WO1999008593A1 - Precordial overlay having electrode assemblies - Google Patents
Precordial overlay having electrode assemblies Download PDFInfo
- Publication number
- WO1999008593A1 WO1999008593A1 PCT/US1998/016799 US9816799W WO9908593A1 WO 1999008593 A1 WO1999008593 A1 WO 1999008593A1 US 9816799 W US9816799 W US 9816799W WO 9908593 A1 WO9908593 A1 WO 9908593A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- electrode
- cut
- overlay
- precordial overlay
- electrode assembly
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/282—Holders for multiple electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6831—Straps, bands or harnesses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/684—Indicating the position of the sensor on the body
- A61B5/6841—Indicating the position of the sensor on the body by using templates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
- A61B2560/0412—Low-profile patch shaped housings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
- A61B2562/182—Electrical shielding, e.g. using a Faraday cage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
- A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
Definitions
- This invention relates to a precordial overlay having electrode assemblies used with electrocardiographs to perform an electrocardiographic analysis on a patient. More particularly, the invention relates to a precordial overlay having electrode assemblies to quickly and properly position on the patient electrodes which lead to the electrocardiograph.
- An electrocardiograph is a diagnostic instrument widely used in the medical field. Electric pulses generated by an individual's heart are transformed by the electrocardiograph to a recording on paper or a monitor screen to obtain an electrocardiogram, commonly referred to as an ECG. A trained medical personnel is able to interpret the ECG and detect any abnormality in the individual ' s heart . Obtaining an ECG from a patient is a standard procedure used in most routine physical examinations. Emergency medical personnel, e.g. paramedics also are often called upon to obtain an ECG from an individual who has experienced chest pains. It is necessary for the medical personnel to quickly perform the test and follow standard emergency procedures depending on the test results.
- the results in the form of the ECG are transmitted by cellular telemetry to a trained physician.
- the physician uses the test results to instruct the medical personnel on emergency procedures to be undertaken immediately or possibly to alert hospital personnel to prepare for an incoming patient.
- Prehospital thrombolytic screening by emergency medical personnel is well recognized in the medical field as an invaluable aid to saving lives.
- Electrodes which are placed on the patient as a part of obtaining an ECG be properly positioned. Mispositioned electrodes can alter ECG tracings and lead to possible errors in a diagnosis. Current procedures in most locales require that twelve electrodes be properly positioned at various locations on the patient. Positioning of the twelve electrodes by the technician in the physician's office is time consuming, but with patience can be correctly done. The emergency medical personnel who is working under more stressful conditions, however, has a much more difficult time in quickly and precisely positioning the individual electrodes.
- U.S. Patent Nos. 4,854,323 and 5,341,806 disclose electrode strips which are flexed to follow the patient's chest contour and seemingly to position each electrode in the proper anatomical location.
- U.S. Patent Nos. 5,224,479 and 5,445,149 disclose harness-type devices which strap onto the patient's chest. Associated electrodes are said to be properly positioned.
- U.S. Patent Nos. 4,121,575, 4,498,480 and 4,593,698 disclose articles which are intended to properly position six electrodes on the patient's chest. Means are provided to fine adjust the precise locations of the six electrodes. It is apparent, though, that quick and reliable electrode positionings are not easily accomplished with the known articles, especially by emergency medical personnel who must work under stressful conditions.
- a precordial overlay used by medical personnel facilitates the quick and precise positioning of electrode assemblies on a patient.
- the overlay is an elongated band configured to lie flat on the patient's chest.
- a set of the electrode assemblies is adjustably mounted on the band.
- the elongated band has a first generally rectangular-shaped section, a second generally rectangular-shaped section, and an intermediate section connecting together the first and second sections. The sections slidably hold the electrode assemblies.
- Electrode assemblies of the invention comprise an electrode, an underlying non- conductive pad secured to the electrode, and an overlying semi-rigid plastic sheet securely fixed to the electrode with peripheral areas of the plastic sheet unattached for limited movement.
- an adhesive layer further underlies the non-conductive pad. All the electrode assemblies are capable of limited adjusting movement in their respective sections of the elongated band prior to use.
- the overlay's configuration is conducive to a medical personnel placing it on a patient's chest so that its associated electrode assemblies are all in the approximate correct locations for an electrocardiographic test.
- a series of quick manual manipulations of the electrode assemblies positions each electrode in the precise location for the test.
- FIG. 1 is an environmental view of a precordial overlay having six electrode assemblies which is lying on a prone patient's chest and in position for an electrocardiographic test .
- FIG. 2 is a top plan view of the precordial overlay of FIG. 1.
- FIG. 3 is a view in section of an electrode assembly taken along line 3-3 of FIG. 2.
- FIG. 4 is an exploded view of the electrode assembly of FIG. 3.
