JP2022079520A - Apparatuses, methods and systems for delivering medication using medication kits - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a system for delivering medication.

SOLUTION: In one aspect, the disclosure is directed to 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 a drug that is correlated with 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 to an opening through which the drug is to be dispensed.

SELECTED DRAWING: Figure 7D

COPYRIGHT: (C)2022,JPO&INPIT

Description

This application provides priority and benefits to US Provisional Patent Application No. 62/332412 entitled "Devices, Methods and Systems for Service of Drugs Using Dosing Kid" filed May 5, 2016. Insist. The application is a partial continuation of US Patent Application No. 15/282732, entitled "Devices, Methods and Systems for Service of Measured Dosage," filed September 30, 2016. US Patent Application No. 14/392087, entitled "System for Service of Drugs," filed September 2, 2015 ("System for Service of Drugs," filed January 30, 2013. This is a partial continuation application of the international application No. PCT / US2013 / 023873 (domestic transition procedure), and the latter application is a US provisional application entitled "System for Service of Drugs" submitted on February 1, 2012. Claims priority over US provisional application No. 61/573674 and US provisional application No. 61/717474, entitled "System for Service of Drugs," filed October 23, 2012. All of the above applications are incorporated herein by reference.

The present disclosure relates to a medicine-dosing device, particularly a pre-labeled dosing device and method for administering an appropriate dose of a drug in an emergency or critically ill treatment setting.

It is very important to administer the right dose of the drug accurately and efficiently in the emergency and intensive care units. The administration of adequate doses of the drug is especially important in emergency or critical care settings involving pediatric patients, as even minor dosing mistakes can lead to unfortunate results. However, no matter how hard the healthcare professional strives, even in the best of circumstances, the dosing process involves multiple steps, which can sometimes lead to inadvertent mistakes. Specifically, in typical situations, 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, the selection of the exact drug to be administered and the dosing device used. Since each step has the potential to lead to errors in the overall dosing process, reducing the number of steps to be performed can significantly increase the overall accuracy and efficiency of the process.

The drug dose is traditionally determined based on the patient's body weight. However, this method can sometimes be inadequate and inaccurate, especially in emergency and critically ill care settings. Therefore, sometimes the height of the patient allows for rapid and efficient determination of the drug dose, which can be used and color coded measuring tapes are used to measure the height of the patient. Specifically, the Broselow® Pediatric Emergency Tape is a well-known device that associates readily available patient height with drug doses. Details of this device and how to use it are disclosed in a patent document (incorporated herein by reference) (see, eg, Patent Documents 1 and 2). In general, the method measures the patient's height, encodes the patient's height into one of the color zones shown on the tape, and uses the color-coded height to determine the dose of the drug administered to the patient. Including deciding. By segmenting into multiple color code zones (each color zone corresponds to a given height range) rather than the inches or centimeters typically used, the patient's height is 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 height measured in meters or inches. For example, the gray zone of the tape corresponds to a height range of 42.20 cm to 60.79 cm, and the pink zone of the tape corresponds to a height zone of 60.80 cm to 67.79 cm. In this way, patients whose height belongs to the first height range are coded as gray and patients whose height belongs to the second height range are coded as pink. Appropriate drug doses for the two patients are selected from the 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 the drug dose has been greatly simplified by the use of the above methods, many other problems that often lead to dosing errors or make the dosing process inefficient still remain. For example, many other calculations, such as calculations relating to the concentration of a drug, need to be performed in order to obtain the correct dose of drug to be administered after the dosage has been determined. In addition, the selection of the correct drug or the appropriate dosing device, or the incorporation of the correct set amount of the drug into the dosing device, can each cause an error or slow down the dosing process to the patient. Due to the type of graduation adjustment used in such systems, even in situations where the dosage is based on a dosing system other than traditional weight-based systems, such as patient age, body surface area or volume. Dosing may be inaccurate. In particular, constant incremental changes in the dose typically used can result in the inaccuracy of dose weighing required when such a system is used.

US Pat. No. 4,716,888 US Pat. No. 6,132,416

Thus, although various techniques designed to simplify the drug dosing and dosing process are available, nonetheless, environmental and time constraints when treatment is given and the dose metering system used. There is a possibility that an error will occur due to the type. Therefore, there is a need for devices and methods for accurately and efficiently delivering drugs, especially to pediatric patients, in the field of emergency or critical care.

Disclosed herein are treatment kits that facilitate the treatment of complex medical problems. Each of the disclosed kits typically targets the treatment of a unique medical problem, and such treatment requires that the unique order of the drug be given in the correct order and dose. In certain high-risk situations, the medical problems involved can endanger a person and mistakes can be life-threatening. In such situations, accurate dose weighing and delivery can save lives.

The treatment kit can provide a vial containing the drug and a dosing device. The dosing device can be configured to receive the drug from the vial and deliver the drug to the patient. In addition, the dosing device can be marked with a coded dose zone. The dose zone can have a variable range and corresponds to a set drug dose. The kit can also include equipment for associating the patient with one of the encoded dose zones.

In some embodiments, the kit is configured to withdraw the drug to be administered attached to the dosing device from the vial in order to fill the dosing device with the dose corresponding to one of the coded dose zones. Can include filling needles. Alternatively, the needle can be permanently attached to the syringe.

