JP5772152B2 - Medical connecting member and manufacturing method thereof - Google Patents

Description

  The present invention relates to a medical connecting member including a flexible hollow tube and a member to be joined which is joined to the tube and has a through hole communicating with the lumen of the tube, and a method for manufacturing the same.

  In the field of medical devices, polyvinyl chloride has been frequently used as a tube material, and polycarbonate has been frequently used as a connector material connected to the tube. However, polyolefin has come to be used as a material for tubes and connectors due to the adverse effect of the plasticizer contained in polyvinyl chloride on the human body. However, since polyolefin does not dissolve in a solvent, the tube and the connector cannot be bonded to each other using the solvent. Therefore, when joining a tube made of polyolefin and a connector made of polyolefin, for example, one of the tube and the connector is inserted into the other lumen and is made of a material having a heat shrinkability higher than that of the tube or the connector. A method of tightening a connection portion between the tube and the connector with a tubular tightening member is employed. However, in this method, the tubular fastening member is contracted by heating to fasten the connecting portion, so that it looks bad. In particular, when the tube is inserted into the connector at the connection site, when the connection site is tightened by the tubular fastening member, the appearance is even worse than when the connector is inserted into the tube.

  Therefore, in recent years, a method for joining a tube and a member to be joined by irradiating the connection part with infrared rays has been disclosed. More specifically, the tube has a multilayer structure of three or more layers, and at least one of them contains an infrared absorber. After inserting either one of the tube and the member to be joined into the other, by irradiating the portion where the tube and the member to be joined are irradiated with infrared rays, the infrared absorber is heated, and using the heat, The tube and the member to be joined are welded to each other (see, for example, Patent Document 1). Patent Document 1 describes that it is preferable to contain an infrared absorber in a layer other than the outermost layer and the innermost layer from the viewpoint of preventing the infrared absorber from eluting into the chemical solution or body fluid.

JP 2007-312942 A

  However, there is a problem that the use of the multi-layered tube increases the cost.

  Therefore, the present invention provides a medical connection member having a good appearance, high biological safety, and relatively inexpensive, and a method for manufacturing the same.

The medical connecting member of the present invention is
A flexible hollow tube;
Including a member to be joined that is joined to the tube and has a through hole communicating with the lumen of the tube;
When one of the tube and the member to be joined is inserted into the other, a portion where the tube and the member to be joined overlap is referred to as a connecting portion, and of the tube and the member to be joined. If the one is called an insert,
The connecting portion is
By irradiating infrared rays to the infrared absorbent supplied between the joined member and the tube to melt the joined member and the tube adjacent to the infrared absorbent, respectively, and then solidifying, A welding region in which the member to be joined and the tube are joined to each other;
A non-contact region where the member to be joined and the tube are not in contact with each other;
A contact region where the facing surfaces of the member to be joined and the tube are in contact with each other but not joined is included along the insertion direction of the insert.

The method for producing the medical connecting member of the present invention comprises:
After inserting one of the tube and the member to be joined into the other, supplying an infrared absorber between the member to be joined and the tube, and then irradiating the infrared absorber with infrared rays, After each of the member to be joined and the tube adjacent to the infrared absorber are melted and solidified, the step of joining the tube and the member to be joined is included.
When the one of the tube and the joined member is referred to as an insert,
The surface facing the tube of the member to be joined before being melted is
A partial contact surface that is partially in contact with the tube, a non-contact surface whose entire circumference does not contact the tube, and a contact surface whose entire circumference is in contact with the tube are arranged in this order along the insertion direction of the insert. Including
In the step, the infrared absorber is supplied between the partial contact surface and the surface of the tube facing the partial contact surface.

  According to the present invention, after irradiating the infrared absorber with infrared rays and melting the bonded member and the tube adjacent to the infrared absorber, respectively, by solidifying, the tube and the bonded member are bonded. A medical connecting member having a good appearance and relatively inexpensive can be provided. Further, in the manufacturing process of the medical connecting member, the connecting portion of the medical connecting member has a surface facing the tube including a contact surface, a non-contact surface, and a partial contact surface in this order. The welded region containing the infrared absorbent and / or its decomposition product used for joining the member to be joined and the tube, the non-contact region where the member to be joined and the tube are not in contact, and the facing surface of the member to be joined and the tube are Contact areas that are in contact with each other but not joined are included in this order along the insertion direction of the insert. Therefore, in the medical connecting member of the present invention, the infrared absorber and / or a decomposition product thereof is prevented from coming into contact with a liquid material such as a chemical solution, and therefore biological safety is high.

FIG. 1 is a front view of a medical connecting member according to Embodiment 1 of the present invention. FIG. 2 is a cross-sectional view of the medical connection member shown in FIG. 1. FIG. 3A is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the first embodiment of the present invention. 3B is an enlarged cross-sectional view taken along the line II ′ of FIG. 3A. FIG. 4A is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the first embodiment of the present invention. 4B is an enlarged cross-sectional view taken along the line II-II ′ of FIG. 4A. FIG. 5A is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the first embodiment of the present invention. 5B is an enlarged cross-sectional view taken along the line III-III ′ of FIG. 4A. FIG. 6 is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the first embodiment of the present invention. FIG. 7 is a front view of the medical connecting member according to the second embodiment of the present invention. 8 is a cross-sectional view of the medical connection member shown in FIG. FIG. 9A is a front view of a member to be joined that constitutes the medical connecting member shown in FIG. 7. FIG. 9B is an IV-IV ′ enlarged cross-sectional view of the member to be joined shown in FIG. 9A. FIG. 10: is sectional drawing which showed 1 process of the manufacturing method of the medical connection member concerning Embodiment 2 of this invention. FIG. 11A is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the second embodiment of the present invention. FIG. 11B is an enlarged cross-sectional view taken along the line VV ′ of FIG. 11A. FIG. 12A is a cross-sectional view illustrating a step of the method for manufacturing the medical connecting member according to the second embodiment of the present invention. 12B is an enlarged cross-sectional view taken along the line VI-VI ′ of FIG. 12A. FIG. 13: is sectional drawing which showed 1 process of the manufacturing method of the medical connection member concerning Embodiment 2 of this invention.

