CA3023362A1 - Apparatuses, methods, and systems for delivering medication using medication kits - Google Patents

Apparatuses, methods, and systems for delivering medication using medication kits Download PDF

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Publication number
CA3023362A1
CA3023362A1 CA3023362A CA3023362A CA3023362A1 CA 3023362 A1 CA3023362 A1 CA 3023362A1 CA 3023362 A CA3023362 A CA 3023362A CA 3023362 A CA3023362 A CA 3023362A CA 3023362 A1 CA3023362 A1 CA 3023362A1
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Canada
Prior art keywords
drug
dosing device
medical treatment
medicine
patient
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3023362A
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French (fr)
Inventor
Caleb HERNANDEZ
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Certa Dose Inc
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Certa Dose Inc
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Filing date
Publication date
Priority claimed from US15/282,732 external-priority patent/US11617835B2/en
Application filed by Certa Dose Inc filed Critical Certa Dose Inc
Publication of CA3023362A1 publication Critical patent/CA3023362A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/1782Devices aiding filling of syringes in situ
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1072Measuring physical dimensions, e.g. size of the entire body or parts thereof measuring distances on the body, e.g. measuring length, height or thickness
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525Dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566Means improving security or handling thereof
    • A61M5/31568Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126Specific display means related to dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6009General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6045General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6081Colour codes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels

Abstract

Aspects of the present disclosure disclose a system for delivering medication. In one aspect, the disclosure is directed a kit that includes a medical dispensing device with a label with a series of zones of varying widths, with each of the zones corresponding to a pre-determined volumetric dose of the drug that is correlated to one of the physical characteristics of a patient. In one specific example, the label is further affixed to the medicine dispensing device such that the smallest dose of the drug to be administered corresponds to a first zone that is proximate an opening through which the drug is to be dispensed.

Description

2 PCT/US2017/031420 APPARATUSES, METHODS, AND SYSTEMS FOR DELIVERING MEDICATION
USING MEDICATION KITS
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No.
62/332,412, filed May 5, 2016, and entitled, "Apparatuses, Methods, and Systems for Delivering Medication Using Medication Kits;" this application is also a continuation-in-part of U.S. Patent Application No. 15/282,732, filed September 30, 2016, and entitled "Apparatuses, Methods, and Systems for Delivering Measured Doses of Medication," and a continuation-in-part of U.S.
Patent Application No. 14/392,087, filed September 2, 2015, and entitled "System for Delivering Medication," which is a national stage entry of PCT Application No.
PCT/U52013/023873, filed January 30, 2013, and entitled, "System for Delivering Medication," which claims priority to U.S. Provisional Application No. 61/593,674, filed February 1, 2012, entitled "System for Delivering Medication," and to U.S. Provisional Application No. 61/717,474, filed October 23, 2012, entitled "System for Delivering Medication." All of the above-referenced applications are hereby expressly incorporated by reference herein.
FIELD OF DISCLOSURE
[0002] The present disclosure relates to a medicine-dosing device, and more particularly to a pre-labeled medicine dosing device and method for administering appropriate doses of medicine in an emergency or critical care situations.

Attorney Docket No. CRTA-001/04W0 320095-xxxx BACKGROUND
[0003] Administering proper drug doses accurately and efficiently during an emergency or intensive care situation is of critical importance. This is particularly of essence in an emergency or critical care situation involving pediatric patients as even small dosing mistakes can lead to disastrous consequences. However, even under the best of circumstances and despite the best of efforts of medical personnel, inadvertent mistakes are sometimes made because of the multitude of steps involved in the drug administration process. More specifically, in a typical situation appropriate drug dosage must first be determined, which usually involves multi step mathematical calculations. This is followed by plurality of steps involved in the actual drug administration process, which may include selection of a correct medicine to be administered or medical dosing device to be used. Because each step carries with it a potential for introducing an error into the overall drug administration process, reducing the number of steps that must be executed can significantly increase the overall accuracy and efficiency of the process.
[0004] Drug dosages conventionally are determined based on the weight of the patient. However this method can, at times, be inappropriate and inaccurate especially in the emergency and critical care situations. Thus, at times, patient length can be used, as it allows for a quick and efficient determination of drug dosages, involves the use of a color coded measuring tape for determining the length of a patient. More specifically, the Broselow Pediatric Emergency Tape is a well known instrument that correlates easily obtainable patient length to drug dosages. The details of the instrument and the method of its use are disclosed in the U.S.
patents 4,716,888 and 6,132,416 to Broselow which are incorporated by reference into the present disclosure. In general, the method involves measuring and coding patient length to one of the color zones provided on the tape and using the color-coded length to determine a drug dosage to be administered to the patient. By segmenting the tape into plurality of color coded zones rather than the typically used inches or centimeters, with each color zone corresponding to a given length range, the length of the patient can be easily read and noted as being of a certain color rather than as a specific measurement in centimeters or inches. In other words, each color-coded length zone corresponds to a certain, predetermined range of the actual lengths as measured in either metric or imperial units. For example, the grey color zone on the tape may correspond to a length range from 42.20 cm to 60.79 cm and the pink color zone on the tape may correspond to the length range from 60.80 cm to 67.79 cm. Thus, a patient whose length falls within the first length range would be coded as gray and a patient whose length falls within the second length range would be coded as pink. The appropriate drug dosages for the two patients would then be selected from a list of predetermined drug dosages listed on the tape. Other commercially available length/weight-based tapes, such as the PediaTape and the Handtevy tape, are used in a similar fashion.
[0005] Although the step of determining drug dosages has been greatly simplified with the use of aforementioned method, a number of other issues still remain that often lead to dosing errors or that make the medication administration process inefficient. For instance, in order to arrive at a correct dose of medicine that is to be administered once the medication dosage is determined a number of other calculations, such as those involving, for example, concentration of the medication, still need to be performed. Furthermore, the selection of a correct medicine, an appropriate medicine dosing device or drawing of a correct predetermined volume of medication into the medicine dosing device can each introduce an error or slow down the process of administering medication to the patient. Even in situations when medication dosages are based on dosing systems other than the conventional weight based systems, such as for example patient age, body surface area or volume, dosing inaccuracies may be observed due to the type of calibrations used in such systems. In particular, a typically used constant incremental change in dosages may result in a loss in needed dosing accuracy when such systems are used.
[0006] Thus, despite the availability of various techniques designed to simplify the process of drug dosage determination and administration, there still exists a possibility of errors because of the pressure of time and the environment under which the treatment is delivered, as well as the type of dosing systems that are being used. Accordingly, there is need for a device for, and method of, accurately and efficiently delivering drugs during an emergency or critical situation, especially to pediatric patients.
SUMMARY
[0007] Medical treatment kits capable of facilitating treatment of complex medical problems is disclosed herein. The disclosed kits are each typically targeted to treatment of a specific medical problem, such treatment requiring that a specific sequence of medications be given in a correct order and dose. In certain high-risk scenarios the medical problems involved may place human live in the balance, and mistakes can be fatal. In these situations correct dosing and delivery can be life saving.
