The present disclosure relates to, for example, a catheter assembly used in a case of performing an infusion, a blood transfusion, or the like.
In a case of constructing an introduction portion of an infusion or a blood transfusion for a patient, for example, a catheter assembly as disclosed in JP 2018-511439 A is used. This catheter assembly has a catheter (flexible catheter tube), a catheter hub fixed to the catheter, and an inner needle (hollow introducer needle) arranged within the catheter.
When using the catheter assembly, a user inserts the catheter and the inner needle into a patient's body. Then, the inner needle is pulled out from the catheter and the catheter hub. Thereafter, the user inserts various medical instruments into the catheter hub from which the inner needle has been pulled out, connects a connector of an infusion tube, and the like, thereby using the catheter assembly as the introduction portion.
Further, the catheter assembly disclosed in JP 2018-511439 A includes a valve body (elastic septum) that is provided in the catheter hub and can be opened and closed and an opening member (valve actuator) arranged on a proximal side of the valve. The valve body inhibits leakage of blood by blocking a space inside the catheter hub at the time of detaching the inner needle. The opening member penetrates through (opens) the valve body along with the insertion of the medical instrument, thereby enabling a medicinal liquid and blood to flow from a medical device side to the catheter side.
Meanwhile, in the configuration in which the opening member penetrates through the valve body along with the introduction of the medical device as described above, there is a possibility that the opening member moves to open the valve body, for example, when an impact force is applied due to a fall or the like.
Therefore, one aspect of the present invention aims to provide a catheter assembly capable of inhibiting opening of a valve body due to movement of an opening member with a simple device configuration.
According to one embodiment, a catheter assembly includes: an inner needle with which a living body is punctured; a catheter through which the inner needle is inserted; a catheter hub provided at a proximal end of the catheter; a valve body provided in an internal space of the catheter hub; an opening member that has a cylindrical barrel portion, a neck portion extending from a distal end of the barrel portion while being reduced in diameter, and a foot portion extending to a proximal side of the barrel portion, is arranged on a proximal side of the valve body, and moves to a distal side along the internal space of the catheter hub to open the valve body by the neck portion; and a movement inhibiting mechanism that generates a resistance force against the movement of the opening member to the distal side. The movement inhibiting mechanism includes a contact portion that generates a frictional force against the catheter hub or the valve body.
According to the catheter assembly of the above embodiment, the opening of the valve body due to the movement of the opening member can be inhibited with a simple device configuration.
Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
A catheter assembly 10 according to the present embodiment has a catheter 12 that is inserted to indwell inside a patient's body (living body) as illustrated in
As illustrated in the drawing, the catheter assembly 10 has an operating member 18 formed of an inner needle 14 and a needle hub 16 fixed to a proximal end of the inner needle 14. Further, the catheter assembly 10 has a catheter indwelling body 22 formed of the above-described catheter 12 and a catheter hub 20 fixed to a proximal end of the catheter 12.
The catheter assembly 10 is assembled with the operating member 18 from the proximal side of the catheter indwelling body 22 in an initial state (product provided state) before use, thereby forming a multi-structure needle 11 through which the inner needle 14 is inserted in the catheter 12. In the multi-structure needle 11, the needle tip 14a of the inner needle 14 protrudes, and the inner needle 14 and the catheter 12 can be integrally punctured the living body. Further, a valve body 24, an opening member 26, and a fixing member 28 are housed inside the catheter hub 20 as illustrated in
When using the catheter assembly 10 illustrated in
As illustrated in
Examples of a constituent material of the inner needle 14 include a metal material such as stainless steel, aluminum or an aluminum alloy, and titanium or a titanium alloy, a hard resin, ceramics, and the like. The inner needle 14 is firmly fixed to the needle hub 16 by a fixing means such as fusion, adhesion, and fitting.
The needle hub 16 forms a grip portion to be gripped by the user in the initial state in which the catheter indwelling body 22 and the operating member 18 are assembled. The needle hub 16 includes a hub main body 34 that is directly gripped by the user, and an inner needle support portion 36 that is integrally molded at a distal end of the hub main body 34.
The hub main body 34 is formed to have a shape and a size that allow the multi-structure needle 11 to be stably operated. The hub main body 34 is formed in a cylindrical shape on the proximal side and is gradually deformed into an elliptical shape toward the distal side, and has a cavity portion 34a formed inside.
