[go: up one dir, main page]

WO2018055629A1 - Dispositif et procédé de réparation de valvule mitrale - Google Patents

Dispositif et procédé de réparation de valvule mitrale Download PDF

Info

Publication number
WO2018055629A1
WO2018055629A1 PCT/IL2017/051078 IL2017051078W WO2018055629A1 WO 2018055629 A1 WO2018055629 A1 WO 2018055629A1 IL 2017051078 W IL2017051078 W IL 2017051078W WO 2018055629 A1 WO2018055629 A1 WO 2018055629A1
Authority
WO
WIPO (PCT)
Prior art keywords
posterior
ring
bridge
legs
mitral valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2017/051078
Other languages
English (en)
Inventor
Jacob Zeitani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innercore Medical Ltd
Original Assignee
Innercore Medical Ltd
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
Application filed by Innercore Medical Ltd filed Critical Innercore Medical Ltd
Priority to BR112019005927A priority Critical patent/BR112019005927A2/pt
Priority to CN201780059306.6A priority patent/CN109789016A/zh
Priority to EP17852548.1A priority patent/EP3515364A4/fr
Publication of WO2018055629A1 publication Critical patent/WO2018055629A1/fr
Priority to US16/143,512 priority patent/US10583008B2/en
Anticipated expiration legal-status Critical
Priority to US16/578,437 priority patent/US20200030096A1/en
Ceased legal-status Critical Current

Links

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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses

