Catheter fixture

Abstract

To provide a catheter fixture which can be easily installed to a catheter hub fitting part.SOLUTION: A catheter fixture 10 for fixing a catheter fitting part 100 at which a catheter hub and an outer cylinder of a retained needle are fit to each other. The catheter fixture 10 includes: a base stand 11; and a fixture body 12. The fixture body 12 includes: a retained needle fixing part 20; and a catheter hub fixing part 30 provided at an interval from the retained needle fixing part 20. The retained needle fixing part 20 includes a first hollow part 21 therein, and a groove 23 on the top thereof. In the first hollow part 21, a furthermost inner diameter of an inclination part 24 formed on one end side is equal to or larger than a maximum diameter of the catheter fitting part 100, and the inner diameter of the inclination part 24 decreases toward the other side. The catheter hub fixing part 30 includes a second hollow part 31 therein, and a groove 33 in communication with the second hollow part 31 is formed on the top thereof.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a catheter fixing device. [Background technology]

[0002] In the medical field, catheters are placed inside a patient's body to administer drugs, nutrients, and the like. During this process, the catheter may become dislodged or bent due to various factors, both internal and external, such as the patient's movement or unintentional contact with the catheter. For this reason, the exposed portion of the catheter is fixed to the body surface using tape, adhesive, a fixing device, or the like. For example, the fixing device proposed in Patent Document 1 includes an adhesive base portion attached to the body surface near the catheter's exit and a cover portion attached to the top surface of the adhesive base portion, and the midsection of the catheter is sandwiched and fixed between the adhesive base portion and the cover portion.

[0003] In the pediatric field, including neonates, pediatric peripherally inserted central venous catheters (hereinafter also referred to as "PI catheters") are often used. PI catheter introducers can be used to insert PI catheters into the body, but peripheral venous indwelling needles (hereinafter also referred to as "indwelling needles") generally used for intravenous drips are also often used. The indwelling needle comprises an outer tube 122, a cannula portion 121 provided at the tip of the outer tube 122, an inner needle inserted into the cannula portion 121, and an inner tube provided at the base end of the inner needle. The outer tube 122 and the cannula portion 121 are shown in Figure 15.

[0004] The catheter hub 110 is configured such that at least a portion of the connection between the proximal end of the PI catheter 101 and the medical solution tube 102 is covered with a protective resin. In the example of Fig. 15, two medical solution tubes 102A and 102B are connected to the proximal end of the PI catheter 101, and the medical solution tubes 102A and 102B are connected to a medical solution pack (not shown). The medical solution contained in the medical solution pack passes through the medical solution tubes 102A and 102B into the PI catheter 101 and is introduced into the body.

[0005] When inserting the PI catheter 101 into the body, first, with the inner needle protruding from the tip of the cannula portion 121 of the indwelling needle, the operator inserts the inner needle and the cannula portion 121 into a blood vessel such as a vein at a predetermined location on the body surface, such as the back of a newborn's hand. Next, the inner needle and inner tube are withdrawn from the cannula portion 121. The PI catheter 101 is then inserted from the proximal end side of the outer tube 122 of the indwelling needle 120. The PI catheter 101 is inserted into a blood vessel in the body through the outer tube 122 and the cannula portion 121. The PI catheter 101 is inserted into the body to an appropriate length according to the patient's physique. Once the insertion of the PI catheter 101 is complete, the cannula portion 121 is withdrawn from the blood vessel and the body surface S. Then, the catheter hub 110 connected to the proximal end of the PI catheter 101 is fitted onto the outer tube 122 of the indwelling needle 120. Next, to protect the area around the portion of the body surface S from which the PI catheter 101 protrudes, this portion is covered with a medical film. The film fixes the portion of the PI catheter 101 that is outside the body surface S, between the cannula portion 121 and the body surface S, and the tip of the cannula portion 121, to the body surface S. In the above explanation, the cannula portion 121 is withdrawn from the blood vessel and the body surface S, but the cannula portion 121 may remain inserted into the body surface S and the blood vessel without being withdrawn. In the following explanation, the catheter hub 110 and the outer tube 122 of the indwelling needle 120 are referred to as the "catheter fitting portion 100," and Figure 15 shows the catheter fitting portion 100 in which the catheter hub 110 is fitted inside the outer tube 122 of the indwelling needle 120.

[0006] Because the catheter hub 110 is fitted to the outer tube 122 of the indwelling needle 120, the catheter fitting portion 100 may loosen or come off over time due to the patient's movements or unintentional contact with the catheter fitting portion 100. This requires repeated fitting of the catheter fitting portion 100. Furthermore, repeated fitting can cause the PI catheter 101 to bend inside the outer tube 122 of the indwelling needle 120, which can lead to problems such as uneven flow rates in the administered medicinal solution or the prescribed amount of medicinal solution not being administered.

[0007] For this reason, the applicant has proposed a fixture for fixing the catheter fitting portion 100. As shown in Figure 16, the catheter fixture 200 described in Non-Patent Document 1 comprises a base 211 and a cylindrical fixture main body 210 provided on the base. The fixture main body 210 has openings 212, 212 formed at both ends along the axial direction, and the upper side is cut away to form a groove 213. A hollow portion 214 is formed inside the fixture main body 210, and the hollow portion 214 is formed in a shape corresponding to the outer shapes of the catheter hub 110 and the outer tube 122 of the indwelling needle 120. The groove 213 and the openings 212, 212 communicate with the hollow portion 214. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] Patent No. 7309240 [Non-patent literature]

[0009] [Non-Patent Document 1] Naoki Takeshita, Kazuyuki Ikeda, and Tomoko Iehara, "A concrete example of solving clinical problems using 3D printers: Innovations in PI catheter fixation," Journal of the Japanese Society of Pediatric Cardiology, Vol. 38, No. 4, 2022, pp. 265-267 Summary of the Invention [Problem to be solved by the invention]

[0010] To fit the catheter fitting portion 100 into the catheter fixing device 200 described in Non-Patent Document 1, the operator first inserts the base end side of the catheter hub 110 of the catheter fitting portion 100 obliquely into the fixing device main body 210 through the groove 213, as shown in Figure 17. Then, a force is applied to the catheter fitting portion 100 in the direction of arrow A2 in Figure 17, and the catheter fitting portion 100 is pushed from above through the groove 213 and into the hollow portion 214. Then, the base end side of the catheter hub 110 is further inserted into the base end side of the fixing device main body 210, and the catheter fitting portion 100 is fitted into the hollow portion 214 of the catheter fixing device 200.

