Device for implantation in the left atrial appendage of the heart

Abstract

The invention relates to a device for implantation in the left atrial appendage of a heart, the device comprising a docking station and a closure; the docking station comprising a radially expandable element adjustable between a collapsed orientation suitable for intraluminal delivery and a deployed orientation configured to anchor within the left atrial appendage and to fluidly isolate the left atrial appendage from the left atrium, the docking station further comprising a recessed socket accessible from the left atrium through an opening; the closure covering the opening. A modular active element is configured for detachable engagement within the recessed socket of the docking station. The modular active element comprises a therapeutic element or a sensing element; the therapeutic element configured to electrically stimulate heart tissue, thermally stimulate heart tissue, electroporate heart tissue, or deliver a substance to heart tissue or a chamber of the heart; the sensing element configured to detect a parameter selected from temperature, pressure, electrical signals, heart rate, or respiratory rate.

Description

Technical Field

[0001] This invention relates to a device for implantation in the left atrial appendage of the heart. The invention also envisions methods for treatment or diagnosis using this device, particularly for the diagnosis of cardiac function. Background Technology

[0002] Heart disease is a major human problem, and over the past 20 years, devices designed for in-situ treatment and monitoring of the heart have been developed. The space within a beating heart is extremely limited, posing a significant challenge to the development of safe and effective in-situ cardiac implants.

[0003] Medical implantable devices for the left atrial appendage (LAA) of the heart are known from the literature and typically include a catheter and a radially expandable member disposed at the distal end of the catheter, which is configured for deployment in the ostium of the LAA and fluidly isolating the LAA from the heart. These devices are typically operatively connected to an external controller via the catheter; operable to treat tissue of the LAA to alter its electrical properties; and ultimately electrically isolate the LAA from cardiac tissue as a means of suppressing or preventing atrial fibrillation. Some of these devices also include sensors that sense parameters of the LAA tissue. WO2016 / 202708 describes an exemplary device.

[0004] The object of this invention is to overcome at least one of the problems described above. Summary of the Invention

[0005] The applicant has recognized that the LAA can provide additional space to accommodate cardiac treatment / sensing devices, and that by using an LAA implant, the LAA can be safely and definitively isolated, potentially creating additional space within the heart while remaining isolated from it. This space can then be used as a container for treatment or monitoring devices or as a gateway for accessing the external surface of the heart from within or from outside the heart to the interior of the heart.

[0006] This invention addresses the need for a cardiac monitoring / treatment device that can be safely implanted in the heart without adversely affecting cardiac function and is configured for modular adjustment. The device comprises two main components: a docking station and a modular active element; the docking station is designed for implantation within the left atrial appendage (LAA) of the heart, wherein the docking station is anchored to the wall of the LAA; the modular active element is designed for detachable engagement within a recessed channel (port) formed in the docking station. The modular active element can be a treatment device or a sensing device and can be removed from the docking station while remaining in situ in the heart and replaced with a different modular active element (e.g., a tissue ablation module replaced by a cardiac parameter sensor), or replaced with a novel identical modular active element, or replaced with an identical modular active element with a new battery. The treatment or sensing device can be configured for treatment or sensing operations applied to the LAA, the heart, cardiac chambers (e.g., the left atrium), or blood flowing through the heart. Modular active elements and recessed ports are configured for detachable engagement to allow for the disengagement and retraction of the modular active elements, as well as the reattachment of the same or different modular active elements, while the docking station remains in situ within the cardiac arterial airway (LAA). Therefore, this invention provides a safe and convenient device for treating or monitoring cardiac conditions. The recessed port extends through the docking station, thereby allowing portions of the modular active elements (e.g., therapeutic or sensing devices) to enter the occluded LAA.

[0007] In a first aspect, the present invention provides a device for implantation into a body cavity (e.g., the left atrial appendage of the heart), the device comprising a docking station including a radially expandable element adjustable between a contractile orientation and a deployment orientation suitable for intracavitary delivery, the deployment orientation being configured to be located within the left atrial appendage (and preferably, fluidly isolating the left atrial appendage from the left atrium). In one embodiment, the docking station includes a recessed port accessible from the left atrium. The device typically includes a modular active element configured for detachable engagement within the recessed port of the docking station.

[0008] In one embodiment, the proximal surface of the recessed socket includes a closure configured to prevent fluid from entering the recessed socket. Various forms of closures are described herein, including self-closing closures and puncture-resistant closures.

[0009] In one embodiment, at least one of the modular active element and the docking station includes (or is magnetized) a magnet configured to guide the modular active element into the recessed socket.

[0010] Modular active components typically include therapeutic or sensing elements. Therapeutic or sensing elements can be radially expandable. Sensing elements can be configured to detect any parameter, examples of which include parameters selected from temperature, pressure, pH, electrical signals, heart rate, or respiratory rate.

[0011] In one embodiment, the modular active element is a therapeutic element configured to electrically stimulate the heart, ablate cardiac tissue (by any means, including thermal, electrical, radiation, physical, or chemical ablation), or deliver substances to the heart, heart wall, or blood flow.

[0012] In one embodiment, the therapeutic element includes thermal and non-thermal energy delivery elements (such as RF), reversible and irreversible electroporation cryogenic elements, or capacitive coupling. The element may be an electrode or an electrode array. The cryogenic element may be a radially expandable balloon.

[0013] In one embodiment, the therapeutic or sensing element is configured for adjustment between a shrink delivery configuration and a deployment active configuration. Generally, in these embodiments, the therapeutic or sensing element is positioned toward the distal end of the modular active element and configured for deployment distal to a recessed socket.

[0014] In one embodiment, the docking station and the modular active element are configured for electrical connection when the modular active element is operatively engaged within a recessed socket. In another embodiment, the docking station is configured to provide electrical connection between the modular active element and surrounding tissue via radially expandable elements.

[0015] In one embodiment, the recessed socket extends fully through the docking station, thereby providing access to the occluded LAA when the docking station is deployed.

[0016] In one embodiment, the modular active element is sized to fully engage within the recessed port. In another embodiment, the modular active element is sized to engage within the recessed port to close it. When the port is open, such as when the recessed port closure includes a puncture-resistant membrane or cap, this prevents fluid from flowing through the recessed port from the heart to the LAA.

[0017] In one embodiment, a modular active element is configured to engage within a recessed port, wherein a proximal portion of the modular active element is disposed proximal to the recessed port and / or a distal portion of the modular active element is disposed distal to the recessed port. In one embodiment, a modular active element is configured to reside within a recessed port having a proximal portion extending into the left atrium. In one embodiment, the proximal portion extending into the left atrium includes a therapeutic or sensing element.

[0018] In one embodiment, the modular active element is sized to fit within the heart. In one embodiment, the modular active element is sized to fit within the left atrium (including the left atrial appendage). In another embodiment, the modular active element is sized to fit within the left atrial appendage.