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

Drug vials and dosing devices can be labeled. In some embodiments, the vial and dosing device can be marked with the name of the drug and / or the concentration of the drug. In addition or instead, vials and dosing devices can be labeled with the symbol, which can correspond to the concentration of the drug and / or the drug.

In some embodiments, the instrument for associating a patient with one of the coded dose zones can be a color coded measurement tape. The patient can be measured with a color coded measuring tape to determine the color coded dose zone when filling the dosing device with the drug.

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

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

In some embodiments, the kit can provide a second vial of the second drug and a second dosing device configured to receive the second drug from the second vial and deliver the second drug to the patient. The second dosing device can be marked with a coded dose zone with a second variable width corresponding to the second set drug dose. The second set drug dose and the second coded dose zone may differ from the set drug dose and the coded dose zone.

In addition, the vials and dosing devices can be marked with a first symbol, which can correspond to the drug and the concentration of the drug. The second vial and the second dosing device can be marked with a second symbol, which can correspond to the concentration of the second drug and the second drug. The second symbol can be different from the first symbol.

In some embodiments, the second agent can be at a different concentration than the first agent.

In some embodiments, the kit can also include an instruction sheet. The instruction sheet can clearly indicate 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 comprises associating a patient with one of multiple encoded dose zones using the instruments included in the treatment kit. A first vial containing the first drug can be selected from the medical kit and the first drug can be withdrawn from the first vial to fill the first dosing device included in the treatment kit with the first dose of the first drug. The first dose can correspond to one of the first plurality of coded dose zones, the first dosing apparatus is marked with the first plurality of coded dose zones and the first plurality of coded dose zones. Has a first variable width. A second vial containing the second drug can be selected from the treatment kit, and the second drug can be withdrawn from the second vial in order to fill the second dosage device included in the treatment kit with the second dose of the second drug. The second dose can correspond to one of the second plurality of coded dose zones, and the second dosing device is marked with the second plurality of coded dose zones. The second plurality of encoded dose zones can have a second variable width. The first drug and the second drug can be administered to the patient using the first and second dosing devices. The order of administration of the first and second agents can be indicated by the instructions associated with the treatment kit.

It is a perspective view of the dosing apparatus according to one embodiment of this disclosure. It is a perspective view of the dosing apparatus according to one embodiment of this disclosure. It is a perspective view of the dosing apparatus according to one embodiment of this disclosure. It is a perspective view of the dosing apparatus according to one embodiment of this disclosure. It is a perspective view of another embodiment of the dosing apparatus according to one embodiment of this disclosure. It is a perspective view of the dosing apparatus according to another embodiment of this disclosure. It is a perspective view of the dosing apparatus according to another embodiment of this disclosure. It is a perspective view of the dosing apparatus according to another embodiment of this disclosure. It is a perspective view of the dosing apparatus according to another embodiment of this disclosure. FIG. 3 is a plan view of a label showing a color-coded dosage. FIG. 3 is a plan view of a label showing a color-coded dosage. FIG. 3 is a plan view of a label showing a color-coded dosage. FIG. 3 is a plan view of a label showing a color-coded dosage. It is a flowchart which shows the method of determining and printing a color coded dosage label. It is a flowchart which shows the method of administering a drug using the prefilling mark-marked dosing apparatus disclosed. Shown are measuring instruments used to measure a patient's color-coded height. Demonstrates how to administer a drug using an emergency treatment kit that includes a pre-marked dosing device. Shown is an emergency treatment kit for administering a pharmaceutical product according to one embodiment of the present disclosure. Shown are preferred treatment kits for administering pharmaceuticals to treat anaphylaxis, allergies and / or asthma. A preferred treatment kit for administering a drug corresponding to rapid induction intubation is shown. A preferred embodiment of an adult syringe is shown. A preferred embodiment of an adult syringe is shown. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure. Includes data showing improvements in drug delivery using the systems and methods of the present disclosure.

This application describes a device, system and method for administering an appropriate dose of a drug to a patient. The device and system are configured to address the five rights of drug delivery, that is, giving the right drug in the right dose to the right patient at the right time and by the right route. In particular, pre-marked dosage metering / subdivision feeders designed to minimize dosing errors and improve the overall accuracy and efficiency of drug administration in the emergency and critical care setting are provided.

As discussed in detail below, in one embodiment, the dosing device 10 is a syringe 15 comprising an elongated torso 30 and a plunger 50 marked with a set color-coded pharmaceutical volume dose 100. The dosing device according to one embodiment can further be prefilled with the fluid 105 corresponding to the drug to be administered to the patient. Also disclosed are methods of determining specific volume doses of multiple pharmaceuticals based on various factors. In particular, according to one embodiment, the method comprises, for example, creating a label indicating a dose determined based on the volume volume and / or drug concentration of the dosing device or marking the dose on the dosing device.

It also discusses methods for administering appropriate dosages using pre-marked dosing devices. The disclosed method can significantly reduce the time required to determine a single dosage and administer to a patient, while at the same time reducing the risk of miscalculation or misadministration of the dose.

