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.
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 providing a cap that can be configured to achieve reliable sealing over an extending portion of the catheter (e.g., funnel) while withstanding the forces and loads to which it may be subjected while being carried in a handbag, purse or other receptacle which can compromise the seal. Side loads, i.e., radial or tangential loads on the cap can be a particular problem, especially on the portion of the cap opposite the hinge location. The catheter packages described herein address these concerns.
In one aspect, the present disclosure is directed to a catheter package, including a case having a hollow tube which is closed at one end and open at the other end, and a cap. The package may include a hinge having one end connected to the cap and a second end connected to said other end of the hollow tube. The hinge permits 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. A seal is connected to at least one of the cap and case. The seal is 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.
In another aspect, the present disclosure is directed to a catheter package including a case having a hollow tube which is dosed at one end and open at the other end and a cap. The package may include a hinge having one end connected to the cap and a second end connected to the other end of the hollow tube. The hinge permits 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. A seal connected to at least one of the cap and case is provided. The seal is engageable with the other of the cap and case when the cap is in the closed position to form a seal between the cap and case that can be repeatedly made and broken whenever the user closes or opens the cap, respectively.
In a further aspect, the present disclosure is directed to a catheter package that has a hollow plastic case for receiving the catheter. The case has a generally tubular wall closed at one end by a bottom wall. The opposite end of the case is open and has a cap attached to it by a hinge. The cap is selectably movable between open and closed positions in which the cap uncovers or covers the open end of the case, respectively. The cap has a tab extending from the bottom edge of the cap with a hook on the bottom edge of the tab. A depression is formed on the top of the case where it can receive the tab. There is a detent in the depression. When the cap is placed in the closed position the tab fits into the depression and the hook engages the detent to retain the cap in the closed position by releasably resisting vertical lifting forces on the cap. Engagement of the tab in the depression also prevents lateral forces on the closed cap from dislodging the cap or impairing its seal.
In a still further aspect, the present disclosure is directed to a catheter package that has a hollow plastic tube for receiving the catheter. The tube has a generally cylindrical wall closed at one end by a bottom wall. The opposite end of the cylindrical wall has a cylindrical ferrule which is open at its end and defines a rim. At least partially surrounding the ferrule is a collar. At least a portion of the collar is separated from the ferrule, leaving a gap between the ferrule and the collar. The cap is attached by a hinge to the collar. The cap is selectably movable between open and closed positions in which the cap uncovers or covers the open end of the ferrule, respectively. The cap may have a skirt which surrounds the ferrule to cover the ferrule completely. A tongue on the collar is engageable with a groove on the exterior of the cap to retain the cap in the closed position when the cap is pivoted onto the top of the case.
In another aspect, the present disclosure is directed to a catheter package that has a hollow plastic tube for receiving the catheter. The tube has a wall of generally rectangular cross section and is closed at one end by a bottom wall. The opposite end of the tube's wall flares outwardly to an enlarged shoulder with a top land. A cap is attached to the tube by a hinge which allows the cap to move selectably between open and closed positons on the tube. The bottom of the cap has a sealing surface that engages the shoulder when the cap is closed. A seal is placed between the cap and shoulder to seal the interior of the package. Just below the shoulder there is an arcuate rail on the exterior of the tube. A similar rail is located on the exterior of the cap at the cap's lower edge. The cap's rail has a gap in it. A movable slider is engageable with the rails and slidable therealong to alternately lock the closed cap and tube together or unlock the cap for opening when the slider is moved so as to be opposite the gap in the cap rail. Placing the slider in the gap allows opening of the cap.
In another aspect the present disclosure is directed to a catheter package having a hollow plastic case for receiving the catheter. The case has a generally cylindrical wall closed at one end by a bottom wall. The opposite end of the cylindrical wall has a cylindrical ferrule which is open at its end and defines a rim. A cap is attached to the case by a hinge. The cap is made of a relatively stiff material and is engageable with the ferrule to resist side loads. The interior of the cap carries a dome-shaped bell made of a softer material than the cap itself. When the cap is closed the bell is engages the ferrule to seal the case.