[0019] In one embodiment, the recessed conduit is configured for radial expansion when receiving a modular active element. In this embodiment, the modular active element may have a diameter larger than the diameter of the recessed conduit. Insertion of the modular active element into the recessed socket subjects the recessed socket to tensile forces, thereby forcing it to expand radially. The socket may be formed of an elastically deformable material, such as a suitable elastic polymer or an expandable mesh, configured to retain its initial dimensions when the modular active element is removed. Alternatively, the socket may be tubular, having adjacent but unconnected longitudinal segments; these longitudinal segments are longitudinally abutted when the socket is not expanded, but separate when the socket expands. The modular active element may have a distal end that tapers inward (i.e., funnel shape), which allows the distal end of the modular active element to be inserted into the recessed socket before radial expansion, thereby affecting the radial expansion of the socket with further insertion of the element into the socket.

[0020] In one embodiment, the closure of the recessed port includes a mesh cap; when the device is deployed in the LAA, the mesh cap typically fluidly isolates the left atrium from the LAA. In one embodiment, the mesh includes a self-closing orifice.

[0021] In one embodiment, the closure includes a puncture-resistant membrane cover.

[0022] In one embodiment, the self-closing closure element includes an inflatable valve.

[0023] In one embodiment, the closure is configured to promote epithelial cell proliferation.

[0024] In one embodiment, the self-closing closure includes an openable flap and an associated biasing device for biasing the flap to a closed position. In one embodiment, the biasing device includes a spring element attached to the flap, such as a hinged spring as disclosed herein.

[0025] In one embodiment, the radially expandable element is a radially expandable cage. In one embodiment, the recessed socket is a conduit; the conduit extends at least partially (and in one embodiment, completely) axially through and into the radially expandable cage or element. In one embodiment, the radially expandable element includes a proximal portion, a cap for the recessed socket, and a generally cylindrical distal portion; the proximal portion has a generally annular shape and includes an opening for the recessed socket.

[0026] In one embodiment, the modular active element and the recessed socket are configured for mutual engagement when the modular active element is fully received in the recessed socket.

[0027] In one embodiment, the modular active element and recessed socket configuration are used for screw-fit detachable engagement.

[0028] In one embodiment, the modular active element and recessed socket configuration are used for interference-fit detachable engagement.

[0029] In one embodiment, the modular active element includes a radially expandable anchor configured to anchor the modular active element in a recessed socket (or as a engagement device) upon engagement. In one embodiment, the radially expandable anchor is inflatable.

[0030] In one embodiment, the modular active element includes a distal radially expandable anchor and / or a proximal radially expandable anchor, the distal radially expandable anchor being configured to be deployed distal to the conduit or radially expandable element when the modular active element engages a recessed socket, and the proximal radially expandable anchor being configured to be deployed proximal to the conduit or radially expandable element when the modular active element engages a recessed socket.

[0031] In one embodiment, the modular active element includes an inductor.

[0032] In one embodiment, the inductor includes an inductor coil that is optionally adjustable between a contraction orientation suitable for in-cavity delivery and a radially deployed expansion orientation.

[0033] In one embodiment, the inductor coil is disposed on the distal end of the modular active element and configured for deployment on the distal side of the recessed conduit.

[0034] In one embodiment, the modular active element includes a resonant power circuit configured with a plurality of coils adapted to provide a desired Q factor greater than or equal to 0.5.

[0035] In one embodiment, the modular active element includes a capacitor paired with an inductor to provide a first LC circuit.

[0036] In one embodiment, the modular active element includes an RC circuit operatively connected to a DC regulator and adapted to provide a steady-state current to the circuit.

[0037] In one embodiment, the modular active element includes a second LC circuit located outside the modular active element, which is adapted to provide magnetic flux to power the LC circuit.

[0038] In one embodiment, the proximal end of the modular active element includes an anchoring formation configured to engage a contraction loop.

[0039] In one embodiment, the modular active element is configured to remain attached to its delivery conduit during use. The delivery conduit may include control elements for the modular active element, including power source appliances and data relay appliances. The conduit and the modular active element are configured for disengagement from the docking station and intracavitary withdrawal. The modular active element is configured for disengagement from the delivery conduit, and the conduit is configured to replace the attachment of the modular active element. The conduit and the replacement modular active element are intracavitarily delivered to the docking station, and the modular active element operatively engages within a recessed socket.

[0040] In one embodiment, the cap at the distal end of the docking station includes a network of electrode receiving conduits extending radially from the center of the cap to its periphery. Electrodes positioned at the distal end of a delivery conduit are screwed through the conduits, which guide the distal ends of the electrodes to the periphery of the cap, which will be adjacent to the wall of the LAA during use. In one embodiment, the circumference of the tissue engagement portion of the cap includes a plurality of holes configured to expose the distal ends of the electrodes to the wall of the LAA. The conduits and electrodes are configured for disengagement and withdrawal from the docking station, thereby leaving the docking station in situ.

[0041] In one embodiment, the radially expandable element includes one or more brush members configured to engage tissue upon deployment of the radially expandable element. The brush facilitates attachment of the element to the tissue upon deployment and also forms a fluid tight seal against the tissue. For example, the radially expandable element may be a cage formed of wire, and at least one of the wires may include a brush member. As used herein, the term "brush member" generally refers to a ridge and a plurality of bristles coupled to the ridge, extending outward (generally radially outward) from the ridge. The bristles may have an axial, circumferential, or helical arrangement. Brush members and methods of their manufacture are described in the following documents: US8528147, EP0800781, and DE10328445. The bristles may be porous, which facilitates tissue integration. The pores may be formed during extrusion or after cutting or laser treatment.

[0042] The present invention also provides a system including the device of the present invention and a delivery conduit that delivers a modular active element cavity-to-cavity conduit of a docking station. In one embodiment, the delivery conduit is configured to receive a modular active element (typically received within a distal end of the conduit), deliver the modular active element cavity-to-cavity to the docking station, and partially or completely dispense the modular active element from the distal end of the delivery conduit into a recessed port of the docking station. In one embodiment, the delivery conduit includes an internal element configured for detachable attachment to a proximal end of the modular active element and axial movement relative to the conduit. In one embodiment, the internal element is configured to rotate the modular active element about a longitudinal axis of the conduit.

[0043] In one embodiment, the present invention provides an apparatus for occluding a body cavity, the apparatus comprising an implantable occlusion device operatively attached to an elongated catheter member configured for intracavitary delivery and deployment of the occlusion device within the body cavity, the occlusion device including a radially expandable element detachably attached to the elongated catheter member and adjustable between a contraction orientation adapted for intracavitary delivery and a deployment orientation configured to occlude the body cavity; wherein the radially expandable element includes one or more brush members configured to engage tissue upon deployment of the radially expandable element. In one embodiment, the apparatus includes an energy delivery element configured to deliver energy to surrounding tissue to heat the tissue. In one embodiment, the apparatus includes a sensor configured to detect parameters of the wall of the body cavity. In one embodiment, the energy delivery element and the sensor are optionally configured for axial movement independent of the radially expandable element, whereby the energy delivery element and the sensor can retract intracavitarily during use, thereby retaining the radially expandable element in situ to occlude the body cavity.

