JP7297446B2 - Devices, methods and systems for delivering pharmaceuticals using medication kits - Google Patents

Description

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/332,412, entitled "Devices, Methods and Systems for Delivering Pharmaceuticals Using Medication Kits," filed May 5, 2016. claim. Said application is a continuation-in-part of U.S. patent application Ser. U.S. patent application Ser. No. 14/392,087, entitled "Systems For The latter application is a continuation-in-part of International Application No. PCT/US2013/023873 entitled "System for Delivering Pharmaceutical Products" filed February 1, 2012. No. 61/593,674 and priority to U.S. Provisional Application No. 61/717,474, entitled "Systems for Delivering Pharmaceutical Products," filed Oct. 23, 2012. All of the above applications are incorporated herein by reference.

FIELD OF THE DISCLOSURE The present disclosure relates to medicine-dosing devices, particularly pre-labeled dosing devices and methods for administering appropriate amounts of medication in emergency or critical care settings.

Accurately and efficiently administering the right amount of medication in emergency and intensive care settings is very important. Administering the right amount of medication is particularly important in emergency or critical care settings involving pediatric patients, as even minor medication errors can lead to unfortunate consequences. However, even in the best of circumstances, despite the best efforts of healthcare professionals, the multi-step process of medications can sometimes lead to inadvertent errors. Specifically, in a typical situation, the appropriate drug dose must first be determined, which usually involves multiple mathematical calculation steps. The actual dosing process then involves multiple steps, including, for example, selecting the exact drug to be administered and the dosing device to be used. Reducing the number of steps to be performed can significantly increase the overall accuracy and efficiency of the process, since each step has the potential to introduce errors into the overall dosing process.

Drug dosages are conventionally determined based on the patient's weight. However, this method can sometimes be inappropriate and inaccurate, especially in emergency and critical care settings. Therefore, sometimes a patient's height can be used as it allows for rapid and efficient determination of drug dose, and a color-coded measuring tape is used to measure the patient's height. Specifically, the Broselow® Pediatric Emergency Tape is a well-known device that is readily available and relates patient height to drug dose. Details of this instrument and its method of use are disclosed in certain US patents, which are incorporated by reference into the present disclosure (see, eg, US Pat. In general terms, the method measures the patient's height, codes the patient's height into one of the color zones shown on the tape, and uses the color-coded height to determine the drug dose to be administered to the patient. Including deciding. By segmenting into multiple color-coded zones (each color zone corresponding to a given height range) rather than the typically used inches or centimeters, the patient's height can be specified in centimeters or inches. It can be easily read and recorded as a specific color rather than a measured value. In other words, each color-coded height zone corresponds to a specific set range of actual heights measured in meters or inches. For example, the gray zone of the tape corresponds to the height range of 42.20 cm to 60.79 cm, and the pink zone of the tape corresponds to the height zone of 60.80 cm to 67.79 cm. In this way, patients whose height falls within a first height range are coded as gray, and patients whose height falls within a second height range are coded as pink. Appropriate drug doses for the two patients are selected from a list of set drug doses listed on the tape. Other commercially available height/weight based tapes such as Pedia Tape and Handtevy Tape are used as well.

Although the step of determining drug doses has been greatly simplified through the use of the methods described above, there still remain many other problems that often lead to dosing errors or make the dosing process inefficient. For example, in order to obtain the correct dose of medicament to be administered after the dosage has been determined, many other calculations, such as calculations of the concentration of the medicament, need to be performed. Furthermore, selecting the correct medicament or appropriate dispensing device, or drawing an accurate set amount of medicament into the dispensing device, can each introduce errors or slow down the patient dosing process. Also in situations where the dosage is based on a dosing system other than a conventional weight-based system, such as patient age, body surface area or volume, because of the type of calibration used in such systems, Dose metering may be inaccurate. In particular, the typically used fixed incremental changes in dose can result in the lack of dose metering accuracy required when such systems are used.

U.S. Pat. No. 4,716,888 U.S. Pat. No. 6,132,416

Thus, while various techniques are available designed to simplify the process of drug dosing and administration, they are nevertheless subject to the circumstances and time constraints in which therapy is administered and the dose metering systems used. A possibility exists for errors due to type. Accordingly, there is a need for devices and methods for accurately and efficiently delivering medications, especially to pediatric patients in emergency or critical care settings.

Disclosed herein are therapeutic kits that can facilitate treatment of complex medical problems. Each of the disclosed kits is typically targeted to treat a unique medical problem, and such treatment requires a unique sequence of pharmaceutical agents to be given in the correct sequence and dosage. In certain high-risk situations, related medical problems can put people at risk and mistakes can be life-threatening. In such situations, accurate dose metering and delivery can save lives.

A treatment kit can provide a vial containing a drug and a dispensing device. The dispensing device can be configured to receive medication from the vial and deliver the medication to the patient. Furthermore, the dispensing device can be marked with coded dose zones. The dose zones can have varying widths and correspond to set drug doses. The kit can also include a device for associating the patient with one of the coded dose zones.

In some embodiments, the kit is configured to attach to the dispensing device to draw the drug to be administered from the vial in order to fill the dispensing device with a dose of drug corresponding to one of the coded dose zones. A filling needle can be included. Alternatively, the needle can be permanently attached to the syringe.

The dispensing device can be a syringe, and in some implementations the syringe can be permanently attached to the needle.

Medication vials and dispensing devices may be labeled. In some embodiments, vials and dosing devices can be marked with the name of the drug and/or the concentration of the drug. Additionally or alternatively, vials and dispensing devices can be labeled with symbols, and the symbols can correspond to drugs and/or drug concentrations.

