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EP-4364777-B1 - INTERMITTENT-CATHETER ASSEMBLIES AND METHODS THEREOF

EP4364777B1EP 4364777 B1EP4364777 B1EP 4364777B1EP-4364777-B1

Inventors

  • Legaspi, Ronald N.
  • HUGHETT, JAMES DAVID
  • DAW, Kyle

Dates

Publication Date
20260506
Application Date
20210729

Claims (15)

  1. An intermittent-catheter assembly (100;300;400), comprising: a collapsible catheter housing (102;302;402) including: an inner sleeve (106;306;406); and an outer sleeve (108;308;408) slidably mounted over the inner sleeve; and an intermittent catheter (104;304;404) including: a funnel (118;318;418) having a funnel opening (122;322;422) for voiding urine; and a catheter tube (120;320;420) coupled to the funnel, the intermittent-catheter assembly having: a storage state in which the intermittent catheter is sealed within the catheter housing; and an opened state in which the catheter housing is collapsed exposing the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing; the intermittent catheter further including a cap (110;410) coupled to the funnel by a living hinge (114;414) or the intermittent catheter further including a cap (310) integrated into an end portion of the funnel opposite the catheter tube.
  2. The intermittent-catheter assembly of claim 1, wherein the funnel opening opens in a proximal end of the funnel opposite the catheter tube.
  3. The intermittent-catheter assembly of claim 1, wherein the intermittent catheter further includes the cap integrated into an end portion of the funnel opposite the catheter tube, and wherein the funnel opening opens in a side of the funnel.
  4. The intermittent-catheter assembly of any claim of claims 1 or 2, wherein the cap includes an annular seal (112;312;412) around a perimeter of the cap, and optionally, wherein the seal is an 'O'-ring disposed in an annular groove around the perimeter of the cap.
  5. The intermittent-catheter assembly of any claim of claims 1-4, further comprising a lubricant disposed in the inner sleeve between the inner sleeve and the catheter tube in the storage state of the intermittent-catheter assembly.
  6. The intermittent-catheter assembly of any claim of claims 1-5, wherein the catheter housing is configured to collapse when a distal end of the inner sleeve is held against a surface and the outer sleeve is moved toward the surface, thereby exposing the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing.
  7. The intermittent-catheter assembly of any claim of claims 1-6, wherein the funnel includes a plurality of ridges (124;324;424) integrated into an outer surface of the funnel, the ridges configured for gripping the funnel as a handle while removing the intermittent catheter from the catheter housing or voiding urine.
  8. The intermittent-catheter assembly of any claim of claims 1-7, wherein the catheter tube includes a plurality of eyelets (126;326;426) proximate a catheter tip (128;328;428), the eyelets in fluid communication with the funnel opening (122;322;422).
  9. A method of an intermittent-catheter assembly (100;300;400), comprising: obtaining the intermittent-catheter assembly in a storage state thereof, the intermittent-catheter assembly including an intermittent catheter disposed in a catheter housing (102;302;402); transitioning the intermittent-catheter assembly into an opened state thereof, the transitioning of the intermittent-catheter assembly into the opened state including: grasping an outer sleeve (108;308;408) of the catheter housing; holding a distal end of the intermittent-catheter assembly against a surface by the outer sleeve; and moving the outer sleeve toward the surface to expose a funnel of the intermittent catheter; and removing the intermittent catheter from the catheter housing by a funnel of the intermittent catheter, wherein the intermittent catheter includes a cap (110;410) coupled to the funnel by a living hinge (114;414) or the intermittent catheter further including a cap (310) integrated into an end portion of the funnel opposite the catheter tube.
  10. The method of claim 9, wherein the moving of the outer sleeve toward the surface slides the outer sleeve over an inner sleeve of the catheter housing, the outer sleeve mounted over the inner sleeve.
  11. The method of either claim 9 or 10, wherein moving the outer sleeve toward the surface to expose the funnel of the intermittent catheter includes exposing a funnel opening in a side of the funnel.
  12. The method of claim 9, wherein the moving of the outer sleeve toward the surface collapses a collapsible outer cover of the catheter housing, the outer sleeve coupled to the outer cover.
  13. The method of any of claims 9, 10 or 12, further comprising uncapping the cap, the cap capping a funnel opening in a proximal end of the funnel.
  14. The method of any claim of claims 9-13, further comprising inserting a catheter tube of the intermittent catheter into a urethra; and voiding urine from a bladder.
  15. The method of claim 14, further comprising: removing the catheter tube from the urethra after the voiding of the urine from the bladder; and inserting the intermittent catheter into the catheter housing, optionally, with concomitant capping of the proximal opening of the funnel, thereby sealing the intermittent catheter in the catheter housing and preventing residual urine leakage from the intermittent-catheter assembly in the storage state of the intermittent-catheter assembly.