Devices Refer to FIGS. 1A-1D to discuss in detail the first embodiment of the pre-labeled pharmaceutical weighing / subdivision feeding device 10. As shown in FIG. 1A, the dosing device 10 according to one embodiment is a syringe 15 comprising a proximal end 25 and a distal end 20 opposite the proximal end. The syringe is a container such as a syringe barrel 30 at the distal end for holding the drug to be administered, and a proximal end proximally from an opening 36 located at the proximal end 35 of the syringe barrel. Includes a plunger 50 extending to the proximal end 55 of the plunger of portion 25. Both the syringe barrel and the plunger are manufactured from plastic, glass or any other suitable clear medical material that is inert or does not disturb the chemical balance of the internal fluid.

As shown in FIG. 1B, the syringe barrel 30 is elongated, substantially cylindrical, and includes a distal end 31 and a proximal end 35. The syringe barrel further includes an outer circumferential surface 37 and an inner circumferential surface 38. A chamber 32 capable of accepting the plunger and holding the fluid in is formed by the inner circumferential surface 38 of the barrel between the distal end 31 and the proximal end 35. The flange 33, which serves as a finger grip for facilitating handling of the syringe, is formed integrally with the proximal end of the barrel to form an opening 36 for receiving the plunger. Close to the opening 36, along the inner surface of the barrel, is a ridge 34 (FIG. 1C) that prevents the plunger from slipping off the barrel when engaged with the barrel.

The opening 36 circulates with the chamber 32 and the hole 39 located at the distal end 20 of the syringe barrel. The tip 30 for attaching a needle, a nozzle or a tube for discharging the liquid contained in the syringe barrel 30 is integrally formed with the distal end 20 of the barrel and flows through the hole 39. The tip portion may include an inner member 41 and an outer member 42 coaxially positioned. According to one embodiment, the tip can include a luer taper attachment. In some embodiments, the tip can be configured based on the type of agent in which the syringe is used for delivery. For example, a syringe configured for oral medicine can use an oral tip, in particular the oral tip is different from an intravenous (IV) or intermuscular (IM) tip, thereby. The drug can be delivered by the correct route. Similarly, syringes configured for IV and IM agents can be configured to have IV and IM tips so that they can be delivered by the correct route, respectively.

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 seal between the inner surface of the barrel and the plunger to prevent the contents of the syringe from coming out of the back of the syringe. The annular flange 53 is integrally formed with the proximal end 55 of the plunger rod. The plunger 50 has an elongated shape that complements the shape of the chamber 30 and is pushed along the chamber (inside the cylindrical barrel or tube) so that the syringe can be pushed through the hole 39 at the tip or distal end of the barrel. Designed to drain fluid. Alternatively, the plunger may include other configurations capable of pushing the fluid from the inside of the chamber 30 through the tip 40 or the hole 39.

According to one embodiment of the present disclosure, the dosing apparatus can be prefilled with preselected agents. Initially, when the dosing device is prefilled and the syringe is in the pre-dosing position, the substantial length of the plunger rod extends longitudinally out of the syringe barrel. In other words, as shown in FIG. 1A, prior to drug administration, only the plunger rod gasket 52 and the 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 rest of the length of the plunger is outside the barrel so that it is in its most stretched state.

Alternatively, the dosing device is not prefilled. The dosing device can be marked, for example, drug name, concentration, volume mark, color coded zone and the like. The healthcare professional draws the appropriate concentration of drug (ie, the drug named on the device) into the dosing device to reach the appropriate volume marking and / or color coding zone. In some embodiments, the dosing device is obtained as part of a kit containing a pharmaceutical container containing the drug to be administered. The drug in the pharmaceutical container is withdrawn into the dosing device immediately before the dosing process. In such an embodiment, the plunger rod can remain inside the syringe barrel until the drug is drawn into the syringe. Dosing devices can be clearly marked to avoid confusion as to which syringe to use for which drug. As further discussed below, such markings can include plungers of different colors to avoid confusion. As a specific embodiment, 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 medicinal volume dose and is prefilled with a fluid 105 corresponding to the medicinal product to be administered to the patient. Plunger 80 and can be included. In this configuration, as shown in FIG. 2C, the syringe barrel comprises an inner tubular body 75 that aligns approximately coaxially with the larger diameter of the cylindrical barrel. The inner tubular body has a needle 76 positioned coaxially within the inner tubular body and longitudinally aligned with the inner tubular body. The plunger 80 shown in FIG. 2D comprises a substantially cylindrical member or vial 81 and a stopper 82. Since the syringe barrel and plunger are initially separated, as shown in FIG. 2B, the plunger 60 is placed in the syringe barrel so that the stopper 82 is fully engaged with the inner tubular body 75 and the needle 76 prior to drug administration. It needs to be inserted into the proximal end 35.

According to yet another embodiment of the present disclosure, the plunger and / or the plunger stopper can be collar-coded based on the drug placed in the barrel. Such color coding of the plunger can further increase the efficiency of drug administration, and the plunger's visual examination allows quick verification of the accuracy of the drug being administered, making administration more error-free. Can be done. The name and / or concentration of the agent can be further marked on the plunger and / or the plunger stopper on behalf of or in addition to the color coded plunger and / or the plunger stopper to further limit the possibility of error.

