Indwelling catheter and catheter assembly

Abstract

An indwelling catheter (10) comprises a catheter shaft (26). The catheter shaft (26) is provided with an indwelling part (30) that remains in a body and an exposed part (34) that is provided at the base end side of the indwelling part (30) and that is disposed so as to be exposed to the outside of a patient (P). An outer wall (301) of the indwelling part (30) is provided with a stopper structure (36) that restricts movement of the catheter shaft (26) in an indwelled state. The stopper structure (36) has a stopper part (46) comprising a protrusion (48) that protrudes from the outer wall (301) of the catheter shaft (26).

Description

Indwelling catheter and catheter assembly

[0001] The present invention relates to indwelling catheters and catheter assemblies.

[0002] JP 2013-500793 A discloses a drug solution administration device for administering a drug solution to a living body. The drug solution administration device has an indwelling catheter that is placed in the living body.

[0003] Special Publication No. 2013-500793

[0004] When an indwelling catheter is placed in a living body, it is preferable that the indwelling catheter does not move from a predetermined position.

[0005] The present invention aims to solve the above-mentioned problems.

[0006] (1) An aspect of the present invention is an indwelling catheter comprising a catheter shaft to be placed in a blood vessel or subcutaneous tissue of a living body, the catheter shaft comprising: an inner cavity extending in an axial direction and through which a medicinal solution flows; a distal end opening provided at the distal end of the catheter shaft and communicating with the inner cavity; an indwelling section including at least the distal end of the catheter shaft and placed in the blood vessel or subcutaneous tissue; an exposed section provided on the proximal end side of the indwelling section and arranged exposed to the outside of the skin of the living body; and a stopper structure provided on the outer wall of at least one of the indwelling section and the exposed section and restricting movement of the catheter shaft when placed in the blood vessel or subcutaneous tissue, the stopper structure having a stopper section consisting of at least one of a convex section protruding from the outer wall and a concave section recessed into the outer wall.

[0007] According to this indwelling catheter, when the indwelling catheter is placed in a blood vessel or subcutaneously in a living body, the stopper portion abuts against the tissue or skin in the living body and is engaged, thereby effectively preventing the indwelling catheter from shifting from its predetermined position. This allows the indwelling catheter to be placed stably. By configuring the stopper portion as at least one of a convex portion and a concave portion, the stopper structure can be easily realized.

[0008] (2) In the indwelling catheter described in (1) above, at least a part of the stopper structure may be provided on the outer wall of the indwelling portion.

[0009] With this configuration, when the indwelling catheter is inserted into a blood vessel or subcutaneously, the stopper portion on the outside of the indwelling portion comes into contact with tissue inside the living body, thereby preventing the indwelling catheter from moving.

[0010] (3) In the indwelling catheter described in (2) above, the indwelling section has a tip region including the tip opening, and an expanded diameter region including an expanded diameter section provided in the proximal direction of the tip region and expanded radially outward from the tip region, and the expanded diameter section may be the stopper section and provided at the tip of the expanded diameter region.

[0011] With this configuration, when the indwelling catheter is placed, the enlarged portion of the enlarged region comes into contact with tissue inside the living body, thereby suppressing movement of the indwelling catheter in the insertion direction.

[0012] (4) In the indwelling catheter described in (3) above, the indwelling section may have an intermediate region provided between the tip region and the enlarged diameter portion of the enlarged diameter region, and the outer wall of the intermediate region may have a side hole communicating with the inner cavity.

[0013] This configuration allows the drug solution to be administered from the side hole in addition to the tip opening.

[0014] (5) In the indwelling catheter described in (4) above, the tip region may have a tip tapered portion whose diameter decreases toward the tip of the catheter shaft, and the stopper structure may consist only of the enlarged diameter portion.

[0015] With this configuration, the tapered tip portion reduces insertion resistance when inserting the indwelling catheter into a blood vessel or under the skin, and since the stopper structure is only the enlarged diameter portion, the indwelling catheter can be easily inserted.

[0016] (6) In the indwelling catheter described in (4) above, the stopper portion may be a first stopper portion, and the outer wall of the intermediate region may be provided with a second stopper portion.

[0017] With this configuration, the first stopper portion provided in the expanded diameter region and the second stopper portion provided in the intermediate region can more effectively suppress movement of the indwelling portion within the body when the indwelling catheter is placed.

[0018] (7) In the indwelling catheter described in (6) above, the second stopper portion may include an annular rib protruding in a direction perpendicular to the axial direction of the catheter shaft.

[0019] With this configuration, by providing an annular rib perpendicular to the insertion direction of the indwelling catheter, the rib comes into close contact with the tissue inside the body during placement, more effectively preventing displacement of the indwelling part.

[0020] (8) In the indwelling catheter described in (7) above, the side hole may be provided between the stopper portion and the second stopper portion.

[0021] With this configuration, the side hole is provided between the stopper portion and the second stopper portion that protrude radially from the catheter shaft, making it difficult for the two stopper portions to block the side hole with tissue inside the body, facilitating the administration of a medicinal solution through the side hole.

[0022] (9) In the indwelling catheter described in (6) above, the second stopper portion may be a groove that is recessed radially into the outer wall of the catheter shaft and extends in the axial direction of the catheter shaft.

[0023] With this configuration, by making the second stopper portion a groove, the second stopper portion does not protrude from the outer wall of the catheter shaft and extends along the insertion direction, thereby reducing insertion resistance into the living body when inserting the indwelling catheter and making insertion easier.

[0024] (10) In the indwelling catheter described in (9) above, the groove may be provided with the side hole.

[0025] With this configuration, by providing a side hole in the groove, the side hole is less likely to be blocked by tissue in the body when an indwelling catheter is placed, making it easier to administer medicinal liquids through the side hole.

