WO1992008407A1 - Mounting patch for diagnostic transducer - Google Patents

Mounting patch for diagnostic transducer Download PDF

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Publication number
WO1992008407A1
WO1992008407A1 PCT/US1991/008350 US9108350W WO9208407A1 WO 1992008407 A1 WO1992008407 A1 WO 1992008407A1 US 9108350 W US9108350 W US 9108350W WO 9208407 A1 WO9208407 A1 WO 9208407A1
Authority
WO
WIPO (PCT)
Prior art keywords
patch
patient
pliable
transducer
conformable
Prior art date
Application number
PCT/US1991/008350
Other languages
French (fr)
Inventor
Thomas C. Gorsuch
Edward A. Barlow, Jr.
Original Assignee
Seismed Instruments, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seismed Instruments, Inc. filed Critical Seismed Instruments, Inc.
Publication of WO1992008407A1 publication Critical patent/WO1992008407A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282Holders for multiple electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00Instruments for auscultation
    • A61B7/02Stethoscopes
    • A61B7/04Electric stethoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4209Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4236Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4272Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Acoustics & Sound (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Cardiology (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

An apparatus for positioning a diagnostic transducer on the surface of a patient. The apparatus includes a conformable patch and a coupler. The conformable patch is adapted to be fixed to the surface of a patient and the coupler is attached to the transducer to provide mating engagement with the conformable patch. The apparatus further includes electrical contacts for transmission of electrical signals from the surface of the patient to a signal detection system. The electrical contacts include electrical pads extending from the conformable patch, electrical connections for connecting the electrical pads to the surface of the patient, and transmission pathways for transmission of signals from the electrical pads to the signal detection system.

Description

MOUNTING PATCH FOR DIAGNOSTIC TRANSDUCER
Background of the Invention Field of the Invention The present invention relates to apparatus for diagnostic monitoring of the heart and more particularly to apparatus for positioning a heart wall motion transducer on the surface of a patient. The apparatus provides mechanical coupling between the patient and the transducer. In a preferred form, the apparatus includes an array of electrodes for collecting a surface ECG from the patient.
Description of the Background Art U.S. Patent 3,695,253 to Vielhauer teaches apparatus for physiological investigation, and shows the use of an accelerometer positioned on the chest near the apex of the heart.
The Vielhauer reference does not teach a mechanism to position or attach the transducer to the patient's chest and a stated object of Vielhauer is to provide apparatus which may be used without attachment to the subject.
Other non-invasive mounting systems, such as that taught by U.S. Patent Re 31,097 to Vas, require specialized structures for positioning the system transducer on the surface of the patient.
The mounting patch of the present invention is intended for use with a diagnostic medical device disclosed in U.S. Patent Application Serial No. 07/495,262 (copending) which teaches, inter alia, the use of a relatively heavy transducer resting upon the chest of a patient undergoing a diagnostic test. The mounting patch permits the transducer to be accurately repositioned on the surface of the patient. The mounting patch of the present invention is an alternative to the mounting structures disclosed in U.S. Patent application. Serial No. 07/495,457 (copending) which teaches, inter alia, a rigid plate¬ like structure which attaches to the patient's chest. Summary of the Invention In contrast to prior art structures, the present invention provides a conformal patch which is used to permit accurate positioning and repositioning of the heart motion transducer on the surface of the patient.
As described in copending U.S. Patent Application Serial No. 07/495,262, incorporated by reference herein, coronary artery disease may be detected by monitoring changes in the compression wave signature of the heart due to exercise-induced ischemia.
In accordance with the teaching of the incorporated reference, compression wave recordings may be taken from the patient pre-exercise, post-exercise, and during recovery from exercise. The stress due to exercise unmasks ischemia caused by coronary artery disease by altering the ventricular wall motion of the heart during periods of normal sinus rhythm. In practice, the diagnostic protocol requires that the heart wall motion transducer be rapidly and accurately repositioned after exercise to the same location on the patient where baseline pre-exercise measurements were made.
The "patch" apparatus disclosed herein is conformal and flexible which permits it to move with the body of the patient to minimize discomfort during exercise. The patch is preferably made from substantially incompressible material to permit efficient transmission of the compression wave signal from the patient's body to the transducer.
It is also preferred to incorporate an ECG electrode system within the "patch" structure. The electrode array on the patch is electrically coupled to the diagnostic equipment when the transducer is placed on the patch.