[0011] In the catheter fixing device 200 of Non-Patent Document 1, the width of the groove 213 is designed to be smaller than the width of the catheter fitting part 100 to prevent the catheter fitting part 100 from slipping out. Therefore, when passing the catheter fitting part 100 through the groove 213, the catheter fitting part 100 pushes the fixing device main body 210 outward in the width direction, and the catheter fitting part 100 is pushed into the hollow part 214 of the fixing device main body 210. However, a strong force is required to push the fixing device main body 210 open, and in a narrow space such as the inside of an incubator, it is very difficult to perform an operation requiring such a strong force.

[0012] The present invention has been made in view of the above problems, and an object of the present invention is to provide a catheter fixing device that can be easily attached to a catheter hub fitting portion. [Means for solving the problem]

[0013] To achieve the above object, the present invention includes the following subject matter.

[0014] Item 1: A catheter fixing device for fixing a catheter fitting part in which a catheter hub, which connects a catheter and a tube through which a medicinal solution flows, and an outer tube of an indwelling needle are fitted together, The base and a fixture body provided on an upper surface of the base and to which the catheter fitting portion is fixed, The fixture body is an indwelling needle fixing part provided on one side of the fixing device main body in the longitudinal direction, and a catheter hub fixing part provided on the other side of the fixing device main body in the longitudinal direction and spaced apart from the indwelling needle fixing part, the indwelling needle fixing part has a first hollow part formed therein and a groove formed in an upper part thereof that communicates with the first hollow part, the first hollow portion has a first inclined portion formed on one side, the inner diameter of the first inclined portion on the one side being equal to or larger than the maximum diameter of the catheter fitting portion, and the inner diameter of the first inclined portion becoming smaller toward the other side, A catheter fixing device, wherein the catheter hub fixing portion has a second hollow portion therein and a groove communicating with the second hollow portion is formed in the upper portion.

[0015] Clause 2: The first hollow portion further includes a second inclined portion formed continuously with the first inclined portion on the other side of the first inclined portion, Item 2. The catheter fixing device according to item 1, wherein the second inclined portion has a shape corresponding to the outer peripheral surface of the outer cylinder of the indwelling needle.

[0016] Item 3: The catheter fixing device according to item 1 or 2, wherein the first hollow portion has a recess on the other side of the first inclined portion into which a flange portion provided on the other end of the outer tube of the indwelling needle fits.

[0017] Item 4: A catheter fixing device according to any one of items 1 to 3, wherein the first hollow portion is provided at the othermost side with a hub support portion for supporting the catheter hub.

[0018] Item 5: A catheter fixing device according to any one of items 1 to 4, further comprising a sheet material attached to the underside of the base.

[0019] Item 6: The catheter fixing device according to any one of items 1 to 5, wherein the axial directions of the first and second hollow portions of the fixing device main body are inclined with respect to the upper surface of the base. [Effects of the Invention]

[0020] According to the present invention, a catheter fixing device can be provided that allows easy attachment of a catheter hub fitting portion. [Brief explanation of the drawings]

[0021] [Figure 1] 1 is a perspective view showing a state in which a catheter fixing device according to an embodiment of the present invention is attached to a catheter hub fitting portion. FIG. [Figure 2] FIG. 1 is a side view of a catheter fixing device. [Figure 3] FIG. 2 is a plan view of the catheter fixing device. [Figure 4] FIG. 3 is a cross-sectional view taken along line AA in FIG. 2. [Figure 5] FIG. 4 is a cross-sectional view taken along line BB in FIG. 3. [Figure 6] FIG. 6 is a cross-sectional view taken along line CC in FIG. 5. [Figure 7] FIG. 6 is a cross-sectional view taken along line DD in FIG. 5. [Figure 8] FIG. 6 is a cross-sectional view taken along line EE in FIG. 5. [Figure 9] FIG. 6 is a cross-sectional view taken along line FF in FIG. 5. [Figure 10] FIG. 6 is a cross-sectional view taken along line GG in FIG. 5. [Figure 11] FIG. 6 is a cross-sectional view taken along line HH in FIG. 5. [Figure 12] FIG. 6 is a cross-sectional view taken along line II in FIG. 5. [Figure 13] FIG. 10 is an explanatory diagram showing an example of use of a catheter fixing device attached to a catheter hub fitting portion. [Figure 14] 10A to 10C are explanatory diagrams showing the procedure for attaching the catheter fixing device to the catheter hub fitting portion. [Figure 15] FIG. 1 is a perspective view of a catheter hub fitting. [Figure 16] FIG. 1 is a perspective view showing a catheter fixing device of the prior art. [Figure 17] 17A to 17C are explanatory views showing the procedure for attaching the catheter fixture shown in FIG. 16 to a catheter hub fitting portion. DETAILED DESCRIPTION OF THE INVENTION

[0022] (Catheter fitting portion 100) First, the catheter fitting portion 100 fixed by the catheter fixing device 10 of the present invention will be described with reference to Figure 15. The catheter fitting portion 100 described below is the same as that described in the background art, in which a catheter hub 110 and an outer tube 122 of a peripheral venous indwelling needle 120 (indwelling needle 120) fit together. The catheter hub 110 and indwelling needle 120 shown in Figure 15 are merely examples, and known catheters that are generally available on the market may also be used.

[0023] In the following description of the catheter fitting part 100, unless otherwise specified, the side of the indwelling needle 120 will be referred to as the tip side, and the side of the catheter hub 110 will be referred to as the base side. The direction in which the cannula portion 121 of the indwelling needle 120 extends will be referred to as the length direction or axial direction, which is the direction along the tip side and the base side. The direction perpendicular to the length direction and parallel to the bottom surface of the catheter hub 110 (described later) will be referred to as the width direction, and the direction perpendicular to the length direction and the width direction will be referred to as the height direction. As will be described later, the tip side can also be said to be the downstream side of the flow of the medicinal solution, and the base side to be the upstream side of the flow of the medicinal solution.

