US20160256269A1 - Devices for treating paravalvular leakage and methods use thereof - Google Patents
Devices for treating paravalvular leakage and methods use thereof Download PDFInfo
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- US20160256269A1 US20160256269A1 US15/061,549 US201615061549A US2016256269A1 US 20160256269 A1 US20160256269 A1 US 20160256269A1 US 201615061549 A US201615061549 A US 201615061549A US 2016256269 A1 US2016256269 A1 US 2016256269A1
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- anchor
- elongate
- anchor member
- openings
- paravalvular leakage
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- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- 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
- A61F2/2463—Implants forming part of the valve leaflets
-
- 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
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- A—HUMAN NECESSITIES
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00619—Locking means for locking the implement in expanded state
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- A—HUMAN NECESSITIES
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- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0406—Pledgets
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- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0419—H-fasteners
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- 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
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0069—Sealing means
Definitions
- FIG. 1 illustrates an artificial valve 1600 that may include, for example, a multi-leaflet structure 1602 and that may be implemented in an appropriate manner as will be appreciated by those of ordinary skill in the art. Additionally, a small opening or space 1604 between the heart 1606 and the valve 1600 is shown as may occur in some instances of valve replacement. This opening or space 1604 results in undesired leaking during pumping of the heart and is termed a valvular or paravalvular leak.
- the anchor includes at least one elongate anchor member. In some embodiments, the anchor includes one elongate anchor member. In some embodiments, the anchor includes two elongate anchor members. In yet other embodiments, the anchor includes three or more elongate anchor members. In certain embodiments, the two, three, or more elongate anchor members are made of a same material. In certain other embodiments, the two, three, or more elongate anchor members are made of different materials.
- the anchor has an elongate configuration where the elongate anchor member is relaxed and extended. In some embodiments, the anchor has a shortened configuration when the elongate anchor member(s) is folded or otherwise shortened. In certain embodiments, the anchor is in its shortened configuration when deployed and/or secured.
- the elongate anchor member is made of a flexible material.
- the flexible material is a surgical grade fabric.
- the elongate anchor member may also take various forms such as woven or nonwoven fabrics, polymers, metals, other suitable materials, or combinations thereof.
- the surgical grade fabric used in various embodiments of the present teachings can be constructed from a polyester, such as Dacron®, RTM, PTFE, UHMPE, HDPE, polypropylene, polysulfone, or other biocompatible plastic.
- the elongate anchor member causes a tissue response, for example, tissue growth.
- the surface finish of the anchor member is textured to induce tissue response and tissue in-growth for improved stabilization.
- the anchor member comprises porous materials to promote tissue in-growth.
- one or more of the edges and/or other portions of the anchor member are modified, for example, to prevent from fraying.
- one or more of the edges or other portions of the anchor member are coated with a material that locks the fibers in place. Other methods can also be used to lock the fibers at one or more edges of the anchor member in place.
- the anchor includes at least one tensioning member.
- the tensioning member causes both ends of the elongate anchor member to move towards each other. This motion can create a shortened distal portion and/or a shortened proximal portion. In certain embodiments, doing so secures the paravalvular leakage between the distal and the proximal portions of the elongate anchor member.
- an anchor of the present teachings includes two elongate anchor members
- the tensioning member causes at least one of the two elongate anchor members to move towards the other elongate anchor member. In certain embodiments, the tensioning member causes both of the elongate anchor members to move towards each other.
- the tensioning member causes at least one of the three or more elongate anchor members to move towards another elongate anchor member. In certain embodiments, the tensioning member causes all of the three or more elongate anchor members to move towards one another. This motion can create shorten elongate anchor members. In certain other embodiments, doing so secures the paravalvular leakage between two of the elongate anchor members.
- the tensioning member is in the form of a suture, as defined herein. It will be appreciated that the tensioning member may take forms other than a suture, such as any other small-diameter members having a suitable tensile strength for the intended anchoring use.
- one or both of the tensioning member and the elongate anchor member are made of a resorbable polymer.
- a resorbable polymer is polyactic acid, polyglycolic acid, polycaprolactone, or a combination thereof.
- Other resorbable polymers that are known to those skilled in the art can also be used without undue experimentation and thus are within the scope of the present teachings.
- the material that is used to make the anchor i.e., the elongate anchor member(s), the tensioning member, or both, is multilayered.
- the material includes a coating of resorbable polymer.
- the materials includes a semipermeable polymer that optionally is impregnated with one or more of the compounds discussed herein. In certain embodiments, the one or more compounds is released in a controlled manner.
- the anchor including the elongate anchor member(s), the tensioning member, or both, includes one or more compounds that address issues associated with the product performance.
- one or more compounds can be embedded in the anchor member.
- the one or more compounds are released over time after implantation. These compounds can reduce calcification, protein deposition, thrombus formation, or a combination of some or all of these conditions.
- the one or more compounds can also be used to stimulate a biological response, for example, to induce tissue in-growth.
- the compound is an anti-inflammatory agent.
- the compound reduces tissue proliferation adjacent to the device.
- the tensioning member extends through openings along the elongate anchor member as described herein such that tightening the tensioning member will cause the elongate anchor member to fold.
- anchor deployment may take on various forms due to the flexible nature of the anchor member, especially when a highly flexible fabric or other materials is used. For example, a fabric material or other similarly flexible materials may be folded or otherwise deformed during a deployment to a leakage site.
- the method includes providing an anchor as described herein, positioning the anchor through a paravalvular leakage, deploying the anchor where at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage.
- the method includes applying tension to the tensioning member so that at least a part of the distal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration.
- the method includes deploying the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage.
- the method includes applying tension to the tensioning member so that at least a part of the proximal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration.
- the method includes providing an anchor as described herein, positioning the anchor through a paravalvular leakage, deploying the anchor where at least a part of a first elongate anchor member is on one side of the paravalvular leakage. In various embodiments, the method includes applying tension to the tensioning member so that at least a part of the first elongate anchor member transitions from the elongate configuration to the shortened configuration. In various embodiments, the method includes deploying the anchor wherein at least a part of a second elongate anchor member is on the other side of the paravalvular leakage.
- the method includes applying tension to the tensioning member so that at least a part of the second elongate anchor member transitions from the elongate configuration to the shortened configuration.
- the anchor used in repairing a paravalvular leakage can include two or more elongate anchor members and a tensioning member can pass through one, two, or more of the elongate anchor members.
- anchors of the present teachings is used percutaneously.
- the anchors are delivered percutaneously.
- anchors of the present teachings are used in minimally invasive surgeries.
- anchors of the present teachings are used in open-heart surgeries.
- the method includes introducing a catheter approximately at the paravalvular leakage site. In some embodiments, the method includes withdrawing the catheter to deploy the anchor where at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor where at least a part of a first elongate anchor member is on one side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor wherein at least a part of a second elongate anchor member is on the other side of the paravalvular leakage.
- a clinician deploys a plurality of anchors in a paravalvular leakage, when necessary and practical.
- At least half number of the folds is distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage.
- At least some of the folds is distal to the paravalvular leakage. In various embodiments, upon deployment, at least some of the folds are proximal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are distal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are proximal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are distal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are proximal to the paravalvular leakage.
- At least one of the folds is in the paravalvular leakage. In some embodiments, upon deployment, at least some of the folds are distal to the paravalvular leakage and at least one of the folds is in the paravalvular leakage. In some embodiments, at least some of the folds are proximal to the paravalvular leakage and at least one of the folds is in the paravalvular leakage. In certain embodiments, upon deployment, at least some of the folds are distal to the paravalvular leakage, at least one of the folds is in the paravalvular leakage, and at least some of the folds are proximal to the paravalvular leakage.
- At least a part of a first anchor member upon deployment, at least a part of a first anchor member is distal to the paravalvular leakage. In various embodiments, upon deployment, at least a part of a second anchor member is proximal to the paravalvular leakage. In various embodiments, upon deployment, at least a part of an anchor member is in the paravalvular leakage. In some embodiments, upon deployment, at least a part of a first anchor member is distal to the paravalvular leakage and at least a part of a second anchor member is proximal to the paravalvular leakage.
- At least a part of a first anchor member is distal to the paravalvular leakage, at least a part of a second anchor member is proximal to the paravalvular leakage, and at least a part of a third anchor member is in the paravalvular leakage.
- the elongate anchor member also includes a marker.
- the marker can be in the form of threads, beads, or other forms. Without limiting the scope of the present teachings, the marker allows the anchor member to be visualized by using a radiographic imaging equipment using x-ray, magnetic resonance, ultrasound, fluoroscopic, or other visualization techniques.
- markers are attached to the anchor member.
- the markers can be wrapped, laminated, and/or bonded through a welding process.
- An adhesive such as cyanoacrylate or other adhesives known to those skilled in the art can also be used to attach a marker to the anchor member.
- the marker is a radiopaque marker.
- the radiopaque marker is made of titanium, tungsten, platinum, irridium, gold, an alloy of any of these materials, or a composite having any of the above materials. Other materials that are known to those skilled in the art can also be used.
- the marker is a paramagnetic marker.
- the paramagnetic marker is made of a material containing gadolinium, iron, platinum, manganese, cobalt, fluorine, or other paramagnetic materials.
- the markers each comprises other MR visible materials that are known to those skilled in the arts.
- the marker is an echogenic marker.
- the echogenic marker is made of a material that is capable of reflecting increased ultrasound waves. Some echogenic materials are described herein elsewhere.
- the marker protrudes out of or is flush with the anchor. In various embodiments, the markers are arranged on the implant in a pattern.
- the anchor or a component thereof is treated so that the anchor or a part thereof is visible under a visualization technique.
- the visualization technique is based on ultrasound.
- the visualization technique is echocardiography.
- an elongate anchor member of the present teachings is treated so that it is visible in a visualization technique.
- a part of the elongate anchor member is treated so that it is visible in a visualization technique.
- a marker of the present teachings is treated so that it is visible in a visualization technique.
- the treatment is performed on a surface of an anchor or a component thereof.
- a surface of at least a part of the elongate anchor member is treated so that the elongate anchor member is visible in a visualization technique. In certain embodiments, a surface of at least a part of the marker is treated so that the marker is visible in a visualization technique.
- the treatment is performed with an echogenic material.
- the material can contain fluorine element.
- the material includes a perfluoro compound.
- the material includes perflutren.
- the material includes perflexane.
- the material includes sulfur hexafluoride.
- the material includes another echogenic material known to persons with ordinary skill in the art.
- the method includes locating a paravalvular leakage.
- a paravalvular leakage can be detected and/or located by using echocardiography, computed tomography (CT), or cardiac magnetic resonance.
- CT computed tomography
- the method includes locating a paravalvular leakage by using echocardiography.
- the device includes a catheter and an anchor as described herein.
- the catheter includes a distal end and a lumen having an opening at the distal end.
- the anchor is provided at least partially in the lumen.
