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The use of a Trilogy system by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from one or more parameters may be deemed useful in providing optimum patient management.

This submittal covers a device that allows the placement of a ventricular catheter and up to three probes through one bolt. The pressure sensor is an air-based system that has a deformable chamber. The pressure in the chamber mirrors ICP. It is transmitted to an external transducer. The submittal also includes several procedure accessories, a device that sets the proper length of a probe to be inserted into the Trilogy, a tripod that indicates the correct drill angle, a series of tubes that fit on the shank of the bolt that cause the distal end of the bolt to stop when it reaches the inner table, an improved drill bit stop and an improved pump that injects air into the catheter's sensing system.

The use of a Hummingbird HUMV-500 or HUMV-500MR by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.

The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen. An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter.

The use of MPS (or MPS-T) by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from a second or third parameter may be deemed useful in optimum patient management.

MPS- Oxiport is a system capable of draining CSF, sensing ICP and receiving two monitoring probes such as oxygen or temperature. MPS stands for Multiple Parameter System. The system consists of bolt, a bolt insert and a ventricular catheter. A slidable insert is common on the catheter at the factory. After the catheter is situated in a ventricle, the insert is moved down the catheter and into the throat of the bolt. The insert has an o-ring that forms a seal with the bolt. It also has two guide tubes. The guide tubes allow the surgeon to place probes such as an oxygen or temperature sensor in the insert has a fixation element that joins the insert to the bolt and three pigtails with Toughy-Borst fittings to fix the monitoring probes and the ventricular catheter to the insert.

The use of a ACT III Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.

The ACT III Ventricular Catheter consists of a 10 Fr. ventricular catheter in combination with an external pressure transducer. The catheter has two lumens. One lumen drains CSF. The second lumen transmits ICP from the brain to the external transducer by means of an air tube within the lumen. The air tube communicates with a flaccid bladder on the distal end of the catheter. The bladder's volume and internal pressure change according to P1 V = P2 V2. The catheter's proximal end terminates in a piston with an o-ring. The piston is joined to an external transducer. The pressure seen by the bladder/catheter/transducer mirrors the pressure in the brain. The CSF drainage function is provided by a dedicated lumen within the catheter. The CSF drainage function is typical of ventricular catheters. The length of the catheter fenestrated with radial holes is the same length as that provided by a conventional drainage catheter. The active drainage length of the catheter is preserved by mounting the bladder on the side of the catheter on a segment not penetrated by radial holes. The technique used to place a ventricular catheter is the same as that used to place a conventional ventricular catheter. Once the distal end of the catheter is placed in the brain, the proximal end of the catheter is placed in the sheath of a trocar and tunneled beneath the scalp in a forward direction. The proximal end of the catheter is bifurcated in order to separate the air lumen and drainage lumen. It is desirable to keep the size of the proximal end of the catheter small and thereby minimize the diameter of the trocar sheath passed beneath the scalp. The size of the proximal end of the catheter has been minimized by the use of a tube-within-a-lumen design. In this design, a dedicated air tube is inserted into a lumen which, to distinguish it from the drainage lumen, will be referred to hereafter as the second lumen. The air tube is bonded to the distal end of the second lumen. The tube then exits the sidewall of the second lumen near the proximal end of the catheter. This construction allows the air tube to separate from the main catheter without the use of a molded bifurcation. As will be seen in the drawings, the concept provides a proximal configuration much smaller than a conventional molded bifurcation. Once tunneled beneath the scalp, the air tube is pneumatically connected the transducer. The transducer is mounted within a special transducer housing that features a cylinder designed to engage the catheter's piston. The bladder is activated when the piston on the end of the air tube is placed in the cylinder. Connecting the piston to the cvlinder causes the air in the cylinder to be injected into the bladder. The bladder air is restored once per shift by removing and replacing the transducer housing. The transducer is incorporated into to a standard patient monitoring cable. The cable can be connected to a patient monitor without the need for a special intermediate instrument.

The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston. A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap. The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system. The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.