Device for occluding a body lumen

Abstract

Devices for occluding a body lumen, such as the left atrial appendage of a subject's heart, are described. The devices include an implantable occlusion device including a proximal connection hub and a radially expandable body configured to radially expand to fluidly occlude the left atrial appendage upon deployment from a collapsed configuration to a radially expanded configuration; an elongate deployment catheter having a central lumen; an elongate delivery catheter disposed in the central lumen of the elongate deployment catheter and having a distal connection hub detachably attached to the proximal connection hub of the implantable occlusion device for transluminal delivery of the implantable occlusion device to the left atrial appendage, wherein the elongate deployment catheter is axially movable proximally relative to the elongate delivery catheter to deploy the implantable occlusion device. The devices include an anchoring module including a circumferential array of anchoring arms configured to adjust from (a) a delivery configuration in which the array of anchoring arms is axially arranged and (b) a deployed configuration in which the anchoring arms splay radially outward to engage a wall of the left atrial appendage through an open section of a sidewall of the occlusion device.

Description

Technical Field

[0001] This invention relates to devices for occluding body cavities, specifically the left atrial appendage (LAA) of the heart. The invention also relates to methods for occluding body cavities such as the left atrial appendage of the heart. Background Technology

[0002] Atrial fibrillation (AF) is a common heart rhythm disorder affecting approximately 6 million people in the United States alone. In the US, AF is the second leading cause of stroke and accounts for nearly one-third of strokes in older adults. As our population continues to age, this problem is likely to become even more prevalent. In over 90% of cases—where blood clots (thrombi) are present in AF patients—clots develop in the left atrial appendage (LAA) of the heart. Because blood clots when it stops flowing, the irregular heartbeats of AF cause blood to pool in the LAA, where clots or thrombi can form. These clots can break off from the LAA and may enter the cerebral circulation causing a stroke, the coronary circulation causing a myocardial infarction, the peripheral circulation causing limb ischemia, or other vascular beds. The LAA is a muscular pouch attached to the left atrium. Mechanical occlusion of the LAA can reduce the incidence of stroke in AF patients, and there is growing interest in surgical and endovascular methods for removing isolated LAAs.

[0003] Anticoagulants can be used to prevent stroke in patients diagnosed with atrial fibrillation (AF). However, many people cannot take these medications due to potential side effects. Drug therapy can also cause bleeding and can be difficult to control because determining the dosage is challenging. Recent studies have shown that eliminating the left atrial fibrillation artery (LAA) by occlusion or closure can prevent thrombus formation in the LAA, thereby reducing the incidence of stroke in patients diagnosed with AF. Therefore, occlusion or closure of the LAA can significantly reduce the incidence of stroke in patients with atrial fibrillation without the complications associated with drug therapy.

[0004] Devices for occlusion of the left atrial appendage (LAA) are described, for example, in EP3606448, EP3606447, US2015 / 0196300, and WO2013 / 067118. The devices include a delivery catheter and a radially deployable, expandable occlusion device detachably attached to the occlusion device. The device is advanced via a vascular system to position the occlusion device within the LAA, which is then deployed to circumferentially engage the wall of the LAA and fluidly occlude it. Tissue mapping and ablation electrodes attached to the deployed occlusion device can then be used to treat the wall of the LAA to electrically isolate the LAA, thereby treating atrial fibrillation.

[0005] LAA occlusion devices generally include anchoring elements that are deployed together with the radially expandable occlusion device as part of the occlusion device. In the devices of US2015 / 0196300 and WO2013 / 067118, the anchoring elements include barbs attached to the distal end of the expandable cage. When the cage is deployed and engaged with the wall of the LAA, the barbs engage the wall simultaneously with the cage, thereby securing the cage to the wall. Furthermore, the barbs engage the wall of the LAA distal to the cage, thus located distal to the portion of the LAA wall that is ablated during treatment.

[0006] US2018 / 0250014 describes an apparatus for occluding a body cavity, comprising a tubular foam body and a compliant cage disposed within the tubular foam body. In one embodiment, the compliant cage includes anchoring barbs that extend through the tubular foam body after deployment. The barbs are connected together and deployed together with the cage frame as they form part of the cage frame.

[0007] The purpose of this invention is to at least overcome the above-mentioned problems. Summary of the Invention

[0008] The applicant recognized that prior art devices in which anchoring elements are connected together as part of a radially deployable cage structure are undesirable for anchoring in non-uniform structures such as the left atrial appendage (LAA). This is because the anchoring elements are deployed with the cage and, after deployment, arranged in a predetermined (generally uniform) shape along the circumference of the cage. The applicant solved this problem by providing a circumferential array of anchoring arms that are connected to and extend distally from a proximal hub of the occlusion device, wherein the arms are configured in a delivery configuration that is generally axially arranged from the array of anchoring arms and in a deployment configuration that allows the anchoring arms to radially open outward to engage the walls of the left atrial appendage through openings in the sidewalls of the occlusion device, and are pivotally self-adjusting. Because the arms can be deployed independently of each other (and are generally not connected to the radially expandable body), this design allows the arms to engage LAAs with non-uniform shapes, wherein the arms radially open outward independently of each other to accommodate non-uniform LAA anatomy (e.g., self-adjusting). This applies to LAA anatomy that includes wall indentations, in which the body can be radially expanded to engage the indented segments of the wall without joining the wall, but the array of arms is self-adjusting to circumferentially engage the wall of the LAA including the indented segments.

[0009] Furthermore, the applicant recognized the advantage of being able to deploy the occlusion device partially to engage the wall of the LAA while the anchoring barbs are not fully deployed and not yet engaged with the tissue. This allows the user to partially deploy the occlusion device to engage the wall of the LAA, check the positioning, and reposition the device (or perform initial treatment steps) if necessary, before fully deploying the device so that the anchoring barbs engage the tissue. This is achieved by providing a device that separates the anchoring module from the radially expandable occlusion body, thereby allowing individual control of the deployment of each component. In one embodiment, the device is configured to be deployed in at least two steps: a first partial deployment step, in which the occlusion device expands radially to engage the tissue and the anchoring arms are not fully deployed; and a second deployment step, in which the anchoring arms are fully deployed to engage the tissue and anchor the occlusion device. In one embodiment of the device described herein, the occlusion device has a proximal hub portion and a radially expandable portion, and anchoring arms are attached to and extend distally from the proximal hub and are movable independently of the radially expandable portion, thereby providing the flexibility to allow the radially expandable portion (e.g., a mesh cage) to engage with tissue before the anchoring barbs are fully deployed. Delayed deployment of the anchoring arms can be achieved by shaping the arms, specifically the proximal ends, to cooperate with the occlusion device during deployment such that they are only fully deployed when the occlusion device is nearly or fully deployed. Other methods for delaying the deployment of the anchoring arms relative to the deployment of the radially expandable portion are described herein.

