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WO2018187027A1 - Pansement pour surveiller le gonflement à un site sélectionné sur le corps d'un patient et procédé de surveillance du gonflement à un site sélectionné sur le corps d'un patient - Google Patents

Pansement pour surveiller le gonflement à un site sélectionné sur le corps d'un patient et procédé de surveillance du gonflement à un site sélectionné sur le corps d'un patient Download PDF

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Publication number
WO2018187027A1
WO2018187027A1 PCT/US2018/023232 US2018023232W WO2018187027A1 WO 2018187027 A1 WO2018187027 A1 WO 2018187027A1 US 2018023232 W US2018023232 W US 2018023232W WO 2018187027 A1 WO2018187027 A1 WO 2018187027A1
Authority
WO
WIPO (PCT)
Prior art keywords
bandage
section
patient
site
selected site
Prior art date
Application number
PCT/US2018/023232
Other languages
English (en)
Inventor
Steven B. Krupnick
David Krupnick
Original Assignee
Webb Medical LLC
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
Priority claimed from US15/806,849 external-priority patent/US20180280612A1/en
Application filed by Webb Medical LLC filed Critical Webb Medical LLC
Priority to EP18781276.3A priority Critical patent/EP3606415A1/fr
Priority to AU2018247480A priority patent/AU2018247480A1/en
Priority to US16/498,178 priority patent/US20200054279A1/en
Priority to JP2019555225A priority patent/JP2020515358A/ja
Publication of WO2018187027A1 publication Critical patent/WO2018187027A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02042—Determining blood loss or bleeding, e.g. during a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • 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
    • A61B2562/0261—Strain gauges
    • 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
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • 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
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6828—Leg
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/7405—Details of notification to user or communication with user or patient; User input means using sound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1588—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/332—Force measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital

Definitions

  • the disclosed invention relates generally to bandages and more particularly to bandages for monitoring a selected site, e.g., an intravenous (IV) site, on the body of a patient and methods of using such bandages to monitor such selected sites.
  • a selected site e.g., an intravenous (IV) site
  • a "blown vein” is a term used to describe what happens to a vein when it ruptures or gets punctured causing blood to leak outside of the vein itself.
  • a vein may blow due to it being perforated by a needle that is too large or inserted incorrectly, or by a needle that is implanted too deeply into the vein causing both sides of the vein to be perforated and leading to possible blood leaking out of either end and potentially leading to infiltration or extravasation. Infiltration occurs when an intravenous fluid or medications leak into the surrounding tissue.
  • a vein blows For example, some patients have inherently weak vein walls. There are also some specific age groups that are more prone to developing fragile veins. For example, geriatric patients commonly have weak vein walls due to age-related degeneration of connective tissues. Pediatric patients may also have weak vein walls which have not had sufficient time to develop.
  • a blown vein is not dangerous nevertheless when a vein blows it should be treated immediately since fl uid infiltration can result in painful swelling of the surrounding tissue.
  • the medication being administered by the intravenous needle is caustic or otherwise dangerous, such as some chemotherapy drugs, dangerous extravasation can result in permanent damage to tissue surrounding the site of the blown vein.
  • the subject invention addresses that need by providing bandages and methods of use which are simple in construction, low in cost, easy to use and which monitor the state of a venous needle access site ( IV site) to provide an alarm signal in the event of a venous blow.
  • bandages constructed in accordance with this invention can also be used to monitor the amount of swelling at a selected site at the body of a patient, not necessarily an IV site, to determine the amount of swelling at that site.
  • a bandage for use at a selected site, e.g., an IV site, on the body of a patient to determine swelling thereat.
  • the bandage comprises a first section, a second section, a bridge section, and electronic circuitry.
  • the first section is configured to be secured to the skin of the patient at a first securement location adjacent the selected site.
  • the second section is configured to be secured to the skin of the patient at a second securement location adjacent the selected site.
  • the second location is spaced from the first location.
  • the bridge section interconnects and bridges the first and second sections.
  • the bridge section is expandable and configured to be expanded or stretched if the spacing between the first and second sections increases as a result of swelling at the selected site.
