Low-traumatic urethral catheter with small holes and manufacturing method

Abstract

A catheter having at least one small hole shaped to reduce urethral trauma at the proximal insertion end of the catheter.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 463,262, filed on 1 May 2023, the disclosure of which Provisional Patent Application is incorporated herein by reference in its entirety.

[0002] This disclosure relates, in general, to a urethral catheter. More specifically, this disclosure relates to an intermittent urethral catheter having a small hole shaped to reduce the likelihood of urethral discomfort occurring during catheterization. [Background technology]

[0003] An intermittent urethral catheter includes a catheter shaft with a proximal insertion end portion that is inserted into the bladder through the urethra. Once in the bladder, urine enters the catheter through one or more openings, often called pits. The urine enters the openings and is drained through the catheter's drainage lumen and out through the distal drainage opening at the distal end portion of the catheter shaft.

[0004] Figures 1 and 2 show examples of prior art for intermittent urethral catheters. Catheter C includes a long catheter shaft S having a proximal insertion end portion P and a distal end portion D. The proximal insertion end portion P includes a terminal proximal end 10 suitable for insertion into the urethra. The proximal insertion end portion includes small holes E1 and E2 shaped as slots or elliptical openings for receiving urine and inserting it into the internal conduit or lumen of the catheter shaft S. The distal end portion D may include a distal opening that fluidly connects the catheter C to a collection container, such as a collection bag, or to a discharge member F, such as a funnel, for directing urine to a waste container, such as a toilet.

[0005] The catheter includes a longitudinal axis A. The catheter is a long cylinder, but has several surfaces that can be defined with respect to the arrangement of catheter holes. As shown in Figures 1 and 2, there is a top surface 13 which is the surface of the first hole E1. There is also a second surface or bottom surface 15 which is the surface of the second hole E2. There are two opposing surfaces 17 and 19, which are the left and right surfaces, respectively, that lie on a plane perpendicular to the top and bottom surfaces 13 and 15 of the catheter with axis A as the center.

[0006] Users who repeatedly use intermittent catheters may experience urethral trauma, particularly to the urethral mucosa, due to repeated insertion and removal of the intermittent urethral catheter. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Prior art catheters use two slot-shaped holes for drainage during use. While this drainage may be effective, there is a need for holes that enhance comfort during catheter insertion and withdrawal and reduce the likelihood of urethral discomfort during catheterization. The catheter holes of this disclosure are shaped to minimize urethral discomfort during catheterization. [Means for solving the problem]

[0008] In one embodiment, an intermittent urethral catheter includes a catheter shaft having a proximal insertion end portion for advancing through the urethra into the bladder and a distal discharge end portion having a discharge opening. The catheter shaft has a discharge lumen communicating with the discharge opening. The catheter includes at least one small hole on the catheter shaft at the proximal insertion end portion. The small hole has a diamond shape.

[0009] In another embodiment, an intermittent urethral catheter includes a catheter shaft having a proximal insertion end portion for advancing through the urethra into the bladder and a distal discharge end portion having a discharge opening. The catheter shaft has a discharge lumen communicating with the discharge opening. The catheter includes at least one small hole on the catheter shaft at the proximal insertion end portion. The small hole has an outline that is divided into several adjacent portions.

[0010] In yet another embodiment, the intermittent urethral catheter includes a catheter shaft having a proximal insertion end portion for advancing through the urethra into the bladder and a distal discharge end portion having a discharge opening. The catheter shaft has a discharge lumen communicating with the discharge opening. The catheter includes at least one small hole on the catheter shaft at the proximal insertion end portion. The at least one small hole includes an intermediate open hole portion and at least one outer recessed groove portion.