[0008] The medical treatment kit may provide a vial, including a drug, and a medicine dosing device. The medicine dosing device may be configured to receive the drug from the vial and deliver the drug to a patient. Further, the dosing device may be marked with coded dosage zones, which can have varying widths, and which correspond to predetermined drug doses. The kit may also include an instrument for associating the patient with one of the coded dosage zones.
[0009] In some embodiments, the kit may include a filling needle that attaches to the medicine dosing device and which is configured to draw the drug to be administered from the vial, so as to fill the medicine dosing device with a dose of the drug that corresponds to one of the coded dosage zones. Alternatively, the needle may be permanently attached to the syringe.
[0010] The medicine dosing device may be a syringe, and in some implementations, the syringe may be permanently attached to the needle.
[0011] The vial of the drug and the medicine dosing device may be labelled. In some embodiments, the vial and medicine dosing device are marked with the name and/or concentration of the drug. Additionally or alternatively, the vial and the medicine dosing device may be labelled with a symbol, and the symbol may correspond to the drug and/or the concentration of the drug.
[0012] In some implementations, the instrument for associating the patient with one of the coded dosage zones may be a color coded measuring tape. The patient may be measured with the color coded measuring tape in order to determine the color coded dosage zone to which the medical dosing device should be filled with the drug.
[0013] The medical treatment kit may further comprise an instruction sheet, which may provide steps for administering the drug.
[0014] The predetermined drug doses and/or the widths of the coded dosage zones marked on the medicine dosing device may correspond to the drug that is included in the vial.
[0015] In some embodiments, the kit may provide a second vial of a second drug and a second medicine dosing device that is configured to receive the second drug from the second vial and deliver the second drug to the patient. The second medicine dosing device may be marked with coded dosage zones of second varying widths that correspond to second predetermined drug doses. The second predetermined drug doses and the second coded dosage zones may be different than the predetermined drug doses and coded dosage zones.
[0016] Furthermore, the vial and the medicine dosing device may be marked with a first symbol, and the first symbol may correspond to the drug and a concentration of the drug. The second vial and the second medicine dosing device may be marked with a second symbol, and the second symbol may correspond to the second drug and a concentration of the second drug. The second symbol may be different from the first symbol.
[0017] In some implementations, the second drug may be a different concentration of the first drug.
[0018] In some embodiments, the kit may also include an instruction sheet. The instruction sheet may specify that the first drug should be administered to the patient before the second drug is administered to the patient.
[0019] A method of administering a plurality of drugs to a patient is also disclosed. The method may include associating the patient with one of a plurality of coded dosage zones using an instrument included within a medical treatment kit. A first vial containing a first drug may be selected from the medical treatment kit, and the first drug may be drawn from the first vial so as to fill a first medicine dosing device included within the medical treatment kit with a first dose of the first drug. The first dose may correspond to the one of the first plurality of coded dosage zones, wherein the first medicine dosing device is marked with the first plurality of coded dosage zones, and the first plurality of coded dosage zones are of first varying widths. A second vial containing a second drug may be selected from the medical treatment kit, and the second drug may be drawn from the second vial to as to fill a second medicine dosing device that is included within the medical treatment kit with a second dose of the second drug. The second dose may correspond to the one of the second plurality of coded dosage zones, wherein the second medicine dosing device is marked with the second plurality of coded dosage zones. The second plurality of coded dosage zones may be of second varying widths. The first drug and the second drug may be administered to the patient using the first medicine dosing device and the second medicine dosing deice. A sequence of administration of the first drug and the second drug may be indicated by instructions that are associated with the medical treatment kit.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIGS. 1A-1D are perspective views of a medicine-dosing device according to one embodiment of the current disclosure.
[0021] FIG. 1E is a perspective view of another embodiment of a medicine-dosing device according to an embodiment of the current disclosure.
[0022] FIGS. 2A -2D are perspective views of a medicine-dosing device according to another embodiment of the current disclosure.
[0023] FIGS. 3A ¨ 3D are plan views of the labels with the color-coded medication doses.
[0024] FIG. 4 is flow diagram showing a method of determining and printing the color-coded medication dose labels.
[0025] FIG. 5 is flow diagram showing a method of administering a medication using the disclosed pre-filled and marked medicine-dosing device.
[0026] FIG. 6 illustrates a measuring instrument used to determine a color-coded length of a patient.
[0027] FIG. 7A illustrates a method of administering a medication using the disclosed emergency medical treatment kit that includes the pre-marked medicine dosing device.
[0028] FIG. 7B illustrates the emergency medical treatment kit for administering a medication according to one embodiment of the current disclosure.
[0029] FIG. 7C illustrates an exemplary medical treatment kit for administering medication to treat anaphylaxis, allergy, and/or asthma.
[0030] FIG. 7D illustrates an exemplary medical treatment kit for administering medication corresponding to rapid sequence intubation.
[0031] FIGS. 7E-F illustrate exemplary embodiments of an adult syringe.
[0032] FIGS. 8A-8F includes data showing improvements in the drug delivery using the system and methods of the current disclosure.
DETAILED DESCRIPTION
[0033] The present application describes a device, system, and method for administering proper medication doses to patients. The device and system are configured to address the five rights of medicine delivery; that is, giving the right patient the right drug in the right dose by the right route at the right time. In particular, a pre-marked medicine dosing/dispensing device designed to minimize medication dosing errors, as well as to improve the overall accuracy and efficiency of administering medication, especially in the emergency and critical care situations, is provided.
[0034] As discussed in detail below, in one embodiment the medicine dosing device 10 is a syringe 15 that includes an elongate barrel 30 marked with predetermined color-coded volumetric medicine doses 100 and a plunger 50. The medicine-dosing device, according to one embodiment, may be further pre-filled with a fluid 105 that corresponds to a medication to be administered to a patient. A method for determining specific volumetric doses for a plurality of medications based on different factors is also disclosed. In particular, according to one embodiment the method involves generating labels or marking medical dosing devices with doses that are determined based on, for example, volumetric capacity of medical dosing device and/or drug concentration.
[0035] Also, a method for administering proper medication doses using the pre-marked medicine-dosing device is discussed. The method disclosed leads to a significant reduction in the amount of time required to determine and administer a dose of medication to a patient and at the same time decreases the risk that such doses will be miscalculated or otherwise erroneously administered.
DEVICE
[0036] For a detailed discussion of the first embodiment of the pre-labeled medicine dosing/dispensing device 10, reference is now made to FIGS. 1A-1D. As shown in FIG. 1A, the medicine dosing device 10 according to one embodiment is a syringe 15 that includes a proximal end 25 and a distal end 20 opposite the proximal end. The syringe includes a vessel, such as a syringe barrel 30 at the distal end for holding therein a medicine that is to be dispensed, and a plunger 50 that extends proximally from an opening 36 located at the proximal end 35 of the syringe barrel to the proximal end 55 of the plunger at the proximal end 25.
The syringe barrel and plunger are both manufactured from material such as plastic, glass or any other suitable transparent medical grade material that is inert or will not disrupt the chemical balance of the fluid inside.