  • the electronic circuitry comprises a detection component mounted on the bridge section.
  • the electronic circuitry is configured to provide an electrical signal in response to the expansion of the bridge section as detected by the detection component.
  • the bandage is an alarm bandage and the selected site is an IV site at which an intravenous needle extends into a vein of the patient at the IV site.
  • the detection component comprises a breakable link configured to break or otherwise rupture in the event that the bridge section expands or stretches beyond a predetermined threshold, whereupon the electrical signal is provided.
  • the electronic circuitry additionally comprises an electrical power supply and wherein one of the first section and the second section includes the electrical power supply.
  • the electronic circuitry additionally comprises an alarm producing member for producing an alarm in response to the electrical signal.
  • the expandable section comprises an elastic cloth.
  • the electronic circuitry is comprises a printed circuit.
  • the electrical power supply is a printed batter ⁇ '.
  • the alarm producin member is a printed speaker.
  • the electronic circuitry additionally comprises a separate unit including an electrical power supply and an alarm producing member.
  • the separate unit is configured to be releasably electrically connected to the bandage.
  • the bandage is configured to provide a wireless electrical alarm signal from the bandage to a remote location.
  • the separate unit is configured for wirelessly transmitting the alarm signal to a remote location.
  • the first and second sections are configured for adhesive securement to the skin of the patient.
  • the bandage is a monitoring bandage and the detection component comprises a strain gauge configured to determine the amount that the bridge section expands or stretches.
  • the electronic circuitry is configured to provide the electrical signal indicating the amount that the bridge section expands or stretches as determined by the strain gauge.
  • the bridge section is also configured to be contracted if the spacing between the first section and the second section decreases, and wherein the strain gauge is configured to determine the amount that the bridge section contracts.
  • the electronic circuitry is configured to provide the electrical signal indicating the amount that the bridge section contracts as determined by the strain gauge.
  • the first section and the second section form respective portions of a sleeve configured to be placed around the selected site of the patient' s body.
  • Another aspect of this invention is a method of monitoring a selected site on the body of to provide an electrical signal in the event of swelling of tissue at the selected site.
  • the method comprises providing a bandage that comprises a first section, a second section, an expandable bridge section interconnecting the first and second sections, and electronic circuitry.
  • the electronic circuitry comprises a detection component mounted on the bridge section.
  • the electronic circuitry is configured to provide an electrical signal in response to the expansion or stretching of the bridge section as detected by the detection component.
  • the first section of the bandage is secured onto the skin of a patient adj acent the selected site.
  • the second section of the bandage is secured onto the skin of the patient adjacent the selected site, whereupon the bridging section is disposed over the selected site.
  • the selected site is an IV site and the electrical signal is provided if the stretching or expansion of the bridge section exceeds a predetermined threshold indicative of an IV blow-out or infiltration.
  • the detection component comprises a breakable link configured to break or otherwise rupture in the event that the bridge section expands or stretches beyond the predetermined threshold, whereupon the electrical signal is produced.
  • the electrical signal is wirelessly transmitted to a remote location as an alarm signal.
  • the bridge section is pre-stretched to a point just below the predetermined threshold before the bandage is secured to the skin of the patient.
  • the first and second sections are adhesi vely secured to the skin of the patient.
  • the detection component comprises a strain gauge mounted on the bridge section, wherein the strain gauge determines the amount that the bridge section expands or stretches, w hereupon the electronic circuitry provides the electrical signal indicating the amount that the bridge section has expanded or stretched as determined by the strain gauge.
  • the bridge section is also configured to be contracted i f the spacing between the first section and second section decreases, and wherein the strain gauge determines the amount that the bridge section contracts, whereupon the electronic circuitry provides the electrical signal indicating the amount that the bridge section has contracted as determined by the strain gauge.
  • the selected site comprises an I V site, wherein the bandage is secured to the patient's body at the IV site to monitor the condition thereof and to provide an alarm signal in the event of swelling at the IV site indicating an IV blow-out or infiltration.
