Clinical Need
Percutaneous Transluminal Coronary Angioplasty (PTCA) and its peripheral equivalent
PTA (Percutaneous Transluminal Angioplasty), is the established procedure
to remove calcified lesions (narrowing) in the vascular system (arteriosclerosis).
The deployment of stents with traditional PET balloons initially proved problematic
with some stent designs damaging the PTCA balloon sufficiently to result in
balloon rupture with attendant complications. In the year 2000 Morgan Stanley
Dean Witter reported that 770,000 coronary angioplasty procedures were carried
out in the US alone.
Conventional high-pressure balloons are usually manufactured from blow moulded PET or very hard polyurethane. The inherent problems with PET balloons arise from the material and manufacturing processes with products typically causing difficulties in delivering the balloon through small diameter catheters. The material itself is prone to scratching or puncture that leads to potential failure during high pressure inflation. Conventional polyurethane balloons need to be thick walled to maintain the high pressure and again this causes problems in delivering the balloons through a catheter or cannula.
Current Development
Status
RANIER has developed and patented a braided, high pressure, tough balloon
technology designed to achieve very high deployment pressures without bursting.
The design variables available with RANIER’s braided balloon design allow
for a semi-compliant balloon that expands from the centre thus mitigating
the undesirable "dog-boning" feature of traditional balloons during stent
placement.
Our technology allows us to manufacture a range of balloon sizes from 2 to 30mm OD and greater using the same manufacturing principles. The balloon is capable of giving different balloon locking diameters, either to increase the diameter of the balloon past its resting diameter or alternatively decrease the balloon diameter when a high pressure is applied. This, coupled with the discreet variation of wall thickness, gives the manufacturer the ability to change the dimensions of the balloon throughout an inflation profile. Our PTCA balloon prototypes have been subjected to extensive pressure testing. The early results have been most encouraging. Extensive laboratory testing has shown that some braid polymer combinations are capable of achieving pressures in excess of 40 atmospheres. Further testing on a range of balloon sizes has indicated that braid reinforced polyurethane balloons are capable of higher inflation pressures than blown PET balloons of similar dimensions.
Intellectual Property
RANIER has an international patent application covering the design and manufacture
of the braid reinforced balloon. PCT/IB97/00956 filed in 1999 granted in some
states.
Commercialisation
The field of braid reinforced balloons for many medical applications is potentially
a valuable route for exploitation of our current IP. Applications other than
those mentioned could include balloon dilators or any other percutaneous surgery
dilators such as biliary duct dilators for example. RANIER is currently looking
for licensing partners for a range of balloon applications.
