>>SCOPE: Boston Scientific Project Description
Endoscopic Band Ligation is a method of providing hemostasis to bleeding within the GI tract. In particular, it is a preferred method for treating esophageal varices and anorectal hemorrhoids. Band ligators deploy elastomeric bands from caps that are mounted on the distal end of an endoscope.
The ligating unit is a tubular plastic attachment with seven elastic bands stretched around it. The proximal portion fits over the end of an endoscope. The clear color of the attachment and the central placement of the bands allows a clinician wide visibility of patient anatomy during a ligation procedure. One pulling filament strung around one side of the band allows consecutive releases of the bands. This filament extends through the working channel of the endoscope and is attached to the trip wire.
The handle, which contains a clockwise-rotating plastic spool, is inserted into the proximal end of the working channel. The spool is marked with arrow heads at the starting position and "clicks" when rotated 180 degrees, indicating the release of one band. The handle has a silicone grommet with a pinhole for the tripwire and a female luer fitting with a reflux valve for irrigation. The handle also has a pre-attached Velcro strap scope fastener for affixing the handle to the endoscope. The tripwire is a stainless steel wire with a loop connector at the distal end. The tripwire comes attached to the handle and is connected to the pulling filament of the ligating unit during setup.
The single deployment filament is attached to the series of bands by means of hand tied knots. The indexing to allow deployment of bands one at a time is facilitated by indexing of the deployment spool to reel in a fixed distance of thread in each deployment cycle. this reeling in of thread rolls a single band off the housing cap and releases a knot to buffer the subsequent band from deployment until the next deployment cycle. The training and labor and physical challenge to construct these devices leads to expense and a degree of production operator turn over.
These challenges of construction make it attractive for Boston Scientific to have an alternate method for deployment of ligation bands. In addition, alternate deployment methods could facilitate easier product setup and usage by the customer. Therefore, my SCOPE team is working with Boston Scientific to redesign the Super 7 product to improve manufacturability and product performance.
