Urinary catheter with drainage holes and eyelets

Abstract

An intermittent urinary catheter, comprising a catheter shaft having a proximal insertion end portion and a distal drainage end portion, the catheter shaft having a drainage lumen; a plurality of drainage apertures located on the proximal insertion end portion, the plurality of drainage apertures including at least one eyelet (31) and at least one drainage hole (34a); wherein the at least one eyelet has a cross-sectional area of at least 2 mm2 and the at least one drainage hole has a cross-sectional area of at least 0.45 mm2 and at most 1.9 mm2.

Description

Urinary Catheter with Drainage Holes and EyeletsThe present application claims the benefit of and prior to U.S. Patent Application No. 63 / 653,153, filed on May 29, 2024, which is hereby incorporated by reference.Field of the Disclosure

[0001] This disclosure relates generally to urinary catheters. More particularly, this disclosure relates to intermittent urinary catheters with a plurality of drainage apertures associated with the proximal insertion end portion of the catheter.Background

[0002] Intermittent urinary catheters include a catheter shaft having a proximal insertion end portion that is inserted through the urethra and into the bladder. Once in the bladder, the urine enters the catheter through one or more openings. The urine enters into the opening(s) and drains through a drainage lumen of the catheter and out of a distal drainage opening in the distal end portion of the catheter shaft.

[0003] Figs. 1 , 2, and 3 illustrate a prior art example of an intermittent urinary catheter. Catheter C includes an elongated catheter shaft S having a proximal insertion end portion P and a distal end portion D. Proximal insertion end portion P includes a terminal proximal end 100 that is suitable for insertion into the urethra. The proximal insertion end portion includes eyelets E1 and E2 for receiving urine there through and into an internal conduit or lumen of catheter shaft S. Distal end portion D may include a distal opening that is in fluid communication with a drainage member F, such as a funnel, for fluidly connecting catheter C to a collection container, such as a collection bag, or for directing urine to a waste receptacle, such as a toilet.

[0004] The catheter includes longitudinal axis A. Although the catheter is an elongated cylinder, there are a number of surfaces that can be defined in relation to the placement of the catheter eyelets. As shown in Fig. 1 , 2, and 3 there is top surface 13, which is the surface of the first eyelet E1 . There is also a second surface, or bottom surface 15, which is the surface of the second eyelet E2. There are two opposing surfaces, 17 and 19, respectively the left and rightsurfaces, that are on a perpendicular plane about the axis A from the top and bottom surfaces 13, 15 of the catheter.

[0005] As shown in Figs. 4 and 5, an additional prior art catheter includes a plurality of drainage holes 21a-21dd, 23a-23dd and 25a-25dd. The drainage holes are uniformly spaced at the center of each of the four faces 13, 15, 17, and 19. Although face 15 is not shown in the figures, complimentary holes are also found on face 15.

[0006] The first prior art catheter utilizes two eyelets for better draining during use. The second prior art catheter utilizes a large number of drainage holes. However, this draining may not be completely effective and may result in residue.

[0007] There remains a need for catheters with improved draining so as to maximize flow rate but minimize the maximum suction force at any of the plurality of drainage apertures.Summary

[0008] In a first aspect, an intermittent urinary catheter includes a catheter shaft having a proximal insertion end portion for advancement through a urethra into a bladder and a distal drainage end portion having a drainage opening. The catheter shaft has a drainage lumen in communication with the drainage opening. The intermittent urinary catheter includes a plurality of drainage apertures located on the proximal insertion end portion of the catheter. The flow rate out through the plurality of drainage apertures is at least 7.4 ml / s and the maximum suction force at any of the plurality of drainage apertures is less than -3 mN.Brief Description of the Drawings

[0009] Fig. 1 is a perspective view of a first prior art urinary catheter;

[0010] Fig. 2 is a side view of the proximal insertion end of the first prior art urinary catheter of Fig. 1 ;

[0011] Fig. 3 is a second side view of the proximal insertion end of the first prior art urinary catheter of Fig. 1 ;

[0012] Fig. 4 is across-sectional view of the proximal insertion end of second prior art urinary catheter;

[0013] Fig. 5 is a second side view of the proximal insertion end of the second prior art urinary catheter;

