending on the medical device to be connected. For example, it may be a messuler or an male lure. The cap portion 125, the first plug 121, the second plug 122, and the connector portion 126 can be integrally molded.

A connector or the like having a messuler can be connected to the rear end of the tube 104 connected to the connector portion 126. This allows various medical devices to be connected to the tube 104. When used to supply a bioadhesive, a syringe filled with the drug, a pump for supplying the drug, or the like can be connected to the tube 104.

The adhesive 103 may be selected according to the materials of the different diameter tube 101 and the hub 102. For example, an epoxy-based, acrylic-based, or polyamide-based adhesive can be used.

In the multiluminal catheter 100 of the present embodiment, since the hub 102 is directly fixed to the rear end of the different diameter tube 101 by using the adhesive 103, it is not necessary to improve the molding accuracy of the different diameter tube 101 and the hub 102. .. Therefore, molding becomes easy and the manufacturing cost can be reduced. In addition, the hub 102 can be made smaller, and the operability of the catheter is improved. Further, since the ratio of the inner diameters of the two lumens is almost constant over the entire length of the catheter and the ratio of the inner diameters of the plugs is also almost the same, two drugs can be administered from a syringe or the like connected to the rear end of the tube 104. If sent out, the two drugs can be easily supplied to the treatment site at a constant ratio.

The tube 104 connected to the first lumen 111 and the tube 104 connected to the second lumen 112 may have the same inner diameter. However, the value of the ratio of the inner diameters of the two tubes 104 may match the value of the ratio of the inner diameters of the first lumen 111 and the second lumen 112, φ ₁ / φ ₂ .

The multiluminal catheter 100 of the present embodiment can be used, for example, for supplying a two-component bioadhesive to the treatment site. The bioadhesive is not particularly limited, and examples thereof include a fibrin-based adhesive using thrombin and fibrinogen. In addition, gelatin-based, polylactic acid-based or polysaccharide-based adhesives can be mentioned. Not limited to bioadhesives, it can also be used as a catheter to supply other drugs. Further, although the double lumen catheter having two lumens has been described, the number of lumens is not limited to two and may be three or more.

The method for manufacturing a multi-lumen catheter of the present disclosure can manufacture a multi-lumen catheter in which communication between lumens is unlikely to occur, and a multi-lumen catheter and a method for manufacturing the same, etc., which supply a plurality of drugs to a treatment site without mixing them. It is useful as.

100 Multi-lumen catheter 101 Different diameter tube 101A Different diameter tube 102 Hub 103 Adhesive 111 First lumen 112 Second lumen 115 Boundary wall 121 First plug 122 Second plug 125 Cap part 125A Top plate part 125B Collar 125C Adhesive supply path 126 Connector

Claims (6)

A step of fixing the hub with an adhesive to the rear end of a tube having a first lumen and a second lumen and having an outer diameter larger than the tip at the rear end is provided.
The hub has a cap portion that is externally fitted to the different diameter tube, and a tubular first plug and a second plug that protrude toward the tip side from the cap portion.
The cap portion has a top plate portion and a collar portion surrounding the top plate portion, and the distance between the first plug and the second plug and the collar portion is the distance between the different diameter tube and the cap portion. It is larger than the wall thickness of the portion inserted between the first plug and the second plug and the flange portion.
In the step of fixing the hub with an adhesive, the inside of the cap portion is filled with the adhesive, the first plug is inserted into the first lumen, and the second plug is the second. to be inserted into the lumen, said by the adhesive inserting the different diameters tube to the cap portion which is filled between the outer wall and the inner wall of the collar portion of the different diameter tube, the first Manufacture of a multiluminal catheter in which the adhesive is filled between the inner wall of the lumen and the outer wall of the first plug and between the inner wall of the second lumen and the outer wall of the second plug. Method. A step of fixing the hub with an adhesive to the rear end of a tube having a first lumen and a second lumen and having an outer diameter larger than the tip at the rear end is provided.
The hub has a cap portion that is externally fitted to the different diameter tube, a tubular first plug and a second plug that protrude toward the tip side from the cap portion, and an adhesive supply path that penetrates the cap portion. Have and
The cap portion has a top plate portion and a collar portion surrounding the top plate portion, and the distance between the first plug and the second plug and the collar portion is the distance between the different diameter tube and the cap portion. It is larger than the wall thickness of the portion inserted between the first plug and the second plug and the flange portion.
In the step of fixing the hub with an adhesive, the cap portion is inserted so that the first plug is inserted into the first lumen and the second plug is inserted into the second lumen. The different diameter tube is inserted, and then the adhesive is supplied from the adhesive supply path, and between the outer wall of the different diameter tube and the inner wall of the flange portion, the inner wall of the first lumen and the said. A method for manufacturing a multiluminal catheter , in which the adhesive is filled between the outer wall of the first plug and between the inner wall of the second lumen and the outer wall of the second plug . The cap portion has a top plate portion and a collar portion surrounding the top plate portion.
The multi-tube according to claim 2, wherein the adhesive supply path has openings in the side surface of the top plate portion or the rear end side surface of the top plate portion and the front end side surface of the top plate portion. A method for manufacturing a lumen catheter. A different diameter tube having a first lumen and a second lumen and having an outer diameter larger than the tip at the rear end,
A hub fixed with an adhesive is provided at the rear end of the different diameter tube.
The hub has a cap portion that is externally fitted to the different diameter tube, a tubular portion that protrudes from the cap portion to the tip side, and is inserted into the first lumen and the first plug and the second lumen. With a second plug inserted,
The cap portion has a top plate portion and a collar portion surrounding the top plate portion, and the distance between the first plug and the second plug and the collar portion is the distance between the different diameter tube and the cap portion. It is larger than the wall thickness of the portion inserted between the first plug and the second plug and the flange portion.
The adhesive is applied between the outer wall of the different diameter tube and the inner wall of the flange portion, between the inner wall of the first lumen and the outer wall of the first plug, and the inner wall of the second lumen. A multiluminal catheter filled between the outer wall of the second plug . The multiluminal catheter according to claim 4, wherein the cross-sectional shape of the first lumen and the rear end portion of the second lumen is a shape in which a circle is distorted in at least one direction. The multiluminal catheter according to claim 4 or 5, wherein the inner diameter of the first lumen is different from the inner diameter of the second lumen.

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