  • the selected site is a limb or the head of the patient, and wherein the monitoring bandage is placed on the patient's body at the selected site to monitor the amount of swelling thereat.
  • Fig. 1 is top plan view of one exemplary embodiment of an alarm bandage constructed in accordance with one aspect of this invention, with the alarm bandage being shown mounted on the hand of a patient recei vin an intravenous infusion to provide a warning or alarm in the event of an IV blow-out or infiltration at the IV site which causes swelling at that site;
  • Fig. 2 is a slightly enlarged top plan view of the bandage shown in Fig. 1 ;
  • Fig. 3 is a sectional view taken along line 3 - 3 of Fig. 2;
  • Fig. 4 is a top plan view, similar to Fig. 1 , but showing an alternative exemplary embodiment of an alarm bandage constructed in accordance with this invention and forming a portion of an IV blow-out or infiltration alarm system;
  • Fig. 5 is an enlarged top plan view of the bandage shown in Fig. 4;
  • Fig. 6 is top plan view of one exemplary embodiment of a monitoring bandage constructed in accordance with one aspect of this invention, with the monitoring bandage being shown mounted on the hand of a patient at an IV site to provide a warning or alarm in the event of an IV blow-out or infiltration at the IV site which causes swelling at that site;
  • Fig. 7 is a slightly enlarged top plan view of the bandage shown in Fig. 6;
  • Fig. 8 is a sectional view taken along line 8 - 8 of Fig. 7;
  • Fig. 9 is a top plan view, similar to Fig. 7, but showing an alternative exemplary embodiment of a monitorin bandage constructed in accordance with this invention.
  • Fig. 10 is an enl arged top plan view of the monitoring bandage shown in Fig.
  • FIG. 1 1 is an illustration of the exemplary embodiment of a monitoring bandage of Fig 6 shown mounted on the lower limb of a patient to monitor the amount of swelling at that limb;
  • Fig. 12 is an illustration, similar, to Fig. 1 1 , but showing an alternative embodiment of a monitoring bandage constructed in accordance with this invention shown mounted on the lower limb of a patient to monitor the amount of swelling at that limb.
  • Fig. 1 an exemplary embodiment of an alarm bandage 20 constructed in accordance with this invention shown in one typical application, e.g., at an IV site.
  • the details of the bandage 20 will be described shortly.
  • the bandage 20 is configured to be secured, e.g. , adhesively secured, to the skin of a patient at the IV site to automatically monitor the status of swelling at the IV site and provide an alarm signal in the event that the vein in which the needle extends blows, which will result in swelling of adjacent tissue.
  • the bandage 20 is configured to be secured, e.g. , adhesively secured, to the skin of a patient at the IV site to automatically monitor the status of swelling at the IV site and provide an alarm signal in the event that the vein in which the needle extends blows, which will result in swelling of adjacent tissue.
  • the bandage 20 is located on the back of the hand 10 of a patient at an IV site 1 4 into which an intravenous ( IV) needle 1 2 extends, and disposed over the immediately adjacent area which will likely become swollen in the event that the vein into which the needle 12 extends blows.
  • IV intravenous
  • the bandage 20 basically comprises a first side section 22. a second side section 24 and a bridge section 26.
  • the first and second side sections are each formed of any suitable material, e.g. , like that of a conventional adhesive bandage, or a knitted or woven fabric or a non-woven material.
  • the side sections 22 and 24 are each formed of a patch of a woven fabric, plastic (PVC, polyethylene or polyurethane), or latex strip.
  • the material making up the side sections may or may not be waterproof and can be air-tight, if desired.
  • each side section is in the form of a layer 28 of a conventional skin- engaging adhesi ve, such as but not limited to, acrylate, includin methacrylates and epoxy diacrylates (which are also known as vinyl resins), or any other suitable adhesive materials.
  • the bridge section 26 is in the form of an expandable or stretchable web of any suitable elastic material, e.g., elastic cloth.
  • the bridge section is fixedly secured to the first side section 22 at a joint 30 and is fixedly secured to the second side section 24 at a joint 32.
  • a detection component, in the form of a breakable link portion 34. of electronic circuitry (to be described shortly) is located on the bridge sect ion 26.
