JP2023069819A - Method of manufacturing catheter assembly and catheter assembly - Google Patents

Abstract

To provide a catheter assembly and a method of manufacturing the same.SOLUTION: In the method of manufacturing catheter assemblies, in a coating process, a coating material 48 applied to a catheter 22 and to an inner needle, with the inner needle 34 of a needle member 18 inserted into an insertion hole of an inner needle attachment part 52 and the inner needle inserted into a lumen of a catheter member 16 so that the catheter member is positioned between the tip of the inner needle and the inner needle attachment part 52. In a joining process, a catheter attachment part 50 is joined to the inner needle attachment part after the coating process.SELECTED DRAWING: Figure 8

Description

The present invention relates to a method for manufacturing a catheter assembly and a catheter assembly.

Japanese Patent Laid-Open No. 2003-100002 discloses a catheter assembly. The catheter assembly includes a hollow catheter member, a needle member, and a catheter manipulation member. The catheter member has a catheter and a catheter hub. The needle member has an inner needle inserted through the lumen of the catheter member and an inner needle hub attached to the proximal end of the inner needle. The catheter operation member includes a catheter mounting section that can be attached to and detached from the catheter member, and an inner needle mounting section that can be attached to the inner needle. The catheter mounting part covers the catheter. The inner needle mounting portion has an insertion hole through which the inner needle is inserted. The inner surface forming the insertion hole extends so as to cover the inner needle in the circumferential direction. The catheter control member is a one-piece molded piece.

When using such a catheter assembly, first, the catheter and the inner needle are punctured into the blood vessel of the human body. The user then moves the catheter control member toward the tip of the catheter. The catheter then advances along the inner needle. At this time, since the inner needle is inserted through the insertion hole of the catheter operating member, the catheter operating member is not separated from the inner needle. This allows the catheter to remain in the blood vessel. After placing the catheter in the blood vessel, the inner needle is withdrawn from the catheter member and the catheter operating member toward the proximal end of the needle member. The catheter control member is then removed from the catheter member.

WO2018/181195

By the way, when manufacturing the catheter assembly as described above, the inner needle of the needle member is passed through the insertion hole of the catheter operating member, and then passed through the lumen of the catheter member. After that, a coating process is performed to apply a coating material to the catheter and the inner needle. However, in this case, the catheter mounting portion is positioned so as to cover the catheter during the coating process, so the catheter mounting portion becomes an obstacle. Therefore, there is a possibility that the coating process cannot be performed efficiently.

An object of the present invention is to solve the problems described above.

A first aspect of the present invention comprises a hollow catheter member having a catheter and a catheter hub, an inner needle inserted through a lumen of the catheter member, a needle hub attached to the proximal end of the inner needle, and a catheter operating member for moving the catheter member along the inner needle, wherein the catheter operating member is detachable from the catheter member and an inner needle mounting portion located between the catheter mounting portion and the proximal end of the needle member and having an insertion hole through which the inner needle is inserted, the catheter mounting portion comprising: At least part of the catheter is covered while attached to the catheter member, the inner needle of the needle member is inserted through the insertion hole of the inner needle attachment portion, and the tip of the inner needle and the inner needle attachment are inserted. a coating step of applying a coating material to the catheter and the inner needle in a state in which the inner needle is passed through the lumen of the catheter member so that the catheter member is disposed between the catheter member and the coating; a bonding step of bonding the catheter mounting portion to the inner needle mounting portion after the step.

A second aspect of the present invention includes a hollow catheter member having a catheter and a catheter hub, an inner needle inserted through a lumen of the catheter member, a needle hub attached to the proximal end of the inner needle, and a catheter operating member for moving the catheter member along the inner needle, wherein the catheter and the inner needle are coated with a coating material The catheter operating member has a catheter mounting portion that can be attached to and detached from the catheter member, and an insertion hole that is positioned between the catheter mounting portion and the proximal end of the needle member and through which the inner needle is inserted. and a needle mounting portion, wherein the catheter mounting portion covers at least a portion of the catheter while being mounted on the catheter member, and the catheter mounting portion and the inner needle mounting portion are separate parts. A catheter assembly according to claim 1, wherein a proximal end of said catheter fitting has a first junction and said inner needle fitting has a second junction to which said first junction is joined.

