This patent application is assigned to
The following quote was obtained by the news editors from the background information supplied by the inventors: "In the heart, the mitral valve is located between the left atrium and the left ventricle, while the tricuspid valve is located between the right atrium and the right ventricle. Each valve consists of thin leaflets, located between the atrium and the ventricle. The valve leaflets are attached to the inner wall of the ventricle by a series of fibers called chordae. In a healthy heart, when the ventricles contract during systole, the valve leaflets are apposed and thus prevent backflow of blood from the ventricle into the atrium. When the ventricles relax during diastole, the valve opens to allow blood to flow from the atrium into the ventricle.
"In mitral valve prolapse, the chordaes have become elongated due to myxomatous degeneration in which collagen in the heart structures forms abnormally and causes thickening, enlargement, and redundancy of the leaflets and chordae. In addition this process may causes rupture of chordae. Under these conditions, the leaflets prolapse (flap backwards into the left atrium) during systole when the ventricles contract, allowing regurgitation of blood through the valve from the ventricle into the atrium. When severe, mitral regurgitation leads to heart failure and abnormal heart rhythms.
"Mitral valve prolapse is the most common heart valve abnormality, affecting five to ten percent of the world population. Significant (moderate to severe) mitral regurgitation is much less common For example, in one study of two million untreated people in the U.S, moderate or severe mitral regurgitation was found to occur in about 2-3 percent of people
"Surgery is required for people with severe mitral regurgitation. Guidelines from the
"Methods for non-invasive or minimally invasive mitral valve prolapse repair have been developed.
"One method for treating heart valve prolapse involves binding together the two leaflets along the free edges of the leaflets using a clip. A method and system for suturing valve leaflets is disclosed, for example, in U.S. Pat. No. 8,062,313 to Kimblad. A clip for holding together valve leaflets is disclosed, for example, in U.S. Pat. No. 8,029,518 to
"Another method of valve repair involves introducing one or more artificial filaments to replace torn chordate. The filaments, sometimes referred to as 'neochordae', are attached at one end to a valve leaflet and at another end to cardiac tissue. A system of this type is disclosed, for example, in U.S. Pat. No. 8,043,368 to Crabtree. These methods require reliable determination of the required length of the neochordae to be introduced, which can be difficult to obtain in a beating heart. In most systems of this type it is difficult to adjust the lengths of the neochordae after deployment."
In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "In one of its aspects, the present invention provides a device for treating a mitral or tricuspid valve. The device of the invention comprises an anchor having an expanded configuration in which the anchor is deployedon one or both sides of the prolapsed area of a valve leaflet to be treated, and a low caliber configuration in which the anchor is delivered to the site of its deployment. One or more sutures are attached to the anchor. After deployment of the anchor on the valve leaflet being treated, the sutures pass ventricle wall and are then sewn outside the ventricle wall to function as prosthetic chordae, as explained below. The proper length of the artificial chordae can be obtained under echocardiography.
"The anchor may have any form that allows the anchor to be applied to one or both of the leaflet surfaces.
"In its second aspect, the present invention provides a delivery system for delivering the device of the invention to the site of its deployment in the body. The delivery system comprises a needle into which the device of the invention can be inserted with the anchor in its undeployed configuration. The delivery system further comprises a catheter dimensioned to receive the needle, and a pusher that is used to to push the device through the needle, as explained below.
"In use, device of the invention in its undeployed configuration is inserted into the needle and the needle is inserted into the catheter or thess. The tube is inserted through a chest incision, and into the ventricle via apex until the echo guided tip of the tube is just below the prolapsed area of the leaflet to be treated. The device is then pushed in the needle until the tip of the needle pierces the valve leaflet being treated.
"The anchor is then released from the needle and allowed to attain its deployed configuration on one or both sides of the leaflet being treated. Attainment of the deployed configuration may occur spontaneously upon release of the anchor from the tube (for example, if the anchor is made from a resiliently flexible material), or upon a temperature transition, in the case of a anchor formed from a shape memory alloy such as Nitinol. The anchor may be coated, for example, with pericardium or various drugs such as antibiotics.