[0044] The present invention also relates to a method comprising the following steps:

[0045] The device of the present invention is delivered intracavitarily to the left atrial appendage of the heart of the recipient;

[0046] The device is deployed to anchor it in the left atrial appendage;

[0047] Actuate modular active elements to perform the first operation in situ within the heart;

[0048] After a period of time, the modular active components are detached from the docking station and extracted from the object cavity.

[0049] The replacement modular active component will be delivered cavity-to-heart of the object;

[0050] Insert the replacement modular active component into the recessed conduit of the docking station and insert it to engage the recessed conduit; and

[0051] Actuate modular active elements to perform a second operation in situ within the heart.

[0052] In one embodiment, the first and second operations are each independently a therapeutic operation (i.e., LAA tissue ablation, drug or gene therapy delivery) or a sensing operation (i.e., detection of electrical signals, pressure, or temperature in the LAA). The first and second operations may be different or the same. The modular active element and the alternative modular active element may be different or the same. For example, one may include a therapeutic element and the other may include a sensing element, or both may include a therapeutic or sensing element.

[0053] In one embodiment, the step of disengaging the modular active element from the docking station and extracting the modular active element from within the object cavity employs a conduit having an outer portion and an inner portion. The outer portion is configured to abut a proximal surface of a radially expandable element surrounding an opening of a recessed socket. The inner portion is configured for axial movement into the recessed socket and engagement with a proximal end of the modular active element. Typically, the inner portion of the conduit has a piercing tip configured to pierce a cap covering the opening of the recessed socket. Suitably, the outer portion of the conduit includes a magnet to facilitate proper positioning against the proximal surface of the radially expandable element.

[0054] In one embodiment, the replacement modular active element includes a radially expandable anchor configured to anchor the replacement modular active element in a recessed socket upon engagement, wherein the method includes the step of deploying the anchor after the replacement modular active element has been inserted into the recessed conduit. In one embodiment, the radially expandable anchor is inflatable.

[0055] The method of the present invention can be a method of occlusion, transvascularization, or electrical isolation of the LAA, wherein the modular active element includes a tissue ablation element for direct (wherein, a portion of the element is configured to engage the LAA tissue) or indirect (wherein, the tissue ablation element is configured to deliver ablation energy to the tissue via a radially expandable element) ablation of the tissue.

[0056] The present invention also provides a component kit comprising the device according to the invention and at least one (i.e., 1, 2, 3, 4, 5) replacement modular active element.

[0057] In one embodiment, the modular active element is a tissue ablation device, and the alternative modular active element is selected from a treatment device or a sensing device.

[0058] In one embodiment, the kit includes a conduit having an outer portion and an inner portion; the outer portion is configured to abut a proximal surface of a radially expandable element surrounding an opening in a recessed socket, and the inner portion is configured for engagement with a proximal end of a modular active element and optionally for axial movement into the recessed socket.

[0059] In one embodiment, the inner portion of the catheter has a piercing tip configured to pierce a cap covering an opening that covers the recessed insertion port.

[0060] In another aspect, the present invention provides a device for implantation in the left atrial appendage of the heart, the device comprising:

[0061] A docking station comprising a radially expandable element, a recessed port, and a closure, the radially expandable element being adjustable between a contraction orientation and a deployment orientation suitable for intraluminal delivery, the deployment orientation being configured to anchor within the left atrial appendage and fluidly isolate the left atrial appendage from the left atrium, the recessed port being accessible from the left atrium through an opening, and the closure covering the opening; and

[0062] A modular active element configured for detachable engagement within a recessed socket of a docking station, wherein the modular active element includes an inductor.

[0063] In one embodiment, the inductor includes an inductor coil that is optionally adjustable between a contraction orientation suitable for intracavity delivery and a radial deployment expansion orientation. In one embodiment, the inductor coil is disposed on the distal end of a modular active element and configured for deployment on the distal side of a recessed conduit.

[0064] In another aspect, the present invention provides a device for implantation in the left atrial appendage of the heart, the device comprising:

[0065] A docking station comprising a radially expandable element, a recessed port, and a closure, the radially expandable element being adjustable between a contraction orientation and a deployment orientation suitable for intraluminal delivery, the deployment orientation being configured to anchor within the left atrial appendage and fluidly isolate the left atrial appendage from the left atrium, the recessed port being accessible from the left atrium through an opening, and the closure covering the opening; and

[0066] A modular active element configured for detachable engagement within a recessed socket of a docking station, wherein the modular active element includes a resonant power circuit configured with multiple coils adapted to provide a desired Q factor greater than or equal to 0.5.

[0067] In another aspect, the present invention provides a device for implantation in the left atrial appendage of the heart, the device comprising:

[0068] A docking station comprising a radially expandable element, a recessed port, and a closure, the radially expandable element being adjustable between a contraction orientation and a deployment orientation suitable for intraluminal delivery, the deployment orientation being configured to anchor within the left atrial appendage and fluidly isolate the left atrial appendage from the left atrium, the recessed port being accessible from the left atrium through an opening, and the closure covering the opening; and

[0069] A modular active element configured for detachable engagement within a recessed socket of a docking station, wherein the modular active element includes a capacitor paired with an inductor to provide a first LC circuit.

[0070] In one embodiment, the modular active element includes an RC circuit operatively connected to a DC regulator and adapted to provide a steady-state current to the circuit.

[0071] In one embodiment, the modular active element includes a second LC circuit located outside the modular active element, which is adapted to provide magnetic flux to power the LC circuit.

[0072] Other aspects and preferred embodiments of the invention are defined and described in the other claims explained below. Attached Figure Description

[0073] Figures 1A to 1F The diagram illustrates a docking station of the present invention in a deployment configuration having a radially expandable cage, wherein the proximal end is generally annular and has a recessed conduit, and the distal end has a cylindrical shape; and a reclosable orifice is shown to facilitate the removal and insertion of modular active components. Figure 1A A docking station with a mesh cover at the proximal end of a covered cage is shown, and Figure 1B The docking station, which was removed for clear purposes, is shown. Figure 1B The distal end of the conduit attached to the docking station is also shown. Figure 1C and Figure 1D This is a side view of the docking station, showing it in an open ( Figure 1C ) and closing ( Figure 1D The reclosable hole is configured. Figure 1E and Figure 1F This is the end view of the docking station.

[0074] Figure 2A and Figure 2B A cover for the proximal end of the docking station is shown, the docking station having a closure ( Figure 2A ) and open ( Figure 2BThe reclosable orifice is configured in the form of a polymer valve.

[0075] Figures 2C to 2F This is a side sectional view of the docking station, showing the valves in a closed configuration. Figure 2C ) and the valve in which the catheter protrudes through the open configuration of the valve ( Figure 2D ), delivered to the modular active components in the recessed socket ( Figure 2E ), and the removed catheter ( Figure 2F ) and the closed valve.

[0076] Figures 3A-3F Four different ways in which modular active components and conduits interact are shown, namely, threaded engagement (…). Figure 3A ), over-compensation () Figure 3B ), anchored deployment ( Figure 3C ), balloon deployment ( Figure 3D ) and spring engagement ( Figure 3E and Figure 3F ).

