case studies
Case Study # 1
Focus on Shape Transformation
One engineer at a medical device company is working on a device that will be delivered through a catheter. The radially-expanding device requires a covering that will facilitate tissue in-growth in a short amount of time. Thickness of the medical fabric is critical as the device and the covering must be able to be compacted down into the catheter and delivered to the site with relative ease. Their question for Secant Medical: "What type of fabric structure can you create for this application?"
Secant Medical has created many medical fabrics designed to be delivered via catheter. One of the best options from a geometry standpoint is a braided medical fabric. Braided medical fabrics can be made in a tubular form in order to easily cover and attach to the device in question. Medical fabric braids also have the ability to "foreshorten," meaning they can expand radially with axial compression, and collapse with axial tension. This property makes a braided medical fabric ideal for loading into a catheter in compact form and then undergoing shape transformation when delivered by a physician.
Secant Medical works with several manufacturers of yarns and materials and holds significant inventories of material options, giving us a large degree of freedom to create desired properties and dial them in to the device. In this case, the solution involves providing a high amount of surface area while keeping the device covering thin enough to fit inside the catheter. Mission accomplished.
Case Study # 2
Keying in on Complex Geometries
A product technology group at one company is interested in exploring medical textile structures in tensile applications. The engineering team has a specific requirement for the load that the structure must demonstrate; it also must pass a certain number of cycles in order to be viable. It is critical that the medical fabric have key geometrical features that allow it to interact with the currently attachment instruments used in their product. The dimensional characteristics are important in both the width and thickness. The structure should be visible under fluoroscopy during routine patient evaluations. The client's question to Secant Medical: "Can such a structure be made using textile technologies?"
Segments of the medical device industry are looking to leverage minimally invasive technologies, which makes implantable medical fabrics an ideal option. One of the most versatile structures that Secant Medical can manufacture is also one of the most robust. A woven medical fabric is typically thought of as one that is made in two dimensions, width and length. With some of the custom machinery that we developed over the years, it is now possible to achieve significant thickness in carefully designed woven structures. The combination of special weaving techniques and fiber orientation makes this solution possible.
Secant Medical has to the ability to include unique design elements in woven structures such as holes, flares, and reinforcement zones. These can be brought together in a structure to closely replicate nearly any desired geometry. Many shapes can be replicated to behave and perform similar to existing structures.
Case Study # 3
Seamless Technologies, Seamless Manufacturing
A noted surgeon is interested in improving nerve repair and regeneration by using a conduit to bridge a nerve gap during the regeneration process. The conduit must be approximately 2 mm in diameter and able to bend at least 90° without kinking. The conduit must be biocompatible to prevent interference with the nerve growth and absorbable to eliminate a second surgery for removal. The surgeon has contacted a device manufacturer for assistance. The question posed to Secant Medical: "Can such a conduit be made using textile technologies?"
Secant Medical developed a seamless woven tube made from polyglycolic acid (PGA), and worked closely with the device manufacturer to refine the crimping process that provides the required flexibility and kink resistance. Working with PGA presented challenges due to the extreme sensitivity of the material to moisture. Environmental controls and strict monitoring procedures were developed to ensure minimal exposure. After the initial design phase of the device was completed, Secant Medical assumed contract manufacturing responsibility for the device, managing all production phases from raw materials through sterilization.
Contact us for more information on our biomedical engineering research and development support for the development and manufacture of your medical device.