WO2019013994A1 - Ancrages de tissu dotés d'éléments de support de charge - Google Patents

Ancrages de tissu dotés d'éléments de support de charge Download PDF

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Publication number
WO2019013994A1
WO2019013994A1 PCT/US2018/040147 US2018040147W WO2019013994A1 WO 2019013994 A1 WO2019013994 A1 WO 2019013994A1 US 2018040147 W US2018040147 W US 2018040147W WO 2019013994 A1 WO2019013994 A1 WO 2019013994A1
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WO
WIPO (PCT)
Prior art keywords
tissue
coupling portion
anchor
flexible membrane
expandable
Prior art date
Application number
PCT/US2018/040147
Other languages
English (en)
Inventor
Patrick Griffin
Evin Donnelly
Michael ENNEN
Original Assignee
4Tech Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 4Tech Inc. filed Critical 4Tech Inc.
Publication of WO2019013994A1 publication Critical patent/WO2019013994A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • 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
    • 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
    • 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
    • A61B2017/00601—Implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/048—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery for reducing heart wall tension, e.g. sutures with a pad on each extremity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • 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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2487—Devices within the heart chamber, e.g. splints

Definitions

  • the present invention relates generally to tissue anchors, and specifically to tissue anchors for implantation at cardiac sites.
  • Tissue anchors are used for anchoring elements, such as pacemaker electrode leads or sutures, to tissue, such as bone or soft tissue.
  • tissue anchor that includes a shaft, a tissue-coupling element, and a flexible elongate tension member.
  • the tissue-coupling element includes a wire, which is shaped as an open loop coil having, in some applications, more than one coil revolution when the tissue anchor is unconstrained, i.e., expanded from a linear state to a coiled state.
  • the tension member includes a distal portion, that is fixed to a site on the open loop coil, a proximal portion, which has a longitudinal segment that runs alongside at least a portion of the shaft, and a crossing portion, which (i) is disposed between the distal and the proximal portions along the tension member, and (ii) crosses at least a portion of the open loop when the tissue anchor is expanded.
  • the tissue anchor is configured to allow relative axial motion between the at least a portion of the shaft and the longitudinal segment of the proximal portion of the tension member when the tissue anchor is expanded.
  • tissue anchor that includes an anchor shaft; a tissue-coupling element, which (a) extends from a distal end of the anchor shaft, (b) comprises a wire, and (c) is shaped as an open shape when the tissue anchor is unconstrained by a deployment tool; and a flexible elongate tension member, which (a) extends from a distal site on the open shape, the distal site located within 7 mm of a distal end of the open shape, and (b) includes a proximal portion, which has a longitudinal segment that runs alongside at least a portion of the anchor shaft when the tissue anchor is unconstrained by the deployment tool.
  • the tissue anchor is configured to allow relative axial motion between the at least a portion of the anchor shaft and the longitudinal segment of the proximal portion of the flexible elongate tension member when the tissue anchor is unconstrained by the deployment tool.
  • An expandable tissue anchor is provided that is deliverable to a cardiac chamber in an unexpanded generally elongate configuration within a deployment tool.
  • the expandable tissue anchor is configured to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to the expandable tissue anchor and thus to the cardiac tissue wall, once the expandable tissue anchor is deployed, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue. For some applications, such motion alters the geometry of a cardiac valve, such as the tricuspid valve or the mitral valve.
  • the expandable tissue anchor comprises an elongate tissue- coupling portion, which is configured to expand on a second side of the cardiac tissue wall.
  • the expandable tissue anchor further comprises a flexible membrane coupled to the expandable tissue anchor, and configured to expand to a generally planar configuration.
  • the expanded tissue-coupling portion and the expanded flexible membrane can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to the tissue-coupling portion.
  • the flexible membrane generally reduces the contact pressure between the tissue-coupling portion and the second side of the cardiac tissue wall, thereby increasing the load-bearing capacity of the expandable tissue anchor. As a result, the flexible membrane generally reduces the likelihood of the tissue-coupling portion damaging or being pulled through the cardiac tissue wall, particularly if the tissue is diseased.
  • the flexible membrane is coupled to the tissue-coupling portion.
  • the flexible membrane when the flexible membrane expands to the generally planar configuration, the flexible membrane is partially surrounded by the tissue-coupling portion.
  • the flexible membrane is coupled to an anchor head that supports the tissue-coupling portion at a proximal end of the tissue- coupling portion.
  • the flexible membrane is shaped as a disc.
  • an expandable tissue anchor configured to be delivered to a cardiac chamber using a deployment tool, and to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to the expandable tissue anchor and thus to the cardiac tissue wall, once the expandable tissue anchor is deployed, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue, the expandable tissue anchor including:
  • an elongate tissue-coupling portion configured to be delivered in an unexpanded generally elongate configuration through the cardiac tissue wall from a first side of the cardiac tissue wall to a second side of the cardiac tissue wall, the tissue-coupling portion further configured to expand on the second side of the cardiac tissue wall;
  • a flexible membrane coupled to the expandable tissue anchor, and configured to expand to a generally planar configuration, such that the expanded tissue-coupling portion and the expanded flexible membrane can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to the tissue-coupling portion.