[0011] In addition, in another embodiment, a method for forming a catheter hole on the surface of a catheter includes applying a first die to the surface of the catheter to form a recessed catheter surface, and applying a second die to the recessed surface of the catheter to form a hole opening on the surface of the catheter. The resulting hole includes an open middle portion and at least one outer recessed portion. [Brief explanation of the drawing]

[0012] [Figure 1] This is a perspective view of a prior art urethral catheter. [Figure 2] Figure 1 is a side view of the proximal insertion end of a prior art urethral catheter. [Figure 3] This is an enlarged front view of a portion of the proximal insertion end of a urethral catheter with a hole according to an exemplary embodiment of the present disclosure. [Figure 4] Figure 3 is an enlarged perspective view of a portion of the proximal insertion end of a urethral catheter. [Figure 5] This is an enlarged front view of a portion of the proximal insertion end of a urethral catheter with a hole according to an exemplary embodiment of the present disclosure. [Figure 6] It is an enlarged perspective view of a part of the proximal insertion end of the urethral catheter of FIG. 5. [Figure 7] It is an enlarged front view of a part of the proximal insertion end of the urethral catheter with a small hole according to an exemplary embodiment of the present disclosure. [Figure 8] It is an enlarged perspective view of a part of the proximal insertion end of the urethral catheter of FIG. 7. [Figure 9A] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 9B] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 9C] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 10] It is an enlarged front view of a part of the proximal insertion end of the urethral catheter with a small hole according to an exemplary embodiment of the present disclosure. [Figure 11] It is an enlarged perspective view of a part of the proximal insertion end of the urethral catheter of FIG. 10. [Figure 12A] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 12B] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 12C] It is an enlarged cross-sectional view of a part of the proximal insertion end of the urethral catheter of FIGS. 7 and 8. [Figure 13] It is a bottom perspective view of a die for forming a part of a small hole according to an exemplary embodiment of the present disclosure. [Figure 14] It is a side view of the die of FIG. 13. [Figure 15] It is a perspective view of the compressed catheter wall after application of the die of FIGS. 13 and 14. [Figure 16] It is a perspective view of a die for forming a part of a small hole according to an exemplary embodiment of the present disclosure. [Figure 17] It is a perspective view of the compressed catheter wall after application of the die of FIG. 16. [Figure 18] It is a bottom perspective view of a die for forming a part of a small hole according to an exemplary embodiment of the present disclosure. [Figure 19] Figure 18 is a side view of the die. [Figure 20] Figures 18 and 19 are perspective views of the compressed catheter wall after the application of the die. [Figure 21] This is a perspective view of a die for forming a portion of a hole in an exemplary embodiment of the present disclosure. [Figure 22] Figure 21 is a perspective view of the compressed catheter wall after the application of the die. [Modes for carrying out the invention]

[0013] This disclosure relates to an intermittent urethral catheter having a proximal insertion tip. The urethral catheter includes at least one uniquely shaped hole located relatively close to the proximal end of the catheter shaft.

[0014] Referring here to the figures, several embodiments of the urethral catheter of this disclosure, which may be an intermittent urethral catheter, are shown. The figures show the proximal insertion end portion of the catheter. Similar to Figure 1, the urethral catheter may include a distal end portion (not shown). In embodiments of the catheter disclosed herein, the distal end portion of the catheter shaft includes a discharge opening and may optionally include a discharge member (not shown) or be connected to a collection bag (not shown). Furthermore, the urethral catheter includes a discharge lumen communicating with the distal end discharge opening of the catheter shaft.

[0015] The proximal insertion end portion includes the terminal proximal end. In embodiments disclosed herein, the terminal proximal end may be a closed end or an open end. If the end is an open end, the end includes an opening that communicates with the exhaust lumen.

[0016] The proximal insertion end portion may include at least one hole. In some embodiments, the proximal insertion end portion may include at least two holes. One or more holes may be located at positions E1 and E2, one on each of the surfaces 13 and 15 of the urethral catheter, as in the catheter of the prior art. Additionally, if two or more holes are present, they may be selectively arranged, for example, two holes on surface 13 or surface 15, or two on one of surfaces 13 and 15 and one on the other.