Definitions

  • the present invention relates to a device and method for correcting mitral valve insufficiency, and more particularly, to a device capable of restoring valve leaflet coaptation.
  • Mitral regurgitation (MR) - also referred to as mitral insufficiency or mitral incompetence - is a common disorder caused by insufficient closure (coaptation) of the mitral valve leaflets when the left ventricle contracts. This leads to abnormal leaking of blood backwards from the left ventricle, through the mitral valve and into the left atrium.
  • MR Magnetic Reduction Function
  • DMR Degenerative Mitral Regurgitation
  • FMR functional mitral regurgitation
  • Treatment of mitral valve regurgitation includes medication such as diuretics beta blockers, heart rhythm regulators and/or surgery for augmenting or replacing mitral valve function.
  • Mitral valve augmentation is typically effected via implantation of a ring-like device at the valve annulus.
  • the procedure termed annuloplasty, reshapes the mitral valve annulus to reestablish the physiological configuration and improve leaflet coaptation.
  • Mitral valve repair can be achieved by ring implantation alone, however, cases involving leaflets with sever anomalies and/or chordate elongation or damage to papillary muscles oftentimes require additional repair procedures.
  • an annuloplasty device for mitral valve repair comprising a ring-like body having a posterior portion adapted to be implanted on a posterior aspect of the mitral valve annulus and an anterior portion connected to opposing legs being configured for crossing through opposing regions of a commissure of the valve when the posterior portion of the ring-like body is implanted on the posterior aspect of the mitral valve annulus, each of the opposing legs extends away from, and is angled medially and posteriorly with respect to, the ring-like body.
  • a posterior angle of a first leg of the opposing legs is greater than the angle of a second leg.
  • the anterior portion is open with each end transitioning to a leg of the opposing legs.
  • distal ends of the opposing leg are interconnected via a bridge.
  • the posterior angle of the first leg is 5-20 degrees greater than the angle of the second leg.
  • each end of the anterior portion transitions to the leg through a series of inward, backward and downward bends.
  • the device further comprising a cuff covering the ring.
  • the device further comprises a cuff covering the bridge.
  • the device further comprises a cuff covering at least a portion of the legs.
  • a first leg of the opposing legs crosses through a postero-medial commissure and a second leg crosses through an antero -lateral commissure.
  • the posterior portion of the ring-like body is curved at a radius of 10-20 mm.
  • the distance from the posterior end of the ring-like body to the commissures ranges between 3 to 9 mm.
  • the inward bend has a radius of curvature of 0.5-1.5 mm.
  • the cuff includes a first polymeric layer and a second fabric layer.
  • the first polymeric layer is made of silicone.
  • the cuff is fabricated from a polymer.
  • the polymer is silicone
  • the polymer is covered with a fabric (e.g. polyester).
  • a fabric e.g. polyester
  • the polymer is covered with a fabric (e.g. ePTFE).
  • a fabric e.g. ePTFE
  • the ring-like body is fabricated from a wire having a diameter of 0.5-1.5 mm.
  • the wire is composed of stainless steel, Nitinol or a Cobalt Chromium alloy.
  • a distance between the bridge and the ring-like body is 5 -30 mm.
  • each of the opposing legs is bent at a middle portion thereof.
  • a length of each of the opposing legs is in a range of 15-40 mm.
  • the bridge length is proportional to the ring size, and can be 15-35 mm.
  • an annuloplasty device for mitral valve repair comprising a ring-like body having a posterior portion adapted to be implanted on a posterior aspect of the mitral valve annulus and an anterior portion connected to opposing legs being configured for crossing through opposing regions of a commissure of the valve when the posterior portion of the ring-like body is implanted on the posterior aspect of the mitral valve annulus, wherein a length and a medial and posterior angle of the legs is selected so as to enable a bridge interconnecting the legs to reside within a rectangular volume defined by: 25 x 15 x 9 mm when the rectangular volume is positioned 5 mm below, with a 2-5 mm (preferably 5mm) posterior offset to, the ring-like body.
  • a method of treating mitral valve insufficiency comprising: (a) providing an annuloplasty device having a posterior C-shaped portion and an anterior portion terminating with opposing legs interconnected via a bridge; and (b) anchoring the posterior C-shaped portion of the device on a posterior aspect of the mitral valve annulus such that the opposing legs cross through opposing regions of a commissure of the valve and extend away from, and angle medially and posteriorly with respect to, the posterior portion.
  • the ring-like body spans the antero-lateral and postero-medial trigons and then curved backwards to the commissars with the legs crossing at the commissures.
