Patent Description:
Stroke is one of the leading causes of death and disability in the United States. Atrial fibrillation (AF), which promotes the formation of blood clots, increasing the risk for stroke <NUM> to <NUM> times compared to the general population. The use of warfarin or oral anti-coagulant, is currently the mainstay of treatment for reducing the risk of stroke due to AF. This therapy, however, is systemic and increases the risk of bleeding dramatically. Therefore, alternative treatments that locally prevent the development of thrombi in the atrium are desirable. It has been documented that the left atrial appendage (LAA) is the source for more than <NUM>% of thrombi in patients with non-rheumatic AF. The LAA is a small sac in the muscle wall of the left atrium, and blood may become stagnant and clot when the atrium does not effectively contract; stroke occurs when these clots are pumped out of the heart and into the brain.

<CIT> discloses an occlusion device. The exemplary occlusion device includes a cap chamber and a bulb chamber for occluding a left atrial appendage (LAA). After delivery to the LAA, the cap chamber and the bulb chamber are each inflated via various amounts of fluid(s) to occlude the LAA.

<CIT> discloses devices and methods for occluding the left atrial appendage. An occlusion device can include an expandable lattice structure having a proximal portion configured to be positioned at or near the ostium of the LAA, a distal portion configured to extend into an interior portion of the LAA, and a contact portion between the proximal and distal portions. The expandable lattice structure includes an occlusive braid configured to contact and seal with tissue of the LAA and a structural braid enveloped by the occlusive braid. The structural braid can be coupled to the occlusive braid at a proximal hub located at the proximal portion of the lattice structure. The structural braid is configured to drive the occlusive braid radially outward. The occlusive braid can have an atrial face at the proximal portion facing the left atrium LA, and the atrial face can have a low-profile contour that mitigates thrombus formation at the atrial face.

<CIT> discloses implant devices for modifying blood flow between an atrial appendage and its associated atrium, are customized for use in subject atrial appendages. The implant devices are tailored to uniquely match individual anatomical characteristics. Cardiac imaging techniques are used to obtain data on the size, shape and orientation of the subject atrial appendage. The raw imaging data is electronically processed using computer modeling to obtain multi-dimensional anatomical images of the subject atrial appendages. Three-dimensional computer aided design tools are used to generate customized device designs from the anatomical images of the subject atrial appendages.

The occluder device described herein enables the occlusion of the LAA with a non-pharmacologic alternative to anticoagulant medications. The occlusion of the LAA can reduce the likelihood of stroke in patients with AF. The present disclosure describes a system and method for sealing the LAA and reducing the risk of clot formation. The present system can seal the LAA to prevent leakage of blood and dislodgement of the device, which can reduce the need for the continual treatment of the patient with anti-coagulants. In some implementations, the present system provided a better seal by providing a patient-specific occluding device.

The present application provides a method as defined in independent claim <NUM>. Optional features are defined in the dependent claims.

The MSO device <NUM> is configured to occlude the patient's LAA. In other implementations, the MSO device <NUM> is configured to occlude other portions of the patient's heart. For example, the MSO device <NUM> can be used in patent ductus arteriosus closures, atrial septal defect closures, and heart valve repairs.

The catheter <NUM> is configured for insertion at a patient's femoral artery. The tip of the catheter <NUM> is advanced through a patient's arterial system toward the patient's LAA. The catheter <NUM> includes an elongate flexible body that can include PET, nylon, polyethylene, polyether ether ketone, or any combination thereof. In some implementations, the catheter <NUM> is configured for insertion through a laparoscopic or other surgical opening to be advanced toward the outer surface of the LAA <NUM>.

In some implementations, the catheter <NUM> has a length between about <NUM> and about <NUM>. In some implementations, the outer diameter of the catheter <NUM> is between about <NUM> and about <NUM>, between about <NUM> and about <NUM>, between about <NUM> and about <NUM>, and between about <NUM> and about <NUM>. The catheter <NUM> can have a French size between about <NUM> and about <NUM>, between about <NUM> and about <NUM>, or between about <NUM> and about <NUM>. In some implementations, the catheter <NUM> includes a solid core to enable the deployment tip of the catheter <NUM> to be controlled. For example, the core can include a stainless steel, nitinol, nickel titanium alloy, or polymeric materials that can be rotated by the surgeon to control the rotation of the catheter <NUM>. In some implementations, the catheter <NUM> includes radiopaque to enable the surgeon to visualize the placement of the catheter <NUM> within the patient with the use of X-ray imaging. In some implementations, the catheter <NUM> includes an inflatable balloon. The inflatable balloon is configured to inflate and at least partially block the LAA during the deployment of the MSO device <NUM>.

