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The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

The RB12 consists of a gamma sterilized single use polystyrene closed end cylinder shaped capsule with a small hole at the closed end which contains a stainless steel cutting blade and a polyethylene seal. The capsule connects to a re-useable handpiece (HP1000) via a quick twist and lock system and suits both left and right handed operators. The HP1000 has an inner piston which automatically locates in the internal seal when the capsule is connected. This creates an airtight loop to the attached syringe via the suction tube/syringe adaptor. The inner piston is pushed forward when the thumb trigger is activated pushing the blade forward past the capsule hole cutting the specimen. The RBI2 design uses a combination of a re-useable handpiece and a disposable (single use) capsule. The capsule is supplied to the end users in a sterile state completely assembled with an internal blade and seal. A syringe is connected to the rear end of the internal trigger tube via a piece of suction tube and a syringe/tube adaptor (supplied sterile with capsules). The disposable is placed onto the outer tubing that is housed within the handle. While placing the capsule the internal trigger tube automatically locates and passes through the seal. When capsule is placed onto the handpiece it creates an air loop from the syringe to the front section of the capsule. The capsule is placed against the mucosal wall of the rectum of the patient covering the capsule port. When the syringe is withdrawn this causes negative pressure in the capsule sucking the mucosal and sub mucosal into the capsule. The thumb trigger is pushed forward which pushes the blade forward cutting the tissue that has been sucked into the port. The front of the capsule remains airtight as the trigger/inner tube slides through the internal seal.