Infusion Unit

Abstract

Improvements in an infusion unit are disclosed. The infusion unit is a portable pump that can be used with patient that have wrist access or decubital PICC/MID-LINES without the risk of line accidently getting pulled. The infusion unit is in the shape of a conveniently shell that has an appearance of an arm cast. There are no hoses that extend beyond the body of the infusion unit and any vein penetration is completely covered under the body of the infusion unit. The secure enclosed unit prevents unauthorized tampering and entry into the unit. The medication dosing can be remotely monitored, fusion resumed, changed by nursing and the patient. The infusion unit has a wireless connection to a network to adjust medication and monitor vital signs, namely heart rate, O2 level and blood pressure that can be monitored and recorded for review.

Claims

1. An infusion unit comprising: a folding housing that is configured to be secured around an arm of a person; said infusion unit further including at least one internal reservoir for temporally holding a medication in a bladder; a connection from said at least one internal reservoir to an IV needle; a dispensing mechanism that forces said medication from within said at least one internal reservoir through said IV needle; said at least one internal reservoir is an IV fluid solution bag that has at least one exit hole that connect to said IV needle, and a controller that operates said dispensing mechanism.

2. The infusion unit according to claim 1, further includes at least one monitoring sensor that is configured to monitor at least one vital sign of said person.

3. The infusion unit according to claim 2, wherein said vital sign is selected from a group consisting of a heart rate, an O2 content, blood pressure and electrocardiogram.

4. The infusion unit according to claim 1, wherein said dispensing mechanism is a motor.

5. The infusion unit according to claim 4, wherein said motor is a stepper motor that turns a plurality of bearings that temporally squeeze and IV line.

6. The infusion unit according to claim 1, further includes an interface that allows said controller to be programmed externally from said cylindrical housing.

7. The infusion unit according to claim 1, further includes a touch display.

8. The infusion unit according to claim 1, wherein said at least one internal reservoir has an internal volume of 250 ml or less.

9. The infusion unit according to claim 1, wherein there are at least two reservoirs.

10. The infusion unit according to claim 9, wherein each of said at least two reservoirs have an internal volume of 5 cc or less.

11. The infusion unit according to claim 1, wherein said cylindrical housing has an interior padded liner.

12. The infusion unit according to claim 1, further includes a flow sensor.

13. The infusion unit according to claim 1, further includes an air bubble sensor.

14. The infusion unit according to claim 1, further includes an outer shell with a hinge and a lock.

15. The infusion unit according to claim 1, further includes a sensor that detect a presence of said at least one internal reservoir.

16. The infusion unit according to claim 1, further includes an internal power supply.

17. The infusion unit according to claim 1, further includes a wireless connection to an external communication device.

18. The infusion unit according to claim 1, further includes a scanner that is configured to read a content of said at least one internal reservoir.

19. The infusion unit according to claim 1, further includes a tamper detection mechanism.

20. The infusion unit according to claim 1, further includes a global positioning system (GPS).

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0019] FIG. 1 shows a first embodiment of a large infusion unit.

[0020] FIG. 2 shows a reservoir with the drive system.

[0021] FIG. 3 shows a second embodiment of a micro infusion unit.

[0022] FIG. 4 shows a light case with disposable tubing.

[0023] FIG. 5 shows the drive system with a controller.

[0024] FIG. 6 shows the dispensing barrel.

[0025] FIG. 7 shows a Luer lock syringe.

[0026] FIG. 8 shows a reservoir gear pump.

[0027] FIG. 9 shows the pump driving fluid into a vein.

[0028] FIG. 10 shows a large chamber plunger and chamber.

[0029] FIG. 11 the large chamber drive housing.

[0030] FIG. 12 shows a block diagram of the control electronics.

[0031] FIG. 13 shows an electrical block diagram.

[0032] FIG. 14 show a flow chart for the infusion unit.

[0033] FIG. 15 shows a patient wearing the infusion unit.

[0034] FIG. 16 shows a pictorial diagram of the doctor interface.

[0035] FIG. 17 shows a perspective cross-section of a second preferred embodiment of the infusion unit.

[0036] FIG. 18 shows perspective top view of the flow sensing and control components.

DETAILED DESCRIPTION OF THE INVENTION

[0037] It will be readily understood that the components of the present invention, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the system and method of the present invention, as represented in the drawings, is not intended to limit the scope of the invention but is merely representative of various embodiments of the invention. The illustrated embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout.