For example, the MSO device <NUM> can be manufactured using a mold that includes both a hard portion (Veroclear, Stratasys) and soft portion (Tango+, Stratasys). One mold can be manufactured for each side of the MSO device <NUM>. Each mold can be filled with a homogenous silicone blend of 69wt% Dragon Skin®<NUM> (DS20; Smooth-On, Inc. 3wt% Silicone Thinner® (Smooth-On, Inc. ), and <NUM>. 7wt% Sylgard®<NUM> mixture. The silicone blend and molds can then be baked in an oven at <NUM> for <NUM> minutes. Next, the partially cured silicone blend can be removed from the molds. The two halves of the MSO device <NUM> can be aligned and bonded together by with DS20 pre-polymer. The coupled halves can be returned to the oven at <NUM> for one hour. Pure DS20 can be used instead of the silicone blend for the seams because the pure DS20 has a higher viscosity and stays in position after placement on the seam. Once fully cured and cooled, the MSO device <NUM> can be plasma treated and soaked in 12vol% <NUM>-glycidoxypropyltrimethoxysilane (GPTS; Sigma Aldrich) for one hour. After cleaning and drying the occluder, the MSO device <NUM> can be rinsed in a solution of ~10wt% PCU in dimethylacetamide (DMAC; Sigma Aldrich). The MSO device <NUM> can be baked in an oven at <NUM> for <NUM> hours, and then dipped again into the PCU solution. The MSO device <NUM> can be placed in a <NUM> oven overnight to fully cure the PCU surface coating. In some implementations, other injection molding processes can be used to manufacture the MSO devices described herein.

The materials of the MSO device <NUM> are biocompatible. In some implementations, the outer surface of the MSO device <NUM> is configured to enable endothelialization. For example, the surface of the MSO device <NUM> facing the left atrium can be covered by endothelial cells approximately <NUM> days after implantation. This can effectively create a wall between the left atrium and the MSO device <NUM>.

<FIG> illustrate different, class-specific configurations of the MSO device <NUM>. The MSO device <NUM> is designed in response to non-invasive computed tomography (CT) imaging, magnetic resonance imaging, or other imaging techniques. For example, 3D renderings of the CT images can be segmented to produce a solid structure of a patient's LAA <NUM>. When manufactured and deployed, the class-specific (or patient specific) MSO device <NUM> can substantially seal or otherwise fill the LAA <NUM>. In some implementations, the MSO device <NUM> can be manufactured in different shape templates. The shape templates can match the different morphology classes of the LAA <NUM>. The shape templates can be categorized into four LAA shapes. The shape templates include, but are not limited to, a cactus shape, a chicken wing shape, a windsock shape, and a cauliflower shape. The type of shape in a patient scan can be automatically detected and the corresponding shape template will be transformed and fitted to the LAA boundary using machine learning techniques. By designing balloons that fit snugly to the complex geometries of the LAA, both the risk of leakage and dislodgement are reduced. The morphology class can also be a patient-specific morphology class. The patient-specific morphology class shape is designed to match the patient's specific anatomy. Each MSO device <NUM> with a patient-specific morphology class shape can be a custom manufactured MSO device <NUM>. The custom manufactured MSO <NUM> device can be manufactured to match and substantially fill the LAA of the patient.

The figures, described herein, are for illustration purposes only. It is to be understood that in some instances various aspects of the described implementations may be shown exaggerated or enlarged to facilitate an understanding of the described implementations. In the drawings, like reference characters generally refer to like features, functionally similar and/or structurally similar elements throughout the various drawings. The drawings are not necessarily to scale, and emphasis is instead being placed upon illustrating the principles of the teachings. The system and method may be better understood from the following illustrative description with reference to the following drawings in which:.

