WO1994005207A1 - Disposable sensing device with cutaneous conformance - Google Patents

Disposable sensing device with cutaneous conformance Download PDF

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Publication number
WO1994005207A1
WO1994005207A1 PCT/US1993/008237 US9308237W WO9405207A1 WO 1994005207 A1 WO1994005207 A1 WO 1994005207A1 US 9308237 W US9308237 W US 9308237W WO 9405207 A1 WO9405207 A1 WO 9405207A1
Authority
WO
WIPO (PCT)
Prior art keywords
εaid
diaphragm
sensing device
layer
electrical
Prior art date
Application number
PCT/US1993/008237
Other languages
French (fr)
Inventor
William Reeves
Christian Hilmer
Douglas R. Miller
Original Assignee
Mcg International, 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 Mcg International, Inc. filed Critical Mcg International, Inc.
Priority to AU50996/93A priority Critical patent/AU5099693A/en
Priority to EP93920452A priority patent/EP0659058B1/en
Priority to CA002144169A priority patent/CA2144169C/en
Priority to DE69323085T priority patent/DE69323085T2/en
Publication of WO1994005207A1 publication Critical patent/WO1994005207A1/en

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01H—MEASUREMENT OF MECHANICAL VIBRATIONS OR ULTRASONIC, SONIC OR INFRASONIC WAVES
    • G01H11/00—Measuring mechanical vibrations or ultrasonic, sonic or infrasonic waves by detecting changes in electric or magnetic properties
    • G01H11/06—Measuring mechanical vibrations or ultrasonic, sonic or infrasonic waves by detecting changes in electric or magnetic properties by electric means
    • G01H11/08—Measuring mechanical vibrations or ultrasonic, sonic or infrasonic waves by detecting changes in electric or magnetic properties by electric means using piezoelectric devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/003—Detecting lung or respiration noise
    • G—PHYSICS
    • G10—MUSICAL INSTRUMENTS; ACOUSTICS
    • G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
    • G10K11/00—Methods or devices for transmitting, conducting or directing sound in general; Methods or devices for protecting against, or for damping, noise or other acoustic waves in general
    • G10K11/004—Mounting transducers, e.g. provided with mechanical moving or orienting device
    • 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
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0204—Acoustic sensors

Definitions

  • the present invention relates to an improved sensing device for capturing cardiac output (SI and S2) and acoustic and vibratory outputs from arterial blood flow off the chest and appendages.
  • BACKGROUND ART There are many types of sensors, transducers and pickups used in general industrial applications. Several are specifically designed to capture heart sounds and body noises. One such sensor or pickup for heart sounds is a condenser microphone. This type of microphone is specifically designed for 2-D phonocardiography systems for capturing heart sounds off the human chest for interpretation.
  • the sensing device of the present invention which is capable of capturing acoustic and vibratory energies.
  • the sensing device has a diaphragm formed from a thin piezoelectric polymer film transducer material, a thin film of conductive material on two surfaces of the diaphragm for receiving and transmitting excitation signals from the polymer film material, and a layer of adhesive material applied to the subject attachment side of the sensing to mechanically couple the sensing device to the subject.
  • the diaphragm is formed by a polyvinylidene fluoride material which, with no or very little input voltage, is capable of generating its own output voltage in proportion to the excitation caused by the acoustic and/or vibratory energies.
  • This type of material has been found to be extremely advantageous because it offers no or little possibility of a subject being shocked or burned from input voltages. Additionally, extraneous background noise is not captured as the transmission relies mainly on physical contact of the sensor to the body.
  • This material is sufficiently flexible to allow a sensor to be formed that is flexible enough to conform with the flesh and become part of the flesh for maximum transfer of energy.
  • an important and unique feature of the sensor device of the present invention is the thin layer of adhesive material which is applied to the subject attachment side of the sensing device.
  • an adhesive is used which has the physical properties of adhesion, viscosity, and duro eter (hardness and elasticity) which create an integral mechanical bond between sensor and flesh for maximum transfer of acoustic and vibratory energies.
  • the sensing device of the present invention may include a backing formed from a stiff acoustic dampening material.
  • the backing serves to insulate the sensor diaphragm from any extraneous background noises and, by virtue of this insulating effect, creates a unidirectional acoustic material pickup which receives acoustic and vibratory signals from the flesh while remaining isolated from background noise by virtue of the backing material.
  • An embodiment of a sensing device which comprises an adhesive patch with an array of sensing devices for picking up multiple acoustic output and for triangulating signals to pinpoint the location and source of the acoustic output, e.g., from which human heart valve a murmur is emanating.
  • Yet another sensing device which has multiple layers of the thin piezoelectric polymer film material for generating excitation signals in response to said acoustic cardiac output.
  • Figure 1 is a cross sectional view of a first embodiment of a sensing device in accordance with the present invention
  • Figure 2 illustrates a portion of a top surface of the sensor diaphragm of the sensing device of Figure 1
  • Figure 3 is a cross sectional view of a second embodiment of a sensing device in accordance with the present invention
  • Figure 4 is a top view of the sensing device of Figure 3
  • Figure 5 is a cross sectional view of a first electrical connector which may be used with the sensing devices of the present invention
  • Figure 6A is a cross sectional view of a second electrical connector which may be used with the sensing devices of the present invention
  • Figure 6B is a top view of the male portion of the connector of Figure 6A;
  • Figure 7 is a top view of a sensor array patch using the sensing devices of the present invention.
  • Figure 8 is a cross sectional view of a bayonet type connector which may be used with the sensing devices of the present invention
  • Figure 9 is a cross sectional view of the male portion of the connector of Figure 8.
  • FIGS 10 and 11 illustrate yet another sensing device in accordance with the present invention.
  • Figures 12-15 illustrate a process for making a sensor in accordance with the present invention.
  • FIG. 1 illustrates a first embodiment of a sensing device 10 in accordance with the present invention.
  • the sensing device 10 includes a diaphragm in the form of a thin layer 12 for capturing acoustic and vibratory energies. It has been found that an improved sensing device is obtained when the layer 12 is formed from a piezoelectric polymer transducer material capable of generating its own voltage output when excited by an acoustic or vibratory output.
  • a piezoelectric polymer transducer material capable of generating its own voltage output when excited by an acoustic or vibratory output.
  • One such material which may be used for the layer 12 is a polyvinylidene fluoride material (PVDF) sold under the trademark KYVAR by Atochem Sensors Inc. of Valley Forge, Pennsylvania.