  • the vertical distance from the curve end to the descending legs ranges between 3-8 mm.
  • the method further comprising (c) suturing said bridge to at least one leaflet of the mitral valve.
  • the method further comprising (c) attaching the bridge directly to the at least one leaflet of the mitral valve using a running suture.
  • the method further comprising (c) attaching the bridge to the at least one leaflet of the mitral valve using artificial chords. According to still further features in the described preferred embodiments, the method further comprising attaching said bridge to the inferior left ventricle wall using a trans-wall suture.
  • an annuloplasty device for mitral valve repair comprising a ring-like body having a posterior portion adapted to be implanted on a posterior aspect of the mitral valve annulus and a pair of opposing legs being configured for crossing through opposing regions of a commissure of the valve when said posterior portion of said ring-like body is implanted on the posterior aspect of the mitral valve annulus, each of the opposing legs extending away from the ring-like body and angled medially and posteriorly with respect to, the ring-like body.
  • each of said opposing legs extends directly from said ring-like body.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing a mitral repair device that corrects short and long term insufficiencies in the annular, leaflet and sub valvular components of the mitral valve.
  • FIG. 1 illustrates various portions of one embodiment of the present device.
  • FIGs. 2A-D are various views of the wire frame of one embodiment of the present device showing typical device geometry and dimensions.
  • FIGs. 3A-G are various views of one embodiment of the present device with the ring-like body and bridge covered with suturing cuffs.
  • FIG. 4 illustrates positioning of one embodiment of the present device with respect to the mitral valve annulus and chordae.
  • FIGs. 5A-C illustrate several engineering prototypes of one embodiment of the present device.
  • FIGs. 6A-C illustrate positioning of a virtual rectangular volume with respect to the ring-like body for defining a desired position of the bridge; dimensions and distances are in mm.
  • FIGs. 7A-B illustrates another embodiment of the present device in which the open eyelets angle up from the ring-like body.
  • FIG. 8 illustrates a prototype device with fabric suturing cuffs covering the ringlike body and bridge.
  • the present invention is of a device which can be used to repair mitral valve insufficiency. Specifically, the present invention can be used to restore short and long term valve leaflet coaptation in cases of mitral regurgitation due to leaflet and/or chordate tendineae pathology and dysfunction and address problems arising from postoperative ventricle remodeling related to valve repair or continuous remodeling.
  • Mitral valve insufficiency can be effectively treated via implantation of annuloplasty rings which restore leaflet coaptation via annulus reshaping.
  • ring implantation alone is oftentimes less effective in the long term since both leaflets and the sub-valvular apparatus can contribute to insufficiency (e.g., myxomatous leaflets chordate elongation/rupture, altered left ventricle spherity index).
  • left ventricle geometry and volume might change in the post-operative period (i.e. the ventricle anatomy is restored to the non-pathological state or changes of the distance between the two papillary muscles) resulting in modification of the optimal chordae length leading to prolapse or tethering of the leaflets when the ventricle contracts.
  • the present inventors postulated that in order to minimize the negative effects of ventricular remodeling in the post-operative period, to facilitated chordate implantation and in the same time to guaranty correct length or to allow direct leaflet fixation.
  • the posterior leaflet might be directly attached to the bridge, reducing the risk of SAM (systolic anterior motion, a known surgical risk in such patients).
  • annuloplasty device In order to provide such function, the present inventor devised an annuloplasty device using the following guidelines:
  • artificial chords can be attached to device prior to implantation reducing ischemic time during the operation; the ease of repair and artificial chords implantation also notably reduces ischemia when the heart is not perfused; (d) device configuration minimizes interference with leaflets and chordae and minimizes contact with the LV wall;
  • the inventor discovered during experimentation with prototypes that for such a device to be effective must enable leaflet anchoring to the device directly or via artificial chords while minimizing or completely avoiding contact with the chordae tendineae and other heart structure (e.g., leaflets papillary muscle and myocardium).
  • chordae tendineae and other heart structure e.g., leaflets papillary muscle and myocardium.
  • an annuloplasty device for mitral valve repair.