Alternatively, the dosing device can include any container, such as a tube, vial, bag or bottle, from which the desired drug can be placed and the desired drug can be discharged. For example, the dosing device can be a bag containing an IV fluid. According to this embodiment, the bag can be marked with a series of color coded zones along with conventional volume marking. When used in combination with conventional volume marking, color-coded zones can serve as a reminder to healthcare professionals of the exact volume of each drug that can be given to the patient based on the patient's color zone. The color coded zone can also be used as a hint to put the exact total volume subdivided into the IV pump for a given drug.

Next, marking on the surface of the dosing device will 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 marking comprises a series of substantially translucent bands or zones 100 indicating possible dosages administered to the patient. The marking shown in the figure includes a series of color coded zones, but the marking can also include zones with various 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 dosing device, or a label or sleeve that can be attached or placed on the outer surface of the dosing device can be created. The markings attached are such that when the device is filled, the fluid level can be easily seen through the markings.

FIG. 3A shows a plurality of labels according to one embodiment of the present disclosure. Each label 300 is substantially rectangular and has a size based on the volume capacity of the dosing device to which the label is attached. In other words, as the volume varies with the dosing device, the size or dimensions of the label are adjusted accordingly to adequately cover the outer surface of the dosing device as a result of the variation in the outer circumferential surface of the device. Ru. For example, if the 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 changes in the outer surface of the barrel.

Along with the change in label size, the appropriate change in the width of the color band or zone printed on the corresponding label is also added depending on the dosing device used to supply the drug. Specifically, it is necessary to make changes to the width of the color band or zone to maintain the same pharmaceutical volume dose across the various dosing devices, taking into account volume fluctuations in the medication-dispensing device. There is. For example, as shown in FIG. 3B, the label of the same drug loaded into a 10 cc pensa and a 5 cc dosing device is different for each color band or zone in order to keep the dosing dose the same for both dosing devices. It has two widths. In other words, the width of the color bands 351A-351A on the label 310 of the 10 cc device is the same amount to the patient in order to supply the same amount of medicinal product using the 10 cc dosing device as compared to the case of using the 5 cc dosing device. Smaller than the color bands 351B-359B on the label 305 of the 5cc dosing device to deliver the medicinal product of.

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, the higher concentration drug corresponds to a smaller volume dose or smaller band width of the lower concentration drug.

As shown in FIG. 3C, the label 300 has opposing parallel sides 315 and 320, and opposing parallel ends 325 and 330, with varying widths corresponding to dosages for patients with specific characteristics. Includes a series of continuous color bands or zones 351 to 359 having. The properties correspond to the patient's height (as described above), weight, age, body surface area / volume and / or similar. Specifically, each color band is formed by a leading edge 335 and a trailing edge 340 parallel to the opposite ends 325 and 330 of the label and is a predefined color code when the label is attached to the dosing device. It has a range corresponding to the volume of the drug at the set dose suitable for the patient with the characteristics belonging to the range. In other words, each color band or zone on the label represents a dosage correlated with its color coded height range, weight range, age range, body surface area / volume range or other physiological characteristics.

Further, referring to FIG. 3C, according to one embodiment, nine separate color bands 351 to distinguish nine different dosages corresponding to nine separate color coded patient characteristic ranges. ~ 359 can be used. Specifically, each of the colors corresponds to one of nine different doses of the unique drug. As shown in FIG. 3C, in one particular embodiment, the band colors include gray 351 and pink 352, red 353, purple 354, yellow 355, white 356, blue 357, orange 358 and green 359, and are gray. The band corresponds to the lowest dosage and the green band corresponds to the maximum dosage that can be delivered. The solid black line 365 can be used at the boundaries between various color bands or zones to facilitate the process of drug administration, as discussed in more detail below. The description is given with reference to the specific colors shown in FIGS. 3A-3C, but it should be seen that other colors or markings can be used. Instead or in addition, color names can be printed in color bands or zones in addition to or in place of colors.

According to yet another embodiment shown in FIG. 3D, the label comprises 10 different color bands, the 10th color band corresponding to the maximum dosage 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 properties (eg, height, weight, etc.) fall outside the previously disclosed color range. For example, a universal label according to this embodiment can be affixed to a universal dosing device that can be used for both pediatric and adult patients, eliminating the need to have two separate dosing systems for two separate patient groups. .. However, although the specific number of color bands has been discussed in the above examples, it should be found that any number of color bands can be used to allow for more precise dosing. In some cases, the pre-defined zones or zones can be further subdivided into zonules or subzones to allow for more precise dosing. As a non-limiting example, in some embodiments, 36 markings (subzones) can be included within the nine color zones. This can increase the accuracy of administering the drug to the patient.

Also, according to another embodiment of the present disclosure, as shown in FIG. 3C, one of the edges of the label comprises a mark 370 to ensure that the label is accurately attached or positioned to the syringe or plunger. Can be done. For example, the label can be attached to the barrel in the opposite direction and marked on the edge of the label aligned with the distal end of the syringe barrel to prevent subsequent inaccurate doses. .. For example, the edge of a label with a color band corresponding to the minimum dose can include a mark on its leading edge that facilitates alignment of the label with the distal end of the syringe barrel.

