Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
1999-02-05
2001-06-19
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S347000, C128S903000
Reexamination Certificate
active
06248067
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to Holter-type monitor systems and, in particular embodiments, to devices and methods for Holter-type monitoring of an analyte sensor to determine a characteristic of a body.
BACKGROUND OF THE INVENTION
Over the years, bodily characteristics have been determined by obtaining a sample of bodily fluid. For example, diabetics often test for blood glucose levels. Traditional blood glucose determinations have utilized a painful finger prick using a lancet to withdraw a small blood sample. This results in discomfort from the lancet as it contacts nerves in the subcutaneous tissue. The pain of lancing and the cumulative discomfort from multiple needle pricks is a strong reason why patients fail to comply with a medical testing regimen used to determine a change in characteristic over a period of time. Although non-invasive systems have been proposed, or are in development, none to date have been commercialized that are effective and provide accurate results. In addition, all of these systems are designed to provide data at discrete points and do not provide continuous data to show the variations in the characteristic between testing times.
A variety of implantable electrochemical sensors have been developed for detecting and/or quantifying specific agents or compositions in a patient's blood. For instance, glucose sensors have been developed for use in obtaining an indication of blood glucose levels in a diabetic patient. Such readings are useful in monitoring and/or adjusting a treatment regimen which typically includes the regular administration of insulin to the patient. Thus, blood glucose readings improve medical therapies with semi-automated medication infusion pumps of the external type, as generally described in U.S. Pat. Nos. 4,562,751; 4,678,408; and 4,685,903; or automated implantable medication infusion pumps, as generally described in U.S. Pat. No. 4,573,994, which are herein incorporated by reference. Typical thin film sensors are described in commonly assigned U.S. Pat. Nos. 5,390,671; 5,391,250; 5,482,473; and 5,586,553 which are incorporated by reference herein. See also U.S. Pat. No. 5,299,571. However, the monitors for these continuous sensors provide alarms, updates, trend information and require sophisticated hardware to allow the user to program the monitor, calibrate the sensor, enter data and view data in the monitor and to provide realtime feedback to the user. This sophisticated hardware makes it most practical for users that require continuous monitoring with feedback to maintain tight control over their conditions. In addition, these systems require the user to be trained in their use, even if to be worn for short periods of time to collect medical data which will be analyzed later by a doctor.
Doctors often need continuous measurements of a body parameter over a period of time to make an accurate diagnosis of a condition. For instance, Holter monitor systems are used to measure the EKG of a patient's heart over a period of time to detect abnormalities in the heart beat of the patient. Abnormalities detected in this manner may detect heart disease that would otherwise go undetected. These tests, while very useful are limited to monitoring of bio-mechanical physical changes in the body, such as a heart beat, respiration rate, blood pressure or the like.
SUMMARY OF THE DISCLOSURE
It is an object of an embodiment of the present invention to provide an improved Holter-type monitor system with an analyte sensor set and monitor connection device, which obviates for practical purposes, the above mentioned limitations.
According to an embodiment of the invention, a Holter-type monitor system includes a remotely located data receiving device, an analyte sensor for producing signal indicative of a characteristic of a user, and a Holter-type recording device. In preferred embodiments, the Holter-type recording device includes a housing, a sensor connector, a processor, and a data port. The sensor connector receives the produced signals from the analyte sensor. The processor is coupled to the sensor connector and stores the signals from the analyte sensor for delivery to the remotely located data receiving device. The download data port of the Holter-type recording device is coupled to the processor for downloading the stored signals to the remotely located data receiving device through the data port. In preferred embodiments, the data receiving device is a characteristic monitor. However, in other embodiments, the data receiving device is a data receiver that provides data to another device, an RF programmer, a medication delivery device (such as an infusion pump), or the like. In particular embodiments, the data port of the Holter-type recording device downloads the stored signals by radio frequencies, infrared emissions, or the like. Additional embodiments may include data storage memory and interface controls.
In particular embodiments, the analyte sensor is an implantable, percutaneous or skin surface analyte sensor, and the sensor connector of the Holter-type recording device includes a cable that is connected to the implantable, percutaneous or skin surface analyte sensor. Also, the analyte sensor can be configured for a wired connection to a characteristic monitor, and the sensor connector of the Holter-type recording device is formed to connect to the configured analyte sensor. Still further embodiments of the Holter-type recording device include a receiver to receive data and instructions from the remotely located data receiving device, or the like.
Embodiments of the Holter-type recording device may include a bio-compatible adhesive to secure the housing to a skin surface of the user. Preferably, the housing of the Holter-type recording device is less than about 1.5 inches in diameter by 0.25 inches thick. In addition, the housing is resistant to fluids when immersed in a fluid, and operable in a temperature range of 0° C. to 50° C. The Holter-type recording device may also include a power source that has an operable life of at least 2 weeks.
Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.
REFERENCES:
patent: 4494950 (1985-01-01), Fischell
patent: 5417222 (1995-05-01), Dempsey et al.
patent: 5507288 (1996-04-01), Bocker et al.
patent: 5569186 (1996-10-01), Lord et al.
patent: 5665065 (1997-09-01), Colman et al.
patent: 5701894 (1997-12-01), Cherry et al.
patent: 6103033 (2000-08-01), Say et al.
patent: 6134461 (2000-10-01), Say et al.
patent: 0880936 (1998-12-01), None
patent: 9401039 (1994-01-01), None
patent: 9956613 (1999-11-01), None
T. Arai, et al., “A Portable Transcutaneous Blood Glucose Monitoring System Using Non-Invasive Collection of Suction Effusion Fluid from Skin”,IEEE, pp. 812-813 (1994).
Causey, III James D.
Kovelman Paul H.
Mastrototaro John J.
Purvis Richard E.
MiniMed Inc.
MiniMed Inc.
Winakur Eric F.
LandOfFree
Analyte sensor and holter-type monitor system and method of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Analyte sensor and holter-type monitor system and method of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Analyte sensor and holter-type monitor system and method of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2504422