Stylet and urinary catheter set

Abstract

To provide a stylet capable of suppressing sufficiently, motion in a longitudinal direction of the stylet in a urethral catheter in insertion into a urinary tract, and a urinary tract catheter set.SOLUTION: A stylet 20 longer than a urethral catheter 10 has: first and second bent parts 23, 24, both side parts of the first and second bent parts 23, 24 of the stylet 20 not inserted into the urethral catheter 10, are spread shapes. The first bent part 23 of the stylet 20 inserted into the urethral catheter 10 is exposed from a funnel part 12, the second bent part 24 is positioned in the funnel part 12. Both side parts of the first and second bent parts 23, 24 are respectively pressed to opposed inner surfaces 12a in the funnel part 12, for regulating motion of the stylet 20 in a longitudinal direction in the urethral catheter 10.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to a stylet and a urethral catheter set.

Background Art

[0002] For patients with difficulty urinating, a urethral catheter may be inserted into the urethra and its tip may be retained in the bladder, and urine in the bladder may be discharged to an external urine storage bag or the like through a urine drainage port provided at the tip (Patent Document 1).

[0003] The intermediate part connecting the funnel part (rear end part) disposed outside the urethra and the tip part in the urethral catheter is composed of a flexible tube having flexibility in order to reduce the foreign body sensation and discomfort when inserted into the urethra. Generally, a urethral catheter having a flexible intermediate part is difficult to insert into the urethra as it is, so it is inserted into the urethra with a stylet inserted as a core material (for example, Patent Document 2). In particular, pediatric urethral catheters are thinner and softer than those for adults, so the use of a stylet is necessary.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, with conventional stylelets, the movement of the stylet once inserted into the urethral catheter is not restricted, so the stylet may move lengthwise within the catheter when the catheter is inserted into the urethra. If the tip of the stylet protrudes from the urinary catheter's opening, the tip of the stylet can injure the urethra and potentially cause infection.

[0006] The present invention aims to provide a stylet and a urethral catheter set that can sufficiently restrict the longitudinal movement of the stylet within the urethra when the urethral catheter is inserted into the urethra. [Means for solving the problem]

[0007] The present invention includes the following configuration. [1] A stylet for a urethral catheter, Its total length is longer than that of a urinary catheter. A first bent portion is formed which is bent or curved, and a second bent portion is formed which is bent or curved further back than the first bent portion. The portions on both sides of the first bend are widened, and the portions on both sides of the second bend are widened, A stylet in which, when inserted to the tip of the urethral catheter, the first bend is exposed outside the rear end opening of the funnel portion of the urethral catheter, the second bend is positioned within the funnel portion, and the longitudinal movement of the stylet within the urethral catheter is restricted by the fact that both sides of the first bend and both sides of the second bend are pressed against opposing inner surfaces within the funnel portion. [2] The stylet according to [1], which is bent at the first bending portion and also bent at the second bending portion. [3] A urethral catheter set comprising a urethral catheter and a stylet inserted into the urethral catheter, The total length of the stylet is longer than the total length of the urethral catheter. The stylet has a first bent portion that is bent or curved, and a second bent portion that is bent or curved further back than the first bent portion. When the stylet is not inserted into the urethral catheter, both sides of the first bend are flared, and both sides of the second bend are flared. A urethral catheter set wherein, when the stylet is inserted to the tip of the urethral catheter, the first bend is exposed outside the rear end opening of the funnel portion of the urethral catheter, the second bend is positioned inside the funnel portion, and the longitudinal movement of the stylet within the urethral catheter is restricted by pressing both sides of the first bend and both sides of the second bend of the stylet against opposing inner surfaces inside the funnel portion. [4] The urethral catheter set according to [3], wherein the stylet is bent at the first bending portion and also bent at the second bending portion. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a stylet and a urethral catheter set that can sufficiently restrict the longitudinal movement of the stylet within the urethra when the urethral catheter is inserted into the urethra. [Brief explanation of the drawing]

[0009] [Figure 1] This is a side view showing the schematic configuration of a urethral catheter set in one embodiment. [Figure 2] Figure 1 is a cross-sectional view of the urethral catheter in the urethral catheter set, cut along a plane containing its central axis. [Figure 3] Figure 1 is a side view showing the urethral catheter with the balloon inflated. [Figure 4] Figure 1 is a schematic diagram showing the urethral catheter set with the stylet not inserted into the urethral catheter. [Figure 5]It is a cross-sectional view showing an enlarged view of the inside of the funnel portion when the stylet is inserted into the urethral catheter. [Figure 6] It is a schematic configuration diagram showing a stylet of another example of the embodiment. [Figure 7] It is a schematic configuration diagram showing a stylet of another example of the embodiment.