Brief Description of the Drawing In the drawings, in which like reference numerals indicate corresponding structures throughout the views:
FIG. 1 is a schematic view of the invention in use in a diagnostic setting; FIG. 2 is an exploded perspective view of the conformal patch, the cooperating base plate assembly, and the transducer;
FIG. 3 is a bottom plan view of a first embodiment of the upper mounting plate. FIG. 4 is a bottom plan view of the lower cover plate of the mounting base plate assembly.
FIG. 5 is a top view of a first embodiment of the conformable patch.
FIG. 6 is a cross-section view through line 6-6 of Fig. 5.
FIG. 7 is a top view of a second embodiment of the conformable patch.
FIG. 8 is a cross-sectional view through line 8-8 of Fig. 7. FIG. 9 is an exploded perspective view of a second embodiment of the mounting base plate, transducer, and conformal patch.
FIG. 10 is a bottom plan view of a second embodiment of the mounting base plate. FIG. 11 is a sectional view through line 11-11 of Fig. 10.
FIG. 12 is an elevational view of the mounting base plate of Fig. 10.
FIG. 13 is a top view of a third embodiment of the conformal patch.
FIG. 14 is a sectional view through line 14-14 of Fig. 13.
Detailed Description of the Preferred Embodiments
FIG. 1 depicts the patch in use. The conformal patch 10 serves to connect transducer 12 to patient 14. The mounting base plate assembly 16 serves to adapt transducer 12 to patch 10. Patch 10 is placed upon the patient's 14 chest, preferably above the Xiphoid process of the sternum.
The transducer 12 and the patch ECG electrodes are coupled to a signal processing module 18 through cabling 24. The signal processing module 18, digitizes the electrocardiogram (ECG) marker channel data 26 as well as the compression wave data and also serves to electrically isolate the patient 14 from the computer 20 and the display module 18. In use, the patient reclines and transducer 12 with the attached .mounting plate, is placed upon patch 10. The patch 10 is adhesively coupled to the patient's skin. A simultaneous recording is made of the patient's surface electrogram in conjunction with the compression wave activity resulting from heart movement while patient 14 is lying down. Once a suitable baseline record is made, patient 14 stands up and undergoes a strenuous exercise protocol which elevates the heart rate. This exercise, in the presence of coronary artery disease, generates a transient ischemia of the heart tissue. Promptly at the conclusion of the exercise protocol, the patient is again placed in a supine position. Once again, transducer 12 and attached mounting base plate assembly 16, are placed on conformal patch 10, and a post-exercise recording of heart wall motion data is made. Transducer 12 remains on patient 14 during a recovery or rest period while the patient's metabolic state returns to the baseline condition. In this fashion, transducer 12 is used to collect pre- exercise, post-exercise and recovery data.
At the conclusion of the testing protocol, the ECG marker channel data 26 is displayed in conjunction with pre-exercise compression wave data 28, post- exercise compression wave data 30 and recovery from exercise compression wave data 32 on display module 22. In general, the pre-exercise and recovery wave forms should be similar in morphology and content. If patient 14 suffers from coronary artery disease, the transient ischemia should generate pronounced changes in the underlying ventricular wall motion which will generate an abnormal compression wave record. This diagnostic technique requires that transducer 12 be promptly coupled to patient 14 after the exercise protocol, preferably within two minutes of completion of the rigorous exercise protocol. In addition, it is very important that transducer 12 be coupled in the same position for pre-exercise, post- exercise and recovery data collection, i.e. within about 1.5 cm of its original orientation.
In this connection, flexible patch 10 is adhesively attached to patient 14 to provide a fixed reference point for transducer 12. In general, conformal patch 10 is adhesively mounted on patient 14 through the use of a conventional medical electrode adhesive. Patch 10 relieves testing personnel of the exacting task of repositioning the transducer 12 accelerometer after the exercise protocol by sight or by feeling for the Xiphoid process. Moreover, in a small percentage of cases, especially with barrel-chested patients, patch 10 is required for proper connection to the sternum. It is preferred to incorporate ECG electrodes within patch 10, and have the electrical connections required for recording the surface electrogra made automatically as transducer 12 is placed onto pliable patch 10.
To further aid in the re-positioning of transducer 12 onto the chest of patient 14, different embodiments of patch 10 can include slots, bars, depressions, or other positioning structures.
Referring to Figure 2, there is shown an exploded perspective view of the invention showing the relationship between transducer 12, upper mounting plate 15, lower cover plate 17 and conformal patch 10.