The inner needle support portion 36 is formed in a columnar shape protruding from the hub main body 34 in the distal direction, and holds a proximal portion of the inner needle 14 at the central portion thereof. A pair of arms 38 to hold a flange 54 of the catheter hub 20 are provided on both side portions of the inner needle support portion 36. The arm 38 is housed in an arm accommodating portion 37 that restricts the outward displacement of the arm 38. The arm accommodating portion 37 is assembled so as to be capable of moving backward with respect to the arm 38, and is configured such that a distal end of the arm 38 is open outward to release the engagement with the catheter hub 20 when the arm accommodating portion 37 retracts from the arm 38.
A constituent material of the needle hub 16 is not particularly limited, but a thermoplastic resin, such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and a methacrylate-butylene-styrene copolymer can be applied.
On the other hand, the catheter 12 is formed as a flexible hollow body in which a lumen 13 is formed inside. An outer shape of the catheter 12 and the lumen 13 are formed in a perfect circular shape in cross-sectional view orthogonal to the axial direction, and extend along the axial direction of the catheter 12. The lumen 13 communicates with a distal opening 13a formed at a distal end of the catheter 12 and a proximal opening 13b (see
A material forming the catheter 12 is not particularly limited, but a transparent soft resin material may be applied. For example, a fluorine-based resin such as polytetrafluoroethylene (PTFE), an ethylene-tetrafluoroethylene copolymer (ETFE), and a perfluoroalkoxy fluorine resin (PFA), an olefin-based resin such as polyethylene and polypropylene or a mixture thereof, polyurethane, polyester, polyamide, a polyether nylon resin, a mixture of the olefin-based resin and an ethylene-vinyl acetate copolymer, and the like may be used.
A length of the catheter 12 is not particularly limited, and can be appropriately designed according to the application, various conditions, and the like, and is set to, for example, about 14 to 500 mm. The proximal end of the catheter 12 is inserted and fixed inside the catheter hub 20.
The catheter hub 20 is arranged on a patient's skin in a state in which the catheter 12 has been inserted into the patient's blood vessel, and is fixed onto the skin with a tape or the like, thereby being placed together with the catheter 12. A material forming the catheter hub 20 is not particularly limited, but, for example, the materials used for the needle hub 16 can be appropriately adopted.
The catheter hub 20 is formed in a tubular shape tapered in a distal direction. An internal space 50 is provided inside the catheter hub 20, and the internal space 50 communicates with the proximal opening 13b (see
The catheter 12 and the catheter hub 20 are fixed by a fixing means such as caulking, fusion, adhesion, and fitting. Incidentally, a caulking pin 56 is inserted, and the catheter 12 is sandwiched between the inner wall 20a of the catheter hub 20 and the caulking pin 56 to fix the catheter 12 in the example of
As illustrated in
For example, the valve body 24 has an annular portion 58 fixed to the inner wall 20a of the catheter hub 20 and a valve main body 60 protruding from the annular portion 58 in the distal direction. As illustrated in
The valve main body 60 is formed in a cylindrical shape on the annular portion 58 side and is formed in a tubular shape having a pair of inclined portions 62 that approach each other in the distal direction. A valve space 25 that narrows in the distal direction is formed inside the valve body 24.
Further, an end surface 63 extending in the width direction is formed at distal ends of the pair of inclined portions 62. A slit 64 is formed in the end surface 63. The slit 64 extends along the longitudinal direction of the end surface 63, extends between the pair of inclined portions 62 to a side portion of the valve main body 60, and extends to a distal end of the annular portion 58. The slit 64 allows the insertion of the inner needle 14 and is restored by an elastic restoring force after the inner needle 14 is removed.
Further, the pair of inclined portions 62 of the valve main body 60 are configured to be greatly separated from each other to open the slit 64 as illustrated in
As illustrated in
The barrel portion 68 is formed to have an outer diameter slightly smaller than an inner diameter of the internal space 50 of the catheter hub 20, and includes a barrel-portion-side space portion 74a that is a part of the space portion 74 inside. An outer peripheral surface of the barrel portion 68 is formed in a circular shape in cross-sectional view orthogonal to the axial direction of the opening member 26. The barrel-portion-side space portion 74a communicates with a proximal opening 68a provided at a proximal end of the barrel portion 68.
The neck portion 70 is formed to have a diameter that can be inserted inside the annular portion 58 of the valve body 24. As illustrated in
As illustrated in
An axial length of the neck rib 73 is set such that a distal end of the neck portion 70 is separated from the valve main body 60 when the neck rib 73 abuts on the proximal portion of the annular portion 58. Incidentally, the neck rib 73 is formed in a size that enters an inner diameter portion of the annular portion 58 and does not interfere with the movement of the opening member 26 in the distal direction when the opening member 26 is pressed to the distal side with a force equal to or greater than a predetermined load.
