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WO2013026999A1 - Système de gestion de plaies - Google Patents

Système de gestion de plaies Download PDF

Info

Publication number
WO2013026999A1
WO2013026999A1 PCT/GB2012/000667 GB2012000667W WO2013026999A1 WO 2013026999 A1 WO2013026999 A1 WO 2013026999A1 GB 2012000667 W GB2012000667 W GB 2012000667W WO 2013026999 A1 WO2013026999 A1 WO 2013026999A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
management system
wound management
dressing
sensors
Prior art date
Application number
PCT/GB2012/000667
Other languages
English (en)
Inventor
Iain Elder
Original Assignee
Pulse Innovate Ltd
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 GBGB1114352.6A external-priority patent/GB201114352D0/en
Priority claimed from GBGB1206918.3A external-priority patent/GB201206918D0/en
Application filed by Pulse Innovate Ltd filed Critical Pulse Innovate Ltd
Publication of WO2013026999A1 publication Critical patent/WO2013026999A1/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
    • A61B5/44—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
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0468—Specially adapted for promoting wound healing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • 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
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • 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
    • A61B5/68—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

Definitions

  • the present invention relates to a system, apparatus and method for management of wounds.
  • the present invention relates to a system for diagnosis and apparatus to assist in wound treatment which is particularly applicable to treatment of leg ulcers.
  • Chronic wounds almost without exception contain bacterial flora. These bacteria may be indigenous to the patient or might be exogenous to the wound. Closure of a wound is effectively possible by control of the level of this bacterial flora. Just because there is bacteria and foreign matter present within a wound, does not give rise to an infection; no negative impact may be realised. Accordingly wound control is not determined by control of the presence of bacteria, other organisms and foreign bodies at a wound site. The provision of wound information enables a tailored response by a physician whereby to enable wound repair to be facilitated; any treatment can be treated topically as opposed to having to use systemic antibiotics. This would also lead to less clinical intervention/hospitalisation (e.g. due to sepsis) and would reduce the use of antibiotics and other complications of infection.
  • Modern dressings usually use synthetic polymers and range in complexity depending on application. Ordinary dressings are passive constructs such as gauze that simply cover the wound. Interactive materials contain polymeric films and foams which have properties suitable for shallow wounds with low exudates, permitting wound checking. Finally bioactive wound dressings are produced using materials such as hydrocolloids, alginates and collagens with state of the art dressings incorporating active ingredients such as antimicrobials and growth factors. It is known that the maintenance of a moist wound environment promotes the healing of wounds, especially burns and chronic wounds such as ulcers. However, it is also desirable to avoid excessive moisture or pooling of wound exudate on the wound, since liquid exudate causes maceration of skin adjacent to . the wound and other difficulties. Furthermore, liquid exudate can leak from the wound site and contaminate clothes or bedding.
  • US 2006111657 provides a wound treatment device comprising a water- impermeable envelope having at least one aperture, wherein the envelope contains a therapeutic substance, and the aperture in the envelope is blocked by a material that breaks down in the presence of one or more active components of wound fluid thereby permitting the therapeutic substance to contact the wound fluid.
  • GB2408330 provides a wound dressing wherein the pH of a wound may be assessed using a film preferably of hydrogel which changes colour in dependence upon pH. Wound pH information may be used to facilitate selection of the appropriate treatment to which the wound should be subjected.
  • the hydrogel film is incorporated into a dressing.
  • the present invention seeks to provide an improved wound dressing which seeks to provide feedback data relating to healing progress of the wound.
  • a wound management system incorporating one or more sensors relating to measurement of a physiological condition, the system comprising a sensor array printed on a flexible substrate to monitor the healing process by means of measurement of at least two or more parameters such as temperature, moisture, impedance, Ph, levels of particular compounds or gases, light absorption or light transmission, the sensors being arranged in at least a two dimensional triangulation arrangement whereby to assist in clinical decisions.
  • the present invention accordingly enables control of a wound infection to be more simply managed by the review of certain key indicators associated with wound exudate components that are present at a wound site.
  • the sensors are arranged to provide an informatics capability relative to wound progress, the informatics capability enabling data to be transmitted, to a remote device.
  • the sensors could provide data to processor circuitry which can process the data for storage or transmission or for storage and subsequent transmission via wi-fi data transfer protocols.
  • processor circuitry can process the data for storage or transmission or for storage and subsequent transmission via wi-fi data transfer protocols.
  • a history / library of wound conditions using different demographics e.g. gender, age, condition and dressing type can be generated. This will in turn have a major influence ensuring that the right treatment is given at an early stage to prevent the misuse of drugs, thereby playing a major role in reducing the drugs bill.
