Surgery – Diagnostic testing
Reexamination Certificate
1999-04-16
2001-03-13
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C128S903000
Reexamination Certificate
active
06200265
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to physiologic data acquisition and storage in an implantable medical device. More particularly, the present invention pertains to a peripheral memory apparatus for attachment on a patient's skin that cooperates with an internal memory of an implantable medical device to provide for an expanded data storage capability.
BACKGROUND OF THE INVENTION
Various medical devices have been developed that acquire information from one or more physiologic sensors or transducers. A typical physiologic sensor transduces a measurable parameter of the human body, such as blood pressure, temperature, or oxygen saturation, for example, into corresponding electrical signals. In many implantable medical device applications, it is often desirable or necessary to acquire physiologic data for extended periods of time and on a continuous basis. Moreover, in many applications, it is often desirable or necessary to provide for such extended periods of physiologic data acquisition through use of an apparatus that is both convenient for the patient to use and one which does not draw public attention to the patient's condition. It is well understood that conspicuous or easily noticed medical devices and equipment often provide a disincentive for patients to participate in needed testing, evaluation, and therapies.
A problem well known to designers of implantable medical devices, such as pacemakers, for example, concerns the necessity to use low power components, including low power memory components, within the implantable medical device. Use of low power components is considered necessary in order to provided for extended periods of implantable electronic device operation and to reduce the need to repeatedly replace batteries which can only be accomplished through surgical means. As a consequence, conventional implantable medical devices typically employ low voltage, low current memory devices which have limited storage capacity and access speed, and often lag behind the state-of-the-art in memory technology by several years. These and other limitations significantly decrease the data storage and access capability of implantable medical devices, and often precludes the opportunity to integrate high capacity, low cost, state-of-the-art memory devices in implantable medical device designs.
Various implementations of portable or user-worn electrocardiographic recording/monitoring devices are known in the art, examples of which may be found in the issued U.S. Patents listed in Table 1 below.
TABLE 1
Patent No.
Inventor(s)
Issue Date
5,759,199
Snell et al.
Jun. 2, 1998
5,634,468
Platt et al.
Jun. 3, 1997
5,511,553
Segalowitz
Apr. 30, 1996
5,289,824
Mills et al.
Mar. 1, 1994
5,191,891
Righter
Mar. 9, 1993
5,113,869
Nappholz et al.
May 19, 1992
4,622,979
Katchis et al.
Nov. 18, 1986
The patents listed in Table 1 hereinabove are hereby incorporated by reference herein in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, the Detailed Description of Various Embodiments, and the Claims set forth below, many of the devices and methods disclosed in the patents identified below and listed above in Table 1 may be modified advantageously by using the teachings of the present invention.
A conventional portable or user-worn electrocardiographic (ECG) monitor/recorder, such as those disclosed in one or more of the patents listed in Table 1 above, typically requires an external harness to secure the device to a patient during use. Moreover, such conventional ECG monitoring devices are generally conspicuous and readily perceivable by others, and must typically be removed prior to exposure to water or other hostile environments. As was previously described hereinabove, an important and often necessary requirement for providing effective testing and evaluation is ensuring that the monitoring device will be worn by the patient during the entirety of the testing period.
An ECG monitoring/recording device which is conspicuous to onlookers creates a disincentive to wear such devices. Such conventional ECG monitoring devices must also be removed during bathing or swimming, thus interrupting the acquisition of data during these times. Also, conventional ECG monitoring/recording devices are limited in terms of their ability to acquire only electrocardiographic data obtained through contact with the patient's skin.
SUMMARY OF THE INVENTION
The present invention has certain objects. That is, various embodiments of the present invention provide solutions to one or more problems existing in the prior art with respect to the acquisition and storage of physiologic data, particularly physiologic data acquired by an implantable medical device (IMD). Such problems associated with prior art implantable medical device storage approaches include, for example, a limited capacity for storing physiologic and other data, particularly physiologic data acquired on a continuous basis over an extended period of time; the inability to exploit state-of-the-art, high capacity/high speed, low-cost memory technologies; a dependency on sophisticated uplink and data storage systems for extracting physiologic data acquired by an implantable medical device; and the inconvenience associated with requiring a patient to visit a physician location to facilitate uplinking of IMD data on a repeated basis in order to prevent saturation of the IMD memory and possible loss of physiologic data due to IMD memory saturation.
Various embodiments of the present invention have the object of solving at least one of the foregoing problems. While some systems have been able to solve the general problem of storing limited amounts of physiologic data in an implantable medical device, such approaches have generally resulted in implementations that require frequent uplinking of acquired physiologic data to expensive receiving/storing systems and requiring patients to make frequent visits to a physician's office to extract physiologic data stored in the implantable medical device. It is therefore another object of the present invention to provide an improved apparatus and methodology for acquiring and storing physiologic, diagnostic, and other data acquired by an implantable medical device that fulfills at least one of the foregoing objects.
In comparison to known implementations of implantable medical device storage devices, various embodiments of the present invention may provide one or more of the following advantages: providing expanded memory resources for the purpose of storing physiologic and other data acquired or produced by an implantable medical device, providing for the continuous storage of physiologic data acquired by an implantable medical device over an extended period of time, such as on the order of days, increasing the ease by which large amounts of physiologic data may be acquired, providing a comfortable and inconspicuous apparatus for effectively extending the memory capacity of an implantable medical device, eliminating the need for a patient to make repeated visits to a physician's office for the sole purpose of extracting physiologic data stored in an implantable medical device, downloading patch programs which are programmed into IMD random access memory (RAM) to allow functional changes to the implanted device for problem patients, to test and evaluate algorithms, to gather data for research activities, and the like, and allowing all or nearly all of the RAM memory to be used for downloadable patches, with the diagnostic data being stored in the peripheral memory patch.
Some embodiments of the invention include one or more of the following features: a peripheral memory patch apparatus for attachment to a patient's skin which includes a high capacity memory for storing physiologic data uplinked from an implantable medical device; a resilient substrate that provides support for memory and other electronic components which flexes in a complimentary manner in response to a patient's
Thompson David L.
Walsh Kevin K.
Medtronic Inc.
Patton Harold R.
Winakur Eric F.
Wolde-Michael Girma
Woods Thomas F.
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