<FIG> illustrate a plurality of human LAA <NUM> morphologies <NUM>. The morphologies <NUM> were captured using non-invasive CT imaging. The morphologies <NUM> were categorized into different classes. Each of the morphologies <NUM> can include a plurality of lobes. The template shapes of the MSO device <NUM> can include one or more lobes <NUM>. For example, the MSO device <NUM> can include between <NUM> and about <NUM> lobes. Each of the lobes can have a central axis <NUM>. The lobes <NUM> can project in different directions such that the axis <NUM> of each lobe <NUM> is askew from the other axes <NUM>. <FIG> illustrates a plurality of morphologies <NUM> that are categorized into a windsock class. The MSO device <NUM> illustrated in <FIG> is configured in the windsock template shape. The windsock template shape includes two lobes <NUM>. <FIG> illustrates a plurality of morphologies <NUM> that are categorized into a cactus class. The MSO device <NUM> illustrated in <FIG> is configured in the cactus template shape. The cactus template shape includes three lobes <NUM>. <FIG> illustrates a plurality of morphologies <NUM> that were categorized into a cauliflower class. The MSO device <NUM> illustrated in <FIG> is configured in the cauliflower template shape. The cauliflower template shape includes three lobes <NUM>. The lobes <NUM> of the cauliflower template shape include a larger, primary lobe and two secondary lobes. <FIG> illustrates a plurality of morphologies <NUM> that were categorized into a chicken wing class. The MSO device <NUM> illustrated in <FIG> is configured in the chicken wing template shape. The chicken wing template shape includes two lobes <NUM>. The angle between the axes <NUM> in the windsock template can be greater than that of the angle between the axes <NUM> in the template chicken wing shape. A template for each of the classes can be generated by determining the overlap of each of a plurality of morphologies <NUM> within a respective class. In some implementations, the chicken wing template class can include main lobe that is about <NUM>-<NUM> long and the angle between the axes <NUM> of the main lobe and a second lobe can be less than about <NUM>°. In some implementations, the chicken wing template includes a single, main lobe that is greater than <NUM> and is folded at an angle less than about <NUM>°, which can be referred to as a folded-lobe. The windsock template class includes a main lobe that is about <NUM>-<NUM> long and the angle between the axes <NUM> of the main lobe and a second lobe can be greater than about <NUM>°. In some implementations, the windsock template includes a single, main lobe that is greater than <NUM> and is folded at an angle greater than about <NUM>°, which can be referred to as a folded-lobe. The cactus template class includes a main lobe that is between about <NUM>-<NUM> long and includes more than two secondary lobes that are each longer than about <NUM> or which may be longer than about <NUM>. The cauliflower class template can include a main lobe that is about <NUM>-<NUM> long and one or more secondary lobes that are not forked.

4A-4C illustrate a plurality of example MSO devices <NUM> for different morphology classes. Referring to FIG. 4A, the morphology <NUM> is classified into the cauliflower class. The morphology <NUM> is classified into the chicken wing class. The morphology <NUM> is classified into the cactus class. The row <NUM> (<FIG>) and row <NUM> (<FIG>) illustrate different views of a class-specific MSO device <NUM> corresponding to the respective morphologies <NUM> (cauliflower class, left pane of <FIG>), <NUM> (chicken wing class, middle pane of <FIG>and <FIG>), and <NUM> (cactus class, right pane of <FIG>) under which they are listed.

<FIG> illustrate example methods for implanting a MSO device <NUM> not forming part of the invention. The MSO device <NUM> can be deployed via a number of procedures. In one example, the MSO device <NUM> can be deployed via a transcatheter method where the MSO device <NUM> is inflated from the ostium of the LAA <NUM>. In another example, the MSO device <NUM> can be deployed surgically and inflated from the distal end of the LAA <NUM>.

<FIG> illustrate an example occluder system <NUM> during the different stages of a transcatheter deployment. The occluder system <NUM> includes the MSO device <NUM>. The occluder system <NUM> also includes a catheter through which the MSO device <NUM> is deployed. For illustrative purposes, in <FIG> the MSO device <NUM> is deployed into an in vitro testing system <NUM>. The in vitro testing system <NUM> includes an artificial LAA <NUM>. While illustrated in relation to the in vitro testing system <NUM>, the occluder system <NUM> described herein is also configured to in vivo testing. For example, the occluder system <NUM> described herein can be used to occlude the LAA of a patient.