In some implementations, the device for associating the patient with one of the coded dose zones can be a color-coded measuring tape. The patient can be measured with a color-coded measuring tape to determine color-coded dose zones when filling the drug dispensing device.

The treatment kit can further include an instruction sheet indicating steps for administering the drug.

The set drug dose and/or the width of the coded dose zone marked on the dispensing device can correspond to the drug contained in the vial.

In some embodiments, the kit can provide a second vial of a second drug and a second dispensing device configured to receive the second drug from the second vial and deliver the second drug to the patient. A second dispensing device may be marked with a second varying width coded dose zone corresponding to a second set drug dose. The second set drug dose and second coded dose zone may be different than said set drug dose and coded dose zone.

Additionally, the vial and dispensing device can be marked with a first symbol, which can correspond to the drug and the concentration of the drug. A second vial and a second dispensing device can be marked with a second symbol, and the second symbol can correspond to the second drug and the concentration of the second drug. The second symbol can be different than the first symbol.

In some implementations, the second drug can have a different concentration than the first drug.

In some embodiments, the kit can also include an instruction sheet. The instruction sheet can specify that the first drug should be administered to the patient before the second drug is administered to the patient.

Also disclosed are methods of administering multiple agents to a single patient. The method includes associating a patient with one of a plurality of coded dose zones using an instrument included in a treatment kit. A first vial containing a first drug is selected from the medical kit, and the first drug can be drawn from the first vial to fill a first dispensing device included in the treatment kit with a first dose of the first drug. The first dose can correspond to one of the first plurality of coded dose zones, the first dispensing device marked with the first plurality of coded dose zones, the first plurality of coded dose zones has a first varying width. A second vial containing a second drug can be selected from the treatment kit, and the second drug can be drawn from the second vial to fill a second dispensing device included in the treatment kit with a second dose of the second drug. The second dose can correspond to one of the second plurality of coded dose zones and the second dispensing device is marked with the second plurality of coded dose zones. The second plurality of coded dose zones can have a second varying width. The first drug and the second drug can be administered to the patient using the first drug delivery device and the second drug delivery device. The order of administration of the first and second agents can be indicated by instructions associated with the treatment kit.

1 is a perspective view of a dispensing device according to one embodiment of the present disclosure; FIG. 1 is a perspective view of a dispensing device according to one embodiment of the present disclosure; FIG. 1 is a perspective view of a dispensing device according to one embodiment of the present disclosure; FIG. 1 is a perspective view of a dispensing device according to one embodiment of the present disclosure; FIG. FIG. 13 is a perspective view of another embodiment of a dispensing device according to one embodiment of the present disclosure; Fig. 10 is a perspective view of a dispensing device according to another embodiment of the present disclosure; Fig. 10 is a perspective view of a dispensing device according to another embodiment of the present disclosure; Fig. 10 is a perspective view of a dispensing device according to another embodiment of the present disclosure; Fig. 10 is a perspective view of a dispensing device according to another embodiment of the present disclosure; FIG. 2 is a plan view of a label showing color-coded dosages; FIG. 2 is a plan view of a label showing color-coded dosages; FIG. 2 is a plan view of a label showing color-coded dosages; FIG. 2 is a plan view of a label showing color-coded dosages; Fig. 3 is a flow chart showing a method for determining and printing color-coded dosage labels; 1 is a flow chart illustrating a method of administering a medication using the disclosed prefill marked dispensing device. Fig. 3 shows a measuring instrument used to measure a patient's color-coded height; FIG. 11 illustrates a method of administering a medication using a first aid kit containing a pre-marked dosing device; FIG. 1 shows a first aid kit for administering pharmaceuticals according to one embodiment of the present disclosure. A preferred treatment kit for administering pharmaceuticals to treat anaphylaxis, allergy and/or asthma is shown. Fig. 2 shows a preferred therapeutic kit for administering pharmaceuticals for rapid lead-in intubation. Figure 3 shows a preferred embodiment of an adult syringe. Figure 3 shows a preferred embodiment of an adult syringe. Includes data demonstrating improved drug delivery using the disclosed systems and methods. Includes data demonstrating improved drug delivery using the disclosed systems and methods. Includes data demonstrating improved drug delivery using the disclosed systems and methods. Includes data demonstrating improved drug delivery using the disclosed systems and methods. Includes data demonstrating improved drug delivery using the disclosed systems and methods. Includes data demonstrating improved drug delivery using the disclosed systems and methods.

The present application describes devices, systems and methods for administering appropriate doses of pharmaceutical agents to patients. The devices and systems are configured to address the five right of drug delivery: giving the right drug in the right dose, by the right route, to the right patient at the right time. In particular, a pre-marked medication dose metering/dispensing device designed to minimize medication errors and improve the overall accuracy and efficiency of medication administration in emergency and critical care settings is provided.

As discussed in detail below, in one embodiment, the dispensing device 10 is a syringe 15 that includes an elongated barrel 30 and a plunger 50 marked with a set color-coded medicament volume dose 100. The dispensing device according to one embodiment can also be pre-filled with a fluid 105 corresponding to the medication to be administered to the patient. Also disclosed are methods for determining specific volumetric doses of multiple pharmaceutical agents based on various factors. In particular, according to one embodiment, the method includes creating a label or marking the dose on the dispensing device, for example, indicating the dose determined based on the volumetric capacity and/or drug concentration of the dispensing device.

Also discussed is a method for administering the proper dosage using a pre-marked dosing device. The disclosed method can significantly reduce the time required to determine and administer a single dosage to a patient, while reducing the risk of miscalculation or misadministration of said dosage.

