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EP-4736927-A2 - MEDICAL DEVICE PACKAGE WITH FLIP CAP HAVING A SNAP FIT

EP4736927A2EP 4736927 A2EP4736927 A2EP 4736927A2EP-4736927-A2

Abstract

A package for a medical device such as an intermittent catheter has a case with open and closed ends. A hinge connects a cap to the case to permit movement of the cap between open and closed positions. A seal connected to one of the cap and case is engageable with the other to maintain a sterile environment inside the package. The seal can be repeatedly made and broken whenever the user closes or opens the cap. The case includes a pair of slots at the open end. A pair of latches is formed in the cap. The latches fit into the slots to prevent lateral forces from distorting the cap when the cap is closed. A first use indication label spans a depression in the outer contour of a closed cap and case, assuring visual confirmation of breach of the label upon first opening of the cap.

Inventors

  • MCMENAMIN, Martin
  • NAUGHTON, VINCENT
  • O'BRIEN, Daniel, E.
  • PUPINO, Scott, J.
  • CREAVEN, MARTIN, P.
  • HANLEY, Joseph, N.
  • MCFADDEN, Kieran, J.
  • O'GRADY, Claire

Assignees

  • Hollister Incorporated

Dates

Publication Date
20260506
Application Date
20180221

Claims (13)

  1. A medical device package for a catheter, comprising: a case having a tubular wall which is closed at one end and open at the other end; a cap; a hinge having one end connected to the cap and a second end connected to said other end of the hollow tube, the hinge permitting selectable movement of the cap between an open position, wherein access is provided to the open end of the hollow tube, and a closed position, wherein the cap prevents access to the open end of the hollow tube; and at least one rib formed on and extending radially from the interior of the tubular wall, the rib being disposed in a circumferential location near the open end of the tubular wall where the rib is engageable with the catheter to prevent tilting of the catheter away from the hinge and to a position where it could interfere with closing of the cap.
  2. The medical device package of claim 1 further comprising a seal connected to at least one of the cap and case, the seal being engageable with the other of the cap and case when the cap is in the closed position to form a barrier between the cap and case that maintains a sterile environment inside the case and cap.
  3. The medical device package of claim 1 wherein the case includes a projection at the open end of the case, the projection having a cylindrical exterior, and the cap includes a shell having a cylindrical interior that receives the projection therein when the cap is in the closed position.
  4. The medical device package of claim 3 further comprising a seal connected to the exterior of the projection where the seal is engageable with the interior of the shell portion when the cap is in the closed position.
  5. The medical device package of claim 1 further comprising at least one latch formed on one of the case and cap; and at least one slot formed in the other of the case and cap, the latch and slot being engageable with one another when the cap is closed.
  6. The medical device package of claim 5 wherein the latch has at least one undercut which defines a tab.
  7. The medical device package of claim 6 wherein the slot defines at least one ear, the tab and ear being disposed so as to flex past one another during an opening or closing movement of the cap.
  8. The medical device package of claim 7 further comprising a second latch and each latch has an undercut which defines a pair of tabs; and a second slot which together with the first slot defines a detent having a pair of ears, the tabs and ears being disposed so as to flex past one another during an opening or closing movement of the cap.
  9. The medical device package of claim 1 further comprising a hydration liner having a seat sized to engage the internal surface of the tubular wall of the case, the hydration liner further including a hollow tube attached to the seat and extending therefrom to an open end, the hollow tube having an outside diameter less than the internal diameter of the tubular wall of the case.
  10. The medical device package of claim 1 wherein the catheter comprises a funnel and the rib is engageable with the funnel.
  11. The medical device package of claim 2 wherein the seal is an O-ring.
  12. The medical device package of any one of claims 1-11 further comprising an insert having a collet mounted in the case, with the projection attached to the collet.
  13. The medical device package of claim 12 wherein the collet forms a seal with an internal surface of the tubular wall.

Description

Cross-reference to Related Applications The present application claims the benefit of and priority to: U.S. Provisional Patent Application No. 62/461,635, filed February 21, 2017; and International Application No. PCT/US17/28979, filed April 21, 2017, the disclosures of all of which are hereby incorporated herein by reference. Field of the Disclosure This disclosure relates generally to packaging for medical devices such as urinary catheters. More particularly, this disclosure relates to compact catheters, such as urinary catheters, and the packaging, storing and hydrating/lubricating of such catheters. Background Intermittent catheterization is a good option for many users who suffer from a neurogenic bladder, that is, an atonic or unstable bladder associated with a neurological condition, such as diabetes, stroke, or spinal cord injury. Very often a neurogenic bladder is caused by conditions which may also result in diminished dexterity of the user. Commonly, in intermittent catheterization single use, individually packaged, sterile catheters are used. Catheters often include a surface treatment that reduces friction to allow for easier and less traumatic insertion into and through the user's urethra. Regardless of whether a surface treatment is used or what type of surface treatment is used, some type of package for the catheter is required. In the past various kinds of packages have been used, including molded containers of assorted sizes and shapes, bags and pouches made of plastic or metal foil, and similar kinds of devices While these prior art packages generally accomplish the objective of protecting the catheter during transport, storage and preparation for use, they suffer from disadvantages that range from fundamental - the packages may break open prematurely; to economic - the package designs are wasteful of material and labor; to the annoying - the packages confuse users as to how to open them or are difficult for a user of low dexterity to easily access the catheter, or the packages tend to spill the hydrating medium upon opening. Accordingly, what is needed is a catheter package that is economical to manufacture and fill, reliable throughout its useful life, and simple and intuitive to use. It is also desirable to have a compact package which is can be discreetly carried by the user in a purse or pouch; discrete to dispose of in a waste bin; and intuitive and easy to open, particularly by a user with low dexterity. Additional desirable features of the package include easy removal of the catheter from the case; easy reclosing of the case after use; hygienic use; and it should be discreet and clean to carry after use. Because users often carry intermittent catheters with them in containers such as purses, handbags, shoulder bags, backpacks and the like, the sealed catheter package should be capable of withstanding_compression and other forces to which such containers are typically subjected. More particularly, the catheter package should remain sealed even when subjected to such forces so as to, among other things, maintain the sterility of the catheter within the package. Furthermore, users will often prefer to return a used catheter to their purse or bag for subsequent disposal. Accordingly, the catheter package should be capable of receiving a used catheter back in the package and then being reclosed in a sealed and secured manner. Thus, a catheter package with a reliably reclosable cap would also be desired. Convenience may be further enhanced if the reclosable cap is attached to the remainder of the package so the cap does not become misplaced during use of the catheter. As described above, many users of intermittent catheters have limited manual dexterity that can make it difficult for them to open a package and extract a catheter from the package. Thus, while reliable and secure capping and re-capping are a desired aspect of a compact catheter, also desired is the ability to easily open the package, access and extract the catheter. Accordingly, it would be desirable to provide a catheter and catheter package wherein extraction of the catheter is made easier by presenting at least a portion of the catheter (that is not inserted into the urethra of the user, such as the funnel) beyond an open end of the package when the cap is removed. Thus, the end of the funnel is presented for easy extraction and/or for easy and hygienic attachment of a urine collection bag, if desired. Of course, having at least a portion of catheter or the funnel extending beyond the open end of the package may make the above-described sterile sealing, capping and recapping operations more difficult to achieve. For example, providing a cap hinge that is unobtrusive but affords an arc of motion for the cap that allows the cap to clear the funnel during opening and closing movements and attain the aforementioned sealing (capping) and re-sealing (e.g., "dynamic sealing") presents one challenge. Still another challenge is