Description

PRIORITY This application claims the benefit of priority to U.S. Provisional Patent Application No. 63/060,615, filed August 3, 2020, and U.S. Provisional Patent Application No. 63/211,922, filed June 17, 2021. BACKGROUND Users of urinary catheters such as intermittent catheters self-catheterize four to six times a day. As such, a simple-to-use intermittent catheter that ensures sterility before use and facilitate cleanliness after use is needed. EP 1858575 A1 discloses an assembly for preparing a medical device, in particular a urinary catheter, by releasing a fluid medium onto the device. The device is packed in a package which contains the fluid medium confined in a compartment. To ensure preparation of the device, the package is adapted to open the compartment and the package in one and the same opening action, preferably so that the compartment opens at the latest when the package opens. In that way, removal of the device from the package requires opening of the compartment and the device is therefore wetted automatically as part of the opening procedure. Disclosed herein are intermittent-catheter assemblies and methods thereof that address the foregoing. SUMMARY According to a first aspect, there is provided an intermittent-catheter assembly according to claim 1. In some embodiments, the funnel opening opens in a proximal end of the funnel opposite the catheter tube. In some embodiments, the funnel opening opens in a side of the funnel. In some embodiments, the cap includes an annular seal around a perimeter of the cap. In some embodiments, the seal is an 'O'-ring disposed in an annular groove around the perimeter of the cap. In some embodiments, the intermittent-catheter assembly further includes a lubricant disposed in the inner sleeve between the inner sleeve and the catheter tube in the storage state of the intermittent-catheter assembly. In some embodiments, the catheter housing is configured to collapse when a distal end of the inner sleeve is held against a surface and the outer sleeve is moved toward the surface. When collapsed, the catheter housing exposes the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing. In some embodiments, the funnel includes a plurality of ridges integrated into an outer surface of the funnel. The ridges are configured for gripping the funnel as a handle while removing the intermittent catheter from the catheter housing or voiding urine. In some embodiments, the catheter tube includes a plurality of eyelets proximate a catheter tip. The eyelets are in fluid communication with the funnel opening. According to a second aspect, there is provided a method of an intermittent-catheter assembly according to claim 9. In some embodiments, the sleeve-moving step slides the outer sleeve over an inner sleeve of the catheter housing. The outer sleeve is mounted over the inner sleeve. In some embodiments, the sleeve-moving step includes exposing a funnel opening in a side of the funnel. In some embodiments, the sleeve-moving step collapses a collapsible outer cover of the catheter housing. The outer sleeve is coupled to the outer cover. In some embodiments, the method further includes another alternative uncapping step. The other alternative uncapping step includes uncapping a cap capping a funnel opening in a proximal end of the funnel. The cap is coupled to the funnel by a living hinge. In some embodiments, the method further includes a first catheter-inserting step and a urine-voiding step. The first catheter-inserting step includes inserting a catheter tube of the intermittent catheter into a urethra. The urine-voiding step includes voiding urine from a bladder. In some embodiments, the method further includes a second catheter-removing step and a second catheter-inserting step. The second catheter-removing step includes removing the catheter tube from the urethra after the urine-voiding step. The second catheter-inserting step includes inserting the intermittent catheter into the catheter housing. Optionally, the second catheter-inserting step is performed concomitantly with a capping step of capping the proximal opening of the funnel. The second catheter-inserting step with the optional capping step seals the intermittent catheter in the catheter housing and prevents residual urine leakage from the intermittent-catheter assembly in the storage state of the intermittent-catheter assembly. These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail. DRAWINGS FIG. 1 illustrates a first intermittent-catheter assembly in a storage state.FIG. 2 illustrates the intermittent-catheter assembly of FIG. 1 in an opened state.FIG. 3 illustrates an intermittent catheter of the intermittent-catheter assembly of FIG. 1.FIG. 4 illustrates a second interm