- FIG. 1 shows an artificial valve implanted into a heart having a paravalvular leakage
- FIG. 2 is a perspective view of an exemplary anchor in accordance with the present teachings
- FIG. 3A is a side view of an anchor positioned in a paravalvular leakage in accordance with some embodiments of the present teachings
- FIG. 3B is a side view similar to FIG. 3A , but illustrating the distal portion of the exemplary anchor being moved toward the paravalvular leakage
- FIG. 3C is a side view similar to FIG. 3B , but showing the distal portion of the exemplary anchor fully compressed and engaged against the paravalvular leakage,
- FIG. 3D is a side view similar to FIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage
- FIG. 3E illustrates the proximal and distal portions of the exemplary anchor fully compressed against opposite sides of the paravalvular leakage
- FIG. 3F is an enlarged cross sectional view of an exemplary anchor fully deployed and fastened with a paravalvular leakage between proximal and distal anchor portions
- FIG. 3G is a side view of an anchor positioned in a paravalvular leakage in accordance with some embodiments of the present teachings
- FIG. 3H is a side view similar to FIG. 3A , but illustrating the distal portion of the exemplary anchor being moved toward the paravalvular leakage
- FIG. 3I is a side view similar to FIG. 3B , but showing the distal portion of the exemplary anchor fully compressed and engaged against the paravalvular leakage,
- FIG. 3J is a side view similar to FIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage
- FIG. 3K is a side view similar to FIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage
- FIG. 3L is an enlarged cross sectional view of an exemplary anchor fully deployed and fastened with a paravalvular leakage between proximal and distal anchor portions
- FIG. 4 is a side elevation view of an exemplary anchor in accordance with some embodiments of the present teachings.
- FIGS. 5A-5D are respective side views illustrating a sequence of steps used for securing the anchor to a paravalvular leakage in accordance with some embodiments of the present teachings
- FIG. 5E is a view similar to FIG. 5D , but illustrating an alternative tip and tensioning member arrangement in accordance with some embodiments of the present teachings,
- FIG. 6A is a front view of the elongate anchor member of an anchor in accordance with some embodiments of the present teachings
- FIG. 6B is a front elevation view similar to FIG. 6A , but illustrating radiopaque markers in accordance with some embodiments of the present teachings
- FIG. 6C is a front elevation view of an alternative elongate anchor member having a varying width along its length in accordance with some embodiments of the present teachings
- FIG. 6D is a side elevation view of another alternative elongate anchor member utilizing more rigid fold sections separated by living hinges in accordance with some embodiments of the present teachings,
- FIG. 7A is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 7B is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 7C is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 8 is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 10A is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 10B is a side elevation view of the anchor in FIG. 10A .
- FIG. 11 is a perspective view of an exemplary anchor deployed across a paravalvular leakage in accordance with the present teachings
- FIG. 12A is a perspective view of an anchor in accordance with some embodiments of the present teachings.
- FIG. 12C is a side elevation view of the anchor of FIGS. 12A-12B .
- FIG. 12D is top plan view of the anchor of FIGS. 12A-12B .
- proximal means closest to the operator (less into the body) and “distal” means furthest from the operator (further into the body). In positioning a medical device from a downstream access point, distal is more upstream and proximal is more downstream.
- tensioning member means a member which can take forms of a suture, cable, wire, or any other small diameter, flexible, semi-rigid or rigid material having a suitable tensile strength for the intended use.
- wire can be a strand, a cord, a fiber, a yarn, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
- suture used herein can be a strand, a wire, a cord, a fiber, a yarn, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
- an anchor 10 constructed in accordance with some embodiments of the present teachings generally includes a tensioning member 12 , such as a suture, extending through spaced apart points along an elongate anchor member 14 of flexible material, such as a surgical grade fabric.
- a tensioning member 12 such as a suture
- the tensioning member 12 may take other forms other than suture material, such as cable or any other small diameter member having a high enough tensile strength for the intended use.
- the elongate anchor member 14 may also take various forms such as woven or nonwoven fabrics, polymers, metals, or other suitable materials or combinations of materials.
- One or more separate pledgets or other securement members may be used in conjunction with the elongate anchor member 14 for added securement and/or concealing the elongate anchor member 14 and, for example, thereby inhibiting blood clotting within or adjacent to the folds that will be formed in the elongate anchor member 14 .
- a woven or nonwoven material may contain additional materials, such as threads, beads or other elements that cause at least portions of the elongate anchor member 14 to be radiopaque.
- additional materials such as threads, beads or other elements that cause at least portions of the elongate anchor member 14 to be radiopaque.
- a surgical grade fabric constructed from polyester, such as Dacron® is contemplated for use in constructing the elongate anchor member 14 .
- One of many possible alternative materials for use in constructing the elongate anchor member 14 is polytetrafluoroethylene (PTFE).
- Anchor 10 may be partly or wholly formed from materials that are absorbed into the patient's tissue over time, depending on the intended use.
- edges and/or other portions of the elongate anchor member 14 may be suitably modified to prevent fraying, such as by being coated with a material that locks the fibers in place, or otherwise modified in a manner that locks the fibers at least at the edges of the elongate anchor member 14 in place.
- the suture 12 may extend from a proximal portion 14 a of the elongate anchor member 14 to a distal end portion 14 b and then loop back through spaced apart points of the elongate anchor member 14 to the proximal portion 14 a where a knot 16 or other stop member is located.
- the suture 12 extends through spaced apart locations along the elongate anchor member 14 such that tensioning of the suture 12 or other tensioning member will cause the elongate anchor member 14 to form folded portions 14 c when the tensioning member 12 is placed under tension or pulled.
- the elongate anchor member 14 is activated in this manner between essentially an elongate configuration, such as shown in FIG.
- a shortened configuration such as a folded or otherwise shortened configuration having an expanded width in at least one dimension as compared to the elongate configuration.
- the deployment orientation may take on various forms due to the flexible nature of the elongate anchor member 14 , especially when using a highly flexible fabric or other material.
- a fabric material or other similarly flexible materials may be folded or otherwise deformed for carrying purposes within a catheter and/or during deployment to a paravalvular leakage site and then suitably activated at the leakage site.
- the elongate anchor member 14 and attached suture 12 are initially inserted through a paravalvular leakage site 20 as generally shown in FIG. 3A .
- One end or portion 12 a of the suture 12 is then pulled and thereby placed under tension.
- suture portion 12 a may extend to a location outside the patient's body for pulling or tensioning, or it may be grasped by a suitable mechanism within the catheter and pulled or tensioned. Pulling suture portion 12 a may initially draw the distal portion 14 b of the elongate anchor member 14 toward the paravalvular leakage site 20 as shown in FIG. 3B .
- the proximal portion 14 a begins to be drawn and compressed against a proximal side of the paravalvular leakage site 20 as shown in FIGS. 3C-3E .
- end 12 a of the suture 12 is being pulled downwardly (as viewed for purposes of discussion in FIGS. 3C-3E ) and, since the suture 12 is looped in a reverse direction through distal end portion 14 b of the elongate anchor member 14 , the knot 16 at the end of the suture 12 moves upwardly and brings the proximal portion 14 a of the elongate anchor member 14 with it.
- proximal portion 14 a of the elongate anchor member 14 is being folded and drawn along the suture 12 toward the paravalvular leakage 20 and then firmly compressed against the proximal side of the paravalvular leakage 20 as shown in FIG. 3E .
- a suitable locker element such as a crimp member 22 , a knot or other element may be used to maintain the suture 12 and elongate anchor member 14 in the positions shown in FIG. 3F securely anchoring the proximal and distal portions 14 a, 14 b of the elongate anchor member 14 folded against opposite sides of the paravalvular leakage 20 .
- Anchors having two or more elongate anchor members can also be used to repair a paravalvular leakage.
- an anchor includes a distal elongate anchor member 14 b ′, a proximal elongate anchor member 14 a ′, and a tensioning member 12 slideably connecting the distal elongate anchor member 14 b ′ and the proximal elongate anchor member 14 a ′.
- one end of the tensioning member passes through the proximal elongate anchor member 14 a ′ and the distal elongate anchor member 14 b ′, loops back, passes through the distal elongate anchor member 14 b ′ and the proximal elongate anchor member 14 a ′, and forms a knot 16 around the tensioning member 12 .
- the other end, or the proximal end 12 a ′, of the tensioning member extends through a delivery catheter and exists outside of the body. The passing through an elongate anchor member can be achieved by passing through one or two holes in the elongate anchor member or threading through the elongate anchor member itself.
- the method of repairing a paravalvular leakage includes, as shown in FIG. 3G , inserting the distal elongate anchor member 14 b ′ and attached tensioning member 12 through a paravalvular leakage 20 .
- the method includes pulling the proximal end 12 a of the tensioning member 12 .
- the pulling of the tensioning member in some embodiments, folds at least a portion of the distal elongate anchor member 14 b ′ and/or draws the distal elongate anchor member towards the paravalvular leakage site 20 , as shown FIG. 3H .
- the method includes continuing pulling the proximal end 12 a of the tensioning member 12 to compress the distal elongate anchor member 14 b ′ against the paravalvular leakage 20 , as shown in FIG. 3I .
- the method includes folding at least a portion of the proximal elongate anchor member 14 a ′ and drawing the proximal elongate anchor member 14 a ′ towards the paravalvular leakage site 20 , as shown in FIG. 3J .
- the folding of at least a portion of the proximal elongate anchor member 14 a ′ and/or the drawing of the proximal elongate anchor member 14 a ′, in certain embodiments, are achieved sequentially or simultaneously by continuing pulling the proximal end 12 a of the tensioning member 12 .
- the method includes using a suitable locker element 22 to maintain the anchor 10 in the deployed configuration, as shown in FIG. 3L .
- FIG. 4 is a side elevation view of an anchor 70 according to some embodiments of the present teachings.
- This anchor includes a distal tip 76 .
- this anchor includes a proximal radiopaque band 90 and a distal radiopaque band 92 .
- Both the radiopaque bands can be attached to the suture 72 , as shown in FIG. 4 , or otherwise secured to the suture 72 , at the proximal end portion of the anchor member 74 and to either the interior or exterior of the distal tip 76 , respectively, or any other part of the anchor 70 .
- these bands or other markers 90 and 92 will indicate to the clinician that the anchor 70 has been deployed, activated, fully compressed, and/or fastened, as necessary during the procedure.
- the tip 76 itself may alternatively be formed from a radiopaque material.
- the knot 94 formed in the suture 72 or other tensioning member is a slip knot through which another portion of the suture 72 slides during activation of the anchor 70 . It will be appreciated that this slip knot 94 may be replaced by another element which serves substantially or approximately the same purpose but takes the form, for example, of a small tubular element or other feature similar in function to a slip knot.
- the elongate anchor member 74 may be about 40 mm long by about 3 mm wide. This may be desirable to achieve a lower profile. These embodiments may lead to more versatile applications, lower incidents of blood clotting, easier use, etc. Of course, any other desired dimensions and shapes may be used, depending on application needs.
- the tensioning member or suture 72 can advantageously extend through respective fold portions 74 c of the elongate anchor member 74 in essentially an hourglass configuration. Specifically, adjacent portions of the suture 72 located near the proximal and distal end portions 74 a, 74 b of the anchor member 74 are spaced farther apart than the adjacent portions of the suture 72 in the middle of the anchor member 74 .
- radiopaque markers such as distinct areas of dots 95 , may be used for enabling the clinician to visualize the folds of the elongate anchor member 74 during deployment and securement of the elongate anchor member 74 .
