Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-08-31
2004-05-11
Layno, Carl (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C128S903000, C607S002000
Reexamination Certificate
active
06735479
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to medical devices and communications systems. Specifically, the invention relates to a method and apparatus that allows a patient to manage and positively affect the onset, time course and severity of various disease conditions. The invention includes an implanted medical device that provides patient data to a home monitoring system, which also has various additional inputs to improve and modify the patient's environment and life style. The patient's implanted device, home monitoring system, and a remote expert station maintain data communication via standard telemetry systems, home network systems such as Bluetooth, HomeRF, or WLAN, and the Internet, worldwide web, intranet, extranet, cellular, or other similar network or communication systems.
BACKGROUND OF THE INVENTION
Lifestyle and environmental factors are major impactors of disease progression, remission, and even onset. For example in “Primary Prevention of Coronary Heart Disease in Women through Diet and Lifestyle”, Stamper, et al, New England Journal of Medicine, Vol 343, No 1, Jul. 6, 2000, pg 16-22 found that 82% of coronary artery disease is attributed to a lack of adherence to a low risk lifestyle (such as, diet, moderate exercise and abstinence from smoking). Additionally, in “Environmental and Heritable Factors in the Causation of Cancer—Analyses of Cohorts of Twins from Sweden, Denmark, and Finland”, Lichtenstein, et al, New England Journal of Medicine, Vol 343, No 2, Jul. 13, 2000, pg 78-85 found that in a study of twins “inherited genetic factors make a minor contribution to susceptibility to most types of neoplasms” and that “the environment has the principal role in causing sporadic cancer”. Lastly, in “Coronary Heart Disease in Women—An Ounce of Prevention”, Nabel, New England Journal of Medicine, Vol 343, No 8, Aug. 24, 2000, pg 572-4 found that “lifestyle related risk factors—specifically, smoking, overweight, lack of exercise and poor diet—(increased) the risk of coronary artery disease”. Women who had none of the risk factors had an 83% reduction in coronary events than the women with one or more risk factors.
We propose that by providing feedback and consoling to patients with implantable medical devices (IMDs, i.e., PCD, pacemaker, neurostimulator, drug pump, ILR, Chronicle monitor, etc.), we can impact environmental factors, diet, exercise level, medicant intake adherence, etc., and provide a substantial proactive, preventative positive impact on the onset, progression and quality of life of many types of cardiac and heart failure patients. Additionally, non-implanted patients may also greatly benefit from this system because the system is adaptable to be used as a preventative tool for those most susceptible to diseases (through heredity, work environment, etc.) or in the beginning stages of a progressive disease.
The concept of home health care began in the 1850's when traveling health care professionals, usually physicians, provided in-home visits to those who were in need of health care and unable to seek such care outside of the home. From the outset, however, traveling between various patients' homes constituted “downtime” for the health care professional. In the middle of the twentieth century, this type of medical service was transferred from the physician to nurses or other health care workers. During the past decade, providing home health care has become more difficult due to the shortage of health care professionals in general and, in particular, of those who provide home health care. Because of this shortage as well as the increase in medical costs, home health care visits are generally limited to basic needs of the most ill patients and/or medical emergencies.
On the other hand, the number of patients who are home bound has been increasing. Many terminally ill patients, such as heart failure or cancer patients among others, are sent home to live with their families who provide 24-hour in-home care. Other patients with chronic health problems reside in their homes where they receive necessary support and treatment on an “as needed” basis. Through the auspices of hospices or other support groups, nurses or health care workers provide medical care and evaluation on a periodic basis—usually a ½ hour visit once or twice a week. Although these visits provide the contracted services, nonetheless they suffer from minimal oversight of a physician-ordered treatment and/or preventative plan.
Additionally, with longevity increases of the past several decades, more elderly people are living longer and developing disease states that are initiated or made more pronounced by the environmental conditions as stated in the herein above listed articles. The ill elderly are often given a treatment plan by their physician that can positively impact their longevity and quality of life if followed correctly and religiously. Often a spouse or adult children must monitor, administer and console the patient's adherence to this plan of treatment. This manual, ad hoc process often is time consuming, confusing, prone to errors and not well administered in many cases.
Patients with implantable medical devices (IMDs) also require regular checkups to determine whether their IMDs have been functioning properly. Most patients with IMDs must be monitored bi-annually, at the very least. Such monitoring may occur transtelephonically from the patient's home or via telemetry as has been disclosed in U.S. Pat. No. 5,752,976 issued to Duffin, et al, “World Wide Patient Location and Data Telemetry System for Implantable Medical Devices”, incorporated herein by reference in its totality. The '976 patent however does not describe a system that provides automatic feedback to a patient to reinforce positive activities and monitor adherence to a physician ordered treatment regime.
Various solutions to these issues, in addition to the '976 patent, have been suggested in the art. U.S. Pat. No. 5,553,609 issued to Chen, et al, “Intelligent Remote Visual Monitoring System for Home Health Care Service” discloses a computer-based remote visual monitoring system connected transtelephonically to a remote master-monitoring computer. This system is intended for use by a visiting nurse during an in-home patient health care visit. Separate audio and visual equipment facilitates communication between the patient's home and a remote station. The '609 patent, however, does not teach a method for continuous monitoring, treatment adherence and consoling patients with IMDs.
A remote visual monitoring system for home health care is disclosed in U.S. Pat. No. 5,553,609 issued to Chen, et al, “Intelligent Remote Visual Monitoring System for Home Health Care Service”. The system has several layers, including units in the patient's home, the caregiver's office, and the supervisory control center. Audiovisual equipment in the patient's home and at the caregiver's office provides two-way communications during a home visit. There is also a provision for generating and maintaining the patient's medical records. U.S. Pat. No. 5,872,923 issued to Schwartz, et al, “Collaborative Video Conferencing System” discloses a video conferencing system, wherein multiple parties at different locations can view, and modify, a common image on their computer displays. The invention also provides a video camera at each computer, which takes a video picture of each party. The systems described in the '609 and '923 patents, however, do not provide for continuous monitoring, treatment adherence and consoling patients with IMDs.
What is needed is a system that provides guidance, monitoring, and feedback to a patient to follow a suggested treatment or therapy plan by his/her physician to allow life style changes that will positively affect their disease onset and/or progression and associated medical problems.
SUMMARY OF THE INVENTION
The present invention enables the capture of non-technical, health-related, exercise activitie
Fabian Willa
Kaufman Hal
Moore David
Thompson David L.
Layno Carl
Medtronic Inc.
Soldner Michael C.
Wolde-Michael Girma
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