[0014] Fig. 6 is a cross-sectional view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0015] Fig. 7 is a second side view of the proximal insertion end of the urinary catheter of Fig. 6;

[0016] Fig. 8 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0017] Fig. 9 is a second side view of the proximal insertion end of the urinary catheter of Fig. 8;

[0018] Fig. 10 is a cross-sectional view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0019] Fig. 11 is a second side view of the proximal insertion end of the urinary catheter of Fig. 10;

[0020] Fig. 12 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0021] Fig. 13 is a second side view of the proximal insertion end of the urinary catheter of Fig. 12;

[0022] Fig. 14 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0023] Fig. 15 is a second side view of the proximal insertion end of the urinary catheter of Fig. 14;

[0024] Fig. 16 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;

[0025] Fig. 17 is a side view of the proximal insertion end of the urinary catheter of Fig. 16;

[0026] Fig. 18 is a schematic view of the experimental set-up for the CFD simulations;

[0027] Fig. 19 is a graph of the pressures at the eyelets of the first control catheter;

[0028] Fig. 20 is a graph of the flow rates at the outlet and eyelets of the first control catheter;

[0029] Fig. 21 is a graph of the pressures at various drainage holes of the second control catheter;

[0030] Fig. 22 is a graph of the flow rates at the outlet and the various drainage holes of the second control catheter;

[0031] Fig. 23 is a graph of the pressures at the eyelets and drainage holes of the first design of Figs. 6 and 7;

[0032] Fig. 24 is a graph of the flow rates at the outlet, eyelets and drainage holes of the first design of Figs. 6 and 7;

[0033] Fig. 25 is a graph of the pressures at the eyelets and drainage holes of the second design of Figs. 8 and 9;

[0034] Fig. 26 is a graph of the flow rates at the outlet, eyelets and drainage holes of the second design of Figs. 8 and 9;

[0035] Fig. 27 is a graph of the pressures at the eyelets and drainage holes of the third design of Figs. 10 and 11 ;

[0036] Fig. 28 is a graph of the flow rates at the outlet, eyelets and drainage holes of the third design of Figs. 10 and 11 ;

[0037] Fig. 29 is a graph of the pressures at the eyelets of the fourth design of Figs. 12 and 13;

[0038] Fig. 30 is a graph of the flow rates and the outlet and eyelets of the fourth design of Figs. 12 and 13;

[0039] Fig. 31 is a graph of the minimum pressures for each of the first and second control catheters and the catheters of designs 1 -4;

[0040] Fig. 32 is a graph of the outlet flow rates for each of the first and second control catheters and the catheters of designs 1 -4;

[0041] Fig. 33 is a graph of the suction forces at the lowest eyelet or drainage hole for each of the first and second control catheters and the catheters of designs 1-4; and

[0042] Fig. 34 is a graph of the suction forces at the lowest eyelet or drainage hole for each of the second control catheter and the catheters of designs 2 and 3 at a different scale.Detailed Description of the Embodiments

[0043] The present disclosure is directed to intermittent urinary catheters having proximal insertion tips, wherein the urinary catheters include a plurality of drainage apertures, such as eyelets and drainage holes, which are positioned relatively close to the proximal terminal end of the catheter shaft.

[0044] Turning now to Figs. 6-17, a number of embodiments of urinary catheters of the present disclosure are shown. The figures include the proximalinsertion end portion P of the catheters. Similar to Fig. 1 , the urinary catheter may include a distal end portion (not shown). In the embodiments of the catheters disclosed herein, the distal end portion of the catheter shaft includes a drainage opening and, optionally, may include a drainage member (not shown) or be connected to a collection bag (not shown). Furthermore, the urinary catheter includes a drainage lumen that is in communication with the distal end drainage opening of the catheter shaft.

[0045] The proximal insertion end portion P includes a terminal proximal end 100 (labeled in various figures). In the embodiments disclosed herein, the terminal proximal end 100 may be a closed end or an open end. When the terminal end 100 is an open end, the terminal end includes an opening in communication with drainage lumen.

