Urethral catheter with drainage hole

Abstract

A catheter having a plurality of openings at the proximal insertion end portion of the catheter.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 476,248, filed December 20, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to urinary catheters. More particularly, the present disclosure relates to intermittent urinary catheters having multiple drainage openings associated with a proximal insertion end portion of the catheter. [Background technology]

[0003] An intermittent urinary catheter includes a catheter shaft having a proximal insertion end portion that is inserted through the urethra into the bladder. Once inserted into the bladder, urine enters the catheter through one or more openings. The urine enters the opening(s), passes through the drainage lumen of the catheter, and exits through a distal drainage opening at the distal end portion of the catheter shaft.

[0004] 1 and 2 show a prior art example of an intermittent urinary catheter. The catheter C comprises an elongate catheter shaft S having a proximal insertion end portion P and a distal end portion D. The proximal insertion end portion P comprises a proximal terminal end 100 suitable for insertion into the urethra. The proximal insertion end portion comprises eyelets E1 and E2 for receiving urine through the eyelets E1 and E2 into an internal conduit or lumen of the catheter shaft S. The distal end portion D may have a distal opening in fluid communication with a drainage member F, such as a funnel, for fluidly connecting the catheter C to a collection container, such as a collection bag, or for directing urine to a waste receptacle, such as a toilet.

[0005] The catheter has a longitudinal axis A. Although the catheter is elongated and cylindrical, multiple planes can be defined relative to the placement of the catheter's eyelets. As shown in FIGS. 1 and 2, there is a top surface 13 on which the first eyelet E1 lies. There is also a second, or bottom, surface 15 on which the second eyelet E2 lies. There are two opposing surfaces 17 and 19, which lie in planes perpendicular to the top and bottom surfaces 13 and 15 of the catheter about axis A, and these surfaces are the left and right surfaces, respectively.

[0006] Prior art catheters utilize two eyelets for drainage during use. However, this drainage may not be completely effective and may result in residual urine remaining in the bladder. Additionally, there is a need for eyelets that reduce the likelihood of urethral trauma during catheter insertion. Summary of the Invention [Problem to be solved by the invention]

[0007] There remains a need for improved drainage in catheters. Catheters of the present disclosure have configurations with smaller drainage holes and have designs where the sum of the cross-sectional area of ​​all drainage holes and eyelets is equal to or greater than the cross-sectional area of ​​the lumen. [Means for solving the problem]

[0008] In one embodiment, the intermittent urinary catheter comprises a catheter shaft having a proximal insertion end portion for advancement through the urethra into the bladder and a distal discharge end portion having a discharge opening. The catheter shaft has a discharge lumen in communication with the discharge opening. The catheter shaft has a discharge lumen in communication with the discharge opening. The catheter comprises a plurality of openings in the proximal insertion end portion of the catheter shaft. The total cross-sectional area of ​​the plurality of openings is greater than or equal to the cross-sectional area of ​​the lumen. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a prior art urinary catheter. [Figure 2] FIG. 2 is a side view of the proximal insertion end of the prior art urinary catheter of FIG. 1. [Figure 3] FIG. 1 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 4] FIG. 1 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 5] FIG. 1 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 6] FIG. 1 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 7] FIG. 1 is a top view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 8] FIG. 1 is a side perspective view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 9] FIG. 1 is a bottom view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 10] FIG. 1 is a bottom view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 11] FIG. 1 is a side perspective view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 12] FIG. 1 is a top view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 13] FIG. 1 is a top view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 14] FIG. 1 is a bottom view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 15] FIG. 1 is a side perspective view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 16] FIG. 1 is a top view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. [Figure 17] FIG. 1 is a side view of the proximal insertion end of a urinary catheter according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present disclosure relates to an intermittent urinary catheter having a proximal insertion tip, the urinary catheter including multiple openings, such as at least one eyelet and at least one drain hole, positioned relatively near the proximal end of the catheter shaft.

[0011] Referring now to the figures, several embodiments of the urinary catheter of the present disclosure are shown. These figures include a proximal insertion end portion P of the catheter. As in FIG. 1 , the urinary catheter can include a distal end portion (not shown). In the catheter embodiments disclosed herein, the distal end portion of the catheter shaft includes a drain opening and may optionally include a drain member (not shown) or be connected to a collection bag (not shown). Additionally, the urinary catheter includes a drain lumen in communication with the drain opening at the distal end of the catheter shaft.