Mode for Carrying Out the Invention

[0010] Hereinafter, an example of the stylet and the urethral catheter set of the present invention will be shown and described based on the drawings. In the following description, the dimensions and the like of the illustrated drawings are merely examples, and the present invention is not necessarily limited thereto, and it can be appropriately changed and implemented without changing the gist thereof.

[0011] [Urethral Catheter Set] FIG. 1 is a side view showing a schematic configuration of a urethral catheter set 1 according to an embodiment of the present invention. The urethral catheter set 1 includes a urethral catheter 10 and a stylet 20 inserted into the urethral catheter 10.

[0012] In the following description, the "tip" of the urethral catheter 10 and the stylet 20 means the end on the side that is placed in the bladder when inserted into the urethra. Also, the "rear end" of the urethral catheter 10 and the stylet 20 means the opposite side of the tip, and is the end on the side that is located outside the urethra in the state where the tip portions of the urethral catheter 10 and the stylet 20 are placed in the bladder.

[0013] (Urethral Catheter) The urethral catheter 10 is a long tubular medical instrument for discharging urine in the bladder to the outside of the body by being inserted into the urethra. As the urethral catheter 10, a known urethral catheter can be adopted without particular limitation.

[0014] As shown in FIGS. 1 and 2, the urethral catheter 10 in this example includes a tip portion 11 to be placed in the bladder, a funnel portion 12 that can be connected to a urine storage bag (urine storage container) outside the urethra, a tubular intermediate portion 13 connecting the tip portion 11 and the funnel portion 12, and a balloon 14 provided on the outer surface of the tip portion 11.

[0015] The tip portion 11 of the urethral catheter 10 is a short tube with a hemispherical tip. On the outer surface of the tip portion 11, a urine introduction port (side hole) 11a for introducing urine in the bladder into the catheter is formed. The urine introduction port 11a is formed on the tip side of the portion where the balloon 14 is provided on the outer surface of the tip portion 11. The number of urine introduction ports 11a may be one or two or more.

[0016] The funnel portion 12 includes a first port 15 and a second port 16 branching from the side surface near the tip thereof. The first port 15 is a port for connecting to a urine storage bag via a connector or the like. The second port 16 is a port for connecting to a liquid feeding device (such as an inflator) that can feed a fluid for inflating the balloon via a connector or the like.

[0017] The intermediate portion 13 is composed of a flexible and soft tube. The intermediate portion 13 in this example is a double tube having an outer tube 13a and an inner tube 13b inserted into the outer tube 13a.

[0018] The outer tube 13a and the balloon 14 in this example are integrally formed by a single tubular member 31. The tip of the tubular member 31 is fitted onto the rear end of the tip portion 11 and joined in a liquid-tight manner, and the rear end of the tubular member 31 is fitted onto the tip of the funnel portion 12 and joined in a liquid-tight manner. At the tip of the tubular member 31, the portion between the outer tube 13a and the balloon 14, and the tip end of the balloon 14 are both joined in a liquid-tight manner to the outer surface of the tip portion 11 around the entire circumference of the axis. When fluid is supplied between these two joints, the balloon 14 inflates as shown in Figure 3. The outer tube 13a and the balloon 14 may be formed from separate components.

[0019] As shown in Figure 2, in the urethral catheter 10, the inside of the tip portion 11, the inside of the outer tube 13a of the intermediate portion 13, and the inside of the first port 15 of the funnel portion 12 are all in communication, forming a main lumen 17 that functions as a urinary tract, extending from the urinary inlet 11a of the tip portion 11 to the posterior end opening of the first port 15.

[0020] Furthermore, the inner tube 13b of the intermediate section 13 is connected such that its rear end communicates with the flow path inside the second port 16, and its front end communicates with the inside of the balloon 14. The inside of the inner tube 13b of the intermediate section 13 and the inside of the second port 16 form a sub-flumen 18 that functions as a flow path for the fluid that inflates the balloon 14. Thus, the urethral catheter 10 in this example is a double-lumen type catheter.

[0021] The outer surface of the outer tube 13a (tubular member 31) may be coated with an antibacterial coating, a hydrophilic coating, a water-repellent coating, etc. The inner surface of the outer tube 13a may be coated with a water-repellent coating, a hydrophilic coating, etc. Examples of antibacterial coating materials include silver particles and zeolite silver particles. Examples of hydrophilic coating materials include N,N-dimethylacrylamide and polyvinylpyrrolidone. Examples of hydrophobic coating materials include fluororesins.

