Single-use disposable elapsed time indicator using absorbent material

Abstract

The single-use disposable elapsed time indicator and method for using the same include an indicator that may have a flexible chamber for holding an aqueous medium and a slot having a viewing window and a longitudinal axis. The slot is connected to the chamber via a passageway having a breakable seal therein. An absorbent material that swells upon exposure to the aqueous medium is disposed at a first end of the slot. A graduated scale along the longitudinal axis of the slot for indicating the period of elapsed time is also included. The absorbent material is configured to expand along the longitudinal axis from the first end of the slot toward the opposite end of the slot, thereby indicating the elapsed time on the graduated scale.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to single-use, disposable elapsed time indicators, and more particularly to elapsed time indicators usable with medical devices that operate based on the swelling of absorbent material within the indicator. [Background technology]

[0002] Many medical devices have a limited shelf life and are designed to be usable for a limited period of time after the device is deployed. These items typically involve a single event, a time limit, or limited access. For example, nearly all modern medical device disposables, such as syringes, needleless access connectors, needle-free connectors (NFCs), and catheters, have a desired expiration date for their use after the device is deployed or activated.

[0003] In some cases, the start time of when the device is put into use is recorded or noted by the medical professional, but this is not always the case, and in many cases the length of time the device will be put into use is not known.

[0004] Disposable time-indicating devices are also known, see U.S. Patent Nos. 3,954,011, 5,602,804, and 8,388,131.

[0005] However, there remains a need for a disposable elapsed time indicator that can be used in a medical environment, and in particular a progress indicating device that can display the elapsed and remaining time period to provide medical personnel with sufficient time to prepare for the particular device being monitored. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 3,954,011 [Patent Document 2] U.S. Patent No. 5,602,804 [Patent Document 3] U.S. Patent No. 8,388,131 Summary of the Invention [Means for solving the problem]

[0007] An aspect of the subject technology relates to a single-use, disposable elapsed time indicator including an absorbent material configured to swell along a graduated scale upon exposure to an aqueous medium to indicate a period of elapsed time. Such an indicator comprises a flexible chamber for holding the aqueous medium; a slot having a first end and a second end opposite the first end, the slot having a viewing window and a longitudinal axis, the first end of the slot connected to the chamber via a passageway having a breakable seal therein; an absorbent material disposed therein at the first end of the slot, the absorbent material swelling upon exposure to the aqueous medium; and a graduated scale along the longitudinal axis of the slot for indicating a period of elapsed time. Advantageously, the absorbent material is configured to expand along the longitudinal axis of the slot from the first end of the slot toward the second end of the slot, thereby indicating elapsed time on the graduated scale. The graduated scale can represent the period of elapsed time in hours or days.

[0008] Further aspects of the subject technology include methods of using a single-use, disposable elapsed time indicator. Such methods can include an indicator comprising an absorbent material configured to swell along a graduated scale upon exposure to an aqueous medium to indicate a period of elapsed time, and include activating the indicator by contacting the absorbent material with the aqueous medium. Further methods include activating the device by depressing a flexible chamber holding the aqueous medium to force the aqueous medium from the flexible chamber into a slot containing the absorbent material, thereby breaking a breakable seal between the flexible chamber and the slot.

[0009] The above-described embodiments may include one or more of the following features, individually or in combination: for example, the absorbent material includes polyacrylic acid or copolymers thereof, polyacrylates or copolymers thereof, polyacrylamides or copolymers thereof, and / or the aqueous medium is deionized water or distilled water.

