TWI409058B - Liquid containment system for holding control solution and presenting control solution to medical device - 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

Liquid containment system for storing a control solution and presenting a control solution to a medical device Related application

This application is a continuation-in-part of U.S. Patent Application Serial No. 11/121,592 (filed on May 4, 2005), the entire disclosure of which is incorporated herein by reference. The present application claims the benefit of U.S. Provisional Patent Application Serial No. 60/857,391, filed on Jan. 7, 2006, the entire disclosure of which is incorporated herein by reference.

In many medical and laboratory applications, it is necessary to provide or administer a single-dose or indeed measured dose of the liquid, such as a pharmaceutical, pharmaceutical, and control solution for evaluating the diagnostic system. In particular, laboratory applications involving diagnostic tests and in some medical applications require an extremely precise number of agents during the assay. To this end, certain agents and agents are provided in a container or package that can only give a single dose of a single dose of liquid or a liquid having a multi-dose volume.

One such application requiring a precise amount of medicament fluid is for measuring analytes in physiological fluids (eg, blood, interstitial fluid, urine, and saliva) (eg, glucose, cholesterol, anesthetics, or The manufacture of systems for the concentration of analogs is used in systems for patients. Such systems typically include a test strip containing the drug 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.

During the production and manufacture of test strips, the quality control of the test strips is usually done by batch sampling, in which a monitoring agent that mimics blood (often referred to as a control solution) 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. 5,187,100 and 5,605,837. During the manufacturing process, the accuracy of the test strip gauge is also checked using a gauge having a test strip that is known to meet quality control standards and has been coated with a control solution.

Similarly, the quality control of the test strip and the measuring instrument is directly performed 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 health care provider, and a check that typically indicates quality control in the event of any of the following events: opening a new test strip package; Use a new gauge; when training or learning to use the gauge and test strip; after the gauge is dropped or the like; when the analyte measurement does not reflect the patient's current sensation (for example, when the glucose measurement shows Blood glucose is substantially high, but the patient feels quite normal; or, when the glucose measurement is normal but the patient feels sick.

Control results that fall outside the expected range may indicate: user program error; the meter or test strip container becomes dirty; the test strip is contaminated, deteriorated, damaged or expired; the meter fails; the control solution expires; and/or the control solution is Accept the temperature range, and so on.

The above control solution is usually packaged in a plastic container or glass vial. The illustration of Figure 1 is a prior art container 1 with a removable cover 2 for containing and dispensing a control solution. The allocation of the container The ends are typically configured to have a small opening at the end of the cone 3 whereby the squeeze bottle can dispense relatively inaccurate control solution droplets.

With continued reference to Figure 1, container 1 holds a volume of control solution (typically about 3 to 5 milliliters) which provides a dose of about 100 to 200 (typically about 3 months). To apply the control solution, the lid 2 can be removed and the container 1 can be tilted to maintain the dispensing portion 3 a few millimeters above the drug area of the test strip. The user then applies a slight squeeze pressure to the container to dispense a drop of control solution over the medicament area.

Such containers and the steps for dispensing a control solution therefrom have several disadvantages. For example, repeated opening of the container for a longer period of time would cause the control solution to be repeatedly exposed to contaminants in the air or on surfaces (eg, fingers with contaminants). In addition, since the user of the control solution may have poor dexterity (eg, a diabetic patient), the user may often miss and/or drop the cover, which may further contaminate the solution. Such contaminants can lead to erroneous analyte test results. If the control solution is determined to be contaminated, then all of the control solution must be discarded and a new container opened, which adds cost. In addition, when this happens, the user may not be able to immediately obtain a new container of the control solution, and it is possible that he or she is at a medical risk.

Furthermore, a problem with prior art control solution containers is that the efficacy of the control solution has long expired prior to the use of a majority of the control solution due to the relatively large volume of control solution, which also increases the cost of treating the patient. The shelf-life of the control solution sealed in the original container is typically about one to two years, but once the user opens the solution container, the shelf life drops rapidly to several months due to the aforementioned contamination problems.

In addition, the user may forget to put back the lid onto the container, causing the control solution to evaporate and become an analyte concentration that would result in an erroneous value. In addition, it is difficult to accurately and accurately dispense the necessary volume of control solution from prior art containers. The volume dispensed will be highly dependent on the user, as it may over-squeeze the container and apply too much control solution or under-squeeze to apply too little solution.