[0024] The indwelling needle 120 has a tip that is placed subcutaneously for the purpose of administering a medicinal solution or the like subcutaneously, a so-called intravenous drip. The indwelling needle 120 comprises a cannula portion 121 and a cylindrical outer tube 122 connected to the base end side of the cannula portion 121. Generally, an indwelling needle includes, in addition to the cannula portion 121 and the outer tube 122, an inner needle that is inserted into the cannula portion 121 and an inner tube that is provided at the base end of the inner needle. However, the catheter fitting portion 100 fixed by the catheter fixing device 10 of the present invention includes the cannula portion 121 and the outer tube 122 of the indwelling needle but does not include the inner needle or the inner tube. Therefore, in this specification, the cannula portion 121 and the outer tube 122 are referred to as the "indwelling needle."

[0025] The cannula portion 121 has a through-hole (not shown) formed along its length for inserting a pediatric peripherally inserted central venous catheter 101 (PI catheter 101). The outer tube 122 has a hollow portion therein, and the hollow portion has a circular cross section perpendicular to the longitudinal direction. The hollow portion communicates with the through-hole of the cannula portion 121. The cannula portion 121 is made of a flexible material. Flexibility refers to the property of having flexibility at room temperature and normal pressure, and being able to be deformed, such as flexed, bent, or folded, even when force is applied, without shearing or breaking.

[0026] The outer tube 122 has a step 122a formed at a position slightly distal from the center of the length of the outer tube 122, separating the first portion 122b from the second portion 122c on the proximal side, and the outer diameter is discontinuous at the step 122a. Alternatively, the outer tube 122 may have no step, and the first portion 122b and the second portion 122c may be formed continuously. The outer diameters of the first portion 122b and the second portion 122c decrease continuously toward the distal end. The axis X of the through-hole in the cannula portion 121 coincides with the axis of the hollow inside the outer tube 122.

[0027] A pair of flanges 123 are provided on the base-side edge of the outer peripheral surface 122d of the outer tube 122. The flanges 123 are provided point-symmetrically with respect to the center in a cross section perpendicular to the longitudinal direction of the cylindrical outer tube 122, and protrude radially outward. Although the flanges 123 are provided only on a portion of the circumferential edge, they may be provided around the entire circumferential edge. Furthermore, instead of the flanges 123, a protrusion or thread corresponding to a luer lock conforming to ISO 80369-7 may be formed.

[0028] In this embodiment, the indwelling needle 120 is fitted into the catheter hub 110 as the catheter fitting portion 100, but generally the indwelling needle 120 is connected to a syringe or an intravenous tube, and a pair of flange portions 123, protrusions, screw portions, etc. provided on the outer surface 122d of the indwelling needle 120 are used to connect to the syringe or intravenous tube.

[0029] The surface on the base end side of the outer tube 122 has an opening 122e for inserting the catheter hub 110. The maximum diameter of the catheter fitting portion 100 is the length between the end of one flange portion 123 and the end of the other flange portion 123, which is the length L11 passing through the center of the outer tube 122 (hereinafter also referred to as "the length L11 between the ends of the pair of flange portions 123").

[0030] The outer tube 122 may be transparent to allow the interior to be seen. Note that "transparent" means that one side of an object can be seen from the other side, and includes so-called "semi-transparent." Furthermore, the indwelling needle 120 may be colored while being transparent.

[0031] The catheter hub 110 is a connection portion where the proximal end of the PI catheter 101 and the drug solution tube 102 are connected and covered with protective resin 111. The catheter hub 110 has a rectangular cross section perpendicular to the longitudinal direction. The catheter hub 110 includes a first hub portion 112 whose width (also referred to as "width") and height (also referred to as "thickness") increase toward the proximal end, and a second hub portion 113 formed continuously with the first hub portion 112 and whose width and thickness decrease toward the proximal end. That is, in a cross section perpendicular to the longitudinal direction of the catheter hub 110, the cross-sectional area of the boundary between the first hub portion 112 and the second hub portion 113 is the largest. In the cross section with the largest area, the maximum value of the length between any two points on the periphery is smaller than the length L11 between the ends of a pair of flanges 123. The first hub portion 112 and the second hub portion 113 have bottom surfaces 112a and 113a, both side surfaces 112b and 113b, and top surfaces 112c and 113c, respectively.

[0032] The distal end portion of the first hub portion 112 of the catheter hub 110 is sized to be inserted into the hollow from the opening 122e of the outer tube 122 of the indwelling needle 120 and to abut against the inner surface of the hollow.

[0033] In the example shown in FIG. 14, two drug solution tubes 102, 102A and 102B, are provided as drug solution tubes 102. These drug solution tubes 102A and 102B are arranged side by side in the width direction and protrude from the proximal surface of catheter hub 110. The number of drug solution tubes 102 is not limited, and one or three or more drug solution tubes 102 may be connected to PI catheter 101. The proximal ends of the two drug solution tubes 102 are each connected to a drug solution pack (not shown), and drug solutions contained in the drug solution packs are introduced into the body through drug solution tubes 102A and 102B and PI catheter 101. The drug solution may be any liquid that can be introduced into the body by intravenous drip, such as a drug, saline solution, or an infusion containing sugar, electrolytes, and amino acid sugar.

[0034] When inserting the PI catheter 101 into the body, the operator first inserts the cannula portion 121 of the indwelling needle 120 into a blood vessel such as a vein through the skin at a predetermined location, such as the back of a newborn's hand. Then, the operator inserts the PI catheter 101 from the base end side of the outer tube 122 of the indwelling needle 120. The PI catheter 101 is inserted into the body through the cannula portion 121. The PI catheter 101 is adjusted to a desired length in advance, and insertion of the PI catheter 101 is completed when the distal end portion of the catheter hub 110 is inserted and fitted into the hollow interior of the outer tube 122 of the indwelling needle 120 from the base end side. At this time, the catheter hub 110 is engaged with the outer tube 122 of the indwelling needle 120 due to frictional force generated between the outer surface of the catheter hub 110 and the inner surface of the outer tube 122.

