WO2014201384A1 - Valve mitrale transcathéter - Google Patents

Valve mitrale transcathéter Download PDF

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Publication number
WO2014201384A1
WO2014201384A1 PCT/US2014/042347 US2014042347W WO2014201384A1 WO 2014201384 A1 WO2014201384 A1 WO 2014201384A1 US 2014042347 W US2014042347 W US 2014042347W WO 2014201384 A1 WO2014201384 A1 WO 2014201384A1
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WO
WIPO (PCT)
Prior art keywords
mitral valve
frame
valve
set forth
transcatheter mitral
Prior art date
Application number
PCT/US2014/042347
Other languages
English (en)
Other versions
WO2014201384A8 (fr
Inventor
Arash Kheradvar
Original Assignee
The Regents Of The University Of California
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 US14/221,194 external-priority patent/US20140277414A1/en
Application filed by The Regents Of The University Of California filed Critical The Regents Of The University Of California
Priority to US14/898,048 priority Critical patent/US9968445B2/en
Publication of WO2014201384A1 publication Critical patent/WO2014201384A1/fr
Publication of WO2014201384A8 publication Critical patent/WO2014201384A8/fr

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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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0095—Saddle-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts

Definitions

  • the present invention relates to a heart valv system and, more
  • MR Mitral Regurgitation
  • Dysfunction in the mitral valve can arise from abnormalities of any part of the mitral valve apparatus, including the leaflets., annulus, chordae tendineae, and papillary muscles. Additional anatomical support for mitral valve function comes from the left atrial wall and ventricular myocardium adjacent to the papillary muscles. Proper valve function depends on the interaction, of all of the anatomic components and a minor dyssynchrony can result in significant valvular dysfunction.. With the deranged valvular structure and/or function permitting backflow there is a resultant left ventricular volume overload. Over time and with deterioration of the mitrai valve function, this volume overload results in left ventricular dilation and dysfunction.
  • MR pathologic regurgitation
  • MR is due to a primary abnormality of the valve apparatus
  • primary MR The most common causes of primary M R are mitral, valve prolapse, rheumatic heart disease and infective endocarditis.
  • Far less common causes of primary MR include trauma and. congenital heart disease such as a valve cleft.
  • Secondary MR is most commonly due to ischemic heart disease, left ventricular systolic dysfunction and dilatation (i.e., Functional MR) and least commonly hypertrophic cardiomyopathy.
  • annular calcification is a cause of MR, however this rarely progresses past moderate and infrequently requires intervention.
  • MR mitrai valve repair and replacement
  • MR is a mechanical problem
  • medical tlierapy has been shown to be inadequate, and a mechanical intervention (e.g., repair or replacemetvi) is required to improve mortality.
  • Valve competesice needs to be restored in order to remove the volume overload and its deleterious consequences.
  • Another controversy within the field of mitral valve repair and replacement is the timing of the intervention.
  • Ilie percutaneous approach to valve replacement is a welcome option for many patients due to its sparing of aggressive surgery and reducing the associated comorbidities based on the minimally invasive nature of the procedure.
  • the lure of percutaneous technologies lies in providing cost-e fective solutions to heart valve disease, thereby allowing more timely interventions with acceptable efficacy and minimal complications, especially for patients who cannot undergo surgery. These technologies can help avoid open heart surgery in severely ill patients and reduce the number of reoperations in young patients with congenital heart defects.
  • a percutanously delivered mitral valve For example, one challenge is the development of a system that will secure the valve in place and developing a fully functional and durable valve that can be crimped into a catheter.
  • Transcatheter aortic valve implantation takes advantage of the fact that the stenotic aortic valve is heavily calcified.
  • a stented design is ideal as the calcium acts as an anchor for the stent and keeps the valve from migrating. Placing a stented valve in a non- calcified aortic valve would create a much higher risk for valve
  • th mitral valve The predominant disease process of th mitral valve is mitral regurgitation. This disease is not generally associated with a heavily calcified valve, although thai can be the case. Therefore, a fixation apparatus of a percutaneous mitral valve is critical to maintain valve position in the face of physiologic stress.
  • the developed valve should also be robust enough to last as long as commercially avai lable bio- prosthetic valves yet have a low enough profile that can be delivered thouuh a catheter. Again this challenge is one that can be overcome with careful design and utilizing the natural design that evolution has given, to the native mitral valve.
  • the mitral valve position presents unique challenges for the placement of a transcatheter valve, including, but not limited to: inherent anatomic features of the mitral valve (MV) that make fixation and peiivalvular seal with currently available devices a challenge, the lack of a calcium bed to fix the valve, and challenges in deli very catheter size due to the increased annul us diameter of the mitral when compared to the aortic valve.
