WO2004054472A2 - Method and apparatus for testing pulsatile endurance of a vascular implant - Google Patents
Method and apparatus for testing pulsatile endurance of a vascular implant Download PDFInfo
- Publication number
- WO2004054472A2 WO2004054472A2 PCT/GB2003/005467 GB0305467W WO2004054472A2 WO 2004054472 A2 WO2004054472 A2 WO 2004054472A2 GB 0305467 W GB0305467 W GB 0305467W WO 2004054472 A2 WO2004054472 A2 WO 2004054472A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- implant
- insert
- cavity
- pressure
- repeatedly
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2472—Devices for testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/912—Method or apparatus for measuring or testing prosthetic
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/912—Method or apparatus for measuring or testing prosthetic
- Y10S623/913—Heart
Definitions
- the present invention relates to a method and apparatus for testing pulsatile endurance of a vascular implant.
- Prosthetic vascular implants such as heart-valves, stents, grafts and stent-grafts used for human implantation are subjected to the continuous fluctuating stress of blood pressure. It is therefore necessary to test such implants to prove their durability over a lifetime of exposure to pulsatile blood pressure.
- a number of prior art documents disclose destructive methods of testing non-resilient vessels (such as glass bottles) by inserting a resilient insert such as a bladder into the vessel and subjecting the bladder to extremely high expansive pressure to see if the vessel breaks (see for example US 3,895,514; GB 2,177,220; GB 1,531,557; and GB 2,149,126). None of these methods would be suitable for the pulsatile testing of a vascular implant.
- the fatigue process relies upon a first raised liquid pressure inside the tube expanding the tube and a second, lowered, liquid pressure allowing the tube to contract.
- a first raised liquid pressure inside the tube expanding the tube and a second, lowered, liquid pressure allowing the tube to contract.
- the radial resilience of the implant causes it to expand with the tube.
- the tube contracts it squeezes the implant back to its original size.
- the implant presents a significant surface area across the lumen of the vessel, such as a tapered stent or stent graft
- the force per unit area along the axis of the implant is increased in proportion with the inflation pressure of the tube.
- This elevated pressure induces failure modes such as limb separation or migration which would not occur at physiological pressures.
- Stent grafts frequently are designed for use in bifurcated vessels and require bifurcated test tubes for their testing. Stent-grafts are also intended for use in aneurysms.
- a further issue in endurance testing arises from the need to complete life-time tests in a commercially appropriate period of time.
- vascular implants are tested for 400,000,000 cycles which represent approximately 10 years of implantation life at a heart rate of 80 beats per minute.
- Many companies test large implants at approximately 35 Hz, allowing testing to be completed in approximately 19 weeks.
- the testing method described above has a frequency limit which arises from the radial resilience and the surface area of the implant. This arises from the following mechanism:
- the radial resilience of the implant causes the wall of the implant to follow the wall of the tube.
- this resilience may not be sufficient to overcome the frictional drag of the fluid through which the implant wall must move and the implant wall is likely therefore to move more slowly than the wall of the tube.
- the vascular implant can lag behind the movement of the wall of the tube.
- the strain induced in the implant reduces as the frequency increases and the change in diameter of the implant no longer matches the change in diameter of the tube.
- a method for testing pulsatile endurance of a vascular implant comprising providing a resilient insert, inserting the insert into the vascular implant, and repeatedly expanding and contracting the insert, thereby expanding and contracting the implant.
- the insert may be such as to be expanded and contracted mechanically (for example it may comprise an expandable stent), it preferably has a cavity therein and is repeatedly expanded and contracted by repeatedly increasing and decreasing the pressure in the cavity.
- the preferred frequency of expansion/contraction is at least 25Hz, more preferably from 25 to 100Hz, most preferably from 50 to 100Hz.
- the improved technique preferably employs a tube which is deployed inside the vascular implant, the tube being made of a resilient material such as latex rubber, silicone rubber, poly-urethane or similar.
- the tube is made with very thin walls so that inflation pressures within the tube are transferred directly to the inner surface of the implant under test.
- contraceptive condoms provide an ideal tube for testing larger implants.
- Such an arrangement has the advantage that should the tube break during the test, a replacement tube can be threaded into the implant without risk of damage to the implant. In this way, failure of a tube will never automatically require the test implant to be rejected nor lose the testing time up to the moment of failure.
- a second benefit of such an arrangement is that physiological pressures can be used within the tube because there is very little attenuation of the pressure by the very thin walls.
