WO2018067734A1

WO2018067734A1 - Medication delivery method and device with remote control

Info

Publication number: WO2018067734A1
Application number: PCT/US2017/055190
Authority: WO
Inventors: H. Randall CRAIG M.D.
Original assignee: Craig M D H Randall
Priority date: 2016-10-04
Filing date: 2017-10-04
Publication date: 2018-04-12

Abstract

A Drug Delivery Device comprised of a wearable subcutaneous or intravenous intermittent injection system controlled by a built-in microprocessor remotely programmable by an off-site operator, worn by a human or animal subject. Intermittent subcutaneous drug delivery is by indwelling subcutaneous needle, intermittently inserted subcutaneous needle, or transdermal spray system. Intermittent intravenous drug delivery is by indwelling intravenous needle or intermittent inserted intravenous needle. Two or more drugs are deliverable by parallel, separately controlled devices incorporated into a single unit, through a shared needle or individual, parallel separate needle systems. The built-in microprocessor controls timing and fluid volume of the intermittently delivered drug and mechanical operation of the needle or spray portion of the device, and is under outside control by the remote operator. Control of the program is by continuous monitoring with rapid adjustments in drug delivery dose and timing, intermittent delivery, or intermittent download of a drug delivery protocol.

Description

Medication Delivery Method and Device with Remote Control

Background

Wearable portable drug delivery devices have been in clinical use since the 1970s, for example a Gn H pulsatile delivery by indwelling subcutaneous needle attached to a small pump device worn on the patient's belt to treat hypogonadotrophic hypogonadism. Over the past few years, a large number of more sophisticated wearable commercial drug delivery systems have been brought to market. Examples include the OmniPod System marketed by the Insulet Corporation and the MiniMed system marketed by the Medtronic Corporation as insulin delivery systems. The Omnipod device is a small rectangular pod attached to the skin by an adhesive and contains a refillable insulin reservoir, with insulin delivered intermittently by a small retractable subcutaneous needle. This unit can be directly programmed through a built-in touchscreen, or by a handheld dedicated short range wireless remote control unit. The OmniPod unit has also been used to deliver GnRH hormone to treat hypogonadotrophic hypogonadism. A change in the drug delivery dose and timing program must be done by the patient or medical personnel with direct access to the device or the short range control unit.

The currently available commercial drug delivery devices deliver only one type of drug and currently have no commercially available long-range remote-control capability. Recent prior art designs address long-distance control of automated wearable drug delivery devices. Long-range control would have the advantage of medical personnel or dedicated artificial intelligent system review of laboratory data and patient symptoms and use this information to make adjustments in dose and timing from a distant medical office.

Many medical syndromes require treatment using two or more drugs working in concert to obtain an optimal clinical outcome, and this would require using two or more wearable systems simultaneously, with attendant independent multiple control systems and subsequent potential for increased drug delivery errors. Examples would include diabetic therapy with simultaneous short half-life insulin (regular or Humulin) and long half-life insulin (Lente), or fertility therapy using simultaneous hFSH and hMG with frequent daily dose adjustments, enhanced by a separate single- dose hCG ovulation trigger injection. Other examples include delivery of short-acting (heparin) and long-acting (Lovenox) injectable anticoagulants, and human growth hormone (hGH) with ultra-low- dose estradiol to treat childhood growth hormone deficiency or Turner's syndrome.

After all the medication in the reservoir has been injected, it must be refilled by the patient or medical personnel, typically using a syringe and needle to inject fresh medication into the reservoir through a sealed membrane or valve. The frequent need for low-volume refills can be improved by utilizing an adjacent second reservoir containing the same medication , or a simplified prefilled cartridge reservoir replacement system.

Summary

A Drug Delivery Device comprised of a wearable subcutaneous, intravenous intermittent, or intramuscular injection system controlled by a built-in microprocessor which can be remotely programmed by an off -site operator. The device is worn by a human or animal subject by means of skin adhesive, bandage wrap, dedicated pouch apparel, or attached to clothing or belt. Intermittent subcutaneous drug delivery is by indwelling subcutaneous needle, intermittently inserted subcutaneous needle, or transdermal spray system. Intermittent intravenous drug delivery is by indwelling intravenous needle or intermittent inserted intravenous needle. For patients who require intermittent delivery of two or more different drugs, parallel separately controlled devices can be incorporated into a single unit, with delivery of two or more drugs done through a shared needle or individual parallel separate needle systems.