[0010] In a first aspect, the present invention relates to a device for occluding a body cavity such as the left atrial appendage of the heart, comprising:

[0011] An implantable occlusion device is configured to expand radially upon deployment from a contractile configuration to a radially expanding configuration, thereby fluidly occluding the left atrial appendage;

[0012] A slender delivery catheter with a distal connection hub that can be attached to an implantable occlusion device for transcavitary delivery of the implantable occlusion device to the left atrial appendage;

[0013] The device is characterized by comprising an anchoring module, the anchoring module including a circumferential array of anchoring arms, the circumferential array of anchoring arms being configured to be adjustable from (a) and (b):

[0014] (a) The delivery configuration of the array of anchor arms, which is generally axially arranged, and

[0015] (b) A deployment configuration in which the anchoring arm is radially outwardly extended to engage the wall of the left atrial appendage through an opening in the sidewall of the sealing device.

[0016] This device of the present invention can also be used to capture emboli in the bloodstream. In such embodiments, the occlusion device can be replaced by an embolus capture device designed to filter blood and capture and retain emboli that pass through the bloodstream. The embolus capture device can be a cage with a mesh size, configured to allow blood to pass through but retain emboli of a defined minimum size. The embolus capture device can also be configured to fluidly occlude blood vessels.

[0017] In another aspect, the present invention relates to a device for capturing emboli in a blood vessel, comprising:

[0018] An implantable embolic capture device is configured to expand radially when deployed from a contraction configuration to a radial expansion configuration;

[0019] A slender delivery catheter with a distal connecting hub that can be attached to an implantable embolic capture device for transluminal delivery of the device to a target blood vessel.

[0020] The device is characterized by comprising an anchoring module, the anchoring module including a circumferential array of anchoring arms, the circumferential array of anchoring arms being configured to be adjustable from (a) and (b):

[0021] (a) The delivery configuration of the array of anchor arms, which is generally axially arranged, and

[0022] (b) Deployment configuration in which the anchoring arm is radially outward to engage the wall of the blood vessel through the sidewall of the implantable embolism capture device.

[0023] In any embodiment, the device includes an elongated deployment catheter having a central lumen, wherein an elongated delivery catheter is disposed within the central lumen of the elongated deployment catheter, wherein the elongated deployment catheter is axially movable proximally relative to the elongated delivery catheter to deploy an implantable occlusion device or an implantable embolus capture device.

[0024] In any embodiment, the implantable occlusion device or implantable embolic capture device includes a proximal connecting hub and a radially expandable body configured to expand radially as deployed from a contraction configuration to a radially expandable configuration.

[0025] In any implementation, the anchoring arm can move independently of (e.g., not attached to) the radially expandable body.

[0026] In any implementation, the anchoring arm is attached to the proximal connecting hub and extends distally therefrom.

[0027] In any implementation, the anchor arms can be adjusted from the delivery configuration to the deployment configuration independently of each other.

[0028] In any implementation, the anchoring arms are configured to pivot radially outward about their proximal ends during deployment.

[0029] In any implementation, the anchoring arm can self-adjust from the delivery configuration to the deployment configuration.

[0030] Each anchoring arm generally has a proximal end that connects to the connecting hub. This connection generally allows the arms to hinge from an axial configuration to a radially outward angled configuration. The anchoring arms are generally movable independently of each other, allowing some arms to be angled outward more than others. This enables the arms of the anchoring module to adapt to the anatomy of the body cavity to which the device is positioned.

[0031] In any implementation, the anchoring arm is directly connected to the proximal hub of the plugging device or the embolism capture device.

[0032] In another embodiment, the anchoring arm is indirectly connected to the proximal hub. The anchoring module may include an anchoring module hub configured to be detachably attached to the proximal hub of the occlusion body. The anchoring module is axially movable relative to the occlusion device or capture device. This embodiment allows the occlusion device / capture device and the anchoring module to be delivered to the target location separately, and also allows for recapture and retraction of the anchoring module before the occlusion device / capture device is withdrawn.

[0033] In any embodiment, the anchoring module hub includes a proximal cover element configured to abut a proximal side of the radially expandable body when the anchoring module hub is attached to a proximal hub of the plugging device or capture device. In any embodiment, the proximal side of the radially expandable body is concave, and the proximal hub is disposed in a distally recessed portion of the proximal side. In any embodiment, the proximal cover element may be configured to fluidly seal the proximal side of the radially expandable body. In any embodiment, the proximal cover element may be configured to fluidly plug the proximal hub when the anchoring module hub and the proximal hub are attached together. The proximal cover is generally a planar element. The proximal cover may be formed of a liquid-impermeable material. The proximal cover may be attached to the distal periphery of the anchoring module hub and extend radially outward from the anchoring module hub. An anchoring module including the anchoring module hub and the proximal cover element... Figure 9 It is displayed in the middle.

[0034] In any embodiment, the device is configured to be adjusted to a partial deployment configuration in which the anchoring arm engages the wall of the body cavity from the side wall of the occlusion device or the capture device, while the anchoring arm does not engage with the wall of the body cavity, and to a full deployment configuration in which the anchoring arm engages with the wall of the body cavity to anchor the occlusion device or the capture device in the body cavity.

[0035] In any embodiment, one or more, and generally all, anchoring arms have a proximal segment and a distal segment, wherein the proximal segment has a bend region (e.g., a shoulder) configured to engage with the proximal end of the radially expandable body during deployment to deploy the device in a partially deployed configuration, and subsequently in a fully deployed configuration. This allows the radially expandable element to be deployed to engage the wall of the body cavity, after which the anchoring arm engages the wall.

[0036] In any embodiment, the bending region of the arm includes an S-shaped section having a proximal inward bending portion and a distal outward bending portion.

[0037] In any implementation, the anchoring module is configured to self-deploy when an implantable blocking or capture device is deployed.

[0038] In any implementation, each anchoring arm in the deployment configuration extends radially outward at an angle of 30-80° to the central axis of the implantable occlusion or capture device.

[0039] In any implementation, the axial length of the anchoring arm is less than 70% of the axial length of the cage.

[0040] In any embodiment, the axial length of the anchor arm is 70% to 130% of the axial length of the cage.

[0041] In any implementation, the radially expandable body includes a wire mesh cage.

[0042] In any embodiment, the sidewall of the cage has a proximal portion, a distal portion, and a middle portion, wherein the mesh size of the middle portion is larger than the mesh size of the distal or proximal portion.

[0043] In any embodiment, the middle portion of the cage includes one or more supports that project radially outward from the sidewalls of the cage.

[0044] In any embodiment, one or more pillars projecting radially outward from the sidewall of the mesh cage include tissue therapy electrodes.

[0045] In any embodiment, the proximal end of the blocking or capturing device has a recessed base, and the proximal connecting hub is disposed in the recessed base.

[0046] In any implementation, the distal end of one or more of the anchoring arms includes an anchoring barb configured to engage the tissue.

[0047] In any implementation, the anchor barb bends radially outward.

[0048] In any implementation, the anchoring barb bends radially outward and proximally.

[0049] In any embodiment, the anchoring barb has a distal section extending proximally parallel to the longitudinal axis of the plugging device.

[0050] In any embodiment, the anchoring barb includes two or more forked portions, and in one embodiment it is forked.

[0051] In any implementation, the anchor barb fork provides a distal barb portion and a proximal barb portion.

[0052] In any implementation, the anchor barb is laterally forked.

