Medication delivery device

The disclosure is directed to a medication delivery device and a removable elongate member and cartridge system, and methods of use thereof. The medication delivery device is designed to be programmed by physicians or other health care personnel who enter medication orders into the computerized physician order entry (CPOE) of the electronic health record (EHR) in the usual fashion. These commands are then used to program the medication delivery device. The medication delivery device uses standard vials as cartridges to administer medication to the patient, syringe, or similar device.

CROSS REFERENCE TO RELATED APPLICATIONS

TECHNICAL FIELD

This disclosure relates to a medication delivery device and an elongate member and fluid cartridge system and methods of use thereof, such as the delivery of fluids in medical settings.

BACKGROUND

The conventional method of preparing parenteral, or non-oral, medications de novo for patients is tedious, time-consuming, and error-prone. This method requires, among other things, drawing medication from a vial into a syringe. Once in a syringe, medication is administered by hand or pump. When given by hand, these medications require 35 seconds and 41 steps to prepare and administer (1). Human error can be attributed to over 80% of medication errors by using conventional method (2). Additional time and steps are required for medication to be given by infusion or syringe pumps, and these can introduce errors not found from giving medication by hand (3).

Medication Delivery Device

The medication delivery device is designed to assist in the preparation and administration of parenteral medications. The medication delivery device administers parental medication packaged in vials into the body including intravenous, epidural, intrathecal, among others, syringe, or similar device.

Automatic Loading of Vials

The medication delivery device uses vials as pre-filled fluid cartridges that are placed into fluid cartridge holders, which have an L shaped hingeable door that is normally open when they are empty and closes when cartridge is placed into them. The fluid cartridge holders and L shaped hingeable door are made of metal or magnets which are held firmly in place by turning on an electromagnet underneath fluid cartridge holder. The electromagnet or motor turns the fluid cartridge holders or pre-filled fluid cartridges to present the fluid cartridges to the camera. The electromagnet with or without a solenoid attached to fluid cartridge holders reverses polarity to push fluid cartridge holders or pre-filled fluid cartridges onto the spikes of the tubing.

Medication Delivery Device Programming

The medication delivery device is programmed by physicians and other health care personnel by entering a medication order into the CPOE of the EHR. Modification of the prescription may be suggested by clinical decision support system (CDSS).

Because the CPOE is a centralized repository of patient data, the medication delivery device reliably and faithfully receives data that can be used to administer medication. At present, nurses interpret the medication order and administer medication by hand or manually reenter the order into the syringe or infusion pump.

The medication delivery device retrieves three groups of information from the CPOE: demographic, laboratory, and prescription information.

Demographic information includes, among other things, patient name, birthdate, and measured body weight. Laboratory information includes pregnancy, creatinine, and international normalized ratio (INR). Prescription information is taken from the CPOE of the EHR and includes medication name, dosage, and frequency. Any number of safeguards can then be implemented by the CDSS to modify the prescription based on laboratory information to adjust the medication dose due to allergies, drug-drug interactions (DDI), kidney and liver function, among others. Additional doses of medication can be automatically scheduled. This information is processed by the medication delivery device to calculate the precise dose to give to patients or dispense into a syringe or similar device to give to a patient.

For example, a physician uses the EHR to enter the dose of morphine into the CPOE. The dose is reduced by the CDSS for renal failure. The volume of medication is 2.5 milliliters and time is 10 seconds and is sent to the medication delivery device to be administered to the patient or dispensed into a syringe or similar device to give to a patient.

The medication delivery device retrieves the medication order from the CPOE of the EHR by software or other means, which is typically written as an order sentence. For morphine, for example, it is written as: morphine 2.5-5 mg q3-4hr PRN infused intravenously over 4-5 minutes.

Software of the medication delivery device separates the order sentence into its four main component parts of name, dose, frequency, and time in the table below:

Additional separation by software converts the name into the National Drug Code (NDC) and frequency into a number and separates the components of the dose and time into its number and units.

In this fashion, the medication delivery device can understand the volume of medication to dispense over time.

Data variables related to the delivery of medication may be included including maximum number of doses. Other data may be dependent on the patient such as blood pressure which may be used to titrate vasopressors, bispectral index (BIS) for sedatives, creatinine for opioids, and INR for anticoagulants.

Bar Code Medication Administration (BCMA)

Once it is programmed by the CPOE of the EHR, the medication delivery device awaits the preparation of medication. The process of preparing medication with the medication delivery device involves health care personnel placing a vial onto the spike of an administration set of the medication delivery device. A camera is positioned in front of the barcode of an incoming vial. The process of preparing medication has been described in 11 steps (steps 12-22) (1), and 28 steps (steps 1-11, 23-30, 32, 34-41) required by convention method are rendered unnecessary (1).

Once the vial is placed into the medication delivery device, a camera of the medication delivery device, an implementation of BCMA, reads the NDC from the barcode, which is machine-readable data. The NDC, a unique 10-digit, 3-segment number, provides information on final marketed drugs submitted to FDA and serves as a universal product identifier for medication. Once scanned, the medication delivery device identifies contents in the cartridge by accessing a remote server over a network by querying a database from the FDA (https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) that provides information about the product including the medication name, concentration, and volume to verify that the proper medication is entered into the medication delivery device. Additional information can be obtained including package description, product type name, proprietary name, Drug Enforcement Administration (DEA) schedule, package size, among others.

The information processor can perform various rules in the remote server to identify cartridges that, for example, have been recalled, expired, or previously used. It may also perform security checks such as verifying that the barcode was originally generated from a verified system for generating barcode. The remote server can also generate a digital signature as a further step to ensure the validity of the barcode.

The resulting information is digitized and as such, processes including the preparation and administration of medication, documentation, inventory, and billing, which are usually performed manually, can be performed automatically.