[0026] (11) In the indwelling catheter described in (6) above, the second stopper portion may be provided with a rib that protrudes in a direction intersecting the axial direction of the catheter shaft and extends spirally around the axis of the catheter shaft.

[0027] With this configuration, by providing a spiral rib that intersects with the insertion direction of the indwelling catheter, the rib effectively adheres to the tissue inside the body during placement, more effectively preventing displacement of the indwelling part.

[0028] (12) In the indwelling catheter described in any one of (3) to (11) above, the enlarged diameter section may include a tapered section whose diameter decreases toward the tip of the catheter shaft.

[0029] This configuration reduces insertion resistance when placing the indwelling catheter, making it easy to insert into the living body.

[0030] (13) In the indwelling catheter described in (5) above, the enlarged diameter portion has an end face arranged toward the tip and facing the tip region, the end face of the enlarged diameter portion is a surface extending in a direction intersecting the axial direction of the catheter shaft, and the angle of the end face with respect to the axial direction may be in the range of 70° to 90°.

[0031] With this configuration, the end face of the enlarged diameter section is arranged at approximately right angles to the insertion direction, so that when the indwelling catheter is inserted, the end face abuts against the tissue inside the body, effectively locking it in place.

[0032] (14) In the indwelling catheter described in (1) above, at least a part of the stopper structure may be provided on the outer wall of the exposed portion, and when the catheter shaft is placed in the blood vessel or subcutaneously, the stopper structure may abut against the skin of the living body.

[0033] With this configuration, the stopper structure abuts against the skin outside the body, effectively preventing the indwelling catheter from moving while indwelling, and the insertion depth of the indwelling catheter can be controlled.

[0034] (15) In the indwelling catheter described in (14) above, the exposed portion may have an enlarged diameter portion at the boundary between the indwelling portion and the exposed portion, the enlarged diameter portion being larger than the indwelling portion.

[0035] With this configuration, when the indwelling catheter is placed, the enlarged diameter portion of the exposed portion comes into contact with the skin of the living body, thereby suppressing movement of the indwelling catheter in the insertion direction.

[0036] (16) A catheter assembly comprising the indwelling catheter described in (3) above and an inner needle that is removably inserted into the inner cavity of the catheter shaft, wherein at least the expanded diameter portion of the catheter shaft is formed from an elastically deformable material, and a radial gap may be formed between the inner surface of the expanded diameter region of the catheter shaft and the inner needle.

[0037] With this configuration, when the inner needle is inserted into the lumen of the indwelling catheter and the living body is punctured, the enlarged region including the enlarged portion comes into contact with the living body, causing the enlarged region to deform radially inward, and the enlarged region is pushed into the gap between it and the inner needle and punctures the living body together with the inner needle.Therefore, even if the catheter shaft has an enlarged portion, insertion resistance during insertion is effectively suppressed.

[0038] (17) The indwelling catheter may include the indwelling catheter described in (1) above, and an inner needle that is removably inserted into the lumen of the catheter shaft.

[0039] With this configuration, after the inner needle is removed from the indwelling catheter, the indwelling portion of the indwelling catheter remains in place within the living body without shifting position.

[0040] According to the present invention, when an indwelling catheter is placed in a blood vessel or subcutaneously in a living body, the stopper portion abuts against tissue or skin in the living body to lock the catheter in place, effectively preventing the catheter from shifting from its predetermined position. This allows the indwelling catheter to be placed stably. The stopper structure can be easily realized by configuring the stopper portion as at least one of a convex portion and a concave portion.

[0041] FIG. 1 is a plan view of a drug solution administration device equipped with an indwelling catheter according to a first embodiment of the present invention. FIG. 2 is a cross-sectional view of a needle unit of the drug solution administration device. FIG. 3A is a plan view showing the tip of a multiple needle with an inner needle inserted into the indwelling catheter. FIG. 3B is a cross-sectional view taken along line IIIB-IIIB in FIG. 3A. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. 3A. FIG. 5A is an explanatory diagram showing the tip of the indwelling catheter of the drug solution administration device of FIG. 1 inserted and placed in a body. FIG. 5B is an explanatory diagram showing the administration of a drug solution from an indwelling catheter placed in a body. FIG. 6A is an external perspective view showing the tip of an indwelling catheter and a needle member according to a second embodiment of the present invention. FIG. 6B is a plan view of the indwelling catheter and needle member shown in FIG. 6A. FIG. 6C is a cross-sectional view taken along line VIC-VIC in FIG. 6B. FIG. 7 is an explanatory diagram showing the administration of a drug solution with the indwelling catheter shown in FIG. 6A placed in a body. FIG. 8A is an external perspective view showing the distal end of an indwelling catheter and needle member according to a third embodiment of the present invention. FIG. 8B is a plan view of the indwelling catheter and needle member shown in FIG. 8A. FIG. 8C is a cross-sectional view taken along line VIIIC-VIIIC in FIG. 8B. FIG. 9 is an explanatory diagram showing the state in which the indwelling catheter shown in FIG. 8A is left in a living body and a medicinal solution is administered. FIG. 10A is an external perspective view showing the distal end of an indwelling catheter and needle member according to a fourth embodiment of the present invention. FIG. 10B is a plan view of the indwelling catheter and needle member shown in FIG. 10A. FIG. 10C is an explanatory diagram showing the state in which the indwelling catheter shown in FIG. 10A is left in a living body and a medicinal solution is administered. FIG. 11A is a plan view showing the distal end of an indwelling catheter and needle member according to a fifth embodiment of the present invention. FIG. 11B is an explanatory diagram showing the state in which the indwelling catheter shown in FIG. 11A is left in a living body and a medicinal solution is administered. FIG. 12A is a plan view showing the distal end of an indwelling catheter and needle member according to a sixth embodiment of the present invention. FIG. 12B is an explanatory diagram showing the state in which the indwelling catheter shown in FIG. 12A is indwelled in the body and a medicinal solution is administered.

