DEVICES, METHODS AND APPLICATIONS FOR INTELLIGENT MEDICAL PACKAGING

Abstract

An intelligent package system for holding or delivering medical pharmaceuticals, controlled substances, or hazardous materials includes at least one integral active display, a controller and one or more of the following: a programmable memory; one or more sensors; a communication interface device; a power source; one or more user input devices; and an externally connected device in communication with the controller/display. The active display allows static as well as dynamic visual information to be presented, and may be printed or stamped directly onto the surface of the pharmaceutical container or packaging to provide for enhanced information display, access, and visibility.

Description

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser. No. 60/715,692, filed on Sep. 9, 2005, the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to medical containers and, more particularly, to active displays or labels for use with medical containers to allow static and/or dynamic information to be provided visually to users thereof.

There are many types of containers used to store and deliver medical pharmaceuticals. Some examples include contrast agents used for medical imaging procedures, blood, plasma, parenteral feeding solutions, lipid solutions, re-hydration fluids, such as ringers-lactate solution, and special therapeutic drugs. These containers may include bags, bottles, syringes, or other custom packages or delivery containers. Many of these containers contain printed, attached, or embedded labels based on paper or foil materials, however, these labels have many limitations.

For example, current label technology is static and inflexible—only a fixed and limited amount of information may be displayed. Static labels have limited space for information; so many pharmaceuticals must be packaged with a separate package insert containing instructions on dosing, indications for use, contraindications, potential side effects, and other important information. These package inserts may be lost, if they are not attached to the container. Small print makes these labels difficult to read, especially in low light conditions and for those with visual impairment. Any changes to the information on the pharmaceutical container or package insert require new printing. In addition, regulations require region or state specific language, increasing the number of label types that must be provided, or increasing the length and complexity of the package or package insert. For example, many pharmaceutical packages have label pullouts or label fanfolds are required, adding cost and complexity. The technology used with these containers and package inserts are easily counterfeited, providing little protection of product authenticity or integrity. Finally, complex labels and package inserts are not well suited for gaining the operators attention, due to the volume and complexity of the information contained within a small space.

SUMMARY OF THE INVENTION

Containers, packages, or delivery systems and instruments with active displays may provide many benefits. An active display allows static as well as dynamic visual information to be presented. Polymer LED and Organic LED technologies may be suitable for these active displays. Polymer light emitting display (PLED) technology is a relatively recent, low power, low cost, easy to manufacture flexible display technology. PLED technology is also sometimes referred to as “organic display technology” or “OLED technology”. This display technology may be coupled with pharmaceutical packages and containers to provide an integral information display. Integral displays may be printed or stamped directly onto the surface of the pharmaceutical container or packaging to provide for enhanced information display, access, and visibility.

In one aspect, the present invention provides a stand-alone intelligent package system for medical, pharmaceutical or hazardous material applications, including at least one integral active display.

In another aspect, the present invention provides a method for using a pharmaceutical or a controlled or hazardous materials container with an incorporated display includes the presentation of operator instructions, indications for use, cautions or warnings to one or more users.

In another aspect, the present invention provides a method for using a pharmaceutical container with an incorporated display. The display is activated through operator input, a sensor input condition at some periodic time interval, or by connection to or from an associated device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a syringe having a printed polymer light emitting display on the outer surface of the syringe barrel.

FIG. 2 illustrates a syringe having a self-powered display similar to that in FIG. 1.

FIG. 3 illustrates a foil covered pharmaceutical container with an integral display.

FIG. 4 illustrates a bag container with an integral display.

FIG. 5 illustrates a pharmaceutical bottle container with an integral display.

FIG. 6 illustrates a multiple-in-line syringe (MILS) pump.