A database client can accept pricing data from Medicaid (https://data.medicaid.gov/) (4) or others. Pricing data can also be enterer manually to give visibility to medication data or calculate inventory terminology including the ones below:

Table 1: Inventory terminology
1. Prescription inventory
2. New prescriptions
3. Renewed prescriptions
4. Average prescription charge
5. Government programs (Medicaid and Medicare Part D)
6. Other third-party programs
7. Percentage of prescriptions dispensed generic
8. Cost of goods sold
9. Prescription sales
10. Inventory turn days
11. Inventory turnover (annual)
12. Inventory turnover days
13. Prescription inventory turnover (annual)
14. Prescription inventory turnover days
15. Prescriptions costs
16. Sales per employee
17. Prescription sales per square foot
18. Sales to assets
19. Return on investment
20. Debt to worth
21. Current ratio
22. Quick ratio
23. Accounts receivable turnover (annual)
24. Accounts receivable collection (days)
25. Accounts payable turnover (annual)
26. Accounts payable turnover (days)
27. Cost of dispensing formula (5)

Medication is Dispensed from Vials by Open Loop Control

The medication delivery device uses vials as cartridges to dispense medication. Various techniques can be contemplated to dispense medication from a vial including an air-over-fluid technique at a constant flow with the medication delivery device.

Vials are closed cartridges with medication that comprises fluid over a column of air. In an air-over-fluid technique, air is forced into the vial with positive pressure in one port and medication inside is displaced through another port. As medication is dispensed, the volume of air increases as the volume of medication decreases. In other words, the non-compressible fluid in the vial is replaced with compressible air. Because the cartridge is rigid and made of glass or plastic, the cartridge cannot collapse on itself and evacuate air as in the case with a flexible bag. In order to administer a constant flow of fluid over time, the pressure delivered by the pump inside the vial must increase over time.

The medication delivery device uses a constant positive pressure pump at a constant voltage and a pressure controller consisting of a pressure sensor and variable orifice valve. The pressure sensor has a continuous air path with the air within the vial to measure and maintain ambient atmospheric pressure when the device is not administering medication. An air-over-fluid technique using positive pressure is used to administer medication from vials.

When the medication delivery device receives an order to administer medication, the medication delivery device interprets data from the EHR, CPOE, and CDSS to determine flow, which is volume over time. The pump turns on and the pressure controller determines the voltage to apply to the variable orifice valve to allow medication to be administered from the vial constantly. The pressure inside the vial increases to dispense a constant flow of fluid. The orifice of the valve where air is expelled will increase with time to maintain constant pressure inside the vial and constant flow out of the vial.

Changes to temperature and altitude can affect the pressure within a closed cartridge in predictable ways and are governed by Henry's law, where the dissolved air in a fluid is proportional to its partial pressure above the fluid. When a vial is punctured by the administration set has an increase in temperature from being left out in the sun or increases in altitude from a patient being medically evacuated by helicopter in austere clinical environments, the pressure in the cartridge increases. This increase in pressure inside the cartridge may lead to an over infusion of medication from pumps, and air bubbles that may be present in administration set can expand according to Boyle's law. Likewise, a decrease in temperature and altitude, from the medication delivery device descending in an aircraft or submarine, can decrease the pressure in the vial and can cause an under infusion from pumps (6).

These challenges imposed on this medication administration system with the pressure pump and controller are handled in the same fashion as administering medication at room temperature and sea level. Variations in medication administration during changes in temperature and altitude are compensated by the pressure sensor and variable orifice valve.

The medication delivery device is currently designed to minimize variations in medication delivery from changes in temperature and altitude. First, bubbles that form within the vial should float to the top of the vial, which has a column of air. Second, the device has a valve that can vent the vial when medication is not being administered. Third, it has a pressure controller that continuously measures the pressure within the vial and can adjust its orifice and therefore the pressure infused into the vial and medication dispensed from the vial.

Dispensing of Medication is Verified by Closed Loop Controls

The medication delivery device uses closed loop controls to verify dispensing of medication with camera by artificial intelligence. The technique is to non-invasively identify the starting and change in the fluid level line and volume in a closed cartridge in real-time. Most parenteral medications are clear with the viscosity and appearance of water, and they are often packaged in equally clear vials.

The medication delivery device uses two main methods to verify the volume of fluid administered: fully convolutional neural network (FCN) and machine vision.

The same camera to read the barcode can be used to with closed loop control. The FCN uses an image from the camera to produce a pixelized annotation for semantic segmentation or delineation of fluid from glass (7).

First, based on information from the NDC from the barcode, the medication delivery device can identify the size of the vial. Predictions of the vial outline and fluid level line can be made, and the view of the camera focuses to the expected fluid level line. As the fluid dispenses from the vial, the fluid level line should move and bubbles form from the bottom and move up until the fluid level line in the vial.

Attention can be set to the vial outline and estimated fluid level line for semantic segmentation by FCN. Second, FCN can independently determine the vial outline and set the region of interest (ROI) for semantic segmentation of the fluid level line within the vial. One technique to use with the FCN is to apply a valve filter to focus attention to the known position of the vial in the image. A ROI mask is placed into the FCN in front of a binary map representation of the image. Pixels of the ROI is set to one, and the background set to zero (8).

In addition, machine vision can be used in conjunction with FCN to provide independent information. Any variation of the fluid level line by more than 5% is rejected. Various techniques are used including line object and frame difference. For line object, camera additionally detects angle of the line from the 0 degrees.

With frame difference, the camera looks for changes in the fluid level line once the starting line is determined and calculates the volume of fluid that was dispensed and remaining in the vial.

If there is agreement between each method of line detection, the fluid inside the cartridge is highlighted and a pixelized annotation of the fluid is made. The image is further annotated to identify every 0.1 ml of the fluid. As fluid is dispensed from the vial, a comparison is made between the volume delivered according to the CPOE of the EHR and annotated fluid missing from the vial.

Because the device uses an air-over-fluid technique that forces air into the cartridge to displace fluid, the camera expects to detect bubbles forming within the vial to ensure that the device is dispensing. If the device commands the medication delivery device to dispense and there are no bubbles seen within the vial, the pump is not operating properly and will not administer medication.