[0022] When using the urethral catheter 10, the tip 11 and middle section 13 are inserted into the urethra. Once the tip 11 reaches the bladder, fluid is sent through the sub-lumen 18 to inflate the balloon 14, and the tip 11 is kept in place within the bladder. In this state, urine from the bladder is introduced into the urethral catheter 10 through the urinary inlet 11a provided in the tip 11 and discharged through the main lumen 17 into an external urine collection bag.

[0023] The various dimensions of the urethral catheter 10 are not particularly limited and should be set appropriately according to the intended use, such as for adults or children. The total length of the urethral catheter 10 can be, for example, 340 to 440 mm. The tip portion 11 can have, for example, an outer diameter of 6Fr to 26Fr and a length of 10 to 40 mm. The intermediate section 13 can have, for example, an outer diameter of 6Fr to 26Fr mm and a length of 300 to 430 mm.

[0024] The material of the tip 11, middle section 13, and balloon 14 of the urethral catheter 10 is not particularly limited, and examples include latex, silicone rubber, polystyrene-based thermoplastic elastomer, polyolefin-based thermoplastic elastomer, polyurethane-based thermoplastic elastomer, and vinyl-based thermoplastic elastomer. Among these, latex and silicone rubber are preferred. These materials may be used individually or in combination of two or more.

[0025] (Stylet) As shown in Figure 4, the stylet 20 is a long, thin, rod-shaped member. The stylet 20 is inserted as a core material into the urethral catheter 10 when the catheter is inserted into the urethra. After the urethral catheter 10 is inserted, the stylet 20 is immediately removed.

[0026] The total length L1 of the stylet 20 is longer than the total length L of the urethral catheter 10. However, "total length of stylet 20" refers to the length from the tip 21 to the rear end 22 when the stylet 20 is in a straightened state. Furthermore, "total length of the urethral catheter 10" refers to the length from the tip 11 of the urethral catheter 10 to the rear end of the first port 15 of the funnel portion 12 when the catheter is in a straight line, that is, the length from the tip to the rear end when the main lumen is in a straight line.

[0027] As shown in Figure 4, the stylet 20 in this example has a first bent portion 23 and a second bent portion 24 that is bent further back towards the rear end 22 than the first bent portion 23. When the stylet 20 is not inserted into the urethral catheter 10, the first portion 20a from the tip 21 to the first bend 23, the second portion 20b from the first bend 23 to the second bend 24, and the third portion 20c from the second bend 24 to the rear end 22 of the stylet 20 are all approximately straight.

[0028] The second portion 20b moves away from the first portion 20a as it moves from the first bend portion 23 towards the second bend portion 24. In other words, the portions on both sides of the first bend portion 23 of the stylet 20 have a widened shape. The third portion 20c moves away from the second portion 20b as it moves from the second bend 24 toward the rear end 22. That is, the portions on both sides of the second bend 24 of the stylet 20 also have a widened shape. In this example, the third portion 20c also moves away from the first portion 20a as it moves from the second bend 24 toward the rear end 22. In other words, the rear end portion including the first bend 23 and the second bend 24 in this example is Z-shaped.

[0029] The length L2 from the tip 21 of the stylet 20 to the first bend 23 is longer than the total length L of the urethral catheter 10. As a result, when the stylet 20 is inserted to the tip of the urethral catheter 10, the first bend 23 of the stylet 20 is exposed outside the rear end opening of the funnel portion 12 of the urethral catheter 10, as shown in Figures 1 and 5.

[0030] The difference (L2-L) between the length L2 from the tip 21 of the stylet 20 to the first bend 23 and the total length L of the urethral catheter 10 is preferably 20 mm or more, and more preferably 30 mm or more. If the difference (L2-L) is above the lower limit, the portion of the stylet 20 exposed from the urethral catheter 10 is easier to grasp, making it easier to remove the stylet 20 after inserting the urethral catheter 10 into the urethra. The difference (L2-L) is preferably 50 mm or less, and more preferably 40 mm or less. If the difference (L2-L) is below the upper limit, it does not affect the operability of the catheter. The preferred lower and upper limits of the difference (L2-L) can be arbitrarily combined, for example, 30 to 40 mm is preferred.

[0031] When the stylet 20 is inserted to the tip of the urethral catheter 10, the second bent portion 24 of the stylet 20 is positioned within the funnel portion 12 of the urethral catheter 10. The length L3 of the stylet 20 from the first bend 23 to the second bend 24 should be adjusted so that the second bend 24 of the stylet 20 fits within the funnel portion 12 of the urethral catheter 10 when the stylet 20 is inserted into the urethral catheter 10. The length L3 can be adjusted appropriately according to the dimensions of the funnel portion 12 of the urethral catheter 10, and can be, for example, 50 to 100 mm.

