Can I use FloShield on my robotic laparoscopic cases?
Presently, FloShield is only available for surgical cases which utilize a 5 or 10 mm laparoscope without the aid of a robotic device such as the da Vinci® Si HD™ Surgical System. A Robotic FloShield version has been developed and we are working through the various regulatory, manufacturing and quality validations necessary to market this product within the USA. An 8.5mm Robotic FloShield, which is compatible with the da Vinci® Si HD™ Surgical System will be available in March 2014.
How many cases have been performed with FloShield?
Over 10,000 cases have been successfully performed with the 5mm and 10mm versions of FloShield. FloShield features the Vortex Barrier Technology™ which rapidly defog the lens while creating a barrier of dry CO2 gas that prevents the lens from accumulating debris during surgery. Flo-X in situ provides the clinician with an intraoperative surfactant flush which cleans the lens without removing it from the surgical site. Surgeons, for the first time, can now take control in maintaining a consistently clear image throughout the entire laparoscopic surgery.
Is any capital equipment required?
No capital equipment is required and FloShield is fully disposable.
Is there any clinical data available on FloShield?
- A retrospective study1 demonstrated a time savings in
Roux-En-Y bariatric surgery.
- A small prospective study2 demonstrated a clear difference in
the number of times surgery was interrupted for cleaning during
- In a clinical assessment of 30 laparoscopic cases3, the data
showed that the clinicians went from an average of 6 scope
removals per hour to .005 scope removals per hour when
Is FloShield expensive?
FloShield replaces all other laparoscopic clarity products, costs only slightly more than a trocar, and is a fraction of the cost of surgical staplers or energy instruments. If FloShield saves 10-20 minutes in a two-hour case, it pays for itself many times over.
There are additional benefits which include increased focus/concentration during a case with dramatically fewer interruptions, rapid vision recovery after an abrupt loss of vision and maximizes the visual benefits of modern optics and displays.
What other products do I need use in order to maintain consistent visual clarity throughout my surgery?
None! FloShield provides a comprehensive, all in one solution for laparoscopic clarity and there is no need for any other ancillary products. FloShield eliminates the need to use other products that:
- Require the removal of the laparoscope from the surgical site
to be cleaned with an anti-fog solution and/or cloth
- Heat the laparoscope
- Heat the insufflation tubing or CO2
- Clean the inside of the trocar
Does FloShield fit all Laparoscopes?
FloShield fits the majority of available laparoscopes including Storz, Stryker, Olympus and Wolf. FloShield comes in 5mm and 10mm versions with 0, 30 and 45 degree angled options in both standard and extended lengths.
How does FloShield’s Vortex Barrier Technology work?
The FloShield tube system connects to the existing insufflation tubing and diverts a portion of the CO2 gas down through 4 unique microscopic channels to the distal tip of the scope. The unique patented design sends the CO2 gas down the channels at varying speeds creating a vortex barrier of CO2 gas. This vortex works simultaneously to defog the lens while providing a barrier of dry gas over the lens that shields it from condensation, debris and smoke.
What is Flo-X?
Flo-X is a cleaning solution that can be used to clean the scope lens. Flo-X is a biocompatible surfactant that is much more effective as a cleaning agent than plain water or sterile saline. The user may apply Flo-X onto the lens outside of the patient or it can be dispensed intra-operatively using FloShield and Flo-X in situ.
The ingredients used in the solution are docusate sodium, saline and phosphate buffer solution. Docusate sodium is a surfactant that is commonly used throughout the pharmaceutical industry. It is FDA approved and has been safely used for years in many health care products. The only contraindication for the use of docusate sodium is sensitivity to the product itself and this is extremely rare.
How do I use Flo-X in situ?
FloShield comes with two syringes containing 10ml of solution in each syringe. The syringe is connected to the Flo-X dispenser on the tube set and user will normally dispense approximately 2ml of solution each time the lens needs to be cleaned. The clinician slightly depresses the syringe to release Flo-X on the face of the lens. The flow of solution is stopped by removing finger pressure on the syringe. This cleaning/flushing process can be done without removing the scope from the surgical site.
What is the Flo-X Blow-Off Bulb used for?
After dispensing Flo-X onto the lens intraoperatively, it is suggested that the blow off bulb be squeezed 2-3 times in order to provide a bolus of CO2 gas over the lens to aid in drying the lens. It takes approximately 5 seconds for the lens to dry. More than 2-3 squeezes of the bulb are unnecessary.
Why do I need to use the Trocar Vent Adaptor?
FloShield diverts a portion of the CO2 gas from the insufflator in order to create the Vortex Barrier at the distal tip of the laparoscope. To maintain a constant fog free and debris free lens, it is critical to provide a consistent nonstop flow of CO2 gas and this requires the insufflator to be in an “ON” mode throughout the entire surgical case. By placing the Trocar Vent Adaptor on an ancillary trocar and turning the stopcock on, this will ensure that FloShield’s Vortex Barrier Technology™ will provide visual clarity throughout the entire case.
What size Trocars do I use with FloShield?
In order to accommodate the FloShield Sheath, you must use a 7/8mm trocar with a 5mm laparoscope and a 12mm trocar with a 10mm laparoscope.
Why do you state that FloShield virtually eliminates the need to remove the scope during surgery?
Our stated goal is to ELIMINATE the need to remove the laparoscope while maximizing the visual clarity over the course of the entire MIS procedure. In one clinical assessment of 30 cases3, the clinicians dramatically reduced the need to interrupt surgery to clean the laparoscope by over 99% when using FloShield (the data showed that the overall scope removals went from 6 /hour to 0.005/hour).
However, experience has shown us, that there are occasional times when the debris and smoke seem to “bake on” the lens. This has been observed to be especially true in long cases and/or cases with a high utilization of electro surgery/ultrasonic energy. Thus, we have virtually eliminated the need to remove the scope for cleaning/defogging when utilizing FloShield but realize that there are rare circumstances when the scope must be removed and cleaned manually.