Publications – Compliance
Medical Device Testing
Comparison of Radial Expansion of Stents
by | RMBS 2008 | Publications, Compliance, High Speed Photography, Silicone Mock Arteries, Stent Testing
Ramesh R, Conti JC, Strope ER, Thompson M, Price KS, Murray D
RMBS 2008
Keywords: radial expansion, stent durability, deflection, mock vessels, coronary artery
Abstract
Coronary artery disease results in hardening of the arteries. The main reason is that cholesterol and plaque build up on the inner walls of the arteries. This results in restricting the blood flow to the heart causing injury to the heart muscle. Recently, non-surgical processes are being used to open up …
Linear Elastic Mechanics of Mock Arteries: Empirical Versus …
by | RMBS 2007 | Publications, Compliance, High Speed Photography, Silicone Mock Arteries
Biomedical Science Instrumentation, 43, pp. 54-62, (2007)
Ramesh Rajesh, Conti JC, Strope ER
RMBS 2007
Keywords: linear elastic mechanics, stent durability, deflection, pulsatile, accelerated, mock artery, high speed photography, laser micrometry
Abstract
Evaluation of a medical device requires human or animal studies to be conducted. In the past decade, the use of mock arteries or mock vessels has found its place in the cardiovascular industry …
Mock Vascular Compliance During Intravascular Product Testing
by | 2006 | Publications, Compliance, Silicone Mock Arteries
J. C. CONTI, PH.D.
Dynatek Dalta Scientific Instruments, 105 E. Fourth Street, Galena, MO 65656
One of the most interesting topics raised at all standards, regulatory agency, and contractor meetings is related to the role that the mechanical compliance of mock arteries plays on the testing of medical products destined for intra arterial deployment or implantation.
Single Versus Double Ended High Frequency Pressurization of Mock
by | RMBS 2006 | Publications, Compliance, High Speed Photography, Silicone Mock Arteries
Biomedical Science Instrumentation, 42, pp. 446-451, (2006)
Ramesh, R, Conti JC, Strope ER
RMBS 2006
Introduction:
Frequency response characteristics of mock arteries play a very significant role in high frequency durability testing of medical devices such as grafts and stents. In vitro durability testing of stents depends on cyclic load applied by the mock artery on the medical device.
Comparing Several Analytical Methods When Determining Dynamic Compliance of Arteries and Vascular Grafts
by | SFB 2005 | Publications, Compliance, Silicone Mock Arteries
Ramesh, R, Conti JC
SFB 2005
Introduction
Proper evaluation of mechanical characteristics of intravascular medical products often makes it necessary for researchers to conduct animal studies. Silicone mock arteries used in medical device testing have been proven to be the better alternative to animals. Radial compliance of mock arteries depends on radius and internal pressure and plays a critical role in in vitro experiments. Mock arteries are tested for radial compliance according to standards set by the AAMI/ISO committee…
Frequency Dependent Hysteresis of Silicone and Latex Mock Arteries Used in Stent Testing
by | RMBS 2005 | Publications, Compliance, High Speed Photo, Silicone Mock Arteries
Ramesh Rajesh, Strope ER, Price KS, Conti JC
RMBS 2005
Keywords: Compliance, Latex, Silicone, Artery, Frequency, Hysteresis, Stent, Testing, Vessels
Abstract
Mock arteries also called as mock vessels are one of the best alternatives available to researchers in evaluating the mechanical characteristics and durability of intravascular medical products without having to use animal and human clinical studies. The behavior of mock arteries depends on the frequency of loading. This makes it essential to evaluate and analyze the compliance …
High Speed Photographic Verification of Intravascular Stent Strains During Accelerated Durability Testing
by | RMBS 2004 | Publications, Compliance, High Speed Photography
Biomedical Science Instrumentation, 40, pp. 219-224, (2004)
Kattelola, Brunda, Conti, JC, Strope, ER
Keywords: Stent, Durability, Vascular, Intravascular, Verification, Strain, High Speed Photographic, Mock Artery and Silicone.
RMBS 2004
Abstract
Most stent durability testing does not predict resulting clinical failures. Standards committees have taken on the task of …
Radial Compliance of Natural and Mock Arteries: How This Property Defines the Cyclic Loading of Deployed Vascular Stents
by | SFB Workshop 2002 | Publications, Compliance, Silicone Mock Arteries
SFB Workshop 2002
Slides
Radial Compliance Of Natural And Mock Arteries: How This Property Defines The Cyclic Loading Of Deployed Vascular Stents
by | RMBS 2002 | Publications, Compliance, Silicone Mock Arteries
Biomedical Science Instrumentation, 38, pp. 163-172, (2002)
J. C. CONTI, PH.D.
RMBS 2002
There has been a disturbing number of unexpected mechanical failures in deployed vascular stents and stent grafts. An analysis of the mechanical properties of mock arteries used to carry out standard durability testing on the aforementioned medical products suggests that some of the problems might be related to a frequency dependent change in the properties of these recipient vessels. This could lead to…
The Durability of Silicone versus Latex Mock Arteries
by | RMBS 2001 | Publications, Compliance, Silicone Mock Arteries
Biomedical Science Instrumentation, 37, pp. 305-312, (2001)
CONTI, JC, Strope, ER, Goldenberg, LM, Price, KS
RMBS 2001
Keywords: mock, arteries, stents, in-vitro, durability, accelerated, fatigue, compliance, silicone, latex.
