Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
1999-01-29
2001-01-09
Cohen, Lee (Department: 3739)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S386000, C600S393000
Reexamination Certificate
active
06173198
ABSTRACT:
FIELD OF THE INVENTION
This invention relates in general to biomedical monitoring, and more particularly to a method and apparatus for use in accurately placing biomedical sensor electrodes upon a patient's body for electrocardiographic recordings and the like.
BACKGROUND OF THE INVENTION
Analytical diagnostics which are made by utilization of electrocardiograms (ECGs) have been generally used for diagnosis and monitoring of various forms of cardiopathologies, such as for patients with implanted pacemakers. As one of existing electrocardiographs, there has been widely used the so-called trans-telephonic monitor for use in trans-telephonic medicine, i.e. the reading of data to be sent, e.g. over the telephone line, to a special facility where the diagnosis is performed remotely at a central facility, such as described in U.S. Pat. No. 5,321,618 to Gessman for “Apparatus and Method for Remotely Monitoring Implanted Cardioverter Defibrillators”, issued Jun. 14, 1994. This is especially useful for the long-term monitoring of patients, with e.g. heart trouble, because it reduces the need for the patient to go to a clinic or hospital. Trans-telephonic medicine and home monitoring is also useful for the control of patients, with e.g. heart trouble, residing in localities without adequate medical facilities.
In the art of electrocardiographic recordings, one of the essential conditions for successful recording is the correct biomedical sensor electrode positioning on the body. Incorrect biomedical sensor electrode positioning can make diagnosis and treatment difficult or erroneous. Typically a specially trained health care professional will demonstrate to a patient the correct placement of the biomedical sensor electrodes. The patient is then expected to be able to correctly position the biomedical sensor electrodes. This can be a problem because patients must remember the correct placement sites, often after a significant amount of time has passed since the initial demonstration.
Each human body is unique, and the placement sites for biomedical sensors vary among individuals. Incorrect electrocardiographic recordings can result if the template is not adaptable to each individual patient. Use of an adjustable vest with built-in biomedical sensor electrodes to provide for correct positioning of the biomedical sensor electrodes has been known in the art. Examples of vests with built-in biomedical sensor electrodes include U.S. Pat. No. 5,224,479 to Sekine for “ECG Diagnostic Pad”, issued Jul. 6, 1993, and U.S. Pat. No. 5,445,149 to Rotolo et al. for “Electrocardiography Electrode Positioning Device”, issued Aug. 29, 1995. The vests known in the art also can be uncomfortable. The vests are more intrusive than just biomedical sensor electrodes because they must surround the entire torso to achieve accurate biomedical sensor electrode placement. The vests must also fit the torso tightly to achieve consistent placement of biomedical sensor electrodes.
It would be desirable to provide an inexpensive technique for repetitive and accurate placement of biomedical sensor electrodes for medical diagnosis and at-home patient monitoring. For the foregoing reasons, there is a need for an inexpensive, adaptable technique that can be used as a reference for the accurate placement of sensors upon an individual human body, which also facilitate subsequent placement of such biomedical sensor electrodes.
SUMMARY OF THE INVENTION
The present invention is directed to an apparatus that satisfies the need for assistance in accurate sensor placement by the at-home patient, to this end a template may be used as a reference for the accurate placement of sensors upon the human body.
The apparatus may include an adaptable template which may be used for accurate placement of biomedical sensor electrodes, the template has a template frame that may be positioned, e.g., with respect to at least one anatomical site on the human body, such as the sternal notch. At least one template arm may be connectable to the template frame. The template arms extend from the placement sites for the biomedical sensor electrodes to the template frame. The lengths of the template arms and the template frame then can be adjusted to provide accurate referencing for the correct placement of biomedical sensor electrodes upon an individual patient.
The apparatus and method described in this manner may thus adapt to each unique human individuals' body. The distance between the desired placement site of the sensors and the template frame can be adjusted by trimming the template arm to the necessary length. By defining the distance between the placement site of the sensors and the template frame, and then referencing the template frame to the unique anatomy of an individual patient, the accurate placement of sensors is achieved.
Unlike vests used for positioning biomedical sensor electrodes, the adjustable template is inexpensive and has the advantage of using standard sensors. The use of standard electrodes reduces the cost of the apparatus. The use of a template is further distinguished from vests because the vests must be worn. The template is not worn and therefore reduces patient discomfort.
Briefly summarized, the present invention relates to a positioning device for the accurate placement of biomedical sensor electrodes. The positioning device in a preferred embodiment has a template frame and one or more template arms. The template frame is able to be referenced to at least one anatomical site upon the human body, such as the sternal notch or the navel. Template arms extend from the template frame to the biomedical sensor electrode positioning site. The length of the template arms corresponds to the distance from the template frame to the biomedical sensor electrode positioning site. The template arms reference the biomedical sensor electrode positioning sites with respect to the template frame. The template frame references the template arms with respect to anatomical sites upon the human body. In this manner, a positioning device is provided for the correct placement of biomedical sensor electrodes upon an individual human body.
These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings.
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patent: 4583549 (1986-04-01), Manoli
patent: 4957109 (1990-09-01), Groeger et al.
patent: 5042481 (1991-08-01), Suzuki et al.
patent: 5184620 (1993-02-01), Cudahy et al.
patent: 5224479 (1993-07-01), Sekine
patent: 5321618 (1994-06-01), Gessman
patent: 5445149 (1995-08-01), Rotolo et al.
patent: 5678545 (1997-10-01), Stratbucker
patent: 5865741 (1999-02-01), Kelly et al.
Bui Tuan
Deckert Clint
Schulze Arthur E.
Baxter International Inc.
Cohen Lee
Gryzlo Matthew J.
Wallenstein & Wagner
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