The opening member 26 is arranged proximal of the valve main body 60 of the valve body 24 in an initial state. In this state, the neck portion 70 at the distal end of the opening member 26 is configured to be maintained in the state of being separated from the valve main body 60 and to inhibit the opening of the valve body 24.
As illustrated in
The pair of side holes 80 are formed in the tapered portion of the distal end of the neck portion 70. The pair of side holes 80 oppose each other with the neck-portion-side space 74b interposed therebetween. Each of the side holes 80 is provided at a predetermined distance from the distal opening 78, penetrates the neck portion 70 in the thickness direction, and causes the neck-portion-side space 74b to communicate with the outside of the neck portion 70.
The opening member 26 is positioned such that the slit 64 of the valve body 24 and the pair of side holes 80 are at the same phase (circumferential position) in the initial state. With such positioning, each of the side holes 80 is exposed to a site where the slit 64 of the valve body 24 is open when the opening member 26 opens the valve main body 60 along with the insertion of the connector 95 as illustrated in
When the neck rib 73 of the opening member 26 abuts on the proximal portion of the annular portion 58, the distal opening 78 of the opening member 26 is positioned so as not to come into contact with inner surfaces of the pair of inclined portions 62 of the valve main body 60. That is, the distal opening 78 of the opening member 26 is located proximal of the inner surface portion of the inclined portion 62 located on a path where the distal opening 78 of the opening member 26 moves to the distal side. As a result, it is possible to inhibit the opening member 26 from inadvertently opening the valve main body 60 before use.
As illustrated in
As illustrated in
The fixing member 28 includes a fixed tubular body 82 having a through-hole 82a, and an annular convex portion 84 provided at a proximal end of the fixed tubular body 82. The proximal end of the fixed tubular body 82 forms the proximal opening portion 52 of the catheter hub 20. The fixed tubular body 82 is formed with a pair of notch portions 86 in which the pair of foot portions 72 of the opening member 26 are inserted. The pair of notch portions 86 are provided at opposing positions with the through-hole 82a interposed therebetween, and extend in the proximal direction from a distal end of the fixed tubular body 82. The annular convex portion 84 is arranged in a tubular groove portion 54a inside the flange 54 formed at the proximal end of the catheter hub 20 to inhibit the displacement of the fixing member 28 in the distal direction as illustrated in
The catheter assembly 10 according to the present embodiment is configured as described above, and effects thereof will be described hereinafter.
The catheter assembly 10 is used in a case of constructing the inlet/outlet for the infusion, the blood transfusion, the blood sampling, or the like to the patient. The user grips and operates the needle hub 16 of the catheter assembly 10 in the initial state illustrated in
When the needle tip 14a of the inner needle 14 reaches the blood vessel, blood flows into the lumen 13 of the catheter 12. As a result, the user can visually recognize a flashback of blood and confirm that the lumen 13 has been inserted in the blood vessel. When flowing inside the lumen 13 of the catheter 12 in the proximal direction, the blood flows into the internal space 50 of the catheter hub 20 from the proximal opening 13b (see
In the puncture state, the user advances the catheter 12 relative to the inner needle 14 and inserts the catheter 12 into the blood vessel. At a stage where the catheter 12 is inserted into the blood vessel to some extent, the operating member 18 is retracted with respect to the catheter indwelling body 22. As a result, the inner needle 14 is detached from the catheter 12.
In the catheter hub 20, when the needle tip 14a of the inner needle 14 is pulled out from the valve body 24, the valve main body 60 is elastically restored, and the slit 64 is closed. As a result, blood is blocked by the valve body 24, and blood is inhibited from flowing out to the proximal side. Further, if the inner needle 14 and the needle hub 16 are retracted, the inner needle 14 is detached from the proximal opening 13b of the catheter hub 20. That is, the inside of the catheter hub 20 is in the state illustrated in
As illustrated in
In the indwelling state of the catheter indwelling body 22, the user can insert the connector 95, which communicates with a tube of an infusion line, a syringe, or the like, into the internal space 50 through the proximal opening of the catheter hub 20 as illustrated in
As the opening member 26 is pressed via the connector 95, the neck rib 73 moves inside the valve body 24 while pushing and widening the annular portion 58. Then, the neck portion 70 opens the slit 64 by separating the pair of inclined portions 62 from each other as illustrated in
The catheter assembly 10 of the present embodiment has the following effects.
