EP4391971A1 - Valve mitrale postérieure prothétique implantable - Google Patents

Valve mitrale postérieure prothétique implantable

Info

Publication number
EP4391971A1
EP4391971A1 EP22893852.8A EP22893852A EP4391971A1 EP 4391971 A1 EP4391971 A1 EP 4391971A1 EP 22893852 A EP22893852 A EP 22893852A EP 4391971 A1 EP4391971 A1 EP 4391971A1
Authority
EP
European Patent Office
Prior art keywords
frame
native
leaflet
statement
posterior
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.)
Pending
Application number
EP22893852.8A
Other languages
German (de)
English (en)
Other versions
EP4391971A4 (fr
Inventor
Kenneth M. Martin
Takashi Harry Ino
Christopher Blake Finnegan
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.)
Reniva Inc
Original Assignee
Reniva Inc
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 Reniva Inc filed Critical Reniva Inc
Publication of EP4391971A1 publication Critical patent/EP4391971A1/fr
Publication of EP4391971A4 publication Critical patent/EP4391971A4/fr
Pending 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
    • A61F2/2454—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
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • 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

Definitions

  • the mitral valve is located between the left atrium 57(upper heart chamber that receives oxygenated blood from the lungs) and the left ventricle 58 (the heart’s main pumping chamber that pushes blood into the aorta).
  • blood flows one way, as shown by arrow 71, through the mitral valve's anterior leaflet 63 and posterior leaflet 64, which open to allow blood to enter the left ventricle, and close to prevent blood from leaking backwards from the left ventricle to the left atrium.
  • mitral valve insufficiency or mitral valve regurgitation the leaflets 63, 64 do not close tightly and blood leaks back into the left atrium 57, for example due to heart enlargement.
  • the posterior leaflet 64 of the mitral valve composes approximately 3/5 of the circumference of the mitral annulus 62 and comprises three individual scallops identified as Pl (medial scallop), P2 (middle scallop), and P3 (lateral scallop).
  • the three corresponding segments of the anterior leaflet 63 are Al (medial segment), A2 (middle segment), and A3 (lateral segment).
  • a mitral valve repair apparatus comprising a frame having an annulus section, an atrial section extending from a superior aspect of the frame, and a ventricle section extending from an inferior aspect of the frame; a posterior leaflet having one or more scallops connected to the frame such that the one or more scallops extend from the frame for coaptation against a native anterior leaflet when the frame is deployed; at least one arm member connected to the frame such that the at least one arm member extends laterally in a curved configuration configured to approximate a curvature of a native mitral annulus when the frame is deployed; and an anchoring leg connected to the frame such that the anchoring leg extends in a superior direction from a posterior side of the frame and defines a capture region between the anchoring leg and the posterior side where the capture region is sized to receive at least a portion of a native posterior leaflet in an elongated state when the frame is deployed.
  • Statement 2 The apparatus of Statement 1, wherein the at least one arm member comprises a first arm and a second arm each extending laterally from the frame.
  • Statement 3 The apparatus of any of Statements 1-2, wherein the first arm member comprises a first anchor point and the second arm member comprises a second anchor point where each anchor point is configured to align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject.
  • Statement 4 The apparatus of Statements 3, wherein each of the first and second anchor points comprise the medial and the lateral trigone and an area having a radius of 3 mm surrounding each of the medial and lateral trigones.
  • Statement 5 The apparatus of any of Statements 3-4, wherein the first and second anchor points each comprise an opening for accommodating a position of the medial and the lateral trigones.
  • Statement 7 The apparatus of any of Statements 1-6, wherein at least a portion of the mitral valve repair apparatus comprises a membrane or fabric layer.
  • Statement 8 The apparatus of any of Statements 1-7, wherein the one or more scallops comprise a Pl, P2, and P3 scallop each connected to the frame.
  • Statement 9 The apparatus of any of Statements 1-8, wherein the posterior leaflet has a width configured to span an arc length of between 0 to 100% of the native posterior leaflet.
  • Statement 10 The apparatus of Statement 9, wherein the width of the posterior leaflet is configured to span the arc length of between 30 to 80% of the native posterior leaflet.
  • Statement 11 The apparatus of Statement 9, wherein the width of the posterior leaflet is configured to span the arc length of between 50 to 75% of the native posterior leaflet.
  • Statement 12 The apparatus of any of Statements 1-11, wherein the anchoring leg has a width sized for introduction between a chordae tendinea bundle of a lateral papillary muscle and a chordae tendinea bundle of a medial papillary muscle of a subject.
  • Statement 14 The apparatus of any of Statements 1-13, wherein the anchoring leg comprises a first leg attachment connected to a first portion of the frame and a second leg attachment connected to a second portion of the frame such that the anchoring leg has a middle section defining a radially outward bend.
  • Statement 16 The apparatus of Statement 15, wherein the first arm member comprises a first anchor point and the second arm member comprises a second anchor point where each anchor point is configured to align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject.
  • Statement 19 The apparatus of Statement 18, wherein the first and second anchor points each comprise a slot for accommodating the position of the medial and the lateral trigones.