[0035] (Catheter fixing device 10) A catheter fixing device 10 of the present invention will be described with reference to Figures 1 to 12. The catheter fixing device 10 is used to fix a catheter fitting part 100 in which a catheter hub 110 and an outer tube 122 of an indwelling needle 120 are fitted together. The catheter fixing device 10 comprises a base 11 and a fixing device main body 12 that is provided on the upper surface of the base 11 and has the catheter fitting part 100 attached and fixed in its internal space. The base 11 and fixing device main body 12 are integrally molded using a 3D printer, a mold, or the like, using a material such as synthetic resin.

[0036] The fixing device main body 12 comprises an indwelling needle fixing portion 20 and a catheter hub fixing portion 30, and the indwelling needle fixing portion 20 and the catheter hub fixing portion 30 are arranged along the length direction of the fixing device main body 12.

[0037] In the description of the catheter fixing device 10, unless otherwise specified, one side or distal end refers to the side of the fixing device main body 12 on which the indwelling needle fixing part 20 is located along the longitudinal direction, which is the left side in FIG. 2. The other side or proximal end refers to the opposite side of the one side, which is the right side in FIG. 2. The longitudinal direction refers to the left-right direction in FIG. 2. The up-down direction refers to the direction perpendicular to the plane including the top surface of the base 11 and perpendicular to the longitudinal direction. The up-down direction does not necessarily have to be along the vertical direction. The direction perpendicular to the up-down direction and the longitudinal direction is referred to as the width direction. When the catheter fitting part 100 is fitted into the catheter fixing device 10, an imaginary line extending the cannula part 121 of the indwelling needle 120 in the longitudinal direction is referred to as the "axis X of the fixing device main body 12" or "axis X," and the direction along axis X is referred to as the axial direction. The axial direction is along the longitudinal direction of the catheter fitting part 100. The direction perpendicular to the axial and width directions is referred to as the height direction. When viewed from a plane, the length direction and axial direction include directions toward the distal end or proximal end, and when viewed from a cross section perpendicular to the axial direction, the height direction and vertical direction include directions toward the top or bottom.

[0038] (Base 11) Base 11 is a plate-like member, and as shown in FIG. 3, is rectangular in plan view (viewed from above). The length and width of base 11 are approximately the same as the length and width of fixing device main body 12. In one example, base 11 is 18 mm long, 10 mm wide, and 2 mm thick (vertical length). However, the shape and thickness of base 11 are not limited to these. From the perspective of saving space, it is preferable that base 11 is as small as possible, but from the perspective of forming fixing device main body 12 on the upper surface and stably placing catheter fixing device 10 on the patient's body surface S, a larger size is preferable.

[0039] (Fixture body 12) As shown in Figures 2 and 3, an indwelling needle fixing part 20 is formed on the upper surface of the base 11 at the distal end in the longitudinal direction, and a catheter hub fixing part 30 is formed at the proximal end in the longitudinal direction, with a gap 13 between the indwelling needle fixing part 20. In other words, the indwelling needle fixing part 20 and the catheter hub fixing part 30 are connected at their lower ends by the base 11, but are not connected at any other portions. In this embodiment, the axial length L1 (Figure 2) of the gap 13 between the indwelling needle fixing part 20 and the catheter hub fixing part 30 is set to 1 mm for ease of fabrication, but is not limited to 1 mm and can be determined as appropriate. In this embodiment, the axial length L2 of the indwelling needle fixing part 20 is set to 6 mm, and the axial length L2 of the catheter hub fixing part 30 is set to 10 mm, but is not limited to these values and can be determined as appropriate depending on the lengths of the catheter hub 110 and the indwelling needle 120 of the catheter fitting part 100.

[0040] The indwelling needle fixing part 20 and the catheter hub fixing part 30 each have a first hollow part 21 and a second hollow part 31 therein. The catheter fitting part 100 is fitted into the first hollow part 21 and the second hollow part 31. An axis X passes through the first hollow part 21 and the second hollow part 31. When the catheter fixing device 100 is attached to the catheter fitting part 100, as shown in Figures 1 and 3, the outer tube 122 of the indwelling needle 120 and a portion of the distal end side of the catheter hub 110 are housed and fixed in the first hollow part 21 of the indwelling needle fixing part 20. The catheter hub 110 is housed and fixed in the second hollow part 31 of the catheter hub fixing part 30.

[0041] (Indwelling needle fixing part 20) Indwelling needle fixing part 20 has openings 22 formed at both axial ends and is cylindrical with the top cut off along the axial direction. A groove 23 is formed in the top along the axial direction. Groove 23 divides indwelling needle fixing part 20 symmetrically along a line along the height direction into two parts 20A and 20B (FIGS. 3, 6-9), and the two parts 20A and 20B are connected at their lower ends by base 11.

[0042] A first hollow portion 21 formed inside the indwelling needle fixing portion 20 communicates with the groove 23. As shown in Figures 4 and 5, the first hollow portion 21 has an inclined portion 24, a recessed portion 25, and a hub support portion 26 that are connected in the axial direction from the tip end side to the base end side.

[0043] The inclined portion 24 includes a first inclined portion 24a on the distal side and a second inclined portion 24b formed closer to the proximal end than the first inclined portion 24a. FIG. 6 shows a cross section perpendicular to the axial direction of the catheter fixing device 10 at the position of the first inclined portion 24a. The cross-sectional shape of the first inclined portion 24a is approximately circular. More specifically, it has a shape in which a portion of a circle is separated by a straight line P2 that does not pass through the center point P, and is formed by an arc P1 with a central angle of 180 degrees or more and an imaginary straight line P2 connecting both ends of the arc. The first inclined portion 24a is defined by the inner surface 24e of the indwelling needle fixing part 20, whose cross-sectional shape is an arc. In this embodiment, the central angle is set to 270 degrees.

[0044] In the first inclined portion 24a, the second inclined portion 24b (described later), the recess 25, and the third portion 36 of the catheter hub fixing portion 30, the inner diameter refers to the diameter of an imaginary circle including the arc P1. The center point P of the circle is located on the axis X.

[0045] 4 and 5, the inner diameter of the first inclined portion 24a decreases toward the base end. The inner diameter L4 of the opening 22 on the tip side of the first inclined portion 24a is the same as or larger than the length L11 between the ends of the pair of flange portions 123, which is the maximum diameter of the catheter fitting portion 100. In this embodiment, the inner diameter L4 of the opening 22 on the tip side is set to 6 mm.