TABLE-US-00001 Item Numbers and Description 18 Micro infusion unit 19 Large infusion unit 20 reservoir 21 IV line 22 window 23 bottom housing 24 plunger 25 inner layer 26 exit holes 27 platen swing arm 28 drive bearing(s) 29 tube plattent 30 outer shell 31 holes 32 outer shell 33 middle shell 34 plunger cavity 35 drive cavity 36 motor cavity 37 bladder cavity 38 bladder/IV bag 39 circular platter 40 large volume syringe 41 curved seal 42 plastic tubing 43 disposable tubing 44 seal 45 vials 46 plunger(s) 47 plunger top 50 stepper motor 51 screw of stepper motor 52 reservoir gear pump 53 wiring 54 circuit board 55 display 56 pull tab 57 anchor tab 60 battery 62 charging pads 63 transformer 64 plug 65 touch display 66 LED(s) 70 Arduino control system 71 sensor(s) 72 buttons 73 transmitter/receiver 74 antenna 75 signal 77 transmitter/receiver 78 computer 79 display 80 computer 81 distance 82, 83, 84 infusion device 85 hinge 86 monitor strap 87 lining 88 security lock 89 patient 90 main PCB 91 voltage regulator(s) 92 voltage out 93 connector 94 air bubble detector 95 flow rate sensor 96 O2 & pulse sensor 97 ECG sensor 110 start 111 power on 112 reset to defaults 113 put syringe 114 verify syringe 115 display selection 116 display message 117 wait 118 verify syringe 119 check selection 120 route plan 121 default settings 122 custom settings 123 select rate and type 124 alert/alarm 125 check field 127 close lid 128 check the lid 129 start the process 130 emergency stop 131 bubble detected 132 stop process 133 normal process 134 alert message 135 hold hardware 136 alert/alarm 137 side connector 140 stop

[0038] FIG. 1 shows a first embodiment of a large infusion unit 19 and FIG. 2 shows a reservoir with the drive system. The infusion unit has an appearance of an arm cast that is secured around an arm of a user with no exposed IV-lines that can be a source of infection and the IV-lines can't be accidental pull out of an arm. The inner layer 25 is an interior padded soft sponge Styrofoam lining to give skin maximum comfort and keeps the infusion unit in place on an arm. The middle layer is the medication compartments with refillable chambers in a curve syringe compartment for a large chamber of medication or micro-syringes where one or more small volume chambers are located. The large chamber can have a volume of up to 125 cc or more. The smaller chamber can have up to 5 or more micro syringes with a volume of 5 cc or 10 cc. The outer shell 30 is the solid cover with protection of the syringes. In the preferred embodiment the infusion unit is constructed from light weight material of fiberglass material with plastic syringes. The infusion unit is constructed with side hinges (shown and described in other figures herein) so a forearm is placed and secure between the two halves of the unit.

[0039] Starting at the top of the large infusion unit 19 is a reservoir 20. The reservoir 20 preferably made from aluminum and has an IV-line access 21 that pushes fluid through the IV-line access 21 and in the vein of a patient. The IV-line access 21 is located under the reservoir 20 where it is protected from a user to gain access to the IV line, and this also keeps the IV line in an area that prevents accidental harm. The central part of the body is an outer shell 30 that is a solid cover with protection for the syringe(s). The outer shell has hinges or locks to cover and secure the forearm therein. The entire unit is a strong light-weight construction. This provides structure for the housing and protection to the internal medication.

[0040] In this embodiment, the medication is contained within a large volume syringe 40 that has a volume of 100-500 cc. The large volume syringe 40 has a unique plastic curved syringe that has a curved seal 44. The bottom housing 23 includes the stepper motors 50, a controller and power supply, in this case Lithium-Ion rechargeable batteries. Within the housing is a curved seal 44 that is driven by a screw axle 51 from a stepper motor 50. This figure shows three stepper motors 50, but as few as one or more can be used to drive the curved seal 44.

[0041] Another version of the large infusion unit 19 has one or two separate curved chambers located on opposite sides of the infusion unit. The two curved syringes are with 4 stepper motors 50 where two stepper motors are on each of the two curved syringes. The stepper motors 50 are with pancake unipolar leadscrew motors with 12 v Lithium battery powered and computer controlled reverse drive to reset the syringe to zero. The multiple stepper motors 50 ensures that the curved seal 44 is moved in a horizontal relationship. A microcontroller (not shown in this figure) connects the battery 60 to the stepper motor(s).

