Evidence map›Paper›PMID 39215308›Full record

ArticleBiomedical engineering online2024

Development of a patient-specific model of the human coronary system for percutaneous transluminal coronary angioplasty balloon catheter training and testing.

C Amstutz, M Ilic, N Fontaine, L Siegenthaler, J Illi, A Haeberlin, A Zurbuchen, J Burger

Abstract read
In one paragraph

Article in Biomedical engineering online, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

C AmstutzSchool of Biomedical and Precision Engineering, Faculty of Medicine, University of Bern, Güterstrasse 24/26, CH-3010, Bern, Switzerland. Cornelia.Amstutz@unibe.ch.ORCID http://orcid.org/0000-0003-2755-8138
M IlicDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
N FontaineSchool of Biomedical and Precision Engineering, Faculty of Medicine, University of Bern, Güterstrasse 24/26, CH-3010, Bern, Switzerland.
L SiegenthalerSchool of Biomedical and Precision Engineering, Faculty of Medicine, University of Bern, Güterstrasse 24/26, CH-3010, Bern, Switzerland.
J IlliDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
A HaeberlinDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0002-9283-0110
A ZurbuchenSchool of Biomedical and Precision Engineering, Faculty of Medicine, University of Bern, Güterstrasse 24/26, CH-3010, Bern, Switzerland.ORCID http://orcid.org/0000-0003-0920-378X
J BurgerSchool of Biomedical and Precision Engineering, Faculty of Medicine, University of Bern, Güterstrasse 24/26, CH-3010, Bern, Switzerland.

Funding

Innosuisse - Schweizerische Agentur für Innovationsförderung 32091.1 IP-LS
6 · The paper itself

Abstract

backgroundTo treat stenosed coronary arteries, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must combine pushability, trackability, crossability, and rewrap behavior. The existing anatomic track model (ASTM F2394) for catheter testing lacks 3D morphology, vessel tortuosity, and compliance, making evaluating performance characteristics difficult. This study aimed to develop a three-dimensional patient-specific phantom (3DPSP) for device testing and safe training for interventional cardiologists.

methodsA range of silicone materials with different shore hardnesses (00-30-45 A) and wall thicknesses (0.5 mm, 1 mm, 2 mm) were tested to determine compliance for creating coronary vessel phantoms. Compliance was assessed using optical coherence tomography (OCT) and compared to values in the literature. Stenosis was induced using multilayer casting and brushing methods, with gypsum added for calcification. The radial tensile properties of the samples were investigated, and the relationship between Young's modulus and compliance was determined. Various methods have been introduced to approximate the friction between silicone and real coronary vessel walls. Computerized tomography (CT) scans were used to obtain patient-specific anatomy from the femoral artery to the coronary arteries. Artery lumens were segmented from the CT scans to create dissolvable 3D-printed core models.

resultsA 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4

conclusionThis study presents a novel method for crafting 3DPSPs with realistic mechanical and frictional properties. The proposed approach enables the creation of comprehensive and anatomically precise setups spanning the right femoral artery to the coronary arteries, highlighting the importance of such realistic environments for advancing medical device development and fostering safe training conditions.

Indexed as

Angioplasty, Balloon, CoronaryCoronary VesselsHumansMaterials TestingModels, AnatomicPatient-Specific ModelingPhantoms, ImagingSiliconesTomography, Optical CoherenceSilicones3DPSPAdditive manufacturingFrictionPatient-specific phantomsPTCA balloon catheterSilicone compliance

Identifiers

PMID39215308
PMCPMC11363638

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.