The built in microprocessor controls the timing and fluid volume (dose) of the intermittently delivered drug and the mechanical operation of the needle or transdermal spray portion of the device, and it is under outside control by the remote operator who can adjust the delivery timing, drug dose, and delivery method. Remote-control of the device is by Wi-Fi, satellite link, cellular telephone connection, or intermittent direct connection to a computer or communication device with a wire and suitable interface such as USB port or landline telephone port. More powerful processors may also be included as necessary in the system. Control of the drug delivery program is by continuous monitoring with rapid adjustments in drug delivery dose and timing, intermittent delivery (for instance several times per day), or intermittent download of a drug delivery protocol subject to updated modification. Control of the remote programming can be by the patient using a computer, dedicated remote control unit, cell phone app, or the remote programming can be done off-site by a physician or other medical personnel, pre-programmed algorithm, or artificial intelligence system. For more sophisticated applications, control of the programming can be done using a feedback mechanism such as a physiologic sensing system permanently or intermittently attached to or used by the patient. An example would be a glucose monitoring sensor with intermittent blood sugar result feedback to the remote monitor, medical personnel, or control algorithm which/who will then appropriately adjust insulin doses. The physiologic sensor component can be a separate unit, skin sensor, standard intravenous or fingerstick blood test, or can even be built into the drug delivery device as a comprehensive single unit system.

The proposed invention uses short-range or long-range remote-control of drug dose and timing using a wearable multichannel drug delivery device capable of independent delivery of two or more drugs, simultaneously or in tandem, consolidated into a single device. Safety features incorporated into the system include encryption of wireless remote data from the device to the remote operator (such as feedback sensor data, lab results, or patients clinical symptoms and audio or text messages from the patient), and from the remote operator back to the device (adjusted drug dose and delivery timing, and updated messages from medical personnel to the patient). An additional safety or courtesy feature would be use of a short audio signal (beep) from the device a few seconds before the mechanical subcutaneous injection or transdermal spray is initiated so that this patient is not surprised by a scheduled needlestick. For vision or hearing impaired patients, this audio signal can be replaced by a device vibration or flashing light pre-injection signal. Alternately, the same type signal can also be sent to the patient's cell phone instead of or in addition to the injection device, and a similar signal can be used to alert the patient to an incoming message from the remote operator or medical personnel, or for device maintenance items such as low battery or low drug volume in the reservoir. Device maintenance data can also be sent to the patient's cell phone or computer for real-time updates on drug reservoir levels, past injection history, projected reservoir refill times for each independent medication, etc.

To avoid the relatively complex and error prone task of refilling the medication reservoir with syringe and needle or pour bottle, a medication cartridge system can be substituted. When the reservoir refill signal is displayed, or when the reservoir is nearly or completely exhausted, the empty medication cartridge is removed and a new cartridge is inserted. Cartridge size and shape variations can be used in multichannel devices so that only specific medications fit in dedicated injection channels to prevent mix up errors. Built-in device sensors can be used to read information off each inserted cartridge to confirm and report the medication type, concentration, and insertion time, including age and expiration date of perishable medications.

An example of a clinical application of this invention would be multiple fertility drug injections for patients undergoing in vitro fertilization therapy. With current technology, patients undergoing ovarian stimulation to produce eggs for in vitro fertilization must inject three or more types of fertility drugs up to two times per day subcutaneously over a period of 10 to 20 days. This is done to induce the ovaries to produce several eggs which are subsequently aspirated from the ovary using a needle, then fertilized with sperm in a laboratory. During the treatment period, the patient has ovarian ultrasound and blood tests every day or every few days to measure estrogen, progesterone, and other hormone levels. These test results are immediately reviewed by a physician, and used to determine frequent adjustments in the dose and timing of subsequent fertility drug injections. Injections are done by the patient at home using mechanical subcutaneous injection pens, or with medication extracted from a multidose bottle using a syringe and needle, and with manual adjustment of each dose per telephone instructions by the physician or nurse.

