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WO1993010828A1 - Systeme medical de detection de fuites - Google Patents

Systeme medical de detection de fuites Download PDF

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Publication number
WO1993010828A1
WO1993010828A1 PCT/US1992/010477 US9210477W WO9310828A1 WO 1993010828 A1 WO1993010828 A1 WO 1993010828A1 US 9210477 W US9210477 W US 9210477W WO 9310828 A1 WO9310828 A1 WO 9310828A1
Authority
WO
WIPO (PCT)
Prior art keywords
conductive
layer
medical
glove
medical garment
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US1992/010477
Other languages
English (en)
Inventor
Donald Carmichael
John R. Searle
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO1993010828A1 publication Critical patent/WO1993010828A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/40—Investigating fluid-tightness of structures by using electric means, e.g. by observing electric discharges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
    • A61B42/30—Devices for detecting perforations, leaks or tears
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/16—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means
    • G01M3/18—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/186—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • G01M3/187—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using electric detection means for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators for flexible or elastic containers

Definitions

  • the present invention relates to sterile surgical garments and in particular to novel surgical garments and device for detecting the existence of a leak in the sterile barrier of the surgical garments.
  • This sterile barrier generally includes gloves, and may also include sleeves and/or a full sterile gown.
  • a medical garment adapted to be worn by a medical practitioner during medical procedures having a nonconductive layer and a conductive layer over the nonconductive layer. At least one of these layers is normally substantially moisture impermeable. Means for electrically connecting the conductive layer to an electrical detection circuit is also provided.
  • a system for detecting breaks in a substantially moisture impermeable barrier between a medical practitioner and a patient during medical procedures which includes a medical garment haying a nonconductive layer and a conductive layer over the nonconductive layer, at least one of these layers being normally substantially moisture impermeable.
  • the system also includes means for electrically connecting the conductive layer to an electrical conductor, means for imposing an electrical bias between the conductive layer and the medical practitioner and means for electrically connecting the medical practitioner to the detection means so that, in the event of a break in the substantially moisture impermeable layer, conductive liquids entering the break will permit a detectable flow of electricity between the electrical conductor and the medical practitioner.
  • Means for detecting the flow of electrical current are also provided.
  • a medical garment adapted to be worn by a medical practitioner during medical procedures having a nonconductive layer sandwiched between respective first and second conductive layers is provided. At least one of said layers is normally substantially moisture impermeable. Means for electrically connecting said first and second conductive layers to an electrical detection circuit are also provided.
  • FIG. 1 depicts a system in accordance with a preferred embodiment of the present invention, including a multi-layer glove, a gown having a multi-layer contact panel, electrical conductors and an electrical detection device, in use by a medical practitioner.
  • Fig. 2 is a diagrammatic cross-sectional view of a portion of a glove constructed in accordance with a preferred embodiment of the present invention, as depicted in Fig. 1, taken along the line 2-2.
  • Fig. 2a is simplified schematic of a gown contact panel and monitor in accordance with a preferred embodiment of the present invention, in partial cross- section and in use by a medical practitioner.
  • Fig. 2b is simplified schematic of a glove having two conductive layers in accordance with a preferred embodiment of the present invention, in partial cross-section, connected to a monitor by means of electrical conductors and in use by a medical practitioner.
  • Fig. 2c is simplified schematic of a glove having two conductive layers in accordance with a preferred embodiment of the present invention, in partial cross-section, with a directly connected monitor and in use by a medical practitioner.
  • Fig. 3 is a simplified schematic of the system in accordance with a preferred embodiment of the present invention, incorporating both a multi-layer glove and gown contact panel, a portion of which is depicted in diagrammatic cross-section, in use by a medical practitioner.
