JP2021132976A - Indwelling catheter and catheter assembly - Google Patents

Abstract

To provide an indwelling catheter and catheter assembly configured to be able to insert a medical member in a lumen of a catheter shaft via a tip opening of the catheter shaft and capable of suppressing the occurrence of thrombus in the lumen of the catheter shaft.SOLUTION: An opening/closing part 24 of an indwelling catheter 12 of a catheter assembly 10 includes a valve element 26 and a connection part 28. When pressure in a tip end direction is applied to the valve element 26, the valve element 26 tilts in the tip end direction with respect to the catheter shaft 16, while elastically deforming the connection part 28, to deform from a closed position to an open position. In a sate where no pressure in the tip end direction is applied to the valve element 26, the valve element is returned from the open position to the closed position by the restitutive force of the connection part 28.SELECTED DRAWING: Figure 4

Description

The present invention relates to indwelling catheters and catheter assemblies.

For example, in an indwelling catheter used for drug administration, when drug administration is stopped with the catheter shaft indwelled in a blood vessel, blood may flow into the lumen of the catheter shaft from the tip opening of the catheter shaft. If such a state continues for a long time, the blood in the lumen of the catheter shaft may coagulate to form a thrombus and the lumen of the catheter shaft may be blocked.

In Patent Document 1, the tip opening of the catheter shaft is closed with a closing member, and a slit that can be opened and closed is formed in the peripheral wall portion of the catheter shaft, so that blood flows into the lumen of the catheter shaft while drug administration is stopped. An indwelling catheter that suppresses the above is disclosed.

Japanese Patent No. 5896101

In an indwelling catheter as described above, since the tip opening of the catheter shaft is closed by a closing member, a medical member (needle body, guide wire, etc.) is inserted into the lumen of the catheter shaft through the tip opening of the catheter shaft. Can't.

The present invention has been made in consideration of such a problem, and a medical member can be inserted into the lumen of the catheter shaft through the opening at the tip of the catheter shaft, and a thrombus in the lumen of the catheter shaft can be inserted. It is an object of the present invention to provide an indwelling catheter and a catheter assembly capable of suppressing the occurrence of.

One aspect of the present invention is an indwelling catheter provided with a tubular catheter shaft to be indwelled in a blood vessel, the catheter shaft having a tip opening opened on the tip surface of the catheter shaft and opening and closing the tip opening. An opening / closing portion is provided, and the opening / closing portion opens the tip opening at a closing position that contacts the tip surface of the catheter shaft to close the tip opening and is separated from the tip surface of the catheter shaft. It has a valve body that can be displaced to an open position, and an elastically deformable connecting portion that connects the valve body and the tip end portion of the catheter shaft to each other, and the valve body is directed toward the tip end of the valve body. When the pressure is applied, the connecting portion is elastically deformed and tilted toward the tip of the catheter shaft to displace from the closed position to the open position, and the pressure in the tip direction acts on the valve body. It is an indwelling catheter that returns from the open position to the closed position by the restoring force of the connecting portion in the state where the connection is not performed.

Another aspect of the present invention is a catheter assembly comprising the indwelling catheter described above, a needle body inserted into the lumen of the catheter shaft, and a needle hub provided at the proximal end of the needle body. be.

According to the present invention, the medical member is inserted into the lumen of the catheter shaft from the proximal end side and a pressure in the distal end direction is applied to the valve body to displace the valve body from the closed position to the open position of the catheter shaft. The tip opening can be opened. As a result, the medical member can be inserted into the lumen of the catheter shaft through the opening at the tip of the catheter shaft. In addition, the medical member is retracted or removed from the tip opening of the catheter shaft toward the proximal end to remove the pressure acting on the valve body, so that the valve body is positioned in the closed position by the restoring force of the connecting portion. Can be done. As a result, it is possible to prevent blood in the blood vessel from flowing into the lumen of the catheter shaft through the tip opening of the catheter shaft. Therefore, the occurrence of thrombus in the lumen of the catheter shaft can be suppressed.