For instance, if an early morning ultrasound test shows ovarian egg follicle diameters of 21 mm, and the morning estradiol level was 1200 and progesterone level was 0.4, the physician may decide to decrease the daily 2 PM dose of hFSH from 150 IU down to 75 IU and increase the dose of hMG from 37.5 IU up to 75 IU, and then administer a single hCG dose 10,000 units at 9 PM. The physician also requests that the patient return for repeat ultrasound and lab test appointments the next day at 10 AM. The physician instructions are then relayed by the medical office staff to the patient by telephone in the early afternoon, and the patient then has to adjust the dose settings on two separate subcutaneous injection pens, one for hFSH and the other for hMG, and proceed with the self injection of these two medications at 2 PM. She then has to adjust the dose for the hCG injection and administered it to herself at 9 PM that night. The next morning she reports to the medical office at 10 AM to repeat this process all over again. During a two-week period of time, the patient may have to repeat this daily routine a total of seven to 10 times.

This entire process can be greatly simplified by the current invention, using a parallel three channel automated injection device remotely controlled by the medical staff. Before the cycle, each channel reservoir in the device is filled with the appropriate medication: hFSH, hMG, and hCG. The device is then applied to the patient's skin using a biological adhesive, typically to the upper arm or lower abdomen. The patient then periodically reports to the medical office for ultrasound and laboratory tests. The test results are reviewed by the physician who then enters the appropriate changes in dose and timing for each medication into the patient's electronic database. The automated system then encrypts and wirelessly relays this data to the drug delivery device microprocessor where it is stored in the device memory. The device then automatically injects the proper dose of hFSH and hMG at 2 PM, then automatically injects the proper dose of hCG at 9 PM. The message to the patient to report to the clinic at 10 AM the next morning is displayed on the device touchscreen and/or cell phone, and the patient touches the confirm icon (or uses the touchscreen to change the appointment time). The device then automatically encrypts and relays this information back to the remote operator and database confirming that the injections were done at the proper dose and time, and confirms the patient will arrive for her appointment at the scheduled time the next day. All of this information is displayed in the patient's electronic database to be accessed as needed by the physician and clinic personnel.

This three channel example can be expanded to four or more channels to permit administration of additional subcutaneous medications, or the three channels can be reduced to only one or two channels for simpler single or double drug regiments. For instance, a fertility drug protocol may require daily subcutaneous injections of Gn Ha (such as Lupron) and every other day injection of G-CSF (such as Neupagen) along with a daily dose of hGH (such as Humatrope) in addition to the aforementioned hFSH, hMG, and hCG medications. These can all be accommodated by a larger six channel drug delivery device controlled by a single microprocessor, or the addition of a separate three channel device placed at another location which would be wirelessly tied to the same control database. The addition of more channels can also be used to increase the stored volume of a higher dose medication in order to reduce or eliminate reservoir refills - once the first reservoir is exhausted, the system automatically activates the second reservoir of the same medication.

The patient never has to receive a phone call with instructions from the clinic, or adjust the dose on an injector pen, or inject herself several times a day. She simply has to show up for the ultrasound and blood test appointments, while the dose and timing information for the medication injections are done accurately and automatically by the drug delivery device. When the treatment cycle is completed, the clinic staff detaches the device from the patient, and it is then sterilized to be used for the next patient in another treatment cycle. Economic advantages of this system include eliminating the cost of disposable injector pens, reducing the cost of personnel time for multiple phone calls, and decreasing the cost of medical errors which are an inherent part of the self administered injection method. Any maintenance items or refill requirements are addressed by the clinic at the patient's next visit, and the bidirectional data for drug dose, timing, injection confirmation, and clinic/patient messaging is date and time stamped for accurate record-keeping and medical legal archiving. Standard ovarian stimulation protocols customized to patient age and diagnosis categories can be preprogrammed into the system at the beginning the cycle, then modified as needed depending on patient response.