  • the flexible membrane is coupled to the tissue-coupling portion.
  • the expandable tissue anchor configured is configured such that when the flexible membrane expands to the generally planar configuration, the flexible membrane is partially surrounded by the tissue-coupling portion.
  • the expandable tissue anchor further includes a flexible elongate tension member coupled to a portion of the tissue-coupling portion of the expandable tissue anchor such that the tensile force can be applied to the tissue-coupling portion after it has been expanded, and the flexible membrane is coupled to the tissue-coupling portion and the flexible elongate tension member, and configured to expand to the generally planar configuration at least partially surrounded by the tissue-coupling portion and the flexible elongate tension member, when the tissue-coupling portion expands.
  • the expandable tissue anchor further including an anchor head that supports the tissue-coupling portion at a proximal end of the tissue-coupling portion.
  • the expandable tissue anchor configured is configured such that the tissue-coupling portion of the expandable tissue anchor, once expanded on the second side of the cardiac tissue wall, assumes a shape generally orthogonal to a central longitudinal axis of the anchor head.
  • the expandable tissue anchor configured is configured such that the flexible membrane, once expanded on the second side of the cardiac tissue wall, assumes a shape generally orthogonal to a central longitudinal axis of the anchor head.
  • the flexible membrane includes a material selected from the group of materials consisting of: expanded polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (PET).
  • ePTFE expanded polytetrafluoroethylene
  • PET polyethylene terephthalate
  • the flexible membrane is configured such that when the flexible membrane expands to the generally planar configuration and the expanded tissue- coupling portion and the expanded flexible membrane are drawn tightly against the second side of the cardiac tissue wall, the flexible membrane is disposed between at least a portion of the tissue-coupling portion and the second side of the cardiac tissue wall, so as to prevent direct contact between the second side of the cardiac tissue wall and the at least a portion of the tissue-coupling portion.
  • the expandable tissue anchor further includes an anchor head that supports the tissue-coupling portion at a proximal end of the tissue-coupling portion, and the flexible membrane is coupled to the anchor head.
  • the tissue-coupling portion includes a wire and a distal tip member, which (a) is fixed to a distal end of the wire and (b) at a widest longitudinal site along the distal tip member, has a greatest outer cross-sectional area that equals at least 150% of an average cross-sectional area of the wire, and
  • the flexible membrane is arranged, when expanded, to prevent direct contact between the distal tip member of the tissue-coupling portion and the second side of the cardiac tissue wall when the flexible membrane expands to the generally planar configuration and the expanded tissue-coupling portion and the expanded flexible membrane are drawn tightly against the second side of the cardiac tissue wall.
  • the flexible membrane is shaped as a disc.
  • the flexible membrane includes a polymer.
  • the polymer may be woven, electrospun, braided, or knitted.
  • the flexible membrane further includes a shape-memory structure fixed to a portion of the polymer.
  • the flexible membrane is shaped so as to define a reinforced opening, through which a portion of the anchor head passes.
  • the expandable tissue anchor is configured such that when the flexible membrane expands to the generally planar configuration and the expanded tissue-coupling portion and the expanded flexible membrane are drawn tightly against the second side of the cardiac tissue wall, the flexible membrane forms a hemostatic seal of an opening through the cardiac tissue wall through which the anchor head passes.
  • the expandable tissue anchor configured is configured such that the flexible membrane, once expanded on the second side of the cardiac tissue wall, assumes a shape generally orthogonal to a central longitudinal axis of the anchor head.
  • the expandable tissue anchor configured is configured such that the tissue-coupling portion of the expandable tissue anchor, once expanded on the second side of the cardiac tissue wall, assumes a shape generally orthogonal to a central longitudinal axis of the anchor head.
  • an anchor system includes the expandable tissue anchor and further includes the deployment tool; the deployment tool includes a hollow delivery shaft; and the anchor head, the tissue-coupling portion, and the flexible membrane are removably disposed in the hollow delivery shaft, with the flexible membrane folded about a portion of the tissue-coupling portion.
  • the tissue-coupling portion and the flexible membrane are removably disposed in the hollow delivery shaft such that a distal end of the tissue-coupling portion extends distally beyond a distally-most-disposed portion of the flexible membrane.
  • the tissue-coupling portion includes a wire and a distal tip member, which (a) is fixed to a distal end of the wire and (b) at a widest longitudinal site along the distal tip member, has a greatest outer cross-sectional area that equals at least 150% of an average cross-sectional area of the wire, and
  • the tissue-coupling portion and the flexible membrane are removably disposed in the hollow delivery shaft such that a proximal end of the distal tip member is disposed distally beyond the distally-most-disposed portion of the flexible membrane.
  • the expandable tissue anchor further includes a flexible elongate tension member coupled to a portion of the tissue-coupling portion of the expandable tissue anchor such that the tensile force can be applied to the tissue-coupling portion after it has been expanded.