[0037] As illustrated in FIG. 1B the syringe barrel 30 is elongate and substantially cylindrical and includes a distal end 31 and a proximal end 35. The syringe barrel further includes and outer circumferential surface 37 and an inner circumferential surface 38. A chamber 32 capable of receiving a plunger and retaining a fluid therein is defined by the inner circumferential surface
38 of the barrel between the distal and proximal ends 31 and 35. A flange 33, which can serve as a finger grip to provide for an easier handing of the syringe, is integrally formed with the proximal end of the barrel and defines an opening 36 for receiving the plunger. Proximate the opening 36, along the inner surface of the barrel, is a ridge 34, shown in FIG. 1C, that prevents the plunger from slipping out of the barrel once it is engaged with the barrel.
[0038] The opening 36 is in communication with the chamber 32 and an orifice
39 located at the distal end 20 of the syringe barrel. A tip 40 for attaching a needle, nozzle or tubing for expelling the liquid contained within the syringe barrel 30 is integrally formed with the distal end 20 of the barrel and in communication with the orifice 39. The tip may include coaxially positioned inner 41 and outer 42 members. According to one embodiment the tip may include a Luer taper fitting.
In some embodiments, the tip may be configured based on the type of drug that the syringe is used to deliver. For example, oral tips may be used on syringes configured for medicines that are oral, and in particular, the oral tip may be different from an intravenous ("IV") or intermuscular ("IM") tip, thereby ensuring that the medicine is delivered by the right route.
Similarly, syringes configured for IV and IM drugs may be configured with IV
and IM tips, respectively, such that they, too, can only be delivered via the right route.
[0039] The plunger 50, according to one embodiment shown in FIG. 1B, includes a plunger rod 51 and a rubber or plastic gasket or stopper 52 attached to the distal end 56 of the plunger rod.
The gasket forms a tight seal between the inner surface of the barrel and the plunger in order to prevent the contents of the syringe from escaping out the back of the syringe.
An annular flange 53 is integrally formed with the proximal end 55 of the plunger rod. The plunger 50 has an elongate shape complementary to that of the chamber 30 and is designed such that it can be pushed along the chamber (inside of the cylindrical barrel or tube) allowing the syringe to expel fluid through the tip 40 or orifice 39 at the distal end of the barrel.
Alternatively the plunger can include any other configuration capable of forcing the fluid from inside the chamber 30 through the tip 40 or orifice 39.
[0040] According to one embodiment of the present disclosure, the medicine dosing device may be prefilled with a pre-selected drug. Initially, when the medicine dosing device is prefilled and the syringe is in the pre-medication administration position, the substantial length of the plunger rod extends longitudinally outside of the syringe barrel. In other words, as shown in FIG IA, prior to the administration of the medicine, only the gasket 52 and the distal end 56 of the plunger rod are initially inside the syringe barrel, at the proximal end 35 of the barrel, with the remaining part of the plunger length outside of the barrel such that its proximal end 55 is in its most extended configuration.
[0041] Alternatively, the medicine dosing device may not be prefilled. The medicine dosing device may be marked, for example, with a drug name, concentration, volumetric markings, color coded zones, and/or the like. A medical professional may draw the drug (i.e., the drug with the name marked on the device) with the proper concentration into the medicine dosing device to reach the appropriate volumetric markings and/or color coded zones. In some embodiments, the medicine dosing device comes as a part of a kit that includes a medicine vessel containing the drug to be administered. The drug in the medicine vessel may be drawn into the medicine dosing device immediately prior to the drug administration process. In such embodiments, the plunger rod may remain inside the syringe barrel until the drug is drawn into the syringe. In order to avoid confusion as to which syringe is to be used with which drug, the medicine dosing devices may be marked clearly. As discussed further below, such markings may include different colored plungers in order to avoid confusion. As a specific example, a kit containing etomidate and succinocholine could have a red plunger for use with etomidate and a blue one for use with succinocholine.
[0042] According to another embodiment shown in FIGS. 2A, syringe 15 may include an elongate barrel 70 and a plunger 80 marked with predetermined color-coded volumetric medicine doses 100 and prefilled with a fluid 105 that corresponds to a medication to be administered to a patient. In this configuration, as illustrated in FIG. 2C the syringe barrel includes an inner tubular body 75 that is generally coaxially aligned with the larger diameter of the cylindrical barrel. The inner tubular body has a needle 76 coaxially positioned within the inner tubular body and longitudinally aligned with the inner tubular body. The plunger 80, shown in FIG. 2D, includes a substantially cylindrical member or vial 81 and a stopper 82.
Because the syringe barrel and the plunger are initially separated, as shown in FIG. 2B, prior to the administration of the medication, the plunger 80 needs to be inserted into the proximal end 35 of the syringe barrel, such that the stopper 82 fully engages with the inner tubular body 75 and the needle 76.
[0043] According to yet another embodiment of the current disclosure the plunger and/or plunger stopper can be color coded based on the medication contained in the barrel. Such color coding of the plunger can further increase efficiency with which medication is administered and can make the administration even less error prone as visual inspection of the plunger can provide a quick verification of the correctness of the medication to be administered.
Alternatively or in addition to the color coded plunger and/or plunger stopper, the plunger and/or plunger stopper may be further marked with the name and/or concentration of the drug to further limit the possibility that a mistake is made.
[0044] Alternatively the medicine dosing device can include any vessel, such as for example tube, vial, bag or bottle, capable of containing therein and expelling therefrom a desired medicine. For example, the medicine dosing device could be a bag containing an IV fluid.
According to this embodiment, the bag may be marked with a series of color coded zones along with the traditional volume markings. When used in combination with the traditional volume markings, the color coded zones could serve as a reminder to the medical personnel of a correct volume of each medication that can be given to a patient based on the patient's color zone. The color coded zones may also be used as a key for entering a correct total volume to be dispensed into the IV pump for a given medication.
[0045] The description will now turn to the markings on the surface of the medicine dosing device. In case of a syringe, the markings may be placed along a circumferential surface of the syringe barrel or plunger. As shown in FIGS. 1 through 3, the markings include a series of substantially translucent bands or zones 100 indicative of the possible medicine doses to be administered to a patient. Although the markings shown in the figures include a series of color coded zones, the markings could also include zones with different patterns, textures, etc.
Regardless of the type of the marking used, the markings are either directly imprinted, painted, etched or stained on an inside or outside surface of the medicine dosing device or a label or sleeve may be generated that can be affixed or placed over the outer surface of the medicine dosing device. The applied markings are such that the fluid level, once the device is filled, can be easily seen through the markings.
[0046] FIG. 3A shows a plurality of labels in accordance with one embodiment of the current disclosure. Each label 300 is substantially rectangular in shape and is sized based on the volumetric capacity of the medical dosing device to which the label is to be affixed. In other words, because of the volumetric variations among the medicine dosing devices and as a result of variations in the circumferential outer surface of such devices, the size or dimensions of the label is adjusted accordingly to ensure that it properly covers the outer surface of the of the medical dosing device. For example, when labels are made for syringes with two different volumetric barrel capacities, the label size is either increased or decreased in both length and width to accommodate for the changes in the outer surface of the barrel.