  • Other major cost saving will be accrued in saving nursing time, as they will be able to prioritise home visits, and make major savings on travelling costs, both which take up the majority of costs for district and community nursing. It will also have an impact in reducing our carbon footprint.
  • the wound management system could include a sensor array printed on a flexible substrate such as a flexible printed circuit to enable at least some of the functionality of the dressing, by way of provision of transmission path, capacitance or impedance.
  • a micro sensor camera array may be present, whereby to enable images to be transferred from the wound.
  • Nano-fibres, provided with a conductive coating may be used in the construction of the dressing system to enable an electric current to be passed about the wound.
  • the wound management system can comprise a rechargeable electrical cell or battery.
  • the rechargeable electrical cell or battery is a one of a cadmium-nickel, lithium-ion or lithium-polymer cell or battery. Even more preferably the electrical cell or battery is plastically deformable.
  • Figures 4 & 4a shows an arrangement of components upon two layers of a wound system as shown in Figure 1;
  • FIG 1 is an exploded view of a wound treatment system according to an embodiment of the present invention.
  • the system includes a wound containment and exudate absorbing layer (A), an encapsulation layer (B), a sensor support layer (C), an encapsulation/strike through barrier (D) and an electromagnetic element support layer (E).
  • the electromagnetic element as illustrated in Figure 2 preferably comprises a planar spiral copper coil on a polymeric substrate and a high- permeability magnetic layer (equivalent to the core of a conventional electromagnet) in the form of a ceramic/polymer composite; an electrical cell, such as a lithium ion-ion electrical cell (often referred to as a battery) can be placed between the encapsulation barrier and encapsulation layer.
  • the copper spiral may be fabricated by Focussed Field Deposition (FFD) onto a flexible polyamide substrate.
  • FFD Focussed Field Deposition
  • the ceramic/polymer composite is deposited on both sides of the substrate by stencil and screen printing, above and below the copper spiral coil, with respect to layer E.
  • FFD technology which is a non-immersion additive electroplating process, was primarily designed to produce flexible circuitry using electro deposited copper extracted from copper sulphate solutions. Because copper is deposited on the substrate only where necessary and only in the amount needed, the process will significantly lower production costs compared with prior similar technologies.
  • the advantages of using FFD for the copper spiral coil are that it: - is a non-immersion process - allows multiple substrate choice - uses independent circuit patterns with no connections or robber bars means no waste - has a totally controlled thicknesses capability across thickness profile.
  • the mass fraction of the ceramic in the ceramic/polymer composite must be greater than the mass fractions of fillers typically incorporated into polymer-matrix thick films.
  • such a high mass fraction of filler can adversely affect adhesion and can make the film susceptible to mechanical failure and delamination during flexure.
  • flexible lithium ion batteries such as the flexible lithium polymer electrical cells as produced by Solicore, Inc., marketed under their "Flexion" trade name.
  • Such lithium cells are available in a variety of shapes and sizes.
  • 3V at 10mA can be provided in a package dimensioned at less than 26 x 29 x 0.45mm.
  • a recharging mechanism can be created in combination with the exudates. Since an exudate is an electrolyte, a galvanic cell can be created, by the use of metal terminals in contact with exudate. Suitable metals have been determined to be copper and zinc; a 1.1V potential difference can be obtained across a sulphate salt bridge, the zinc becomes oxidized and passes into solution and the copper-ion solution is reduced. Zinc metal becomes oxidised to zinc oxide and the copper is reduced. A simple overview of a zinc-copper electrochemical cell is shown in Figure 3.
  • the mass fraction of the ceramic in the ceramic/polymer composite must be greater than the mass fractions of fillers typically incorporated into polymer-matrix thick films.
  • such a high mass fraction of filler can adversely affect adhesion and can make the film susceptible to mechanical failure and delamination during flexure.
  • Layer C as well as being an encapsulation layer can also act to support sensors, in which case, electrical connections as present between layers El and D may also be required.
  • a sensor array fixed into layer C could assist in the monitoring of wound progression or regression through the measurement of cell impedance, pH value and Nitric Oxide levels. It will be appreciated that sensors relating to specific conditions may benefit from being supported on a particular layer; indeed it is necessary for certain indications to be measured within the exudate, for example.
  • the particular order of layers may change; specific layers may not be required, such as the indicative membrane layer and the particular layers will be dependent upon the need of a wound to be dressed, as will be readily appreciated by healthcare professionals.
  • the delivery will require the patterning of sensor arrays to gather information at discrete points over the wound area. This will be developed through printing technology and acquisition of data from these will be achieved through a wireless communication. Data processing and display will be required to provide a tool to diagnose wound state and this will include progression through capture of longitudinal data. Remote monitoring will require data transmission through appropriate telecommunications, with emphasis on security and patient sensitive information. Healing enhancement will be delivered through electromagnetic stimulation. Power will be required to achieve this and the aim will be to deliver this through power scavenging or rechargeable battery technology.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

