US20210244910A1 - Medical Device Package with a Twist Cap - Google Patents
Medical Device Package with a Twist Cap Download PDFInfo
- Publication number
- US20210244910A1 US20210244910A1 US17/245,280 US202117245280A US2021244910A1 US 20210244910 A1 US20210244910 A1 US 20210244910A1 US 202117245280 A US202117245280 A US 202117245280A US 2021244910 A1 US2021244910 A1 US 2021244910A1
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- US
- United States
- Prior art keywords
- cap
- case
- medical device
- catheter
- package
- 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.)
- Abandoned
Links
- 230000036571 hydration Effects 0.000 claims description 31
- 238000006703 hydration reaction Methods 0.000 claims description 31
- 239000011324 bead Substances 0.000 claims description 18
- 239000000463 material Substances 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 9
- 230000013011 mating Effects 0.000 claims description 2
- 210000002700 urine Anatomy 0.000 description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 238000004806 packaging method and process Methods 0.000 description 7
- 238000000034 method Methods 0.000 description 6
- 230000008901 benefit Effects 0.000 description 5
- 230000007246 mechanism Effects 0.000 description 5
- 239000004033 plastic Substances 0.000 description 5
- 229920003023 plastic Polymers 0.000 description 5
- 230000002485 urinary effect Effects 0.000 description 5
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- UQMRAFJOBWOFNS-UHFFFAOYSA-N butyl 2-(2,4-dichlorophenoxy)acetate Chemical compound CCCCOC(=O)COC1=CC=C(Cl)C=C1Cl UQMRAFJOBWOFNS-UHFFFAOYSA-N 0.000 description 4
- 238000011109 contamination Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000007789 sealing Methods 0.000 description 4
- 238000004381 surface treatment Methods 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 230000000717 retained effect Effects 0.000 description 3
- 230000005856 abnormality Effects 0.000 description 2
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 description 2
- 210000000078 claw Anatomy 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 230000000887 hydrating effect Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 201000006417 multiple sclerosis Diseases 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 206010016275 Fear Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- -1 but not limited to Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 230000001050 lubricating effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 208000020431 spinal cord injury Diseases 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 210000003708 urethra Anatomy 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Images
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
- A61M25/002—Packages specially adapted therefor ; catheter kit packages
Definitions
- 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 various abnormalities of the urinary system. Very often, such abnormalities of the urinary system are caused by a spinal cord injury which may also result in diminished dexterity of the user.
- catheters In intermittent catheterization, a 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.
- a compact package which is: discreet to carry before use; discrete to dispose of in a waste bin; and intuitive and easy to open. 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.
- the present disclosure includes a hard plastic packaging that holds a short, hydrophilic coated catheter.
- the catheter may have a length of, by way of example only, about 91 mm of exposed length.
- a funnel is attached to the catheter.
- the funnel may be, for example, about 40 mm long.
- the hard packaging includes a case that enables the properties of vapor hydration through a hydration liner that separates a water chamber from the hydrophilic coated catheter.
- a twist cap is provided that attaches to the case to form a hygienic seal.
- the package case has a hollow plastic tube for receiving the catheter.
- the tube has a wall closed at one end by a bottom wall.
- Toward the opposite end of the wall there is a radially extending shoulder.
- Above the shoulder there is a cylindrical ferrule which is open at its end and defines a rim.
- External threads are formed on the outer surface of the ferrule.
- a cap may be removably attached to the ferrule by threads. The cap is selectably installed or removed from the case such that the cap covers or uncovers the open end of the ferrule, respectively.
- the cap may have a skirt which carries internal threads that engages with the mating threads on the ferrule.
- the internal wall of the cap has a seal bead extending radially inwardly just above the threads.
- the seal bead is engageable with the external wall of the ferrule.
- the external wall of the ferrule could have a seal bead extending radially outwardly just above the threads that is engageable with the internal wall of the cap.
- the seal beads are located above the threads instead of below them. This provides a manufacturing advantage in that the parts can be made narrower. Furthermore, there is no seal between the bottom of the cap and the shoulder on the case. That area is vented so an interior seal can be tested in a vacuum test.
- the product is opened by twisting the cap one quarter turn.
- the opening torque is selected to be small enough to make the cap easy to open but great enough such that the cap will not release by itself or under normal handling conditions.
- the cap Once the cap is off the case, it exposes the catheter which can then be picked up by the user.
- the cap Once the cap is twisted open, the sterile seal that existed between the case and cap is breached and the catheter is no longer contained in a sterile environment and is ready to use.
- the cap may be temporarily stored on the bottom of the case where the cap may be attached by a snap fit. When the cap is removed and the catheter removed, the user can re-capture the catheter in the case for disposal if they so wish. Once the cap is back into its original state the packaging retains its original sealing qualities (meaning it will not leak), with the tamper evident feature the only indicator that the product has been used.
- FIG. 1 is a perspective view of the catheter package of the disclosure, showing the cap installed on the case in a closed condition.
- FIG. 2 is a perspective view of the catheter package of the disclosure, showing the cap removed from the case to expose a funnel portion of a catheter in the case.
- FIG. 3 is a side elevation view of the package of FIG. 1 .
- FIG. 3A is a perspective view of another embodiment of a package assembly of the present disclosure.
- FIG. 4 is a vertical section taken along line 4 - 4 of FIG. 1 .
- FIG. 5 is a section similar to FIG. 4 showing the cap and upper end of the case on an enlarged scale.
- FIG. 6 is a section similar to FIG. 5 showing the engaging threads of the cap and ferrule on a further enlarged scale.