[0047] Along with the changes in the label size, appropriate corresponding changes to the widths of the color bands or zones that are printed on the label are also made based on medicine dosing device used to dispense the medication. More specifically, in order to take into account the variations in the volume of a medicine-dispensing device, the changes to the widths of the color bands or zones need to be made in order to maintain the same volumetric dose of medicine across various medicine dispensing devices. For example, as shown in FIG. 3B, labels for the same medicine loaded into a 10 cc medicine dispensing device and 5 cc dispensing device have two different widths for each color band or zone in order to keep the medicine doses the same for both medicine dosing devices. In other words, in order to dispense the same amount of medication using a 10 cc dispensing device as compared to using a 5 cc dispensing device, the width of the color bands 351A ¨ 359A on the label 310 for the 10 cc device would be smaller than the color bands 351B ¨ 359B on the label 305 for the 5 cc dispensing device in order to deliver the same amount of medication to the patient.
[0048] Similarly, the concentration of the medication that is used also affects the widths of the color bands or zones printed on the label. More specifically, the widths of the color bands or zones are determined based on the concentration of the medication, with the medication at a higher concentration corresponding to a smaller volumetric dose, or smaller band width, than the medication at a lower concentration.
[0049] As depicted in FIG. 3C the label 300 has opposing parallel sides 315 and 320 and opposing parallel ends 325 and 330 and includes a series of consecutive color bands or zones 351 through 359 of varying widths that correspond to the medication doses for patients with a particular characteristic. The characteristic may correspond to patient length (as discussed above), patient weight, patient age, patient surface area/volume, and/or the like.
More specifically, each color band has a width that is defined by leading 335 and trailing 340 edges that are parallel to the opposing ends 325 and 330 of the label and which, once the label is affixed to the medicine dispensing device, corresponds in volume to a predetermined dose of medicine appropriate for the patient having a characteristic that falls within a predefined color-coded range. In other words, each color band or zone on the label represents a medication dose correlated to respective color-coded length range, weight range, age range, surface area/volume range, or other physiological characteristic.
[0050] Still referring to FIG. 3C, according to one embodiment, nine distinct color bands 351-359 can be used to distinguish between nine different doses of medication corresponding to nine distinct color coded patient characteristic ranges. More specifically, each of the colors corresponds to one of nine different doses of a specific medication. As shown in the FIG. 3C, in one particular implementation, band colors may include grey 351, pink 352, red 353, purple 354, yellow 355, white 356, blue 357, orange 358 and green 359, with the grey color band corresponding to the smallest dose of the medication and the green color band corresponding to the largest dose of medication that can be delivered. A solid black lines 365 may be utilized at the boundaries between the various color bands or zones to facilitate the process of drug administration as will be discussed in more detail below. Although, the discussion will be made with reference to the specific colors shown in the FIGS. 3A-3C, it can be readily appreciated that other colors or markings may be used. Alternatively or additionally, color names may be printed within the band or zone widths in addition to or instead of colors.
[0051] According to yet another embodiment shown in FIG 3D, a label may include ten different bands of colors with the tenth band 360 corresponding to the largest dose of medication that can be delivered. In this particular embodiment the largest dose can correspond to the universal dose that can be delivered to any patient whose characteristic (e.g., length, weight, etc.) falls outside of the previously disclosed colored ranges. For example, the universal label in accordance with this embodiment can be applied to the universal medicine-dosing device that can be used for both pediatric and adult patients and as such eliminates a need for having two separate medicine dosing systems for the two distinct patient groups. Although, in the examples provided above a specific number of color bands have been discussed, it should be noted that any number of color bands that allow for more precise medicine dosing can be used. In some cases, the previously defined bands or zones can be further subdivided into sub-band or sub-zone to allow for a more precise medicine dosing. As a non-limiting example, in some embodiments, there may be thirty-six markings (sub-zones) within nine color zones. This may increase precision when administering a drug to a patient.
[0052] Also, in accordance with another embodiment of the current disclosure, and as shown in FIG. 3C one of the label edges can include a mark 370 that would help ensure that the label is correctly affixed or positioned on the syringe or plunger. For example, the label edge that is to be aligned with the distal end of the syringe barrel can be marked in order to prevent affixing the label to the barrel in the reverse direction, and thus leading to the incorrect doses being administered at a later time. For example, the edge of the label with the color band corresponding to the smallest dose can include a mark at its leading edge that facilitates the alignment of the label with a distal end of the syringe barrel.
[0053] Furthermore, in accordance with another embodiment as shown in FIG. 3A, the label may include the name of the medication that is to be administered or any other information that maybe important to ensuring that a correct medication would be administered to the patient. In particular, the name of the medication can be imprinted along the length of the label or any other position as long as it provides for an easy verification of the correctness of the medicine in the medicine-dosing device. Additionally, for drugs that are administered at time intervals, the label may be marked with the corresponding time interval, or a separate calendar, either paper or electronic, may be provided such that the patient and/or medical professionals can keep track of dosing intervals.
METHOD OF DETERMINING AND GENERATING DOSING INFORMATION
[0054] The discussion will now turn to a method 400 for determining the medicine doses for a plurality of medications and medicine dispensing devices. In one particular example, shown in FIG. 4, the method may include generating of a color-coded dose label that can be applied to a selected medical dosing device. As shown in FIG. 4, the method 400 begins at step 401 during which the selection of the medicine for which the dosing label is to be generated is made. As related to emergency or critical care situation some of the most commonly used medications include, for example, atropine, lidocaine, fentanyl, epinephrine, etomidate, ketamine, succinylcholine, rocuronium, and midazolam to name a few. However, it should be appreciated that the method can be equally applied to any other medication that can be administered using the disclosed medicine dispensing device.
[0055] Once the medication for which a label is to be generated is identified, the doses of the drug for each of the color coded characteristic (e.g., length, weight, etc.) zones previously discussed is determined at step 402. Depending on the drug, the width of the color coded zones may differ. Table 1 below provides doses in mg for some of the above listed drugs. As can be seen in Table 1, the doses for each drug differ not only based on the type of the drug but also based on the length (i.e., characteristic) of the patient. Thus, for example, as shown in Table 1, a dose for a patient falling within the yellow color-coded length zone is 26 mg for succinylcholine and 13 mg for rocuronium. In case the same drug is to be administered to two different patients whose length falls within different color coded lengths, two different medication doses would be used as shown. For example, in the case of epinephrine, with one of the patient lengths being coded as red and the other as blue, the dose of medication to be administered to each patient would be 0.085 mg and 0.21 mg, respectively. Alternatively, doses of the drug may be determined based on dosing recommendations other than those based on the length of the patient, such as, for example, the patient's weight, age, surface area/volume, and/or the like.
[0056] After the dose to be administered to the patient is determined at step 402, the drug concentration for the drug selected in step 401 is then determined at step 403. The concentration of the drug is directly related to the volume that needs to be administered.