It is a perspective view of the catheter assembly which concerns on one Embodiment of this invention. It is an exploded perspective view of the catheter assembly of FIG. It is a front view which looked at the indwelling catheter of FIG. 2 from the tip direction. 4A is a cross-sectional view taken along the IVA-IVA line of FIG. 3, FIG. 4B is a cross-sectional view taken along the IVB-IVB line of FIG. 4A, and FIG. 4C is taken along the IVC-IVC line of FIG. 4A. It is a cross-sectional view along. FIG. 5A is a first explanatory view of the drug administration procedure using the catheter assembly, and FIG. 5B is a second explanatory view of the drug administration procedure. FIG. 6A is a third explanatory view of the drug solution administration procedure, and FIG. 6B is a cross-sectional explanatory view taken along the VIB-VIB line of FIG. 6A. FIG. 7A is a fourth explanatory view of the drug administration procedure, and FIG. 7B is a fifth explanatory view of the drug administration procedure. FIG. 8A is an explanatory view of the slit according to the modified example, and FIG. 8B is a cross-sectional explanatory view taken along the line VIIIB-VIIIB of FIG. 8A.

Hereinafter, a suitable embodiment of the indwelling catheter and the catheter assembly according to the present invention will be described with reference to the accompanying drawings.

The catheter assembly 10 according to the embodiment of the present invention is configured as an indwelling needle (peripheral intravenous indwelling catheter) for administering a drug (infusion solution) into a blood vessel of a patient (living body). As shown in FIGS. 1 and 2, the catheter assembly 10 has an indwelling catheter 12 and a puncture needle 14. The indwelling catheter 12 has a catheter shaft 16 and a catheter hub 18 provided at the proximal end of the catheter shaft 16.

The catheter shaft 16 is a flexible tubular member that can be continuously inserted into a patient's blood vessel. The catheter shaft 16 has a lumen 16a extending along the axial direction over its entire length. A tip opening 16b communicating with the lumen 16a is formed on the tip surface 15 of the catheter shaft 16 (see FIG. 4A).

The constituent material of the catheter shaft 16 is not particularly limited, but a transparent resin material, particularly a soft resin material is preferable, and for example, polytetrafluoroethylene (PTFE) and ethylene / tetrafluoroethylene co-weight. Fluororesin such as coalescence (ETFE), perfluoroalkoxy alkane resin (PFA), olefin resin such as polyethylene and polypropylene or a mixture thereof, polyurethane, polyester, polyamide, polyether nylon resin, olefin resin and ethylene-vinyl acetate Examples thereof include a mixture with a copolymer.

The catheter hub 18 is formed in a hollow shape (cylindrical shape). The catheter hub 18 is preferably made of a material that is harder than the catheter shaft 16. The constituent material of the catheter hub 18 is not particularly limited, but is thermoplastic, for example, polypropylene, polycarbonate, polyamide, polysulphon, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, ABS resin and the like. A resin can be preferably used.

The puncture needle 14 includes a needle body 20 and a needle hub 22 provided at a base end portion of the needle body 20. The needle body 20 is a tubular member having rigidity capable of puncturing the patient's skin. The needle body 20 has a lumen 20a extending along the axial direction (see FIG. 2). The needle body 20 is inserted into the lumen 16a of the catheter shaft 16 and the lumen 18a of the catheter hub 18 in the initial state (assembled state) of the catheter assembly 10 (see FIGS. 1 and 2).

Examples of the constituent material of the needle body 20 include metal materials such as stainless steel, aluminum, aluminum alloy, titanium, and titanium alloy. The needle body 20 is formed sufficiently longer than the catheter shaft 16 and protrudes from the tip opening 16b of the catheter shaft 16 in the initial state of the catheter assembly 10 (see FIG. 1).

In FIG. 1, a blade surface 23 inclined with respect to the axis of the needle body 20 is formed at the tip end portion of the needle body 20. The blade surface 23 is formed with a tip opening 20b communicating with the lumen 20a of the needle body 20.

The needle hub 22 is formed in a hollow shape (cylindrical shape). Examples of the constituent material of the needle hub 22 include the same constituent materials as those of the catheter hub 18 described above. The base end portion of the needle body 20 is fixed to the tip end portion of the needle hub 22. The needle hub 22 functions as an operating unit of the catheter assembly 10.