Another disadvantage of prior art control solution dispensers is that while 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 control solutions. Progress is limited.

In particular, progress has been made in minimizing the pain experienced by patients in obtaining samples of blood or interstitial fluids and minimizing the time and number of steps required to complete glucose concentration measurements. The former can be achieved by reducing the size of the sample volume required to accurately perform analyte measurements and reducing the size of the needle that takes the sample fluid. The latter can be achieved by integrating various components for the measurement process.

Specifically, at this time, microneedle and test strips have been integrated. In the tester device, 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.

In addition, some of these specific embodiments are partially automated or semi-automatically assigned to the tester for accessing and collecting the sample fluid, but during fluid access and collection, electronically or photometrically (as appropriate) The contact or engagement with the meter, thereby eliminating the need for the user to process the test strip.

The microneedle configuration clearly saves time and reduces the risk of harming patients and contaminating test strips and gauges. Similarly, in a single step, access to the physiological fluid (puncture of the skin with a microneedle), transfer only (with capillary channels) the minimum number of samples required for the sensor, and determine the target analyte concentration within the sample (with which it is bonded) Measuring instrument).

To evaluate the performance of this integrated system, the meter is equipped with "onboard" diagnostic electronics and software, as well as the effectiveness of a sensor that provides a control solution to test the test strip.

In this case, as described above, although the prior art control solution dispenser can be used to evaluate the test strip by dispensing a small drop of the control solution in the designated sensor zone of the test strip, it does not take into account the evaluation of the integrated microneedles. Effectiveness. One may deposit a small drop of the control solution on a sterile substrate and place 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 sterilized The risk of contamination of the control solution is high.

Even though such prior art can assure a sterile substrate, this is not meant to truly mimic the operational state, wherein the needle is dispensed by a fluid that penetrates the surface of the skin and is taken under the skin by capillary action. More specifically, some factors cannot be evaluated, such as the speed, angle and depth of the needle when piercing the skin, the strength of the tip, and the needle body providing proper capillary action to allow the solid medium in the fluid to flow under actual operating conditions. Ability.

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.

In response to the above prior art problems, 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 several structures, such as a nested containment well for maintaining a stable control solution. Particular embodiments may include an indicator (eg, 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;

The present disclosure is directed to several devices for containing a control solution (eg, a liquid solution containing a quantity of one or more given chemicals/analytes) and presenting the solution to a medical device, eg, for calibrating the medical device /Systems and methods. A medical device for use in a particular embodiment of the invention may comprise and/or contain a lancet 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 receiving device may: (1) present a control liquid to a medical device in a manner simulating a patient's finger (control liquid); (2) accommodating the control solution in such a manner that the solution can preserve integrity over a long period of time; and/or, (3) presenting an indication relating to the useful state of the container in which the control solution is stored, eg, Use "or" unused or an indication of the physical property state of the control solution itself, for example, pH.

In accordance with the present disclosure, a control solution container, applicator, or containment device/system can be configured and configured to be mountable within a target area of a medical device (eg, a portable glucose measuring device). Inserting the containment device/system into a specially predetermined medical device can be used to activate a mechanical probe to activate a spring-loaded blood collection needle in the medical device. The sensor can be directly attached to the blood collection needle, so that it can be directly sucked through the blood collection needle to the sensor when the dispenser is punctured.

Particular embodiments of the present disclosure provide a system (eg, a containment and presentation device) that is comprised of a body or container for containing a control solution and a cover comprising a foil laminate material suitable for covering a portion of the container . This cover can be used as a barrier to contain liquids, and in some applications simulates the action of a blood collection device in a medical device to 'puncture' the skin. The container system has sufficient length and rigidity to activate the spring-loaded lancet and sensor when pressed into the target zone of the device. Another functional feature of such dispensers/systems is that they do not readily leak the control solution when the container does not require pressurization.

Figure 2 illustrates a specific embodiment of the liquid containment system 200 of the present invention. System 200 has a body that includes an inner wall 201 that defines an inner well 202 that is adapted to receive a control solution. System 200 can include an outer wall 203 defining an outer well, such as concentric with inner wall 201, as desired. The inner wall 201 and the outer wall 203 can be disposed on the platform 206. The liquid containment system 200 can include a large, flat surface or base 207 for use as a handle to facilitate use. The base 207 can also be used as a space to allow imprinting of identification marks (eg, lot number or product identification).