In other words, a smaller volume of the same medication needs to be administered for a solution with a higher concentration than for a solution with a lower concentration.
[0057] The next step, step 404, involves selection of a medicine dispensing device to which the label is to be applied. As described above, because medicine dispensing devices come in various volumetric sizes, a medicine dispensing devices conversion factor that is based on the length and width of the medicine dosing device and/or the concentration of the medication may be used to take into account the variations in size and/or shape of different medicine dispensing devices for which the label is to be generated. Thus, once the medicine dispensing device of a particular volume is selected for administering the selected medication, a corresponding conversion factor listed in Table 1 can be used in order to calculate both the individual color band/zone widths and a total band widths that correspond to the determined medication doses (step 405). More specifically, the width of each color band/zone that corresponds to the determined medication dose is calculated based on the dose of the drug to be administered, the solution concentration and medicine dispensing device volumetric capacity. According to one embodiment all of the calculations may be performed by a computer processing unit (CPU) in response to a user provided input.
[0058] Applying of the label to the medicine dosing device may take place once the width of each color band or zone is determined and the label is printed. For instance, when the label is to be applied to a syringe having a barrel and a plunger, with the barrel designed for holding the medicine that is to be dispensed, the label may be place along the outer circumferential surface of the barrel by aligning one of the edges of the label that corresponds to a color band of the smallest dosing with the distal edge of the syringe barrel of the medicine dispensing device 10.
Alternatively, in a syringe in which a plunger serves as a vessel for holding the medicine, the label may be placed along the outer circumferential surface of the plunger by aligning one of the edges of the label that corresponds to a color band of the smallest dosing with the proximal end of the medicine dosing device.
[0059] Although the pre-calculated band/zone widths for each of the selected medication, medicine dispensing device volumetric capacity and solution concentration may be printed on a label that can be applied to the medicine dispensing device, the dosing information may also be directly imprinted, etched, stained or painted on the medicine dispensing device. Alternatively, the dosing information can be printed on a sleeve that can be placed over the medicine dispensing device.
[0060] Depending on the embodiment, the appropriately labeled medicine-dosing device may be prefilled with a desired medication, with the fluid volume corresponding to the maximum dose that can be administered to the patient whose, for example, length falls within the maximum length zone. When the medicine dosing unit is prefilled with the selected medication the label can be applied either before or after the medicine dosing device is filled. In case the medicine dosing device is filled with a selected medication immediately prior to the medication administration process, as might be the case when the medicine dosing device is included as a part of a kit that includes the medical dosing device and a vessel filled with a drug to be administered, an empty pre-labeled medicine dosing device is supplied for use.
Accordingly, a fluid volume that corresponds to a predetermined dose for a given patient may be drawn into the pre-labeled medicine dosing device from the container immediately prior to drug administration.

Drug Color- Dose (mg) Concentration Medicine Conversion Color band Total Coded (mg/m1) Dosing Factor or zone Distance Length Device (mm/cc) width (mm) (cc) (mm) Epinephrine Gray 0.04 0.1 3 16 6.4 6.4 Pink 0.065 0.1 3 16 4 10.4 Red 0.085 0.1 3 16 3.2 13.6 Purple 0.1 0.1 3 16 2.4 16 Yellow 0.13 0.1 3 16 4.8 20.8 White 0.17 0.1 3 16 6.4 27.2 Blue 0.21 0.1 3 16 6.4 33.6 Orange 0.27 0.1 3 16 9.6 43.2 Green 0.33 0.1 3 16 9.6 52.8 Fentanyl Gray 12 50 3 16 3.84 3.84 Pink 20 50 3 16 2.56 6.4 Red 25 50 3 16 1.6 8 Purple 32 50 3 16 2.24 10.24 Yellow 40 50 3 16 2.56 12.8 White 50 50 3 16 3.2 16 Blue 63 50 3 16 4.16 20.16 Orange 80 50 3 16 5.44 25.6 Green 100 50 3 16 6.4 32 Midazolam-RSI Gray 1.2 1 12 5.16 6.192 6.129 Pink 2 1 12 5.16 4.128 10.32 Red 2.5 1 12 5.16 2.58 12.9 Purple 3.2 1 12 5.16 3.612 16.512 Yellow 4 1 12 5.16 4.128 20.64 White 5 1 12 5.16 5.16 25.8 Blue 6.3 1 12 5.16 6.708 32.508 Orange 8 1 12 5.16 8.772 41.28 Green 10 1 12 5.16 10.32 51.6 Ketamine Gray 6.75 10 6 8 5.4 5.4 Pink 13 10 6 8 5 10.4 Red 17 10 6 8 3.2 13.6 Purple 20 10 6 8 2.4 16 Yellow 26 10 6 8 4.8 20.8 White 33 10 6 8 5.6 26.4 Blue 42 10 6 8 7.2 33.6 Orange 50 10 6 8 6.4 40 Green 66 10 6 8 12.8 52.8 Etomidate Gray 0.9 2 5 9 4.05 4.05 Pink 2 2 5 9 4.95 9 Red 2.5 2 5 9 2.25 11.25 Purple 3.2 2 5 9 3.15 14.4 Yellow 4 2 5 9 3.6 18 White 5 2 5 9 4.5 22.5 Blue 6.3 2 5 9 5.85 28.35 Orange 8 2 5 9 7.65 36 Green 10 2 5 9 9 45 Atropine Gray 0.1 0.1 5 9 9 9 Pink 0.13 0.1 5 9 2.7 11.7 Red 0.17 0.1 5 9 3.6 15.3 Purple 021 0.1 5 9 3.6 18.9 Yellow 0.26 0.1 5 9 4.5 23.4 White 0.33 0.1 5 9 6.3 29.7 Blue 0.42 0.1 5 9 8.1 37.8 Orange 0.5 0.1 5 9 7.2 45 Green 0.5 0.1 5 9 0 45 Succinylcholine Gray 8 20 3 16 6.4 6.4 Pink 13 20 3 16 4 10.4 Red 17 20 3 16 3.2 13.6 Purple 20 20 3 16 2.4 16 Yellow 26 20 3 16 4.8 20.8 White 30 20 3 16 3.2 24 Blue 40 20 3 16 8 32 Orange 53 20 3 16 10.4 42.4 Green 66 20 3 16 10.4 52.8 Rocuronium Gray 4 10 3 16 6.4 6.4 Pink 7 10 3 16 4.8 11.2 Red 9 10 3 16 3.2 14.4 Purple 10 10 3 16 1.6 16 Yellow 13 10 3 16 4.8 20.8 White 16 10 3 16 4.8 25.6 Blue 21 10 3 16 8 33.6 Orange 27 10 3 16 9.6 43.2 Green 33 10 3 16 9.6 52.8 Lidocaine-RSI Gray 6 20 3 16 4.8 4.8 Pink 10 20 3 16 3.2 8 Red 13 20 3 16 2.4 10.4 Purple 15 20 3 16 1.6 12 Yellow 20 20 3 16 4 16 White 25 20 3 16 4 20 Blue 32 20 3 16 5.6 25.6 Orange 40 20 3 16 6.4 32 Green 50 20 3 16 8 40 _ _ METHOD OF ADMINISTERING DRUGS
[0061] The medicine dosing device assembled according to the steps discussed above may be used to safely and efficiently deliver drugs. FIG 5 is a flow diagram 500 of a method for administering drugs to a patient using the disclosed medicine dosing device 10 according to one embodiment. In this particular example, the disclosed method provides steps for efficiently administering a selected medicine to a patient from a prefilled and pre-marked medicine dosing device. As shown in the figure, the method begins at step 501 at which a color-coded length or any other physical characteristic of the patient is determined. In case of the length, a Broselow tape or any other similar type of instrument that provides color-coded length ranges can be used at this step. As shown in Figure 6, the color coded length may be obtained by placing a patient 600 along the tape 601 and noting the color-coded length of the patient on the tape.
