Catheter product with first use indication label

Abstract

A catheter product (1) with a package, a catheter and a first use indication label (17). The package includes a cap (14) and a case (12). The first use indication label (17) is affixed to the outer surface of the cap (14) and the outer surface of the case (14) so as to span the junction line. The first use indication label (17) changes color when the cap (14) is moved to the open position.

Description

Attorney Docket No. 3400-0331.01 (807PCT)CATHETER PRODUCT WITH FIRST USE INDICATION LABELField of the Disclosure

[0001] This disclosure relates generally to packaging for medical devices such as urinary catheters. More particularly, this disclosure relates to a catheter product with a color-changing first use indication label. Applicant claims priority of invention to US Provisional Application 63 / 680,913, filed August 8, 2024, the content of which is incorporated herein by reference.Background

[0002] 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.

[0003] 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.

[0004] 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.

[0005] A challenge for package designers is the need to provide confirmation to the user whether or not a package has been previously opened. This challenge is heightened where the matching outside geometry of the case and cap makes it difficult to tell whether they have been previously opened. Confirmation as to whether the seal on a package has been breached (either by intentional use of the product or by accidental opening) is important as, if the seal has been breached, then the product’s sterility could be compromised. It is known to apply to the package a first use indication label that spans the separation line of the cap and case. The label will then tear upon first opening of the package. However, itAttorney Docket No. 3400-0331.01 (807PCT) has been found that the label can tear so cleanly that upon reclosing of the cap the adjoining pieces of the torn label fit back together so well as to make the tear line difficult to see. In this case there are no obvious signs that the cap has been opened, despite the initial tearing of the label. A label with a further indication of first use is, therefore, desirable.Summary

[0006] In one aspect, the present disclosure is directed to a catheter product with a package, a catheter, and a first use indication label. The package includes a case having a tubular wall which is closed at one end and open at an open end, said open end of the tubular wall having an outer surface and a cap having a top wall and a side wall, said side wall defining a bottom land and an outer surface adjacent the bottom land, said outer surface of the side wall having an outer dimension that matches the outer dimension of the tubular wall. The cap has an open position, wherein access is provided to the open end of the tubular wall, and a closed position, wherein the cap prevents access to the open end of the tubular wall, the bottom land of the cap together with the top land of the case defining a junction line where the cap and case are adjacent one another when the cap is closed. The first use indication label is affixed to the outer surface of the cap and the outer surface of the case so as to span the junction line wherein the first use indication label changes color when the cap is moved to the open position.

[0007] In another aspect, an intermittent urinary catheter product includes a package with a case having a wall. The case defines an internal cavity configured to house at least a portion of an intermittent urinary catheter. The package also has an openable cap associated with the case. The openable cap has an outer surface. The openable cap has an open position, wherein access is provided to the internal cavity, and a closed position, wherein the cap prevents access to the internal cavity. The outer surface of the cap with an outer surface of the wall of the case defines a junction line where the cap and case are adjacent to one another when the cap is closed. The product also includes a first use indication label affixed to the outer surface of the cap and the outer surface of the wall of the case so as to span the junction line, wherein the first use indication label changes color when the cap is moved to the open position.Attorney Docket No. 3400-0331.01 (807PCT)

[0008] The catheter product of the present disclosure permits a user to quickly assess whether a catheter product has been used or opened based on the appearance of the color of the first use indication label.Brief Description of the Drawings

[0009] Fig. 1 is a perspective view of a first embodiment of the package of the present disclosure, with the cap in the closed position.

[0010] Fig. 2 is a rear elevation view of the package of Fig. 1 .

[0011] Fig. 3 is a right side elevation view of the package of Fig.1.

[0012] Fig. 4 is a front elevation view of the package of Fig.1.

[0013] Fig. 5 is a perspective view of the upper portion of the case of Fig. 1 , with the cap in an open position.

[0014] Fig. 6 is a perspective view of the catheter product with the package of Fig. 1 after application of the first use indication label.

[0015] Fig. 7 a right side elevation view of the catheter product of Fig 6.

