Development of a patient-specific model of the human coronary system for percutaneous transluminal coronary angioplasty balloon catheter training and testing.
3DPSP
Additive manufacturing
Friction
PTCA balloon catheter
Patient-specific phantoms
Silicone compliance
Journal
Biomedical engineering online
ISSN: 1475-925X
Titre abrégé: Biomed Eng Online
Pays: England
ID NLM: 101147518
Informations de publication
Date de publication:
30 Aug 2024
30 Aug 2024
Historique:
received:
20
05
2024
accepted:
22
07
2024
medline:
31
8
2024
pubmed:
31
8
2024
entrez:
30
8
2024
Statut:
epublish
Résumé
To 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. A 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. A 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4 This 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.
Sections du résumé
BACKGROUND
BACKGROUND
To 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.
METHODS
METHODS
A 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.
RESULTS
RESULTS
A 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4
CONCLUSION
CONCLUSIONS
This 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.
Identifiants
pubmed: 39215308
doi: 10.1186/s12938-024-01271-7
pii: 10.1186/s12938-024-01271-7
pmc: PMC11363638
doi:
Substances chimiques
Silicones
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
89Subventions
Organisme : Innosuisse - Schweizerische Agentur für Innovationsförderung
ID : 32091.1 IP-LS
Informations de copyright
© 2024. The Author(s).
Références
Proc Inst Mech Eng H. 2016 Feb;230(2):153-65
pubmed: 26721906
Eur Heart J. 2020 Jan 7;41(2):200-203
pubmed: 31909425
Technol Health Care. 2017 Dec 4;25(6):1139-1146
pubmed: 28946605
Clin Cardiol. 1992 Jun;15(6):451-7
pubmed: 1617826
Hear Res. 2021 May;404:108205
pubmed: 33618163
Exp Mech. 2021 Jan;61(1):53-66
pubmed: 33583946
JACC Cardiovasc Interv. 2022 Jul 11;15(13):e159-e161
pubmed: 35798492
Sci Rep. 2020 Jul 16;10(1):11855
pubmed: 32678286
J Invasive Cardiol. 2015 Jul;27(7):E139-42
pubmed: 26136288
Bioengineered. 2017 Mar 4;8(2):154-170
pubmed: 27588460
J Cardiovasc Magn Reson. 2013 Jan 16;15:2
pubmed: 23324211
Soft Matter. 2019 Apr 17;15(16):3353-3361
pubmed: 30924833
Circulation. 2000 Aug 1;102(5):506-10
pubmed: 10920061
J Am Coll Cardiol. 2002 May 15;39(10):1637-43
pubmed: 12020491
Front Bioeng Biotechnol. 2023 Dec 01;11:1274673
pubmed: 38107617
J Am Coll Cardiol. 1994 Mar 15;23(4):879-84
pubmed: 8106692
Heart Lung Circ. 2022 Sep;31(9):1203-1218
pubmed: 35680498
Am J Case Rep. 2020 Apr 19;21:e923007
pubmed: 32305993
Int J Card Imaging. 1999 Aug;15(4):287-94
pubmed: 10517378
J Invasive Cardiol. 2012 Dec;24(12):650-4
pubmed: 23220980
EuroIntervention. 2018 Feb 02;13(15):e1794-e1803
pubmed: 29131803
Am Heart J. 1998 Dec;136(6):1088-95
pubmed: 9842025
Biomed Mater Eng. 2003;13(4):327-43
pubmed: 14646048
Am J Physiol Heart Circ Physiol. 2000 Apr;278(4):H1407
pubmed: 10787279
Med Eng Phys. 1998 Oct;20(7):523-33
pubmed: 9832028
Mater Sci Eng C Mater Biol Appl. 2013 Jul 1;33(5):2550-4
pubmed: 23623067
Lancet. 2017 Jan 7;389(10064):37-55
pubmed: 27863813
Dent Mater. 2009 Aug;25(8):956-9
pubmed: 19286248
J Invasive Cardiol. 2019 Sep;31(9):272-277
pubmed: 31199349
Ann Biomed Eng. 2018 Nov;46(11):1697-1721
pubmed: 29987543
Circ Res. 2022 Jun 10;130(12):1869-1887
pubmed: 35679358