- FIG. 6A is a perspective view showing a user connecting a urine collection bag to the catheter assembly.
- FIG. 6B is a perspective view illustrating that the package assembly may be positioned in different orientations during connection to the urine collection bag.
- FIG. 6C is a perspective view showing the urine collection bag attached to the funnel of the catheter.
- FIG. 6D is a perspective view of the catheter being removed from the package assembly.
- FIG. 7 is a perspective view of a hydration liner that can be used in the package of the present disclosure.
- FIG. 8 is a top plan view of the hydration liner of FIG. 7 .
- FIG. 9 is a side elevation view of the hydration liner.
- FIG. 10 is a longitudinal section through the hydration liner.
- FIG. 11 is a perspective view of another embodiment of a hydration liner that can be used with the packages and assemblies of the present disclosure.
- FIG. 12 is a side elevation view of the hydration liner of FIG. 11 .
- FIG. 13 is a perspective view of a second embodiment of the disclosure, showing a catheter package with a twist-off cap in a closed position.
- FIG. 14 is a longitudinal section taken along line 14 - 14 of FIG. 13 , with a catheter disposed within the package.
- FIG. 15 is a section taken along line 15 - 15 of FIG. 14 ;
- FIG. 16 is a view similar to FIG. 14 showing a further alternate embodiment of a liner.
- the present disclosure is directed to packages for medical devices such as intermittent urinary catheters.
- the package is shown generally at 10 in FIGS. 1-3 .
- the major components of the package are a case 12 and a cap 14 .
- the cap is threadably engageable with the case such that a user can selectably remove the cap from the case and subsequently replace the cap on the case.
- FIGS. 1 and 3 show the cap installed on the case so the package is in a closed condition.
- FIG. 2 shows the cap removed from the case and resting adjacent the case so the package is in an open condition. With the case open the funnel 16 of a catheter is visible protruding above the case.
- the tube portion of the catheter is within the case and thus not shown in FIGS. 1-3 but the catheter tube 18 is visible in FIGS. 4-6 .
- FIG. 3A illustrates another embodiment of the present disclosure wherein the top 140 of the package 110 has any of features disclosed herein but the bottom 144 of the package 142 , which forms or defines the hollow tube that houses the catheter tube, is made from a flexible material.
- the bottom 144 of the package 110 may be made from one or more flexible polymeric and/or metal foil sheets.
- the sheet may be a laminate that includes both polymeric and metal layers.
- the bottom 144 of the package 110 may be formed from a front sheet 146 and a back sheet 148 wherein the sheets 146 and 148 are sealed together along the side edges 150 and bottom edge 152 .
- the top edges 154 of the sheets 146 and 148 may be attached to the top 140 of the package 142 , by for example, adhesive or welding.
- the case includes a hollow tube 20 which terminates at an end wall 22 that closes the bottom of the tube 20 .
- the tube 20 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise.
- the upper end of the tube 20 has an internal rib 24 that protrudes radially inwardly from the internal wall surface of the tube 20 .
- a radially inwardly protruding lip 26 is a radially inwardly protruding lip 26 .
- the rib 24 and lip 26 cooperate to locate and support a hydration liner that will be described below in connection with FIGS. 7-10 .
- the rib 24 and lip 26 are axially located in an area of the tube 20 where the external wall of the tube has a radially outwardly extending shoulder 28 . Above the shoulder 28 there is a cylindrical ferrule 30 . The ferrule terminates at an open end which defines a rim 32 . In some respects the ferrule 30 can be considered part of the upper end of the tube 20 .
- External threads 34 are formed on the external surface of the ferrule 30 . Above the threads 34 is an external bead 36 .
- a similar internal bead 38 is formed on the internal wall of the ferrule. Internal bead is axially located about even with the bottom thread 34 .
- the internal bead 38 may engage the bottom edge of the catheter funnel 16 , as best seen in FIGS. 5 and 6 , to lightly secure the catheter in the case. This retaining feature will prevent inadvertent removal of the catheter should an open case be turned upside down.
- the cap includes a hollow shell 40 which has a longitudinal wall 42 and terminates at a top wall 44 that closes the top of the shell 40 .
- the longitudinal wall 42 of the shell 40 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise.
- the longitudinal wall 42 tapers radially outwardly toward its open bottom end 46 . This tapered portion defines a skirt 48 . On the interior wall of the shell, axially located about where the skirt 48 begins, there is an internal bead 50 .
- This internal bead 50 cooperates with the external bead 36 on the ferrule 30 to form a liquid-tight seal between an installed cap 14 and the case 12 .
- This axial location of the cooperating beads 36 and 50 affords a more compact construction of the parts than would be the case if the beads were axially located near the open bottom end 46 of the shell 40 .
- the skirt 48 of the cap also has on its internal wall three threads 52 . These threads are engageable with the threads 34 on the ferrule. As best seen in FIG. 2 , the threads 52 are not continuous with one another. Instead, they are separate from one another and extend circumferentially approximately 90°. With this design a quarter turn of the cap will release or engage the threads.
- the distal end of the funnel 16 projects above the rim 32 and extends or projects out of the opening of the package so that the funnel 16 may be accessed and grasped by the user to remove the catheter 18 from the package.
- the catheter 18 is retained within the package by, for example, an interaction between the internal bead or rib 38 of case 12 and flange of the funnel 16 , until the user applies sufficient force to remove the catheter from the package. For example, axial movement of the catheter to move the flange past the rib 38 .
- this retention feature prevents the catheter 18 from inadvertently falling out of the package 10 .