  The “hollow tube having flexibility” is a tube used in the medical field, and liquids such as blood, chemicals, nutrients, body fluids, and physiological saline flow in the lumen. This tube is, for example, a container containing an infusion solution, a container containing an enteral nutrient, a blood bag, or a liquid circuit connected to a container filled with peritoneal dialysate, or a blood circuit used for hemodialysis, etc. Used for.

  The “member to be joined” is a component constituting a medical device and is joined to the tube, and has a through-hole through which a liquid such as blood, a chemical solution, a nutrient, a body fluid, and physiological saline flows. For example, there are a connector, an adapter, a three-way stopcock, a drip tube, a mixed injection part, a bottle needle, and the like.

  When the tube is inserted into the through-hole of the member to be joined, the “insert” is a tube. When the member to be joined is inserted into the lumen of the tube, the “insert” is to be joined. It is a member.

  In the present application, “joining” means that the resin melted by heat is mixed and then solidified, whereby the tube and the member to be joined are bonded to each other.

  In one example of a preferable medical connecting member of the present invention (hereinafter, “medical connecting member” may be abbreviated as “connecting member”), a tube is inserted into the through hole of the member to be joined. That is, the tube is an insert. And the clearance gap exists between the inner peripheral surface of a to-be-joined member, and the outer peripheral surface of a tube in the opposite side to the non-contact area | region side of the welding area | region of a connection part. In this case, it is preferable because an infrared absorber is easily supplied between the tube and the member to be joined in the manufacturing process of the medical connecting member.

  In an example of the preferable medical connecting member of the present invention, the member to be joined is inserted into the lumen of the tube. That is, the member to be joined is an insert. And the clearance gap exists between the outer peripheral surface of the said to-be-joined member, and the inner peripheral surface of the said tube in the opposite side to the non-contact area | region side of the welding area | region of a connection part. In this case, it is preferable because an infrared absorber is easily supplied between the tube and the member to be joined in the manufacturing process of the medical connecting member.

In an example of the preferable manufacturing method of the medical connection member of this invention, a tube is inserted in the through-hole of a to-be-joined member. That is, the tube is an insert. In this case, the inner peripheral surface of the member to be joined includes the partial contact surface, the non-contact surface, and the contact surface in this order along the tube insertion direction. Then, assuming that the maximum inner diameter at the portion having the partial contact surface of the member to be joined is W1 _max , the inner diameter at the portion having the non-contact surface is W3, and the inner diameter at the portion having the contact surface is W2, W2 <W1max <W3 is satisfied. It is preferable. The reason for this is, for example, that the adhesiveness of W2, W1max <W3 is high, so that the partial contact surface and the partial contact surface of the tube facing the partial contact surface into the liquid passing through the through-hole of the member to be joined and the lumen of the tube This is because the elution of the infrared absorber and / or its decomposition product supplied between the outer peripheral surfaces can be prevented more reliably.

  Further, when the tube is an insert, the non-contact surface is referred to as a first non-contact surface, and the inner peripheral surface of the member to be joined is opposite to the first non-contact surface side of the partial contact surface. Furthermore, it is preferable that the second contactless surface which is adjacent to the partial contact surface and does not contact the outer peripheral surface of the tube is provided. In this case, since there is a gap between the second non-contact surface and the outer peripheral surface of the tube facing the second non-contact surface, it is easy to supply the infrared absorbent, which is preferable.

In an example of the preferable manufacturing method of the medical connection member of this invention, a to-be-joined member is inserted in the lumen | bore of the said tube. That is, the member to be joined is an insert. In this case, the outer peripheral surface of the bonded member includes a partial contact surface, a non-contact surface, and a contact surface in this order along the insertion direction of the bonded member into the lumen of the tube. Then, assuming that the maximum outer diameter of the part having the partial contact surface of the member to be joined is X2 _max , the outer diameter of the part having the non-contact surface is X3, and the outer diameter of the part having the contact surface is X1, X3 <X2 _max < It is preferable to satisfy X1. The reason for this is, for example, that the contact surface and the inner peripheral surface of the tube facing the contact surface have higher adhesion than the case where X1, X2 _max > X3, and X1 = X2 _max. Elution of the infrared absorbing agent and / or its degradation product supplied between the partial contact surface and the inner peripheral surface of the tube facing the partial contact surface into the liquid passing through the hole or the lumen of the tube is even more This is because it can be surely prevented.

  Further, when the member to be joined is an insert, the non-contact surface is referred to as a first non-contact surface, and the outer peripheral surface of the member to be joined is opposite to the first non-contact surface side of the partial contact surface. It is preferable that the side has a second non-contact surface that is adjacent to the partial contact surface and does not contact the inner peripheral surface of the tube. In this case, since there is a gap between the second non-contact surface and the inner peripheral surface of the tube facing the second non-contact surface, it is easy to supply the infrared absorbent, which is preferable.

  In an example of the preferable manufacturing method of the medical connection member of this invention, a partial contact surface is a pear ground or has a rib.

  Hereinafter, embodiments of the present invention will be described in detail. However, it goes without saying that the present invention is not limited to the following embodiments.

(Embodiment 1)
FIG. 1 is a front view of a medical connecting member according to Embodiment 1 of the present invention, and FIG. 2 is a cross-sectional view taken along the central axis of the medical connecting member shown in FIG.

  As shown in FIGS. 1 and 2, the medical connecting member 1 of this embodiment includes a hollow tube 2 and a member 3 to be joined. A through hole 3c penetrating in the longitudinal direction is formed in the member 3 to be joined, and the member 3 to be joined has a rotationally symmetric shape with respect to the central axis 1a. The member 3 to be joined has an insertion portion 3d that can be inserted into, for example, a flexible tube 4 different from the tube 2 on the side opposite to the side joined to the tube 2 at both ends in the longitudinal direction. doing. In the connecting member 1, the tube 2 is inserted into the through hole 3 c of the member 3 to be joined, so that a part of the tube 2 and a part of the member 3 to be joined are orthogonal to the axial direction of the central axis 1 a The connection part 6 which overlapped with is included.