Apparatus To discuss in detail a first embodiment of a pre-labeled pharmaceutical metering/dispensing apparatus 10, reference is made to FIGS. 1A-1D. As shown in FIG. 1A, the dispensing 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 has a container, such as a syringe barrel 30 at its distal end for holding the medicament to be administered therein, and a proximal end proximally from an opening 36 located at the proximal end 35 of the syringe barrel. and a plunger 50 extending to a plunger proximal end 55 of portion 25 . Both the syringe barrel and plunger are made of plastic, glass or any other suitable transparent medical grade material that is inert or does not disturb the chemical balance of the fluids therein.

As shown in FIG. 1B, syringe barrel 30 is elongated, substantially cylindrical, and includes distal end 31 and proximal end 35 . The syringe barrel further includes an outer circumferential surface 37 and an inner circumferential surface 38 . A chamber 32 capable of receiving the plunger and retaining fluid therein is formed by the inner circumferential surface 38 of the barrel between the distal end 31 and the proximal end 35 . A flange 33, which serves as a finger grip to facilitate handling of the syringe, is integrally formed with the proximal end of the barrel and defines an opening 36 for receiving the plunger. Proximate opening 36 and along the inner surface of the barrel are ridges 34 (FIG. 1C) that prevent the plunger from sliding out of the barrel once it engages the barrel.

Opening 36 communicates with chamber 32 and bore 39 located in distal end 20 of the syringe barrel. A tip 30 for attaching a needle, nozzle, or tubing for draining the liquid contained within the syringe barrel 30 is integrally formed with the distal end 20 of the barrel and communicates with the bore 39 . The tip can include an inner member 41 and an outer member 42 that are coaxially positioned. According to one embodiment, the tip can include a luer taper fitting. In some embodiments, the tip can be configured based on the type of drug that the syringe is used for delivery. For example, a syringe configured for oral medication can use an oral tip, and in particular, an oral tip differs from an intravenous (IV) or intermuscular (IM) tip, thereby: Medication can be delivered by the correct route. Similarly, syringes configured for IV and IM medicaments can be configured with IV and IM tips so that they can be delivered by the correct route, respectively.

A 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 a distal end 56 of the plunger rod. The gasket forms a seal between the inner surface of the barrel and the plunger to prevent the contents of the syringe from exiting 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 elongated shape complementary to the shape of the chamber 30 and pushes along the chamber (inside the cylindrical barrel or tube) so that the syringe passes through the tip or hole 39 in the distal end of the barrel. Designed to allow fluid to drain. Alternatively, the plunger may include other configurations that allow fluid to be forced from within chamber 30 through tip 40 or bore 39 .

According to one embodiment of the present disclosure, the dispensing device can be prefilled with a preselected medicament. Initially, when the dosing device is prefilled and the syringe is in the pre-dosing position, a substantial length of the plunger rod extends longitudinally outside the syringe barrel. In other words, as shown in FIG. 1A, prior to drug administration, only the plunger rod gasket 52 and distal end 56 are initially inside the syringe barrel at the proximal end 35 of the barrel, and the proximal end 55 of the plunger. The remainder of the plunger length is outside the barrel so that it is in its most extended state.

Alternatively, the dispensing device is not prefilled. Dispensing devices can be marked, for example, with drug names, concentrations, volume markings, color-coded zones, and the like. The healthcare worker draws the appropriate concentration of medication (ie, medication marked with the name on the device) into the dispensing device to reach the appropriate volume-marked and/or color-coded zones. In some embodiments, the dosing device is provided as part of a kit that includes a pharmaceutical container containing the drug to be administered. The medicament in the medicament container is drawn into the dosing device just prior to the dosing process. In such embodiments, the plunger rod can remain inside the syringe barrel until the drug is drawn into the syringe. To avoid confusion as to which syringe to use for which drug, the dispensing device can be clearly marked. As discussed further below, such marking may include different colored plungers to avoid confusion. As a specific example, a kit containing etomidate and succinocholine can have a red plunger for use with etomidate and a blue plunger for use with succinocholine.

According to another embodiment shown in FIG. 2A, the syringe 15 is marked with an elongated barrel 70 and a set color-coded medicament volume dose and prefilled with a fluid 105 corresponding to the medicament to be administered to the patient. a plunger 80; In this configuration, the syringe barrel includes an inner tubular body 75 generally coaxially aligned with the larger diameter of the cylindrical barrel, as shown in FIG. 2C. The inner tubular body has a needle 76 coaxially positioned within and longitudinally aligned with the inner tubular body. Plunger 80 shown in FIG. 2D includes a substantially cylindrical member or vial 81 and stopper 82 . Since the syringe barrel and plunger are initially separated, as shown in FIG. 2B, plunger 60 is moved out of the syringe barrel so that stopper 82 fully engages inner tubular body 75 and needle 76 prior to drug administration. It should be inserted into the proximal end 35 .

According to yet another embodiment of the present disclosure, the plunger and/or plunger stopper can be collar coded based on the drug contained within the barrel. Such color-coding of the plunger can further increase the efficiency of drug delivery, and visual inspection of the plunger allows quick verification of the correctness of the drug being dispensed, thus making dosing less error-prone. can be done. Alternatively or in addition to the color-coded plunger and/or plunger stopper, the plunger and/or plunger stopper can be further marked with the name and/or concentration of the drug to further limit the possibility of errors.

Alternatively, the dispensing device can comprise any container into which the desired medicament can be placed and from which the desired medicament can be expelled, such as, for example, a tube, vial, bag or bottle. For example, the dispensing device can be a bag containing IV fluid. According to this embodiment, the bag can be marked with a series of color-coded zones along with conventional volumetric markings. When used in combination with conventional volume markings, the color-coded zones can serve as a reminder to medical personnel of the exact volume of each medication that can be given to the patient based on the patient's color zone. Color-coded zones can also be used as hints for entering the correct total volume dispensed into the IV pump for a given medication.