- the catheter is at risk of coming into contact with surfaces that may contaminate the catheter which can result in increasing the risk of infection.
- retaining the catheter 18 within the opened package 10 until it is ready for use can assist in reducing the risk of undesired contamination. This is particularly useful for individuals with limited dexterity and for those who have the habit of commencing the catheterization procedure by opening the package and then proceeding with the other steps of the catheterization procedure.
- each of the features of the catheter extending beyond rim 32 the opening of the package 10 and the catheter retention feature may provide benefits to the user.
- FIG. 6A for illustrative purposes, there is shown a typical urine collection bag 130 that includes a urine collection reservoir 132 , such as a plastic bag, a tube 134 for the passage of urine into the collection reservoir 132 and a connector 136 that connects the tube 134 to the funnel 120 of the catheter.
- the connector 136 may include a tapered end portion 138 which is sized to be fitted within the opening of the funnel 120 and be retained within the funnel 120 by a friction fit.
- the connector 136 is inserted into the funnel 120 and force is applied to securely fit the connector within the funnel.
- the user In conventional packages already know in the field, the user first removes the catheter from the package and then attaches the urine collection bag to the funnel by grasping the funnel. While connecting the collection bag to the funnel, the user tries to avoid contact with the catheter tube, so as to avoid contamination thereof. This may be difficult for users with limited dexterity and may lead to an increased risk of contamination.
- the user may grasp the outside of the package 10 (as opposed to only grasping the funnel) to connect the urine collection bag 130 without having to first remove the catheter from the package.
- the ability to be able to grip the outside of the package 10 provides a larger gripping surface for the user for the user to manipulate the catheter 118 and also reduces the risk of contamination because the catheter 118 remains protected within the package 10 during connection of the connector 136 and the funnel 120 . Furthermore, as shown in FIG.
- the package 10 may be held in virtually any orientation without the concern of the catheter 118 falling out of the package 10 . This can be beneficial to users with limited dexterity, especially those that would need to hold the package 10 upside down or with the opening in a downward orientation in order to connect the urine collection bag 130 to the catheter funnel 120 .
- this feature allows the user to see the insertion of the connector 136 into the funnel 120 and visually inspect the connection. Additionally, after the connection has been made, the user may grasp the distal portion of the funnel 120 extending from the opening of the package 10 to remove the catheter 118 from the package 10 , as shown in FIG. 20 .
- a hydration liner is shown generally at 54 .
- the hydration liner is sized to fit within the tube 20 of the case 12 .
- the liner 54 rests in the tube 20 of the case 20 with the catheter's tube portion 18 (but not the funnel portion) within the liner 54 .
- the liner defines a space between the liner's exterior surface and the case's interior surface within which a hydration mechanism, such as liquid water may reside. This permits hydration of the surface treatment on the catheter.
- the liner 54 may be a relatively rigid plastic such as LDPE or HDPE or other relevant materials.
- the Liner has a generally hollow tube 56 .
- a seat portion 58 of slightly increased outside diameter compared to the remainder of the tube 56 .
- the seat portion 58 is sized to engage the internal wall of the tube 20 .
- Such engagement is enhanced by a pair of interference ribs 60 formed on the external surface of the seat 58 .
- the external surface of the seat 58 has at its top edge a crab claw seal 62 .
- the seal 62 provides a moisture-tight seal against the interior wall of the tube 20 .
- the walls of the liner tube 56 have formed therein one or more passages or windows 64 .
- the windows will be covered with a patch (not shown) of liquid impermeable/vapor permeable material such as, but not limited to, calcium carbonate.
- the patches will allow passage of water vapor (for hydration of the catheter) but will block passage of liquid water droplets.
- the patch might be heat sealed around the perimeter of the window.
- FIGS. 11 and 12 illustrate another embodiment of a hydration liner that is shown generally at 54 a .
- hydration liner 54 a is sized to fit within the case shown in FIGS. 1-6 or any other suitable case.
- the liner 54 a rests in the tube of the case with the catheter's tube portion positioned within the liner.
- the upper seat portion 58 a may have a substantially smooth surface that is sized to engage the internal wall of the package case, such as by a friction fit.
- the upper seat portion may be held in place by fiction fit, heat sealing, adhesive and/or any other suitable manner of attachment.
- the substantially smooth surface of the seat portion 58 a may, optionally, include a detent or recess that engages, for example, a protruding lip that may be formed on the interior surface of the tube, such as the lip 26 shown in FIG. 6 .
- the friction fit, heat sealing and/or adhesive between the internal wall of the package and the seat portion 58 a may provide a moisture-tight seal or the seat portion 58 a may include a seal such as crab the claw seal 62 described above.
- the walls of the liner tube 56 a may have formed therein one or more passages or windows 64 a that may be covered with a liquid impermeable/vapor permeable material.
- the liner tubes disclosed herein may have one or more mechanisms or features that assist in aligning the liner tube during the manufacturing process.
- the alignment features and mechanisms may be used to orientate or align the liner tube during a process for attaching the liquid impermeable/vapor permeable material to the liner tube.
- the alignment features assist in aligning and holding the liner tuber during a heat sealing process for attaching a liquid impermeable/vapor permeable calcium carbonate material to the liner tube.
- Such aligning mechanisms and features may also be used to transfer and orientate the liner tube along a production line.
- the case may also include alignment features, which may correspond to the alignment features of the liner tube, that assist in aligning the liner tube and case relative to one another during assembly of the package so that the liner tube is in a desired orientation relative to the case.