According to the first aspect of the present invention, in the coating step, since the catheter mounting portion is not attached, the catheter operating member does not interfere when the coating material is applied to the catheter and the inner needle. Therefore, the coating process can be efficiently performed. In addition, since the catheter mounting portion is bonded to the inner needle mounting portion in the bonding step, the catheter can be advanced smoothly along the inner needle by operating the catheter operating member when the catheter assembly is used.

According to the second aspect of the present invention, after applying the coating material to the catheter and the inner needle, the first joint portion of the catheter mounting portion can be joined to the second joint portion of the inner needle mounting portion. Therefore, the catheter operating member does not get in the way when the coating material is applied to the inner needle and the catheter. Thereby, a coating process can be performed efficiently. Further, when the catheter assembly is used, the catheter can be advanced smoothly along the inner needle by operating the catheter operating member.

1 is a perspective view of a catheter assembly according to one embodiment of the present invention; FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 1; FIG. 3 is an exploded perspective view of the assembly body of FIG. 2; FIG. FIG. 4 is a perspective view of the assembled main body as seen obliquely from below. FIG. 5A is a vertical cross-sectional view of the proximal end of the assembly body. FIG. 5B is a cross-sectional view along line VB-VB of FIG. 5A. FIG. 6 is a flow chart illustrating a method of manufacturing the catheter assembly of FIG. FIG. 7 is an explanatory diagram of the first assembly step. FIG. 8 is an explanatory diagram of the joining process. FIG. 9 is an explanatory diagram of the second assembly process. 10 is a first explanatory view of the operating procedure of the catheter assembly of FIG. 1; FIG. 11 is a second explanatory view of the operating procedure of the catheter assembly of FIG. 1; FIG. FIG. 12 is a partially omitted vertical cross-sectional view of an assembly body provided with a catheter operating member according to a first modification. FIG. 13 is a longitudinal sectional view with partial omission of an assembly body provided with a catheter operating member according to a second modification.

As shown in FIG. 1, a catheter assembly 10 according to one embodiment of the present invention is used for fluid infusion, blood transfusion, blood collection, or the like. The catheter assembly 10 inserts and indwells the catheter 22 inside the body to allow communication between the inside and the outside of the body. Catheter assembly 10 allows insertion of catheters longer than peripheral venous catheters (eg, central venous catheters, PICCs, midline catheters, etc.). Note that the catheter assembly 10 may be configured to allow insertion of a peripheral intravenous catheter. Moreover, the catheter assembly 10 is not limited to an intravenous catheter, and may be configured to allow insertion of an arterial catheter such as a peripheral artery catheter.

The catheter assembly 10 extends in one direction (the arrow X direction). The catheter assembly 10 has a tip at one end (the direction of the arrow Xa) in the extending direction. The catheter assembly 10 has a proximal end at the other end (direction of arrow Xb) in the extending direction. In the following description, the direction of arrow Xa may be referred to as the "distal direction" and the direction of arrow Xb may be referred to as the "proximal direction". The configuration of the catheter assembly 10 in the initial state will be described below.

1 and 2, catheter assembly 10 includes assembly body 12 and grip 14 . Assembly body 12 includes a hollow catheter member 16 , needle member 18 and catheter manipulation member 20 .

In FIG. 3, catheter member 16 comprises catheter 22 and catheter hub 24 . Catheter 22 has flexibility. The catheter 22 has a lumen 26 that is large enough to accommodate the inner needle 34 of the needle member 18 and to allow liquid medicine, blood, and the like to flow. The tip of the catheter 22 (the end in the direction of arrow Xa) has a reduced diameter to reduce puncture resistance.

The total length of the catheter 22 is not particularly limited, and can be appropriately designed according to the application, various conditions, etc., and is set to approximately 14 mm to 500 mm, for example. Also, the total length of the catheter 22 may be set to approximately 30 mm to 400 mm. Furthermore, the total length of the catheter 22 may be set to approximately 76 mm to 200 mm. The proximal end portion (the end portion in the direction of arrow Xb) of the catheter 22 is fixed to the catheter hub 24 by caulking, fusion bonding, adhesion, or the like.