[0046] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, as shown in Figures 4 to 6, the inner surface 24e defining the first inclined portion 24a does not abut against the outer peripheral surface 122d of the outer tube 122 of the catheter fitting portion 100.

[0047] FIG. 7 shows a cross section perpendicular to the axial direction of the catheter fixture 10 at the position of the second inclined portion 24b. The cross-sectional shape of the second inclined portion 24b is approximately circular. More specifically, it is a shape obtained by cutting a portion of a circle with a straight line P2 that does not pass through the center P, and is formed by an arc P1 with a central angle of 180 degrees or more and an imaginary straight line P2 connecting both ends of the arc. The cross-sectional shape of the second inclined portion 24b is defined by an inner surface 24f of the arc. As shown in FIGS. 4 and 5, the inner diameter of the second inclined portion 24b increases slightly toward the base end. The inner diameter of the second inclined portion 24b is set to correspond to the outer shape of the outer circumferential surface 122d of the outer tube 122 of the indwelling needle 120, which is located on the distal side of the flange portion 123.

[0048] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the inner surface 24f defining the second inclined portion 24b abuts against the outer surface 122d of the outer tube 122 of the indwelling needle 120, which is the portion closer to the tip than the flange portion 123, thereby fixing the outer tube 122 of the indwelling needle 120.

[0049] The absolute value of the rate of change of the inner diameter per unit length along the axial direction of the second inclined portion 24b is smaller than the absolute value of the rate of change of the inner diameter of the first inclined portion 24a. In other words, in Figure 4, the absolute value of the change in the tilt of the second inclined portion 24b with respect to the axial direction is smaller than the absolute value of the tilt of the first inclined portion 24a with respect to the axial direction.

[0050] In this embodiment, the axial length of the inclined portion 24 is set to 4 mm, the axial length of the first inclined portion 24a is set to 3 mm, and the axial length of the second inclined portion 24b is set to 1 mm, but this is not limited to these values. If the axial length of the second inclined portion 24b is too short, the outer tube 122 of the indwelling needle 120 cannot be sufficiently fixed. Furthermore, when the catheter fixture 10 is attached from the base end side of the catheter fitting portion 100, the pair of flanges 123 of the outer tube 122 of the indwelling needle 120 pass through the second inclined portion 24b while pushing the second inclined portion 24b outward. However, if the second inclined portion 24b is too long, a strong force is required to pass the flanges 123. The axial length of the second inclined portion 24b is determined appropriately taking these points into consideration.

[0051] The inclined portion 24 may be formed only by the first inclined portion 24a, and may not have the second inclined portion 24b. In this case, the base end side end of the first inclined portion 24a abuts against a portion of the outer peripheral surface 122d of the outer tube 122 of the indwelling needle 120 that is closer to the tip side than the flange portion 123, thereby supporting and fixing the outer tube 122 of the indwelling needle 120.

[0052] FIG. 8 shows a cross section perpendicular to the axial direction of the catheter fixture 10 at the position of the recess 25. The cross-sectional shape of the recess 25 is approximately circular. Specifically, the shape is obtained by cutting a portion of a circle with a straight line P2 that does not pass through the center point P, and is formed by an arc P1 with a central angle of 180 degrees or more and an imaginary straight line P2 connecting both ends of the arc. In this embodiment, the central angle is set to 270 degrees. The cross-sectional shape of the recess 25 is defined by an inner surface 25a of the arc and step slopes 25b, 25c (FIG. 4) between the second inclined portion 24b and the hub support portion 26. The inner diameter L5 (FIG. 4) of the recess 25 is constant along the axial direction. The recess 25 may be of any size as long as it can accommodate the pair of flanges 123 of the outer tube 122 of the indwelling needle 120. In addition, if the outer tube 122 of the indwelling needle 120 has a flange formed around the entire circumference instead of the pair of flanges 123, or if a protrusion or threaded portion corresponding to a luer lock is formed, the recess 25 is designed to have a size capable of accommodating the flange, protrusion, or threaded portion. In this embodiment, the inner diameter L5 of the recess 25 is larger than the inner diameter of the second inclined portion 24b and the width of the hub support portion 26, and is set to be the same as the inner diameter L4 of the opening 22 at the tip end of the first inclined portion 24a and the length L11 between the ends of the pair of flanges 123, but may be larger than these. In addition, the axial length of the recess 25 is set to be the same as or longer than the axial length of the pair of flanges 123.

[0053] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the inner surface 25a and the stepped slopes 25b, 25c that define the recess 25 abut against the side surfaces and the base end and tip end surfaces of the pair of flange portions 123 of the outer tube 122 of the indwelling needle 120, thereby supporting the outer tube 122 of the indwelling needle 120 in a non-removable state.

[0054] 9 shows a cross section perpendicular to the axial direction of the catheter fixing device 10 at the position of the hub support part 26, which has a rectangular cross section. The hub support part 26 supports the catheter hub 110 that protrudes from the base end side of the outer tube 122 of the indwelling needle 120, and is defined by a bottom surface 26a, a side surface 26b, and an upper surface 26c.

[0055] 9, when the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the bottom surface 26a and top surface 26c that define the hub support portion 26 abut against the bottom surface 112a and top surface 112c of the catheter hub 110, respectively, but do not abut against the side surface 26b. The hub support portion 26 of the catheter hub 110 only needs to be able to pass through, and at least one of the bottom surface 112a, both side surfaces 112b, and top surface 112c of the catheter hub 110 may abut against the bottom surface 26a, side surfaces 26b, and top surface 26c that define the hub support portion 26, or may not abut against any surface of the catheter hub 110.

[0056] As shown in FIG. 3, the groove 23 is formed by a first groove 23a to a fourth groove 23d connected in the axial direction. The first groove 23a is located on the distal end side and communicates with the first inclined portion 24a of the inclined portion 24, and the width of the first groove 23a decreases toward the proximal end. The second groove 23b is located proximal to the first groove 23a and communicates with the second inclined portion 24b, and its width increases slightly toward the proximal end. The third groove 23c is located proximal to the second groove 23b and communicates with the recess 25. Its width is constant along the axial direction and is set to be the same as the width of the first groove 23a at its distal end. The fourth groove 23d is located proximal to the third groove 23c and communicates with the hub support portion 26. Its width is constant along the axial direction and is set to be the same as the width of the second groove 23b at its proximal end.

