EP4637895A1 - Urinary catheter with drainage holes - Google Patents

Urinary catheter with drainage holes

Info

Publication number
EP4637895A1
EP4637895A1 EP23837865.7A EP23837865A EP4637895A1 EP 4637895 A1 EP4637895 A1 EP 4637895A1 EP 23837865 A EP23837865 A EP 23837865A EP 4637895 A1 EP4637895 A1 EP 4637895A1
Authority
EP
European Patent Office
Prior art keywords
catheter
drainage
cross
holes
urinary catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23837865.7A
Other languages
German (de)
French (fr)
Inventor
Damien BIGGINS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hollister Inc
Original Assignee
Hollister Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hollister Inc filed Critical Hollister Inc
Publication of EP4637895A1 publication Critical patent/EP4637895A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains

Definitions

  • This disclosure relates generally to urinary catheters. More particularly, this disclosure relates to intermittent urinary catheters with a plurality of drainage openings associated with the proximal insertion end portion of the catheter.
  • 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.
  • Figs. 1 and 2 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 therethrough 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.
  • a drainage member F such as a funnel
  • 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 and 2, 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 right surfaces, that are on a perpendicular plane about the axis A from the top and bottom surfaces 13, 15 of the catheter.
  • the prior art catheter utilizes two eyelets tor draining during use. However, this draining may not be completely effective and may result in residue urine remaining in the bladder. Additionally, there is a need for eyelets that reduce the chance of urethral trauma during catheterization.
  • Catheters of the current disclosure include arrangements with smaller drainage holes and includes designs where the sum of the cross-sectional areas of all of the drainage holes and eyelets is equal to or greater than the cross-sectional area of the lumen.
  • an intermittent urinary catheter includes a catheter shaft having a proximal insertion end portion for advancement through the 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 catheter includes a plurality of openings on the catheter shaft at the proximal insertion end portion. The total cross-sectional area of the plurality of openings is greater than or equal to a cross-sectional area of the lumen.
  • FIG. 1 is a perspective view of a prior art urinary catheter
  • FIG. 2 is a side view of the proximal insertion end of the prior art urinary catheter of Fig. 1 ;
  • FIG. 3 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 4 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 5 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • FIG. 6 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 7 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • FIG. 8 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • FIG. 9 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 10 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • FIG. 11 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 12 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 13 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 14 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 15 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure
  • Fig. 16 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure.
  • Fig. 17 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure.
  • the present disclosure is directed to intermittent urinary catheters having proximal insertion tips, wherein the urinary catheters include a plurality of openings, such as at least one eyelet and at least one drainage hole, which are positioned relatively close to the proximal terminal end of the catheter shaft.
  • the urinary catheters include a plurality of openings, such as at least one eyelet and at least one drainage hole, which are positioned relatively close to the proximal terminal end of the catheter shaft.
  • the figures include the proximal insertion end portion P of the catheters. Similar to Fig. 1 , the urinary catheter may include a distal end portion (not shown).
  • 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).
  • the urinary catheter includes a drainage lumen that is in communication with the distal end drainage opening of the catheter shaft.
  • the proximal insertion end portion P includes a terminal proximal end 100.
  • the terminal proximal end 100 may be a closed end or an open end.
  • the terminal end 100 is an open end, the terminal end includes an opening in communication with drainage lumen.
  • the proximal insertion end portion P may also include a plurality of openings.
  • the proximal insertion end portion P may include a plurality of drainage holes and may also include at least one eyelet. In certain embodiments, the proximal insertion end portion may not include any eyelets.
  • the drainage holes or holes may be positioned differently relative to the eyelet or eyelets in different embodiments of the current disclosure. In embodiments with a single eyelet, the drainage holes may be located proximately or distally from the eyelet relative to the terminal proximal end 100 of the catheter.
