Patent Description:
The left atrial appendage (LAA) is a cavity that presents in the left atrium of the heart. In patients with atrial fibrillation, the passage and steadiness of blood within this cavity can cause thrombus formation, which increases the risk of stroke. Percutaneous LAA occlusion is a therapy for the prevention of stroke in patients with atrial fibrillation. LAA occlusion is used as an alternative to, or in combination with, oral anticoagulant therapy. LAA occlusion has favorable clinical outcomes, but commercially-available devices are typically self-expandable, and not designed to adapt to the LAA anatomy, and thus sometimes result in complications or suboptimal outcomes. In these environments, some of the currently available occlusion devices are limited by the poor adaptability of the device to the defect (lack of conformability) and by a lack of intra-device sealing (due to the high-flow environment).

Publication <CIT> discloses an occlusion device as defined in the preamble of independent claim <NUM>.

<CIT> describes an occluder device for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, including a compliant balloon defining a fluid-tight balloon chamber and provided with a balloon channel forming a longitudinal passage from a proximal side to a distal side of the balloon; a tip element disposed at the distal side of the balloon, a base element disposed at the proximal side of the balloon, and connecting means comprising at least one connecting strut attached to the tip element and to the base element, the tip element and the base element each having a guide opening substantially coaxial to the balloon channel for slidingly receiving therein a guidewire for the device; elongated actuating means disposed longitudinally slidable in the balloon channel, releasably connectable to the tip element, and longitudinally slidable with respect to the base element; locking means for maintaining a predetermined distance between the tip element and the base element; and proximal connector means for releasably connecting the occluder device to correspondingly configured distal connector means of a catheter device. The balloon includes a fluid port for filling and unfilling a fluid into and from the balloon chamber. An occluder system comprises an occluder device and a catheter device cooperating therewith.

<CIT> describes apparatus for permanent placement across an ostium of a left atrial appendage in a patient, which includes a filtering membrane configured to extend across the ostium of the left atrial appendage. The filtering membrane has a permeable structure which allows blood to flow through but substantially inhibits thrombus from passing therethrough. The apparatus also includes a support structure comprising a plurality of fingers which are radially outwardly expandable with respect to a longitudinal axis to permanently engage the interior wall of the left atrial appendage. The filtering membrane is attached to the support structure extending across the ostium of the left atrial appendage.

The present invention concerns an occlusion device comprising the features defined in the independent claim <NUM>.

<FIG> is a schematic illustration of an occlusion device <NUM> for occluding a left atrial appendage (LAA), in accordance with an application of the present invention. Occlusion device <NUM> is for use with a delivery system <NUM>, which is described in more detail hereinbelow with reference to <FIG>. Delivery system <NUM> and the other delivery systems described herein are typically transcatheter delivery systems that enable percutaneous deployment of the occlusion devices.

Reference is also made to <FIG>, which are schematic cross-sectional illustrations of occlusion device <NUM> and a distal portion of delivery system <NUM>, in accordance with an application of the present invention. <FIG> shows occlusion device <NUM> with a locking mechanism <NUM> thereof in an unlocked state and valve <NUM> thereof in an open state, as described hereinbelow. <FIG> shows occlusion device <NUM> with locking mechanism <NUM> in a locked state and valve <NUM> in a closed state, as described hereinbelow.

For some applications, occlusion device <NUM> comprises:.

Occlusion device <NUM> is configured such that proximally longitudinally moving actuating shaft <NUM> expands balloon <NUM> in a radial or a lateral direction by shortening the distance between distal and proximal end portions <NUM> and <NUM> of balloon <NUM> to a desired distance.

Locking mechanism <NUM> is configured, when in the locked state, to maintain, between distal end portion <NUM> of balloon <NUM> and proximal end portion <NUM> of balloon <NUM>, the distance set using actuating shaft <NUM>.

For some applications, occlusion device <NUM> is shaped so as to define a fluid flow path <NUM> along (e.g., alongside, as shown) a portion of actuating shaft <NUM>. Valve <NUM> is configured to selectively:.

For some applications, occlusion device <NUM> is configured such that reduction of the distance, by proximal longitudinal movement of actuating shaft <NUM>:.

For some applications, the first predetermined distance does not equal the second predetermined distance. For example, the first predetermined distance may be less than the second predetermined distance, such that the proximal longitudinal movement of actuating shaft <NUM> first automatically transitions valve <NUM> from the open state to the closed state and subsequently automatically transitions locking mechanism <NUM> from the unlocked state to the locked state. Alternatively, the first predetermined distance may be greater than the second predetermined distance, such that this sequence is reversed.

Further alternatively, for some applications, the first predetermined distance equals the second predetermined distance, such that the proximal longitudinal movement of actuating shaft <NUM> simultaneously automatically transitions valve <NUM> from the open state to the closed state and automatically transitions locking mechanism <NUM> from the unlocked state to the locked state.

For some applications, in order to cause the above-mentioned proximal longitudinal movement of actuating shaft <NUM>, delivery system <NUM> comprises a pull shaft <NUM>, which is releasably coupled a proximal end portion of actuating shaft <NUM>. For example, a distal portion of pull shaft <NUM> may comprise a pull-shaft coupling <NUM>, which may, for example, be shaped so as to define a thread that removably engages a corresponding thread defined by the proximal end portion of actuating shaft <NUM>. Rotation of pull shaft <NUM> disengages shaft coupling <NUM> from the corresponding thread defined by the proximal end portion of actuating shaft <NUM>.