  • the portion 34 is in the form of a printed circuit, e.g., a l ink of electrically conductive ink.
  • the l ink 34 is printed on and extends across the width of the bridging section 26 and is configured to break or rupture in the event that the bridging section expands to a point in excess of a predetermined threshold.
  • the electronic circuitry also includes a power source (e.g., a battery) 36, a loudspeaker 38, and associated circuitry (not shown) interconnecting the link, the battery and the loudspeaker to each other.
  • the electronic circuitry is configured to automatically provide an audible alarm signal from the loudspeaker 38 in the event that the link 34 ruptures or otherwise breaks.
  • the bandage 20 is as follows.
  • the bandage is applied to the skin of the patient at the location of the IV site 1 4 by pre-stretching the bridge section 26 to a point just below the point at which the conductive ink link 34 will rupture or otherwise break.
  • the bridge section With the bridge section pre-stretched, the bridge section is juxtaposed over the IV site and the adhesive underside 28 of the first side section 22 of the bandage is brought into engagement with the skin of the patient on one side of the IV site and the adhesive underside 28 of the second side section 24 of the bandage is brought into engagement with the skin of the patient on the other side of the IV site. Accordingly, the pre-stretched bridge portion 26 of the bandage will be located over the IV site 14, like shown in Fig.
  • the components making up the electronic circuitry e.g., the printed link 34, the printed battery 36 and the printed loudspeaker 38 are merely exemplary of various components that can be used, in the bandage providing that some type of alarm signal is automatically produced by the circuitry in the event that the bridge section is stretched or otherwise expanded beyond a predetermined threshold.
  • the alarm need not be an audible alarm.
  • the alarm can be a visual alarm. In fact, the alarm may be both audible and visual.
  • the alarm (whatever type it is) need not be produced at the location of the bandage itself, but may be transmitted either wirelessly or otherwise to some remote location, e.g., a nurse's station, to alert personnel thereat that the I V site needs to be checked since it has l ikely blown.
  • Fig. 4 there is shown an alternative embodiment of an alarm bandage 120 constructed in accordance with this invention.
  • the bandage 120 is identical in many respects to the bandage 20, except for the details of the electronic circuitry which provides the alarm signal.
  • the components of the bandage 120 which are identical to the components of the bandage 20 will be given the same reference numbers and all the details of their construction and operation will not be reiterated.
  • the bandage 120 basically comprises a first side section 22, a second side section 24 and a bridge section 26.
  • the underside of each side section 22 and 24 is in the form of a layer 28 of a conventional skin-engaging adhesive.
  • the bridge section is fixedly secured to the first side section 22 at a joint 30 and is fixedly secured to the second side section 24 at a joint 32.
  • a breakable l ink portion 34 is printed on and extends across the width of the bridging section 26 and is configured to break or rupture in the event that the bridging section expands to a point in excess of a predetermined threshold.
  • the side sect ion 24 includes a pair of electrical connectors 40 and 42 which form portions of the electronic circuitry of the bandage.
  • the connectors 40 and 42 are electrically connected to opposite sides of the breakable conductive link 34 by electrical conductors (not shown).
  • the connectors 40 and 42 are configured to be connected to electrical conductors 44 and 46, respectively, of a separate unit 48.
  • the unit 48 includes the remainder of the electronic circuitry of the bandage and basically comprises a housing in which a battery (not shown) for powering the electroni c circuitry is located.
  • the unit 48 also serves to house a loudspeaker 50.
  • the loudspeaker is configured to provide an audible alarm in the event that the breakable link 34 ruptures or otherwise breaks, like described above.
  • the unit 48 can be of an alternative construction.
  • the alarm provided by the unit 48 need not be an audible alarm, but can be a visual alarm or a combination of an audible and visible alarm.
  • the unit 48 may be constructed to transmit the alarm wirelessly or by some other means to a remote station 52.
  • the printed circuit (breakable) link 34 may be constructed so that it is micro-perforated, thereby making it easier to break when the bridge section is expanded.