  • Fig. 4 is a block diagram of an electrical detection and alarm circuit in accordance with a preferred embodiment of the present invention.
  • Fig. 5 is a schematic of an electrical detection and alarm circuit in accordance with a preferred embodiment of the present invention. Detailed Description
  • a system 10 for detecting breaks in a sterile barrier between a medical practitioner 11 and a patient (not shown) during medical procedures is depicted.
  • this sterile barrier includes two gloves 12 (only one of which is shown) and a sterile, generally disposable, gown 13 comprised of moisture resistant material.
  • Gown 13 includes sleeves 14 and a torso portion 15.
  • the sterile barrier may consist of gloves 12 alone, or gloves 12 along with moisture resistant sleeves 14.
  • gloves 12 are of a novel construction, including at least one non-conductive layer 16 and a conductive layer 17 over the non-conductive layer.
  • the glove also includes an outer layer 18. This multi-layer construction is schematically depicted in cross section in Figs. 2 and 3.
  • At least one of layers 16, 17 or 18 must be normally substantially moisture impermeable in order to create a substantially moisture impermeable, and sterile, barrier between the medical practitioner and the patient.
  • at least non-conductive layer 16 is normally substantially moisture impermeable. In that way, perspiration from the medical practitioner 11 will not come in contact with conductive layer 16 to unintentionally complete an electrical circuit between the body of the medical practitioner 11 and the conductive layer 17 , in the absence of a break in layer 8
  • Layers 17 and 18 are also conveniently substantially moisture impermeable, although this is not essential to the invention.
  • nonconductive layer 16 is composed of latex, which is currently the material used in gloves today. Polyurethane may also be used.
  • the conductive layer 17 is a flexible conductive material, preferably an elastic conductive polymer a few thousand of an inch thick. Latex mixed with graphite is the preferred material.
  • the optional third layer 18 is conveniently an outer layer of latex. Where such a third layer 18 is employed, conductive layer 17 may be simply a layer of graphite sandwiched between layers 16 and 18.
  • a thin film of conductive material, such as aluminum, silver, tin or tin oxide vacuum deposited or sputtered onto the outside of layer 16 or the inside of layer 18 may also serve as the conductive layer 17.
  • These three layers are preferably bonded together to form a glove with about the same thickness as conventional surgical gloves.
  • the cuff of glove 12 also has an exposed contact area 19 for connection of an electrical conductor 20 to conductive layer 17.
  • the gown 13 used in the present invention preferably is made of a sterile, moisture resistance multi-layered paper, similar to that presently in use.
  • the gown 13 in accordance with the present invention also includes a contact panel 21 constructed in a manner similar to glove 12. That is, contact panel 21 preferably includes at least one non-conductive layer 16' and a conductive layer 17' over the non-conductive layer 16'. At least one of these layers is substantially moisture resistant, preferably layer 16'.
  • the contact panel 21 also includes an outer layer 18'. This multi-layer construction is schematically depicted in cross section in Figs. 2a and 3. Non-conductive layer 18' may also be omitted entirely. All layers of contact panel 21 are preferably bonded together, although this is not essential.
  • Contact panel 21 may be separate from gown 13, or may be integrally incorporated therein. Furthermore, the moisture resistant material of the gown 13 itself may serve as one of the layers of contact panel 21 as depicted in Fig. 3, such as layer 16'. Preferably, contact panel 21 is positioned in the front torso area 15 of the gown 13, where patient contact is most likely to occur. However, contact panel 21 may also be positioned at other places on the gown 13, or may be integral throughout the entire gown 13, or any part or parts thereof.
  • the contact panel 21 would be positioned in a part of sleeves 14, or integral therewith, in the similar manner to a full gown 13.
  • Conductive layer 17 of glove 12 includes a portion 19 (19') left uncovered by layer 18 (18') to permit connection of an electrical conductor 20 (20'), i.e., a wire, to conductive layer 17 (17').
  • the electrical conductor 20 (20') is attached to portion 19 (19') of conductive layer 17 (17') by means of connection 24.
  • Connection 24 (24') is conveniently an adhesive contact of the type commonly used for E.K.G. monitoring, but may also be a snap connection, adhesive, spring clip, or any other convenient means.
  • the other end of conductor 20 (20') is attached to an electronic monitor 22, the construction and operation of which is described below.