- the precordial overlay having electrode assemblies of the invention is used for quick and proper placement of electrodes on a patient who is having an electrocardiographic test performed.
- the precordial overlay and electrode assemblies are primarily used by emergency medical personnel who often must quickly obtain an ECG. They can as well be used by medical personnel in a doctor's office setting as part of a routine physical examination.
- the precordial overlay is depicted in the figures. It comprises an elongated band shaped to overlie a patient's chest and a plurality of electrode assemblies.
- the electrode assemblies are adjustably mounted on the elongated band.
- five electrode assemblies are slidably positioned in linear cut-outs while one electrode assembly is slidably positioned in a circular cut-out.
- the precordial overlay's configuration allows emergency medical personnel to place the elongated band onto the patient's chest in the correct gross approximate location and then readily fine adjust the individual electrode assemblies with their electrodes in precise chest locations.
- Electrodes used in conventional twelve lead electrocardiographic tests are not shown in FIG. 1. As well known, they are individually positioned at more remote body locations as currently done and are not a part of the invention.
- the precordial overlay 10 comprises an elongated band 11 and six electrodes identified by their medical nomenclature as V1-V6.
- the electrode assemblies of the invention as described in detail below include the electrodes V1-V6.
- the band 11 is thin and substantially flat. It is also sufficiently flexible to follow the contour of a patient's chest. As best seen in FIG. 2, it has a first generally rectangular-shaped section 12, a second generally rectangular-shaped section 13 and an intermediate section 14. The two generally rectangular-shaped sections are off-set from one another and extend in the same longitudinal direction.
- the intermediate section 14 connects the first and second generally rectangular-shaped sections 12 and 13.
- the shape of the band generally coincides with the area of the chest where the electrodes VI -V6 must be positioned to obtain a reliable ECG.
- the exact size of the elongated band is dependent on the size of the patient being tested, taking into consideration sex, age and body weight. Generally, because of the electrodes adjustability as described below, two sizes of the precordial overlay are adequate. A larger size is used for adults and a smaller size is used for children under the age of 14. Routine experimentation only is needed to determine the exact dimensions of the elongated band to meet its stated objectives.
- the elongated band forming a part of the precordial overlay is made of a non-conductive material.
- a synthetic polymeric film is preferred because of its low material cost and capability of being given a desired shape by mass production techniques such as die-cutting.
- the precordial overlay of the invention is disposable primarily because the elongated band is capable of being produced at a reasonable cost.
- Polyethylene, polypropylene, polyvinylchloride, polyacrylate, polytetrafluoroethylene, nylon and polyester are examples of suitable polymeric films.
- a polyester film available as Mylar is particularly preferred.
- Discreet cut-outs are provided in the body of the elongated band to accommodate the electrodes .
- Linear cut-outs 15 and 16 in the first generally rectangular- shaped section 12 are configured to receive electrodes VI and V2 and allow them to laterally slide for precise positioning purposes.
- the cut-outs 15 and 16 are approximately centered in the first section 12 and run in the same lateral direction. One cut-out can be used in place of the two cut-outs, though is less preferred.
- Each cut-out 15 and 16 has a length to allow at least about 1.0 inch (2.54 cm) of electrode lateral movement.
- the cut-outs 15 and 16 are each about 1.5 inches (3.81 cm) to about 2.5 inches (6.35 cm) long and about 0.5 inches (1.27 cm) to about 1.0 inches (2.54 cm) wide.
- Linear cut-outs 17, 18 and 19 in the second generally rectangular-shaped section 13 are configured to receive electrodes V4 , V5 and V6 in a manner which allows them to slide within their respective cut-out until properly positioned for the particular patient.
- Cut-outs 17, 18, and 19 each have a length to allow at least about 1.0 inch (2.54 cm) of electrode lateral movement.
- cut-out 17 is about 1.5 inches (3.81 cm) to about 2.0 inches (5.08 cm) long.
- cut-out 18 is about 1.5 inches (3.81 cm) to about 2.5 inches (6.35 cm) long.
- cut-out 19 is about 1.5 inches (3.81 cm) to about 5.5 inches (13.97 cm) long. All three cut-outs are about 0.5 inches (1.27 cm) to about 1.0 inches (2.54 cm) wide.
- Each cut-out allows only limited lateral movement of its associated electrode.
- One cut-out extending the length of cut-outs 17-19 can be used instead of the three cut-outs 17-19.
- the three separate cut- outs are preferred to provide added precision in positioning of each of the electrodes V4 , V5 and V6.
- the cut-out 20 (shown in dotted line form) in the intermediate section 14 is dimensioned to receive an electrode and slidably hold it in position.
- the cut- out 20 is generally circular in shape with an about 0.5 inches (1.27 cm) to about 1.5 inches (3.81 cm) diameter. This relatively small cut-out is sufficient to allow limited movement of the electrode V3 in two directions .