Typically, occlusion device <NUM> is configured to be releasably connected to delivery system <NUM>. For some applications, occlusion device <NUM> is configured such that fluid flow path <NUM> is coupled in fluid communication with delivery system <NUM> when occlusion device <NUM> is releasably connected to delivery system <NUM>, such as shown in <FIG>.

For some applications, actuating shaft <NUM> is shaped so as to define, at least in part, a distal tip <NUM> disposed at distal end portion <NUM> of balloon <NUM>, as shown in <FIG> and <FIG>.

For some other applications, occlusion device <NUM> further comprises a distal tip disposed at distal end portion <NUM> of balloon <NUM>, and actuating shaft <NUM> is connected to the distal tip (configuration not shown).

Alternatively or additionally, for some applications, occlusion device <NUM> further comprises a proximal base disposed at proximal end portion <NUM> of balloon <NUM>, and actuating shaft <NUM> is moveable (e.g., longitudinally or rotationally) with respect to the proximal base (configuration not shown).

For some applications, valve <NUM> is disposed along actuating shaft <NUM>, such as shown in <FIG>.

For some applications, occlusion device <NUM> further comprises a proximal tube <NUM>, which is axially fixed with respect to proximal end portion <NUM> of balloon <NUM>. Actuating shaft <NUM> is slidably disposed partially within proximal tube <NUM>, e.g., so as to indirectly connect actuating shaft <NUM> to proximal end portion <NUM> via proximal tube <NUM>. For some of these applications, occlusion device <NUM> is shaped so as to define fluid flow path <NUM> along the portion of actuating shaft <NUM>, radially between an external surface of actuating shaft <NUM> and an internal surface of proximal tube <NUM>, such as shown in <FIG>. Optionally, valve <NUM> is disposed along actuating shaft <NUM>.

For some applications, valve <NUM> comprises a seal <NUM> around at least a portion of (e.g., entirely around) the external surface of actuating shaft <NUM>. Valve <NUM> is configured to assume (a) the open state when seal <NUM> is disposed at one or more first axial positions 56A with respect to proximal tube <NUM> (one such first axial position is shown in <FIG>), and (b) the closed state when seal <NUM> is disposed at one or more second axial positions 56B with respect to proximal tube <NUM> (one such second axial position is shown in <FIG>). The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, seal <NUM> may comprise an O-ring, as shown in <FIG>, e.g., a single O-ring or a series of O-rings. Optionally, one or more additional seals <NUM>, e.g., one or more O-rings, are provided to provide further stabilization an alignment of the distal tube inside the proximal tube by friction.

For some applications, seal <NUM>, actuating shaft <NUM>, and proximal tube <NUM> are arranged such that seal <NUM> blocks fluid flow out of a distal end <NUM> of proximal tube <NUM>, at least when seal <NUM> is disposed at the one or more first axial positions 56A with respect to proximal tube <NUM>, such as shown in <FIG>. Alternatively or additionally, friction between seal <NUM> and the inner surface of proximal tube <NUM> increases structural stability, and/or enables stepwise inflation/implantation.

For some applications, a wall of proximal tube <NUM> is shaped so as to define one or more tabs <NUM> through the wall. The one or more tabs <NUM> are biased to flex radially inward. When valve <NUM> is in the open state, as shown in <FIG>, fluid flow path <NUM> passes through the wall between respective proximal ends <NUM> of the one or more tabs <NUM> and a non-tabbed portion <NUM> of the wall axially adjacent the one or more tabs <NUM>, such as proximal to the one or more tabs <NUM>, as shown.

For some applications, the external surface of actuating shaft <NUM> is shaped so as to define one or more protrusions <NUM> around at least a portion of (e.g., entirely around) actuating shaft <NUM>. Proximal ends <NUM> of the one or more tabs <NUM> are shaped so as to prevent distal movement of the one or more protrusions <NUM> when the one or more protrusions <NUM> are disposed proximal to the proximal ends <NUM> of the one or more tabs <NUM>, such as shown in <FIG>, thereby causing locking mechanism <NUM> to assume the locked state.

For some applications, occlusion device <NUM> further comprises a proximal LAA-orifice cover <NUM>, which:.

This indirect connection of proximal LAA-orifice cover <NUM> to balloon <NUM> generally prevents an anodic reaction between the typically super-elastic (e.g., Nitinol) material of frame <NUM> of proximal LAA-orifice cover <NUM> and the typically plastically deformable (e.g., stainless steel) material of struts <NUM>, described hereinbelow. Such a reaction might have occurred if the two elements were instead welded or otherwise bonded together in contact with each other. (Connection of the elements via an independent and passive element, such as an internal tube or shaft, also does not cause such a reaction. ) Alternatively, proximal LAA-orifice cover <NUM> is directly connected to balloon <NUM>, such as if frame <NUM> comprises a different plastically-deformable material, such as titanium.

For some applications, occlusion device <NUM> further comprises orifice-support stent <NUM>, described hereinbelow with reference to <FIG> and <FIG>.

For some applications, actuating shaft <NUM> is shaped so as to define a guidewire lumen <NUM> for slidingly receiving therein a guidewire and/or passage of liquid injected under pressure, such as contrast media injected from the proximal handle of the delivery tool to the distal end of the occlusion device. Alternatively, for other applications, actuating shaft <NUM> is not shaped so as to define a guidewire lumen.

For some applications, compliant balloon <NUM> comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethylmethacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide, and polyether block amide (PEBA).

For some applications, balloon <NUM> has an average wall thickness of between <NUM> and <NUM> microns. Alternatively or additionally, for some applications, balloon <NUM> has, at a thinnest portion of a wall of balloon <NUM>, a thinnest wall thickness of between <NUM> and <NUM> microns.