  • Statement 23 The apparatus of Statement 22, wherein the width of the posterior leaflet is configured to span the arc length of between 30 to 80% of the native posterior leaflet.
  • Statement 25 The apparatus of any of Statements 15-24, wherein the anchoring leg has a width sized for introduction between a chordae tendinea bundle of a lateral papillary muscle and a chordae tendinea bundle of a medial papillary muscle of a subject.
  • Statement 27 The apparatus of any of Statements 15-26, wherein the anchoring leg comprises a first leg attachment connected to a first portion of the frame and a second leg attachment connected to a second portion of the frame such that the anchoring leg has a middle section defining a radially outward bend.
  • Statement 30 The method of any of Statements 28-29, wherein deploying the frame further comprises securing a native posterior leaflet within a capture region between the anchoring leg and the posterior side of the frame.
  • Statement 42 A prosthetic mitral half valve for implanting into a native mitral valve comprising native leaflets connected to chordae tendinea, wherein the prosthetic mitral half valve is sized and configured to avoid interfering with the chordae tendinea.
  • a prosthetic mitral half valve for implanting into a native mitral valve comprising a native annulus and native leaflets connected to chordae tendinea, the prosthetic valve comprising a structural frame carrying a prosthetic posterior leaflet, wherein the structural frame extends no more than 20 mm from the mitral annulus into the left ventricle in areas where native chordae tendinea reside, when the prosthetic valve is implanted in the native valve.
  • Statement 46 The prosthetic valve of Statement 45 wherein the ventricle section extends no more than 15, 10, or 8 mm from the annulus section.
  • Statement 49 The prosthetic mitral half valve of Statement 48, wherein the first anchor region is configured to accept a first tissue anchor and aligned to pass the first tissue anchor into a first trigone, and the second anchor region is configured to accept a second tissue anchor and aligned to pass the second tissue anchor into a second trigone.
  • Statement 50 The prosthetic mitral half valve of Statement 49, wherein the first and second tissue anchors are each inserted from a right atrium, each respectively through the first and second anchor regions, then each respectively through the trigones.
  • Statement 52 The prosthetic mitral half valve of Statement 51, wherein the third anchor region is configured to contact the posterior aspect of the native mitral valve.
  • Statement 53 The prosthetic mitral half valve of Statement 52, wherein the third anchor region is configured to contact an AV groove of the posterior aspect.
  • Statement 58 The prosthetic mitral half valve of Statement 57, comprising a prosthetic leaflet positioned between the trigone anchors.
  • Statement 60 The prosthetic mitral half valve of Statement 59, wherein the anchor interfaces are holes or channels.
  • Statement 73 A single leaflet mitral valve implant as in Statement 72, wherein the first atrial anchor comprises a first free end spaced apart from a second free end of the second atrial anchor.
  • Statement 78 A single leaflet mitral valve implant as in Statement 75 in combination with Statement 65, wherein the ventricular anchor comprises a means for stabilizing the implant without puncturing native tissue.
  • Statement 79 A method of repairing a native mitral valve, comprising the steps of: Identifying a mitral valve having an annulus and a flow path between a native anterior leaflet and a defective native posterior leaflet; stabilizing the defective native posterior leaflet out of the flow path; and supporting a prosthetic posterior leaflet configured to move between a first position in coaptation with the native anterior leaflet to close the flow path and a second position spaced apart from the native anterior leaflet to open the flow path.
  • Statement 80 A method as in Statement 79, wherein the stabilizing is accomplished by positioning a structural frame of the prosthetic posterior leaflet along at least a portion of a first side and a second side of the native posterior leaflet to entrap the leaflet.
  • Statement 81 A method as in Statement 80, wherein the native posterior leaflet is entrapped at a position out of the flow path and spaced apart from an adjacent ventricular wall.
  • Statement 82 A method as in Statement 81, wherein the position out of the flow path and spaced apart from an adjacent ventricular wall comprises a distance in a range of 5 to 10 mm between the entrapped posterior leaflet and the ventricular wall during ventricular systole.
  • Statement 83 A method as in Statement 79, wherein the supporting step comprises positioning a frame adjacent the annulus, the frame having at least one ventricular anchor, at least one atrial anchor, and the prosthetic posterior leaflet.
  • Statement 84 A method as in Statement 83, wherein the positioning step comprises transvascular advance of a deployment catheter to the vicinity of the mitral valve, and deploying the frame from the deployment catheter.
  • Statement 89 A partial mitral valve implant as in Statement 88, further comprising a ventricular anchor carried by the support frame.
  • Statement 95 A partial mitral valve implant as in Statement 94, further comprising a second atrial anchor comprising an arcuate support arm configured to extend circumferentially in a second direction around the flow path.
  • Statement 96 A partial mitral valve implant as in Statement 95, wherein the first atrial anchor comprises a first free end spaced apart from a second free end of the second atrial anchor.
  • FIGURE 7C is an illustration of an inferior perspective of a prosthetic mitral valve.
  • the annulus section 122 may have a plurality of annulus cells 145 (e.g., seven as shown in Figure 3A, nine as shown in Figure 3B), each being spaces defined by a first annulus cell strut 146 and a second annulus cell strut 147.
  • Each annulus cell 145 may have an annulus cell length 148, which may be in a range of 6 to 15 mm, and an annulus cell width 149, which may be in a range of 2 to 12 mm.