[0017] The small hole extends through the proximal insertion end and communicates with the discharge lumen. The urethral catheter shaft includes a side wall having an outer surface and an inner surface. The small hole extends from the outer surface to the inner surface through the side wall. The outer surface and the surface defining the small hole may have a hydrophilic coating thereon.

[0018] The most proximal hole may be located approximately 2 mm to 30 mm, preferably 8 mm to 24 mm, or more preferably 5 mm to 15 mm, from the proximal end 10 of the catheter.

[0019] There are several different shapes disclosed in the embodiments of this specification. In certain embodiments having two or more holes, each of the holes may differ in size and shape. In another alternative embodiment, all of the holes are the same shape. In yet another alternative embodiment, the holes may have a combination of shapes in the same embodiment.

[0020] The holes function to drain fluid outside the catheter into the catheter lumen. The holes disclosed herein each include an opening or passage that extends through the catheter wall and is bounded by the catheter wall.

[0021] The cross-sectional area of ​​each hole may vary depending on the embodiment. The holes disclosed herein have a total opening cross-sectional area of ​​approximately 1.4 mm². 2 ~6.0mm 2 Or approximately 1.6 mm 2 ~5.6mm 2It may be within this range. During manufacturing, the size of the small holes may vary slightly, mainly due to finishing techniques (e.g., rounding the edges to make the outside more comfortable for the user). The cross-sectional area of ​​the discharge hole opening may be in any plane parallel to the central axis of the catheter.

[0022] Several different hole shapes are disclosed in Figures 3-12. These are non-limiting, and other configurations are within the scope of this disclosure. In the embodiments, only one hole is shown, but it is understood that a second hole of the same shape may also be present in the catheter in any given embodiment. Additional holes of the same shape may be present in various positions. In addition, each unique hole shape may be accompanied by a conventional slot or one or more other shaped holes at the proximal insertion end of the catheter.

[0023] Figures 3 and 4 show possible embodiments of a portion of the proximal end of catheter 20 in which the catheter bore 22 is diamond-shaped. The diamond-shaped bore maintains the current drainage rate of a typical elliptical / slotted bore, but the end of the bore gradually tapers to guide the tissue out more gently than a steeper semicircular shape.

[0024] The small hole 22 has four straight sections 23a, 23b, 23c, and 23d on each of the four sides of the diamond. The small hole 22 also has four rounded edges 24a, 24b, 24c, and 24d at the "tip" of the diamond. The small hole 22 may be on at least one of the top surface 13 and bottom surface 15 of the catheter and may be located on each surface. Each catheter may have multiple catheter holes 22 arranged in different patterns. The catheter holes 22 are approximately 1.0 mm in diameter. 2 ~about 5mm 2 Or approximately 1.2 mm 2 ~about 4.4mm 2It may have a cross-sectional area. Each straight portion may be from about 0.4 mm to about 2.0 mm or from about 0.5 mm to about 1.8 mm. Each of the portions 23 may be of substantially the same length, but in other embodiments, the lengths may vary such that at least two different lengths are present in the portions 23 of the small holes 22. The catheter small holes may have a depth 25 of from about 0.30 mm to about 1.0 mm or from about 0.45 to about 0.8 mm as shown in FIG. 4. This depth may be consistent around the outer periphery of the small hole or may vary at different locations. The rounded edge may include a radius of curvature from about 0.05 mm to about 0.5 mm. Additionally, the transition portion 25A between the outer surface of the catheter and the wall 25B of the small hole may be a smooth or rounded transition portion without an edge.

[0025] FIGS. 5 and 6 show possible embodiments of the proximal end portion 30 of a catheter tube having small holes 32. The small holes 32 include a shape or boundary in which the inner split portion forms a lattice design with four hole portions 33a, 33b, 33c, and 33d. The overall shape is generally in the shape of a slot or an ellipse. The conventional slot-shaped contour with the addition of the lattice design inside limits the possibility of tissue being drawn into the small holes during insertion and removal while still maintaining the function and appearance of the slot small hole design.