  • Another electrical conductor 23 extends from monitor 22 and is attached to the body of the medical practitioner 11 by means of contact 25, which is conveniently an adhesive contact of the type commonly employed for E.K.G. monitoring.
  • system 10 forms an electrical circuit between conductive layer 17 (17') and the body of the medical practitioner 11.
  • the circuit is incomplete (i.e., open) as long as layer 16 (16') remains moisture impermeable.
  • bodily fluid i.e., blood, plasma or perspiration
  • bodily fluids are conductive, this fluid will conduct electricity between the conductive layer 17 (or 17') and the body of the medical practitioner 11, thus completing the electrical circuit and permitting current to flow.
  • Monitor 22 is preferably small, in the range of 2 x 1 x 1/2 cm, and preferably disposable. Monitor 22 may be separate or incorporated into the disposable gown 13 worn in sterile procedures. Conveniently, monitor 22 would be located near the neck-line or front of the gown where it could be easily seen and heard.
  • Monitor 22 includes a current detection circuit 26 for detecting flow of current and for activating annunciators 27 (i.e., alarms) in the event such current flow is detected.
  • annunciators 27 i.e., alarms
  • Monitor 22 measures electrical conductivity between electrodes 24 (24') connected by wires 20 (20') and 23.
  • a low conductivity measurement (approximately less than 2 x 10 ⁇ 7 Siemens or greater than 5 x 10 6 Ohm) by detection circuit 26 will not activate the alarms 27.
  • Higher conductivity (less resistance) will activate the alarms 27, preferably with pulsing visual and/or auditory signals whose repetition rate is proportional to conductivity (inversely proportional to resistance) .
  • the pulsing is controlled by a variable pulse rate generator 28.
  • a low repetition rate indicates a small compromise in the sterile barrier.
  • a high or increasing rate indicates a significant loss of effectiveness of the sterile barrier.
  • Monitor 22 includes a battery 29 for powering the current detection circuit 26, for creating a safe, low voltage electrical bias between leads 20 (20') and 23, and for powering alarms 27.
  • Monitor 22 consumes a negligible amount of energy from the battery when it is inactive (in storage, or in use but with an intact and therefore insulating sterile barrier) . Thus, the monitor can be stored "on". The power source should remain viable for two to three years with the monitor in the inactive state.
  • the pulse rate generator 28 is conveniently an integrated circuit (IC) .
  • Pulse rate generator 28 to annunciator driver 31 produces an output of pulses whose repetition rate is proportional to the current between the electrodes arid therefore proportional to the conductivity of the sterile barrier.
  • Annunciator driver 31 contains a high current switch which is suitable for turning on and off the visible and auditory annunciators 27.
  • the visible annunciator is preferably a high efficiency light emitting diode (LED) 33.
  • the auditory annunciator 34 is preferably a high efficiency piezoelectric buzzer.
  • the audio frequency oscillator needed to drive the piezoelectric element is contained within the housing of integrated circuit 28.
  • the drive oscillator may also be incorporated within annunciator driver 31.
  • the current detection circuit 26 is conveniently constructed as depicted in Fig. 5.
  • Transistor Ql acts as a switch to power the 7555 IC.
  • Resistors R3, Rl, the electrodes, R2, and R5 are in parallel with C2 to form a current path from the base of Ql to circuit common.
  • electrode resistance is less than about 5 Meg ohms
  • Ql conducts and the collector current charges C3 to an operating voltage of about 2 volts and the voltage at IC pin 3 rises to near the operating voltage.
  • the current in the electrode circuit charges C2 as well.
  • Diode Dl becomes forward biased and supplies current to charge C2 as the electrode resistance falls. It is reversed biased when the monitor is inactive.
  • Oscillation begins when the voltage IC pin 6 reaches 2/3 of the IC operating voltage.
  • the pin 6 voltage depends on electrode resistance and the time required to charge C2. Thus brief episodes of conductivity in the electrode circuit are ignored.
  • IC pin 6 reaches its threshold voltage the IC changes state, pin 3 changes from about 2 volts to about 0 volts, and C2 discharges through R4 and D2.
  • IC pin 2 reaches a lower threshold of 1/3 of the IC operating voltage at which time the IC returns to the initial state, and C2 begins to charge again.
  • pin 7 changes from an open condition to a current sink which activates the auditory alarm 34 and visible alarm 33.
  • a protection circuit 35 is preferably included in the present invention.
