TW200845955A - Container for maintaining stabilized control solution and container for single-use control solution including prior use indicator - Google Patents

Abstract

Aspects and embodiments of the present disclosure are directed to devices and methods for the containment and presentation of a control solution to a medical device. Such devices and methods can be directed to containers (e. g., containment and presentation devices) that include structures such as nested containment wells for maintaining a stabilized control solution. Embodiments can include an indicator, such as one to indicate status of a seal for a container and/or for a liquid inside such a container.

Description

200845955 IX. INSTRUCTIONS: [Technical field to which the invention pertains] Related Applications This application is a continuation of U.S. Patent Application Serial No. 11/121,592 (Application No. 5: May 4, 2005), the entire contents of which are Incorporated herein as a reference. The present application claims the benefit of U.S. Provisional Patent Application Serial No. 60/857,391, the entire disclosure of which is incorporated herein by reference. 10 [Prior Art] In many medical and laboratory applications, it is necessary to provide or administer a single-dose or green-measured dose of a liquid, such as a pharmaceutical, pharmaceutical, and control solution for evaluating a diagnostic system. . In particular, laboratory applications involving diagnostic tests and, in some medical applications, require an extremely precise number of agents during the testing process. To this end, certain agents and agents are provided in containers or packages that can only give a single dose of liquid in a single dose or in a multi-dose volume > One such application requiring a precise amount of medicament fluid is for the measurement of analytes in physiological fluids (eg, blood, fluid, interstitial fluid, 20 urine and saliva) (eg, glucose, cholesterol, The manufacture of a system of concentrations of anesthetics or analogues thereof is used in systems for patients. Such systems typically include a test strip containing the agent material applied to the physiological sample, and a meter configured to accept the test strip and measure the target analyte concentration of the sample on the test strip. 200845955