[0010] Further advantages of the subject technology will become readily apparent to those skilled in the art from the following detailed description, in which only certain aspects of the subject technology are shown and described, by way of example only. As will be recognized, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects, all without departing from the subject technology. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification to provide a further understanding, illustrate disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0012] [Figure 1] 1A-1C depict a single-use disposable elapsed time indicating device according to aspects of the present disclosure. [Figure 2A] 2 is an exploded view of the single-use disposable elapsed time indicator device of FIG. 1. [Figure 2B] 2 is an exploded view of the single-use disposable elapsed time indicator device of FIG. 1. [Figure 3A] 10A-10C illustrate the operation of a single-use disposable elapsed time indicator according to aspects of the present disclosure. [Figure 3B] 10A-10C illustrate the operation of a single-use disposable elapsed time indicator according to aspects of the present disclosure. [Figure 3C] 10A-10C illustrate the operation of a single-use disposable elapsed time indicator according to aspects of the present disclosure. [Figure 3D]10A-10C illustrate the operation of a single-use disposable elapsed time indicator according to aspects of the present disclosure. [Figure 3E] 10A-10C illustrate the operation of a single-use disposable elapsed time indicator according to aspects of the present disclosure. [Figure 4] 10A-10C illustrate a method of using a single-use disposable elapsed time indicating device according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided as non-limiting examples of particular embodiments. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring concepts of the subject technology.

[0014] It should be understood that this disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are now disclosed according to specific, but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and in modified forms depending on the desired application or implementation.

[0015] Referring now more particularly to the drawings, in which like reference numerals refer to like or corresponding elements throughout the several views, FIGS. 1 and 2A-2B illustrate a single-use, disposable elapsed time indicator (100) according to an embodiment of the present disclosure. As shown, the indicator includes a flexible chamber 102 for holding an aqueous medium 103 and a slot 104 having a first end 104a and a second end 104b opposite the first end and having a longitudinal axis (X). The first end 104a of the slot 104 is connected to the chamber 102 via a passageway 106 having a breakable seal 108 therein. In certain embodiments of the present disclosure, the slot has a volume smaller than the volume of the aqueous medium in the chamber. Consequently, the chamber has a volume greater than the volume of the slot.

[0016] The indicator further includes an absorbent material 105 within the slot 104 and disposed at a first end 104a of the slot 104. The absorbent material 105 swells when exposed to the aqueous medium 103. A breakable seal 108 within the passageway 106 separates and prevents the aqueous medium 103 from contacting the absorbent material 105 within the slot 104 until the breakable seal is ruptured. The breakable seal is configured to rupture upon pressure from aqueous medium being forced into the slot through the passageway, such as by depressing a flexible chamber holding the aqueous medium. The slot can also include a viewing window 112 along the longitudinal axis (X) for viewing the absorbent material.

[0017] A graduated scale 110 is disposed along the longitudinal axis (X) of the slot (104) for indicating periods of elapsed time. The graduated scale has markings to represent elapsed time periods, such as markings for elapsed periods in hours or days. The markings may be in the form of scales or lines with numbers, words, symbols, and may be disposed along the viewing window 112 on the surface of the chamber. In this case, the associated elapsed time period may be indicated by the markings, such as a verbal description of the time period (e.g., hour 1, hour 2, etc., day 1, day 2, day 3, day 4, etc.), or simply by multiple scales with numbers themselves (e.g., 1, 2, 3, 4, etc.).

[0018] Indicator devices according to aspects of the present disclosure can also include fasteners for securing the indicator to a medical device. For example, the indicator can include holes 130 through which a wire or string can be threaded and used to secure the indicator to a particular medical device for tracking elapsed time. Alternatively, or in combination with a string or wire, indicator devices according to aspects of the present disclosure can also include an adhesive, such as a peel-off sticker, on the surface of the indicator for adhering the indicator to the medical device.

[0019] 2A-2B show exploded views of the indicator of FIG. 1. As shown in FIG. 2, a transparent cover 120 (part A) can be bonded to an injection-molded mating part (B) that includes a flexible chamber 102, a slot 104, a passageway 106, a breakable seal 108, and a graduated scale 110. The breakable seal can be a thin, plastic plate-like element within the passageway that forms the breakable seal upon installation of the cover. Prior to bonding of the cover 112, an absorbent material 105 can be placed within a first end of the slot in mating part B, and an aqueous medium 103 can be added to the chamber in mating part B. When the transparent cover 120 is attached to mating part B, the cover creates a viewing window 112 along the longitudinal axis of the slot for viewing swelling of the absorbent material. Alternatively, mating part B can be transparent and cover A can be opaque, or both parts can be transparent, although such a configuration tends to provide less contrast against the absorbent material.