  • an anchor system includes the expandable tissue anchor and further includes a tether affixed to the flexible elongate tension member such that the tensile force can be applied to the expandable tissue anchor via the tether and the flexible elongate tension member.
  • the expandable tissue anchor is configured such that when the cardiac tissue wall is a myocardial tissue wall, the tissue-coupling portion of the expandable tissue anchor can be advanced into the pericardial cavity between visceral pericardium and parietal pericardium, generally alongside and against the parietal pericardium, without penetrating the parietal pericardium.
  • the tissue-coupling portion includes a wire and a distal tip member, which (a) is fixed to a distal end of the wire and (b) at a widest longitudinal site along the distal tip member, has a greatest outer cross-sectional area that equals at least 150% of an average cross-sectional area of the wire.
  • the expandable tissue anchor includes a wire, a distal portion of the wire is shaped so as to define at least a portion of the tissue-coupling portion, and a proximal portion of the wire is shaped so as to define at least a portion of the anchor head.
  • a method for moving a cardiac tissue wall at a target site relative to adjacent cardiac tissue including:
  • an expandable tissue anchor in an unexpanded generally elongate configuration within a deployment tool, the expandable tissue anchor including an elongate tissue-coupling portion, and a flexible membrane coupled to the expandable tissue anchor;
  • tissue-coupling portion in an unexpanded generally elongate configuration through the cardiac tissue wall from a first side of the wall to a second side of the wall, such that (a) the tissue-coupling portion expands, on the second side of the cardiac tissue wall, and (b) the flexible membrane expands to a generally planar configuration, thereby anchoring the expandable tissue anchor to the cardiac tissue wall at the target site;
  • the flexible membrane is coupled to the tissue-coupling portion.
  • the flexible membrane when the flexible membrane expands to the generally planar configuration, the flexible membrane is partially surrounded by the tissue-coupling portion.
  • applying a tensile force to the tissue-coupling portion includes applying the tensile force to a flexible elongate tension member coupled to a portion of the tissue-coupling portion,
  • the flexible membrane is coupled to the tissue-coupling portion and the flexible elongate tension member
  • delivering the tissue-coupling portion includes delivering the tissue-coupling portion through the cardiac tissue wall such that the flexible membrane expands to the generally planar configuration at least partially surrounded by the tissue-coupling portion and the flexible elongate tension member, when the tissue-coupling portion expands.
  • delivering the tissue-coupling portion includes delivering the tissue-coupling portion through the cardiac tissue wall such that when the flexible membrane expands to the generally planar configuration, the flexible membrane is disposed between at least a portion of the tissue-coupling portion and the second side of the cardiac tissue wall, so as to prevent direct contact between the second side of the cardiac tissue wall and the at least a portion of the tissue-coupling portion.
  • delivering the tissue-coupling portion includes delivering the tissue-coupling portion through the cardiac tissue wall such that when the flexible membrane expands to the generally planar configuration, the flexible membrane forms a hemostatic seal of an opening through the cardiac tissue wall through which the anchor head passes.
  • delivering the expandable tissue anchor includes delivering the expandable tissue anchor in the unexpanded generally elongate configuration with the anchor head, the tissue-coupling portion, and the flexible membrane removably disposed in a hollow delivery shaft of the deployment tool, with the flexible membrane folded about a portion of the tissue-coupling portion.
  • applying a tensile force to the tissue-coupling portion includes applying the tensile force to a flexible elongate tension member coupled to a portion of the tissue-coupling portion.
  • applying the tensile force to the flexible elongate tension member includes applying the tensile force to a tether affixed to the flexible elongate tension member.
  • the method further includes implanting a second tissue anchor, separate and distinct from the expandable tissue anchor.
  • the cardiac tissue is a myocardial tissue wall
  • delivering the tissue-coupling portion in the unexpanded generally elongate configuration through the cardiac tissue wall includes delivering the tissue-coupling portion through the cardiac tissue wall into the pericardial cavity between visceral pericardium and parietal pericardium, generally alongside and against the parietal pericardium, without penetrating the parietal pericardium.
  • Fig. 1 is a schematic illustration of an expandable tissue anchor that is configured to be anchored to a cardiac tissue wall at a target site, in accordance with an application of the present invention
  • Figs. 2A-B are schematic illustrations of a method of deploying the expandable tissue anchor of Fig. 1 through a myocardial tissue wall, in accordance with an application of the present invention
  • FIG. 3 is a schematic illustration of another expandable tissue anchor that is configured to be anchored to a cardiac tissue wall at a target site, in accordance with an application of the present invention
  • Fig. 4 is a schematic illustration of yet another expandable tissue anchor that is configured to be anchored to a cardiac tissue wall at a target site, in accordance with an application of the present invention
  • Figs. 5A-B are schematic illustrations of a method of deploying the expandable tissue anchor of Fig. 4 through a myocardial tissue wall, in accordance with an application of the present invention
  • Figs. 6A-C are schematic illustrations of shape-memory configurations of a flexible membrane of the expandable tissue anchor of Fig. 4, in accordance with respective applications of the present invention.