  • the length of the side sections 22 and 24 of the bandage can be chosen for the particular anatomy to which they will be adhesively secured.
  • one or both of the side sections 22 and 24 can be considerably longer in length than the exemplary embodiments shown in Figs. 1 and 4, so that one side section would be adhesively secured to the skin of the patient just laterally of the IV site, whereas the other side section would extend around the hand or arm of the patient (depending upon the location of the IV site) to the opposite side.
  • Fig. 6 there is shown an exemplary embodiment of a monitoring bandage 220 constructed in accordance with this invention shown in one typical application.
  • the bandage 220 is configured to monitor the amount of swelling at a selected site on the body of a patient and to provide a signal indicative thereof. That signal may be used to provide an alarm when the bandage is used to monitor an IV site and that site swells due to an IV blow-out or infiltration.
  • the monitoring bandage 220 can be used to merely monitor the amount of swelling or reduction in swelling at any selected site on the patient's body, not necessarily an IV site.
  • the monitoring bandage 220 is configured to be secured, e.g., adhesively secured, to the skin of a patient at the selected site to determine the amount of swelling at that site.
  • the selected site is an IV site
  • the bandage is configured to automatically monitor the swelling status of the IV site and provide an alarm signal in the event that the vein in which the needle extends blows or the tissue adjacent the monitoring site becomes infiltrated with the IV fluid, which action will result in concomitant swelling at the IV site.
  • the bandage 220 is located on the back of the hand 10 of a patient in the same manner as bandages 20 and 120 as described above.
  • the bandage 220 basically comprises a first side section 222. a second side section 224 and a bridge section 226.
  • the first and second side sections are each formed of any suitable material, like that of a conventional adhesive bandage.
  • the side sections 222 and 224 are each formed of a patch of a woven fabric, plastic (PVC, polyethylene or polyurethane), or latex strip.
  • the material making up the side section may or may not be w aterproof and can be air-tight, if desired.
  • the underside of each side section is in the form of a layer 228 of a conventional skin-engaging adhesive, such as but not limited to, acrylate, including methaciy lates and epoxy diacrylates.
  • the bridge section 226 is in the form of an expandable or stretchable web of any suitable elastic material, e.g., elastic cloth.
  • the bridge section is fixedly secured to the first side section 222 at a joint 230 and is fixedly secured to the second side section 224 at a joint 232.
  • a detection component in the form of a strain gauge 234, is located on the bridge section.
  • the strain gauge 234 is located on the outer surface of the bridge section, but can be located on the inner surface of the bridge section, if desired.
  • the strain gauge forms a portion of electronic circuitry, and is configured to provide an electrical signal responsive to the force applied on it.
  • the strain gauge can be any suitable type of conventional device, e.g., resistive, capacitive. etc..
  • the strain gauge can be formed of any suitable material capable of affordable mass production, e.g., printing on a flexible substrate.
  • suitable materials are: silicon nano-membranes, silver nanoparticle ink, thin films of carbon nanotubes, graphene films, metallic nanoparticles, and other materials that are capable of measuring deformations as large as 100-150% with a relatively large gauge factor, e.g., up to 30 or greater.
  • the electronic circuitry also includes a power source (e.g., a battery) 236, a loudspeaker 238, and associated circuitry (not shown) interconnecting the strain gauge, the battery and the loudspeaker to each other.
  • the electronic circuitry is configured to automatically provide an audible alarm signal from the loudspeaker 238 in the event that the strain gauge determines that the selected site of the patient's body over which the strain gauge is located has swelled beyond a predetermined threshold value, thereby indicating the likelihood of a blown vein or other infiltration of the IV fluid into adjacent tissue at the IV site.
  • the strain gauge and its associated electronic circuit of the bandage 220 may be configured to provide an electrical output signal indicative of the amount of swelling at the IV site irrespective of whether or not it exceeds a predetermined threshold, e.g., an alarm value.
  • the bandage 220 is as follows.
  • the bandage is applied to the skin of the patient at the location of the IV site 14.