- a third benefit of such a system is that the mechanical properties of the vessel surrounding the implant under test can be varied at different points and the vessel can even be made of separate components because there is no longer a requirement that the outer tube be fluid- tight. This allows the compliance of different regions to be optimised without the requirement that the entire 'vessel' is made from the same material.
- a fourth benefit of the such a system is that the internal tube is very soft and this permits the test implant to be bent or angled severely, purely by means of restraints, rather than requiring a custom made, angled tube.
- a fifth benefit of the system allows the test frequency to be increased because the implant is driven internally to expand rather than relying upon its radial resilience.
- the above described system provides a positively driven method of expanding an implant and additional resilience from the outer tube to compress an implant. The movement of the wall of the implant is then much less dependent upon the characteristics of the implant alone and testing can be carried out at frequencies of 50 Hz to 100 Hz. At this speed, testing to 400 million cycles can be completed in 7 weeks.
- the diameters of implant that can be accommodated by such a machine lie in the range 2mm to 50mm, although if having sufficiently thin walls, the inner test tube can be significantly under- or over-sized.
- the wall thickness of the inner tube preferably lies in the range from 0.03 mm to 0.2 mm, although with loss in performance, some benefits of the inner tube can still be gained if the wall thickness is several millimetres.
- a preferred method of obtaining high frequency expansion and contraction of the insert is to employ a modulator such as a rotating valve or oscillating piston to modulate a continuous supply of air into a series of pulses of the required frequency.
- a modulator such as a rotating valve or oscillating piston to modulate a continuous supply of air into a series of pulses of the required frequency.
- Figure 1 illustrates an arrangement of apparatus set up to test bifurcated implants in accordance with the invention.
- the apparatus of Figure 1 comprises:
- a supporting gantry (1) A supporting gantry (1).
- Short outer tube to reduce compliance at the neck of the implant (5).
- This arrangement employs ultra-thin walled condoms as inner tubes (4) used as a pair to fill the single main body of the implant (3) and its twin legs.
- bungs (6) and (7) are used to limit the extent to which each tube can expand length-wise.
- this limit is arranged to lie within a portion of outer tube which runs continuously to the vascular implant. In this way, there is no path for the inner tube to expand or herniate beyond the vascular sample or outside the outer tube. This limits the ultimate strain put on the inner tube and prevents it from bursting unless very high pressures are employed.
- a further improvement employed in this arrangement is the use of compressed air as the pressurising medium for the inner tubes.
- a rotating valve or oscillating piston can be used and the design of such a valve or piston is greatly simplified by only being required to modulate the pressure of air.
- Other workers using saline filled systems generally require the pressure modulator to operate directly on salt water which involves the problems of corrosion and leakage.
- the rotating valve (known as a "pulser”) consists of a cylindrical housing into which is fitted a rotating cylinder.
- the cylinder has two holes through it, perpendicular to its main axis of rotation. These are perpendicular and axially displaced with respect to each other along the axis of rotation.
- the housing has two parallel holes through it, which are axially aligned with the holes in the cylinder.
- the transverse holes become alternately aligned and misaligned with those in housing.
- pressure When aligned with the inlet tube, pressure is transmitted to the condom.
- the pressure pulse may be adjusted by changing the initial air pressure, the size of the exhaust port and the speed of rotation of the cylinder.
- a further benefit of employing air to pressurise the system is that the mass of oscillating fluid is significantly reduced compared to using saline solution. This in turn reduces the power required of the modulating system.
- the vascular implant is maintained at physiological temperatures and in saline.
- the implant can be kept in saline by placing the entire system in a bath of salt water at an appropriate temperature.
- the change in volume per pressure pulse can be large and this places significant demands on the modulator.
- Compressed air systems are more demanding than liquid-filled systems in this respect because of the compressibility of the gas.