[0077] Figures 4A-4C This demonstrates how modular active components can be electrically connected to the organization of a LAA via radially scalable components.

[0078] Figure 5 This illustrates how the proximal end of a radially expandable element can have a sealing skirt configured to engage an irregularly shaped LAA.

[0079] Figure 6A , Figure 6B and Figure 6C A delivery conduit with a modular active element is shown, which incorporates a magnet to help guide the delivery conduit toward the opening of the conduit.

[0080] Figures 7A-7C Modular active components for tissue ablation are shown: Figure 7A Modular active components in an active deployment configuration are shown, and Figure 7B A modular active element in a shrink delivery configuration is shown. Figure 7C The deployment of modular active components integrated within the conduit is shown.

[0081] Figure 8A Modular active components including an inflatable balloon are shown. Figure 8B For along Figure 8A The sectional view intercepted by line 1-1, and Figure 8C A modular active element including an inflatable balloon with different compartments configured to deliver different cryoablation treatments is shown.

[0082] Figure 9A modular active element with two inflatable balloons is shown, which are engaged within a conduit.

[0083] Figure 10 A modular active element incorporating a hook-like structure is shown, configured to engage a delivery / removal device.

[0084] Figure 11A and Figure 11B A device for left atrial monitoring is shown, which incorporates an inductor coil for remote power supply or charging of the device.

[0085] Figures 12A to 12H A method using the apparatus of the present invention is shown. Detailed Implementation

[0086] All publications, patents and patent applications and other references mentioned herein are incorporated herein by reference in their entirety for all purposes, as if each individual publication, patent or patent application were expressly and individually indicated as incorporated by reference and whose contents are fully described herein.

[0087] Definitions and general preferred settings

[0088] In the context of this document and unless otherwise expressly indicated, these terms are intended to have the following meanings in addition to any broader (or narrower) meanings that may have in the art.

[0089] Unless the context otherwise requires, the singular as used herein shall be understood to include the plural, and vice versa. The term “a (a)” or “an” as used in relation to an entity shall be regarded as referring to one or more of that entity. Therefore, the terms “a (a)” (or “an)”, “one or more”, and “at least one” are used interchangeably herein.

[0090] As used herein, the term “comprising” or variations thereof (such as “comprises” or “comprising”) should be considered as indicating the inclusion of any stated and formal (e.g., features, elements, characteristics, properties, method / process steps, or limitations) or groups of integers (e.g., features, elements, characteristics, properties, method / process steps, or limitations), but not excluding any other integers or groups of integers. Therefore, as used herein, the term “comprising” is inclusive or open-ended and does not exclude additional, unmentioned integers or method / process steps.

[0091] As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to encompass any disorder, symptom, abnormality, lesion, ailment, condition, or symptom in which physiological function is impaired regardless of its etiological nature (or, in fact, regardless of whether an etiological basis for the disease exists). Therefore, the term covers conditions arising from infection, trauma, injury, surgery, radiation ablation, poisoning, or malnutrition.

[0092] As used herein, the term "treatment" or "treating" refers to an intervention (e.g., administering a drug to a subject) that cures, improves, or alleviates the symptoms of a disease, or eliminates (or mitigates) the effects of its cause (e.g., reducing the accumulation of pathological levels of lysosomal enzymes). In this context, the term is used synonymously with the term "therapy."

[0093] Furthermore, the terms "treatment" or "treating" refer to an intervention (e.g., administering a drug to a subject) that prevents or delays the onset or progression of a disease, or reduces (or eliminates) its incidence in the treated population. In this context, the term "treatment" is used synonymously with the term "prevention."

[0094] As used herein, an effective or therapeutically effective dose of a drug is defined as the amount that can be administered to a subject without excessive toxicity, irritation, allergic reactions, or other problems or complications; this dose is proportionate to a reasonable removal / risk ratio but sufficient to provide the desired effect, such as treatment or prevention manifested as a permanent or temporary improvement in the subject's condition. This dose will vary for each subject, depending on the individual's age and general condition, method of administration, and other factors. Therefore, while it is impossible to prescribe an exact effective dose, those skilled in the art will be able to determine an appropriate "effective" dose in any case using routine testing and background common sense. In this context, therapeutic outcomes include the elimination or reduction of symptoms, reduction of pain or discomfort, prolongation of survival, improvement of mobility, and other markers of clinical improvement. A therapeutic outcome need not be a complete cure.

[0095] In the context of treatment and effective quantity as defined above, the term object (which, where context permits, should be considered to include "person," "animal," "patient," or "mammal") defines any object, particularly a mammalian object on which treatment is being performed. Mammal objects include, but are not limited to, humans, livestock, farm animals, zoo animals, sporting animals, pet animals (such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, and beef cattle), primates (such as apes, monkeys, orangutans, and chimpanzees), canines (such as dogs and wolves), felines (such as cats, lions, and tigers), equines (such as horses, donkeys, and zebras), edible animals (such as beef cattle, pigs, and sheep), ungulates (such as deer and giraffes), and rodents (such as mice, rats, hamsters, and guinea pigs). In a preferred embodiment, the object is a human.

[0096] "Intracavitary delivery" means delivery of a device through an internal body cavity to a target site (e.g., the heart), such as via an artery or vein. In one embodiment, the device of the present invention is advanced through an artery or vein into the left atrium of the heart and at least partially into the LAA.

[0097] A "docking station" refers to a part of the device of the present invention, which is anchored to and held within the medial aspect of an individual's heart, inside the left atrial appendage (LAA), thereby allowing for the periodic replacement of a modular active element. For example, the modular active element could be a battery-powered sensor that requires periodic battery replacement. The docking station generally includes a radially expandable element deployed to house the device within the LAA; and generally includes a recessed conduit (port) accessible from the left atrium and configured for detachable engagement with the modular active element. In one embodiment, the radially expandable element includes an expandable cage having a conduit (typically an axial conduit). The conduit typically has an opening on the proximal side of the docking station to allow access from the left atrium. The conduit is generally covered by a cap that typically has a reclosable orifice configured to allow the modular active element to enter the conduit and close after the element has been placed in the conduit (i.e., a self-closing orifice). Various types of reclosable orifices are disclosed herein, including flap valves and puncturable membranes. In one embodiment, the reclosable aperture includes a flap and an associated biasing device configured to bias the flap to a closed position.