  • PVDF polyvinylidene fluoride material
  • piezoelectric polymer transducer material is advantageous because it allows a sensor to be formed which is truly non-invasive in that no energies are beamed into the subject to capture blood flow characteristics. This material allows a passive listening technique to be used. This type of material is also advantageous in that unlike an ultrasound probe, no high frequencies energies have to be beamed into the subject's body and bounced off tissue and blood in order to get an indication of blood flow in arteries and through valves. Still another advantage associated with the use of this type of material is the absence of any need to apply an excitation voltage to the material. Sensing devices formed from this material may be used with maximum safety on human subjects, including small children and infants, with no risk of electric shock or burns.
  • the device 10 further includes a thin film coating of metal on opposed surfaces of the polymer film material 12.
  • the metal coatings 14 and 16 may be formed from any suitable conductive metal or metal alloy known in the art such as aluminum, nickel, copper and alloys thereof and may be applied to the surfaces of the polymer material using any suitable technique known in the art.
  • each layer is formed from aluminum or an aluminum alloy because such metals are inexpensive and have a relatively high impedance value.
  • the metal coating layers 14 and 16 act as conductive surfaces for receiving and transmitting the excitation signal from the film material 12 along substantially the entire length of the film material and for transmitting excitation signals to electrical contacts or terminals 18 and 20 on the sensing device. As best shown in Figure 2, each of the metal coating layers stops short of the edges of the polymer film material layer so as to prevent the creation of short circuits. Additionally, each of the metal coating layers 14 and 16 has one of the electrical contacts 18 and 20 associated therewith.
  • the terminals 18 and 20 may be any two electrical termination points located on the thin metallic films. They may be formed by solder connections, spade connections or any other type of low impedance electrical connection. At least one of the electrical terminals 18 or 20 passes through the thin film polymer material layer 12 to the thin metal layer on the opposite side.
  • the sensing device 10 further comprises a bow or frame 22 for stretching and holding the polymer film material 12 in tension.
  • the bow 22 may be formed from a rigid polymer material or any other suitable non-conductive material. It may be adhesively bonded or mechanically fastened to the material 12 using any suitable means known in the art. As can be seen from Figure 1, the bow 22 is configured so that there is an air gap 30 between it and the upper surfaces of the sensor diaphragm. If desired, the bow 22 can have a two piece construction with the thin film polymer layer 12 forming the diaphragm being positioned intermediate the two pieces. The bow 22 acts to hold the piezoelectric film portion of the sensor in tension as a diaphragm both in the rest state and when the sensor is attached to the subject.
  • the tension acts to create a more sensitive diaphragm out of the piezoelectric polymer transducer film as any minute acoustic or vibratory excitations are magnified by orders of magnitude.
  • the bow or frame 22 also acts to isolate the diaphragm from extraneous noise and effectively creates a unidi ensional acoustic sensor.
  • Two electrical leads 24 and 26 are attached to the electrical terminals 18 and 20 and are preferably of low impedance.
  • the leads 24 and 26 may be electrically shielded, may have any desired length, and may be connected to the terminals 18 and 20 in any desired manner.
  • the leads 24 and 26 pass through a strain relief device 28 in the bow 22.
  • the strain relief device and the leads can be molded into the bow or frame or may be mechanically assembled as three separate items.
  • the strain relief device 28 may be formed by a rubber grom et or by an epoxy material.
  • a thin film layer 34 of peel and stick adhesive is applied to the subject side of the sensing device 10 and the bow 22.
  • the adhesive acts to mechanically couple the sensor to the flesh in such a way that the sensor and flesh conform and become one. This insures that the maximum amount of acoustic and vibratory energy from heart valves and major arteries within the body is received by the diaphragm formed by the piezoelectric polymer material layer.
  • the adhesive used to form the thin film layer 34 may be any suitable adhesive known in the art such as the adhesive used in a product called "Double-Stick Discs" manufactured by 3M.
  • the sensing device 10 may be electrically connected by the leads 24 and 26 to any suitable display device and/or microprocessor (not shown) known in the art. Before the signal from the sensor is transmitted to the display device and/or microprocessor, it may be passed through an appropriate analog conditioning circuit 32 for filtering and amplifying the output signal to rid it of extraneous background noise and to highlight the low frequency heart sounds.
  • the circuit 32 may be any suitable conditioning circuit known in the art. One type of conditioning circuit which can be used is shown in co-pending
  • sensing device 10' comprises a thin film piezoelectric transducer material layer 12', metal coating layers 14' and 16', and adhesive layer 34' on the subject side of the sensing device.
  • the sensing device of Figures 3 and 4 differs from the device of Figure 1 in two respects.
  • the first is that the sensor diaphragm formed by the polymer transducer material layer 12' and the metal coating layers 14' and 16' is supported by a backing 35 of at least one of a polymer foam material and a molded polymer material.
  • the backing 35 is preferably attached by adhesive to the sensor diaphragm in such a way that the diaphragm is in a slight amount of tension when at rest. As before, this aids the diaphragm in its sensitivity to any minute amount of acoustic or vibratory excitation.
  • the backing and adhesive may be pliable and of such a duro eter (hardness and spring rate) that they allow the diaphragm to conform to the flesh without distortion.
  • the second difference between the sensing devices of Figures 1 and 3 is the electrical connection between the leads 24' and 26' and the metal conductive layers 14' and 16'.
  • the electrical connections are formed by quick connectors 36 and 38, one of which terminates the upper conductive coating layer and the other which terminates the lower conductive coating layer.
  • Quick connectors are used to provide a security lock so that the sensing device 10' can be used only with compatible type( ⁇ ) of electrical leads. This helps to provide a measure of patient safety in that one cannot connect high voltage leads or ECG leads to the subject. Also, it insures that other types of incompatible or mismatched sensors are not used by mistake.
  • Figure 5 illustrates one type of quick connector which can be used with the sensor of Figure 3.
  • the connector includes a male portion 40 which is mounted on or electrically connected to one of the metallization layers 14' or 16'.
  • the male portion 40 extends through the backing 35 and has a raised snap connector portion 42.
  • the quick connector further includes a female portion 43 to which one of the leads 24' or 26' is electrically connected.
  • the female portion 43 has an electrical contact layer 44 formed from an electrically conductive metal or metal alloy and an outer non-conductive cover 46 formed from a molded polymer material or any other suitable electrically non-conductive material. As shown in Figure 5, the layer 44 is shaped to conform to the shape of the male portion 40 and the raised snap connector portion 42. In this way, a secure connection can be made between the male and female portions.
  • a sensor terminal connector 48 may be provided to insure that the backing 35 does not move relative to the male portion 40 of the quick connector.
  • the connector 48 may be formed by a metal ring crimped onto the male portion 40 of the quick connector.
  • Figure ⁇ 6A and 6B illustrate another quick connector device 36', 38' which may be employed with the sensing devices of the present invention.