[0053] In any embodiment, the bifurcation of the anchoring barb is angled in the axial direction to enhance the barb's ability to engage with the wall of the body cavity (e.g., the LAA oral wall).

[0054] In any implementation, the anchoring barb includes an anti-slip material or coating. This can be an anti-slip micron or nanostructured material to enhance resistance to migration while minimizing tissue damage.

[0055] In any implementation, the anchoring barb includes a contrast agent to enhance visualization during imaging, such as fluorescence imaging.

[0056] In any embodiment, one or more of the anchoring barbs are coated with a pharmaceutically active agent.

[0057] In any embodiment, one or more of the anchoring barbs include tissue parameter sensors. The sensors can detect any tissue parameter, such as temperature, blood flow, pH, or electrical activity.

[0058] In any embodiment, one or more of the anchoring arms may include lumens for delivering fluid to the wall of the LAA. The delivery catheter may include lumens for delivering fluid to the anchoring arms, and the lumens may be configured to be fluidly connected to one or more anchoring arms having lumens. The fluid may be a therapeutic agent or a diagnostic reagent; examples include drugs, contrast agents, or alcohol for tissue ablation.

[0059] In any embodiment, at least one of the anchor arms has a distal section that bends at the middle of its end such that when the anchor arm is deployed, the inner section is angled radially outward and the outer section extends parallel to the longitudinal axis of the plugging device.

[0060] In any implementation, the anchoring module is configured to move axially from a position remote from the occlusion device to a position within the occlusion device relative to the occlusion device.

[0061] In any embodiment, the sealing device includes a central proximal hub with a hollow cavity and a radially expandable body connected to the central proximal hub, wherein an axially movable anchoring module is configured to move axially through the central cavity of the central proximal hub.

[0062] In any embodiment, the device includes a tissue treatment or diagnostic module. The tissue treatment module may be configured to electrotherapy the tissue via cryotherapy, microwave therapy, or RF energy therapy. The tissue diagnostic module may be configured to map the electrical activity of body cavities or adjacent structures.

[0063] In any implementation, the treatment module includes an electrode. This electrode may be composed of carbon-based materials, graphite, graphene, or carbon nanostructures to enhance structural and operational functionality.

[0064] In any implementation, the treatment module includes an array of electrodes.

[0065] In any implementation, the treatment module includes a circumferential array of electrodes.

[0066] In any implementation, the treatment module includes a circumferential array of electrodes attached to and deployable with the occlusion device.

[0067] In any embodiment, the device includes a handle, which includes an actuation device for deploying the plugging equipment and the anchoring module.

[0068] In any implementation, the actuation device of the handle is configured to control the deployment of the anchoring module independently of the deployment of the blocking device.

[0069] In any implementation, the actuation device of the handle is configured to suspend the deployment of the anchoring module in a partially deployed configuration when the blocking device (e.g., a radially expandable body) is fully or nearly fully deployed.

[0070] In another aspect, the present invention provides a method for fluidly sealing a body cavity, comprising the following steps:

[0071] An apparatus according to the invention is provided, wherein the occlusion device and the delivery conduit are disposed within a deployment conduit;

[0072] The device of the present invention is propelled into the body cavity until the distal end of the device is positioned within the body cavity;

[0073] The device is deployed by retracting the deployment conduit relative to the delivery conduit, thereby deploying the occlusion device and anchoring arm;

[0074] Disconnect the delivery catheter from the occlusion device; and

[0075] The delivery and deployment catheters are retracted, leaving the occlusion device implanted within the body cavity.

[0076] In any implementation, the deployment steps include:

[0077] The first deployment step includes partially deploying the occlusion device within the body cavity such that the sidewalls of the occlusion device engage the body cavity but are not fully deployed, and the anchoring arm is partially deployed without engaging the body cavity; and

[0078] The second deployment step includes fully deploying the occlusion device to engage with the body cavity and fully deploying the anchoring arms to engage with the body cavity.

[0079] In any implementation, the method includes the step of treating tissue with an occlusion device after the first deployment step and before the second deployment step.

[0080] In any implementation, the treatment step includes ablating tissue in the body cavity using a tissue ablation element attached to the occlusion device.

[0081] In any implementation, the method includes the step of repositioning the occlusion device in the body cavity between the first deployment step and the second deployment step.

[0082] In any implementation, the step of repositioning the occlusion device within the body cavity includes recapturing the occlusion device and adjusting the position of the recapturing occlusion device as it is recapturing.

[0083] In any implementation, the deployment step includes imaging the occlusion device within the body cavity.

[0084] In any implementation, the occlusion device is deployed at least 80% during partial deployment, while the anchoring arm does not engage with the tissue in the body cavity.

[0085] In another aspect, the present invention provides a method for capturing emboli in blood vessels, comprising the following steps:

[0086] An apparatus according to the invention is provided, wherein an embolus capture device and a delivery catheter are disposed within a deployment catheter;

[0087] The device of the present invention is propelled cavitarily until it is positioned in a blood vessel;

[0088] The device is deployed by retracting the deployment catheter relative to the delivery catheter to deploy the embolus capture device and anchoring arm;

[0089] Disconnect the delivery catheter from the embolus capture device; and

[0090] The delivery and deployment catheters are retracted, thus leaving the embolus capture device implanted within the body cavity.

[0091] In any implementation, the deployment steps include:

[0092] The first deployment step includes partially deploying the embolism capture device in the blood vessel such that the sidewalls of the embolism capture device engage with the blood vessel but are not fully deployed, and the anchoring arm is partially deployed without contacting the blood vessel; and

[0093] The second deployment step includes fully deploying the embolism capture device to engage with the blood vessel and fully deploying the anchoring arms to engage with the blood vessel.

[0094] In any implementation, the method includes the step of repositioning the embolus capture device in a blood vessel between a first deployment step and a second deployment step.

[0095] In any embodiment, the step of repositioning the embolism capture device within the blood vessel includes recapturing the embolism capture device and adjusting the position of the recaptured embolism capture device as it is recaptured.

[0096] In any implementation, the deployment step includes imaging the embolus capture device within the blood vessel.

[0097] In any implementation, the embolus capture device is deployed at least 80% during partial deployment, while the anchoring arm does not engage with the tissue of the blood vessel.

[0098] In any implementation, the method includes recapturing the anchoring module and the embolus capture device, as well as retracting the recapturing means to remove the embolus captured within the embolus capture device. Attached Figure Description

[0099] Figure 1A This is a perspective view of a sealing device forming part of an apparatus according to the invention, showing the sealing device in a fully deployed configuration, wherein the end of the anchoring arm protrudes through a hole in the sidewall of the sealing device. For clarity, the sealing device is shown but the delivery or deployment conduit is not shown.

[0100] Figure 1B Figure 1 is a cross-sectional view of the occlusion device, showing the proximal hub of the occlusion device and a radially expandable (e.g., a mesh cage) and an anchoring arm attached to the proximal hub and opening outward at an angle of approximately 45 degrees to the longitudinal axis of the device in a fully deployed configuration.