La présente invention concerne un système, un appareil et un procédé de gestion de plaies. En particulier, la présente invention concerne, de façon non limitative, un système de diagnostic et un appareil d'assistance pour le traitement de plaies, dont l'utilisation est en particulier indiquée pour le traitement d'ulcères de la jambe. La présente invention vise également à proposer un système de pansement intelligent qui permettra une gestion améliorée du soin de plaies chroniques à la fois du point de vue du patient et d'un point de vue économique. Le remplacement du pansement, soit dans une clinique, soit dans un lieu situé à distance devrait être réalisé en fonction de l'état de la plaie tel que déterminé par l'intermédiaire d'un diagnostic fondé sur des preuves. Un système de pansement selon la présente invention permettra la collecte d'informations sur l'état de la plaie par l'intermédiaire de technologies de détection incorporées (température, pH, humidité et impédance cellulaire) qui répondent à des stimuli physiques. Les signaux résultants seront transmis et peuvent être surveillés dans un environnement clinique ou dans un lieu de résidence, soit par le patient, soit à distance par le professionnel de santé à l'aide d'une technologie de télécommunication. Le pansement administrera également une thérapie régénérative par l'intermédiaire d'une application appropriée d'une stimulation électromagnétique en réponse à l'état de la plaie.
PCT/GB2012/000667 2011-08-19 2012-08-20 Système de gestion de plaies WO2013026999A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB1114352.6A GB201114352D0 (en) 2011-08-19 2011-08-19 System,apparatus and method for management of wounds
GB1114352.6 2011-08-19
GB1206918.3 2012-04-19
GBGB1206918.3A GB201206918D0 (en) 2012-04-19 2012-04-19 A wound management system

Publications (1)

Publication Number Publication Date
WO2013026999A1 true WO2013026999A1 (fr) 2013-02-28

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Application Number Title Priority Date Filing Date
PCT/GB2012/000667 WO2013026999A1 (fr) 2011-08-19 2012-08-20 Système de gestion de plaies

Country Status (1)

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WO (1) WO2013026999A1 (fr)