  • the quick connector device 36', 38' also has a male portion 40 and a female portion 43 of a construction identical to that of the connector device shown in Figure 5. It differs however in that it includes a mechanical lock which consists of embossed metal letters 56 on the top surface 58 of the raised snap connector portion 42 and mating letters 60 formed in the female portion 43.
  • Figure 7 illustrates a novel patch type sensing device 62 in which an array of four sensing devices 10 and 10' are embedded within or mounted to a relatively large adhesive patch formed from a compliant plastic material such as a compliant polymer foam material.
  • a compliant plastic material is used for the patch so that the sensing device 62 may take the form of that portion of the subject's body over which it is to be placed.
  • An adhesive layer (not shown) may be formed on the underside of the plastic material to insure a good connection between the subject and the sensing device( ⁇ ) .
  • the adhesive layer may only be to the underside of the individual sensors in contact with the subject.
  • the patch sensing device 62 thus described is useful for picking up multiple acoustic outputs and for triangulating the excitation output signals so as to pinpoint the location and source of the acoustic output, e.g., from which human heart valve a murmur is emanating or from which artery or other blood flow passage/vessel a sound emanates.
  • the four sensing devices 10, 10' can be positioned within or on the sensor patch material so that they cover the four heart valves of the subject.
  • the sensing devices 10, 10' may have individual leads to a conditioning circuit or display device or may share common leads.
  • ECG electrodes 64 may also be embedded within or mounted to the plastic material forming the patch sensing device.
  • sensing device 62 has been illustrated as having four sensing devices 10, 10', it can actually have any desired number of sensing devices.
  • the patch device 62 could have only two sensing devices, 10, 10'.
  • Figures 8 and 9 illustrate a unique bayonet connector 66 which may be used for the leads attached to the sensing devices 10 and 10'.
  • the connector 66 includes a female portion 68 and a male portion 70.
  • the female portion 68 preferably has an inner metal contact layer 72 for receiving a mating male contact and a molded plastic non-conductive cover 74.
  • the male portion comprises a molded non-conductive cover portion 76 formed from a suitable plastic material and a male pin 78 formed from a suitable metal or metal alloy.
  • the male pin 78 and the receptacle 80 within the female contact layer 72 are provided with mating shapes.
  • the male pin 78 may be provided with a tip 82 having a desired radius or curvature and an edge 84 which has a region 86 of different taper near the tip.
  • the taper angle ⁇ of the edge portion 84 may be different than the taper angle ⁇ of the remainder of the pin.
  • the receptacle 80 would be shaped to have an identical configuration so that the male pin would fit snugly therein.
  • Still another type of connector which may be employed with the sensing devices of the present invention is one in which an integrated circuit chip 150 is placed on the head of the sensing device.
  • the chip may be used to accomplish a variety of tasks.
  • the chip may carry the sensor serial number and manufacturing lot code for FDA traceability.
  • the chip may also carry the wave pattern of the dynamic response of the sensor so that the back end electronics recognize the sensor as a compatible device, thus providing system security.
  • the sensor chip may have a code reflecting the diameter size of the sensor so as to let the back end electronics recognize it as a fetal sensor, infant/child sensor or an adult sensor.
  • the various coded signals described above allow the sensor and back end electronics to proceed through an initialization sequence before normal communications will occur.
  • FIGS 10 and 11 illustrate still another embodiment of a sensing device 10" in accordance with the present invention.
  • This sensing device 10" has a sensing diaphragm formed by two layers 88 and 90 of thin polymer piezoelectric transducer material of the type previously discussed.
  • the sensing device further includes metallization layers 92, 93, 94 and 95 and snap connector contacts 96 and 98 connected to respective ones of the metallization layers.
  • Two of the metallization layers 92 and 95 are + layers, while the other two layers 93 and 94 are - layers.
  • Each metallization layer may, if desired, have a layer of a polymer protective coating material theron.
  • An adhesive layer 102 is formed between the metallization layers 92 and 95 to hold the two layers in a desired position and at a desired tension level.
  • the adhesive which is used for the layer 102 preferably has insulative properties.
  • Each of the electrical contacts 96 and 98 is formed by a metal or metal alloy members held in place by a respective two part rivet 97.
  • the electrical contacts 96 and 98 are connected to respective ones of the metallization layers by leads 108 and 110.
  • the leads 108 and 110 may each be formed from a silver or carbon bearing conductive elastomer material. Air gaps 89 and 91 are provided to avoid short circuits between certain metallization layers and the leads.
  • the sensing device further includes an adhesive layer 100 on the subject side of the device and a ⁇ tiffener 104 for acoustically isolating the sensing device from background noise and for holding the sensing diaphragm in tension.
  • the stiffener 104 may be formed from any ⁇ uitable pla ⁇ tic material and may be ⁇ haped to form an air gap 103 with the ⁇ en ⁇ ing diaphragm.
  • the stiffener 104 also serves as a mechanical mounting for the connectors 96 and 98.
  • the proces ⁇ to make sensors of the type described herein starts with raw sheets 120 of PVDF piezoelectric film material.
  • the film material is cleaned and mounted on a rotating drum in a vapor depostion machine.
  • An ultrahigh vacuum is pulled on the chamber and aluminum, nickel, copper or alloys thereof are sputtered onto the film in thin layers 122. This process is repeated for both sides.
  • Leads 123 and termination rings 125 may be formed during this step.
  • Appropriate masking (not shown) can be done to keep the metallization off of non-conductive area ⁇ for design purposes. At this point, several proces ⁇ e ⁇ can occur, but there i ⁇ the option of having them occur down ⁇ tream.
  • the sheets of metallized PVDF film material are provided with a layer of polymer protective coating.
  • the sheets of metallized PVDF film material are also provided with a layer of double backed sticky adhesive applied to one side of the metallization after the protective coating ⁇ are applied.
  • the protective coating ⁇ erve ⁇ to keep the adhesive from shorting out the metallization.
  • the sheets of proce ⁇ ed PVDF material with metallization, protective coating and adhe ⁇ ive can be die cut to fabricate the substantially dog-boned shaped pattern of sensors and leads shown in Figure 12 which will be folded over to form a double layered sen ⁇ or (more than two layers can be used if desired) .
  • the sensor diaphragms can be prepared.
  • the dog bone shaped piece ⁇ must be cleaned of all debris and contaminants. A thin layer of anerobic adhesive is applied to the side with no adhesive. As ⁇ hown in Figure 13, the ⁇ ensor is folded over to make the double layered sensor 124 and the diaphragms are sandwiched in a fixture to bond them tightly.
  • the whole fixture is then placed in a vacuum chamber (not shown) with ultra high vacuum to outga ⁇ all air and gas bubbles from the adhe ⁇ ive. This creates an integral and substantially uniform bond between sen ⁇ or layers so that the dynamic response of the ⁇ ensor is linear and proportional across the entire face of the ⁇ en ⁇ or.