[0098] "Radially expandable element" refers to a body that expands from a contractile delivery configuration to an expanded deployment configuration. The body can take various forms, such as a wireframe structure formed of braided or mesh material. Examples of expandable wireframe structures suitable for intracavitary delivery are known in the literature and described, for example, in WO01 / 87168, US6652548, US2004 / 219028, US6454775, US4909789, US5573530, and WO2013 / 109756. Other body forms suitable for use with the present invention include plate-shaped or dish-shaped platforms or inflatable balloons or supports. In one embodiment, the body is formed of a metal, such as a shape memory metal, such as nitinol. The body can have any shape suitable for the purposes of the present invention, such as a disc or a sphere. In one embodiment, the body includes a tissue ablation device. In one embodiment, the ablation device includes an array of electrical components. In one embodiment, the array of electrical components is configured to deliver ablation energy in a specific pattern while mapping temperature. In one embodiment, an array of electrical components is configured to pace cardiac tissue for ablation and disruption of disordered signals in the left atrial appendage (LAA). In one embodiment, the distal surface of a radially expandable element includes a covering configured to promote epithelial cell proliferation. In one embodiment, the body includes a stepped radial force stiffness curve from distal to proximal. In one embodiment, the body includes a metal mesh cage frame. In one embodiment, the coupling between the body and the catheter assembly is located distal to the left atrium facing the side of the body. In one embodiment, the body in a deployment configuration has a radial diameter at the deployment point that is at least 10% larger than the radial diameter of the left atrial appendage. In one embodiment, the distal body is configured to be non-invasive to cardiac tissue. In one embodiment, the body covering is configured to allow for self-closing contraction of the delivery component (i.e., the catheter assembly). In one embodiment, the body includes a woven mesh frame that, in one embodiment, facilitates collagen infiltration during heat transfer to promote increased resistance to migration. In one embodiment, the electrode array generates an electrical graph or curve of electrical impedance measurements of the ablation zone and surrounding tissue to characterize the electrical properties of the tissue, wherein this characterization is optionally used as a measurement and confirmation value of ablation efficiency.

[0099] A "modular active element" refers to a device designed for detachable engagement with a recessed conduit formed in a docking station. The modular active element can be a therapeutic or sensing element and is typically configured for removal from the docking station while remaining in situ within the heart and being replaced with a different modular active element (e.g., a tissue ablation module replaced by a cardiac parameter sensor), a new type of the same modular active element, or the same modular active element with a new battery. The therapeutic or sensing element can be configured for therapeutic or sensing operations applied to the left atrial appendage (LAA), the heart, cardiac chambers (e.g., the left atrium), or blood flowing through the heart. The modular active element and the recessed conduit (socket) are generally configured for detachable engagement to allow for disengagement and retraction of the modular active element and reattachment of the same or different modular active elements while the docking station remains in situ within the LAA of the heart. In one embodiment, the modular active element is sized to fit within the heart. In another embodiment, the modular active element is sized to fit within the left atrium (including the left atrial appendage). In one embodiment, the modular active element is sized to fit within the left atrial appendage.

[0100] A “closure” or “cap” generally refers to a layer disposed on the proximal side of a radially expandable element that covers the opening to the recessed port. It is designed to prevent blood flow through the occlusion device into the LAA. It may be formed of a woven mesh material and may include a reclosable closure, such as an overlapping material flap or a polymer valve, or may include a puncture-resistant cap. In some embodiments, a connecting hub is disposed in a recess between the cap and the concave proximal surface of the radially expandable body.

[0101] "A covering / lid configured to promote epithelial cell proliferation" means a material used to promote epithelial proliferation of a distal or proximal body. In one embodiment, the covering is a membrane comprising an agent that promotes epithelial cell proliferation. Examples include growth factors such as fibroblast growth factor, transforming growth factor, epidermal growth factor, and platelet-derived growth factor; cells such as endothelial cells or endothelial progenitor cells; and biological materials such as tissues or tissue components. Examples of tissue components include endothelial tissue, extracellular matrix, submucosa, dura mater, pericardium, endocardium, chorion, peritoneum, and basement membrane tissue. In one embodiment, the covering is porous. In one embodiment, the covering is a biocompatible scaffold formed of biological material. In one embodiment, the covering is a porous scaffold formed of biological material such as collagen. In one embodiment, the covering is a lyophilized scaffold.

[0102] "Radially scalable" means scalable from a shrinking configuration suitable for delivery to a deployment expansion location. Typically, the body is radially scalable about the longitudinal axis of the device. One or both of the bodies may be self-scalable. In another embodiment, the body is not self-scalable but configured for manual deployment. Scalable bodies configured for manual expansion are described in PCT / IE2014 / 000005.

[0103] "Removable engagement" means that modular active components and conduits are configured to allow the modular active components to be attached to and subsequently detached from the conduit, thereby allowing the modular active components to be detached from the conduit and withdrawn from the body, and replaced with the same or different modular active components. This article describes various means of removable attachment, including snap-fit, friction fit, threaded screw, and magnetic arrangement.

[0104] "Intracavitary delivery" applied to the device or a portion thereof (docking station or modular active element) of the present invention means delivery through a body cavity to a target site (e.g., the heart), such as delivery via an artery or vein. In one embodiment, the device of the present invention is advanced through an artery or vein to deliver the occlusion device to the left atrium of the heart, and is at least partially located in the LAA.

[0105] In docking stations, "anchors" refer to protrusions that are typically located around the perimeter of the body and configured to project into the wall of the LAA. Examples of suitable anchors include hooks or barbs. Generally, anchors comprise multiple individual anchors, for example, arranged around the perimeter of a radially expandable element.

[0106] "Sensor" or "sensing element" means an electrical sensor configured to detect environmental parameters within or near the LAA, such as blood flow, electrical signal activity, pressure, impedance, humidity, temperature, radiation, etc. The sensor may include appropriately spaced emitting and sensing sensors. In one embodiment, the sensor is an electrode. In one embodiment, the sensor is configured to detect fluid flow. In one embodiment, the sensor is configured to detect conductivity. In one embodiment, the sensor is configured to detect impedance. In one embodiment, the sensor is configured to detect acoustic (i.e., photoacoustic and acousto-optic) signals. In one embodiment, the sensor is configured to detect optical signals that typically indicate changes in blood flow in surrounding tissue. In one embodiment, the sensor is configured to detect stretching. In one embodiment, the sensor is configured to detect humidity. In one embodiment, the sensor is configured for wireless transmission of the detected signals to a processor. The sensor can be used in real time during the method of the present invention to allow the surgeon to determine the time of adequate occlusion of the LAA, for example, to determine blood flow or electrical activity within the LAA. Examples of suitable sensors include optical sensors, radio frequency sensors, microwave sensors, and sensors based on lower frequency electromagnetic waves (i.e., from DC to RF), radio frequency waves (from RF to MW), and microwave sensors (GHz). In one embodiment, the device of the present invention is configured for axial movement of the sensor relative to a radially expandable body. In one embodiment, the device of the present invention is configured for rotational movement of the sensor generally about the longitudinal axis of the device. This facilitates sensor positioning and enables fully circumferential sensing. In one embodiment, the sensor is configured to detect parameters of the left atrium. In one embodiment, the sensor is configured to perform in vivo dosimetry to detect radiation dose, ideally in real time.

[0107] "Optical sensors" refer to sensors suitable for detecting changes in blood flow within tissue, and these sensors generally involve directing light at the tissue and measuring the reflected / transmitted light. These sensors are particularly sensitive to detecting changes in blood flow in adjacent tissues and are therefore suitable for detecting blood flow blockages in tissues such as arterial blood vessels (LAA). Examples include optical probes using pulse oximeters, photoplasmometry, near-infrared spectroscopy, contrast-enhanced ultrasound imaging, diffusion-correlation spectroscopy (DCS), transmission or reflection sensors, LED RGB, laser Doppler flowmeters, diffusion reflection, fluorescence / autofluorescence, near-infrared (NIR) imaging, diffusion-correlation spectroscopy, and optical coherence tomography. An example of a spectral sensor is a device that transmits light of two wavelengths through tissue to a photodetector, which measures the absorbance change at each wavelength, allowing the absorbance to be determined solely from pulsating arterial blood (excluding venous blood, muscle, fat, etc.). Photogrammetry measures changes in tissue volume caused by a heartbeat, detected by illuminating the tissue with light from a single LED and then measuring the light reflected to a photodiode.