As shown in Figures 3 through 6, for example, using a clear combination of pressure, temperature and time with the cover 208 (e.g., laminated foil), the system is accurately filled by the internal well of the dispenser prior to sealing. 200 can be used to reliably present a control solution to the lancet at the time of puncture.

The perspective view of Fig. 3 is a diagram showing the liquid containing structure of the foil laminated seal/cover 208 in the specific embodiment of Fig. 2. Fig. 4 is a front plan view showing the liquid accommodating structure and the foil laminate seal of Fig. 3. Figure 5 is a side plan view of the liquid containment structure and foil laminate seal of Figure 3. 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 of Fig. 6A.

Continuing to refer to Figures 2 through 6A, 6B, further enhancing the usability of the containment system 200 can be accomplished by adding small tabs 205 to reliably guide the system 200 to a target area of a predetermined medical device, thereby ensuring / Assist the blood collection needle in medical equipment to have a good 'pinning'.

Please refer to Figure 4 in particular. Another feature is that the dispenser/system can be in contact with the lancet being punctured at any time (or generally at any time) in any direction of use. This multi-directional performance is illustrated by the circular features 209 used in the central portion of the cover 208.

Aspects and embodiments of the present disclosure are directed to coping with liquid loss (For example, by vaporizing the containment structure (or several) (eg, inner wall 201)), appropriate protection can be provided for the liquid (control) solution that is desired to be contained. 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 best to have minimal fluid loss (<5%) during the life of the medical device monitoring product (for example, in order for the control solution to still be used to monitor the efficacy of the medical device), the evaporation control should be noted. . However, certain specific components of the solution may also deteriorate over time. For example, in the case of a glucose control solution, glucose will decrease with oxidation over time, while evaporation of water will increase the glucose concentration.

In a particular embodiment of the present disclosure, the two factors (eg, container material, flexible diaphragm material, fill volume) and factors affecting the rate of oxidation (eg, pH) can be balanced by manipulating factors that affect evaporation rate (eg, pH) Phenomena, to accommodate some control that changes over time, thereby changing the useful shelf life of the control solution product.

Particular embodiments of the present disclosure can balance the above factors with respect to control liquids/solutions. For example, a presentation and containment device structure as described herein can include one or more (eg, multiple) vapor barriers to reduce water loss, as well as selecting materials to further control evaporation. For example, for a nominal wall thickness of 100 microns at 26 ° C / 65% relative humidity, high water density polyethylene (HDPE) has a water vapor transmission rate of about one-third (0.4 to low density polyethylene (LDPE)). 1.4 g / m ^ 2 / day). Thus, by varying the materials used to construct the containment device, the rate of water consumption can be controlled.

Moreover, in a particular embodiment of the present disclosure, the water consumption by evaporation can be further controlled using the second fill liquid. As can be seen by the drawings (e.g., inner well 202 of Fig. 2), the central portion of system 200 of the present invention can be used to accommodate and present a control solution for sampling a blood collection needle of a medical device. A second compartment (eg, outer well 204 of FIG. 2) may surround the central space and may be additionally filled with liquid to provide additional water vapor pressure within the surrounding space thereby significantly reducing evaporation due to the central well Water consumption. In addition to the water vapor barrier provided by the material for system 200 and the cover 208 (i.e., the sealing foil), this property can also be used to balance the loss of evaporation and glucose by oxidation to provide and increase the control solution. Useful useful life in system 200.

The material used for the flexible cover 208 can be varied to further adjust the water vapor loss of the system 200, but this barrier typically contributes the least to the total water consumption. For example, a typical flexible foil laminate can have a water vapor transmission rate of 0.0006 grams per square meter per day, or for some specific embodiments/applications, the water vapor transmission rate can be less than the rate at which the HDPE is at the wall of the device. 0.04%.

In addition to or in addition to the above features, the apparatus/method of the present disclosure may provide a status indicator, for example, a clear indication of the use (state). Since the exemplary embodiment can be a single use device/method, it is preferred to succeed each time the first 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.

