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
  • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
  • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• • 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
  • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
  • A61F2/2466—Delivery devices therefor

Definitions

• the mitral valve is comprised of an anterior leaflet and a posterior leaflet.
• the bases of the leaflets are fixed to a circumferential partly fibrous structure, the annulus, preventing dehiscence of the valve.
• a subvalvular apparatus of chordae and papillary muscles prevents the valve from prolapsing into the left atrium.
• Mitral valve disease can be expressed as a complex variety of pathological lesions of either valve or subvalvular structures, but can also be related to the functional status of the valve. Functionally the mitral valve disease can be categorized into two anomalies, increased leaflet motion i.e. leaflet prolapse leading to regurgitation, or diminished leaflet motion i.e. restricted leaflet motion leading to obstruction and/or regurgitation of blood flow.
• a transvalvular intraannular delivery system includes a percutaneous delivery catheter comprising an elongate body; a movable outer sheath; and a transvalvular intraannular implant having a longitudinal axis and comprising a valve leaflet support portion and an anchoring portion, the valve leaflet support portion at least partially longitudinally offset from the anchoring portion, wherein the transvalvular implant is configured to be transformable from a first radially reduced configuration to a second radially enlarged configuration; wherein the transvalvular implant is configured to be housed within the percutaneous delivery catheter in its first radially reduced configuration, wherein the transvalvular implant is configured to be positioned in its second radially enlarged configuration within a heart valve annulus such that the implant is oriented in the valve annulus such that the longitudinal axis of the implant is oriented substantially transversely to a coaptive edge of a heart valve positioned within the valve annulus.
• the central portion is narrower than both the first anchoring portion and the second anchoring portion.
• the central portion can also include an offset support portion and a first arm portion and a second arm portion, the offset support portion wider than the first arm portion and second arm portion.
• the central portion can have a variety of cross- sectional shapes, for example, substantially triangular, rectangular, square, circular, ovoid, or others.
• a method of treating aortic regurgitation includes the steps of delivering a first tissue anchor to a first location along the wall of an aortic interleaflet triangle; delivering a second tissue anchor to a second location along the wall of the aortic interleaflet triangle, the second tissue anchor operably connected to the first tissue anchor; and reducing the distance from the first location to the second location to improve aortic leaflet coaptivity during diastole.
• the first tissue anchor and the second tissue anchor are operably connected via a tether. Reducing the distance from the first location to the second location can involve applying tension to the tether. Tension can be applied using a cinching mechanism in some embodiments.
• FIG. 4 is a bottom view of the normal mitral valve of FIG. 2 during diastole looking from the left atrium to the left ventricle.
• FIG. 5 is a cross-sectional schematic view of the normal mitral valve of FIG. 1 during systole, illustrating the depth of the coaption zone.
• FIG. 10 is a bottom view of the mitral valve of FIG. 9 having a prolapsed posterior leaflet looking from the left atrium to the left ventricle.
• FIG. 28 is a cross-sectional view of a heart during systole with a transvalvular band implanted in the mitral annulus.
• FIG. 32 is a cross-sectional schematic view of the mitral valve of FIG. 28 during systole with a transvalvular band implanted in the mitral annulus.
• FIG. 36 is a bottom view of the mitral valve during systole with another embodiment of the transvalvular band implanted in the mitral annulus looking from the left atrium to the left ventricle.
• FIG. 37 is a cross-sectional view of a transvalvular band with a transverse leaflet support.
• FIG. 43D is a side elevational view of the implant of FIG. 43C.
• FIG. 44B is a cross sectional view taken along the line 44B-44B of FIG. 44A.
• FIG. 47C is a schematic view as in FIG. 47B, with the tissue anchor deployment guides removed.
• FIG. 53 is a side elevational perspective view of a transvalvular band in accordance with the present invention.
• FIG. 58 is a perspective view of the aortic valve.
• FIG. 74 is a bottom view of a dilated aortic root with a dilated interleaflet triangle looking from the aorta to the left ventricle.
• FIG. 75 is a bottom view of a dilated aortic root with multiple dilated interleaflet triangles looking from the aorta to the left ventricle.
• FIG. 86 illustrates a transapical catheter with chordae cutting instrument engaged in the marginal chordae of the posterior leaflet of the mitral valve.
• FIG. 87 illustrates the transmitral annular band in place across the mitral annulus, in systole, preventing the prolapse of the posterior leaflet into the left atrium. The cut marginal chordae are shown. The coaptation of the leaflet shown with no regurgitation into the left atrium during systole.
• FIG. 3 illustrates a bottom view of normal mitral valve 18 in systole, looking from the left atrium and to the left ventricle. As shown, the anterior leaflet 24 and posterior leaflet 26 are properly coapted, thereby forming a coaptive edge 40 that forms a seal that prevents retrograde flow of blood through the mitral valve 18, which is known as mitral regurgitation.
• FIG. 4 illustrates a bottom view of normal mitral valve 18 in diastole.
