Sutured Mediated Vascular Closure System
This device permits a suture inside a sheath to be inserted into an artery and then deploys twin needles which pierce the artery wall and capture the suture thereby permitting a consistent subcutaneous knot to be tied.
Our customer needed to hold relative position (within 0.002) between the tips of two 0.020 diameter needles captured in plastic. This had been achieved with the use of a microscope during the prototyping phase, however, the challenge for SCG was to develop an effective method to reliably achieve this in high volume production. Once molded, the needle tips could not be allowed to come in contact with each other or any outside materials. SCG was able to develop a solution to high volume manufacturing and a packaging solution which protected the needles after molding until ready for final assembly at our customer.
- Needle: 304 Stainless
- Molding Material: RFL 4036 Nylon with PTFE
- Achieved high volume solution which adequately maintained critical top to tip position.
- Developed packaging solution to protect parts until use.
- Product helped reduce a patient's time to ambulation from 8 hours to 2 hours.
- Eliminated the need to apply excessive pressure on sore areas during hemostasis and thereby reduced patient discomfort.