Additionally, amounts, ratios, and other numerical values are sometimes presented herein in a range format. It is to be understood that such range format is used for convenience and brevity and should be understood flexibly to include numerical values explicitly specified as limits of a range, but also to include all individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly specified.

While the present disclosure has been described and illustrated with reference to specific embodiments thereof, these descriptions and illustrations do not limit the present disclosure. It should be understood by those skilled in the art that various changes may be made without departing from the scope of the present disclosure as defined by the appended claims. The illustrations may not be necessarily drawn to scale. There may be distinctions between the artistic renditions in the present disclosure and the actual apparatus due to manufacturing processes and tolerances. There may be other embodiments of the present disclosure which are not specifically illustrated. The specification and drawings are to be regarded as illustrative rather than restrictive. Modifications may be made to adapt a particular situation, material, composition of matter, technique, or process to the objective, and scope of the present disclosure. All such modifications are intended to be within the scope of the claims appended hereto. While the techniques disclosed herein have been described with reference to particular operations performed in a particular order, it will be understood that these operations may be combined, sub-divided, or re-ordered without departing from the teachings of the present disclosure. Accordingly, unless specifically indicated herein, the order and grouping of the operations are not limitations of the present disclosure.

The various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways as the described concepts are not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.

<FIG> illustrates an example occluder system <NUM> within the heart <NUM> of a patient. The occluder system <NUM> includes an occluder device <NUM> that can be deployed through a catheter <NUM>. The occluder device <NUM> can also be referred to as a morphology-specific occluder (MSO) device <NUM>. The MSO device <NUM> can be deployed from the catheter <NUM> and into the LAA <NUM> of the heart <NUM>. Once deployed, the MSO device <NUM> can be anchored to the LAA <NUM> and detached from the catheter <NUM>. In some implementations, the system <NUM> is a surgical or other kit that includes the MSO device <NUM> and catheter <NUM>.

The MSO device <NUM> can be configured, selected, or manufactured for the patient into whom the MSO device <NUM> is implanted. The MSO device <NUM> can be an inflatable balloon implant with a geometry that substantially matches the anatomical morphology of the patient's LAA <NUM>. The MSO device <NUM> can include a plurality of lobes that when inflated substantially match the LAA shape of a specific patient or the shape of a LAA morphology class. As described below, the morphology of the patient's LAA <NUM> can be ascertained by non-invasive computed tomography (CT) imaging. The MSO device <NUM> can be non-spherical when inflated. The MSO device <NUM> can have a number of advantages over a spherical balloon shape. While a spherical balloon-shaped device that is composed of soft materials can conform to most shapes, the spherical device may need to be over-inflated to fill the patient's LAA <NUM>. The inflation of the spherical device can induce strain on both the elastomeric material of the spherical device, the multi-lobular LAA structures, and the tissue surrounding the LAA. Over-inflation of a spherical device to obtain full occlusion could also compress the circumflex artery that runs underneath the LAA. In some implementations, the MSO device <NUM> can be manufactured for a specific patient. The morphology of the patient's LAA <NUM> is categorized into a class and a specific shape of the MSO device <NUM> can be selected based on the class.

<FIG> illustrates an example MSO device <NUM>. <FIG> illustrates a cross-sectional view of the example MSO device <NUM> in an inflated state. The inflated state can be any state where the MSO device <NUM> is expanded with respect to the configuration of the MSO device <NUM> prior to deployed (e.g., when the MSO device <NUM> is within the catheter <NUM>). The MSO device <NUM> can be expanded or otherwise inflated with a fluid, gas, foam, or other material. In some implementations, the MSO device <NUM> can be self-expanding. For example, the walls of the MSO device <NUM> can include nitinol ribs that deploy to an expanded state once the MSO device <NUM> is deployed from the catheter <NUM>.

The MSO device <NUM> includes a valve <NUM> through which the MSO device <NUM> can be filled. The valve <NUM> can enable a lumen <NUM> to be inserted in a first direction and into an interior space of the MSO device <NUM> but substantially prevents fluid from flowing in the opposite direction. The MSO device <NUM> can be monolithically integrated with the valve <NUM>. The valve <NUM> can enable a surgeon to fill the MSO device <NUM> without leakage once disengaged from the catheter <NUM>. The MSO device <NUM> can be filled with a hardening material to stabilize the MSO device <NUM> within the LAA <NUM> after implantation. The fluid to inflate the MSO device <NUM> can be passed to the interior of the MSO device <NUM> via a lumen <NUM>. In some implementations, the lumen <NUM> is inserted through the valve <NUM> during the MSO device's non-deployed state (e.g., when the MSO device <NUM> is in the catheter <NUM>).