  • MV mitral valve
  • Urns a continuing need exists for a well-designed percutaneous technology for mitral valve replacement that would revolutionize the treatment of valvular heart disease for millions of people.
  • the mitral valve includes a saddie-shaped annul us frame with two prongs extending therefrom. Two leaflets are attached with the frame and prongs to form a bi-leafiet mitral valve.
  • the frame and prongs are formed of a shape memory material, such as NitinoL
  • a fixture extends from the frame.
  • the fixture is, for example, one or more clamps.
  • the frame is configurable between a collapsed configuration and an open configuration, such the collapsed configuration allows the transcatheter mitral valve to be deli vered into position against a native mitral valve annul us and upon expandin to the open configuration, the transcatheter mitral valve is secured in place by the fixture.
  • the leaflets are Formed of bovine pericardial tissue, leaflet tissue material, and polymeric material, ail of any desired width.
  • the prongs have a prong length, with the prong length being between 5 millimeters and 30 millimeters.
  • the saddle-shaped annul us frame has an annu!us rise reflecting curvature of the saddie-shaped annukis frame, the annulus rise being between 2 millimeters and 5 millimeters.
  • the prongs each include a prong axis and extend from the saddie-shaped annulas frame at an intersection, such that a prong angle exists between the prong axis and a vertical axis rising vertically from the intersection, where the prong angle is between 5 degrees and 40 degrees, in another aspect, the prong angle is approximately 20.2 degrees.
  • the present invention also comprises a method for tormina and usins the invention described herein.
  • FIG. 1 A is an isometric-view illustration of a bioprosthetic mitral, valve according to the principles of the present invention
  • FIG. 1 B is a bottom-view illustration of the mitral valve according to the principles of the present invention.
  • FIG. 2 A is a front-view illustration of the mitral valve according to the principles of the present invention, depicting the valve as being open;
  • FIG. 2B is an isometric-view illustration of the mitral valve according to the principles of the present invention, depicting the valve with foreground leaflets removed for illustrative purposes;
  • FIG, 2C is a left-view illustration of the mitral valve according to the principles of the present nvention, depicting the valve with foreground leaflets removed for illustrative purposes;
  • FIG. 3 is an illustration depicting stress test results of a short and long bi-leaflet type valve, as contrasted with a tri-ieaflet type valve;
  • FIG. 4A is a bottom- iew illustration of a saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 4B is an top-view illustration of the saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 4C is a left- view illustration of the saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 4D is a right-view illustration of the saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 4E is a front-view illustration of the saddle-shaped annulus frame according to the principles of the present invention.
  • FIG . 4F is a rear-view illustration of the saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 4G is an isometric-view illustration of ihe saddle-shaped annulus frame according to the principles of the present invention.
  • FIG. 5 A is an interior-view illustration of a heart chamber, depicting a native mitral valve annulus;
  • FIG. 513 is an interior- view illustration of the heart chamber, depicting a bioprosthetic mitral valve as attached with a native mitral valve according to the principles of the present invention
  • FIG. 5C is an interior- view illustration of the heart chamber, depicting a bioprostheiic mitral valve as attached with a native mitral valve according to the principles of the present invention
  • FIG. 6A an. isometric- view illustration of the saddle-shaped anriulus frame, depicting the frame as changing between an open and collapsed configuration
  • FIG. 6B a side-view illustration of the saddle-shaped amrums frame, depicting the frame as changing between an open and collapsed configuration
  • FIG. 6C a front-view illustration of the saddle-shaped annulus frame, depicting the frame as changing between an open and collapsed configuration
  • FIG. 7 A is an illustration of a delivery catheter according to the
  • FIG. 7B is an. illustration of a delivery catheter according to the
  • FIG. 7C is an illustration of a delivery catheter according to the
  • F G. 7D is an illustration of a delivery catheter according to the
  • FIG. 8 is an illustration depicting an anatomical approach taken during a tramapical mitral valve replacemen t according to the principles of the present invention.
  • the present invention relates to a heart valve system and, more
  • a natural miiral valve is a unique valvular structure whose number of leaflets and the saddle shape of its annulus make it distinct from the other three valves inside the heart.
  • a btoprosthesis has not heretofore been developed that capitalizes on these characteristics or empioys a bileaflet design.
  • a hioprosthetic miiral valve that employs the native saddle shaped annulus and a novel bi-leaflet design.
  • the present invention is directed to a percutaneous bi-leaflet mitral valve and a deli very catheter for transapieal implantation of the percutaneous mitral valve.
  • the mitral valve can be implemented and delivered using any suitable delivery system.