- These dots or other radiopaque markers may be printed on the anchor member 74 .
- dots 95 or other markers may be formed with a platinum powder base ink or other suitable material that is radiopaque and biologically compatible. This radiopaque material may also add stiffness to the fold sections 74 c thereby helping to maintain the fold sections 74 c flat and increasing retention force on the paravalvular leakage. Meanwhile, the fold lines 74 d between fold sections 74 c can remain highly flexible to create tight radius fold lines.
- each of the holes 96 that the tensioning member or suture 72 is received through may be marked by circles 98 surrounding each hole 96 or other markers for visualizing purposes during assembly of the tensioning member or suture 72 with the elongate anchor member 74 .
- holes 96 may be eliminated and the suture 72 may be threaded with a needle through the anchor member 74 .
- the tensioning member or suture 72 may be threaded or otherwise attached along the anchor member 74 in any number of manners including, for example, x-patterns or other crossing patterns, zig-zag patterns, etc. that may alter the folded or otherwise shortened or compressed footprint of the anchor into various beneficial shapes, such as flower shapes, circular shapes or other rounded shapes, ball shapes or other configurations. Modifications of the manner in which the tensioning member or suture 72 is threaded or otherwise attached along the length of anchor member 74 may result in higher or lower tensioning force being required to compress the anchor and/or higher or lower friction holding force that may help maintain the anchor in the compressed or shortened configuration.
- the width of the elongate anchor member 74 ′ may be varied along its length, such as by tapering, stepping, or forming an hourglass shape or shapes along the length of the anchor member 14 .
- having proximal and distal end portions 75 , 77 of wider dimension than an intermediate or middle portion or portions 79 along the length of anchor member 74 ′ will allow these wider portions 75 , 77 may cover over the more intermediate folded portions 79 and prevent unnecessary contact with adjacent tissue during use.
- the elongate anchor member 74 may have variable stiffness including, for example, a relatively rigid perimeter or relatively rigid edges 74 e, 74 f ( FIG. 6A ) or intermittent relatively rigid sections 74 c ′′ separated by flexible sections such as living hinges 74 d ′′ ( FIG. 6D ) that may aid in folding and securing the elongate anchor member 74 ′′ into a folded condition.
- FIGS. 5A-5D illustrate a series of steps for deploying and securely fastening the anchor 70 to a paravalvular leakage site 100 according to some embodiments of the present teachings.
- the combination of the elongate anchor member 74 and tensioning member or suture 72 is deployed through the paravalvular leakage site 100 .
- One end or portion 72 a of the suture 72 that extends through the slip knot 94 is then pulled. This causes the distal portion 74 b of the elongate anchor member 74 to fold and compress against the distal side of the paravalvular leakage 100 .
- FIG. 5A the combination of the elongate anchor member 74 and tensioning member or suture 72 is deployed through the paravalvular leakage site 100 .
- One end or portion 72 a of the suture 72 that extends through the slip knot 94 is then pulled. This causes the distal portion 74 b of the elongate anchor member 74 to fold and compress against the distal side of the paravalvular leakage 100
- FIG. 5B further pulling the tensioning member 72 causes the slip knot 94 to ride upwardly or distally along the suture 72 and against a proximal portion 74 a of the elongate anchor member 74 , thereby folding and compressing the proximal portion 74 a against the proximal side of the paravalvular leakage 100 as shown in FIG. 5C .
- a suitable crimp or locking element 102 may be used to securely lock the slip knot 94 in place relative to the suture or tensioning member segment which extends therethrough. This will lock the entire anchor 70 in place with the respective proximal and distal folded anchor member portions 74 a, 74 b securely retaining the paravalvular leakage 100 therebetween.
- FIG. 5D shows the tip 76 acting as a retainer on top of the distal end portion 74 b to assist in holding the distal end portion 74 b in place.
- FIG. 5E shows an alternative in which the tensioning member is threaded through at least one hole 76 a more centrally located in the tip. Yet another alternative would be to thread the tensioning member through two centrally located holes instead of through the proximal end of the tip 76 and one centrally located hole 76 a as shown in FIG. 5E . These alternatives allow the tip 76 to act more like a “T”-bar with forces acting in a more perpendicular or normal manner relative to the distal end portion 74 b of the anchor member 74 .
- FIG. 7A illustrates an exemplary anchor of the present teachings.
- the elongate anchor member has a rectangle profile as illustrated in FIG. 7A .
- the elongate anchor member has an hour glass profile as illustrated in FIG. 7B .
- the elongate anchor member can have other profiles, and accordingly, the embodiments discussed herein are not limiting to the scope of the present teachings.
- an anchor 200 constructed in accordance with some embodiments of the present teachings generally includes a tensioning member 201 extending from a proximal end portion 212 of an elongate anchor member 210 to a distal end portion 214 .
- the tensioning member 201 loops back and extends from the distal end 214 to the proximal end portion 212 .
- the tensioning member 201 passes through a plurality of openings along the elongate anchor member 210 .
- one end of the tensioning member 201 after it extends from the proximal end to the distal end and loops back to the proximal end of the anchor member 210 , forms a knot 220 around the other end portion of the tensioning member 201 .
- the knot 220 slides along the other end portion of the tensioning member 201 in such way that it pulls the free end of the tensioning member 201 proximally, causing the knot 220 moving distally and shortening the longitudinal length of the anchor member 210 .
- the elongate anchor member 210 is folded and the ends of the anchor member 210 are drawn toward each other.
- the elongate anchor member 210 also can include at least one pre-set folding line (not shown) which allows the elongate anchor member 210 to be fold at the pre-set folding line.
- an anchor such as that referred to as anchor 200 , shortens at one of the proximal and distal ends. For example, when the tensioning member 201 is pulled, at least a part of the distal portion 214 folds first while the proximal end 212 substantially maintains its elongated configuration. In some embodiments, this occurs when the distal portion 214 is deployed. In certain embodiments, this occurs when the distal portion 214 is deployed and the proximal portion 212 is not deployed, for example, because the proximal portion 212 is restrained in a delivery catheter (not shown).
- the elongate anchor member has two sets of openings 225 , 226 (first openings 225 and second openings 226 ).
- the tensioning member 201 extends from the proximal end portion 212 of the anchor member 210 to the distal end portion 214 of the anchor member 210 through the first set of openings 225 .
- the tensioning member 201 loops back and further extends from the distal end portion of the anchor member 210 to the proximal end of the anchor member through the second set of openings 226 .
- the tensioning member 201 extends from the proximal end of the anchor member 210 distally, travels from one side of the anchor member 210 to another side by passing through the first opening 225 closest to the proximal end of the anchor member 210 in the first set of openings 225 ; the tensioning member 201 further extends distally, passes through the next opening 225 distal to the first opening 225 in the first set of openings 225 .
- the tensioning member extends further distally repeating above steps until it passes through the last opening 225 in the first set of openings 225 and reaches the distal end of the anchor member 210 .
- anchor members 210 having between four and twelve openings 225 in the first set of openings can be made and used by one with ordinary skill in the art without undue experimentation.
- the tensioning member 201 upon reaching the distal end of the anchor member 210 , the tensioning member 201 loops back, extends proximally, travels from one side of the anchor member 210 to another side by passing through the first opening 226 closest to the distal end of the anchor member 210 in the second set of openings 226 .
- the tensioning member 201 further extends proximally, travels to the first side of the anchor member 210 by passing through the next opening 226 proximal to the first opening 226 in the second set of openings 226 .
- the tensioning member 201 extends further proximally repeating the above steps until it passes through the last opening 226 in the second set of openings 226 and reaches the proximal end of the anchor member 210 .
- Elongate anchor members 210 having between four and twelve openings 226 in this set can be made and used by one with ordinary skill in the art without undue experimentation.
- the tensioning member 201 extends from one side of the anchor member 210 distally, loops back, and ends on the same side of the anchor member 210 . In other embodiments, the tensioning member 201 extends from one side of the anchor member 210 distally, loops back, and ends on a different side of the anchor member 210 .
- the number of openings 225 in the first set and the number of openings 226 in the second set are the same as illustrated in FIG. 7A . In other embodiments, the number of openings 225 in the first set and the number of openings 226 in the second set are different.
- first and second sets of openings 225 , 226 are different as illustrated in FIG. 7A . In other embodiments, the first and second sets of openings 225 , 226 share at least one opening as illustrated in FIG. 7C . This common opening is identified with reference character 227 in FIG. 7C .
- the anchor member 210 can have an hour glass profile as illustrated in FIG. 7B .
- the anchor member 210 has a pair of sections 229 of increased width (with one being located at the proximal end portion 212 and one at the distal end portion 214 ).
- At least one opening 225 in the first set of openings 225 has a corresponding opening 226 in the second set of openings 226 and together they form a pair of openings on the anchor members 210 .
- at least one pair of openings 225 , 226 form a line perpendicular to the longitudinal axis of the anchor member 210 .
- at least one pair of the openings 225 , 226 forms a line parallel to the longitudinal axis of the anchor member 210 .
- at least one pair of the openings 225 , 226 form a line that forms an angle with the longitudinal axis of the anchor member 210 .
- lines formed by all of the pairs of openings 225 , 226 are in the same orientation with one another. For example, they can be parallel to one another and/or perpendicular to the longitudinal axis of the anchor member 210 as illustrated in FIG. 7A . In another embodiment, they can all be parallel to the longitudinal axis of the anchor member 210 . In yet other embodiments, the lines formed by all the pairs of openings 225 , 226 can have random directions.
- the two openings 225 , 226 in a pair are 2-3 mm apart from each other. In some embodiments, the distance between two opening 225 , 226 is the same in each pair. In some embodiments, the distance between two openings 225 , 226 is different from one pair to another.
- the distance between two adjacent openings 225 , 225 (or 226 , 226 ) in the same set, defined by the distance from one opening to the next closest one in the same set of openings (either 225 or 226 ), is about 5-12 mm. In some embodiments, the distances between each adjacent openings 225 , 225 (or 226 , 226 ) is the same as each other. In some embodiments, the distances between each adjacent openings is different from each other.
- At least one pair of the openings 225 , 226 are at the lateral center of the anchor member. In some embodiments, all the pairs of openings 225 , 226 are at the lateral center of the anchor member. In some embodiments, at least one pair of the openings 225 , 226 is biased toward one side of the anchor member 210 . In some embodiments, all the pairs of openings 225 , 226 are biased toward the same side of the anchor member. In some embodiments, each of the pairs of openings is biased toward different sides of the anchor member 210 .
- all the openings 225 , 226 in at least one set of openings, or in both the sets of openings form a straight line. In various embodiments, all the openings in at least one set of the openings, or in both the sets of openings, form a curved line.
- FIGS. 8 illustrates an exemplary elongate profile of an exemplary anchor 300 that includes an elongate anchor member 310 and wherein the openings 225 in the first set of openings 225 form a straight line parallel to the longitudinal axis of the anchor member 310 , and the openings 226 in the second set of openings 226 form another straight line parallel to the longitudinal axis of the anchor member 310 and at a distance from the line formed by the first set of openings 225 .