  • Figs. 7A-B are schematic illustrations of a flexible membrane and a tissue- coupling portion, respectively, of the expandable tissue anchor of Fig. 4, in accordance with an application of the present invention.
  • Fig. 1 is a schematic illustration of an expandable tissue anchor 20 that is configured to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to expandable tissue anchor 20 and thus to the cardiac tissue wall, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue, in accordance with an application of the present invention.
  • Expandable tissue anchor 20 comprises an elongate tissue-coupling portion 30, which optionally is supported by an anchor head 96 at a proximal end 34 of tissue-coupling portion 30.
  • Tissue-coupling portion 30 is configured to be delivered in an unexpanded generally elongate configuration, such as described hereinbelow with reference to Fig.
  • Tissue-coupling portion 30 is further configured, upon deployment, to expand (e.g., self-expand), on the second side of the cardiac tissue wall, such as described hereinbelow with reference to Fig. 2B.
  • Figs. 1 and 2B show tissue-coupling portion 30 expanded.
  • expanded tissue- coupling portion 30 has less than one turn, as shown in the figures, while for other applications, expanded tissue-coupling portion 30 has one turn (configuration not shown) or more than one turn (configuration not shown, but, for example, may be as shown in Figs. 5B-D, 6A-B, 7A-B, 9A-G, and/or 91 of above-mentioned PCT Publication WO 2016/087934).
  • Expandable tissue anchor 20 further comprises a flexible membrane 40 coupled to tissue-coupling portion 30.
  • Flexible membrane 40 is configured to expand (e.g., self- expand) to a generally planar configuration, typically partially surrounded by tissue- coupling portion 30, when tissue-coupling portion 30 expands, such that expanded tissue- coupling portion 30 and expanded flexible membrane 40 can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to tissue-coupling portion 30.
  • Flexible membrane 40 generally reduces the contact pressure between tissue-coupling portion 30 and the second side of the cardiac tissue wall, thereby increasing the load-bearing capacity of expandable tissue anchor 20. As a result, flexible membrane 40 generally reduces the likelihood of tissue-coupling portion 30 damaging or being pulled through the cardiac tissue wall, particularly if the tissue is diseased.
  • flexible membrane 40 is highly stretchable, such that flexible membrane 40 stretches and does not impede tissue-coupling portion 30 from assuming the unexpanded generally elongate configuration, as shown in Fig. 2A.
  • flexible membrane 40 may comprise expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET).
  • ePTFE expanded polytetrafluoroethylene
  • PET polyethylene terephthalate
  • the stretchability and/or flexibility of flexible membrane 40 in one or more axes may be achieved by flexible membrane 40 comprising a cut or woven pattern of a relatively non-elastic polymer, such as PET.
  • expandable tissue anchor 20 further comprises a flexible elongate tension member 46 coupled to a portion of tissue-coupling portion 30 of expandable tissue anchor 20.
  • a flexible elongate tension member 46 coupled to a portion of tissue-coupling portion 30 of expandable tissue anchor 20.
  • the tensile force can be applied to tissue-coupling portion 30 after it has been expanded.
  • the tensile force may have the benefit of bringing the anchor close to the tissue wall to which it is applied.
  • an anchor system 50 is provided that comprises expandable tissue anchor 20 and a tether 52 affixed to elongate tension member 46 such that the tensile force can be applied to expandable tissue anchor 20 via tether 52 and elongate tension member 46.
  • expandable tissue anchor 20 further comprises a tube 54 that surrounds a proximal portion of flexible elongate tension member 46.
  • anchor system 50 further comprises a second tissue anchor, separate and distinct from expandable tissue anchor 20, such as is shown in above-mentioned PCT Publication WO 2016/087934.
  • the second tissue anchor, and additional anchors if so desired is couplable or coupled to expandable tissue anchor 20 by one or more tethers that include tether 52.
  • flexible membrane 40 is coupled to tissue-coupling portion 30 and elongate tension member 46, and configured to expand (e.g., self-expand) to the generally planar configuration at least partially surrounded by tissue-coupling portion 30 and elongate tension member 46, when tissue-coupling portion 30 expands.
  • tissue-coupling portion 30 and/or flexible membrane 40 once expanded on the second side of the cardiac tissue wall, such as described hereinbelow with reference to Fig. 2B, assume a shape generally orthogonal to a central longitudinal axis of anchor head 96, as shown in Fig. 1, although it need not be orthogonal.
  • anchor head 96 further comprises a sealing element 74, which is sized and shaped to be inserted with anchor head 96 into an incision through the cardiac tissue wall. Sealing element 74, along with at least a portion of anchor head 96, remains in the incision upon completion of the implantation of expandable tissue anchor 20. Sealing element 74 promotes hemostasis to provide sealing of the incision.
  • sealing element 74 comprises a mesh, which may comprise nickel titanium, covered with a membrane. The membrane may comprise a bioabsorbable polymer, which breaks down after healing and hemostasis occur.