  • the diaphragms are then removed from the fixturing and cleaned.
  • the next step is to assemble the diaphragms to the ⁇ tiffener/electrode a ⁇ embly.
  • the leads 126, 128 of the sen ⁇ or diaphragm ⁇ are placed into the rivet like connector ⁇ 130, 132 of the snap lead connectors.
  • the snap connectors are crimped in place onto the stiffener 134 as they capture and make electrical contact with the diaphragm leads.
  • a thin layer of anerobic adhesive 129 is applied to the upper rim of the diaphragm and the diaphragm i ⁇ placed against the lower rim of the stiffener 134.
  • a special fixture is attached to the diaphragm/stiffener assembly during adhesive curing.
  • This fixture has an expanding collet (not shown) with a rubber surface which pres ⁇ es against the diaphragm as it expands and, by virtue of the friction between the rubber and diaphragm, the collet acts to expand the diaphragm uniformly in an outward radial direction, and places the diaphragm in a slight degree of tension during adhesive curing.
  • the entire fixture is placed in a vacuum chamber under ultra high vacuum during curing.
  • the proces ⁇ of holding the diaphragm in tension and curing in a vacuum acts to have the diaphragm remain in tension after curing so as to remove all rimples and crease ⁇ from the thin film so the sensor has a uniform and linear dynamic response acros ⁇ the entire diameter.
  • the sensing device( ⁇ ) of the present invention can be mounted to auscultation point ⁇ on the chest and the neck. They can also be used on any pulse capturing point on the body, including the abdomen of a pregnant woman for capturing fetal heart sounds.
  • the sensing device( ⁇ ) can be u ⁇ ed with adults, infants, small children and animals.
  • the sen ⁇ ing device( ⁇ ) of the pre ⁇ ent invention are flexible enough to conform to fle ⁇ h in ⁇ uch a way that they essentially couple with the flesh and become part of the flesh for maxi ur. transfer of energy.
  • the sensing device( ⁇ ) of the present invention are sufficiently sensitive to detect turbulent blood flow due to blockages in major arteries and vein ⁇ deep within the body of a ⁇ ubject.
  • Another advantage to the ⁇ en ⁇ ing device( ⁇ ) of the pre ⁇ ent invention i ⁇ that they can be sterilized for one use. After such use, they can be discarded. This allows the sensing device(s) to be u ⁇ ed in operating roo ⁇ , intensive care units, and other environments where ⁇ terility i ⁇ critical.
  • the ⁇ ensing device( ⁇ ) may be reused if so desired.
  • the sen ⁇ ing device( ⁇ ) of the pre ⁇ ent invention may be quickly connected and di ⁇ connected from electrical leads and thus may easily be discarded after one or more uses and replaced by another sensing device.
  • Still another advantage of the ⁇ ensing device(s) of the pre ⁇ ent invention i ⁇ that they have excellent frequency re ⁇ ponse and sensitivity which can be tailored to low frequencie ⁇ (below 4000 Hz) and low amplitude (le ⁇ than 5 dB) signals from the heart and major arteries.
  • the sen ⁇ ing device( ⁇ ) can come in a wide variety of ⁇ ize de ⁇ igned to maximize acou ⁇ tic localization.
  • the device( ⁇ ) may have a diameter of about one-half inch for adults and a diameter of about one quarter inch for children.

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  • Medical Informatics (AREA)
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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

The present invention relates to a sensing device (10) for capturing acoustic heart sounds. The sensing device has a diaphragm (12) formed from a piezoelectric transducer material which generates excitation signals in response to acoustic and vibratory energy outputs. The sensing device includes metallization layers (14, 16) on the diaphragm for receiving and transmitting the excitation signals to an ouput display device via associated electrical contacts (18, 20) and electrical leads (24, 26) and also includes a layer of adhesive material (34) for coupling the sensing device to the subject. The sensing device further includes snap connectors (36, 38) for allowing the device to be quickly disengaged from electrical leads and discarded. A patch sensor device (62) is disclosed which enables acoustic outputs to be triangulated and pinpointed.

Description

DISPOSABLE SENSING DEVICE WITH CUTANEOUS CONFORMANCE
TECHNICAL FIELD The present invention relates to an improved sensing device for capturing cardiac output (SI and S2) and acoustic and vibratory outputs from arterial blood flow off the chest and appendages.
BACKGROUND ART There are many types of sensors, transducers and pickups used in general industrial applications. Several are specifically designed to capture heart sounds and body noises. One such sensor or pickup for heart sounds is a condenser microphone. This type of microphone is specifically designed for 2-D phonocardiography systems for capturing heart sounds off the human chest for interpretation.
Other prior art devices include accelerometers and piezoelectric crystal devices for capturing low frequency vibrations off the human chest as an indication of heart muscle damage. Apexcariography, vectorcardiography and seismocardiograph equipment all use probes to capture signals off the flesh. One of the inherent drawbacks of these prior art devices is the fact that they rely on rigid metal or ceramic sensors which do not conform to the curves, appendages and/or body hair of a subject. This makes any type of integral mechanical coupling very difficult. As a result, the efficiency and thus the accuracy of the sensor is greatly diminished and critical heart sound energy, which is an integral part of the detection and diagnosis of heart disease, is lost.
Some prior art sensors, for this purpose and other industrial applications, are formed by accelerometers and piezoelectric crystals epoxied onto appendages of the body. None of these sensors however has a desirable set of pliable conformance characteristics. Still further none of these known sensors utilize quick connect and disconnect leads on the sensor for electrical lead connection. Accordingly, it is an object of the present invention to provide a sensing device for capturing acoustic and vibratory energies, caused by turbulent blood flow through major vessels, the heart and its valves, and muscle disfunction of the heart, off the flesh of a subject.
It is a further object of the present invention to provide a sensing device as above having a set of pliable conformance characteristics for coupling the sensing device to the flesh for maximum energy transfer. It is yet a further object of the present invention to provide a sensing device as above which can be sterilized and which has utility in operating rooms, intensive care units, and other environments where sterility is critical.
It is still another object of the present invention to provide a sensing device as above which can be quickly connected and disconnected from electrical leads to create an easily disposable sensing device which can be used once and discarded.
Still other objects and advantages of the present invention are set forth in the following description and drawings wherein like reference numerals depict like elements.
DISCLOSURE OF INVENTION The foregoing objects and advantages are attained by the sensing device of the present invention which is capable of capturing acoustic and vibratory energies. In accordance with the present invention, the sensing device has a diaphragm formed from a thin piezoelectric polymer film transducer material, a thin film of conductive material on two surfaces of the diaphragm for receiving and transmitting excitation signals from the polymer film material, and a layer of adhesive material applied to the subject attachment side of the sensing to mechanically couple the sensing device to the subject.