[0042] As shown in FIG. 1 , an indwelling catheter 10 according to the first embodiment is used in a drug solution administration device 12 .

[0043] The medicinal solution administration device 12 is configured to be placed on a body surface P1 (skin, see FIG. 5A ) such as the abdomen of a patient P (living body, see FIG. 5A ) and to automatically administer a medicinal solution S (see FIG. 5B ) into the body. The medicinal solution administration device 12 is used, for example, when administering the medicinal solution S to the patient P a predetermined time after a medical procedure has been performed on the patient P, or when administering the medicinal solution S gradually over time. The medicinal solution S administered by the medicinal solution administration device 12 is, for example, a liquid pharmaceutical such as an antibody drug, an anticancer drug, a chemotherapy agent, an anesthetic, an antibiotic, insulin, a blood product, or a nutrient.

[0044] The medicinal solution administration device 12 includes a needle unit 14 and a device main body 16. The needle unit 14 is placed on the body surface P1 and inside the body (in a blood vessel or subcutaneously P2, see FIG. 5A ) and constitutes an introduction section for the medicinal solution S into the patient P. The needle unit 14 includes an indwelling catheter 10, a needle member 18 inserted through the indwelling catheter 10, a holder 20 that holds the indwelling catheter 10, a patch 22 connected to the holder 20, and a release sheet 24 overlaid on the patch 22.

[0045] As shown in Figure 2, the indwelling catheter 10 has a catheter shaft 26 that is placed inside the body of a patient P, and a catheter hub 28 that holds the proximal end of the catheter shaft 26. Note that the patch 22 and the release sheet 24 are not shown in Figure 2. The catheter shaft 26 is a flexible tubular body made of, for example, a resin material.

[0046] Examples of materials that can be used to form the catheter shaft 26 include fluorine-based resins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA); olefin-based resins such as polyethylene and polypropylene; and mixtures of these resins; polyurethane; polyester; polyamide; polyether nylon resin; and mixtures of olefin-based resins and ethylene-vinyl acetate copolymer.

[0047] As shown in Fig. 3A, the catheter shaft 26 includes a lumen 261 (see Fig. 3B), a tip opening 262, the indwelling section 30, the exposed section 34, and a stopper structure 36. The lumen 261 is formed inside the catheter shaft 26. The lumen 261 extends in the axial direction of the catheter shaft 26, and a medicinal solution S (see Fig. 5B) flows through it. As shown in Fig. 3B, the tip opening 262 is provided at the tip of the catheter shaft 26 and communicates with the lumen 261.

[0048] 3A, the retention section 30 includes the distal end of the catheter shaft 26 and is provided in the range extending to the intermediate section between the distal end and the proximal end, and the retention catheter 10 is retained in the body of the patient P (see FIG. 5A). The retention section 30 includes a distal region 321, an expanded diameter region 322 provided toward the proximal end of the distal region 321, and an intermediate region 323 provided between the distal region 321 and the expanded diameter region 322.

[0049] The distal region 321 is a predetermined region extending from the distal end of the indwelling section 30 toward the proximal end, including the distal opening 262. The distal region 321 has a distal tapered section 38 whose diameter decreases toward the distal end of the catheter shaft 26. In other words, the distal end of the distal region 321 has the smallest diameter.

[0050] The expanded diameter region 322 has an expanded diameter section 40 that is expanded radially outward more than the distal region 321. The expanded diameter section 40 is provided at the distal end of the expanded diameter region 322. The distal end of the expanded diameter section 40 has a tapered section 42 that narrows in diameter toward the distal end. The tapered section 42 is connected to the proximal end of the intermediate region 323. The angle of the tapered section 42 with respect to the axial direction of the catheter shaft 26 is, for example, in the range of 10° to 69°. It is more preferable that the angle of the tapered section 42 be in the range of 15° to 45°.

[0051] The intermediate region 323 is a region between the base end of the distal region 321 and the distal end of the expanded diameter region 322 in the axial direction of the catheter shaft 26. The diameter of the intermediate region 323 is approximately the same as the diameter of the proximal end of the distal region 321. The diameter of the intermediate region 323 is smaller than the diameter of the expanded diameter section 40. The outer wall 301 of the intermediate region 323 is provided with a side hole 44. As shown in FIG. 4 , the side hole 44 radially penetrates the outer wall 301 and communicates with the lumen 261. As shown in FIG. 3A , the side hole 44 is located closer to the expanded diameter region 322 in the axial direction of the intermediate region 323. Note that the side hole 44 is not limited to being located closer to the expanded diameter region 322 in the intermediate region 323. For example, the side hole 44 may be located closer to the distal region 321 in the intermediate region 323, or the side hole 44 may be located in the center of the intermediate region 323.

[0052] The exposed portion 34 is provided on the proximal end side of the retention portion 30 (expanded diameter region 322) and is positioned so as to be exposed to the outside of the body surface P1 (skin) when the retention portion 30 is retained in the body of a patient P (see FIG. 5A ). A boundary portion BL between the retention portion 30 and the exposed portion 34 is the position that comes into contact with the body surface P1 when the retention catheter 10 is retained in the living body.

[0053] The stopper structure 36 is provided on the outer wall 301 of the retention portion 30. The stopper structure 36 restricts movement of the catheter shaft 26 including the retention portion 30 relative to the patient P when the retention portion 30 is retained in the body of the patient P. Note that the stopper structure 36 is not limited to being provided on the outer wall 301 of the retention portion 30.