  • a delivery system can be implemented and delivered using any suitable delivery system.
  • the mitral valve can be formed, in any desired shape
  • the mitral val ve 100 is desirably fanned to replicate the natural design of a mitral valve to provide a physiologic advantage in flow and left ventricular function.
  • an annular frame 102 is formed that is shaped into a saddle-shaped annulus frame with two prongs 104 extending therefrom for attachment of and holding the leaflets 106 (e.g., bi-leaflets).
  • the leaflets are affixed with the frame 102 and the prongs 104.
  • the frame 102 is formed of any suitably flexible yet stable material, a non-limiting example of which includes super elastic Nitinol wire.
  • the leaflets 106 are formed of any suitably flexible and biocompatible material, non- limiting examples of which include bovine pericardial tissue, leaflet tissue material, and polymeric material, ail of any desired width.
  • the bovine pericardial tissue is
  • the frame 102 annulus is sutured to the bovine pericardial tissue leaflets 106.
  • polymeric material examples include
  • Polysilox nes Polyietralluoroethylene (PTFE) family, polyureihane, and polyvinyl alcohol (PVA).
  • Polysiloxanes are Silicone and Oxygen based polymers.
  • Other non-limiting examples of polymeric .materials include Teflon, ePTFE, Gore-Tex®, Dacron based Polyurethanes, including polyester, polyether. polycarbonate, and polysiloxane, J-3 polyurethane (an aliphatic PCU), polyether PDMS, J-3 poiyureiliaiie, Estane (a PEU) and Lycra (a PEUIJ), and POSS-PCU (polyhedral oligomeric
  • silsesquioxanes-poSy carbonate soft segment material comprised of interpenetrating networks (IPNs) o Myaluronan (HA) and Linear Low
  • LLDPE Density Polyethylene
  • HA-LLDPE IPNs HA-LLDPE
  • the two leaflets 106 and the saddle-shaped annul us frame 102 are also sutured to each other via the two prongs 104 that extend from the anuuhrs alongside the leaflets 106.
  • the supporting prongs 104 act in similar fashion to the chordae tendineae, preventing the leaflets 106 from being prolapsed toward the atrium.
  • the mitral valve 100 can also be formed to include one or more clamps 1 8 (i.e., a fixture) thai extend from the annul us frame 102. As shown in th bottom view of FIG, IB, the clamps 108 extend from the frame 108 to allow the valve 1 0 to be compressed for delivery to the implantation site (as shown in FSGs. 4A through 4C) and when implanted, assist in affixing the bioprosthetic mitral valve 100 (of the present invention) with the anmihts of the patients existing and natural mitral valve.
  • clamps 1 8 i.e., a fixture
  • the clamps 108 extend from the frame 108 to allow the valve 1 0 to be compressed for delivery to the implantation site (as shown in FSGs. 4A through 4C) and when implanted, assist in affixing the bioprosthetic mitral valve 100 (of the present invention) with the anmihts of the patients existing and natural mitral valve.
  • FIGs. 2A through 2C depict front
  • FIG. 2 A illustrates the frame 102 and the hi-leaflet 106 design .
  • the valve 100 can be formed of any suitable dimensions to be positioned within a patient's existing natural mitral valve an tilus.
  • the mitral valve 100 can be designed for an adult heart with an annu!us frame 1 2 diameter of between 15 and 35 mil limeters.
  • the frame 102 diameter is approximately
  • FIG. 28 shows an isometric- view, depicting a mid-section of the valve (with a front leaflet removed for illustrative purposes).
  • the itsno! annulus frame 102 is surrounded by the pericardial tissue (i.e., leaflet 1 6 material).
  • mitral annulus has been, shown to be a significant parameter in the diagnosis of func tional disorders such as mitral valve prolapse, functional mitral regurgitation and acute ischemic mitral regurgitation.
  • the mitral valv is a major
  • FIG. 2C is a left view of the image shown in FIG. 2B, depicting the valve 100 in an open configuration.
  • die prong length 200 is the length of the prong 104 as it rises from an intersection 201 of the frame 102, The prong length 200 is formed at any desired length.
  • the prong length 200 is sufficiently long to allow the annul us frame 102 to rest against the annuius of the native mitral valve, while extending from the intersection 201 to a length that allows the leaflet 106 to cover (or support) an existing native mitral valve leaflet
  • the prong length 200 is between 5 and 30 mm.
  • the prong length 200 is desirably approximatel 1 1 mm or 25 mm. For example, if approximately 11 mm, then the valve 100 would be considered a short leaflet valve. Alternatively, if approximately 25 mm, then the valve 1 0 would be considered a long leaflet valve.