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During the production and manufacture of test strips, the quality control of the test strips is usually done by batch sampling method, in which a monitoring agent (often referred to as a control solution) that mimics blood is used to test the accuracy of the test strip. Sex and effectiveness. Examples of such control solutions are described in U.S. Patent Nos. 5,1,871 and 5,605,837. During the manufacturing process, the accuracy of the test strip gauge is also checked using a gauge with a test strip that is known to meet quality control standards and has been coated with a control solution. Similarly, the quality of the test strip and the measuring instrument is directly controlled by the patient or user of the measuring instrument and the test strip and the medical staff who treat the patient. For example, when a meter is received or a new test strip is packaged, a control solution is provided to the patient or medical worker, and the quality (4) check is usually indicated at the time of the event: open a new package; use new Measuring instrument; when Lin or learning to use the measuring instrument and test strip; after the measuring instrument is dropped or the like; when the analyte measurement result cannot be reversed, the patient's current feeling (for example, when the glucose measurement shows substantial Two quasi-blood glucose 'but the patient feels phase # normal"; or, when the glucose measurement is normal but the patient feels sick. 20 Control results that fall outside the expected range may indicate: user program error; measuring instrument or test strip container is dirty; test strip contamination, deterioration period '·meter failure; control returning; and/or control solution is available Accept the temperature range, and so on. The upper and lower sides are packed in plastic containers or glass vials (—&quot;Μ). The illustration in Fig. 1 is with a detachable cover 2, with I and a dispensing control. (4) Prior art container. The container is allocated 6 200845955. The end is usually configured at the end of the shaft 3 to open the extrusion. Accurate control solution droplets. For further reference to the figure i, the container i holds a certain volume (usually about 3 to 5 ml), which is about (10) to "about 3 months." To apply the control solution, the cover 2 can be removed. Then, the user is applying a light pressure to the valley state to dispense a drop of the control solution on the drug area. The container will = gas:, the surface (for example, the user has contaminant two h wood. In addition, because the user of the control solution can ") 15 20 :: body, for example:: two = 7 can often miss and Two: The results of the analyte test. If ^==== can cause the tea to be thrown all the control solution, and the capacity of the _ must be added, in the event of this, the user may add cost. The new two = can make him or her in the medical winds of the first technical control solution container door % Η, relative to the 四 (four) according to the solution 'the effectiveness of using most (4) of the solution has long expired, this also: Ling liquid The difference is the price of the control solution sealed in the original container. It is about one to two years, but旦ί life) — Rapidly lowering the container due to the above-mentioned pollution problems' shelf life 7 200845955 In addition, the user may forget to put back the cover on the container, causing the control solution to evaporate and become an analyte concentration that would result in an erroneous value. It is difficult to accurately and accurately dispense the necessary volume of the control solution from the prior art container. The volume dispensed will be highly dependent on the user, as it may be too much to squeeze the container over 5 degrees and apply too much control solution or under squeeze. Too little solution. Another disadvantage of prior art control solution dispensers is that although systems and devices for measuring analyte concentrations have progressed rapidly, they are used in conjunction with such advanced systems and devices to accommodate and dispense controls. The progress of the 10 sides of the solution is limited. In particular, it is necessary to minimize the pain experienced by the patient when taking samples of blood or interstitial fluid and to minimize the time and number of steps required to complete the glucose concentration measurement. Progress. Reduce the sample size and reduction required to accurately perform analyte measurements The former can be achieved by taking the 15 needle size of the sample fluid. The latter can be realized by integrating various components used in the measurement process. I Specifically, at this time, microneedle and test strip have been integrated. The integrated needle/test strip has a capillary channel extending from the opening in the tip end of the microneedle to a sensor reagent area or matrix region within the test strip. Additionally, such specific embodiments Some of them are used by the measuring instrument to automatically or semi-automatically distribute the tester to access and collect the sample fluid. However, during fluid access and collection, the instrument is contacted electronically or photometrically (as the case may be) or Engage, thereby eliminating the need for the user to process the test strip. 8 200845955 The microneedle configuration clearly saves time and reduces the risk of harming the patient and contaminating the test strip and meter. Similarly, in a single step, the physiological fluid can be accessed (puncture of the skin with a microneedle), only the minimum number of samples required for the sensor (using the capillary channel), and the concentration of the target analyte within the sample can be determined (with 5 Bonded measuring instrument). To evaluate the performance of this integrated system, the meter is equipped with "onboard" diagnostic electronics and software, as well as a control solution to provide the effectiveness of the sensor for testing the test strip. In this case, as described above, although a prior art control solution dispenser can be used to evaluate the test strip by dispensing a small drop of the control solution 10 in the designated sensor zone of the test strip, it does not take into account the evaluation of the integration micro The effectiveness of the needle. One may deposit a small drop of the control solution on a sterile substrate with the tip of the microneedle in the droplet to evaluate the effectiveness of the capillary channel; however, this requires additional components and steps, and if the substrate is not properly killed 15 The risk of contamination of the control solution is high. Even though such prior art can assure a sterile substrate, this does not mean that the operational state can be mimicked realistically, wherein the needle is dispensed by a fluid that penetrates the surface of the skin and is capillaryly acted upon under the skin. More specifically, there are some factors that cannot be evaluated, such as the 20 speed, angle and depth of the needle when piercing the skin, the strength of the tip, and the proper capillary action of the needle to allow the solid medium in the fluid to be able to The ability to flow. Therefore, there is a need to improve techniques and systems for containing and dispensing control solutions and other agents and reagents for single dose use. 9 200845955 SUMMARY OF THE INVENTION In response to the problems of the prior art described above, the present disclosure discloses several systems, methods, and modes of display. The systems and techniques of the present disclosure are directed to a container for holding a stable control solution and/or a single use control solution containing a usage status indicator. Aspects and embodiments of the present disclosure are directed to devices and methods for accommodating and presenting a control solution to a medical device, such as a patient who draws blood from a patient/user's finger with a lancet during surgery. The containment and presentation devices can comprise a number of structures, such as a nested containment well for maintaining a stable control solution. Particular embodiments may include an indicator (e.g., an indicator or pH indicator has been used) to indicate the condition of the seal of the container and/or the control solution within the container. Other features and advantages of the present disclosure will be appreciated by reference to the <RTIgt; 15 [Embodiment] ^ The present disclosure is directed to several methods for containing a control solution (eg, containing a liquid solution of one or more given chemistries/analytes) and presenting the solution to a medical device, for example, for calibration The device for medical equipment / 20 systems and methods. A medical device for use in a particular embodiment of the invention may comprise and/or contain a blood collection needle that is intended to puncture the skin when the patient's finger is placed in the aperture of the device. According to the present disclosure, a specific embodiment of a control solution accommodating device can (1) present a control liquid to a medical device in a manner of appointing a patient's finger 10 200845955