- the alignment features may include one or more protrusions 55 a located at the closed end 57 a of the liner tube 56 a .
- the alignment features of the liner tube 56 a may include flat surfaces located on the sides of liner tube 56 a that, optionally, may be tapered.
- liner tube 56 a includes a flat, tapered surface 65 a .
- the liner tube 56 a may include a plurality of flat surfaces.
- the liner tube 56 a may include flat, tapered surfaces 65 a on opposed sides of the tube.
- the seat 58 a of the liner tube 56 a may include alignment features that include notches or cutouts 67 a . It will be understood that the liner tubes may include one or more of above described alignment features.
- This product is helpful as it addresses issues that many intermittent catheter users are experiencing, especially around the areas of hygiene after use, ease of removal of the catheter and the opening of the product.
- the package of the present disclosure is superior to currently available products, especially in discreet female intermittent catheters.
- a typical intermittent catheter user is a multiple sclerosis sufferer.
- Multiple sclerosis sufferers have varying levels of dexterity and grip strength which can also vary from day to day in some patients. Having an easy to open package is reassuring that they will always able to void their bladder confidently.
- the hygienic re-capture of the catheter into its packaging is also an important feature of the packaging that other catheters do not fully address; with the twist cap concept of the present disclosure the catheter can be safely captured after use without fears of spills.
- Our catheter funnel unlike many prior art funnels, is also able to be used with drainage bags made by a variety of manufacturers. It is also noted that the case's opening and closing mechanism is familiar to everyone used to dealing with everyday closures. Further, the amount of the funnel presented to the user makes it easy to grasp.
- FIGS. 13-15 illustrate a further alternate embodiment of the catheter package according to the present disclosure.
- This package shown generally at 84 , includes a container 86 and a cap 88 .
- the cap 88 in this embodiment is a twist cap that is threadably connectable to the container 86 and is selectably movable by a user between a closed position, shown in FIGS. 13 and 14 , and an open position (not shown) wherein the cap 88 is removed from the container 86 .
- the container 86 in this embodiment is a three-part structure including a hydration liner 54 , a case 90 , and a sleeve 92 .
- Each of these three parts is basically an elongated, hollow tube, open at the top end, with the open top end being selectably openable and closable by the cap 88 .
- the hydration liner 54 fits within the case 90 which in turn fits within the sleeve 92 , as seen in FIGS. 14 and 15 .
- the structure and function of the hydration liner 54 is the same as in FIGS. 7-10 so the description of the hydration liner 54 will not be repeated here.
- the case includes a hollow tube 94 which terminates at an end wall 96 that closes the bottom of the tube 94 .
- the tube 94 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise.
- the upper end of the tube 94 has a radially outwardly extending shoulder 98 . Above the shoulder 98 there is a cylindrical ferrule 100 .
- the ferrule terminates at an open end which defines a rim 102 .
- the ferrule 100 can be considered part of the upper end of the tube 94 except the ferrule is cylindrical, not rectangular.
- External threads 104 are formed on the external surface of the ferrule 100 .
- the internal surface of the ferrule 100 is engageable with the bottom of the funnel 14 in a press fit while the internal surface of the tube 94 at the location opposite the shoulder 98 engages the seat 32 of the hydration liner 24 in a press fit.
- the sleeve 92 is essentially an enlarged version of the case 90 but without a radial shoulder or cylindrical ferrule.
- the sleeve has a hollow tube 106 that terminates at the bottom at an inwardly directed flange 108 .
- the upper end of the tube 106 has a notch 110 adjacent its top land 112 .
- the notch 110 receives the shoulder 98 of the case 90 .
- the top land 112 has an outer contour that is essentially the same as that shown at 114 in FIG. 7 .
- the cap includes a hollow shell which has a longitudinal wall 116 and terminates at a top wall 118 that closes the top of the shell.
- the longitudinal wall 116 of the shell is shown here with a generally rectangular cross-sectional shape on the exterior surface. It will be understood the external cross-sectional shape could alternately be cylindrical or otherwise so long as it matches the cross-sectional shape of the top land 112 of the sleeve 92 .
- the longitudinal wall 116 of the cap has on its internal surface three helical threads 120 . These threads are engageable with the threads 104 on the ferrule.
- the matching outer contours of the container 86 and cap 88 provides a smooth, continuous shape for the package 84 as a whole. There are no discontinuities, protrusions or interruptions of any kind in the outside of the package, thereby affording an aesthetically pleasing appearance to the package. For certain users of intermittent catheters this provides an extra measure of comfort, security and discretion.
- FIG. 16 An alternate version of a liner 54 A is shown in FIG. 16 .
- the liner is similar to the liner of FIGS. 7 and 14 except that the length of the hollow tube 56 (shown in FIG. 7 ) is truncated when compared to the hollow tube 56 of FIG. 7 .
- This truncated version of the liner 54 A may be used where direct hydration of the catheter tubing with liquid water is utilized.
- the upper portion of the seat of the liner 54 A will seal against the interior surface of the tube 20 .
- the catheter tubing will seal against the bottom of the funnel. After removal of the catheter if the case is laid on its side the liner 56 A will prevent leakage of hydration water out the open top of the case.
- liner 54 A serves as a plug to retain hydration water even when the catheter is not in the package.
