Invention for Networked system to interoperable communications and remote monitoring of drug delivery.

Invented by Stephen J. Brown, Robert Bosch Healthcare Systems Inc

The Robert Bosch Healthcare Systems Inc invention works as follows

A networked system that communicates information to patients and allows remote monitoring of the patient. The system contains a server and remote interface that allow the patient to enter a list of questions into the server. The remote interface can be a personal computer connected to the server via an Internet connection. A measurement apparatus is used to provide information about a patient’s treatment and condition. The remote programmable apparatus can also be connected to the server through a communication network such as the Internet. Remotely programmable apparatus communicates with the patient according to a script program that is received from the server. The script generator is used to generate the script program using the queries that were entered via the remote interface. Remotely programmable apparatus receives and executes the script program to communicate with the patient and to receive the answers. The responses are then transmitted to the server. The measurement data may include data about physiological conditions and drug delivery data, which can be used for paperless recording at remote locations.

Background for Networked system to interoperable communications and remote monitoring of drug delivery.

Remote Communication and Monitoring Systems.

Over 100 million Americans have chronic conditions. This accounts for $700 billion annually in medical expenses. Many healthcare providers offer outpatient and home healthcare services to their patients in an attempt to reduce medical costs. These programs can be especially beneficial for patients with chronic illnesses who have to treat their disease on a daily basis. These programs are only possible if healthcare providers can remotely monitor patients to prevent costly and complicated medical issues. The elderly and poor are the most vulnerable patients and require the most efficient and cost-effective monitoring systems.

Prior attempts at remotely monitoring patients included modems and personal computers to establish communication between patients, healthcare providers and patients. Computers are too costly to give away, and patients with computers are just a fraction of the population. Computer owners are often young and well-educated, with good healthcare coverage. These patients don’t have the greatest unmet health needs. Patients with the greatest unmet medical need are those who are poor or elderly and don’t have computers, or are not familiar with using them.

Similar efforts to establish communication between patients, healthcare providers and each other have used the internet and internet terminals. While internet terminals may be more affordable than personal computers, they can still be too costly to hand out to patients.

Moreover, the monthly access fees for on-line access are prohibitive for patients with low income.

Other methods of remotely monitoring patients include the use medical monitoring devices that have built-in modems. These devices can be used to monitor blood glucose, heart rate, and respiratory flow. These monitoring devices can only collect physiological data from patients. These devices do not allow for dynamic and flexible querying of patients for additional information such as quality-of-life measures or psychosocial variables. They do not allow remote monitoring of or recording of the drug doses administered to a patient or self-administered.

Prior attempts at remotely monitoring patients have used interactive telephones or video response systems. These interactive systems are described in U.S. Pat. No. Kirk et al. received 5,390,238. U.S. Pat. No. No. 18, 1995, and U.S. Patent No. No. August 15, 1995. These systems have one drawback: they require patients to call a central facility for monitoring or require that the central facility calls the patient according to a strict monitoring schedule.

If patients are required to call the central center, only compliant patients will call the central facility regularly to be monitored. Patients who are not compliant will wait until an emergency occurs before calling the central facility. This defeats the purpose of the monitoring system. The monitoring system is intruding on the patient’s privacy and causing resistance over time.

Poor patients will also find them prohibitively costly. These systems are also difficult to identify every patient individually. These systems cannot collect medical data from monitors such as heart rate monitors, blood glucose meters, and respiratory flow meters.

Remote Monitoring Drug Delivery

The value of electronic medical records replacing paper records has become widely known in the health care sector. Electronic medical records allow patients and health care professionals to share, store, retrieve and share their medical information much more easily and accurately. Sharing medical information is especially important for treatment programs that involve injections of insulin, human growth hormone, and other medications.

These injections are typically performed with disposable syringes. There is no device that electronically records and measures dose information from disposable syringes. The patient or the health care worker injecting the dose is then required to manually record the dose amount in a logbook.

Due to the frequent injections (often several times per day for diabetics), it is difficult for patients to keep accurate records. Studies have shown that patients’ own records and memories are often inaccurate and incomplete. In an effort to please their doctor, a patient might cheat by making self-recorded entries. This can make patient monitoring difficult over the long-term and could even put the patient at risk.

Efforts have been made in electronic management systems to assist patients with self-administered drugs programs. U.S. Pat. No. Beckers issued No. 5,019,974 which describes a microprocessor-based, hand-held recorder that interfaces to a master computer. A keyboard allows the patient to enter therapy information into his recorder. The display on the recorder allows for patient to see treatment guidelines. A blood glucose meter is also included in the recorder for recording patient’s glucose levels.

Beckers’ recorder does not automatically record and measure doses from disposable syringes. The patient must manually enter dose information into the recorder after injecting a dose using switches or keys. This is a significant improvement over having written records, but the patient’s memories and recordings are still unreliable, so the effectiveness of the drug program will be limited.

There have been attempts to create devices that can deliver predetermined amounts of medication and keep track of the dosage. U.S. Pat. No. Sanderson et. al. received no. 5,176,502 Sanderson et al. published a syringe pump that can be used to expel a predetermined dose of medication from a needle. The syringe pumps include a syringe retentioner to hold the syringe, and a driver to engage the plunger. To expel the medication, an electric motor propels the plunger and driver into the barrel of the syringe.

The monitoring circuit monitors the driver’s movements during medication delivery. A linear potentiometer with an electrically conductive strip made of resistive material is part of the monitoring circuit. The driver’s electrical contact is engaged by the resistive material. The resistive material is placed such that it engages an electrical contact of the driver. This changes the voltage of a monitoring circuit and indicates the position of a plunger within the barrel. The microprocessor compares the voltage signals received from the monitoring circuit to preprogrammed signals in order to determine if the plunger displacement is correct for the delivery of the prescribed dose. The microprocessor has a control mechanism that regulates the driver’s movements to deliver the prescribed dose.

Sanderson’s syringe pump allows electronic recording of dose information. However, it was only intended to inject medication directly into an intravenous vein. It cannot inject patients directly. The syringe pump must push the plunger to record the dose. The syringe pump can’t be used by a healthcare worker to inject patients directly or an outpatient to follow a self-injection program.

U.S. Pat. reveals “Another device to inject a preset amount of medication and record the dose injected.” No. No. 4,950,246 was issued to Muller in August 1990. Muller describes an electric motor-driven, battery-operated injection pen with a pump rod. An electronic control unit controls the electric motor and includes a microprocessor that stores dose information. An electronic control unit is also connected to the injection pen. This sensor can be used to electrically determine the position of the pump rod and the amount of medication being injected.

Though the Muller injection pen measures and electronically records dose information it also has multiple injection pen. This makes it an expensive device that requires complicated electronic equipment to record and deliver doses. The injection pen is also not disposable because it combines a syringe with an electronic recorder. Even if the pen is contaminated with blood, the patient will need to use it again for every injection. Patients who wish to electronically record and measure injection dose information can’t use the injection pen because it is not cost-effective, convenient or hygienic.

U.S. Pat. No. No. The scanners can read bar codes on syringes and ampoules as well as flow meters. This intelligent reader also allows users to weigh a syringe prior to and after an injection in order to record and determine the amount of medicine administered. This data can be printed or displayed as a record.

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