In a preferred embodiment of the present invention, the diaphragm is formed by a polyvinylidene fluoride material which, with no or very little input voltage, is capable of generating its own output voltage in proportion to the excitation caused by the acoustic and/or vibratory energies. This type of material has been found to be extremely advantageous because it offers no or little possibility of a subject being shocked or burned from input voltages. Additionally, extraneous background noise is not captured as the transmission relies mainly on physical contact of the sensor to the body. This material is sufficiently flexible to allow a sensor to be formed that is flexible enough to conform with the flesh and become part of the flesh for maximum transfer of energy.
As previously mentioned, thin layers of conductive material are applied to opposed sides of the diaphragm material and terminated with electrical lead connections. In this way, a continuous sensor circuit is created.
An important and unique feature of the sensor device of the present invention is the thin layer of adhesive material which is applied to the subject attachment side of the sensing device. Preferably, an adhesive is used which has the physical properties of adhesion, viscosity, and duro eter (hardness and elasticity) which create an integral mechanical bond between sensor and flesh for maximum transfer of acoustic and vibratory energies. if desired, the sensing device of the present invention may include a backing formed from a stiff acoustic dampening material. The backing serves to insulate the sensor diaphragm from any extraneous background noises and, by virtue of this insulating effect, creates a unidirectional acoustic material pickup which receives acoustic and vibratory signals from the flesh while remaining isolated from background noise by virtue of the backing material.
An embodiment of a sensing device is disclosed which comprises an adhesive patch with an array of sensing devices for picking up multiple acoustic output and for triangulating signals to pinpoint the location and source of the acoustic output, e.g., from which human heart valve a murmur is emanating.
Yet another sensing device is disclosed which has multiple layers of the thin piezoelectric polymer film material for generating excitation signals in response to said acoustic cardiac output.
Still other features of the present invention will be described in detail in the following description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a cross sectional view of a first embodiment of a sensing device in accordance with the present invention; Figure 2 illustrates a portion of a top surface of the sensor diaphragm of the sensing device of Figure 1; Figure 3 is a cross sectional view of a second embodiment of a sensing device in accordance with the present invention; Figure 4 is a top view of the sensing device of Figure 3; Figure 5 is a cross sectional view of a first electrical connector which may be used with the sensing devices of the present invention;
Figure 6A is a cross sectional view of a second electrical connector which may be used with the sensing devices of the present invention;
Figure 6B is a top view of the male portion of the connector of Figure 6A;
Figure 7 is a top view of a sensor array patch using the sensing devices of the present invention;
Figure 8 is a cross sectional view of a bayonet type connector which may be used with the sensing devices of the present invention;
Figure 9 is a cross sectional view of the male portion of the connector of Figure 8;
Figures 10 and 11 illustrate yet another sensing device in accordance with the present invention; and
Figures 12-15 illustrate a process for making a sensor in accordance with the present invention.
MODEfS) FOR CARRYING OUT THE INVENTION
Referring now to the drawings, Figure 1 illustrates a first embodiment of a sensing device 10 in accordance with the present invention. The sensing device 10 includes a diaphragm in the form of a thin layer 12 for capturing acoustic and vibratory energies. It has been found that an improved sensing device is obtained when the layer 12 is formed from a piezoelectric polymer transducer material capable of generating its own voltage output when excited by an acoustic or vibratory output. One such material which may be used for the layer 12 is a polyvinylidene fluoride material (PVDF) sold under the trademark KYVAR by Atochem Sensors Inc. of Valley Forge, Pennsylvania.
The use of a piezoelectric polymer transducer material is advantageous because it allows a sensor to be formed which is truly non-invasive in that no energies are beamed into the subject to capture blood flow characteristics. This material allows a passive listening technique to be used. This type of material is also advantageous in that unlike an ultrasound probe, no high frequencies energies have to be beamed into the subject's body and bounced off tissue and blood in order to get an indication of blood flow in arteries and through valves. Still another advantage associated with the use of this type of material is the absence of any need to apply an excitation voltage to the material. Sensing devices formed from this material may be used with maximum safety on human subjects, including small children and infants, with no risk of electric shock or burns.
The device 10 further includes a thin film coating of metal on opposed surfaces of the polymer film material 12. The metal coatings 14 and 16 may be formed from any suitable conductive metal or metal alloy known in the art such as aluminum, nickel, copper and alloys thereof and may be applied to the surfaces of the polymer material using any suitable technique known in the art. Preferably, each layer is formed from aluminum or an aluminum alloy because such metals are inexpensive and have a relatively high impedance value. The metal coating layers 14 and 16 act as conductive surfaces for receiving and transmitting the excitation signal from the film material 12 along substantially the entire length of the film material and for transmitting excitation signals to electrical contacts or terminals 18 and 20 on the sensing device. As best shown in Figure 2, each of the metal coating layers stops short of the edges of the polymer film material layer so as to prevent the creation of short circuits. Additionally, each of the metal coating layers 14 and 16 has one of the electrical contacts 18 and 20 associated therewith.
The terminals 18 and 20 may be any two electrical termination points located on the thin metallic films. They may be formed by solder connections, spade connections or any other type of low impedance electrical connection. At least one of the electrical terminals 18 or 20 passes through the thin film polymer material layer 12 to the thin metal layer on the opposite side.
The sensing device 10 further comprises a bow or frame 22 for stretching and holding the polymer film material 12 in tension. The bow 22 may be formed from a rigid polymer material or any other suitable non-conductive material. It may be adhesively bonded or mechanically fastened to the material 12 using any suitable means known in the art. As can be seen from Figure 1, the bow 22 is configured so that there is an air gap 30 between it and the upper surfaces of the sensor diaphragm. If desired, the bow 22 can have a two piece construction with the thin film polymer layer 12 forming the diaphragm being positioned intermediate the two pieces. The bow 22 acts to hold the piezoelectric film portion of the sensor in tension as a diaphragm both in the rest state and when the sensor is attached to the subject. The tension acts to create a more sensitive diaphragm out of the piezoelectric polymer transducer film as any minute acoustic or vibratory excitations are magnified by orders of magnitude. The bow or frame 22 also acts to isolate the diaphragm from extraneous noise and effectively creates a unidi ensional acoustic sensor.
Two electrical leads 24 and 26 are attached to the electrical terminals 18 and 20 and are preferably of low impedance. The leads 24 and 26 may be electrically shielded, may have any desired length, and may be connected to the terminals 18 and 20 in any desired manner.
The leads 24 and 26 pass through a strain relief device 28 in the bow 22. The strain relief device and the leads can be molded into the bow or frame or may be mechanically assembled as three separate items. The strain relief device 28 may be formed by a rubber grom et or by an epoxy material.