• FIG. 5 provides a side cross-sectional view of a normal mitral valve 18 in systole. As shown in FIG. 5, the valve leaflets 24 and 26 do not normally cross the plane P defined by the annulus and the free edges 36 and 38 coapt together to form a coaptive edge 40.
• Mitral regurgitation can also be caused by an elongated valve leaflet 24 and 26.
• an elongated anterior leaflet 24 as shown in FIG. 11, can prevent the valve leaflets 24 and 26 from properly coapting during mitral valve 18 closure. This can lead to excessive bulging of the anterior leaflet 24 into the left atrium 12 and misalignment of the free edges 36 and 38 during coaptation, which can lead to mitral regurgitation.
• the contact surface 56 can be concave, straight, a combination of convex, concave and/or straight, or two concave or straight portions joined together at an apex.
• the transvalvular band 50 can have a substantially constant width between the first end 52 and the second end 54.
• the first end 52 has a first anchoring portion 58 and the second end 54 has a second anchoring portion 60.
• FIG. 23A illustrates a further implementation of the invention, adapted to treat ischemic mitral regurgitation with posterior annuloplasty.
• a transvalvular band 61 is provided for spanning the leaflet coaption plane as has been described herein. Any of the features described in connection with other transvalvular bands disclosed herein may be incorporated into the transvalvular band 61.
• the transvalvular band 50 is oriented in the annulus 28 so that the transvalvular band 50 is positioned approximately transversely to the coaptive edge 42 formed by the closure of the mitral valve leaflets 24 and 26.
• the transvalvular band 50 can also be positioned over the prolapsed portion of the anterior leaflet 26 so that the transvalvular band 50 can directly support the prolapsed portion of the anterior leaflet 24 and keep the anterior leaflet 24 inferior to the plane of the mitral valve annulus 28, i.e., elevated in the direction of the ventricle or of antegrade flow, thereby preventing or reducing prolapse and mitral regurgitation.
• the approach to the mitral valve may be antegrade and require entry into the left atrium via the pulmonary vein or by crossing the interatrial septum.
• approach to the mitral valve can be retrograde where the left ventricle is entered through the aortic valve.
• the interventional tools and supporting catheter(s) will be advanced to the heart intravascularly where they may be positioned adjacent the target cardiac valve in a variety of manners, as described elsewhere herein. While the methods will preferably be percutaneous and intravascular, many of the implants and catheters described herein will, of course, also be useful for performing open surgical techniques where the heart is beating or stopped and the heart valve accessed through the myocardial tissue. Many of the devices will also find use in minimally invasive procedures where access is achieved thorascopically and where the heart will usually be stopped but in some instances could remain beating.
• a first and second flexible connection 296 reside in a plane configured to be substantially parallel to the axis of coaption the as implanted orientation.
• the lateral edges of the each of the first leaflet support 292 and second leaflet support 294 are provided with at least one and preferably two or three eyes 298, fabric patches, or other anchor attachment structure, for receiving a tissue anchor.
• FIGS. 47A through 47E A further implementation of the invention is illustrated in connection with FIGS. 47A through 47E.
• the first control line 300 and third control line 304 have been replaced by a first guide tube 310 and a second guide tube 312.
• First guide tube 310 and second guide tube 312 each has the double function of controlling deployment of the implant, as well as enabling introduction of a tissue anchor therethrough. This avoids the use of a separate tissue anchor deployment catheter such as that described above.
• any of a variety of the implants of the present invention may alternatively be introduced across the ventricle, such as in a transapical approach.
• the retrograde approach to the mitral valve will necessitate certain modifications to both the implant and the deployment system, as will be appreciated by those of skill in the art in view of the disclosure herein.
• the mesh 337 may conveniently be a layer or pad of Dacron or other material, such as an integration of a silicone core with a Dacron jacket, which facilitates both piercing by an attachment structure, as well as tissue in-growth for long term retention.
• the first support 333 and second support 335 may comprise a radio opaque material, or be provided with radio opaque markers to enable aiming the anchor deployment system into the mesh 337 under fluoroscopic visualization.
• proximal traction on the catheter 320 and on the control wire 300 pulls the transvalvular band 324 snuggly against the left atrial side of the mitral valve, such that the first attachment structure 326 and second attachment structure 328 are seated against the valve annulus.
• a first anchor guide 330 and a second anchor guide 332 have been distally advanced from the distal end of the catheter 320.
• Anchor guides 330 and 332 may be alternatively associated with or carried by the catheter 320 in a variety of ways.
• the first and second anchor guides 330 and 332 may be pivotably carried by the catheter 320, such that they may be inclined radially outwardly from the longitudinal axis of the catheter in the distal direction.
• a retention element in the form of a first anchor 334 is illustrated as having been distally advanced from the first anchor guide 330, through the tissue in the vicinity of the mitral valve annulus, and through the first attachment structure 326. Penetration of the first anchor 334 through the first attachment structure 326 may be accomplished while providing proximal traction on the control wire 300.