  As shown in FIG. 2, the connecting portion 6 has a welding region 31, a non-contact region 32, and a contact region 33, from one tip 3 a side to the other tip 3 n side of the member 3 to be joined. In order. The arrangement direction A of the welding region 31, the non-contact region 32, and the contact region 33 is the same as the insertion direction of the tube 2 into the through-hole 3c of the member 3 to be joined.

  In the welding region 31, the member to be joined 3 and the tube 2 are joined to each other. The welding region 31 is supplied between the partial contact surface 3e (see FIG. 3A) of the member 3 to be bonded and the outer peripheral surface 2a facing the partial contact surface 3e of the tube 2 inserted into the member 3 before bonding. Infrared absorber 7 (see FIGS. 5A and 5B) is formed by irradiating infrared rays to melt bonded member 3 and tube 2 adjacent to infrared absorber 7 and then solidifying them. . Therefore, the welding region 31 includes the infrared absorbent 7 and / or the decomposed product of the infrared absorbent 7 used in the manufacturing process of the connecting member 1. In the non-contact region 32, the inner peripheral surface 3i of the member 3 to be joined and the outer peripheral surface 2a of the tube 2 are not in contact with each other. In the contact region 33, the inner peripheral surface 3g (see FIG. 3A) of the member 3 to be joined and the outer peripheral surface 2a of the tube 2 (see FIG. 3A) are in contact with each other, but are not joined.

  The presence of the infrared absorbent 7 and / or the decomposed product of the infrared absorbent 7 in the welding region 31 can be confirmed by, for example, an infrared spectrophotometer (IR), liquid chromatography, gas chromatography or the like.

  The tube 2 preferably has a single layer structure from the viewpoint of cost reduction. The tube 2 has a constant inner diameter and outer diameter over the entire length in the longitudinal direction, for example. However, the above “constant” includes those in an error range that cannot be avoided in forming. Specifically, the inner diameter and the outer diameter each include an error within a range of ± 0.2 mm from a predetermined value. The tube 2 can be produced by a known method such as an injection molding method. The shape of the inner peripheral surface 2b surrounding the opening of the tube 2 viewed along the central axis 1a is circular, and its center coincides with the central axis 1a.

  The material of the tube 2 is preferably an olefin polymer because it is highly safe and has a low melting point. In the present application, the olefin polymer is a homopolymer or copolymer obtained by polymerizing an olefin monomer and an olefin monomer or other monomer, and is derived from the olefin monomer. The thing which contains 50 weight% or more of structural units to say.

  The olefin polymer is, for example, selected from the group consisting of polypropylene, polyethylene (low pressure, medium pressure, high pressure), linear low density polyethylene, polyolefins such as boribten (homopolymer), propylene, ethylene, and butene. Examples thereof include copolymers obtained by copolymerization of at least one kind of olefin monomer, and among these, polypropylene is preferable.

  In order to maintain the elasticity, the tube 2 may further contain additives such as a lubricant, an antioxidant, an anti-tacking agent, a plasticizer, and a surfactant in addition to the above materials.

  There is no restriction | limiting in particular about the outer diameter and inner diameter of the tube 2, Usually, an outer diameter is 1.0-6.0 mm, and an inner diameter is 0.5-4.5 mm, Especially an outer diameter is 2.0-. The present invention can be suitably applied to the joining of the thin tube 2 having the inner diameter of 5.0 mm and the inner diameter of 1.0 to 3.8 mm and the member 3 to be joined. When a small-diameter tube is inserted into the through-hole of the member to be joined and the connecting portion thereof is fastened with the tubular fastening member, the appearance is poor and the joining strength is weak. Even when the outer diameter of the tube inserted into the tube is as small as about 1.0 to 3.0 mm, the appearance of the connecting member is good and the bonding strength is high.

  As shown in FIG. 4A, the insertion length W12 of the tube 2 is suitably 8 to 12 mm from the viewpoint of ensuring biological safety and ensuring high liquid tightness.

  As shown in FIG. 3A, the member 3 to be joined has a substantially cylindrical shape. The to-be-joined member 3 has the internal peripheral surface which opposes the center axis | shaft 1a by having the through-hole 3c penetrated in the longitudinal direction. The inner peripheral surface 3i of the member 3 to be joined before the tube 2 is joined has the partial contact surface 3e, the non-contact surface 3f, and the contact surface 3g at the end of the member 3 to be joined due to the difference in distance from the central axis 1a. It has in this order from the 3a side.

As shown in FIGS. 3A and 3B, the partial contact surface 3 e of the member 3 to be joined has, for example, a plurality of ribs 3 h extending in the same direction as the longitudinal direction of the member 3 to be joined. Therefore, the partial contact surface 3e has a recess 3j between the pair of ribs 3h. The inner diameter of the part having the partial contact surface 3e of the member 3 to be joined has a minimum inner diameter W1 _min and a maximum inner diameter W1 _max because the partial contact surface 3e includes a plurality of ribs 3h. Since the minimum inner diameter W1 _min is slightly smaller than the outer diameter of the tube 2 and the maximum inner diameter W1 _max is slightly larger than the outer diameter of the tube 2, the tube 2 is inserted into the through hole 3c of the member 3 to be joined. , as shown in Figure 4B, the ribs 3h is in contact with the outer peripheral surface of the tube 2, its top 3h _t according to the degree of elasticity of the tube 2 pushes the tube 2 from the outside in the radial direction. On the other hand, the tube 2 is not filled on the lower side (the side far from the central axis 1a) in the recess 3j, and at least a part of the portion corresponding to the recess 3j on the inner peripheral surface of the member 3 to be joined is a tube. 2 is not in contact with the outer peripheral surface. Therefore, in a state where the tube 2 is inserted into the member 3 to be joined, the gap between the non-contact surface 3f and the outer peripheral surface 2a of the tube 2 facing the non-contact surface 3f is communicated with the outside of the member 3 to be joined. The outer peripheral surface 2a of the tube 2 facing the partial contact surface 3e and the partial contact surface 3e so that a narrow passage 8 (see FIG. 4B) is formed between the inner peripheral surface of the member 3 to be joined and the outer peripheral surface of the tube 2. And partly touch. The height H of the rib 3h, the distance W4 between the pair of ribs 3h (see FIG. 3B), the shape of the recess 3j, etc. are filled with the infrared absorbent over the entire length in the longitudinal direction of the passage 8 by capillary action. As described above, it is preferable to appropriately set according to the material of the tube 2 and the viscosity of the infrared absorbent. In particular, if the material of the tube 2 is a material that shrinks due to heat, the height H of the rib 3h, the interval W4 between the pair of ribs 3h (see FIG. 3B), and the like also take into account the degree of shrinkage. Preferably it is set.