[0101] Figure 2A and Figure 2B yes Figure 1B A detailed view of the device shows the proximal connecting hub of the occlusion device, the proximal end of the radially expandable cage connected to the connecting hub, and two of the anchoring arms in a fully deployed configuration. This figure illustrates how the bends (e.g., shoulders) at the proximal ends of the anchoring arms mate with the proximal ends of the radially expandable cage to delay the full deployment of the anchoring arms until the proximal ends of the cage have been deployed, thereby ensuring that the radially expandable cage can be fully or nearly fully deployed before the anchoring arms are fully deployed.

[0102] Figures 3A to 3C An example of the device of the present invention being deployed in the left atrial appendage of the heart is shown, illustrating an occlusion device, a delivery catheter (dashed line) attached to the occlusion device, and an external deployment catheter retracted relative to the occlusion device and anchoring arm for deployment of the occlusion device and anchoring arm. Figure 3A The initial stage of deployment is shown, in which the anchoring arm and the sealing device are partially deployed, with the arm inside the sealing device and the sealing device not in contact with the wall of the LAA. Figure 3B The partial deployment of the device is shown, in which the plugging device has been further deployed to engage the sidewall of the LAA, and the anchoring arm has been further deployed but not fully deployed and remains within the plugging device. Figure 3C The complete deployment of the device is shown, with the plugging device and anchoring arm fully deployed through holes in the sidewall of the plugging device to contact the wall of the LAA. Figure 3C In the middle, the device is anchored in the LAA.

[0103] Figures 4A to 4C This is a further example of a device being deployed according to the invention, specifically demonstrating the self-deployment of the occlusion device and anchoring module through the phased retraction of the deployment conduit. Figure 4A The device shows a plugging device and an anchoring module in a delivery configuration housed within a deployment conduit, with the anchoring arm of the anchoring module in an axially bundled configuration. Figure 4B The diagram shows the device in the first phase of partial deployment, where the outer deployment conduit has been partially retracted to expose the distal and central sections of the radially expandable body. As can be seen from this figure, at this deployment stage, the radially expandable body has not yet expanded to its full width, and the anchoring arms are constrained into an axially bundled configuration. Figure 4C The example device is in the second stage of partial deployment, where the deployment conduit has been further retracted (approximately 90%), exposing most of the radially expandable body. In this stage, the mouth of the deployment conduit contacts the bend in each anchoring arm, thus maintaining the arms in an axially bundled configuration. Further retraction of the deployment conduit in this stage would allow the arms to be deployed radially outward.

[0104] Figures 5A to 5C This is an example of a further deployment of the device in Figure 4, where the radially expandable body has been removed to more clearly illustrate how the anchoring arm responds to the deployment of the conduit from... Figure 4C The location shown is retracted and deployed. In Figure 5A (is with) Figure 4C In the same deployment phase shown, the bend in the arm contacts the orifice of the deployment conduit, thereby keeping the arm in an axially bundled configuration. Figure 5BThis demonstrates how further retraction of the deployment catheter allows the arm to begin radially outward deployment, where deployment is controlled by the engagement between the arm's bend area and the orifice of the deployment catheter. Figure 5C During this process, further retraction of the deployment catheter completely exposes the bend area of ​​the arm outside the mouth of the deployment catheter (proud), thereby allowing the arm to fully self-deploy into contact with the tissue.

[0105] Figure 6 This is an elevation view of an apparatus according to an alternative embodiment of the invention, showing an optional design of an anchoring barb at the distal end of the anchoring arm.

[0106] Figure 7 This is an elevation view of an apparatus according to an alternative embodiment of the invention, showing an optional design of an anchoring barb at the distal end of the anchoring arm.

[0107] Figure 8 This is an elevation view of an apparatus according to an alternative embodiment of the invention, showing an optional design of an anchoring barb at the distal end of the anchoring arm.

[0108] Figure 9 It is a side elevation view of an axially movable anchoring module engaged with a sealing device, with the anchoring arm deployed simultaneously, showing the anchoring module hub engaging the proximal hub of the sealing device and the proximal cover element adjacent to the proximal side of the radially expandable body. Detailed Implementation

[0109] All publications, patents, patent applications and other references mentioned herein are incorporated herein by reference in their entirety for all purposes, just as each individual publication, patent or patent application is specifically and individually indicated to be incorporated by reference and its contents fully described.

[0110] Definitions and general settings

[0111] As used herein, and unless otherwise specifically stated, the following terms are intended to have the following meanings, in addition to any broader (or narrower) meaning that may be enjoyed in the art:

[0112] Unless the context otherwise requires, the use of the singular in this document shall be understood to include the plural, and vice versa. The terms “a” or “an” used in relation to entities shall be understood to refer to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably in this document.

[0113] As used herein, the term "comprise" or its variations such as "comprises" or "comprising" should be understood to indicate that any stated integer (e.g., feature, element, characteristic, property, method / process step, or limitation) or group of integers (e.g., feature, element, characteristic, property, method / process step, or limitation) is included, but does not exclude any other integers or groups of integers. Therefore, as used herein, the term "comprise" is inclusive or open-ended and does not exclude additional, unstated integers or method / process steps.

[0114] 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, illness, abnormality, pathology, symptom, condition, or syndrome that impairs physiological function, regardless of the nature of the cause (or whether an etiological basis for the disease has actually been established). Therefore, it covers conditions caused by infection, trauma, injury, surgery, radiation ablation, age, poisoning, or nutritional deficiencies.

[0115] As used herein, the term "treatment" refers to an intervention (e.g., administration of a drug to a subject) that cures, improves, or alleviates the symptoms of a disease or eliminates its cause (one or more) (e.g., an increase in tight junction protein levels) (or mitigates its effects). In this context, the term is used synonymously with the term "therapy".

[0116] Furthermore, the term "treatment" refers to an intervention (e.g., administering an agent to a subject) that prevents or delays the onset or progression of a disease or reduces (or eradicates) its incidence in the treated population. In this context, the term "treatment" is used synonymously with the term "prevention."

[0117] As used herein, an effective or therapeutically effective dose defines an amount that can be administered to a subject without excessive toxicity, irritation, allergic reactions, or other problems or complications, commensurate with a reasonable benefit / risk ratio, but sufficient to provide the desired effect (e.g., treatment or prevention manifested by permanent or temporary improvement in the subject's condition). This dose will vary from subject to subject, depending on the individual's age and general condition, method of administration, and other factors. Therefore, while an exact effective dose cannot be specified, those skilled in the art will be able to determine an appropriate "effective" dose in any individual case using routine testing and general background knowledge. In this context, treatment outcomes include eradication or relief of symptoms, reduction of pain or discomfort, prolonged survival, improved motor function, and other markers of clinical improvement. Treatment outcomes need not be a complete cure. Improvements may be observed in terms of bio / molecular markers, clinical or observational improvements. In a preferred embodiment, the method of the present invention is applicable to humans, large racing animals (horses, camels, dogs), and domestic companion animals (cats and dogs).

[0118] In the context of treatment and effective dosage as defined above, the term "object" (which, where circumstances permit, should be understood to include "individual," "animal," "patient," or "mammal") defines any object referred to in the treatment, particularly a mammalian object. Mammal objects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sporting animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, camels, bison, cattle, and dairy cows; 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; food animals such as dairy cows, 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. As used herein, the term "horse" refers to equine mammals, including horses, donkeys, asses, kiangs, and zebras.