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Abstract
Description
- The present application is a divisional of U.S. patent application Ser. No. 16/094,912, filed Oct. 19, 2018, which is a National Stage Application of PCT International Application No. PCT/US2017/028937, filed Apr. 21, 2017 which claims the benefit of and priority to: U.S. Provisional Patent Application No. 62/326,355, filed Apr. 22, 2016; U.S. Provisional Patent Application No. 62/431,856, filed Dec. 9, 2016; and U.S. Provisional Patent Application No. 62/448,762, filed Jan. 20, 2017; the disclosures of all of which are hereby incorporated herein by reference.
- 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 various abnormalities of the urinary system. Very often, such abnormalities of the urinary system are caused by a spinal cord injury which may also result in diminished dexterity of the user.
- Commonly, in intermittent catheterization, a 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 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 the packages tend to spill the hydrating medium upon opening. 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: discreet to carry before use; discrete to dispose of in a waste bin; and intuitive and easy to open. 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.
- In one aspect, the present disclosure includes a hard plastic packaging that holds a short, hydrophilic coated catheter. The catheter may have a length of, by way of example only, about 91 mm of exposed length. A funnel is attached to the catheter. The funnel may be, for example, about 40 mm long. The hard packaging includes a case that enables the properties of vapor hydration through a hydration liner that separates a water chamber from the hydrophilic coated catheter. A twist cap is provided that attaches to the case to form a hygienic seal.
- In one embodiment of the present disclosure, the package case has a hollow plastic tube for receiving the catheter. The tube has a wall closed at one end by a bottom wall. Toward the opposite end of the wall there is a radially extending shoulder. Above the shoulder there is a cylindrical ferrule which is open at its end and defines a rim. External threads are formed on the outer surface of the ferrule. A cap may be removably attached to the ferrule by threads. The cap is selectably installed or removed from the case such that the cap covers or uncovers the open end of the ferrule, respectively. The cap may have a skirt which carries internal threads that engages with the mating threads on the ferrule.
- The internal wall of the cap has a seal bead extending radially inwardly just above the threads. The seal bead is engageable with the external wall of the ferrule. Alternatively, the external wall of the ferrule could have a seal bead extending radially outwardly just above the threads that is engageable with the internal wall of the cap. The seal beads are located above the threads instead of below them. This provides a manufacturing advantage in that the parts can be made narrower. Furthermore, there is no seal between the bottom of the cap and the shoulder on the case. That area is vented so an interior seal can be tested in a vacuum test.
- The product is opened by twisting the cap one quarter turn. The opening torque is selected to be small enough to make the cap easy to open but great enough such that the cap will not release by itself or under normal handling conditions. Once the cap is off the case, it exposes the catheter which can then be picked up by the user. Once the cap is twisted open, the sterile seal that existed between the case and cap is breached and the catheter is no longer contained in a sterile environment and is ready to use. During use of the catheter the cap may be temporarily stored on the bottom of the case where the cap may be attached by a snap fit. When the cap is removed and the catheter removed, the user can re-capture the catheter in the case for disposal if they so wish. Once the cap is back into its original state the packaging retains its original sealing qualities (meaning it will not leak), with the tamper evident feature the only indicator that the product has been used.
-
FIG. 1 is a perspective view of the catheter package of the disclosure, showing the cap installed on the case in a closed condition. -
FIG. 2 is a perspective view of the catheter package of the disclosure, showing the cap removed from the case to expose a funnel portion of a catheter in the case. -
FIG. 3 is a side elevation view of the package ofFIG. 1 . -
FIG. 3A is a perspective view of another embodiment of a package assembly of the present disclosure. -
FIG. 4 is a vertical section taken along line 4-4 ofFIG. 1 . -
FIG. 5 is a section similar toFIG. 4 showing the cap and upper end of the case on an enlarged scale. -
FIG. 6 is a section similar toFIG. 5 showing the engaging threads of the cap and ferrule on a further enlarged scale. -
FIG. 6A is a perspective view showing a user connecting a urine collection bag to the catheter assembly. -
FIG. 6B is a perspective view illustrating that the package assembly may be positioned in different orientations during connection to the urine collection bag. -
FIG. 6C is a perspective view showing the urine collection bag attached to the funnel of the catheter. -
FIG. 6D is a perspective view of the catheter being removed from the package assembly. -
FIG. 7 is a perspective view of a hydration liner that can be used in the package of the present disclosure. -
FIG. 8 is a top plan view of the hydration liner ofFIG. 7 . -
FIG. 9 is a side elevation view of the hydration liner. -
FIG. 10 is a longitudinal section through the hydration liner. -
FIG. 11 is a perspective view of another embodiment of a hydration liner that can be used with the packages and assemblies of the present disclosure. -
FIG. 12 is a side elevation view of the hydration liner ofFIG. 11 . -
FIG. 13 is a perspective view of a second embodiment of the disclosure, showing a catheter package with a twist-off cap in a closed position. -
FIG. 14 is a longitudinal section taken along line 14-14 ofFIG. 13 , with a catheter disposed within the package. -
FIG. 15 is a section taken along line 15-15 ofFIG. 14 ; and -
FIG. 16 is a view similar toFIG. 14 showing a further alternate embodiment of a liner. - The present disclosure is directed to packages for medical devices such as intermittent urinary catheters. The package is shown generally at 10 in
FIGS. 1-3 . The major components of the package are acase 12 and acap 14. The cap is threadably engageable with the case such that a user can selectably remove the cap from the case and subsequently replace the cap on the case.FIGS. 1 and 3 show the cap installed on the case so the package is in a closed condition.FIG. 2 shows the cap removed from the case and resting adjacent the case so the package is in an open condition. With the case open thefunnel 16 of a catheter is visible protruding above the case. The tube portion of the catheter is within the case and thus not shown inFIGS. 1-3 but thecatheter tube 18 is visible inFIGS. 4-6 . -