As shown in FIGS. 1 to 4B, the catheter shaft 16 is provided with an opening / closing portion 24 for opening / closing the tip opening 16b of the catheter shaft 16. The opening / closing portion 24 is made of the same material as the catheter shaft 16. The opening / closing portion 24 and the catheter shaft 16 are integrally molded products. However, the opening / closing portion 24 may be joined to the tip end portion of the catheter shaft 16.

The opening / closing portion 24 has a valve body 26 and a connecting portion 28. The valve body 26 has a closed position (position in FIG. 2) that contacts the tip surface 15 of the catheter shaft 16 to close the tip opening 16b and an open position that opens the tip opening 16b away from the tip surface 15 (FIG. 1). It can be displaced to (position). As shown in FIGS. 1 to 3, the valve body 26 is formed in a square flat plate shape. However, the valve body 26 may have a circular shape or a polygonal shape (other than a square shape). The connecting portion 28 connects the valve body 26 and the tip end portion of the catheter shaft 16 to each other. Specifically, the connecting portion 28 is provided only on a part of the distal end surface 15 of the catheter shaft 16. The connecting portion 28 is elastically deformable.

In FIG. 3, the connecting portion 28 extends by a predetermined angle θ in the circumferential direction of the catheter shaft 16. The predetermined angle θ is preferably set in the range of, for example, 10 ° or more and 45 ° or less. When the predetermined angle θ is 10 ° or more, it is possible to effectively prevent the connecting portion 28 from breaking during the opening / closing operation of the valve body 26. When the predetermined angle θ is 45 ° or less, the opening / closing operation of the opening / closing unit 24 can be smoothly performed. However, the predetermined angle θ can be appropriately set according to the size, material, and the like of the catheter shaft 16.

As shown in FIG. 4A, in the valve body 26, when a pressure in the tip direction is applied to the valve body 26, the valve body 26 is tilted in the tip direction with respect to the catheter shaft 16 while elastically deforming the connecting portion 28. Displace from the closed position to the open position. In the initial state of the catheter assembly 10, the valve body 26 is pressed in the distal direction by the needle body 20 (medical member) against the lumen 16a of the catheter shaft 16 and is located in the open state (see FIG. 1).

Further, the valve body 26 is closed by the restoring force of the connecting portion 28 in a state where pressure in the tip direction is not applied to the valve body 26 (for example, a state in which the needle body 20 is removed from the lumen 16a of the catheter shaft 16). Located in position (see Figure 2). The valve body 26 covers the entire tip opening 16b of the catheter shaft 16 from the tip direction and is in contact with the entire tip surface 15 of the catheter shaft 16 in a closed position. The valve body 26 is formed to be one size larger than the outer shape of the tip of the catheter shaft 16.

In FIGS. 4A and 4B, a slit 30 extending linearly along the axial direction of the catheter shaft 16 is provided on the peripheral wall portion at the tip of the catheter shaft 16. In other words, the slit 30 is formed by the end faces of a pair of lip portions 32 forming a part of the peripheral wall portion of the catheter shaft 16 (see FIGS. 4A and 4C).

As shown in FIGS. 4A to 4C, a cover portion 34 that covers the slit 30 is provided on the inner peripheral surface of the catheter shaft 16. The cover portion 34 is formed in a quadrangular shape. Only one side of the cover portion 34 is provided on the inner peripheral surface of the catheter shaft 16.

The cover portion 34 is in contact with or in close contact with the pair of lip portions 32 so as to cover the entire slit 30 in a state where no negative pressure is applied to the lumen 16a of the catheter shaft 16. When a negative pressure acts on the lumen 16a of the catheter shaft 16, the cover portion 34 is displaced so that the slit 30 is exposed to the lumen 16a of the catheter shaft 16. The state in which a negative pressure acts on the lumen 16a of the catheter shaft 16 means a state in which the internal pressure of the catheter shaft 16 is lower than the external pressure.

Next, a procedure for drug administration using the catheter assembly 10 will be described.

As shown in FIG. 1, in the initial state of the catheter assembly 10, the needle body 20 inserts the lumen 16a of the catheter shaft 16 from the proximal end side, and the opening / closing portion 24 is in the open position. That is, the blade surface 23 projects in the distal direction from the distal end opening 16b of the catheter shaft 16 in a state of facing upward. Further, the slit 30 is closed.