[0026] Each portion 33 includes three sides. All of the portions 33 intersect at the central point 36 of the small hole 32. Two of the three sides of each portion are adjacent to adjacent portions. These two sides 34 and 35 are relatively straight. The other side 38 of each portion is rounded. The side 34a of portion 33a is adjacent to the side 34b of portion 33b, and the side 35a is adjacent to the side 35c of portion 33c. The side 34c of portion 33c is adjacent to the side 34d of portion 33d. The side 35d of portion 33d is adjacent to the side 35b of portion 33b. Each portion 33 may have a cross-sectional area of from about 0.4 mm 2 to about 1.4 mm 2 The total cross-sectional area of the four portions or small holes 32 may be from about 1.4 mm 2 to about 6.0 mm 2 or from about 1.6 mm 2 to 5.6 mm 2The four sections are aligned along adjacent sides to form the shape of a clover leaf with a cross-shaped opening or an ellipse / slot, as described above. The holes have a depth of 0.35 mm to approximately 1.0 mm or approximately 0.45 mm to approximately 0.8 mm, and this depth may be consistent or vary throughout the holes. As described above, the transition between the outer surface of the catheter and the walls of the holes may be smooth or rounded.

[0027] Figures 7–9 show possible embodiments of the portion 40 with a hole 42 at the proximal end of a catheter tube. The hole 42 includes a molded open middle portion 49 and two grooved portions 46a, 46b at the top and bottom of the inner hole portion 49. Although two grooves are shown in the hole, the hole may have one or more grooves. Holes with added marks or grooves extending in accordance with the direction of use help guide tissue to enter and exit the hole more gently. Furthermore, any hole disclosed herein may include one or more grooves extending proximal or distally from the hole. For example, grooves may extend proximal and / or distally from the hole shown in Figures 3 and 4.

[0028] The inner hole portion 49 may be a desirable shape including a hexagon as shown in Figures 7-9. The hexagon may include six sides of equal length, or sides of varying lengths as shown in Figures 7 and 8. In an exemplary embodiment, the open middle portion 49 is a hexagon with two opposing sides 43a and 43b longer than the remaining sides. The open middle portion 49 of the small hole 42 also includes two sets of sides at any end of the opposing sides 43a and 43b, and sides 45a, 45b, 45c, and 45d. The edges of the hexagon are rounded, and the rounded edges at the top and bottom are labeled 44a and 44b. The inner hexagon of the small hole has a depth 47 of about 0.25 to about 1.0 mm or about 0.3 mm to about 0.8 mm. The depth 47 may be consistent throughout the hexagon or vary. The cross-sectional area of ​​the inner hexagon is about 2.2 mm². 2 ~about 10mm 2 Or approximately 2.3 mm² to 8.5 mm 2This is possible. The length of the small hole, including the groove portion, from the top 56a of groove portion 55a to the bottom 56b of groove portion 55b, is approximately 10 mm to approximately 30 mm.

[0029] Each of the rounded top and bottom edges 44a and 44b may include groove portions extending from each of the edges 44a and 44b. In exemplary embodiments, each of the rounded top and bottom edges has groove portions 46a, 46b extending from each of the rounded top and bottom edges. The grooves may vary in depth, with deeper portions near the inner shape of the rounded edges 44a and 44b and shallower portions near the tips 48a and 48b of the grooves. In some embodiments, the deepest part of the groove portion may be near the open intermediate hole portion. In other embodiments, the deepest part may be at a different location along the groove portion. The depth of the grooves may vary from about 0.05 mm to about 0.4 mm, with the deepest part being about 0.15 mm to about 0.4 mm and the shallowest part being about 0.05 mm to about 0.1 mm. The grooves may be triangular or segmented cone-shaped. The tips 48a and 48b may be rounded. The length of each groove from the rounded edges 44a and 44b to the rounded tips 48a and 48b may be approximately 2.5 mm to approximately 15 mm.