(control ι · · way to accommodate pairs: liquid. (= solution, the useful state of the container that can preserve integrity for a long time has a wide range of '() present and save the value of the control solution. The physical property status of the night itself The indication, for example, the pH 5 value according to this &amp; (applica^): 'The control solution container, the dispenser medical device (for example, the % is inspected and configured to be able to use the facility/preparation ^ The target area of the 'type 匍 糖 糖 糖 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 The container and the cover body can be composed of i as a cover body of the partial container. This simulates the medical equipment;: nano =,, == can act to straighten the skin of the tooth. When pressed into the second r's eye area Shou' the container system has sufficient length and rigidity to start the blood needle and sensor. Another function of the dispenser/system is 20 '疋di is not: no easy to expose the control solution when adding ink The brother ^ diagram is not the liquid containment structure / system of the present invention - one of the specific two The system 2GG has a body including an inner wall 2G1, and the inner wall is used to fit the inner well 2〇2 of the control solution. The system port 3 defines the outer wall 2〇3 of the outer well, if necessary, for example, the inner wall The central wall 201, 203 can be disposed on the platform 2〇 6. The liquid containment system 200 can include a large, flat surface or base for use as a handle to facilitate use. The base 207 can also be used as an allowable pressure. Printing a space for identification marks (eg, lot number or product identification). 5 As shown in Figures 3 through 6, for example, a clear combination of pressure, temperature and time is used with the cover 208 (e.g., laminated foil), Prior to sealing, by accurately filling the inner well of the dispenser, the structure 200 can be used to reliably present the lancet at the time of puncture. The perspective view of Fig. 3 is shown in Fig. 2. For example, a foil stacking layer is provided. The liquid accommodating structure of the sealing member/cover body 208. Fig. 4 is a front plan view showing the liquid accommodating structure and the foil laminate seal of Fig. 3. Fig. 5 is a third drawing. Side view of liquid containment structure and foil laminate seal Fig. 6A is a top plan view of the liquid containing structure of Fig. 3; Fig. 6B is a cross-sectional view of the receiving structure taken along the cutting plane R-R edge 15 of Fig. 6A.