- FIG. 9 illustrates an exemplary elongate profile of an exemplary anchor 400 that includes an elongate anchor member 410 .
- the openings 225 in the first set of openings form a curve with the openings 225 in the middle portion of the anchor member closest to the lateral center of the anchor member 410
- the openings 226 in the second set of openings form another curve with the openings 226 in the middle portion of the anchor member 410 closest to the lateral center of the anchor member 410
- the two curves have a lateral distance from each other and together form an “hour glass” shape.
- FIGS. 10A and 10B illustrate an exemplary elongate profile of an exemplary anchor 500 that includes an elongate anchor member 510 . All openings 225 , 226 in both sets of the openings are aligned with each other forming a straight line parallel to the longitudinal axis of the anchor member 510 .
- FIG. 10B is a side elevation view of the anchor member 510 showing the routing of the tensioning member 201 through the anchor member 510 .
- At least one pre-set folding line is created between two pairs of the openings 225 , 226 , as illustrated in FIG. 12A .
- the pre-set folding line can be made by heat setting with or without a mold. One skilled in the art would understand that other methods can also be used to create pre-set folding lines without undue experimentations.
- the pre-set folding lines allow the elongate anchor member to fold at pre-defined places.
- a pre-set folding line is created between every two pairs of the openings 225 , 226 , for example, as illustrated in FIGS. 8-10 .
- the elongate anchor member (e.g., anchor member 210 ) shortens and creates folds as illustrated in FIG. 11 .
- the number of the folds in the anchor in its deployed profile ranges from 4 to 12.
- the number of the folds is the same as the number of the openings in at least one set of the openings 225 , 226 .
- the number of the folds has no particular relationship with the number of the openings in either set of the openings 225 , 226 .
- the number of the folds is the same as the number of the pre-set folding lines plus one. In other embodiments, the number of the folds has no particular relationship with the number of the pre-set folding lines.
- FIGS. 12A-D illustrate an exemplary embodiment of the present teachings. Specifically, FIGS. 12A and 12D illustrate an exemplary elongate profile and an exemplary deployed profile, respectively, of an anchor 600 of the present teachings.
- the anchor 600 includes an elongate anchor member 610 .
- the elongate anchor member 610 has two sets of openings 225 , 226 through which the tensioning member 201 weaves.
- the tensioning member 201 weaves through the first set of openings 225 as it extends from the proximal end to the distal end of the anchor member 610 and weaves through the second set of openings 226 as it returns from the distal end to the proximal end of the anchor member 610 .
- At least one opening in the first set of openings corresponds with another opening in the second set of openings and together they form a pair of openings on the anchor member.
- FIG. 12A there are 5 pairs of openings 225 , 226 in the distal portion of the anchor member, and 3 pairs of openings 225 , 226 in the proximal portion of the anchor member 510 .
- each pair of the openings 225 , 226 in the distal end section of the distal portion of the anchor member form an imaginary line and the imaginary lines from the opening pairs 225 , 226 in the distal portion of the anchor member 610 are parallel to one another and perpendicular to the longitudinal axis of the anchor member 610 , and at the lateral center of the anchor member 610 ; all openings 225 , 226 in the proximal end section of the distal portion of the anchor member 610 align with one another and form an imaginary straight line that is parallel to the longitudinal axis of the entire distal portion of the anchor member 610 , and at the lateral center of the entire distal portion of the anchor member 610 .
- all openings 225 , 226 from both set of openings align with one another and form an imaginary straight line that is parallel to the longitudinal axis of the anchor member 610 and at the lateral center of the anchor member 610 .
- the amount of pairs of opening in distal and/or proximal portions of the anchor member 610 can be of any number other than what has been described here.
- FIG. 12A further illustrates exemplary pre-set folding lines in an elongate anchor member of the present teachings.
- the folding lines (indicated in the drawings as “L”) in the proximal portions and the distal end portion of the distal portion of the anchor member 610 are parallel to one another and perpendicular to the longitudinal axis of the anchor member 610 .
- the pre-set folding lines L between the distal end section and proximal end section of the distal portion of the anchor member 610 are angled to the other pre-set folding lines L.
- specific pre-set folding patterns is shown in FIG. 12A , one with ordinary skill in the art would understand that other patterns, numbers can be incorporated to form pre-set folding lines L.
- both distal and proximal portions of the anchor member 610 are parallel to one another and perpendicular to the longitudinal axis of the anchor member 610 , and only a middle portion 615 between the distal and proximal portions of the anchor member 610 are angled, so as to forming a transitional section across the paravalvular leakage upon deployment. Therefore what is shown in FIG. 12A should not be considered as being limiting.
- FIG. 12A further illustrates an exemplary narrow section in the distal end portion of the anchor member.
- This narrow section is the result of radiopaque marker being crimped onto the anchor member.
- radiopaque marker being crimped onto the anchor member.
- FIG. 12B illustrates an exemplary deployment profile of an embodiment of the present teachings across a paravalvular leakage site.
- There are 8 folds in the deployed anchor as shown in FIG. 12B among which 5 are distal to the paravalvular leakage and 3 are proximal to the leakage.
- the number of folds in each side of the paravalvular leakage should not be viewed as limiting.
- the folded panels at the proximal portion of the anchor member and at the proximal end section of the distal portion of the anchor member orientate in one direction
- the folded panels in the distal end portion of the anchor member orientate in another direction that is perpendicular to folded panels in the other direction.
- transitional folds between the distal and proximal end section of the distal portion of the anchor member are located at the angled pre-set folding line.
- the transitional folds are distal to the paravalvular leakage and are generally indicated with the reference character 601 (in other words, the change in folding direction is identified at 601 ).
- the transitional folds can be proximal to the paravalvular leakage, or across the paravalvular leakage, and thus what has be illustrated here should not be viewed as limiting.
- FIG. 12C is a view of the exemplary anchor shown in FIGS. 12A and B in its deployed configuration.
- the distal deployed anchor portion has a width “x” established by the width of the anchor and a length “y” determined by the distance between two pairs of the openings.
- the proximal deployed anchor portion has a width “y” established by the distance between the two pairs of the openings and a length “x” established by the width of the anchor.
- the configuration in the exemplary embodiment shown in FIGS. 12A-D increases the overall width of the deployed anchor. This configuration prevents the tensioning member from cutting the panel and the paravalvular leakage and increases the retention force of the anchor against the leakage site.
- At least two adjacent anchor panels 603 , 605 are disposed in a crisscrossed manner in that the longitudinal axes of the adjacent anchor panels 603 , 605 are disposed perpendicular to one another as shown.
- all the openings from both sets of openings in the distal portion of the anchor member can align with each other to form an imaginary straight line that is parallel to the longitudinal axis of the anchor member, and/or each pair of the openings in the proximal portion of the anchor member can form an imaginary line and all the imaginary lines so formed are parallel to one another and perpendicular to the longitudinal axis of the anchor member.
- openings in either or both set of the openings can form any configuration so long as it serves the intended purpose.
Abstract
An aspect of the present teachings includes a method of percutaneously treating a paravalvular leakage. In a preferred embodiment, the method includes providing an anchor having an elongate anchor member and a tensioning member, positioning the anchor through a paravalvular leakage, deploying the anchor wherein at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage, and applying tension to the tensioning member so that at least a part of the distal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration. Another aspect of the present teachings includes a device that can be used in a method of percutaneously treating a paravalvular leakage.
Description
- This application is based on and claims priority to U.S. Provisional Patent Application 62/128,997, filed Mar. 5, 2015, the entire contents of which is incorporated by reference herein as if expressly set forth in its respective entirety herein.
- Paravalvular leakage is a complication associated with the implantation of a prosthetic valve. It may occur both in traditional surgical or minimally invasive transcatheter approaches.
FIG. 1 illustrates anartificial valve 1600 that may include, for example, amulti-leaflet structure 1602 and that may be implemented in an appropriate manner as will be appreciated by those of ordinary skill in the art. Additionally, a small opening orspace 1604 between theheart 1606 and thevalve 1600 is shown as may occur in some instances of valve replacement. This opening orspace 1604 results in undesired leaking during pumping of the heart and is termed a valvular or paravalvular leak. - Accordingly, devices and methods are needed for correcting paravalvular leakage after implantation of a stented prosthetic valve.
- One aspect of the present teachings includes an anchor for treating a paravalvular leakage. In various embodiments, the anchor includes at least one elongate anchor member. In some embodiments, the anchor includes one elongate anchor member. In some embodiments, the anchor includes two elongate anchor members. In yet other embodiments, the anchor includes three or more elongate anchor members. In certain embodiments, the two, three, or more elongate anchor members are made of a same material. In certain other embodiments, the two, three, or more elongate anchor members are made of different materials.
- In some embodiments, the anchor has an elongate configuration where the elongate anchor member is relaxed and extended. In some embodiments, the anchor has a shortened configuration when the elongate anchor member(s) is folded or otherwise shortened. In certain embodiments, the anchor is in its shortened configuration when deployed and/or secured.
- According to various embodiments of the present teachings, the elongate anchor member is made of a flexible material. In some embodiments, the flexible material is a surgical grade fabric. The elongate anchor member may also take various forms such as woven or nonwoven fabrics, polymers, metals, other suitable materials, or combinations thereof. For example, the surgical grade fabric used in various embodiments of the present teachings can be constructed from a polyester, such as Dacron®, RTM, PTFE, UHMPE, HDPE, polypropylene, polysulfone, or other biocompatible plastic.
- In various embodiments, the elongate anchor member causes a tissue response, for example, tissue growth. In some embodiments, the surface finish of the anchor member is textured to induce tissue response and tissue in-growth for improved stabilization. In other embodiments, the anchor member comprises porous materials to promote tissue in-growth.
- In various embodiments, one or more of the edges and/or other portions of the anchor member are modified, for example, to prevent from fraying. In some embodiments, one or more of the edges or other portions of the anchor member are coated with a material that locks the fibers in place. Other methods can also be used to lock the fibers at one or more edges of the anchor member in place.
- In various embodiments, the anchor includes at least one tensioning member. In some embodiments, the tensioning member causes both ends of the elongate anchor member to move towards each other. This motion can create a shortened distal portion and/or a shortened proximal portion. In certain embodiments, doing so secures the paravalvular leakage between the distal and the proximal portions of the elongate anchor member.
- In embodiments where an anchor of the present teachings includes two elongate anchor members, the tensioning member causes at least one of the two elongate anchor members to move towards the other elongate anchor member. In certain embodiments, the tensioning member causes both of the elongate anchor members to move towards each other. In embodiments where an anchor of the present teachings includes three or more elongate anchor members, the tensioning member causes at least one of the three or more elongate anchor members to move towards another elongate anchor member. In certain embodiments, the tensioning member causes all of the three or more elongate anchor members to move towards one another. This motion can create shorten elongate anchor members. In certain other embodiments, doing so secures the paravalvular leakage between two of the elongate anchor members.
- According to various embodiments of the present teachings, the tensioning member is in the form of a suture, as defined herein. It will be appreciated that the tensioning member may take forms other than a suture, such as any other small-diameter members having a suitable tensile strength for the intended anchoring use.