  • the device includes a ring-like body (open or closed with complete or partial metal core) having a posterior portion adapted to be implanted on a posterior aspect of the mitral valve annulus and an anterior portion terminating with opposing legs configured for crossing through opposing regions of a commissure of the valve. The ends of the opposing legs interconnect via a bridge portion.
  • the ring like body when positioned at the mitral valve, lies parallel to the annulus plane and the opposing legs are at an angle thereto with the bridge positioned in the left ventricle directly below the valve opening.
  • Figures 1-3G illustrate one embodiment of the present device which is referred to herein as device 10.
  • Figure 1 illustrates the general configuration and various portions of device 10.
  • Device 10 includes a posterior portion 12 and an anterior portion 14 (shown separated by dashed line in Figure 1).
  • Posterior portion 12 and the co-planar region of anterior portion 14 form a ring-like body 11.
  • Posterior portion 12 is a substantially C-shaped flat ring which is configured to be anchored to a posterior aspect of the mitral valve annulus.
  • the radius of curvature of posterior portion 12 can be 10-20 mm.
  • Anterior portion 14 is contiguous with posterior portion 12 and includes a series of inward and downward bends (20 and 22 respectively) to a pair of opposing legs 16; legs 16 are adjoined by a bridge 18 at distal ends thereof.
  • inward bend 20 and downward bend 22 are selected in order to enable legs 16 to cross through the postero-medial and antero-lateral commissure regions of the valve. These curvatures are also selected along with the length of legs 16 and bridge 18 in order to position legs 16 and bridge 18 in the ventricle away from chordae, while allowing suturing of artificial chords [e.g. Gore- Tex, polytetrafluoroethylene (ePTFE) or polypropylene] from bridge 18 to the valve leaflets. In the functional disease, the bridge 18 can be used to suspend the papillary muscle.
  • Bend 20 has a radius of curvature of 0.5-2 mm
  • bend 22 has a radius of curvature of 1-3 mm.
  • Bend 20 also has the added function of forming an open eyelet 24.
  • Legs 16, correlated to ring size, can be 15-40 mm long while bridge 18 can have a length of 15-35 mm.
  • bends 20 are situated at opposite trigones (left and right fibrous trigones), enabling anchoring of eyelets 24 to these fibrous regions.
  • Device 10 can be fabricated from stainless steel, cobalt chromium or Nitinol wire having a diameter of 0.5-1.5 mm.
  • the device is fabricated by cold forming a wire over a machined mandrel and welding and/or crimping the ends of the wire to form bridge 18.
  • the formed device is heat treated and electropolished.
  • Bridge 18 can also be a polymeric or alloy tube glued over the bent end portions of legs 16.
  • device 10 can be fabricated by laser cutting a sheet or tube or by 3D printing a polymer or an alloy/metal.
  • the transition region between legs 16 and bridge 18 (indicated by 26 in Figure 1) can have a radius of curvature of 0.5-2 mm.
  • Legs 16 can tilt backward (towards posterior portion 12) and inward (towards device 10 symmetric centerline) at various angles controlled by bends 20 and 22 and additional bend in each leg 16 (30 in Figure 2B).
  • Device 10 is constructed such that the forces on ring-like body 12 during the heart cycle are in the range of 0.02-3 N).
  • Figures 2A-D illustrate various views of device 10 and provide exemplary dimensions for the various device portions described hereinabove as well as illustrate the overall device 10 geometry.
  • the backward bend of legs 16 is shown in Figure 2A, while Figure 2B show the inward bend of legs 16 which is determined by bend 22 and bend 30 (at a mid-portion of each leg 16).
  • Bend 30 can be 5-20 degrees and is at the same distance from ring-like body 11 in each leg 16 or at different distances.
  • Figure 2B illustrates a device 10 in which bends 30 are at the same distance (14.9 mm) from ring-like body 11.
  • the embodiment of device 10 shown in Figures 2A and 2C-D is asymmetric with respect to the extent each leg 16 tilts backward. Such asymmetry is demonstrated by the difference in tilt shown in Figures 2A and C and can include a 5-20 degree difference between the backward angulations of legs (10 degree difference between legs 16 shown in Figures 2A and C).
  • Embodiments of device 10 can also include legs that are angled at several points along their length (see, for example, Figures 2B, 5C and 7B). Such angle points can provide both medial and posterior tilting (angulation) of the legs.
  • a first angle can tilt the legs medially (inward) at an angle less then 90 degrees (70-85 degrees).
  • a second angle of 60-85 degree can be introduced mid leg about 2-10 mm from the first angle point.
  • posterior angulation can be achieved with one or more angle points.
  • the posterior (backward) angle between the legs and ring-like body (and annular plane) can be between 30 and 70 degrees and is derived from the leg height and length (see Example 3).