As shown in FIG. 5A, the user punctures the blood vessel 102 through the skin 100 in the initial state of the catheter assembly 10. As a result, the tip opening 20b of the needle body 20, the tip opening 16b of the catheter shaft 16, and the slit 30 are located in the blood vessel 102. Then, in FIG. 5B, the user removes the puncture needle 14 from the indwelling catheter 12 with the tip of the catheter shaft 16 indwelled in the blood vessel 102. Then, the valve body 26 is displaced from the open position to the closed position by the restoring force of the connecting portion 28. As a result, the tip opening 16b of the catheter shaft 16 is closed by the valve body 26. At this time, the valve body 26 is pressed against the tip surface 15 of the catheter shaft 16 by blood.

Subsequently, the user connects a suction tool (for example, a syringe or the like) (not shown) to the base end portion of the catheter hub 18 for suction. Then, the lumen 16a of the catheter shaft 16 becomes a negative pressure. As a result, as shown in FIGS. 6A and 6B, the cover portion 34 is pulled inward of the catheter shaft 16, so that the slit 30 is exposed in the lumen 16a of the catheter shaft 16.

Then, the pair of lip portions 32 are deformed so as to fall inward of the catheter shaft 16, so that the slit 30 is opened. Therefore, blood in the blood vessel 102 is guided from the slit 30 to the catheter hub 18 via the lumen 16a of the catheter shaft 16. Therefore, the user can confirm that the tip of the catheter shaft 16 is located in the blood vessel 102 (the state of securing the blood vessel of the catheter shaft 16) by visually recognizing the blood guided to the catheter hub 18. ..

Next, a drug supply device (infusion device) (not shown) is connected to the proximal end of the catheter hub 18 to supply the drug to the lumen 16a of the catheter shaft 16. Then, the valve body 26 is pressed toward the tip by the drug. Therefore, as shown in FIG. 7A, the valve body 26 is displaced from the closed position to the open position by tilting the connecting portion 28 in the distal direction with respect to the catheter shaft 16 while elastically deforming the connecting portion 28. That is, the tip opening 16b of the catheter shaft 16 is opened. Therefore, the drug is led out into the blood vessel 102 via the tip opening 16b of the catheter shaft 16.

The cover portion 34 is pressed against the pair of lip portions 32 by the chemical so as to cover the slit 30. That is, the cover portion 34 blocks the communication between the lumen 16a of the catheter shaft 16 and the inside of the blood vessel 102 via the slit 30. Therefore, it is possible to prevent the drug from being led out from the lumen 16a of the catheter shaft 16 into the blood vessel 102 through the slit 30.

Then, when the drug administration is suspended, as shown in FIG. 7B, the pressure in the distal end direction of the valve body 26 due to the drug is released, so that the valve body 26 is moved from the open position to the closed position by the restoring force of the connecting portion 28. Displace. That is, the tip opening 16b of the catheter shaft 16 is closed by the valve body 26. At this time, the valve body 26 is pressed against the tip surface 15 of the catheter shaft 16 by blood. As a result, when the drug administration is suspended, blood is prevented from flowing into the lumen 16a through the tip opening 16b of the catheter shaft 16. Therefore, the generation of thrombus in the lumen 16a of the catheter shaft 16 is suppressed. Since the lumen 16a of the catheter shaft 16 is not under negative pressure, the slit 30 is closed. After completion of drug administration, the catheter shaft 16 is removed from the blood vessel 102.

The indwelling catheter 12 and the catheter assembly 10 according to the present embodiment have the following effects.

In the indwelling catheter 12, the opening / closing portion 24 has a closed position of contacting the tip surface 15 of the catheter shaft 16 to close the tip opening 16b and an open position of opening the tip opening 16b away from the tip surface 15 of the catheter shaft 16. It has a valve body 26 that can be displaced, and an elastically deformable connecting portion 28 that connects the valve body 26 and the tip end portion of the catheter shaft 16 to each other. When a pressure in the distal end direction is applied to the valve body 26, the valve body 26 is displaced from the closed position to the open position by tilting toward the distal end with respect to the catheter shaft 16 while elastically deforming the connecting portion 28. The valve body 26 returns from the open position to the closed position by the restoring force of the connecting portion 28 in a state where the pressure in the tip direction is not applied to the valve body 26.