  • the bridge section is juxtaposed over the IV site and the adhesive underside 228 of the first side section 222 of the bandage is brought into engagement with the skin of the patient on one side of the IV site and the adhesive underside 228 of the second side section 224 of the bandage is brouglit into engagement with the skin of the patient on the other side of the IV site.
  • the bridge portion 226 of the bandage will be located over, i.e., bridge, the IV site 14, like shown in Fig.
  • the components making up the electronic circuitry e.g. , the strain gauge 234, the printed battery 236 and the printed loudspeaker 238 are merely exemplary of various components that can be used, in the bandage 220 providing that some type of alarm signal is automatically produced by the circuitry in the event that the bridge section force read by the strain gauge exceeds a predeterrriined threshold.
  • the alarm need not be an audible alarm.
  • the alarm can be a visual alarm. In fact, the alarm may be both audible and visual.
  • the alarm (whatever type it is) need not be produced at the location of the bandage itself, but may be transmitted either wirelessly or otherwise, e.g., a LAN, to some remote location, e.g., a nurse's station, to alert personnel thereat that the IV site needs to be checked since it has likely blown.
  • Fig. 9 there is shown still another alternati ve embodiment of a monitoring bandage 320 constructed in accordance with this invention.
  • the bandage 320 is identical in many respects to the monitoring bandage 220, except for the details of the electronic circuitry w hich provides the alarm signal.
  • the components of the bandage 320 which are identical to the components of the bandage 220 will be gi ven the same reference numbers and all the details of their construction and operation will not be reiterated.
  • the bandage 320 basically comprises a first side section 222. a second side section 224 and a bridge section 226.
  • each side section 222 and 224 is in the form of a layer 228 of a conventional skin-engaging adhesive.
  • the bridge section is fixedly secured to the first side section 222 at a joint 230 and is fixedly secured to the second side section 224 at a joint 232.
  • a strain gauge 234 is printed on the bridging section 226 and is con figured to provide a signal indicative of the force applied to it.
  • the side section 224 includes a pair of electrical connectors 240 and 242 which form portions of the electronic circuitry of the bandage. The connectors 240 and 242 are electrically connected to the strain gauge 234 by electrical conductors (not shown).
  • the connectors 240 and 242 are configured to be connected to electrical conductors 244 and 246, respectively, of a separate unit 248.
  • the unit 248 includes the remainder of the electronic circuitry of the bandage and basically comprises a housing in which a baiters (not shown) for powering the electronic circuitry is located.
  • the unit 248 also serves to house a loudspeaker 250.
  • the loudspeaker is configured to provide an audible alarm in the event that strain gauge detects a force applied to it which is in excess of a predetermined threshold, like described above.
  • the unit 248 can be of an alternative construction.
  • the alarm provided by the unit 248 need not be an audible alarm, but can be a visual alarm o a combination of an audible and visible alarm.
  • the unit 248 may be constructed to transmit the alarm to a remote station 252.
  • the monitoring bandage 320 is capable of providing a signal indicative of the amount of swelling at the selected site as detected by the strain gauge
  • the bandages 320 and 220 (and any other bandage constructed in accordance with this invention), need not be used to only provide signals in the event of an alarm condition, e.g., a blown vein.
  • the monitoring bandages of this invention can be used in any application to provide a signal representing the amount of swelling detected, irrespective of whether or not it exceeds a predetermined threshold or alarm level.
  • the monitorin bandages of this invention can be used to provide output signals indicative of the lessening of swelling at a selected site of the patient's body.
  • the strain gauge need not be a printed circuit, so long as it is somewhat flexible and mass producible on a relatively low cost basis.
  • the length of the side sections 222 and 224 of the bandages 220 and 320 can be chosen for the particular anatomy to which they will be adhesively secured.
  • one or both of the side sections 222 and 224 can be considerably longer in length than the exemplary embodiments shown in Figs.
  • the electronic circuitry can be set with a predetermined amount of "strain" already on the bandage at the time of its application to the selected site. That action has the effect of zeroing the bandage for the purposes of monitoring swelling at the selected site, which would limit the problems of a patient flexing or moving around during the application process.