The constituent material of the catheter 22 is not particularly limited, but a soft resin material is suitable. Specifically, the constituent materials of the catheter 22 include, for example, polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorine-based resins such as perfluoroalkoxy fluorine resin (PFA), polyethylene, and polypropylene. and mixtures thereof, polyurethanes, polyesters, polyamides, polyether nylon resins, mixtures of olefin resins and ethylene/vinyl acetate copolymers, and the like.

Catheter hub 24 has a lumen 28 through which inner needle 34 of needle member 18 extends. Catheter member 16 has a lumen 40 . Lumen 40 includes lumen 26 of catheter 22 and lumen 28 of catheter hub 24 . Catheter hub 24 comprises a hub body 30 and a tubular portion 32 . The tubular portion 32 has a tubular shape that tapers in the distal direction. The lumen 28 of the hub body 30 accommodates a hemostasis valve and plug (not shown). Tubular portion 32 extends from the distal end of hub body 30 toward the distal end of catheter 22 .

The constituent material of the catheter hub 24 is not particularly limited, but thermoplastic resin is suitable. Concretely, examples of the constituent material of the catheter hub 24 include polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, and the like.

Needle member 18 includes an inner needle 34 and a needle hub 36 . The inner needle 34 is a hollow needle having rigidity capable of puncturing the skin of a living body. The total length of inner needle 34 is longer than the total length of catheter 22 . The tip of the inner needle 34 has a sharp needle point 38 . As shown in FIGS. 1 and 2, inner needle 34 is inserted through lumen 40 of catheter member 16 . The tip of the inner needle 34 is exposed through the tip opening 42 of the catheter 22 .

In FIG. 3, the inner needle 34 has a lumen 44 extending along the axial direction of the inner needle 34 . Lumen 44 communicates with distal opening 46 of inner needle 34 . Examples of the constituent material of the inner needle 34 include metal materials, hard resins, and ceramics. Examples of metal materials include stainless steel, aluminum, and titanium. The proximal end of inner needle 34 is secured to needle hub 36 by fusion, gluing, insert molding, or the like. Inner needle 34 may be a solid needle.

The needle hub 36 is a plate-like member extending along the axial direction of the inner needle 34 . Needle hub 36 is constructed, for example, from materials similar to catheter hub 24 described above.

A coating material 48 is applied to the distal end of the catheter assembly 10 to reduce insertion resistance (penetration resistance) of the catheter 22 . A coating material 48 is applied to the outer peripheral surface of the catheter 22 . The coating material 48 is applied around the catheter 22 in the circumferential direction. The coating material 48 is preferably applied from the distal end of the catheter 22 toward the proximal end of the catheter 22 (in the direction of the arrow Xb) over ⅔ or more of the total length of the catheter 22 .

The coating material 48 is also applied to the outer peripheral surface of the tip of the inner needle 34 exposed from the tip opening 42 of the catheter 22 . Note that the coating material 48 may also be applied to the inner peripheral surface of the catheter 22 . Also, the coating material 48 may be applied to a portion of the outer peripheral surface of the inner needle 34 that is covered by the catheter 22 .

The material constituting the coating material 48 is not particularly limited as long as it can increase the lubricity of the catheter 22. For example, materials such as silicone, maleic anhydride-based polymer, acrylic acid-based polymer, and sulfobetaine-based polymer can be used. should be applied. Coating material 48 may also be a material that enhances hydrophilicity, water repellency, antibacterial properties, or antithrombotic properties.

The catheter control member 20 is manipulated by the user in moving the catheter member 16 along the inner needle 34 . The catheter operation member 20 covers at least part of the catheter 22 from above.

The catheter operation member 20 includes a catheter mounting portion 50 and an inner needle mounting portion 52 . The catheter mounting portion 50 and the inner needle mounting portion 52 are separate components. The catheter mounting section 50 is attachable to and detachable from the catheter member 16 . The catheter mounting portion 50 extends along the axial direction (arrow X direction) of the catheter 22 . The total length of the catheter mounting portion 50 is shorter than the total length of the catheter member 16 .