[0119] "Implantable occlusion device" means a device configured for implantation in a body cavity, specifically implanted in the heart at least partially or completely within the left atrial appendage, and which, upon actuation / deployment, at least partially or completely fluidly occludes the body cavity. The occlusion device is generally detachably connected to a delivery catheter that delivers the occlusion device to the target site and typically remains attached during occlusion, sensing, and energy delivery therapy, and in one embodiment, is typically detached and removed from the body after energy delivery therapy, leaving the occlusion device implanted in the body cavity. The occlusion device generally includes a central proximal connecting hub for attachment to the delivery catheter and a radially expandable body. Occlusion can be complete occlusion (closure) or partial occlusion (narrowing or near-complete occlusion) of the body cavity. The occlusion device generally includes a body that can expand from a contractile delivery configuration to an expanded deployment configuration. The body can take various forms, such as a wire frame structure formed of woven or mesh materials (e.g., a mesh cage). Examples of expandable wire frame structures suitable for transcavitary delivery are known in the literature and described, for example, in WO01 / 87168, US6652548, US2004 / 219028, US6454775, US4909789, US5573530, and WO2013 / 109756. Other forms of bodies suitable for the present invention include scaffolds or stents. In one embodiment, the body is formed of a metal, such as a shape memory metal like nitinol. The body may have any shape suitable for the purposes of the present invention, such as cylindrical, disc-shaped, or spherical. In a preferred embodiment, the device includes a cylindrical body, such as a cylindrical cage body. In one embodiment, the body includes a module for supplying energy to the tissue. In one embodiment, the ablation device includes an array of electrodes, generally a circumferential array. In one embodiment, the array of electrodes is configured to deliver a pulsed field ablation to the tissue. In one embodiment, the distal side of the radially expandable body includes a covering configured to promote epithelial cell proliferation. In one embodiment, the body includes a stepped radial force stiffness profile from distal to proximal. In one embodiment, the body includes a metal mesh cage support. In one embodiment, a coupler (e.g., a connecting hub) between the body and the catheter assembly is located distally on the left atrial side of the body. In one embodiment, the radial diameter of the body in the deployment configuration is at least 10% larger than the radial diameter at the left atrial appendage deployment point. In one embodiment, the distal portion is configured to be non-invasive to cardiac tissue. In one embodiment, the body includes a braided mesh support, which, in one embodiment, facilitates collagen infiltration during heat delivery, thereby promoting increased anti-migration properties. Examples of implantable occlusion devices for body cavities, specifically LAAs, are described in WO2018 / 185256, WO2018 / 185255, and WO2020 / 074738.

[0120] "Body cavity" refers to a cavity in the body, and can be a long and narrow cavity such as a vessel (i.e., artery, vein, lymphatic vessel, urethra, ureter, sinus, ear canal, nasal cavity, bronchus) or a ring-shaped space in the heart such as the left atrial appendage, left ventricular outflow tract, aortic valve, mitral valve, mitral valve continuity, or a heart valve or valve opening.

[0121] A “thrombus capture device” (or “capture device”) refers to a body configured to radially expand from a contractile delivery configuration to a deployed radially expanded configuration suitable for implantation in a blood vessel. The device is configured to filter blood and capture emboli in the blood. The device generally comprises a radially expandable body configured for deployment in a blood vessel to filter blood and typically includes a proximal hub. The radially expandable body can take various forms, such as a wire frame structure (e.g., a mesh cage) formed of braided or mesh material. The device can be configured for deployment in the inferior vena cava. Other forms of bodies suitable for the present invention include plate-like or disc-shaped stents. In one embodiment, the body is formed of a metal, such as a shape memory metal like nitinol. The body can have any shape suitable for the purposes of the present invention, such as cylindrical, disc-shaped, or spherical. In a preferred embodiment, the device comprises a cylindrical body, such as a cylindrical cage body. The cage can have an open distal end, an open proximal end, or a closed distal and proximal end. Examples of embolic capture devices include the SENTRY Bioconvertible Inferior Vana Cava (IVC) filter from Boston Scientific, the CELECT Platinum Vena Cava filter from Cook Medical, and the DENALI Vena Cava filter from Beckton Dickinson.

[0122] "Removably attached" means that the device is configured such that the occlusion or capture device is attached to an elongated delivery catheter during delivery and can be released after deployment and treatment, thereby implanting the device in the heart and retracting the elongated delivery catheter, leaving the device in place. Generally, the device includes a control mechanism for remotely separating the device or radially expandable element from the elongated catheter assembly. Typically, an actuation switch for the control mechanism is located on a control handle.

[0123] "Transcaval delivery" means delivering an occlusion device or capture device through a body cavity, such as via an artery or vein, to a target site (e.g., the heart). 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 at least partially within the left atrium (LAA). In one embodiment, the device is delivered such that a distal portion is disposed within the LAA and a proximal portion is disposed within the left atrium just outside the LAA. In one embodiment, the device is delivered such that a distal portion is disposed within the LAA and a proximal portion is disposed within the left atrium adjacent to the opening of the LAA. In one embodiment, the device is delivered such that both the distal and proximal portions are disposed within the LAA.

[0124] "Anchoring module" refers to an anchoring arm, and preferably an array of anchoring arms, which can be deployed to anchor an occlusion device or capture device within a body cavity. The anchoring arms may be made of a shape memory material such as nitinol. The anchoring arms are generally adjustable (e.g., pivotally adjustable about their proximal ends) from an axial position before deployment (where the anchoring arms are generally bundled together along or near the longitudinal axis of the device) to an outwardly flared configuration. When fully deployed, the distal ends of at least some of the anchoring arms generally extend through holes in a radially expandable body to engage tissue. The anchoring arms are generally biased to an outwardly flared configuration and deployed via a release restraint member such as a deployment conduit. This is also referred to herein as self-deployment. In some embodiments described herein, the anchoring arms are attached to a proximal hub of the occlusion or capture device. The anchoring module is generally not radially movable relative to the radially expandable body. In another embodiment, the anchoring module is movable relative to the occlusion or capture device. For example, an anchoring module may be attached to an anchoring catheter and is axially movable through a cavity in a proximal connecting hub (e.g., a delivery catheter) to deliver the anchoring module into a radially expandable body. The anchoring module may include an anchoring module hub. The proximal connecting hub and the hub of the anchoring module may be configured for detachable attachment, thereby providing anchoring arms within the radially expandable body for deployment therewith. The anchoring module may include at least two, three, four, five, or six anchoring arms. In any embodiment, one or more of the anchoring arms include a tissue therapeutic element such as a tissue ablation electrode.

[0125] A “knock zone” refers to a portion of the proximal section of the anchoring arm, shaped to engage with the proximal end of the radially expandable body during deployment to delay full deployment of the anchoring arm until the proximal end of the radially expandable body is deployed beyond the deployment conduit. It generally comprises a radially outward-curving shoulder. It may include a radially outward-curving proximal knock zone and a radially inward-curving distal knock zone (e.g., an S-shaped section). Optionally, the proximal portion of the arm may be curved at the midpoint of its end.