- the cut-outs 15 and 16 in the first section 12 overlie the patient's fourth rib and the cut-outs 17-19 in the second section 13 overlie the patient's fifth rib.
- the cut-out 20 in the intermediate section 14 overlies an intercostal area between the fourth and fifth ribs or slightly overlies the fifth rib.
- each of the electrodes V1-V6 is a part of an electrode assembly 24.
- Each electrode assembly 24 is designed to move within one of the cut-outs of the precordial overlay described above.
- the assemblies also include an underlying non-conductive pad 29 and an overlying clear plastic sheet 30.
- an underlying adhesive layer 31 and a backing strip 32 are found on the electrode assembly 24 to hold the assembly to the patient during use.
- Each of the components of the electrode assembly 24 is described in detail below.
- the vertically extending conductive metal post 25 receives a cap head 28 of a lead or wire which is connected to the electrocardiograph.
- the post has a diameter less than the width of a cut-out in the precordial overlay. This facilitates grasping the electrode and manually moving the electrode assembly in the cut-out.
- the lower conductive plate 26 can take on different forms. It can, for example, be a flat metal disc as shown.
- the post 25 and plate 26 can be an integral unit or separate components joined together.
- the underlying foam disk 27 is secured to an underside of the conductive plate. It is used for comfort reasons in that it is the part of the electrode that contacts the patient's skin during the electrocardiographic test.
- the disk 27 is substantially saturated with a conducting gel. Still with reference to FIG.
- the electrode V4 illustrated is mounted on a non-conductive pad 29 for ease of handling purposes.
- the pad has a width greater than that of the cut-out with which it is associated.
- the pad 29 has an approximately centered circular cut-out 34.
- the cutout provides a communication means between the conductive plate 26 and the patient.
- the foam disk 27 with the conductive gel covers the underside of the plate 26, the circular cutout 34 is needed to receive the foam disk 27.
- the pad 29 itself is preferably a foam material.
- a clear plastic sheet layer 30 overlies the non- conductive pad 29 and surrounds the metal post 25 of the electrode. Its width also is greater than that of the precordial overlay cut-out with which it is associated.
- the plastic sheet 30 is secured to the pad 29 at the conductive plate 26 only, such that its peripheral areas are free or unattached.
- the plastic sheet's function is to provide a means to slidably hold the pad 29 and its associated electrode V4 in the cut- out 17.
- a semi-rigid plastic sheet is optimum for this purpose.
- the electrode V4 extends up through the cutout 17. Its associated pad 29 on the underside of the cut-out 17 and the associated plastic sheet 30 on the topside of the cut-out 17 in effect trap the electrode within the cut-out 17 of the precordial overlay 11 while allowing a sliding movement.
- An adhesive means is provided to temporarily hold the precordial overlay to the patient's chest during use.
- a series of self-stick adhesive strips can be used on the precordial overlay's topside to extend off its peripheral edges and onto the patient's chest. This allows the overlay to be taped to the patient once the overlay is in its proper approximate location.
- a self-stick adhesive can be provided on the underside of the precordial overlay.
- the adhesive can cover or appear as strategically placed patches on the underside of the elongated band 11. More preferably and as illustrated, the adhesive is a part of the electrode assembly 24. The adhesive is found on the underside of at least some of the individual non- conductive pads.
- an adhesive layer 31 extends up to and surrounds the underlying foam disk 27 of the electrode V .
- a removable full piece or two part split backing strip 32 is used to protect the adhesive layer during shipping and storage.
- the backing 32 is removed to expose the adhesive layer 31.
- numeric scales 33 are printed onto the elongated band 11 of the precordial overlay. The scales are located just below the cut-outs 15 and 16 in the first generally rectangular-shaped section 12 and below the cut-outs 17-19 in the second generally rectangular- shaped section 13. The numeric scales are used to record precise electrode placements in case a second reading is needed to verify an initial ECG.
- the medical emergency personnel initially and temporarily positions the elongated band of the precordial overlay 10 on a patient using well known anatomical landmarks, e.g. a sternum notch.
- the VI and V2 electrodes are first adjusted for the particular patient.
- the V4-V6 electrodes are adjusted.
- the adjustments are made by placing the elongated band onto or at least near the patient's chest. Once the six electrodes are positioned and adjustments made, the backing is removed from the adhesive layer on the underside of each of the pads to expose the adhesive layers.
- the elongated band is then placed on the patient where it remains until the ECG is obtained.
- the precordial overlay and electrode assemblies are discarded.
- the precordial overlay and the electrode assemblies serve a very real need, especially in the emergency medical field. Paramedics and other medical personnel can be trained in proper use of the overlay in a relatively short time. Proper placement of electrode assemblies with their electrodes V1-V6 on a patient by a properly trained medical personnel is assured. Furthermore, repeatable ECG test results are a near certainty.