[0016] Fig. 8 is a cross-sectional view of the cap of the product of Fig. 6.

[0017] Fig. 9 is a cross-sectional view of a first use indication label applied to a catheter package surface including a sachet on top of the first layer of the label.

[0018] Fig. 10 is a cross-sectional view of a first use indication label applied to a catheter package surface including a sachet encapsulated within a first layer of the first use indication label.

[0019] Fig. 11 is a cross-sectional view of a first use indication label applied to a catheter package surface including a sachet encapsulated between the layers of the first use indication label.

[0020] Fig. 12 is a cross-sectional view of a first use indication label applied to a catheter package surface with dye incorporated into a layer of the label.

[0021] Fig. 13 is a cross-sectional view of a first use indication label applied to a catheter package surface with a sachet of dye incorporated into the label.

[0022] Fig. 14 is a cross-sectional view of a first use indication label applied to a catheter package surface with a sachet of dye incorporated into the label.

[0023] Fig. 15 is a cross-sectional view of a first use indication label applied to a catheter package surface with dye and a liquid incorporated into a layer of the label.Attorney Docket No. 3400-0331.01 (807PCT)Detailed Description of the Embodiments

[0024] The present disclosure is directed to catheter products, such as intermittent urinary catheter products. The catheter products include a package, a urinary catheter (such as a male or female intermittent urinary catheter), and a first use indication label. The package of the catheter product can be encompassed by any traditional catheter package, with a preferred embodiment shown in Figs. 1-5. The catheter product generally includes a package with a case that defines an internal cavity configured to house at least a portion of an intermittent urinary catheter. The package also has an openable cap associated with the case. The openable cap has an outer surface. The openable cap has an open position, wherein access is provided to the internal cavity, and a closed position, wherein the cap prevents access to the internal cavity. The outer surface of the cap with an outer surface of the wall of the case defines a junction line where the cap and case are adjacent to one another when the cap is closed.

[0025] A urinary catheter package is shown generally at 10 in Fig. 1 . Fig. 1 shows the major components of the package including a case 12, and a cap 14. Although Fig. 1 does not show the product contained within the package 10, the product may include a urinary catheter 16 (Fig. 8) which includes catheter tubing 18 (Fig. 8) and a funnel 24 attached to one end of the tubing (partially shown in Fig. 5 and shown in Fig. 8).

[0026] Details of an exemplary case 12 will now be described. The case is preferably molded from a suitable plastic material, such as polypropylene, although other materials could be used. A foaming agent may be added to the polypropylene at levels ranging from 1-3%, and preferably about 1 .5%. A suitable foaming agent is available from Trexel, Inc. of Wilmington, MA. The case includes a hollow tubular wall 26. The tubular wall 26 terminates at an end wall 28 that closes the bottom of the tubular wall. The interior surface of the tubular wall may be generally cylindrical and define an inner cavity 22 (Fig. 8) of the case. The exterior or outer surface of the tubular wall 26 may have either a cylindrical or rectangular cross-sectional shape or the cross-section could be otherwise. As shown in Fig. 1 , most of the exterior surface of the tubular wall 26 has a generally rectangular cross-section with large-radiused corners 30 joining four sides 32, although as shown even the sides 32 are not perfectly flat as they have a slightAttorney Docket No. 3400-0331.01 (807PCT) curvature on their outer surfaces. Above this rectangular portion the tubular wall 26 flares outwardly somewhat at a neck portion 34 to increase the diameter of the tube. The top of the neck 34 joins a cylindrical collar 36. The collar terminates at an open end of the tubular wall 26.