  • the annulus cell length 148 may be adapted to span the height of a patient’s mitral valve annulus 62.
  • struts that form ventricle petals may extend inferiorly no further than leaflet connection frames 168 for the P2 leaflet so that there is minimal frame material extending caudally into the ventricle to leave as much room as possible for native chordae to remain unimpinged.
  • Leg attachment features 171, 171 A, 171B provide a secure connection of the leg 190 to the frame 120.
  • leg attachments 171 A may be spaced from leg attachments 17 IB with a vertical distance in a range of 2 to 10 mm (e.g., 4 mm) and horizontal distance in a range of 0 to 5 mm, and may have indents, holes, protrusions or other features that prevent a suture from sliding on the frame, which functions to hold the leg securely to the frame and prevent it from sliding or rotation with respect to the frame.
  • a leg attachment feature for connecting one of two ends of a leg may include a first hole 171 A, a second hole 17 IB, and a suture indent 171.
  • the width for example the annulus section width 152 as shown in Figure 3A, may be configured so that when the frame 120 is shape set the annulus section width 152 corresponds with an arc length 153 ( Figure 8D) chosen to match a predetermined percentage of an arc length between the commissures of the native mitral annulus, for example the predetermined percentage may be in a range of 30 to 100% (e.g., 30 to 80%, 40 to 80%, 50 to 70%).
  • a method of implanting the prosthetic valve may include finding a center line of the native mitral valve in the transverse plane and rotationally aligning the prosthetic valve so that the center line of the prosthetic valve is within +/- 25 degrees of the center line of the native mitral valve and deploying anchors to secure the prosthetic valve in said rotational alignment; or a method of implanting the prosthetic valve may include rotationally aligning the prosthetic valve so that the prosthetic Pl scallop replaces a portion of the native Pl scallop in a first range of 30 to 90% (e.g., 30 to 80%, 40 to 80%, 50 to 70%) and the prosthetic P2 scallop replaces a portion of the native P2 scallop in a second range of 30 to 90% (e.g., 30 to 80%, 40 to 80%, 50 to 70%), wherein the first range
  • annulus section 122 may be sized to be the same or slightly less than the native posterior annulus so minimal or no force is applied to the native annulus and yet the native posterior leaflet is contained between the prosthetic valve and native tissue.
  • a curvature 155 of the annulus section 122 in a sagittal plane may include a concave curvature on the posterior side 104 of the frame 120 created by shape setting annulus section 122 to closely resemble curvature of the native posterior annulus so the curved annulus section mates well with the native annulus.
  • the curvature of the structural frame 120 in a sagittal plane may include a flaring out of the atrial section and ventricle section.
  • Attachment features of the arms 210 may include arm suture attachments 139 in the atrial section 121, wherein a wire (e.g., upper wire) forming a horizontal arm is bent in an upward vertical direction and sutured to the arm suture attachments 139.
  • a wire e.g., upper wire
  • Attachment features for anchoring the leg 190 to the structural frame 120 are shown in Figure 4A, Figure 8A and Figure 8B, wherein the attachment features 171 may include adaptations to the frame 120 that allow connection of an anchoring leg (e.g., a leg that is wire-formed or laser cut) to the frame in a secure manner that prevents displacement or rotation of the leg relative to the frame.
  • Leg attachment features may be part of a laser cut strut of the frame such as an annulus strut or ventricle strut.
  • Leg attachment features may include suture attachment points, holes through which ends of the leg are passed 171 A, 17 IB, indents for containing sutures 171, holes through which sutures are threaded, or other features that are friction fit, form fit, press fit, for example.
  • Leg attachment features may be distanced horizontally and vertically from one another to securely connect the base of the leg to the frame.
  • the anchoring leg may function to clip the prosthetic valve over native tissue, which may include compressing or moving at least a portion of the native posterior leaflet 64 out of the mitral orifice, or straddling the chordae bundle (for example passing between native chordae); anchor the prosthetic valve preventing it from being dislodged under the pressures of a beating heart, in particular ventricular pressure; selfcenter the prosthetic valve so it seats itself correctly in the native tissue by passing between the chordae tendineae 65 that are connected to the lateral papillary muscle 66 and the chordae tendineae 65 connected to the medial papillary muscle 67, particularly with just one leg; and stabilize the prosthetic valve rotationally.
  • the tissue By capturing and condensing at least a portion of the native posterior leaflet between the prosthetic valve and the native posterior mitral annulus, the tissue contributes to creating a fluid seal preventing perivalvular leaks.
  • the middle section of the leg may have a radially outward bend 196, (e.g., having bend angle 196A in a range of 90 to 135 degrees, and a radius of curvature in a range of 1 to 8 mm), which may be adapted to seat into the AV groove 68 behind the native posterior leaflet and inferior to the mitral annulus 62, facilitate delivery by providing a wide space to capture and funnel the native posterior leaflet between the leg 190 and the ventricle section 123 of the frame 120, to spread contact forces, or to provide an eyelet loop for passing a tissue anchor through.
  • the end of the leg may include a loop in the wire forming the leg.
  • the loop may be adapted, for example have a curvature, that closely resembles the tissue surface in the AV groove where the leg contacts to disperse contact forces over more space, which may hold the prosthetic securely and reduce pressure applied to tissue.
