No assignee for this patent application has been made.
News editors obtained the following quote from the background information supplied by the inventors: "a) Transcatheter Aortic Valve Implantation (TA VI)
"In addition to the initial commercially approved devices for transcatheter aortic valve implantation (TAVI) such as the Edwards-Sapien.TM. THV balloon expandable bovine bioprosthesis (Edwards Lifesciences INC,
"Several valves for TAVI are currently at an early stage of pre-clinical or clinical evaluation. Referring to Table 1, in general, new valves incorporate features aiming to reduce delivery catheter diameter, facilitate accurate positioning, reduce para-valvular leaks, or allow device retrieval. In the following paragraphs we will describe some of the publicly known programs.
"The Direct Flow Medical Aortic Valve, developed by
"The Lotus Valve System developed by
"The Heart Leaflet Technologies ('HLT') valve, developed by
"The JenaClip, developed by
"The Engager valve, formerly developed by Ventor, recently acquired by
"The AorTx Device, developed by
"The Bailey-Palmaz Perc Valve, developed by
"The Paniagua Heart Valve, developed by
"Symetis Acurate valve (Symetis, Lausanne,
"Although these valves may incorporate desirable features, little information is currently available on their efficacy, procedural outcomes, and durability.
"b) Percutaneous Transcatheter Mitral Valve Repair ('MVR')
"Recently, new techniques have been developed to treat mitral regurgitation ('MW') with percutaneous approach, in order to restore valve function without surgical incision and cardio-pulmonary by-pass.
"Recently a new classification of percutaneous MVR technologies on the basis of functional anatomy grouping the devices into those targeting the leaflets (percutaneous leaflet plication, percutaneous leaflet coaptation, percutaneous leaflet ablation), the annulus (indirect: coronary sinus approach or an asymmetrical approach; direct: true percutaneous or a hybrid approach), the chordae (percutaneous chordal implantation), or the LV (percutaneous LV remodeling) has been proposed, as shown in Table 2.
"a) Leaflet Plication.
"This technology is based on the surgical Alfieri technique which brings the anterior and posterior leaflets together with a suture, creating a 'double orifice' MV. This re-establishes leaflet coaptation, thereby reducing MR.
"As example, the MitraClip system, developed by
"Also, the MitraFlex, developed by TransCardiac Therapeutics,
"b) Leaflet Ablation.
"Radiofrequency energy is delivered to the leaflet(s) to effect structural (fibrosis) or functional (reduced motion) alteration.
"As example, the Thermocool irrigation ablation electrode, developed by
"c) Leaflet Space Occupier.
"The device acting is positioned across the MV orifice to provide a surface against which the leaflets can coapt, reducing MR.
"As example, the Percu-Pro device, developed by Cardiosolutions,
"a) Indirect Annuloplasty
"This approach mimics surgical annuloplasty rings, which are commonly used for repair of both degenerative and functional MR.
"Coronary Sinus ('CS') Approach: This approach involves implantation of devices within the CS with the aim of 'pushing' the posterior annulus anteriorly, thereby reducing the septal-lateral (anterior-posterior) dimension of the MA.
"As example, the
"As another example, the Carillon Mitral Contour System, developed by
"As a further example, the Viacor percutaneous transvenous mitral annuloplasty device, developed by
"Asymmetrical Approach: This group of devices uses the proximity of the CS to the annulus to try to reshape the mitral annulus ('MA') but in addition exert traction force on another portion of the left atrium ('LA') or right atrium, resulting in asymmetrical forces. The aim is to reduce septal-lateral dimension and decrease MR.
"As an example,
"b) Annuloplasty (Direct):
"Percutaneous Mechanical Cinching Approach: This technology reshapes the MA directly without using the CS, approaching the MA from the LV or the LA side. Sutures or some other device are implanted onto the MA itself and used to directly 'cinch' the MA. Devices.
"As an example, the Mitralign device, developed by Mitralign,
"As another example, the Accucinch Annuloplasty System, developed by Guided Delivery Systems,
"As a further example, the Millipede system, developed by
"Percutaneous Energy-Mediated Cinching Approach: Heat energy is applied to the MA, causing scarring and shrinkage of the MA.
"As an example, QuantumCor, developed by QuantumCor,
"Also, ReCor device, developed by ReCor,
"Hybrid Approach: An annuloplasty ring is implanted surgically and can be subsequently adjusted via transseptal access if MR recurs or worsens.
"As an example, the Adjustable Annuloplasty Ring, developed by MitralSolutions,
"Also, Dynamic annuloplasty Ring System, developed by
"Synthetic chords or sutures are implanted either from a transapical or transseptal approach and anchored onto the LV myocardium at one end, with the leaflet at the other. The length of the chord is then adjusted to achieve optimal leaflet coaptation, as exemplified by the following devices, the MitraFlex, developed by TransCardiac Therapeutics, and the NeoChord, developed by
"The MitraFlex and Neochord devices place an anchor in the inner LV myocardium and another on the leaflet via a transapical approach and connect both with a synthetic 'chord' trough trans-apical approach.