For some applications, occlusion device <NUM> further comprises connecting struts <NUM> fixed to distal end portion <NUM> of balloon <NUM> and to proximal end portion <NUM> of balloon <NUM>. Struts <NUM> may be disposed inside balloon <NUM>, outside balloon <NUM>, or some inside and some outside balloon <NUM>. For some applications, struts <NUM> are arranged as a frame. For some applications, struts <NUM> are arranged in a cage-like arrangement. Typically, struts <NUM> comprise a plastically-deformable material, such as stainless steel or titanium. Typically, struts <NUM> help shape balloon <NUM> as the balloon chamber is inflated and/or the balloon is shortened.

Typically, occlusion device <NUM> is configured such that inflation of balloon chamber <NUM> plastically deforms connecting struts <NUM>. For some applications, occlusion device <NUM> is configured such that shortening of balloon <NUM> plastically deforms connecting struts <NUM>.

For some applications, struts <NUM> are configured such that inflation of balloon chamber <NUM> primarily causes radial deformation of struts <NUM>, rather than deformation of the struts in a distal or proximal direction. To this end, first lateral portions 81A of struts <NUM> arranged along a lateral surface of balloon <NUM> may be more compliant than second end portions 81B of struts <NUM> arranged on a distal surface of balloon <NUM> and/or on a proximal surface of balloon <NUM>. For example, first lateral portions 81A may be thinner than second end portions 81B, as shown in <FIG>, and/or first lateral portions 81A may be shaped to be more compliant, e.g., have a serpentine (e.g., sinusoidal) shape, as shown. Typically, first lateral portions 81A are oriented parallel to a central longitudinal axis of occlusion device <NUM>.

Reference is now made to <FIG>, which are schematic illustrations of steps of a method of deploying occlusion device <NUM> using delivery system <NUM>, in accordance with an application of the present invention.

Reference is also made to <FIG>, which are schematic cross-sectional views of a portion of the steps of the method shown in <FIG>, in accordance with an application of the present invention.

<FIG> schematically shows occlusion device <NUM> releasably disposed in a radially-compressed state within a sheath <NUM> of delivery system <NUM>. Typically, a greatest distance between proximal end portion <NUM> of balloon <NUM> and distal end portion <NUM> of balloon <NUM> is at least <NUM> (e.g., at least <NUM>), no more than <NUM> (e.g. no more than <NUM>), and/or between <NUM> and <NUM> (e.g., between <NUM> and <NUM>), when occlusion device <NUM> is in this radially-compressed state.

For some applications, occlusion device <NUM> comprises a proximal connector <NUM> that is configured to releasably connect occlusion device <NUM> to a correspondingly configured distal connector <NUM> of delivery system <NUM>.

For some applications, distal connector <NUM> comprises one or more legs that engage one or more respective coupling sites (e.g., slots) of proximal connector <NUM>, such as perhaps best seen in <FIG>. For example, the legs may be configured to biased radially outward when in an unconstrained, resting state, and may be held radially inward engaging the coupling sites of proximal connector <NUM>, such as by implant catheter <NUM>, as shown in <FIG>. Proximal withdrawal of implant catheter <NUM> with respect to occlusion device <NUM> release the legs, as shown in <FIG>.

Alternatively, proximal connector <NUM> is shaped so as to define a thread (configuration not shown).

For some applications, delivery system <NUM> comprises an implant catheter <NUM> that is connected to an operating handle (not shown). Implant catheter <NUM> comprises (a) a longitudinal passageway for a guidewire, (b) distal connector <NUM> for releasably connecting implant catheter <NUM> to correspondingly configured proximal connector <NUM> of occlusion device <NUM>, and (c) an inflation tube channel releasably connectable to fluid flow path <NUM> of occlusion device <NUM>. The longitudinal passageway may alternatively or additionally be used to inject contrast media from the handle to a distal opening of the inflation tube channel distally to the balloon.

<FIG> shows occlusion device <NUM> after sheath <NUM> has been proximally withdrawn, thereby releasing occlusion device <NUM>. <FIG> also shows proximal LAA-orifice cover <NUM> in its radially-expanded state. Typically, frame <NUM> of proximal LAA-orifice cover <NUM> comprises a shape-memory memory, e.g., a super-elastic metal, which causes cover <NUM> to automatically transition to the radially-expanded state upon release from sheath <NUM>. Balloon <NUM> remains in a non-inflated, elongate configuration at this stage of deployment.

Typically, a healthcare worker places the distal end of occlusion device <NUM> into the LAA, using delivery system navigation.

As shown in <FIG>, the healthcare worker inflates balloon chamber <NUM>. <FIG> shows occlusion device <NUM> upon partial inflation of balloon chamber <NUM>, while <FIG> shows occlusion device <NUM> upon complete inflation of balloon chamber <NUM>. Balloon <NUM> may be inflated by filling balloon chamber <NUM> with any fluid, including but not limited to saline solution (optionally comprising a contrast medium), blood (e.g., autologous blood), foam, and/or a glue (e.g., a gel, a liquid polymer that can change its proprieties to become rigid, or a hydrogel that remains a gel or self-cures at body temperature).

For some applications, struts <NUM> are shaped so as to define a plurality of spikes <NUM> that are initially generally axially oriented, as shown in <FIG>, and are configured to extend more radially upon expansion of balloon <NUM> to serve as tissue-engaging barbs, as shown in <FIG>.