In use, upper mounting plate 15 and cover plate 17 from a unitary structure which is semi-permanently attached to transducer 12, while conformal patch 10 is adhesively connected to the skin of patient 14.
The ECG electrodes and transducer output are cabled 24 to the remote diagnostic equipment. In operation, it is preferred that transducer/base plate assembly be placed on the conformal patch 10 to complete both the mechanical coupling between transducer 12 and patient 14, and the electrical connection between the diagnostic equipment and the ECG patch electrodes. Figures 2-4 disclose a first embodiment of mounting base plate assembly 16. In general, upper mounting plate 15 and lower cover plate 17 of mounting base plate assembly 16 are formed from a rigid plastic material such as ABS or polycarbonate, which is sufficiently rigid to transmit the cardiac compression wave signal from patient 14 to transducer 12. Upper mounting plate 15 and cover plate 17 are constructed and arranged so that they fit together and form an unitary structure which is used to couple transducer 12 to patch 10.
FIG. 3 shows interior surface 51 of upper plate 15 with lower cover plate 17 removed. Upper plate 15 is substantially circular in shape, and can be of varying diameters depending on the diameter of the base of transducer 12. A diameter of approximately two and one-fourth inches is preferred for upper plate 15 since this is the diameter of the transducer.
As shown in FIG. 3, upper mounting plate 15 assembly includes coupler connectors 40, 41, 42 and leads 43, 44, 45. Also shown are three substantially semi-circular raised pedestals 46, 48, 50 are integrally formed on the lower interior surface 51 of upper mounting plate 15, approximately one hundred twenty degrees apart, and are made of the same material as upper plate 15. Pedestals 46, 48, 50 have surfaces 52, 53, 54 on which coupler connectors 40, 41, 42 are positioned. The preferred height of pedestals 46, 48, 50 can vary from one-fourth to one-half inches. Generally, pedestals 46, 48, 50 are of a height so that when lower cover plate 17 is fitted on and positioned in upper mounting plate 15 to create mounting base plate assembly 16, coupler connectors 40, 41, 42 on semi¬ circular pedestals 46, 48, 50 create a level flush surface with cover plate 17. The coupler connectors 40, 41, 42 may be made of any conductive material, preferably corrosion resistant metal. They may be applied adhesively or retained mechanically. They may be thin metallic foil backed by a conductive adhesive, such as manufactured by 3M.
Referring to FIG. 4, the lower mating surface 61 of cover plate 17 is shown. This cover plate 17 has a substantially planar circular shape with extending flanges 55, 56, 57. Lower cover plate 17 is shaped so as to fit securely onto upper mounting plate 15, with extending flanges 55, 56, 57 fitting tightly around pedestals 46, 48, 50 of upper plate 15 so that a flush, level surface results, and leads 43, 44, 45 are protected.
The raised key segments 58, 60 extend vertically from the planar surface 61 of lower cover plate 17 when upper plate 15 and lower plate 17 are assembled. Hub 62 is integrally formed with pedestals 58, 60 out of a rigid plastic material, and is positioned around mounting aperture 34C. The key segments 58, 60 extend approximately one-sixteenths inch to three-sixteenths inch above the surface 61 of lower plate 17, and are approximately one-half inch wide and one inch in length from the center of mounting aperture 34C* if a two and one-fourth inch diameter upper plate 15 is utilized. Hub 62 extends approximately one-eight to one-fourth inch from surface 61 of lower cover plate 17, such that hub 62 is at a greater height than pedestals 58, 60, and can be of varying shapes, but having a radius to approximately match that of recess 72 on patch 10. When lower cover plate 17 is positioned on upper mounting plate 15 to form mounting base plate assembly 16, pedestals 58, 60 and hub 62 are on the outer, 405Xextersurface 61 of cover plate 17 so as to be able to cooperatively engage with patch 10.
