Lesion preconditioning is an important basis for successful coronary intervention. In response to the problem that ordinary balloons may slip during preexpansion, the sphenoidal balloon has been developed. The emergence of the spiked balloon has improved the outcome of complex lesion pre-processing, which can improve the immediate success rate and long-term prognosis of the procedure.
The Spine Balloon was developed by Dr Wayne Ogata in Japan in 2000, officially launched in Japan in 2003 and entered the Chinese market in 2012. The special nylon spines are used as cutting parts, embedded and fixed on the surface of the balloon, and the spine cutting parts can be embedded in the plaque to prevent the balloon from slipping out of the balloon. This special balloon has both anti-slip and dilatation effects, and the nylon cutter is highly flexible and safe.
01 Structural design and working principle of the spiny balloon
The ratchet balloon design is mainly composed of two structural parts: the balloon and the three 120°distributed nylon wires attached to the surface of the balloon constitute the ratchet prongs. The spine prongs are generally nylon and other polymer materials, the prongs are tautly embedded in the diseased plaque when the balloon is expanded, continuously extruding and cutting the plaque, causing the plaque to split, avoiding balloon slippage to the greatest extent possible, and reducing the impact on the vascular wall and the number of balloon expansions, thus improving the accuracy and effectiveness of the expansion. In addition, the wedge-shaped structure of the sphenoidal balloon has a strong‘riveting force’, which makes it easier to pass through the lesion, and the low distending pressure can cause indentation of the calcified lesion, so that the catheter can reach the lesion in depth when the balloon is tightened, and the repetition of the above operation can provide a track for the delivery of the balloon to improve the passage rate.
In addition, the spine balloon can rapidly retract its surface spines to a smaller diameter after deflation, thus safely withdrawing from the coronary vessels, reducing the risk of scratching the normal vessel wall by the microblade, and preventing the occurrence of adverse cardiovascular events.
The spiny balloon surface is designed with small spikes, ideal for less rigid calcified lesions as it indents rather than cuts, thus reducing the risk of damage to the arterial wall, scoring over the plaque and helping to control dilatation.
02 Indications for sphenoidal ballooning
The Spine Balloon is indicated in scenarios such as mild to moderate coronary artery calcification disease, as well as in-stent restenosis, bifurcation lesions, opening lesions, and small vessel lesions. Or for further lesion preconditioning after coronary plaque spinning to ensure that the lesion area is adequately dilated and cleared.
When the sphenoidal balloon fails to pass through a calcified lesion, a creeping technique within the calcified lesion can achieve good dilatation.
Precautions: (1) Avoid rotating the balloon within the coronary artery as this may result in entanglement with the nylon. (2) The nylon is fixed to the ends of the balloon, not to the surface of the balloon. There is a risk of entanglement of the second guidewire as it passes over the balloon. (3) Try not to apply the spiked balloon within the stent mesh to avoid the occurrence of entanglement.
03 Advantages of the sphenoidal balloon
- Effective treatment of moderately calcified lesions with lower risk of stripping;
- prevention of balloon slippage: 3 special nylon spine elements and the piggyback catheter frame a wedge-shaped structure, which can increase the balloon embedding capacity, thus reducing the probability of balloon slippage, effectively reducing the number of balloon dilatations and shortening the procedure time;
- clinical advantages: reduction of slippage and improvement of stent apposition;
- the spine balloon has a smaller size and good retraction, and can be embedded in a conical structure in the calcified area with multiple dilatations. Smaller spine balloon, good retraction, can be embedded in the calcified area with a conical structure, multiple dilatations in the calcified area, safe withdrawal after full dilatation, less damage to the vessel wall than regular and cut balloons;
- less effective in very hard or fibrous plaques, in which case more aggressive tools may be required.