- In various embodiments, one or both of the tensioning member and the elongate anchor member are made of a resorbable polymer. In some embodiments, such a resorbable polymer is polyactic acid, polyglycolic acid, polycaprolactone, or a combination thereof. Other resorbable polymers that are known to those skilled in the art can also be used without undue experimentation and thus are within the scope of the present teachings. In various embodiments, the material that is used to make the anchor, i.e., the elongate anchor member(s), the tensioning member, or both, is multilayered. In some embodiments, the material includes a coating of resorbable polymer. In other some embodiments, the materials includes a semipermeable polymer that optionally is impregnated with one or more of the compounds discussed herein. In certain embodiments, the one or more compounds is released in a controlled manner.
- In various embodiments, the anchor, including the elongate anchor member(s), the tensioning member, or both, includes one or more compounds that address issues associated with the product performance. For example, one or more compounds can be embedded in the anchor member. In certain embodiments, the one or more compounds are released over time after implantation. These compounds can reduce calcification, protein deposition, thrombus formation, or a combination of some or all of these conditions. The one or more compounds can also be used to stimulate a biological response, for example, to induce tissue in-growth. In some embodiments, the compound is an anti-inflammatory agent. In some embodiments, the compound reduces tissue proliferation adjacent to the device. One with ordinary skill in the art would understand that numerous agents are available for the above applications and can select such an agent without undue experimentation for each of the applications. As such, anchors having one or more of the numerous agents are within the scope of the present teachings.
- In various embodiments, the tensioning member extends through openings along the elongate anchor member as described herein such that tightening the tensioning member will cause the elongate anchor member to fold. Although certain examples of anchor deployment are described herein, one with ordinary skill in the art would appreciate that deployment of the anchor may take on various forms due to the flexible nature of the anchor member, especially when a highly flexible fabric or other materials is used. For example, a fabric material or other similarly flexible materials may be folded or otherwise deformed during a deployment to a leakage site.
- Another aspect of the present teachings includes methods of treating a paravalvular leakage. In various embodiments, the method includes providing an anchor as described herein, positioning the anchor through a paravalvular leakage, deploying the anchor where at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage. In various embodiments, the method includes applying tension to the tensioning member so that at least a part of the distal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration. In various embodiments, the method includes deploying the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage. In various embodiments, the method includes applying tension to the tensioning member so that at least a part of the proximal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration.
- In various embodiments, the method includes providing an anchor as described herein, positioning the anchor through a paravalvular leakage, deploying the anchor where at least a part of a first elongate anchor member is on one side of the paravalvular leakage. In various embodiments, the method includes applying tension to the tensioning member so that at least a part of the first elongate anchor member transitions from the elongate configuration to the shortened configuration. In various embodiments, the method includes deploying the anchor wherein at least a part of a second elongate anchor member is on the other side of the paravalvular leakage. In various embodiments, the method includes applying tension to the tensioning member so that at least a part of the second elongate anchor member transitions from the elongate configuration to the shortened configuration. And in these embodiments, the anchor used in repairing a paravalvular leakage can include two or more elongate anchor members and a tensioning member can pass through one, two, or more of the elongate anchor members.
- In various embodiments, anchors of the present teachings is used percutaneously. For example, the anchors are delivered percutaneously. In other embodiments, anchors of the present teachings are used in minimally invasive surgeries. In yet other embodiments, anchors of the present teachings are used in open-heart surgeries.
- In various embodiments, the method includes introducing a catheter approximately at the paravalvular leakage site. In some embodiments, the method includes withdrawing the catheter to deploy the anchor where at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor where at least a part of a first elongate anchor member is on one side of the paravalvular leakage. In some embodiments, the method includes withdrawing the catheter to deploy the anchor wherein at least a part of a second elongate anchor member is on the other side of the paravalvular leakage.
- In various embodiments, a clinician deploys a plurality of anchors in a paravalvular leakage, when necessary and practical.
- In various embodiments, upon deployment, at least half number of the folds is distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are distal to the paravalvular leakage and the rest of the folds are proximal to the paravalvular leakage.
- In various embodiments, upon deployment, at least some of the folds is distal to the paravalvular leakage. In various embodiments, upon deployment, at least some of the folds are proximal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are distal to the paravalvular leakage. In other embodiments, upon deployment, less than half of the folds are proximal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are distal to the paravalvular leakage. In yet other embodiments, upon deployment, more than half of the folds are proximal to the paravalvular leakage.
- In various embodiments, upon deployment, at least one of the folds is in the paravalvular leakage. In some embodiments, upon deployment, at least some of the folds are distal to the paravalvular leakage and at least one of the folds is in the paravalvular leakage. In some embodiments, at least some of the folds are proximal to the paravalvular leakage and at least one of the folds is in the paravalvular leakage. In certain embodiments, upon deployment, at least some of the folds are distal to the paravalvular leakage, at least one of the folds is in the paravalvular leakage, and at least some of the folds are proximal to the paravalvular leakage.
- In various embodiments, upon deployment, at least a part of a first anchor member is distal to the paravalvular leakage. In various embodiments, upon deployment, at least a part of a second anchor member is proximal to the paravalvular leakage. In various embodiments, upon deployment, at least a part of an anchor member is in the paravalvular leakage. In some embodiments, upon deployment, at least a part of a first anchor member is distal to the paravalvular leakage and at least a part of a second anchor member is proximal to the paravalvular leakage. In certain embodiments, upon deployment, at least a part of a first anchor member is distal to the paravalvular leakage, at least a part of a second anchor member is proximal to the paravalvular leakage, and at least a part of a third anchor member is in the paravalvular leakage.
- In various embodiments, the elongate anchor member also includes a marker. The marker can be in the form of threads, beads, or other forms. Without limiting the scope of the present teachings, the marker allows the anchor member to be visualized by using a radiographic imaging equipment using x-ray, magnetic resonance, ultrasound, fluoroscopic, or other visualization techniques. In some embodiments, markers are attached to the anchor member. For example, the markers can be wrapped, laminated, and/or bonded through a welding process. An adhesive such as cyanoacrylate or other adhesives known to those skilled in the art can also be used to attach a marker to the anchor member.
- In some embodiments, the marker is a radiopaque marker. In certain embodiments, the radiopaque marker is made of titanium, tungsten, platinum, irridium, gold, an alloy of any of these materials, or a composite having any of the above materials. Other materials that are known to those skilled in the art can also be used.
- In some embodiments, the marker is a paramagnetic marker. In certain embodiments, the paramagnetic marker is made of a material containing gadolinium, iron, platinum, manganese, cobalt, fluorine, or other paramagnetic materials. In yet other embodiments, the markers each comprises other MR visible materials that are known to those skilled in the arts.
- In some embodiments, the marker is an echogenic marker. In certain embodiments, the echogenic marker is made of a material that is capable of reflecting increased ultrasound waves. Some echogenic materials are described herein elsewhere.
- In various embodiments, the marker protrudes out of or is flush with the anchor. In various embodiments, the markers are arranged on the implant in a pattern.
- In various embodiments, the anchor or a component thereof is treated so that the anchor or a part thereof is visible under a visualization technique. In some embodiments, the visualization technique is based on ultrasound. For example, the visualization technique is echocardiography. In some embodiments, an elongate anchor member of the present teachings is treated so that it is visible in a visualization technique. In certain embodiments, a part of the elongate anchor member is treated so that it is visible in a visualization technique. In some embodiments, a marker of the present teachings is treated so that it is visible in a visualization technique. In some embodiments, the treatment is performed on a surface of an anchor or a component thereof. In certain embodiments, a surface of at least a part of the elongate anchor member is treated so that the elongate anchor member is visible in a visualization technique. In certain embodiments, a surface of at least a part of the marker is treated so that the marker is visible in a visualization technique.
- In various embodiments, the treatment is performed with an echogenic material. For example, the material can contain fluorine element. In some embodiments, the material includes a perfluoro compound. In certain embodiments, the material includes perflutren. In certain embodiments, the material includes perflexane. In certain embodiments, the material includes sulfur hexafluoride. In other embodiments, the material includes another echogenic material known to persons with ordinary skill in the art.
- In various embodiments, the method includes locating a paravalvular leakage. For example, a paravalvular leakage can be detected and/or located by using echocardiography, computed tomography (CT), or cardiac magnetic resonance. In some embodiments, the method includes locating a paravalvular leakage by using echocardiography.
- Yet another aspect of the present teachings includes a device used to treat a paravalvular leakage. In various embodiments, the device includes a catheter and an anchor as described herein. In some embodiments, the catheter includes a distal end and a lumen having an opening at the distal end. In some embodiments, the anchor is provided at least partially in the lumen.
- Without wishing to narrow the scope of the enclosed claims, the present teachings may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which:
-
FIG. 1 shows an artificial valve implanted into a heart having a paravalvular leakage, -
FIG. 2 is a perspective view of an exemplary anchor in accordance with the present teachings, -
FIG. 3A is a side view of an anchor positioned in a paravalvular leakage in accordance with some embodiments of the present teachings, -
FIG. 3B is a side view similar toFIG. 3A , but illustrating the distal portion of the exemplary anchor being moved toward the paravalvular leakage, -
FIG. 3C is a side view similar toFIG. 3B , but showing the distal portion of the exemplary anchor fully compressed and engaged against the paravalvular leakage, -
FIG. 3D is a side view similar toFIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage, -
FIG. 3E illustrates the proximal and distal portions of the exemplary anchor fully compressed against opposite sides of the paravalvular leakage, -
FIG. 3F is an enlarged cross sectional view of an exemplary anchor fully deployed and fastened with a paravalvular leakage between proximal and distal anchor portions, -
FIG. 3G is a side view of an anchor positioned in a paravalvular leakage in accordance with some embodiments of the present teachings, -
FIG. 3H is a side view similar toFIG. 3A , but illustrating the distal portion of the exemplary anchor being moved toward the paravalvular leakage, -
FIG. 3I is a side view similar toFIG. 3B , but showing the distal portion of the exemplary anchor fully compressed and engaged against the paravalvular leakage, -
FIG. 3J is a side view similar toFIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage, -
FIG. 3K is a side view similar toFIG. 3C but illustrating the proximal portion of the exemplary anchor being moved toward the paravalvular leakage, -
FIG. 3L is an enlarged cross sectional view of an exemplary anchor fully deployed and fastened with a paravalvular leakage between proximal and distal anchor portions, -
FIG. 4 is a side elevation view of an exemplary anchor in accordance with some embodiments of the present teachings, -
FIGS. 5A-5D are respective side views illustrating a sequence of steps used for securing the anchor to a paravalvular leakage in accordance with some embodiments of the present teachings, -
FIG. 5E is a view similar toFIG. 5D , but illustrating an alternative tip and tensioning member arrangement in accordance with some embodiments of the present teachings, -
FIG. 6A is a front view of the elongate anchor member of an anchor in accordance with some embodiments of the present teachings, -
FIG. 6B is a front elevation view similar toFIG. 6A , but illustrating radiopaque markers in accordance with some embodiments of the present teachings, -
FIG. 6C is a front elevation view of an alternative elongate anchor member having a varying width along its length in accordance with some embodiments of the present teachings, -
FIG. 6D is a side elevation view of another alternative elongate anchor member utilizing more rigid fold sections separated by living hinges in accordance with some embodiments of the present teachings, -
FIG. 7A is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 7B is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 7C is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 8 is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 9 is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 10A is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 10B is a side elevation view of the anchor inFIG. 10A , -
FIG. 11 is a perspective view of an exemplary anchor deployed across a paravalvular leakage in accordance with the present teachings, -
FIG. 12A is a perspective view of an anchor in accordance with some embodiments of the present teachings, -
FIG. 12B is a cross-sectional view of an anchor deployed across a paravalvular leakage in accordance with some embodiments of the present teachings, -
FIG. 12C is a side elevation view of the anchor ofFIGS. 12A-12B , and -
FIG. 12D is top plan view of the anchor ofFIGS. 12A-12B . - Certain specific details are set forth in the following description and Figures to provide an understanding of various embodiments of the present teachings. Those of ordinary skill in the relevant art will understand that various features of the present teachings may be used alone or in numerous combinations depending on the needs and preferences of the user. Those skilled in the art can also practice other embodiments of the present teachings without one or more of the details described below. Thus, it is not the intention of the present teachings to restrict or in any way limit the scope of the appended claims to such details. While various processes are described with reference to steps and sequences in the following disclosure, the steps and sequences of steps should not be taken as required to practice all embodiments of the present teachings.