As shown in FIGS. 3 and 4 , the catheter mounting section 50 has an operating plate section 54 , a cover section 56 , a plurality of operating tabs 58 , a first support section 60 and a second support section 62 . The operation plate portion 54 is positioned above the catheter 22 . The operation plate portion 54 has flexibility. In other words, the operation plate portion 54 is configured to be bendable in the thickness direction of the operation plate portion 54 . The width of the operation plate portion 54 is wider than the outer diameter of the catheter 22 .

The cover portion 56 extends from the proximal end of the operation plate portion 54 in the proximal direction (the arrow Xb direction). The cover portion 56 opens downward. The cover portion 56 has a cross-sectional shape like an upside-down U shape, and includes an upper surface portion and a side surface portion. The cover portion 56 covers the catheter hub 24 . The proximal end of the cover portion 56 is located in the proximal direction (direction of arrow Xb) relative to the proximal end of the catheter hub 24 .

In FIG. 3 , a plurality of operation tabs 58 protrude upward from the upper surface of the operation plate portion 54 . A plurality of operation tabs 58 are arranged at intervals along the extending direction of the operation plate portion 54 . Among the plurality of operation tabs 58 , the operation tab 58 positioned most in the direction of the arrow Xa protrudes upward from the other plurality of operation tabs 58 .

In FIG. 4 , the first support portion 60 protrudes downward from the lower surface of the tip portion of the operation plate portion 54 . The first support portion 60 extends along the extending direction of the operation plate portion 54 . The first support portion 60 has a first support slit 66 that opens downward. The first support slit 66 extends along the extending direction of the operation plate portion 54 (the arrow X direction). A longitudinal intermediate portion of the catheter 22 is detachably fitted in the first support slit 66 .

The second support portion 62 is positioned at the tip portion of the cover portion 56 . The second support portion 62 has a second support slit 68 that opens downward. The proximal end of the catheter 22 is detachably fitted in the second support slit 68 .

The inner needle mounting portion 52 is positioned between the catheter mounting portion 50 and the proximal end of the needle member 18 (see FIG. 2). As shown in FIGS. 4-5B, the inner needle attachment portion 52 is attached to the inner needle 34 . The inner needle mounting portion 52 includes a plate-like portion 70 and a projecting portion 72 . The plate-like portion 70 covers the proximal end surface of the catheter hub 24 . The plate-like portion 70 is in contact with the proximal end surface of the catheter hub 24 . Note that the plate-like portion 70 may be close to the proximal end surface of the catheter hub 24 .

5A and 5B, the plate-like portion 70 has an insertion hole 74 through which the inner needle 34 is inserted. The insertion hole 74 penetrates the plate-like portion 70 in the thickness direction (arrow X direction) of the plate-like portion 70 . The inner surface forming the insertion hole 74 extends so as to cover the inner needle 34 in the circumferential direction. The inner diameter (diameter) of the insertion hole 74 is slightly larger than the outer diameter of the inner needle 34 .

As shown in FIGS. 4 and 5A, the protruding portion 72 protrudes from the plate-like portion 70 in the proximal direction (arrow Xb direction). The width of the protrusion 72 is larger than the diameter of the inner needle 34 . The protrusion 72 has a recess 76 in which the inner needle 34 is arranged. The recess 76 opens below the projecting portion 72 . In other words, the lower surface of the protrusion 72 has a recess 76 that is recessed upward. The cross section of the recess 76 has a semicircular shape. The recess 76 communicates with the insertion hole 74 (see FIG. 5A).

In FIG. 5A, the catheter mounting portion 50 and the inner needle mounting portion 52 are separate components. Each of the catheter mounting portion 50 and the inner needle mounting portion 52 is an integrally molded product made of a resin material. The catheter mounting portion 50 has a first junction 78 . The first joint portion 78 is located at the proximal end portion of the cover portion 56 . The first joint portion 78 includes a first joint surface 80 positioned on the proximal end surface of the cover portion 56 . The first joint surface 80 extends over the entire base end surface of the cover portion 56 .

The inner needle mounting portion 52 has a second joint portion 82 to which the first joint portion 78 is joined. The second joint portion 82 is located on the plate-like portion 70 . The second joint portion 82 includes a second joint surface 84 positioned on a plane of the plate-like portion 70 facing the arrow Xa direction. The first joint surface 80 and the second joint surface 84 are joined together with an adhesive 86 . Examples of the adhesive 86 include UV adhesive, epoxy adhesive, acrylic adhesive, and the like. The first joint portion 78 and the second joint portion 82 may be joined together by welding.