- the precordial overlay and electrode assemblies are inexpensive to produce and, resultingly, can be discarded after only one use. This disposable nature of the overlay and assemblies eliminates any concern for sanitation in that it is not necessary to clean the product after use.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU91043/98A AU9104398A (en) | 1997-08-15 | 1998-08-13 | Precordial overlay having electrode assemblies |
EP98943197A EP1003417B1 (en) | 1997-08-15 | 1998-08-13 | Precordial overlay having electrode assemblies |
CA002300141A CA2300141A1 (en) | 1997-08-15 | 1998-08-13 | Precordial overlay having electrode assemblies |
DE69832388T DE69832388T2 (en) | 1997-08-15 | 1998-08-13 | BODY COVER WITH ELECTRODE ARRANGEMENTS |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/911,818 US5995861A (en) | 1996-08-16 | 1997-08-15 | Precordial overlay for positioning electrocardiograph electrodes |
US08/911,818 | 1997-08-15 | ||
US09/113,417 | 1998-07-10 | ||
US09/113,417 US6141575A (en) | 1996-08-16 | 1998-07-10 | Electrode assemblies |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999008593A1 true WO1999008593A1 (en) | 1999-02-25 |
Family
ID=26811031
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/016799 WO1999008593A1 (en) | 1997-08-15 | 1998-08-13 | Precordial overlay having electrode assemblies |
Country Status (6)
Country | Link |
---|---|
US (1) | US6141575A (en) |
EP (2) | EP1003417B1 (en) |
AU (1) | AU9104398A (en) |
CA (1) | CA2300141A1 (en) |
DE (1) | DE69832388T2 (en) |
WO (1) | WO1999008593A1 (en) |
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US5928142A (en) * | 1996-12-17 | 1999-07-27 | Ndm, Inc. | Biomedical electrode having a disposable electrode and a reusable leadwire adapter that interfaces with a standard leadwire connector |
US5921925A (en) * | 1997-05-30 | 1999-07-13 | Ndm, Inc. | Biomedical electrode having a disposable electrode and a reusable leadwire adapter that interfaces with a standard leadwire connector |
-
1998
- 1998-07-10 US US09/113,417 patent/US6141575A/en not_active Expired - Lifetime
- 1998-08-13 DE DE69832388T patent/DE69832388T2/en not_active Expired - Fee Related
- 1998-08-13 EP EP98943197A patent/EP1003417B1/en not_active Expired - Lifetime
- 1998-08-13 WO PCT/US1998/016799 patent/WO1999008593A1/en active IP Right Grant
- 1998-08-13 CA CA002300141A patent/CA2300141A1/en not_active Abandoned
- 1998-08-13 EP EP05024420A patent/EP1637074A1/en not_active Withdrawn
- 1998-08-13 AU AU91043/98A patent/AU9104398A/en not_active Abandoned
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0396048A1 (en) * | 1989-05-01 | 1990-11-07 | Medard Limited Company | Electrocardiographic electrode assembly |
EP0562208A1 (en) * | 1991-12-27 | 1993-09-29 | Juan Hernandez Herrero | Chest-piece for positioning ECG electrodes |
DE4210684A1 (en) * | 1992-04-02 | 1993-10-07 | Bernd Fink | Electrode system for electrocardiographs with load selector and ECG leads - has leads connected respectively to ECG electrodes, and amplifier and recorder and leads positioned on breast shield provided with slits |
DE9316259U1 (en) * | 1993-10-25 | 1994-02-10 | Arbo Robotron Medizin Technolo | Biomedical electrode |
WO1997004703A1 (en) * | 1995-07-28 | 1997-02-13 | Cardiotronics International, Inc. | Disposable electro-dermal device |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2055231A1 (en) * | 2007-10-31 | 2009-05-06 | Roessingh Research & Development B.V. | Flexible electrode holder |
NL1034611C2 (en) * | 2007-10-31 | 2009-05-06 | Roessingh Res And Dev B V | Flexible electrode holder. |
FR2964550A1 (en) * | 2010-09-09 | 2012-03-16 | Yves Faisandier | Charged device for collecting electrocardiographic signal from torso of patient, has soleplate and/or plate associated with attachment, connection cable locking system, and electric connector that is arranged in contact with electrode |
Also Published As
Publication number | Publication date |
---|---|
CA2300141A1 (en) | 1999-02-25 |
EP1003417A1 (en) | 2000-05-31 |
DE69832388T2 (en) | 2006-08-03 |
EP1637074A1 (en) | 2006-03-22 |
AU9104398A (en) | 1999-03-08 |
DE69832388D1 (en) | 2005-12-22 |
US6141575A (en) | 2000-10-31 |
EP1003417B1 (en) | 2005-11-16 |
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