[0054] The stopper structure 36 has a stopper portion 46. The stopper portion 46 is composed of a convex portion 48 that protrudes from the outer wall 301 of the indwelling section 30 of the catheter shaft 26. The convex portion 48 is an expanded diameter portion 40 that protrudes from the outer wall 301 in a direction intersecting the axial direction of the catheter shaft 26. The expanded diameter portion 40 is a stepped convex portion 48 that protrudes radially outward from the intermediate region 323. The stopper structure 36 in the indwelling catheter 10 consists only of the expanded diameter portion 40. Note that the stopper portion 46 is not limited to being composed of a convex portion 48 that protrudes from the outer wall 301 of the catheter shaft 26. For example, the stopper portion 46 may be composed only of a recess that is recessed into the outer wall 301 of the catheter shaft 26.

[0055] As shown in Figure 2, the catheter hub 28 has a hollow cylindrical hub body 281 and a hollow cylindrical side port 282 that protrudes obliquely from the side of the hub body 281. The catheter hub 28 is made of, for example, a resin material and is harder than the catheter shaft 26. The proximal end of the catheter shaft 26 is fixed to the distal end of the hub body 281. A valve body 50 made of an elastic material is disposed inside the hub body 281, closer to the proximal end than the distal opening of the side port 282. The side port 282 protrudes obliquely toward the proximal end from an intermediate portion between the distal and proximal ends of the hub body 281.

[0056] As shown in FIG. 3A , a catheter assembly 52 is formed by the indwelling catheter 10 and a needle member 18. As shown in FIG. 2 , the needle member 18 has an inner needle 54 inserted into the indwelling catheter 10 and a needle holder 56 that holds the base end of the inner needle 54. The needle member 18 is detachably attached to the indwelling catheter 10. The inner needle 54 is removably inserted into the lumen 261 of the catheter shaft 26 (see FIG. 3B ). As shown in FIG. 2 , in the initial state of the needle unit 14, the distal end of the inner needle 54, including the needle tip 541, protrudes from the distal opening 262 of the catheter shaft 26 (see FIG. 3B ), and the catheter shaft 26 and the inner needle 54 overlap to form a multi-needle 58. As shown in FIG. 3B , a radial gap 60 is formed between the inner circumferential surface of the expanded diameter region 322 of the catheter shaft 26 and the outer circumferential surface of the inner needle 54.

[0057] 2, the proximal end of the inner needle 54 is fixed to the needle holder 56. In the initial state, the inner needle 54 penetrates the valve body 50. In the initial state, the portion of the multiple needle 58 that protrudes distally from the catheter hub 28 is covered by a tubular protector 62.

[0058] The needle holder 56 is detachably connected to the catheter hub 28. Specifically, a pair of engagement arms 64 of the needle holder 56 engage with the base end of the hub body 281. When the user presses the base end sides of the engagement arms 64 inward, the tip sides of the engagement arms 64 are displaced outward, making the needle holder 56 detachable from the catheter hub 28. A gripping member 66 that is gripped by the user is fixed to the base end of the needle holder 56 (see FIG. 1 ).

[0059] As shown in Figure 1, the holder 20 holds the proximal end (catheter hub 28) of the indwelling catheter 10. The holder 20 has a base portion 68 and a hub holding portion 70. The base portion 68 is formed in a flat plate shape. The patch 22 is fixed to the base portion 68. The hub holding portion 70 protrudes upward from the base portion 68 and holds the catheter hub 28.

[0060] The patch 22 is a sheet-like member having an adhesive surface 76 to be attached to the body surface P1 of the patient P. The multiple needles 58 and the protector 62 pass through openings 72 formed in the patch 22. A transparent film-like dressing material 74 is provided on the tip side of the surface 22a of the patch 22. The multiple needles 58 and the protector 62 pass through the dressing material 74.

[0061] The release sheet 24 is overlaid on the lower surface of the patch body 22. The release sheet 24 is removable from the adhesive surface 76 (see FIG. 5A ). The release sheet 24 has a first sheet 241 overlaid on the distal end side of the patch body 22, and a second sheet 242 overlaid on the patch body 22 on the proximal end side of the first sheet 241.

[0062] The needle unit 14 further includes a tube 78 and a connector portion 80. The tube 78 is flexible. One end of the tube 78 is connected to and fixed to the side port 282 of the catheter hub 28. The other end of the tube 78 is connected to and fixed to the connector portion 80.

[0063] In the initial state of the needle unit 14, an adapter member 82 is detachably connected to the base end of the connector portion 80. A priming liquid delivery device (e.g., a syringe, etc.) (not shown) can be connected to the base end of the adapter member 82. The adapter member 82 has a pair of connecting arms 84. Claw portions 86 provided at the tip of each connecting arm 84 engage with the side of the connector portion 80. When the user presses the base end side of the connecting arm 84 inward, the tip side of the connecting arm 84 is displaced outward, making the adapter member 82 detachable from the connector portion 80. The connector portion 80 with the adapter member 82 detached can be connected to the device main body 16.

[0064] Device body 16 is a device for supplying medicinal solution S toward needle unit 14. Although not shown in detail, device body 16 includes a medicinal solution container that stores medicinal solution S, a gasket slidably disposed within the medicinal solution container, a movement mechanism that moves the gasket toward the distal end to deliver medicinal solution S from the medicinal solution container, a control unit that controls the movement mechanism, and a power supply unit that supplies power to the movement mechanism, etc. Device body 16 further includes a connection unit 161 that can be connected to connector unit 80 of needle unit 14.

[0065] Next, the operation of the drug solution administration device 12 equipped with the indwelling catheter 10 will be described.

[0066] The user connects a priming fluid delivery device (not shown) to the adapter member 82 and delivers the priming fluid to fill the inside of the tube 78 and the catheter hub 28 with the priming fluid (first priming). Next, the user removes the protector 62 from the multiple needle 58.

[0067] 5A , the user inserts the multiple needle 58 from the body surface P1 into the body (into the subcutaneous tissue P2 in this embodiment). Specifically, the distal end tapered portion 38 of the catheter shaft 26 is inserted from the body surface P1 into the subcutaneous tissue P2 together with the distal end of the inner needle 54. After the distal end of the multiple needle 58 (the retention portion 30 of the catheter shaft 26) reaches a predetermined position, the user peels the first sheet 241 of the release sheet 24 from the adhesive product 22 and attaches the distal end side of the adhesive product 22 to the body surface P1.