<FIG> and <FIG> show occlusion device <NUM> after (a) valve <NUM> has transitioned from the open state to the closed state, (b) actuating shaft <NUM> has been proximally longitudinally moved to expand balloon <NUM> in a radial or a lateral direction by shortening the distance between distal and proximal end portions <NUM> and <NUM> of balloon <NUM> to a desired distance, and (c) locking mechanism <NUM> has transitioned from the unlocked state to the locked state, as described hereinabove with reference to <FIG>. Typically, after balloon <NUM> has been finally filled, actuating shaft <NUM> is proximally longitudinally moved to expand balloon <NUM> in a radial or a lateral direction by shortening the distance between distal and proximal end portions <NUM> and <NUM> of balloon <NUM> to a desired distance. Proximal connector <NUM> of occlusion device <NUM> is still releasably connected to correspondingly configured distal connector <NUM> of delivery system <NUM>.

<FIG> and <FIG> show occlusion device <NUM> after proximal connector <NUM> of occlusion device <NUM> has been released from distal connector <NUM> of delivery system <NUM>.

<FIG> also shows occlusion device <NUM> after pull shaft <NUM> has been decoupled from the proximal end portion of actuating shaft <NUM>, such as by rotating pull shaft <NUM> to unscrew it, as described hereinabove.

Reference is now made to <FIG>, which is a schematic illustration of occlusion device <NUM> implanted to occlude an LAA <NUM>, in accordance with an application of the present invention. As can be seen, balloon <NUM> is disposed within LAA <NUM>, and proximal LAA-orifice cover <NUM> is disposed in a left atrium <NUM> outside LAA <NUM>, against the atrial wall surrounding the orifice of LAA <NUM>, thereby creating a continuum with the atrium at the LAA level. Typically, proximal LAA-orifice cover <NUM> protrudes only minimally because of its relatively flat shape, so as not to interfere with blood flow and not to cause thrombosis. Typically, struts <NUM> provide most of the anchoring of occlusion device <NUM>, and balloon <NUM> provides most of the sealing of the LAA. In addition, in configurations in which covering <NUM> of proximal LAA-orifice cover <NUM> is blood-impermeable, proximal LAA-orifice cover <NUM> provides additional sealing of the LAA, primarily to inhibit creation of thrombi on the balloon surface at the orifice level.

For some applications, proximal LAA-orifice cover <NUM> is asymmetric about proximal tube <NUM>, e.g., elliptical or with a radius greater in one direction than in the perpendicular direction.

For some applications, proximal LAA-orifice cover <NUM> is configured to have an adjustable greatest dimension measured perpendicular to proximal tube <NUM>. For example, rotation of a proximal LAA-orifice cover <NUM> adjustment mechanism may adjust the greatest dimension.

For some applications, covering <NUM> of proximal LAA-orifice cover <NUM> is blood-permeable, so as to serve as filter for the passage of blood in and out of the LAA. For other applications, covering <NUM> is not blood-permeable, so as to create a secondary sealing of the LAA in addition to the sealing provided by balloon <NUM>.

For some applications, proximal LAA-orifice cover <NUM> is bioresorbable and/or drug-eluting.

Reference is now made to <FIG>, which is a schematic illustration of an occlusion device <NUM> for occluding an LAA, in accordance with an application of the present invention. Occlusion device <NUM> is for use with a delivery system <NUM>. Other than as described hereinbelow, occlusion device <NUM> is similar to occlusion device <NUM>, described hereinabove with reference to <FIG>, and may implement any of the features thereof, mutatis mutandis. Similarly, other than as described hereinbelow, delivery system <NUM> is similar to delivery system <NUM>, described hereinabove with reference to <FIG>, and may implement any of the features thereof, mutatis mutandis. Like reference numerals refer to like parts.

Reference is also made to <FIG>, which are schematic cross-sectional illustrations of occlusion device <NUM> and a distal portion of delivery system <NUM>, in accordance with an application of the present invention. <FIG> show occlusion device <NUM> connected to delivery system <NUM>, with valve <NUM> of occlusion device <NUM> in an open state, as described hereinbelow. <FIG> shows occlusion device <NUM> with balloon <NUM> thereof in an elongated state, and <FIG> show occlusion device <NUM> with balloon <NUM> in a shortened state. <FIG> shows occlusion device <NUM> connected to delivery system <NUM>, with valve <NUM> in a closed state.

Occlusion device <NUM> is shaped so as to define a fluid flow path <NUM> having one or more fluid-flow-path openings <NUM> to balloon chamber <NUM>. Typically, occlusion device <NUM> is configured such that fluid flow path <NUM> is coupled in fluid communication with delivery system <NUM> when occlusion device <NUM> is releasably connected to delivery system <NUM>.

For example, elastomer sleeve <NUM> may comprise silicone.

Elastomer sleeve <NUM> is configured to have a resting state in which the sleeve covers and seals the one or more fluid-flow-path openings <NUM>, such that valve <NUM> is in a closed state, as shown in <FIG>.

Delivery system <NUM> is configured to be releasably connected to occlusion device <NUM>. Delivery system <NUM> comprises a valve-opening prop <NUM>, which is configured:.

This configuration enables separate control of shortening of balloon <NUM> and closing of valve <NUM>. Alternatively, valve-opening prop <NUM> (e.g., tubular portion <NUM> thereof, described below) is fixed to pull shaft <NUM>.

For some applications, valve-opening prop <NUM> comprises one or more tabs <NUM> that extend radially outward from an axis of elastomer sleeve <NUM>, so as to prop open elastomer sleeve <NUM>.