[0020] The flexible chamber, slot, passageway, and rupturable seal can be individually constructed from one or more of plastic, polycarbonate, polyacrylate, polyester, polyolefin such as polypropylene, acrylonitrile-butadiene-styrene, etc. In certain embodiments of the present disclosure, the flexible chamber, slot, passageway, and rupturable seal are constructed from the same material and formed by injection molding. A cover, which can be constructed from, for example, paperboard, aluminum foil, clear plastic, etc., can then be attached to the injection molded article to cover the flexible chamber, slot, passageway, and rupturable seal. Such materials are useful in the manufacture of medical devices and can withstand sterilization. Advantageously, single-use disposable elapsed time indicators according to aspects of the present disclosure are sterilizable, i.e., the indicator can be exposed to radiation or heat sufficient to sterilize the device.

[0021] As shown by these exemplary figures, the flexible chamber 102 is in the form of a bulb that can be depressed to force aqueous medium from the chamber into the passageway, rupturing the breakable seal 108 and contacting the absorbent material 105. A check valve (not shown) can also be included in the passageway to prevent or reduce the flow of aqueous medium into the flexible chamber. As further shown in these exemplary figures, the slot is in the form of a rectangular cavity with a viewing window. In certain aspects of the present disclosure, the volume of the slot (e.g., 2 ml) is less than the volume (e.g., 5 ml) of the chamber filled with aqueous medium, e.g., water, such as deionized or distilled water.

[0022] The absorbent material is configured to expand along the longitudinal axis of the slot from the first end of the slot toward the second end of the slot, thereby marking elapsed time on a graduated scale. For example, upon contact with an aqueous medium, the absorbent material swells at a predetermined rate, which is used to define the hours and / or days on the scale. In this case, the various markings on the graduated scale can be used to track elapsed time as the absorbent material swells to match, approach, or cross the markings. The various markings on the graduated scale can also be used to estimate the time remaining until a given device reaches its end of life.

[0023] In embodiments of the present disclosure, sample calculations can be used to estimate the swelling rate of absorbent polymers, such as hydrogels. For example, the swelling rate is given by the Voigt model equation: S t =S e (1-e -t / r ) In this equation, t is the swelling time and S t is the swelling volume at time t, and S e is the equilibrium swelling, i.e., the swelling capacity or maximum water-holding capacity at infinite time, and r is called the rate parameter, which is the time required to reach equilibrium of 0.63. Based on such calculations, the swelling rate, and therefore the elapsed time, of a given absorbent material can be estimated.

[0024] Absorbent materials that can be used with indicator devices according to embodiments of the present disclosure include, for example, polyacrylic acid or copolymers thereof, polyacrylates (such as sodium polyacrylate) or copolymers thereof, and polyacrylamide or copolymers thereof. Superabsorbent polymers, such as sodium polyacrylate and its copolymers, can absorb and retain large amounts of liquid in proportion to their mass. Such absorbent polymers can swell up to 400 times their original size and are used in wound dressings and surgical pads to absorb blood, food packaging to absorb excess moisture, and are sterilizable.

[0025] To enhance the contrast of the absorbent material relative to the indicator device, the absorbent material and / or aqueous medium can include a dye to color the absorbent material. Such dyes can include dark red, blue, green, or any color to enhance the contrast of the absorbent material. Such dyes can aid in identifying the location of the absorbent material along the longitudinal axis of the slot as the absorbent material swells.

[0026] The aqueous medium can be simply water, such as distilled water, deionized water, or tap water. Additionally, the aqueous medium can include one or more alcohols, such as isopropanol and / or ethanol, in addition to water. The amount that an absorbent material swells is related, in part, to the length of time the material remains in contact with the aqueous medium and the type of aqueous medium. In the case of sodium polyacrylate, it has been observed that the material can absorb up to 10 times more water in distilled water than in tap water due to the difference in ionic concentration between tap water and distilled water.

