Clinical Overview

The Clinical Problem

are inserted into patients' bodies through the mouth or nose, or through the skin into arteries or veins primarily by 'feel', based on the medical practitioner's training and experience. This is appropriately referred to as 'blind' placement, which leads to a relatively high incidence of errors that require either repositioning of catheters or their complete replacement. The practice of blind placement reduces the efficiency of patient management, is time consuming, costly, unpleasant for patients, and in some cases can lead to death or serious injury. X-rays, which are taken after the operator has passed the catheter through a vein to its intended site, are currently used to confirm whether a catheter has been placed correctly. Approximately 10% of venous catheter placements are not placed correctly first time, which means that X-rays are often needed to confirm final placement, leading to patients being exposed to higher levels of radiation, greater costs and time required for treatment.

X-ray confirmation of placements is currently the 'gold standard'. However, X-rays are expensive, time-consuming, and they are taken after completion of procedures, which can disrupt patient comfort and the recovery process. Seriously ill patients may not be able to be moved to take confirmatory X-rays. Patient disruption interferes with treatment and puts the patient at risk unnecessarily. Rapid and effective delivery of medication and/or treatment to critically ill patents routinely involves the use of purpose-designed catheters. Specially trained clinical nurses, doctors, anaesthetists and radiologists place catheters.

Micronix's solution

The company's technology can offer a solution for catheter placements made anywhere in the body, where the placement site has a recognised relationship to specific anatomical landmarks.

The market for the company's catheter placement technology includes:

Small gauge catheters that contain multiple
lumens
Applications that require precise position sensing, e.g., cardiac mapping and placing temporary cardiac pacing wires.
Other position sensing applications, including orthopaedic and surgical applications that currently rely on fluoroscopy.
Imaging systems that require the display of relationships between surface anatomical features and structures inside the body, e.g., fluoroscopy (the combined technology would reduce the radiation dose that patients are exposed to).
Merged applications with complementary technologies such as ultrasound, which is currently used for vein location prior to catheter insertion.
Applications for investigational and interventional devices (e.g., applications in orthopaedics in which devices other than catheters are configured with transmitters).

The Company's current products have four components:

The main unit (MU) which houses a colour screen.
The guiding insert (GI), which is fitted inside a catheter, contains a miniature coil assembly acting as a transmitter.
A receiver unit (RU), which receives the signal transmitted from the catheter tip by the GI.
A battery operated graphics printer.

The Technology has a wide range of commercial applications. The distinguishing feature of the Technology is its ability to use inductive sensing. The Receiver Unit is placed in a set position (relative to the patient's surface anatomy), and it measures the electromagnetic field (EMF) or signal transmitted by the Guiding Insert within the tip of the catheter. This EMF signal is then translated into a graphic display on the screen of the Main Unit, of the catheter's position relative to the RU, appearing as a real-time graphic recording of the catheter's movement path, that can also be printed out for storage with the patient's medical record. Instead of using the radiographic landmarks that are used when reading X-rays, the Technology uses surface anatomical landmarks as references for the operator placing the catheter. The result is a display of multiple views of the catheter's trajectory at the bedside, which overcomes the problems associated with blind placement. This enables medical professionals to make real-time adjustments during the procedure and to achieve safe, first time, reliable placement of catheters. The Technology provides a permanent record of each procedure without involving the cost, patient disruption, inconvenience and exposure to radiation associated with X-rays. The Technology also will reduce the risk of death or injury associated with misplacements. X-ray techniques that are available at the bedside do not provide multiple views of relationships of catheter tips to visual landmarks used by clinicians as references to confirm correct placements.

The only comparable technology in terms of accurate, real-time monitoring capability is fluoroscopy, which uses enhanced X-ray images to aid clinicians in decision-making, through real time observation of the movement of injected contrast media or devices, such as radio-opaque catheters. Fluoroscopy costs (on average) $1,000 per placement and is used in about 5% of cardiac catheter placements and less often for feeding tube placement, generally only after difficulties are encountered during blind placement. Fluoroscopy involves the patient being exposed to high doses of radiation, which are potentially hazardous for both patients and medical staff.