[0027] Further details of the structure of the collar 36 are best seen in Fig. 5. The open end of the collar is cylindrical in shape and thus has circular internal and external edges. Thus, the external shape in this embodiment is circular and the external dimension would be an outside diameter. However, other external shapes could be used and the external dimension of a non-circular collar would not technically be a diameter. The thickness of the wall 26 creates a radial surface or top land 40 on the open end of the collar 36. The top land 40 is the radial surface at the greatest axial extent of the collar 36. In the orientation of the drawings, it is the highest or topmost radial surface. The collar 36 includes several features of varying axial extent. These include a shoulder 38, sloping portions 38A (opposing slope portion not shown) of the shoulder that define a pair of slots 44, 46 (shown in Fig. 4) and a detent 48 between the slots. The shoulder 38 extends arcuately about 180° and is centered near the mid-point of a hinge 42. The top land 40 at the shoulder 38 extends circumferentially in two directions from the mid-point of the hinge 42 and merges with gradually downwardly sloping portions 38A (and opposing slope portion not shown) that join slots 44, 46. The slots terminate at a detent 48. The detent has a pair of undercuts 50 on its lateral edges that define ears 52A and 52B (shown in Fig. 4). The surfaces of the undercuts 50 and ears 52A, 52B (shown in Fig. 4), while not solely axial, include an axial component. The top land 40 at the detent 48 has the same height or axial location as the top land at the shoulder 38.

[0028] The hinge 42 as shown is preferably a living hinge of the butterfly type, but other hinge arrangements could be used. The hinge connects to the collar 36 and the cap 14 to permit selectable movement of the cap between open and closed positions. The package may also be without a hinge and involve a twist cap or some other joining mechanism.

[0029] Details of the cap 14 will now be described. They are best seen in Fig. 5. The cap is hinged to the case 12 by hinge 42 and is selectively movable by a user between a closed position and an open position. Fig. 5 shows the capAttorney Docket No. 3400-0331.01 (807PCT) in the open position. The cap 14 includes a generally cup-shaped shell 62 having a top wall 64 joined to a generally cylindrical side wall 66. The top wall 64 and side wall 66 may merge on one side of the cap to form a lip 68 that makes it easy for a user to engage the cap with a finger or thumb. Alternately, the lip 68 can be used to assist in opening the cap by placing the lip 68 in engagement with the edge of a table or similar surface and pulling the case downwardly. The hinge 42 is attached to the side wall 66. The side wall terminates at a bottom land 70. The bottom land is the radial surface that mates with the top land 40 of the collar 36 when the cap is closed. It is the portion of the open end of the side wall 66 having the least axial separation from the top wall 64. Like the top land 40, the bottom land 70 is cylindrical. Two latches 72, 74 may extend from the bottom land 70 axially away from the top wall 64 of the cap. When the cap is in the closed position the latches extend or project downwardly from the bottom land 70 of the cap. Each latch has a sloping edge 72A, 74A that extends from a sill portion 71 of the bottom land 70 to a crest surface 72B, 74B of the latch. The facing edges of the latches 72, 74 have undercuts 72C (not shown), 74C that form tabs 72D, 74D and define a gap 76 in the cap between the latches. Similarly to the undercuts 50 and ears 52A, 52B, the undercuts 72C (not shown), 74C and tabs 72D, 74D include an axial component.

[0030] When the cap is closed the bottom land 70 of the cap 14 mates with the top land 40 of the collar 36. That is, the sill 71 engages the shoulder 38, and the gap surface 76 engages the top land 40 on the detent 48. Also, the sloping edges 72A, 74A engage the sloping portions 38A, 38B (not shown), and the crests 72B, 74B engage the slots 44 and 46. Finally, as the cap closes the tabs 72D, 74D of the cap snap past the ears 52A, 52B of the detent 48 to allow the detent to end up disposed in the gap 76. That is, ears 52A, 52B of the detent end up disposed in the undercuts 72C (not shown), 74C of the latches 72, 74. Similarly, the tabs 72D, 74D end up disposed in the undercuts 50A, 50B of the detent 48. During closing or opening movement of the cap the tabs 72D, 74D and ears 52A, 52B interfere with one another but flex slightly to allow these parts to slide past one another in either an opening or closing direction. Thus, when the cap is closed the cap and collar present a smooth, but interlocking external surface on the top of the package. Furthermore, when the cap is closed the axialAttorney Docket No. 3400-0331.01 (807PCT) components of the latches 72, 74 and detent 48 end up adjacent one another which will prevent any lateral forces on the cap from dislodging the cap or degrading the seal between the cap and O-ring.