[0012] The proximal insertion end portion P comprises a proximal end portion 100. In the embodiments disclosed herein, the proximal end portion 100 may be closed or open. If the end portion 100 is open, the end portion comprises an opening that communicates with the exhaust lumen.

[0013] The proximal insertion end portion P may also include multiple openings. The proximal insertion end portion P may include multiple drain holes and may also include at least one eyelet. In certain embodiments, the proximal insertion end portion may not include an eyelet. The drain hole(s) may be variously positioned relative to the eyelet(s) in various embodiments of the present disclosure. In embodiments having a single eyelet, the drain hole may be located proximally or distally from the eyelet relative to the proximal end portion 100 of the catheter. The hole(s) may be located on the same surface as the eyelet or on at least one of the left side 17 and right side 19 of the catheter.

[0014] The drainage hole(s) and eyelet(s) extend through the proximal insertion end portion P and communicate with the drainage lumen. The urinary catheter shaft includes a sidewall having an outer surface and an inner surface. The drainage hole(s) and eyelet(s) extend through the sidewall from the outer surface to the inner surface. The outer surface may be provided with a hydrophilic coating.

[0015] The most proximal drainage hole or eyelet can be located from about 2 mm to about 30 mm, preferably from about 8 mm to about 24 mm, and more preferably from about 5 mm to about 15 mm from the proximal end 100 of the catheter.

[0016] The drain holes and eyelets of the embodiments disclosed herein can be formed by any suitable method, including, but not limited to, mechanical punching, thermoforming, ultrasonic cutting, laser cutting, etc. The drain holes and eyelets of the embodiments disclosed herein are positioned to maximize drainage capacity and efficiency.

[0017] In the illustrated embodiment, each of the drain holes may vary in size and shape. For example, in certain embodiments, the drain holes have a generally round shape. However, in other alternatives, the drain holes may have other shapes, such as oval, oblong, polygonal, or irregular. In another alternative, all of the drain holes are the same shape. In yet other alternatives, the drain holes may have a combination of shapes within the same embodiment.

[0018] In the illustrated embodiment, the eyelets have a generally oval shape. However, in other alternatives, the eyelets may have other shapes, such as oval, circular, or polygonal. The eyelets may be any of the sizes described above. In yet other alternatives, the eyelets may have various sizes and shapes relative to one another.

[0019] Both drain holes and eyelets function to allow fluid to flow from the surface of the catheter into the catheter lumen. Eyelets are significantly larger in size than drain holes. The eyelets and drain holes disclosed herein each comprise an opening or passageway that penetrates and is bounded by the catheter wall. The cross-sectional area of ​​a drain hole is smaller than that of an eyelet, such that even the largest drain hole has a cross-sectional area smaller than that of the smallest eyelet.

[0020] The cross-sectional area of ​​each drain hole can vary depending on the embodiment. In general, the total cross-sectional area of ​​the drain holes and eyelets combined is greater than or equal to the cross-sectional area of ​​the lumen of a catheter, in a plane perpendicular to central axis A, such as plane 40, having lumen diameter 50 shown in FIG. 3. For example, the lumen of a C14 catheter has a cross-sectional area of ​​approximately 7.50 mm 2 ~Approx. 7.60mm 2 , or approximately 7.55 mm 2 In a typical prior art catheter, the cross-sectional area of ​​one eyelet is approximately 2.50 mm 2 ~approx. 3.00mm 2 , or approximately 2.80 mm 2 In the case of a prior art catheter with two eyelets, the total cross-sectional area of ​​the two eyelets is approximately 5.0 mm 2 ~approx. 6.0mm 2 , or 5.59 mm 2 This sum is less than the cross-sectional area of ​​the lumen.

[0021] When a drain hole or eyelet is formed, there may be slight variations in size, primarily due to finishing techniques (such as rounding edges to make the exterior more comfortable for the user). The cross-sectional area of ​​the drain hole opening can be in any plane parallel to the central axis A of the catheter. In preferred embodiments, this plane is where the drain hole opening or diameter is smallest, and is shown as 44 in Figure 4, 46 in Figure 5, and 48 in Figure 6.

[0022] Several different arrangements of the eyelet(s) and drain hole(s) are disclosed in Figures 7-17. These are non-limiting and other arrangements are within the scope of this disclosure.