The marking on the surface of the dispensing device will now be described. For syringes, the markings can be placed along the circumference of the syringe barrel or plunger. As shown in FIGS. 1-3, the markings include a series of substantially translucent bands or zones 100 that indicate potential pharmaceutical doses to be administered to the patient. Although the markings shown in the figures include a series of color-coded zones, markings can also include zones with varying zones, textures, and the like. Regardless of the type of marking used, the marking can be printed, painted, etched or dyed directly on the inner or outer surface of the dispensing device, or can be made into a label or sleeve that can be attached or placed on the outer surface of the dispensing device. The markings applied are such that the fluid level can be readily seen through the markings when the device is filled.

FIG. 3A shows multiple labels according to one embodiment of the present disclosure. Each label 300 is substantially rectangular and has a size based on the volumetric capacity of the dispensing device to which the label is applied. In other words, as the dispensing device varies in volume, and as a result of variations in the outer circumferential surface of the device, the size or dimensions of the label are adjusted accordingly to adequately cover the outer surface of the dispensing device. be. For example, if a label is made for syringes with two different barrel volume capacities, the label size is increased or decreased in both length and width to accommodate variations in the outer surface of the barrel.

Along with changes in label size, appropriate changes in the width of the corresponding color bands or zones printed on the label are also added depending on the dispensing device used to dispense the medication. Specifically, the need to vary the width of the collar band or zone to account for variations in the volume of medicine-dispensing devices and maintain the same drug volume dose between various dispensing devices. There is For example, as shown in FIG. 3B, labels for the same drug loaded on a 10 cc penser and a 5 cc dosing device may be different for each color band or zone to maintain the same drug dose for both dosing devices. It has two widths. In other words, the width of the color bands 351A-351A on the label 310 for the 10cc device should be the same for the patient to deliver the same amount of medication using the 10cc device as compared to using the 5cc device. smaller than the collar strips 351B-359B on the label 305 of the 5 cc dosing device to deliver 10 cc of medication.

Similarly, the concentration of the drug used also affects the width of the color band or zone printed on the label. Specifically, the width of the color band or zone is determined based on the concentration of the drug, with higher concentration drugs corresponding to smaller volumetric doses or smaller band widths than lower concentration drugs.

As shown in FIG. 3C, the label 300 has opposite parallel sides 315 and 320 and opposite parallel edges 325 and 330 with varying widths corresponding to dosages for patients with particular characteristics. contains a series of continuous color bands or zones 351-359 with The characteristics correspond to patient height (as described above), weight, age, body surface area/volume and/or the like. Specifically, each color band is formed by a leading edge 335 and a trailing edge 340 parallel to opposite ends 325 and 330 of the label and a predetermined color code when the label is applied to the dispensing device. It has a width corresponding to a volume of medicament with a set dose suitable for a patient having characteristics falling within the range of tolerance. In other words, each color band or zone on the label represents a dosage correlated to a respective color-coded height range, weight range, age range, body surface area/volume range, or other physiological characteristic.

Still referring to FIG. 3C, according to one embodiment, nine separate color bands 351 are used to distinguish between nine different dosages corresponding to nine separate color-coded patient characteristic ranges. ~359 can be used. Specifically, each color corresponds to one of nine different doses of a unique drug. As shown in FIG. 3C, in one particular implementation, the band colors include gray 351, pink 352, red 353, purple 354, yellow 355, white 356, blue 357, orange 358 and green 359; The green band corresponds to the lowest dose and the green band to the maximum dose that can be delivered. A solid black line 365 can be used as a boundary between various color bands or zones to facilitate the process of drug administration, as discussed in more detail below. Although the description will be made with reference to the specific colors shown in Figures 3A-3C, it should be understood that other colors or markings can be used. Alternatively or additionally, color names can be printed in color bands or zones in addition to or instead of colors.

According to yet another embodiment shown in FIG. 3D, the label includes ten different color bands, the tenth color band corresponding to the maximum dose that can be delivered. In this particular embodiment, the maximum dose can correspond to a universal dose that can be delivered to any patient whose characteristics (eg, height, weight, etc.) fall outside the previously disclosed color ranges. For example, a universal label according to this embodiment can be applied to a universal dosing device that can be used for both pediatric and adult patients, thus eliminating the need to have two separate dosing systems for two separate patient groups. . However, while a unique number of color bands were discussed in the above examples, it should be appreciated that any number of color bands could be used to allow for more precise dosing. In some instances, a pre-defined zone or zone can be further subdivided into frenulums or subzones to allow for more precise dosing. As a non-limiting example, in some embodiments, 36 markings (sub-zones) can be included within 9 color zones. This can increase the precision in administering drugs to patients.

Also, according to another embodiment of the present disclosure, as shown in FIG. 3C, one of the edges of the label includes a mark 370 to ensure that the label is properly applied or positioned on the syringe or plunger. can be done. For example, the edge of the label aligned with the distal end of the syringe barrel can be marked to prevent the label from being attached to the barrel in the opposite direction, resulting in an incorrect dose being administered later. . For example, the edge of the label with the color band corresponding to the minimum dose can include markings on its leading edge to facilitate alignment of the label with the distal end of the syringe barrel.

Further, according to another embodiment shown in FIG. 3A, the label may include the name of the medication to be administered or any other information possibly important to ensure that the correct medication is administered to the patient. . In particular, the name of the drug can be imprinted along the length of the label or in any other location so long as it allows easy verification of the correctness of the drug in the dispensing device. Additionally, for medications that are administered at intervals, the label may either mark the corresponding time intervals or a separate calendar (paper or electronic ) can be installed.