[0057] The width of grooves 23a to 23c is such that at least the medicinal solution tube 102 can pass through. The smaller the width, the more the inner surface of the first hollow portion 21 can cover the upper side of the catheter fitting portion 100, and the more securely the catheter fitting portion 100 can be fixed to the catheter fixture 10. On the other hand, if the outer tube 122 of the indwelling needle of the catheter fitting portion 100 is transparent, it is possible to visually check through groove 23 whether or not the PI catheter 101 is bent inside the outer tube 122, and this can be made easier by setting the width of groove 23 to be large. The widths of grooves 23a to 23d are determined appropriately from these viewpoints.

[0058] (catheter hub fixing part 30) The catheter hub fixing part 30 has openings 32 at both axial ends and is cylindrical with the top cut out along the axial direction. A groove 33 is formed in the top along the axial direction. The groove 33 divides the catheter hub fixing part 30 symmetrically into two parts 30A and 30B (FIGS. 3, 10-12) along a line along the height direction, and the two parts 30A and 30B are connected at their lower ends by a base 11.

[0059] A second hollow portion 31 formed inside the catheter hub fixing portion 30 communicates with the groove 33. As shown in Figures 4 and 5, the second hollow portion 31 comprises a first portion 34, a second portion 35, and a third portion 36 connected in the axial direction from the distal end to the proximal end.

[0060] Figure 10 shows a cross section perpendicular to the axial direction of the catheter fixing device 10 at the position of the first portion 34, and the cross section of the first portion 34 has a substantially rectangular shape. The first portion 34 is defined by a bottom surface 34a and a side surface 34b. As shown in Figure 4, the width of the first portion 34 increases slightly toward the base end. As shown in Figure 5, the position of the bottom surface 34a that defines the first portion 34 along the height direction is constant along the axial direction.

[0061] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the bottom surface 34a and the side surface 34b that define the first portion 34 abut against the bottom surface 112a and the side surface 112b, respectively, of the catheter hub 110. Note that it is sufficient for the first portion 34 to be able to pass through the catheter hub 110, and the bottom surface 34a and the side surface 34b do not have to abut against the bottom surface 112a and the side surface 112b of the catheter hub 110.

[0062] 11 shows a cross section perpendicular to the axial direction of the catheter fixing device 10 at the position of the second portion 35, and the cross section of the second portion 35 has a substantially rectangular shape. The second portion 35 is defined by a bottom surface 35a, a side surface 35b, and an upper surface 35c. As shown in FIG. 4, the width of the second portion 35 is constant along the axial direction. As shown in FIG. 5, the bottom surface 35a that defines the second portion 35 is higher along the axial direction at a position along the height direction.

[0063] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the bottom surface 35a, side surface 35b, and top surface 35c that define the second portion 35 abut against the bottom surface 113a, side surface 113b, and top surface 113c, respectively, of the catheter hub 110. Note that the side surface 35b and top surface 35c that define the second portion 35 do not necessarily have to abut against the side surface 113b and top surface 113c of the catheter hub 110; as long as the bottom surface 35a abuts against the bottom surface 113a of the catheter hub 110, the catheter hub 110 can be supported.

[0064] 12 shows a cross section perpendicular to the axial direction of the catheter fixing device 10 at the position of the third portion 36, and the cross-sectional shape of the third portion 36 is approximately circular. In detail, the cross-sectional shape of the third portion 36 is a shape obtained by cutting a part of a circle by a straight line P2 that does not pass through the center P, and is a shape formed by an arc P1 with a central angle of 180 degrees or more and an imaginary straight line P2 connecting both ends of the arc. The inner diameter of the third portion 36 is set to a size that allows the catheter hub 110 to be inserted.

[0065] When the catheter fixing device 10 is fitted and attached to the catheter fitting portion 100, the inner circumferential surface 36a defining the third portion 36 does not abut against the catheter hub 110. However, the inner circumferential surface 36a may abut against the bottom surface 35a, side surface 35b, and top surface 35c of the catheter hub 110.

[0066] As shown in FIG. 3 , the groove 33 is formed by a first groove 33a located on the distal side, a second groove 33b located closer to the proximal end than the first groove 33a, and a third groove 33c located closest to the proximal end, which are connected in the axial direction. The width of the first groove 33a increases slightly toward the proximal end and communicates with the distal side of the first portion 34. At an opening 32 on the distal side of the first portion 34, the width of the first groove 33a is equal to that of the first portion 34, and the first portion 34 is open at the top. The second groove 33b has a constant width and communicates with the proximal side of the first portion 34 and the distal side of the second portion 35. The third groove 33c has a width smaller than the second groove 33b, approximately half the width of the second groove 33b, and communicates with the proximal side of the second portion 35 and the third portion 36.

[0067] The width of the grooves 33a to 33c is set to a width that allows at least the passage of the medical solution tube 102. The smaller the width, the more the inner surface of the second hollow section 31 can cover the upper side of the catheter hub 110, and the more firmly the catheter fitting section 100 can be fixed to the catheter fixing device 10. On the other hand, as the contact area increases, the frictional force generated between the catheter hub 110 and the inner surface of the second hollow section 31 increases, and a strong force is required for installation. The width of the grooves 33a to 33c is determined appropriately from these perspectives.

[0068] (Tilt angle α of fixture body 12) As shown in Figure 5, the fixture main body 12 is provided on the upper surface of the base 11 so that the catheter hub fixing part 30 is located above the indwelling needle fixing part 20. The axis X of the fixture main body 12, which passes through the catheter hub fixing part 30 and the first hollow part 21 and second hollow part 31 of the indwelling needle fixing part 20, is tilted with respect to a direction parallel to the upper surface of the base. A spacer 14 is provided integrally with the base 11 between the upper surface of the base 11 and the indwelling needle fixing part 20 and catheter hub fixing part 30 of the fixture main body 12, for fixing the fixture main body 12 at an angle.