- As used herein, the term “proximal” means closest to the operator (less into the body) and “distal” means furthest from the operator (further into the body). In positioning a medical device from a downstream access point, distal is more upstream and proximal is more downstream.
- As used herein, the term “tensioning member” means a member which can take forms of a suture, cable, wire, or any other small diameter, flexible, semi-rigid or rigid material having a suitable tensile strength for the intended use. In addition, as used herein, the term “wire” can be a strand, a cord, a fiber, a yarn, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
- The term “suture” used herein can be a strand, a wire, a cord, a fiber, a yarn, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
- Unless otherwise specified, all numbers expressing quantities, measurements, and other properties or parameters used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless otherwise indicated, it should be understood that the numerical parameters set forth in the following specification and attached claims are approximations. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, numerical parameters should be read in light of the number of reported significant digits and the application of ordinary rounding techniques.
- Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present teachings belong. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present teachings. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
- It will be appreciated that like reference numerals are used herein to refer to like elements in all embodiments and reference numerals with prime marks (′) or double prime marks (″) refer to like elements that have been modified in a manner as described herein or otherwise shown in the associated Figure.
- Referring first to
FIG. 2 , an anchor 10 constructed in accordance with some embodiments of the present teachings generally includes a tensioningmember 12, such as a suture, extending through spaced apart points along an elongate anchor member 14 of flexible material, such as a surgical grade fabric. It will be appreciated that the tensioningmember 12 may take other forms other than suture material, such as cable or any other small diameter member having a high enough tensile strength for the intended use. The elongate anchor member 14 may also take various forms such as woven or nonwoven fabrics, polymers, metals, or other suitable materials or combinations of materials. One or more separate pledgets or other securement members (not shown) may be used in conjunction with the elongate anchor member 14 for added securement and/or concealing the elongate anchor member 14 and, for example, thereby inhibiting blood clotting within or adjacent to the folds that will be formed in the elongate anchor member 14. - A woven or nonwoven material may contain additional materials, such as threads, beads or other elements that cause at least portions of the elongate anchor member 14 to be radiopaque. Currently, a surgical grade fabric constructed from polyester, such as Dacron®, is contemplated for use in constructing the elongate anchor member 14. One of many possible alternative materials for use in constructing the elongate anchor member 14 is polytetrafluoroethylene (PTFE). Anchor 10 may be partly or wholly formed from materials that are absorbed into the patient's tissue over time, depending on the intended use. The edges and/or other portions of the elongate anchor member 14 may be suitably modified to prevent fraying, such as by being coated with a material that locks the fibers in place, or otherwise modified in a manner that locks the fibers at least at the edges of the elongate anchor member 14 in place.
- The
suture 12 may extend from aproximal portion 14 a of the elongate anchor member 14 to adistal end portion 14 b and then loop back through spaced apart points of the elongate anchor member 14 to theproximal portion 14 a where a knot 16 or other stop member is located. As will become apparent, thesuture 12 extends through spaced apart locations along the elongate anchor member 14 such that tensioning of thesuture 12 or other tensioning member will cause the elongate anchor member 14 to form folded portions 14 c when the tensioningmember 12 is placed under tension or pulled. Thus, the elongate anchor member 14 is activated in this manner between essentially an elongate configuration, such as shown inFIG. 2 , and a shortened configuration, such as a folded or otherwise shortened configuration having an expanded width in at least one dimension as compared to the elongate configuration. It will be appreciated that the deployment orientation may take on various forms due to the flexible nature of the elongate anchor member 14, especially when using a highly flexible fabric or other material. For example, a fabric material or other similarly flexible materials may be folded or otherwise deformed for carrying purposes within a catheter and/or during deployment to a paravalvular leakage site and then suitably activated at the leakage site. - More specifically referring to
FIGS. 3A-3E , the elongate anchor member 14 and attachedsuture 12 are initially inserted through aparavalvular leakage site 20 as generally shown inFIG. 3A . One end or portion 12 a of thesuture 12 is then pulled and thereby placed under tension. It will be appreciated that, for catheter-based procedures, suture portion 12 a may extend to a location outside the patient's body for pulling or tensioning, or it may be grasped by a suitable mechanism within the catheter and pulled or tensioned. Pulling suture portion 12 a may initially draw thedistal portion 14 b of the elongate anchor member 14 toward theparavalvular leakage site 20 as shown inFIG. 3B . Once thedistal portion 14 b is compressed against theleakage site 20, theproximal portion 14 a begins to be drawn and compressed against a proximal side of theparavalvular leakage site 20 as shown inFIGS. 3C-3E . This occurs because end 12 a of thesuture 12 is being pulled downwardly (as viewed for purposes of discussion inFIGS. 3C-3E ) and, since thesuture 12 is looped in a reverse direction throughdistal end portion 14 b of the elongate anchor member 14, the knot 16 at the end of thesuture 12 moves upwardly and brings theproximal portion 14 a of the elongate anchor member 14 with it. In this manner, theproximal portion 14 a of the elongate anchor member 14 is being folded and drawn along thesuture 12 toward theparavalvular leakage 20 and then firmly compressed against the proximal side of theparavalvular leakage 20 as shown inFIG. 3E . As further shown inFIG. 3F , a suitable locker element, such as a crimp member 22, a knot or other element may be used to maintain thesuture 12 and elongate anchor member 14 in the positions shown inFIG. 3F securely anchoring the proximal anddistal portions paravalvular leakage 20. - Anchors having two or more elongate anchor members can also be used to repair a paravalvular leakage. Thus, as shown in
FIG. 3G , in various embodiments, an anchor includes a distalelongate anchor member 14 b′, a proximalelongate anchor member 14 a′, and a tensioningmember 12 slideably connecting the distalelongate anchor member 14 b′ and the proximalelongate anchor member 14 a′. In some embodiments, one end of the tensioning member passes through the proximalelongate anchor member 14 a′ and the distalelongate anchor member 14 b′, loops back, passes through the distalelongate anchor member 14 b′ and the proximalelongate anchor member 14 a′, and forms a knot 16 around the tensioningmember 12. In certain embodiments, the other end, or the proximal end 12 a′, of the tensioning member extends through a delivery catheter and exists outside of the body. The passing through an elongate anchor member can be achieved by passing through one or two holes in the elongate anchor member or threading through the elongate anchor member itself. - Thus, the method of repairing a paravalvular leakage, in some embodiments, includes, as shown in
FIG. 3G , inserting the distalelongate anchor member 14 b′ and attached tensioningmember 12 through aparavalvular leakage 20. In some embodiments, the method includes pulling the proximal end 12 a of the tensioningmember 12. The pulling of the tensioning member, in some embodiments, folds at least a portion of the distalelongate anchor member 14 b′ and/or draws the distal elongate anchor member towards theparavalvular leakage site 20, as shownFIG. 3H . In some embodiments, the method includes continuing pulling the proximal end 12 a of the tensioningmember 12 to compress the distalelongate anchor member 14 b′ against theparavalvular leakage 20, as shown inFIG. 3I . In some embodiments, the method includes folding at least a portion of the proximalelongate anchor member 14 a′ and drawing the proximalelongate anchor member 14 a′ towards theparavalvular leakage site 20, as shown inFIG. 3J . The folding of at least a portion of the proximalelongate anchor member 14 a′ and/or the drawing of the proximalelongate anchor member 14 a′, in certain embodiments, are achieved sequentially or simultaneously by continuing pulling the proximal end 12 a of the tensioningmember 12. As the distalelongate anchor member 14 b′ and the proximalelongate anchor member 14 a′ are compressed against theparavalvular leakage 20, in some embodiments, the method includes using a suitable locker element 22 to maintain the anchor 10 in the deployed configuration, as shown inFIG. 3L . -
FIG. 4 is a side elevation view of ananchor 70 according to some embodiments of the present teachings. This anchor includes a distal tip 76. In addition, this anchor includes a proximalradiopaque band 90 and a distal radiopaque band 92. Both the radiopaque bands can be attached to the suture 72, as shown inFIG. 4 , or otherwise secured to the suture 72, at the proximal end portion of theanchor member 74 and to either the interior or exterior of the distal tip 76, respectively, or any other part of theanchor 70. Without wishing to be bound by any particular theory, under a fluoroscope, these bands orother markers 90 and 92 will indicate to the clinician that theanchor 70 has been deployed, activated, fully compressed, and/or fastened, as necessary during the procedure. - The tip 76 itself may alternatively be formed from a radiopaque material. In this embodiment, the
knot 94 formed in the suture 72 or other tensioning member is a slip knot through which another portion of the suture 72 slides during activation of theanchor 70. It will be appreciated that thisslip knot 94 may be replaced by another element which serves substantially or approximately the same purpose but takes the form, for example, of a small tubular element or other feature similar in function to a slip knot. - In various embodiments, the
elongate anchor member 74 may be about 40 mm long by about 3 mm wide. This may be desirable to achieve a lower profile. These embodiments may lead to more versatile applications, lower incidents of blood clotting, easier use, etc. Of course, any other desired dimensions and shapes may be used, depending on application needs. - As further shown in
FIGS. 4 and 6A , the tensioning member or suture 72 can advantageously extend through respective fold portions 74 c of theelongate anchor member 74 in essentially an hourglass configuration. Specifically, adjacent portions of the suture 72 located near the proximal anddistal end portions anchor member 74 are spaced farther apart than the adjacent portions of the suture 72 in the middle of theanchor member 74. - As further shown in
FIG. 6B , radiopaque markers, such as distinct areas of dots 95, may be used for enabling the clinician to visualize the folds of theelongate anchor member 74 during deployment and securement of theelongate anchor member 74. These dots or other radiopaque markers may be printed on theanchor member 74. For example, dots 95 or other markers may be formed with a platinum powder base ink or other suitable material that is radiopaque and biologically compatible. This radiopaque material may also add stiffness to the fold sections 74 c thereby helping to maintain the fold sections 74 c flat and increasing retention force on the paravalvular leakage. Meanwhile, the fold lines 74 d between fold sections 74 c can remain highly flexible to create tight radius fold lines. - As further shown in
FIG. 6A , each of the holes 96 that the tensioning member or suture 72 is received through may be marked by circles 98 surrounding each hole 96 or other markers for visualizing purposes during assembly of the tensioning member or suture 72 with theelongate anchor member 74. Optionally, holes 96 may be eliminated and the suture 72 may be threaded with a needle through theanchor member 74. One could also, for example, choose different sets of holes 96 alonganchor member 74 for receiving the tensioning member or suture 72 thereby changing the width of the folds and/or number of folds and/or shape of the folds depending on the application needs or desires of the clinician. - The tensioning member or suture 72 may be threaded or otherwise attached along the