Methods of Measuring and Generating Dosing Information A method 400 for determining drug doses and dispensing devices for multiple pharmaceuticals will now be discussed. In one particular example, shown in FIG. 4, this can include creating a Collar-coded dose label that can be applied to the selected dispensing device. As shown in FIG. 4, method 400 begins at step 401 where a selection of a drug for which a dose label is to be generated is made. Some of the most commonly used drugs, as they relate to emergency or critical care, include, for example, atropine, lidocaine, fentanyl, epinephrine, etomidate, ketamine, succinylcholine, rocuronium and midazolam. However, it should be appreciated that the methods are equally applicable to any other pharmaceutical agent that can be administered using the disclosed dispensing device.

Once the drug for which the label to be produced has been identified, the drug dosage for each of the color-coded characteristics (eg, height, weight, etc.) zones described above is determined in step 402 . Depending on the drug, the width of the color-coded zones can vary. Table 1 below shows doses (in mg) for some of the drugs listed above. As can be seen from Table 1, the dose of each drug varies based not only on the type of drug, but also on the patient's height (ie, characteristics). Thus, for example, as shown in Table 1, the dose for patients belonging to the yellow color-coded stature zone is 26 mg for succinylcholine and 13 mg for rocuronium. If the same drug is administered to two different patients whose heights belong to two different color-coded heights, two different dosages are used. For example, for epinephrine, the doses administered to each patient are 0.085 mg and 0.21 mg for patients with conditions coded red and those coded blue, respectively. Alternatively, the dose of the drug can be determined based on dosage recommendations other than based on patient height, such as patient weight, age, body surface area/volume and/or the like.

After the dose to be administered to the patient is determined in step 402, the drug concentration of the drug selected in step 401 is determined in step 403. FIG. Drug concentration is directly proportional to the volume that needs to be administered. In other words, a smaller volume needs to be administered for a highly concentrated solution than for a less concentrated solution of the same drug.

The next step, step 404, involves selecting the dispensing device to be labeled. As noted above, dosage devices are available in a variety of volume sizes, and thus a dosage device conversion factor based on dosage device length and width and/or drug concentration may be used to target a variety of labels to be produced. Variations in the size and/or shape of various dispensing devices can be taken into account. Thus, once a dosage device of a particular volume has been selected to administer the selected pharmaceutical agent, the individual color bands corresponding to the dosage determined using the corresponding conversion factors listed in Table 1 /Zones and total bandwidths can both be calculated. Specifically, the width of each colored band/zone corresponding to a determined dosage is calculated based on the drug dosage to be administered, the solution concentration and the volumetric capacity of the dispensing device. According to one embodiment, all of the calculations can be performed by a computer processing unit (CPU) in response to user input.

Labeling of the dispensing device can be done once the width of each color band or zone is determined and the label is printed. For example, if a syringe having a barrel and plunger is labeled and the barrel is designed to hold the medicament to be dispensed, the label may be labeled with one of the edges of the label corresponding to the color strip of the lowest dose. can be positioned along the outer circumferential surface of the barrel by aligning with the distal edge of the syringe barrel. Or, in syringes in which the plunger acts as a container to hold the medicament, the label may be placed on the outside of the plunger by aligning one of the edges of the label corresponding to the minimum dose color band with the proximal end of the dispensing device. It can be placed along the surface of the sake cup.

Pre-calculated bands/zones for each of the selected drug, volumetric capacity of the dispensing device and solution concentration can be printed on a label attached to the dispensing device, while the dosing information can be stamped, etched or dyed directly onto the dispensing device. Or it can be painted. Alternatively, the dosing information can be printed on a sleeve that can be placed over the dosing device.

Depending on the embodiment, an appropriately labeled dosing device can be pre-filled with the desired medicament, the fluid volume corresponding to the maximum dose that can be administered to a patient, for example, whose height falls in the maximum stature zone. When the dispensing device is prefilled with a selected drug, the label can be applied before or after filling the dispensing device. If the dispensing device is to be filled with a selected pharmaceutical agent just prior to the dispensing process, such as when the dispensing device is included as part of a kit that includes the dispensing device and a container filled with the drug to be administered, it is pre-labeled. A pre-attached empty dispensing device is supplied for use. Therefore, just prior to administration, from the container, a volume of fluid corresponding to the dose set for a given patient is drawn into the pre-labeled dispensing device.

Methods of Administering Medications A dispensing device assembled according to the steps described above can be used to safely and efficiently deliver medications. FIG. 5 is a flowchart 500 of a method of administering medication to a patient using the disclosed dispensing device 10 according to one embodiment. In this particular embodiment, the disclosed method includes steps for efficiently administering a medicament selected from pre-filled and pre-marked dispensing devices to a patient. As shown, the method begins at step 501 in which the patient's color-coded height or any other physical characteristic is measured. In the case of height, browslow tape or any other similar type of device that indicates a color-coded height range can be used in this step. As shown in FIG. 6, the color-coded height can be obtained by placing the patient 600 along the tape 601 and noting the patient's color-coded height on the tape. Alternatively, any other physiological characteristic such as weight, age, body surface area or volume that can be color coded and associated with dosage can be used.

Once the patient's height or any other physiological characteristic has been measured and/or coded into a unique color range, a prefilled dispensing device 10 containing the medication to be administered is selected in step 502. . Medication selection can be verified by reading the name of the medication imprinted along the outer surface of the prefilled dispensing device or by checking the color of the plunger rod as described above.

