Prof. Dr. Roshan Shishoo Shishoo Consulting AB, Sweden Lift-group seminar “Opportunities for Textiles in Medical” Technology, Vaals 13th Dec. 2006 INTRODUCTION by Prof. Dr. Roshan Shishoo Shishoo Consulting AB, Sweden ©Shishoo Consulting AB

Medical textiles, end-use consumption by region, 1995-2005 (1000 tons) 1000 1995 2000 2005 % CAGR tons ’95-’05 W. Europe 334 351 388 1.5 E. Europe 29 37 56 6.7 N. America 368 388 409 1.1 S. America 30 40 48 5.0 Asia 348 459 608 5.7 Australasia 15 18 21 3.9 Rest of world 54 81 122 8.5 Total 1177 1374 1652* 3.4 * Estimated Source: David Rigby Associates ©Shishoo Consulting AB

Medical,health and personal care sectors Annual global consumption of technical textiles for medical and hygienic applications has gone up by 60% in the last ten years, to nearly 2 million tons. A high proportion consists of nonwovens. ©Shishoo Consulting AB

Broad classification Hygienic absorbent products Hospital and healthcare products Implants,Orthopedic prosthetic and Support devices Scaffolds for tissue engineering ©Shishoo Consulting AB

Major players in the global medical textiles & hygiene markets Company Product Area Procter & Gamble Diapers, Feminine Hygiene, Adult Incontinence, Wipes Kimberly Clark/Scott Diapers , Feminine Hygiene, Wipes, Adult Incontinence, Johnson & Johnson Feminine Hygiene, Wipes, Adult Incontinence, Health care SCA Feminine Hygiene, Wipes, Adult Incontinence Mölnlycke Health Care Medical and Healthcare Baxter Medical Textiles ©Shishoo Consulting AB

Major players in the global medical textiles market Company Product Area Smith & Nephew Medical & Health care 3M Medical /Health care DuPont Healthcare BSN Medical URGO Wound management ©Shishoo Consulting AB

Personal care and hygiene Diapers Sanitary napkins,tampons Incontinence products Dry and wet wipes ©Shishoo Consulting AB

Materials used are Nonwoven Wood pulp Tissue Plastic sheet Super absorbent polymers ©Shishoo Consulting AB

Medical and health care products surgical: caps, gowns, masks sponges, dressings, wipes orthopedic padding bandages, tapes drapes, wraps, packs bed linen, underpads Anti-decubitus pads examination gowns filters for biological liquids drug delivery system ©Shishoo Consulting AB

Medical textiles Natural fibre materials Cotton, wool Man-made fibre materials Viscose, PET, PTFE, PUR, PA and PP Biodegradable fibres PLA, PGA ©Shishoo Consulting AB

OR-gowns Balance of widely different properties Performance Requirement Balance of widely different properties Protection against possible contamination of fluid-borne viruses and bacteria Comfortable Providing freedom of movement Reusable/disposable ©Shishoo Consulting AB

OR-gowns /drapes Resistance to penetration Barrier materials for protection against biological hazards (liquids and aerosols) Resistance to penetration during wet contact with micro-organisms during dry contact with micro-organisms of wet airborne micro-organisms of dry airborne micro-organisms ©Shishoo Consulting AB

OR-gowns/ drapes Special woven fabrics Special nonwoven structures Breathable fabrics Coated fabrics (microporus coating) Laminated fabrics (hydrophilic or microporous membrane) ©Shishoo Consulting AB

Elastic bandages provide support assist in the healing of strained muscles assist in the treatment of various conditions ©Shishoo Consulting AB

Longitudinal stretch produces radial compressional forces Compressive bandages and pressure garments Novel textile structures Incorporation of elastomeric yarns Longitudinal stretch produces radial compressional forces ©Shishoo Consulting AB

Wound dressings Reinforcement (soft, flexible, elastic) Hydrophobic layer Woven, knitted • Silicon gel nonwoven • Polyurethane gel Polymeric foam Functions: Fluid permeable, peel strength-gel/fabric, tensile strength-gel, non-tackiness Skin ©Shishoo Consulting AB

Anti-thrombosis stockings Tubular stockings produced on circular and flat weft-knitting machines Double-bar raschel warp-knitting machines Conical tubular construction Multiple joining of two knitted layers by using an additional yarn system Optimum compression pressure ©Shishoo Consulting AB