[0068] 5B , the user pulls the inner needle 54 in the proximal direction relative to the indwelling catheter 10, thereby removing the inner needle 54 from the indwelling catheter 10. The indwelling section 30 of the catheter shaft 26 is placed at a predetermined position within the subcutaneous tissue P2. At this time, the stopper section 46 of the indwelling section 30 comes into contact with tissue within the subcutaneous tissue P2, so that the indwelling section 30 is placed in a locked state at a predetermined position within the body.

[0069] 1, the user peels off the second sheet 242 of the release sheet 24 from the patch 22 and attaches the proximal end side of the patch 22 to the body surface P1. Next, the user performs a second priming by delivering priming liquid using a priming liquid delivery device (not shown). In the second priming, the catheter shaft 26 is filled with priming liquid.

[0070] Next, the user connects the needle unit 14 to the device body 16 by connecting the connector portion 80 to the device body 16. Specifically, the user operates the pair of connecting arms 84 of the adapter member 82 to disengage the connecting arms 84 from the connector portion 80, and then removes the adapter member 82 from the connector portion 80. Next, the user connects the connector portion 80, with the adapter member 82 removed, to the connecting portion 161 of the device body 16.

[0071] Next, the user presses a power switch (not shown) provided on the device main body 16. This starts up the device main body 16. The device main body 16 delivers the medicinal solution S and automatically administers the medicinal solution S to the patient P via the tube 78 and the indwelling catheter 10. Note that a patch (not shown) is also provided on the device main body 16, and the device main body 16 is also attached to the body surface P1 by the patch.

[0072] 5B, the medicinal solution S is delivered from the lumen 261 of the catheter shaft 26 into the subcutaneous tissue P2 via the distal end opening 262. The medicinal solution S also flows out from the lumen 261 of the catheter shaft 26 into the subcutaneous tissue P2 via the side hole 44.

[0073] The first embodiment has the following advantages.

[0074] As shown in Figure 3A, the catheter shaft 26 of the indwelling catheter 10 comprises an indwelling section 30 that is placed inside the body of a patient P (living body) (in a blood vessel or subcutaneously P2, see Figure 5A), and an exposed section 34 that is provided on the proximal end side of the indwelling section 30 and is arranged exposed to the outside of the patient P. The outer wall 301 of the indwelling section 30 is provided with a stopper structure 36 that restricts movement of the catheter shaft 26 while it is placed inside the body of the patient P. The stopper structure 36 has a stopper portion 46 consisting of a protrusion 48 that protrudes from the outer wall 301.

[0075] As a result, when the indwelling catheter 10 is placed inside the body of the patient P, the stopper portion 46 comes into contact with the tissue or skin (body surface P1) inside the body of the patient P and is thereby locked, effectively preventing the indwelling catheter 10 from shifting from its predetermined position, thereby enabling stable placement of the indwelling catheter 10. By configuring the stopper portion 46 from the protrusion 48, the stopper structure 36 can be easily realized.

[0076] At least a portion of the stopper structure 36 is provided on the outer wall 301 of the retention section 30. As a result, as shown in Fig. 5B, when the retention catheter 10 is inserted into the body (inside the subcutaneous tissue P2), the stopper portion 46 on the outside of the retention section 30 comes into contact with tissue inside the body of the patient P (inside the blood vessels or the subcutaneous tissue P2), thereby preventing the retention catheter 10 from moving.

[0077] 3A , the retention section 30 has a distal region 321 including a distal opening 262, and an expanded diameter region 322 including an expanded diameter section 40 provided proximal to the distal region 321 and expanded radially outward from the distal region 321. The expanded diameter section 40 is a stopper section 46, and is provided at the distal end of the expanded diameter region 322. As a result, when the retention catheter 10 is retained in the body of a patient P, the expanded diameter section 40 of the expanded diameter region 322 comes into contact with tissue inside the body (in a blood vessel or subcutaneous tissue P2), thereby suppressing movement of the retention catheter 10 in the insertion direction.

[0078] The retention section 30 has an intermediate region 323 provided between the tip region 321 and the expanded diameter section 40 of the expanded diameter region 322, and the outer wall 301 of the intermediate region 323 has a side hole 44 that communicates with the lumen 261. This makes it possible to administer the medicinal solution S from the side hole 44 in addition to the tip opening 262.

[0079] The distal region 321 has a distal tapered section 38 whose diameter decreases toward the distal end of the catheter shaft 26, and the stopper structure 36 consists only of an expanded diameter section 40. As a result, the distal tapered section 38 reduces insertion resistance when inserting the indwelling catheter 10 into the body (into a blood vessel or subcutaneously P2), and because the stopper structure 36 consists only of the expanded diameter section 40, the indwelling catheter 10 can be easily inserted.

[0080] The expanded diameter section 40 includes a tapered section 42 that narrows in diameter toward the tip of the catheter shaft 26. This reduces insertion resistance when the indwelling catheter 10 is placed inside the body (subcutaneously P2), making it easier to insert into the body of the patient P.

[0081] As shown in Fig. 3B , the catheter shaft 26 constituting the catheter assembly 52 has at least the enlarged diameter portion 40 formed from an elastically deformable material, and there is a radial gap 60 between the inner circumferential surface of the enlarged diameter region 322 of the catheter shaft 26 and the inner needle 54. As a result, as shown in Fig. 5A , when the patient P is punctured with the inner needle 54 inserted into the lumen 261 of the indwelling catheter 10, the enlarged diameter region 322 including the enlarged diameter portion 40 comes into contact with tissue inside the body (in a blood vessel or subcutaneous tissue P2), causing the enlarged diameter region 322 to deform radially inward and be pushed into the gap 60 between the enlarged diameter region 322 and the inner needle 54, and then the enlarged diameter region 322 is inserted into the body together with the inner needle 54. Therefore, even when the catheter shaft 26 has the enlarged diameter portion 40, insertion resistance during insertion of the indwelling catheter 10 is effectively reduced.