  The length W9 (FIG. 3A) in the same direction as the longitudinal direction of the connecting member 1 in the welding region 31 is preferably 1 to 4 mm and more preferably 2 to 3 mm from the viewpoint of ensuring high bonding strength. Therefore, from the same viewpoint, the length of the partial contact surface 3e in the same direction as the longitudinal direction of the member 3 to be joined is preferably 1 to 4 mm, and more preferably 2 to 3 mm.

  As shown in FIG. 3A, since the inner diameter W3 of the portion having the non-contact surface 3f of the member 3 to be joined is larger than the outer diameter M of the tube 2, the tube 2 is inserted into the member 3 to be joined. The non-contact surface 3f and the outer peripheral surface 2a of the tube 2 facing the non-contact surface 3f do not contact each other. Therefore, in the manufacturing process of the connecting member 1, the infrared absorbent 7 (see FIGS. 5A and 5B) supplied between the partial contact surface 3e and the outer peripheral surface 2a of the tube 2 facing the partial contact surface 3e is partially contacted. Intrusion between the non-contact surface 3f and the outer peripheral surface 2a of the tube 2 facing the non-contact surface 3f beyond the space between the surface 3e and the outer peripheral surface 2a of the tube 2 facing the partial contact surface 3e is suppressed. Yes.

  The distance W5 (see FIG. 4A) between the non-contact surface 3f and the outer peripheral surface of the tube 2 facing the non-contact surface 3f is the supply of the infrared absorbent 7 to the passage 8 (see FIG. 4B) utilizing capillary action. From the viewpoint of facilitating, the thickness is preferably 0.1 to 1 mm, and more preferably 0.2 to 0.8 mm.

  The length W10 (FIG. 3A) of the non-contact region 32 in the same direction as the longitudinal direction of the connecting member 1 ensures high biological safety and facilitates the supply of the infrared absorbent to the passage 8 utilizing capillary action. In view of the above, it is preferably 1 to 4 mm, and more preferably 2 to 3 mm. Therefore, the length of the non-contact surface 3f in the same direction as the longitudinal direction of the member 3 to be joined is preferably 1 to 4 mm and more preferably 2 to 3 mm from the same viewpoint.

  As shown in FIG. 3A, the inner diameter W2 at the portion having the contact surface 3g of the member 3 to be joined is equal to or slightly equal to the outer diameter M of the tube 2 before being inserted into the through hole 3c of the member 3 to be joined. Small is preferable. When the inner diameter W2 is slightly smaller than the outer diameter M of the tube 2, when the tube 2 is inserted into the through hole 3c of the member 3 to be joined, the contact surface 3g and the outer peripheral surface 2a of the tube 2 facing the contact surface 3g are brought into close contact with each other. In the connecting portion 6 (see FIG. 2), the liquid tightness between the tube 2 and the member 3 to be joined is improved. In this case, even if the infrared absorber enters between the non-contact surface 3f and the outer peripheral surface 2a of the tube 2 facing the non-contact surface 3f, the outer peripheral surface of the tube 2 facing the contact surface 3g and the contact surface 3g. Since 2a is closely_contact | adhered, it can suppress more reliably that the infrared absorber 7 and / or its decomposition product contact the liquid substance which flows through the lumen | bore of the tube 2, and the through-hole 3c of the to-be-joined member 3. FIG.

  The length W11 (see FIG. 3A) of the contact region 33 (see FIG. 2) in the same direction as the longitudinal direction of the connecting member 1 ensures high biological safety, high liquid-tightness, and ease of assembly. From the viewpoint, it is preferably 1 to 4 mm, and more preferably 2 to 3 mm. Therefore, from the same viewpoint, the length of the contact surface 3g in the same direction as the longitudinal direction of the member 3 to be joined is preferably 1 to 4 mm, and more preferably 2 to 3 mm.

From the above, the inner diameter W2, the maximum inner diameter W1 _max, and an inner diameter W3 of the workpieces 3, W2 <it is sufficient to satisfy the W3 and W1 _max <W3 but liquid-tightness and biological safety from the viewpoint of improvement, more preferably a W2 <W1 _max <W3.

As shown in FIG. 3B, the maximum thickness W7 _max and minimum thickness W7 _max at a point having the partial contact surfaces 3e of the workpieces 3, considering the laser transmittance, each with 0.5~1.2mm Preferably, it is 0.4 to 1.1 mm.

  As shown in FIG. 3A, it is preferable that the inner diameter W6 of the bonded member 3 on the opposite side of the contact surface 3g to the non-contact surface 3f side is smaller than the inner diameter W2. Moreover, it is preferable that the inner peripheral surface 3i of the member 3 to be joined includes a step surface 3m with which one end face 2c of the tube 2 comes into contact when the tube 2 is inserted into the through hole 3c of the member 3 to be joined. In this case, the tube 2 is inserted into the through-hole 3c of the joined member 3 until the end surface 2c of the tube 2 abuts on the stepped surface 3m. While being able to insert in the through-hole 3c, since the end surface 2c of the tube 2 contacts the level | step difference surface 3m, liquid-tightness and biological safety can be improved more.

