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WO2007130987A2 - Valvule cardiaque artificielle utilisee a des fins de formation et de test - Google Patents

Valvule cardiaque artificielle utilisee a des fins de formation et de test Download PDF

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Publication number
WO2007130987A2
WO2007130987A2 PCT/US2007/067946 US2007067946W WO2007130987A2 WO 2007130987 A2 WO2007130987 A2 WO 2007130987A2 US 2007067946 W US2007067946 W US 2007067946W WO 2007130987 A2 WO2007130987 A2 WO 2007130987A2
Authority
WO
WIPO (PCT)
Prior art keywords
simulated
heart valve
root
tubular body
annular ledge
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/067946
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English (en)
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WO2007130987A3 (fr
Inventor
Lafrance Hugues
Robert Stobie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/414,953 external-priority patent/US20070269784A1/en
Priority claimed from US11/414,954 external-priority patent/US8021161B2/en
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Priority to CA002649487A priority Critical patent/CA2649487A1/fr
Publication of WO2007130987A2 publication Critical patent/WO2007130987A2/fr
Publication of WO2007130987A3 publication Critical patent/WO2007130987A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/32—Anatomical models with moving parts

Definitions

  • the present invention relates to fixtures and methods for testing the performance of prosthetic heart valves and, in particular, a simulated diseased heart valve root in a heart training model for a more realistic test.
  • Heart valve replacement may be indicated when there is a narrowing of the native heart valve, commonly referred to as stenosis, or when the native valve leaks or regurgitates, such as when the leaflets are calcified.
  • the native valve may be excised and replaced with either a biologic or a mechanical valve.
  • Prosthetic valves attach to the patient's fibrous heart valve annulus, with or without the leaflets being present.
  • Conventional heart valve surgery is an open-heart procedure that is highly invasive, resulting in significant risks that include bleeding, infection, stroke, heart attack, arrhythmia, renal failure, adverse reactions to the anesthesia medications, as well as sudden death. Fully 2-5% of patients die during surgery.
  • PVT's device is designed for percutaneous delivery in a cardiac catheterization laboratory under local anesthesia using fluoroscopic guidance, thereby avoiding general anesthesia and open-heart surgery.
  • Other percutaneously- or surgically-delivered expandable valves are also being tested.
  • the entire field will be denoted herein as the delivery and implantation of expandable valves.
  • Expandable heart valves use either balloon-or self-expanding stents as anchors.
  • animal models i.e., ovine and porcine
  • MIS minimally invasive surgical
  • percutaneous aortic valves the animals used are typically healthy specimens whose heart valves are unlike the calcified or otherwise distorted annuluses of the typical prosthetic valve recipient.
  • Implantation training is often done using animal models as well.
  • the present invention provides a simulated heart valve root that more faithfully re-creates the anatomy of a diseased patient.
  • the aortic root may be used for training purposes, or alternatively in a flow tester to examine the implanted valve in use for paravalvular leaks.
  • the simulated heart valve root may be incorporated into a simulated heart for more realistic training purposes.
  • the present invention provides a simulated human heart valve root, comprising a flexible, generally tubular body having an inner wall defining an annular ledge having a feature simulating an abnormal pathology incorporated therein.
  • the feature simulating an abnormal pathology may be simulated calcification.
  • the simulated calcification is provided by at least one discrete node made of a material that is harder than the tubular body.
  • the discrete node may be formed by the head of a pin passed through the tubular body.
  • the heart valve root is an aortic root such that the annular ledge has alternating cusps and commissures, and wherein the simulated calcification is provided by a plurality of discrete nodes distributed around the annular ledge, at least one of which is located at one of the commissures.
  • the simulated calcification is provided by areas of hardness around the annular ledge.
  • the tubular body has a Shore A hardness of between about 5 A and 4OA and the simulated calcification is made of a material that is harder than the tubular body.
  • the feature simulating an abnormal pathology may also comprise a tear in the annular ledge.
  • the present invention also provides a simulated human heart valve root system, comprising a flexible, generally tubular body having an inner wall defining an annular ledge, and a reinforcing sleeve surrounding the tubular body that has greater hoop strength than the tubular body.