  • the hole(s) may be located on the same surfaces as the eyelet or on at least one of the left and right surfaces 17 and 19 of the catheter.
  • the drainage hole(s) and eyelet(s) extend through the proximal insertion end portion P and in communication 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 have a hydrophilic coating disposed thereon.
  • the proximal most drainage hole or eyelet may be located between about 2 mm and about 30 mm, preferably between about 8 mm and about 24 mm, or more preferably between about 5 mm and about 15 mm from the terminal proximal end 100 of the catheter.
  • the drainage holes and eyelets 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.
  • each of the drainage holes may vary in size and shape.
  • the drainage holes have a generally round shape.
  • the drainage holes may have other shapes, such as oval, oblong, polygonal or irregular.
  • all of the drainage holes are the same shape.
  • the drainage holes may have a combination of shapes in the same embodiment.
  • the eyelets have a generally oval shape.
  • the eyelets may have other shapes, such as oval, circular, or polygonal.
  • the eyelets may have any of the sizes described above.
  • the eyelets may have various sizes and shapes relative to one another.
  • 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 any drainage hole is smaller than the cross-sectional area of any eyelet, such that even the largest drainage hole has a cross-sectional area which is smaller than the cross-sectional area of the smallest eyelet.
  • the cross-sectional area of each drainage hole may vary depending on the embodiment. Overall, the total cross-sectional area of the drainage holes and eyelets combined is greater than or equal to the cross-sectional area of the lumen of the catheter, taken at a perpendicular plane from the center axis A, such as plane 40, with a diameter 50 of the lumen, shown in Fig. 3.
  • the lumen of a C14 catheter for instance, has a cross-sectional area of about 7.50 mm 2 to about 7.60 mm 2 , or about 7.55 mm 2 .
  • the cross-sectional area of one eyelet is about 2.50 mm 2 to about 3.00 mm 2 , or about 2.80 mm 2 .
  • the total cross-sectional area of the two eyelets is about 5.0 to about 6.0 mm 2 , or 5.59 mm 2 . This total is less than the cross-sectional area of the lumen.
  • a drainage hole or eyelet may vary slightly in size, primarily due to finishing techniques (such as rounding of the edges in order to make the outside surface more comfortable for a user).
  • the cross-sectional area of the drainage hole opening can be taken at any parallel plane to the center axis A of the catheter. In a preferred embodiment, the plane is at the smallest opening or diameter of the drainage hole, shown as 44 in Fig. 4, 46 in Fig. 5, and 48 in Fig. 6.
  • FIG. 7-17 A number of different eyelet(s) and drainage hole(s) arrangements are disclosed in Figs. 7-17. These are non-limiting and other arrangements are within the scope of this disclosure.
  • Figs. 7 and 8 show a possible embodiment with a set of five drainage holes 20a, 20b, 20c, 20d, and 20e arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2.
  • the illustrated catheter may include only one eyelet.
  • Holes 20 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the top surface 13 of the catheter.
  • E2 is arranged on the bottom surface 15 of the catheter as determined from the longitudinal axis A of the catheter.
  • the holes are arranged in offset rows, with 20a and 20b in the most proximal row, 20c located below 20a and 20b and between the two holes and 20d and 20e as the most distal row. 20d and 20e are directly below 20a and 20b.
  • the drainage holes are shown as circular, but may be any known or acceptable shape, such as oval.
  • the approximate diameter of each hole is 1 .10mm and the approximate cross-sectional area of each hole is about 0.95 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings added together is about 4.75 mm 2
  • the cross-sectional area of the opening of the eyelet is about 2.8 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross- sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 .
  • the holes are located at about 12 mm from the terminal proximal end 100 of the catheter.
  • Fig. 9 shows another possible embodiment with a set of five drainage holes 22a, 22b, 22c, 22d, and 22e arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2.
  • the illustrated catheter may include only one eyelet.
  • Holes 22 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the bottom surface 15 of the catheter.
  • E1 is arranged on the top surface 13 of the catheter as determined from 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 22a and 22b and between the two holes and 22d and 22e as the most distal row. 22d and 22e are directly below 22a and 22b.
  • the drainage 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 opening of the eyelet is about 4.75 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 .
  • the holes are located at about 24 mm from the terminal proximal end 100 of the catheter. [00040] Figs.
  • FIGS. 10 and 11 show an alternative with a set of seven drainage holes 24a, 24b, 24c, 24d, 24e, 24f, 24g arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2.
  • the illustrated catheter may include only one eyelet.
  • Holes 24 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the bottom surface 15 of the catheter.