20 Continuing to refer to Figures 2 through 6, further enhancing the usability of the containment structure 200 can be ensured by the addition of the tabs 205 to reliably guide the structure 2 to the target area of the intended medical device. / Assist the lancet in medical equipment with a good 'pin.' Cup j is specifically referred to in Figure 4. Another feature is the lancet contact of the dispenser/system in any direction of use (or at any time). This multi-directionality (4) and the circular feature map that is being pierced are used in the central portion of the cover 208. Aspects of this disclosure and specific examples, by way of coping with liquid loss 12 200845955 (eg, through the containment structure) (or several) (for example, 201) and gasification) and provide appropriate protection for the liquid (control) solution that it is intended to contain. Particular embodiments of the present disclosure can cope with other liquid losses, such as by the cover 208, as will be described below. Since in many cases it is preferred to have minimal fluid loss (&lt; 5%) during the life of the medical device monitoring product (e.g., in order for the control solution to still be used to monitor the efficacy of the medical device), the evaporation control must be note. However, certain specific components of the solution may also deteriorate over time. For example, in the case of a 10 15 20 glucose control solution, glucose may decrease in oxidation over time as the water evaporates to increase the glucose concentration. In a particular embodiment of the present disclosure, this can be balanced by manipulation of factors affecting evaporation rate = prime (eg, 'container material, flexible diaphragm material, fill volume) =, gasification rate (eg, pH) Two phenomena, ^: some control that changes over time, thereby changing the useful shelf life of the mouth of the control solution house. ^ The specific examples of the various methods can be used to balance the above factors regarding the control liquid / spoon! For example, the presenting and accommodating device structure as described herein can have two or more (eg, multiple) vapor barrier layers (ν_Γ ^ 乂 water consumption (Waterl〇ss), and select materials to further control steaming. The water vapor transmission rate of 1 〇〇 micron nominal wall thickness and bis density polyethylene (10) PE at 26 ° C / 65% relative humidity is approximately low density :). One-third of A4 i U gram / square meter / speed I can control water 13 by changing the material used to construct the accommodating device. 200845955 Furthermore, in a specific embodiment of the present disclosure, The second liquid can be used to control the water consumption through evaporation. As can be seen from the drawings (e.g., inner well 2G2 of Figure 2), the central portion of the apparatus of the present invention can be used to sample the blood collection needle of the medical device with the control solution. The second ^ (e.g., the outer well 204 of Fig. 2) may surround the central space and be filled with liquid to provide additional water vapor in the surrounding space to reduce water consumption due to evaporation of the central well. In addition to the water vapor barrier provided by the material for the farmer and the sealing foil 2〇8, 10 15