Because of the time and effort required for self administering medications, injectable fertility drugs are historically done only once or twice a day. With an automated drug delivery device, the medication doses can be divided into much smaller units given more frequently throughout the day to achieve a more physiologic profile, and possibly improve response to the medication and reduce overall dose and costs. The physician can order the overall daily dose of each medication, and the control software can automatically divide this total dose into smaller, more frequent, and more accurate sub doses given throughout the day. For example, a single 180 iu dose of hFSH injected every 24 hours can instead be divided into 30 iu doses injected every 4 hours. In addition, determination of the proper day-to-day dose adjustments of these fertility drugs is relatively easy to calculate for routine patients using standard algorithms, and these can be programmed into the automated system to further reduce physician and clinic personnel time. The physician can simply oversee the data profile on the cycle database and override the algorithm if needed. As artificial intelligence programs become more sophisticated, less physician and clinic personnel time may be needed to manage fertility drug cycles in the future.

The convenience and efficiency of the system can be further improved by technical advances in the lab data acquisition component of the system. With improvements in blood sampling, sensory, and imaging technology, phlebotomy blood tests can be replaced by fingerstick tests, or by implanted optical or physiologic sensors to measure blood levels of glucose, estradiol, progesterone, etc. With these technical advances, this invention would allow the remote monitoring of data acquired by automated patient laboratory and imaging systems to be reviewed by a physician or medical staff, or by an algorithm or artificial intelligence program, and would further reduce personnel time, cost, and error rates while increasing patient convenience. Examples of injectable medications include:

Insulin (short and long acting), Gonadatropin Releasing Hormone (GnRH), Gonadatropin Releasing Hormone analog (GnRHa), Lupron, Ganarelex, Lutinizing Hormone (LH), Follicle Stimulating Hormone (FSH), chorionic gonadotropin (hCG), human Growth Hormone (hGH), Thyrotropin Releasing Hormone (TRH), Thyroid Stimulating Hormone (TSH), thyroxine (T4), levothyroxine (L - T4), T3, Mixed thyroid Tl, T2, T3, and/or T4 (Naturethroid, Armour thyroid), corticosteroid (Cortisol, dexamethasone, prednisone, betamethasone, hydrocortisone), aldosterone, adrenocorticotropic hormone (ACTH), corticotropin releasing hormone (CRH), Insulin-like Growth Factor (IGF), ACTH, Oxytocin, heparin, Lovenox, estrogen receptor antagonist (clomiphene, tamoxifen), aromatase antagonist (letrozole, Arimidex, Femara), estrogen (estrone, estradiol, estradiol), progesterone, progestin, testosterone, androgen, granulocyte colony stimulating factor (G - CSF), insulin like growth factor (IGF), insulin enhancers (metformin, Actos), glucagon like peptide (GLP), glucagon like peptide receptor agonist (GLP - 1, GLP - 2), somatostatin receptor agonist, glucagon (GCG), cholecystokinin B (CCKB), glucose dependent insulinatropic peptide (GIP), vasopressin, or any other subcutaneous or intramuscular medication.

Brief Description of the Drawings

Fig. 1A is a prior art example of a drug delivery device having two separate fluid reservoirs sharing a single needle through a two-position valve controlled by a microprocessor.

Fig. IB is an example of a drug delivery device having two separate fluid reservoirs sharing a single needle through a two-position valve controlled by a microprocessor combined with a novel separate third reservoir connected to a separate second needle.

Fig. 2A is an example of a drug delivery device having two separate fluid reservoirs, each connected to a separate independent needle and each driven by its own independent motor.

Fig. 2B is an example of a drug delivery device having two separate fluid reservoirs, each connected to a separate independent needle and both driven by a shared motor through the same transmission mechanism.

Fig. 3A is a cutaway view of an apparatus according to the invention for performing the disclosed method. Fig. 3B is a top-down view of the apparatus in Fig. 3A.