[0082] As shown in FIG. 6A , the indwelling catheter 10A according to the second embodiment includes a catheter shaft 26A that is placed inside the body of a patient P (in a blood vessel or subcutaneously P2), and the catheter shaft 26A has a stopper structure 36A. As shown in FIG. 6B , the stopper structure 36A includes a first stopper portion 461 and a second stopper portion 462A. The first stopper portion 461 corresponds to the stopper portion 46 of the indwelling catheter 10 of the first embodiment and is the expanded diameter portion 40 provided at the tip of the expanded diameter region 322. The second stopper portion 462A is provided on the outer wall 301 of the intermediate region 323 of the indwelling section 30. The second stopper portion 462A includes an annular rib 90 that protrudes in a direction perpendicular to the axial direction of the catheter shaft 26A. The rib 90 is provided at the tip of the intermediate region 323. As shown in FIG. 6C , the outer peripheral surface of the rib 90 is formed in an arc shape that bulges outward in the radial direction. The diameter of the rib 90 is, for example, equal to or smaller than the diameter of the enlarged diameter portion 40. Note that the rib 90 is not limited to being formed in a ring shape along the outer wall 301 of the intermediate region 323. The rib 90 may be provided on only a portion of the outer wall 301 of the intermediate region 323 in the circumferential direction. The outer wall 301 of the intermediate region 323 has a side hole 44, and the side hole 44 is disposed between the first stopper portion 461 and the second stopper portion 462A.

[0083] 7 , when the retention section 30 of the indwelling catheter 10A is retained under the subcutaneous tissue P2 of the patient P, the subcutaneous tissue P2 covers the first stopper portion 461 and the second stopper portion 462A of the retention section 30. When the retention section 30 of the indwelling catheter 10A is retained under the subcutaneous tissue P2 of the patient P, the first and second stopper portions 461, 462A come into contact with the tissue in the subcutaneous tissue P2, thereby retaining the retention section 30 of the indwelling catheter 10A in a predetermined position inside the body.

[0084] The second embodiment has the following advantages.

[0085] 6B , the outer wall 301 of the intermediate region 323 of the indwelling catheter 10A is provided with a second stopper portion 462A that is separate from the first stopper portion 461. As a result, the first stopper portion 461 provided in the expanded diameter region 322 and the second stopper portion 462A provided in the intermediate region 323 can more effectively suppress movement of the indwelling section 30 inside the body of the patient P when the indwelling catheter 10A is indwelled.

[0086] The second stopper portion 462A has an annular rib 90 that protrudes in a direction perpendicular to the axial direction of the catheter shaft 26A. By providing the annular rib 90 perpendicular to the insertion direction of the indwelling catheter 10A, when the indwelling catheter 10A is placed, the rib 90 comes into close contact with the tissue inside the body (in the blood vessel or subcutaneous tissue P2), more effectively preventing the indwelling portion 30 from shifting position.

[0087] 6C , a side hole 44 is provided between the first stopper portion 461 and the second stopper portion 462A. This prevents the space between the radially protruding first stopper portion 461 and the second stopper portion 462A from being covered by intracorporeal tissue when the retention portion 30 is retained subcutaneously P2. That is, the first stopper portion 461 and the second stopper portion 462A create a space between the intracorporeal tissue and the outer wall 301 of the intermediate region 323. This makes it difficult for the side hole 44 disposed between the first stopper portion 461 and the second stopper portion 462A to be blocked, facilitating administration of the medicinal solution S through the side hole 44.

[0088] As shown in FIG. 8A , the indwelling catheter 10B according to the third embodiment includes a catheter shaft 26B that is placed inside the body of a patient P (in a blood vessel or subcutaneously P2), and the catheter shaft 26B has a stopper structure 36B. As shown in FIG. 8B , the stopper structure 36B includes a first stopper portion 461 and a second stopper portion 462B. The second stopper portion 462B is provided in the indwelling section 30. The second stopper portion 462B is formed across the distal end region 321, the intermediate region 323, and the expanded diameter region 322. As shown in FIG. 8C , the second stopper portion 462B is formed by a recess 92 that is recessed radially from the outer wall 301 of the catheter shaft 26B. As shown in FIG. 8B , the recess 92 is a groove 94 that extends in the axial direction of the catheter shaft 26B. As shown in FIG. 8C , a plurality of grooves 94 are provided in the catheter shaft 26B. The number of grooves 94 is, for example, four. The multiple grooves 94 are spaced apart from one another in the circumferential direction of the catheter shaft 26B. The number of grooves 94 is not limited to four. For example, the number of grooves 94 may be three or less, or five or more.

[0089] A side hole 44 is provided in the groove 94 in the intermediate region 323 of the retention section 30. The side hole 44 opens to the bottom of the groove 94 and communicates with the lumen 261.

[0090] As shown in Figure 9, when the retention section 30 of the retention catheter 10B is retained inside the body of a patient P (inside the subcutaneous tissue P2), the tip of the first stopper section 461 of the retention section 30 comes into contact with the tissue inside the subcutaneous tissue P2, and the tissue inside the subcutaneous tissue P2 enters the groove 94 of the second stopper section 462B, so that the retention section 30 is retained in a predetermined position inside the body.

[0091] The third embodiment has the following advantages.