[0031] The top land 40 of the shoulder 38 and detent exposed such that the bottom land 70 of a closed cap will rest on the top land 40 of the collar. When it does so, the external or outer surface of the wall of the cap and the external or outer surface of the wall 26 of case 12 define a junction line. Additionally, the external surfaces of the side wall 66 of the cap and the collar 26, optionally, may match in a smooth, continuous surface. The external dimensions of the cap and collar may be the same at the junction line of the top and bottom lands.

[0032] There is a groove surrounding the external surface of the projection 23. It receives the O-ring 20. The O-ring 20 engages the internal surface of the cap’s side wall to prevent any leakage of liquids from the interior of the case 12. The O-ring 20 provides a dynamic seal in that the cap can be opened and closed numerous times and each time the cap is closed the O-ring 20 will again prevent any escape of moisture from the package.

[0033] The upper, exterior edge of the detent 48 may have an indentation joining the outer surface of the detent to the top land 40 of the detent. In this embodiment the indentation is in the form of a chamfer or beveled edge. The label 17 may be located such that a portion of the label spans the indentation, if present. The indentation creates a void, gap or hiatus in the otherwise continuous surface defined by the exterior of the closed cap and case.

[0034] It will be noted that in some alternatives the general design preference for the package / case is to have the outer surfaces or contours of the closed cap and case match one another at the junction line where they meet. This provides a smooth, continuous outer contour to the package as a whole. Optionally, there are no overlapping outer surfaces of the cap and case.Optionally, there are no offsets, discontinuities, corners or exposed edges. This structure provides aesthetic benefits as well as the sealing benefits explained above. However, the smooth continuous outer contour may assist in providing underlying support to the first use indication label, allowing it to tear in a clean line.

[0035] The catheter product 1 also includes a first use indication label 17, which is shown in Figs. 6-15. The first use indication label 17 is attached to theAttorney Docket No. 3400-0331.01 (807PCT) exterior surfaces of case 12 (such at the collar 36) and cap 14, preferably by an adhesive, although other attachment methods could be used.

[0036] The label 17 may include a visual color indicator to provide a clear indication that the product has been used, or the package has been opened. The color change is such that a color change is done when the catheter package is opened. The color change may be from any first color to a second color. In one embodiment, the first color is white and the second color is red. The first color may also be beige. The second color may also be blue. The color change may also be from a darker color to a light version of the same color or vice versa. The color change may also be from a dark color to a white or beige. The entire label may include the visual indicator or there may be a single layer with a visual indicator.

[0037] The color change can be a variety of mechanisms. The color change may be by exposure to water or another liquid. The material of the label can be such that upon exposure to water, or another liquid, the label changes color.

[0038] The water or liquid exposure during opening can be accomplished a number of ways. In one embodiment, the label may be modified by adding a container or sachet of liquid 19. The container or sachet of liquid 19 may be applied to the top of the label, as shown in Fig. 9. The sachet 19 may be applied to a top layer 23 of the label 17. Although only a top layer of the label is shown, the label 17 may have any number of layers. The label is applied to the surface of the catheter package, centered at line 25, or the intersection line of the top land 40 and the detent 48. The sachet 19 may burst or open when pressure is applied to open to the catheter package.

[0039] The container or sachet of liquid may be also encapsulated into any surface of the label, such as shown in Fig. 10, or between two layers 21 , 23 of a label as shown in Fig. 11. When the package is opened, the encapsulated liquid of the sachet 19 is released causing the liquid sensitive portion of the label to irreversibly change color. The sachet may have a weak line or area that easily ruptures when the label is moved or touched. Although two layers of the label are shown, more than two layers may be included in the label.

[0040] The liquid or water may also be encapsulated in polymeric material / film which dissolves readily when in touch with liquid or water andAttorney Docket No. 3400-0331.01 (807PCT) releases liquid or water which has a reaction with the label material resulting in color changes. The liquid or water may also be released when the package is opened and the label is stretched or broken. Water dissolving polymers include high-molecular-weight polyethylene glycol (PEGs), polysaccharides (dextran), alignates, natural gums (acacia), carboxypolymethylene, and cellulose derivatives.