FIG. 3A illustrates another embodiment of the present disclosure wherein the top 140 of thepackage 110 has any of features disclosed herein but thebottom 144 of thepackage 142, which forms or defines the hollow tube that houses the catheter tube, is made from a flexible material. For example, thebottom 144 of thepackage 110 may be made from one or more flexible polymeric and/or metal foil sheets. The sheet may be a laminate that includes both polymeric and metal layers. In the illustrated embodiment, thebottom 144 of thepackage 110 may be formed from afront sheet 146 and aback sheet 148 wherein thesheets bottom edge 152. Thetop edges 154 of thesheets package 142, by for example, adhesive or welding. - Details of the
case 12 will now be described in connection withFIGS. 4-6 . The case includes ahollow tube 20 which terminates at anend wall 22 that closes the bottom of thetube 20. Thetube 20 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise. As can be best seen inFIG. 6 the upper end of thetube 20 has aninternal rib 24 that protrudes radially inwardly from the internal wall surface of thetube 20. Just above therib 24 is a radially inwardly protrudinglip 26. Therib 24 andlip 26 cooperate to locate and support a hydration liner that will be described below in connection withFIGS. 7-10 . - The
rib 24 andlip 26 are axially located in an area of thetube 20 where the external wall of the tube has a radially outwardly extendingshoulder 28. Above theshoulder 28 there is acylindrical ferrule 30. The ferrule terminates at an open end which defines arim 32. In some respects theferrule 30 can be considered part of the upper end of thetube 20.External threads 34 are formed on the external surface of theferrule 30. Above thethreads 34 is anexternal bead 36. A similarinternal bead 38 is formed on the internal wall of the ferrule. Internal bead is axially located about even with thebottom thread 34. Theinternal bead 38 may engage the bottom edge of thecatheter funnel 16, as best seen inFIGS. 5 and 6 , to lightly secure the catheter in the case. This retaining feature will prevent inadvertent removal of the catheter should an open case be turned upside down. - Details of the
cap 14 will now be described in connection withFIGS. 4-6 . The cap includes ahollow shell 40 which has alongitudinal wall 42 and terminates at atop wall 44 that closes the top of theshell 40. Thelongitudinal wall 42 of theshell 40 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise. Thelongitudinal wall 42 tapers radially outwardly toward its openbottom end 46. This tapered portion defines askirt 48. On the interior wall of the shell, axially located about where theskirt 48 begins, there is aninternal bead 50. Thisinternal bead 50 cooperates with theexternal bead 36 on theferrule 30 to form a liquid-tight seal between an installedcap 14 and thecase 12. This axial location of the cooperatingbeads bottom end 46 of theshell 40. - The
skirt 48 of the cap also has on its internal wall threethreads 52. These threads are engageable with thethreads 34 on the ferrule. As best seen inFIG. 2 , thethreads 52 are not continuous with one another. Instead, they are separate from one another and extend circumferentially approximately 90°. With this design a quarter turn of the cap will release or engage the threads. - As shown in
FIGS. 5 and 6 and explained above, upon opening of thepackage 10, the distal end of thefunnel 16 projects above therim 32 and extends or projects out of the opening of the package so that thefunnel 16 may be accessed and grasped by the user to remove thecatheter 18 from the package. As also discussed above, thecatheter 18 is retained within the package by, for example, an interaction between the internal bead orrib 38 ofcase 12 and flange of thefunnel 16, until the user applies sufficient force to remove the catheter from the package. For example, axial movement of the catheter to move the flange past therib 38. One of the benefits of this retention feature is that the engagement between thecatheter 18 and thecase 12 resists inadvertent removal of thecatheter 18 so that thecatheter 18 remains within the openedpackage 10 until the user actively removes thecatheter 18 for use. In other words, the retention feature prevents thecatheter 18 from inadvertently falling out of thepackage 10. For in conventional package assemblies wherein the catheter may inadvertently fall out of the package, the catheter is at risk of coming into contact with surfaces that may contaminate the catheter which can result in increasing the risk of infection. Thus, retaining thecatheter 18 within the openedpackage 10 until it is ready for use can assist in reducing the risk of undesired contamination. This is particularly useful for individuals with limited dexterity and for those who have the habit of commencing the catheterization procedure by opening the package and then proceeding with the other steps of the catheterization procedure. - Referring to
FIGS. 6A-6D , there are some catheterization procedures that require the use of aurine collection bag 130 and/or the user prefers to use aurine collection bag 130. In catheterization procedures that use aurine collection bag 130, each of the features of the catheter extending beyondrim 32 the opening of thepackage 10 and the catheter retention feature may provide benefits to the user. - Turning first to the retaining feature, which retains the
catheter 118 within thepackage 10 until the user applies sufficient force to thecatheter 118 to remove it from thepackage 10. Referring toFIG. 6A , for illustrative purposes, there is shown a typicalurine collection bag 130 that includes aurine collection reservoir 132, such as a plastic bag, atube 134 for the passage of urine into thecollection reservoir 132 and aconnector 136 that connects thetube 134 to thefunnel 120 of the catheter. In the illustrated embodiment, theconnector 136 may include atapered end portion 138 which is sized to be fitted within the opening of thefunnel 120 and be retained within thefunnel 120 by a friction fit. Referring toFIGS. 6A and 6B , to connect theurine collection bag 130 to thefunnel 120, theconnector 136 is inserted into thefunnel 120 and force is applied to securely fit the connector within the funnel. - In conventional packages already know in the field, the user first removes the catheter from the package and then attaches the urine collection bag to the funnel by grasping the funnel. While connecting the collection bag to the funnel, the user tries to avoid contact with the catheter tube, so as to avoid contamination thereof. This may be difficult for users with limited dexterity and may lead to an increased risk of contamination.