Fig. 4 shows a drug delivery device according to the invention having either a single fluid reservoir or two or more separate fluid reservoirs connected to two or more independent needles through a distribution valve controlled by a microprocessor.

Fig. 5 shows a drug delivery device having two or more fluid reservoirs connected to two or more independent needles through a through a multi-function valve controlled by a microprocessor.

Fig. 6 shows a drug delivery device and associated warning systems according to an embodiment of the invention.

Fig. 7 shows an example of a default multiple medication program according to an embodiment of the invention.

Fig. 8 shows an example of remote operator override of a default multiple drug program.

Fig 9 shows an example of periodic customized adjustments of a multiple medication program.

Fig. 10 shows an example of medication delivery dose and frequency adjustments to maintain a therapeutic range.

Fig. 11 shows an example of combining injectable medications having long and short half-life versions to achieve an optimal therapeutic range.

Fig. 12 shows a label detecting sensor and drug reservoir label system according to an embodiment of the invention.

Fig. 13 shows a cutaway view of the label detecting sensor system of Fig. 12 according to an embodiment of the invention.

Detailed Description

A shared needle system 100 known in the art is shown in Fig. 1A. A first fluid reservoir 101 and a second fluid reservoir 102 are connected to a valve 103. Medication from either first fluid reservoir 101 or second fluid reservoir 102 passes through valve 103 according to control instructions received from microprocessor 104 . The selected medication is delivered to the patient through needle 105 by operation of actuator 106. As known in the art, the first and second reservoirs may either utilize a single motor or a shared motor with a transmission for injecting medications.

The shared needle system 100 of Fig. 1A is combined with a novel third fluid reservoir 113 in the system 110 of Fig. IB. Third fluid reservoir 113 operates independently from the shared-needle system and delivers medication to the patient through a second independent needle 115 by operation of actuator 116.

A simplified illustration of an independent channel motor system 200 is shown in Fig. 2A. First fluid reservoir 201 and second fluid reservoir 211 contain medications which are injected independently of each other through separate needles by operation of first plunger 203 and second plunger 213, respectively. First plunger 203 is driven by first motor 202, delivering medication from reservoir 201 to needle 205. Second plunger 213 is driven by second motor 212, delivering medication from reservoir 211 to needle 215.

A simplified illustration of a shared channel motor system 220 is shown in Fig. 2B. First fluid reservoir 221 and second fluid reservoir 231 contain medications which are injected independently of each other through separate needles by operation of first plunger 223 and second plunger 233, respectively. First plunger 223 and second plunger 233 are driven by a shared motor 240 through transmission 230.

A simplified illustration of a device for delivery of more than one medication according to an embodiment of the invention is shown in Fig. 3A. The alert reader will recognize that the device pictured in this and other figures is not a circuit diagram and electrical complexity is omitted for the sake of clarity in the drawings. Delivery device 300 is contained within housing 395 and wearable on the skin 390 of a patient by adhesive layer 380. Housing 395 contains two or more fluid reservoirs 301, 311 for storage of medications and delivery through separate needles 305, 306. At scheduled delivery times, needles 305, 315 are driven by actuators 306, 316 and puncture the skin 390 of the patient. Injection of medications from fluid reservoirs 301, 311 is performed by motors 302, 312 through valve 303 and needles 305, 315. Motors 302, 312 are operated by power from battery 370. Delivery device 300 may also include additional channels, each having its own fluid reservoir 321, motor 322 and needle 323. Medication delivery instructions may be transmitted to device 300 from a remote location through wireless transmitter/receiver 330 or from another device through wire connection port 340. Microprocessor 304 controls the operation of motors 302, 312 according to instructions received. According to some aspects of the invention, a display screen 350 may be incorporated into device 300 for displaying messages to a user. According to some aspects of the invention, an alert or alarm system 360 may be incorporated into device 300 to inform a user of an imminent needlestick by one or more needles 305, 315. A top-down view of the simplified illustration of Fig. 3A is shown in Fig. 3B, with like numbers used for indicating like features.