  If the non-contact surface 3f is referred to as a first non-contact surface 3f, the inner peripheral surface of the member 3 to be joined is a partial contact surface on the side opposite to the first non-contact surface 3f side of the partial contact surface 3e. It is preferable to have a second non-contact surface 3k that is adjacent to 3e and whose entire circumference does not contact the inner peripheral surface of the tube 2. For example, the second non-contact surface 3k is preferably a tapered surface 3k having an inner diameter that increases toward the tip 3a of the member 3 to be joined. In this case, in the manufacturing process of the connecting member 1, a gap 9 is formed between the second non-contact surface 3k (tapered surface 3k) and the outer peripheral surface 2a of the tube 2 facing the second non-contact surface 3k (see FIGS. 4A and 5A). There will be. The shape of the gap 9 viewed along the central axis 1a is annular. If the infrared absorbent 7 is temporarily stored in the gap 9, the operation of supplying the infrared absorbent 7 between the partial contact surface 3e and the outer peripheral surface 2a of the tube 2 facing the partial contact surface 3e can be easily performed. And the uniformity of the supply of the infrared absorber 7 is also improved.

  The material of the member 3 to be joined is preferably an olefin polymer, and specifically, polyolefin (homopolymer) such as polypropylene, polyethylene (low pressure, medium pressure, high pressure), linear low density polyethylene, boribten, Examples thereof include a copolymer obtained by copolymerizing two or more olefinic monomers selected from the group consisting of propylene, ethylene, and butene. Among these, polypropylene is preferable.

  The hardness of the member 3 to be joined is preferably R40 to R140, and more preferably R50 to R100. These values are values measured based on JIS-K7202.

  Examples of the combination of the material of the tube 2 and the material of the member 3 to be joined include polypropylene / polypropylene, polyethylene / polyethylene, and the like. Polypropylene / polypropylene is preferable because of good compatibility and high joint strength.

  As an infrared absorber used in the manufacturing process of the connecting member 1, one having an absorption coefficient E of 20 or more with respect to light in the near infrared region having a wavelength of 900 to 1200 nm is preferable. For example, Clearweld ( Clearweld (registered trademark), manufactured by Gentex).

  Next, an example of the manufacturing method of the connection member of this invention is demonstrated. Here, an example of the manufacturing method of the connection member 1 of (Embodiment 1) is demonstrated.

  As shown in FIGS. 3A and 4A, first, the tube 2 is inserted into the through hole 3c of the member to be joined 3 until the end surface 2c of the tube 2 reaches the stepped surface 3m.

  Next, as shown in FIGS. 5A and 5B, the infrared absorbent 7 is supplied to the gap 9. The supply of the infrared absorbent 7 is performed uniformly in the circumferential direction of the annular gap 9 so that bonding unevenness does not occur in the circumferential direction of the tube 2 and the member 3 to be joined. Then, the infrared absorbent 7 enters the passage 8 (see FIG. 4B) by capillary action, and the infrared absorbent 7 is supplied between the partial contact surface 3e and the outer peripheral surface 2a facing the partial contact surface 3e of the tube 2. Will be.

  From the viewpoint of improving biological safety, the supply amount of the infrared absorbent 7 can fill the passage 8 (FIG. 4B) with the infrared absorbent 7. It is preferable that the amount is such that it does not penetrate to the outer peripheral surface 2a of the tube 2 facing the contact surface 3f, or is small even if it enters. Moreover, it is preferable that the supply amount of the infrared absorber 7 is an amount that does not reach the contact surface 3g from the viewpoint of improving biological safety.

  Next, as shown in FIG. 6, infrared rays are applied to the infrared absorber 7 supplied from the outer peripheral side of the bonded member 3 between the partial contact surface 3 e and the outer peripheral surface of the tube 2 facing the partial contact surface 3 e. Irradiate. Then, the infrared absorber 7 absorbs infrared rays and generates heat. Due to this heat, the partial contact surface 3e and the outer peripheral surface facing the partial contact surface 3e of the tube 2 are respectively melted. Since the member 3 and the tube 2 are formed of resin materials that are compatible with each other, the molten resin of the member 3 to be melted and the molten resin of the tube 2 are mixed, and the molten resin is mutually mixed. Is solidified, the tube 2 and the member 3 to be joined are firmly joined.

  The infrared ray used for joining the tube 2 and the member 3 to be joined may be an electromagnetic wave having a wavelength of 900 to 1200 nm, and a semiconductor laser device may be used as the infrared irradiation device.

  What is necessary is just to set suitably infrared irradiation conditions, such as a laser irradiation amount (J / mm), according to the kind of infrared absorber, the material of the tube 2 and the to-be-joined member 3, etc. FIG.

  The joining strength between the tube 2 and the member to be joined 3 in the connecting member 1 thus obtained is preferably 50N or more, and more preferably 80N or more. This joint strength is a value measured by the method described in the fracture strength test 1.4 defined in the JIS T 3211 appendix.

  The airtightness of the connecting member 1 thus obtained is preferably 1 MPa or more, and more preferably 3 MPa or more. This airtightness is a value measured by the method described in the airtightness test 1.2 defined in the JIS T 3211 appendix.

(Embodiment 2)
FIG. 7 is a front view of the medical connecting member according to the second embodiment of the present invention, and FIG. 8 is a cross-sectional view taken along the central axis of the medical connecting member shown in FIG.

  As shown in FIGS. 7 and 8, the medical connecting member 10 of this embodiment includes a hollow tube 12 and a member 13 to be joined. A through hole 13c penetrating in the longitudinal direction is formed in the member 13 to be joined, and has a rotationally symmetric shape with respect to the central axis 10a. The to-be-joined member 13 has an insertion part (not shown) that can be inserted into, for example, a flexible tube different from the tube 12 on the side opposite to the side joined to the tube 12 in both longitudinal ends. )have. The connecting member 10 has a direction in which a part of the tube 12 and a part of the member 13 to be joined are orthogonal to the axial direction of the central axis 10a when the member 13 to be joined is inserted into the lumen 12c of the tube 12. The connection part 16 which overlapped with is included.

  As shown in FIG. 8, the connecting portion 16 includes a welding region 131, a non-contact region 132, and a contact region 133 in this order from the one tip 12 b side of the tube 12 toward the other tip side. The arrangement direction B of the welding region 131, the non-contact region 132, and the contact region 133 is the same as the insertion direction of the member 13 to be joined to the tube 12.