[0042] FIG. 3 shows a second embodiment of a micro infusion unit 18. The micro infusion unit 18 has a plurality of vials 45. As an example, there can be 10 vials 45, each having an internal volume of 25 cc for a total volume of 250 ml but other quantity of vials 45 and volumes are contemplated depending upon the mechanical design and the amount of medication that is required. The use of micro vials 45 allows for spacing the micro vials 45 around the circumference of the outer shell 30. The reservoir 20 in this embodiment collects the fluid from the vials 45 before the medication is passed into the IV line 21. While s single reservoir 20 is shown, there could be different reservoir that collect and pass fluids into the IV line 21. As an example, different medications can be dispensed in the day and a different blend dispensed in the evenings to assist a person in sleeping.

[0043] A plurality of stepper motors 50 are used in this embodiment. In this embodiment it is contemplated to use 10 stepper motors 50, with 5 motors placed on each side of the infusion unit. Each stepper motor 50 has a lead screw(s) 51. Once the medication has been depleted the lead screw(s) 51 can be reversed and returned to the initial position. While 5 injection units on each side is shown and disclosed, more or less than 5 drive systems per side is also contemplated.

[0044] Each syringe is 2 cc to 3 cc to give a total volume of between 20 and 3 cc, but syringes with larger or smaller volumes can also be used. The stepper motor pushes the syringe pistons one at a time or in any programmed sequence until the syringes emptying into the IV. There are sensors that detect when the syringes are empty or if air is present in the syringe and/or the delivery line.

[0045] A stepper motor 50 is located at the bottom of each vial 45. A screw of each stepper 51 drives medication from within the vial(s) 45 into the reservoir 20. A battery 60 connects the stepper motors 50 to the control electronics and can drive all of the stepper motors 50 in unison or sequentially. Detailed figures and descriptions of the different features are shown in the following figures.

[0046] FIG. 4 shows a light case with disposable tubing with a reservoir 20 shown in broken line at the dispensing end of the vials 45. The outer case is shown as an outer shell 30 that provides both structural strength and light weight. Because aluminum is not transparent a plurality of holes 31 are placed through the outer shell 30 so the level of fluid within the vials 45 can be viewed without opening the infusion unit. The holes 31 are shown in a spiral pattern but could also be placed linearly along the vials 45. There may also be indicia near the holes to allow for a visual measurement of the remaining medication in the vials 45.

[0047] FIG. 5 shows the drive system with a controller. The circuit board 54 that holds the controller is supplied power by the battery 60 and connects with wiring 53 to the stepper motor(s) 50. The batteries are replaceable or rechargeable using a phone charging device or an indictive charger. Stepper motors 50 provide a high level of accuracy and the output shaft of the stepper motors 50 is with a drive screw 51 that can incrementally drive the plunger 24.

[0048] The stepper motor(s) 50 provide accuracy in controlling and pushing the fluid in precise and calculated manner. Unique mechanism is built under the device floor which pushes piston 41 of the commercially available prefilled 60 cc syringe in a precise manner to move the fluid out of the syringe into the tubing and finally into the patient's blood stream. It is contemplated to use other low volume pump and large volume pump with separate designs.

[0049] Low Volume Pump (FRN) has a look of forearm cast with two prefilled syringes for a total of 4 stepper motors 50 (2 on each side). This embodiment is not shown. There is a pancake unipolar leadscrew motors with Lithium battery powered and computer controlled reverse drive to reset the syringe to zero.

[0050] FIG. 6 shows the dispensing barrel vial 45 and FIG. 7 shows a Luer lock syringe. Arduino control system that will run in systemic way-system 1 to system 10 and once fluid is depleted the screw of the stepper motor 51 will run reverse by moving the plunger 24 back to its initial position. In this embodiment the vial 45 contains 25 cc of medication that is pushed with the plunger 24.

[0051] 60 cc syringes (or other volume) is placed in the housing which fits on an adult forearm with a tube connected to an IV line. The housing supports and contains the stepper motor(s) 50 and a controlling module. The stepper motor 50 has long screw 51 attached to the piston of the syringe (shown in other figures herein. This pump is used with low volume precision infusions of antibiotics, hormonal replacements and other low volume drugs. The range of this device 2 cc/hr. to 80 cc per hour. This rate of infusion is commonly used for patients who need antibiotics at home or in nursing home or hospitals.

[0052] FIG. 8 shows a reservoir gear pump and FIG. 9 shows the pump driving fluid into a vein. The vials connect into the bottom of the reservoir 20. In FIG. 8 the reservoir pump gear 52 is shown and in FIG. 9 the reservoir pump gear 52 is shown connecting between one of the vials 45 into the IV line 21 where the pump gear 52 can push the medication through the IV line 21 and into a patient.