[0046] The proximal insertion end portion P may include a plurality of drainage apertures. The drainage apertures may include eyelets, drainage holes, or a combination of both. The drainage apertures may be positioned differently in different embodiments of the current disclosure. The drainage holes may be located proximately or distally from the eyelets relative to the terminal proximal end 100 of the catheter. The drainage hole or holes may be located between the eyelets. The drainage holes may also be a combination of these locations, i.e. , some of the holes proximal the most proximate eyelet, closer to the proximal end of the catheter and some of the holes between the two eyelets. The hole(s) may be located on the same surfaces as the eyelets or one at least one of the left and right surfaces 17 and 19 of the catheter.

[0047] The drainage apertures extend through the catheter sidewall in the proximal insertion end portion P and are in communication with the drainage lumen. The urinary catheter shaft includes a sidewall having an outer surface and an inner surface. The drainage apertures extend through the sidewall from the outer surface to the inner surface. The outer surface may have a hydrophilic coating disposed thereon.

[0048] The proximal most drainage aperture may be located between about 2 mm and about 50 mm, or preferably between about 5 mm and about 40 mm from the proximal terminal end 100 of the catheter.

[0049] The drainage apertures of the embodiments disclosed herein may be formed in any suitable manner, including but not limited to, mechanical punching,thermal forming, ultrasonic cutting, laser cutting, etc. The drainage holes and eyelets in the embodiments disclosed herein are arranged to maximize the drainage ability and efficiency.

[0050] In the illustrated embodiments, each of the drainage holes is generally the same size and shape. For instance, the drainage holes have a generally round shape. However, in other embodiments, the drainage holes may have other shapes, such as oval, oblong, polygonal or irregular. In alternative embodiments, the drainage holes may have various sizes and shapes relative to one another.

[0051] In the illustrated embodiments (except for the extended eyelet embodiments), the eyelets have a generally oval shape. However, in other embodiments, the eyelets may have other shapes, such as oval, circular, or polygonal. The eyelets may have any of the sizes described above. In alternative embodiments, the eyelets may have various sizes and shapes relative to one another.

[0052] The drainage holes and eyelets both function to drain fluid from the surface of the catheter to the inner lumen of the catheter. The eyelets are notably larger in size when compared to the drainage holes. The eyelets and drainage holes disclosed herein each include an opening or passageway that extends through and is bounded by the catheter wall. The cross-sectional area of the opening of the eyelet taken at any location along the catheter wall defining the opening is at least 2 mm2. The cross-sectional area of eyelet may be from 2 mm2to 10 mm2. The cross-sectional area of the opening of the drainage holes taken at any location along the catheter wall defining the opening is greater than 0.45 mm2and at most 1 .9 mm2. In one alternative, the cross-sectional area of the drainage hole is at least 0.5 mm2and at most is 1 .9 mm2. In one alternative, a single drainage hole has a diameter of at least 0.8 mm and at most 1 .56 mm. In another alternative, a single drainage hole may have a square shape with where in sides have a length from about 0.89 mm to about 1 .38 mm. In another alternative, a single drainage hole may have a rectangular shape with a width from about 0.04 mm to about 0.8 mm and length from about 1 .1 mm to 4 mm and the cross- sectional area of the opening is at least 0.5 mm2and at most is 1 .9 mm2. The ratio of the cross-sectional area of an eyelet’s opening to the cross-sectional area of a single drainage hole’s opening is from 20:1 and can be 1 .1 :1 . Alternatively, orin addition to, the relative sizes, the flow rate of fluid through a drainage hole is about 0.95 to 1 / 20 the flow rate of fluid through the eyelet. Optionally, the smallest cross-sectional length (e.g., diameter) of the drainage holes taken from one point D of the catheter sidewall defining the hole to a direct opposite point D' on the catheter sidewall can range from about 0.8 mm to about 1 .6 mm, and / or the largest cross-sectional length of the eyelets taken from one point D" of the catheter sidewall defining the eyelet to a direct opposite point D'" on the catheter sidewall can range from 1 .5 mm to 5 mm. An eyelet may have a width from about 1 .34 mm to about 2.0 mm and a length from about 1 .5 mm to about 5 mm. In comparison, a length or a width of an eyelet is at least 2 times the diameter of a drainage hole, but can be 4 times larger or even 6 times larger than the diameter of a drainage hole. Additionally, the cross-sectional area of an eyelet is at least 4 times larger than the cross-sectional area of a drainage hole, but can be 5 times larger or even 6 times larger than the cross-sectional area of a drainage hole.