  • the length of the legs are related to the deepest point of the ring (the nadir) where the distance from that point can range between 5 mm posterior to the nadir and 7 mm anterior.
  • the bridge interconnecting the legs should be positioned between 0 and 10 mm from the deepest point of the posterior annulus.
  • the native annulus and the differences of planes of the trigons in comparison to the posterior annulus cause the device to tilt/bend anteriorly.
  • the portion of device 10 which resides in the left atrium can be anchored to the valve annulus using sutures staples T-anchors and the like, as in common surgical procedure.
  • portions of device 10 can be covered with a tubular cuff (sleeve) in order to stabilize the anchoring device (e.g. suture) with respect to device 10.
  • Figures 3A-F illustrate various views of device 10 which includes a tubular cuff 32 covering ring-like body 11 and a tubular cuff 34 covering bridge 18.
  • Tubular cuffs 32 and 34 can be fabricated from a polymer or a fabric or a combination thereof (intermixed or at different layers). Such a polymer or fabric can be selected suitable for promoting tissue ingrowth. Examples of polymers include silicone and polyurethane which can be over-molded or coated to a final diameter of 1.2-2 mm while examples of suitable fabrics include knitted, braided or woven PET, polyethylene, terephthalate polyester with a thickness of 0.2-0.6 mm.
  • the legs 16 can be also be partially or fully covered with any of the above polymers or fabrics.
  • Figure 3G illustrates a device 10 configured as a closed ring, with a roughly D- shaped ring-like body 11 having posterior and anterior portions (12 and 14 respectively).
  • legs 16 are attached directly to the ring-like body 11 and descend to form bridge 18 as described above.
  • the manner in which legs 16 are attached to ring-like body 11 can also be implemented with an open ring such as that shown in Figures 3A-F.
  • Ring-like body 11 is positioned at the atrial side of the valve while legs 16 and bridge 18 are positioned at the ventricular side of the valve. Ring-like body 11 is anchored to the posterior aspect of the mitral valve annulus (e.g. by suturing cuff 32 to annulus tissue) to secure device 10 in position.
  • Artificial chords 40 can be attached between bridge 18 and posterior and/or anterior leaflets (e.g. sutured to cuff 34 and leaflets). Artificial chords 40 can be surgical sutures (e.g. polypropylene).
  • Figures 7A-B illustrate another embodiment of the present device in which eyelets 24 are angled above ring-like body 11.
  • Figure 7 A is a side view of device 10 while Figure 7B is a posterior view of device 10.
  • the annulus of a diseased mitral valve does not always lie within a single plane but rather angles upwards at the regions of the commissures.
  • the open eyelet region of device 10 angles up from the plane of ring-like body. The angle selected is set with respect to the posterior end of ring-like body 11 (as shown in Figure 7A) and can be anywhere from 3-15 degrees (10 degrees shown in Figure 7A).
  • Implantation of device 10 of the present invention can be effected as follows.
  • the mitral valve face is exposed from the atrial side and interrupted sutures are placed through the posterior mitral annulus to the region of the trigones securing the device to the circumference of the annulus.
  • the leaflets and sub-valvular apparatus are evaluated by the surgeon and ruptured chords are resected if necessary.
  • the location of artificial chord suturing at the leaflets is determined and marked.
  • the annulus or the anterior leaflet is then sized (distance between trigones) using a dedicated sizer. An appropriately sized device is selected and device 10 is attached to a handle.
  • the device is oriented with respect to the trigones using the handle such that bends 20 are aligned with the trigones and posterior portion 12 abuts the posterior aspect of the annulus.
  • the surgeon determines the required length of artificial chords by measuring the distance between the tip of the prolapsed leaflet to bridge 18 using notches on the holder (chord length may also be predetermined by means of transesophageal echocardiogram before proceeding with surgery).
  • Chord length may also be predetermined by means of transesophageal echocardiogram before proceeding with surgery.
  • a selected number of artificial chords are sutured at the desired location on bridge 18 via a double suture.
  • the artificial chords are then passed through holes in the holder to prevent loss of free suture ends in the left ventricle.
  • the anchoring sutures stitched through the annulus are threaded through the antero-lateral portion (near eyelets 24) of cuff 32 (covering ring-like body 11) and ring-like body 11 of device 10 is secured against the valve.
  • the holder is detached from device 10 and the artificial chords are retrieved via the handle.
  • the sutures are tightened and knotted around the ring, starting with the sutures placed at the commissures.
  • the artificial chords are sutured to the leaflets. Excess of the sutures, after anchoring the valve and leaflets are resected. When the chordae causing leaflets tethering, such as in ischemic disease, the culprit chordae can be resected and replaced by artificial chords.