Alternatively, any other physiological characteristic, such as for example, weight, age, body surface area or volume, that can be color coded and correlated to medication doses can be used.
[0062] Once the patient length or any other physiological characteristic is determined and/or coded to a specific color range, a prefilled medicine dispensing device 10 containing medication to be administered is selected at step 502. The medication selection is verified by either reading the name of the medication imprinted along the outer surface of the pre-filled medicine dispensing device or by verifying the color of the plunger rod as discussed above.
[0063] After the color code for the patient length or other characteristic is determined and noted and the correctness of the medicine to be administered is verified, the appropriate dose of medication to be dispensed or its corresponding volume is determined at step 503. The appropriate dose may be determined by a physician or other medical professional who calculates the appropriate dose based on at least one patient characteristic. The calculated dose may be a precise amount of a drug to be administered. Additionally, the physician or other medical professional who administers the medication may determine a color code for the patient based on at least one patient characteristic. For example, if the patient length or other characteristic is determined as falling within the blue color range on the measuring tape, the volume of medication to be administered to the patient will be the volume within the blue color band or zone on the medicine dosing device.
[0064] Because (in this embodiment) the medicine dispensing unit is prefilled with medication, the appropriate dose of medicine can be obtained by purging any excess of medication from the prefilled syringe until the determined/calculated volume (dose) of the medication is reached as indicated in step 504. In other words, with the prefilled volume of the medicine dispensing device may correspond to the maximum dose that can be administered to a patient. Therefore, unless the calculated dose is the maximum possible dose, some of the medication has to be purged from the prefilled medicine-dosing device prior to administering of the drug.
[0065] Thus, according to one embodiment the plunger is pushed along the inside of the barrel toward the distal end 31 of the barrel until the proximal end of the plunger 54 arrives at the calculated dose. Once the administering medical professional has purged the excess medicine such that the calculated dose is the only medication that remains in the medicine dosing device, the administering medical professional verifies that the calculated dose, and the amount of medication that remains in the medicine dosing device, is within the color coded range determined for the patient. For example, in case of the above mentioned patient whose length or other characteristic was coded as being blue, with the blue band having a leading edge proximate the distal end of the barrel and the trailing edge proximate the proximal end of the barrel, the plunger is pushed toward the distal end of the barrel until the distal end of the plunger is aligned with the calculated dose, and then the administering medical professional ensures that the plunger is between the leading edge and trailing edge of the blue band. Once all the excess fluid is purged from the prefilled dosing device per step 504, the correctness of the medicine dose is verified at step 505 and the medicine is then administered to the patient at step 506.
MEDICATION KIT
[0066] Administering drugs to pediatric patients is particularly problematic in emergency situations. As discussed above, determining the dosage for pediatric patients involves first determining the number of milligrams of a drug to give to the patient based on their weight and/or height. Next, the number of milliliters of the drug to give the patient must be determined based on the concentration of the medication. As a result, there is a risk of human error involved in performing the calculations necessary to determine a proper dosage. In addition, errors can arise when medical personnel, often in emergency situations, grab or otherwise a select a syringe having different units than those contemplated by the calculations. These errors can be compounded when treating a patient with a sequence of drugs, i.e., when multiple medications are being administered.
[0067] Moreover, in certain cases a sequence of multiple drugs must be administered in a particular order. So in addition to the above-mentioned errors, further errors may arise as a result of delivering the multiple medications in the incorrect sequence. Furthermore, there is also risk that certain medications may not be immediately available to the medical staff, and a delay in obtaining the medication can cause harm to the patient. For example, if too much sedative is delivered to a patient, an antidote may be used to reverse the overdose and prevent harm to the patient. However, when the sedative is given and the antidote is not readily available, a delay may be harmful to the patient.
[0068] Using kits of the type described herein may reduce some or all of these risks. For example, the use of such kits may help to ensure that correct dosages are administered using the correct timing and sequencing. In addition, the use of the present kits helps to ensure that appropriate antidotes and the like are available in the event of any errors in dosing or sequencing.
In some embodiments, the kits may be available based on the drug(s) and/or treatment(s) to be administered.
[0069] Embodiments of the kits may include one or more of: a medication, a plurality of medications, medication dosing devices, and/or the like. The kits may also include instructions and an instrument, such as a Broselow tape or any other similar type of device, that provide color-coded length ranges as discussed above with reference to FIG. 6. For treatment kits that require a sequence of drugs, the medications and/or medication dosing devices may be labeled accordingly. For example, the first medication to be administered and the corresponding medication dosing device may be labelled "1," the second medication and corresponding medication dosing device may be labelled "2," and so on. Further, in embodiments where an antidote to the drug (or one of the drugs) is provided, the antidote medication and the antidote dosing device may be labelled accordingly.
[0070] Within a kit, the medication may be stored in a vial, and the medication dosing device may be a syringe, such as the syringe discussed above with respect to FIGS. 1-3. In some embodiments, one or all of the medications may be stored within a syringe. The syringes may be customized for each drug. Syringes with different volumetric capacities may be used depending on the medication. Further, the label size and width of floor bands or zones varies depending on the drug and/or drug concentration. Accordingly, the name of the medication and the concentration of the medication to be used with that syringe may be printed on the syringe (or on the label that is placed on that syringe).
[0071] In some embodiments, the medicine-dosing device can be used to administer drugs to patients following the method shown in FIG. 7A. In particular, the method for administering drugs can begin with the selection of an emergency medical treatment kit that includes a drug to be administered to the patient (step 701). As shown in FIG. 7B, the medical treatment kit may include a container, such as box, bag, pouch or any other suitable container capable of holding the medicine dosing device therein, labeled on the outside surface with the name of the medication contained in the container among other things. For example, according to one embodiment, in addition to having the name of the drug listed on the label, the label may also include information on the concentration of the drug and/or instruction on how to use the kit to administer the drug. The medical treatment kit may further include a pre-marked medicine dosing device, such as for example a syringe, with the color-coded zones calibrated to the different drug doses for the selected drug. The syringe markings may also include the name of the drug that is to be delivered or any other information that may be helpful in ensuring that the drug is correctly delivered to the patient. The medical treatment kit may also include a needle, such as a blunt filling needle that can be plastic or made of any other suitable material, for facilitating drawing of the drug into the syringe. The medical treatment kit may also contain a container, such a bottle, vial, etc, for holding the drug that is labeled with the drug name on the outside of the container. The container may include a stopper or a lid that helps to contain the drug inside the container. The stopper or lid may be made from, for example, rubber or any other suitable material that can be easily punctured with the filling needle, such that the drug from the container can be easily drawn into the medicine-dosing device.