7A and 7B are perspective views showing a barrier foil film or paper layer 701 for use as a state finger in accordance with other embodiments 700A, 700B of the present invention. The use of the cover of the display. This cover can be used to seal the containment structure/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 containment system 200 by capillary action, for example, the paper layer can be sandwiched between the aluminum foil and the protective polyester outer layer. Between (indicated by 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) 701 can indicate that the paper layer 701 of the device has been properly disposed of 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 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 body having 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 more flat and, therefore, more like a finger. Although the top surface is depicted as being planar, one or both of the top surfaces may comprise a wavy or curved portion or may be wavy or curved.

Figure 9A is a top plan view of the liquid containing structure/system 800 of Figure 8; Figure 9B is a drawing of the receiving structure along the cutting plane C-C of Figure 9A. Sectional view.

Figure 10 illustrates another 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. Cost, but the minimum space to indicate the number can be reserved if necessary.

Figure 11A is a top plan view of the liquid containment structure/system 1000 of Figure 10; and 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 with a larger handle portion 1205 for It is used by people with limited finger sensitivity and can provide up to 4 surfaces to accommodate more marker information. Although the illustrated handle portion 1205 has four sides, it can include any desired number of surfaces.

13A is a top plan view of the liquid containment structure/system 1200 of FIG. 12; and FIG. 13B is a cross-sectional view of the containment structure/system 1200 taken along the cutting plane T-T of FIG. 13A.

FIG. 14 illustrates a particular embodiment 1400 of using a plurality of liquid containment systems 1401 (eg, similar to system 2 of FIG. 2) on plate 1402. As illustrated, the tablet 1402 can be configured and configured to have a desired size whereby a desired number of containment systems can be configured on the flat panel 1402, for example, arranged in an M x N array.

The plate 1402 can be a perforated plate, as shown by perforations 1403(1)-1403(4), to allow for the dispensing of one or more units, and the plate 1402 can have any length, allowing for a roll to facilitate storage or distribution. .

Accordingly, particular embodiments of the present disclosure may provide a control solution containment structure/system that: exhibits a very precise and repeatable single dose; prevents contamination of unused control solutions; minimizes user exposure to the injection solution Risk; provide a practical number of single-dose units, for example, for a single user to use within a given time period, or for large-scale use by a large number of users in a hospital or clinic, for example; to help maximize control solution Shelf life and effectiveness; the integrated test system provides multiple aspects of quality control assessment; easy and convenient to use and store; and cost effective in manufacturing and storage.

Although the foregoing is described in terms of the best mode and/or other exemplary embodiments, it is understood that various modifications may be made and the teachings of the present disclosure can be implemented in various forms and embodiments. For many applications.

1‧‧‧ container

2‧‧‧ cover

3‧‧‧Distribution part, cone

200‧‧‧ system

201‧‧‧ inner wall

202‧‧‧Inner

203‧‧‧ outer wall

204‧‧‧outdoor

205‧‧‧Small tabs

206‧‧‧ platform

207‧‧‧Surface or base

208‧‧‧ cover

209‧‧‧Circular features

700A, 700B‧‧‧Specific examples

701‧‧‧Block foil or paper layer

800‧‧‧Liquid containment structure/system

801, 803‧‧‧ inside and outside

802, 804‧‧ inside and outside wells

806‧‧‧ platform

1000‧‧‧ system

1001, 1003‧‧‧ inside and outside

1002, 1004‧‧ inside and outside wells

1200‧‧‧ system

1201, 1203‧‧‧ inside and outside

1202, 1204‧‧ inside and outside wells

1205‧‧‧Handle part

1400‧‧‧Specific examples

1401‧‧‧Liquid containment system

1402‧‧‧ tablet

1403‧‧‧Perforation

The aspects of the disclosure may be more fully understood from the following description of the appended claims, which are considered to be only illustrative in nature and not restrictive. The drawings are not necessarily to scale, the