For some applications, valve-opening prop <NUM> is configured such that axial sliding thereof with respect to elastomer sleeve <NUM> (e.g., in a proximal direction) transitions valve-opening prop <NUM> from the propping position to the non-propping position, as shown in the transition between <FIG> and <FIG>.

For some applications, occlusion device <NUM> further comprises a proximal tube <NUM>, which is axially fixed with respect to proximal end portion <NUM> of balloon <NUM>. For some applications, actuating shaft <NUM> is slidably disposed partially within proximal tube <NUM>.

For some applications, a seal, such as an O-ring (as shown), is provided, and friction between the seal and the inner surface of a proximal tube <NUM> increases structural stability. Alternatively or additionally, the O-ring, upon completion of the shortening of the balloon, is disposed proximal to the one or more fluid-flow-path openings <NUM> and blocks additional fluid from passing through the one or more fluid-flow-path openings <NUM> and elastomer sleeve <NUM>.

For some applications, valve-opening prop <NUM> comprises a tubular portion <NUM>, which is disposed at least partially within proximal tube <NUM>. For some of these applications, valve-opening prop <NUM> comprises the one or more tabs <NUM>, which extend (a) axially away from tubular portion <NUM> (e.g., in a distal direction) and (b) radially outward from proximal tube <NUM>, so as to prop open elastomer sleeve <NUM>. For some applications, the one or more tabs <NUM> pass through at least a portion of the one or more fluid-flow-path openings <NUM> when valve-opening prop <NUM> is in the propping position, such as shown in <FIG> and <FIG>. Alternatively, for some applications, proximal tube <NUM> is shaped so as to define one or more access openings through a wall of proximal tube <NUM>, and the one or more tabs <NUM> pass through the one or more access openings at least when valve-opening prop <NUM> is in the propping position (configuration not shown).

For some applications, occlusion device <NUM> further comprises proximal LAA-orifice cover <NUM>, which is fixed to proximal tube <NUM> radially surrounding proximal tube <NUM>. Proximal LAA-orifice cover <NUM> may implement any of the techniques described hereinabove and/or hereinbelow. For some of these applications, occlusion device <NUM> further comprises an orifice-support stent <NUM>, described hereinbelow with reference to <FIG> and <FIG>.

For some applications, occlusion device <NUM> further comprises a locking mechanism, which is configured to assume locked and unlocked states, and which is configured, when in the locked state, to maintain, between distal end portion <NUM> of balloon <NUM> and proximal end portion <NUM> of balloon <NUM>, the distance set using actuating shaft <NUM>. The locking mechanism may implement any of the locking mechanisms described herein, mutatis mutandis.

For some applications, actuating shaft <NUM> is shaped so as to define, at least in part, a distal tip <NUM> disposed at distal end portion <NUM> of balloon <NUM>.

For some applications, occlusion device <NUM> further comprises connecting struts <NUM> fixed to distal end portion <NUM> of balloon <NUM> and to proximal end portion <NUM> of balloon <NUM>. Typically, occlusion device <NUM> is configured such that inflation of balloon chamber <NUM> plastically deforms connecting struts <NUM>. For some applications, occlusion device <NUM> is configured such that shortening of balloon <NUM> plastically deforms connecting struts <NUM>.

For some applications, delivery system <NUM> further comprising implant catheter <NUM>, such as described hereinabove with reference to <FIG>.

Reference is now made to <FIG>, which is a schematic illustration of an occlusion device <NUM> for occluding an LAA, in accordance with an application of the present invention. For clarity of illustration, a balloon is not shown connected to struts <NUM> in <FIG>, even though it is an actual element of the occlusion device. Occlusion device <NUM> is for use with a delivery system. Other than as described hereinbelow, occlusion device <NUM> is similar to occlusion device <NUM>, described hereinabove with reference to <FIG> and <FIG>, and may implement any of the features thereof, mutatis mutandis. Like reference numerals refer to like parts. Similarly, other than as described hereinbelow, the delivery system is similar to delivery system <NUM>, described hereinabove with reference to <FIG>, and may implement any of the features thereof, mutatis mutandis.

Occlusion device <NUM> comprises a valve <NUM>, comprising elastomer sleeve <NUM> that surrounds a portion of actuating shaft <NUM>. Elastomer sleeve <NUM> is configured to have a resting state in which the sleeve covers and seals the one or more fluid-flow-path openings <NUM>, such that the valve is in a closed state (not shown in <FIG>, but similar to the state shown in <FIG> for occlusion device <NUM>).

Unlike delivery system <NUM> of occlusion device <NUM>, the delivery system of the present configuration does not comprise valve-opening prop <NUM>. Instead, the delivery system comprises one or more guidewires <NUM>, which:.

For some applications, the one or more guidewires <NUM> pass through at least a portion of the one or more fluid-flow-path openings <NUM> when the one or more guidewires are in the propping position.

Reference is now made to <FIG>, which is a schematic illustration of an occlusion device <NUM> for occluding an LAA, in accordance with an application of the present invention. Occlusion device <NUM> is for use with a delivery system <NUM>. Like reference numerals refer to like parts.

Reference is also made to <FIG>, which are schematic cross-sectional illustrations of occlusion device <NUM> and a distal portion of delivery system <NUM>, in accordance with an application of the present invention. <FIG> show occlusion device <NUM> connected to delivery system <NUM>. <FIG> shows occlusion device <NUM> with balloon <NUM> thereof in an elongated state, and <FIG> shows occlusion device <NUM> with balloon <NUM> in a shortened state.