[0126] “Cover”: Generally, implantable occlusion devices have a proximal cover that is impermeable to blood and may include a reclosable orifice, such as an overlapping flap material. The reclosable orifice may be configured to allow the distal end of the catheter to pass through it while preventing blood flow through the orifice. The occlusion device may include a connecting hub distal to the cover and configured to couple with the distal end of the catheter. The cover may be configured to act as a scaffold for in vivo endothelialization. The cover may be formed of a woven mesh material.

[0127] "A covering configured to act as a scaffold for in vivo endothelialization" means that the material used promotes endothelialization of the distal or proximal host. In one embodiment, the covering is a membrane containing 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, serosum, peritoneum, and basement membrane tissue. In one embodiment, the covering is porous. In one embodiment, the covering is a biocompatible scaffold formed from biological materials. In one embodiment, the covering is a porous scaffold formed from biological materials such as collagen. In one embodiment, the covering is a lyophilized scaffold.

[0128] The device of the present invention may include a module for supplying energy to tissue. As used herein, a “module for supplying energy to tissue” refers to an array of tissue therapeutic elements configured to treat tissue by applying, for example, thermal, cold, acoustic, optical, microwave, or RF energy. These elements may be electrodes. Electrodes disposed on an implantable occlusion device are configured to be electrically coupled to an electrical controller. The electrodes are generally individually coupled to the controller to allow for electrode-specific energy supply. The array of electrodes is generally arranged circumferentially on the implantable device and is configured to contact the walls of the body cavity in a circumferential manner when the device is deployed. The electrodes are configured to deliver energy circumferentially around the walls of the body cavity, typically a PFA. The electrodes may also serve as sensors to detect electrical parameters of the body cavity wall tissue, such as impedance or electrical activity (voltage), or electrical mapping of the LAA or heart. The electrodes may be configured to measure electrical parameters radially across the body cavity wall or circumferentially along a segment of the body cavity wall circumferentially. In general, radial measurements of electrical parameters such as impedance across the body cavity walls use electrodes in an array of electrodes and a grounding mat or floor mat placed on the patient's body (often the legs). Circumferential measurements of electrical parameters such as impedance along a segment of the body cavity use two electrodes, one as the power electrode and the other as the detection electrode. Electrical parameters such as impedance can be measured at a single frequency or within a certain frequency range.

[0129] The device of this invention can be used to prevent, treat, or diagnose cardiac conditions such as atrial fibrillation. This invention may also relate to methods for preventing, treating, or diagnosing atrial fibrillation. "Atrial fibrillation," or "AF," is a common cardiac arrhythmia affecting approximately 6 million patients in the United States alone. In the United States, AF is the second leading cause of stroke and accounts for nearly one-third of strokes in older adults. In more than 90% of cases—where blood clots (thrombi) are present in patients with AF—clots develop in the left atrial appendage (LAA) of the heart. Because blood clots when it stops flowing, the irregular heartbeats of AF can cause blood to pool in the left atrial appendage, where clots or thrombi can form. These clots can break off from the left atrial appendage and may enter the cerebral circulation causing a stroke, the coronary circulation causing a myocardial infarction, the peripheral circulation causing limb ischemia, and other vascular beds. The term encompasses all forms of atrial fibrillation, including paroxysmal (intermittent) AF and persistent and long-term persistent AF (PLPAF).

[0130] The device of the present invention can be used to prevent, treat, or diagnose cardiac conditions such as ischemic events. The present invention may also relate to methods for preventing, treating, or diagnosing ischemic events. An "ischemic event" refers to a restriction of blood supply to a body organ or tissue, resulting in insufficient supply of oxygen and glucose to the affected organ or tissue. This term includes stroke, a blood clot blocking blood supply to the brain causing obstruction of blood flow to a portion of the brain and resulting damage to the affected portion, and transient ischemic events (TIAs), also known as "mini-strokes," which are similar to strokes but are transient in nature and generally do not cause lasting damage to the brain. When a restriction of blood supply occurs in the coronary arteries, an ischemic event is called a myocardial infarction (MI) or heart attack.

[0131] The occlusion or capture device may be self-deployable. The radially expandable body may be self-deployable. At least one of the anchoring arms may be self-deployable. The occlusion body may be made of shape memory material. The radially expandable body may be made of shape memory material. At least one of the anchoring arms may be self-deployable. The anchoring module is axially movable relative to the device. The anchoring module is rotatable relative to the device about the longitudinal axis of the device. The device is rotatable about the longitudinal axis of the device. The anchoring module may be secured to the device. When deployed, the device may have a lateral dimension (width) at least 10%, 15%, 20%, or 25% larger than the width of the body cavity to be treated. The radially expandable body may radially expand to the width of the body cavity without fully deploying the anchoring arms. The proximal end of the radially expandable body may be configured to engage with the proximal end of at least one anchoring arm during device deployment to retain the anchoring arm within the radially expandable body until the radially expandable body is fully deployed.

[0132] Example

[0133] The invention will now be described with reference to specific embodiments. These are merely exemplary and for illustrative purposes only: they are not intended to limit the scope of the claimed patent or the described invention in any way. These examples constitute the best mode of carrying out the invention as currently considered.

[0134] Refer to the attached diagram and first refer to... Figure 1A and Figure 1B This illustrates a first embodiment of an occlusion device, generally indicated by reference numeral 1, forming part of an apparatus according to the invention. The occlusion device is shown in a fully deployed configuration, but the deployment conduit and delivery conduit are not shown. The occlusion device includes a proximal connecting hub 2 having an inner cavity 2B, a radially expandable body (in this case, a mesh cage 3), and an anchoring module comprising a circumferential array of anchoring arms 4 attached to the proximal connecting hub. In this embodiment, the anchoring module has ten arms.

[0135] The mesh cage 3 is cylindrical when deployed, having an open distal end 5 and a closed proximal end 6 with a concave recess 6A. A proximal portion 2A of the proximal connecting hub 2 is disposed within the recess 6A of the proximal end 5 of the mesh cage 3. Although not shown, a fluid-impermeable covering member will fit onto the proximal end of the cage to prevent blood from entering the proximal connecting hub. The covering member includes a closable aperture allowing a delivery catheter to enter the recess 6A for connection with the proximal connecting hub 2.

[0136] The cage 3 has three sections: a proximal section 8 with a smaller mesh size, for example, about 2.5 mm; a distal section 9 with a mesh size of about 2.5 mm; and a central section 10 with a hole 11 for receiving an anchoring arm during deployment. The hole 11 is large enough to prevent the end of the anchoring arm from getting caught on the net during deployment; in the illustrated embodiment, the hole has an axial length of about 5 mm and a width of about 8 mm. The cage is made of a shape memory material, nitinol, and is configured to expand radially to the illustrated configuration when deployed. Generally, deployment involves retracting the restraint deployment conduit to release the cage, at which point it expands to contact the wall of the body cavity to which it is positioned. Generally, the radially expandable body (e.g., the cage) is configured to be oversized relative to the body cavity to which it is deployed when deployed, for example, oversized by about 5-30%, and more specifically about 15-20%.