  • the reinforcing sleeve is desirably made of the material is harder than the material of the tubular body.
  • the reinforcing sleeve is molded around the tubular body so as to be in intimate contact with the entire exterior wall of the tubular body.
  • the reinforcing sleeve comprises an outer sleeve made of a rigid material and an intermediate sleeve formed of a hardenable material poured into an annular space between the outer sleeve and the tubular body.
  • Another aspect of the invention is a method of testing a prosthetic heart valve, including the steps of providing a simulated heart valve root, securing a prosthetic heart valve to be tested within the heart valve root, and applying pulsatile flow to the prosthetic heart valve within the heart valve root.
  • the simulated heart valve root includes a tubular body formed of a flexible material and defining an annular ledge including a feature simulating an abnormal pathology incorporated into the annular ledge. Such a feature may comprise simulated calcification or a tear in the annular ledge.
  • the method may further include monitoring for leaks around the periphery of the prosthetic heart valve within the heart valve root.
  • the present invention also provides a system for training a physician to implant a prosthetic heart valve, including a simulated heart defined by an entire simulated heart or portion thereof.
  • a simulated heart valve root mounts in the simulated heart and is open to an access port for introducing a prosthetic heart valve.
  • the simulated heart valve root includes a tubular body formed of a flexible material and defining an annular ledge.
  • the annular ledge of the simulated heart valve root may further include a feature simulating an abnormal pathology, such a simulated calcification or a simulated tear in the annular ledge.
  • the feature simulating an abnormal pathology is radiopaque and the flexible material is not.
  • a means for vibrating the simulated heart is provided for more realism.
  • a simulated radiopaque rib cage or spinal column may be provided around the simulated heart.
  • a method of training a physician to implant a prosthetic heart valve utilizes a simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge.
  • the heart valve root is mounted in a fixture having an access port, and physicians are instructed in delivering and implanting a prosthetic heart valve within the heart valve root.
  • the fixture may be subject to vibratory motion, or fluid may be directed through the heart valve root.
  • the method desirably includes blocking direct visual access to the heart valve root and providing a system for indirectly visualizing the step of delivering and implanting the prosthetic heart valve.
  • the annular ledge of the simulated heart valve root may include a radiopaque feature simulating an abnormal pathology, wherein the system for indirectly visualizing can distinguish between radiopaque and non-radiopaque materials.
  • the fixture comprises a simulated heart including an entire simulated heart or portion thereof.
  • at least one additional radiopaque anatomical feature may be provided around the simulated heart, such as the rib cage or spinal column.
  • Another method of the present invention for training a physician to implant a prosthetic heart valve includes providing a simulated heart valve root including a tubular body formed of a flexible material and defining an annular ledge.
  • the heart valve root mounts in a simulated heart including an entire simulated heart or portion thereof which blocks direct visual access to the heart valve root.
  • a system for indirectly visualizing the heart valve root is provided.
  • the heart valve root includes a feature simulating an abnormal pathology, and the system for indirectly visualizing can distinguish between the feature in the flexible material.
  • Fig. 1 is an exploded perspective view of two components of an exemplary simulated aortic root system of the present invention
  • Fig. 2 is a perspective view of the exemplary simulated aortic root system of Fig.
  • Fig. 3 is an assembled perspective view of the simulated aortic root system
  • Fig. 4 is a top plan view of the exemplary simulated aortic root system
  • Fig. 5 is a partially sectioned elevational view of the simulated aortic root system
  • Fig. 6 is a layout view of a simulated aortic root used in the system of Fig. 1;
  • Figs. 7-9 are radial sectional views through the simulated aortic root taken, respectively, along lines 7-7, 8-8, and 9-9 of Fig. 6;
  • Fig. 10 is a sectional view of a simulated aortic root positioned within a training model of the heart, and showing a simulated chest cavity in phantom.
  • the present invention provides a simulated aortic root that is constructed to more realistically mimic the diseased annulus of the typical patient.
  • the simulated aortic root of the present invention provides calcification and other anatomical abnormalities that more faithfully re-creates the diseased aortic root.