The base 13 of the transducer is connected to upper plate 15, and lower plate 17, using a screw positioned through mounting holes 34A, 34B and 34C. One embodiment of contact patch 10 which can be utilized with mounting base plate assembly 16 is shown in a top view in Figure 5 and in a cross-section view in Figure 6. Patch 10 is made out of a polyvinylchloride material which is pliable and flexible but not overly elastic, such as Transilwrap Flexible Vinyl #35. It is preferred to have patch 10 made from a substantially incompressible material to permit efficient transmission of the compression wave signal from the patient's body to the transducer 14. Patch 10 is of a generally flat, circular ring shape, although the shape can vary to meet the shape of mounting base plate assembly 16. The diameter of patch 10 can vary, depending on the diameter of mounting base plate assembly 16, but a diameter of approximately 2.25 inches is preferred for patch 10. Positioning slot 68, 70 can be made of a rigid plastic material or can be molded onto patch 10. Positioning slots 68, 70 extend one-sixteenth inch to one-eighth inch from surface 77 of patch 10, and must be of a length and width or shape so as to cooperatively engage with key segments 58, 60 on lower surface 61 of lower cover plate 17. Positioning slots 68, 70 insure that mounting base plate assembly 16 and transducer 12 are rapidly and correctly repositioned on patient 14 in the same location and orientation before and after the exercise protocol. Recess 72 is constructed and arranged so as to fit loosely over hub 62 on lower cover plate 17. As can be seen in Figures 5 and 6, semi¬ circular electrode patch connectors 64, 65, 66 are positioned along perimeter 88 of patch 10, and are spaced approximately one hundred twenty degrees apart from one another. Electrode patch connectors 64, 65, 66 are made of a flexible electrically conductive material 76 such as metal foil, and are adhesively attached to surface 77 of conformal, pliable patch 10. Electrode patch connectors 64, 65, 66 are approximately one-eighth to one-fourth inch in height and are shaped to cooperatively engage coupler connectors 40, 41, 42.
As shown, the electrode patch connectors 64 and 66 can be inclined approximately fifteen degrees by incorporating additional solid plastic or equivalent solid material 76 on surface 77 of patch 10. This geometry ensures a reliable electrical connection between the coupler connectors and the electrode patch connectors.
In the preferred form, the edge of conductive foil 74 must meet the edge of raised pads 64 and 66. Electrode patch connector 65 is not raised, (and will have a 1.75 surface radius). A copper conductive foil 74, such as No. 9703 electrically conductive adhesive transfer tape manufactured by 3M, is positioned with an adhesive on the surface of solid electrode patch connectors 64, 65, 66 and then folded over edge 88 of patch 10 and adhered to lower surface 79 of patch 10 with an adhesive, so that a contiguous conductive foil layer 74 is on both surfaces 77, 79 of patch 10. A conductive adhesive or gel 78, such as MS4000 Conductive Adhesive Hydrogel manufactured by LecTec, Inc. is placed over conductive foil layer 74 on each electrode patch connector 64, 65, 66 on lower surface 79 of patch 10 so that it slightly overlaps the semi-circular conductive foil shape of conductive foil layer 74.
A suitable release liner which can be easily removed may be provided on the conductive adhesive material 78 to protect the adhesive 78 and to insure that adhesive 78 remains intact and in place prior to use. Release liner 80 can be a one-piece generally circular liner having a diameter substantially equal to than the diameter of patch 10, or can be separate semi¬ circular pieces which extend slightly beyond the area of the conductive adhesive material 78 positioned over conductive foil layer 74 on electrode patch connectors 64, 65, and 66. Release liner 80 for conductive adhesive hydrogel 78 is generally supplied with the hydrogel 78 as part of the MS4000 product.
A second embodiment of conformable patch 10 can be seen in a top view in Figure 7, and in a cross- section view in Figure 8. As in Figures 5 and 6, conformable patch 10 is a flat, annular ring having positioning key segments or slots 68, 70 and central aperture 72. Patch 10 and positioning slots 68, 70 are made out of the same materials discussed above in reference to Figs. 5 and 6. The shape of conformal patch 10 is keyed to match and mate with the base plate assembly 16, and a patch diameter of two and one-fourth inch diameter is regarded as sufficient for patch 10. Semi-circular electrode patch connectors 82, 83, 84 are supported by resilient foam support pads made of a foam material such as No. 4775, adhesive-backed polyether high density material manufactured by Lundell Manufacturing. Electrode patch connectors 82, 83, 84 are adhered to surface 77 of patch 10 equidistant from one another, approximately one hundred twenty degrees apart, resting against perimeter 88 of patch 10 and extending towards aperture 72. The foam support pads are cut in a generally semi-circular shape and in an uncompressed state is approximately one-half inches in height. Size and shape of electrode patch connectors 64, 65, 66 mirror coupler connectors 40, 41, 42.