FIG. 7 illustrates a container with a display and an associated device within an operating environment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

Polymer light emitting displays emit light when provided with electrical energy. A display consists of polymer material manufactured on a substrate of glass or plastic. Polymers are chemical substances that consist of large molecules that are, themselves, made from many smaller and simpler molecules. Most of these types of displays do not require additional components such as filters and polarizers. The display technology is very energy efficient, visible in bright ambient light, and may be manufactured in thin form factors that will operate with low voltages. These displays also have a very wide viewing angle and high contrast, which are limitations of several other display technologies. Polymer light emitting displays may be constructed for monochrome or color operation with an operating life of 10,000 to 20,000 hours under typical operating conditions. They also have very fast switching speeds (up to 1000 times faster than LCDs) and so may be used for dynamic display applications, such as video display. Polymer light emitting displays are constructed by placing an amorphous semi-conducting polymer film, such as polyvinylcarbazol (PVK), or polyparaphenylene, typically less than 100 nm thick, between two metallic electrodes forming an anode and cathode on a transparent substrate. Transparent electrodes are commonly made of indium tin oxide (ITO), 0.1 to 0.3 mm thick, aluminum, or other thin conductive transparent material. ITO is typically used for the anode and aluminum for the cathode, though ITO may be used for both. Charges are injected into the polymer from the electrodes; recombination of charges within the substrate of the electron-hole pairs generates light. The wavelength of the emitted light depends on the particular band gap of the polymer used, the color of the substrate, and any embedded dyes. An almost infinite color range within the visible and IR spectrum is possible. The entire assembly is typically printed or placed onto a glass or polyethyleneterephthalate (PET) surface as a substrate. Polymer light emitting displays may be used with active or passive matrix configurations, depending on the size and performance needed.

Displays may be constructed using ink-jet printing, stamp printing, spin coating, or screen-printing methods for depositing the polymer and conductive films onto the substrate. Also, because of the relatively low manufacturing and materials costs for these displays, they are well suited to disposable use, a common requirement for maintaining patient-to-patient sterility with medical devices and packages.

The drawing in FIG. 1 illustrates a syringe 2 with a printed polymer light emitting display 100 on the outer surface 20 of the syringe barrel 22. Attached to and beneath the display 100 are printed conductors 101, which carry electrical power and communication signals to the display from the attached injector system (not shown). The syringe 2 is typically made of glass or molded plastic material such as polypropylene, polyethylene, polycarbonate or PET. When the syringe 2 is attached to the injector system, power is provided and the display 100 is able to show information. In this example, the display 100 contains an operator message to instruct them to check for air in the syringe 2, as well as information on the contents and status of the material inside the syringe 2.

As an alternative configuration, the display 100 may be used as an illumination device for a package to identify the materials within or to provide light for reading traditional printed labels. For example, it may be useful in some medical applications to illuminate the interior contents of the syringe 2 or delivery container to verify the contents or that the container is completely filled with the correct amount and type of fluid or drug. As another example, some drugs may require optical or infrared illumination for activation or fluid assurance. Infrared illumination may be used to warm or heat contents of the container. In addition, illumination may be used to excite or cause fluorescence of the contents to identify verify the contents of the container (i.e. IR fluoroscopy or spectroscopy).

This technology is especially suited for illumination applications where it is difficult to apply a standard light source or method, such as incandescent, fluorescent, LED, or other source, due to volume or space, or form factor limitations. This technology is also suitable for low power, low cost, low voltage applications, as common with hand-held, portable, or disposable instruments and containers. The technology may also be used to provide illumination or active labeling for invasive and non-invasive medical instruments, for example, illumination associated with endoscope or laparoscopy instruments.

The drawing in FIG. 2 illustrates a syringe 2 with a display 200, similar to that described in FIG. 1. In this case there are no power signals to the syringe 2 from the attached injector system as the display 200 is self-powered and communication with the display 200 is performed in a wireless fashion.

The drawing in FIG. 3 illustrates a foil covered pharmaceutical container 3 with an integral display 300. In this case the container 3 is a foil bag containing a pharmaceutical solution. The display 300 also contains a printed battery 310 as a power source, shown on the lower darkened portion of the display area. The display 300 indicates the contents and status of the bag 3, as well as the time expired since opening. When the time since opening exceeds a predetermined limit, the bag 3 must be replaced or removed. Note that removing a protective cover 320 from the display surface 330 or removing a pull-tab is used to activate the display 300. Note that it is also possible to activate the display 300 by some other switch mechanism, such as a printed overlay button on the display area itself or elsewhere on the container.