  • a fabric sock 195 (e.g., made from felt, woven fibers, or stretchable material) may be connected to the leg over the Nitinol wire leg or laser-cut leg to further spread forces and reduce pressure to minimize traumatic forces on AV groove tissue, to encourage tissue ingrowth for long-term durability, and to reduce risk of ventricular or atrial puncture or undesired iatrogenic injury.
  • the apex 193 of the leg 190 may be tapered, as shown in Figure 7C, which may facilitate a step of deploying the prosthetic valve and guiding the leg 190 between the lateral and medial chordae tendinea 65.
  • the leg 190 may have a radiopaque marker 200 which may be positioned on its apex 193, or the leg may be entirely radiopaque.
  • a prosthetic valve 100 may have more than one leg 190, or may have one center leg 190 and additional legs having different features.
  • One single leg 190 may be advantageous because as it is deployed from a delivery sheath it may be easier to direct a single protracting leg through a space between chordae bundles without tangling the chordae; it may consume less space in a delivery sheath making it easier to advance through the sheath or allowing a smaller sheath; and it may allow the prosthetic valve 100 to self-center more easily.
  • additional legs may provide greater anchoring or stability.
  • a flexible prosthetic leaflet may be connected to the structural frame, for example to the ventricle section 123 and may mimic in part the function and geometry of the native posterior leaflet 64, primarily to seal against the native anterior leaflet 63 when the left ventricle is full or contracting to prevent or reduce regurgitation of blood back into the left atrium.
  • Functions of the prosthetic leaflet may include: Providing a seal against the anterior leaflet 63 during ventricular systole; Opening fully to maximize GOA during ventricular diastole (in particular, during ventricular filling and atrial contraction); Providing stability of the prosthetic valve when in a closed position by directing the force applied by ventricular blood pressure evenly around the posterior mitral annulus. Together with the leg 190 and arms 210, this stabilizing force may help to prevent the prosthetic valve from being pushed superiorly into the atrium, and from moving in a roll, yaw or pitch motion.
  • a prosthetic posterior leaflet may be made from a synthetic material (e.g., polyurethane) or a natural material such as porcine or bovine pericardium.
  • the material may have physical properties similar to a native posterior leaflet including flexibility, strength, or the durability to withstand latest FDA standards for cycles of opening and closing, and hold a ventricular pressure.
  • the prosthetic posterior leaflet 260 may include three scallops that at least partially replace the three native scallops of the posterior mitral leaflet 64. These may include a Pl or lateral scallop 261, a P2 or central scallop 262, and a P3 or medial scallop 263.
  • Figure 6A shows a two-dimensional pattern of a Pl and P3 scallop 261, 263, which may be identical in dimensions, and a P2 scallop 262.
  • the two-dimensional leaflet patterns may have darts that are gathered and sewn to create a three-dimensional half-dome shape that may facilitate a billowing effect to capture blood during ventricular systole.
  • the P2 prosthetic scallop 262 may have two darts 270
  • the Pl and P3 261, 263 prosthetic scallops may have one dart 271 each.
  • Figure 6B shows a two-dimensional pattern of another design of a Pl and P3 scallop 261, 263, which may be identical in dimensions, and a P2 scallop 262.
  • the coaptation zone 267 may be larger than a native leaflet’s coaptation zone, which may function to improve the seal with the anterior mitral valve, in particular with patients who have functional MR wherein the leaflets are pulled apart from one another creating a leak.
  • the extra coaptation zone length may also accommodate a range of valve dimensions that vary from patient to patient.
  • the coaptation zone 267 may be in a range of 4 mm to 10 mm (e.g., 4 to 8 mm, 5 to 8 mm) (see Figure 7B and Figure 8B).
  • the coaptation zone 267 may be chosen to optimize a seal of a diseased mitral valve yet not be too large, which may negatively reduce GOA or require an increased valve gradient or opening force.
  • the P2 scallop 262 may have a width 268 that is wider than the width 269 of the Pl and P2 scallops 261, 263.
  • the P2 scallop may have a width in a range of 1.3 to 1.8 times the width of the Pl and P3 scallops.
  • Each leaflet may have two side flaps 264, an inferior edge 265, and a superior arc 266.
  • Figure 7A shows, from a superior perspective, a prosthetic posterior leaflet with scallops 261, 262, 263 attached to the structural frame 120.
  • the structural frame 120 may be clad with a membrane layer 175 (e.g., polyurethane) and may be further clad with a fabric layer 176 at least on the external side 108 of the structural frame 120.
  • the superior arc 266 of each scallop may be sewn to members of the structural frame, for example to the superior annulus cell struts 131, the atrial petal struts 132, or annulus cell struts 146, or to the membrane 175 or fabric 176 layers.
  • each scallop is longer than the straight distance between the leaflet connection frames that the scallop is connected to causing the inferior edge 265 to billow away from the structural frame 120 in a deployed configuration creating a cavity in the scallop that is only open at the inferior edge 265, which allows the scallops to fill with blood when pressure in the left ventricle is greater than in the left atrium.
  • the scallops are flexible enough to be deflated and pressed against the structural frame, pushing out any blood held in the scallop cavities, when atrial pressure exceeds ventricular pressure. Since the ventricular section 123 is flared radially the scallops are moved out of the path of blood through the mitral orifice when deflated to maximize GOA.