The catheter assembly 10 of the present embodiment includes: the inner needle 14 with which the living body is punctured; the catheter 12 through which the inner needle 14 is inserted; the catheter hub 20 provided at the proximal end of the catheter 12; the valve body 24 provided in the internal space 50 of the catheter hub 20; and the opening member 26 that has the cylindrical barrel portion 68, the neck portion 70 extending from the distal end of the barrel portion 68 while being reduced in diameter, and the foot portion 72 extending to the proximal side of the barrel portion 68, is arranged on the proximal side of the valve body 24, and moves to the distal side along the internal space 50 of the catheter hub 20 to open the valve body 24 by the neck portion 70; and the movement inhibiting mechanism that generates the resistance force against the movement of the opening member 26 to the distal side. The movement inhibiting mechanism includes the contact portion that generates the frictional force against the catheter hub 20 or the valve body 24.
According to the catheter assembly 10, the contact portion can inhibit the opening member 26 from moving to the distal side due to an impact or the like, and thus, the valve body 24 can be inhibited from being opened unintentionally.
In the above-described catheter assembly 10, the contact portion may include the neck rib 73 that protrudes toward the outer peripheral side of the neck portion 70 and abuts on the valve body 24. With this configuration, the neck rib 73 restricts the movement of the opening member 26 to the distal end, so that the valve body 24 can be inhibited from being open unintentionally. Further, regarding details of the neck rib 73, for example, both sides of a rib width can be reduced in diameter in a tapered shape toward the outer periphery to appropriately adjust a frictional force and push the opening member 26 in the distal direction. Further, corners of the contact portion and the side surface are preferably rounded.
The opening member 26 has been described with the embodiment in which the cylindrical barrel portion 68, the neck portion 70 extending from the distal end of the barrel portion 68 while being reduced in diameter, and the foot portion 72 extending to the proximal side of the barrel portion 68, but may adopt a mode of being formed of the cylindrical barrel portion 68 and the neck portion 70 extending from the distal end of the barrel portion 68. Even in such a mode, the above-described effects can be achieved by providing a movement inhibiting mechanism that generates a resistance force against the movement of the opening member 26 to the distal side and providing the movement inhibiting mechanism with a contact portion that generates a frictional force against the catheter hub 20 or the valve body 24.
Hereinafter, other embodiments of the present invention will be described. Incidentally, an element having the same configuration or the same function as that of the first embodiment will be denoted by the same reference sign, and the detailed description thereof will be omitted in the following description.
As illustrated in
As illustrated in
As illustrated in
As illustrated in
According to the opening member 26B provided with such a foot portion 72B, it is possible to obtain the same effects as those of the opening member 26A formed with the foot portion 72A widening outward.
As illustrated in
As illustrated in
Incidentally, the rib structure 75 has a structure in which the thickness of the foot portion 72 is gradually increased toward the proximal side, so that the same effects as those of the second embodiment can be obtained.
As illustrated in
Incidentally, the frictional force of the rib structure 75 is appropriately set within a range that does not interfere with the connection of the connector 95 to the catheter hub 20. As a result, the opening member 26D can be pressed by the connector 95 to open the valve body 24.
An opening member 26E according to the present embodiment is provided with an island-shaped convex portion 77 (protruding structure) formed so as to protrude outward more than an outer diameter of the barrel portion 68 at a boundary portion between the barrel portion 68 and the foot portion 72 as illustrated in
As illustrated in
Incidentally, the frictional force generated by the convex portion 77 and the concave portion 23 is appropriately set within a range that does not interfere with the connection of the connector 95 to the catheter hub 20A. As a result, the opening member 26E can be pressed by the connector 95 to open the valve body 24. Further, the movement inhibiting mechanism may be formed of only the convex portion.
As illustrated in
As illustrated in
As illustrated in
Incidentally, the frictional force generated by the concave portion 79 and the convex portion 27 is appropriately set within a range that does not interfere with the connection of the connector 95 to the catheter hub 20B. As a result, the opening member 26F can be pressed by the connector 95 to open the valve body 24. Further, the movement inhibiting mechanism may be formed of only the convex portion.
Although the present invention has been described with reference to the preferred embodiments above, the present invention is not limited to the above-described embodiments, and various modifications can be made within a scope not departing from a gist of the present invention.
Number | Date | Country | Kind |
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2019-063152 | Mar 2019 | JP | national |
This application is a bypass continuation of PCT Application No. PCT/JP2020/010601, filed on Mar. 11, 2020, which claims priority to Japanese Application No. 2019-063152, filed on Mar. 28, 2019. The contents of these applications are hereby incorporated by reference in their entireties.
Number | Date | Country | |
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Parent | PCT/JP2020/010601 | Mar 2020 | US |
Child | 17408336 | US |