[0032] The length L4 of the stylet 20 from the first bend 23 to the second bend 24 can be adjusted as appropriate. With the stylet 20 inserted to the tip of the urethral catheter 10, the rear end 22 of the stylet 20 may be located inside the funnel portion 12 of the urethral catheter 10, or it may protrude outward from the rear end opening of the funnel portion 12.

[0033] The length L4 of the stylet 20 from the first bend 23 to the second bend 24 can be adjusted as appropriate to match the dimensions of the funnel portion 12 of the urethral catheter 10, and can be, for example, 10 to 40 mm.

[0034] As shown in Figure 5, the two sides of the first bend 23 of the stylet 20, which are open before insertion into the urethral catheter 10, are compressed together within the funnel portion 12 once the stylet 20 is inserted into the urethral catheter 10. Within the funnel portion 12, the two sides of the first bend 23 of the stylet 20 are pressed against opposing inner surfaces 12a within the funnel portion 12 by a restoring force that tries to return them to their original open state. This force, which causes the two sides of the first bend 23 of the stylet 20 to press against the inner surfaces 12a of the funnel portion 12, restricts the longitudinal movement of the stylet 20 within the urethral catheter 10.

[0035] When the stylet 20 is not inserted into the urethral catheter 10, the angle θ1 (Figure 4) between the first portion 20a and the second portion 20b on both sides of the first bend 23 is preferably 50° or more, and more preferably 60° or more. If the angle θ1 is greater than or equal to the lower limit, the force pressing both sides of the first bend 23 of the stylet 20 against the inner surface 12a of the funnel portion 12 becomes stronger, and the longitudinal movement of the stylet 20 within the urethral catheter 10 is more easily restricted. The angle θ1 is preferably 90° or less, and more preferably 80° or less. If the angle θ1 is less than or equal to the upper limit, the operability when fixing the stylet to the catheter is good. The preferred lower and upper limits of the angle θ1 can be arbitrarily combined, for example, 60 to 80° is preferred.

[0036] Furthermore, as shown in Figure 5, both sides of the second bend 24 of the stylet 20, which are open before insertion into the urethral catheter 10, are compressed together within the funnel portion 12 when the stylet 20 is inserted into the urethral catheter 10. Within the funnel portion 12, both sides of the second bend 24 of the stylet 20 are pressed against opposing inner surfaces 12a within the funnel portion 12 by a restoring force that tries to return them to their original open state. This force, which causes both sides of the second bend 24 of the stylet 20 to be pressed against the inner surfaces 12a of the funnel portion 12, further restricts the longitudinal movement of the stylet 20 within the urethral catheter 10.

[0037] When the stylet 20 is not inserted into the urethral catheter 10, the angle θ2 (Figure 4) between the second portion 20b and the third portion 20c on both sides of the second bend 24 of the stylet 20 is preferably 50° or more, and more preferably 60° or more. If the angle θ2 is greater than or equal to the lower limit, the force pressing both sides of the second bend 24 of the stylet 20 against the inner surface 12a of the funnel portion 12 becomes stronger, and the longitudinal movement of the stylet 20 within the urethral catheter 10 is more easily restricted. The angle θ2 is preferably 90° or less, and more preferably 80° or less. If the angle θ2 is less than or equal to the upper limit, the operability when fixing the stylet to the catheter is good. The preferred lower and upper limits of the angle θ2 can be arbitrarily combined, for example, 60 to 80° is preferred.

[0038] The material of the stylet 20 is not particularly limited, and examples include metal and resin. Examples of metals include pseudoelastic alloys such as Ni-Ti alloys, shape memory alloys, stainless steel, cobalt alloys, gold, platinum, and tungsten alloys. Examples of resins include polyolefins, polyvinyl chlorides, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, and PEEK.

[0039] In terms of the greater restoring force that causes both sides of the first bend 23 and both sides of the second bend of the stylet 20 to return to their open state within the funnel portion 12, and the greater the bracing force within the funnel portion 12, the material of the stylet 20 is preferably PEEK. The material of Stylet 20 may be used individually or in combination of two or more types.

[0040] The method for manufacturing the stylet 20 is not particularly limited. For example, a rod-shaped stylet can be formed by extrusion molding. Furthermore, by bending it by hand, a first bent portion and a second bent portion can be formed in the stylet.