[0053] FIG. 10 shows a large chamber plunger, chamber, and FIG. 11 the large chamber drive housing. This is a high-volume pump (FRN) that uses a unique kidney shaped syringe (MRZ) with a capacity of 400 cc that could be wrapped around the forearm via forearm stabilizer. The plunger top 47 of the slider will wrap around the syringe. The plunger top 47 slider has on top of its stepper motor 50 and controlling hardware. The motor 50 drives a screw 51 mechanism that pulls the curved seal 41 of the syringe piston thus pushing the fluid out of the syringe into the tubing which will go into the IV line and into the patient's veins. The bottom of the large volume syringe 40 has a plurality of exit holes 26 to decrease the thrust pressure and increase the desired output. The multiple exit holes can be combined into a single IV line. This embodiment can be used in the field by EMS for injured patients or in the battlefield for soldiers.

[0054] The middle shell 33 in FIG. 11 houses the drive system, plunger and syringe. The plunger and syringe fit within the plunger cavity 34. The drive motor fits within the motor cavity 36 and the drive screw connects to the tabs on the plunger and syringe within the drive cavity 35.

[0055] The high-volume infusion unit is shown with prefilled 400 cc syringe(s) wrapped only on the dorsal aspect of the forearm and stabilizing plastic board on the other side of the forearm tied by hook and loop bands on either side. The infusion unit can be used in the field such as battlefield injured soldiers without need for a pole and IV bag.

[0056] FIG. 12 shows a block diagram of the control electronics. The controller 70 includes an Arduino control system to dispense medication. The controller can have buttons 72 and an optional display as a user interface at the infusion unit. The user interface can include a touch display 65 or a non-touch display. One or a plurality of status LED's 66 for status. One or more sensors 71 can monitor fluid levels in the medication and can include patient vital signs, including, but not limited to heart rate, O2 and blood pressure. The sensor(s) that are present can detect when a syringe has air or is empty. The infusion unit can include GPS 55 to track the patient and the infusion unit for security and to easily locate a patient. The infusion unit is powered by batteries 60 that can be recharged with charging pads 61 or with inductive charging. While the infusion unit is self-contained a transmitter/receiver unit 73 with an antenna 74 allows for changing or monitoring the patient and the infusion unit through wired or wireless communication.

[0057] The communication can be with Bluetooth, WIFI or cellular connection to a programming and/or monitoring device. The programming and/or monitoring device has an antenna 76 connected to a transmitter/receiver 77 module. A computer 78, cellular device, wireless device, tablet or phone device has a display 79 and user interface to program and/or monitor the infusion device. One example is shown and described in the following figures.

[0058] FIG. 13 shows an electrical block diagram. This block diagram has a main PCB 90 block and a sensor data block 71. Unregulated voltage is regulated with a 5-volt regulator 91A that drives the motor 50 and a 3.3-volt regulator 91B that powers the sensors and the controller 70. There may also be voltage outputs for 5 volts 92A and 3.3 volts 92B. In one contemplated embodiment an Arduino control system is used. The controller 70 is shown connected to a touch display 65 to show information to a doctor, user or care giver and to also allow for the user to select/enter information. A connector 93 provides an electrical connection to the sensors.

[0059] The sensor data block 71 has connections for at least one of an air bubble detector sensor 94 that can detect if air is in the IV line. A flow rate sensor 95 ensures that medication is being supplied at the proscribed rate. The infusion device can also monitor vital signs of a user and can include at least one of O2 sensor, pulse sensor 96, blood pressure and electrocardiogram sensor ECG 97.

[0060] FIG. 14 show a flow chart for the infusion unit. The infusion units starts 110 when power is turned on 111. As the infusion unit starts it will perform reset to defaults 112 setting. The infusion unit will check is if at least one syringe 113 is installed and will verify the presence of at least one syringe 114. If there is no syringe, then a message will be displayed 116 on the screen. The infusion unit will wait a period of time, in this example 2 minutes 117 and will again check if a syringe has been installed the verify the presence of at least one syringe.118. If a syringe has not been installed an alert or alarm 136 can be shown or an audible alarm can be announced. While a 2-minute delay is shown, this can be any appropriate period.

[0061] If a syringe is detected, the infusion unit can have a scanner that can read the type of medication from a barcode or other visual or RFID indicator on the medication syringe or IV medication bag. The infusion unit can match the barcode or RFID to a suggested medication or to a patient record to load settings. When a syringe is installed the infusion unit will then show the display selection 115 and will check the proscribed selection 119. The selection will then set a route plan 120. The doctor or other provider can make a custom setting 112 or allow for the default setting 121. In the custom setting 122 the rate and type 123 of the medication is entered.