Further, according to another embodiment shown in FIG. 3A, the label can include the name of the drug to be administered or any other information that is probably important for ensuring that the patient is given the correct drug. .. In particular, the name of the drug can be imprinted along the length of the label or anywhere else as long as the accuracy of the drug in the dosing device can be easily verified. In addition, for drugs administered at time intervals, the label should be marked with the corresponding time interval or a separate calendar (paper or electronic) to allow patients and / or healthcare professionals to track the dosing interval. ) Can be installed.

Methods for Measuring and Generating Dosing Information Next, we discuss method 400 for determining dosages and dosing devices for multiple medications. In one particular embodiment shown in FIG. 4, the creation of a collar coded dose label that can be affixed to the selected dosing device can be included. As shown in FIG. 4, method 400 begins with step 401 in which the drug of interest for the dose label produced is selected. As for emergency or critical care, some examples of the most commonly used medicines can include, for example, atropine, lidocaine, fentanyl, epinephrine, etomidate, ketamine, succinylcholine, rocuronium and midazolam. However, it should be found that the method can be similarly applied to any other drug that can be administered using the disclosed dosing device.

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

After the dose to be administered to the patient is determined in step 402, the drug concentration of the agent selected in step 401 is determined in step 403. The drug concentration is directly proportional to the volume that needs to be administered. In other words, for a higher concentration solution than for a lower concentration solution of the same drug, the volume that needs to be administered is smaller.

The next step, or step 404, relates to the selection of the dosing device to be labeled. As mentioned above, dosing devices are available in various volume sizes, so a variety of labels are made using the dosing device conversion factor based on the length and width of the dosing device and / or the concentration of the drug. Variations in the size and / or shape of various dosing devices can be taken into account. Thus, once a particular volume of dosing device has been selected to administer the selected drug, the individual color bands corresponding to the determined dosage using the corresponding conversion factors listed in Table 1. / Both zone and total band width can be calculated. Specifically, the width of each color band / zone corresponding to the determined dosage is calculated based on the dose of the drug administered, the solution concentration and the volume volume of the dosing device. According to one embodiment, all of the calculations can be performed by the computer processing unit (CPU) in response to user input.

Labeling to the dosing device can be performed once the width of each color band or zone is determined and the label is printed. For example, if a syringe with a barrel and plunger is labeled and the barrel is designed to hold the medicine to be fed, the label will be labeled on one of the edges of the label corresponding to the minimum dose color band. Can be placed along the outer circumference of the barrel by aligning with the distal edge of the syringe barrel. Alternatively, in a syringe in which the plunger acts as a container for holding the drug, the label is 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 dosing device. It can be placed along the surface of the sake.

Pre-calculated bands / zones for each of the selected drug, volume volume and solution concentration of the dosing device can be printed on the label attached to the dosing device, but the dosing information is directly stamped, etched and stained on the dosing device. Alternatively, 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, a properly labeled dosing device can be prefilled with the desired drug, and the fluid volume corresponds to, for example, the maximum dose that can be administered to a patient belonging to the maximum height zone. When the selected medicinal product is prefilled in the dosing device, the label may be affixed before or after filling the dosing device. Pre-labeled when the medication device is filled with the drug selected immediately prior to the dosing process, such as when the dosing device is included as part of a kit containing the dosing device and a container filled with the drug to be administered. An empty dosing device attached is supplied for use. Therefore, just prior to administration, the fluid volume corresponding to the dose set for a given patient can be drawn from the container into the pre-labeled dosing device.

Method of Drug Administration A dosing device assembled according to the steps described above can be used to deliver a drug safely and efficiently. FIG. 5 is a flowchart 500 of a method of administering a drug to a patient using the dosing apparatus 10 disclosed according to one embodiment. In this particular embodiment, the disclosed method comprises the step of efficiently administering to a patient a drug selected from prefilled and premarked dosing devices. As shown in the figure, the method begins with step 501, in which the patient's color coded height or any other physical characteristic is measured. For height, blowrose wax tape or any other similar type of device indicating 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 writing down the patient's color coded height on the tape. Alternatively, any other physiological property that can be color coded and associated with the dosage, such as body weight, age, body surface area or volume, can be used.

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

Once the color code of the patient's height or other characteristics has been measured and noted and the medication administered is confirmed to be accurate, the appropriate dosage to be delivered or the corresponding volume is determined in step 503. .. The appropriate dose can be determined by the physician or other healthcare professional who calculates the appropriate dose based on the characteristics of at least one patient. The calculated dose can be the exact amount of drug administered. In addition, the physician or other healthcare professional who administers the drug can determine the patient's color code based on at least one patient characteristic. For example, if the patient height or other characteristic is measured to belong to the blue range of the measuring tape, the volume of the drug administered to the patient is the volume within the blue color band on the dosing device.

Since the dosing device is prefilled (in this embodiment), the appropriate dose of the drug is a syringe prefilled until the determined / calculated volume (dose) of the drug is reached, as shown in step 504. It can be obtained by draining excess drug 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 drug must be withdrawn from the prefilled dosing device prior to drug administration.