[0108] A “therapeutic element” is a device configured to deliver treatment to the heart or bloodstream. Examples include energy delivery elements and drug delivery devices (e.g., devices configured to release chemically or biologically active agents, such as drugs, gene therapy, etc.). An “energy delivery element” is a device configured to receive energy and direct that energy to tissue, ideally converting that energy into heat to heat the tissue (thereby causing collagen denaturation (tissue ablation)). Tissue ablation devices are known to a person skilled in the art and operate based on emitting thermal energy (hot or cold), microwave energy, radiofrequency energy, radiation, other types of energy suitable for tissue ablation, or chemicals configured to ablate tissue. Tissue ablation devices are sold by ANGIODYNAMICS and include the STARBURST radiofrequency ablation system and the ACCULIS microwave ablation system. Examples of tissue ablation chemicals include alcohols, heated saline, and heated water. Typically, the liquid is heated to at least 45°C, i.e., 45°C to 70°C. In one embodiment, the tissue ablation device includes an array of electrodes or electrical components typically configured to deliver heat to adjacent tissue (alcohol, heated saline, heated water). In one embodiment, one or more electrodes include at least one or two thermocouples electrically in communication with the electrodes. In one embodiment, one or more electrodes are configured to deliver RF or microwave energy. In one embodiment, one or more electrodes are configured to deliver both reversible and irreversible electroporation. In one embodiment, one or more electrodes are configured to deliver via capacitive coupling. In one embodiment, the device of the present invention is configured for axial movement of the energy delivery element relative to a radially expandable body. In one embodiment, the energy delivery element includes a radially expandable body. In one embodiment, the device of the present invention is configured for rotational movement of the energy delivery element generally about a longitudinal axis of the device. This facilitates the positioning of the energy delivery element and facilitates achieving complete circumferential tissue ablation. In one embodiment, the energy delivery element includes a radioactive material suitable for radiotherapy. In one embodiment, the energy delivery element is configured to apply the radioactive material to tissue, for example, a radioactive substance, such as a pill or gel. The radioactive substance may include radioactive iodine, cesium, or palladium isotopes. In one embodiment, the material takes the form of "seeds," which are small (typically about 0.8 × 4.5 mm) cylinders containing a radioactive element within a stainless steel casing. Multiple seeds (typically between 80 and 120) are positioned to contact cardiac tissue by attaching them to a stand or a radially expandable element. The seeds can be permanently retained in place while the emitted radiation decays over time. Common radioactive isotopes used in the seeds are iodine-125, palladium-103, and cesium-131. After several weeks or months, the radiation level emitted by the source will decrease to almost zero. However, ineffective seeds left at the treatment site have no lasting effect.The goal of the seed is to ensure that the total dose received by the heart cells is sufficient to kill them, thereby permanently and electrically isolating the tissue in contact with the seed.

[0109] Atrial fibrillation, or AF, is a common cardiac rhythm disorder that affects an estimated six million patients in the United States alone. AF is the second leading cause of stroke in the US and accounts for nearly one-third of strokes in older adults. In more than 90% of AF cases, blood clots (thrombi) develop in the left atrial appendage (LAA) of the heart. The irregular heartbeat of AF causes blood to pool in the LAA, and clots and thrombi can form in the LAA as blood clotting occurs while the blood is stagnant. These blood clots can break off from the LAA and enter the cerebral circulation, causing stroke; the coronary circulation, causing myocardial infarction; the peripheral circulation, causing limb ischemia; and other vascular beds. The term encompasses all forms of atrial fibrillation, including paroxysmal (intermittent) AF as well as persistent and long-term persistent AF (PLPAF).

[0110] An "ischemic event" refers to a restriction in the blood supply to a body organ or tissue, resulting in a shortage of oxygen and glucose to the affected organ or tissue. This term includes stroke, obstruction of the blood supply to a part of the brain (caused by a blood clot blocking the blood supply to the brain), and damage to the affected part of the brain, as well as transient ischemic events (TIAs) (also known as "mini-strokes"); TIAs are similar to strokes but are transient in nature and generally do not cause lasting damage to the brain. Ischemic events are known as myocardial infarction (MI) or heart attack when blood supply to the coronary arteries is restricted.

[0111] An "inductor" typically refers to a two-terminal electrical component that stores energy in a magnetic field when current flows through it. Inductors generally take the form of wire coils and may or may not have a magnetic core.

[0112] A "resonant power circuit" typically refers to an LC circuit connected to a voltage or current source. Resonant power circuits generally generate a strong magnetic field, which can be used to wirelessly transmit power to a receiving circuit.

[0113] The "desired Q factor" usually refers to the ratio between the center frequency and the bandwidth of a resonant LC circuit.

[0114] "RC circuit" usually refers to an electronic circuit composed of resistors and capacitors.

[0115] A "DC regulator" typically refers to an electronic component that converts non-DC (usually AC) signals into DC signals.

[0116] "LC circuit" usually refers to an electronic circuit composed of inductors and capacitors.

[0117] illustration

[0118] The present invention will now be described with reference to specific examples. These examples are exemplary and for illustrative purposes only: they are not intended to limit in any way to the claimed monopoly or the invention described. These examples constitute the best mode contemplated for practicing the present invention.

[0119] Refer to the accompanying drawings, and initially refer to... Figures 1A to 1F The diagram shows a docking station 2, which forms part of the device 1 of the invention, shown in its deployment configuration, and includes a radially expandable element (in this case, a cage 3); the radially expandable element has an annular proximal end 4 with a recessed socket 5. Figure 1D ) and the cylindrical distal end 6. (e.g.) Figures 1A to 1C As shown, the proximal end of the cage includes a mesh cover 7; the mesh cover 7 is blood-impermeable and fluidly isolates the LAA from the left atrium during use when the device is anchored to the LAA. A reclosable orifice is provided above the recessed port 5 in the form of a flap 8 and an associated hinged spring clamp 9, the associated hinged spring clamp 9 being configured to bias the flap to a closed position. The purpose of the reclosable orifice is to allow access from the left atrium to the recessed port when the modular active element is removed and replaced, and at other times to fluidly isolate the recessed port from the left atrium. Figure 1B In the diagram, the modular active element 12 is shown engaged within the recessed socket 5, and the delivery conduit 10 is shown adjacent to the nozzle of the recessed socket 5.

[0120] Figure 2A and Figure 2B An embodiment of a reclosable flap 8 formed on a mesh cover 7 is shown. The mesh cover 7 includes a plurality of valve leaflets 11, which are biased to... Figure 2A The closed orientation shown can be pushed inward when force is applied. Figure 2B The open configuration is shown. The valve material used for this leaflet can be the same material used in replacement heart valves (such as TAV1, for example, porcine epicardial tissue).