"Babic is based on continuous suture tracks created from the LV puncture through the puncture of the target leaflet and are exteriorized via the trans-septal route. A pledget is apposed onto the exteriorized venous sutures and anchored onto the atrial side of the leaflet by retracting the guiding sutures from the epicardial end. A polymer tube is then interposed between the leaflet and free myocardial wall and secured at the epicardial surface by an adjustable knob.
"A device is used to reduce the anterior-posterior dimension of the LV. This indirectly decreases the septallateral annular distance and also brings the LV papillary muscles closer to the leaflets.
"The Mardil-BACE, developed by
"5. Percutaneous MVR Technologies
"At present time, different devices, such as CardiaAQ, Endovalve, Lutter, Tiara for transcatheter mitral valve replacement therapy using antegrade, transvenous, trans-septal, catheter-based approach are under development. To our knowledge, they are all in the early stages of design and development and have not been approved for clinical use, and in some of them animal studies are ongoing. The challenges are formidable: the MA has an asymmetrical saddle shape, and different anchoring designs might be necessary for different MR etiologies. LV out flow obstruction might occur due to retained native valve tissue. Furthermore paravalvular leaks might also pose a problem.
"In all these devices different concepts of anchoring system 20 have been developed to achieve a stabilization of the valve: anchoring below the annulus through hooks (CardiaAQ), subvalvular fixation toward mitral chord or with anchoring in the annulus with movable leaflets (Endovalve) in a nitinol self expanding tubular frame.
"As an example, the CardiAQ, developed by
"Also, the Endovalve- Herrmann prosthesis, developed by
"Animal models have been successful, and a true percutaneous version is planned.
"TABLE-US-00001 TABLE 2 Percutaneous Mitral Valve Regurgitation Technologies Mechanism Site of Action of Action Devices Status Leaflets Leaflet Plication 1. MitraClip RCT Edge to Edge 2. Mitraflex Currently CE mark Preclinical Leaflet Ablution Thermocool Preclinical Leaflet Space Occupier Percu-Pro Phase I trial Annulus Indirect Annuloplasty Coronary sinus 1. Monare FIM approach 2. Carillon Feasibility study (CS reshaping) 3. Viacor Ongoing/completed Asymetrical Approach 1. St Jude Device Preclinical 2. NIH-Cerclage technology Direct annuloplasty Percutaneous 1. Mitralign FIM mechanical 2. Accucinch GDS FIM cinching 3. Millipede ring Preclinical system Percutaneous energy 1. QuantumCor Preclinical mediated 2. ReCor Faesibility study ongoing cinching Hybrid 1. Mitral solutions Preclinical 2. MiCardia Chordal implants Artificial chord 1. Neochord, Preclinical Transapical 2. MitraFlex Artificial chord Babic Preclinical Transapical/Transeptal LV LV (and MA) Mardil-BACE FIM remodeling Percutaneous MVR Transeptul CardiaQ prosthesis Preclinical Technologies Minithoracotomy Endovalve-Hermann Preclinical prosthesis Transapical Lutter prosthesis Preclinical Transapical Tiara prosthesis Preclinical
"The Lutter prosthesis, a nitinol stent-valve, implanted transapically. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and a trileaflet bovine pericardial valve.
"The Tiara (
"As described above, the mitral valve apparatus has multiple components and displays a complex anatomical shape and structure thus limiting the number of any prevailing mitral valve repair solutions. The mitral valve technologies currently under development are actually composed of rigid valve structures, which usually distort the mitral valve plane and apparatus with unknown clinical results. Thus, there is a need for improved designs, which are conforming better to the mitral valve geometry as to keep a physiologic mitral inflow plane following valve apparatus implantation.
"In regards to the percutaneous valves under development, several issues need to be considered. Balloon expandable structures depend on permanent plastic deformation induced by device expansion to a specific diameter and length. Although commonly used for treating calcified aortic stenosis, these structures are not proper fit for non-symmetrical shapes such as the mitral valve. Often resulting in para-valvular leaks following device implantation, symmetrical balloon geometries are not ideal. Although, self-expanding structures are an improvement over balloon expandable ones, a one-piece structure in a symmetrical upper and lower part of mitral valve apparatus is not ideal either. Different radial pressures might be needed against surrounding tissue potentially causing deleterious effects such as conduction system disturbances or tissue disruption. The self-positioning singular or multi-disk concept may improve upon the aforementioned limitations by securing the leaflet in between disks of different radial force, aligning a prosthetic valve to blood inflow angle and avoiding dislodgment through anchoring at the base of the mitral valve apparatus."