According to such a configuration, the needle body 20 is inserted into the lumen 16a of the catheter shaft 16 from the proximal end side and a pressure in the distal end direction is applied to the valve body 26 to move the valve body 26 from the closed position to the open position. The tip opening 16b of the catheter shaft 16 can be opened by displacing the catheter shaft 16. As a result, the needle body 20 can be inserted into the lumen 16a of the catheter shaft 16 through the tip opening 16b of the catheter shaft 16.

Further, the needle body 20 is retracted or removed from the tip opening 16b of the catheter shaft 16 toward the proximal end side to remove the pressure acting on the valve body 26, so that the valve body 26 is reconstructed by the restoring force of the connecting portion 28. It can be positioned in a closed position. As a result, it is possible to prevent blood in the blood vessel 102 from flowing into the lumen 16a of the catheter shaft 16 through the tip opening 16b of the catheter shaft 16. Therefore, the occurrence of thrombus in the lumen 16a of the catheter shaft 16 can be suppressed.

The connecting portion 28 is provided only on a part of the distal end surface 15 of the catheter shaft 16.

According to such a configuration, the connecting portion 28 can be elastically deformed to effectively tilt the valve body 26 with respect to the catheter shaft 16.

The opening / closing portion 24 and the catheter shaft 16 are integrally molded products.

With such a configuration, the indwelling catheter 12 can be easily molded.

A slit 30 that can be opened and closed is formed in the peripheral wall portion at the tip of the catheter shaft 16, and the slit 30 is opened when a negative pressure acts on the lumen 16a of the catheter shaft 16.

According to such a configuration, by applying a negative pressure to the lumen 16a of the catheter shaft 16, blood in the blood vessel 102 can be introduced from the slit 30 into the lumen 16a of the catheter shaft 16. Thereby, the user can confirm the securing of the blood vessel of the catheter shaft 16 by visually recognizing the inflow of blood into the lumen 16a of the catheter shaft 16.

A cover portion 34 for covering the slit 30 is provided on the inner peripheral surface of the catheter shaft 16. The cover portion 34 is displaced so that the slit 30 is exposed to the lumen 16a of the catheter shaft 16 when a negative pressure acts on the lumen 16a of the catheter shaft 16.

According to such a configuration, when the drug is introduced into the lumen 16a of the catheter shaft 16, the cover portion 34 can suppress the drug from being led out from the slit 30 to the outside of the catheter shaft 16. Further, by applying a negative pressure to the lumen 16a of the catheter shaft 16, blood can be introduced from the slit 30 into the lumen 16a of the catheter shaft 16.

The catheter assembly 10 is not limited to the above-described configuration. As shown in FIGS. 8A and 8B, a C-shaped slit 40 may be formed in the peripheral wall portion of the catheter shaft 16 instead of the linear slit 30. In this case, a flap valve 42 is formed inside the slit 40 on the peripheral wall portion of the catheter shaft 16. At least a part of the slit 40 is inclined inward of the flap valve 42 from the inner peripheral surface of the catheter shaft 16 toward the outer peripheral surface (see FIG. 8B).

When a negative pressure acts on the lumen 16a of the catheter shaft 16, the flap valve 42 elastically deforms so as to collapse inward of the catheter shaft 16 as shown in FIG. 8B. As a result, the slit 40 is opened. On the other hand, when a positive pressure acts on the lumen 16a of the catheter shaft 16, the flap valve 42 comes into contact with the peripheral wall surface (the surface forming the slit 40) of the catheter shaft 16. Therefore, the slit 40 maintains the closed state. That is, the slit 40 is opened only when a negative pressure acts on the lumen 16a of the catheter shaft 16.

The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the gist of the present invention. The indwelling catheter according to the present invention is not limited to the indwelling catheter 12 constituting the peripheral vein indwelling catheter (PIVC) described above, and may constitute a peripheral insertion central venous catheter (PICC). In a peripherally inserted central venous catheter, a guide wire as a medical member is inserted into the lumen of the catheter shaft.

The above embodiments can be summarized as follows.