[0053] Additional drainage holes will improve flow rate through lumen of the catheter. The flow rate of a liquid through the at least one eyelet plus one drainage hole is at least 1 .1 times faster than the rate of a liquid through the at least one eyelet. With the presence of multi drainage holes the flow rate through lumen is at least 1 .2 times faster than the rate of a liquid through the at least 2 drainage hole.

[0054] A number of different eyelet(s) and drainage hole(s) arrangements are disclosed in Figs. 6-17. These are non-limiting and other arrangements are within the scope of this disclosure.

[0055] Figs. 6 and 7 show a possible embodiment with four drainage holes 26a, 26b, 28a, 28b and two eyelets 27, 29. Fig. 6 is a partial cross-sectional view that shows surface 13 and the cross-section of the catheter above and below eyelet 27. Drainage holes 26a and 26b are on surface 19 and drainage holes 28a and 28b are opposite the drainage holes 26a, 26b on surface 17 determined from the longitudinal axis A of the catheter. Eyelets 27 and 29 are on opposite surfaces 13 and 15 determined from the longitudinal axis A of the catheter. One eyelet or pair of drainage holes are on each surface of the catheter. Drainage holes 26a and 28a are arranged proximally from the first eyelet 27, toward the terminal proximal end of the catheter. Drainage holes 26b and 28b are arranged between the first and second eyelet, more proximal than the second eyelet 29.Both 26a and 26b are slightly proximal to their opposite sided drainage hole 28a, 28b. Second eyelet 29 is the most distal drainage aperture. Eyelets 27 and 29 are located more distally than the eyelets of the first prior art catheter, shown in Figs. 1 -3. They are approximately 5-8 mm further than the first prior art catheter, shown in Figs. 1 -3. The eyelets and / or drainage holes may be arranged more proximal to the terminal proximal end 100 of the catheter. Drainage holes 26b and 28b may be alternatively arranged more distal to the second eyelet 29. Drainage holes 26a and 28a and 26b and 28b are laterally offset, but may also be directly opposite at the same proximal location. Although the drainage apertures are assigned to surfaces 13, 15, 17, 19 it is within the scope of this embodiment that each aperture can be present on any surface, with at least one drainage hole or an eyelet present on each surface.

[0056] Figs. 8 and 9 show a possible embodiment with two sets of four drainage holes (34a-d, 32a-d) and two eyelets 31 ,33. The first eyelet 31 and first set of drainage holes 34a, 34b, 34c, and 34d are located more proximal to the terminal end 100 of the catheter. The first drainage hole 34a being the proximal most drainage aperture or the drainage aperture closest to the terminal end 100. The drainage holes 34a-d and eyelet 31 are located on opposite longitudinal surfaces 15,13 of the catheter determined from the longitudinal axis A of the catheter. The second eyelet 33 and the second set of drainage holes 32a, 32b, 32c, and 32d are located more distal to the terminal end 100 of the catheter. The drainage holes 32a-d and eyelet 33 are located on opposite longitudinal surfaces 13,15 of the catheter determined from the longitudinal axis A of the catheter.Drainage hole 32d is the most distally located drainage aperture from the terminal end 100 of the catheter. Both sets of drainage holes 32a-d and 34a-d are spaced relatively equally and can be arranged in a column with an axis parallel to the axis A of the catheter. Figs. 8 and 9 show the top and bottom holes as slightly proximal and distal to the associated eyelet and the two middle holes as roughly directly opposite the associated eyelet, although the locations can be slightly varied. The faces (13, 15, 17, 19) upon which each eyelet or set of drainage holes is located may vary. Eyelets 31 and 33 may be in the same location as E1 and E2 of the first control catheter. The sets of drainage holes and the corresponding eyelet are on opposite surfaces of the catheter. Alternately, the sets of drainage holes may be present on the catheter surfaces without eyelets.Although the drainage apertures are assigned to surfaces 13, 15, it is within the scope of this embodiment that each aperture can be present on any surface, with a set of drainage holes or an eyelet present on each surface.