  • the annuius rise 204 is a measurement that reflects the curvature of the saddle-shaped annuius frame 102.
  • the antmius rise 204 is the distance between a Sine 206 that crosses the bottom most portion of the frame 102 ⁇ illustrated at the intersection 2 1 ) and a line 208 that crosses an apex of the curvature.
  • the annuius rise 204 is any desired distance that operates to maximize flow and valve 100 function and that assists the valve 1 0 in maintaining affixation with a native mitral valve. Further, the annuius rise 204 assists in positioning the clamps 108 such that they operate effectively to clamp the valve 100 against the native mitral valve annuius.
  • the annuius rise 204 is between 2 and 5 mm.
  • die an nuisanceus rise 204 is approximately 3.25 mm.
  • the prong angle 202 is the angle between a prong axis 210 and a
  • the prong angle 202 is any suitable angle that operates to maximize .flow and valve 100 function and that assists the valve 100 in maintaining affixation with a native mitral valve.
  • the prong angel. 202 is between 5 and 40 degrees. In another aspect and as another non-limiting example, the prong angle 202 is approximately 20.2 degrees.
  • the mitral valve 1.00 has been, designed to exhibit optimal fluid
  • CAT I A by Dassault Systemes Americas Corp., located at 175 Wyman Street, Wa!tham, MA 02451 , USA
  • ABAQUS by SI IJLIA, a division of Dassault Systemes Americas Corp.
  • SI IJLIA a division of Dassault Systemes Americas Corp.
  • the additional sources of momentum-transfer derive either from the added mass effect, in which the streamlines act as a ' boundary that drives the ambient fluid into motion when the vortex is being formed, or from fluid entrapment inside the isolated transmittal vortex bubble.
  • the proximity of the leaflet tips to the ventricular wall will significantly affect the process of vortex formation, and the flow pattern observed downstream of the bileaflet prototype that generates an asymmetric vortex may be closer to reality as shown before.
  • a major concern with any bioprosthetic heart valve is durability. Minimizing the stress on the leaflets and distributing it more evenly is critical to maintaining functionality and durability of the valve. ] As illustrated in FIG.
  • FIG. 3 illustrates testing results of two versions of a bi-leaflet type valve (i.e., short leaflet val ve and long leaflet valve). Depicted at the top of FIG.
  • FIG. 3 are a bottom view 300 and front view 302 of the stress distribution over the leaflets of a short leaflet bi-leaflet valve. Also depicted are a bottom view 304 and from view 306 of the stress distribution over the leaflets of long leaflet bi- leaflet type valve.
  • the short and Song bi-leaflet type valves are to be contrasted with the stress distributions of a traditional tri-leaflet valve., shown in the bottom 308 and f ont 310 views, respectively.
  • the lighter areas in the images illustrate higher stress regions or points, with the areas of greatest stress 312 for each design being circled with a dashed line.
  • a mold can be used that mimics the saddle shape annulus of the native mitral valve.
  • the mold is formed of ei ther aluminum or stainless steel (or any other suitable material) based on the temperature of the furnace that is used for heat treatment, which is determined in conjunction with a machinist skilled in the art.
  • CATIA design software is used for part design, and fabrication of the mold can be easily accoraplisbed using a hired machinist that is skilled in the art, such as those commonly employed by the University of California Irvine, in Irvine, California, USA,
  • the mold is used to mount the frame material for heat treatment.
  • the mold is used to mount the Nitinol wires for heat treatment.
  • Nitinol alloys are materials that have two very unique properties'. shape memory and supere!asticity.
  • Shape memor refers to the ability of Nitinol. to deform at one temperature, and then recover its original, iindeformed shape upon heating above its "transformation temperature”. Siiperelasticity occurs at a narrow temperature range just above its transformation temperature; in this case, no heating is necessary to cause the undeforrned shape to recover.
  • Nitinol exhibits enormous elasticity, some 1 -30 times that of ordinary metal.
  • Nitinol is used in this design (as a non-limiting example of a suitable frame material) to provide a collapsible .frame for the valve.
  • FIGs. A. through 4G which illustrate a bottom view, a top view, a left view, a right view, a front view, a rear view, and an isometric view, respectively, of the frame J 02.
  • FIGs. 4A through 4G illustrate a specific dimensions illustrated in FIGs. 4A through 4G for illustrative purposes of a single non-l imiting example of suitable dimensions.
  • valve characteristics such as annulus height (i.e., prong length), curvature (i.e., annulus rise) and the critical prong angle, are optimized by constraining the Nitinol wire to a specialized mold designed for an adult heart with an annulus diameter of approximately 25 mm (or any other suitable dimension as described above).