Introduction
During the last century or so the ability of the human race to heal its own medical problems has experienced a growth rate that staggers the imagination. Not only have the technologies and techniques…
Current Trends in the Durability Testing of Medical Products
by | SFB Workshop 1999 | Publications, Stent Testing
James C. Conti, Elaine R. Strope
SFB Workshop 1999
The general theory and approach to high speed testing will be reviewed. This year’s workshop will focus primarily on those testing techniques that have been developed or upgraded during the last twelve months. In particular, the latest approaches to the testing of stents, stent/grafts, septal defect closure devices, bifurcated grafts, left ventricular assist devices, adhesive bonds, and packaging will be reviewed. This workshop will give attendees a broad understanding of the issues that must be considered when designing and carrying out high speed dynamic testing …
Current Trends in the Durability Testing of Medical Products
by | SFB Workshop 1998 | Publications, Compliance
WORKSHOP
J.C. Conti, E.R. Strope
SFB Workshop 1998
Last year’s workshop covered the history and more recent approaches used to evaluate the durability of a variety of medical products in vitro. The general theory and approach to high speed testing was reviewed. This year’s workshop will focus primarily on those testing techniques that have been developed or upgraded during the last twelve months. In particular, the latest approaches to the testing of stents, stent/grafts, septal defect closure devices, bifurcated grafts, left ventricular assist devices, adhesive bonds,…
Mock Arterial Compliance: Influence of Hydration, Temperature, Mandril Location, Age and Lot
by | SFB 1998 | Publications, Compliance
J.C. Conti, E.R. Strope and K. Price
SFB 1998
Introduction
The use of latex or other synthetic arterial conduits is vital to the testing programs of intravascular devices that must be flexed for various periods of time. Not only are fairly precise morphological characteristics important but the three-dimensional pressure/volume or compliance characteristics are extremely important when using these mock vessels to evaluate intravascular stents, intra-aortic balloons, stent grafts, etc.
Accelerated Mechanical Testing
by Dynatek Labs | SFB Workshop 1997 | Publications, Compliance
SFB Workshop 1997
Slides
Cardiovascular Considerations
by | FDA 1997| Publications, Compliance
Presentation to the FDA 1997
Slides
State-of-the-Art Stent Testing: A Review of Protocols, Concerns, and Considerations for the End User
by | Society for Cardiac Angiography and Interventions 1997 | Publications, Compliance
J.C. Conti, E.R. Strope, L.D. Spence
Dynatek Dalta Scientific Instruments, PO Box 254, Galena, MO 65656
Society for Cardiac Angiography and Interventions 1997 (Not Accepted)
Currently there are at least eighteen different stent designs used clinically worldwide. In addition, it is projected that there are as many as three dozen more under evaluation in non-clinical laboratory settings throughout the world. Although the primary concern for the cardiologist is long-term clinical efficacy, the plethora of stents presents a design …
Evaluation of the Dynamic Mechanical Properties and Fatigue Resistance of Vascular Grafts Dynamic
by | FIICMSSM-Washington, DC 1997 | Publications, Compliance
FIICMSSM-Washington, DC 1997
The first step in any In Vitro testing program must include a careful analysis of the mechanical and chemical environments that the device being tested will experience once implanted. Once this is done, the next step in the process is to determine the three dimensional properties of the experimental vascular grafts at biologically relevant pressures. These properties should be determined at In Vivo frequencies (ca. 70bpm) and then again at higher frequencies. The evaluation of mechanical property vs. frequency is critically important to allow an investigator …
Frequency Dependent Radial Compliance of Latex Tubing
by | RMBS 1997| Publications, Compliance
Biomedical Science Instrumentation, 33, pp. 524-529, (1997)
J.C. CONTI, E.R. Strope, D.J. Rohde, L.D. Spence
RMBS 1997
Keywords: Compliance, latex, tubing, mechanical, grafts, stent, artery, frequency, radial, testing
Abstract
Custom latex tubing is often used in medical device evaluation. Examples include thin-walled devices used to reduce leakage of porous vascular grafts, and thicker-walled prototypes used as mechanically equivalent synthetic arteries. Medical devices such as stents and balloons are introduced…
Relating the Frequency Dependent Radial Compliance to the Tensile Modulus of Polyurethane Vascular Grafts
by | SFB 1996 | Publications, Compliance
5th World Biomaterials Congress, Transactions Volume 2, 434, (1996)
Bozzi, R, Conti JC, Rohde D, Soldani G, Spence L, Strope E, and Withrow D
SFB 1996
Introduction
Since first introduced as a biomaterial in 1967, (1) polyurethanes have been utilized as candidate materials for vascular grafts. They show a high degree of toughness combined with a tendency to be blood compatible. It has been suggested that compliance matching of vascular grafts to …
Measuring the Dynamic Compliance of Vascular Grafts
by | FDA 1990 | Publications, Compliance
FDA 1990
Slides
The Effective Measurement of Dynamic Internal Compliance of Vascular Grafts
by | AAMI 1990 | Publications, Compliance
25th Annual Meeting of the Association for the Advancement of Medical Instrumentation, Proceedings, 22, (1990)
J. C. Conti, Ph.D., E. R. Strope, Ph.D., D. J. Rohde
AAMI 1990
Introduction
The clinical importance of matching the compliance of a vascular graft to the host vessel has been a point of contention for many years (ref.). One possible explanation for this unsettled controversy could be that the compliance determinations used to evaluate compliance/patency correlations …
A New Technique to Determine Vascular Compliance In Vivo
by | NHLBI 1989 | Publications, Compliance
James C. Conti, Ph.D., Elaine R. Strope, Ph.D., Donald Rohde, Howard P. Greisler, MD
Presented By: James C. Conti, Ph.D.
NHLBI 1989
There currently is a need for a simple, accurate and reproducible technique to determine the in vivo compliance of arteries and veins.1 The injected volume technique monitors the pressure-volume relationship of an artery, vein or vascular graft and thereby allows an investigator to evaluate the three-dimensional physical properties of these objects.
Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327