[0057] Figs. 10 and 11 include two sets of drainage holes, 38a-f and 39a-f and two eyelets 35, 37. The eyelets are located on two opposite surfaces 13, 15 as determined from the longitudinal axis A of the catheter. The two sets of drainage holes 38a-f and 39a-f are located on two opposite surfaces 19, 17 as determined from the longitudinal axis A of the catheter. Eyelets 35, 37 are located proximal from the two sets of drainage holes closer to the terminal proximal end 100, with eyelet 35 as the most proximal drainage aperture. Eyelets 35 and 37 may be in the same location as E1 and E2 of the first control catheter. The two sets of drainage holes are staggered proximally and can be equidistant, with 38a as the proximal most drainage hole and 39f as the distal most drainage hole. The two sets of drainage holes may be in offset columns with an axis that is parallel to the axis A on the catheter. Alternately, the drainage holes are not staggered proximally and directly opposite. Also alternately, the drainage holes may be also arranged on the same surface or surfaces as either eyelet. Although the drainage apertures are assigned a surface 13, 15, 17, 19, it is within the scope of this embodiment that each aperture can be present on any surface, with a set of drainage holes or an eyelet present on each surface.

[0058] Figs. 12 and 13 show an embodiment which includes two uniquely shaped eyelets 41 and 43. The eyelets include the slot portion 41 b, 43b but also include an extended portion 41 a, 43a. The eyelets are on opposite surfaces 13 and 15 as determined from the longitudinal axis A of the catheter. The extended portion 41 a, 43a of each eyelet extends distally from one end of the slot portion 41 b, 43b, respectively. The extended portion may extend from the proximal end, distal end, or either side of the slot portion. The extended portion includes the same depth and length as the slot portion, with a smaller width W’ that is smaller than the width W of the slot portion 41 b, 43b. In the illustrated embodiment, the width W of the slot portions 41 , 43b and width W’ of extended portions 41 a, 43a are measured about the circumference or arc of the catheter tube. Eyelet 41 is more proximally located or closer to the terminal proximal end 100 versus eyelet 43. The approximate location of each eyelet is similar to E1 and E2 of the first control catheter. The tapered or "tailed" eyelet configuration, with wider endcloser and combined with narrow end to the catheter tip, should provide a more gradual flow which as the eyelet is inserted wider region first, relative to a standard non-tapered design. This would result in gradual suction pressure or force and flow rate. Upon withdrawal the tapered or "tailed" feature will slow the flow more gradually rather than coming to abrupt stop. The taper could be extended or shortened in order to increase or decrease the effect. Alternately, there may be additional similarly shaped eyelets on the catheter on the same faces or different faces of the catheter. Also, at least one drainage hole may be added above, between or below the eyelets.

[0059] Figs. 14 and 15 show an embodiment which includes five drainage apertures including two eyelets 45 and 51 and three uniquely sized drainage holes 47, 49 and 53. Eyelets 45 and 51 are on opposite surfaces 13 and 15 as determined from the longitudinal axis A of the catheter. Drainage holes 47, 49 and 53 are on the same catheter surface 13 as eyelet 45. Eyelet 45 is the most proximal aperture located closest to the terminal proximal end 100. Drainage holes 47 and 49 are located proximally between eyelets 45 and 51 , with hole 47 more proximal than drainage hole 49. Drainage hole 53 is located almost directly opposite eyelet 51 . The longitudinal positions for these drainage holes can be reversed or otherwise changed relative to one another. The approximate location and sizes of the drainage apertures may vary slightly within this embodiment. The approximate location of each eyelet is similar to E1 and E2 of the first control catheter. The drainage holes and the eyelets are on two opposite surfaces of the catheter. Alternately, the sets of drainage holes may be present on the catheter surfaces without eyelets or at least one of the eyelets can be present on the opposite surface with the single eyelet.