[0027] Figures 3A-3E illustrate operation of a single-use, disposable elapsed time indicator according to an embodiment of the present disclosure. As shown in the initial state in Figure 3A, the aqueous medium is retained within the chamber and the breakable seal is intact. The absorbent material is positioned proximate the first end of the slot, e.g., at the bottom of the viewing window, and is pre-calibrated for elapsed time along a graduated scale. The indicator can be activated by depressing the flexible chamber to force the aqueous medium from the chamber into the slot and break the seal. As shown in Figures 3B-3D, after a predetermined time, the absorbent material swells and expands along the longitudinal axis from the first end of the slot toward the second end of the slot, e.g., the top. The rate of expansion of the absorbent material within the slot is a function of time. When the viewing window is completely filled, as shown in Figure 3E, the total time has elapsed. In this final position, the indicator prompts the medical professional to take necessary action at the end of the elapsed time, such as cleaning or replacing the particular medical device. The indicator can be calibrated to display the amount of elapsed time from hours to days.

[0028] Further aspects of the subject technology include methods of using a single-use, disposable elapsed time indicator. Such methods can include an indicator including an absorbent material configured to swell along a graduated scale upon exposure to an aqueous medium to indicate a period of elapsed time, and include activating the indicator by contacting the absorbent material with the aqueous medium. FIG. 4 illustrates an exemplary method of using a single-use, disposable elapsed time indicator according to aspects of the present disclosure. In step 410, an indicator (e.g., single-use, disposable elapsed time indicator 100) is secured to a medical component (e.g., a needleless connector, an intravenous set, a urinary drainage bag, a secondary set, an oncology set, etc.). In aspects of the present disclosure, the indicator can be secured to the medical device by adhesive, string, or the like.

[0029] In step 420, the indicator is activated, which may include depressing the flexible chamber to break the breakable seal and force the aqueous medium into contact with the absorbent material. In step 430, a determination of the elapsed time since activation of the indicator is determined by observing the absorbent material along a graduated scale. For example, as the absorbent material expands at a predetermined rate along the longitudinal axis of the slot, a graduated scale having markings along the slot indicates the elapsed time at a plurality of different marks. The elapsed time is indicated by noting the expansion of the absorbent material along the graduated scale, which provides a visual reference of the elapsed time associated with the expanded material at any given time after activation.

[0030] Examples The following examples are intended to further illustrate certain preferred embodiments of the invention and are not limiting in nature. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein.

[0031] Experiments were conducted in which a ball of sodium polyacrylate was added to a glass tube. Water was then added, and the initial time of water addition was recorded. The sodium polyacrylate ball contained a red dye (toy ball), and the water was distilled. The ball expanded over time, from 0 to 12 hours in some experiments and from 0 to 8 days in others.

[0032] A linear expansion with time was observed.

[0033] The experiments were carried out at normal room temperature.

[0034] It is understood that any particular order or hierarchy of blocks in the disclosed process methods describes an example approach. Based on design or implementation preferences, it is understood that the particular order or hierarchy of blocks in the processes may be rearranged, or all of the blocks described may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0035] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications of these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0036] Reference to a singular element is not intended to mean "one and only one" unless expressly stated to be so, but rather "one or more." The term "some" refers to one or more unless otherwise specified. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and sub-headings, if present, are used for convenience only and do not limit the invention.

[0037] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0038] As used herein, the phrase "at least one of" preceding a list of items each separated by the word "or" modifies the entire list, not each item in the list. The phrase "at least one of" does not require the selection of at least one item. Rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0039] Use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure relating to an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as "an aspect" may refer to one or more aspects, and vice versa. Use of a phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure relating to an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as "an embodiment" may refer to one or more embodiments, and vice versa. Use of a phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure relating to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0040] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, dimensions, sizes, and other specifications set forth herein, including those in the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and with that customary in the art to which they pertain.