  • annulus height i.e., prong length
  • curvature i.e., annulus rise
  • critical prong angle are optimized by constraining the Nitinol wire to a specialized mold designed for an adult heart with an annulus diameter of approximately 25 mm (or any other suitable dimension as described above).
  • Hie supporting prongs 104 can be formed or fused to the frame using any suitable formation or fixation technique, non-limiting examples of wh ich i nclude being wi elded to the frame 102, being press fit within a tiny tube, or both, or any other suitable technique.
  • Nitinol components of the val ve 100 will share super-elastic properties and thus be amenable to the deformation required to fit into the delivery system. Proper design and optimal spread of these prongs 104 are critical. as the bovine pericardial leaflets 106 will ultimately be sutured to the prongs 104.
  • a fabric or sheet material can optionally be used to enclose the Nitinoi annuius frame 102 and prongs 104. As a non- mitmg example, a
  • polyester stretch fabric which is commercially available from Bard Medical (located at 8195 Industrial Boulevard, Covington, GA 3001.4, USA), can be used to enclose the Nitinoi annuius frame 102 and support prongs 104.
  • This fabric serves the purpose of creating a surface which the pericardial leaflets 106 can be sewn to, and providing the annular frame 102 with a surface or substrate that will induce a more rapid overgrowth by the endothelium. The sooner the percutaneous iy placed valve 1.00 has its annuius frame 102 covered by endothelium, the more stable the bioprosthesis will be. Finally, the pericardial leaflets 106 will be sutured to the prongs 1 4 and/or frame 102.
  • the mechanical assembly of the valve 100 will be complete and the valve 100 can be imp! anted within the patient through percutaneous transcatheter deli ery.
  • the fabric or sheet is used and attached to the frame 102 and prongs 104.
  • the leaflets 106 are atiached directly to the frame 102 and prongs 104 without the inclusion of such a fabric or sheet.
  • the valve frame 102 can be formed to include a sub-ar uiar fixture.
  • the sub- annular fixture is any suitable mechanism or device that assists the valve
  • the annuius frame 102 can machined to include one more ' Nitinoi clamps 1 8 (e.g., between two to ten; however, desirably, two) that are machined into the frame 102, in this example and as shown in FIG. SC, the Nitinoi clamps 108 will be evenly distributed below the annuius 102, which upon valve expansion, the Nitinol annulus 302 would be triggered to spring closed and grasp the native valve annulus 500 between the damp 108 and the Nitinol annulus frame 102.
  • FIG. 1 8 e.g., between two to ten; however, desirably, two
  • FIG. 5 A is aa interior view of a heart chamber, depicting a native mitral valve annulus 500.
  • FKJ. 5C is an interior view of the heart chamber. showing the Nitinol clamps 108 as extending radially from the annulus frame 102 of the mitral val ve 100 to grab the heart ti ssue 502 and fix the valve 1.00 in place against the native mitral valve. ote that the valve leaflets are removed for illustrative purposes.
  • FIG. 5B Another example of a design for the fixture is illustrated in FIG. 5B and includes a second Nitinol annular ring 51 , which would sit below the first (i.e., the annular frame 102), allowing the capture of the native annulus 500 between the two rings 510 and .102.
  • the valve is a dual ring version that includes two rings (i.e., frame 102 and ring 510) that are connected with one another, with one sitting on the atria! side and the other on the ventricular side of the annulus 500 and press the annulus 500 between them.
  • the second Nitinol annular ring 510 it is desirable for the second Nitinol annular ring 510 to be slightly thinner and more collapsed in the delivery catheter than the first ring (i.e., the annular frame 102).
  • a reduction in collapsed size is critical when designing a percutaneous heart valve, as the smaller the collapsed configuration, the Sower profile the delivery system can be, whether thai is transapical or transfemoral.
  • the s per-elastic properties of N itinol wi ll allow for the valve to be deformed fitting the design of the catheter.
  • the profile or French size of the delivery system is minimized, then, ihe myocardial injury, in the case of transap ical, or vasc u lar injury in the case of trans-femoral, c an be minimized.
  • FlGs, 6A, 6B. and 6C illustrate isometric, side, and front views, respectively, of the annular frame 102.
  • the figures depict the annular frame 102 as folding between an open configuration 600 and a collapsed configuration 602. Also as shown, the frame 102 is moved into the collapsed configuration 602 by pressing the clamps 108 toward one another and the prongs f 04 toward one another. Because the Nitinol annular frame 102 is shape set into the open configuration 600, once delivered to the appropriate place and released, the annular frame 102 will automatically revert from the collapsed 602 to open configuration 600, thereby affixing the valve in place against the native mitral annulus.