Performance can also be used to balance evaporation and oxidation of the -6: supply and increase the useful life of the control solution in the unit 20 。. The material used for the flexible seal 208 can be altered to further soften (10), water vapor loss, but this - the barrier is generally the smallest part of the total water = contribution. For example, a typical flexible foil laminate may have a water vapor transmission rate of 〇·〇(10)6^/m^m/day, or for some specific embodiments/applications, the water vapor transmission rate may be less than the cost of the ribs. 0%。 The device wall rate of 0. 04%. In addition to or in addition to the above features, the apparatus/method of the present disclosure may provide a status indicator, such as a clear indication of 'use (state). Since the exemplary embodiment can be a single use device/method, it is preferred to succeed each time the second time. Thus, in accordance with a particular embodiment of the present disclosure, a flexible barrier foil film having a paper layer can be used to seal the associated presentation and containment device. The perspective views of Figs. 7 and 7 are based on the second embodiment of the present invention, 700 Α, 700 Β, which shows that the resist film or paper layer 7 is used as the cover of the state indicator. This - cover can be used to seal the 20 200845955 nanostructure/system described herein, for example, system 200 of FIG. The paper layer 701 in the drawing allows for the printing of pictures or other symbols, and the paper layer can also be used to transfer the solution in the holding device 200 by capillary action, for example, the paper layer can be sandwiched between the aluminum foil and the outer layer of the protective polyester. Between (indicated by 5 701). In operation, when the paper layer 701 is wetted with a holding solution (which may contain selected/desired dyes and/or selected/desired pH values), the entire covered surface (or portion) of the device may fade. (Visually apparent) as an indicator that has been used by the device. Thus, the paper layer (or other absorbent layer of material) 7 01 can indicate that the seal 701 of the device has been properly handled and has been used. The addition of the indicator ink printed on the paper further enhances this effect to provide a bold, bold pattern (e.g., black bars) for use as a more visually significant indicator. Figure 8 illustrates another specific is embodiment of the liquid containment structure/system 800 of the present invention. System 800 is similar to system 200 of Figure 2 in that it includes a main &gt; body with inner and outer walls 801, 803 (each defining outer wells 802, 804, respectively). However, system 800 also includes inner and outer walls 801, 803 whose top surface is sharpened (i.e., higher from the side of platform 806) such that the top surface of the foil overlay is flatter and, therefore, more like a finger. Although the top surface is depicted as a flat surface, one or both of the top surfaces may comprise a corrugated or curved portion or may be wavy or curved as a whole. Figure 9A is a top plan view of the liquid containment structure/system 800 of Figure 8; and Figure 9B is a cross-sectional view of the containment structure taken along the cutting plane C-C of Figure 9A. 15 200845955 Figure 10 illustrates another specific embodiment of the liquid containment structure/system 1000 of the present invention. System 1000 is similar to system 2 of FIG. 2 in that it includes a body having inner and outer walls 1001, 1003 (each defining inner and outer wells 1002, 1004, respectively), however it also includes a base with a smaller handle portion to reduce material. 5 cost, but the minimum space to mark the number can be reserved if necessary. Figure 11A is a top plan view of the liquid storage structure/system 1 of Figure 1; Figure 11B is a cross-sectional view of the containment structure taken along the cutting plane S-S of Figure 11A. Figure 12 illustrates another embodiment of the liquid containment structure/system 1200 of the present invention. System 1200 is similar to system 2 of FIG. 2 in that it includes a body having inner and outer walls 1201, 1203 (each defining inner and outer wells 1202, 1204, respectively). However, it also includes a base having a larger handle portion 12〇5. It is used by people with limited finger sensitivity and can provide up to 4 surfaces to accommodate more markup information. Although the illustrated handle portion 205 has four sides, it can include any desired number of surfaces. Figure 13A is a top plan view of the liquid containment structure/system 1200 of Figure 12; and Figure 13B is a cross-sectional view of the containment structure/system 1200 of Figure 13A taken along the cutting plane T-T. Figure 14 illustrates a specific embodiment 1400 of using a plurality of liquid containment systems 1401 (e.g., similar to system 2 of Figure 2) on the plate 14A. The flat panel 1402 can be configured and configured to have a desired size so that a desired number of containment systems can be configured on the flat panel 14A, for example, arranged in a ΜX Ν array. The plate 1402 can be a perforated plate, such as perforations 1403(1)-1403(4), 16 200845955, to allow for the dispensing of one or more units, and the plate 1402 can have any length, allowing for a cylindrical shape for storage. Or assigned. Accordingly, particular embodiments of the present disclosure may provide a control solution containing structure/system that exhibits a very precise and repeatable single dose; prevents unused control solution from being contaminated; minimizes user contact ejection Risk of solution; provide a practical number of single-dose units, for example, for a single user to use within a given time period, or for large quantities of users in a hospital or clinic, for example, in a short period of time; Shelf life and effectiveness; for the integrated test system can provide a number of aspects of quality: 2 and storage of the first and in the manufacturing and 15 20: the style and / or other exemplary embodiments should be private &amp; And they can still make various modifications, and the teachings of Tailu _ Valley can be implemented in various forms and concrete; = in many application systems. And the second can be applied [simplified description of the drawings] In the following description, please refer to the attached drawings for more complete content, such jr 円 円 i i i i i L 〇曰 L L 白 白 白 白 揭示 揭示In order to have only the illustration % u in nature, the invention is not limited. It is not intended to emphasize the principle of the present invention in accordance with t_β =. Rather, the legend of Figure 1 is for accommodating and dispensing the control solvent. The first w technology of R is shown in Figure 2. The physical properties of the nanostructure according to one embodiment of the present disclosure 17 200845955; 3 is a perspective view of the liquid receiving structure of the sealing member; FIG. 2 is a front view of the liquid accommodating structure and the box-stacked sealing member of the fourth and fourth wth; 5 is a side plan view of the liquid accommodating structure and the box laminated seal of FIG. 3; _ 6 is a top plan view of the liquid accommodating structure of FIG. 3; 6 Β ' is the 6th 容纳 accommodating structure along the A cross-sectional view drawn by the cutting plane R_R; 1 透视 7A and 7B are perspective views illustrating the utilization of a foil barrier film according to other specific examples of the present disclosure; Another embodiment of the liquid containing structure of the present invention is illustrated, the top surface of which is tapered such that the top surface of the laminated foil laminate is relatively flat and thus resembles a finger; 15 Figure 9A is the eighth a top plan view of the liquid containing structure; Figure 9A is a cross-sectional view of the containment structure taken along the cutting plane c-c; Figure 10 illustrates another embodiment of the liquid containment structure of the present invention having a smaller handle portion to reduce material costs, however The minimum space for marking the number may be reserved if necessary; 20 Figure 11A is a top plan view of the liquid containing structure of Figure 10; Figure 11B is a sectional view of the receiving structure taken along the cutting plane sS of Figure 11A; The figure illustrates another embodiment of the liquid containment structure of the present invention, which has a larger handle portion for the sensitivity of the finger. It is very useful for 18 200845955, and can provide up to 4 surfaces to accommodate more marking information. Fig. 13 is a view showing a modification of the embodiment of Fig. 12 which uses a columnar square handle portion; and Fig. 14 illustrates a case where a relatively large number of the liquid containing structure 5 of the present invention is used in a flat plate. Although the specific embodiments are illustrated in the drawings, the embodiments of the present invention will be understood, and the embodiments are described and described in the context of the present disclosure. Variations of other specific embodiments. 0 [Main component symbol description] 1 Container 2 Cover 3 Distribution part, cone 200 Liquid containment structure / System 201 Inner wall 202 Inner well 203 Outer wall 204 Outer well 205 Small tab 206 Platform 207 Surface or base 208 Cover 209 Round Shape feature 19 200845955