  • FIGs. 2A-B are schematic illustrations of a method of deploying expandable tissue anchor 20 through a myocardial tissue wall 60, in accordance with an application of the present invention.
  • expandable tissue anchor 20 may also be deployed through other cardiac tissue walls, such as the interatrial septum, either at or not at the fossa ovalis, or through other non- cardiac tissue walls.
  • the tissue anchors described herein may be deployed in any number of bodily locations where it is desired to anchor into or behind tissue for purposes of moving such tissue relative to adjacent tissue.
  • the method of Figs. 2A-B may also be used for deploying expandable tissue anchor 120, described hereinbelow with reference to Fig. 3, and deploying expandable tissue anchor 220, described hereinbelow with reference to Figs. 4-7B.
  • expandable tissue anchor 20 is delivered to a target site, such as a cardiac chamber, in an unexpanded generally elongate configuration within a deployment tool 70, which may comprise a hollow delivery shaft 72, e.g., a hollow needle, such as shown.
  • the cardiac chamber may be a right atrium 64 (as shown), a right ventricle 66 (configuration not shown), a left atrium (configuration not shown), or a left ventricle (configuration not shown).
  • hollow delivery shaft 72 comprises a hollow needle
  • the hollow needle is used to puncture through a first side of a myocardial tissue wall 60 and visceral pericardium 82 (which is part of the epicardium), avoiding vasculature such as the right coronary artery (RCA) 78.
  • deployment tool 70 is then further directed into the pericardial cavity 80 between visceral pericardium 82 and parietal pericardium 84, carefully avoiding puncturing parietal pericardium 84 and fibrous pericardium 86.
  • tissue-coupling portion 30 expands, on the second side of myocardial tissue wall 60, and flexible membrane 40 expands to a generally planar configuration partially surrounded by tissue-coupling portion 30, thereby anchoring expandable tissue anchor 20 to myocardial tissue wall 60.
  • flexible membrane 40 when flexible membrane 40 expands to the generally planar configuration, flexible membrane 40 is disposed between at least a portion of tissue-coupling portion 30 and the second side of myocardial tissue wall 60, so as to prevent direct contact between the second side of myocardial tissue wall 60 and the at least a portion of tissue-coupling portion 30.
  • no portion of tissue-coupling portion 30 directly contacts the second side of myocardial tissue wall 60.
  • Flexible membrane 40 may prevent all of this direct contact, or only a portion of this direct contact, in which case the remainder of the direct contact is prevented by the geometry of tissue-coupling portion 30 and/or the second side of the wall, and/or by another element of tissue anchor 20.
  • flexible membrane 40 is not disposed between tissue-coupling portion 30 and the second side of myocardial tissue wall 60; for example, flexible membrane 40 may be wrapped around tissue-coupling portion 30 in a direction reverse that shown in Figs. 1 and 2B, such that flexible membrane 40 is farther from anchor head 96 than shown in Figs. 1 and 2B (configuration not shown).
  • expandable tissue anchor 20 Once expandable tissue anchor 20 has been anchored to myocardial tissue wall 60 at the target site, expanded tissue-coupling portion 30 and expanded flexible membrane 40 are tightly drawn against the second side of myocardial tissue wall 60 at the target site by applying a tensile force, using tether 52, to tissue-coupling portion 30 and thus to myocardial tissue wall 60, so as to move myocardial tissue wall 60 at the target site relative to adjacent cardiac tissue.
  • a nearby cardiac valve such as the tricuspid valve or the mitral valve.
  • expanded tissue-coupling portion 30 when expanded tissue-coupling portion 30 is tightly drawn against the second side of myocardial tissue wall 60, expanded tissue-coupling portion 30 may or may not directly contact the second side of myocardial tissue wall 60, or may partially directly contact the second side, such as described hereinabove; in other words, "drawing tightly against” should not be understood as requiring direct contact, either in the configuration described herein with reference to Figs. 1 -2B, the configuration described herein with reference to Fig. 3, or the configuration described herein with reference to Figs. 4-7B. (By way of analogy, a cyclist's hands are drawn tightly against handlebars, even though cycling gloves intervene and prevent direct contact of the cyclist's hands with the handlebars.)
  • tissue-coupling portion 30 (and flexible membrane 40) are delivered through myocardial tissue wall 60, into pericardial cavity 80, generally alongside and against parietal pericardium 84, without penetrating the parietal pericardium 84.
  • a second tissue anchor is implanted, separate and distinct from expandable tissue anchor 20.
  • tissue-coupling portion 30 comprises a distal tip member 88, which is fixed to a distal end of a wire 89 of tissue-coupling portion 30.
  • Distal tip member 88 at a widest longitudinal site along distal tip member 88, has a greatest outer cross-sectional area that equals at least 150% (e.g., at least 200%, or at least 300%) of an average cross-sectional area of wire 89.
  • the cross- sectional area of distal tip member 88 is measured perpendicular to a central longitudinal axis of distal tip member 88.