  • the present invention also includes a delivery system that could fasciiitate transapical implantation or
  • transfemoral or direct aortic delivery routes to the mitral valve that delivers the mitral valve in the collapsed configuration 602 and once released, allows the mitral valve to revert to the open configuration 600 and become affixed with the native mitral valve.
  • the specific deli very catheter as described and illustrated is provided as a non-limiting example of such a delivery system and that any other suitable mitral valve delivery system can be employed to implant the mitral valve against the native mitral annuius.
  • the design is for a transapical delivery system to
  • the catheter is minimized in size to provide the lowest diameter possible to minimize apical injury on implantation and bleeding risk once the catheter is removed.
  • the catheter has a diameter in range of 12 F.r to 32 Fr.
  • the catheter is directed to the transapical approach.
  • the anatomical position of the mitral valve makes a transfemoral approach much more complicated than it is for the aortic valve.
  • Accessing the mitral valve from a transfemoral approach requires either a venous approach with a puncture through the intra-atrial septum, or an approach through the aortic valve initial !y then retrograde through the mitral.
  • Bot vascular approaches have major drawbacks and complications. For instance, as with all procedures involving percutaneous vascular access, the risks of bleeding and major vascular injury are significant.
  • transapical catheter allows a larger internal diameter than a transfemora! catheter.
  • the catheter is devised for the transapical approach for mitral valve implantation. Goals of the catheter are: (1 ) A low profile, to enhance access and improve closure (2) Hemosiatic control to minimize blood loss during insertion, and (3) Minimal left ventricular trauma during insertion.
  • Delivery systems for the various transcatheter aortic valves consist mainly of a main delivery catheter, an external delivery control system and a balloon lumen for those valves that are balloon expandable.
  • FIG. 7 A illustrates an example schematic of a first stage of transapical valve delivery where the valve 100 is starting to protrude from the delivery catheter 701 (and its sheath 700).
  • FIG. 7B illustrates the still crimped valve 100 once it has been removed from the delivery catheter for positioning, while FIG. 7C illustrates a partially unfolded valve 100.
  • F G. 7D illustrates a fully unfolded valve in the open configuration 600.
  • posterior leaflets are removed for illustrative purposes.
  • the delivery catheter 701 includes a sheath 700 with a size on the order of 25-30
  • This catheter is designed with a corresponding dilator with a central lumen 702 for a rigid wire 704 thai will be inserted to start the delivery process.
  • the catheter 701 and sheath 700 design are well-developed technologies that are clearly understood by those skilled in the art.
  • valve 100 is crimped (into the collapsed configuration 602 ⁇ and positioned in the sheath 700.
  • the rigid wire 704 is pushed to force the valve 100 from the sheath 700 to engage with and attach with the native mitral annulus.
  • catheter 701 includes an external delivery' and control system (i.e., handle). This system will consist of a one handed control, that will allow the operator four degrees-of-freedom, with movement in the x, y and z planes, along with rotation along the axis of the sheath 700. Once the valve 100 is in optimal position, the device will allow the operator to partially deploy the valve to ensure optimal position under Fluoroscopy and 3-Diniensional Transesophageal Echocardiography.
  • an external delivery' and control system i.e., handle.
  • This system will consist of a one handed control, that will allow the operator four degrees-of-freedom, with movement in the x, y and z planes, along with rotation along the axis of the sheath 700.
  • the device Once the valve 100 is in optimal position, the device will allow the operator to partially deploy the valve to ensure optimal position under Fluoroscopy and 3-Diniensional Transesophageal Echocardiography.
  • Such a catheter and delivery and control system is described in
  • delivery and control system will allow for re-sheathing of the valve 100 and the ability to re-deploy in an alternate location. After an optimal position has been obtained, the system will release the valve and it will secure itself in place.
  • Another advantage to the transapical system is the decreased complexity in movement of the deli very and control system.
  • FIG. 8 provides an illustration depicting the anatomical approach taken during a transapical mitral valve replacement according to the principles of the present invention.
  • the caiheier 701 is used for transapical implantation of the bioprosthetic mitral valve (of the present invention).
  • the earner 701 is used to position the bioprosthetic mitral valve 100 in place against the patient's native mitral valve 800 and its corresponding native valve annukis 500 (as depicted in F!Gs. SB and 5C).
  • the mitral valve 100 according to the principles of the present in ention is to be positioned into an existing human mitral valve 800 (i.e., the native mitral valve) and left in place to support the existing native mitral, valve, in one aspect, the mitral valve 100 is simply left in. place to support the existing native mitral valve 800.
  • the mitral valve 100 can be further affixed with the existing native mitral valve 800 using any fixation technique.