The legend in Figure 1 is a prior art container for holding and dispensing a control solution; 2 is a view showing physical properties of a liquid containing structure according to an embodiment of the present disclosure; FIG. 3 is a perspective view showing a liquid containing structure of a foil laminated seal added to a second embodiment; Figure 3 is a front plan view of the liquid containing structure and the foil laminated seal of Figure 3; Figure 5 is a side plan view of the liquid containing structure and the foil laminated seal of Figure 3; Figure 6A is the liquid of Figure 3. A top plan view of the receiving structure; FIG. 6B is a cross-sectional view of the receiving structure taken along the cutting plane RR in FIG. 6A; and a perspective view of FIGS. 7A and 7B illustrating the blocking foil in accordance with other embodiments of the present disclosure. Use of a foil barrier film; Figure 8 illustrates another embodiment of the liquid containment structure of the present invention, the top surface of which is tapered such that the top surface of the foil overlay is relatively flat, thus, 9A is a top plan view of the liquid accommodating structure of FIG. 8; FIG. 9B is a cross-sectional view of the accommodating structure along the cutting plane CC of FIG. 9A; FIG. 10 is a view of the liquid accommodating structure of the present invention. Another specific embodiment has The small handle portion is used to reduce the material cost, but the minimum space for marking the number can be reserved if necessary; the 11A is a top plan view of the liquid receiving structure of FIG. 10; and the 11B is the 11A drawing of the receiving structure along the cutting A cross-sectional view drawn by the plane SS; Fig. 12 illustrates another embodiment of the liquid containing structure of the present invention For example, it has a larger handle portion for people with limited finger sensitivity, and can provide up to 4 surfaces to accommodate more marking information; Figures 13A and 13B show a variation of the specific embodiment of Figure 12 That is, a columnar square handle portion is used; and, Fig. 14 illustrates a case where a relatively large number of the liquid containing structure 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.

200‧‧‧Liquid containment structure/system

201‧‧‧ inner wall

202‧‧‧Inner

203‧‧‧ outer wall

204‧‧‧outdoor

205‧‧‧Small tabs

206‧‧‧ platform

207‧‧‧Surface or base

208‧‧‧ cover

209‧‧‧Circular features

Claims (21)

A liquid containment system for preserving a control solution and presenting a control solution to a medical device, the system comprising: a body comprising two walls defining two wells, each adapted to hold a solution, Wherein the two wells are configured as an inner well and an outer well, and the inner well is nested in the outer well; a control solution is disposed in the inner well; and a second filled liquid is configured In the outer well, for providing a desired steam pressure; and a cover comprising a seal, the seal comprising a flexible sealing material, the cover system being configured and configured to seal the two The well, wherein in a sealed state, the control solution is separated from the second fill liquid, and wherein the cover is adapted to be pierced to present the control solution to a medical device. The liquid containment system of claim 1, wherein the main system comprises a base. The liquid containment system of claim 2, wherein the two walls comprise an inner wall and an outer wall, the inner wall and the outer wall each including a distal surface, and wherein the outer surface of the inner wall is farther from the outer wall The surface is further away from the base. A liquid containing system according to claim 3, wherein the inner wall The far surface is inclined to the central axis. The liquid containment system of claim 3, wherein the distal surface of the outer wall is inclined to the central axis. The liquid containment system of claim 3, wherein the inner surfaces of the inner wall and the outer wall are contoured. The liquid containment system of claim 3, wherein the inner wall and the outer wall are circular. The liquid containment system of claim 3, wherein the inner wall and the outer wall are elliptical. The liquid containment system of claim 8, wherein the inner wall and the outer wall are concentrically disposed about a central axis. The liquid containment system of claim 1, wherein the body comprises high density polyethylene or low density polyethylene. The liquid containment system of claim 1, wherein the cover comprises a flexible foil laminate. The liquid accommodating system of claim 1, wherein the cover The body contains a vapor barrier layer. The liquid containment system of claim 1, wherein the cover comprises a use indicator. The liquid containment system of claim 1, wherein the cover comprises a pH indicator. The liquid containment system of claim 1, wherein the control solution comprises a dye. The liquid containment system of claim 1, wherein the control solution has a desired pH. The liquid containment system of claim 1, wherein the seal comprises: a flexible foil laminate; a protective polyester layer; and a paper disposed between the foil laminate and the protective polyester layer Floor. The liquid containment system of claim 17, wherein the foil laminate comprises an aluminum foil. The liquid accommodating system of claim 17, wherein the paper The layer will react to the desired pH, which will give a visual indication upon absorption of the desired pH of the control solution. The liquid containment system of claim 17 further comprising a vapor barrier layer disposed on the flexible foil laminate or the paper layer. The liquid containment system of claim 1, wherein the inner wall and the outer wall each have a bottom surface, and wherein the inner wall and the bottom surface of the outer wall are positioned differently along a longitudinal axis of the body position.