  • the design of the leaflets in combination with the structural frame and other features as disclosed herein, which may allow a maximum diastolic GOA may allow the prosthetic valve to establish a diastolic pressure gradient between the left atrium and left ventricle that is less than or equal to 5 mmHg (e.g., no more than 4 mmHg, no more than 3 mmHg, no more than 2 mmHg, no more than 1 mmHg, 0 mmHg).
  • the diastolic GOA with the prosthetic valve implanted may be at least 90% (e.g., at least 95%, 100%) of the diastolic GOA of the native heart without the prosthetic valve implanted.
  • the arms 210 may be constructed from a wire such as superelastic Nitinol forming a loop wherein each end of the wire is connected to the structural frame 120, such as the arm attachment features 139.
  • the wire loop may form a slot 211 with a substantially consistent width (e.g., in a range of .5 to 3 mm) for a length in a range of 5 to 35 mm, which may be configured to align with trigones 52, 53 in a variation of locations and for passage of a shaft of a tissue anchor 280 and engagement of a tissue anchor flange 281.
  • the arm 210 may have at least one stabilization bend 212 for securely connecting the wire to the structural frame 120.
  • the arm 210 may have an upper wire 216 that is bent in a superior direction and is connected (for example sutured, welded, crimped, inserted through holes, friction fit) to the structural frame at arm attachment points 139 in the atrial section 121; and the arm may have a lower wire 217 that is bent in an inferior direction and is connected to the structural frame at arm connection points in the annulus section 122 and the ventricle section 123.
  • the posterior force may be created in part by resilient deformation of the superelastic Nitinol arms, selecting an appropriate size of prosthetic valve to fit the patient’s heart, placing tissue anchors in selectable arm anchor points.
  • Arms 210 may be fabricated from the same wire that a leg 190 is fabricated from.
  • a prosthetic valve 100 may be provided with tissue anchors 280 held in anchor points 215 of the arms 210, for example slidably held in slots 211 or eyelets 213.
  • Arms 210 may have multiple eyelets providing a variety of anchoring points 215 ( Figure 7C).
  • a method of selecting a prosthetic valve to be implanted in a patient from a group of valves having varying sizes may comprise selecting a prosthetic valve having a major arc length between each arm anchor point 215 that is within an amount in a range of 0 to 10 mm of a major arc length between the center of the patient’s left trigone and the center of the patient’s right trigone.
  • Anchoring features for connecting to frame may include upper and lower bends and vertically and horizontally spaced suture locations, to securely hold the arms and prevent rotation, pivoting or sliding.
  • the arm’s upper bend may be secured to the atrial region of the frame and the lower bend may be secured to the ventricle region of the frame, which may allow the forces applied by the arms on to the frame to be applied to the atrial and ventricle regions.
  • the arms may be covered with fabric (e.g., felt), which may function to encourage tissue ingrowth and to prevent the anchor from sliding in the channel.
  • fabric e.g., felt
  • the anterior arm bridge 209 may function to prevent the arms 210 from splaying apart, which may prevent distortion of the mitral annulus that can lead to progression of mitral regurgitation.
  • the anterior arm bridge 209 may function, along with the arms and structural frame, to provide an annulus framework into which a different prosthetic valve may be implanted if additional intervention is required.
  • a target native tissue anchor position may include the posterior annulus or native posterior leaflet, wherein one or more anchors 280 may be anchored to one or more anchor points 201 on a leg 190 and one or more anchor points 202 on atrial petals 130 (Figure 12C).
  • a prosthetic valve 100 may be provided with tissue anchors positioned in an anchor point and ready to be passed into or through tissue.
  • tissue anchors may have two flanges holding an anchor point between them.
  • tissue anchors may be provided separately from the prosthetic valve and advanced into an anchor point during implantation, for example after the prosthetic valve 100 is deployed from a delivery sheath and positioned in the target location at the posterior mitral valve.
  • FIG. 9A to 9C An example of a tissue anchor 280 as shown in Figure 9A to 9C may have a generally tubular shape with a penetrating tip 282 in the form of a sharpened rod (e.g., sharpened with a trocar tip, beveled tip, pencil tip).
  • the anchor may have an internal lumen which contains and anchoring feature 283 in the form of deployable barbs that are deployed by a delivery catheter 240, for example by pushing a rod in the delivery catheter that advances the deployable barbs 283 within the lumen pushing the barbs out of side holes 285 of the anchor.
  • the barbs 283 may be made from a superelastic Nitinol wire that has sharp ends and may be bent so the ends are directed proximally or toward the flange 281.
  • the wire may form a loop that is contained in the anchor’ s lumen, which prevents the deployed ends of the barb from rotating and provides a connection to a delivery feature 284 such as a thread or rod of a delivery catheter
  • An anchor delivery catheter 240 may be the same component as a prosthetic valve delivery shaft 230 contained withing a delivery sheath 220
  • Tissue anchors may be adapted to be passed through or connected to an anchor point on a leg 201 and atrial petal 202 and through tissue such as the posterior annulus 62 as shown for example in Figure 12C.
  • the structural frame 120, arm(s) 210, or leg(s) 190 may be covered at least partly in a fabric such as felt or a woven fabric, which may facilitate tissue ingrowth to advantageously hold the prosthetic valve 100 securely to native tissue to improve longevity.
  • the fabric layer 176 may be attached to areas of the prosthetic valve 100 intended to securely contact native tissue such as the external side 108 of the atrial section 121 or annulus section 122.