Once the patient height or other characteristic color code has been measured and noted and the medication administered has been verified as accurate, the appropriate dosage or volume to be delivered is determined in step 503. . Appropriate doses can be determined by a physician or other medical practitioner who calculates appropriate doses based on at least one patient characteristic. A calculated dose can be the exact amount of drug to be administered. In addition, the physician or other medical personnel administering the medication can determine the patient's color code based on at least one patient characteristic. For example, if a patient's height or other characteristic is measured to fall within the blue range of the measuring tape, the volume of medication administered to the patient is the volume within the blue color band on the dispensing device.

Since the dispensing device (in this embodiment) is pre-filled with medication, the appropriate dose of medication is obtained by filling the pre-filled syringe until the determined/calculated volume (dose) of medication is reached as shown in step 504. can be obtained by excreting excess medication from In other words, the prefilled volume of the dosing device can correspond to the maximum dose that can be administered to the patient. Therefore, unless the calculated dose is the maximum possible dose, a portion of the medicament must be expelled from the prefilled dispensing device prior to medicament administration.

Thus, according to one embodiment, the plunger is pushed along the interior of the barrel toward the distal end 31 of the barrel until the proximal end of plunger 54 reaches the calculated dose. Once the dispensing healthcare worker expels the excess medication so that only the calculated dose remains in the medication dispensing device, the healthcare provider will ensure that the calculated dose and the amount of medication remaining in the medication dispensing device is the color determined for the patient. Make sure it is within the coding range. For example, for the patient described above whose height or other characteristic is coded blue, the blue band has a leading edge proximate the distal end of the barrel and a 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, after which the medicator should notice that the plunger is positioned between the leading and trailing edges of the blue band. make sure it exists. Once all excess liquid has been removed from the pre-filled dispensing device in step 504, the accuracy of the medication dose is verified in step 505 and the medication is administered to the patient in step 506.

Medication Kits Medication administration to pediatric patients is particularly problematic in emergency medical settings. As noted above, dosing of a pediatric patient primarily involves determining the number of kilograms of drug to administer to the patient based on their weight and/or height. The number of milliliters of drug to give to the patient must then be determined based on the drug concentration. As a result, there is a risk of human error in performing the calculations necessary to determine the appropriate dose. Further, errors can often occur in emergency situations in which medical personnel grasp or select syringes having units that differ from those assumed by calculations. These errors can be compounded when treating a patient with a range of drugs, ie when multiple medications are administered.

Moreover, in certain cases, a series of multiple drugs must be administered in a particular order. Thus, in addition to the errors discussed above, additional errors can result from delivering multiple medicaments in an incorrect order. Additionally, there is the risk that certain medicines may not be readily available to medical staff, and delays in obtaining these medicines can be detrimental to patients. For example, if too much sedative is delivered to a patient, an antidote can be used to reverse the overdose and prevent harm to the patient. However, if sedatives are given and antidotes are not readily available, the time delay can be harmful to the patient.

Some or all of the above risks can be reduced by using kits of the type described herein. For example, use of such kits helps ensure that precise doses can be administered using precise timing and sequencing. Additionally, the use of the kit ensures that appropriate antidotes and the like are available in the event of dose metering or sequencing errors. In some embodiments, kits are available based on the drug administered and/or treatment given.

Kit embodiments may include one or more of a pharmaceutical agent, multiple pharmaceutical agents, a dispensing device, and/or the like. The kit may also include instructions and browslow tape or any other similar type of device that indicates color-coded height as discussed above with reference to FIG. For treatments requiring a series of medications, the medication and/or dispensing device can be labeled accordingly. For example, the first administered drug and its associated dosing device is labeled "1", the second drug and its corresponding dosing device is labeled "2", and so on. be able to. Additionally, in embodiments in which an antidote for the drug (or one of the drugs) is provided, the antidote and antidote dispensing device may also be labeled accordingly.

Within the kit, the medicament can be stored in a vial and the dosing device can be a syringe, such as the syringes discussed above in connection with FIGS. 1-3. In some embodiments, one or all of the pharmaceutical agents can be stored within the syringe. Syringes can be made for each drug. Syringes with different volume capacities can be used depending on the drug. In addition, the label size and width of the color band or zone will vary depending on the drug and/or drug concentration. Thus, the name of the drug used in the syringe and the concentration of the drug can be printed on the syringe (or a label attached to the syringe).

In some embodiments, the dispensing device can be used to administer medication to a patient according to the method shown in Figure 7A. In particular, a method for drug administration can begin with selection (step 701) of an emergency kit containing drugs to be administered to a patient. As shown in FIG. 7B, the treatment kit may comprise a box, bag, pouch or any other suitable container capable of holding a dosing device inside which is labeled with the name of the medication specifically placed within the container. It can include a container such as a container. For example, according to one embodiment, in addition to listing the name of the drug on the label, the label also includes information regarding the concentration of the drug and/or instructions on how to use the kit for drug administration. be able to. The treatment kit may further include pre-marked dosing devices, such as syringes with color-coded zones that are calibrated to various drug doses for the selected drug. The markings on the syringe may also include the name of the drug to be delivered or any other information that helps ensure that the drug is properly delivered to the patient. The treatment kit may also include a needle, such as a blunt filling needle made of plastic or any other suitable material, to facilitate drawing of the drug into the syringe. The therapeutic kit can also include a container, such as a bottle, vial, etc., for holding the drug, the outer surface of the container being labeled with the name of the drug. The container can include a stopper or lid that helps contain the medicament within the container. The stopper or lid can be made of, for example, rubber or any other suitable material that can be easily pierced by a filling needle to facilitate drawing of the medicament from the container into the dispensing device.

