IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0944438
(2004-09-17)
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등록번호 |
US-7343943
(2008-03-18)
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발명자
/ 주소 |
- Khan,Abdul Wahid
- Nasiri,Abdolhosein
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출원인 / 주소 |
- ForHealth Technologies, Inc.
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대리인 / 주소 |
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인용정보 |
피인용 횟수 :
39 인용 특허 :
20 |
초록
▼
An automated system is provided and includes a safety and cost reducing feature that is capable of detecting whether an underfill condition exists within the product container as a unit dose of medication is delivered thereto. More specifically, the medication is typically injected into the product
An automated system is provided and includes a safety and cost reducing feature that is capable of detecting whether an underfill condition exists within the product container as a unit dose of medication is delivered thereto. More specifically, the medication is typically injected into the product container under action of a delivery device, such as a pump, and the underfill detection device is capable of calculating if air (air bubbles) has been dispensed into the product container and based on this information, the device is able to measure the amount of the unit dose of medication within the product container and if necessary, additional medication can be added if it is determined that an underfill condition exists in order to compensate for the presence of the air bubbles.
대표청구항
▼
What is claimed is: 1. An automated medication preparation system including preparation and dispensing of medication to an individual product container and detection of any underfill condition where an insufficient amount of medication is delivered to the product container, the system comprising: a
What is claimed is: 1. An automated medication preparation system including preparation and dispensing of medication to an individual product container and detection of any underfill condition where an insufficient amount of medication is delivered to the product container, the system comprising: an automated device for preparing and dispensing a prescribed unit dose of medication; a controller operatively connected to the automated device, the controller receiving a first input that represents a volume of the prescribed unit dose of medication that is to be delivered to the product container; and an optical device for detecting the underfill condition when the actual amount of the unit dose of medication that is delivered to the product container is less than the value of the first input and whereupon, if an underfill condition is detected, then the controller instructs the automated device to deliver medication to the product container until the amount of medication in the product container is equal to the inputted volume, wherein the optical device is configured to detect an object within the unit dose of medication that causes the underfill condition. 2. The automated system of claim 1, wherein the automated device comprises an automated syringe preparation that includes reconstitution of the medication and delivery of the unit dose of the reconstituted medication to a syringe from a drug vial, the automated device includes a fluid delivery device for delivering the prescribed unit dose of medication to the syringe in a just-in-time for use manner, wherein the fluid delivery device is adapted to aspirate the reconstituted medication into a main fluid conduit and later discharging reconstituted medication from the drug vial into the syringe. 3. The automated system of claim 2, wherein the fluid delivery device is fluidly connected to the main conduit that is selectively connected at its opposite end to the diluent source and to a means for creating either negative pressure or positive within the main conduit for aspirating fluid into the main conduit or discharging fluid therefrom, respectively and wherein the means comprises (1) a collection member for storing diluent received from either the diluent source or diluent that is drawn into the collection member from a downstream section of the main conduit; and (2) a control unit and a valve mechanism that are operatively connected to the collection member to create negative pressure therein to draw fluid therein or to create positive pressure to force fluid to be discharged therefrom. 4. The automated system of claim 3, wherein the collection member comprises: a first syringe having a barrel with an interior having a first volume; and a second syringe having a barrel with an interior having a second volume; wherein each of the first and second syringes having a slideable plunger contained in the respective barrel and each syringe being in selective fluid communication with each of the diluent source and the main conduit that leads to the fluid delivery device. 5. The automated system of claim 4, wherein the control unit comprises: a first syringe driver associated with the first syringe for selectively moving the plunger a prescribed distance; a second syringe driver associated with the second syringe for selectively moving the plunger a prescribed distance; and the valve mechanism includes a first valve for providing selective fluid communication between the control unit and the diluent source and a second valve for providing selective fluid communication between the control unit and the downstream section of the main conduit. 6. The automated system of claim 5, wherein the first and second syringes are fluidly interconnected by a connector conduit that has a valve associated therewith for permitting selective flow between the syringes. 7. The automated system of claim 5, wherein at least one of the first and second syringes has an input port and an output port with the input port being connected to a first conduit that connects at its opposite end to the diluent source with a valve being associated with the first conduit to provide selective communication between the diluent source and the input port, the output port being connected to a second conduit that connects at its opposite end to the main conduit with a valve being associated with the second conduit to provide selective communication between the output port and the main conduit. 8. The automated system of claim 5, wherein each of the first and second syringe drivers comprises a stepper motor that operates such that an incremental distance of movement of the plunger is equated to a number of steps through which the motor is driven, thereby permitting precise control over the exact distance that the plunger is moved. 9. The automated system of claim 1, further including a particulate sensor proximate a main fluid conduit to detect foreign matter present in the unit dose of medication, the main fluid conduit being part of the automated device and holds the unit dose of medication prior to delivery to the product container. 