In yet another aspect the present disclosure is directed to a catheter package having a hollow plastic case for receiving the catheter and a soft cap for selectably opening and closing the case. The cap has a frame made of a relatively rigid material and which includes an annular ring and an axial spine. The remainder of the cap is attached to the frame and spine and is made of a material softer than the frame.
In a still further aspect, the present disclosure is directed to a catheter package that has a hollow plastic case for receiving the catheter. One end of the case has a cylindrical ferrule which is open at its end and defines a rim. At least partially surrounding the ferrule is a collar. At least a portion of the collar is separated from the ferrule, leaving a gap between the ferrule and the collar. A cap is attached by a hinge to the collar. The cap is selectably movable between open and closed positions in which the cap uncovers or covers the open end of the ferrule, respectively. A soft liner on the interior of the cap engages the ferrule when the cap is closed to seal the ferrule. Latch fingers extend radially from the ferrule. The cap may have a skirt which has an opening for receiving the latch fingers to releasably retain the cap in a closed position.
In an additional aspect, the present disclosure is directed to a catheter package that has a hollow plastic case for receiving the catheter. The case is molded with an open top that is sealed with a separate cover. The cover can be a heat sealed foil or the like. The package can be opened by removing the cover. Alternately, the package can be opened by breaking through a molded-in, thin wall section of the case near the top.
In a further additional aspect, the present disclosure is directed to a catheter package that has a hollow plastic case for receiving the catheter. The case has a generally tubular wall closed at one end by a bottom wall. The opposite end of the case is open and has a cap attached to it by a hinge. The cap is selectably movable between open and closed positions in which the cap uncovers or covers the open end of the case, respectively. A locking arm is pivotably connected to the case. The locking arm can pivot upwardly to engage a decent on the cap when the cap is closed and thereby retain the cap in the closed position.
Most of the packages of the present disclosure permit a user to retrieve the catheter from the case and re-capture it if they so wish. Once the cap is locked back into its closed position the package retains its original sealing qualities (meaning it will not leak), with a feature, such as a label that breaks upon opening, indicating that the product has been used. Another potential indication of use could be stress marks created in the hinge when the user first opens the product.
The present disclosure is directed to packages for medical devices such as intermittent urinary catheters. A first embodiment of such a package is shown generally at 10 in
The hinge 16 as shown is a living hinge, but other hinge arrangements could be used. The hinge connects to the case 12 and the cap 14 to permit selectable movement of the cap between open and closed positions. The cap 14 is selectably movable between the open position shown in
The cap has a tab 24 extending from the bottom edge of the cap. There is an inwardly directed hook 26 on the bottom edge of the tab 24. A depression 28 is formed on the top of the case 12 and defines side edges 30. The depression is aligned with the tab 24 when the cap is closed. There is a detent 32 formed in the depression 28. When the cap is placed in the closed position the tab 24 fits into the depression 28 as seen in
A second embodiment of a package for medical devices such as intermittent urinary catheters is shown generally at 34 in
A third embodiment of a package for urinary catheters is shown generally at 58 in
A fourth embodiment of a package for urinary catheters is shown generally at 82 in
A fifth embodiment of a package for urinary catheters is shown generally at 104 in
A sixth embodiment of a package for urinary catheters is shown generally at 126 in
A seventh embodiment of a package for urinary catheters is shown generally at 146 in
An eighth embodiment of a package for urinary catheters is shown generally at 154 in
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 modification can be made without departing from the spirit and scope of the invention disclosed herein.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/577,035, filed Oct. 25, 2017, the disclosure of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2018/056693 | 10/19/2018 | WO | 00 |
Number | Date | Country | |
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62577035 | Oct 2017 | US |