Occlusion device <NUM> further comprises proximal LAA-orifice cover <NUM>, which (a) is configured to assume a radially-compressed state and a radially-expanded state, (b) comprises frame <NUM> and covering <NUM> fixed to frame <NUM>, and (c) when in the radially-expanded state, is generally orthogonal to actuating shaft <NUM> and has a greatest dimension, measured perpendicular to actuating shaft <NUM>, of at least <NUM> (e.g., at least <NUM>), no more than <NUM> (e.g., no more than <NUM>), and/or between <NUM> and <NUM> (e.g., between <NUM> and <NUM>).

Occlusion device <NUM> still further comprises an orifice-support stent <NUM>, which is configured to enhance support at the orifice of the LAA. Orifice-support stent <NUM> is configured to be positioned at least partially within the LAA, such as entirely within the LAA. Orifice-support stent <NUM> is:.

As used in the present application, including in the claims and the Inventive Concepts, the phrase "generally cylindrical" is not limited to generally circularly cylindrical, and also includes within its scope other generally cylindrical shapes, such as generally elliptically cylindrical.

For some applications, orifice-support stent <NUM>, when in the radially-expanded state, has (i) a greatest dimension, measured perpendicular to actuating shaft <NUM>, of at least <NUM>, no more than <NUM>, and/or between <NUM> and <NUM>, and/or (ii) an axial length of at least <NUM> (e.g. at least <NUM>), no more than <NUM>, and/or between <NUM> and <NUM>.

For some applications, orifice-support stent <NUM> is not fixed to balloon <NUM>, such that a shape of balloon <NUM> can change independently of a shape of orifice-support stent <NUM>. Alternatively or additionally, lack of direct physical contact between orifice-support stent <NUM> and connecting struts <NUM> of occlusion device <NUM> prevents an anodic reaction between the typically super-elastic (e.g., Nitinol) material of struts <NUM> and the typically plastically deformable (e.g., stainless steel) material of orifice-support stent <NUM>. Such a reaction might have occurred if the two elements were instead welded or otherwise bonded together in contact with each other. (Connection of the elements via an independent and passive element, such as an internal tube or shaft, also does not cause such a reaction.

For some applications, orifice-support stent <NUM> comprises a super-elastic or plastically-deformable metal.

Typically, occlusion device <NUM> is configured such that inflation of balloon chamber <NUM> transitions orifice-support stent <NUM> from its radially-compressed state to its radially-expanded state. For some applications, because orifice-support stent <NUM> comprises a super-elastic metal, such as Nitinol, the stent, when crimped, will have a minimum diameter given by the thickness of its wall struts. When released, the stent tends to transition to its released diameter, which is higher than the crimped diameter. In configurations in which balloon <NUM> is inflated within the stent, the stent will over-stretch, and its diameter will be greater than its released diameter, to an extent that depends upon the design and ability of over-dilatation of the stent struts.

For some applications, occlusion device <NUM> further comprises a proximal tube <NUM>, which is axially fixed with respect to proximal end portion <NUM> of balloon <NUM>. For these applications, proximal LAA-orifice cover <NUM> is fixed to proximal tube <NUM> radially surrounding proximal tube <NUM>, and is indirectly connected to balloon <NUM> via proximal tube <NUM> and is not directly connected to balloon <NUM>.

Reference is also made to <FIG>, which is a schematic cross-sectional illustration of occlusion device <NUM> and a distal portion of delivery system <NUM>, in accordance with an application of the present invention. Both <FIG> show occlusion device <NUM> connected to delivery system <NUM>. <FIG> shows occlusion device <NUM> with balloon <NUM> thereof in an elongated state, and <FIG> shows occlusion device <NUM> with balloon <NUM> in a shortened state, as described hereinbelow.

Spring <NUM> is (a) disposed at least partially within balloon chamber <NUM>, (b) connected (directly or indirectly, such as via a tube) to a distal end portion <NUM> of balloon <NUM> and proximal tube <NUM>, and (c) has a relaxed length, as shown in <FIG>. When spring <NUM> has the relaxed length, distal end portion <NUM> of balloon <NUM> is at a relaxed distance from proximal end portion <NUM> of balloon <NUM>, as shown in <FIG>.

Delivery system <NUM> is configured to be releasably connected to occlusion device <NUM>. Delivery system <NUM> comprises a stylet <NUM>, which is removably disposed through proximal tube <NUM> and within spring <NUM>. Occlusion device <NUM> is configured such that a degree of distal advancement of stylet <NUM> within spring <NUM> sets a tensed length of spring <NUM>, which in turn sets a tensed distance between distal and proximal end portions <NUM> and <NUM> of balloon <NUM>, the tensed distance greater than the relaxed distance. One possible tensed distance is shown in <FIG>.

Typically, during deployment of occlusion device <NUM> in the LAA, occlusion device <NUM> is advanced into the LAA with spring <NUM> in the elongated tensed state. Balloon chamber <NUM> is typically inflated while spring <NUM> is in the elongated tensed state, such as shown in <FIG>, and valve <NUM> is transitioned to the closed state, such as using techniques described herein. Thereafter, stylet <NUM> is partially proximally withdrawn, allowing spring <NUM> to shorten to its resting state, as shown in <FIG>.

For some applications, a distal end portion of stylet <NUM> is releasably connected to an occlusion-device connector <NUM> of occlusion device <NUM>, which is connected to distal end portion <NUM> of balloon <NUM>. (Even though stylet <NUM> would generally remain in place even if not connected to occlusion device <NUM>, if not thus connected stylet <NUM> might become disengaged from the center of spring <NUM> and become entangled with spring <NUM> during maneuvering of occlusion device <NUM> and inflation of balloon <NUM> during deployment. ) For these applications, stylet <NUM> is disconnected from occlusion-device connector <NUM> after spring <NUM> has been allowed to shorten. For example, the end portion of stylet <NUM> and occlusion-device connector <NUM> may define respective threads.