10. The automated system of claim 9, wherein the particulate sensor is a photoelectric sensor that detects any reflection of an emitted beam which is indicative of foreign matter being present in the unit dose of medication that is contained within the main fluid conduit. 11. The automated system of claim 10, wherein the particulate sensor includes a light-emitting element for producing the light beam and a light-receiving element for receiving any light beam that reflects off of the foreign matter, the particulate sensor generating and sending a signal to the controller if the particulate sensor detects the foreign matter. 12. The automated system of claim 9, wherein the particulate sensor is a diffusive-reflective sensor that is configured to detect particles as small as 50 micron, the light-emitting element and the light-receiving element being contained within a single housing that is positioned facing a main conduit. 13. The automated system of claim 12, wherein the particulate t sensor is configured and has a sensitivity such that it is capable of detecting air bubbles as well as the foreign matter in the form of solid particles. 14. The automated system of claim 1, wherein the optical device comprises a bubble sensor that comprises a photoelectric sensor that lacks sensitivity to detect minute particles but is capable of detecting air bubbles and generates a signal when air bubbles are detected, the signal being sent to the controller. 15. The automated system of claim 14, further comprising a particulate sensor to detect foreign matter present in the unit dose of medication, wherein the particulate sensor comprises a diffusive-reflective sensor that is capable of detecting both air bubbles and solid particles and the bubble sensor in combination with the particulate sensor forms a filter to filer out false positives that can result if the particulate sensor detects air bubbles as opposed to solid particles such that if a master controller in communication with both sensors and receives signals from both the particulate sensor and bubble sensor then the controller filters out the false positive and the aspirated unit dose of medication is delivered to the syringe. 16. The automated system of claim 1, wherein the optical device is configured such that it sends a signal if an air bubble is detected and the controller is in communication with the optical device and receives a second input and a third input, with the second input representing a flow rate of the unit dose of medication as it is delivered under action of the automated device, the third input representing an elapsed time period that the optical device detects air bubbles in the unit dose of medication, whereupon, the controller calculates a volume of the air bubbles in the unit dose of medication as a product of the second and third inputs, with the actual amount of the unit dose of medication that is delivered to the product container being the first input minus the volume of the air bubbles. 17. The automated system of claim 16, wherein there are more than one third input and the controller calculates the total elapsed time period as a sum of multiple third inputs. 18. The automated system of claim 16, wherein the controller calculates the volume of air bubbles as a product of an inner diameter of a main fluid conduit that receives and holds the unit dose of medication prior to delivery to the product container. 19. The automated system of claim 16, wherein the elapsed time period for each air bubble is a time period beginning with a starting point where the optical device detects the air bubble and ends with an ending point where the optical device no longer detects presence of the air bubble. 20. The automated system of claim 3, wherein the fluid delivery device is fluidly connected to the main conduit and to a means for creating negative or position pressure within the main conduit for aspirating fluid into the main conduit or discharging fluid therefrom, respectively. 21. The automated system of claim 20, wherein the fluid delivery device comprises at least one syringe for generating positive and negative pressure. 22. A method for automated preparation of a medication including automated preparation and dispensing of medication to an individual product container and detection of an underfill condition where an insufficient amount of medication is delivered to the product container comprising the steps of: providing an automated device for preparing and dispensing a prescribed unit dose of medication; operatively connecting a controller to the automated device; inputting a first value to the controller that represents a volume of the prescribed unit dose of medication that is to be delivered to the product container; providing an optical device for detecting the underfill condition when the actual amount of the unit dose of medication that is delivered to the product container is less than the inputted volume; and whereupon, if an underfill condition is detected, then the controller instructs the automated device to deliver medication to the product container until the amount of medication in the container is equal to the inputted volume. 23. A method of claim 22, further including the steps of: disposing a first sensor to detect foreign matter present in the unit dose of medication; detecting by means of the first sensor the presence of any foreign matter in the unit dose of medication; and delivering the unit dose of medication to the product container in a just-in-time manner if the unit dose of medication is free of foreign matter and whereupon, if foreign matter is detected, a signal is delivered to the controller and the unit dose of medication is prevented from being delivered to the product container. 24. The method of claim 23, wherein the step of detecting the presence of foreign matter comprises the steps of: emitting a light beam from the first sensor toward the unit dose of medication contained in a main fluid conduit that has been aspirated and is ready for delivery to the product container; detecting whether the light beam is reflected as a result of contacting foreign matter that is contained in the medication in the main fluid conduit; and if the light beam is reflected, then the signal is delivered to the controller and the unit dose of medication is prevented from being delivered to the product container. 25. The method of claim 23, further comprising the step of: differentiating between air bubbles and the foreign matter, wherein the first sensor only generates a signal instructing that the unit dose of medication be discarded if foreign matter is present in the medication as oppossed to air bubbles. 