[0121] Figures 2C to 2F The operation of the valve is illustrated. Figure 2C In the diagram, the valve is shown in a closed configuration, thereby fluidly isolating the left atrium from the LAA and the recessed inlet 5. Figure 2D The image shows a delivery catheter 10 including a modular active element 12, the delivery catheter 10 protruding through a valve, wherein the valve leaflets are tightly conformed to the catheter sidewalls. Figure 2E In the middle, the modular active component 12 has been delivered to and engaged with the recessed socket 5; and in Figure 2F In the middle, catheter 10 has been withdrawn, thus allowing the valve to close.

[0122] Figure 3A Several different methods are shown, in which the modular active element 12 and the recessed socket 5 are detachably engaged, i.e., threaded engagement. Figure 3A The modular active element 12 and the inner wall of the recessed socket 5 have mating threads configured to allow the modular active element 12 to be screwed into the recessed socket; interference fit ( Figure 3B ), wherein element 12 has a distal end 12A, the distal end 12A being configured for radial expansion to frictionally engage with a conduit; anchoring deployment ( Figure 3C ), wherein the distal end 12A and proximal end 12B of element 12 have anchoring elements 14, the anchoring elements 14 being configured to extend radially outward at each end of the conduit 5 to provide engagement; balloon deployment ( Figure 3D ), wherein the distal end 12A of element 12 has an inflatable balloon 16; and is engaged with a spring ( Figure 3E and Figure 3F The distal end 5A of the recessed conduit 5 tapers inward, and the distal end of the modular active element has a circumferential slot 17, the size of which is set to engage the inwardly tapering end 5A of the recessed conduit.

[0123] Figure 4A , Figure 4B and Figure 4C An embodiment of the device of the present invention is shown, wherein the radially expandable element 3 includes a series of radially conductive elements 30, thereby providing electrical communication between the modular active element 12 (when engaged in the recessed socket 5) and the wall of the LAA. In this embodiment, the conductive elements are attached to the inside of the mesh cap and can be used as energy delivery elements to deliver ablation energy from the modular active element 12 to the wall of the LAA to electrically isolate the LAA. In another embodiment, the conductive elements 30 may be sensors configured to detect parameters of the wall of the LAA.

[0124] Figure 5 An embodiment of a radially expandable element is shown; wherein the circumferential periphery of the cage 3 has a double-layered mesh 29, the mesh 29 being configured to more easily engage the walls of the LAA circumferentially, and may include bristles, or be abrasive, or be incorporated into a unidirectional anchor.

[0125] Figure 6A An embodiment of the device of the present invention is shown, wherein the distal end of the modular active element 12 is incorporated with a magnet of a first polarity 22, and the periphery of the recessed socket 5 is incorporated with a magnet of a second polarity 24 to facilitate insertion of the element 12 into the recessed socket 5. Figure 6BAnother embodiment of the device of the present invention is shown, wherein the delivery conduit 10 has a magnetized head of a first polarity 26, and the periphery of the recessed socket 5 is incorporated with a magnet of a second polarity 27 to dock the conduit and the recessed socket during delivery of the modular active element 12. Figure 6C Another embodiment of the device of the present invention is shown, wherein the delivery conduit 10 has a magnetized head of a first polarity 26, and the periphery of the recessed socket 5 incorporates a magnet of a second polarity 27 to mate the conduit and the recessed socket during delivery of the modular active element 12. In this embodiment, the modular active element 12 disposed within the conduit 10 has a piercing tip configured to pierce the mesh cap 7.

[0126] Figures 7A-7C A modular active element for tissue ablation and a radially expandable RF electrode coil 32 are shown. The modular active element for tissue ablation forms part of the device of the present invention and has an inflatable balloon 31. The radially expandable RF electrode coil 32 is disposed distal to the RF electrode. In this embodiment, the device of the present invention includes a catheter 10, which remains attached to the modular active element 12 during use of the device. The catheter and the modular active element are configured to be withdrawn from the docking station and withdrawn from the patient's cavity. The modular active element is detachable from the catheter, can be replaced with another modular active element before being delivered intracavitarily to the left atrium, and can be re-engaged to the docking station and deployed via a recessed port. Figure 7A Modular active components in a partially deployed active configuration are shown, and Figure 7B A modular active element in a shrink delivery configuration is shown. Figure 7C A modular active element is shown deployed and anchored in a LAA, wherein an RF coil 32 is deployed within a cage 12 and contacts the LAA tissue for tissue ablation.

[0127] Figure 8A A modular active element 40 including a coaxially mounted inflatable balloon 41 is shown; Figure 8B For along Figure 8A The cross-sectional view taken by line 1-1 shows multiple independent lumens in element 40 for inflation and deflation of the balloon, for providing light, and for optical imaging. Figure 8C A modular active element including an inflatable balloon with different compartments configured to deliver different cryoablation treatments is shown. The ablation treatment can be regionally controlled or activated depending on the ablation application (i.e., distal and proximal facing areas).

[0128] Figure 9A modular active element 50 with two inflatable balloons 51, 52 is shown, which are attached within the LAA. In this embodiment, the first balloon 51 is configured to deliver cryotherapy to adjacent LAA tissue to ablate tissue at the treatment area 53; and the second balloon 52 is configured to receive warm fluid to heat tissue near the phrenic nerve to protect the nerve from ablation by cryotherapy of the adjacent treatment area 53.

[0129] Figure 10 An embodiment of a modular active element forming part of the device of the present invention is shown, wherein the proximal end of element 12 includes an extension 54 that can be gripped by a loop 55 to allow removal of the modular active element 12 from the recessed socket 5.

[0130] Figures 11A-11B An embodiment of a modular active element forming part of the apparatus of the present invention is shown, the modular active element being configured for delivery ( Figure 11A ) is located inside the delivery catheter 10, and in a deployment configuration ( Figure 11B The modular active element engages within the recessed socket 5 of docking station 2. The charging coil 55 is operatively connected to battery 56 and has distal and proximal anchoring arms 57 biased to extend outwards and anchor the element within the recessed socket as it exits the delivery conduit. The coil 55 is configured to receive power from an external source and relay data to a remote receiver.

[0131] Figures 12A to 12H An embodiment of the method of using the device of the present invention is shown. Figure 1 shows the device of the present invention with a delivery catheter 10A attached to the left atrium (LAA) near the left atrium of the human heart. Figure 12B The device is shown in a deployment configuration, wherein docking station 2 is anchored in the mouth of LAA and modular active element 62 engages within the recessed socket 5 of docking station. Figure 12C The catheter 10A is shown, which detaches from the docking station before contracting from the heart's cavity. Figure 12D An extraction conduit 10B with a magnetized head 26 having a proximal surface close to the docking station is shown; and Figure 12E A catheter is shown that engages with a docking station and protrudes through a reclosable valve in a cap, and a modular active element 62 retracts from the recessed port of the docking station into the withdrawable catheter. Figure 12F An extraction catheter 10B with in-situ modular active elements is shown, which is used for intracavitary extraction from the heart. Figure 12H A replacement catheter 10C is shown, comprising a replacement modular active element 63, which approaches the docking station and protrudes through the reclosable valve before being delivered into the empty recessed port 5, as shown. Figure 12H As shown.

