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The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.

The Rapid Barostat Bag system consists of a pump unit and a disposable catheter. The pump uses an air compressor pneumatic system and is operated through a touch screen. It is electrically powered by rechargeable batteries and is wirelessly connected to a peripheral remote control for the patient to input different levels of sensation during the study. The catheter is made up of single-lumen PVC tubing with a plastic non-compliant barostat balloon at the distal end, and a female luer at the proximal end. The balloon end of the catheter is inserted into a patient's rectum, and the luer end is connected to the pump. The study, also known as RBB Protocol, consists of two or more rounds of inflation and deflation of the catheter. The first round will inflate the balloon to the set internal pressure of 40 mmHg to determine the maximum volume of the rectum. The second round of inflation will be used to determine the volumetric points of sensation, urge, and discomfort associated with the patient's rectum. During the study, the pump will push air through the catheter tubing into the barostat balloon at a constant rate of 2 mL/sec, while displaying the fluctuating pressure within the balloon onto the pump's touch screen display. When the patient begins to feel the sensation of the inflated balloon, they would push the "sensation" button on the remote control to transmit a signal to the pump. The inflation volume and pressure will be recorded at that point of reference. The pump will continue to inflate the balloon for the patient to report the point of the feeling of urge, and then discomfort, and the data points are collected and stored in the systems internal memory. Upon pressing the discomfort indicator button, the system will automatically stop the inflow of air into the balloon and begin to rapidly deflate the balloon at 3 mL/sec. By extrapolating the volume and pressure measurements recorded within the barostat balloon, the pump will be able to provide the healthcare professional with clearer data for a more accurate diagnosis of anorectal functions and rectum disorder.

The Pressurized Infusion Pump (Electrically Powered Models #PIP-4-4SS, PIP-4-6SS, PIP-4-8SS, PIP-4-12SS, and Portable Models #PIP-6-4SS, PIP-6-6SS, PIP-6-8SS, PIP-6-12SS, PIP-6-16SS, PIP-6-22SS, PIP-6-24SS, PIP-6-36SS) is intended to provide a regulated and channeled perfusate of water to a motility catheter to perform manometric motility studies along the gastrointestinal tract. The Pressurized Infusion Pump is intended to be used with a separate legally marketed compatible motility catheter and separate computerized gastrointestinal monitoring system.

These pressurized infusion pumps consist of an electrical compartment, a water chamber, a regulator and a set of gauges, and flow restrictors. The electrical compartment unit consists of a compressor motor, a pressure switch, a pressure gauge, and a drying cylinder. When turned on, the motor will compress air into the drying cylinder, which will remove the water byproduct from the compression. The pressure switch will turn the motor off at 42psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 18psi. For the Portable Pressurized Infusion Pump, an air hose connects the electrical unit to the main pump housing to deliver the pressurized air to the pump. The pressurized air will flow through a high pressure gauge (to display the pressure of the supplied compressed air), to a regulator (which will regulate the pressurized air down to 17psi), then a low pressure gauge (to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The regulated air will push the water out of the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.60mL/min before it travels through a pressure transducer to the motility catheter. At the proximal end of the motility catheter are female luers that connect to the top of the pressure transducers on the infusion pump. The water will flow through the entire length of the motility catheter to the distal end where the pressure ports are located. The motility catheter is then inserted into the patient and placed along the specific section of the gastrointestinal system being measured. With the regulated pressurized water flowing through the catheter at a constant rate, when the gut muscles contract, it will constrict the flow of water through the pressure ports, and the pressure change will be transmitted back through the water flow to the pressure transducer on the pressurized infusion pump, where the signal will be displayed onto the computer.

The sphincter of Oddi manometric pump and catheter are used in conjunction with a computerized motility system for motility studies, to measure the Contraction rates along the gastrointestinal system (specifically the sphincter of Oddi); for research or diagnostic purposes within a clinical setting.

This system consists of a water-perfused SOM pump, an air compressor unit, and a Toouli SOM Sleeve catheter. The air compressor unit consists of a compressor motor, a pressure switch, a pressure gauge, and a drying cylinder. When turned on, the motor will compress air into the drying cylinder, which will remove the water by-product from the compression. The pressure switch will turn the motor off at 30psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 10psi. An air hose connects the air compressor unit to the SOM pump to deliver the pressurized air to the SOM pump. The pressurized air will flow through a high pressure gauge (to display the pressure of the supplied compressed air), to a regulator (which will regulate the pressurized air down to 5psi), then a low pressure gauge (to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The regulated air will push the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.18mL/min before it travels through a pressure transducer to the Toouli SOM Sleeve catheter. The proximal end of the Toouli SOM Sleeve catheter has a female luer that connects to the top of the pressure transducer on the SOM pump. The water will flow through the entire length of the Toouli SOM Sleeve catheter to the distal end where a silicone sleeve sensor is located. The Toouli SOM Sleeve catheter is then inserted through the biopsy channel of an endoscope, and then the sleeve sensor is positioned along the Sphincter of Oddi. With the regulated pressurized water flowing through the sleeve sensor at a constant rate, when the sphincter contracts, it will constrict the flow of water through the sleeve sensor, and the pressure change will be transmitted back through the water flow to the pressure transducer on the SOM pump, where the signal will be displayed onto the computer.