[0060] Figs. 16 and 17 show an embodiment which includes five drainage apertures including two eyelets 63 and 55 and three uniquely sized drainage holes 57, 59 and 61 . Eyelets 63 and 55 are on opposite surfaces 13 and 15 as determined from the longitudinal axis A of the catheter. Drainage holes 57, 59 and 61 are on the same catheter surface 13 as eyelet 63. Eyelet 55 and drainage hole 57 are the most proximal drainage apertures located closest to the terminal proximal end 100. Drainage holes 59 and 61 are located proximally between eyelets 55 and 63, with hole 59 more proximal than drainage hole 61. Drainage hole 57 is located almost directly opposite eyelet 55. The approximate locationand sizes of the drainage apertures may vary slightly within this embodiment. The approximate location of each eyelet is similar to E1 and E2 of the first control catheter. The longitudinal positions for these drainage holes can be reversed or otherwise changed relative to one another. The drainage holes and the eyelets are on two opposite surfaces of the catheter. Alternately, the sets of drainage holes may be present on the catheter surfaces without eyelets or at least one of the eyelets can be present on the opposite surface with the single eyelet. Hybrid shape of circular and rectangular eyelets, provides combined benefits of both circular micro-eyelets and rectangular larger eyelets such as reducing suction pressure or force and maintaining the flow rate, whilst enabling passage of larger size sediment (> size of micro-eyelets) present in the urine.

[0061] The embodiments of the current disclosure were evaluated for pressure and flow rate, along with suction force. The measurements were done using Computational Fluid Dynamics (CFD) simulations of catheters having the Catheter tip designs described herein. The experimental design set-up 200 is shown in Fig. 18. A rectangular tank 201 with a bottom outlet 203 and a catheter holding seal 213 is included in the experimental set up. The tank 201 is filled to a certain height / level 221 with a fluid 215. There is a space 219 at the top for air. The catheter 211 with an outside height 225 is inserted into the tank up to a height 223. The tank has a width 217.

[0062] In the simulation, a 1 .5L tank was used to mimic a bladder, and flow rate measurements aligned with EN ISO 20696:2018 “Sterile urethral catheters for single use.” A square tank made of clear plastic was used. The bottom of the tank had an orifice incorporating a seal to hold a catheter whilst maintaining no leakage of fluid. A plug was inserted into the funnel of the catheter, and it was inserted upwards from the bottom orifice of the tank. The tank was filled with fluid of a known volume. The plug of the funnel was removed, which enabled the flow of fluid from the tank through catheter eyelets and lumen out of the funnel. The volume of fluid flowing out as a function of time was measured, and the flow rate was calculated. 500ml volume of synthetic urine, Sigmatrix urine diluent (SAE0074-1 L), supplied by Merck (viscosity of 1 .0 cP measured by Anton Parr SVM3001 at room temperature - 22°C) was used. A miniature pressure transducer of <1 ,2mm diameter is inserted into lumen to measure the pressure or a miniature micro strain gauge of < 1 mm diameter to measure the force.

[0063] In one example, the width of the tank is 115 mm. The height of the catheter tip in the tank is 65 mm for Control 1 , Designs 1 -4 and 85 mm for Control 2. The fluid level 221 is 117 mm. The outside height 225of the catheter 211 is 250 mm.

[0064] Fig. 19 is a graph showing the pressure data from the CFD simulation for control 1 at eyelet E1 and eyelet E2. The graph shows recorded pressure [Pa] over time [s].

[0065] Fig. 20 is a graph showing the flow rate from the CFD simulation of the first control catheter and the rates at the outlet, eyelet E1 , and eyelet E2. The graph shows the flow rate [ml / s] over time [s].

[0066] Fig. 21 is a graph showing the pressures from the CFD simulation at particular drainage holes along the length of the second control catheter, including drainage holes 23a, 23b, 23c, 23j, 23t, 23bb, 23cc, and 23dd. The graph shows recorded pressure [Pa] over time [s].

[0067] Fig. 22 is a graph showing the flow rates from the CFD simulation of the second control catheter at specific drainage holes 23a, 23b, 23c, 23j , 23t, 23bb, 23cc, and 23dd and the outlet. The graph shows the flow rate [ml / s] over time [s],

[0068] Fig. 23 is a graph showing pressures from the CFD simulation for the drainage apertures of the embodiment of Figs. 6 and 7, referred to as design 1 . The graph shows pressures for each drainage aperture including eyelets 27, 29 and drainage holes 26a, 26b, 28a, and 28b. The graph shows recorded pressure [Pa] over time [s].