  • the cross-sectional area of wire 89 is measured perpendicular to a central longitudinal axis of the wire, and is not a cross-sectional area of tissue-coupling portion 30.
  • a distal portion of wire 89 is shaped so as to define at least a portion of tissue-coupling portion 30, and a proximal portion of wire 89 is shaped so as to define at least a portion of anchor head 96.
  • Wire 89 may be solid or hollow (i.e., tubular).
  • hollow delivery shaft 72 comprises a hollow needle and a sharp distal end of the hollow needle extends distally beyond the distal end of distal tip member 88, such that distal tip member 88 is disposed within the hollow needle, such as shown in Fig. 2A.
  • hollow delivery shaft 72 does not comprise a sharp distal tip, and instead distal tip member 88 is shaped so as to define a sharp dilator tip (configuration not shown).
  • Distal tip member 88 is disposed such that a proximal end of the distal tip member 88 is flush with a distal end of hollow delivery shaft 72, and thus serves as a distal cap of hollow delivery shaft 72.
  • hollow delivery shaft 72 of deployment tool 70 has an outer cross-sectional area which equals between 90% and 1 10% (e.g., 100%) of the greatest outer cross-sectional area of distal tip member 88.
  • This latter configuration may allow the use of a lower profile hollow delivery shaft 72 than in the former configuration, because the bore of the shaft does need to accommodate the relative wide distal tip member 88.
  • Such a lower profile may reduce the wound/puncture size and result in less bleeding.
  • FIG. 3 is a schematic illustration of an expandable tissue anchor 120 that is configured to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to expandable tissue anchor 120 and thus to the cardiac tissue wall, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue, in accordance with an application of the present invention.
  • expandable tissue anchor 120 is generally similar to tissue anchor 20, described hereinabove with reference to Figs. 1-2B, and like reference numerals refer to like parts.
  • Expandable tissue anchor 120 may implement any of the techniques described hereinabove for expandable tissue anchor 20.
  • Tissue anchor 120 further comprises a sleeve 90 that encloses a portion of flexible elongate tension member 46 between (a) tissue-coupling portion 30 of expandable tissue anchor 120 and (b) a distal opening 94 of a passage 91 through expandable tissue anchor 120, such that expanded tissue-coupling portion 30 (and, optionally, sleeve 90) can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to tissue-coupling portion 30.
  • Distal opening 94 of passage 91 is typically located near (e.g., at) a distal end 92 of anchor head 96. A portion of flexible elongate tension member 46 is slidably disposed through passage 91.
  • passage 91 is defined by anchor head 96 (as shown).
  • distal opening 94 may be defined by a tubular anchor shaft 32 that anchor head 96 comprises; anchor head 96 may optionally implement techniques described in above-mentioned PCT Publication WO 2016/087934.
  • anchor head 96 comprises one or more collars 97, such as distal and proximal collars 97A and 97B, as shown, or exactly one collar 97 (configuration not shown).
  • distal opening 94 is defined by a distal end of distal collar 97A (as shown in Figs. 1, 2A-B, and 3) or a distal end of the exactly one collar 97 (configuration not shown).
  • distal opening 94 is defined by a lateral surface of the distal collar.
  • passage 91 includes more than one passage 91, as shown.
  • passage 91 is alternatively or additionally defined by another portion of expandable tissue anchor 120, such as both tissue-coupling portion 30 of expandable tissue anchor 120 and anchor head 96 of expandable tissue anchor 120.
  • Passage 91 is typically a channel, but may also be a groove (e.g., a U-shaped groove).
  • Sleeve 90 and passage 91 are sized and shaped such that the size and shape of passage 91 prevent proximal movement of sleeve 90 past passage 91 (e.g., prevent proximal movement of sleeve 90 into distal opening 94). Sleeve 90 and passage 91 thus limit movement of tissue-coupling portion 30 toward distal end 92 of anchor head 96 upon application of the tensile force to flexible elongate tension member 46.
  • sleeve 90 has sufficient axial stiffness and too large an outer diameter to pass through passage 91 (e.g., including distal opening 94), and a distal (far) end 93 of sleeve 90 contacts tissue-coupling portion 30 near a junction 95 between flexible elongate tension member 46 and tissue-coupling portion 30.
  • Sleeve 90 because of its axial stiffness, thus limits compression and deformation of expanded tissue-coupling portion 30 by flexible elongate tension member 46. A portion of the load (tension) applied by flexible elongate tension member 46 brings sleeve 90 into contact with expandable tissue anchor 20 near or at distal opening 94.
  • Additional load (tension) applied by flexible elongate tension member 46 increases the total load on expanded tissue-coupling portion 30 (without further compressing or deforming expanded tissue-coupling portion 30), (b) optionally is diverted to elastic or plastic deformation of sleeve 90, and (c) pulls on the entire expandable tissue anchor 20.
  • flexible membrane 40 is coupled to tissue-coupling portion 30 and sleeve 90, and configured to expand (e.g., self-expand) to the generally planar configuration at least partially surrounded by tissue-coupling portion 30 and sleeve 90, when tissue-coupling portion 30 expands.