  • the bioprosthetic mitral valve 100 can sewn or hooked against the native mitral valve 800.
  • the leaflets of the bioprosthetic mitral valve 1 0 can be sewn against the native mitral valve 800 leaflets.
  • the saddle-shaped frame of the bioprosthetic mitral valve 100 can be sewn against the native valve amwhts 500.
  • Such a process can be accomplished using any suitable mechanism or device that is operable for in vivo fixation or stitching.
  • NeoChord, Inc. located at 7700 Equitable Drive, Suite 206, Eden Prairie, MN 55344, USA
  • the Neochord mitral valve repair device can be employed to stitch the frame 102 against the native valve anuums 500 and/or the leaflets 106 aeainst the native mitral valve leaflets.
  • the Neochord device instead of sewing a torn leaflet, is used to suture the mitral valve 100 in place against the native mitral valve 800.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne une valve mitrale transcathéter. La valve mitrale comprend un cadre annulaire en forme de selle avec deux dents s'étendant à partir dudit cadre. Deux cuspides sont fixées au cadre et aux dents pour former une valve mitrale bicuspide. Le cadre peut être replié dans une configuration repliée qui permet le transport et l'implantation au niveau d'une position mitrale. Lorsqu'elle se trouve au niveau de la position mitrale, la valve se déploie dans une configuration ouverte et est fixée en place par une fixation, par exemple des pinces, qui s'étendent à partir du cadre.
PCT/US2014/042347 2013-06-14 2014-06-13 Valve mitrale transcathéter WO2014201384A1 (fr)

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US61/835,083 2013-06-14
US14/221,194 US20140277414A1 (en) 2011-08-05 2014-03-20 Percutaneous heart valve delivery systems
US14/221,194 2014-03-20

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US9034033B2 (en) 2011-10-19 2015-05-19 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9125740B2 (en) 2011-06-21 2015-09-08 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9421098B2 (en) 2010-12-23 2016-08-23 Twelve, Inc. System for mitral valve repair and replacement
US9655722B2 (en) 2011-10-19 2017-05-23 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9763780B2 (en) 2011-10-19 2017-09-19 Twelve, Inc. Devices, systems and methods for heart valve replacement
US9901443B2 (en) 2011-10-19 2018-02-27 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10111747B2 (en) 2013-05-20 2018-10-30 Twelve, Inc. Implantable heart valve devices, mitral valve repair devices and associated systems and methods
US10238490B2 (en) 2015-08-21 2019-03-26 Twelve, Inc. Implant heart valve devices, mitral valve repair devices and associated systems and methods
US10265172B2 (en) 2016-04-29 2019-04-23 Medtronic Vascular, Inc. Prosthetic heart valve devices with tethered anchors and associated systems and methods
US10433961B2 (en) 2017-04-18 2019-10-08 Twelve, Inc. Delivery systems with tethers for prosthetic heart valve devices and associated methods
US10575950B2 (en) 2017-04-18 2020-03-03 Twelve, Inc. Hydraulic systems for delivering prosthetic heart valve devices and associated methods
US10646338B2 (en) 2017-06-02 2020-05-12 Twelve, Inc. Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods
US10702380B2 (en) 2011-10-19 2020-07-07 Twelve, Inc. Devices, systems and methods for heart valve replacement
US10702378B2 (en) 2017-04-18 2020-07-07 Twelve, Inc. Prosthetic heart valve device and associated systems and methods
US10709591B2 (en) 2017-06-06 2020-07-14 Twelve, Inc. Crimping device and method for loading stents and prosthetic heart valves
US10729541B2 (en) 2017-07-06 2020-08-04 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US10786352B2 (en) 2017-07-06 2020-09-29 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US10792151B2 (en) 2017-05-11 2020-10-06 Twelve, Inc. Delivery systems for delivering prosthetic heart valve devices and associated methods
US11076952B2 (en) * 2013-06-14 2021-08-03 The Regents Of The University Of California Collapsible atrioventricular valve prosthesis
US11129714B2 (en) 2012-03-01 2021-09-28 Twelve, Inc. Hydraulic delivery systems for prosthetic heart valve devices and associated methods
US11202704B2 (en) 2011-10-19 2021-12-21 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

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US9421098B2 (en) 2010-12-23 2016-08-23 Twelve, Inc. System for mitral valve repair and replacement
US10517725B2 (en) 2010-12-23 2019-12-31 Twelve, Inc. System for mitral valve repair and replacement
