Latest Advances in Biomedical Textiles and Healthcare Products at Medical Textiles 2004
SangWon Chung, NCSU College of Textiles
Held in conjunction with Industrial Fabrics Association International’s annual IFAI Expo 2004 (as well as 4th International Conference on Safety & Protective Fabrics), Medical Textiles 2004 was organized by North Carolina State University (NCSU) and IFAI in Pittsburgh, Pennsylvania October 26-27, 2004. The conference was designed to introduce new ideas, new resources and new opportunities of the medical textile industry; highlighting new materials, textile applications and trends in medical textiles, surgery, general and sports medicine, nursing, rehabilitation and biomedical engineering.
Three distinct keynote presentations were given: 1) Richard O’Sullivan from Johns Hopkins University presenting Future Trends in the Delivery of Medical and Healthcare Services,' 2) Dr. A. Blanton Godfrey from North Carolina State University presenting Quality Management in the Healthcare sector; and 3) Elaine Duncan from Paladin Medical, Inc. reporting on Regulatory Issues, FDA and International Requirements.
were divided into 7 sessions:
-Materials in Medical Applications and Healthcare
-Wound Closures/Suture Materials
-Orthopedic Devices and Compression Therapy
-Wound Care and Antimicrobials
-Protective Medical Textiles and Barrier Fabrics
-Future Directions and Opportunities for Healthcare Products
Among these sessions, several authors were especially noticeable in terms of their innovative approach to the needs of the medical and healthcare sector. At the Wound closures/Suture Materials session, clinical performance of suture materials was featured as well as recent development of absorbable suture materials. Recent advances on barbed suture technology were also introduced by Dr. Jeffery C. Leung from Quill Medical, Inc which presented the state-of-art technology on wound closure.
BARBED SUTURE TECHNOLOGY
The current increased dependence on less invasive surgical techniques puts additional demands on the performance of surgical sutures. Not only must good knot security be maintained, but the surface lubricant must ensure ease of manipulation, minimal tissue drag, and good biocompatibility with acceptable inflammatory and immunological responses. But Dr. Leung introduced a novel self-anchoring suture consisting of bi-directional barbs formed on a conventional monofilament suture, which can alleviate complications associated with suture knots and obviate the need to tie a knot.
Magnified Mid Section of Quill Barbed Suture™
Its efficacy in wound closure and biomedical performance has been demonstrated in several surgical repair models, both in vitro and in vivo. In particular, it has shown superior wound retention when compared with a conventional suture in tendon repair. The barbed suture has been shown to possess satisfactory profiles in tensile strength, wound holding strength, resorption, and tissue reaction. The barb geometry of this new suture has also been fully characterized, and research has shown that specific design parameters can be optimized for specific surgical applications. Significantly, the barbed suture technology is broadly applicable to a range of polymeric materials with dissimilar properties. Advances in this new technology have led to special uses where a barbed suture can provide solutions in challenging procedures such as endoscopic surgeries where knot tying can be extremely cumbersome. The use of barbed sutures has likewise emerged as an elegantly simple alternative in cosmetic and reconstructive surgeries to shift, sustain, repair, and manage tissue without the need for lengthy incisions.
Being able to manage and re-position tissues without making an incision is a benefit highly sought by surgeons and patients alike. The future lies well for even broader applications of barbed sutures in medicine.
At the cardiovascular session, Historical perspective of vascular prostheses, structures and coatings were introduced as well as vascular scaffolds using biomimetic design. Latest endovascular stent-graft developments were presented by Dr. Roy Greenberg from the Cleveland Clinic Foundation. Vascular grafts have been used to replace diseased or damaged arteries for over 40 years. Polyester (PET) and polytetrafluoroethylene (PTFE) grafts predominate the market. Despite the frequency and long history of use within the vascular tree, material issues remain a frequent cause of complications and challenges. Consequently, all graft materials must be designed with an intended purpose and tested to that effect using a battery of preclinical and animal studies. Following preclinical analysis, clinical trials have been performed to ensure that the desired results match the product goal. Issues with respect to assessment of fabric acceptability have become more complex when evaluated in the context of an endovascular procedure. A series of unique stresses and strains are now placed on the graft material as a result of compact loading, suturing, and mating with metallic support structures (stents).
Furthermore, technology has been pushed to provide thinner material to lower delivery profiles without compromising tensile strength and overall durability.
grafts mainly treat aortic aneurysms (abdominal aneurysm/ thoracic aneurysm)
in a less invasive, morbid and lethal method.
The material properties that have to be considered are like the
The endovascular grafts deal with the potential problems such as false aneurysm, thrombosis, expansion of aneurysm, dilation, infection, migration, and endoleak.
Ideal fabrics and ideal stents do not exist; however, progress is being made with respect to modification of current materials and the evaluation of novel devices.
a joint session with the 4th International Conference on Safety & Protective
Fabrics, hospital requirements for infection control were
introduced as well as two distinguished presentations given by
from Standard Textile
Inc. He introduced standards and specifications for protective
barrier fabrics featuring the FDA and EU’s standards and
test methods followed by market segmentation among the disposable
MARKET SEGMENTATION: DISPOSABLE VS. REUSABLE
There are not many decisions facing healthcare providers that elicit as much emotion as the decision to use single use (disposable) or multiple use (reusable) products. There are good products on both sided of the fence and the decision to go in one direction or the other is dependent on many factors. What is important are the trends being seen in healthcare and how these trends are manifesting themselves relative to segmentation of these two product groups. By understanding these trends it is hoped that end users can make better decisions for their facility and the community they serve, patient care and clinical outcomes can be improved and the manufactures can focus their development efforts on delivering high value products and services. The marketplace trends are listed below.
#1 As cost pressure mount, movement will be towards the lowest cost per use product. (As acquisition cost for an individual item goes up the cost per use generally benefits reusable products.)
#2 As purchasing groups and individual facilities look at ways to reduce costs, outsourcing will continue to be looked at as a viable option.
#3 Environmental issues surrounding medical waste will continue to grow. (Reusable will continue to dominate market share in environmentally sensitive regions including Europe and the east coast of the US.)
#4 As new or perceived infection control concerns develop, short term movement will be towards single use products.
Due to the dynamic nature of the healthcare marketplace, there will be multiple factors that any facility will take into consideration when selecting their product group, namely; facility user-costs, environment, availability of outsourcing and history.
Both product groups provide viable options but the single most important factor is that the choices being made should be based on the scientific evidence and a logical decision making process that involves all affected parties.
In addition to these sessions, Smart Bandages for Orthopedic Support and Prosthetic and Orthopedic Devices for the Repair and Rehabilitation of Sports Injuries were introduced at the fourth session, entitled Orthopedic Devices and Compression Therapy. The Wound Care and Antimicrobials session presented antimicrobial strategies for wound care products as well as approaches to controlling micro-organisms in hospital situations. Finally, Future Directions and Opportunities for Healthcare Products were featured, presenting market status and growth opportunities for hygiene and healthcare products, introducing wearable healthcare systems and the next generation materials, such as genetically engineered, nano and conductive fibers. The last session offered the new future of medical textiles community.
The conference ended as a great success, overall providing vast information of innovative research and unique perspectives on market trends and data. The presentations made the first Medical Textiles 2004 an informative and successful venue!