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EP3034054A1 (fr) * 2014-12-16 2016-06-22 Absorbest AB Pansement pourvu d'un capteur et son procédé de fabrication
WO2016166731A1 (fr) * 2015-04-15 2016-10-20 King Abdullah University Of Science And Technology Pansement comprenant des éléments électroniques réutilisables pour surveillance sans fil
WO2017015208A1 (fr) * 2015-07-17 2017-01-26 Hollister Incorporated Pansement et méthode de traitement de plaies aiguës et chroniques
CN108371584A (zh) * 2018-02-07 2018-08-07 苏州元禾医疗器械有限公司 一种智能敷料
CN108498078A (zh) * 2018-04-24 2018-09-07 张新平 物联组网的评估指挥系统
WO2019048638A1 (fr) * 2017-09-10 2019-03-14 Smith & Nephew Plc Pansements de thérapie de plaie activés par capteur et systèmes mettant en œuvre une cybersécurité
US10288590B2 (en) 2013-10-08 2019-05-14 Smith & Nephew Plc PH indicator device and formulation
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US10610624B2 (en) 2013-03-14 2020-04-07 Smith & Nephew, Inc. Reduced pressure therapy blockage detection
US10639502B2 (en) 2010-10-12 2020-05-05 Smith & Nephew, Inc. Medical device
US10991185B1 (en) 2020-07-20 2021-04-27 Abbott Laboratories Digital pass verification systems and methods
CN112890805A (zh) * 2021-01-14 2021-06-04 四川大学华西医院 一种自动寻找伤口并识别伤口状态的仪器
US11076997B2 (en) 2017-07-25 2021-08-03 Smith & Nephew Plc Restriction of sensor-monitored region for sensor-enabled wound dressings
US11315681B2 (en) 2015-10-07 2022-04-26 Smith & Nephew, Inc. Reduced pressure therapy device operation and authorization monitoring
US11324424B2 (en) 2017-03-09 2022-05-10 Smith & Nephew Plc Apparatus and method for imaging blood in a target region of tissue
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US11559438B2 (en) 2017-11-15 2023-01-24 Smith & Nephew Plc Integrated sensor enabled wound monitoring and/or therapy dressings and systems
CN115645149A (zh) * 2022-12-14 2023-01-31 宁夏医科大学总医院 一种用于慢性伤口的智能敷料系统
US11596553B2 (en) 2017-09-27 2023-03-07 Smith & Nephew Plc Ph sensing for sensor enabled negative pressure wound monitoring and therapy apparatuses
US11602461B2 (en) 2016-05-13 2023-03-14 Smith & Nephew, Inc. Automatic wound coupling detection in negative pressure wound therapy systems
US11633153B2 (en) 2017-06-23 2023-04-25 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11638664B2 (en) 2017-07-25 2023-05-02 Smith & Nephew Plc Biocompatible encapsulation and component stress relief for sensor enabled negative pressure wound therapy dressings
US11690570B2 (en) 2017-03-09 2023-07-04 Smith & Nephew Plc Wound dressing, patch member and method of sensing one or more wound parameters
US11712508B2 (en) 2017-07-10 2023-08-01 Smith & Nephew, Inc. Systems and methods for directly interacting with communications module of wound therapy apparatus
US11717447B2 (en) 2016-05-13 2023-08-08 Smith & Nephew Plc Sensor enabled wound monitoring and therapy apparatus
US11759144B2 (en) 2017-09-10 2023-09-19 Smith & Nephew Plc Systems and methods for inspection of encapsulation and components in sensor equipped wound dressings
US11791030B2 (en) 2017-05-15 2023-10-17 Smith & Nephew Plc Wound analysis device and method
US11793924B2 (en) 2018-12-19 2023-10-24 T.J.Smith And Nephew, Limited Systems and methods for delivering prescribed wound therapy
US11839464B2 (en) 2017-09-28 2023-12-12 Smith & Nephew, Plc Neurostimulation and monitoring using sensor enabled wound monitoring and therapy apparatus
US11883262B2 (en) 2017-04-11 2024-01-30 Smith & Nephew Plc Component positioning and stress relief for sensor enabled wound dressings
US11925735B2 (en) 2017-08-10 2024-03-12 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11931165B2 (en) 2017-09-10 2024-03-19 Smith & Nephew Plc Electrostatic discharge protection for sensors in wound therapy
US11944418B2 (en) 2018-09-12 2024-04-02 Smith & Nephew Plc Device, apparatus and method of determining skin perfusion pressure
US11969538B2 (en) 2018-12-21 2024-04-30 T.J.Smith And Nephew, Limited Wound therapy systems and methods with multiple power sources
US11974903B2 (en) 2017-03-07 2024-05-07 Smith & Nephew, Inc. Reduced pressure therapy systems and methods including an antenna
US12002566B2 (en) 2013-03-14 2024-06-04 Smith & Nephew, Inc. Attachment system for mounting apparatus
US12011942B2 (en) 2019-03-18 2024-06-18 Smith & Nephew Plc Rules for sensor integrated substrates
US12016994B2 (en) 2019-10-07 2024-06-25 Smith & Nephew Plc Sensor enabled negative pressure wound monitoring apparatus with different impedances inks
US12033738B2 (en) 2017-05-15 2024-07-09 Smith & Nephew Plc Negative pressure wound therapy system using eulerian video magnification
US12090264B2 (en) 2012-05-22 2024-09-17 Smith & Nephew Plc Apparatuses and methods for wound therapy
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Publication number Priority date Publication date Assignee Title
EP0122085A1 (fr) 1983-04-06 1984-10-17 Smith and Nephew Associated Companies p.l.c. Pansement
EP0123465A2 (fr) 1983-04-13 1984-10-31 SMITH & NEPHEW plc Pansement chirurgical adhésif
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