A copper conductive foil layer 74, such as No. 9703 electrically conductive adhesive transfer tape manufactured by 3M, is positioned over and adhered to the foam supports starting at upper edge 87 of foam 86 nearest aperture 72. Conductive foil layer 74 extends towards perimeter 88 of conformable patch 10, covering only the top surface of the foam pads. Conductive foil layer 74 extends and is adhered to lower surface 79 of conformal patch 10. Thus, a generally contiguous semi¬ circular piece of conductive foil 74 is positioned over both surfaces 77, 79 of conformal patch 10, with foil 74 tapering in at the point where conductive layer 74 folds over perimeter edge 88 of contact patch 10. Conductive foil layer 74 is compressed or pinched at the position where foil 74 tapers along perimeter edge 88 of conformal patch 10 so that foam 86 of electrode patch connectors 82, 83, 84 has an angle of approximately 12 degrees to 15 degrees, as can be seen in Figure 8. This form of construction assists in making a good low noise electrical connection between the patch and the mounting plate. A conductive adhesive material 78, such as
MS4000 conductive hydrogel manufactured by LecTec, is placed on the conductive foil layer 74 located on each electrode patch connector 82, 83, 84 on the lower surface 79 of conformal patch 10 so that the conductive adhesive material 78 overlaps the edge of conductive foil layer 74 slightly. The three patches of conductive adhesive 78, 82, 83, 84 can be covered by a one-piece, easy release liner which has a diameter less than the diameter of patch 10, or by separate, semi-circular pieces of a release liner which slightly overlap the area of conductive adhesive material 78, as discussed in more detail above.
Figure 9 is an exploded perspective view of another embodiment showing the relationship of transducer 12 to base plate 90 to conformal patch 10.
Conformal patch 10 is adhesively attached to the skin of patient 14 using conventional medical electrode adhesives. It is preferred to incorporate ECG electrodes within patch 10, and have the electrical connections required for recording the surface electrogram made automatically when transducer 12 is placed onto pliable patch 10. The ECG electrodes and signal collection electrodes from transducer 12 are cabled 24 to the remote diagnostic equipment 18, 20, 22. Mounting base plate 90 of Figure 9 is shown in more detail in Figure 10. In general, mounting base plate 90 is formed from a rigid plastic material such as ABS, polycarbonate or PVC, which is sufficiently rigid to transmit the cardiac compression wave signal from patient 14 to the transducer 12. As shown in Figure 10, three semi-circular raised pedestals 91, 92 and 93 are integrally formed on the lower, surface 89 of base plate 90. As shown, base plate 90 includes coupler connectors
94, 95, 96 and leads 97, 98, 99. Leads 97, 98, 99 are mechanically secured or soldered to the electrodes. In operation, electrical contact with the diagnostic equipment 18, 20, 22 coupled to the cable 24 is made by placing the contact patches of coupler connectors 94,
95, 96 over cooperative pedestal receiving depressions 106, 107, 108 within the contact patch 10 itself. Transducer 12 is rigidly attached to mounting base plate 90 through a fixing screw (not shown) . Center hole 104 is recessed to match the flat head screw (not shown) by an angle of approximately 55 degrees.
Referring now to Figure 11, mounting base plate 90 is shown in cross-section. Lead 99 is buried within base plate 90 and extends through pedestal 93 to coupler connector 96. Center hole 104 is recessed and angled, cutting through base plate 90.
Figure 12 is an elevational view of mounting base plate 90. Coupler connector 96 is positioned on the surface of pedestal 93, which in turn is.located on surface 89 of base plate 90.
Turning to Figure 13, a top view of a third embodiment of contact patch 10 is shown, with a cross- section view of contact patch 10 in Figure 14.
Semicircular wells or depressions 106, 107, 108 are provided on conformal patch 10 as shown in Figures 13 and 14 to receive pedestals 91, 92, 93 positioned on base plate 90.
In the illustrative patch depicted in Figure 13, the wells or depressions 106, 107, 108 for receiving pedestals 91, 92, 93 on base plate 90 are symmetrically positioned around the periphery or perimeter 88 of patch 10.