[0041] After the liquid is released, a liquid absorbent or liquid sensitive portion of the label then reacts to the liquid and results in a visual indication. The liquid absorbent or sensitive layer may be the first or top layer 23 which changes in color upon exposure to water or liquid. The liquid absorbent or sensitive layer may also be a lower layer. In this embodiment, the first layer dissolves or breaks upon exposure to water or other liquid, so that it can reach the second layer and this second or lower layer is absorbent or liquid sensitive and provides the color indication.

[0042] In another embodiment, a top layer dissolves or breaks upon exposure to water or other liquid and reveals a different colored lower layer providing a visual color change indication.

[0043] The liquid absorbent or liquid sensitive portion may be a pH sensitive layer or material, such as litmus paper or other pH sensitive material. The layer of material will change color when exposed to an acidic or basic substance, such as an acidic or basic liquid, depending on the nature of the layer of the label. The pH sensitive material may be any visible layer of the label so that a user can see the color change. The pH sensitive layer or material may be the first or top layer which changes in color upon exposure to the acidic or basic liquid. The pH sensitive material or layer may also be a lower layer. In this embodiment, the first layer dissolves or breaks upon exposure to the liquid, so that it can reach the second layer and this second or lower layer is pH sensitive and provides the color indication.

[0044] The visual color change indication may also include a water or liquid soluble dye or dyes to effectuate the visual color change. The dye or dyes may be incorporated into layer or layers of the first use indication label 17 and release when exposed to water or another liquid. The dye may be incorporated into the first or top layer 23, such as shown in Fig. 12, and released with exposure to liquid or water. The dye may also be incorporated into a second or bottom layer 21 andAttorney Docket No. 3400-0331.01 (807PCT) the dye may migrate to the top layer 23 upon exposure to liquid or water. The dye or dyes may also be in the liquid sachet or as a separate sachet 27, as shown in figures 13 and 14.

[0045] In another embodiment, the water or liquid and dye are both incorporated into the layers of the label. One may be in a first layer and one in another layer or both may be in a single layer such as shown in Fig. 15, with the liquid 29 and the dye 31 .

[0046] Other color changing mechanisms may also be utilized in the label to indicate it has been opened. The mechanism may include an indicator or sensor. Examples include strain gauge or conductivity wire. Another mechanism may be a flexible pressure-sensor film which on applied stress and strain alter the color of the film or layer of the label.

[0047] The label may also include stress whitening. Stress whitening or color change occurs when the label is stressed or stretched (such as by opening the package). The color change may be from a vibrant color such as red to a light or non-existent color such as beige or white. At least one layer or layers of the label may be comprised of an amorphous material or a brittle polymer such as PS (polystyrene), PMMA (poly(methyl methacrylate), ABS (acrylonitrile butadiene styrene), MABS (methylmethacrylate acrylonitrile butadiene), and polycarbonate. These materials incorporated into a layer or layer can cause a complete color change or a partial color change, still resulting in a visual color change indication in the label. Any mechanism can be used that causes a permanent, irreversible indication that the package has been opened.

[0048] 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

Attorney Docket No. 3400-0331 .01 (807PCT)Claims1 . A catheter product, comprising: a package including: a case having a tubular wall which is closed at one end and open at an open end, said open end of the tubular wall having an outer surface; a cap having a top wall and a side wall, said side wall defining a bottom land and an outer surface adjacent the bottom land, said outer surface of the side wall having an outer dimension that matches the outer dimension of the tubular wall; the cap having an open position, wherein access is provided to the open end of the tubular wall, and a closed position, wherein the cap prevents access to the open end of the tubular wall, the bottom land of the cap together with the top land of the case defining a junction line where the cap and case are adjacent one another when the cap is closed; a catheter; and a first use indication label affixed to the outer surface of the cap and the outer surface of the case so as to span the junction line wherein the first use indication label changes color when the cap is moved to the open position.