[0030] Figure 9A includes a cross-section of the catheter with the small hole 42 shown in Figures 7 and 8. Figures 9B and 9C are enlarged portions of the cross-section of 9A. The radii of curvature at different points of the small hole 42 are shown in Figures 9B and 9C and are labeled R1, R2, and R3. Figure 9B shows a radius R3 of 0.15 mm. Figure 9C shows radii R1 of 0.15 mm and radii R2 of 0.05 mm.

[0031] Figures 10-12 show possible embodiments of the portion 50 with a small hole 52 at the proximal end of the catheter tube. The small hole 52 includes an open middle portion 59 and two grooved portions 55a and 55b at the top and bottom. The open middle portion may be any desired shape, including a slot or an elongated ellipse, as shown in Figures 10-12. The slot may include two longer straight sides 51a and 51b and two rounded upper and bottom sides 53a and 53b. The internal slot shape of the open middle portion has a depth of about 0.45 mm to about 0.8 mm. The cross-sectional area of ​​the internal slot is about 1.1 mm². 2 ~approximately 3.9mm 2 This is possible. The length of the small hole, including the groove portion, from the top or tip 56a of groove portion 55a to the bottom or tip 56b of groove portion 55b is approximately 10 mm to approximately 30 mm.

[0032] Each of the rounded top and bottom edges 53a and 53b may include groove portions extending from each of the edges 53a and 53b. In exemplary embodiments, each of the rounded top and bottom edges may include groove portions 55a and 55b extending from each of the rounded top and bottom edges. The grooves may vary in depth, with deeper portions near the inner shape of the rounded edges 53a and 53b and shallower portions at the tips 56a and 56b of the grooves. The groove depth may vary from about 0.05 mm to about 0.4 mm, with the deepest portion being about 0.15 mm to about 0.4 mm and the shallowest portion being about 0.05 mm to about 0.1 mm. The grooves may be triangular or segmented cone-shaped. The tips 56a and 56b may be rounded. The length of each groove from the rounded edges 53a and 53b to the rounded tips 56a and 56b can range from approximately 2.5 mm to approximately 15 mm.

[0033] Figure 12A includes a cross-section of the small-hole catheter. Figures 12B and 12C are enlarged portions of the cross-section of 12A. Figures 12B and 12C are enlarged portions of the cross-section of 9A. The radii of curvature at different locations of the small hole 52 in Figures 10 and 11 are shown in Figures 12B and 12C, labeled R4, R5, and R6. Figure 12B shows a radius R6 of 0.15 mm. Figure 12C shows two different radii R4 and R5 at two locations, each 0.10 mm.

[0034] The holes in the embodiments disclosed herein can be formed by any preferred method, including, but not limited to, drilling, thermoforming, ultrasonic cutting, laser cutting, and molding during a molding process.

[0035] Small holes with grooves (Figures 7-12) can be formed by stamping and / or punching processes. The process involves the use of at least two different stamps / dies and two different stamping operations. Two different exemplary sets of dies are shown, the first set in Figures 13-16 and the second set in Figures 18-21. The difference between the two dies is primarily the inner shape. Hexagonal and slotted are shown as possible inner shapes, but any desired shape can be used as the inner shape.

[0036] The first die is applied to the catheter surface so that the recess is formed with an intermediate shape and two grooved portions on the opposite side of the intermediate shape. Subsequently, the second die is applied to the embossed or recessed catheter surface formed after the application of the first die, resulting in an open portion in the middle of the small hole.

[0037] The first and / or second die may be heated or subjected to other forms of energy. Heat or other forms of energy may be applied to the die after and / or during the application of the first and / or second die. Additional forms of energy may include ultrasound, high-frequency laser energy, etc. In some alternative configurations, the temperature and / or energy level of the die is such that the pressure of the die on the catheter surface, combined with heat / energy, produces the desired shape and / or notches on the catheter surface.