The ROI map is a binary image with pixels marking the ROI as 1 and the rest of the image as 0. It is entered into the FCN and superimposed on the image. The image, ROI, and machine vision are separately and independently evaluated by a convolution layer. Image filters convolved with bias addition of the image from the FCN and machine vision generates a feature map, and valve filters of the ROI from the FCN is convoluted similarly generate a relevance map. A normalized feature map is made from the feature and relevance maps. Elements from the maps undergo element wise multiplication are passed through a Rectified Linear Unit (ReLU) to eliminate negative map elements to produce a normalized map that is passed though the next layer of the FCN.

Prevention of Air Embolism

Once the medication is dispensed from the vial into the administration set, air should not enter the administration set to reduce the risk of air embolism to the patient. Air can be kept separate from the fluid in a variety of ways. First, one camera is positioned in front of each vial such that bubbles must be seen in the vial for the device to be administering medication. Second, the air orifice is placed above the medication orifice in the administration set such that medication can continue to drain from the vial beyond the point that the camera can see bubbles forming in the vial, and when bubbles are not seen in the vial, the device turns the pump off. Third, the medical device incorporates a mechanical stabilizer that does not use power to decrease low- and high-frequency vibrations to keep the vials upright so that air is not entailed into the fluid path of the administration set. Fourth, the microprocessor incorporates an accelerometer to measure changes in velocity and gyroscope to calculate the degree of the X-, Y-, and Z- axes to report the level of the medication delivery device.

SUMMARY

The disclosure provides for a medication delivery device. The disclosure further provides that the medication delivery device can deliver metered doses of medication in an accurate and precise manner.

The disclosure provides for a medication delivery device delivering metered doses of fluids in an accurate and precise manner comprising: (a) an elongate member having a first and second end; (b) a plurality of fluid cartridge adapters spaced along the length of the elongate member, wherein each adapter is adapted to receive fluid from a removable fluid cartridge; (c) a fluid channel that is centrally disposed within the elongate member and fluidly linked to the fluid cartridge adapters, wherein the fluid channel's first end is enclosed in the elongate member while the second end is fluidly linked to an exit portal; (d) an external computer that programs the medication delivery device at the time of order entry; (e) one or more pressure modifying devices that are pressureably linked to the fluid channel so that a change in pressure from the pressure modifying device causes fluid to move into the fluid channel; (f) one or more valves to prevent fluid from moving back into cartridge and to ensure fluid only moves to exit portal; (g) one or more scanners to detect one or more machine-readable indicators on a removable fluid cartridge once the removable fluid cartridge is inserted into the medication delivery device, and then the scanners can output information provided by the machine-readable indicator to a computer; and (h) one or more scanners to detect the volume of the fluid in the cartridge.

In an embodiment, the disclosure provides for a medication delivery device disclosed herein comprising a computer that has an attached or wireless device to communicate with another computer to receive demographic, laboratory, prescription, or entire electronic health record data from patients. In another embodiment, the medication delivery device receives data to semi autonomously or autonomously program the administration of fluid from the medication delivery device. In yet another embodiment, the medication delivery device modifies the program based on interpretation of the data.

In a particular embodiment, the disclosure provides for a medication delivery device disclosed herein comprising a plurality of pre-filled removable fluid cartridges, wherein each removable fluid cartridge comprises a fluid ejection port, an injection port, a machine-readable indicator, and a window to view the inside volume of the cartridge.

In an embodiment, the disclosure provides that one or more barcode reader comprising a camera, sensor, scanner, or scanner that reads the barcode from the cartridge. In another embodiment an operatively connected information processor can be used to read the barcode to accurately and quickly identify characteristics of the medication.

In one particular embodiment of this patent, an information processor receives a machine-readable indicator or plurality of machine-readable indicators on cartridges and consists of an information processor operatively connected to a computer to interpret the machine-readable indicator information and output information provided by such indicator to an operatively connected locally to a computer and a remote server.

In another particular embodiment of this patent, the output information generated by the medication delivery device for generating and using barcode can be used to generate reports on inventory and supply chain management, reordering, usage, billing, among other reasons.

In a particular embodiment of this patent, the scanner records the time, date, and location onto a remote server to track current inventory on hand of medications throughout a health care facility and is visible though creating reports. This system is designed to support supply chain management and just-in-time (JIT) inventory strategy.

In another embodiment of this patent, the scanner can be used to generate reports to assign charges to patients or expense to related parties.

In another embodiment of this patent, the scanner receives the credentials of the user who may be a pharmacist, a pharmacist technician, or other qualified personnel to handle cartridges.

In an embodiment, the disclosure provides for a medication delivery device disclosed herein comprising a plurality of fluid cartridge holders physically attached to a turning motor to facilitate the presentation of the cartridge to a machine-readable indicator or sensor.

In a particular embodiment, the disclosure provides for the medication delivery device disclosed herein comprising an attached portion of the structural housing can slide freely vertically up and down or horizontally side to side to further prevent movement of elongate member. In one embodiment, one or more pegs fitting into one or more corresponding holes in the elongate member to restrict the elongate member's movement. In another embodiment, the pegs are pressureably in contact and connected with pressure modifying device and pressure controller and centrally disposed in elongate member. In a further embodiment, the structural housing is further comprised of tubing, wherein the tubing cannot be reversibly attached to the pegs. In yet a further embodiment one or more injection ports of an elongate member's reversibly attached to the removable fluid cartridges.

In a further embodiment, the pump is controllable by a computer or software such as a CPOE, EHR, or database semi autonomously or autonomously. In yet a further embodiment, the pump's operation can be controlled by commands entered by a user on user interface connected to a computer. In a certain embodiment, a user interface may be connected to a computer that can be used to control the pump either directly, wirelessly, or remotely. In a further embodiment, the pump may be controlled by a computer that is accessed through the Internet, network, or phone line from commands entered on a user interface that is connected to an alternate computer.