According to another embodiment of the invention, multiple needles may deliver medication from a single fluid reservoir or from two or more reservoirs. Such a device 400 is shown in Fig. 4. Device 400 allocates multiple injections between different injection locations, instead of multiple injections at the same injection location. Needles 405, 415, 425, 435 are spaced apart from each other in order to distribute repeated needlesticks between locations, either for patient comfort, to prevent proximity of two different medications with biochemical incompatibility, to reduce the volume of medication fluid in a small tissue space, or other necessity. Delivery of medication from fluid reservoir 401 to one of needles 405, 415, 425, 435 is controlled by microprocessor 404. Microprocessor 404 controls distribution of medication from fluid reservoir 401 through valve 403 to the selected needle and signals the associated actuator 406, 416, 426 and 436 to perform the injection. In other embodiments, device 400 may have one or more additional fluid reservoirs 402 and may have one or more shared additional needles and actuators, depending upon requirements.

A multi-function valve may be utilized in another embodiment of the invention to allow different combinations of medications from two or more fluid reservoirs to be delivered through either one, two or more needle and actuator systems. Such a device 500 is shown in Fig. 5. In this embodiment, two fluid reservoirs 501, 502 contain two different medications. Delivery of medications either separately or in any combination from fluid reservoirs 501, 502 to any combination of needles 505, 515 is controlled by microprocessor 504. Microprocessor 504 controls distribution and combination of medications from fluid reservoirs 501, 502 through multi-function valve 503 to the selected needle or needles and signals the associated actuator or actuators 506, 516 to perform the injections. In other embodiments, device 500 may have one or more additional fluid reservoirs 521 and one or more additional needles and actuators 525, 526, depending upon requirements.

A medication delivery device with an alarm/alert system according to an embodiment of the invention is shown in Fig. 6. System 600 may include medication delivery device 610, device remote control 640 and mobile phone 650. The primary purpose of system 600 is to warn a patient of an impending needlestick 620 by issuing an alert. Medication delivery device 610 may transmit warning signals to remote control 640 or to mobile phone 650 through wireless transmitter 630. Medication delivery device 610 may alternatively issue a warning signal internally, either through flashing light 660, speaker 670 or vibration device 680.

An exemplary timeline illustration of delivery of two or more injectable medications as executed by the default program in the microprocessor memory is shown in Fig. 7. In this example, three different drugs are injected in an ordered sequence, at specific times every day and night, repeating every 24 hours.

An exemplary timeline illustration of delivery of two or more injectable medications as executed by the default program in the microprocessor memory interrupted periodically by a central operator, such as a physician or medical office personnel, with a different custom override program is shown in Fig. 8. In this example, the override program may replace the default program as a new default program or the original default program may resume after a specified amount of time, dependent upon individual requirements.

An exemplary timeline illustration of delivery of two or more injectable medications with ongoing periodic adjustments by a remote operator, physician, or medical personnel, in either the type of medication, dose amount, or timing of injections delivered by the device is shown in Fig. 9. In addition, Fig. 9 also illustrates an alarm and alert system according to an embodiment to convey messages to the user from medical personnel. As shown in Fig. 9, the dose and timing of fertility medications hFSH, hMG and hCG are periodically adjusted over a four-day period of time by the medical office. Messages from the office to the user are conveyed at appropriate times, usually before a change in the drug delivery regimen.

An exemplary timeline illustration of delivery of a single version of an injectable medication with a fixed half-life is shown in Fig. 10. The illustration of Fig. 10 demonstrates adjustments required to maintain the serum concentration of the medication within the therapeutic range of the drug. The optimal example illustrated is a programmed initial loading dose of the drug, followed by frequent small follow-up doses. The injectable dose schedule illustrated would be very difficult to achieve through standard patient self-injection using syringes due to the precise timing and frequency of injections. As an example, some medications, such as pulsatile Gn h, must be injected every 45 to 90 minutes throughout the day and night. The automated medication delivery device provides reliable delivery of multiple small injection doses automatically with no effort required of the patient. Subsequent minimization of errors in dosing and frequency is also beneficial. An exemplary timeline illustration of delivery of two different versions of an injectable medication having different half-lives is shown in Fig. 11. Such a medication could be Lente insulin which has a long half-life, typically injected every 24 hours and regular insulin which has a short half- life, typically injected every few hours to supplement the long half-life insulin. The combined long and short half-life medication portion of this illustration demonstrates and effective scheme to maintain the medication within a relatively narrow therapeutic range by infrequent but fixed periodic injection of the long half-life medication, supplemented by multiple injections of the short half-life version of the same drug. Fig. 11 also demonstrates initial delay of the short half-life injections because of the decay curve of the long half-life medication. After this period of delay, the dose of the frequent short half-life medication is gradually increased to compensate for the decreasing concentration of the long half-life drug.