anchor member 74 in any number of manners including, for example, x-patterns or other crossing patterns, zig-zag patterns, etc. that may alter the folded or otherwise shortened or compressed footprint of the anchor into various beneficial shapes, such as flower shapes, circular shapes or other rounded shapes, ball shapes or other configurations. Modifications of the manner in which the tensioning member or suture 72 is threaded or otherwise attached along the length ofanchor member 74 may result in higher or lower tensioning force being required to compress the anchor and/or higher or lower friction holding force that may help maintain the anchor in the compressed or shortened configuration. - The width of the
elongate anchor member 74′ may be varied along its length, such as by tapering, stepping, or forming an hourglass shape or shapes along the length of the anchor member 14. For example, as illustrated inFIG. 6C , having proximal anddistal end portions 75, 77 of wider dimension than an intermediate or middle portion orportions 79 along the length ofanchor member 74′ will allow thesewider portions 75, 77 may cover over the more intermediate foldedportions 79 and prevent unnecessary contact with adjacent tissue during use. - The
elongate anchor member 74 may have variable stiffness including, for example, a relatively rigid perimeter or relatively rigid edges 74 e, 74 f (FIG. 6A ) or intermittent relatively rigid sections 74 c″ separated by flexible sections such as living hinges 74 d″ (FIG. 6D ) that may aid in folding and securing theelongate anchor member 74″ into a folded condition. -
FIGS. 5A-5D illustrate a series of steps for deploying and securely fastening theanchor 70 to aparavalvular leakage site 100 according to some embodiments of the present teachings. Generally, as shown inFIG. 5A , the combination of theelongate anchor member 74 and tensioning member or suture 72 is deployed through theparavalvular leakage site 100. One end or portion 72 a of the suture 72 that extends through theslip knot 94 is then pulled. This causes thedistal portion 74 b of theelongate anchor member 74 to fold and compress against the distal side of theparavalvular leakage 100. As shown inFIG. 5B , further pulling the tensioning member 72 causes theslip knot 94 to ride upwardly or distally along the suture 72 and against aproximal portion 74 a of theelongate anchor member 74, thereby folding and compressing theproximal portion 74 a against the proximal side of theparavalvular leakage 100 as shown inFIG. 5C . As shown inFIG. 5D , a suitable crimp or locking element 102 may be used to securely lock theslip knot 94 in place relative to the suture or tensioning member segment which extends therethrough. This will lock theentire anchor 70 in place with the respective proximal and distal foldedanchor member portions paravalvular leakage 100 therebetween.FIG. 5D shows the tip 76 acting as a retainer on top of thedistal end portion 74 b to assist in holding thedistal end portion 74 b in place. -
FIG. 5E shows an alternative in which the tensioning member is threaded through at least one hole 76 a more centrally located in the tip. Yet another alternative would be to thread the tensioning member through two centrally located holes instead of through the proximal end of the tip 76 and one centrally located hole 76 a as shown inFIG. 5E . These alternatives allow the tip 76 to act more like a “T”-bar with forces acting in a more perpendicular or normal manner relative to thedistal end portion 74 b of theanchor member 74. -
FIG. 7A illustrates an exemplary anchor of the present teachings. In various embodiments, the elongate anchor member has a rectangle profile as illustrated inFIG. 7A . In other embodiments, the elongate anchor member has an hour glass profile as illustrated inFIG. 7B . One skilled in the art would understand that the elongate anchor member can have other profiles, and accordingly, the embodiments discussed herein are not limiting to the scope of the present teachings. - Referring to
FIG. 7A , ananchor 200 constructed in accordance with some embodiments of the present teachings generally includes atensioning member 201 extending from aproximal end portion 212 of anelongate anchor member 210 to adistal end portion 214. In some embodiments, the tensioningmember 201 loops back and extends from thedistal end 214 to theproximal end portion 212. In some embodiments, the tensioningmember 201 passes through a plurality of openings along theelongate anchor member 210. In some embodiments, one end of the tensioningmember 201, after it extends from the proximal end to the distal end and loops back to the proximal end of theanchor member 210, forms aknot 220 around the other end portion of the tensioningmember 201. In some embodiments, theknot 220 slides along the other end portion of the tensioningmember 201 in such way that it pulls the free end of the tensioningmember 201 proximally, causing theknot 220 moving distally and shortening the longitudinal length of theanchor member 210. By doing so in these embodiments, theelongate anchor member 210 is folded and the ends of theanchor member 210 are drawn toward each other. In certain embodiments, theelongate anchor member 210 also can include at least one pre-set folding line (not shown) which allows theelongate anchor member 210 to be fold at the pre-set folding line. - In various embodiments, an anchor, such as that referred to as
anchor 200, shortens at one of the proximal and distal ends. For example, when the tensioningmember 201 is pulled, at least a part of thedistal portion 214 folds first while theproximal end 212 substantially maintains its elongated configuration. In some embodiments, this occurs when thedistal portion 214 is deployed. In certain embodiments, this occurs when thedistal portion 214 is deployed and theproximal portion 212 is not deployed, for example, because theproximal portion 212 is restrained in a delivery catheter (not shown). In other embodiments, when the tensioningmember 201 is pulled, at least a part of theproximal portion 212 folds first while thedistal portion 214 substantially maintains its elongated configuration. It will be appreciated by a person with ordinary skill in the art that an anchor of the present teachings may also be folded in a sequential manner under other circumstances. - As seen in
FIG. 7A , in various embodiments, the elongate anchor member has two sets ofopenings 225, 226 (first openings 225 and second openings 226). In some embodiments, the tensioningmember 201 extends from theproximal end portion 212 of theanchor member 210 to thedistal end portion 214 of theanchor member 210 through the first set ofopenings 225. Upon reaching the distal end of theelongate anchor member 210, in some embodiments, the tensioningmember 201 loops back and further extends from the distal end portion of theanchor member 210 to the proximal end of the anchor member through the second set ofopenings 226. - In certain embodiments, as shown in
FIG. 7A , the tensioningmember 201 extends from the proximal end of theanchor member 210 distally, travels from one side of theanchor member 210 to another side by passing through thefirst opening 225 closest to the proximal end of theanchor member 210 in the first set ofopenings 225; the tensioningmember 201 further extends distally, passes through thenext opening 225 distal to thefirst opening 225 in the first set ofopenings 225. The tensioning member extends further distally repeating above steps until it passes through thelast opening 225 in the first set ofopenings 225 and reaches the distal end of theanchor member 210. In one embodiment of the present teachings, there are tenopenings 225 in the first set ofopenings 225.Anchor members 210 having between four and twelveopenings 225 in the first set of openings can be made and used by one with ordinary skill in the art without undue experimentation. - In various embodiments of the present teachings, upon reaching the distal end of the
anchor member 210, the tensioningmember 201 loops back, extends proximally, travels from one side of theanchor member 210 to another side by passing through thefirst opening 226 closest to the distal end of theanchor member 210 in the second set ofopenings 226. The tensioningmember 201 further extends proximally, travels to the first side of theanchor member 210 by passing through thenext opening 226 proximal to thefirst opening 226 in the second set ofopenings 226. The tensioningmember 201 extends further proximally repeating the above steps until it passes through thelast opening 226 in the second set ofopenings 226 and reaches the proximal end of theanchor member 210. In some embodiments of the present teachings, there are tenopenings 226 in the second set ofopenings 226.Elongate anchor members 210 having between four and twelveopenings 226 in this set can be made and used by one with ordinary skill in the art without undue experimentation. - In various embodiments of the present teachings, as illustrated in
FIG. 7A , the tensioningmember 201 extends from one side of theanchor member 210 distally, loops back, and ends on the same side of theanchor member 210. In other embodiments, the tensioningmember 201 extends from one side of theanchor member 210 distally, loops back, and ends on a different side of theanchor member 210. - In various embodiments of the present teachings, the number of
openings 225 in the first set and the number ofopenings 226 in the second set are the same as illustrated inFIG. 7A . In other embodiments, the number ofopenings 225 in the first set and the number ofopenings 226 in the second set are different. - In some embodiments, the first and second sets of
openings FIG. 7A . In other embodiments, the first and second sets ofopenings FIG. 7C . This common opening is identified withreference character 227 inFIG. 7C . - As mentioned above, the
anchor member 210 can have an hour glass profile as illustrated inFIG. 7B . In this embodiment, theanchor member 210 has a pair ofsections 229 of increased width (with one being located at theproximal end portion 212 and one at the distal end portion 214). - According to various embodiments of the present teachings, at least one
opening 225 in the first set ofopenings 225 has acorresponding opening 226 in the second set ofopenings 226 and together they form a pair of openings on theanchor members 210. In some embodiments, at least one pair ofopenings anchor member 210. In other embodiments, at least one pair of theopenings anchor member 210. In yet other embodiments, at least one pair of theopenings anchor member 210. In some embodiments, lines formed by all of the pairs ofopenings anchor member 210 as illustrated inFIG. 7A . In another embodiment, they can all be parallel to the longitudinal axis of theanchor member 210. In yet other embodiments, the lines formed by all the pairs ofopenings - In various embodiments, the two
openings openings - In various embodiments, the distance between two
adjacent openings 225, 225 (or 226, 226) in the same set, defined by the distance from one opening to the next closest one in the same set of openings (either 225 or 226), is about 5-12 mm. In some embodiments, the distances between eachadjacent openings 225, 225 (or 226, 226) is the same as each other. In some embodiments, the distances between each adjacent openings is different from each other. - In various embodiments, at least one pair of the
openings openings openings anchor member 210. In some embodiments, all the pairs ofopenings anchor member 210. - In various embodiments, all the
openings -
FIGS. 8 illustrates an exemplary elongate profile of anexemplary anchor 300 that includes anelongate anchor member 310 and wherein theopenings 225 in the first set ofopenings 225 form a straight line parallel to the longitudinal axis of theanchor member 310, and theopenings 226 in the second set ofopenings 226 form another straight line parallel to the longitudinal axis of theanchor member 310 and at a distance from the line formed by the first set ofopenings 225. -
FIG. 9 illustrates an exemplary elongate profile of anexemplary anchor 400 that includes anelongate anchor member 410. Theopenings 225 in the first set of openings form a curve with theopenings 225 in the middle portion of the anchor member closest to the lateral center of theanchor member 410, and theopenings 226 in the second set of openings form another curve with theopenings 226 in the middle portion of theanchor member 410 closest to the lateral center of theanchor member 410, and the two curves have a lateral distance from each other and together form an “hour glass” shape. -
FIGS. 10A and 10B illustrate an exemplary elongate profile of anexemplary anchor 500 that includes anelongate anchor member 510. Allopenings anchor member 510.FIG. 10B is a side elevation view of theanchor member 510 showing the routing of the tensioningmember 201 through theanchor member 510. - In various embodiments, at least one pre-set folding line is created between two pairs of the
openings FIG. 12A . The pre-set folding line can be made by heat setting with or without a mold. One skilled in the art would understand that other methods can also be used to create pre-set folding lines without undue experimentations. In some embodiments, the pre-set folding lines allow the elongate anchor member to fold at pre-defined places. In certain embodiments, a pre-set folding line is created between every two pairs of theopenings FIGS. 8-10 . - According to various embodiments of the present teachings, the elongate anchor member (e.g., anchor member 210) shortens and creates folds as illustrated in