When multiple drugs are included in the kit, the vials and syringes corresponding to each drug can be arranged in the package so that there is no confusion as to which vial goes with which syringe. Additionally, different colored plungers can be used to ensure that the correct medications are given to the patient in the correct order. For example, in a situation where two drugs are to be administered in a specified order, the kit would include the first drug in the first vial, the first syringe marked with a color zone for the first drug, and the second syringe marked with a color zone for the first drug. A second drug is contained in the vial and the second syringe is marked with a color zone for the second drug. The plungers in the syringes can be colored so that the first vial and first syringe are not mixed with the second vial and second syringe. The label and/or lid of the first vial can be marked with the same color as the plunger of the first syringe, and the label and/or lid of the second vial can be marked with the same color as the plunger of the second syringe. In this way, when a drug is administered, the dispensing healthcare worker can easily verify that the correct vial/drug-syringe combination is being used.

Alternatively or additionally, if the medicaments are to be delivered in a particular order, numbers can be marked on the end of the plunger to indicate the order in which the medicaments are to be delivered. For example, if the first drug to be dispensed has a green plunger and the second drug to be dispensed has a yellow plunger, the green plunger end will have the number "1" on the end and a yellow color. can have the number "2" on the end. Vials can also be marked with numbers.

If the drug dose is based on the patient's height, the patient's color-coded height may be displayed on a device such as browslow tape or other similar type of device that indicates a color-coded height range as discussed above with reference to FIG. Measurements can be made using the instrument (step 702). Alternatively, other patient characteristics can be used to determine the color-coded range. The appropriate volume of drug to be dispensed can then be determined based on the patient's height, which can be correlated to the color code (step 703). The determined drug volume is then drawn into the dispensing device (step 704), and the administering medical personnel verifies that the determined drug volume is within the color code corresponding to the patient (step 704). step 705). Once the dose is confirmed, the drug can be administered to the patient (step 706). According to one embodiment shown in FIG. 7B, if the dosing device is a syringe with a pre-attached fill needle, the fill needle can be disposed of prior to dosing.

FIG. 7C shows a preferred kit 720 that can be configured to treat anaphylaxis. It can also treat allergies and/or asthma. Such a kit can contain a vial 725 of epinephrine having a specific concentration. For example, epinephrine has a concentration of 1:1000 mg/ml. Syringe 730 (dosing device) can have a permanently attached needle to prevent medication from being accidentally given intravenously. The syringe can have a maximum volume of 0.33ml. The maximum volume of the syringe can be the maximum pediatric dose of epinephrine, or the maximum volume can be slightly larger than the maximum pediatric dose of epinephrine. Syringes can be marked with the color code described above to indicate the correct dose. In some embodiments, the exact dose can be determined based on the child's weight, age, body surface area and/or height. A device 735 such as a browslow tape or any other similar type device that indicates color-coded height ranges (as discussed above with reference to FIG. 6) may also be included in the kit. Instructions 740 can also be included in the kit. The kit can be packaged in container/package 745 . In some embodiments, at least the front of the package can be clear hard plastic so that the contents are visible and in a particular order.

Another preferred kit 750 is shown in FIG. 7D. Kit 750 can be configured for rapid lead-in intubation and can include a range of medications such as etomidate, succinylcholine, atropine and lidocaine. In the FIG. 7D embodiment, kit 750 contains three pharmaceutical agents. Each medicinal product can be stored in a vial 755a, 755b, 755c, each vial 755a, 755b, 755c having a corresponding syringe 760a, 760b, 760c. Syringes 760a, 760b, 760c are each calibrated to one of the drugs, syringe 760a to the drug in vial 755a, syringe 760b to the drug in vial 755b, and syringe 760c. is calibrated to the drug in vial 755c. Calibration is based on color coding, which correlates to the child's weight, age, body surface area and/or height. In some embodiments, a device 765, such as a browslow tape or any other similar type device that indicates a color-coded height range (eg, as described above with reference to FIG. 6), is also included in the kit. can be included in Instrument 765 is used to determine the color gamut for filling vials with medication. Instructions 770 can also be provided. Instructions 770 may indicate one or more of the following steps. measuring the child's weight, age, body surface area and/or height; determining a color based on the measurements; giving Drug 1 based on the appropriate color; Give, give medicine 3 based on the appropriate color.

In some embodiments, each corresponding vial-syringe pair can be contained within a separate set of packages to prevent confusion of vial-syringe pairs. Alternatively or additionally, the vial-syringe pairs are labeled numerically (eg, a vial with the first drug product and its corresponding syringe are each labeled with the number 1, and so on). and/or the syringe can be marked with the corresponding drug and concentration. A vial-syringe pair can be marked with a unique code, either the unique code is used only for the vial-syringe match, or the unique code is for a single drug at a specific concentration. used only. Therefore, the person administering the drug must check that the codes, numbers, etc. match before administering the drug.

Kits can be configured to contain various combinations of pharmaceutical agents for pediatric conditions. Another preferred kit comprises a vial of atropine of the correct concentration, a syringe for the first dose of 1x mg/kg, a second syringe for the second dose of 2x mg/kg, instructions, a container to properly maintain the contents. and/or a supraventricular palpitation kit containing the like. Other preferred kits can be configured for conscious sedation, acute pain and other treatments.

In some implementations, kits can also be made to treat adults, such as treatments/pharmaceuticals that vary based on adult size, weight, and the like. For some medicines, the adult dosage is universal, and for others the dosage varies according to the size of the patient. The concept is the same as for pediatric patients, with larger patients receiving larger doses and smaller patients receiving smaller doses. Size distinctions can be based on the patient's weight, height, body surface area, age and/or the like. For example, some pharmaceuticals may have two dosages, one for large adults and one for small adults. Therefore, the drug delivery device can have two zones. Other pharmaceuticals may require more precision depending on the size of the patient, so the drug delivery device can have more than two zones. In some implementations the zones are color coded (Fig. 7E), in other implementations the zones can be transparent (Fig. 7F).