Thus, according to one embodiment, the plunger is pushed along the interior of the barrel towards the distal end 31 of the barrel until the proximal end of the plunger 54 reaches the calculated dose. Once the medication practitioner has discharged extra medication so that only the calculated dose remains in the medication device, the healthcare professional will determine the calculated dose and the amount of medication remaining in the medication device for the patient. Make sure it is within the coding range. For example, in the case of the above patient whose height or other trait is coded blue, the blue band has a leading edge close to the distal end of the barrel and a trailing edge close to the proximal end of the barrel. , The plunger is pushed towards the distal end of the barrel until the distal end of the plunger is aligned with the calculated dose, after which the medication worker is informed that the plunger is between the leading and trailing edges of the blue band. Make sure you are there. Once all of the excess liquid has been removed from the prefilled dosing device in step 504, the accuracy of the dosage is confirmed in step 505 and the medication is administered to the patient in step 506.

Dosing kits Dosing to pediatric patients is a particular problem in emergency medical settings. As mentioned above, determining the dosage of a pediatric patient first involves determining the number of kilograms of drug to administer to the patient based on its weight and / or height. Next, the number of milliliters of drug given to the patient must be determined based on the concentration of the drug. As a result, there is a risk of human error in performing the calculations necessary to determine the appropriate dose. In addition, errors can often occur in the field of emergency when a healthcare professional grabs or selects a syringe with a unit different from what is expected by the calculation. These errors can be compounded when treating a patient with a series of medications, ie, when multiple medications are administered.

In addition, in certain cases, a series of agents must be administered in a particular order. Therefore, in addition to the errors mentioned above, additional errors may occur as a result of delivering multiple medications in an incorrect order. In addition, there is the risk that certain medications will not be readily available to medical staff, and delays in obtaining these medications can be detrimental to patients. For example, if an excess sedative is delivered to the 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, time dilation can be detrimental to the patient.

By using the types of kits described herein, some or all of the above risks can be reduced. For example, the use of such a kit helps to allow the correct dose to be administered with the correct timing and order. In addition, the kit makes it possible to obtain suitable antidotes and the like in the event of a dose measurement or sequence error. In some embodiments, the kit is available on the basis of the agent administered and / or the treatment administered.

Embodiments of the kit can include medicines, multiple medicines, dosing devices and / or one or more of similar ones. The kit can also include instructions and blowrow tape or any other similar type of device showing color coded height as discussed above with reference to FIG. For treatments that require a series of drugs, the drug and / or the dosing device can be labeled accordingly. For example, the first drug to be administered and the dosing device applied thereto are labeled with "1", the second drug and the corresponding dosing device are labeled with "2", and then the same label is attached. be able to. Further, in embodiments where an antidote for a drug (or one of the drugs) is provided, the antidote and the antidote dosing device can be labeled accordingly.

Within the kit, the drug can be stored in a vial and the dosing device can be a syringe such as the syringe discussed above in connection with FIGS. 1-3. In some embodiments, one or all of the medicines can be stored in a syringe. Syringes can be tailored to each drug. Syringes with different volume volumes can be used depending on the drug. In addition, the label size and the width of the color band or zone will vary depending on the drug and / or the concentration of the drug. Therefore, the name of the drug used in the syringe and the concentration of the drug can be printed on the syringe (or the label affixed to the syringe).

In some embodiments, the dosing device can be used to administer the drug to the patient according to the method shown in FIG. 7A. In particular, the method for drug administration can begin with the selection of an emergency treatment kit (step 701) containing the drug to be administered to the patient. As shown in FIG. 7B, the treatment kit can hold the dosing device in a box, bag, pouch or any other suitable box, bag, pouch or otherwise labeled on the outside with the name of the medicinal product specifically placed in the container. Can include containers such as containers. For example, according to one embodiment, in addition to the name of the drug appearing on the label, the label also contains information about the concentration of the drug and / or instructions on how to use the kit for drug administration. be able to. The treatment kit can further include a pre-marked dosing device such as a syringe with a color coded zone calibrated to the various dosages for the selected drug. The marking on the syringe can also include the name of the drug to be delivered or any other information that helps ensure that the drug is delivered correctly to the patient. The treatment kit can also include a needle to facilitate the entry of the drug into the syringe, such as a blunt filling needle made of plastic or any other suitable material. The treatment kit can also include containers such as bottles, vials, etc. for holding the drug, labeled with the drug name on the outer surface of the container. The container can include a stopper or lid that helps contain the drug inside the container. The stopper or lid can be made of, for example, rubber or any other suitable material that can be easily pierced with a filling needle so that the drug can be easily drawn from the container into the dosing device.

If multiple agents are included in the kit, the vials and syringes corresponding to each agent can be placed within the package without confusion as to which vial corresponds to which syringe. In addition, different colored plungers can be used to ensure that the correct medication is given to the patient in the correct order. For example, in a situation where two agents are administered in a specified order, the kit contains the first agent in a first vial, the first syringe is marked with a color zone for the first agent, and the second. The vial contains the second drug and the second syringe is marked with a color zone for the second drug. The plunger inside the syringe can be colored so that the first vial and the first syringe are not mixed with the second vial and the 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. Thus, when the drug is administered, the dosing healthcare professional can easily confirm that the correct vial / drug-syringe combination is being used.

Alternatively or in addition, if the agents need to be delivered in a particular order, a number may be marked on the end of the plunger to indicate the order in which the agents are delivered. For example, if the first drug administered has a green plunger and the second drug has a yellow plunger, the end of the green plunger has the number "1" at the end and is yellow. The end of the plunger can have the number "2" at the end. You can also mark numbers on vials.