[0072] If more than one drug is included in the kit, the corresponding vials and syringes for each drug may be positioned within the packaging to ensure that there is no confusion as to which vial corresponds to which syringe. Additionally, differently colored plungers may be used in order to ensure that the correct medication is given to the patient in the correct order. For example, in a situation where two drugs are being administered in a specified order, the kit may include a first drug in a first vial with a first syringe marked with the color zones for the first drug, and a second drug in a second vial with a second syringe marked with the color zones for the second drug. To ensure that the first vial and first syringe do not get confused with the second vial and second syringe, the plungers in the syringes may be colored. The color of the label and/or lid of the first vial may be marked with the same color as the plunger of the first syringe, and the color of the label and/or lid of the second vial may be marked with the same color as the plunger of the second syringe. This way, when the drug is being administered, the administrating medical professional can easily to make sure that the correct vial/drug-syringe combination is being used.
[0073] Alternatively or additionally, when the drugs need to be delivered in a particular order, the ends of the plungers may be marked numerically to indicate the order in which the drugs are to be delivered. For example, if the first drug to be administered has a green plunger and the second drug to be administered has a yellow plunger, the end of the green plunger may have a number "1" on the end and the end of the yellow plunger may have a number "2"
on the end.
The vials may also be marked numerically.
[0074] In case drug doses are based on patient's length, the color-coded length of the patient may be determined (step 702) using an instrument such as a Broselow tape or any other similar type of device that provides color-coded length ranges as discussed above with reference to FIG.
6. Alternatively, other patient characteristics may be used to determine a color coded range.
Appropriate volume of the drug to be administered may be subsequently determined based on the patient length, and the patient length may be correlated to a color code (step 703). The determined drug volume may be then drawn into the medicine-dosing device (step 704), and the administering medical professional verifies that the determined drug volume is within the color code corresponding to the patient (step 705). Once the dose is verified, the drug can then be administered to the patient (step 706). According to one embodiment as shown in FIG. 7B, when the medicine-dosing device is a syringe with a pre-attached filling needle, the filling needle might be disposed of prior to the administration of the medication.
[0075] FIG. 7C shows an exemplary kit 720 that may be configured to treat anaphylaxis. It may also treat allergies and/or asthma. Such a kit may contain a vial 725 of epinephrine that has a certain concentration. For example, the epinephrine may have a concentration of 1:1000 mg/ml.
A syringe 730 (dosing device) may be provided with permanent needle attached thereto in order to ensure the medication is not mistakenly given intravenously. The syringe may have a maximum volume of 0.33 mL. The maximum volume of the syringe may be the maximum pediatric dose of epinephrine, or the maximum volume may be slightly larger than the maximum pediatric dose of epinephrine. The syringe is marked, such as with the color coding discussed above, to indicate the correct dose. In some embodiments, the correct dose may be determined based on the child's weight, age, surface area, and/or length. An instrument 735, such as a Broselow tape or any other similar type of device, that provides color-coded length ranges (e.g., as discussed above with reference to FIG. 6) may also be included in the kit.
Instructions 740 may also be included in the kit. The kit may be packaged within a container/package 745. In some embodiments, at least a front side of the packaging may be clear, hard plastic so that the contents are visible and in a particular order.
[0076] Another exemplary kit 750 is shown in FIG. 7D. The kit 750 may be configured for rapid sequence intubation, which may involve a sequence of medications, such as etomidate, succinopcholine, atropine, and lidocaine. In the embodiment of FIG. 7D, the kit 750 includes three medications. Each medication may be stored in a vial 755a, 755b, 755c, and each vial 755a, 755b, 755c has a corresponding syringe 760a, 760b, 760c. The syringes 760a, 760b, 760c are each calibrated to one of the medications, where syringe 760a is calibrated to the medication in vial 755a, syringe 760b is calibrated to the medication in vial 755b, and syringe 760c is calibrated to the medication in vial 755c. The calibration is based on color coding, where the color coding correlates to the child's weight, age, surface area, and/or length. In some embodiments, an instrument 765, such as a Broselow tape or any other similar type of device, that provides color-coded length ranges (e.g., as discussed above with reference to FIG. 6) may also be included in the kit. The instrument 765 is used to determine the color range to which the vial should be filled with the medication. Instructions 770 may also be provided. The instructions 770 may list one or more of the following steps: measure the child's weight, age, surface area, and/or length; determine a color based on the measurement; give medication 1 based on the appropriate color; give medication 2 based on the appropriate color; give medication 3 based on the appropriate color.
[0077] In some embodiments, each corresponding vial-syringe pair may be included within another set of packaging in order to ensure that the vial-syringe pairs are not confused.
Alternatively or in addition, the vial-syringe pairs may be labelled numerically (e.g., the vial with the first medication and the corresponding syringe are each labelled with the number 1 and so on) and/or the syringe may be marked with the corresponding drug and concentration. The vial-syringe pairs may also be marked with a unique symbol, wherein the unique symbol is only used for that vial-syringe match or wherein the unique symbol is only used for a single drug at a particular concentration. Thus, the person administering the drug should check to ensure that the symbol, number, etc. match before administering the drug.
[0078] Kits may be configured to contain various combinations of medication for any pediatric medical condition. Another exemplary kit may be a supra-ventricular tachycardia kit, which may include a vial of atropine in a correct concentration, a syringe for a first dose at lx mg/kg, a second syringe for a second dose at 2x mg/kg, instructions, a container to keep the contents in order, and/or the like. Other exemplary kits may be configured for moderate sedation, acute pain, and other procedures.
[0079] In some implementations, kits may also be generated to treat adults, such as treatments/medications that vary based on the size, weight, etc. of the adult.
For some medications, adult doses are universal; for others, doses may differ based on patient size. The concept is similar to that of pediatric patients, where a larger patient gets a bigger dose and a smaller patient gets a smaller dose. The size differentiation may be based on patient weight, length, surface area, age, and/or the like. For example, some medications have two doses ¨ one for large adults, and one for small adults. Thus, drug delivery device may have two zones.
Other medications may require more precision based on patient size, and therefore the drug delivery device may have more than two zones. In some implementations, the zones may be color coded (see Fig. 7E); in other implementations, the zones may be clear (see Fig. 7F).
[0080] Kits similar to those discussed above may be configured to contain vials and/or syringes configured for adults instead of children. Thus, the drug devices, drugs, and/or drug concentrations may be configured for adults. Kits may be clearly labeled to indicate that they are adult kits or pediatric kits.
[0081] In another embodiment, kits may include both a pediatric syringe and an adult syringe.