[0069] Fig. 24 is a graph showing the flow rates from the CFD simulation for the drainage apertures of the embodiment of Figs. 6 and 7. The graph shows flow rates for the outlet and ach drainage aperture including eyelets 27, 29 and drainage holes 26a, 26b, 28a, and 28b. The graph shows the flow rate [ml / s] over time [s].

[0070] Fig. 25 is a graph showing pressures from the CFD simulation for the drainage apertures of the embodiment of Figs. 8 and 9, referred to as design 2. The graph shows pressures for each drainage aperture including drainage holes 34a-d, 32a-d and eyelets 31 ,33. The graph shows recorded pressure [Pa] over time [s].

[0071] Fig. 26 is a graph showing flow rates from the CFD simulation for the drainage apertures of the embodiment of Figs. 8 and 9. The graph shows flow rates for the outlet and each drainage aperture including drainage holes 34a-d, 32a-d and eyelets 31 ,33. The graph shows the flow rate [ml / s] over time [s].

[0072] Fig. 27 is a graph showing pressures from the CFD simulation for the drainage apertures of the embodiment of Figs. 10 and 11 , or design 3. The graph shows pressures for each drainage aperture including drainage holes 38a-f, 39a-f, and eyelets 35, 37. The graph shows recorded pressure [Pa] over time [s].

[0073] Fig. 28 is a graph showing flow rates from the CFD simulation for the drainage apertures of the embodiment of Figs. 10 and 11 . The graph shows flow rates for the outlet and each drainage aperture including drainage holes 38a-f, 39a-f, and eyelets 35, 37. The graph shows the flow rate [ml / s] over time [s].

[0074] Fig. 29 is a graph showing pressures from the CFD simulation for the drainage apertures of the embodiment of Figs. 12 and 13. The graph shows pressures for each drainage aperture including eyelets 41 ,43. The graph shows recorded pressure [Pa] over time [s].

[0075] Fig. 30 is a graph showing flow rates from the CFD simulation for the drainage apertures of the embodiment of Figs. 12 and 13. The graph shows flow rates for the outlet and each drainage aperture including eyelets 41 ,43. The graph shows the flow rate [ml / s] over time [s]. The graph shows the flow rate [ml / s] over time [s].

[0076] Figs. 31 -34 show graphs comparing aspects of the two control catheters and the first four embodiments of the current disclosure. Design 1 is the embodiment of Figs. 6 and 7, Design 2 is the embodiment of Figs. 8 and 9.Design 3 is the embodiment of Figs. 10 and 11 . Design 4 is the embodiment of Figs. 12 and 13.

[0077] Fig. 31 shows minimum pressures from the CFD simulation for each embodiment of the four embodiments and the two control catheters. The graph shows recorded pressure [Pa] over time [s].

[0078] Fig. 32 shows the outlet flow rates from the CFD simulation for each of the four embodiments and the two control catheters.

[0079] Fig. 33 shows a graph comparing the forces at the lowest drainage aperture from the CFD simulation. For the first control catheter this is eyelet E2. For the second control catheter this is drainage hole 23dd. For design 1 , shown inFigs. 6 and 7, this is eyelet 29. For design 2, shown in Figs. 8 and 9, this is drainage hole 32d. For design 3, shown in Figs. 10 and 11 , this is drainage hole 39F. For design 4, shown in Figs. 12 and 13, this is eyelet 43. The graph shows recorded force [N] over time [s].

[0080] Fig 34 shows a graph comparing the forces at the at the lowest drainage aperture from the CFD simulation for the second control catheter and designs 2 and 3. The graph shows recorded force [N] over time [s].

[0081] The micro-eyelets of size 400 pm result in reducing suction pressure and force and in plurality (n = 80 to 120) maintain the flow rate. However, they won’t be able to pass sediment > 400 pm in size present in the urine through them and retain it in the bladder. They may also struggle to pass > 250 pm through the micro-eyelets. The conventional 2 eyelets of size ~ 4mm x 2mm result in higher suction pressure or force, but are able to pass large sediment of size > 400 pm size through them. The combination of larger size and micro-eyelets enables reduction of suction pressure whilst allowing large size (> 400 pm size) sediment passing through them.