[0062] One or more rates of injection are checked, set or selected 125 and if all of the data is not properly entered an alert and/or alarm 124 can be made. The infusion unit will verify that the lid of the infusion unit has been closed 127 or the user can be prompted to close the lid. The infusion unit will check and verify that the lid has been closed 128 to allow the infusion unit to start the process 129 of injecting the medication.

[0063] While the medication is being injected the infusion unit will monitor the flow of medication to check the IV line for air bubbles 94 and is an air bubble is detected 131 the process is stopped 132. The process can also be stopped if a person presses and emergency stop 130 by pressing a stop button 72. Both of these events will stop the process 132. There are other contemplated scenarios where the process can be stopped, including but not limited to the normal process 133 completing, if the medication stops flowing, or if the vital signs of the person exceed a proscribed safe level.

[0064] When the process of the infusion unit stops there is an alert and message 134. The hardware is placed on a hold 135 position to prevent further injection of medication and the process will come to a stop 140.

[0065] FIG. 15 shows a patient wearing the infusion unit and FIG. 16 shows a pictorial diagram of the doctor interface. From obvious look the infusion device 19 has similarity to having a cast on an arm of a patient 89, secure no tubing and no exposed IV-line therefore there is less chance of infection or accidental pull. Outer shell 32 is the solid cover with protection of the syringes. A middle layer with medication compartments with refills and curve syringe compartment or micro-syringe. The interior is a soft sponge Styrofoam lining 87 to give skin maximum comfort and yet keep the infusion unit 19 in place. The infusion unit 19 will remain light weight due to use of fiberglass material and plastic syringes. The infusion unit will have at least one side hinges 85 thus the forearm is in between the two or three sections of the infusion unit. A security lock 88 holds the halves together and prevents tampering. The housing with the sensors 71 that includes the pulse sensor, flow meter, air bubble detector and the EKG sensor is shown.

[0066] Within the infusion device is a soft sponge Styrofoam lining 87 to give skin maximum comfort and yet keep the infusion unit 19 in place. The infusion unit is shown with a monitor strap 86 where heart rate O2 and other patient vital signs can be monitored with minimal noise and motion interference from the drive motor. It is also contemplated that there can be a thumb hole that further locks the infusion unit onto the forearm of the patient and prevent rotation of the infusion unit to reduce the chance that the IV is disturbed. The infusion device can have a security lock 88 to prevent tampering or removal. This figure shows an optional display 55 or touch display and buttons (not visible) that can be used for programming or locally viewing information regarding the medication within the infusion unit 19.

[0067] A doctor or other medical person can view status or make changes using a computer, tablet, or in FIG. 16 a cellular phone 80. This figure shows rings for the distance 81 between the cellular device 80 and a plurality of infusion units 82, 83 and 84. Each of the infusion units shows a graphical image of the remaining medication. A doctor can select an individual infusion unit to view additional information and make changes from a distance. Changes can be logged, time stamped and stored for future reference. It is also contemplated that the housing can have a side connector 137 (connection) to attach to at least one of a chest of a patient for EKG leas an respiratory rate and blood pressure, blood analysis, glucose lactate information.

[0068] FIG. 17 shows a perspective cross-section of a second preferred embodiment of the infusion unit and FIG. 18 shows perspective top view of the flow sensing and control components. This embodiment of the infusion unit is shown folded on hinge(s) 85 around an arm of a user in FIG. 15, whereas in these figures the bladder cavities 37 are shown in an open configuration. The top housing and the display and control components have been removed to view the internal structure. Within one or both bladder cavities 37 a bladder or common IV fluid solution bag 38 filled with medication is placed within one or both of the bladder cavities 37. An IV line 21 is connected to the IV bag 38 and then into the delivery system of the motor housing 36. The fluid solution bags in this embodiment are 250 cc or less piggy bags.

[0069] Within the motor housing 36 is one or two drive and sensing units. In these figures the IV line 21 passes into the sensor(s) 71 that monitor the flow rate, bubble detection and possible other parameters. A connector 93 on the sensor(s) 71 connect each sensor into the display and control module (not shown in these figures). The medication from the IV bag(s) 38 is drawn (or pushed) through the sensor(s) 71 using a stepper motor 50 that turns a plurality of drive bearings 28 rotate on a circular platter 39 to squeeze the IV line 21 to pump the medication by temporally squeeze the IV line 21. The IV line 21 follows and is restrained within platen swing arm 27 and around a tube platen 29. The IV line 21 then extends into the patient where the medication is dispensed.

[0070] Thus, specific embodiments of an infusion unit have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.