Thus, for a medication where adults and children take the same drug and drug concentration, the kit may include a vial of the drug, a corresponding syringe for pediatric patients, and a corresponding syringe for adult patients. The syringes may be clearly labeled as being an adult syringe or pediatric syringe. The syringes may also have a color or symbol designation to indicate adult or pediatric syringe. For example, adult syringes may have a blue plunger and pediatric syringes may have a red plunger, and/or adult syringes may be labelled "A" for adult and pediatric syringes may be labeled "P" for pediatric or "C" for child(ren)).
EXAMPLES OF IMPROVEMENTS ACHIEVED BY USING THE SYSTEMS AND
METHODS DISCLOSED HEREIN
[0082] As disclosed with reference to all the figures, the pre-labeled medicine dispensing device and the method of making and using it offers several advantages over the currently used systems and methods. First, the pre-marked medicine dispensing device allows to administer medication more accurately as compared to any of the currently available systems.
Furthermore, as shown in FIGS. 8A and 8B, eliminating the step of calculating doses that need to be administered in the high stress environment, as well as eliminating the steps of selecting appropriate medicine dosing device helps to eliminate critical dosing errors, such as critical over dose or critical under dose errors, that usually arise when conventional devices and methods are used.
Also, frequency and severity of non-critical errors as compared to the traditional methods can be reduced as shown in FIGs. 8C and 8D. Lastly, as shown in FIGs. 8E and 8F, time to prepare and deliver medication, as well as time to deliver medications when preparing for rapid sequence intubations (RSI) may be significantly reduced when the medicine-dosing device according to the current disclosure is used as compared to the conventional devices. As such, the pre-labeled medicine dispensing device designed and used in accordance with the disclosed embodiments provides for more simplified, accurate and efficient drug delivery in emergency and critical care situations.
[0083] Example embodiments of the devices, systems and methods have been described herein.
As may be noted elsewhere, these embodiments have been described for illustrative purposes only and are not limiting. Other embodiments are possible and are covered by the disclosure, which will be apparent from the teachings contained herein. Thus, the breadth and scope of the disclosure should not be limited by any of the above-described embodiments but should be defined only in accordance with claims supported by the present disclosure and their equivalents.
Moreover, embodiments of the subject disclosure may include methods, systems and devices which may further include any and all elements/features from any other disclosed methods, systems, and devices, including any and all features corresponding to scientific data exchange. In other words, features from one and/or another disclosed embodiment may be interchangeable with features from other disclosed embodiments, which, in turn, correspond to yet other embodiments. Furthermore, one or more features/elements of disclosed embodiments may be removed and still result in patentable subject matter (and thus, resulting in yet more embodiments of the subject disclosure). Still further, some embodiments are distinguishable from the prior art due to such embodiments specifically lacking one or more features which are found in the prior art. In other words, claims to some embodiments of the disclosure may include one or more negative limitations to specifically note that the claimed embodiment lacks at least one structure, element, and/or feature that is disclosed in the prior art.

Claims (17)

What is claimed is:
1. A medical treatment kit comprising:
a vial including a drug;
a medicine dosing device configured to receive the drug from the vial and deliver the drug to a patient, the medicine dosing device being marked with coded dosage zones of varying widths corresponding to predetermined drug doses; and an instrument for associating the patient with one of the coded dosage zones.
2. The medical treatment kit of claim 1, further comprising:
a filling needle for attaching to the medicine dosing device and for drawing the drug to be administered from the vial so as to fill the medicine dosing device with a dose of the drug corresponding to the one of the coded dosage zones.
3. The medical treatment kit of claim 1, wherein the medicine dosing device is a syringe.
4. The medical treatment kit of claim 3, wherein the syringe is permanently attached to a needle.
5. The medical treatment kit of claim 1, wherein the vial of the drug and the medicine dosing device are labelled with a name of the drug.
6. The medical treatment kit of claim 5, wherein the vial of the drug and the medicine dosing device are labelled with the concentration of the drug.
7. The medical treatment kit of claim 1, wherein the vial of the drug and the medicine dosing device are each marked with a symbol, said symbol corresponding to the drug and a concentration of the drug.
8. The medical treatment kit of claim 1, wherein the instrument is a color coded measuring tape.
9. The medical treatment kit of claim 8, wherein the patient is measured with the color coded measuring tape to determine the coded dosage zone to which the medical dosing device should be filled with the drug.
10. The medical treatment kit of claim 1, further comprising an instruction sheet including steps for administering the drug.
11. The medical treatment kit of claim 1, wherein the predetermined drug doses and the widths of the coded dosage zones correspond to the drug.
12. The medical treatment kit of claim 1, further comprising:
a second vial of a second drug;
a second medicine dosing device configured to receive the second drug from the second vial and deliver the second drug to the patient, the second medicine dosing device being marked with coded dosage zones of second varying widths corresponding to second predetermined drug doses.
13. The medical treatment kit of claim 12, wherein the second predetermined drug doses and second coded dosage zones are different from the predetermined drug doses and coded dosage zones.
14. The medical treatment kit of claim 12, wherein:
the vial and the medicine dosing device are each marked with a first symbol, said first symbol corresponding to the drug and a concentration of the drug; and the second vial and the second medicine dosing device are each marked with a second symbol, said second symbol corresponding to the second drug and a concentration of the second drug, and wherein the second symbol is different from the first symbol.
15. The medical treatment kit of claim 12, wherein the second drug is a different concentration of the first drug.
16. The medical treatment kit of claim 12, further including an instruction sheet specifying that the first drug is to be administered to the patient before the second drug is administered to the patient.
17. A method of administering a plurality of drugs to a patient, the method comprising:
associating, using an instrument included within a medical treatment kit, the patient with one of a first plurality of coded dosage zones;
selecting, from the medical treatment kit, a first vial containing a first drug;

drawing the first drug from the first vial so as to fill a first medicine dosing device included within the medical treatment kit with a first dose of the first drug wherein the first dose corresponds to the one of the first plurality of coded dosage zones, the first medicine dosing device being marked the first plurality of coded dosage zones wherein the first plurality of coded dosage zones are of first varying widths;
selecting, from the medical treatment kit, a second vial containing a second drug;
drawing the second drug from the second vial so as to fill a second medicine dosing device included within the medical treatment kit with a second dose of the second drug wherein the second dose corresponds to the one of the second plurality of coded dosage zones, the second medicine dosing device being marked the second plurality of coded dosage zones wherein the second plurality of coded dosage zones are of second varying widths;
administering the first drug and the second drug to the patient using the first medicine dosing device and the second medicine dosing device wherein a sequence of administration of the first drug and the second drug is indicated by instructions associated with the medical treatment kit.
CA3023362A 2016-05-05 2017-05-05 Apparatuses, methods, and systems for delivering medication using medication kits Pending CA3023362A1 (en)

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US15/282,732 US11617835B2 (en) 2012-02-01 2016-09-30 Apparatuses, methods, and systems for delivering measured doses of medication
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AU2017261355A1 (en) 2018-11-22
KR20190017765A (en) 2019-02-20
JP2019514588A (en) 2019-06-06
CN109641106A (en) 2019-04-16
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AU2017261355B2 (en) 2021-12-09

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