[0132] equivalent

[0133] The foregoing description details the presently preferred embodiments of the invention. In taking this description into account, many modifications and variations in practice are expected to arise for those skilled in the art. These modifications and variations are intended to be covered by the appended claims.

Claims

1. A system for implantation in the left atrial appendage of the heart, comprising a device (1) for implantation in the left atrial appendage of the heart, said device (1) comprising: The docking station (2) includes a radially expandable element (3), a recessed port (5), and a closure (8). The radially expandable element (3) is adjustable between a contractile orientation suitable for intracavitary delivery and a deployment orientation configured to anchor within the left atrial appendage and fluidly isolate the left atrial appendage from the left atrium. The recessed port (5) is accessible from the left atrium through an opening, and the closure (8) covers the opening. and Modular active element (12), the modular active element (12) being configured for detachable engagement within the recessed socket of the docking station; The system includes a delivery catheter (10) for delivering a modular active element (12) into the recessed port (5) of the docking station (2). The recessed socket (5) extends completely through the docking station, thereby providing access to the occluded LAA when the docking station is deployed. The modular active element (12) is configured to be detachably connected to the delivery catheter (10), and the modular active element (12) includes a treatment device (30) or a sensing device.

2. The system according to claim 1, wherein, The modular active element (12) is configured to engage within the recessed socket, wherein a distal portion of the modular active element is disposed on the distal side of the recessed socket, and wherein the distal portion includes the sensing device.

3. The system according to claim 1, wherein, The modular active element (12) is configured to engage within the recessed port, the proximal portion of the modular active element extending into the left atrium, and wherein the proximal portion extending into the left atrium includes the sensing device.

4. The system according to claim 1, wherein the dimensions of the modular active element (12) are set to fit perfectly within the LAA.

5. The system of claim 1, wherein the treatment device or sensing device is configured to adjust between a contraction delivery configuration and an active deployment configuration.

6. The system of claim 1, wherein the treatment device or sensing device is radially expandable.

7. The system of claim 1, wherein the modular active element is a sensing element configured to detect a parameter selected from temperature, pressure, pH, electrical signal, heart rate, or respiratory rate.

8. The system of claim 1, wherein the modular active element is a therapeutic device configured to electrically stimulate the heart, ablate cardiac tissue, or deliver substances to the heart, cardiac wall, or blood flow.

9. The system of claim 8, wherein the treatment device comprises an electrode or an electrode array.

10. The system of claim 1, wherein at least one of the modular active element (12) and the docking station (2) includes a magnet or a magnetizable component (26) to guide the modular active element into the recessed socket.

11. The system of claim 1, wherein the docking station (2) and the modular active element (12) are configured for electrical connection when the modular active element is operatively engaged within the recessed socket (5).

12. The system of claim 1, wherein the docking station (2) is configured to provide an electrical connection between the modular active element (12) and surrounding tissue via the radially expandable element (3).

13. The system of claim 1, wherein the modular active element (12) is sized to engage within the recessed socket (5) to close the recessed socket.

14. The system of claim 1, wherein the recessed socket is configured for radial expansion when receiving a modular active element, wherein the modular active element optionally has a diameter larger than the diameter of the recessed socket, whereby insertion of the modular active element into the recessed socket subjectes the recessed socket to a tensile force, thereby forcing it to expand radially.

15. The system of claim 14, wherein the recessed socket is formed of an elastically deformable material, or is a tubular structure having adjacent but unconnected longitudinal sections that are longitudinally adjacent when the socket is not expanded, but separate when the socket expands.

16. The system of claim 1, wherein the closure of the recessed port includes a mesh cap (7) to fluidly isolate the left atrium from the LAA when the device is deployed in the LAA.

17. The system of claim 16, wherein the mesh cover (7) includes a self-closing hole.

18. The system of claim 1, wherein the closure comprises a puncture-resistant diaphragm or an inflatable valve.

19. The system of claim 1, wherein the closure is configured to promote epithelial cell proliferation.

20. The system according to claim 1, wherein the radially expandable element (3) is a radially expandable cage.

21. The system of claim 1, wherein the radially expandable element includes a proximal portion (4) having a generally annular shape and including an opening of the recessed socket, a cap (7) of the recessed socket, and a generally cylindrical distal portion (6).

22. The system of claim 1, wherein the modular active element and the recessed socket are configured to engage with each other when the modular active element is fully received in the recessed socket.

23. The system of claim 1, wherein the modular active element and the recessed socket are configured for screw-fit detachable engagement or interference-fit detachable engagement.

24. The system of claim 1, wherein the modular active element includes a radially expandable anchor configured to anchor the modular active element in the recessed socket upon engagement.

25. The system of claim 24, wherein the radially expandable anchor is configured to be deployed on the distal or proximal side of the recessed socket or the radially expandable element when the modular active element engages the recessed socket.

26. The system of claim 1, wherein the modular active element comprises an inductor.

27. The system of claim 26, wherein the inductor includes an inductor coil that is optionally adjustable between a contraction orientation suitable for in-cavity delivery and a radial deployment expansion orientation.

28. The system of claim 26 or 27, wherein the inductor coil is disposed on the distal end of the modular active element and configured for deployment on the distal side of the recessed socket.

29. The system of claim 1, wherein the modular active element includes a resonant power circuit configured with a plurality of coils adapted to provide a desired Q factor greater than or equal to 0.

5.

30. The system of claim 1, wherein the modular active element includes a capacitor, the capacitor being paired with an inductor to provide a first LC circuit.

31. The system of claim 1, wherein the modular active element comprises an RC circuit operatively connected to a DC regulator and adapted to provide a steady-state current to the circuit.

32. The system of claim 30, wherein the modular active element includes a second LC circuit located outside the modular active element, the modular active element being adapted to provide magnetic flux to power the LC circuit.

33. The system of claim 1, wherein the delivery catheter includes an internal element configured for detachable attachment to a proximal end of the modular active element and axial movement relative to the catheter.

34. The system of claim 33, wherein the internal element is configured to rotate the modular active element about the longitudinal axis of the conduit.

35. A component kit for implantation in the left atrial appendage of the heart, the component kit comprising the device according to any one of claims 1 to 34 and at least one replacement modular active element.

36. The component kit of claim 35, wherein the modular active element is a tissue ablation device, and the alternative modular active element is selected from a treatment device or a sensing device.

37. The component kit of claim 35 or 36, the component kit comprising a conduit having an outer portion and an inner portion, the outer portion being configured to abut a proximal surface of the radially expandable element surrounding an opening of the recessed socket, the inner portion being configured to engage a proximal end of the modular active element and optionally configured for axial movement into the recessed socket.

38. The component kit of claim 37, wherein the internal portion of the catheter has a piercing tip configured to pierce the cap covering the opening of the recessed insertion port.

Images