  • E1 is arranged on the top surface 13 of the catheter as determined from the longitudinal axis A of the catheter.
  • the holes are arranged in offset rows, with 24a in the most proximal row, 24b and 24c on horizontal sides of 24a and below 24a, 24d directly below 24a and distally below 24b and 24c, 24e and 24f below and on the horizontal sides of 24d, and 24g located the most distal and directly below 24a and 24d.
  • the drainage 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 opening of the eyelet is about 4.75 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 .
  • the holes are located at about 24 mm from the terminal proximal end 100 of the catheter.
  • Fig. 12 shows a possible embodiment with a set of seven drainage holes 26a, 26b, 26c, 26d, 26e, 26f, 26g arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2.
  • the illustrated catheter may include only one eyelet.
  • This embodiment is opposite from the embodiment of Figs. 10 and 11 in that the opposite eyelet is being replaced in the prior art catheter of Fig. 2.
  • Holes 26 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the top surface 13 of the catheter.
  • E2 is arranged on the bottom surface 15 of the catheter as determined from 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 horizontal sides of 26a and below 26a, 26c directly below 26a and distally below 26b and 26c, 26e and 26f below and on the horizontal sides of 26d, and 26g located the most distal and directly below 26a and 26d.
  • the drainage 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 cross-sectional area of each hole is about 0.68 mm 2 .
  • the cross- sectional area of the opening of the eyelet is about 4.75 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 .
  • the holes are located at about 12 mm from the terminal proximal end 100 of the catheter. [00042] Figs.
  • FIG. 13 shows a possible embodiment with a set of nine drainage holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, 30i and a larger drainage hole 28 arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2.
  • Holes 28 and 30 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the bottom surface 15 of the catheter.
  • Eyelet E1 is arranged on the top surface 13 of the catheter as determined from the longitudinal axis A of the catheter.
  • the holes are arranged with the larger hole 28 in the center of the arrangement and 30a-30i arranged in a circle surrounding hole 28.
  • the larger middle drainage hole may be an oval or elliptical shape, while the smaller holes 30 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape.
  • the approximate diameter of hole 28 is from 0.9 mm to 1 .4 mm and the approximate cross-sectional area is 1 ,09mm 2 .
  • the approximate diameter of holes 30a-30i is 0.62 mm and the approximate cross-sectional area is between 0.3 mm 2 .
  • the cross-sectional area of the opening of the eyelet is about 4.75 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross- sectional area of the eyelet is about 4.8:1 .
  • the holes are located at about 24 mm from the terminal proximal end 100 of the catheter.
  • Figs. 14 and 15 show another possible embodiment which includes the set of nine drainage holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, 30i and a larger drainage hole 28 of Fig. 13 at the location of eyelet E2 and another set of nine drainage holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, 34i and larger drainage hole 32 proximal to the other set of holes 30 and 28 at the location of eyelet E1 , on the top surface 13 of the catheter.
  • Each set of holes replaces an eyelet E1 or E2, and each set is on an opposing surface of the catheter.
  • the larger middle drainage holes 28 and 32 may be an oval or elliptical shape, while the smaller holes 34 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape.
  • the larger middle drainage hole may have a diameter of between 0.9 mm and 1 .4 mm and cross- sectional area 1 .09 mm 2 .
  • the smaller drainage holes 34 may have a diameter of 0.62 mm and have a cross-sectional area of 0.3 mm 2 .
  • the cross-sectional area of the opening of the eyelet is about 4.75 mm 2 .
  • the aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross- sectional area of the eyelet is about 4.8:1 .
  • Fig. 16 shows another possible embodiment with nine drainage holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, 34i and larger drainage hole 32 arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2.
  • Holes 32 and 34 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter.
  • drainage holes are in the top surface 13 of the catheter.
  • Eyelet E2 is arranged on the bottom surface 15 of the catheter as determined from the longitudinal axis A of the catheter.
  • the holes are arranged with the larger hole 32 in the center of the arrangement and 34a-34i arranged in a circle surrounding hole 32.
  • the larger middle drainage hole may be an oval or elliptical shape, while the smaller holes 34 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape.
  • Figure 17 includes a group of drainage holes 38 positioned on the proximal insertion end of the catheter.
  • the holes are patterned in a helical configuration or helical pattern about axis A of the catheter shaft.
  • the drainage holes may have a diameter of 0.3 mm to 0.7 mm a cross- sectional area of 1 .9 mm 2 .
  • the group of drainage holes 38 replace the eyelets of the prior art catheter.