1 and 2, the grip 14 has a size and shape that are easy for a user to grip. The grip 14 extends in the arrow X direction. A grip 14 covers the proximal end of the assembly body 12 . Grip 14 includes a lower cover portion 88 and an upper cover portion 90 .

A needle hub 36 is secured to the lower cover portion 88 . The upper cover portion 90 is formed with an opening 92 through which the catheter operation member 20 is exposed. A plurality of operation tabs 58 are exposed to the outside from openings 92 of the upper cover portion 90 . The grip 14 supports the operation plate portion 54 of the catheter operation member 20 so as to be slidable in the arrow X direction.

Next, a method for manufacturing the catheter assembly 10 will be described. As shown in FIG. 6, the method of manufacturing the catheter assembly 10 includes a first assembling step, a coating step, a bonding step, and a second assembling step.

In the manufacturing method of the catheter assembly 10, first, a first assembly step (step S1) is performed. In the first assembly step, as shown in FIG. 7, the inner needle 34 of the needle member 18 is passed through the insertion hole 74 of the inner needle mounting portion 52 . Next, the inner needle 34 is inserted from the proximal end of the catheter hub 24 toward the distal end of the catheter 22 . The catheter member 16 is arranged between the distal end (needle point 38 ) of the inner needle 34 and the inner needle mounting portion 52 after the first assembling step is completed. Also, the tip of the inner needle 34 is exposed in the direction of the arrow Xa from the tip opening 42 of the catheter 22 . Furthermore, the distal end portion (plate-like portion 70 ) of the inner needle mounting portion 52 is located in the direction of the arrow Xb from the proximal end of the catheter hub 24 . In other words, the inner needle mounting portion 52 does not cover the catheter 22 .

Subsequently, a coating process is performed (step S2 in FIG. 6). In the coating step, the coating material 48 is applied to the catheter 22 and the inner needle 34 while the catheter member 16 is attached to the needle member 18 . Specifically, in this embodiment, the catheter 22 and the inner needle 34 are immersed (dipped) in the liquid coating material 48 . The coating process is not limited to dipping. In the coating step, the coating material 48 may be applied to the catheter 22 and the inner needle 34 by spraying or the like.

Then, a joining process is performed (step S3). In the bonding step, as shown in FIG. 8, the catheter mounting portion 50 is bonded to the inner needle mounting portion 52 . Specifically, the first bonding surface 80 of the catheter mounting portion 50 is bonded to the second bonding surface 84 of the inner needle mounting portion 52 with an adhesive 86 . Then, the intermediate portion of the catheter 22 in the extending direction is fitted into the first support slit 66 of the catheter mounting portion 50 , and the proximal end portion of the catheter 22 is fitted into the second support slit 68 of the catheter mounting portion 50 .

Next, a second assembly process is performed (step S4 in FIG. 6). In the second assembling step, the assembly main body 12 is attached to the lower cover portion 88 as shown in FIG. Specifically, needle hub 36 is secured to lower cover portion 88 . Then, the upper cover portion 90 is fixed to the lower cover portion 88 with the upper cover portion 90 covering the lower cover portion 88 from above. Thus, the catheter assembly 10 is manufactured.

Next, the operating procedure of the catheter assembly 10 will be briefly described. When using the catheter assembly 10 , the tip of the catheter assembly 10 (the inner needle 34 and the catheter 22 ) is punctured through the skin 500 . At this time, the needle tip 38 of the inner needle 34 is positioned within the blood vessel.

Next, as shown in FIG. 10, the user pinches the plurality of operation tabs 58 with fingers to move the catheter operation member 20 toward the distal end of the catheter 22 . Catheter member 16 then moves along inner needle 34 in a direction toward the distal end of catheter 22 . At this time, since the inner needle 34 is inserted through the insertion hole 74 of the catheter operating member 20 , the catheter operating member 20 is not separated from the inner needle 34 .

