Saphenous Vein Distention System Procedure

Product Code: SVDS

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Saphenous Vein Distention SystemDevice Description
The Saphenous Vein Distention System is available in two pressure limiting sizes. Comprised of four biocompatible components: 60cc/ml Syringe – PP, Two-way Stopcock – Polypropylene. Pressure Limiting Balloon – Medical Grade Silicone, Irrigation Cannula – Polycarbonate. This device is used for the distention and irrigation of a saphenous vein, which is being tested prior to use as a coronary or peripheral bypass graft. The SVDS-200 limits the nominal pressure to 200 mm Hg. The SVDS-300 limits the nominal pressure to 300 mm Hg.

Warnings
The Saphenous Vein Distention System is indicated for use in patients undergoing heart surgery where the saphenous vein is required as a coronary artery bypass graft.

Contraindications
There are no known contraindications to the use of the Saphenous Vein Distention System. Excessive rapid balloon inflation may cause transient high pressure and should be avoided. Carefully read instructions prior to use.

Sterilization
Contents sterile/non-pyrogenic only if protective package is not opened, damaged or broken. Do not resterilize. DMC Medical Limited is ISO 13485:2003 + AC:2007 approved.

Instructions

  • Assembly: Note: Separate the “Vein Storage Tray” from the primary tray containing the other components and fill it with irrigation fluid. Insert the tip of the irrigation cannula into the distal end of the vein and ligate. Attach the stopcock to the female luer connector of the balloon and place it in a closed postion. Fill the syringe with approximately 50cc/ml of irrigation fluid and attach it to the free end of the stopcock.
  • Priming Procedure: Position the syringe with the tip at a 45° upward angle and with the balloon hanging downward. Open the stopcock and slowly prime the system with approximately 15cc/ml of irrigating fluid. Attach the cannulated vein to the male end of the balloon body and flush a small amount of fluid through the vein to remove residual air. Close the open end of the vein with an atraumatic clamp.
  • Distention Procedure: Gradually inflate the balloon with the syringe’s contents and close the stopcock. The balloon now acts as a reservoir, which continually fills the vein at a constant and known pressure while unsecured branches are tied off. Closing of the stopcock allows the operator to use both hands to manipulate the vein. Localized areas of persistent spasm can be distended without subjecting the entire vein to excessive pressure by either momentarily squeezing the balloon or by digitally compressing the vein on both sides of the involved segment and “milking” the trapped fluid toward the center.