[0023] 7 and 8 show a possible embodiment in which a set of five drain holes 20a, 20b, 20c, 20d, and 20e are located proximally from eyelet E2 toward the proximal end of the catheter, approximately at the location of eyelet E1 in the prior art catheter of FIG. 2. The catheter shown can have only one eyelet. Holes 20 are located on the opposite side of the catheter from eyelet E2, as viewed along the catheter's longitudinal axis A. In the illustrated embodiment, the drain holes are on the top surface 13 of the catheter. E2 is located on the bottom surface 15 of the catheter, as viewed along the catheter's longitudinal axis A. The holes are arranged in offset rows, with 20a and 20b in the proximal-most row, 20c below and between 20a and 20b, and 20d and 20e in the distal-most row. 20d and 20e are directly below 20a and 20b. The discharge holes are shown as circular, but may be any known or acceptable shape, such as oval. The approximate diameter of each hole is 1.10 mm, and the approximate cross-sectional area of ​​each hole is about 0.95 mm. 2 The total cross-sectional area of ​​all the openings of the discharge holes is approximately 4.75 mm 2 The cross-sectional area of ​​the eyelet opening is approximately 2.8 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet is at least equal to the cross-sectional area of ​​the catheter lumen. The ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet is about 1.7:1. The hole is located about 12 mm from the proximal end 100 of the catheter.

[0024] FIG. 9 shows another possible embodiment in which a set of five drain holes 22a, 22b, 22c, 22d, and 22e are positioned distally from eyelet E1, away from the proximal end of the catheter, approximately at the location of E2 in the prior art catheter of FIG. 2. The catheter shown may include only one eyelet. This embodiment is the inverse of the embodiments of FIGS. 7 and 8, since it replaces the opposite eyelet in the prior art catheter of FIG. 2. Holes 22 are located on the opposite side of the catheter from eyelet E1, as viewed along the longitudinal axis A of the catheter. In the illustrated embodiment, the drain holes are on the bottom surface 15 of the catheter. E1 is located on the top surface 13 of the catheter, as viewed along the longitudinal axis A of the catheter. The holes are arranged in offset rows, with 22a and 22b in the most proximal row, 22c located below and between 22a and 22b, and 22d and 22e in the most distal row. 22d and 22e are directly below 22a and 22b. The drain holes are shown as circular, but may be any known or acceptable shape, such as oval. The approximate diameter of each hole is 1.10 mm, and the approximate cross-sectional area of ​​each hole is about 0.95 mm. 2 The cross-sectional area of ​​the eyelet opening is approximately 4.75 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet is at least equal to the cross-sectional area of ​​the catheter lumen. The ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet is about 1.7:1. The hole is located about 24 mm from the proximal end 100 of the catheter.

[0025] 10 and 11 show an alternative embodiment in which a set of seven drain holes 24a, 24b, 24c, 24d, 24e, 24f, and 24g are positioned distally from eyelet E1, away from the proximal end of the catheter, approximately at the location of eyelet E2 in the prior art catheter of FIG. 2. The catheter shown may include only one eyelet. Holes 24 are located on the opposite side of the catheter from eyelet E1, as viewed along the catheter's longitudinal axis A. In the illustrated embodiment, the drain holes are on the bottom surface 15 of the catheter. E1 is located on the top surface 13 of the catheter, as viewed along the catheter's longitudinal axis A. The holes are arranged in offset rows, with 24a in the most proximal row, 24b and 24c on the horizontal side of and below 24a, 24d directly below 24a and distally below 24b and 24c, 24e and 24f on the horizontal side below 24d, and 24g located most distally and directly below 24a and 24d. The drain holes are shown as circular, but may be any known or acceptable shape, such as oval. The approximate diameter of each hole is 0.93 mm, and the approximate cross-sectional area of ​​each hole is about 0.68 mm. 2 The cross-sectional area of ​​the eyelet opening is approximately 4.75 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet is at least equal to the cross-sectional area of ​​the catheter lumen. The ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet is about 1.7:1. The hole is located about 24 mm from the proximal end 100 of the catheter.