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Abstract

Catheters that have a plurality of openings on the proximal insertion end portion of the catheter.

Description

Urinary Catheter with Drainage Holes
Cross-Reference to Related Application
This application claims the benefit of U.S. Provisional Application Serial No. 63/476,248, filed December 20, 2022, the disclosure of which is hereby incorporated by reference in its entirety.
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 openings 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 and 2 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 therethrough 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 and 2, 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 right surfaces, that are on a perpendicular plane about the axis A from the top and bottom surfaces 13, 15 of the catheter.
[0005] The prior art catheter utilizes two eyelets tor draining during use. However, this draining may not be completely effective and may result in residue urine remaining in the bladder. Additionally, there is a need for eyelets that reduce the chance of urethral trauma during catheterization.
[0006] There remains a need for catheters with improved draining.
Catheters of the current disclosure include arrangements with smaller drainage holes and includes designs where the sum of the cross-sectional areas of all of the drainage holes and eyelets is equal to or greater than the cross-sectional area of the lumen.
Summary
[0007] In one aspect, an intermittent urinary catheter includes a catheter shaft having a proximal insertion end portion for advancement through the 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 catheter includes a plurality of openings on the catheter shaft at the proximal insertion end portion. The total cross-sectional area of the plurality of openings is greater than or equal to a cross-sectional area of the lumen.
Brief Description of the Drawings
[0008] Fig. 1 is a perspective view of a prior art urinary catheter;
[0009] Fig. 2 is a side view of the proximal insertion end of the prior art urinary catheter of Fig. 1 ;
[00010] Fig. 3 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00011] Fig. 4 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure; [00012] Fig. 5 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00013] Fig. 6 is an enlarged cross-sectional view of a portion of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00014] Fig. 7 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00015] Fig. 8 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00016] Fig. 9 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00017] Fig. 10 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00018] Fig. 11 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00019] Fig. 12 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00020] Fig. 13 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00021] Fig. 14 is a bottom view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00022] Fig. 15 is a perspective side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure;
[00023] Fig. 16 is a top view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure; and
[00024] Fig. 17 is a side view of the proximal insertion end of a urinary catheter of an exemplary embodiment of the current disclosure.
Detailed Description of the Embodiments
[00025] The present disclosure is directed to intermittent urinary catheters having proximal insertion tips, wherein the urinary catheters include a plurality of openings, such as at least one eyelet and at least one drainage hole, which are positioned relatively close to the proximal terminal end of the catheter shaft. [00026] Turning now to the figures, a number of embodiments of urinary catheters of the present disclosure are shown. The figures include the proximal insertion 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.
[00027] The proximal insertion end portion P includes a terminal proximal end 100. 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.
[00028] The proximal insertion end portion P may also include a plurality of openings. The proximal insertion end portion P may include a plurality of drainage holes and may also include at least one eyelet. In certain embodiments, the proximal insertion end portion may not include any eyelets. The drainage holes or holes may be positioned differently relative to the eyelet or eyelets in different embodiments of the current disclosure. In embodiments with a single eyelet, the drainage holes may be located proximately or distally from the eyelet relative to the terminal proximal end 100 of the catheter. The hole(s) may be located on the same surfaces as the eyelet or on at least one of the left and right surfaces 17 and 19 of the catheter.
[00029] The drainage hole(s) and eyelet(s) extend through the proximal insertion end portion P and in communication 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 have a hydrophilic coating disposed thereon.
[00030] The proximal most drainage hole or eyelet may be located between about 2 mm and about 30 mm, preferably between about 8 mm and about 24 mm, or more preferably between about 5 mm and about 15 mm from the terminal proximal end 100 of the catheter. [00031] The drainage holes and eyelets 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.
[00032] In the illustrated embodiments, each of the drainage holes may vary in size and shape. For instance, in certain embodiments, the drainage holes have a generally round shape. However, in other alternatives, the drainage holes may have other shapes, such as oval, oblong, polygonal or irregular. In another alternatives, all of the drainage holes are the same shape. In yet other alternatives, the drainage holes may have a combination of shapes in the same embodiment.