In a particular embodiment, the disclosure provides for a medication delivery device disclosed herein comprising a computer. In another embodiment, the computer can receive and display the output from the scanner. In a further embodiment, the one or more information storage devices provide information, including, but not limited to, EHR and CPOE, and contraindications for therapeutic agents. In yet a further embodiment, the user interface can relay information to the user from the computer or from connected information storage devices, including allergies, warnings, contraindications, DDI, organ failure, patient laboratory data, patient vital signs, patient measured data, dosing recommendations, and patient specific concerns. In another embodiment, a computer comprising a user interface can integrate one or more global positioning system location sensors in the medication delivery device, elongate member, or cartridges for inventory management.

In a particular embodiment, the disclosure provides for a fluid flow meter disclosed herein comprising a camera, sensor, or scanner to verify the starting, operating, and ending volume of the cartridge. In another embodiment, the fluid flow meter uses FCN, machine vision, computer vision, or algorithms to determine the volume in the cartridge. In yet another embodiment, one camera determines the fluid level line of a plurality of cartridges with a wide-angle lens to bring the image in closer view. In another embodiment, one camera determines the fluid level line of a plurality of cartridges with one or a plurality of mirrors. In yet another embodiment, one camera determines the fluid level line of a plurality of cartridges with one or a plurality of fiber optic pipes. In another embodiment, other techniques can be used to determine the fluid level line including ultrasonic means or mechanical flow meter.

A method for controlling use of the device, comprising: (1) prompting a user to enter information about personnel; (2) retrieving patient information; (3) detecting a machined readable indicator on the surface of the removable fluid cartridge by a scanner when the cartridge is inserted into the device; (4) outputting information from the scanner to an attached computer about the information provided by the machine-readable indicator; (5) using an algorithm that is programmed into the computer to calculate a proper dose for administering to the patient based on the information outputted to the computer by scanner; (6) reading the fluid level line and measuring the fluid volume inside the cartridge; and (7) activating a pressure modifying device and pressure controller to apply pressure to the removable fluid cartridge so as to force fluid from the removable fluid cartridge until the calculated dosage is achieved.

More specifically, the disclosure provides for a medication delivery device that can accept a plurality of pre-filled removable fluid cartridges, wherein the device can then dispense fluid from one or more of these cartridges in a controlled manner by using a pressure modifying device, such as a pump. Moreover, a medication delivery device disclosed herein can detect when a fluid cartridge is inserted in the device, and identify the contents.

An overview of an exemplary drug delivery device of the disclosure is presented inFIG. 1. An elongate member105is comprised of a centrally disposed fluid channel (not shown) and one or more fluid cartridge adapters (not shown), such that fluid channel is fluidly connected to the fluid cartridge adapters through the fluid channel. The elongate member105is also comprised of a centrally disposed pressure channel (not shown) and one or more fluid cartridge adapters, such that pressure channel is pressureably connected to the fluid cartridge adapters through the cartridge adapter. The fluid cartridge adapters are adapted to receive fluid from removable fluid cartridges110, such that fluid can be forced or drawn from the removable fluid cartridges110by using one or more pressure modifying devices (not shown) and pressure controllers (not shown). The fluid can then travel down the fluid channel an out an exit portal115. In a certain embodiment, the medication delivery device may further comprise a structural housing120that is dimensioned so as to contact an elongate member105in order to restrict the movement of the elongate member and to provide overall stability to the device. In particular, structural housing120can slide freely vertically up and down or horizontally side to side to further prevent movement of elongate member105. In the preferred embodiment, one or more pegs (not shown) fitting into one or more corresponding holes (not shown) in the elongate member105to restrict the elongate member's 5 movement. In another embodiment, the pegs are pressureably in contact and connected with pressure modifying device and pressure controller and centrally disposed in elongate member105. In a further embodiment, the structural housing120is further comprised of tubing, wherein the tubing cannot be reversibly attached to the pegs. In yet a further embodiment one or more injection ports of an elongate member's 5 reversibly attached to the removable fluid cartridges110. In another embodiment, an elongate member105comprising a fluid channel, has a plurality of raised hollow projections, such as spikes, nozzles, or tips, that are so dimensioned so that the elongate member105hollow projections can slidably insert into the cartridge110, such that cartridge110is fluidly connected to fluid channel.

In a particular embodiment, the disclosure provides for removable fluid cartridge110further comprising a pierceable port (not shown). In a certain embodiment, the pierceable port is located on one of the accessible faces of the removable fluid cartridge110. Generally, the pierceable port should be located so as to facilitate access to the fluid in the removable fluid cartridge110for the purposes of mixing, withdrawing, and or injecting a gas to the fluids inside. The pierceable port is covered with a material, such as foil, plastic, or a membrane, that can be punctured by a solid object, such as a needle.

The removable fluid cartridge comprises a lighted display125, wherein the lighted display indicates the status of the cartridge110.

The medication delivery device is programmed by physicians or other health care personnel entering a medication order into the CPOE, EHR, or CDSS with a computer130.

A scanner (not shown) is a machine capable of detecting and identifying a machine-readable indicator135or plurality of machine-readable indicators135on a label140. Window145of cartridge110is shown between label140. A scanner can include, but is not limited to, barcode readers, cameras, radio frequency receivers, scanners, or a combination thereof. Barcode readers, cameras, radio frequency receivers, scanners, or a combination thereof of scanner interprets the machine-readable indicator135and transmits this information connected wirelessly, such as by Bluetooth, router, or modem; or remotely over a network, such as through a LAN or through the Internet.

The scanner also uses FCN, machine vision, computer vision, or algorithms to read the fluid level line and volume inside the cartridge110from the window145.

A wide-angle lens150attached to scanner bring the image in closer view. The information processor can perform various rules in the remote server to identify cartridges that, for example, have been recalled, expired, or previously used. It may also perform security checks such as verifying that the barcode was originally generated from a verified system for generating barcode. The remote server can also generate a digital signature as a further step to ensure the validity of the barcode.