An illustration of a label detecting sensor in a channel slot and a drug reservoir labeling system according to an embodiment of the invention is shown in Fig. 12. Medication delivery device 1200 includes first fluid reservoir 1201 with affixed first identifying label 1207 and second fluid reservoir 1211 with affixed second identifying label 1217. Fluid reservoirs 1201, 1211 are housed in first reservoir channel 1209 and second reservoir channel 1219, respectively. Fluid reservoirs 1201, 1211 are joined to needles 1205, 1215 and actuators 1206, 1216, respectively. First label sensor 1208 is positioned on an interior wall of first reservoir channel 1209 and connected to

microprocessor 1204. Second label sensor 1218 is positioned on an interior wall of second reservoir channel 1219 and connected to microprocessor 1204.

A cutaway view of the label detecting sensor system of Fig. 12 is shown in Fig.13.

Medication delivery device 1300 comprises first fluid reservoir channel 1309 with first label sensor 1308 positioned on its interior wall and connected to microprocessor 1304. First fluid reservoir 1301 is inserted into first fluid reservoir channel 1309 after removal of channel slot cover 1320 and secured in place by reattachment of channel slot cover 1320. First identifying label 1307 is affixed to first fluid reservoir 1301 for identification and readable by first label sensor 1308. Motor 1302 injects medication from first fluid reservoir 1301.

Disclosed herein is a method of administering at least two medications to a patient, comprising providing an intermittent injection system to the patient, the intermittent injection system comprising a microprocessor, a transceiver, a first needle in communication with a first reservoir, the first reservoir containing an amount of a first medication; a second needle in communication with a second reservoir, the second reservoir containing an amount of a second medication; connecting the transceiver of the intermittent injection system to a remote controller; programming the microprocessor remotely with a set of instructions comprising a time of delivery of at least one dose of the first medication and also a volume amount of the at least one dose of the first medication, and a time of delivery of at least one dose of the second medication and also a volume amount of the at least one dose of the second medication; attaching the intermittent injection system to the patient; delivering the at least one dose of the first medication to the patient through the first needle according to the set of instructions programmed into the microprocessor of the intermittent injection system; and delivering the at least one dose of the second medication to the patient through the second needle according to the set of instructions programmed into the microprocessor of the intermittent injection system. The disclosed method may also comprise monitoring at least one biochemical condition of the patient by the microcontroller, communicating the at least one biochemical condition of the patient to the long-range remote controller through the transceiver; updating the set of instructions in response to a change in the biochemical condition of the patient; and providing the updated set of instructions to the microcontroller.

Also disclosed herein is an apparatus for delivery of a first medication and at least a second medication, comprising: a microprocessor; a transceiver, wherein the transceiver is wirelessly connected to a remote controller; a first needle attached to a first reservoir, the first reservoir containing an amount of the first medication, wherein the first needle is driven by a first actuator and the first medication is injected by a first plunger attached to a first motor; at least a second needle attached to at least a second reservoir, the at least second reservoir containing an amount of the at least second medication, wherein the second needle is driven by a second actuator and the second medication is injected by a second plunger attached to a second motor; and means attaching the apparatus to a body of a patient.

It will be appreciated that one skilled in the art of medication delivery systems and methods could devise additional obvious improvements and variations upon the invention described and claimed herein. All such obvious improvements and variants are intended to be encompassed by the claims which follow.