- Turning back to
FIGS. 6A-6D , because thecatheter 118 is securely retained within thepackage 10 and the user does not have to be concerned with thecatheter 118 inadvertently falling out of the package, the user may grasp the outside of the package 10 (as opposed to only grasping the funnel) to connect theurine collection bag 130 without having to first remove the catheter from the package. The ability to be able to grip the outside of thepackage 10 provides a larger gripping surface for the user for the user to manipulate thecatheter 118 and also reduces the risk of contamination because thecatheter 118 remains protected within thepackage 10 during connection of theconnector 136 and thefunnel 120. Furthermore, as shown inFIG. 6B , after opening of thecatheter package 10, thepackage 10 may be held in virtually any orientation without the concern of thecatheter 118 falling out of thepackage 10. This can be beneficial to users with limited dexterity, especially those that would need to hold thepackage 10 upside down or with the opening in a downward orientation in order to connect theurine collection bag 130 to thecatheter funnel 120. - Regarding the distal end of the
funnel 120 extending above therim 32 and out of the opening of thepackage 10, this feature allows the user to see the insertion of theconnector 136 into thefunnel 120 and visually inspect the connection. Additionally, after the connection has been made, the user may grasp the distal portion of thefunnel 120 extending from the opening of thepackage 10 to remove thecatheter 118 from thepackage 10, as shown inFIG. 20 . - Turning now to
FIGS. 7-10 , a hydration liner is shown generally at 54. The hydration liner is sized to fit within thetube 20 of thecase 12. Theliner 54 rests in thetube 20 of thecase 20 with the catheter's tube portion 18 (but not the funnel portion) within theliner 54. The liner defines a space between the liner's exterior surface and the case's interior surface within which a hydration mechanism, such as liquid water may reside. This permits hydration of the surface treatment on the catheter. - The
liner 54 may be a relatively rigid plastic such as LDPE or HDPE or other relevant materials. The Liner has a generallyhollow tube 56. At its upper end there is aseat portion 58 of slightly increased outside diameter compared to the remainder of thetube 56. Theseat portion 58 is sized to engage the internal wall of thetube 20. Such engagement is enhanced by a pair ofinterference ribs 60 formed on the external surface of theseat 58. In addition to theribs 60, the external surface of theseat 58 has at its top edge acrab claw seal 62. Theseal 62 provides a moisture-tight seal against the interior wall of thetube 20. The walls of theliner tube 56 have formed therein one or more passages orwindows 64. The windows will be covered with a patch (not shown) of liquid impermeable/vapor permeable material such as, but not limited to, calcium carbonate. The patches will allow passage of water vapor (for hydration of the catheter) but will block passage of liquid water droplets. The patch might be heat sealed around the perimeter of the window. -
FIGS. 11 and 12 illustrate another embodiment of a hydration liner that is shown generally at 54 a. Similar tohydration liner 54,hydration liner 54 a is sized to fit within the case shown inFIGS. 1-6 or any other suitable case. Theliner 54 a rests in the tube of the case with the catheter's tube portion positioned within the liner. Theupper seat portion 58 a may have a substantially smooth surface that is sized to engage the internal wall of the package case, such as by a friction fit. The upper seat portion may be held in place by fiction fit, heat sealing, adhesive and/or any other suitable manner of attachment. In one embodiment, the substantially smooth surface of theseat portion 58 a may, optionally, include a detent or recess that engages, for example, a protruding lip that may be formed on the interior surface of the tube, such as thelip 26 shown inFIG. 6 . The friction fit, heat sealing and/or adhesive between the internal wall of the package and theseat portion 58 a may provide a moisture-tight seal or theseat portion 58 a may include a seal such as crab theclaw seal 62 described above. Similar toliner tube 54, the walls of theliner tube 56 a may have formed therein one or more passages orwindows 64 a that may be covered with a liquid impermeable/vapor permeable material. - The liner tubes disclosed herein may have one or more mechanisms or features that assist in aligning the liner tube during the manufacturing process. For example, when the one or
more windows more protrusions 55 a located at theclosed end 57 a of theliner tube 56 a. Additionally, the alignment features of theliner tube 56 a may include flat surfaces located on the sides ofliner tube 56 a that, optionally, may be tapered. In the illustrated embodiment,liner tube 56 a includes a flat, taperedsurface 65 a. In other examples, theliner tube 56 a may include a plurality of flat surfaces. For instance, theliner tube 56 a may include flat,tapered surfaces 65 a on opposed sides of the tube. Furthermore, theseat 58 a of theliner tube 56 a may include alignment features that include notches orcutouts 67 a. It will be understood that the liner tubes may include one or more of above described alignment features. - This product is helpful as it addresses issues that many intermittent catheter users are experiencing, especially around the areas of hygiene after use, ease of removal of the catheter and the opening of the product. In these criteria the package of the present disclosure is superior to currently available products, especially in discreet female intermittent catheters. For example, a typical intermittent catheter user is a multiple sclerosis sufferer. Multiple sclerosis sufferers have varying levels of dexterity and grip strength which can also vary from day to day in some patients. Having an easy to open package is reassuring that they will always able to void their bladder confidently.