[0092] 8A , the second stopper portion 462B is a groove 94 that is recessed radially into the outer wall 301 of the catheter shaft 26B and extends in the axial direction of the catheter shaft 26B. By forming the second stopper portion 462B as the groove 94, the second stopper portion 462B does not protrude from the outer wall 301 of the catheter shaft 26B, and the groove 94 extends in the insertion direction. This reduces the insertion resistance of the patient P when inserting the indwelling catheter 10B, facilitating insertion. The multiple grooves 94 can enlarge the step in the expanded diameter section 40, allowing the first stopper portion 461 to more effectively lock the indwelling catheter 10B.

[0093] 8C , a side hole 44 is provided in the groove 94. As a result, when the indwelling section 30 of the indwelling catheter 10B is indwelled, the side hole 44 in the groove 94 is less likely to be blocked by tissue within the body (inside the blood vessel or under the skin P2), making it easier to administer the medicinal solution S through the side hole 44.

[0094] As shown in Figure 8A, the catheter assembly 52 is provided with an inner needle 54 that is removably inserted into the lumen 261 of the catheter shaft 26B, so that after the inner needle 54 is removed from the indwelling catheter 10B, the indwelling portion 30 of the indwelling catheter 10B remains in place within the subcutaneous tissue P2 without shifting position.

[0095] As shown in FIG. 10A , an indwelling catheter 10C according to the fourth embodiment includes a catheter shaft 26C that is placed inside the body of a patient P (in a blood vessel or subcutaneously P2), and the catheter shaft 26C has a stopper structure 36C. As shown in FIG. 10B , the stopper structure 36C includes a first stopper portion 461 and a second stopper portion 462C. The second stopper portion 462C is formed across the intermediate region 323 and the expanded diameter region 322 of the indwelling section 30. The second stopper portion 462C includes a rib 96 that protrudes in a direction perpendicular to the axial direction of the catheter shaft 26C and extends spirally around the axis of the catheter shaft 26C. The diameter of the rib 96 is, for example, equal to or smaller than the diameter of the expanded diameter portion 40. Side holes 44 are provided in the outer wall 301 of the intermediate region 323 between axially adjacent portions of the rib 96. The second stopper portion 462C is not limited to being provided in the intermediate region 323 and the expanded diameter region 322. For example, the second stopper portion 462C may be provided over the entire area of ​​the detention section 30 from the distal end region 321 to the expanded diameter region 322.

[0096] 10C , when the retention section 30 of the retention catheter 10C is to be retained inside the body of a patient P (inside the subcutaneous tissue P2), the retention catheter 10C is advanced into the body together with the inner needle 54. The rib 96 of the second stopper section 462C bites into the tissue in the subcutaneous tissue P2, so that the retention section 30 is retained at a predetermined position inside the body and retained therein.

[0097] The fourth embodiment has the following advantages.

[0098] As shown in FIG. 10A , the second stopper portion 462C has a rib 96 that extends spirally around the axis of the catheter shaft 26C. Therefore, when the retention portion 30 is retained inside the body of a patient P (inside the subcutaneous tissue P2), the rib 96 effectively adheres to the tissue inside the body (inside the blood vessel or subcutaneous tissue P2), more effectively preventing the retention portion 30 from shifting position.

[0099] As shown in FIG. 11A , the indwelling catheter 10D according to the fifth embodiment includes a catheter shaft 26D that is placed inside the body of a patient P (in a blood vessel or subcutaneously P2), and the catheter shaft 26D has a stopper structure 36D. The stopper structure 36D includes a stopper portion 46D. The stopper portion 46D is an expanded diameter section 40 that has an end face 98 disposed distally and facing the distal end region 321. The end face 98 is provided between the intermediate region 323 and the expanded diameter region 322. The end face 98 of the expanded diameter section 40 is an annular surface extending radially of the catheter shaft 26D. The end face 98 of the expanded diameter section 40 extends in a direction intersecting the axial direction of the catheter shaft 26D. As shown in FIG. 11A , the angle θ of the end face 98 with respect to the axis L of the catheter shaft 26D is in the range of 70° to 90°.

[0100] As shown in Figure 11B, when the retention portion 30 of the retention catheter 10D is retained inside the body of a patient P (inside the subcutaneous tissue P2), the end face 98 of the stopper portion 46D comes into contact with tissue inside the body (inside a blood vessel or the subcutaneous tissue P2), so that the retention portion 30 is retained in a predetermined position inside the subcutaneous tissue P2.

[0101] The fifth embodiment has the following advantages.

[0102] The enlarged diameter portion 40 of the stopper structure 36D has an end face 98 arranged toward the tip and facing the tip region 321, and the end face 98 of the enlarged diameter portion 40 is a surface extending in a direction intersecting the axial direction of the catheter shaft 26D, and the angle θ of the end face 98 with respect to the axial direction is in the range of 70° to 90°.

[0103] As a result, when the retention section 30 is placed inside the body of the patient P, the end face 98 of the expanded diameter section 40 is arranged to be approximately perpendicular to the insertion direction, thereby more effectively suppressing further movement of the retention section 30 inside the body toward the tip.

[0104] 11B , the catheter shaft 26D constituting the catheter assembly 52 has at least the enlarged diameter section 40 formed from an elastically deformable material, and there is a radial gap 60 between the inner circumferential surface of the enlarged diameter region 322 of the catheter shaft 26D and the inner needle 54. As a result, when the patient P is punctured with the inner needle 54 inserted into the lumen 261 of the indwelling catheter 10D, the enlarged diameter region 322 including the enlarged diameter section 40 comes into contact with tissue inside the body (in a blood vessel or subcutaneous tissue P2), causing the enlarged diameter region 322 to deform radially inward and be pushed into the gap 60 between the catheter shaft 26D and the inner needle 54, and then being inserted into the body together with the inner needle 54. Therefore, even when the catheter shaft 26D has an enlarged diameter section 40 that is approximately perpendicular, insertion resistance during insertion of the indwelling catheter 10D is reduced.