A thin film layer 34 of peel and stick adhesive is applied to the subject side of the sensing device 10 and the bow 22. The adhesive acts to mechanically couple the sensor to the flesh in such a way that the sensor and flesh conform and become one. This insures that the maximum amount of acoustic and vibratory energy from heart valves and major arteries within the body is received by the diaphragm formed by the piezoelectric polymer material layer. The adhesive used to form the thin film layer 34 may be any suitable adhesive known in the art such as the adhesive used in a product called "Double-Stick Discs" manufactured by 3M.
The sensing device 10 may be electrically connected by the leads 24 and 26 to any suitable display device and/or microprocessor (not shown) known in the art. Before the signal from the sensor is transmitted to the display device and/or microprocessor, it may be passed through an appropriate analog conditioning circuit 32 for filtering and amplifying the output signal to rid it of extraneous background noise and to highlight the low frequency heart sounds. The circuit 32 may be any suitable conditioning circuit known in the art. One type of conditioning circuit which can be used is shown in co-pending
U.S. Patent Application No. 942,438, filed on 9 September, 1992.
An alternate embodiment of a sensing device 10' in accordance with the present invention is illustrated in Figures 3 and 4. As before, the sensing device 10' comprises a thin film piezoelectric transducer material layer 12', metal coating layers 14' and 16', and adhesive layer 34' on the subject side of the sensing device.
The sensing device of Figures 3 and 4 differs from the device of Figure 1 in two respects. The first is that the sensor diaphragm formed by the polymer transducer material layer 12' and the metal coating layers 14' and 16' is supported by a backing 35 of at least one of a polymer foam material and a molded polymer material. The backing 35 is preferably attached by adhesive to the sensor diaphragm in such a way that the diaphragm is in a slight amount of tension when at rest. As before, this aids the diaphragm in its sensitivity to any minute amount of acoustic or vibratory excitation. The backing and adhesive may be pliable and of such a duro eter (hardness and spring rate) that they allow the diaphragm to conform to the flesh without distortion.
The second difference between the sensing devices of Figures 1 and 3 is the electrical connection between the leads 24' and 26' and the metal conductive layers 14' and 16'. In the embodiment of Figure 3, the electrical connections are formed by quick connectors 36 and 38, one of which terminates the upper conductive coating layer and the other which terminates the lower conductive coating layer. Quick connectors are used to provide a security lock so that the sensing device 10' can be used only with compatible type(ε) of electrical leads. This helps to provide a measure of patient safety in that one cannot connect high voltage leads or ECG leads to the subject. Also, it insures that other types of incompatible or mismatched sensors are not used by mistake.
Figure 5 illustrates one type of quick connector which can be used with the sensor of Figure 3. The connector includes a male portion 40 which is mounted on or electrically connected to one of the metallization layers 14' or 16'. The male portion 40 extends through the backing 35 and has a raised snap connector portion 42. The quick connector further includes a female portion 43 to which one of the leads 24' or 26' is electrically connected.
The female portion 43 has an electrical contact layer 44 formed from an electrically conductive metal or metal alloy and an outer non-conductive cover 46 formed from a molded polymer material or any other suitable electrically non-conductive material. As shown in Figure 5, the layer 44 is shaped to conform to the shape of the male portion 40 and the raised snap connector portion 42. In this way, a secure connection can be made between the male and female portions.
As shown in Figure 3, a sensor terminal connector 48 may be provided to insure that the backing 35 does not move relative to the male portion 40 of the quick connector. The connector 48 may be formed by a metal ring crimped onto the male portion 40 of the quick connector. Figureε 6A and 6B illustrate another quick connector device 36', 38' which may be employed with the sensing devices of the present invention. The quick connector device 36', 38' also has a male portion 40 and a female portion 43 of a construction identical to that of the connector device shown in Figure 5. It differs however in that it includes a mechanical lock which consists of embossed metal letters 56 on the top surface 58 of the raised snap connector portion 42 and mating letters 60 formed in the female portion 43. This type of mechanical lock is particularly useful in insuring that non-compatible leads are not used with the sensing device of the present invention. While the mechanical lock has been illustrated using the letters " CG", it should be recognized that the mechanical lock could be formed by any desired combination of embossed letters, numbers and symbols.
Figure 7 illustrates a novel patch type sensing device 62 in which an array of four sensing devices 10 and 10' are embedded within or mounted to a relatively large adhesive patch formed from a compliant plastic material such as a compliant polymer foam material. A compliant plastic material is used for the patch so that the sensing device 62 may take the form of that portion of the subject's body over which it is to be placed. An adhesive layer (not shown) may be formed on the underside of the plastic material to insure a good connection between the subject and the sensing device(ε) . Alternatively, in a situation where the sensing devices 10 or 10' are embedded within the plastic material and have a lower surface in contact with the subject, the adhesive layer (not shown) may only be to the underside of the individual sensors in contact with the subject.
The patch sensing device 62 thus described is useful for picking up multiple acoustic outputs and for triangulating the excitation output signals so as to pinpoint the location and source of the acoustic output, e.g., from which human heart valve a murmur is emanating or from which artery or other blood flow passage/vessel a sound emanates. The four sensing devices 10, 10' can be positioned within or on the sensor patch material so that they cover the four heart valves of the subject. The sensing devices 10, 10' may have individual leads to a conditioning circuit or display device or may share common leads. If desired, ECG electrodes 64 may also be embedded within or mounted to the plastic material forming the patch sensing device.
While the sensing device 62 has been illustrated as having four sensing devices 10, 10', it can actually have any desired number of sensing devices. For example, the patch device 62 could have only two sensing devices, 10, 10'. Figures 8 and 9 illustrate a unique bayonet connector 66 which may be used for the leads attached to the sensing devices 10 and 10'. The connector 66 includes a female portion 68 and a male portion 70. The female portion 68 preferably has an inner metal contact layer 72 for receiving a mating male contact and a molded plastic non-conductive cover 74. The male portion comprises a molded non-conductive cover portion 76 formed from a suitable plastic material and a male pin 78 formed from a suitable metal or metal alloy.
To insure that non-compatible leads are not utilized, the male pin 78 and the receptacle 80 within the female contact layer 72 are provided with mating shapes. For example, the male pin 78 may be provided with a tip 82 having a desired radius or curvature and an edge 84 which has a region 86 of different taper near the tip. For example, the taper angle β of the edge portion 84 may be different than the taper angle α of the remainder of the pin. Of course, the receptacle 80 would be shaped to have an identical configuration so that the male pin would fit snugly therein.