The embodiment is an indwelling catheter (12) provided with a tubular catheter shaft (16) that is indwelled in a blood vessel (102), the catheter shaft having an opening in the distal end surface (15) of the catheter shaft. The tip opening (16b) and the opening / closing portion (24) for opening / closing the tip opening are provided, and the opening / closing portion has a closing position of contacting the tip surface of the catheter shaft to close the tip opening. A valve body (26) that can be displaced from the tip surface of the catheter shaft to an open position that opens the tip opening, and an elastically deformable valve body that connects the valve body and the tip of the catheter shaft to each other. The valve body has a connecting portion (28), and when a pressure in the tip direction is applied to the valve body, the valve body tilts in the tip direction with respect to the catheter shaft while elastically deforming the connecting portion. Discloses an indwelling catheter that is displaced from the closed position to the open position and returns from the open position to the closed position by the restoring force of the connecting portion in a state where no pressure in the distal direction is applied to the valve body. ing.

In the indwelling catheter described above, the connecting portion may be provided only on a part of the distal end surface of the catheter shaft.

In the above-mentioned indwelling catheter, the opening / closing portion and the catheter shaft may be integrally molded products.

In the above-mentioned indwelling catheter, slits (30, 40) that can be opened and closed are formed in the peripheral wall portion at the tip of the catheter shaft, and the slits are formed when a negative pressure acts on the lumen (16a) of the catheter shaft. You may open it.

In the above-mentioned indwelling catheter, a cover portion (34) for covering the slit is provided on the inner peripheral surface of the catheter shaft, and the cover portion is when a negative pressure acts on the lumen of the catheter shaft. The slit may be displaced so as to be exposed in the lumen of the catheter shaft.

In the indwelling catheter described above, the indwelling catheter may include a catheter hub (18) provided at the proximal end of the catheter shaft.

In the above embodiment, a catheter including the above-mentioned indwelling catheter, a needle body (20) inserted into the lumen of the catheter shaft, and a needle hub (22) provided at a base end portion of the needle body. The assembly (10) is disclosed.

10 ... Catheter assembly 12 ... Indwelling catheter 16 ... Catheter shaft 18 ... Catheter hub 20 ... Needle body 22 ... Needle hub 24 ... Opening and closing part 26 ... Valve body 28 ... Connecting parts 30, 40 ... Slit 34 ... Cover part 102 ... Blood vessel

Claims (7)

An indwelling catheter with a tubular catheter shaft that is indwelled in a blood vessel.
The catheter shaft has
The tip opening opened on the tip surface of the catheter shaft and
An opening / closing portion for opening / closing the tip opening is provided.
The opening / closing part
A valve body that can be displaced to a closed position that contacts the tip surface of the catheter shaft to close the tip opening and an open position that separates the catheter shaft from the tip surface and opens the tip opening.
It has an elastically deformable connecting portion that connects the valve body and the tip end portion of the catheter shaft to each other.
When a pressure in the distal end direction is applied to the valve body, the valve body is displaced from the closed position to the open position by tilting toward the distal end with respect to the catheter shaft while elastically deforming the connecting portion. An indwelling catheter that returns from the open position to the closed position by the restoring force of the connecting portion in a state where pressure in the distal direction is not applied to the valve body. The indwelling catheter according to claim 1.
An indwelling catheter in which the connecting portion is provided only on a part of the distal end surface of the catheter shaft. The indwelling catheter according to claim 1 or 2.
An indwelling catheter in which the opening / closing portion and the catheter shaft are integrally molded products. The indwelling catheter according to any one of claims 1 to 3.
A slit that can be opened and closed is formed in the peripheral wall of the tip of the catheter shaft.
The slit is an indwelling catheter that opens when a negative pressure acts on the lumen of the catheter shaft. The indwelling catheter according to claim 4.
A cover portion for covering the slit is provided on the inner peripheral surface of the catheter shaft.
The cover portion is an indwelling catheter in which the slit is displaced so as to be exposed in the lumen of the catheter shaft when a negative pressure is applied to the lumen of the catheter shaft. The indwelling catheter according to any one of claims 1 to 5.
The indwelling catheter is an indwelling catheter including a catheter hub provided at a proximal end of the catheter shaft. The indwelling catheter according to any one of claims 1 to 6,
The needle body inserted into the lumen of the catheter shaft and
A catheter assembly comprising a needle hub provided at the proximal end of the needle body.

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