Kits similar to those described above can be configured to include vials and/or syringes configured for adults rather than children. Accordingly, the dispensing device, drug and/or drug concentration can be configured for adult use. Kits can be clearly labeled to indicate whether they are adult or pediatric kits.

In another embodiment, the kit can include both pediatric and adult syringes. Thus, for pharmaceuticals in which adults and children take the same drug in the same concentration, the kit may include a vial of drug, a corresponding syringe for pediatric patients, and a corresponding syringe for adult patients. Syringes can be clearly labeled as adult or pediatric syringes. Syringes may also have color or code markings to indicate adult or pediatric use. For example, an adult syringe has a blue plunger, a pediatric syringe has a red plunger, and/or the adult syringe is labeled with an "A" for adult and the pediatric syringe is labeled with a pediatric "P". ” or “C” for child (ren).

As disclosed with reference to all of the figures, the pre-labeled dispensing device and methods of making and using the same have several advantages over currently used systems and methods. First, pre-marked dosing devices allow medication to be administered more accurately than any currently available system. Further, as shown in FIGS. 8A and 8B, eliminating the steps of calculating the dose that needs to be administered in a stressful environment and eliminating the steps of selecting an appropriate dosing device is an advantage of conventional devices and methods. Helps eliminate dangerous dosing errors, such as dangerous overdose or dangerous underdose, which commonly occur when drugs are used. Also, the frequency and severity of non-critical errors compared to conventional methods can be reduced as shown in FIGS. 8C and 8D. Also, as shown in FIGS. 8E and 8F, the time to prepare and deliver the medication and the time to deliver the medication when preparing for rapid entry intubation (RSI) may vary depending on the dosage device according to the present disclosure. can be significantly reduced compared to conventional devices. Thus, pre-labeled medication devices designed and used in accordance with the disclosed embodiments enable more simplified, accurate and efficient drug delivery in emergency and critical care settings.

Example embodiments of apparatus, systems and methods have been described herein. As can be seen elsewhere, these embodiments are described only by way of illustration and not limitation. Other embodiments apparent from the teachings contained herein are possible and are encompassed by the disclosure. Accordingly, the scope of the disclosure should not be limited by any of the above-described embodiments, but should be defined solely in accordance with the claims supported by this disclosure and its equivalents. Further, embodiments of the present disclosure may include any element/feature of any other disclosed method, system and apparatus including any feature corresponding to scientific data exchange. In other words, features of one and/or another disclosed embodiment are interchangeable with features of other disclosed embodiments, which in turn correspond to other embodiments. Additionally, one or more features/elements of the disclosed embodiments may be removed and still be patentable subject matter (thus resulting in further embodiments of the present disclosure). Moreover, some embodiments are distinguishable from the prior art because they do not explicitly possess one or more features found in the prior art. In other words, the claims of some embodiments of the present disclosure are either one or May contain multiple negative limitations.

Claims (13)

a vial containing a drug;
A dosing device configured to receive the drug from the vial and deliver the drug to a patient, the dosing device corresponding to a set drug dose and varying with the drug and the concentration of the drug. a dispensing device marked with a plurality of coded dose zones having a width of
an instrument for associating the patient with one of the plurality of coded dose zones, comprising:
The therapeutic kit comprises:
a second vial of a second drug;
a second dispensing device configured to receive the second medication from the second vial and deliver the second medication to the patient, wherein the second medication dispensing device corresponds to a second set medication dose; and a second dispensing device marked with a second plurality of coded dose zones having different widths depending on the second drug and the concentration of the second drug;
the vial and the dosing device are each marked with a first symbol, the first symbol corresponding to the drug and the concentration of the drug;
The second vial and the second dispensing device are each marked with a second symbol, the second symbol corresponding to the second drug and the concentration of the second drug, and the second symbol corresponding to the second drug. Unlike 1 symbol,
each of the dosing device and the second dosing device is a syringe including a plunger;
the vial and the plunger of the dosing device are marked with the same color;
the second vial and the plunger of the second dispensing device are marked with the same color different from the color marked on the plunger of the dispensing device of the vial;
A treatment kit, wherein the end of the plunger of the dosing device and the end of the plunger of the second dosing device are marked with the order of delivery of the medicament and the second medicament, respectively. 2. The treatment kit of claim 1, wherein the vial and the dosing device are labeled with the time intervals of the medicament. a filling needle for attaching to the dispensing device and for withdrawing the drug administered from the vial to fill the dispensing device with a dose of the drug corresponding to the one of the plurality of coded dose zones; 11. The therapeutic kit of claim 1, further comprising. 3. The treatment kit of claim 1, wherein said syringe is permanently attached to a needle. 2. The treatment kit of claim 1, wherein the vial of the drug and the dispensing device are labeled with the name of the drug. 6. The treatment kit of claim 5, wherein the vial of the drug and the dispensing device are labeled with the concentration of the drug. 3. The treatment kit of claim 1, wherein said instrument is a color-coded measuring tape. 8. The treatment kit of claim 7 , wherein the patient is scaled with the color-coded measuring tape to determine the coded dose zone in which the dispensing device is to be filled with the drug. 11. The therapeutic kit of claim 1, further comprising instructions including steps for administering said agent. 2. The treatment kit of claim 1, wherein the set drug dose and the width of the plurality of coded dose zones correspond to the drug. 2. The treatment kit of claim 1, wherein the second set drug dose and the second plurality of coded dose zones are different than the set drug dose and the coded dose zones. 2. The therapeutic kit of claim 1, wherein said second drug is at a different concentration than said drug. 11. The treatment kit of Claim 1, further comprising instructions specifying that the drug is to be administered to the patient before the second drug is administered to the patient.

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