In operation, it is preferred that transducer 12 be simply nested into conformal patch 10 to complete both the mechanical coupling between transducer 12, mounted on base plate 90, and patient 14, and the electrical connection between the diagnostic equipment and the patch electrodes. It is preferred to perforate the conformal material of patch 10 in the depression areas 106, 107, 108 under electrode patch connectors 112, 113, 114 to permit electrical contact with the conductive adhesive 78 placed over each electrode patch connector 112, 113, 114 on lower surface 79 of patch 10 as shown in Figure 14. It is preferred to make patch 10 out of a polyvinylchloride material which is flexible and pliable, but not overly elastic, as discussed above. As can be seen in Figure 13, patch 10 is disc shaped, having a diameter to match that of base plate 90. In general, a patch 10 having a diameter of about two and one-fourth inches is sufficient for this embodiment. Referring to Figure 14, lip 110 is integrally joined to conformal patch 10 along perimeter 88 of patch 10. Lip 110 is made of the same polyvinylchloride material that is used for patch 10, and is approximately one-thirty second inch to one-fourth inch in height. Depressions 107, 106, 108 are integrally molded into patch 10 with lip 110 extending vertically from upper base surface 77 of patch 10. Semi-circular perforations or apertures 116, 118, 120 are formed within semi¬ circular depressions 106, 107, 108, as seen in Figures 13 and 14. Preferably, at least 0.062 inches of patch 10 material must be present between perimeter 88 of patch 10 and lip 110. Semi-circular electrode patch connectors 112, 113, 114 are made of copper conductive foil 74, such as No. 9703 electrically conductive adhesive transfer tape manufactured by 3M, which is placed in depressions 106, 107 and 108 over perforations 116, 118, 120. In addition, at least 0.062 inches of foil extends up the side of lip 110 on conformal patch 10. Conductive adhesive 78, such as MS4000 conductive hydrogel manufactured by LecTec, is placed on the lower surface 79 of patch 10 so that conductive adhesive 78 adheres to electrode patch connectors 112, 113, 114 and overlaps and extends beyond perforations 116, 118, 120. Electrode patch connectors 112, 113, 114 make electrical contact with conductive adhesive 78. As discussed above with references to Figures 1-8, a release liner covers the conductive adhesive 78 positioned over the three foil 74 lined depressions 106, 107, 108. Either a one- piece liner or separate liners of sufficient dimensions to cover the entire area of conductive adhesive 78 on each electrode patch connector coupler 112, 113, 114 can be utilized as discussed above. It is important that the liner be easily removed, and that when the liner is removed, conductive adhesive 78 is not pulled off patch 10. Adhesive 78 is described in more detail above. In operation, release liners 80 would be removed from patch electrode connectors 112, 113, 114 of patch 10, and patch 10 would be located and adhesively attached on the sternum area of the patient 14. Transducer 12, affixed to cooperating mounting base plate 90, would be positioned on patch 10 by cooperatively mating pedestals 91, 92, 93 with depression cavities 106, 107, 108, thereby mechanically coupling patient 14 to transducer 12, creating an electrical connection between the diagnostic equipment and the electrode patch connectors. Once a suitable position for mounting patch 10 has been achieved, patch 10 will remain in place for the rest of the diagnostic procedure -.
In general, the rotational orientation of compression wave transducer 12 does not affect the measurements made by the transducer. Typically, there is flexibility with respect to the lead configuration used for detecting the surface ECG of the patient as well. Consequently, in some clinical settings, it is desirable to provide a patch which permits the operator to rotate the transducer 12 between selected locations defined by the mounting patch 10. In operation, the electrode array is used to collect ECG data that is used to synchronize and control data reduction of the compression wave data. For this purpose, reliable detection of the electrographic R-wave is a principal design objective for optimizing the electrical performance of the mounting pad electrode array.
The reliable transduction of the compression wave signal is the principal mechanical parameter to be optimized. It has been found that plastic materials offer sufficient rigidity to perform this function.
It should be apparent that several different approaches may be taken to the internal cabling of the mounting plate. Numerous variations in geometry and materials choice may be made without departing from the invention.

Claims

What is claimed is:
1. An apparatus for positioning a cardiac compression wave transducer on a surface of a patient for detecting compression waves resulting from heart activity, comprising:
(a) a conformable patch adapted for adhesive connection to said surface of said patient having a first surface and a second surface; and
(b) coupling means for mating engagement with said conformable patch, said coupling means having a first surface and a second surface, said first surface adapted to engage said conformal patch, said second surface adapted to coupled to said transducer.
2. The apparatus according to claim 1, further comprising:
(a) adhesive means proximate said second surface of said conformable patch for attachment of said conformable patch to said patient, said first surface of said patch having engaging means for mating engagement with said coupling means.
3. The apparatus according to claim 2, wherein said first surface of said first plate is attached to said transducer and said second surface of said second plate has mating means for mating engagement with said engaging means of said conformable patch.