  • This protection circuit is comprised of Rl, R2, and Cl, depicted in Figs. 4 and 5, and serves to impede direct current shocks, as well as radio frequency (RF) currents originating from an electrosurgical unit, for example, and passing through the electrode circuit which includes the medical practitioner.
  • RF radio frequency
  • the series impedance offered by Rl, R2, and Cl is preferably approximately 100K ohms at RF frequencies and should be sufficiently high to prevent burns at the electrode sites. The shunting effect of Cl also prevents RF frequency currents from affecting the rest of the circuit.
  • an exposed, but sterile, conductive test area 36 is preferably positioned at a convenient place on gown 13 and connected by lead 37 to conductor 23.
  • glove 12 preferably includes an exposed, but sterile, conductive test area 38 connected to the conductive layer 30.
  • the apparatus of the present invention is used in the same manner as conventional gloves and gowns.
  • the medical practitioner i.e., a surgeon, attired in non-sterile "scrubs" first washes his or her hands and arms in the usual fashion. He or she then enters the operating room and a pre-packaged, sterile gown constructed in accordance with the present invention is placed onto the surgeon by the sterile scrub nurse and tied in back by the non-sterile circulating nurse.
  • the non-sterile circulating nurse would then place lead 25 onto the surgeon's neck since the neck is not sterile.
  • the sterile gloves 12 constructed in accordance with present invention are put on the surgeon. At this point the surgeon attaches the appropriate lead 20, which is sterile, to the conductive layer of the gloves 12.
  • the two leads 23 and 20 (20') are insulated from each other and the circuit is incomplete.
  • bodily fluid would be free to pass between the surgeon and the conductive layer 17 (17') in the glove 12 or gown contact panel 21, thus completing the circuit and triggering the alarm.
  • the operating room personnel could stop and assess where the leak occurred and remedy it by changing the glove or gown.
  • leads 20 and 20' may be connected to each other or separate. If leads 20 and 20' are kept separate, a separate detection circuit 26 is required for each lead. The advantage of this approach is that the alarms 27 will be unique to that lead, thus indicating whether the leak occurred in the moisture impermeable layer 16 of glove 12 or moisture resistant layer 16' or the gown contact panel. Separate circuits can also be employed for each of the two gloves 12. This simplifies finding the leak. However, if 20 and 20' are connected together, only a single detection circuit is required, which simplifies construction. However, in this case, location of the leak would need to be done manually. In another embodiment of the invention, depicted schematically in Figs.
  • the multilayer medical garment includes at least one nonconductive layer 18a sandwiched between first and second conductive layers, respectively 17 and 17a.
  • nonconductive layer 18a is normally substantially moisture impermeable.
  • an outer (or second) nonconductive layer 18 may be included on the outside of conductive layer 17.
  • an inner (or third) nonconductive layer 16 is included on the inside of conductive layer 17a, between medical practitioner 11 and conductive layer 17a.
  • either or both of nonconductive layers 16 and 18 are normally substantially moisture impermeable.
  • conductive layers 17 and 17a may be normally subtantially moisture impermeable.
  • electrodes 24 and 25 are connected to conductive layers 17 and 17a, respectively, and an electrical bias imposed between them through contacts 24 and 25.
  • the electrical current passes between the first and second conductive layers through the (now breached) nonconductive layer 18a, thus completing the electrical ciruit.
  • monitors may conveniently be used on each of the left glove, right glove, contact panel, etc. Use of such separate monitors simplifies locating and correcting a leak in the event of an alarm.
  • contacts 24 and 25 may be connected to monitor 22 by means of conductors 20 and 23.
  • monitor 22 may be attached directly to each of the left glove, right glove, contact panel, etc. (by clipping it, for instance) , the electrical connection being made by means of contacts 24 and 25, thus elimnating conductors 20 and 24.
  • Another advantage of the two conductive layer embodiment is that the medical practitioner 11 is not needed as part of the electrical circuit. Thus, a leak may be detected even if the layer next to the medical practioner (either 17a or 16) is not leaking.
  • a leak may be detected even in the absence of fluid contact between medical practitioner and patient, and preferably, prior to such contact.
  • the operation and use of the two conductive layer embodiment of the invention is substantially the same as the single conductive layer embodiment previously described.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)