  In the welding region 131, the member to be joined 13 and the tube 12 are joined to each other. Prior to joining, the welding region 131 is provided with an infrared absorber 17 (FIG. 12A) supplied between the partial contact surface 13e (see FIG. 9A) of the member 13 to be joined and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e. , See FIG. 12B), the member to be joined 13 and the tube 12 adjacent to the infrared absorber 17 are each melted and then solidified, and then solidified. Therefore, the welding region 131 contains the infrared absorbent 17 and / or the decomposed product of the infrared absorbent 17 used in the manufacturing process of the connecting member 10. In the non-contact region 132, the outer peripheral surface 13f (see FIG. 10) of the member 13 to be joined and the inner peripheral surface 12a of the tube 12 are not in contact with each other. In the contact region 133, the outer peripheral surface 13g (see FIG. 10) of the member 13 to be joined and the inner peripheral surface 12a of the tube 12 are in contact with each other, but are not joined.

  The material etc. of the tube 12 are the same as the tube 12 which comprises the connection member 1 of Embodiment 1. FIG. When the member 13 to be joined is inserted into the tube 12, the tube 12 is slightly deformed by being pressed by a rib 13h (see FIGS. 9B and 11B) included in a partial contact surface 13e of the member 13 to be joined which will be described later. It has enough elasticity. The tube 12 used in the present embodiment also preferably has a single-layer structure, and the inner diameter and the outer diameter are also constant over the entire length in the longitudinal direction. The shape of the inner peripheral surface 12a surrounding the opening of the tube 12 seen along the central axis 10a is circular, and the center thereof coincides with the central axis 10a.

  There is no restriction | limiting in particular about the outer diameter and inner diameter of the tube 12, Usually, an outer diameter is 3-12 mm and it is 2-10 mm in internal diameter.

  The insertion length X12 (see FIG. 12A) of the joined member 13 is suitably 8 to 12 mm from the viewpoint of ensuring biological safety and ensuring high liquid tightness.

  As shown in FIG. 9A, the member 13 to be joined has a substantially cylindrical shape. Due to the difference in distance from the central axis 10a, the outer peripheral surface 13i of the member 13 to be bonded has its contact surface 13g, non-contact surface 13f, and partial contact surface 13e moved from one tip 13n side to the other tip side of the member 13 to be joined. It has in this order.

9A to 9B, the partial contact surface 13e of the member 13 to be bonded has a plurality of ribs 13h extending in the same direction as the longitudinal direction of the member 13 to be bonded. Therefore, the partial contact surface 13e has a recess 13j between the pair of ribs 13h. The outer diameter at the portion having the partial contact surface 13e of the member to be joined 13 has a minimum outer diameter X2 _min and a maximum outer diameter X2 _max because the partial contact surface 13e includes a plurality of ribs 13h. Since the minimum outer diameter X2 _min is slightly smaller than the inner diameter of the tube 12 and the maximum outer diameter X2 _max is slightly larger than the inner diameter of the tube 12, when the member 13 to be joined is inserted into the lumen of the tube 12, FIG. as shown, the ribs 13h is in contact with the inner peripheral surface of the tube 12, the top portion 13h _t according to the degree of elasticity of the tube 12 pushes the tube 12 from the inside in the radial direction. On the other hand, the tube 12 is not filled on the lower side (the side closer to the central axis 10a) in the recess 13j, and at least a part of the outer surface of the member 13 to be joined corresponding to the recess 13j is the tube 12. It is not in contact with the inner peripheral surface. Therefore, in a state where the inside of the member to be joined 13 is inserted into the tube 12, as shown in FIG. 11B, the gap between the non-contact surface 13f and the outer peripheral surface 12a of the tube 12 facing the non-contact surface 13f, and the joint Partial contact is made so that a narrow passage 18 communicating with the outside of the member 13 is formed between the outer peripheral surface 13i (see FIG. 10) of the joined member 13 and the inner peripheral surface 12a (see FIG. 10) of the tube 12. The surface 13e and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e are in partial contact. As shown in FIG. 9B, the height L of the rib 13h, the distance X4 between the pair of ribs 13h, the shape of the recess 13j, and the like are such that the infrared absorber 17 has a length in the longitudinal direction of the passage 18 due to capillary action. It is preferable to set appropriately according to the material of the tube 12, the viscosity of the infrared absorber 17, etc. so as to be filled. In particular, if the material of the tube 12 is a material that shrinks due to heat, the height L of the ribs 13h and the interval X4 between the pair of ribs 13h are preferably set in consideration of the degree of shrinkage. .

  The length X9 (FIG. 10A) in the same direction as the longitudinal direction of the connecting member 10 in the welding region 131 is preferably 1 to 4 mm, and more preferably 2 to 3 mm, from the viewpoint of ensuring high bonding strength. Therefore, from the same viewpoint, the length of the partial contact surface 13e in the same direction as the longitudinal direction of the member 13 to be joined is preferably 1 to 4 mm, and more preferably 2 to 3 mm.

  As shown in FIGS. 8 to 10, the outer diameter X <b> 3 at the portion having the non-contact surface 13 f (see FIG. 10) of the member to be bonded 13 is smaller than the inner diameter of the tube 12. In a state where 13 is inserted, the non-contact surface 13f and the inner peripheral surface 12a of the tube 12 facing the non-contact surface 13f do not contact each other. Therefore, in the manufacturing process of the connecting member 10, the infrared absorber 17 (see FIGS. 12A and 12B) supplied between the partial contact surface 13e and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e is partially It may enter between the non-contact surface 13f and the inner peripheral surface 12a of the tube 12 facing the non-contact surface 13f beyond the contact surface 13e and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e. It is suppressed.

  The distance X5 (see FIG. 11A) between the non-contact surface 13f and the inner peripheral surface 12a of the tube 12 facing the non-contact surface 13f is the distance of the infrared absorbent 17 to the passage 18 (see FIG. 11B) utilizing capillary action. From the viewpoint of facilitating supply, the thickness is preferably 0.1 to 1 mm, and preferably 0.2 to 0.8 mm.