Optionally, stylet <NUM> is flexible, e.g., highly flexible, to accommodate variations in LAA anatomy, including curvature of the LAA.

Reference is now made to <FIG>, <FIG>, and <FIG>, which are schematic illustrations of an occlusion device <NUM> for occluding an LAA, in accordance with an application of the present invention. Occlusion device <NUM> is for use with a delivery system, such as delivery system <NUM>, described hereinabove with reference to <FIG>; delivery system <NUM>, described hereinabove with reference to <FIG>; delivery system <NUM>, described hereinabove with reference to <FIG>; or delivery system <NUM>, described hereinabove with reference to <FIG>, mutatis mutandis. Other than as described hereinbelow, occlusion device <NUM> is similar to occlusion device <NUM>, described hereinabove with reference to <FIG>, and may implement any of the features thereof, mutatis mutandis. Like reference numerals refer to like parts. Alternatively or additionally, occlusion device <NUM> may optionally implement any of the features of occlusion device <NUM>, described hereinabove with reference to <FIG> and <FIG>; occlusion device <NUM>, described hereinabove with reference to <FIG> and <FIG>; occlusion device <NUM>, described hereinabove with reference to <FIG>; and/or occlusion device <NUM>, described hereinabove with reference to <FIG>, mutatis mutandis. By way of example and not limitation, occlusion device <NUM> may optionally comprise proximal LAA-orifice cover <NUM>, such as shown in the figures. Similarly, these other occlusion devices described herein may optionally implement any of the features of occlusion device <NUM>, mutatis mutandis.

<FIG> show occlusion device <NUM> after sheath <NUM>, shown in <FIG>, has been proximally withdraw, thereby releasing occlusion device <NUM>, and allowing proximal LAA-orifice cover <NUM> to transition to its radially-expanded state. This is similar to the state of deployment of occlusion device <NUM> shown in <FIG>. Balloon <NUM> remains in a non-inflated, elongate configuration at this stage of deployment.

<FIG> show occlusion device <NUM> upon partial inflation of balloon chamber <NUM>.

<FIG> show occlusion device <NUM> upon final inflation of balloon chamber <NUM>. Balloon chamber <NUM> can be inflated at different final inflation levels, depending on the extent of radial expansion necessary for the particular anatomy of the LAA. Typically, occlusion device <NUM> is configured to be radially expandable to a diameter of between <NUM> and <NUM>, e.g., between <NUM> and <NUM>, such as between <NUM> and <NUM>.

Occlusion device <NUM> comprises connecting struts <NUM> fixed to distal end portion <NUM> of balloon <NUM> and to proximal end portion <NUM> of balloon <NUM>. Struts <NUM> may implement any of the features of struts <NUM>, described hereinabove, mutatis mutandis. First lateral portions 581A of struts <NUM> are arranged along a lateral surface of balloon <NUM>. Second distal-end portions 581B of struts <NUM> are arranged on a distal surface of balloon <NUM>. Third proximal-end portions 581C of struts <NUM> are arranged on a proximal surface of balloon <NUM>. Typically, second distal-end portions 581B and third proximal-end portions 581C are generally straight. Typically, first lateral portions 581A are oriented parallel to a central longitudinal axis of occlusion device <NUM>.

For some applications, distal interface portions 583A of struts <NUM> join first lateral portions 581A and second distal-end portions 581B, respectively, and/or proximal interface portions 583B join first lateral portions 581A and third proximal-end portions 581C, respectively. Occlusion device <NUM> is configured such that upon inflation of balloon chamber <NUM>, distal interface portions 583A and proximal interface portions 583B are curved, such as shown in <FIG> and <FIG>. (<FIG> shown balloon chamber <NUM> uninflated, <FIG> show balloon chamber <NUM> partially inflated, and <FIG> show balloon chamber <NUM> finally inflated. ) For some of these applications, distal interface portions 583A and/or proximal interface portions 583B have a serpentine (e.g., sinusoidal) shape, as shown. This serpentine shape causes distal interface portions 583A and/or proximal interface portions 583B to be more compliant than first lateral portions 581A, second distal-end portions 581B, and/or third proximal-end portions 581C. As a result, occlusion device <NUM>, upon inflation and shortening of balloon <NUM>, assumes a more cylindrical shape that it otherwise would. Optionally, first lateral portions 581A of struts <NUM> are generally straight, which also contributes to the cylindrical shape of occlusion device <NUM>.

For some applications, distal end portions 585A of struts <NUM> join second distal-end portions 581B of struts <NUM> to distal end portion <NUM> of balloon <NUM>, respectively, and/or proximal end portions 585B of struts <NUM> join third proximal-end portions 581C of struts <NUM> to proximal end portion <NUM> of balloon <NUM>, respectively. Occlusion device <NUM> is configured such that upon inflation of balloon chamber <NUM>, distal end portions 585A and proximal end portions 585B are curved. (<FIG> shown balloon chamber <NUM> uninflated, <FIG> show balloon chamber <NUM> partially inflated, and <FIG> show balloon chamber <NUM> finally inflated. ) For some of these applications, distal end portions 585A and/or proximal end portions 585B have a serpentine (e.g., sinusoidal) shape, as shown. This serpentine shape allows distal end portions 585A and/or proximal end portions 585B to elongate, thereby allowing occlusion device <NUM> to radially expand, such as to a diameter, for example, of between <NUM> and <NUM>, e.g., between <NUM> and <NUM>, such as between <NUM> and <NUM>. This serpentine shape also allows distal end portions 585A and/or proximal end portions 585B to selectively elongate, thereby accommodating expansion of balloon <NUM> to different extents in different radial directions.