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 une valve mitrale postérieure prothétique implantable dans laquelle une variation comprend généralement un cadre. Un feuillet postérieur ayant une ou plusieurs échancrures peut être relié au cadre de telle sorte que les échancrures s'étendent à partir du cadre pour une coaptation contre un feuillet antérieur natif lorsque le cadre est déployé. Au moins un élément de bras peut être relié au cadre de telle sorte que l'élément de bras s'étend latéralement dans une configuration incurvée configurée pour se rapprocher d'une courbure d'un anneau mitral natif lorsque le cadre est déployé, et une patte d'ancrage peut être reliée au cadre et s'étendre dans une direction supérieure à partir d'un côté postérieur du cadre et définit une région de capture entre la patte d'ancrage et le côté postérieur. La région de capture peut être dimensionnée pour recevoir au moins une partie d'un feuillet postérieur natif dans un état allongé lorsque le cadre est déployé.
EP22893852.8A 2021-11-14 2022-11-10 Valve mitrale postérieure prothétique implantable Pending EP4391971A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163279157P 2021-11-14 2021-11-14
US202263380553P 2022-10-21 2022-10-21
PCT/US2022/079665 WO2023086904A1 (fr) 2021-11-14 2022-11-10 Valve mitrale postérieure prothétique implantable

Publications (2)