  • the papillary muscle can be pulled and anchored to bridge 18, such that the native chordae do not tether the leaflets.
  • chordate implantation can be done in a continuous running fashion passing through the bridge and leaflet for part or all length of the treated free margin leaflet.
  • the entire posterior leaflet can be sutured to bridge 18 to disable movement. Under such conditions, coaptation will be between the anterior leaflet and a "wall" formed by the posterior leaflet.
  • a suture can be threaded through bridge 18 and the free margin of the diseased leaflet.
  • the above general approach can be varied/modified based on mitral valve pathology - degenerative or functional.
  • one or both leaflets can be fixed directly to the bridge, using a surgical suture. Such a procedure can be done especially when excessive leaflet tissue is noted like in Barlow disease.
  • chordae when artificial chordae are indicated for use, the chordae are first attached to the bridge and then anchored at the right position in the leaflet. Such a procedure is indicated when chordae are torn or elongated.
  • the bridge can be used to anchor one or both leaflets.
  • the artificial chordae can be passed in a running fashion between the bridge and free margin of the leaflet and finally fixed at the two extremities. In such a procedure less knots are required, and equal tension on the chordae and leaflet can be achieved.
  • valve apparatus In functional disease typically the valve apparatus is intact and the valve dysfunction is related to left ventricle geometry changes which result in changes in papillary muscles position.
  • papillary and native mitral chordae pull the leaflets into the left ventricle cavity, resulting in mitral regurgitation.
  • the tethering most frequently can be noted in the postero-medial papillary muscle affecting both anterior and posterior leaflets corresponding to the P3 and A3 leaflet regions.
  • the fibrotic end of the culprit papillary muscle can be detached completely or partially and reattached to the bridge.
  • Another surgical technique to eliminate tethering is to pull, via suture, the whole papillary muscle (papillary muscle suspension) and attach it to the bridge.
  • the dilated/infarcted left ventricular wall can be suspended via trans-wall suture anchoring to the bridge. The entire myocardium wall is pulled toward the mitral annulus, thus eliminating the tethering of the mitral valve apparatus.
  • one or more chordae can be detached and new artificial chordae can be attached between the bridge and free leaflet margin.
  • the heart was inflated with water and the anatomy was measured using common approaches.
  • the valve was measured using a mitral valve sizer, the prototypes were placed on the valve annulus and the LV was filled with water.
  • the length of the legs should be selected such that coaptation is above the bridge and the legs do not touch the papillary muscle.
  • a bridge to ring-like plane distance of 20 mm was found to be optimal in these experiments.
  • the legs should angle backward (to posterior to ring-like body) such that they angle towards the heart wall in order to enable free movement of the Anterior leaflet.
  • An inward angle of 10° was found to be optimal in these experiments.
  • the position of the bridge can be determined by positioning the present device with respect to a virtual rectangular space.
  • the VRS is 15 mm in height, 25 mm in length and 9 mm in width and is positioned 5 mm below the plane of the ring-like body ( Figure 6A) with a 2-5 mm posterior offset thereto ( Figure 6A).
  • the position of the bridge is effected by the length and angle of the legs.
  • the backward angle of the legs is derived from the length of the legs and their distance from the anterior end of the ring-like body (i.e. the distance where the base of the legs starts).
  • a 100 kg porcine was sedated and the chest cavity was opened via a midline sternotomy approach.
  • Pre-operative ultrasound was performed to assess MR. Heparin was administered and following right atrium cannulation for vein return and ascending aorta cannulation for antegrade perfusion, a cardiopulmonary bypass was established.
  • the Mitral valve was exposed via the Left Atrium and sutures were placed at the circumference of the posterior side of the annulus.
  • the valve size was measured using a sizer and an intra-commis sural approach.
  • the appropriate device size was selected and sutures were placed around the annulus and passed through the outer side of the polyester cuff of the device. The device was positioned against the valve annulus and the sutures were knotted at the trigones in order to assure correct positioning.
  • Ultrasound was performed following the implantation procedure to assess valve function. In the second phase of the procedure, two chordates were cut at P2 to induce MR. Following MR inducement, two artificial chords were attached from the bridge of the device to the