[0038] Figures 13-16 show a first set of dies for forming the small holes shown in Figures 7-9. The bottom of the die 100 includes a base surface 104 with a hexagonal projection 101 and triangular projections 102 and 103 with concave bottoms corresponding to the grooved portion of the small hole, as shown in Figure 13. The projections 102 and 103 are located on the opposite sides (top and bottom) of the hexagonal projection 101. Figure 14 shows a side view of the die 100, clearly showing the projections 101, 102 and 103 protruding from the bottom of the die. The projection 101 extends further from the base surface 104 of the die than the projections 102 and 103. Figure 15 shows a flattened portion of the catheter 100 with the first die 100 applied, which results in a recess 109. The corresponding recessed portions 111, 112 and 113 are embossed on the catheter surface. The recessed portion 111 corresponds to the hexagonal protruding portion 101. The recessed portions 112 and 113, respectively, correspond to the protruding portions 102 and 103.

[0039] A second die 120 is shown in Figure 16. This second die is then applied to the flat, recessed surface or catheter 110 shown in Figure 15. The second die has a stamping surface in the shape of the inside of the hole. Figure 17 shows the resulting hole 129 on the flat surface 130 of the catheter. The hole 129 includes two groove portions 132 and 133 that remain unchanged from the application of the second die 120, and an open hole portion 131 corresponding to the hexagonal portion 101. The second die removes the recessed portion 111 to form the hole 131.

[0040] Figures 18–22 show a second set of dies for forming the holes shown in Figures 10–12. The bottom of die 200 includes a base surface 204 with an elliptical projection 201 and triangular-shaped portions 202 and 203 with concave bases corresponding to the grooved portions of the holes, as shown in Figure 18. The projections 202 and 203 are located on the opposite side of the elliptical projection 201. Figure 19 shows a side view of die 200, clearly showing the projections 201, 202 and 203 protruding from the bottom of the die. Portion 201 extends further from the base surface 204 of the die than portions 202 and 203. Figure 20 shows a flattened portion of the surface of catheter 210, which has been processed by the first die 200, resulting in the concave portions 209. The corresponding concave portions 211, 212 and 213 are embossed on the catheter surface. The recessed projection 211 corresponds to the elliptical projection 201. The recessed portions 212 and 213, respectively, correspond to the projections 202 and 203.

[0041] A second die 220 is shown in Figure 21. The second die has a stamping surface in the shape of the inside of the hole. This second die is then applied to the flat, recessed surface of the catheter 210 in Figure 20. Figure 22 shows the resulting hole 229 on the flat surface 230 of the catheter. The hole 229 includes two groove portions 232 and 233 that remain unchanged from the application of the second die 220, and a hole 231 corresponding to the inside of the ellipse. The second die removed the recess portion 111 to form the hole 231.

[0042] The above examples illustrate catheters with small holes and methods for forming these holes. Different combinations of these holes may be used or arranged.

[0043] Modifications and alterations to the preferred embodiments of the invention described herein will be obvious to those skilled in the art. Such modifications and alterations may be made without departing from the spirit and scope of the invention disclosed herein.

Claims

1. It is an intermittent urethral catheter, A catheter shaft having a proximal insertion end portion for advancing into the bladder through the urethra and a distal discharge end portion having a discharge opening, wherein the catheter shaft has a discharge lumen communicating with the discharge opening, At least one small hole on the catheter shaft at the proximal insertion end portion and Includes, An intermittent urethral catheter in which at least one of the aforementioned holes is diamond-shaped.

2. The intermittent urethral catheter according to claim 1, wherein the aforementioned small hole has a rounded edge.

3. An intermittent urethral catheter according to claim 1 or 2, comprising at least two small holes.

4. An intermittent urethral catheter according to any one of claims 1 to 3, wherein each side of the at least one diamond-shaped hole is substantially the same length.

5. An intermittent urethral catheter according to claim 4, wherein the length of each side is approximately 0.4 mm to approximately 2.0 mm.

6. The cross-sectional area of ​​at least one of the small holes is approximately 1.0 mm². ２ ~about 5mm ２ An intermittent urethral catheter according to any one of claims 1 to 5.