"After deployment of the anchor, the sutures are tied outside the left ventricle wall so as to allow the sutures to function as prosthetic chordate. Thus, in one of its aspects, the invention provides a device for treating a heart valve comprising: (a) an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and (b) one or more sutures attached to the anchor.
"In the device of the invention, the anchor portion may comprise a central hub from which extend two or more wire loops.
"The anchor in the deployed configuration may comprise a first set of one or more wire loops lying in a first plane and a second set of one or more wire loops not lying in the first plane. The second set of wire loops may curved towards the first plane.
"In the low caliber undeployed configuration, the first set of loops may collapsed away from the filaments and the second set of loops may be collapsed towards the filaments.
"The anchor may comprise comprises a resiliently flexible wire ring and the anchor may further comprise one or more cross elements in the wire ring.
"The anchor may comprise a wire rod and the sutures may be attached to the wire to rod.
"In another of its aspects, the invention provides a system for treating a heart valve comprising: (a) A device for treating a heart valve comprising: (i) an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and (ii) one or more sutures attached to the anchor; (b) a delivery catheter having a catheter lumen having proximal end and a distal end; and © a needle slidable in the catheter lumen, the needle having a needle lumen dimensioned to receive the device in the low caliber configuration of the device, the needle further having a sharp tip.
"The system of the invention may comprise a rod configured to push the device in the needle lumen towards the distal end of the catheter. The distal end of the catheter may be provided with a spiral wire.
"The distal end of the catheter may be provided with an inflatable balloon that is visible in echocardiography.
"The invention also provides a method for treating a heart valve comprising: (a) providing a system for treating a heart valve comprising: i) A device for treating a heart valve comprising: an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and one or more sutures attached to the anchor; ii) a delivery catheter having a catheter lumen having proximal end and a distal end; iii) a needle slidable in the catheter lumen, the needle having a needle lumen dimensioned to receive the device in the low caliber configuration of the device, the needle further having a sharp tip; and iv) a rod configured to push the device in the needle lumen towards the distal end of the catheter. (b) inserting the device into the delivery system; © inserting the distal end of the catheter through myocardium of the heart, to until the catheter tip is juxtaposed to the underside of the leaflet; (d) piercing the leaflet with the sharp tip of the needle; (e) pushing the rod towards the tip of the needle until the anchor in its undeployed configuration passes through the needle tip and is released from the catheter; (f) bringing the anchor to it deployed configuration on one or both surfaces of the valve leaflet.
BRIEF DESCRIPTION OF THE DRAWINGS
"In order to understand the disclosure and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
"FIG. 1 shows a device for treating a heart valve leaflet from a first perspective in accordance with one embodiment of the invention;
"FIG. 2 shows the device of FIG. 1 from a second perspective;
"FIG. 3 shows the device of FIG. 1 in an undeployed configuration;
"FIG. 4 shows a device having a wire loop for treating a heart valve leaflet in accordance with another embodiment of the invention;
"FIG. 5 shows the device of FIG. 4 in an undeployed configuration;
"FIG. 6 shows a having a rod device for treating a heart valve leaflet in accordance with another embodiment of the invention;
"FIG. 7 shows the device of FIG. 6 in an undeployed configuration;
"FIG. 8 shows a delivery system for delivering and deploying a device of the invention;
"FIG. 9a shows delivery of a device of the invention to a heart valve leaflet;
"FIG. 9b shows piercing a heart valve leaflet with a needle;
"FIG. 9c shows a first stage in the deployment of a device of the invention at a heart valve;
"FIG. 9d shows a second stage in the deployment of a device of the invention at a heart valve; and
"FIG. 9e shows a device of the invention after deployment in a heart valve and to removal of the delivery device."
URL and more information on this patent application, see: Kudlik, Nachman; Pevnay, Demitry. Device and Method for Heart Valve Repair. Filed
Keywords for this news article include: Surgery, Cardiology, Cardio Device, Heart Disease, Medical Devices, Heart Valve Diseases, Heart Valve Prolapse, Mitral Valve Prolapse, Cardiovascular Diseases, The Medical Research Infrastructure and Health Services Fund of the
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