Landscapes

  • 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)

Abstract

L'invention concerne un dispositif d'annuloplastie pour réparation de valvule mitrale. Le dispositif comprend un corps en forme d'anneau ayant une partie postérieure semi-rigide/rigide conçue pour être implantée sur un aspect postérieur de l'anneau de valvule mitrale et une partie antérieure reliée à des pieds opposées. Les pieds sont conçus pour traverser des régions opposées d'une commissure de la valvule lorsque la partie postérieure du corps en forme d'anneau est implantée sur l'aspect postérieur de l'anneau de valvule mitrale. Les pieds sont caractérisés en ce que chaque pieds s'étend à l'opposé, et est incliné de manière médiane et postérieure par rapport au corps en forme d'anneau, et les pieds sont interconnectés par l'intermédiaire d'un pont.
PCT/IL2017/051078 2013-01-10 2017-09-26 Dispositif et procédé de réparation de valvule mitrale Ceased WO2018055629A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
BR112019005927A BR112019005927A2 (pt) 2016-09-26 2017-09-26 dispositivo de anuloplastia para reparo de válvula mitral e método de tratamento de insuficiência da válvula mitral
CN201780059306.6A CN109789016A (zh) 2016-09-26 2017-09-26 二尖瓣修复装置和方法
EP17852548.1A EP3515364A4 (fr) 2016-09-26 2017-09-26 Dispositif et procédé de réparation de valvule mitrale
US16/143,512 US10583008B2 (en) 2013-01-10 2018-09-27 Devices and implantation methods for treating mitral valve conditions
US16/578,437 US20200030096A1 (en) 2013-01-10 2019-09-23 Devices and implantation methods for treating mitral valve condition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662399523P 2016-09-26 2016-09-26
US62/399,523 2016-09-26

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
PCT/IB2014/058175 Continuation-In-Part WO2014108859A1 (fr) 2013-01-10 2014-01-10 Dispositif utilisable en chirurgie réparatrice de la valvule mitrale
US14/759,349 Continuation-In-Part US20150335427A1 (en) 2013-01-10 2014-01-10 Device for plastic surgery of the mitral valve

Related Child Applications (3)

Application Number Title Priority Date Filing Date
PCT/IB2014/058175 Continuation-In-Part WO2014108859A1 (fr) 2013-01-10 2014-01-10 Dispositif utilisable en chirurgie réparatrice de la valvule mitrale
US14/759,349 Continuation-In-Part US20150335427A1 (en) 2013-01-10 2014-01-10 Device for plastic surgery of the mitral valve
US16/143,512 Continuation-In-Part US10583008B2 (en) 2013-01-10 2018-09-27 Devices and implantation methods for treating mitral valve conditions

Publications (1)

Publication Number Publication Date
WO2018055629A1 true WO2018055629A1 (fr) 2018-03-29

Family

ID=61690792

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2017/051078 Ceased WO2018055629A1 (fr) 2013-01-10 2017-09-26 Dispositif et procédé de réparation de valvule mitrale

Country Status (4)

Country Link
EP (1) EP3515364A4 (fr)
CN (1) CN109789016A (fr)
BR (1) BR112019005927A2 (fr)
WO (1) WO2018055629A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109662805A (zh) * 2019-01-18 2019-04-23 西安增材制造国家研究院有限公司 一种三尖瓣成形环及其制造方法
CN111358597A (zh) * 2020-03-19 2020-07-03 中国医学科学院阜外医院 多功能二尖瓣成形装置
WO2021091944A1 (fr) * 2019-11-05 2021-05-14 Tau Cardio Inc. Dispositif implantable pour réparer une valvule cardiaque
WO2023086904A1 (fr) * 2021-11-14 2023-05-19 Reniva, Inc. Valve mitrale postérieure prothétique implantable

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040127982A1 (en) * 2002-10-01 2004-07-01 Ample Medical, Inc. Devices, systems, and methods for reshaping a heart valve annulus
US20120179247A1 (en) * 2007-11-19 2012-07-12 The Cleveland Clinic Foundation Apparatus and method for treating a regurgitant heart valve
US20150335427A1 (en) * 2013-01-10 2015-11-26 Jacob Zeitani Device for plastic surgery of the mitral valve