26. The method of claim 23, wherein providing the optical device comprises the steps of: disposing a second sensor proximate the automated device, wherein the second sensor has a sensitivity that permits detection of air bubbles and not solid particles; emitting a light beam toward the unit dose of medication that is contained in a main fluid conduit; detecting whether the light beam is reflected and if so, generating an air bubble signal that is delivered to the controller; and processing signals from one or both of the first and second sensors with the master controller such that if the first sensor detects reflection of its emitted light beam and the second sensor detects reflection of its emitted light beam, then the controller determines the existence of a false positive and the reconstituted medication is delivered to the syringe. 27. The method of claim 22, further including the steps of: inputting a second input to the controller, the second input representing a flow rate of the unit dose of medication as it is delivered under action of the automated device; inputting a third input to the controller, the third input representing an elapsed time period that the optical device detects air bubbles in the unit dose of medication as the unit dose of medication is delivered to the product container by the automated device; and calculating with the controller a volume of the air bubbles in the unit dose of medication as a product of the second and third inputs, with the actual amount of the unit dose of medication that is delivered to the product container being the first input minus the volume of the air bubbles. 28. The method of claim 27, wherein there are more than one third input and the method includes the step of: calculating the total elapsed time period as a sum of plural third inputs. 29. The method of claim 22, further including the step of: calculating the volume of air bubbles based on an inner diameter of a main fluid conduit that receives and holds the unit dose of medication prior to delivery to the product container; and calculating an elapsed time period for each air bubble as being a time period beginning with a starting point where the optical device detects the air bubble and ends with an ending point where the optical device no longer detects the presence of the air bubble. 30. The method of claim 22, wherein the automated device is in selective fluid communication with a fluid pump apparatus that is in selective fluid communication with a diluent source, the fluid pump apparatus having a first controllable syringe that is in fluid communication with the diluent source and with a second controllable syringe that is also in selective fluid communication with the fluid delivery device through the main conduit which is primed, each of the syringes being operatively connected to a drive that causes either a positive or negative pressure to exist in a barrel thereof, and the step of reconstituting the medication includes the steps of: opening fluid communication between the diluent source and the first syringe and preventing fluid communication between the second syringe and the fluid delivery device; operating a drive of one of the first and second syringes to create a negative pressure therein resulting in a prescribed amount of diluent being drawn into the barrel thereof; preventing fluid communication between the diluent source and the first syringe and allowing fluid communication between the second syringe and the delivery device; operating the drive so as to discharge the prescribed amount of diluent from one of the first and second syringes into the primed main conduit resulting in the prescribed amount of diluent being discharged through the delivery device and into the vial; agitating contents of the vial; operating a drive of one of the first and second syringes to create a negative pressure therein resulting in the prescribed dosage amount of medication being aspirated into the main conduit with an air block separating the aspirated medication from the diluent in the main conduit due to a volume of diluent, which is equal to the prescribed dosage amount, be drawn into the syringe barrel; positioning the delivery device within the syringe; and operating the drive of one of the first and second syringes to create a positive pressure therein resulting in the prescribed dosage amount of medication being discharged from the main fluid conduit into the syringe as a result of the volume of diluent being discharged from the syringe into the main conduit. 31. An automated medication preparation system including preparation and dispensing of medication to an individual product container and detection of any underfill condition where an insufficient amount of medication is delivered to the product container, the system comprising: an automated device for preparing and dispensing a prescribed unit dose of medication; a controller operatively connected to the automated device, the controller receiving a first input that represents a volume of the prescribed unit dose of medication that is to be delivered to the product container; and an optical device for detecting the underfill condition when the actual amount of the unit dose of medication that is delivered to the product container is less than the value of the first input and whereupon, if an underfill condition is detected, then the controller instructs the automated device to deliver medication to the product container until the amount of medication in the product container is equal to the inputted volume wherein the controller calculates a top off volume of medication that is delivered to the product container when an underfill condition is detected, the top off volume being an amount equal to the first input volume minus the actual amount of the unit dose that is delivered to the product container. 32. An automated medication preparation system including preparation and dispensing of medication to an individual product container and detection of any underfill condition where an insufficient amount of medication is delivered to the product container, the system comprising: an automated device for preparing and dispensing a prescribed unit dose of medication; a controller operatively connected to the automated device, the controller receiving a first input that represents a volume of the prescribed unit dose of medication that is to be delivered to the product container; and an optical device for detecting the underfill condition when the actual amount of the unit dose of medication that is delivered to the product container is less than the value of the first input and whereupon, if an underfill condition is detected, then the controller instructs the automated device to deliver medication to the product container until the amount of medication in the product container is equal to the inputted volume, wherein the optical device is configured to detect at least one condition selected from the group consisting of (a) particles being present in the unit dose of medication and (b) bubbles being present within the unit dose of medication.
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