Publications – Compliance

Medical Device Testing

Comparison of Radial Expansion of Stents

by Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 …

custom stent testing

Radial Compliance of Natural and Mock Arteries: How This Property Defines the Cyclic Loading of Deployed Vascular Stents

by Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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.

 

Stent Testing

Accelerated Mechanical Testing

by Dynatek Labs | SFB Workshop 1997  | Publications, Compliance

SFB Workshop 1997

Slides

SEM Analysis of Particles

Cardiovascular Considerations

by Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 Dynatek Labs | 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 …

 

SVP Stent Tester

Measuring the Dynamic Compliance of Vascular Grafts

by Dynatek Labs | FDA 1990 | Publications, Compliance

FDA 1990

Slides

The Effective Measurement of Dynamic Internal Compliance of Vascular Grafts

by Dynatek Labs | 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 Dynatek Labs | 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

Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
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