Publication Number Publication Date
EP4391971A1 true EP4391971A1 (fr) 2024-07-03
EP4391971A4 EP4391971A4 (fr) 2025-07-16

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP22893852.8A Pending EP4391971A4 (fr) 2021-11-14 2022-11-10 Valve mitrale postérieure prothétique implantable

Country Status (2)

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EP (1) EP4391971A4 (fr)
WO (1) WO2023086904A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4649919A1 (fr) * 2024-05-13 2025-11-19 AVVie GmbH Implant pour améliorer la coaptation d'une valve auriculo-ventriculaire dans un coeur humain

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100217382A1 (en) * 2009-02-25 2010-08-26 Edwards Lifesciences Mitral valve replacement with atrial anchoring
US9439763B2 (en) * 2013-02-04 2016-09-13 Edwards Lifesciences Corporation Prosthetic valve for replacing mitral valve
US9517131B2 (en) * 2014-12-12 2016-12-13 Than Nguyen Cardiac valve repair device
US20190029811A1 (en) * 2016-02-12 2019-01-31 Dfm, Llc Heart valve
EP3515364A4 (fr) * 2016-09-26 2020-04-22 Innercore Medical Ltd. Dispositif et procédé de réparation de valvule mitrale
US11173032B2 (en) * 2017-08-28 2021-11-16 Edwards Lifesciences Corporation Transcatheter device for treating mitral regurgitation
CN111465369B (zh) * 2017-08-31 2023-05-12 半月医疗有限公司 人工瓣叶装置
CN114727864B (zh) * 2019-09-19 2025-10-17 美敦力公司 具有接合结构和多个小叶捕获夹子的瓣膜修复装置

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WO2023086904A1 (fr) 2023-05-19
EP4391971A4 (fr) 2025-07-16

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