• a second transverse element 342 is shown secured to or carried by the ventricular end of the filament 338, to provide a secure anchoring through the tissue wall for the transvalvular band.
• a similar structure is provided on the opposing side of the mitral valve.
• additional anchoring systems such as a total of four or six or eight or more, typically in even numbers to produce bilateral symmetry, may be used.
• the number and configuration of tissue anchors will depend upon the configuration of the transvalvular band, as will be apparent to those of skill in the art in view of the disclosure herein.
• control wire 300 may be left in place as is illustrated in FIG. 49H.
• Control wire 300 is secured to an epicardial anchor 322, to provide a transventricular truss, as has been described.
• the foregoing structure permits the free end 402 to be proximally withdrawn away from the second attachment zone 372 in a manner that draws the transverse element 392 closer to the second attachment zone 372.
• traction on the transverse element 392 causes the suture 394 to engage the engaging element 406, and prevents the transverse element 392 from pulling away from the second attachment zone 372.
• a suture 394 which can be looped through one, two, or more transverse elements 392 of anchors.
• the suture 394 looped through the anchor can function as a pulley, where appropriate traction on the suture 394 can tighten the anchors into place.
• Having a plurality of anchors as shown connected on one loop such as, for example, 2, 3, 4, 5, or more anchors, can advantageously allow one cinching maneuver to tighten all of the anchors at once.
• Deployment tool 408 may comprise an elongate flexible wire having a proximal end 410 and a distal end 412.
• the deployment tool 408 may extend throughout the length of a percutaneous translumenal catheter, with the proximal end 410 exposed or attached to a control to allow axial reciprocal movement of the deployment tool 408.
• the distal end 412 is releasably positioned within an aperture 414 on a first end of the transverse element 392.
• a second end of the transverse element 392 is provided with a sharpened point 416.
• distal axial advance of the deployment tool 408 is utilized to drive the transverse element 392 into a target tissue, to a desired depth.
• proximal retraction on the deployment tool 408 proximally retracts the distal end 412 out of the aperture 414, allowing removal of the deployment tool 408 but leaving the transverse element 392 behind within the target tissue.
• Proximal traction on the free end 402 of the suture 394 enables tightening of the transvalvular band with respect to the transverse element 392.
• releasing the free end 402 allows engaging element 406 to lock the suture 394 against further release, thereby holding the transvalvular band into position.
• FIGS. 55 and 56 illustrate alternative transvalvular bands in accordance with the present invention.
• the attachment zones are provided with tissue anchors configured to pierce the tissue of the valve annulus.
• the tissue anchors each comprise a pointed end, for penetrating tissue and a retention structure for resisting removal of the tissue anchor from the tissue.
• the retention element in FIG. 55 is in the form of a first or second barb or shoulder, as will be understood by those skilled in the art.
• the retention feature of the transvalvular band illustrated in FIG. 56 comprises an arcuate configuration for the tissue-piercing structure.
• the barbs can be used as a primary anchor that can be crimped or otherwise secured in place.
• the barbs could act as positioning features, to temporarily hold the band in place while verifying the position.
• the band could then be anchored in a secondary step, such as using a crimp, staple, suture, or other anchor as described herein.
• the barbs can be self- locking upon penetration through tissue.
• chordae force with respect to time increases and then decays in a non-linear manner during systole.
• a band mimicking this performance could benefit the valvular surface as it returns its coaptive forces to a near normal state.
• a band could cushion or physiologically reduce or prevent physical stress caused by repetitive contact with the coaptive leaflet surfaces.
• any of the aforementioned transvalvular bands can be used or configured for use with the aortic valve, such as to treat aortic regurgitation. Additional embodiments will be discussed further below, including those related to treatment of aortic valve regurgitation due to aortic valve prolapse and dilatation of the ventricular- aortic junction and more specifically relate to the use of a transvalvular band to treat aortic valve prolapse and the use of plicating anchors in the aortic annulus to provide changes in size and shape of the aortic annulus.
• the aortic valve 22 is a complex structure that is best described as a functional and anatomic unit within the aortic root 501.
• the aortic root 501 has four components: the aortic annulus 500, aortic cusps 502, aortic sinuses 510, and the sinotubular junction 512.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (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)

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Publications (1)

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Cited By (51)

Families Citing this family (33)

Citations (11)

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• 2010
  • 2010-10-14 AU AU2010306762A patent/AU2010306762C1/en active Active
  • 2010-10-14 EP EP10824103.5A patent/EP2488126B1/en active Active
  • 2010-10-14 JP JP2012534360A patent/JP5774594B2/ja active Active
  • 2010-10-14 CA CA2777067A patent/CA2777067A1/en not_active Abandoned
  • 2010-10-14 WO PCT/US2010/052695 patent/WO2011047168A1/en not_active Ceased

Patent Citations (12)

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