A scanner for reading information of interest including barcodes (barcode reader) and human-readable information [optical character recognition (OCR)] and operatively connected to a medication delivery device. A medication delivery device has a suitable wireless connection such as a Bluetooth, Wi-Fi, ZigBee, among others to an information storage device155. A medication delivery device is also operatively connected to a web console network such as by a cable; connected wirelessly, such as by Bluetooth, router, or modem; or remotely over a network, such as through a LAN or through the Internet.

An information storage device155can store and may also retrieve information and includes hard drives, tapes, flash drives, computers, and servers. An information storage device155may be directly connected to a database160like a computer, by a cable or plug; connected wirelessly, such as by Bluetooth, router, or modem; or remotely over a network, such as through a LAN. Data stored in database160can be accessed via Bluetooth, router, or modem; or remotely over a network, such as through a LAN.

Fluid cartridge holder165may be comprised of any material or any combination of materials. In a certain embodiment fluid cartridge holder165is comprised of a magnet that placed above an electromagnet (not shown). The fluid cartridge holder165can be of any shape, as long as a portion of a removable fluid cartridge110can be placed inside the fluid cartridge holder165. In the preferred embodiment, the fluid cartridge holder165is circular. In an alternative embodiment, the structural housing120can be dimensioned to receive a removable fluid cartridge110. In yet another alternative embodiment, the disclosure provides that the medication delivery device does not comprise a fluid cartridge holder165.

The fluid cartridge holders165have an L shaped hingeable door (not shown) is normally open and closes when cartridge is placed into fluid cartridge holders165. Underneath fluid cartridge holders165, an electromagnetic can be turned on to lock L shaped hingeable door and turn the fluid cartridge holders165to facilitate the presentation of the cartridge to a camera to read the machine-readable indicator135and fluid level line and volume. The polarity of the electromagnetic can be reversed to allow similar polarity of the electromagnetic to be presented to the fluid cartridge holders165and pull the fluid cartridge holders165and cartridges110onto the fluid cartridge adapter.

When the electromagnetic is be turned off, the cartridge110can be removed by pulling up on it and the L shaped hingeable door opens. In another embodiment, the fluid cartridge holders165can also turn the attached to a turning motor to facilitate the presentation of the cartridge to a machine-readable indicator135. In another embodiment, a solenoid is engaged to the neck of the cartridge110to secure the cartridge110to prevent tampering and theft and another solenoid can pull the fluid cartridge holders165and cartridges110onto the fluid cartridge adapter.

In a certain embodiment, a fluid cartridge holder165is dimensioned so that it can be attached to the medication delivery device. In another embodiment, the fluid cartridge holder165is near to fluid cartridge adapter305. In another embodiment, a fluid cartridge holder165is dimensioned so that it can be attached to structural housing120. In yet another embodiment, a fluid cartridge holder165is dimensioned so that it can be attached to elongate member105. The attachable fluid cartridge holder165can be attached or near to a fluid cartridge adapter305, structural housing120, and/or elongate member105, by any manner known in the art. In a certain embodiment, the disclosure provides that the fluid cartridge holder165can be irreversibly attached to a fluid cartridge adapter305, structural housing120, and/or elongate member105. Examples of irreversible attachment include, but are not limited to, welding, molding, cementing, gluing, and riveting. In an alternative embodiment, the disclosure provides that a fluid cartridge holder165can be reversibly attached to a fluid cartridge adapter305, structural housing120, and/or elongate member105. Examples of reversible attachment include, but are not limited to, locking pins; threaded connections, such as being able to screw a holder165onto an adapter; screws; lock and key type connections; retaining rings; and clasps. An exemplary process of attaching a fluid cartridge holder165to structural housing120by using a solenoid is presented. A fluid cartridge holder165is placed on a solenoid that can move freely vertically up and down or horizontally side to side in a piston-like motion.

A touchscreen170is user console to input or display information. The touchscreen170displays vital information required for user-control of the system including patient names, ID numbers, patient medical history, patient vital statistics, patient weight, drug indications, medication names and other relevant information which can be retrieved by the medication delivery device. The touchscreen170also displays visual indication of battery life and status of wireless communication. A reader180is used to scan the credentials of the user who may be a pharmacist, a pharmacist technician, nurse, physician, or other qualified personnel to handle cartridges. The speaker180enunciates information provided on the machine-readable indicator of one or more removable fluid cartridges after the removable fluid cartridges are inserted into a medication delivery device disclosed herein. The turns the device on and off.

FIG. 2is a top-down angled top exploded view of a medication delivery device. A scanner205is a machine capable of detecting and identifying a machine-readable indicator135or plurality of machine-readable indicators135on a label140. A scanner205can include, but is not limited to, barcode readers, cameras, radio frequency receivers, scanners, or a combination thereof. Barcode readers, cameras, radio frequency receivers, scanners, or a combination thereof of scanner interprets the machine-readable indicator135and transmits this information connected wirelessly, such as by Bluetooth, router, or modem; or remotely over a network, such as through a LAN or through the Internet.

The scanner205also uses FCN, machine vision, computer vision, or algorithms to read the fluid level line and volume inside the cartridge110.

A wide-angle lens150attached to scanner bring the image in closer view. The information processor can perform various rules in the remote server to identify cartridges that, for example, have been recalled, expired, or previously used. It may also perform security checks such as verifying that the barcode was originally generated from a verified system for generating barcode. The remote server can also generate a digital signature as a further step to ensure the validity of the barcode.