  • flexible membrane 40 is coupled directly to elongate tension member 46, rather than to sleeve 90.
  • sleeve 90 may be shaped so as to define a longitudinal slot along the sleeve, through which slot flexible membrane 40 passes to elongate tension member 46 within the sleeve (configuration not shown).
  • sleeve 90 may generally increase the contact area between flexible elongate tension member 46 and the second site of the cardiac tissue wall. As a result, sleeve 90 may generally reduce the likelihood of flexible elongate tension member 46 cutting the cardiac tissue wall, particularly if the tissue is diseased.
  • sleeve 90 has an outer diameter of at least 0.5 mm, no more than 1 mm, and/or between 0.5 and 1 mm, such as 0.75 mm.
  • sleeve 90 has a length of at least 2 mm, no more than 6 mm, and/or between 2 and 6 mm, such as between 3 and 5 mm, e.g., 4 mm. Shorter lengths of sleeve 90 result in a more closed shape of expanded tissue-coupling portion 30, for example, more closed than shown in Fig. 3.
  • sleeve 90 comprises PET, PEEK, a closely wound metal coil spring, porous ePTFE, or woven PET fiber.
  • Sleeve 90 optionally may implement any of the techniques described for sleeve
  • expandable tissue anchor 120 further comprises a second sleeve 98, which encloses a portion of wire 89 of tissue-coupling portion 30.
  • Second sleeve 98 serves to increase the contact area between tissue-coupling portion 30 and the second site of the cardiac tissue wall. As a result, second sleeve 98 may generally reduce the likelihood of wire 89 cutting the cardiac tissue wall, particularly if the tissue is diseased.
  • second sleeve 98 has an inner diameter of 0.5 mm and an outer diameter of 1.0 mm, and/or may comprise, for example, porous ePTFE or woven PET fiber. The combined profile of sleeve 90 and second sleeve 98 is less than the inner diameter of hollow delivery shaft 72.
  • flexible membrane 40 is coupled to tissue-coupling portion 30, sleeve 90, and second sleeve 98, and configured to expand (e.g., self-expand) to the generally planar configuration at least partially surrounded by tissue-coupling portion 30, sleeve 90, and second sleeve 98, when tissue-coupling portion 30 expands.
  • flexible membrane 40 is coupled directly to wire 89 of tissue coupling portion 30, rather than to second sleeve 98.
  • second sleeve 98 may be shaped so as to define a longitudinal slot along the sleeve, through which slot flexible membrane 40 passes to elongate tension member 46 within the sleeve (configuration not shown).
  • FIG. 4 is a schematic illustration of an expandable tissue anchor 220 that is configured to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to expandable tissue anchor 220 and thus to the cardiac tissue wall, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue, in accordance with an application of the present invention.
  • expandable tissue anchor 220 is generally similar to tissue anchor 20, described hereinabove with reference to Figs. 1-2B, and tissue anchor 120, described hereinabove with reference to Fig. 3, and like reference numerals refer to like parts.
  • Expandable tissue anchor 220 may implement any of the techniques described hereinabove for expandable tissue anchor 20 and/or expandable tissue anchor 120.
  • flexible membrane 240 is coupled to anchor head 96.
  • flexible membrane 240 is shaped as a disc 242, which typically is centered about a central longitudinal axis of a distal portion of anchor head 96, as shown.
  • expandable tissue anchor 220 further comprises a retaining ring 243, e.g., comprising a hard material such as a metal, which couples flexible membrane 240 to anchor head 96, typically by sandwiching flexible membrane 240 between retaining ring 243 and a portion of anchor head 96 (e.g., distal end 92 of anchor head 96, which may be defined by a distal surface of distal collar 97A).
  • flexible membrane 240 comprises a polymer 244.
  • polymer 244 may be woven, electrospun, braided, or knitted.
  • FIGs. 5A-B are schematic illustrations of a method of deploying expandable tissue anchor 220 through myocardial tissue wall 60, in accordance with an application of the present invention.
  • the method is generally the same as the method of deploying expandable tissue anchor 20, described hereinabove with reference to Figs. 2A-B.
  • anchor head 96, tissue-coupling portion 30, and flexible membrane 240 are removably disposed in hollow delivery shaft 72 of deployment tool 70, with flexible membrane 240 folded about a portion of tissue- coupling portion 30 (which assumes the unexpanded generally elongate configuration within hollow delivery shaft 72).
  • tissue-coupling portion 30 and flexible membrane 240 are removably disposed in hollow delivery shaft 72 such that a distal end 248 of tissue-coupling portion 30 extends distally beyond a distally-most- disposed portion 256 of flexible membrane 240.