The valve <NUM> can be monolithically integrated into the MSO device <NUM> during the molding process. Monolithically integrating the valve <NUM> with the MSO device <NUM> can enable the MSO device <NUM> to be inflated to a high pressure without delamination of the valve <NUM> from its walls of the MSO device <NUM>. The valve <NUM> can include a polymeric septum that is pierced by lumen <NUM>. Once the MSO device <NUM> is deployed and secured in the LAA <NUM>, the lumen <NUM> can be retracted. The polymeric septum valve can seal the location where the lumen <NUM> previously pierced the septum, sealing the interior of the MSO device <NUM>. The valve <NUM> can also include a cured material (e.g., a quick setting epoxy can be applied to the opening left by the retracted lumen <NUM>). The valve <NUM> can include a mechanical valve that is opened to fill the MSO device <NUM> and then closed once the MSO device <NUM> is filled.

The valve <NUM> can include wings <NUM>. The wings <NUM> are coupled to the internal side of the valve <NUM> to protect the opposing wall of the MSO device <NUM> from being pierced accidentally by the lumen <NUM> during deployment or the filling of the MSO device <NUM>. A portion <NUM> of the valve <NUM> can extend past the walls of the MSO device <NUM>. The portion <NUM> can include attachment anchors <NUM>, which can be sutures. The attachment anchors <NUM> can be used to secure and anchor the MSO device <NUM> to the LAA <NUM>. The portion <NUM> of the MSO device <NUM> can extend to enable a surgeon to maintain contact with the MSO device <NUM> throughout the entire implantation procedure. In some implementations, the attachment anchors <NUM> can be coupled with an outer surface of the wall <NUM>. When positioned on the outer surface of the wall <NUM>, the attachment anchors <NUM> can come into contact with the inner tissue surface of the LAA <NUM>. The attachment anchors <NUM> can be surface features such as, but not limited to, ridges, protrusions, barbs, anchors, needles, or other structures that can increase the friction between the MSO device <NUM> and the LAA <NUM>. The attachment anchors <NUM> can also include bonding agents. For example, an adhesive or protein bonding agent can be applied to the outer surface of the wall <NUM> and coupled the MSO device <NUM> with the LAA <NUM>.

The thickness of the MSO device <NUM> walls <NUM> can be between about <NUM> about <NUM>, between about <NUM> and about <NUM>, between about <NUM> and about <NUM>, or between about <NUM> and about <NUM>. In some implementations, the MSO device <NUM> of the occluder system <NUM> can be fabricated using rapid prototyping techniques, such as direct 3D printing of polyurethane materials or molded from 3D printed templates of silicone materials. These materials can have a wide range of stiffness (ranging from kPa to tens of MPa) and extensibilities (e.g., up to <NUM>%). In some implementations, the material used to fabricate the MSO device <NUM> is intrinsically soft (as to not damage the heart and to not impede contractions of the heart muscle), but robust enough to withstand the forces exerted on the device when implanted. In some implementations, the MSO device <NUM> of the occluder system <NUM> can include polyurethane, silicone, nylon, PET, or a combination thereof. In some implementations, the walls <NUM> (or other components of the MSO device <NUM>) can include a non-stretchable polymer, such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), nylon, or polyvinyl chloride (PVC). In some implementations, the walls <NUM> of the MSO device <NUM> can be reinforced with fabric, metal mesh or wire, or other materials.

<FIG> illustrates the MSO device <NUM> contained within the catheter <NUM>. The MSO device <NUM> can be fully contained within the catheter <NUM> in an undeployed state during the procedure to snake the tip of the catheter <NUM> from an insertion site (e.g., near the patient's groin) to the patient's left atrium. <FIG> illustrates the MSO device <NUM> after partial deployment into the artificial LAA <NUM> from the catheter <NUM>. <FIG> illustrates the MSO device <NUM> fully deployed into the artificial LAA <NUM>. As illustrated in <FIG>, the catheter <NUM> can be retracted from the artificial LAA <NUM> (or patient's heart) after deployment of the MSO device <NUM>.