[0041] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed describes example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on design preferences. Some of the steps, operations, or processes may occur simultaneously. Some or all of the steps, operations, or processes may be performed automatically without user intervention. Where present, the accompanying method claims present elements of the various steps, operations, or processes in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0042] All structural and functional equivalents of the elements of the various aspects described throughout this disclosure that are known or that become known in the future to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public in any way, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, the element is recited using the phrase "step for." Furthermore, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive, similar to the interpretation of "comprise" when used as a transitional phrase in a claim.

[0043] While the "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" of this disclosure are incorporated herein into this disclosure, they are provided as illustrative examples of the disclosure, not as a limiting description. This specification is presented with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the "Description," it is understood that the description provides illustrative examples, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as reflected in the following claims, inventive subject matter lies in less than all features of a single disclosed structure or act. The following claims are incorporated herein into the "Description," with each claim standing on its own as separately claimed subject matter.

[0044] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims by language, including all legal equivalents. Nevertheless, no claim is intended to, and no claim should be construed to, cover subject matter that does not comply with the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. A flexible chamber for holding an aqueous medium, A slot having a first end and a second end opposite the first end, and having an inspection window and a longitudinal axis, wherein the first end of the slot is connected to a chamber via a passage having a breakable seal inside, An absorbent material disposed within and confined to the first end of the slot, which swells when exposed to the aqueous medium, A stepped scale along the longitudinal axis of the slot for indicating the duration of elapsed time, The absorbent material is configured to expand at a predetermined rate along the longitudinal axis of the slot from the first end of the slot toward the previously empty second end of the slot, thereby indicating the elapsed time on the stepped scale. A single-use, disposable elapsed time indicator.

2. The indicator according to claim 1, wherein the slot has a confirmation window along the longitudinal axis for confirming the absorbent material.

3. The indicator according to claim 1, wherein the breakable seal is configured to rupture upon pressure from the aqueous medium being pushed into the slot through the passage.

4. The indicator according to claim 1, wherein the slot has a volume smaller than the volume of the aqueous medium in the chamber.

5. The indicator according to claim 1, wherein the passage further includes a check valve for reducing the flow rate of the aqueous medium in the chamber.

6. The indicator according to claim 1, wherein the absorbent material contains a dye having a certain color.

7. The indicator according to claim 1, wherein the absorbent material comprises polyacrylic acid or a copolymer thereof, polyacrylate or a copolymer thereof, polyacrylamide or a copolymer thereof.

8. The indicator according to claim 1, wherein the absorbent material comprises sodium polyacrylate or a copolymer thereof.

9. The indicator according to claim 1, wherein the aqueous medium is deionized water or distilled water.

10. The indicator according to claim 1, further comprising a fixing device for securing the indicator to a medical device.

11. The indicator according to claim 1, further comprising an adhesive on the surface of the indicator for attaching the indicator to a medical device.

12. The indicator according to claim 1, wherein the stepped scale represents the elapsed time period in hours or days.

13. The indicator according to claim 1, wherein the indicator is sterilized.

14. The indicator according to claim 1, wherein the flexible chamber, the slot, the passage, and the breakable seal are individually or collectively made of one or more of the following: plastic, polycarbonate, polyolefin, or acrylonitrile-butadiene-styrene copolymer.

15. The indicator according to claim 1, wherein the flexible chamber, the slot, the passage, and the breakable seal are made of the same material and formed by injection molding.

16. The indicator according to claim 1, comprising the flexible chamber, the slot, the passage, and a transparent cover attached to the breakable seal.

17. A method of using the single-use disposable elapsed time indicator described in Claim 1, A method comprising activating the indicator by bringing the absorbent substance into contact with the aqueous medium.

18. The method according to claim 17, further comprising fixing the indicator to a medical device.

19. The method according to claim 18, wherein the medical device is a needleless connector, an intravenous injection set, or a urinary catheter bag.

20. The method according to claim 17, wherein activating the device includes pressing down on a flexible chamber holding the aqueous medium to push the aqueous medium out of the flexible chamber into a slot containing the absorbent material, thereby breaking a breakable seal between the flexible chamber and the slot.

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