Anti-decubitus mattresses / pads Hospital patients,home-care patients and nursing home patients can suffer from decubitus ulcers and pressure sores. 2/3rd pressure sores occur in patients over 70 years, In nursing homes: 17-28 % occurence. Healing rate depends on alternating pressure air mattresses, turning schedule( every 2 hours)and topical skin treatment. Pressure should be less than 30 mm Hg. No accurate prediction theories. Foam, air-filled and air-fluidized beds. Sales: over 6 bn US$ ©Shishoo Consulting AB

Alginate and chitosan fibres for medical use Alginate fibres - Biomaterials for wound- protecting bandages Chitosan fibres - acceleration of healing, especially burn wounds ©Shishoo Consulting AB

Textile fibres can be: permanently anti-microbial (bacteriostat) actively reduce the number of bacteria (bactericide) ©Shishoo Consulting AB

Anti-bacterial fibres Anti-bacterial agents in fibres and textiles ( e.g., slow release of silver ions) Anti-bacterial fibres ( e.g., slow release of copper ions ) ©Shishoo Consulting AB

Medical textiles for Intra-corporal use Ligaments Vascular grafts Orthopedic prosthetic devices ©Shishoo Consulting AB

Textiles in medical applications, e. g Textiles in medical applications, e.g. sutures, artificial ligaments, vascular grafts etc. Different functions as implants Replacement of tissue: this is necessary when • no natural tissue is available or • new natural tissue has not the required properties like stability or extensibility Tissue support: the textile structure reinforces new tissue ©Shishoo Consulting AB

For biomedical application where biostability is required Non-resorbable polymers : PTFE,PUR, PES, PP, Carbon Bio-compatibility is a must ©Shishoo Consulting AB

Biodegradable fibres used in implants Collagen Alginate Poly (Lactic Acid) Poly (Glycolic Acid) Polyamines Polyurethanes (-ether) ©Shishoo Consulting AB

Surgical implants High functional fibres High performance textile structures 3-D shaped fabrics from woven, knitted and braided processes ©Shishoo Consulting AB

Fibre-reinforced composites for surgical implants Load-bearing capacity Corrosion resistance Low weight Biocompatibilty Durability X-ray transparency Very low allergic risk Easier handling ©Shishoo Consulting AB

5 ° to 60 ° depends on crossing angle Characteristics of different textile structures with regard to their medical use Woven fabric Weft knitted Warp knitted fabric Braid Nonwovens Strength High Medium Very low Extensibility Low Medium to low Porosity Medium to high Low to high High to medium Pore-size Small to medium Large Small to large Orientation of filaments 0° and 90 ° Loop 5 ° to 60 ° depends on crossing angle Anisotrop or isotrop ©Shishoo Consulting AB

Knitted and woven PES vascular and cardiovascular grafts Surface modification to facilitate tissue growth, e.g., collagen coated With antimicrobial protection using e.g., silver coating ©Shishoo Consulting AB

Scaffolds for tissue growth Novel nonwoven,woven and knitted 3-D substrates. Large specific area, high porosity, formability, handleability. Resorbable fibres PLA,PGA,PU-ether. Degrade with time Biological active surfaces ©Shishoo Consulting AB

Tissue engineering: Reserve parts for the human body Ear Tooth Heart Pancreas Ureter Bone/ ligament Breast Liver Bladder Spinal nerves Source: Illustrerad Vetenskap, No 5, 1999 Skin ©Shishoo Consulting AB

Intelligent textiles for medical applications ©Shishoo Consulting AB

Smart textiles and clothing Electronics & Information Technology INNOVATIVE FIBER Technology & POLYMER Technology SMART SAFETY & PROTECTIVE CLOTHING Wearable Technology Intelligent Textiles ©Shishoo Consulting AB

Where Textiles and Electronics meet (WEARABLE TECHNOLOGY) Smart shirt / Smart clothing : A wireless backbone from multiple sensory locations Sensors and data processing components Health monitors/ Reassurance products ( pulse rate,heart activity, body temperatue ) Medical product ( wound -dressings, compessive bandages) ©Shishoo Consulting AB

European Standards Implemented in all CEN countries Linked to legislation-In practice mandatory Scope of TC 205/ WG 14 is to specify performance requirements and test methods for single use and reusable coverings for patients, clinical staff and equipment used as medical device intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. ©Shishoo Consulting AB

Medical Device Any materials and other articles used for human beings for the purpose of diagnosis, prevention, monitoring & treatment of disease. Surgical gowns and drapes, wound management articles and textile implants are medical devices and their clinical performance is tested through a set of defined properties according to the Coucil Directive 93/42/EEC of 14 June 1993. ©Shishoo Consulting AB

Thank you for your attention ! Dr. Roshan Shishoo Shishoo Consulting AB, Sweden roshan.shishoo@shishooconsulting.se ©Shishoo Consulting AB