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.
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 xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708; xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,208; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,956; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systems,xe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881; xe2x80x9cImplantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,xe2x80x9d filed Nov. 4, 1999, Ser. No. 09/433,477; 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, for example, disclosed in Funke, U.S. Pat. No. 4,987,897 issued Jan. 29, 1991. This patent discloses a system that is at least partially implanted into a living body with a minimum of two implanted devices interconnected by a communication transmission channel. The invention further discloses wireless communications between an external medical device/programmer and the implanted devices.
One of the limitations of the system disclosed in the Funke patent includes the lack of communication between the implanted devices, including the programmer, with a remote clinical station. If, for example, any assessment, monitoring or maintenance is required to be performed on the IMD the patient will have to go to the remote clinic station or the programmer device needs to be brought to the patient""s location. More significantly, the operational worthiness and integrity of the programmer cannot be evaluated remotely thus making it unreliable over time as it interacts with the IMD. Further, in light of the present invetion, the Funke patent does neither suggest nor disclose the communications system between the IMD and a drug dispenser to monitor and assess in the effectiveness of the dose based on the physiological status of the patient.
Yet another example of drug management based on smart drug dispenser units is disclosed by Martindale et al in U.S. Pat. No. 4,360,125 issued on Nov. 23, 1982. In the disclosure, a medication dispenser in which medication to be dispensed is housed including a member operable to allow medication access. The dispenser provides a medication alert signal at preselected times in accordance with a desired medication regimen. A medication access signal is provided when medication access is obtained. Data representative of the relative timing between a medication alert signal and a medication access signal is written into readable memory whereby that data is available to a physician for evaluation. In the preferred embodiment, the data is representative of the time of occurrence of each medication alert signal and medication access signal. The interval between medication alert signals is selectively alterable.
Further, examples of drug management based on smart drug dispensers are disclosed in U.S. Pat. Nos. 4,768,176; 4,768,177; 5,200,891; 5,642,731; 5,752,235 and 5,954,641 all to Kehr et al. Generally all the patents relate to a drug dispensing system with various alert features to monitor and manage the administration of medication and medical treatment regimens. None of these patents suggest or disclose a communication between the drug dispensing systems and an IMD.
Yet another prior art reference provides a multi-module medication delivery system as disclosed by Fischell in U.S. Pat. No. 4,494,950 issued Jan. 22, 1985. The disclosure relates to a system consisting a multiplicity of separate modules that collectively perform a useful biomedical purpose. The modules communicate with each other without the use of interconnecting wires. All the modules may be installed intracorporeal or mounted extracorporeal to the patient. In the alternate, some modules may be intracorporeal with others being extracorporeal. Signals are sent from one module to the other by electromagnetic waves. Physiologic sensor measurements sent from a first module cause a second module to perform some function in a closed loop manner. One extracorporeal module can provide electrical power to an intracorporeal module to operate a data transfer unit for transferring data to the external module.
The Fischell disclosure provides modular communication and cooperation between various medication delivery systems. However, the disclosure does not provide an external pill dispenser which is in wireless communications with IMDs. Further, the system does neither teach nor disclose an external programmer for telemetrically interacting with the pill dispenser.
Accordingly, it would be advantageous to provide a pill dispenser that communicates with IMDs to implement an effective drug management system. Yet another desirable advantage would be to provide a high speed communications scheme to enable the transmission of high fidelity sound, video and data to advance and implement efficient remote drug management of a clinical/therapy system via a programmer thereby enhancing patient clinical care. As discussed herein below, the present invention provides these and other desirable advantages.
The present invention generally relates to a communications scheme in which a remote web-based expert data center interacts with a patient having one or more implantable medical devices (IMDs) via an associated external medical device, preferably a programmer, located in close proximity to the IMDs. The IMDs are adapted to communicate with a pill dispenser to monitor and log pill deposition and effectiveness. Some of the most significant advantages of the invention include the use of various communications media between the remote web-based expert data center and the programmer to remotely exchange clinically significant information and ultimately effect real-time drug intake and prescriptive changes as needed.
One of the many aspects of the present invention includes a real-time access of a programmer or a pill dispenser to a remote web-based expert data center, via a communication network, which includes the Internet. The operative structure of the invention includes the remote web-based expert data center, in which an expert system is maintained, having a bi-directional real-time data, sound and video communications with the programmer via a broad range of communication link systems. The programmer is in turn in telemetric communications with the IMDs such that the IMDs may uplink to the programmer or the programmer may down link to the IMDs, as needed.
Yet another feature of the invention includes a communications scheme that provides a highly integrated and efficient method and structure of clinical information management in which various networks such as Community access Television, Local area Network (LAN), a wide area network (WAN) Integrated Services Digital Network (ISDN), the Public Switched telephone Network (PSTN), the Internet, a wireless network, an asynchronous transfer mode (ATM) network, a laser wave network, satellite, mobile and other similar networks are implemented to transfer voice, data and video between the remote data center and a programmer. In the preferred embodiment, wireless communications systems, a modem and laser wave systems are illustrated as examples only and should be viewed without limiting the invention to these types of communications alone. Further, in the interest of simplicity, the applicants refer to the various communications system, in relevant parts, as a communications system. However, it should be noted that the communication systems, in the context of this invention, are interchangeable and may relate to various schemes of cable, fiber optics, microwave, radio, laser and similar communications or any practical combinations thereof.
Some of the distinguishing features of the present invention include the use of a robust web-based expert data center to collect drug therapy information based on data communication between the IMDs, the pill dispenser and the programmer. Specifcally the invention enables remote evaluation of drug performance in a patient. Although the present invention focuses on the remote real-time monitoring and management of drug therapy information, the system could advantageously be used to monitor clinical trials of drugs or collect clinical data relating to drug interaction or physiological impact of various doses on the patient.
Yet one of the other distinguishing features of the invention includes the use a highly flexible and adaptable communications scheme to promote continuous and real-time communications between a remote expert data center, a programmer and a pill dispenser associated with a plurality of IMDs. The IMDs are structured to share information intracorporeally and may interact with the programmer or the pill dispenser as a unit. Specifically, the IMDs either jointly or severally can be interrogated to implement or extract clinical information as required. In other words, all of the IMDs may be accessed via one IMD or, in the alternate, each one of the IMDs may be accessed individually. The information collected in this manner may be transferred to the data center via the programmer or pill dispenser by up linking the IMDs as needed.
The invention provides significant compatibility and scalability to other web-based applications such as telemedicine and emerging web-based technologies such as tele-immersion. For example, the system may be adapted to webtop applications in which a webtop unit may be used to uplink the patient to a remote data center for drug information exchange between the IMDs and the remote expert data center. In these and other web-based similar applications the data collected, in the manner and substance of the present invention, may be used as a preliminary screening to identify the need for further intervention using the advanced web technologies.
More significantly, the invention provides a system and method to remotely monitor drug effectiveness in a patient. Further, the invention enables a chronic evaluation of drugs in a patient on real time basis. The significance of this method includes the fact that the data collected in this manner could be used to influence the course of drug therapy.