  The length X10 (FIG. 10) of the non-contact region 132 in the same direction as the longitudinal direction of the connecting member 10 ensures high biological safety and facilitates the supply of the infrared absorber to the passage 18 utilizing capillary action. In view of the above, it is preferably 1 to 4 mm, more preferably 2 to 3 mm. Therefore, the length of the non-contact surface 13f in the same direction as the longitudinal direction of the member 13 to be joined is preferably 1 to 4 mm and more preferably 2 to 3 mm from the same viewpoint.

  As shown in FIGS. 8 to 10, the outer diameter X1 at the portion having the contact surface 13g of the member 13 to be joined is equal to or slightly larger than the inner diameter Q of the tube 12 before the member 13 is inserted. And preferred. When the outer diameter X1 is slightly larger than the inner diameter Q of the tube 12, when the member 13 is inserted into the lumen of the tube 12, the contact surface 13g and the inner peripheral surface 12a of the tube 12 facing the contact surface 13g are in close contact with each other. Therefore, it is preferable because the liquid tightness between the tube 12 and the member 13 to be joined in the connecting portion 16 (see FIG. 8) is improved. In this case, even if the infrared absorber enters between the non-contact surface 13f and the inner peripheral surface of the tube 12 facing the non-contact surface 13f, the outer peripheral surface of the tube 12 facing the contact surface 13g and the contact surface 13g. Since the infrared absorber 7 and / or the decomposition product thereof are in contact with the liquid material flowing in the lumen of the tube 12 and the through-hole 13c of the member 13 to be joined, it can be more reliably suppressed.

  The length X11 (FIG. 10) of the contact region 133 (see FIG. 8) in the same direction as the longitudinal direction of the connecting member 10 is ensured from the viewpoint of ensuring high biological safety, ensuring high liquid tightness, and easy assembly. Therefore, the thickness is preferably 1 to 4 mm, and more preferably 2 to 3 mm. Therefore, the length of the contact surface 13g in the same direction as the longitudinal direction of the member 13 to be joined is preferably 1 to 4 mm and more preferably 2 to 3 mm from the same viewpoint.

From the above, the outer diameter X1, the maximum outer diameter X2 _max , and the outer diameter X3 of the member to be bonded 13 (see FIG. 9A) may satisfy X1> X3 and _X2max > X3. From the viewpoint of improvement in sex and biological safety, it is more preferable that X3 < _X2max <X1.

If the non-contact surface 13f is referred to as a first non-contact surface 13f, the outer peripheral surface of the member 13 to be joined is, as shown in FIG. 9A, the first non-contact surface 13f side of the partial contact surface 13e. On the opposite side, as a second non-contact surface that is adjacent to the partial contact surface 13e and whose entire circumference does not contact the inner peripheral surface of the tube 12, for example, a taper that decreases in outer diameter as it is farther from the tip 13n of the member 13 to be joined. It is preferable to have a cylindrical surface 13k ₂ adjacent to the surface 13k ₁ and the tapered surface 13k ₁ and having a diameter smaller than the maximum outer diameter X2 _Max . In this case, in the manufacturing process of the connecting member 10, the second non-contact surface (tapered surface 13k ₁ and cylindrical surface 13k ₂ ) of the member 13 to be joined and the inner peripheral surface 12a of the tube 12 facing the second non-contact surface. A gap 19 (see FIG. 11A) exists between them. The shape of the gap 9 viewed along the axis 10a is annular. If the infrared absorbent 17 is temporarily stored in the gap 19, an operation of supplying the infrared absorbent 17 between the partial contact surface 13e and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e is performed. This is preferable because it is easy and the uniformity of the supply of the infrared absorber 17 is improved.

  The material of the member to be bonded 13 may be the same as that of the member to be bonded 3 used in the first embodiment. The preferable combination of the material of the tube 12 and the member 13 to be joined may be the same as that in the first embodiment.

  The infrared absorber used in the manufacturing process of the connecting member 10 may be the same as that used in the first embodiment.

  Next, another example of the manufacturing method of the connecting member of the present invention will be described. Here, an example of the manufacturing method of the connection member 10 of (Embodiment 2) is demonstrated.

  As shown in FIG. 12A, the member 13 to be joined is inserted into the tube 12.

Next, as shown in FIGS. 12A and 12B, an infrared absorber 17 is supplied between the partial contact surface 13 e (see FIG. 10) and the inner peripheral surface facing the partial contact surface 13 e of the tube 12. The infrared absorber 17 is supplied to the gap 19 between the tube 12 formed by the member 13 to be joined having the second non-contact surface (tapered surface 13k ₁ and cylindrical surface 13k2, see FIG. 9A). Supply in the same manner as in the case of 1. The infrared absorber 17 used may be the same as that used in the first embodiment.

  Next, as shown in FIG. 13, the infrared absorption supplied from the outer peripheral side of the tube 12 between the partial contact surface 13e (see FIG. 10) and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e. The agent 17 (see FIG. 12B) is irradiated with infrared rays. Then, the infrared absorber 17 absorbs infrared rays and generates heat. This heat causes the partial contact surface 13e and the inner peripheral surface 12a of the tube 12 facing the partial contact surface 13e to melt. Since the member 13 and the tube 12 are formed of resin materials that are compatible with each other, the molten resin of the member 13 and the molten resin of the tube 12 are mixed, and the molten resin is mixed with each other. Is solidified, the tube 12 and the member to be joined 13 are firmly joined. The infrared irradiation conditions may be the same as those in the first embodiment.

  In the connecting member 10 obtained in this way, the bonding strength and airtightness of the tube 12 and the member to be bonded 13 may be the same as those in the connecting member 1 of the first embodiment.

  In the first and second embodiments, the partial contact surface of the member to be joined has a plurality of ribs. Instead, a satin finish may be applied to the partial contact surface. The surface roughness of the surface subjected to the satin finish is 0.05 to 1.0 Ra so that the infrared absorber is appropriately supplied between the partial contact surface and the surface of the tube facing the partial contact surface. And preferably 0.1 to 0.5 Ra.

  The present invention can be used for various medical devices including a hollow tube and a member to be bonded to the tube.