Further, the user moves the catheter operating member 20 and bends the operating plate portion 54 upward to remove the catheter 22 from the first support slit 66 . Note that the operation plate portion 54 is positioned on the skin 500 in a curved state. As a result, the catheter 22 is left in the blood vessel and the catheter operating member 20 is released from the grip 14 .

Subsequently, as shown in FIG. 11, the inner needle 34 is removed from the catheter member 16 and catheter operating member 20 in the direction toward the proximal end of the catheter assembly 10 (grip 14). At this time, the inner needle 34 is removed from the insertion hole 74 of the catheter operating member 20 . The catheter handling member 20 is then removed from the catheter member 16 . Specifically, catheter 22 is removed from second support slit 68 by lifting catheter control member 20 upward relative to catheter member 16 .

This embodiment has the following effects.

According to the manufacturing method of the catheter assembly 10 according to the present embodiment, since the catheter mounting portion 50 is not attached in the coating step, the catheter operation member 20 is not applied when the coating material 48 is applied to the catheter 22 and the inner needle 34. never get in the way. Therefore, the coating process can be efficiently performed. In addition, since the catheter mounting portion 50 is bonded to the inner needle mounting portion 52 in the bonding step, the catheter 22 can be smoothly advanced along the inner needle 34 by operating the catheter operation member 20 when the catheter assembly 10 is used. can be made

The first joint portion 78 includes a first joint surface 80 . The second joint portion 82 includes a second joint surface 84 . The first joint surface 80 and the second joint surface 84 are joined together by an adhesive 86 or welding.

With such a configuration, the catheter mounting section 50 can be firmly joined to the inner needle mounting section 52 .

The inner surface forming the insertion hole 74 extends around the inner needle 34 in the circumferential direction.

According to such a configuration, when the catheter operation member 20 is moved toward the distal end of the catheter 22, it is possible to reliably prevent the inner needle mounting portion 52 from detaching from the inner needle .

The distal end of the inner needle mounting portion 52 is positioned between the proximal end of the catheter member 16 and the proximal end of the inner needle 34 .

According to such a configuration, it is possible to prevent the inner needle mounting portion 52 from becoming an obstacle during the coating process.

(First modification)
Next, a catheter operating member 100 according to a first modified example will be described. In the catheter operation member 100 according to this modified example, the same reference numerals are given to the same configurations as those of the catheter operation member 20 described above, and detailed description thereof will be omitted. In the catheter operation member 100 according to this modified example, the same effects as those of the catheter operation member 20 described above are obtained.

As shown in FIG. 12, catheter control member 100 includes first joint 102 and second joint 104 . The first joint portion 102 is located at the proximal end portion of the cover portion 56 . The first joint portion 102 includes a first joint surface 106 located on the inner surface of the proximal end portion of the cover portion 56 . The first joint surface 106 extends along the axial direction of the inner needle 34 .

The second joint portion 104 is located on the plate-like portion 70 . The second joint portion 104 includes a groove portion 108 formed on the outer peripheral surface of the plate-like portion 70 . The first joint portion 102 is arranged in the groove portion 108 . The second joint portion 104 has a second joint surface 110 positioned on the bottom surface of the groove portion 108 . The first joint surface 106 and the second joint surface 110 are joined together by an adhesive 112 . The adhesive 112 may be similar to the adhesive 86 described above.

In this modification, the first joint surface 106 and the second joint surface 110 extend along the axial direction of the inner needle 34 .

With such a configuration, the area (bonding area) of the first bonding surface 106 can be increased without increasing the thickness of the cover portion 56 .

In this modification, the first joint portion 102 and the second joint portion 104 may be joined together by welding.

(Second modification)
Next, a catheter operating member 120 according to a second modified example will be described. In the catheter operation member 120 according to this modified example, the same reference numerals are given to the same configurations as those of the catheter operation member 20 described above, and detailed description thereof will be omitted. In the catheter operation member 120 according to this modified example, the same effects as those of the catheter operation member 20 described above are obtained.

As shown in FIG. 13, catheter control member 120 includes first joint 122 and second joint 124 . The first joint portion 122 includes a fitting convex portion 126 protruding inward from the inner surface of the proximal end portion of the cover portion 56 . In other words, the fitting protrusion 126 protrudes in a direction intersecting with the axial direction of the inner needle 34 . The fitting protrusion 126 extends along the circumferential direction of the inner needle 34 . The second joint portion 124 includes a fitting recess 128 formed on the outer peripheral surface of the plate-like portion 70 . A fitting protrusion 126 is fitted into the fitting recess 128 .