  • These simulated features are critical in teaching positioning and deploying both MIS and percutaneous aortic valves.
  • the more realistic aortic root provides an invaluable tool for in vitro testing to assess the paravalvular and migration performance of MIS and percutaneous prosthetic valves.
  • aortic root refers to at least the tubular section of the aorta (the large artery leaving the heart) that is attached to the heart.
  • the natural aortic root includes the annulus (tough, fibrous ring) and leaflets of the aortic valve, and the openings where the coronary arteries attach (coronary ostia).
  • the simulated aortic root of the present invention includes a tubular body having an inner wall that defines the annulus.
  • simulated heart valve root can be understood to refer to that section of any of the human heart valves equivalent to the aortic root just defined.
  • the simulated heart valve roots of the present invention include flexible, tubular bodies.
  • flexible means having tactile properties similar to the native heart valve root.
  • the physical characteristics of the tissue of the native heart valve root may differ in the population, but in general it can be said to be "soft,” in that it easily yields to pressure, but has structural integrity (as opposed to clay, for example) so that it maintains its general anatomical shape.
  • an exemplary material for the tubular body is silicone rubber, such as a SilastomerTM from Hernon Manufacturing, Inc. of Sanford, FLORIDA.
  • hard or “hardness” refers to the property of a material that does not yield to pressure as easily as the material of the simulated heart valve root. There are varying degrees of hardness, of course, and the present invention is not to be construed as limited to a particular level.
  • the simulated heart valve root includes "areas of hardness” incorporated into the annular ledge which is broadly construed to mean that there are areas that withstand pressure longer, or conversely, yield to pressure later, than the material of the flexible, tubular body.
  • AFM Atomic Force Microscope
  • the researcher determined that calcified deposits were many orders of magnitude stiffer than the surrounding healthy artery wall.
  • most techniques are designed to detect calcification, not necessarily measure its hardness, and an accurate quantification of the widely varying hardness properties of calcification is quite difficult. Therefore, the exemplary magnitudes of hardness provided below for the simulated heart valve roots are to be considered guides only.
  • the areas of hardness are provided by a series of discrete nodes of hardness, in particular using the heads of a number of pins passed through the flexible, tubular bodies. This construction is relatively straightforward, but it should be understood that other ways to provide areas of hardness are available.
  • the areas of hardness are primarily intended to simulate calcification in the simulated heart valve root, especially around the annulus. Calcification is typically more diffuse than the discrete nodes illustrated, and another way to simulate it is to co-mold areas of hardness using a different material than that of the tubular body. Another possible construction is to separately mold the annular ledge of a harder material than the flexible, tubular body and fasten it using adhesive or other such means to the inner wall of the body. Therefore, the term "areas of hardness" refers to discrete nodes or more continuous regions of harder material than the tubular body, however formed.
  • Figs. 1-3 illustrate steps in the formation and a finished simulated aortic root system 20 of the present invention.
  • two components of the system 20 include a simulated aortic root 22 and an outer sleeve 24.
  • a filler material 26 shown during assembly in Fig. 2 creates an intermediate sleeve 28 (shown after assembly in Fig. 3) between the exterior wall of the aortic root 22 and the interior wall of the outer sleeve 24.
  • the exemplary system 20 therefore basically consists of the concentrically arranged aortic root 22, intermediate sleeve 28, and outer sleeve 24.
  • the aortic root 22 is desirably molded from a material that is, when cured or hardened, flexible and soft to simulate native aortic wall tissue.
  • the aortic root 22 comprises a generally tubular body 30 and a flat, circular base flange 32 extending outward from a lower end thereof.
  • the tubular body 30 is nominally oriented about an axis 34 and defines an inner wall 36.
  • the inner wall 36 includes certain simulated anatomical features that will be described in more detail below with respect to Figs. 5-8.
  • the positioning and purpose of a plurality of pins 38 extending through the tubular body 30 will be described below.
  • the tubular outer sleeve is positioned concentrically about the axis 34 and around the tubular body 30.
  • An applicator 40 then fills the annular space between the outer sleeve 24 and tubular body 30 with a curable material 26, as depicted in Fig. 2.