[0137] The radially expandable element is also designed to be deployed fully or almost entirely laterally before it is fully released from the deployment conduit. This is in Figure 3BAn example is provided showing a partially deployed cage (approximately 80% released from the deployment catheter) almost entirely laterally deployed and in contact with the body cavity wall, while the arm is not deployed and not in contact with the tissue. The advantage of this arrangement is that it allows for phased deployment of the device, including a first deployment stage: the cage is deployed to contact the body cavity wall, where the anchoring arm is not fully deployed and therefore the device is not anchored. This allows for the localization of the device to be evaluated (e.g., by imaging). If the device localization is determined to be suboptimal, the device can be recaptured and repositioned, then partially deployed again, its localization checked, and then, if localization is determined to be correct, fully deployed, at which point the anchoring arm is fully deployed to contact the tissue to anchor the device in the body cavity.

[0138] Anchor arm 4 is formed of Nitinol and is biased to Figure 1B The outward-opening position shown allows for deployment during retraction constraint deployment of the catheter. The arm connects to the hub 2 of the occlusion device, not to the radially expandable body (cage), thus allowing for flexible arm movement independent of the cage. Each arm 4 has a proximal end 4A and a distal end 4B. This distal end 4B bends outward and proximally to form a hook-shaped barb 15, which has a tip 16 facing proximally and substantially parallel to the longitudinal axis of the device. This is advantageous because the device in the LAA tends to pull proximally (towards the left atrium), and the oppositely facing barb helps prevent this.

[0139] Figure 2A and Figure 2B An example of the proximal end of the sealing device 1 is shown, illustrating the proximal connecting hub 2, the proximal recessed end 6 of the cage, and the proximal end 4A of the anchoring arm 4. A support 20 at the proximal end of the cage is attached to the radially outward portion A of the connecting hub 2, and the anchoring arm 4 is attached to the radially inward portion B of the hub 2. (See example...) Figure 2B As shown, the proximal end 4A of the anchoring arm has a bend region 22 forming a shoulder 22A. The shoulder 22A mates with the strut 20 at the proximal end of the cage to control the deployment of the arm. Therefore, full deployment of the arm is delayed until the proximal end of the cage is released from the deployment conduit and the cage is fully deployed. This achieves phased deployment of the device as described above and below, holding the anchoring arm within the cage until the cage has been fully released from the deployment conduit.

[0140] Figures 3A to 3C An embodiment of the device of the present invention and its use are further described, specifically the phased deployment and anchoring of the device in a body cavity—in this case, the left atrial appendage (LAA) of the heart. Figure 3A The device of the present invention is shown, comprising an occlusion device 1, an external deployment catheter 25, and an internal delivery catheter 26 (shown in dashed lines). The device is shown distally positioned in the left atrial appendage 27, and approximately 50% of the radially expandable body 3 is deployed beyond the distal end of the deployment catheter and partially deployed to approximately 60% of its full width. Figure 3B During this process, the deployment catheter has been further retracted relative to the occlusion device, such that, with almost complete radial dilatation, approximately 80% of the radially dilatable body is deployed beyond the distal end of the deployment catheter, allowing the wall of the radially dilatable body to engage with the wall of the LAA. At this stage, it can be seen that the anchoring arm 4 is not fully flared outwards and not engaged with the tissue. Contrast dye can be injected into the patient to image the device's position within the LAA. Further testing can be performed to determine the appropriateness of device positioning. If the cardiologist is not satisfied with the positioning, the device can be recaptured and repositioned. Optionally, the device can be used for electroablation of tissue. After the cardiologist is satisfied that the radially dilatable body has been correctly positioned, and as... Figure 3B As shown, the device is actuated to further retract the deployment catheter 25 relative to the delivery catheter 26, thereby fully deploying the radially expandable body 3 and the anchoring arm, which engages the wall of the LAA to anchor the device in place. Further ablation treatment can then be performed. After treatment, the delivery catheter 26 can be actuated to detach from the hub 2 of the occlusion device and withdrawn together with the deployment catheter 25, leaving the occlusion device anchored in situ in the LAA of the heart.

[0141] The device may include a control handle configured to move the deployment catheter and / or detach or attach the delivery catheter and occlusion body relative to the delivery catheter. The control handle may be configured to actuate the deployment of the radially expandable body independently of the anchoring arm. The device may also include a tissue ablation electrode, which is generally formed as part of or attached to the radially expandable body. Electrical leads may be provided to electrically connect the electrode to corresponding electrical leads provided in the delivery catheter. The connection hub of the occlusion device and the delivery catheter may be configured to electrically couple the electrode of the radially expandable body to the electrical leads of the delivery catheter.

[0142] Figures 4A to 4C This is a further example of a device being deployed according to the invention, specifically demonstrating the self-deployment of the occlusion device and anchoring module through the phased retraction of the deployment conduit. Figure 4A The device is shown as a blocking device 1 and an anchoring module in a delivery configuration housed within a deployment conduit 25, with the anchoring arm 4 of the anchoring module in an axially bundled configuration. Figure 4B The device is shown in the first stage of partial deployment, where the deployment conduit 25 has been partially retracted to expose the distal section 9 and central section 10 of the radially expandable body 3. As can be seen from this figure, at this deployment stage, the radially expandable body 3 has not yet expanded to its full width, and the anchoring arm 4 is constrained into an axially bundled configuration. Figure 4CThe example device is in the second stage of partial deployment, where the deployment conduit 25 has been further retracted (approximately 90%), thus exposing most of the radially expandable body 3. In this stage, the opening / lip 29 of the deployment conduit 25 contacts the bend region 22 on each anchoring arm 4, thereby maintaining the arms in an axially bundled configuration. Further retraction of the deployment conduit in this stage would allow the arms to be deployed radially outward.

[0143] Figures 5A to 5C This is an example of a further deployment of the device in Figure 4, where the radially expandable body has been removed to more clearly illustrate how the anchoring arm responds to the deployment of the conduit from... Figure 4C The location shown is retracted and deployed. In Figure 5A (is with) Figure 4C In the same deployment phase shown, the bend region 22 on arm 4 contacts the mouth / lip 29 of the deployment conduit, thereby keeping the arm in an axially bundled configuration. Figure 5B This illustrates how further retraction of the deployment catheter 25 allows arm 4 to begin radially outward deployment, where deployment is controlled by the engagement between the bend region 22 of arm 4 and the orifice / lip 22 of the deployment catheter. Figure 5C In the process, further retraction of the deployment catheter 25 completely exposes the bend area 22 of the arm outside the mouth 29 of the deployment catheter, thereby allowing the arm to be fully deployed into contact with the tissue.

[0144] refer to Figure 6 The image shows an occlusion device, which forms part of an apparatus according to an alternative embodiment of the invention, generally indicated by reference numeral 30, and wherein the portions described with respect to the foregoing embodiments are designated with the same reference numerals. In this embodiment, the distal end 4B of the anchoring arm is longitudinally bifurcated to provide a U-shaped distal barb 15A and a curved proximal barb 15B. The provision of two barbs—one distal and one proximal—indicates an increased chance that at least one barb on each arm will engage tissue, thereby reducing the risk of device migration.