2. An intermittent urinary catheter product, comprising: a package including: a case having a wall and the case defining an internal cavity configured to house at least a portion of an intermittent urinary catheter; an openable cap associated with the case, the openable cap having an outer surface; the openable cap having an open position, wherein access is provided to the internal cavity, and a closed position, wherein the cap prevents access to the internal cavity, the outer surface of the cap with an outer surface of the wall of the case defining a junctionAttorney Docket No. 3400-0331 .01 (807PCT) line where the cap and case are adjacent one another when the cap is closed; and a first use indication label affixed to the outer surface of the cap and the outer surface of the wall of the case so as to span the junction line wherein the first use indication label changes color when the cap is moved to the open position.

3. The catheter product of any of the preceding claims, wherein the first use indication label is liquid sensitive and the color change is initiated by exposure to a liquid.

4. The catheter product of any of the preceding claims, wherein the first use indication label includes a liquid sachet or container on or in at least one layer of the label.

5. The catheter product of claim 4, wherein the at least one layer of the label includes on a top layer of the label.

6. The catheter product of claim 4, wherein the liquid sachet or container is encapsulated in the at least one layer of the label.

7. The catheter product of any of claims 3-5, wherein liquid sachet or container ruptures to expose the label to liquid when the cap is opened.

8. The catheter product of any of claims 2-6, wherein the liquid is water.

9. The catheter product of any one of claims 1 and 2, wherein the first use indication label is pH sensitive and the color change is initiated by exposure to an acidic or basic substance.

10. The catheter product of claim 9, wherein the first use indication label is comprised of litmus paper in at least one layer of the label.1 1 . The catheter product of any of claims 9-10, wherein the substance is a liquid.

12. The catheter product of claim 11 , wherein the first use indication label includes a liquid sachet or container on or in at least one layer of the label.

13. The catheter product of claim 12, wherein the at least one layer of the label includes on a top layer of the label.

14. The catheter product of claim 12, wherein the liquid sachet or container is encapsulated in the at least one layer of the label.

15. The catheter product of any of claims 12-14, wherein liquid sachet orAttorney Docket No. 3400-0331 .01 (807PCT) container ruptures to expose the label to liquid when the cap is opened.

16. The catheter product of any of the preceding claims, wherein the first use indication label is comprised of at least two layers.

17. The catheter product of claim 16 wherein a first layer is dissolvable upon contact with liquid.

18. The catheter product of claim 17, wherein the second layer is colored.

19. The catheter product of any of the preceding claims, wherein at least one layer of the at least one layer includes a dye.

20. The catheter product of any of claims 1 -18, wherein the first use indication label further includes a container or sachet of dye.21 . The catheter product of any of claims 1 and 2, wherein the first use indication label changes color by a color changing mechanism that includes an indicator.

22. The catheter product of any of claims 1 and 2, wherein the first use indication label changes color by a color changing mechanism that includes a sensor.

23. The catheter product of any of claims 1 and 2, wherein the first use indication label includes at least one of a strain gauge, a conductivity wire and a pressure-sensor film in or on at least one layer of the label.

24. The catheter product of any of the preceding claims, wherein the color change is irreversible.

25. The catheter product of any of the preceding claims, wherein the package of the product further comprises a hinge having a first end connected to the cap and second end connected to the case.

26. The catheter product of any of claims 1 and 2, wherein the label includes at least one layer and at least one layer is comprises at least partially of an amorphous material or brittle polymer and the color change occurs when the label is stressed or stretched.

27. The catheter product of claim 26, wherein the color change is from a vibrant color to a light color.

28. The catheter product of claim 26 or 27, wherein the amorphous material or brittle polymer includes at least one of PS (polystyrene), PMMA (poly(methyl methacrylate), ABS (acrylonitrile butadiene styrene), MABS (methylmethacrylateAttorney Docket No. 3400-0331 .01 (807PCT) acrylonitrile butadiene), and polycarbonate.

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