FIG. 11 . In some embodiments, the number of the folds in the anchor in its deployed profile ranges from 4 to 12. In various embodiments, the number of the folds is the same as the number of the openings in at least one set of theopenings openings -
FIGS. 12A-D illustrate an exemplary embodiment of the present teachings. Specifically,FIGS. 12A and 12D illustrate an exemplary elongate profile and an exemplary deployed profile, respectively, of ananchor 600 of the present teachings. Theanchor 600 includes anelongate anchor member 610. As shown inFIG. 12A , theelongate anchor member 610 has two sets ofopenings tensioning member 201 weaves. The tensioningmember 201 weaves through the first set ofopenings 225 as it extends from the proximal end to the distal end of theanchor member 610 and weaves through the second set ofopenings 226 as it returns from the distal end to the proximal end of theanchor member 610. - In various embodiments of the present teachings, at least one opening in the first set of openings corresponds with another opening in the second set of openings and together they form a pair of openings on the anchor member. As shown in
FIG. 12A , there are 5 pairs ofopenings openings anchor member 510. As shown inFIG. 12A , each pair of theopenings anchor member 610 are parallel to one another and perpendicular to the longitudinal axis of theanchor member 610, and at the lateral center of theanchor member 610; allopenings anchor member 610 align with one another and form an imaginary straight line that is parallel to the longitudinal axis of the entire distal portion of theanchor member 610, and at the lateral center of the entire distal portion of theanchor member 610. Thus, in the proximal portion of theanchor member 610, allopenings anchor member 610 and at the lateral center of theanchor member 610. One skilled in the art should understand that the amount of pairs of opening in distal and/or proximal portions of theanchor member 610 can be of any number other than what has been described here. -
FIG. 12A further illustrates exemplary pre-set folding lines in an elongate anchor member of the present teachings. As shown inFIG. 12A , the folding lines (indicated in the drawings as “L”) in the proximal portions and the distal end portion of the distal portion of theanchor member 610 are parallel to one another and perpendicular to the longitudinal axis of theanchor member 610. The pre-set folding lines L between the distal end section and proximal end section of the distal portion of theanchor member 610 are angled to the other pre-set folding lines L. Although specific pre-set folding patterns is shown inFIG. 12A , one with ordinary skill in the art would understand that other patterns, numbers can be incorporated to form pre-set folding lines L. For example, the both distal and proximal portions of theanchor member 610 are parallel to one another and perpendicular to the longitudinal axis of theanchor member 610, and only a middle portion 615 between the distal and proximal portions of theanchor member 610 are angled, so as to forming a transitional section across the paravalvular leakage upon deployment. Therefore what is shown inFIG. 12A should not be considered as being limiting. -
FIG. 12A further illustrates an exemplary narrow section in the distal end portion of the anchor member. This narrow section is the result of radiopaque marker being crimped onto the anchor member. As described above, there are other ways of putting one or more radiopaque markers onto the anchor member. Thus, what is shown in this Figure should not limit the scope of the present teachings. -
FIG. 12B illustrates an exemplary deployment profile of an embodiment of the present teachings across a paravalvular leakage site. There are 8 folds in the deployed anchor as shown inFIG. 12B , among which 5 are distal to the paravalvular leakage and 3 are proximal to the leakage. One skilled in the art would understand that the number of folds in each side of the paravalvular leakage should not be viewed as limiting. As shown inFIG. 12B , the folded panels at the proximal portion of the anchor member and at the proximal end section of the distal portion of the anchor member orientate in one direction, and the folded panels in the distal end portion of the anchor member orientate in another direction that is perpendicular to folded panels in the other direction. The transitional folds between the distal and proximal end section of the distal portion of the anchor member are located at the angled pre-set folding line. In this specific embodiment shown inFIG. 12B , the transitional folds are distal to the paravalvular leakage and are generally indicated with the reference character 601 (in other words, the change in folding direction is identified at 601). One skilled in the art should understand that the transitional folds can be proximal to the paravalvular leakage, or across the paravalvular leakage, and thus what has be illustrated here should not be viewed as limiting. -
FIG. 12C is a view of the exemplary anchor shown inFIGS. 12A and B in its deployed configuration. The distal deployed anchor portion has a width “x” established by the width of the anchor and a length “y” determined by the distance between two pairs of the openings. The proximal deployed anchor portion has a width “y” established by the distance between the two pairs of the openings and a length “x” established by the width of the anchor. As shown in this view, the configuration in the exemplary embodiment shown inFIGS. 12A-D increases the overall width of the deployed anchor. This configuration prevents the tensioning member from cutting the panel and the paravalvular leakage and increases the retention force of the anchor against the leakage site. - In other words as shown in
FIG. 12D , at least twoadjacent anchor panels adjacent anchor panels - Other arrangements can be incorporated into the two sets of openings. For example, all the openings from both sets of openings in the distal portion of the anchor member can align with each other to form an imaginary straight line that is parallel to the longitudinal axis of the anchor member, and/or each pair of the openings in the proximal portion of the anchor member can form an imaginary line and all the imaginary lines so formed are parallel to one another and perpendicular to the longitudinal axis of the anchor member. One skilled in the art would understand that openings in either or both set of the openings can form any configuration so long as it serves the intended purpose.
- Although the present teachings have been described with reference to preferred embodiments, persons ordinarily skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
Claims (35)
1. A method of percutaneously treating a paravalvular leakage comprising the steps of:
providing an anchor, wherein the anchor comprises an elongate anchor member and a tensioning member, wherein the elongate anchor member comprises a distal portion and a first set of openings along a length of the elongate anchor member, and the tensioning member passes through at least two of the first set of openings, wherein the anchor has an elongate configuration and a shortened configuration;
positioning the anchor through a paravalvular leakage;
deploying the anchor wherein at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage; and
applying tension to the tensioning member so that at least a part of the distal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration.
2. The method of claim 1 , wherein the elongate anchor member comprises a proximal portion.
3. The method of claim 1 , wherein the elongate anchor member comprises a second set of openings.
4. The method of claim 2 , wherein the tensioning member extends from the proximal portion to the distal portion of the elongate anchor member.
5. The method of any of claim 2 , wherein the tensioning member extends from the distal portion to the proximal portion of the elongate anchor member.
6. The method of claim 5 , wherein the tensioning member passes through at least two of the first set of openings.
7. The method of claim 5 , wherein the tensioning member passes through at least two of the second set of openings.
8. The method of claim 1 , wherein the elongate anchor member comprises a first folding line and a second folding line, the first folding line being at an angle with respect to the second folding line.
9. The method of claim 2 , further comprising the step of deploying the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage.
10. The method of claim 2 , further comprising the step of applying tension to the tensioning member so that at least a part of the proximal portion of the elongate anchor member transitions from the elongate configuration to the shortened configuration.
11. The method of claim 1 , further comprising the step of introducing a catheter approximately at the paravalvular leakage.
12. The method of claim 11 further comprising the step of withdrawing the catheter to deploy the anchor wherein at least a part of the distal portion of the elongate anchor member is on one side of the paravalvular leakage.
13. The method of claim 11 , further comprising the step of withdrawing the catheter to deploy the anchor wherein at least a part of the proximal portion of the elongate anchor member is on the other side of the paravalvular leakage.
14. The method of claim 1 comprising the step of locating the paravalvular leakage.
15. The method of claim 1 , wherein the elongate anchor member comprises a plurality of panels, wherein a least one of the plurality of panels is defined by a first folding line and a second folding line.
16. The method of claim 18 , wherein at least two of the plurality of panels are at least one of substantially overlapping and partially overlapping in the shortened configuration.
17. The method of claim 15 , wherein the applying of tension of the tensioning member causes at least two of the plurality of panels to fold along one of the first and second folding line.
18. The method of claim 1 , wherein the anchor comprises a second elongate anchor member proximally to the elongate anchor member.
19. The method of claim 18 , further comprising the steps of: deploying the anchor, wherein at least a part of the second elongate anchor member is on the other side of the paravalvular leakage; applying tension to the tensioning member so that at least a part of the second elongate anchor member transitions from the elongate configuration to the shortened configuration;
20. The method of claim 19 , further comprising introducing a catheter approximately at the paravalvular leakage.
21. The method of claim 20 , further comprising the step of withdrawing the catheter to deploy the anchor wherein at least a part of the elongate anchor member is on one side of the paravalvular leakage.
22. The method of claim 20 , further comprising the step of withdrawing the catheter to deploy the anchor wherein at least a part of the second elongate anchor member is on the other side of the paravalvular leakage.
23. An anchor for use in repairing a paravalvular leakage comprising: an elongate anchor member, wherein the elongate anchor member comprises two or more folding lines and two or more panels and two of the two or more panels fold toward each other along one of the two or more folding lines.
24. The anchor of claim 23 , wherein at least two of the two or more folding lines are parallel to each other.
25. The anchor of claim 23 , wherein at least two of the two or more folding lines are at an angle.
26. The anchor of claim 23 , wherein two of the two or more panels are substantially overlapping.
27. The anchor of claim 23 , wherein two of the two or more panels are partially overlapping.
28. The anchor of claims 23 , further comprising a tensioning member.
29. The anchor of claim 23 , wherein the elongate anchor member comprises a first set of openings and a second set of openings along a length of the elongate anchor member, wherein the tensioning member passes through at least two of the first set of openings and passes through at least two of the second set of openings.
30. A device for repairing a paravalvular leakage comprising: a catheter and an anchor, wherein the catheter comprises a distal end and a lumen having an opening at the distal end, and the anchor is provided at least partially in the lumen and comprises an elongate anchor member and a tensioning member, wherein the elongate anchor member comprises a distal portion and a first set of openings along a length of the elongate anchor member; and the tensioning member passes through at least two of the first set of openings.
31. The device of claim 30 , wherein the elongate anchor member comprises a proximal portion.
32. The device of claim 30 , wherein the elongate anchor member comprises a second set of openings along a length of the elongate anchor member.
33. The device of claim 31 , wherein the tensioning member extends from the proximal portion to the distal portion.
34. The device of claim 31 , wherein the tensioning member extends from the distal portion to the proximal portion.
35. The device of claim 32 , wherein the tensioning member passes through at least two of the second set of openings.
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US20190254677A1 (en) | 2019-08-22 |
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