DESCRIPTION OF SYMBOLS 1,10 Medical connection member 2,12 Tube 2c, 12c Tube lumen 3,13 To-be-joined member 3c, 13c Through-hole of to-be-joined member 6,16 Connection part 7,17 Infrared absorber 31,131 Welding region 32 , 132 Non-contact area 33, 133 Contact area 9, 19 Gap 3e, 13e Partial contact surface 3f, 13f Non-contact surface (first non-contact surface)
3 g, 13 g contact surface 3k, 13k _1, 13k ₂ second non-contact surface

Claims (10)

A flexible hollow tube;
The bonded to the tube, it viewed including the bonded members which a through hole is formed which communicates with the lumen of the tube,
When one of the tube and the member to be joined is inserted into the other, a portion where the tube and the member to be joined overlap is referred to as a connecting portion, and of the tube and the member to be joined. When the other is referred as insert the one to be referred to as the insert body,
The connecting portion is
After irradiating infrared rays to the infrared absorbent supplied using the capillary phenomenon between the joined member and the tube to melt the joined member and the tube adjacent to the infrared absorbent, By solidifying, a welding region in which the axially circumferential surfaces facing each other of the member to be joined and the tube are joined,
A non-contact region that is adjacent to the welding region, and is not in contact with the entire circumferential surface facing each other of the member to be joined and the tube;
Wherein adjacent to the non-contact region, said a contact area but axially entire peripheral surface facing each other with the bonded member the tube is contact not bonding of said insert with respect to the subject insertion body Including along the insertion direction,
The entire circumferential surface facing the tube of the member to be joined before being joined to the tube in the welding region is a partial contact surface partially in contact with the tube,
The partial contact surface communicates between the non-contact area and the outside of the inserted body between the surface of the tube facing the partial contact surface, and a plurality of infrared absorbers that can be filled by capillary action. A medical connecting member that forms a passage . The insert is the tube;
On the opposite side to the non-contact region side of the welding region of the connecting portion, the inner surface of the member to be joined and the outer peripheral surface of the tube communicate with the plurality of passages, and the infrared absorber The medical connecting member according to claim 1, wherein there are annular gaps used for supply to the plurality of passages . The insert is the member to be joined;
On the opposite side to the non-contact region side of the welding region of the connecting portion, the plurality of passages are communicated between the outer peripheral surface of the bonded member and the inner peripheral surface of the tube , The medical connecting member according to claim 1, wherein there are annular gaps used for supplying to the plurality of passages . The plurality of passages are formed between the partial contact surface and the surface of the tube facing the partial contact surface, because the partial contact surface has a plurality of ribs or a matte surface. The medical connecting member according to any one of claims 1 to 3. It is a manufacturing method of the medical connection member according to any one of claims 1 to 4 ,
After one of the tube and the member to be joined is inserted into the other, an infrared absorber is supplied between the member to be joined and the tube using a capillary phenomenon , and then the infrared absorber is supplied to the infrared absorber. Irradiating with infrared rays, melting each of the member to be bonded adjacent to the infrared absorber and the tube, and then solidifying, thereby bonding the tube and the member to be bonded;
When that the referred to the other and insert the one of the tube and the bonded members referred to as the insert body,
The tube and facing engagement Cormorants surface of the workpieces before being joined to the tube,
A partial contact surface whose entire circumference in the axial direction partially contacts the tube ;
Adjacent the portion contact surface, and a non-contact surface thereof axial entire periphery does not contact with the tube,
A contact surface which is adjacent to the non-contact surface and whose entire circumference in the axial direction is in contact with the tube, in this order along the insertion direction of the insert relative to the insertion target ,
In the step, by inserting one of the tube and the member to be joined into the other, the non-contact surface and the non-contact surface are interposed between the partial contact surface and the surface of the tube facing the partial contact surface. A plurality of passages are formed to communicate a gap between the tube surface facing the contact surface and the outside of the inserted body, and the infrared absorbing agent passes from the outside of the inserted body by the capillary phenomenon. The method for manufacturing a medical connecting member is supplied between the partial contact surface and the surface of the tube facing the partial contact surface. When the insert is the tube,
The inner peripheral surface of the member to be joined includes the partial contact surface, the non-contact surface, and the contact surface in this order along the insertion direction of the tube with respect to the member to be joined ,
W2 <W1max <W3, where W1max is the maximum inner diameter of the member having the partial contact surface, W3 is the inner diameter of the member having the non-contact surface, and W2 is the inner diameter of the member having the contact surface. The manufacturing method of the medical connection member of Claim 5 satisfied. When the non-contact surface is a first non-contact surface,
The inner peripheral surface of the member to be joined is a second side adjacent to the partial contact surface on the side opposite to the first non-contact surface side of the partial contact surface, and the entire periphery thereof does not contact the outer peripheral surface of the tube. has a non-contact surface,
The medical connecting member according to claim 6 , wherein in the step, the infrared absorbent is supplied to an annular gap communicating with the plurality of passages between an outer peripheral surface of the tube and the second non-contact surface. Manufacturing method. When the insert is a member to be joined,
The outer peripheral surface of the joint member includes a said portion contact surface, wherein a non-contact surface, and the contact surface, before SL along the insertion direction of the workpieces to the lumen of the tube in this order,
Assuming that the maximum outer diameter of the part having the partial contact surface of the member to be joined is X2max, the outer diameter of the part having the non-contact surface is X3, and the outer diameter of the part having the contact surface is X1, X3 <X2max < The method for manufacturing a medical connecting member according to claim 5 , wherein X1 is satisfied. When the non-contact surface is a first non-contact surface,
The outer peripheral surface of the joined member is adjacent to the partial contact surface on the side opposite to the first non-contact surface side of the partial contact surface, and the entire periphery thereof does not contact the inner peripheral surface of the tube. Has a non-contact surface ,
The medical connection according to claim 8 , wherein in the step, the infrared absorbent is supplied to an annular gap communicating with the plurality of passages between an inner peripheral surface of the tube and the second non-contact surface. Manufacturing method of member. The plurality of passages are formed between the partial contact surface and the surface of the tube facing the partial contact surface, because the partial contact surface has a plurality of ribs or a matte surface . The manufacturing method of the medical connection member as described in any one of Claims 5-9 .

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