700A , 700B DETAILED DESCRIPTION 701 Barrier foil film or paper layer 800 Liquid containment structure / system 801 &gt; 803 inner and outer walls 802, 804 inner and outer wells 806 platform 1000 system 1001 &gt; 1003 inner and outer walls 1002, 1004, Outer Well 1200 System 1201 &gt; 1203 Inner and Outer Wall 1202, 1204 Inner and Outer Well 1205 Handle Portion 1400 Concrete Embodiment 1401 Liquid Containment System 1402 Plate 1403 Perforation 20

Claims (1)

200845955 X. Patent Application Range: 1. A liquid containment system for preserving a control solution, the structure comprising: a body comprising one or more wells suitable for preserving liquid; and a cover It is composed of a flexible sealing material. 2. The liquid containment system of claim 1, wherein the body comprises a base. 10 3. The liquid containment system of claim 1, wherein the body comprises high density polyethylene or low density polyethylene. 4. The liquid containment system of claim 1, wherein the cover 15 comprises a flexible foil laminate. 5. The liquid containment system of claim 1, wherein the cover comprises a vapor barrier layer. 20. The liquid containment system of claim 1, wherein the cover comprises a use indicator. 7. The liquid containment system of claim 1, wherein the cover comprises a pH indicator. 21 200845955 8. More patents in the scope of the patent application include the liquid containment system of well item 1, wherein the one or two are concentric and configured as inner and outer wells: the first patent scope The liquid containment system further comprises a control solution in one or more wells. 10. The liquid containment system of claim 8, further comprising a second filled liquid filament disposed in the outer well to provide a desired helium pressure. 11 The liquid containment system of claim 9 of the patent scope, wherein the control &gt; A liquid containment system according to claim 9 wherein the control solution has a desired pH. 13. A seal suitable for use in a control solution containment structure, the seal comprising: a flexible foil laminate; a protective layer; and a foil laminate and the protective polyester layer Between the layers of paper. The seal of claim 13 wherein the foil laminate comprises an aluminum foil. 15. The seal of claim 13, wherein the paper layer is responsive to a desired pH value, wherein the paper layer produces a visual indication upon absorption of the control solution having the desired pH. 16. The seal of claim 13 further comprising a vapor barrier layer disposed on the flexible foil laminate or the paper layer. 10 23