US10028827B2 (en) 2011-06-21 2018-07-24 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US11523900B2 (en) 2011-06-21 2022-12-13 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US10751173B2 (en) 2011-06-21 2020-08-25 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9125740B2 (en) 2011-06-21 2015-09-08 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9572662B2 (en) 2011-06-21 2017-02-21 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9579196B2 (en) 2011-06-21 2017-02-28 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9585751B2 (en) 2011-06-21 2017-03-07 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US11712334B2 (en) 2011-06-21 2023-08-01 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US10034750B2 (en) 2011-06-21 2018-07-31 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US9763780B2 (en) 2011-10-19 2017-09-19 Twelve, Inc. Devices, systems and methods for heart valve replacement
US11617648B2 (en) 2011-10-19 2023-04-04 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9901443B2 (en) 2011-10-19 2018-02-27 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10052204B2 (en) 2011-10-19 2018-08-21 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US11202704B2 (en) 2011-10-19 2021-12-21 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US11197758B2 (en) 2011-10-19 2021-12-14 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10945835B2 (en) 2011-10-19 2021-03-16 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10299927B2 (en) 2011-10-19 2019-05-28 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10299917B2 (en) 2011-10-19 2019-05-28 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10335278B2 (en) 2011-10-19 2019-07-02 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US11826249B2 (en) 2011-10-19 2023-11-28 Twelve, Inc. Devices, systems and methods for heart valve replacement
US9034033B2 (en) 2011-10-19 2015-05-19 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9655722B2 (en) 2011-10-19 2017-05-23 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US11628063B2 (en) 2011-10-19 2023-04-18 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US10702380B2 (en) 2011-10-19 2020-07-07 Twelve, Inc. Devices, systems and methods for heart valve replacement
US10016271B2 (en) 2011-10-19 2018-07-10 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US11497603B2 (en) 2011-10-19 2022-11-15 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9295552B2 (en) 2011-10-19 2016-03-29 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
US9039757B2 (en) 2011-10-19 2015-05-26 Twelve, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
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US11129714B2 (en) 2012-03-01 2021-09-28 Twelve, Inc. Hydraulic delivery systems for prosthetic heart valve devices and associated methods
US10111747B2 (en) 2013-05-20 2018-10-30 Twelve, Inc. Implantable heart valve devices, mitral valve repair devices and associated systems and methods
US11234821B2 (en) 2013-05-20 2022-02-01 Twelve, Inc. Implantable heart valve devices, mitral valve repair devices and associated systems and methods
US11076952B2 (en) * 2013-06-14 2021-08-03 The Regents Of The University Of California Collapsible atrioventricular valve prosthesis
US11576782B2 (en) 2015-08-21 2023-02-14 Twelve, Inc. Implantable heart valve devices, mitral valve repair devices and associated systems and methods
US10820996B2 (en) 2015-08-21 2020-11-03 Twelve, Inc. Implantable heart valve devices, mitral valve repair devices and associated systems and methods
US10238490B2 (en) 2015-08-21 2019-03-26 Twelve, Inc. Implant heart valve devices, mitral valve repair devices and associated systems and methods
US10265172B2 (en) 2016-04-29 2019-04-23 Medtronic Vascular, Inc. Prosthetic heart valve devices with tethered anchors and associated systems and methods
US11033390B2 (en) 2016-04-29 2021-06-15 Medtronic Vascular, Inc. Prosthetic heart valve devices with tethered anchors and associated systems and methods
US11389295B2 (en) 2017-04-18 2022-07-19 Twelve, Inc. Delivery systems with tethers for prosthetic heart valve devices and associated methods
US10575950B2 (en) 2017-04-18 2020-03-03 Twelve, Inc. Hydraulic systems for delivering prosthetic heart valve devices and associated methods
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US11786370B2 (en) 2017-05-11 2023-10-17 Twelve, Inc. Delivery systems for delivering prosthetic heart valve devices and associated methods
US10792151B2 (en) 2017-05-11 2020-10-06 Twelve, Inc. Delivery systems for delivering prosthetic heart valve devices and associated methods
US10646338B2 (en) 2017-06-02 2020-05-12 Twelve, Inc. Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods
US11559398B2 (en) 2017-06-02 2023-01-24 Twelve, Inc. Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods
US10709591B2 (en) 2017-06-06 2020-07-14 Twelve, Inc. Crimping device and method for loading stents and prosthetic heart valves
US11464659B2 (en) 2017-06-06 2022-10-11 Twelve, Inc. Crimping device for loading stents and prosthetic heart valves
US10729541B2 (en) 2017-07-06 2020-08-04 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US10786352B2 (en) 2017-07-06 2020-09-29 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
US11877926B2 (en) 2017-07-06 2024-01-23 Twelve, Inc. Prosthetic heart valve devices and associated systems and methods
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