One or more pressure modifying devices210, such as diaphragm pumps, that can exert positive pressure on the fluid contained in the cartridges110; one or more pressure controllers215, including a pressure sensor and a variable orifice valve in each, that can control positive pressure on the fluid contained in the cartridges110; one or more scanners205, such as a camera, located behind each fluid cartridge adapter and positioned to read the machine-readable indicator135, such as a bar code, present on the side or bottom face of the cartridge110once a cartridge110is inserted into a fluid cartridge adapter, wherein the scanner can then output information provided on the machine-readable indicator135to an information storage device155; one or more scanners205, such as a camera, located behind each fluid cartridge adapter and positioned to read the cartridge fluid level line and volume real-time once a cartridge110is inserted into a fluid cartridge adapter, wherein the scanner205can then output information provided on the machine-readable indicator135to an information storage device155; an information storage device155that can receive the output from the scanner205, such as a camera, and then present information related to the scanner's205output on a touchscreen170, wherein the information storage device155may also be connected directly, wirelessly, or remotely to one or more pressure modifying devices, and/or one way valves to control the flow of pressure each removable fluid cartridge110receives, control the amount of fluid that is released in the fluid channel, control the amount of fluid that is released into the exit portal, and/or be connected to and can present information from one or more information storage devices150; and/or an information storage device155that can receive input from user defined commands from an external information storage device155or software and then present information related to the scanner's205output on a display, wherein the information storage device155may also be connected directly, wirelessly, or remotely to one or more pressure modifying devices210and one or more pressure controllers215to control the flow of pressure each removable fluid cartridge110receives, control the amount of fluid that is released in the fluid channel, control the amount of fluid that is released into the exit portal, and/or connect to and can present information from one or more information storage devices150; one or more scanners located behind each fluid cartridge adapter and positioned to read the cartridge fluid level line and volume once a removable fluid cartridge110is inserted into a fluid cartridge adapter, wherein the scanner205can then output information provided from the fluid cartridge110to an information storage device155.

Electromagnet220is shown underneath fluid cartridge holders165and turns the fluid cartridge holders165, locks the L shaped hingeable door, and pulls the fluid cartridge holders165and cartridges110onto the fluid cartridge adapter305.

Clamp225is attached to the back of the medication delivery device to attach to a pole to stabilize the device.

FIG. 3is a back cut away view of a tubed-shaped elongate member with a plurality of cartridges physically attached to a plurality of raised fluid cartridge adapter to show a fluid and pressure channel within the elongate member, two one-way valves per channel, and hole pressureably connected to the fluid cartridge adapters through pressure channel.

Elongate member105has a plurality of cartridges110physically attached to a plurality of raised fluid cartridge adapter305to allow fluid to access a fluid channel310within the elongate member105and pressure channel315to access the inside of the cartridges and two one-way valves405per channel. Elongate member105has a first end and a second end. Elongate member105may be comprised of any material or any combination of materials. In a certain embodiment the elongate member105is comprised of plastic and silicone. In a further embodiment the elongate member105is comprised of rubber. In yet another embodiment, the elongate member105is comprised of material that is inert to fluids. In yet a further embodiment, the elongate member105is comprised of metal. Generally, elongate member105should be of a sufficient length so that it can potentially accommodate one or more removable fluid cartridges110. In a particular embodiment, elongate member105is from 2 to 36 inches in length. In another embodiment, elongate member105is from 2 to 24 inches in length. In yet another embodiment, elongate member105is from 6 to 24 inches in length. In a further embodiment, elongate member105is from 10 to 24 inches in length. Elongate member105comprises at least one wall defining an enclosed space or tube. Moreover, the width of elongate member105can vary. The first and second end of elongate member105may have relatively the same dimensions or alternatively the ends may have different dimensions. While the figures in this application present an elongate member105, as being substantially tube-shaped, the disclosure provides for elongate member105having substantially a non-tubed shape, a T shape, or a non-T shape. Any shape for elongate member105is acceptable, so long as the elongate member105can further comprise a fluid channel and one or more fluid cartridge adapters305and a pressure channel. In a certain embodiment, elongate member105has a substantially flat lower wall so as to provide stability when elongate member105is placed on a flat surface. However, elongate member105may be in contact with a structural housing120, such that structural housing120can provide needed structural stability. In such a case, elongate member105can have a bottom face that is substantially not flat or have portions that are substantially flat and not flat.

Elongate member105comprises a fluid channel310, pressure channel315, and a plurality of fluid cartridge adapter305. Elongate member105has a first end and a second end. Elongate member105may be comprised of any material or any combination of materials. In a certain embodiment the elongate member105is comprised of plastic and silicone. In a further embodiment the elongate member105is comprised of rubber. In yet another embodiment, the elongate member105is comprised of material that is inert to fluids. In yet a further embodiment, the elongate member105is comprised of metal. Generally, elongate member105should be of a sufficient length so that it can potentially accommodate one or more removable fluid cartridges. In a particular embodiment, elongate member105is from 2 to 36 inches in length. In another embodiment, elongate member105is from 2 to 24 inches in length. In yet another embodiment, elongate member105is from 6 to 24 inches in length. In a further embodiment, elongate member105is from 10 to 24 inches in length. Elongate member105comprises at least one wall defining an enclosed space or tube. Moreover, the width of elongate member105can vary. The first and second end of elongate member105may have relatively the same dimensions or alternatively the ends may have different dimensions. While the Figures in this application present an elongate member105, as being substantially tube-shaped, the disclosure provides for elongate member105having substantially a non-tubed shape, a T shape, or a non-T shape. Any shape for elongate member105is acceptable, so long as the elongate member can further comprise a fluid channel and one or more fluid cartridge adapters305and a pressure channel. In a certain embodiment, elongate member105has a substantially flat lower wall so as to provide stability when elongate member105is placed on a flat surface. However, elongate member105may be in contact with a structural housing120, such that structural housing120can provide needed structural stability. In such a case, elongate member105can have a bottom face that is substantially not flat or have portions that are substantially flat and not flat.