[00033] 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 have any of the sizes described above. In yet other alternatives, the eyelets may have various sizes and shapes relative to one another.
[00034] 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 any drainage hole is smaller than the cross-sectional area of any eyelet, such that even the largest drainage hole has a cross-sectional area which is smaller than the cross-sectional area of the smallest eyelet.
[00035] The cross-sectional area of each drainage hole may vary depending on the embodiment. Overall, the total cross-sectional area of the drainage holes and eyelets combined is greater than or equal to the cross-sectional area of the lumen of the catheter, taken at a perpendicular plane from the center axis A, such as plane 40, with a diameter 50 of the lumen, shown in Fig. 3. The lumen of a C14 catheter for instance, has a cross-sectional area of about 7.50 mm2 to about 7.60 mm2, or about 7.55 mm2. For a typical prior art catheter, the cross-sectional area of one eyelet is about 2.50 mm2 to about 3.00 mm2, or about 2.80 mm2. For a prior art catheter with two eyelets, the total cross-sectional area of the two eyelets is about 5.0 to about 6.0 mm2, or 5.59 mm2. This total is less than the cross-sectional area of the lumen.
[00036] When created, a drainage hole or eyelet may vary slightly in size, primarily due to finishing techniques (such as rounding of the edges in order to make the outside surface more comfortable for a user). The cross-sectional area of the drainage hole opening can be taken at any parallel plane to the center axis A of the catheter. In a preferred embodiment, the plane is at the smallest opening or diameter of the drainage hole, shown as 44 in Fig. 4, 46 in Fig. 5, and 48 in Fig. 6.
[00037] A number of different eyelet(s) and drainage hole(s) arrangements are disclosed in Figs. 7-17. These are non-limiting and other arrangements are within the scope of this disclosure.
[00038] Figs. 7 and 8 show a possible embodiment with a set of five drainage holes 20a, 20b, 20c, 20d, and 20e arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2. The illustrated catheter may include only one eyelet. Holes 20 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the top surface 13 of the catheter. E2 is arranged on the bottom surface 15 of the catheter as determined from the longitudinal axis A of the catheter. The holes are arranged in offset rows, with 20a and 20b in the most proximal row, 20c located below 20a and 20b and between the two holes and 20d and 20e as the most distal row. 20d and 20e are directly below 20a and 20b. The drainage holes are shown as circular, but may be any known or acceptable shape, such as oval. The approximate diameter of each hole is 1 .10mm and the approximate cross-sectional area of each hole is about 0.95 mm2. The aggregate cross-sectional areas of the drainage holes' openings added together is about 4.75 mm2 The cross-sectional area of the opening of the eyelet is about 2.8 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross- sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 . The holes are located at about 12 mm from the terminal proximal end 100 of the catheter. [00039] Fig. 9 shows another possible embodiment with a set of five drainage holes 22a, 22b, 22c, 22d, and 22e arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2. The illustrated catheter may include only one eyelet. This embodiment is opposite from the embodiment of Figs. 7 and 8 in that the opposite eyelet is being replaced in the prior art catheter of Fig. 2. Holes 22 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the bottom surface 15 of the catheter. E1 is arranged on the top surface 13 of the catheter as determined from 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 22a and 22b and between the two holes and 22d and 22e as the most distal row. 22d and 22e are directly below 22a and 22b. The drainage 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 mm2. The cross-sectional area of the opening of the eyelet is about 4.75 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 . The holes are located at about 24 mm from the terminal proximal end 100 of the catheter. [00040] Figs. 10 and 11 show an alternative with a set of seven drainage holes 24a, 24b, 24c, 24d, 24e, 24f, 24g arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2. The illustrated catheter may include only one eyelet. Holes 24 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the bottom surface 15 of the catheter. E1 is arranged on the top surface 13 of the catheter as determined from the longitudinal axis A of the catheter. The holes are arranged in offset rows, with 24a in the most proximal row, 24b and 24c on horizontal sides of 24a and below 24a, 24d directly below 24a and distally below 24b and 24c, 24e and 24f below and on the horizontal sides of 24d, and 24g located the most distal and directly below 24a and 24d. The drainage 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 mm2. The cross-sectional area of the opening of the eyelet is about 4.75 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 . The holes are located at about 24 mm from the terminal proximal end 100 of the catheter.