[0026] FIG. 12 shows a possible embodiment in which a set of seven drain holes 26a, 26b, 26c, 26d, 26e, 26f, and 26g are located proximally from eyelet E2 toward the proximal end of the catheter, approximately at the location of E1 in the prior art catheter of FIG. 2. The catheter shown can include only one eyelet. This embodiment is the inverse of the embodiments of FIGS. 10 and 11, since it replaces the opposite eyelet in the prior art catheter of FIG. 2. Holes 26 are located on the opposite side of the catheter from eyelet E2, as viewed along the longitudinal axis A of the catheter. In the illustrated embodiment, the drain holes are on the top surface 13 of the catheter. E2 is located on the bottom surface 15 of the catheter, as viewed along the longitudinal axis A of the catheter. The holes are arranged in offset rows, with 26a in the most proximal row, 26b and 26b on the horizontal side of and below 26a, 26c just below 26a and distally below 26b and 26c, 26e and 26f on the horizontal side below 26d, and 26g most distally and just below 26a and 26d. The drain holes are shown as circular, but could be any known or acceptable shape, such as oval. The approximate diameter of each hole is 0.93 mm, and the cross-sectional area of ​​each hole is about 0.68 mm. 2 The cross-sectional area of ​​the eyelet opening is approximately 4.75 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet is at least equal to the cross-sectional area of ​​the catheter lumen. The ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet is about 1.7:1. The hole is located about 12 mm from the proximal end 100 of the catheter.

[0027] FIG. 13 shows a possible embodiment in which a set of nine drain holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, and 30i, and a larger drain hole 28, are positioned distally from eyelet E1, away from the proximal end of the catheter, approximately at the location of E2 in the prior art catheter of FIG. 2. Holes 28 and 30 are positioned on the opposite side of the catheter from eyelet E1, as viewed along the catheter's longitudinal axis A. In the illustrated embodiment, the drain holes are on the bottom surface 15 of the catheter. Eyelet E1 is positioned on the top surface 13 of the catheter, as viewed along the catheter's longitudinal axis A. The hole arrangement is such that larger hole 28 is at the center of the arrangement, and holes 30a-30i are arranged in a circle surrounding hole 28. The larger, central drain hole can be elliptical or oval in shape, and the smaller hole 30 is circular in shape. However, the shape of any of the drain holes can be varied and can be any acceptable shape. The approximate diameter of the hole 28 is 0.9 mm to 1.4 mm, and the approximate cross-sectional area is 1.09 mm. 2 The diameter of the holes 30a to 30i is approximately 0.62 mm, and the cross-sectional area is approximately 0.3 mm. 2 The cross-sectional area of ​​the eyelet opening is approximately 4.75 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet is at least equal to the cross-sectional area of ​​the catheter lumen. The ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet is about 4.8:1. The hole is located about 24 mm from the proximal end 100 of the catheter.

[0028] Figures 14 and 15 show another possible embodiment in which the set of nine drain holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, and 30i of Figure 13 and the larger drain hole 28 are located at eyelet E2, and another set of nine drain holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, and 34i and the larger drain hole 32 are located on the top surface 13 of the catheter, proximal to the other set of holes 30 and 28, at eyelet E1. Each set of holes replaces eyelet E1 or E2, and each set is on opposite sides of the catheter. The larger, central drain holes 28 and 32 can be oval or elliptical in shape, and the smaller hole 34 is circular in shape. However, the shape of either drain hole can be varied and can be any acceptable shape. The larger central discharge hole has a diameter of 0.9mm to 1.4mm and a cross-sectional area of ​​1.09mm. 2 The smaller discharge holes 34 may have a diameter of 0.62 mm and a cross-sectional area of ​​0.3 mm. 2 The cross-sectional area of ​​the opening of the eyelet can be about 4.75 mm 2 The total cross-sectional area of ​​the drain hole opening and the cross-sectional area of ​​the eyelet may be at least equal to the cross-sectional area of ​​the catheter lumen, and the ratio of the total cross-sectional area of ​​the drain hole opening to the cross-sectional area of ​​the eyelet may be about 4.8:1.