[0069] The tilt angle α of the axis X of the fixing device main body 12 (also referred to as the "tilt angle α of the fixing device main body 12" or "tilt angle α") is preferably set to be equal to or greater than 0 degrees and equal to or less than 20 degrees, more preferably equal to or greater than 5 degrees and equal to or less than 15 degrees, and in this embodiment is set to be 10 degrees. The tilt angle α may be set to be approximately the same angle as the angle at which the cannula portion 121 of the indwelling needle 120 is inserted into the body surface S.

[0070] (Sheet material 15) A sheet material 15 is provided over the entire underside of the base 11. The sheet material 15 is intended to reduce pressure applied to the patient's body surface S and prevent bedsores. The sheet material 15 may be provided over the entire underside of the base 11, or may be provided only on a portion of the underside of the base 11, such as only on the periphery or only on the center. The thickness of the sheet material 15 is set to, for example, 1 mm.

[0071] The sheet material 15 may be, for example, a silicone sheet, but is not limited to this, and may be a cotton cloth, a nonwoven fabric, or a sheet made of synthetic resin such as polyethylene, polypropylene, polystyrene, or polyvinyl chloride. The catheter fixing device 10 does not necessarily have to be provided with the sheet material 15.

[0072] (Fitting of catheter fitting portion 100 and catheter fixture 10) The operation of fitting the catheter fitting part 100 to the catheter fixture 10 will now be described. Just before the catheter fixture 10 is attached to the catheter fitting part 100, the PI catheter 101 is inserted into the body, as shown in Figure 13. The catheter fitting part 100 is not fixed to the body surface S and is free to move.

[0073] First, the operator holds the catheter fixing device 10 in his / her hand with the indwelling needle fixing part 20 facing the tip side (the indwelling needle 120 side). Then, as shown in Fig. 14, the medical solution tube 102 of the catheter fitting part 100 is passed through the groove 23 of the indwelling needle fixing part 20 of the fixing device main body 12, the groove 33 of the catheter hub fixing part 30, and then through the first hollow part 21 and the second hollow part 31. Then, the catheter fixing device 10 is moved in the direction toward the catheter fitting part 100, i.e., toward the base end side indicated by arrow A1 in Fig. 14.

[0074] The catheter hub 110 of the catheter fitting part 100 is inserted through the opening 22 of the first inclined part 24a of the indwelling needle fixing part 20 of the fixing part main body 12 of the catheter fixing device 10. The inner diameter L4 of the opening 22 on the tip side of the first inclined part 24a is the same as or larger than the length L11 between the ends of the pair of flange parts 123, which is the maximum diameter of the catheter fitting part 100, so the catheter fitting part 100 passes through the opening 22 of the catheter fixing device 10.

[0075] The catheter hub 110 of the catheter fitting part 100 passes through the indwelling needle fixing part 20 and is inserted distally into the catheter hub fixing part 30. When the boundary between the first hub section 112 and the second hub section 113 of the catheter hub 110 abuts against the side surfaces 34b, 34b of the second hollow section 31 of the catheter hub fixing part 30, the two parts 30A, 30B of the catheter hub fixing part 30 are pushed outward in the width direction. The catheter hub 110 moves further toward the proximal end and fits into the second hollow section 31. The catheter hub 110 is fixed in the second hollow section 31 by the reaction force of the force pushing the two parts 30A, 30B apart.

[0076] Additionally, the outer tube 122 of the indwelling needle 120 is inserted into the indwelling needle fixing part 20. Because the inner diameter of the first inclined part 24a decreases toward the base end, the flange 123 of the outer tube 122 of the indwelling needle 120 abuts against the inner surface 24e on the base end side of the first inclined part 24a. When the operator moves the catheter fixing device 10 further toward the tip end, the flange 123 abuts against the inner surfaces 24e, 24f of the first inclined part 24a and the second inclined part 24b of the indwelling needle fixing part 20, and moves further toward the base end while pushing the two parts 20A, 20B of the indwelling needle fixing part 20 outward in the width direction, and fits into the recesses 25. With the pair of flanges 123 fitting into the recesses 25, the catheter fitting part 100 is in a retained state. Furthermore, when the outer surface 122d of the outer tube 122 of the indwelling needle 120 abuts against the inner surface 24f of the second inclined portion 24b, a reaction force is generated against the force applied to the inner surface 24f, and the outer tube 122 of the indwelling needle 120 is fixed to the indwelling needle fixing part 20. As a result, the catheter fitting part 100 is fitted into the catheter fixing device 10.

[0077] 13, the operator covers and protects the area around the protruding portion of the PI catheter 101 on the body surface S with a medical film F. This film F also fixes the portion of the PI catheter 101 outside the body surface S and the tip of the cannula portion 121 to the body surface S. The catheter fixture 10 is then fixed to the body surface S with tape T. At this time, the catheter fixture 10 is placed on the body surface S so that the sheet material 15 of the catheter fixture 10 comes into contact with the patient's body surface S. Note that just before the catheter fixture 10 is attached, a portion of the tip of the cannula portion 121 of the indwelling needle 120 of the catheter fitting part 100 may remain inserted into the body, and the area around the body surface S where the cannula portion 121 is inserted may be protected with the film F.

[0078] According to this embodiment, the indwelling needle fixing part 20 is divided into two parts 20A and 20B by a groove 23 provided in the upper part. Furthermore, a gap 13 is provided between the indwelling needle fixing part 20 and the catheter hub fixing part 30, and the indwelling needle fixing part 20 is not formed integrally with the catheter hub fixing part 30 as in the prior art. This shortens the axial length of the indwelling needle fixing part 20, making it easier to push apart the two parts 20A and 20B. Because the groove 23 and gap 13 make it easier to push apart the indwelling needle fixing part 20 in the width direction, the catheter fixing device 10 is easily fitted into the catheter fitting part 100 without requiring a large force, and the time required for the engagement process is shortened.

[0079] Furthermore, as described above, the indwelling needle fixing part 20 is divided into two parts 20A and 20B with a groove 23 provided at the top, and the two parts 20A and 20B can be pushed apart to attach to the catheter fitting part 100, so that even indwelling needles 120 with outer tubes 122 having different outer diameter lengths can be fixed to the indwelling needle fixing part 20.

[0080] Furthermore, the catheter fixing device 10 can be attached to the catheter fitting part 100 by moving it along the axial direction, and can be attached without having to move the catheter fitting part 100 significantly, such as by lifting the catheter fitting part 100 up and pushing it in from above, as was done in the prior art. This makes it easy to attach the catheter fixing device 10 even in a small working space.