[0082] 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. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.

Claims

Claims1 . An intermittent urinary catheter, comprising: a catheter shaft having a proximal insertion end portion for advancement through a urethra into a bladder and a distal drainage end portion having a drainage opening, the catheter shaft having a drainage lumen in communication with the drainage opening; and a plurality of drainage apertures located on the proximal insertion end portion; wherein a flow rate of fluid from the bladder through the plurality of drainage apertures is at least 7.4 ml / s and a maximum suction force at any one of the plurality of drainage apertures is less than -3 mN.

2. The intermittent urinary catheter of claim 1 , wherein the pressure at any one of the plurality of drainage apertures is at least -1000Pa.

3. The intermittent urinary catheter of any of the preceding claims, wherein the at least one drainage aperture includes at least one eyelet.

4. The intermittent urinary catheter of any of the preceding claims, wherein the at least one drainage aperture includes at least one drainage hole.

5. The intermittent urinary catheter of any of the preceding claims, wherein the at least one drainage aperture includes at least four drainage holes.

6. The intermittent urinary catheter of any of the preceding clams, wherein the drainage apertures include at least four drainage holes and two eyelets, wherein two of the drainage holes are between the eyelets and two of the drainage holes are proximal both eyelets.

7. The intermittent urinary catheter of claim 1 , wherein the plurality of drainage apertures includes two eyelets and two groups of drainage holes, each set of drainage holes arranged opposite each eyelet.

8. The intermittent urinary catheter of claim 1 , wherein the plurality of drainage apertures includes two eyelets and twelve drainage holes, the twelve drainage holes positioned distal to the two eyelets and arranged in two columns, each column having an axis parallel to a longitudinal axis of the catheter shaft in an offset pattern on opposite surfaces of the catheter.

9. The intermittent urinary catheter of claim 8, wherein the drainage holes are arranged on different surfaces than both eyelets.

10. The intermittent urinary catheter of claim 1 , wherein the plurality of drainage apertures includes two eyelets with a distal extension arranged on opposite surfaces of the catheter.11 . The intermittent urinary catheter of claim 1 , wherein the plurality of drainage apertures includes two eyelets and three drainage holes, each drainage hole differently shaped than the other two drainage holes.

12. The intermittent urinary catheter of any of the preceding claims, wherein the plurality of drainage apertures are located between 2 mm and 30 mm, or preferably between 5 mm and 15 mm from a terminal proximal end.

13. The intermittent urinary catheter of any of the preceding claims, wherein the drainage apertures are able to pass large sediment of size > 400 pm.

14. An intermittent urinary catheter, comprising: a catheter shaft having a proximal insertion end portion and a distal drainage end portion, the catheter shaft having a drainage lumen; a plurality of drainage apertures located on the proximal insertion end portion, the plurality of drainage apertures including at least one eyelet and at least one drainage hole; wherein the at least one eyelet has a cross-sectional area of at least 2 mm2and the at least one drainage hole has a cross-sectional area of at least 0.45 mm2and at most 1 .9 mm2.

15. The intermittent urinary catheter of claim 14, wherein the at least one eyelet has a cross-sectional area between 2 mm2and 10 mm2.

16. The intermittent urinary catheter of any one of claims 15-14, wherein the at least one drainage hole has a diameter between 0.8 mm and 1 .56 mm.

17. The intermittent urinary catheter of any one of claims 14-16, wherein the plurality of drainage apertures includes two eyelets and at least four drainage holes.

18. The intermittent urinary catheter of claim 17, wherein two of the drainage holes are positioned between the two eyelets and two of the drainage holes are positioned proximal to both eyelets.

19. The intermittent urinary catheter of any one of claims 14-18, wherein the plurality of drainage apertures are located between 2 mm and 30 mm from a terminal proximal end of the catheter shaft.

20. The intermittent urinary catheter of claim 19, wherein the plurality of drainage apertures are located between 5 mm and 15 mm from the terminal proximal end of the catheter shaft.

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