[00041] Fig. 12 shows a possible embodiment with a set of seven drainage holes 26a, 26b, 26c, 26d, 26e, 26f, 26g arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2. The illustrated catheter may include only one eyelet. This embodiment is opposite from the embodiment of Figs. 10 and 11 in that the opposite eyelet is being replaced in the prior art catheter of Fig. 2. Holes 26 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the top surface 13 of the catheter. E2 is arranged on the bottom surface 15 of the catheter as determined from 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 horizontal sides of 26a and below 26a, 26c directly below 26a and distally below 26b and 26c, 26e and 26f below and on the horizontal sides of 26d, and 26g located the most distal and directly below 26a and 26d. The drainage 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 cross-sectional area of each hole is about 0.68 mm2. The cross- sectional area of the opening of the eyelet is about 4.75 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross-sectional area of the eyelet is about 1 .7:1 . The holes are located at about 12 mm from the terminal proximal end 100 of the catheter. [00042] Figs. 13 shows a possible embodiment with a set of nine drainage holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, 30i and a larger drainage hole 28 arranged distally from eyelet E1 , away from the terminal proximal end of the catheter, located approximately at the location of E2 in the prior art catheter of Fig. 2. Holes 28 and 30 are arranged on an opposite surface of the catheter from the eyelet E1 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the bottom surface 15 of the catheter. Eyelet E1 is arranged on the top surface 13 of the catheter as determined from the longitudinal axis A of the catheter. The holes are arranged with the larger hole 28 in the center of the arrangement and 30a-30i arranged in a circle surrounding hole 28. The larger middle drainage hole may be an oval or elliptical shape, while the smaller holes 30 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape. The approximate diameter of hole 28 is from 0.9 mm to 1 .4 mm and the approximate cross-sectional area is 1 ,09mm2. The approximate diameter of holes 30a-30i is 0.62 mm and the approximate cross-sectional area is between 0.3 mm2. The cross-sectional area of the opening of the eyelet is about 4.75 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross- sectional area of the eyelet is about 4.8:1 . The holes are located at about 24 mm from the terminal proximal end 100 of the catheter.
[00043] Figs. 14 and 15 show another possible embodiment which includes the set of nine drainage holes 30a, 30b, 30c, 30d, 30e, 30f, 30g, 30h, 30i and a larger drainage hole 28 of Fig. 13 at the location of eyelet E2 and another set of nine drainage holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, 34i and larger drainage hole 32 proximal to the other set of holes 30 and 28 at the location of eyelet E1 , on the top surface 13 of the catheter. Each set of holes replaces an eyelet E1 or E2, and each set is on an opposing surface of the catheter. The larger middle drainage holes 28 and 32 may be an oval or elliptical shape, while the smaller holes 34 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape. The larger middle drainage hole may have a diameter of between 0.9 mm and 1 .4 mm and cross- sectional area 1 .09 mm2. The smaller drainage holes 34 may have a diameter of 0.62 mm and have a cross-sectional area of 0.3 mm2. The cross-sectional area of the opening of the eyelet is about 4.75 mm2. The aggregate cross-sectional areas of the drainage holes' openings 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 aggregate cross-sectional areas of the drainage holes' openings to the cross- sectional area of the eyelet is about 4.8:1 .
[00044] Fig. 16 shows another possible embodiment with nine drainage holes 34a, 34b, 34c, 34d, 34e, 34f, 34g, 34h, 34i and larger drainage hole 32 arranged proximally from eyelet E2, toward the terminal proximal end of the catheter, located approximately at the location of E1 in the prior art catheter of Fig. 2.
Holes 32 and 34 are arranged on an opposite surface of the catheter from the eyelet E2 determined from the longitudinal axis A of the catheter. In the illustrated embodiment, drainage holes are in the top surface 13 of the catheter. Eyelet E2 is arranged on the bottom surface 15 of the catheter as determined from the longitudinal axis A of the catheter. The holes are arranged with the larger hole 32 in the center of the arrangement and 34a-34i arranged in a circle surrounding hole 32. The larger middle drainage hole may be an oval or elliptical shape, while the smaller holes 34 are circular in shape. However, the shapes of either drainage hole may vary and be any acceptable shape. The approximate size of the diameter of hole 32 is from 0.9 mm to 1 .4 mm and the approximate cross- sectional area is 1 .09 mm2. The approximate length of the diameter of holes 34a- 34i is 0.62 mm and the approximate cross-sectional area is 0.3 mm2. The holes are located at about 12 mm from the terminal proximal end 100 of the catheter. [00045] Figure 17 includes a group of drainage holes 38 positioned on the proximal insertion end of the catheter. In this embodiment, the holes are patterned in a helical configuration or helical pattern about axis A of the catheter shaft. The drainage holes may have a diameter of 0.3 mm to 0.7 mm a cross- sectional area of 1 .9 mm2. The group of drainage holes 38 replace the eyelets of the prior art catheter.
[00046] The examples described above are examples of catheters with drainage holes. The number and pattern of the holes can be modified in any way so that the total cross-sectional area of the openings (drainage holes and eyelets) is equal or larger than the cross-sectional area of the catheter lumen. [00047] 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