  • Flexible membrane 240 of expandable tissue anchor 220 is configured such that when flexible membrane 240 expands to a generally planar configuration and expanded tissue-coupling portion 30 and expanded flexible membrane 240 are drawn tightly against the second side of the cardiac tissue wall, such as shown in Fig. 5B (and Fig. 4), flexible membrane 240 is disposed between at least a portion of (e.g., all of) tissue-coupling portion 30 and the second side of the cardiac tissue wall (e.g., myocardial tissue wall 60), so as to prevent direct contact between the second side of the cardiac tissue wall and the at least a portion of (e.g., all of) tissue-coupling portion 30. Typically, no portion of tissue- coupling portion 30 directly contacts the second side of the cardiac tissue wall.
  • Flexible membrane 240 may prevent all of this direct contact, or only a portion of this direct contact, in which case the remainder of the direct contact is prevented by the geometry of tissue-coupling portion 30 and/or the second side of the wall, and/or by another element of tissue anchor 220.
  • tissue-coupling portion 30 comprises wire 89 and distal tip member 88, such as described hereinabove with reference to Figs. 1 and 2A- B
  • flexible membrane 240 is arranged, when expanded, to prevent direct contact between distal tip member 88 and the second side of the cardiac tissue wall, such as shown in Fig. 5B.
  • tissue-coupling portion 30 and/or flexible membrane 240 once expanded on the second side of the cardiac tissue wall, assume a shape generally orthogonal to a central longitudinal axis of anchor head 96, as shown in Fig. 5B (and Fig. 4), although it need not be orthogonal.
  • expandable tissue anchor 220 is configured such that when flexible membrane 240 expands to the generally planar configuration upon deployment thereof, as described hereinabove, flexible membrane 240 forms a hemostatic seal of an opening through the cardiac tissue wall through which anchor head 96 passes.
  • flexible membrane 240 further comprises a shape-memory structure 274 fixed to a portion of polymer 244; for example, shape-memory structure 274 may be integrally part of the portion of polymer 244, e.g., woven into the portion of polymer 244.
  • Shape-memory structure 274 is configured to serve as a structural frame that automatically expands flexible membrane 240 to the generally planar configuration upon release from deployment tool 70.
  • Shape- memory structure 274 typically comprises one or more metal wires 276, for example comprising Nitinol or another shape-memory alloy, arranged in a pattern on flexible membrane 240.
  • wires 276 may be stitched or woven into polymer 244 of flexible membrane 240, or otherwise attached thereto.
  • wires 276 of shape-memory structure 274 have a flat stent partem
  • wire 276 of shape-memory structure 274 is arranged in a spiral
  • wires 276 of shape-memory structure 274 are arranged as spokes and circles.
  • flexible membrane 240 is shaped so as to define a reinforced opening 278, through which a portion of anchor head 96 passes.
  • a reinforced region 280 surrounding opening 278 provides the reinforcement.
  • opening 278 may be reinforced by fusing a portion of polymer 244 in reinforced region 280.
  • tissue-coupling portion 30 comprises wire 89 and distal tip member 88
  • tissue-coupling portion 30 and flexible membrane 240 are removably disposed in hollow delivery shaft 72 such that a proximal end 268 of distal tip member 88 is disposed distally beyond distally-most-disposed portion 256 of flexible membrane 240, as shown in Fig. 5 A.
  • a radius R of flexible membrane 240 is typically less than a length L of wire 89 of tissue-coupling portion 30.
  • Radius R of flexible membrane 240 is measured between an outer perimeter 282 of reinforced region 280 and a greatest perimeter of flexible membrane 240 (radius R is not labeled precisely in Fig. 5A, because flexible membrane 240 is shown somewhat wavy).
  • Length L of wire 89 of tissue-coupling portion 30 is measured between distal end 92 of anchor head 96 and proximal end 268 of distal tip member 88. This arrangement avoids overlap between flexible membrane 240 and distal tip member 88 within hollow delivery shaft 72.
  • Flexible membrane 240 is folded about a portion of wire 89 of tissue-coupling portion 30.
  • Patents and patent application publications incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated patents and patent application publications in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.

Abstract

L'invention concerne un ancrage de tissu expansible (20, 220), qui comprend une partie de couplage de tissu allongée (30), qui est conçue pour être distribuée dans une configuration généralement allongée non expansée à travers une paroi de tissu cardiaque, à partir d'un premier côté de la paroi de tissu cardiaque jusqu'à un second côté de la paroi de tissu cardiaque, la partie de couplage de tissu (30) étant en outre conçue pour se dilater sur le second côté de la paroi de tissu cardiaque. Une membrane souple (40, 240) est couplée à l'ancrage de tissu expansible (20, 220) et est conçue pour se dilater jusqu'à une configuration généralement plane, de sorte que la partie de couplage de tissu expansée (30) et la membrane souple expansée (40, 240) puissent être serrées étroitement contre le second côté de la paroi de tissu cardiaque au niveau du site cible, lorsqu'une force de traction est appliquée à la partie de couplage de tissu (30). L'invention décrit également d'autres modes de réalisation.
PCT/US2018/040147 2017-07-10 2018-06-28 Ancrages de tissu dotés d'éléments de support de charge WO2019013994A1 (fr)

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