- The hygienic re-capture of the catheter into its packaging is also an important feature of the packaging that other catheters do not fully address; with the twist cap concept of the present disclosure the catheter can be safely captured after use without fears of spills. Our catheter funnel, unlike many prior art funnels, is also able to be used with drainage bags made by a variety of manufacturers. It is also noted that the case's opening and closing mechanism is familiar to everyone used to dealing with everyday closures. Further, the amount of the funnel presented to the user makes it easy to grasp.
- Among the advantages of the present disclosure are: intuitiveness to open; ease of opening; ease of removal of the catheter from the case; ease of closing of the case after use; discretion and clean to carry after use; and hygienic use.
-
FIGS. 13-15 illustrate a further alternate embodiment of the catheter package according to the present disclosure. This package, shown generally at 84, includes acontainer 86 and acap 88. Thecap 88 in this embodiment is a twist cap that is threadably connectable to thecontainer 86 and is selectably movable by a user between a closed position, shown inFIGS. 13 and 14 , and an open position (not shown) wherein thecap 88 is removed from thecontainer 86. - The
container 86 in this embodiment is a three-part structure including ahydration liner 54, acase 90, and asleeve 92. Each of these three parts is basically an elongated, hollow tube, open at the top end, with the open top end being selectably openable and closable by thecap 88. Thehydration liner 54 fits within thecase 90 which in turn fits within thesleeve 92, as seen inFIGS. 14 and 15 . The structure and function of thehydration liner 54 is the same as inFIGS. 7-10 so the description of thehydration liner 54 will not be repeated here. - Turning now to the details of the
case 90, the case includes ahollow tube 94 which terminates at anend wall 96 that closes the bottom of thetube 94. Thetube 94 is shown here with a generally rectangular cross-sectional shape. It will be understood the cross-sectional shape could alternately be cylindrical or otherwise. The upper end of thetube 94 has a radially outwardly extendingshoulder 98. Above theshoulder 98 there is acylindrical ferrule 100. The ferrule terminates at an open end which defines arim 102. In some respects theferrule 100 can be considered part of the upper end of thetube 94 except the ferrule is cylindrical, not rectangular.External threads 104 are formed on the external surface of theferrule 100. The internal surface of theferrule 100 is engageable with the bottom of thefunnel 14 in a press fit while the internal surface of thetube 94 at the location opposite theshoulder 98 engages theseat 32 of thehydration liner 24 in a press fit. - The
sleeve 92 is essentially an enlarged version of thecase 90 but without a radial shoulder or cylindrical ferrule. As such the sleeve has ahollow tube 106 that terminates at the bottom at an inwardly directedflange 108. The upper end of thetube 106 has anotch 110 adjacent itstop land 112. Thenotch 110 receives theshoulder 98 of thecase 90. Thetop land 112 has an outer contour that is essentially the same as that shown at 114 inFIG. 7 . - Details of the
cap 88 will now be described. The cap includes a hollow shell which has alongitudinal wall 116 and terminates at atop wall 118 that closes the top of the shell. Thelongitudinal wall 116 of the shell is shown here with a generally rectangular cross-sectional shape on the exterior surface. It will be understood the external cross-sectional shape could alternately be cylindrical or otherwise so long as it matches the cross-sectional shape of thetop land 112 of thesleeve 92. Thelongitudinal wall 116 of the cap has on its internal surface threehelical threads 120. These threads are engageable with thethreads 104 on the ferrule. - As best seen in
FIG. 13 , the matching outer contours of thecontainer 86 andcap 88 provides a smooth, continuous shape for thepackage 84 as a whole. There are no discontinuities, protrusions or interruptions of any kind in the outside of the package, thereby affording an aesthetically pleasing appearance to the package. For certain users of intermittent catheters this provides an extra measure of comfort, security and discretion. - An alternate version of a
liner 54A is shown inFIG. 16 . The liner is similar to the liner ofFIGS. 7 and 14 except that the length of the hollow tube 56 (shown inFIG. 7 ) is truncated when compared to thehollow tube 56 ofFIG. 7 . This truncated version of theliner 54A may be used where direct hydration of the catheter tubing with liquid water is utilized. The upper portion of the seat of theliner 54A will seal against the interior surface of thetube 20. The catheter tubing will seal against the bottom of the funnel. After removal of the catheter if the case is laid on its side the liner 56A will prevent leakage of hydration water out the open top of the case. This is because the inside diameter ofliner 54A is small enough to prevent drainage of the small amount of water used for hydration. That is, with the package on its side, there is not enough hydration water to flood the lowermost wall of a horizontally disposed tube to a depth that would leak out through the center of theliner 54A. Thus, theliner 54A serves as a plug to retain hydration water even when the catheter is not in the package. - 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.
Claims (20)
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US11911571B2 (en) | 2020-04-24 | 2024-02-27 | Convatec Limited | Packaging for a medical device |
US11957614B2 (en) | 2019-06-11 | 2024-04-16 | Convatec Technologies, Inc. | Urine collection bags for use with catheter products, kits incorporating the same, and methods therefor |
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Also Published As
Publication number | Publication date |
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AU2017254706A1 (en) | 2018-11-15 |
AU2017254706B2 (en) | 2022-04-28 |
US20240100296A1 (en) | 2024-03-28 |
AU2022209269A1 (en) | 2022-08-25 |
CA3021640A1 (en) | 2017-10-26 |
US20190126004A1 (en) | 2019-05-02 |
WO2017185029A1 (en) | 2017-10-26 |
EP3445435A1 (en) | 2019-02-27 |
US11020561B2 (en) | 2021-06-01 |
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