- the inner tubes can be part-filled with water and small bore tubes can be used.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/538,865 US7254988B2 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant |
JP2004559901A JP4533753B2 (en) | 2002-12-16 | 2003-12-16 | Pulsation durability test method and apparatus for tube graft |
AT03786117T ATE536149T1 (en) | 2002-12-16 | 2003-12-16 | METHOD AND APPARATUS FOR TESTING THE PULSATING DURABILITY OF A VASCULAR IMPLANT |
EP03786117A EP1572031B1 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant |
ES03786117T ES2378818T3 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing the pulsatile resistance of a vascular implant |
AU2003295116A AU2003295116B2 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant |
CA002509820A CA2509820A1 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant |
BRPI0317309-7A BR0317309B1 (en) | 2002-12-16 | 2003-12-16 | METHOD AND APPARATUS FOR TESTING THE PULSABLE RESISTANCE OF A VASCULAR IMPLANT |
MXPA05006404A MXPA05006404A (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0229274.6 | 2002-12-16 | ||
GBGB0229274.6A GB0229274D0 (en) | 2002-12-16 | 2002-12-16 | Instrument for testing pulsatile endurance of vascular implants |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004054472A2 true WO2004054472A2 (en) | 2004-07-01 |
WO2004054472A3 WO2004054472A3 (en) | 2004-09-16 |
Family
ID=9949763
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2003/005467 WO2004054472A2 (en) | 2002-12-16 | 2003-12-16 | Method and apparatus for testing pulsatile endurance of a vascular implant |
Country Status (11)
Country | Link |
---|---|
US (1) | US7254988B2 (en) |
EP (1) | EP1572031B1 (en) |
JP (1) | JP4533753B2 (en) |
AT (1) | ATE536149T1 (en) |
AU (1) | AU2003295116B2 (en) |
BR (1) | BR0317309B1 (en) |
CA (1) | CA2509820A1 (en) |
ES (1) | ES2378818T3 (en) |
GB (1) | GB0229274D0 (en) |
MX (1) | MXPA05006404A (en) |
WO (1) | WO2004054472A2 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005054331B4 (en) * | 2005-11-11 | 2009-09-03 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Material sample for a fatigue test |
CN102279098A (en) * | 2011-03-16 | 2011-12-14 | 东南大学 | Extracorporeal testing device and testing method for fatigue properties of self-dilating cavity bracket |
CN110617955A (en) * | 2019-10-18 | 2019-12-27 | 江苏理工学院 | External testing device for fatigue performance of blood vessel support |
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US20050131520A1 (en) * | 2003-04-28 | 2005-06-16 | Zilla Peter P. | Compliant blood vessel graft |
US7621192B2 (en) * | 2005-07-29 | 2009-11-24 | Dynatek Laboratories, Inc. | Medical device durability test apparatus having an integrated particle counter and method of use |
US7363821B2 (en) * | 2006-08-28 | 2008-04-29 | Cordis Corporation | Systems and methods for fatigue testing stents |
WO2009031329A1 (en) * | 2007-09-07 | 2009-03-12 | Waseda University | Endurance test apparatus for medical instrument and endurance test method |
WO2010102185A2 (en) | 2009-03-06 | 2010-09-10 | Biomedical Device Consultants and Laboratories of Colorado, LLC | Fatigue testing system for prosthetic devices |
US8490504B2 (en) * | 2009-12-22 | 2013-07-23 | Biomedical Device Consultants and Laboratories of Colorado, LLC | Fatigue evaluation of prostheses by radial excitation of tubular structures |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US9417110B2 (en) | 2010-10-12 | 2016-08-16 | Endospan Ltd. | Accelerated bench-testing of medical devices |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US20150185129A1 (en) * | 2011-05-12 | 2015-07-02 | Karmi Nicole Robison | Methods and devices for testing the stability of intraluminal implants |
US8978448B2 (en) * | 2011-10-11 | 2015-03-17 | Trivascular, Inc. | In vitro testing of endovascular device |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US9453788B2 (en) | 2013-02-07 | 2016-09-27 | Dynatek Labs, Inc. | Acute medical particulate testing device |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
US20140327460A1 (en) * | 2013-05-03 | 2014-11-06 | Second Sight Medical Products, Inc. | Test Apparatus and Method for Determining Long Term Reliability of an Implantable Device |
CA3007670A1 (en) | 2016-01-29 | 2017-08-03 | Neovasc Tiara Inc. | Prosthetic valve for avoiding obstruction of outflow |