  • the intermediate sleeve 28 is made of a material that is harder than the material of the tubular body 30.
  • the intermediate sleeve 28 is made of a polyvinylsiloxane, commonly used as dental print polymer.
  • the intermediate sleeve 28 and the outer sleeve 24 together combine to form a "reinforcing sleeve" around the tubular body 30.
  • the outer sleeve 24 is made of a metal or polymer that has much greater hoop strength than the tubular body 30 of the aortic root 22.
  • the hoop strength provided by the outer sleeve 24 is coupled to the tubular body 30. Therefore, when radially outward forces are exerted on the inner wall 36 of the tubular body 30, the intermediate sleeve 28 supported by the outer sleeve 24 indirectly imparts the additional hoop strength to the tubular body.
  • the outer sleeve 24 may directly surround and contact the tubular body 30, without using an intermediate sleeve 28. However, by virtue of its initial liquid state, the intermediate sleeve 28 closely conforms around the exterior wall of the tubular body 30 and therefore provides more uniform reinforcing support. Conversely, the outer sleeve 24 may be removed after formation of the intermediate sleeve 28, with the material properties of the intermediate sleeve supplying the desired hoop strength.
  • any particular construction is to provide a reinforcing sleeve surrounding the tubular body that adds overall hoop strength thereto, and may also add localized rigidity to some or all regions around the tubular body.
  • the benefits of this construction will be explained in more detail below with regard to methods of use of the system.
  • Fig. 4 shows the aortic root system 20 from above, and illustrates the approximately equidistant circumferential placement of the pins 38.
  • Fig. 6 shows the inner wall 36 of the tubular body 30 in plan view as if unrolled from the line 6-6 in Fig. 4.
  • the exemplary contours of the inner wall 36 of a simulated aortic root are evident in Fig. 6.
  • the inner wall 36 simulates features of the aortic root including three arcuate cusps 50 separated by three upstanding commissures 52 (one of the commissures 52 is split and located at the far left and right edges).
  • Rounded pockets or sinuses 54 bow outward above each of the cusps 50.
  • Two openings or simulated coronary ostia 56 extend through the tubular body 30 at the approximate midpoint of two of the three sinuses 54.
  • annular ledge 60 extends radially inward from the tubular body 30, following the undulating cusps 50 and commissures 52.
  • the annular ledge 60 defines somewhat of a wave shape with the cusps 50 defining the troughs and the commissures 50 the peaks.
  • the annular ledge 60 comprises tougher, more fibrous tissue than the adjacent ascending aorta or ventricular tissue, and the native leaflets extend inward therefrom.
  • the regions of calcification are often concentrated about the leaflets and along the annular ledge 60.
  • the present invention provides a simulated aortic root having areas, regions or nodes of calcification.
  • the pins 38 pass through the tubular body 30 and terminate at their inner ends in pinheads simulating nodes of calcification.
  • the pins 38 may be metallic or plastic, as long as the material is harder than the material of the tubular body 30.
  • These discrete nodes may be positioned as desired in the tubular body 30, but are preferably placed along the annular ledge 60. In the illustrated embodiment, there are six pins 38 making six discrete nodes of calcification.
  • nodes 70a, 70b, 70c are positioned at approximately the midpoint of each of the cusps 50, while three nodes 72a, 72b, 72c are positioned at each of the commissures 52.
  • This distribution of the pins 38 is intended to be representative of the typical or average calcification along the annular ledge 60.
  • the discrete nature of the nodes as well as their specific construction are entirely exemplary, and other configurations are contemplated.
  • One such configuration is to provide clusters of the pins 38 more unevenly spread along the annular ledge 60.
  • a segment of elongated simulated calcification formed by a molded portion of the annular ledge 60 may be substituted for the discrete nodes.
  • simulated calcified leaflets may also be added to the tubular body 30 to mimic the pathology prior to leaflet excision, which is sometimes the situation at the time of valve implantation.
  • the tubular body 30 is formed of a material that simulates the native arterial wall.
  • the tubular body 30 may be made of a silicone rubber having a hardness of about 5 Shore A durometer.