[0029] FIG. 16 shows another possible embodiment in which nine drain holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, 34i and a larger drain hole 32 are located proximally from eyelet E2 toward the proximal end of the catheter, approximately at the location of E1 in the prior art catheter of FIG. 2. Holes 32 and 34 are located on the opposite side of the catheter from eyelet E2, as viewed along the longitudinal axis A of the catheter. In the illustrated embodiment, the drain holes are on the top surface 13 of the catheter. Eyelet E2 is located on the bottom surface 15 of the catheter, as viewed along the longitudinal axis A of the catheter. The hole arrangement is such that larger hole 32 is in the center of the arrangement, and holes 34a-34i are arranged in a circle surrounding hole 32. The larger, central drain hole can be elliptical or oval in shape, and the smaller hole 34 is circular in shape. However, the shape of any of the drain holes can be varied and can be any acceptable shape. The diameter of the hole 32 is approximately 0.9 mm to 1.4 mm, and the cross-sectional area is approximately 1.09 mm. 2 The diameter of the holes 34a to 34i is approximately 0.62 mm, and the cross-sectional area is approximately 0.3 mm. 2 The hole is located approximately 12 mm from the proximal end 100 of the catheter.

[0030] Figure 17 includes a group of drain holes 38 positioned at the proximal insertion end of the catheter. In this embodiment, the holes are patterned in a helical configuration or pattern about the axis A of the catheter shaft. The drain holes have diameters between 0.3 mm and 0.7 mm and a cross-sectional area of ​​1.9 mm. 2 A group of drainage holes 38 replaces the eyelets of the prior art catheter.

[0031] The above examples are of catheters with drainage holes. The number and pattern of holes can be varied in any way so that the total cross-sectional area of ​​the openings (drainage holes and eyelets) is equal to or greater than the cross-sectional area of ​​the catheter lumen.

[0032] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art, and such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.

Claims

1. a catheter shaft having a proximal insertion end portion for advancement through the urethra into the bladder and a distal discharge end portion having a discharge opening, the catheter shaft having a discharge lumen in communication with the discharge opening; a plurality of openings in the proximal insertion end portion of the catheter shaft; Equipped with a total cross-sectional area of ​​the plurality of openings is greater than or equal to a cross-sectional area of ​​the lumen; Intermittent urinary catheter.

2. The intermittent urinary catheter of claim 1 , wherein the plurality of openings includes a plurality of drainage holes.

3. 3. The intermittent urinary catheter of claim 1, wherein the plurality of openings includes at least one eyelet.

4. The intermittent urinary catheter of claim 3 , wherein the plurality of openings includes a plurality of drainage holes and a single eyelet.

5. The intermittent urinary catheter of claim 4 , wherein the eyelet is located on a surface of the catheter opposite the drainage hole.

6. The intermittent urinary catheter of claim 2 , wherein the plurality of drainage holes includes holes having at least two different shapes.

7. The intermittent urinary catheter of claim 2 , wherein the plurality of drainage holes include holes of the same shape.

8. The intermittent urinary catheter of claim 2 , wherein the plurality of drain holes are arranged in offset rows.

9. The intermittent urinary catheter of any one of claims 1 to 8, wherein the catheter comprises at least five drainage holes.

10. The intermittent urinary catheter of claim 2 , wherein the plurality of drain holes extend in a spiral pattern around the catheter shaft.

11. The intermittent urinary catheter of claim 4 , wherein the plurality of drain holes are proximal to the eyelet.

12. The intermittent urinary catheter of claim 4 , wherein the plurality of drain holes are distal to the eyelet.

13. The cross-sectional area of ​​one discharge hole is approximately 0.95 mm ２ 3. The intermittent urinary catheter of claim 2, wherein

14. The cross-sectional area of ​​each discharge hole is approximately 0.95 mm ２ 3. The intermittent urinary catheter of claim 2, wherein

15. 5. The intermittent urinary catheter of claim 4, wherein the ratio of the combined cross-sectional area of ​​the plurality of drainage holes to the cross-sectional area of ​​the eyelet is about 1.7:

1.

16. The intermittent urinary catheter of claim 2 , wherein the drain holes of the plurality of drain holes have different cross-sectional areas.

17. At least one discharge hole has a cross-sectional area of ​​1.09 mm ２ and at least one other discharge hole has a cross-sectional area of ​​0.3 mm ２ 17. The intermittent urinary catheter of claim 16, wherein

18. 17. The intermittent urinary catheter of claim 16, wherein one drain hole has a larger cross-sectional area than all other drain holes.

19. 20. The intermittent urinary catheter of claim 18, wherein all other drainage holes have the same cross-sectional area.

20. 20. The intermittent urinary catheter of any one of claims 1 to 19, wherein the catheter shaft has a proximal end portion and the plurality of holes are spaced apart from the proximal end portion by about 2 mm to about 30 mm, preferably about 8 mm to about 24 mm, and preferably about 5 mm to about 15 mm.

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