  • Making use of a strain gauge to determine the amount of swelling at the selected site allows the doctor or other health care provider to have an acceptable amount of sw elling expansion at the site if there is a special medication or other acceptable reason for a site to experience expansion/swelling during a procedure or IV insertion.
  • a monitoring bandage constructed in accordance with this invention can be used for purposes other than detecting vein blowouts and IV infiltrations.
  • the monitoring bandages of this invention can serve as a diagnostic tool or home care aid for swelling detection.
  • the monitoring bandage could be used to monitor a heart or kidney failure patient for swelling of their lower extremities, an early sign of poorly controlled disease, and provide feedback to a medical professional or home care provider.
  • FIG. 11 wherein the exemplary embodiment of the monitoring bandage 220 of Fig 6 is shown mounted on the lower limb, e.g., on the calf 16 just above the ankle 18, of a patient to monitor the amount of swelling at that limb.
  • Fig. 12 is an illustration of another exemplary monitoring bandage 420 constructed in accordance with this invention, shown mounted on the lower limb, e.g. , on the calf 16 just above the ankle I X of a patient.
  • the monitoring bandage 420 is constructed similarly to the monitoring bandage 320 except that instead of making use of first side section 222, a second side section 224 and a bridge section 226, the bandage 420 makes use of a stretchable sleeve or band 422 of any suitable material, e.g., an elasticized fabric or cloth, neoprene. rubber, etc., for encircling the site to be monitored for swelling.
  • the band 422 serves as the first side section, the bridge section, and the second side section.
  • the strain gauge 234 is mounted on that band 422, either on the inside or outside thereof, so that it operates in a manner similar to the strain gauge 234 mounted on the bridge section 226 of the bandage 220.
  • the remainder of the electronic circuit e.g., the power source (e.g., a battery) 236, the loudspeaker 238, and associated circuitry (not shown) interconnecting the strain gauge, the battery and the loudspeaker to each other are also mounted on the sleeve or band.
  • the power source e.g., a battery
  • the loudspeaker 238, and associated circuitry not shown interconnecting the strain gauge, the battery and the loudspeaker to each other are also mounted on the sleeve or band.
  • a monitoring bandage constructed in accordance with this invention can be used to monitor improvement or worsening of a patient's cardiac or renal condition as it relates to their lower extremity edema, thereby helping to determine if the patient is ready for discharge.
  • a key feature of this use being that the monitoring bandage will be monitoring if swelling is decreasin as well as increasing. That ability should provide an important indicator in a physician's decision-making process regarding the health of the patient.
  • the monitoring bandages of this invention are capable of monitoring decreases in swelling, in addition to monitorin increases in swelling, they may act as an important diagnostic device per se for both infants and other patients (geriatric or adult) where swelling has already occurred and the physician or health care provider wants to measure improvement during the patient's treatment.
  • the bandage can be in the form of a large diameter sleeve suitable for encircling the abdominal region of a patient or for encircling the head of a patient.
  • an alarm bandage constructed in accordance e.g., a bandage with a breakable link
  • a monitorin bandage constructed in accordance with this invention e.g., a bandage with a strain gauge
  • Such a bandage should act as fail safe solution for monitorin an IV site during any IV procedure whether in a hospital, some other health care facility, a nursing home. etc.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
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  • Pathology (AREA)
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  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

La présente invention concerne un pansement et un procédé d'utilisation pour surveiller un site sélectionné, par exemple un site IV, d'un patient. Le pansement comprend une première section, une deuxième section, une section de pont et un circuit électronique associé. La première section est fixée à la peau d'un patient sur un côté du site sélectionné. La deuxième section est fixée à la peau du patient sur l'autre côté du site sélectionné. La section de pont est extensible. Le circuit électronique comprend un composant de détection, par exemple, une liaison électronique cassable ou une jauge de contrainte, montée sur la section de pont. Le circuit électronique fournit un signal électrique, par exemple, un signal d'alarme, en réponse à l'extension de la section de pont déterminée par le composant de détection.