The first joint portion 122 may include a plurality of mating protrusions 126 . In this case, the second joint portion 124 includes a plurality of fitting recesses 128 into which a plurality of fitting projections 126 are fitted. The number, shape, and size of each of the fitting projections 126 and fitting recesses 128 can be set as appropriate.

In this modified example, the first joint portion 122 includes a fitting convex portion 126 . The second joint portion 124 includes a mating recess 128 . By fitting the fitting projection 126 into the fitting recess 128, the first joint portion 122 and the second joint portion 124 are joined to each other.

With such a configuration, the catheter mounting section 50 can be easily joined to the inner needle mounting section 52 .

The fitting protrusion 126 protrudes in a direction crossing the axial direction of the inner needle 34 .

With such a configuration, it is possible to prevent the first joint 122 from coming off the second joint 124 when the catheter 22 is advanced along the inner needle 34 by the catheter operation member 20 .

In this modification, the catheter operation member 120 may further have an adhesive for bonding the first joint portion 122 and the second joint portion 124 to each other. The first joint portion 122 may have a fitting recess 128 and the second joint portion 124 may have a fitting protrusion 126 .

It should be noted that the present invention is not limited to the above-described embodiments, and can take various configurations without departing from the gist of the present invention.

This embodiment discloses the following contents.

The above embodiment comprises a hollow catheter member (16) having a catheter (22) and a catheter hub (24), an inner needle (34) inserted through a lumen (40) of said catheter member, and a a needle hub (36) attached to its proximal end; a needle member (18) having a needle hub (36); and a catheter steering member (20, 100, 120) for moving said catheter member along said inner needle. wherein the catheter operating member includes a catheter mounting portion (50) detachable from the catheter member and between the catheter mounting portion and the proximal end of the needle member. and an inner needle mounting portion (52) having an insertion hole (74) through which the inner needle is inserted, wherein the catheter mounting portion is attached to at least one of the catheters while being mounted on the catheter member. portion, the inner needle of the needle member is inserted through the insertion hole of the inner needle mounting portion, and the catheter member is arranged between the tip of the inner needle and the inner needle mounting portion. a coating step of applying a coating material (48) to the catheter and the inner needle in a state in which the inner needle is inserted through the lumen of the catheter member; and a joining step of joining the catheter fittings.

In the method for manufacturing the catheter assembly described above, in the bonding step, the catheter mounting portion may be bonded to the inner needle mounting portion by fitting, fusion, or an adhesive.

The above embodiment includes a hollow catheter member having a catheter and a catheter hub, an inner needle inserted through the lumen of the catheter member, and a needle hub attached to the proximal end of the inner needle. and a catheter operating member for moving the catheter member along the inner needle, wherein the catheter and the inner needle are coated with a coating material, and the catheter The operation member includes a catheter mounting portion that can be attached to and detached from the catheter member, and an inner needle mounting portion that is positioned between the catheter mounting portion and the proximal end of the needle member and has an insertion hole through which the inner needle is inserted. wherein the catheter mounting portion covers at least a portion of the catheter while being mounted on the catheter member, the catheter mounting portion and the inner needle mounting portion are separate parts from each other, and the catheter mounting portion is The proximal end of the section has a first joint (78, 102, 122) and the inner needle mounting section has a second joint (82, 104, 124) to which the first joint is joined. Disclosed is a catheter assembly comprising:

The above catheter assembly, wherein the first interface includes a first interface (80, 106), the second interface includes a second interface (84, 110), and the first interface and said second mating surface may be joined together by fusion or adhesive (86, 112).

Said catheter assembly WHEREIN: A said 1st joint surface and a said 2nd joint surface may extend along the axial direction of the said inner needle.

In the above catheter assembly, the first junction includes either one of a fitting projection (126) and a fitting recess (128), and the second junction comprises the fitting projection and the fitting. The first joint portion and the second joint portion may be joined to each other by fitting the fitting protrusion into the fitting recess, including the other of the joint recesses.