Fluid channel310can be any shape. Fluid channel310can be centrally disposed in elongate member105or alternatively be disposed off-center in elongate member105. The diameter or cross section of fluid channel310can be generally sized to fit the needs of a particular application. For example, for medication applications the fluid channel310may need to be of a sufficient size to allow a large volume of one or more fluids to pass down the channel and out the exit portal. Alternatively, for medical applications the fluid channel310may require a smaller diameter to account for a low volume of fluid passing into the fluid channel310. Fluid channel310has at least one opening present in one end of elongate member105that is connected to an exit portal. Fluid channel310, however, in a certain embodiment, can allow for openings being present in both ends of elongate member105. This second opening could facilitate attaching one or more pressure modifying devices210, such as pumps, compressors, or gas cylinders, and pressure controller215in order to push fluids remaining in fluid channel310out into the exit portal115. This second opening could be also used to attach a reservoir of wash solution so that fluid channel310can be cleaned of any residual fluid originating from one or more removable fluid cartridges110.

In a particular embodiment a fluid cartridge holder165is attached to structural housing120and not attached to a fluid cartridge adapter305. In a further embodiment, a fluid cartridge holder165is attached to structural housing120and attached to a fluid cartridge adapter305. Generally, the fluid cartridge adapter305is adapted to receive a removable fluid cartridge110even when a fluid cartridge holder165is attached to a fluid cartridge adapter305. In a certain embodiment, a fluid cartridge adapter305comprises a male type receptor that can fit into a matching female type receptor on a removable fluid cartridge110. In an alternate embodiment, a removable fluid cartridge110comprises a female type receptor 35 that can fit into a matching male type nozzle on a fluid cartridge adapter305.

In a particular embodiment, removable fluid cartridge110may further comprise machine-readable indicator135, so that once removable fluid cartridge110is slidably inserted into a fluid cartridge holder165, machine-readable indicator135can be read by scanner (not shown). Scanner can also read fluid level and volume through the window145. In a further embodiment, machine-readable indicator135is orientated to be contiguous with window145by slidably inserting removable cartridge110into cartridge holder165so that notch projection 22 is guided into the matching notch depression.

In a certain embodiment, fluid cartridge110may further comprise window145between label140can be visually seen by a user and/or can be identified by a scanner, when a removable cartridge110is inserted into fluid cartridge holder165.

A fluid cartridge adapter305is fluidly connected to fluid channel through a cartridge adapter. Cartridge adapter can be of any length and of any diameter, so long as fluid can flow from a removable fluid cartridge110and through cartridge adapter. In a certain embodiment, cartridge adapter may further comprise a one-way valve, so that fluid can only flow from a removable fluid cartridge into fluid channel. In another embodiment, cartridge adapter may further comprise a one-way valve so that once the valve is closed no fluid can flow from the removable fluid cartridge into a fluid channel. Such locking and one-way valves can be either manually, magnetically, and/or electronically opened or closed. Moreover, the disclosure provides embodiments, for the opening or closing of such valves by entering user defined commands on a user interface that is connected to a computer, which is connected to a medication delivery device disclosed herein.

A fluid cartridge adapter305can have any shape as long as the fluid cartridge adapter can receive fluid from a removable fluid cartridge110. In a certain embodiment, a fluid cartridge adapter305is a hole in the elongate member105that is fluidly connected to fluid channel. A fluid cartridge adapter305may be comprised of any material or any combination of materials. In yet another embodiment, the cartridge adapter305is comprised of material that is inert to fluids. In a certain embodiment, a fluid cartridge adapter305is comprised of plastic. In a further embodiment, a fluid cartridge holder165is comprised of rubber. In yet a further embodiment, fluid cartridge holder165is comprised of metal. A fluid cartridge adapter305can be attached to an elongate member105by any means. In alternative embodiment, a fluid cartridge adapter305can be reversibly attached to an elongate member105. For example, a threaded fluid cartridge adapter305can be screwed into a matching threaded elongate member105. In a preferred embodiment, fluid cartridge adapter305can be fitted onto a raised hollow portion, such as a nozzle or tip, on elongate member105. In another embodiment, a fluid cartridge adapter305is irreversibly attached to an elongate member105. Examples of irreversible attachment include, but are not limited to, welding, molding, cementing, gluing, and riveting.

In the preferred embodiment, the diameter or cross section of the pressure channel can be generally sized to fit the needs of a particular application. For example, for medication applications the pressure channel may need to be of a sufficient size to allow a large volume of one or more gas to pass from each of the fluid cartridge adapter to the fluid cartridge by one or more pressure modifying devices, such as pumps, compressors, or gas cylinders and one or more pressure controllers in order to push fluids from the fluid cartridges 15 out into the exit portal.

In another embodiment, fluid channel can be comprised of one or more tubes that are fluidly connected to one or more removable fluid cartridges110. In a particular embodiment, each fluid cartridge adapter305comprises individual tubing that runs down the length of fluid channel and out to the exit portal. Examples of such tubing, including surgical tubing, or pharmaceutical grade tubing. Moreover, the tubing should have a relatively small diameter so that a plurality of tubing can fit within fluid channel. The plurality of tubing may then be combined into a single tube in the exit portal, if so needed, or alternatively remain separate.

An elongate member105is comprised of a centrally disposed fluid channel (not shown) and one or more fluid cartridge adapters (not shown), such that fluid channel is fluidly connected to the fluid cartridge adapters through the fluid channel. The elongate member105is also comprised of a centrally disposed pressure channel (not shown) and one or more fluid cartridge adapters, such that pressure channel is pressureably connected to the fluid cartridge adapters. The fluid cartridge adapters are adapted to receive fluid from removable fluid cartridges110, such that fluid can be forced or drawn from the removable fluid cartridges110by using one or more pressure modifying devices (not shown) and pressure controllers (not shown). The fluid can then travel down the fluid channel an out an exit portal115. In a certain embodiment, the medication delivery device may further comprise a structural housing120that is dimensioned so as to contact an elongate member105in order to restrict the movement of the elongate member and to provide overall stability to the device. In particular, structural housing120can slide freely vertically up and down or horizontally side to side to further prevent movement of elongate member105. In the preferred embodiment, one or more pegs fitting into one or more corresponding holes in the elongate member105to restrict the elongate member's 5 movement. In another embodiment, the pegs are pressureably in contact and connected with pressure modifying device and pressure controller and centrally disposed in elongate member105.