  • the tubular body 30 may be formed of the silicone rubber having a hardness of 40A durometer.
  • the tubular body 30 is constrained within the intermediate sleeve 28 which is made of a material that is even harder than the tubular body 30.
  • the outer sleeve 24 provides an essentially rigid outer limit to deformation.
  • the tubular body 30 desirably comprises a material having a hardness of between about 5A and 40A durometer supplemented by areas of hardness having a higher level of Shore A hardness.
  • Shore Hardness using either the Shore A or Shore D scale, is the preferred method for rubbers/elastomers and is also commonly used for "softer" plastics such as polyolefins, fluoropolymers, and vinyls.
  • the Shore A scale is used for "softer” rubbers while the Shore D scale is used for "harder” ones.
  • the Shore A Hardness is the relative hardness of elastic materials such as rubber or soft plastics can be determined with an instrument called a Shore A durometer. If the indenter completely penetrates the sample, a reading of 0 is obtained, and if no penetration occurs, a reading of 100 results. The reading is dimensionless. Therefore, the areas of hardness have a Shore A value of greater than that of the material of the tubular body 30, up to 100.
  • the tubular body 30 is made of a silicone rubber having a Shore A hardness of 40
  • the areas of hardness or nodes have a Shore A hardness of between 41- 100.
  • the character of the areas of hardness or nodes need not be homogenous, and the magnitude of stiffness may vary within the areas of hardness.
  • the areas of hardness or nodes are made of a radiopaque material.
  • the simulated heart valve root may be used to test the performance of expandable valves and to train physicians in their implantation. In doing so, the simulated calcification desirably shows up on X-ray or other imaging technique as it would in real life.
  • FIG. 6 and 9 illustrate another feature of the simulated aortic root 22 that may be included to better mimic a diseased valve.
  • a small groove or tear 80 is shown passing generally perpendicularly through the annular ledge 60.
  • Such a vertical tear 80 may occur in natural diseased aortic valves after a valvuloplasty operation. That is, valvuloplasty involves expanding a balloon within the valve to increase the size of the orifice just prior to implant of a prosthetic valve. Sometimes, the annulus is calcified and somewhat brittle, and a valvuloplasty tends to break up the annular ledge at one or more points. Of course, this further increases the uneven nature of the implant site, and increases the chance for leakage around the implanted prosthetic valve.
  • testing for leaks at the region near the tear may be performed after implantation of a prosthetic valve within the simulated aortic root 22.
  • the arbitrary nature of the exemplary nodes 70, 72 and tear 80 highlights the unpredictable nature of a diseased valve which can be simulated in the aortic root 22. For example, there may be more tears than areas of calcification, or vice versa, or there may be just a single region of calcification, or a pair diametrically opposed.
  • the present invention should most broadly be understood as providing at least one feature (calcification, tear, distention) simulating an abnormal pathology incorporated into the annular ledge.
  • MIS minimally invasive surgical
  • the present invention simulates such a diseased annulus for relatively little cost. Prototypes of new expandable valves may be first tested within the simulated heart valve roots of the present invention to gauge efficacy; namely, anti-migration properties and paravalvular sealing.
  • the simulated heart valve roots of the present invention may become an integral part of validation of new prosthetic heart valves, in particular expandable valves.
  • the realistic heart valve roots can be used both to verify the efficacy of the valves and to improve their design by identifying areas of leaking or migration.
  • Fixtures for accelerated wear testing (AWT) of prosthetic heart valves have been used for many years. Most common is a pulsatile flow tester in which a prosthetic valve is secured within a tubular flow conduit through which fluid is pulsed back-and-forth to simulate the systolic-diastolic phases of the heart. Prosthetic valves may be subjected to long durations in the flow tester to test the valve integrity.
  • the more realistic simulated heart valve roots of the present invention may become a required part of validation of new heart valves during the regulatory process.
  • basic fatigue testing such as pulsatile accelerated wear testing is required, but the particular environment is not specified by the regulatory bodies.
  • the present invention may provide a high level of confidence of the efficacy of the valves by providing a much more realistic testing regimen.