US10627315B2 (en) | 2016-02-04 | 2020-04-21 | Dynatek Labs, Inc. | Fatigue to fracture medical device testing method and system |
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WO2019036810A1 (en) | 2017-08-25 | 2019-02-28 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US11087453B2 (en) | 2018-06-11 | 2021-08-10 | Dynatek Labs, Inc. | Automated failure detection for medical device testing systems and methods |
AU2019374743B2 (en) | 2018-11-08 | 2022-03-03 | Neovasc Tiara Inc. | Ventricular deployment of a transcatheter mitral valve prosthesis |
US10898329B2 (en) * | 2019-01-25 | 2021-01-26 | Edwards Lifesciences Corporation | Testing apparatus for prosthetic device |
EP3946163A4 (en) | 2019-04-01 | 2022-12-21 | Neovasc Tiara Inc. | Controllably deployable prosthetic valve |
EP3952792A4 (en) | 2019-04-10 | 2023-01-04 | Neovasc Tiara Inc. | Prosthetic valve with natural blood flow |
CA3140925A1 (en) | 2019-05-20 | 2020-11-26 | Neovasc Tiara Inc. | Introducer with hemostasis mechanism |
AU2020295566B2 (en) | 2019-06-20 | 2023-07-20 | Neovasc Tiara Inc. | Low profile prosthetic mitral valve |
CN110411843B (en) * | 2019-08-02 | 2022-07-15 | 合肥通用机械研究院有限公司 | Pressure container or pipeline air pressure test system and test method |
CN110617954B (en) * | 2019-10-18 | 2021-04-13 | 江苏理工学院 | External bending test device for fatigue performance of intravascular stent |
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US3895514A (en) | 1974-08-15 | 1975-07-22 | John D Northup | Bottle testing apparatus |
GB1531557A (en) | 1977-06-24 | 1978-11-08 | Chloride Silent Power Ltd | Proof-testing of the strength of tubes of sintered ceramic material |
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GB2177220A (en) | 1985-07-10 | 1987-01-14 | Brotherton Engineering Limited | Method and apparatus for pressure testing components |
DE19903476A1 (en) | 1999-01-29 | 2000-08-03 | Inst Implantattechnologie Und | Test set for blood vessel implants uses fluid filled cavity to apply dynamic test pressure for life test |
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-
2002
- 2002-12-16 GB GBGB0229274.6A patent/GB0229274D0/en not_active Ceased
-
2003
- 2003-12-16 WO PCT/GB2003/005467 patent/WO2004054472A2/en active Application Filing
- 2003-12-16 JP JP2004559901A patent/JP4533753B2/en not_active Expired - Fee Related
- 2003-12-16 CA CA002509820A patent/CA2509820A1/en not_active Abandoned
- 2003-12-16 EP EP03786117A patent/EP1572031B1/en not_active Expired - Lifetime
- 2003-12-16 ES ES03786117T patent/ES2378818T3/en not_active Expired - Lifetime
- 2003-12-16 AT AT03786117T patent/ATE536149T1/en active
- 2003-12-16 BR BRPI0317309-7A patent/BR0317309B1/en not_active IP Right Cessation
- 2003-12-16 MX MXPA05006404A patent/MXPA05006404A/en active IP Right Grant
- 2003-12-16 AU AU2003295116A patent/AU2003295116B2/en not_active Ceased
- 2003-12-16 US US10/538,865 patent/US7254988B2/en not_active Expired - Fee Related
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US3895514A (en) | 1974-08-15 | 1975-07-22 | John D Northup | Bottle testing apparatus |
GB1531557A (en) | 1977-06-24 | 1978-11-08 | Chloride Silent Power Ltd | Proof-testing of the strength of tubes of sintered ceramic material |
GB2149126A (en) | 1983-10-27 | 1985-06-05 | Brotherton & Thomas | Pressure testing components |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005054331B4 (en) * | 2005-11-11 | 2009-09-03 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Material sample for a fatigue test |
CN102279098A (en) * | 2011-03-16 | 2011-12-14 | 东南大学 | Extracorporeal testing device and testing method for fatigue properties of self-dilating cavity bracket |
CN110617955A (en) * | 2019-10-18 | 2019-12-27 | 江苏理工学院 | External testing device for fatigue performance of blood vessel support |
Also Published As
Publication number | Publication date |
---|---|
ES2378818T3 (en) | 2012-04-18 |
CA2509820A1 (en) | 2004-07-01 |
EP1572031A2 (en) | 2005-09-14 |
WO2004054472A3 (en) | 2004-09-16 |
US20060230814A1 (en) | 2006-10-19 |
AU2003295116A1 (en) | 2004-07-09 |
ATE536149T1 (en) | 2011-12-15 |
EP1572031B1 (en) | 2011-12-07 |
JP4533753B2 (en) | 2010-09-01 |
AU2003295116B2 (en) | 2009-04-30 |
GB0229274D0 (en) | 2003-01-22 |
US7254988B2 (en) | 2007-08-14 |
BR0317309A (en) | 2005-11-08 |
BR0317309B1 (en) | 2014-06-24 |
JP2006509569A (en) | 2006-03-23 |
MXPA05006404A (en) | 2005-09-08 |
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