The elongate member105comprises a plurality, such as six, fluid cartridge adapters305, wherein each fluid cartridge adapter305further comprises two one-way valves405which prevents fluid from flowing into a removable fluid cartridge110from the fluid channel310and flowing away from the patient, syringe, or similar device in the fluid channel310; a fluid channel310that is enclosed within the elongate member105and in fluidly contact with each fluid cartridge adapter305, and where one end of the fluid channel is enclosed in the elongate member105and the other end is connected to an exit portal115; a pressure channel315that is enclosed within the elongate member105and in pressureably contact with each fluid cartridge adapter305; one or more removable pre-filled cartridges110further comprising a machine-readable indicator135located on the side or bottom face of the cartridge110.

FIG. 4is a multi-view of an elongate member105to show two one-way valves405per channel, hole410, and fluid channel and pressure channel.

In one embodiment, one or more pegs fitting into one or more corresponding holes410in the elongate member105to restrict the elongate member's105movement. In another embodiment, the pegs are pressureably in contact and connected with pressure modifying device210and pressure controller215and centrally disposed in elongate member.

A user selects that the fluid is to be administered using a user entered command on the user interface, wherein the computer then calculates the dose based on the information outputted by the scanner and the information inputted about the patient, wherein the computer adjusts the dose if the user inputted that the patient has organ failure, contraindication, or other concerns by the computer, medication delivery device, CDSS, or other system. Upon confirming the dose by the user, the dispensing system is activated and one or more pressure modifying devices that can exert positive pressure on the fluid contained in a removable fluid cartridge and one or more one or more pressure modifying devices and one or more pressure controllers exerts positive pressure in the removable fluid cartridge so as to force fluid from the removable fluid cartridge out the exit portal and of elongate member, wherein the fluid is expelled out the fluid channel to the exit portal where the fluid is administered to the patient, syringe, or similar device. One or more one or more pressure modifying devices and one or more pressure controllers continues to exert positive pressure on the removable fluid cartridge until the calculated dosage is reached, at which the dispensing system terminates.

In an exemplary medication delivery device of the disclosure, the medication delivery device is comprised of an elongate member comprising a plurality, such as six, fluid cartridge adapters, wherein each fluid cartridge adapter further comprises two one-way valves which prevents fluid from flowing into a removable fluid cartridge from the fluid channel and flowing away from the patient, syringe, or similar device in the fluid channel; a fluid channel that is enclosed within the elongate member and in fluidly contact with each fluid cartridge adapter, and where one end of the fluid channel is enclosed in the elongate member and the other end is connected to an exit portal; a pressure channel that is enclosed within the elongate member and in pressureably contact with each fluid cartridge adapter; one or more removable pre-filled cartridges further comprising a machine-readable indicator located on the side or bottom face of the cartridge; one or more pumps, such as diaphragm pumps, that can exert positive pressure on the fluid contained in the cartridges; one or more pressure controllers, including a pressure sensor and a variable orifice valve in each, that can control positive pressure on the fluid contained in the cartridges; one or more scanners, such as a camera, located behind each fluid cartridge adapter and positioned to read the machine-readable indicator, such as a bar code, present on the side or bottom face of the cartridge once a cartridge is inserted into a fluid cartridge adapter, wherein the scanner can then output information provided on the machine-readable indicator to a computer; one or more scanners, such as a camera, located behind each fluid cartridge adapter and positioned to read the cartridge fluid level line and volume real-time once a cartridge is inserted into a fluid cartridge adapter, wherein the scanner can then output information provided on the machine-readable indicator to a computer; a computer that can receive the output from the scanner, such as a camera, and then present information related to the scanner's output on a display, wherein the computer may also be connected directly, wirelessly, or remotely to one or more pressure modifying devices, and/or one way valves to control the flow of pressure each removable fluid cartridge receives, control the amount of fluid that is released in the fluid channel, control the amount of fluid that is released into the exit portal, and/or be connected to and can present information from one or more information storage devices; and/or a computer that can receive input from user defined commands from an external computer or software and then present information related to the scanner's output on a display, wherein the computer may also be connected directly, wirelessly, or remotely to one or more pressure modifying devices to control the flow of pressure each removable fluid cartridge receives, control the amount of fluid that is released in the fluid channel, control the amount of fluid that is released into the exit portal, and/or connect to and can present information from one or more information storage devices; one or more scanners located behind each fluid cartridge adapter and positioned to read the cartridge fluid level line and volume once a removable fluid cartridge is inserted into a fluid cartridge adapter, wherein the scanner can then output information provided from the fluid cartridge to a computer.

In a further embodiment, a plurality of fluid cartridge adapters consisting of a hole that have a centrally orientated hollow post and side walls in pressureably contact with a pressure channel that is enclosed within the elongate member and in pressureably contact with each fluid cartridge adapter, such that a small bore connector for gases (ISO/DIS 80369-2: Small bore connectors for liquids and gases in healthcare applications—Part 2: Connectors for breathing systems and driving gases applications), luer connector, or similar structure for healthcare applications of the hole of the fluid cartridge adapters of the elongate member can slidably insert into the small bore connector, and wherein once the cartridge is inserted into the hole of the fluid cartridge adapter it will remain in a substantially upright position.

The disclosure provides for a medication delivery device comprising one or more pressure modifying devices, such as diaphragm pumps, that can exert positive pressure on the fluid contained in the cartridges; one or more pressure controllers, including a pressure sensor and a variable orifice valve in each, that can control positive pressure on the fluid contained in the cartridges, that can be controlled by an external computer or software from orders placed by health care personnel or database such as a CPOE and EHR then present information related to the scanner's output on a display. The medication delivery device of the disclosure can therefore automate several tasks that are normally performed manually by health care personnel.

REFERENCES