As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "The aforesaid and other objectives of the present invention are realized by generally providing at least one disk with self-positioning, self-centering, and self-anchoring valve apparatus. In embodiments having a plurality of disks, the apparatus may be built as an assembly of independent self-positioning, self-centering, and self-anchoring components assembled into a single valve apparatus assembly.
"The disk-based valve apparatus comprises multiple components of different shapes and configurations acting as separate and independent anchoring system and allowing self-positioning and centering of a valve-housing component, as a generally median or central waist, containing the valve component.
"The disk-based valve apparatus comprises one or more disks, a valve-housing component and a valve component. The one or more disks may comprise one or more notch or gap. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring mechanism such as but not limited to, needles, hooks, prongs, struts, helical configurations or any other fixation mechanisms.
"The disk-based valve apparatus comprising one or more disks allows the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure.
"The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. The valve apparatus, comprising one or more disks, dependently or independently interacting with each other, is maintained in place by the anchoring of the proximal and/or distal disks. Such mechanism allows the self-positioning, self-centering, ad self-anchoring of the valve, thus, maintaining the overall inflow plane of native valvular apparatus.
"Furthermore, the valve apparatus comprises a double structure having a valve-housing component. The valve-housing component allows the device to be uniquely shaped and to distinguish from all other disk-based valve apparatus. Additionally, the particular shape and configuration of the distal disk ease the distal anchoring of the device. On the other end, the proximal disk facilitates the centering and stability of the valve apparatus.
"The features of the present invention which are believed to be novel are set forth with particularity in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
"The above and other objects, features and advantages of the invention will become more readily apparent from the following description, reference being made to the accompanying drawings in which:
"FIG. 1 presents a side view of the internal component of the valve-component housing of a multi-disk self-expanding valve apparatus in accordance with the present invention.
"FIG. 2 depicts the view from the distal disk of a disk-based valve apparatus in accordance with the present invention in relationship with the mitral valve anatomy.
"FIG. 3 depicts the view from the distal disk of a disk-based valve apparatus in accordance with the present invention, the distal disk having a cross-like shape and being shown in relationship with the mitral valve anatomy.
"FIG. 4A is a scaled bottom view of a multi-disk self-expanding, self-positioning and self-anchoring valve apparatus in accordance with the present invention.
"FIG. 4B is a scaled top view of a multi-disk self-expanding self-positioning and self-anchoring valve apparatus in accordance with the present invention.
"FIG. 4C is a scaled side view of a multi-disk self-expanding self-positioning and self-anchoring valve apparatus in accordance with the present invention.
"FIG. 4D is a perspective view of a single-disk self-expanding self-positioning and self-anchoring valve apparatus in accordance with the present invention having a petal shaped proximal disk and anchoring mechanisms on the ventricular side.
"FIG. 4E is a perspective transversal view of single-disk self-expanding self-positioning and self-anchoring valve apparatus in accordance with the present invention having a petal shaped proximal disk, anchoring mechanisms on the ventricular side and showing the valve component.
"FIG. 5A is a perspective view of a multi-disk self-expanding self-positioning, and self-anchoring valve apparatus in accordance with the present invention comprising two disks being connected to each other or a single component shaped into a proximal and distal disk.
"FIG. 5B is a perspective view of a multi-disk self-expanding, self-positioning, and self-anchoring apparatus in accordance with the present invention comprising independent and disconnected disks.
"FIG. 6 is a perspective view of a multi-lobe self-expanding, self-positioning, and self-anchoring valve apparatus in accordance with the present invention comprising multiple independent units.
"FIG. 7 is a perspective view of a single-disk with multi-lobes self-expanding, self-positioning, and self-anchoring valve apparatus in accordance with the present invention comprising wiring with teardrops end as anchor system.
"FIG. 8A is a perspective view of a single-disk self-expanding, self-positioning and self-anchoring valve apparatus in accordance with the present invention having a petal shaped proximal disk and comprising an anchoring system using hooks.
"FIG. 8B is a perspective view of a caged anchoring mechanism using hooks.
"FIG. 8C is a perspective view of an anchoring mechanism using hooks."
For additional information on this patent application, see: Montorfano, Matteo; Chieffo, Alaide;
Keywords for this news article include: Biomedical, Patents, Surgery, Angiology, Treatment, Cardiology, Myocardium, Aortic Valve, Heart Valves, Mitral Valve, Blood Vessels, Cardio Device, Bioengineering, Bioprosthetics, Medical Devices, Great Cardiac Vein, Surgical Technology, Cardiovascular System, Clinical Trials and Studies, Self-Expanding Nitinol Stent.
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