[0041] As explained above, in the urethral catheter set 1, the stylet 20, when not inserted into the urethral catheter 10, has two bent sections, a first bent section 23 and a second bent section 24, with both sides of each bent section being open. When the stylet 20 is inserted to the tip of the urethral catheter 10, both sides of these bent sections are compressed and housed within the funnel section 12 of the urethral catheter 10. Due to the restoring force that tries to return them to their original open state, both sides of each bent section of the stylet 20 are pressed against the opposing inner surfaces of the funnel section 12.

[0042] In this way, the two bent portions of the stylet 20 are tensed within the funnel portion 12 of the urethral catheter 10, which sufficiently restricts the longitudinal movement of the stylet 20 within the urethral catheter 10. As a result, when inserting the urethral catheter 10 into the urethra, it is prevented that the tip of the stylet 20 may accidentally protrude from the urinary opening 11a of the urethral catheter 10. Therefore, it is prevented that the tip of the stylet 20 may injure the urethra and cause infection.

[0043] Furthermore, even when the stylet 20 is inserted into the urethral catheter 10, the area around the first bent portion 23 of the stylet 20 is exposed from the funnel portion 12. Therefore, when removing the stylet 20, the exposed portion of the stylet 20 is easy to grasp, making the removal process easier.

[0044] Furthermore, the stylet and urethral catheter set of the present invention is not limited to the stylet 20 and urethral catheter set 1 described above. For example, as shown in Figure 6, the stylet 20 may be bent such that the second bend 24 bends so that as it moves from the second bend 24 toward the rear end 22, the third portion 20c moves away from the second portion 20b and approaches the first portion 20a. In other words, the rear end portion including the first bend 23 and the second bend 24 may be triangular in shape.

[0045] Furthermore, the stylet is not limited to those in which the first and second bends are bent; at least one of the first and second bends may be curved. For example, as shown in Figure 7, the stylet 20 may have both the first bend 23 and the second bend 24 curved in an arc shape.

[0046] When the first bend is curved, the preferred lower and upper limits of the angle formed by the extensions of the straight portions on both sides of the first bend of the stylet when it is not inserted into a urethral catheter are the same as the preferred lower and upper limits of the angle θ1 described above. Similarly, when the second bend is curved, the preferred lower and upper limits of the angle formed by the extensions of the straight sections on both sides of the second bend of the stylet when it is not inserted into a urethral catheter are the same as the preferred lower and upper limits of the angle θ2 described above. Furthermore, if at least one of the first and second bends is curved, the radius of curvature of the curved bend is not particularly limited and can be, for example, 10 to 30 mm.

[0047] Furthermore, without departing from the spirit of the present invention, the components in the above embodiments may be replaced with well-known components as appropriate, and the above-described modifications may be combined as appropriate. [Explanation of symbols]

[0048] 1...Urethral catheter set, 10...Urethral catheter, 11...Tip section, 12...Funnel section, 13...Middle section, 13a...Outer tube, 13b...Inner tube, 14...Balloon, 15...First port, 16...Second port, 17...Main lumen, 18...Sub-lumen, 20...Stylet, 21...Tip, 22...Rear end, 23...First bend, 24...Second bend, 31...Tubular member.

Claims

1. A stylet for a urinary catheter, Its total length is longer than that of a urinary catheter. A first bent portion is formed which is bent or curved, and a second bent portion is formed which is bent or curved further back than the first bent portion. The portions on both sides of the first bend are widened, and the portions on both sides of the second bend are widened, A stylet in which, when inserted to the tip of the urethral catheter, the first bend is exposed outside the rear end opening of the funnel portion of the urethral catheter, the second bend is positioned within the funnel portion, and the longitudinal movement of the stylet within the urethral catheter is restricted by the fact that both sides of the first bend and both sides of the second bend are pressed against opposing inner surfaces within the funnel portion.

2. The stylet according to claim 1, which is bent at the first bending portion and bent at the second bending portion.

3. A urethral catheter set comprising a urethral catheter and a stylet inserted into the urethral catheter, The total length of the stylet is longer than the total length of the urethral catheter. The stylet has a first bent portion that is bent or curved, and a second bent portion that is bent or curved further back than the first bent portion. When the stylet is not inserted into the urethral catheter, both sides of the first bend are flared, and both sides of the second bend are flared. A urethral catheter set wherein, when the stylet is inserted to the tip of the urethral catheter, the first bend is exposed outside the rear end opening of the funnel portion of the urethral catheter, the second bend is positioned inside the funnel portion, and the longitudinal movement of the stylet within the urethral catheter is restricted by pressing both sides of the first bend and both sides of the second bend of the stylet against opposing inner surfaces inside the funnel portion.

4. The urethral catheter set according to claim 3, wherein the stylet is bent at the first bending portion and also bent at the second bending portion.

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