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Laurent APERT

Serge LECOMTE

Health care demonstrator

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Laurent APERT

Serge LECOMTE

URGO wound care : professional products

Advanced Dressings Bandages

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Laurent APERT

Serge LECOMTE

History

The field of the wound care is very old and empirical, but the modern scientific

approach is recent and will open many projects or directions for us in the design ofnew products.

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Physiological wound healing

Molecular biology and cellular interactions

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Serge LECOMTE

Physiological wound healing

A dynamic process

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Serge LECOMTE

Chronic wounds

Chronic wounds = non healing wounds

Chronic wounds reduce quality of life and may lead to infections,

amputations and even death !

Increasing with ageing population.

Common chronic wounds

diabetic foot Ulcers,

Pressure ulcers, Leg ulcers (venous stasis ulcers),

Burns.

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Laurent APERT

Serge LECOMTE

Factors that inhibit Wound Healing

Local factors :

Wound hypoxia:Circulation, Local Compression,

Infection,

Environmental Factors (localization ie: sacrum),

Debris and Necrotic Tissue.

Systemic factors Medication :

Glucocorticoids, Non-steroidal anti-inflammatory drugs, Chemotherapy

Malnutrition, Vitamin & Mineral Deficiencies, Metabolic disorders

Diabetes, renal failure, hepatic insufficiency, immunosuppression

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Laurent APERT

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Diagnostic aid of wounds

WHY ?

A diagnostic aid would allow early intervention with suitable treatment.

This lead to less clinical hospitalisation (home care),

and reduce further complications.

HOW ?

Study of clinical criteria (aspect of the wound : colour, redness,temperature, pressure, size, humidity)

Study of the biological markers of healing (enzymes, proteins,number of bacteria, presence of pathogenic germs) and the studyof physicochemical parameters (pH, volume of exudates, etc..)

Prevention of chronic wounds should be the primarygoal in the area of wound care management.

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Laurent APERT

Serge LECOMTE

URGO application in STELLA : general specifications

It must match both technical requirements and regulatory

agreements.

It will be an active medical device that will be hold by a

patient for a delay of several hours to several days.

It will be in contact with healthy skin & wound environment

(ulcers, burns, pressure sores, )

It will give wound healing indicators in real time to the

patient and the medical staff.

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Serge LECOMTE

Main Functions that lead to an embeddeddevice on patient

Functionality: monitoring andrecording data, RFID, wireless

communication with personal huband/or PC.

Stretchable electronic: comfort, painless,better behaviour near articulations, muscle

swelling,skin movement

Ergonomic: thickness, small rigid

parts,

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Generic Design

Personal HUB/ComputerSmart Dressing

Power

Supply

/Storage

Power

Converter &

Distribution

WirelessTransmitter

ProcessingUnitMemory

SensorsAnalogue filterADC

Temperature and Humidity Contrl

30

35

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Body recording

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WHY STRETCHABLE ?

URGO demonstrator:

Will be in direct contact with body during activity ( workingand resting phase )

Must fit mechanical properties of skin specially strechabilityand secondary properties such as breathability.

These conditions are mainly realised by the use of a matrixof interposers on a stretchable and breathable substrate.

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SKIN EXTENSIBILITY MAP ( Stretchability)

25%

17%

21%27%

15%

12 %

8%( Heel)

Joint

stretchability( high level locally)

Muscles swelling

Breathing cycles

ie :Calf contraction ~ 3 %

SkinExtensibility

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General requirements of the demonstrator

Stretchable 3 % to 20 % (better behaviouron joint areas)

Biocompatible (cytotoxicity, skin irritation,sensitization )

Breathable (perspiration management to avoidmaceration)

Chemical resistant (body fluids)

Sterile (sterilisation process assessment)

Comfortable, painless (small rigid parts, thickness)

Regulatory requirements (CE regulatory, Medicaldevice classification, EM constraints)

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Clinical research studies

Preliminary and necessary to the registration and marketing

Give information on:

-Safety

-Efficiency-Indications

-Protocol of use

-Benefits for the patient

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Laurent APERT

Serge LECOMTE

A Broad kind of applications

Wound Healing Diagnostic,

Compressive Therapy,

Hydratation and saturation indicators of dressings,

Physiological parameters ( T , color)

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Serge LECOMTE

Thank you for your

attention