PCT/US2018/023232 2017-04-04 2018-03-20 Pansement pour surveiller le gonflement à un site sélectionné sur le corps d'un patient et procédé de surveillance du gonflement à un site sélectionné sur le corps d'un patient WO2018187027A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP18781276.3A EP3606415A1 (fr) 2017-04-04 2018-03-20 Pansement pour surveiller le gonflement à un site sélectionné sur le corps d'un patient et procédé de surveillance du gonflement à un site sélectionné sur le corps d'un patient
AU2018247480A AU2018247480A1 (en) 2017-04-04 2018-03-20 Bandage for monitoring swelling at a selected site on the body of a patient and method of monitoring swelling at a selected site on the body of a patient
US16/498,178 US20200054279A1 (en) 2017-04-04 2018-03-20 Bandage for monitoring swelling at a selected site on the body of a patient and method of monitoring swelling at a selected site on the body of a patient
JP2019555225A JP2020515358A (ja) 2017-04-04 2018-03-20 患者の身体の選択された部位における膨張を監視するためのバンデージと、患者の身体の選択された部位における膨張を監視する方法

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201762481295P 2017-04-04 2017-04-04
US62/481,295 2017-04-04
US201762550913P 2017-08-28 2017-08-28
US62/550,913 2017-08-28
US15/806,849 2017-11-08
US15/806,849 US20180280612A1 (en) 2017-04-04 2017-11-08 Early warning bandage for intravenous blowout or intravenous infiltration and method of monitoring an intravenous infusion site

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WO2018187027A1 true WO2018187027A1 (fr) 2018-10-11

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JP (1) JP2020515358A (fr)
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WO2021076374A1 (fr) * 2019-10-14 2021-04-22 Becton, Dickinson And Company Capteur pour détecter une infiltration de tissu
WO2022112823A1 (fr) * 2020-11-25 2022-06-02 Claudio Reverberi Dispositif de fixation pour dispositifs d'accès intracorporels
EP4076181A1 (fr) * 2019-12-16 2022-10-26 T.J.Smith and Nephew,Limited Dispositifs de surveillance et de thérapie et leurs procédés d'utilisation
WO2024023097A1 (fr) * 2022-07-25 2024-02-01 Fresenius Kabi Deutschland Gmbh Dispositif de détection d'extravasation
EP4322844A1 (fr) * 2021-04-22 2024-02-21 Bard Peripheral Vascular, Inc. Dispositif habitronique pour surveiller une surcharge de fluide avec des capteurs intégrés

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Cited By (10)

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Publication number Priority date Publication date Assignee Title
WO2021076374A1 (fr) * 2019-10-14 2021-04-22 Becton, Dickinson And Company Capteur pour détecter une infiltration de tissu
CN114599268A (zh) * 2019-10-14 2022-06-07 贝克顿·迪金森公司 用于检测组织渗入的传感器
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JP7534397B2 (ja) 2019-10-14 2024-08-14 ベクトン・ディキンソン・アンド・カンパニー 組織浸潤を検出するためのセンサー
AU2020367732B2 (en) * 2019-10-14 2025-09-18 Becton, Dickinson And Company Sensor for detecting tissue infiltration
EP4076181A1 (fr) * 2019-12-16 2022-10-26 T.J.Smith and Nephew,Limited Dispositifs de surveillance et de thérapie et leurs procédés d'utilisation
EP4076181B1 (fr) * 2019-12-16 2025-07-23 T.J.Smith and Nephew,Limited Dispositifs de surveillance et de thérapie
WO2022112823A1 (fr) * 2020-11-25 2022-06-02 Claudio Reverberi Dispositif de fixation pour dispositifs d'accès intracorporels
EP4322844A1 (fr) * 2021-04-22 2024-02-21 Bard Peripheral Vascular, Inc. Dispositif habitronique pour surveiller une surcharge de fluide avec des capteurs intégrés
WO2024023097A1 (fr) * 2022-07-25 2024-02-01 Fresenius Kabi Deutschland Gmbh Dispositif de détection d'extravasation

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JP2020515358A (ja) 2020-05-28
EP3606415A4 (fr) 2020-02-12
EP3606415A1 (fr) 2020-02-12

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