Claims
1 . 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 openings on the catheter shaft at the proximal insertion end portion; and wherein a total cross-sectional area of the plurality of openings is greater than or equal to a cross-sectional area of the lumen.
2. The intermittent urinary catheter of claim 1 , wherein the plurality of openings includes a plurality of drainage holes.
3. The intermittent urinary catheter of one of any of the preceding claims, wherein the plurality of openings includes at least one eyelet.
4. The intermittent urinary catheter of claim 3, wherein the plurality of openings include a plurality of drainage holes and a single eyelet.
5. The intermittent urinary catheter of claim 4, wherein the eyelet is arranged on the opposite surface of the catheter from the drainage holes.
6. The intermittent urinary catheter of claim 2, wherein the plurality of drainage holes includes holes with at least two different shapes.
7. The intermittent urinary catheter of claim 2, wherein the plurality of drainage holes includes holes of the same shape.
8. The intermittent urinary catheter of claim 2, wherein the plurality of drainage holes are arranged in offset rows.
9. The intermittent urinary catheter of one of any of the preceding claims, wherein the catheter includes at least five drainage holes.
10. The intermittent urinary catheter of claim 2, wherein the plurality of drainage holes are extending in a helical pattern about the catheter shaft.
11 . The intermittent urinary catheter of claim 4, wherein the plurality of drainage holes are proximal to the eyelet.
12. The intermittent urinary catheter of claim 4, wherein the plurality of drainage holes are distal to the eyelet.
13. The intermittent urinary catheter of claim 2, wherein the cross-sectional area of a drainage hole is about 0.95 mm2.
14. The intermittent urinary catheter of claim 2, wherein the cross-sectional area of each drainage hole is about 0.95 mm2.
15. The intermittent urinary catheter of claim 4, wherein a ratio of an aggregate cross-sectional areas 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 drainage holes of the plurality of drainage holes have different cross-sectional areas.
17. The intermittent urinary catheter of claim 16, wherein at least one drainage hole has a cross-sectional area of cross-sectional area 1 .09 mm2 and at least one other drainage hole has a cross-sectional area of 0.3 mm2.
18. The intermittent urinary catheter of claim 16, wherein one drainage hole has a larger cross-sectional area than all of the other drainage holes.
19. The intermittent urinary catheter of claim 18, wherein all of the other drainage holes have the same cross-sectional areas.
20. The intermittent urinary catheter of one of any of the preceding claims, wherein the catheter shaft has proximal terminal end and the plurality of holes are spaced about 2 mm to about 30 mm from the proximal terminal end, preferably spaced between about 8 mm to about 24 mm, or preferably about 5 mm to about 15 mm.
EP23837865.7A 2022-12-20 2023-12-01 Urinary catheter with drainage holes Pending EP4637895A1 (en)

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PCT/US2023/082113 WO2024137169A1 (en) 2022-12-20 2023-12-01 Urinary catheter with drainage holes

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USD1083086S1 (en) 2022-12-20 2025-07-08 Hollister Incorporated Intermittent urinary catheter
US20250161627A1 (en) 2023-10-27 2025-05-22 Nowwell Flow Technology AS Catheter
USD1103378S1 (en) 2024-05-29 2025-11-25 Hollister Incorporated Intermittent urinary catheter
GB202408896D0 (en) * 2024-05-31 2024-08-07 Convatec Ltd Urinary catheters

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US6358229B1 (en) * 1998-02-17 2002-03-19 Conticare Medical, Inc. Urinary drain
MX2021005900A (en) * 2018-11-21 2021-08-11 Coloplast As An intermittent urinary catheter.
US20240123181A1 (en) * 2021-04-16 2024-04-18 Hollister Incorporated Urinary catheter with patterned drainage holes to provide tip flexibility
WO2022251389A1 (en) * 2021-05-26 2022-12-01 Foldé Inc. Flexible catheters and related methods

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