4. The apparatus according to claim 3, wherein said engaging means comprises a plurality of slots arranged on said first surface of said conformable patch, and wherein said mating means extend from said second surface of said second plate for cooperative mating with said slots on said conformable patch, such that said transducer is retained on said conformable patch in a preferred orientation.
5. The apparatus set forth in claim 2, wherein said engaging means comprises a plurality of depressed cavities on said first surface of said conformable patch, and wherein said mating means comprises a plurality of pedestals extending from said second surface of said second plate for nesting engagement with said depressed cavities on said conformable patch, such that said transducer is retained on said patch in a preferred orientation.
6. An apparatus for positioning a heart wall movement transducer on a surface of a patient, comprising:
(a) a pliable patch having a first surface and a second surface adapted to be fixed to said surface of said patient;
(b) coupling means for mating engagement with said pliable patch; and
(c) electrical contact means integral with said pliable patch and said coupling means for transmission of electrical signals from said surface of said patient; whereby heart wall movement can be detected on said surface of said patient through said conformable patch and said coupling means by said transducer, while simultaneously detecting electrical signals from said surface of said patient through said electrical contact means.
7. The apparatus set forth in claim 6, wherein said pliable patch further comprises positioning bars on said first surface of said pliable patch, and wherein said pliable patch is adhesively affixed to said patient.
8. The apparatus as set forth in claim 7, wherein said coupling means comprises:
(a) a cover plate having a plurality of flange extensions, said cover plate having a first surface and a second surface;
(b) cooperative engagement means comprising raised segments, said cooperative engagement means being adjacent said second surface of said cover plate, said cooperative engagement means fitting securely into said positioning bars extending from said first surface of said pliable patch; and
(c) a mounting plate having a first surface and a second surface, said mounting plate having a plurality of pedestals on said second surface, whereby said plurality of flange extensions on said cover plate fit securely proximate said pedestals of said mounting plate.
9. The apparatus according to claim 8, wherein said electrical contact means comprises:
(a) a plurality of electrical pads adjacent said first surface of said conformable patch;
(b) connection means for connecting said electrical pads to said patient; and
(c) transmission means for transmission of signals through said coupling means, whereby said signals are transmitted from said patient through said conformable patch and said coupling means to said signal detection system.
10. The apparatus according to claim 6 wherein said pliable patch has a base portion with a perimeter edge, said base portion having a first surface and a second surface, said pliable patch further comprising a lip extending vertically from said perimeter edge of said pliable patch, said second surface of said base portion having adhesive means for attachment of said pliable patch to said patient.
11. The apparatus according to claim 10, wherein a plurality of depressed regions extending vertically from said base portion of said pliable patch.
12. The apparatus as set forth in claim 11, wherein said coupling means comprises:
(a) a mounting plate having a first surface and a second surface, said mounting plate having a plurality of pedestals on said second surface, for cooperative engagement into said depressed regions extending from said base portion of said pliable patch.
13. An apparatus according to claim 12 wherein said electrical contact means includes a plurality of electrical pads positioned on said first surface of said base portion of said pliable patch, a plurality of apertures in said pliable patch adjacent said electrical pads, and electrically conductive adhesive material positioned on said second surface of said pliable patch base portion for attachment to said patient, said coupling means having mating electrical pads for contacting said electrical pads of said pliable patch on said sensor plate and having leads connected to said electrical pads buried within said sensor plate to transmit said signals from said patient to said signal detection system.
14. An apparatus according to claim 13 wherein said electrical contact means comprises:
(a) a first surface of said plurality of chambers covered with electrical contact material; and
(b) a plurality of apertures within said chambers of said pliable patch adjacent said electrical conductive material of said chambers; and
(c) electrically conductive adhesive material covering said apertures and connected to said electrically conductive material for attachment of said conformable patch to said patient; said raised segments of said base plate of said coupling means covered with electrical contact material for contact with said electrically conductive material in said chambers, said coupling means further comprising leads extending from said electrically conductive material on said raised segments extending to said signal detection system.