If the drug dose is based on the patient's height, the patient's color-coded height may be a blowrose tape or other similar type of device indicating a color-coded height range as discussed above with reference to FIG. It can be measured using an instrument (step 702). Alternatively, other patient characteristics can be used to determine the color coding range. The appropriate volume of drug to be administered can then be determined based on the patient's height, which can correlate with the color code (step 703). The determined drug volume is then retracted into the dosing device (step 704), and the administering healthcare professional confirms 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-mounted filling needle, the filling 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 include a vial 725 of epinephrine with a particular concentration. For example, epinephrine has a concentration of 1: 1000 mg / ml. The syringe 730 (medication device) can be equipped with a permanently attached needle to prevent the medication from being accidentally given intravenously. The syringe can have a maximum volume of 0.33 ml. 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. The syringe can be marked with the color code described above to indicate the exact dose. In some embodiments, the exact dose can be determined based on the child's weight, age, body surface area and / or height. Instrument 735, such as blowrow tape or any other similar type of device that indicates a color coded height range (as discussed above with reference to FIG. 6), can also be included in the kit. Instructions 740 can also be included in the kit. The kit can be packed in a container / package 745. In some embodiments, at least the front surface 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 induction intubation and can include a range of medications such as etomidate, succinylcholine, atropine and lidocaine. FIG. 7D In the embodiment, the kit 750 contains three medicines. Each drug can be stored in vials 755a, 755b, 755c, and each vial 755a, 755b, 755c has a corresponding syringe 760a, 760b, 760c. The syringes 760a, 760b and 760c are each calibrated to match one of the medicines, the syringe 760a to match the medicine in vial 755a and the syringe 760b to fit the medicine in vial 755b, syringe 760c. Is calibrated to match the drug in vial 755c. The graduation adjustment is based on color coding, which correlates with the child's weight, age, body surface area and / or height. In some embodiments, appliances such as blowrow tape or any other similar type of device indicating a color coded height range (eg, as described above with reference to FIG. 6) are also kits. Can be included in. Instrument 765 is used to determine the color range when filling a vial with a medicinal product. Instructions 770 can also be provided. The instruction sheet 770 can indicate one or more of the following steps. That is, measuring the weight, age, body surface area and / or height of a child, determining a color based on the measurement, giving a drug 1 based on an appropriate color, and giving a drug 2 based on an appropriate color. Giving, giving medicine 3 based on the appropriate color.

In some embodiments, each corresponding vial-syringe pair can be included within a separate set of packages so that the vial-syringe pair is not confused. Alternatively or additionally, the vial-syringe pair may be number labeled (eg, vials with a first drug and corresponding syringes each have a number 1 label, and so on). And / or the syringe can be marked with the corresponding drug and concentration. Vial-syringe pairs can be marked with a unique code, the unique code is used only for vial-syringe compatibility, or the unique code is for a single drug of a particular concentration. Only used. Therefore, the person who administers the drug must check that the signs, numbers, etc. match before administering the drug.

The kit can be configured to contain various combinations of medications for pediatric conditions. Another preferred kit is a vial of atropine at the correct concentration, a syringe for the first dose of 1xmg / kg, a second syringe for the second dose of 2xmg / kg, instructions, a container for proper maintenance of the contents. And / or a supraventricular palpitations kit containing similar substances. Other preferred kits can be configured for conscious sedation, acute pain and other treatments.

In some embodiments, the kit can also be made to treat an adult, such as a treatment / drug that varies based on the size, weight, etc. of the adult. For some medicines, adult doses are universal, and for others, doses vary depending on the size of the patient. The concept is the same as for pediatric patients, with larger patients having larger doses and smaller patients having smaller doses. The size distinction can be based on the patient's weight, height, body surface area, age and / or similar. For example, some medicines can have two doses, one for large adults and one for small adults. Therefore, the drug delivery device can have two zones. The drug delivery device can have more than two zones, as other medicinal products may require more precision depending on the size of the patient. In some embodiments, the zones can be color coded (FIG. 7E) and in other embodiments, the zones can be transparent (FIG. 7F).

Kits similar to the kits described above can be configured to include vials and / or syringes configured for adults rather than children. Thus, the dosing device, drug and / or drug concentration can be configured for adults. The kit can be clearly labeled to indicate whether it is an adult kit or a pediatric kit.

In another embodiment, the kit can include both a pediatric syringe and an adult syringe. Thus, for a drug in which an adult and a child take the same drug at the same concentration, the kit can include a vial of the drug, a corresponding syringe for a pediatric patient, and a corresponding syringe for an adult patient. Syringes can be clearly labeled as adult or pediatric syringes. The syringe can also have a color or sign indication to indicate that it is for adults or children. For example, an adult syringe has a blue plunger, a pediatric syringe has a red plunger, and / or an adult syringe is labeled with an adult "A" and a pediatric syringe is labeled with a pediatric "P". "Or can be labeled with a" C "in the child (ren).