Abstract

L'invention concerne un système de détection de fuites dans une barrière imperméable à l'humidité séparant un médecin-praticien (11) d'un patient au cours d'interventions médicales. Le système (10) comprend une blouse chirurgicale (13) enduite d'une couche non-conductrice recouverte d'une couche conductrice, une de ces couches au moins étant imperméable à l'humidité. Le système (10) comprend également une connexion électrique reliée à la couche conductrice, une connexion électrique (23) reliée au médecin-praticien, et un détecteur de conductivité (22) connecté entre ces deux connexions électriques. Une source de courant servant à appliquer une tension de polarisation entre la couche conductrice et le médecin-praticien est également prévue; ainsi, en cas de rupture de la couche imperméable, un liquide conducteur s'infiltrant dans la fissure provoque un flux électrique détectable entre le conducteur électrique et le médecin-praticien (11) qui sera détecté par le détecteur de conductivité (22). Un mode de réalisation avec une couche non-conductrice entre deux couches conductrices est également décrit.
PCT/US1992/010477 1991-12-05 1992-12-04 Systeme medical de detection de fuites Ceased WO1993010828A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US80311891A 1991-12-05 1991-12-05
US803,118 1991-12-05

Publications (1)

Publication Number Publication Date
WO1993010828A1 true WO1993010828A1 (fr) 1993-06-10

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PCT/US1992/010477 Ceased WO1993010828A1 (fr) 1991-12-05 1992-12-04 Systeme medical de detection de fuites

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WO (1) WO1993010828A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658277A (en) * 1990-05-25 1997-08-19 Novatec Medical Products, Inc. Apparatus for electrical connection of glove monitor to patient
EP0824846A4 (fr) * 1995-05-01 1998-07-15 David H Liang Dispositif protecteur sous forme de gant et procede associe
WO2006089377A1 (fr) * 2005-02-28 2006-08-31 Commonwealth Scientific And Industrial Research Organisation Dispositif electronique flexible
WO2015126679A1 (fr) * 2014-02-19 2015-08-27 Microsoft Technology Licensing, Llc Ordinateur vestimentaire muni d'une interface stimulant la peau

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4321925A (en) * 1978-11-09 1982-03-30 Molnlycke Ab Method and a device for controlling the occurrence of perforations in operation gloves
US4910803A (en) * 1987-12-02 1990-03-27 Cukier Daniel S Apparel having a breach indicator
US4956635A (en) * 1989-04-14 1990-09-11 Langdon Robert S Method and apparatus for testing personal barriers
US5036309A (en) * 1990-06-14 1991-07-30 Dennison Jr Everett G Portable system and method for continuously monitoring protective clothing for detecting and signaling the occurrence of a breach therein

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4321925A (en) * 1978-11-09 1982-03-30 Molnlycke Ab Method and a device for controlling the occurrence of perforations in operation gloves
US4910803A (en) * 1987-12-02 1990-03-27 Cukier Daniel S Apparel having a breach indicator
US4956635A (en) * 1989-04-14 1990-09-11 Langdon Robert S Method and apparatus for testing personal barriers
US5036309A (en) * 1990-06-14 1991-07-30 Dennison Jr Everett G Portable system and method for continuously monitoring protective clothing for detecting and signaling the occurrence of a breach therein

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658277A (en) * 1990-05-25 1997-08-19 Novatec Medical Products, Inc. Apparatus for electrical connection of glove monitor to patient
EP0824846A4 (fr) * 1995-05-01 1998-07-15 David H Liang Dispositif protecteur sous forme de gant et procede associe
WO2006089377A1 (fr) * 2005-02-28 2006-08-31 Commonwealth Scientific And Industrial Research Organisation Dispositif electronique flexible
JP2008531137A (ja) * 2005-02-28 2008-08-14 コモンウェルス サイエンティフィック アンド インダストリアル リサーチ オーガニゼイション フレキシブルな電子デバイス
AU2006218256B2 (en) * 2005-02-28 2010-07-08 Commonwealth Scientific And Industrial Research Organisation Flexible electronic device
WO2015126679A1 (fr) * 2014-02-19 2015-08-27 Microsoft Technology Licensing, Llc Ordinateur vestimentaire muni d'une interface stimulant la peau
US9858773B2 (en) 2014-02-19 2018-01-02 Microsoft Technology Licensing, Llc Wearable computer having a skin-stimulating interface

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