Said catheter assembly WHEREIN: The said fitting convex part may protrude in the direction which cross|intersects the axial direction of the said inner needle.

Said catheter assembly WHEREIN: The inner surface which comprises the said penetration hole may extend so that the said inner needle may be circled in the circumferential direction.

In the above catheter assembly, the distal end of the inner needle mounting portion may be located between the proximal end of the catheter member and the proximal end of the inner needle.

DESCRIPTION OF SYMBOLS 10... Catheter assembly 16... Catheter member 18... Needle member 20, 100, 120... Catheter operation member 22... Catheter 24... Catheter hub 34... Inner needle 36... Needle hub 48... Coating material 50... Catheter mounting part 52... Inner needle Mounting portion 74 Insertion holes 78, 102, 122 First joints 80, 106 First joint surfaces 82, 104, 124 Second joints 84, 110 Second joint surfaces 86, 112 Adhesive 126 Fitting convex portion 128 ... Fitting concave portion

Claims (9)

a hollow catheter member having a catheter and a catheter hub;
a needle member having an inner needle inserted through the lumen of the catheter member and a needle hub attached to the proximal end of the inner needle;
a catheter operating member for moving the catheter member along the inner needle, the method comprising:
The catheter operation member is
a catheter mounting section that is detachable from the catheter member;
an inner needle mounting portion located between the catheter mounting portion and the proximal end of the needle member and having an insertion hole through which the inner needle is inserted;
The catheter mounting portion covers at least a portion of the catheter while being mounted on the catheter member,
The catheter member is inserted so that the inner needle of the needle member is inserted through the insertion hole of the inner needle mounting portion and the catheter member is arranged between the tip of the inner needle and the inner needle mounting portion. a coating step of applying a coating material to the catheter and the inner needle while the inner needle is inserted through the lumen;
a bonding step of bonding the catheter mounting portion to the inner needle mounting portion after the coating step. A method of manufacturing the catheter assembly of claim 1, comprising:
The method for manufacturing a catheter assembly, wherein in the bonding step, the catheter mounting portion is bonded to the inner needle mounting portion by fitting, fusion, or an adhesive. a hollow catheter member having a catheter and a catheter hub;
a needle member having an inner needle inserted through the lumen of the catheter member and a needle hub attached to the proximal end of the inner needle;
a catheter manipulation member for moving the catheter member along the inner needle, comprising:
A coating material is applied to the catheter and the inner needle,
The catheter operation member is
a catheter mounting section that is detachable from the catheter member;
an inner needle mounting portion located between the catheter mounting portion and the proximal end of the needle member and having an insertion hole through which the inner needle is inserted;
The catheter mounting portion covers at least a portion of the catheter while being mounted on the catheter member,
The catheter mounting portion and the inner needle mounting portion are separate components,
The proximal end portion of the catheter mounting portion has a first joint,
A catheter assembly, wherein the inner needle mounting portion has a second joint to which the first joint is joined. 4. The catheter assembly of claim 3, wherein
The first joint includes a first joint surface,
The second joint includes a second joint surface,
The catheter assembly, wherein the first joint surface and the second joint surface are joined to each other by fusion or an adhesive. 5. The catheter assembly of claim 4, comprising:
The catheter assembly, wherein the first joint surface and the second joint surface extend along the axial direction of the inner needle. A catheter assembly according to any one of claims 3 to 5,
the first joint portion includes either one of a fitting convex portion and a fitting concave portion;
the second joint portion includes the other of the fitting convex portion and the fitting concave portion;
The catheter assembly, wherein the first joint portion and the second joint portion are joined to each other by fitting the fitting protrusion into the fitting recess. The catheter assembly of claim 6, comprising:
The catheter assembly, wherein the fitting protrusion protrudes in a direction intersecting with the axial direction of the inner needle. A catheter assembly according to any one of claims 3 to 7,
The catheter assembly according to claim 1, wherein the inner surface forming the insertion hole extends around the inner needle in a circumferential direction. A catheter assembly according to any one of claims 3 to 8,
The catheter assembly, wherein the distal end of the inner needle mounting portion is located between the proximal end of the catheter member and the proximal end of the inner needle.

Images