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. 1999 Feb;81(2):206–211. doi: 10.1136/hrt.81.2.206

In vitro validation of the luminal measurement of a novel catheter based moulding technique

S Eccleshall 1, P Jordan 1, N Buller 1, J Townend 1
PMCID: PMC1728921  PMID: 9922361

Abstract

Objective—To investigate a modified angioplasty balloon catheter, which uses a novel balloon polymer to produce luminal moulds.
Design—The catheter was tested in polyurethane phantoms of diameter 1.5 to 4.0 mm. Inflations were to 1.4 atmospheres for 20 seconds at 37°C. The moulds were viewed by reinflating the balloon to 0.34 atmospheres and quantified using macrophotography and caliper measurement.
Results—Evidence of systematic error was found with lumen diameters ⩽ 2.0 mm, accuracy being 0.32 to 0.80 mm and precision 0.23 to 0.24 mm. However, between 2.5 and 4.0 mm the accuracy of measuring luminal diameters was 0.01 mm, the precision 0.06 mm, and the absolute mean error 0.05 mm. The results for percentage diameter stenosis were −1.15%, 0.86%, and 1.21%, and for lesion length they were 0.20, 0.60, and 0.41 mm, respectively.
Conclusions—The prototype catheter shows a high degree of accuracy and precision in phantoms of diameter 2.5 to 4.0 mm—the range within which most interventional work is performed. Further work on this technique as a method of direct three dimensional moulding of the coronary artery lumen is warranted.

 Keywords: moulds; luminal moulding; balloon catheter; coronary artery

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Figure 1  .

Figure 1  

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The catheter: the balloon (a) with central guidewire (b) attaches proximally to the outer tube (c) and distally to the inner tube (d). The outer tube is in continuity with the manifold (e) producing a lumen between the balloon and inflation port (f). The inner tube passes through the manifold proximally at an O-ring (g), which allows it to move freely during inflation and balloon shortening.

Figure 2  .

Figure 2  

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(A) Diagram illustrating an assembled complex phantom. The discs of Tufset (a) are mounted on metal rods (b) to produce a stenotic lumen (c). (B) Photograph of a mould of a complex phantom. The balloon is mounted on a mandrel adjacent to the calibration cylinder. Diameters are measured as shown (solid arrows). Lesion length is measured between the indentations (dotted arrow).

Figure 3  .

Figure 3  

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Modified Bland-Altman plots. (A) The difference between the balloon and phantom for simple lumen diameters in the range 1.5 to 4.0 mm. (B) The difference between the balloon and phantom diameters for complex models in the range 2.5 to 4.0 mm. (C) The difference between the balloon and phantom for changes in luminal diameter ⩽ 1.0 mm. The dotted lines represent the mean signed difference ± 2 SD.    

Selected References

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