[0145] refer to Figure 7 The image shows a sealing device, which forms part of an apparatus according to an alternative embodiment of the invention, generally indicated by reference numeral 40, and wherein the portions described with respect to the foregoing embodiments are designated with the same reference numerals. In this embodiment, the distal end 4B of the anchoring arm laterally bifurcates to provide a V-shaped barb having a first barb portion 15C and a second barb portion 15D. The provision of two side-by-side barbs increases the chance that at least one barb on each arm will engage tissue, thereby reducing the risk of device migration.

[0146] refer to Figure 8The image shows an occlusion device, which forms part of an apparatus according to an alternative embodiment of the invention, generally indicated by reference numeral 50, and wherein the portions described with respect to the foregoing embodiment are designated with the same reference numerals. In this embodiment, the distal end 4B of each anchoring arm is bent at its midpoint such that, when fully deployed, it has a first portion 41 angled radially outward, a second portion 42 disposed within the deployed radially expandable body 3 parallel to the longitudinal axis of the apparatus, and an external U-shaped hook 15E. The barb support is parallel to the support before the barb hooks back. This provides a flat section that pushes against the tissue or support, thereby limiting the amount of perforation into the tissue.

[0147] refer to Figure 9 The image shows a thrombus-catching device, which forms part of an apparatus according to an alternative embodiment of the invention, generally indicated by reference numeral 60, and wherein the portions described with respect to the foregoing embodiments are designated with the same reference numerals. In this embodiment, the anchoring module is axially movable relative to the thrombus-catching device 60 and includes an anchoring arm 4 attached to a central anchoring hub 61. The central anchoring hub 61 is configured to be received within and detachably engaged with the connecting hub 2 of the thrombus-catching device 1. The anchoring module further includes an annular cover element 62 extending radially outward from the hub and having a slightly convex shape, which is configured to fluidly engage with the concave proximal side 6 of the cage 3 to prevent thrombi from passing through the connecting hub 2. The annular cover element 62 is self-adjustable from a contraction delivery configuration to... Figure 9 The radially expanded configuration after deployment is shown. The covering element may be formed of a mesh (e.g., nitinol mesh) designed to self-deploy when a restrictive element, such as a delivery catheter, retracts proximally relative to the anchoring module and has a mesh size set to allow blood passage but capture emboli. In other embodiments, the covering element may be formed of a plurality of elements connected to a central anchoring hub 61, which may be adjusted and overlapped from an axial position where the elements are bundled together and a deployment position where the elements extend radially outward to form the covering element. In other embodiments, the anchoring module does not include the covering element. In such embodiments, the engagement between the anchoring module hub and the occlusion device hub may be a fluid-tight engagement that effectively closes the hub of the occlusion device. In use, the embolus-catching device may be deployed first, and while the delivery catheter is still attached to the proximal hub of the embolus-catching device, the anchoring module is advanced through the delivery catheter, with the anchoring arms in a delivery configuration where they are axially bundled together. The arms are advanced through the hub of the deployed embolus-catching device until the anchoring module hub engages the hub of the embolus-catching device. At this position, the arm will automatically deploy into the embolism capture cage to contact surrounding tissue, anchoring the embolism capture device in the blood vessel. Then, the delivery catheter ( Figure 9 (Not shown in the image) can detach from and retract from the hub of the tether capture device, thereby allowing the cover element of the anchoring module to self-deploy. Figure 9 The radially expanding configuration shown is used to cover the hub of the occlusion device and prevent emboli from moving proximally through the embolus capture device. It should be understood that while this embodiment is described with respect to an embolus capture device, axially movable anchoring modules (with or without annular covering elements) can also be used with body cavity occlusion devices, in which case the covering—if used—would be configured to fluidly seal the hub of the occlusion device to prevent distal blood flow through the hub.

[0148] equivalent

[0149] The foregoing description has detailed the currently preferred embodiments of the invention. Upon considering these descriptions, those skilled in the art will expect various modifications and variations to occur in their practice. These modifications and variations are intended to be covered by the appended claims.

Claims

1. A device (1, 40, 50) configured to seal a body cavity of an object, said device (1, 40, 50) comprising: An implantable occlusion device (1) includes a proximal connecting hub (2) and a radially expandable body (3) configured to expand radially to fluidly occlude the body cavity upon deployment from a contraction configuration to a radial expansion configuration; An elongated delivery catheter (26) having a distal connecting hub detachably attached to a proximal connecting hub of the implantable occlusion device for delivering the implantable occlusion device via a cavity into the body cavity; and An anchoring module comprising a circumferential array of anchoring arms (4), wherein each anchoring arm has a proximal end and is configured to pivotally self-adjust about its proximal end from (a) and (b): (a) a delivery configuration in which the array of anchoring arms is arranged in an axially bundled configuration, and (b) a deployment configuration in which the anchoring arms pivot outward about their proximal ends to engage the wall of the body cavity through an opening segment of the implantable occlusion device. The anchoring arm (4) is attached to and extends distally from the anchoring module hub (61) that forms part of the anchoring module, wherein the anchoring module is axially movable relative to the implantable occlusion device.

2. The device of claim 1, wherein the device comprises an elongated deployment catheter having a central lumen, wherein the elongated delivery catheter is disposed in the central lumen of the elongated deployment catheter, wherein the elongated deployment catheter is axially movable proximally relative to the elongated delivery catheter to deploy the implantable occlusion device or implantable embolus capture device.

3. The device according to claim 1, wherein the proximal connecting hub (2) includes a central cavity, wherein the anchoring module is configured to move axially through the central cavity.

4. The apparatus of claim 1, wherein the anchoring module hub and the proximal connecting hub are configured to engage.

5. The apparatus of claim 1, comprising an anchoring conduit, wherein the anchoring module is attached to the anchoring conduit and is axially movable through a cavity of the elongated delivery conduit and a central cavity in the proximal connecting hub.

6. The apparatus of claim 1, wherein the apparatus is used to fluidly occlude the left atrial appendage (27) of the heart of a subject, wherein the radially expandable body (3) is configured to expand radially to a radially expandable configuration to fluidly occlude the left atrial appendage of the heart.

7. The apparatus according to claim 1, wherein the radially expandable body (3) comprises a wire mesh cage.

8. The device according to claim 1, wherein each anchoring arm (4) in the deployment configuration is radially outward at an angle of 60-80° to the central axis of the implantable occlusion device.

9. The apparatus according to claim 1, wherein the radially expandable body (3) comprises a mesh cage, the mesh cage comprising a sidewall comprising a proximal portion (8), a distal portion (9) and a middle portion (10), the mesh size of the middle portion (10) being larger than the mesh size of the distal portion or the proximal portion.

10. The device of claim 1, wherein the radially expandable body (3) comprises a mesh cage, the mesh cage comprising sidewalls including a proximal portion (8), a distal portion (9), and a middle portion (10), the mesh size of the middle portion (10) being larger than the mesh size of the distal portion or the proximal portion, wherein the middle portion (10) of the mesh cage comprises one or more supports that project radially outward from the sidewalls of the mesh cage and include tissue therapy elements.

11. The apparatus of claim 1, wherein at least one of the anchoring arms includes a fluid delivery chamber having an outlet adjacent to the tip of the anchoring arm, and wherein the delivery conduit includes a cavity configured to be in fluid communication with the fluid delivery chamber of the anchoring arm.

Images