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160030176A1 (en) * 2014-08-04 2016-02-04 Medizinische Universität Wien Implant and method for improving coaptation of an atrioventricular valve
JP2016538076A (ja) * 2013-11-28 2016-12-08 ムバルブ・テクノロジーズ・リミテッド 改善された耐疲労性を有する安定化要素を備える心臓内装置
US9517131B2 (en) * 2014-12-12 2016-12-13 Than Nguyen Cardiac valve repair device
US9629720B2 (en) * 2015-05-04 2017-04-25 Jacques Seguin Apparatus and methods for treating cardiac valve regurgitation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040127982A1 (en) * 2002-10-01 2004-07-01 Ample Medical, Inc. Devices, systems, and methods for reshaping a heart valve annulus
US20120179247A1 (en) * 2007-11-19 2012-07-12 The Cleveland Clinic Foundation Apparatus and method for treating a regurgitant heart valve
US20150335427A1 (en) * 2013-01-10 2015-11-26 Jacob Zeitani Device for plastic surgery of the mitral valve

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3515364A4 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109662805A (zh) * 2019-01-18 2019-04-23 西安增材制造国家研究院有限公司 一种三尖瓣成形环及其制造方法
CN109662805B (zh) * 2019-01-18 2024-02-13 西安增材制造国家研究院有限公司 一种三尖瓣成形环及其制造方法
WO2021091944A1 (fr) * 2019-11-05 2021-05-14 Tau Cardio Inc. Dispositif implantable pour réparer une valvule cardiaque
CN111358597A (zh) * 2020-03-19 2020-07-03 中国医学科学院阜外医院 多功能二尖瓣成形装置
WO2023086904A1 (fr) * 2021-11-14 2023-05-19 Reniva, Inc. Valve mitrale postérieure prothétique implantable

Also Published As

Publication number Publication date
BR112019005927A2 (pt) 2019-06-18
CN109789016A (zh) 2019-05-21
EP3515364A1 (fr) 2019-07-31
EP3515364A4 (fr) 2020-04-22

Similar Documents

Publication Publication Date Title
US20230181319A1 (en) Device that can be implanted in a minimally invasive manner and mitral valve implant system
JP5279124B2 (ja) 後部の葉状部脱出症の治療のための装置およびシステム
AU2003248833B2 (en) Mitral valve annuloplasty ring having a posterior bow
US5450860A (en) Device for tissue repair and method for employing same
US8961598B2 (en) Set of annuloplasty devices with varying anterior-posterior ratios and related methods
US20200030096A1 (en) Devices and implantation methods for treating mitral valve condition
US8216304B2 (en) Annuloplasty ring and holder combination
US7993396B2 (en) Mitral valve annuloplasty ring having an offset posterior bow
US10583008B2 (en) Devices and implantation methods for treating mitral valve conditions
JP2009513253A (ja) 非対称を備えるサドル形状僧帽弁輪状形成人工器官及び関連方法
CN112022439A (zh) 一种人工心脏瓣膜
EP3515364A1 (fr) Dispositif et procédé de réparation de valvule mitrale
WO2012020415A2 (fr) Prothèses d'annuloplastie et techniques chirurgicales
CN212788787U (zh) 一种人工心脏瓣膜
Moorjani et al. Mitral and Tricuspid Valve Operative Techniques
Lee et al. An automated expanded polytetrafluoroethylene suturing and coaxial fastener system for mitral chordae replacement: strength, feasibility, and healing
US11969345B2 (en) Repair device for heart valve repair
US20110034998A1 (en) Annuloplasty tubes
Ambat et al. Chordal Dynamic Repair of Mitral Valve: Stress Analysis Induced Surgical Innovation
HK40083912A (en) Device that can be implanted in a minimally invasive manner and mitral valve implant system
Spratt Mitral Valve repair with the American Correction: The first 100 Cases at roper hospital
Wells How I Assess and Repair the Barlow Mitral Valve

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17852548

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112019005927

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 2017852548

Country of ref document: EP

Effective date: 20190426

ENP Entry into the national phase

Ref document number: 112019005927

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20190326