[0081] Furthermore, since a groove 23 is formed in the upper part of the catheter fixture 10, if the outer tube 122 of the indwelling needle 120 is transparent, the inside of the outer tube 122 of the indwelling needle 120 can be seen through the groove 23 and the outer tube 122 of the indwelling needle 120. Therefore, it can be confirmed whether the PI catheter 101 is bent inside the outer tube 122 of the indwelling needle 120.

[0082] Furthermore, since the base 11 of the catheter fixture 10 is provided with the cushioning sheet material 15, the base 11 does not come into direct contact with the body surface S and compress the body surface S, thereby preventing bedsores.

[0083] When the catheter fitting portion 100 and the catheter fixture 10 are used by fixing them to a body surface S, such as a patient's hand, with tape T or the like, as shown in Figure 13, if the inclination angle α of the catheter fixture 10 is set to 0 degrees, the cannula portion 121 of the indwelling needle 120 of the catheter fitting portion 100 and the PI catheter 101 extending from the cannula portion 121 will extend parallel to the body surface S. To fix the PI catheter 101 or the cannula portion 121 to the body surface S with a film F, the PI catheter 101 or the cannula portion 121 must be bent at a large angle close to a right angle, which may obstruct the flow of medicinal fluid through the PI catheter 101. However, by setting the inclination angle α to be greater than 0 degrees, the PI catheter 101 or the cannula portion 121 can be bent naturally without having to be bent significantly when fixing them to the body surface S with a film F. Therefore, the flow of the medicinal liquid inside the PI catheter 101 is not obstructed.

[0084] There are also cases where only the PI catheter 101 is fixed to the body surface S with the film F, and the catheter fitting part 100 and the catheter fixture 10 are used in a state where they are free to move without being fixed to the body surface S with tape T. In this case, by setting the inclination angle α of the fixture main body 12 to the body surface S to 0 degrees, the overall size (volume) of the catheter fixture 10 can be reduced, and the catheter fixture 10 is less likely to get in the way around the patient's body surface S.

[0085] (Evaluation test) As the catheter fixing device 10, an example shown in Figs. 1 to 11 and a comparative example shown in Figs. 16 and 17 were created. The length of the catheter fixing device 10 in the lengthwise, widthwise, and heightwise directions was the same for the example and the comparative example. The time required for an operator to fit the catheter fixing device 10 of the example and the comparative example into the catheter fitting part 100 placed on the body surface S was measured. The measurement was performed 10 times for each of the example and the comparative example, and the average value was calculated. Fitting was completed in approximately 2.3 seconds for the example, but it took 5.5 seconds for the comparative example.

[0086] The dimensions, materials, shapes, relative positions, etc. of components described as embodiments or shown in the drawings are not intended to limit the scope of the present invention and are merely illustrative examples. Expressions expressing the same state of things, such as "in a certain direction," "along a certain direction," "the same," "identical," "equal," and "homogeneous," not only refer to strict equality, but also to tolerances or differences to the extent that the same function is achieved. Expressions expressing triangular, rectangular, and circular shapes not only refer to shapes in the strict geometric sense, but also to shapes that include irregularities, chamfers, etc., to the extent that the same effect is achieved. Expressions such as "comprise," "include," "have," "includes," or "have" a component are not exclusive expressions that exclude the presence of other components. "Parallel" and "orthogonal" mean substantially "parallel" and "orthogonal," and include not only strict "parallel" and "orthogonal" states, but also include an error of several degrees. In addition, expressions such as "part" are sometimes used, such as "end." For example, "end" refers to a part having a certain range that includes the "end." The same applies to other expressions that include "... part." [Explanation of symbols]

[0087] 10 Catheter Fixation Device 11 Foundation 12 Fixture body 13 intervals 15 Sheet material 20 Indwelling needle fixing part 20A, 20B two parts 21 First hollow section 23(23a~23d) groove 24 Slope 24a 1st slope part 24b 2nd slope part 25 recess 26 Hub support 30 Catheter hub fixing part 31 Second hollow section 33(33a~33c) Groove 100 catheter fitting portion 101 PI catheter 102 Medicinal tube 110 Catheter Hub 120 Indwelling needle 121 Cannula part 122 outer cylinder α Tilt angle

Claims

1. A catheter fixing device for fixing a catheter fitting part in which a catheter hub, which connects a catheter and a tube through which a medicinal solution flows, and an outer cylinder of an indwelling needle are fitted together, The base and a fixture body provided on an upper surface of the base and to which the catheter fitting portion is fixed, The fixture body is an indwelling needle fixing part provided on one side of the fixing device main body in the longitudinal direction, and a catheter hub fixing part provided on the other side of the fixing device main body in the longitudinal direction and spaced apart from the indwelling needle fixing part, the indwelling needle fixing part has a first hollow part formed therein and a groove formed in an upper part thereof that communicates with the first hollow part, the first hollow portion has a first inclined portion formed on one side, the inner diameter of the first inclined portion on the one side being equal to or larger than the maximum diameter of the catheter fitting portion, and the inner diameter of the first inclined portion becoming smaller toward the other side, A catheter fixing device, wherein the catheter hub fixing portion has a second hollow portion therein and a groove communicating with the second hollow portion is formed in the upper portion.

2. the first hollow portion further includes a second inclined portion formed on the other side of the first inclined portion so as to be continuous with the first inclined portion, The catheter fixing device according to claim 1 , wherein the second inclined portion has a shape corresponding to an outer peripheral surface of the outer cylinder of the indwelling needle.

3. The catheter fixing device according to claim 1 , wherein the first hollow portion is provided on the other side of the first inclined portion with a recess into which a flange portion provided on the other end of the outer tube of the indwelling needle fits.

4. The catheter fixing device according to claim 1 , wherein the first hollow portion is provided at the other most side with a hub support portion for supporting the catheter hub.

5. The catheter fixation device according to claim 1 , further comprising a sheet material attached to the underside of the base.

6. 2. The catheter fixing device according to claim 1, wherein the axial directions of the first and second hollow portions of the fixing device main body are inclined with respect to the upper surface of the base.

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