Still another type of connector which may be employed with the sensing devices of the present invention is one in which an integrated circuit chip 150 is placed on the head of the sensing device. The chip may be used to accomplish a variety of tasks. For example, the chip may carry the sensor serial number and manufacturing lot code for FDA traceability. The chip may also carry the wave pattern of the dynamic response of the sensor so that the back end electronics recognize the sensor as a compatible device, thus providing system security. The sensor chip may have a code reflecting the diameter size of the sensor so as to let the back end electronics recognize it as a fetal sensor, infant/child sensor or an adult sensor. The various coded signals described above allow the sensor and back end electronics to proceed through an initialization sequence before normal communications will occur.
Figures 10 and 11 illustrate still another embodiment of a sensing device 10" in accordance with the present invention. This sensing device 10" has a sensing diaphragm formed by two layers 88 and 90 of thin polymer piezoelectric transducer material of the type previously discussed. The sensing device further includes metallization layers 92, 93, 94 and 95 and snap connector contacts 96 and 98 connected to respective ones of the metallization layers. Two of the metallization layers 92 and 95 are + layers, while the other two layers 93 and 94 are - layers. Each metallization layer may, if desired, have a layer of a polymer protective coating material theron. An adhesive layer 102 is formed between the metallization layers 92 and 95 to hold the two layers in a desired position and at a desired tension level. The adhesive which is used for the layer 102 preferably has insulative properties.
Each of the electrical contacts 96 and 98 is formed by a metal or metal alloy members held in place by a respective two part rivet 97. The electrical contacts 96 and 98 are connected to respective ones of the metallization layers by leads 108 and 110. The leads 108 and 110 may each be formed from a silver or carbon bearing conductive elastomer material. Air gaps 89 and 91 are provided to avoid short circuits between certain metallization layers and the leads.
The sensing device further includes an adhesive layer 100 on the subject side of the device and a εtiffener 104 for acoustically isolating the sensing device from background noise and for holding the sensing diaphragm in tension. The stiffener 104 may be formed from any εuitable plaεtic material and may be εhaped to form an air gap 103 with the εenεing diaphragm. The stiffener 104 also serves as a mechanical mounting for the connectors 96 and 98.
The procesε to make sensors of the type described herein starts with raw sheets 120 of PVDF piezoelectric film material. The film material is cleaned and mounted on a rotating drum in a vapor depostion machine. An ultrahigh vacuum is pulled on the chamber and aluminum, nickel, copper or alloys thereof are sputtered onto the film in thin layers 122. This process is repeated for both sides. Leads 123 and termination rings 125 may be formed during this step. Appropriate masking (not shown) can be done to keep the metallization off of non-conductive areaε for design purposes. At this point, several procesεeε can occur, but there iε the option of having them occur downεtream.
For example, to form a sensor similar to that shown in Figures 10 and 11, the sheets of metallized PVDF film material are provided with a layer of polymer protective coating. The sheets of metallized PVDF film material are also provided with a layer of double backed sticky adhesive applied to one side of the metallization after the protective coatingε are applied. The protective coating εerveε to keep the adhesive from shorting out the metallization.
At this point, the sheets of proceεεed PVDF material with metallization, protective coating and adheεive can be die cut to fabricate the substantially dog-boned shaped pattern of sensors and leads shown in Figure 12 which will be folded over to form a double layered senεor (more than two layers can be used if desired) . Once the die cut procesε iε completed, the sensor diaphragms can be prepared.
The dog bone shaped pieceε must be cleaned of all debris and contaminants. A thin layer of anerobic adhesive is applied to the side with no adhesive. As εhown in Figure 13, the εensor is folded over to make the double layered sensor 124 and the diaphragms are sandwiched in a fixture to bond them tightly.
The whole fixture is then placed in a vacuum chamber (not shown) with ultra high vacuum to outgaε all air and gas bubbles from the adheεive. This creates an integral and substantially uniform bond between senεor layers so that the dynamic response of the εensor is linear and proportional across the entire face of the εenεor. The diaphragms are then removed from the fixturing and cleaned.
The next step is to assemble the diaphragms to the εtiffener/electrode aεεembly. As shown in Figure 14, the leads 126, 128 of the senεor diaphragmε are placed into the rivet like connectorε 130, 132 of the snap lead connectors. The snap connectors are crimped in place onto the stiffener 134 as they capture and make electrical contact with the diaphragm leads. A thin layer of anerobic adhesive 129 is applied to the upper rim of the diaphragm and the diaphragm iε placed against the lower rim of the stiffener 134. A special fixture is attached to the diaphragm/stiffener assembly during adhesive curing. This fixture has an expanding collet (not shown) with a rubber surface which presεes against the diaphragm as it expands and, by virtue of the friction between the rubber and diaphragm, the collet acts to expand the diaphragm uniformly in an outward radial direction, and places the diaphragm in a slight degree of tension during adhesive curing. The entire fixture is placed in a vacuum chamber under ultra high vacuum during curing. The procesε of holding the diaphragm in tension and curing in a vacuum acts to have the diaphragm remain in tension after curing so as to remove all rimples and creaseε from the thin film so the sensor has a uniform and linear dynamic response acrosε the entire diameter.
The assembly iε then tested for uniform and radial dynamic reεponεe using a heart sound simulator with known amplitude, frequency and timing characteristicε. It εhould be noted that the application of protective coatingε and adheεive can be done before or after die cutting of film, but the proceεε iε made eaεier by proceεεing uncut εheets of film.
A senεing device haε been deεcribed which iε capable of capturing cardiac output and acouεtic output from arterial blood flow off the cheεt and appendageε. The sensing device(ε) of the present invention can be mounted to auscultation pointε on the chest and the neck. They can also be used on any pulse capturing point on the body, including the abdomen of a pregnant woman for capturing fetal heart sounds. The sensing device(ε) can be uεed with adults, infants, small children and animals. The senεing device(ε) of the preεent invention are flexible enough to conform to fleεh in εuch a way that they essentially couple with the flesh and become part of the flesh for maxi ur. transfer of energy. Still further, the sensing device(ε) of the present invention are sufficiently sensitive to detect turbulent blood flow due to blockages in major arteries and veinε deep within the body of a εubject. Another advantage to the εenεing device(ε) of the preεent invention iε that they can be sterilized for one use. After such use, they can be discarded. This allows the sensing device(s) to be uεed in operating roo ε, intensive care units, and other environments where εterility iε critical. Alternatively, the εensing device(ε) may be reused if so desired.
The senεing device(ε) of the preεent invention may be quickly connected and diεconnected from electrical leads and thus may easily be discarded after one or more uses and replaced by another sensing device.
Still another advantage of the εensing device(s) of the preεent invention iε that they have excellent frequency reεponse and sensitivity which can be tailored to low frequencieε (below 4000 Hz) and low amplitude (leεε than 5 dB) signals from the heart and major arteries.