[0105] 12A , an indwelling catheter 10E according to the sixth embodiment includes a catheter shaft 26E that is placed inside the body of a patient P (in a blood vessel or subcutaneously P2), and the catheter shaft 26E has a stopper structure 36E. At least a portion of the stopper structure 36E is provided on an outer wall 341 of the exposed portion 34. At the boundary between the indwelling portion 30 and the exposed portion 34, the exposed portion 34 has an expanded diameter portion 40 that is larger in diameter than the indwelling portion 30. The expanded diameter portion 40 is a stopper portion 46E of the stopper structure 36E.

[0106] 12B , when the retention section 30 of the retention catheter 10E is retained inside the body of a patient P (inside the subcutaneous tissue P2), the enlarged diameter section 40 of the stopper structure 36E comes into contact with the body surface P1 of the patient P, thereby retaining the retention section 30 in a predetermined position inside the body. The exposed section 34, which is located at the proximal end of the enlarged diameter section 40, is positioned outside the body surface P1 of the patient P and is exposed.

[0107] The sixth embodiment has the following advantages.

[0108] At least a portion of the stopper structure 36E is provided on the outer wall 341 of the exposed portion 34, and when the catheter shaft 26E is placed inside the body of the patient P (in a blood vessel or subcutaneously P2), the expanded diameter portion 40 of the stopper structure 36E abuts against the skin (body surface P1) of the patient P. As a result, the stopper structure 36E abuts against the skin on the outside of the patient P's skin, effectively preventing movement of the indwelling catheter 10E while it is indwelled. The insertion amount of the indwelling catheter 10E can be controlled.

[0109] 12A , at the boundary between the retention section 30 and the exposed section 34, the exposed section 34 has an expanded diameter section 40 that is larger in diameter than the retention section 30. As a result, when the retention catheter 10E is retained, the expanded diameter section 40 of the exposed section 34 comes into contact with the skin (body surface P1) of the patient P, thereby suppressing movement of the retention catheter 10E in the insertion direction.

[0110] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. An indwelling catheter comprising a catheter shaft to be placed in a blood vessel or subcutaneously in a living body, wherein the catheter shaft comprises: an inner cavity extending in the axial direction and through which a medicinal solution flows; a distal end opening provided at the distal end of the catheter shaft and communicating with the inner cavity; an indwelling section including at least the distal end of the catheter shaft and placed in the blood vessel or subcutaneously; an exposed section provided on the proximal end side of the indwelling section and arranged exposed to the outside of the skin of the living body; and a stopper structure provided on the outer wall of at least one of the indwelling section and the exposed section, for restricting movement of the catheter shaft when it is placed in the blood vessel or subcutaneously, wherein the stopper structure has a stopper section consisting of at least one of a convex section protruding from the outer wall and a concave section recessed into the outer wall.

2. An indwelling catheter according to claim 1, wherein at least a part of the stopper structure is provided on the outer wall of the indwelling portion.

3. An indwelling catheter according to claim 2, wherein the indwelling section has a tip region including the tip opening, and an expanded diameter region including an expanded diameter section provided in the proximal direction of the tip region and expanded radially outward from the tip region, the expanded diameter section being the stopper section and provided at the tip of the expanded diameter region.

4. An indwelling catheter according to claim 3, wherein the indwelling section has an intermediate region provided between the tip region and the enlarged diameter portion of the enlarged diameter region, and the outer wall of the intermediate region has a side hole communicating with the inner cavity.

5. An indwelling catheter according to claim 4, wherein the distal end region has a distal end tapered portion whose diameter decreases toward the distal end of the catheter shaft, and the stopper structure is the enlarged diameter portion alone.

6. An indwelling catheter according to claim 4, wherein the stopper portion is a first stopper portion, and the outer wall of the intermediate region is provided with a second stopper portion.

7. An indwelling catheter according to claim 6, wherein the second stopper portion is provided with an annular rib protruding in a direction perpendicular to the axial direction of the catheter shaft.

8. An indwelling catheter according to claim 7, wherein the side hole is provided between the stopper portion and the second stopper portion.

9. An indwelling catheter according to claim 6, wherein the second stopper portion is a groove that is recessed radially into the outer wall of the catheter shaft and extends in the axial direction of the catheter shaft.

10. An indwelling catheter according to claim 9, wherein the groove is provided with the side hole.

11. An indwelling catheter according to claim 6, wherein the second stopper portion is provided with a rib that protrudes in a direction intersecting the axial direction of the catheter shaft and extends spirally around the axis of the catheter shaft.

12. An indwelling catheter according to any one of claims 3 to 11, wherein the enlarged diameter section has a tapered section whose diameter decreases toward the tip of the catheter shaft.

13. An indwelling catheter according to claim 5, wherein the enlarged diameter section has an end face disposed in the distal direction and facing the distal region, the end face of the enlarged diameter section being a surface extending in a direction intersecting the axial direction of the catheter shaft, and the angle of the end face relative to the axial direction being in the range of 70° to 90°.

14. An indwelling catheter according to claim 1, wherein at least a portion of the stopper structure is provided on the outer wall of the exposed portion, and when the catheter shaft is placed in the blood vessel or subcutaneously, the stopper structure abuts against the skin of the living body.

15. An indwelling catheter according to claim 14, wherein the exposed portion has an enlarged diameter portion at the boundary between the indwelling portion and the exposed portion, the enlarged diameter portion being larger than the indwelling portion.

16. A catheter assembly comprising the indwelling catheter according to claim 3 and an inner needle removably inserted into the lumen of the catheter shaft, wherein at least the expanded diameter portion of the catheter shaft is formed from an elastically deformable material, and there is a radial gap between the inner circumferential surface of the expanded diameter region of the catheter shaft and the inner needle.

17. A catheter assembly comprising the indwelling catheter according to claim 1 and an inner needle removably inserted through the lumen of the catheter shaft.

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