Surgery – Diagnostic testing
Reexamination Certificate
1999-12-30
2002-10-29
Shaver, Kevin (Department: 3763)
Surgery
Diagnostic testing
C128S903000, C128S904000, C128S920000, C604S066000, C607S032000, C607S060000
Reexamination Certificate
active
06471645
ABSTRACT:
THE FIELD OF THE INVENTION
The present invention relates to implantable medical devices (IMDs). Specifically, the invention pertains to a remote bi-directional communications between the IMDs and a drug dispenser. More specifically the invention pertains to a closed loop system in which the IMDs monitor and determine the presence of a specific drug dose in the patient's body to send instructions to the drug dispenser or an interface medical unit (IMU) to implement a drug management scheme based on the monitored data. More specifically, the invention provides a dynamic drug management system in which the drug dose is chronically monitored by the IMDs to enhance drug effectiveness and as well monitor patient compliance with recommended drug administration regimen. The invention preferably utilizes a robust communication system integrated with a remote expert data center in a web-enabled environment to transmit the IMDs' data to a physician for evaluation and review thereby enhancing the delivery of therapy and clinical care remotely.
BACKGROUND OF THE INVENTION
A technology-based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the client with care providers irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modern medical practice, developments in communications technology are making it ever more possible to provide a seamless system of remote patient diagnostics, care and medical services in a time and place independent manner.
Prior art methods of clinical services are generally limited to in-hospital operations. For example, if a physician needs to review the performance parameters of an implantable device in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an implantable device warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Further, if the patient with the IMDs is taking a drug, it is often clinically prudent to monitor the dose and its impact on the patient and, as well, on the IMDs. Such a continued treatment plan poses both economic and social problems. Under the exemplary scenario, as the segment of the population with implanted medical devices increases many more hospitals/clinics including service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to down load the stored data from the implantable medical device. Depending on the frequency of data collection this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed. Further, in medical practice it is an industry-wide standard to keep an accurate record of past and contemporaneous procedures relating to an IMD uplink with, for example, a programmer. It is required that the report contain the identification of all the medical devices involved in any interactive procedure. Specifically, all peripheral and major devices that are used in down linking to the IMD need to be reported. Currently, such procedures are manually reported and require an operator or a medical person to diligently enter data during each procedure. One of the limitations of the problems with the reporting procedures is the fact that it is error prone and requires rechecking of the data to verify accuracy.
A further limitation of the prior art relates to the management of multiple medical devices in a single patient. Advances in modern patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a separate physiologic monitor and various other IMDs may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multi-implants requires a continuous update and monitoring of the devices. As is often the case, patients with multi-implanted medical devices may take a variety of medications. It is therefore necessary to monitor drug intake and its effect on the oprerational and functional parameters of the IMDs. More importantly, chronic monitoring of drug intake and its effect on the physiological and clinical conditions of the patient enables a proactive intervention to change the course of an otherwise serious medical condition. Thus, there is a need to monitor drug delivery and effectiveness via IMDs.
Accordingly it is vital to have a drug dispenser unit that would establish a communication system with IMDs. The unique position of IMDs enables a real-time assessment of physiological conditions which may change or indicate a measurable variance due to drug dose and delivery. IMDs could be adapted to provide measurements relating to the physiological impact of drug therapy. Further, IMDs could be adapted to provide a quick evaluation of the effectiveness of a drug to support a clinical decision as to whether a given dose is a prudent course of therapy.
The proliferation of patients with multi-implant medical devices worldwide has made it imperative to provide remote services to the IMDs and timely clinical care to the patient. Frequent use of programmers to communicate with the IMDs and provide various remote services, consistent with co-pending applications titled “Apparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,” filed on Oct. 26, 1999, Ser. No. 09/426,741; “Tactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,” filed Oct. 29, 1999, Ser. No. 09/430,708; “Apparatus and Method for Automated Invoicing of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/430,208; “Apparatus and Method for Remote Self-Identification of Components in Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429,956; “Apparatus and Method to Automate Remote Software Updates of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. /429,960; “Method and Apparatus to Secure Data Transfer From Medical Device Systems,” filed Nov. 2, 1999, Ser. No. 431,881; “Implantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,” filed Nov. 4, 1999, Ser. No. 433,477; which are all incorporated by reference herein in their entirety, has become an important aspect of patient care. Thus, in light of the referenced disclosures, communication with IMDs enhances the delivery of therapy and clinical care in real time. Specifically, as the number of patients with IMDs increases globally, the need to manage drug delivery and intake remotely becomes an economic imperative. Further, IMDs which are communicable and operable in a web-enabled environment, as contemplated by the cited disclosures hereinabove, provide a unique platform to assess the efficacy of drugs and the compliance of patients with prescribed regimens. Further, it is vital to have a drug dispenser that is adapted to have data communications with the IMDs and other data centers to support the remote patient management system contemplated by the present invention.
The prior art provides various types of remote sensing and communications with an implanted medical device. One such system is,
Ferek-Petric Bozidar
Warkentin Dwight H.
Astorino Michael C
Girma Wolde-Michael
Shaver Kevin
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