Yet another advantage is that the senεing device(ε) can come in a wide variety of εize deεigned to maximize acouεtic localization. For example, the device(ε) may have a diameter of about one-half inch for adults and a diameter of about one quarter inch for children.
While it is preferred not to apply an excitation voltage to the polymer film material for picking up the acouεtic and/or vibratory energy, εuch voltageε may be applied if deεired.
It iε apparent that there haε been provided in accordance with thiε invention a diεposable senεing device with contaneouε conformance which fully εatiεfieε the objectε, means and advantages set forth hereinbefore. While the invention has been described in combination with specific embodimentε thereof, it iε evident that many alternativeε, modifications, and variations will be apparent to thoεe εkilled in the art in light of the foregoing deεcription. Accordingly, it iε intended to embrace all εuch alternatives, modifications, and variations as fall within the spirit and broad εcope of the appended claims.

Claims

CLAIMS:
1. A senεing device (10) for capturing cardiac output and acoustic output, said sensing device being characterized by: a diaphragm (12) formed from a piezoelectric transducer material for generating excitation signals in reεponse to acoustic and vibratory outputs; metallization layerε (14, 16) on oppoεed εurfaceε of εaid diaphragm for receiving and transmitting said excitation signals generated by said diaphragm; and a layer of adheεive material (34) for mechanically coupling the senεing device to a deεired portion of a εubject's anatomy.
2. The εenεing device of claim 1 further characterized by εaid diaphragm being formed from a single layer (12) of a thin film piezoelectric polymer transducer material, preferably a polyvinylidene fluoride material.
3. The sensing device of claim 1 further being characterized by said diaphragm being formed from at least two layers (88, 90) of a thin film piezoelectric polymer tranεducer material.
4. The εensing device of claim 1 further being characterized by εaid metallization layerε (14, 16) being formed from a metal εelected from the group consisting of aluminum, an aluminum alloy, nickel, nickel alloys copper and copper alloys.
5. The senεing device of claim 1 further being characterized by: an electrical contact (18, 20) associated with each of said metallization layers and an electrical lead (24, 26) connected to each of εaid electrical contactε.
6. The εenεing device of claim 5 further being characterized by: a bow-εhaped member (22) for applying a tension force to said diaphragm; said diaphragm (12) being mechanically connected to said bow-shaped member; an air gap (30) between εaid bow-shaped member and an upper one (14) of said metallization layerε; and a strain relief device (28) within εaid bow-shaped member through which said electrical leads paεs.
7. The sensing device of claim 5 further being characterized by means (32) for conditioning output signals being transmitted by said electrical leads, said conditioning means serving to filter and amplify said output signals.
8. The εensing device of claim 5 further being characterized by a backing layer (35) adhesively bonded to one of said metallization layers, said backing layer applying a tensile force to said diaphragm and being formed from at least one of a polymer foam material and a molded polymer material.
9. The senεing device of claim 8 further being characterized by: each of the electrical contactε connected to the metallization layers comprising a male portion (40) extending through the backing layer and a terminal connector (48) for insuring that said backing layer does not move relative to εaid male portion; and a εnap connector (36, 38) aεsociated with each of the electrical contacts, said εnap connector having a female portion (43) configured to mate with εaid male portion.
10. The εensing device of claim 9 further being characterized by: εaid female portion having an electrical contact layer (44) housed within an electrically non-conductive housing (46) , said electrical contact layer having a shape which enables mating with the male portion; εaid male portion having e boεεed metal characterε (56) on an upper εurface; and said electrical contact layer having matching metal characters (60) for mating with the metal characters on said male portion.
11. The senεing device of claim 5 further being characterized by: each of said electrical leads containing a bayonet type connector (66) comprising a male portion (70) and a female portion (68) ; εaid male portion having a tip portion (82) with a particular deεign and εaid female portion having a mating deεign (80) ; and εaid tip portion (78) having a deεired radiuε of curvature and an edge (84) with a region (86) of different taper near the tip.
12. The εenεing device of claim 1 further being characterized by an integrated circuit chip (150) placed on εaid sensing device for providing security and insuring compatibility of the device and electrical components to which a signal iε tranεmitted.
13. A patch εenεing device (62) for picking up multiple acouεtic outputε and for triangulating excitation output signals so aε to pinpoint the location and εource of an acoustic output, said device being characterized by: a patch (62) formed from a 'compliant material which can be formed into the shape of a portion of a subject'ε anatomy; εaid patch having a layer of adhesive material along an underside; at leaεt two sensors (10, 10') aεεociated with εaid patch; and each of εaid εenεorε having a diaphragm (12) formed from a piezoelectric polymer transducer material.
14. The sensing device of claim 13 further being characterized by: four εenεorε (10, 10') aεεociated with εaid patch; and εaid four sensorε being poεitioned substantially over the four valves of the subject's heart.
15. A procesε for forming a εenεing device which is characterized by the εtepε of: providing a raw εheet (120) of piezoelectric film material; depoεiting a metallization layer (122) on oppoεed εurfaces of εaid film material; die cutting εaid film material to form a εubεtantially dog- boned shaped pattern of senεor diaphragmε and leadε; and folding said dog-boned shaped pattern on itself to form a double-layered εenεing diaphragm (124) .
16. The proceεε of claim 15 further being characterized by: applying a protective coating layer over each metallization layer prior to said die cutting step; and applying an adheεive layer to a first εurface having a firεt one of εaid metallization layerε and to a εecond εurface having a εecond one of εaid metallization layerε after εaid die cutting εtep.
17. The process of claim 16 further being characterized by: placing said double-layered εenεing diaphragm into a vacuum chamber; creating a vacuum to outgaε any air and gaε bubbles from said adheεive layers and to create an integral and subεtantially uniform bond between εaid εensor layerε; placing εaid εenεing diaphragm in tension; aεεe bling εaid εensing diaphragm in tension to a stiffener assembly; providing said sensing diaphragms with electrical leads; connecting each of said leadε to a respective snap lead electrical connector; and maintaining εaid diaphragm in tension by curing said εensing device in a vacuum.
PCT/US1993/008237 1992-09-09 1993-09-08 Disposable sensing device with cutaneous conformance WO1994005207A1 (en)

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CA002144169A CA2144169C (en) 1992-09-09 1993-09-08 Disposable sensing device with cutaneous conformance
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US5365937A (en) 1994-11-22
DE69323085D1 (en) 1999-02-25
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DE69323085T2 (en) 1999-06-24
CA2144169C (en) 2009-01-20
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US5807268A (en) 1998-09-15
DE69331976D1 (en) 2002-07-04
EP0659058A1 (en) 1995-06-28
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CA2144169A1 (en) 1994-03-17
US5913829A (en) 1999-06-22

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