Claims

1. A method of administering at least two medications to a patient, the method comprising: providing an intermittent injection system to the patient, the intermittent injection system comprising a microprocessor, a transceiver, a first needle in communication with a first reservoir, the first reservoir containing an amount of a first medication; a second needle in communication with a second reservoir, the second reservoir containing an amount of a second medication; connecting the transceiver of the intermittent injection system to a remote controller; programming the microprocessor remotely with a set of instructions comprising: a time of delivery of at least one dose of the first medication and also a volume amount of the at least one dose of the first medication, and a time of delivery of at least one dose of the second medication and also a

volume amount of the at least one dose of the second medication; attaching the intermittent injection system to the patient; delivering the at least one dose of the first medication to the patient through the first needle according to the set of instructions programmed into the microprocessor of the intermittent injection system; and delivering the at least one dose of the second medication to the patient through the second needle according to the set of instructions programmed into the microprocessor of the intermittent injection system.

2. The method of claim 1, wherein the first needle is a subcutaneous needle.

3. The method of claim 1, wherein the first needle is an intravenous needle.

4. The method of claim 1, wherein the first needle is an intramuscular needle.

5. The method of claim 2, wherein the second needle is an intravenous needle.

6. The method of claim 2, wherein the second needle is an intramuscular needle.

7. The method of claim 3, wherein the second needle is an intramuscular needle.

8. The method of claim 1, further comprising: monitoring at least one biochemical condition of the patient by the microcontroller; communicating the at least one biochemical condition of the patient to the remote controller through the transceiver; updating the set of instructions in response to a change in the biochemical condition of the patient; and providing the updated set of instructions to the microcontroller.

9. The method of claim 8, wherein the step of updating the set of instructions is performed by the patient.

10. The method of claim 8, wherein the step of updating the set of instructions is performed by medical personnel.

11. The method of claim 8, further comprising: an automated feedback system in

communication with the patient, whereby the step of updating the set of instructions is performed by the automated feedback system.

12. The method of claim 8, further comprising: an automated messaging system, whereby the step of providing the updated set of instructions to the microcontroller is performed by the automated messaging system.

13. The method of claim 8, further comprising: encrypting the at least one physical condition of the patient prior to communicating the at least one biochemical condition of the patient to the remote controller.

14. The method of claim 8, further comprising: encrypting the updated set of instructions prior to providing the updated set of instructions to the microcontroller.

15. The method of claim 1, further comprising: alerting the patient before a needle stick by a signal originating from the intermittent injection system.

16. The method of claim 15, wherein the signal is transmitted to a mobile telephone.

17. The method of claim 1, further comprising: detaching the intermittent injection system from the patient's body and sterilizing the intermittent injection system for subsequent use.

18. An apparatus for delivery of a first medication and at least a second medication, comprising: a microprocessor; a transceiver, wherein the transceiver is wirelessly connected to a remote controller; a first needle attached to a first reservoir, the first reservoir containing an amount of the first medication, wherein the first needle is driven by a first actuator and the first medication is injected by a first plunger attached to a first motor; at least a second needle attached to at least a second reservoir, the at least second reservoir containing an amount of the at least second medication, wherein the second needle is driven by a second actuator and the second medication is injected by a second plunger attached to a second motor; means attaching the apparatus to a body of a patient.

19. The apparatus of claim 18, wherein the first reservoir and the at least second reservoir are permanently affixed to the apparatus.

20. The apparatus of claim 18, wherein the first reservoir and the at least second reservoir are removable from the apparatus.

21. The apparatus of claim 20, wherein the first reservoir and the at least second reservoir are detachable from the apparatus and attachable to the apparatus at a point of attachment.

22. The apparatus of claim 21, wherein the first reservoir and the at least second reservoir are cartridges of different size.

23. The apparatus of claim 21, wherein the first reservoir and the at least second reservoir are cartridges of different shape.

24. The apparatus of claim 21, further comprising: at least one sensor located at a distance from the point of attachment.

25. The apparatus of claim 24, wherein at least one of the first reservoir and the at least second reservoir contains identifying information readable by the at least one sensor.