In addition it is possible to couple the use of the active display with sensors to indicate delivery parameters, such as flow rate, temperature, pressure, conductivity, or other physical measurement. For example, it may be useful for an IV solution bag to contain an integral flow rate sensor or volume level sensor that provides data, which may be shown on the active display. This information may be communicated to the device by a wired or a wireless system.

The drawing in FIG. 4 illustrates a different container 4 with an integral display 400. In this case the container 4 is a bag, such as those used for holding pharmaceutical solutions such as saline, dextrose, feeding solutions, dialysis solutions, irrigation solutions, or specialty drugs in solution form. Typically, during manufacturing, bags are hot stamped in-line or in a separate step a label is applied either before or after the filling process. In this case, a self-contained flexible display 400 is printed onto the bag surface 14. The display 400 is activated in a similar manner to that described in FIG. 3.

The drawing in FIG. 5 illustrates a pharmaceutical bottle container 5 with an integral display 500. Pharmaceutical bottles are typically made of glass or plastic. The display 500 covers part of the outer surface 15 of the bottle 5 and peels back so that more display 500 area is available. Peeling back the display 500 activates the display 500. The display 500 also contains embedded buttons 501 that may be used to select what information is shown, including the language used. Information from the package insert for the pharmaceutical may be shown on the display 500 in a scrolling fashion so that a paper package insert is not required. Using printed electronics and a small amount of electronic memory, the display 500 can be used to show several pages of information. Controls on the display 500 may be used to control the rate and direction of the information for the user.

The drawing in FIG. 6 illustrates a multiple in-line syringe (MILS) disposable pump 6 module. Displays 600 may be included on the surface of the module to show information related to the pump 6. For example, a small display 600 on the device could indicate pump performance parameters, operating time, or operating life remaining. Printed displays 600 may also be placed on other pump module configurations or delivery path elements such as tubing and connectors and cartridge reservoirs.

The drawing in FIG. 7 illustrates a container 7 with a display 700 and an associated device within some operating environment. The container 7 has a display 700 and controller, and may also have provisions for operator input, memory, sensor devices, a power source, and an interface to other devices. These features may be implemented using conventional or printed organic electronics placed on the surface of the container. Operator input may be from discrete switches, touch sensitive electrodes, or other mechanically activated switches, such as with a peel back protective membrane. Sensor devices may include sensors for temperature, pressure, sterility, or other environmental factors. The interface may be wired, such as with a serial wired communication port, or wireless. For short-range communication, small printed antennas may be used, as with RFID devices, to transmit and receive information from the display device. Coordination of the memory, display, interface, operator input, and sensors is performed by the display 700 and associated controller.

The displays described and shown herein may be externally powered or self-powered using printed battery technology or some other internal power source such as a solar cell. While the technology described involves the use of emissive polymer light emitting displays, other technologies may be used that are transmissive or reflective. Single or multiple displays may be placed on a container or package. In addition, displays may be automatically or manually activated, or activated when attached to a connected system. Displays may be used to show static or dynamic information, such as video. In addition, displays may be placed on rigid or flexible compatible substrate surfaces. Also, containers with displays may be disposable or reusable, depending on the application. Information to the display may be self-contained within the container and display module or may be written to the display from a remote device in a wired or wireless fashion.

Active labels may be used to present large volumes of information, such as for a pharmaceutical or drug package insert. When coupled with a touchpad, touch screen, or other switch or sensing technology, the information contained within the label may be quickly searched, scrolled, or accessed via an index or help function. This may be helpful in a time sensitive or emergency situation. In addition, active labels may be designed such that when coupled with user input technology (i.e. a touchpad, touch screen, or other switch or sensing technology), the operator may annotate, revise, add, delete, or otherwise edit the contents as needed for their particular application.