  • the present invention also permits the investigator to evaluate potential blockage of the coronary ostia 56 by different prosthetic heart valves.
  • the physician may also examine the fit of the particular size of heart valve relative to the coronary ostia 56 to ensure that it will not occluded flow, which is a significant safety feature.
  • Another important aspect of the invention is the technique for constructing the particular shape of the flexible, tubular body 30.
  • a Computed Tomography (CT) scan of a human aortic root is performed, and a positive mold generated from the data.
  • the positive mold defines the inner wall of the tubular body 30, which is then formed by applying the particular material such as silicone rubber around the positive mold.
  • One useful option is to incorporate radio-opaque materials into the tubular body 30 as it is being formed to help visualize the implanted prosthetic heart valve during testing or training.
  • Another useful application for the realistic heart valve root is to incorporate it into a simulated heart unit as a teaching tool for physicians.
  • the entire unit can be covered or otherwise placed outside of the physician's view, who is then tasked with remotely implanting a prosthetic valve into the heart valve root.
  • the heart valve root may be subject to oscillations or pulsatile flow to more faithfully re-create the beating heart movement and/or flow.
  • the entire unit can be made portable so as to provide a highly cost effective and efficient way of familiarizing physicians with the implantation techniques.
  • Fig. 10 illustrates a simulated aortic root system 20 of the present invention incorporated into a larger portable training model 100.
  • the training model 100 includes a simulated heart 102 having an aortic arch 104 connected to a left ventricle 106.
  • the simulated heart 102 may include the entire heart, or may be limited to a portion thereof, such as a conduit/ventricle and valve annulus of interest.
  • the training model 100 may include other anatomical features for a more realistic training regimen; for instance, a simulated rib cage 108 as seen in phantom or a simulated spinal column (not shown).
  • these additional anatomical features are desirably made of a radiopaque material such that during training they show up on an X-ray, or another such system for indirectly visualizing the heart valve root that can distinguish between radiopaque and non-radiopaque material.
  • One possible use for the training model 100 is to teach surgeons or cardiologists how to implant expandable heart valves.
  • a delivery system is shown implanting an expandable valve 110 within the simulated aortic root system 20.
  • the delivery system includes a catheter or cannula 112 shown passing over a guide wire 114 through the apex 116 of the left ventricle 106 into the ventricular cavity, in a so- called antegrade transapical approach.
  • a catheter 118 having a balloon 120 mounted thereon carries the expandable valve 110 to enable its expansion within the aortic root.
  • a self-expanding valve may be implanted.
  • Another approach is to pass the guide wire through the aortic arch 104 and downward toward the left ventricle 106. Such a retrograde approach is typically used with a percutaneous introduction of the balloon catheter 118.
  • an access port in the training model 100 opens to the particular annulus in which the prosthetic heart valve can be implanted.
  • an access port is formed at the apex 116 of the left ventricle 106, while for a percutaneous approach the access port could simply be an open end of the aortic arch, or a more realistic passage through simulated skin.
  • the access port may include an incision 122 formed through simulated tissue and located between two ribs, such as within the fifth intercostal margin as shown. It is even conceivable that the training model 100 may be incorporated within an entire simulated human body, but the very least it is covered or otherwise hidden from the physician's direct view.
  • the physician performs the valve implantation training under as realistic conditions as possible, including viewing the entire operation via a monitor or display headset that receives an X-ray image of the process.
  • the surrounding structure such as the ribs 108 and spine (not shown) mimic the actual operation.
  • the simulated heart 102 may be mounted within a fixture that oscillates, vibrates, or rocks, and generally simulates the dynamic motion of the heart.
  • a model that incorporates pulsatile fluid flow may be used.
  • the fluid systolic and diastolic forces are added such that the physician will be able to experience as near as possible the tactile sensation of implanting the valve numerous times on a simulated beating heart.
  • Such experience is invaluable for a new technology, one for which each surgeon will likely demand a high level of comfort before replacing the known open-heart techniques.
  • AVT advanced wear testing
  • a cardiac valve analyzer e.g., Wieting
  • acrylic chambers designed from RTV silicone rubber castings of human heart passages and associated blood vessels may be utilized to provide appropriate geometries for the valve delivery and hydrodynamic considerations.