7. An intermittent urethral catheter according to any one of claims 1 to 6, wherein the depth of at least one of the small holes is at least 0.3 mm to about 1.0 mm.

8. It is an intermittent urethral catheter, A catheter shaft having a proximal insertion end portion for advancing into the bladder through the urethra and a distal discharge end portion having a discharge opening, wherein the catheter shaft has a discharge lumen communicating with the discharge opening, At least one small hole on the catheter shaft at the proximal insertion end portion and Includes, An intermittent urethral catheter having an outer shape in which at least one of the small holes is divided into several adjacent parts.

9. The intermittent urethral catheter according to claim 8, wherein the external shape is a slot.

10. The intermittent urethral catheter according to claim 8 or 9, wherein the aforementioned several adjacent portions are four.

11. An intermittent urethral catheter according to any one of claims 8 to 10, wherein several adjacent portions are substantially equal in size.

12. The intermittent urethral catheter according to any one of claims 8 to 11, wherein the aforementioned small hole has a rounded edge.

13. An intermittent urethral catheter according to any one of claims 8 to 12, comprising at least two small holes.

14. The cross-sectional area of ​​at least one of the small holes is approximately 1.4 mm². ２ ~approximately 6.0 mm ２ The intermittent urethral catheter according to any one of claims 8 to 13.

15. An intermittent urethral catheter according to any one of claims 8 to 14, wherein the depth of the at least one small hole is at least 0.35 mm to about 1 mm.

16. It is an intermittent urethral catheter, A catheter shaft having a proximal insertion end portion for advancing into the bladder through the urethra and a distal discharge end portion having a discharge opening, wherein the catheter shaft has a discharge lumen communicating with the discharge opening, At least one small hole on the catheter shaft at the proximal insertion end portion and Includes, An intermittent urethral catheter in which the at least one small hole includes an open intermediate portion and at least one outer groove portion.

17. The intermittent urethral catheter according to claim 16, wherein the open intermediate portion has a hexagonal shape.

18. The intermittent urethral catheter according to claim 17, wherein two opposing sides of the hexagon are longer than any of the remaining sides.

19. The intermittent urethral catheter according to claim 16, wherein the open intermediate portion is a slot.

20. The intermittent urethral catheter according to any one of claims 16 to 19, wherein the aforementioned small hole includes at least two outer groove portions.

21. The intermittent urethral catheter according to claim 20, wherein the at least two outer groove portions are located on opposite sides of the open intermediate portion.

22. An intermittent urethral catheter according to any one of claims 16 to 21, wherein the at least one outer groove portion varies in depth, with the deepest portion being near the open intermediate portion.

23. An intermittent urethral catheter according to any one of claims 16 to 22, comprising at least two small holes.

24. An intermittent urethral catheter according to any one of claims 16 to 23, wherein each outer groove portion has a length of approximately 2.5 mm to approximately 15 mm.

25. A method for forming small holes in a catheter on the surface of a catheter, To form a recessed catheter surface, the first die is applied to the surface of the catheter, In order to form a small hole opening on the surface of the catheter, the second die is applied to the recessed catheter surface of the catheter. Includes, A method wherein the resulting hole comprises an open intermediate portion and at least one outer recessed portion.

26. The method according to claim 25, wherein the recessed catheter surface has an intermediate portion that is the shape of the second die.

27. The method according to claim 25, wherein the first die includes an intermediate protruding portion and at least one outer protruding portion.

28. The method according to claim 27, wherein the intermediate protruding portion is in the shape of a slot.

29. The method according to claim 27 or 28, wherein the at least one outward projection is cone-shaped.

30. The method according to any one of claims 27 to 29, wherein the intermediate protrusion extends further than the at least one outer protrusion.

31. The method according to any one of claims 27 to 30, wherein the amount by which the at least one first outward projection extends from the surface of the die varies.

32. The method according to any one of claims 25 to 31, wherein the second die has a hexagonal shape.

33. The method according to any one of claims 25 to 31, wherein the second die is in the shape of a slot.

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