Active labels on containers or packages may also be used for identification and matching the pharmaceutical to the correct patient. For example, an active label on a container may display a bar code pattern so that existing tracking and inventory equipment may be used. In some hospitals, a barcode is placed on a pharmaceutical container label that identifies the prescription, dose, and patient that the medication is for. This barcode label is read by the clinician and matched to the barcode on the patient identification bracelet to confirm that the two match. The barcode on the medication package may be programmed during preparation at the hospital pharmacy so that it may be displayed on the package when it is delivered for administration to the patient. As an alternative, other patient identification information, such as patient name, social security number, hospital identification number, photograph, or other unique biometric information may be programmed to be visible on the active package display so that the prescription may be matched to the patient. If biometric sensors are included on the package, such as a fingerprint scanner, the display may be used to indicate when there is a correct match between the patient and the prescribed medication.

Note that the use of an active display and associated memory may provide tamperproof security features for hazardous or controlled substances. Information may be permanently written and stored to the device at the time of manufacture or when required. This provides an integral digital “watermark” that is associated with the package that provides authentication of the product and user instructions. In addition, the use of an active display may be used to indicate when a container contains an “approved”, “prescribed”, or “sterilized” material or if it does not. The display may also be used to communicate information about product “freshness” or expiration time (“use by date”). Also, this information may be a function of the product storage or operating environment. For example, the “use by date” may be adjusted based on storage temperature or other environmental conditions. In a different embodiment the active display may be coupled with sensing devices such as pressure sensors, gas sensors, chemical sensors, or tamper detecting switches to indicate product tampering or mishandling. Caution and warning messages may be displayed to indicate risks of using the product or deliver instructions for immediate disposal.

The use of an active display may also be used in conjunction with audio transducers to provide sound as well as visual information. This allows possible applications such as instructional videos, entertainment, and advertisements to be included with the product container or package. These features may be useful for the hearing and site impaired.

Note that while the ideas described herein refer to oriented toward pharmaceuticals, drugs, and associated packaging, these ideas may be extended to labeling for other hazardous, regulated time sensitive, environmentally sensitive, or otherwise complex materials or products. For example, these ideas may be used for household chemicals, pesticides, agricultural materials and other consumer or industrial products where instructions for use may be long and complex.

The foregoing description and accompanying drawings set forth the preferred embodiments of the invention at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope of the disclosed invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes and variations that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A stand-alone intelligent package system for medical, pharmaceutical or hazardous material applications, includes:

at least one integral active display.

2. The system of claim 1 where the display is on the outer or inner surface of the container.

3. The system of claim 1 wherein the display is printed, stamped, screened, embedded, or otherwise attached to the container.

4. The system of claim 1 wherein the display is placed as a label on the container or container packaging.

5. The system of claim 1 wherein the display is constructed of organic light-emitting polymer material.

6. A method for using a pharmaceutical or a controlled or hazardous materials container with an incorporated display, comprising:

presenting operator instructions, indications for use, cautions or warnings to one or more users thereof.

7. The method of claim 6, further comprising:

displaying information about the container, contents, or status thereof.

8. The method of claim 7 wherein the information includes dates or times regarding the contents of the container.

9. The method of claim 7 wherein the information includes manufacturing information, performance information or calibration information.

10. The method of claim 7 with the information includes status information regarding the contents of the container.

11. The method of claim 6, further comprising:

displaying information from the device interface or a connected system.

12. The method of claim 6, further comprising:

displaying information from incorporated or separate systems.

13. The method of claim 12 wherein the information is one or more of physical or temporal information.

14. The method of claim 6, further comprising:

display information based on a medication or an intended patient.

15. The method of claim 14 wherein the information is one or more of prescribed dose, preparation instructions or patient identification information.

16. The method of claim 15 wherein the patient identification information includes identification numbers, photographs or biometric data.

17. The method of claim 14 wherein the information is one or more of contraindications, warnings or other safety information.

18. A method for using a pharmaceutical container with incorporated display, comprising:

activating the display through operator input, a sensor input condition, at some periodic time interval, or by connection to or from an associated device.

19. The method of claim 18 wherein the display has an internal memory that is programmed during the time of manufacture, filling, opening, use, or disposal, with information to be displayed at a later time.

20. The method of claim 18 wherein the display can be activated at least once.