As disclosed with reference to all drawings, pre-labeled dosing devices and methods of manufacturing and using them have several advantages over currently used systems and methods. First, the pre-marked dosing device allows the drug to be administered more accurately than any of the systems currently available. Further, as shown in FIGS. 8A and 8B, eliminating the step of calculating the dose that needs to be administered in a stressful environment and eliminating the step of selecting the appropriate dosing device is a conventional device and method. Helps eliminate dangerous dosing errors such as dangerous overdose or dangerous underdose that normally occur when used. Also, the frequency and severity of less significant 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 drug and the time to deliver the drug when preparing for rapid induction intubation (RSI) are the dosing apparatus according to the present disclosure. Can be significantly reduced compared to conventional equipment. Therefore, pre-labeled dosing appliances designed and used according to the disclosed embodiments will enable simpler, more accurate and efficient drug delivery in emergency and critically ill care settings.

In the present specification, examples of embodiments of devices, systems and methods have been described. As can be seen from the other parts, these embodiments are described only by way of example, not by limitation. Other embodiments apparent from the teachings contained herein are possible and are included in the disclosure. Therefore, the scope of disclosure should not be limited by any of the embodiments described above, but should be defined only in accordance with the claims endorsed by this disclosure and its equivalents. Further, embodiments of the present disclosure can include any element / feature of any other disclosed method, system and device, including any feature corresponding to scientific data exchange. In other words, the features of one and / or another disclosed embodiment are interchangeable with the features of the other disclosed embodiments, the latter embodiment further corresponding to the other embodiments. Moreover, one or more features / elements of the disclosed embodiments can be removed and are still patentable (thus, a further embodiment of the present disclosure). Moreover, some embodiments are distinguishable from the prior art because they do not explicitly have one or more features found in the prior art. In other words, the claims of some embodiments of the present disclosure are one or more to articulate that the claimed embodiments do not have at least one structure, element and / or feature disclosed in the prior art. Can include multiple exclusion claims (negative limitation).

Claims (17)

Vials containing the drug and
A dosing device configured to receive the drug from the vial and deliver the drug to a patient, wherein the dosing device has a plurality of encoded doses having a variable range corresponding to a set drug dose. The zone is marked, the dosing device, and
A treatment kit comprising an instrument that associates the patient with one of the encoded dose zones. A filling needle for withdrawing the drug administered from the vial for attachment to the dosing device and for filling the dosing device with the dose corresponding to said one of the plurality of coded dose zones. The treatment kit according to claim 1, further comprising. The treatment kit according to claim 1, wherein the dosing device is a syringe. The treatment kit of claim 3, wherein the syringe is permanently attached to the needle. The treatment kit of claim 1, wherein the vial of the drug and the dosing device are labeled with the name of the drug. The treatment kit of claim 5, wherein the vial of the drug and the dosing device are labeled with the concentration of the drug. The treatment kit according to claim 1, wherein a symbol is marked on the vial of the drug and the dosing device, respectively, and the symbol corresponds to the drug and the concentration of the drug. The treatment kit according to claim 1, wherein the device is a color coded measurement tape. The treatment kit of claim 8, wherein the patient is measured with the color coded measuring tape to determine the coded dose zone in which the dosing device should be filled with the drug. The treatment kit according to claim 1, further comprising an instruction sheet comprising a step for administering the agent. The treatment kit according to claim 1, wherein the set drug dose and the width of the plurality of coded dose zones correspond to the drug. The second vial of the second drug and
A second dosing device configured to receive the second drug from the second vial and deliver the second drug to the patient, the second dosing device corresponding to the second set drug dose. The treatment kit of claim 1, further comprising a second dosing device, wherein a second plurality of encoded dose zones having a second variable width are marked. 12. The treatment kit of claim 12, wherein the second set drug dose and the second plurality of coded dose zones are different from the first set drug dose and the coded dose zone. 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 dosing device are each marked with a second symbol, where the second symbol corresponds to the concentration of the second drug and the second drug, and the second symbol is the first symbol. A different treatment kit according to claim 12. The treatment kit according to claim 12, wherein the second drug has a concentration different from that of the drug. The treatment kit of claim 12, further comprising an instruction indicating that the first agent is administered to the patient before the second agent is administered to the patient. In the method of administering a plurality of drugs to a patient, the above-mentioned method is
The step of associating the patient with one of the first plurality of encoded dose zones using the instruments included in the treatment kit,
At the stage of selecting the first vial containing the first drug from the treatment kit,
Withdrawing the first drug from the first vial in order to fill the first dosage device included in the treatment kit with the first dose of the first drug, wherein the first dose is the first dose. Corresponding to said one of the plurality of coded dose zones, the first dosage apparatus is marked with the first plurality of coded dose zones, and the first plurality of coded dose zones are the first. The stage of withdrawing the first drug, which has a fluctuating range,
At the stage of selecting the second vial containing the second drug from the treatment kit, and
Withdrawing the second drug from the second vial in order to fill the second dosage device included in the treatment kit with the second dose of the second drug, wherein the second dose is the second. Corresponding to said one of the plurality of coded dose zones, the second plurality of coded dose zones are marked on the second dosing device, and the second plurality of coded dose zones are the second variation. The stage of withdrawing the second drug, which has a range of
The first drug and the second drug are administered to the patient using the first medication device and the second medication device, and the order of administration of the first drug and the second drug is the treatment. A method comprising administering the first and second agents, as indicated by the instructions associated with the kit.

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