For some applications, struts <NUM> are shaped so as to define a plurality of spikes <NUM> that extend from outer ends <NUM> (labeled in <FIG> and <FIG>) of second distal-end portions 581B, respectively, and/or third proximal-end portions 581C, respectively. Spikes <NUM> are initially generally axially oriented, when balloon <NUM> is in a non-inflated, elongate configuration, as shown in <FIG>. Spikes <NUM> are configured to extend more radially upon inflation of balloon chamber <NUM> to serve as tissue-engaging barbs, as shown in <FIG>. The respective axes of spikes <NUM> may be parallel with or slightly angled with respect to axes of second distal-end portions 581B and third proximal-end portions 581C.

For some applications, distal interface portions 583A are shaped so as to define respective pairs of parallel serpentine (e.g., sinusoidal) struts 591A and 591B that define respective narrow elongate gaps <NUM> therebetween. When spikes <NUM> are initially generally axially oriented, as shown in <FIG>, the spikes are disposed in respective gaps <NUM>. Respective tips <NUM> of spikes <NUM> are disposed near respective end surfaces <NUM> of gaps <NUM> at respective junctions between the parallel serpentine struts 591A and 591B, such that the respective tips <NUM> of spikes <NUM> are protected by respective end surfaces <NUM> until the spikes are radially deployed. Alternatively or additionally, proximal interface portions 583B and their corresponding spikes <NUM> may implement this feature.

For some applications, connecting struts <NUM> further include closed stent cells <NUM> that connect adjacent pairs of first lateral portions 581A. Optionally, two or more closed stent cells <NUM> arranged in series connect the adjacent pairs of first lateral portions 581A (in the figures, exactly two closed stent cells <NUM> arranged in series are shown connecting the adjacent pairs of first lateral portions 581A); typically, no more than four closed stent cells <NUM> arranged in series, such as exactly two or three closed stent cells <NUM> arranged in series. These connections by closed stent cells <NUM> may help laterally stabilize first lateral portions 581A upon inflation of balloon chamber <NUM>, and may help constrain the shape of balloon <NUM> upon inflation of balloon chamber <NUM>, by helping limit radial expansion of the balloon out of the stent struts. These connections by closed stent cells <NUM> may alternatively or additionally stabilize the implantation of occlusion device <NUM> by friction, by providing a sufficiently large contract surface with the walls of the LAA. Optionally, a single series of two or more closed stent cells <NUM> connect adjacent pairs of first lateral portions 581A, as shown; alternatively, two or more series (e.g., exactly two series) of two or more closed stent cells <NUM> connect adjacent pairs of first lateral portions 581A (configuration not shown).

Typically, an average width of the struts of first lateral portions 581A equals at least <NUM>% of an average width of the struts of closed stent cells <NUM>, such as at least <NUM>%, <NUM>%, or <NUM>%. As mentioned above, typically first lateral portions 581A are oriented parallel to a central longitudinal axis of occlusion device <NUM>. The struts of closed stent cells <NUM> may have these thinner widths in order to allow expansion of the closed stent cells with the expansion of the balloon.

Claim 1:
An occlusion device (<NUM>) for occluding a left atrial appendage (LAA), the occlusion device (<NUM>) for use with a delivery system (<NUM>) including a sheath (<NUM>), the occlusion device (<NUM>) comprising:
a compliant balloon (<NUM>) defining a fluid-tight balloon chamber (<NUM>);
an actuating shaft (<NUM>), which is (a) disposed at least partially within the balloon chamber (<NUM>), (b) connected to a distal end portion (<NUM>) of the balloon (<NUM>), and (c) longitudinally moveable with respect to a proximal end portion (<NUM>) of the balloon (<NUM>) so as to set a distance between the distal and the proximal end portions (<NUM>, <NUM>) of the balloon (<NUM>); and
a locking mechanism, which is configured to assume locked and unlocked states, and which is configured, when in the locked state, to maintain, between the distal end portion (<NUM>) of the balloon (<NUM>) and the proximal end portion (<NUM>) of the balloon (<NUM>), the distance set using the actuating shaft (<NUM>), characterized in that the occlusion device (<NUM>) further comprises:
a proximal LAA-orifice cover (<NUM>), which (a) is configured to assume a radially-compressed state when releasably disposed in the sheath (<NUM>), (b) comprises (i) a frame (<NUM>) comprising a super-elastic metal, which causes the proximal LAA-orifice cover (<NUM>) to automatically transition to a radially-expanded state upon release from the sheath (<NUM>), (ii) and a covering (<NUM>) fixed to the frame (<NUM>), and (c) when in the radially-expanded state, is generally orthogonal to the actuating shaft (<NUM>) and has a greatest dimension, measured perpendicular to the actuating shaft (<NUM>), of between <NUM> and <NUM>; and
an orifice-support stent (<NUM>), which (a) is fixed to and extends distally from the proximal LAA-orifice cover (<NUM>), (b) is configured to assume a radially-compressed state and a radially-expanded state, and (c) is generally cylindrical when in the radially-expanded state, wherein the occlusion device (<NUM>) is configured such that inflation of the balloon chamber (<NUM>) transitions the orifice-support stent (<NUM>) from its radially-compressed state to its radially-expanded state.