  • Saline impelled by an appropriate pump is then pulsed over the valve armulus site.
  • Various flow meters, pressure transducer, optical sensors, and such may be incorporated for testing the valve or implant success, and one or more video scopes may be strategically placed to provide "instant replay" of the implant for debriefing memepose.

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Abstract

La présente invention concerne une racine de valvule cardiaque utilisée pour former les médecins aux techniques d'implantation de prothèses de valvules cardiaques et tester l'efficacité desdites prothèses. La racine de valvule cardiaque artificielle est constituée d'un corps tubulaire souple dont une paroi intérieure définit un rebord annulaire à l'intérieur duquel est implantée la prothèse de valvule cardiaque. Des nœuds ou zones discrètes de calcification simulée peuvent être placés sur le rebord annulaire. Une racine aortique artificielle comprend une alternance de cuspides et de commissures, une calcification étant simulée au niveau de l'une des commissures au moins. Il est également possible de former une déchirure dans le rebord annulaire, dont le but est de simuler une déchirure pouvant provenir d'une procédure de valvuloplastie. Une méthode d'essai comprend notamment de monter la racine de valvule cardiaque artificielle dans un conduit d'écoulement, implanter une prothèse de valvule cardiaque dans la racine, appliquer un courant pulsé à l'ensemble et surveiller la présence de fuites.
PCT/US2007/067946 2006-05-01 2007-05-01 Valvule cardiaque artificielle utilisee a des fins de formation et de test Ceased WO2007130987A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA002649487A CA2649487A1 (fr) 2006-05-01 2007-05-01 Valvule cardiaque artificielle utilisee a des fins de formation et de test

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/414,953 US20070269784A1 (en) 2006-05-01 2006-05-01 Simulated heat and valve root for training and testing
US11/414,954 2006-05-01
US11/414,953 2006-05-01
US11/414,954 US8021161B2 (en) 2006-05-01 2006-05-01 Simulated heart valve root for training and testing

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Cited By (4)

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Publication number Priority date Publication date Assignee Title
WO2010080313A1 (fr) * 2008-12-18 2010-07-15 Ethicon, Inc. Appareil et procédé de test de fuite para-valvulaire
EP3296979A4 (fr) * 2015-05-08 2019-02-13 Japanese Organization for Medical Device Development, Inc. Kit de formation pour reconstuction de valvule aortique
FR3076048A1 (fr) * 2017-12-27 2019-06-28 3D Heart Modeling Reproduction tridimensionnelle d'un tissu anatomique d'interet et son procede d'obtention
CN113990164A (zh) * 2021-11-18 2022-01-28 山东大学 一种心室腔模拟装置及其使用方法与应用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6062866A (en) * 1998-03-27 2000-05-16 Prom; James M. Medical angioplasty model
GB2338582A (en) * 1998-06-19 1999-12-22 Simutech Limited Surgical simulators
CA2362867A1 (fr) * 1999-03-02 2000-09-08 Peter Yong Modele thoracique d'entrainement pour la chirurgie cardiaque endoscopique
US7220127B2 (en) * 2003-12-15 2007-05-22 Medtronic, Inc. Heart model

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010080313A1 (fr) * 2008-12-18 2010-07-15 Ethicon, Inc. Appareil et procédé de test de fuite para-valvulaire
US8230717B2 (en) 2008-12-18 2012-07-31 Ethicon, Inc. Paravalvular leak test apparatus and method
EP3296979A4 (fr) * 2015-05-08 2019-02-13 Japanese Organization for Medical Device Development, Inc. Kit de formation pour reconstuction de valvule aortique
FR3076048A1 (fr) * 2017-12-27 2019-06-28 3D Heart Modeling Reproduction tridimensionnelle d'un tissu anatomique d'interet et son procede d'obtention
CN113990164A (zh) * 2021-11-18 2022-01-28 山东大学 一种心室腔模拟装置及其使用方法与应用
CN113990164B (zh) * 2021-11-18 2022-10-11 山东大学 一种心室腔模拟装置及其使用方法与应用

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