PCT/US1991/008350 1990-11-09 1991-11-08 Mounting patch for diagnostic transducer WO1992008407A1 (en)

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Application Number Priority Date Filing Date Title
US61193290A 1990-11-09 1990-11-09
US611,932 1990-11-09

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WO (1) WO1992008407A1 (en)

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EP0801927A1 (en) * 1992-09-09 1997-10-22 MedAcoustics, Inc. Sensing device with cutaneous conformance
WO2004078038A1 (en) * 2003-03-05 2004-09-16 Meditron Asa Detector patch for biosignals
US7037268B1 (en) 1999-03-01 2006-05-02 Medacoustics, Inc. Low profile acoustic sensor arry and sensors with pleated transmission lines and related methods
WO2007038607A2 (en) * 2005-09-27 2007-04-05 Telzuit Technologies, Llc Apparatus and method for monitoring patients
EP2389860A1 (en) * 2008-06-24 2011-11-30 Biosense Webster, Inc. Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems
ITTO20120613A1 (en) * 2012-07-11 2014-01-12 Torino Politecnico DEVICE FOR THE JOINED ACQUISITION OF AT LEAST AN ELECTROMYOGRAPHIC SIGNAL OF SURFACE AND A ECOGRAPHICAL IMAGE OF A SAME PORTION OF A MUSCLE OF A LIVING, IN PARTICULAR FOR NON-INVASIVE APPLICATIONS, AND RELATIVE METHOD OF
US9375179B2 (en) 2010-12-23 2016-06-28 Biosense Webster, Inc. Single radio-transparent connector for multi-functional reference patch
US9737225B2 (en) 2008-06-24 2017-08-22 Biosense Webster, Inc. Patch and sensor assembly for use in medical device localization and mapping systems

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DE3804616A1 (en) * 1988-02-13 1989-08-24 Schoeller Bernd Dipl Ing Stethoscope with device and method of recording, evaluating and displaying different biosignals
EP0331348A1 (en) * 1988-02-29 1989-09-06 Edward H. M.D. Hon Ultrasound transducer holder

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GB2093188A (en) * 1981-02-17 1982-08-25 Vsesojuznyj Kardiologitsches Positioning echosignal sensor and electrosignal sensors of cardiographic apparatus
US4458687A (en) * 1982-08-12 1984-07-10 Medtronic, Inc. Trans-telephonic acoustical and electrical heart valve monitor system
DE3804616A1 (en) * 1988-02-13 1989-08-24 Schoeller Bernd Dipl Ing Stethoscope with device and method of recording, evaluating and displaying different biosignals
EP0331348A1 (en) * 1988-02-29 1989-09-06 Edward H. M.D. Hon Ultrasound transducer holder

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0801927A1 (en) * 1992-09-09 1997-10-22 MedAcoustics, Inc. Sensing device with cutaneous conformance
US7037268B1 (en) 1999-03-01 2006-05-02 Medacoustics, Inc. Low profile acoustic sensor arry and sensors with pleated transmission lines and related methods
WO2004078038A1 (en) * 2003-03-05 2004-09-16 Meditron Asa Detector patch for biosignals
WO2007038607A2 (en) * 2005-09-27 2007-04-05 Telzuit Technologies, Llc Apparatus and method for monitoring patients
WO2007038607A3 (en) * 2005-09-27 2007-07-05 Telzuit Technologies Llc Apparatus and method for monitoring patients
EP2520223A1 (en) * 2008-06-24 2012-11-07 Biosense Webster, Inc. Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems
EP2389860A1 (en) * 2008-06-24 2011-11-30 Biosense Webster, Inc. Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems
US9014778B2 (en) 2008-06-24 2015-04-21 Biosense Webster, Inc. Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems
US9737225B2 (en) 2008-06-24 2017-08-22 Biosense Webster, Inc. Patch and sensor assembly for use in medical device localization and mapping systems
US9375179B2 (en) 2010-12-23 2016-06-28 Biosense Webster, Inc. Single radio-transparent connector for multi-functional reference patch
US11510621B2 (en) 2010-12-23 2022-11-29 Biosense Webster, Inc. Single radio-transparent connector for multi-functional reference patch
ITTO20120613A1 (en) * 2012-07-11 2014-01-12 Torino Politecnico DEVICE FOR THE JOINED ACQUISITION OF AT LEAST AN ELECTROMYOGRAPHIC SIGNAL OF SURFACE AND A ECOGRAPHICAL IMAGE OF A SAME PORTION OF A MUSCLE OF A LIVING, IN PARTICULAR FOR NON-INVASIVE APPLICATIONS, AND RELATIVE METHOD OF
WO2014009868A3 (en) * 2012-07-11 2014-03-06 Politecnico Di Torino Device for the joint acquisition of at least one surface electromyographic signal and one echographic image of a same portion of a muscle of a living being, in particular for non-invasive applications, and manufacturing method

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