As illustrated in <FIG>, the MSO device <NUM> can be collapsible to fit within the catheter <NUM> and then expanded to fit within the patient's LAA. In some implementations, the MSO device <NUM> is expanded and deployed by infusing a fluid into the MSO device <NUM>. The fluid used to fill the MSO device <NUM> can be cured (chemically, thermally, or with fiber coupled UV light) to ensure the deployed MSO device <NUM> retains its shape and stays lodged within the LAA. Furthermore, by solidifying the liquid, potential issues of balloon rupture will be reduced. As described above, the curable fluid is configured to have mechanical properties, such that the solidified MSO device <NUM> can accommodate the natural contractions of the left atrium and other portions of the heart. The MSO device <NUM> can be filled with epoxies, polyethylene glycol, collagen-based biocompatible polymeric gels, silicon, polyurethane, poly(methyl methacrylate), saline, self-expanding foam particles, or any combination thereof. The fluid (or other material) that fills and inflates the MSO device <NUM> can be referred to as an inflation fluid. In some implementations, a contrast agent or radiopaque material can be added to the filling or MSO device <NUM> to make the MSO device <NUM> visible to imaging devices. In some implementations, the fluids used to fill the MSO device <NUM> are stored in reservoirs that are coupled to the MSO device <NUM> via the catheter <NUM>. The MSO device <NUM> can be filled by injecting the fluid from the reservoir and into the MSO device <NUM> via the lumen <NUM>. In some implementations, the reservoir is a syringe.

<FIG> illustrate an example occluder system <NUM> during the stages of deployment from the distal end of the LAA <NUM>. <FIG> illustrates a first step where a small incision is made in the LAA <NUM>. The catheter <NUM>, which during the initial steps contains the MSO device <NUM>, attachment anchors <NUM>, and a lumen <NUM>, is inserted through the incision and into the LAA <NUM>. As illustrated in <FIG>, purse string sutures <NUM> are made near where the catheter <NUM> is inserted into the LAA <NUM>. <FIG> illustrates the retraction of the catheter <NUM>. As the catheter <NUM> is retracted, the MSO device <NUM> is deployed into and remains within the LAA <NUM>. <FIG> illustrates the filling (also referred to as the expansion or inflation) of the MSO device <NUM>. The lumen <NUM> passes through the valve <NUM> and into the interior of the MSO device <NUM>. The interior of the MSO device <NUM> can be filled with a fluid <NUM>, such as a liquid epoxy. As the MSO device <NUM> is filled, the MSO device <NUM> expands to fill the volume of the LAA <NUM>. After a predetermined amount of time, the fluid <NUM> cures and hardens. In some implementations, the MSO device <NUM> can be filled with a fluid or other material that does not cure or otherwise harden over time (e.g., saline). <FIG> illustrates the anchoring of the MSO device <NUM> to the LAA <NUM>. The attachment anchors <NUM> can be sutures that are tied or otherwise coupled with the purse string sutures <NUM> placed in the LAA <NUM>. The attachment anchors <NUM> can hold the MSO device <NUM> in place and within the LAA <NUM>. In some implementations, the attachment anchors <NUM> can hold the MSO device <NUM> in place as the fluid filling the MSO device <NUM> cures. Once cured, the hardened shape of the MSO device <NUM> can hold the MSO device <NUM> within the LAA <NUM>.

<FIG> illustrates a block diagram of an example method <NUM> for deploying a MSO device not forming part of the invention. The method <NUM> includes receiving imaging data of a patient's LAA (step <NUM>). The method also includes generating a MSO device (step <NUM>). The MSO device is packaged into a catheter (step <NUM>). The method <NUM> also includes temporarily reducing blood flow to the patient's LAA (step <NUM>). The LAA is then flushed (step <NUM>). The MSO device is then deployed into the LAA (step <NUM>.

The steps <NUM>-<NUM> can correspond to the manufacture of the MSO device <NUM>. As set forth above, the method <NUM> includes receiving imaging data of a patient's LAA (step <NUM>). In some implementations, the imaging data includes 3D imaging data received from a CT device. The imaging data can be processed to determine the volumetric shape of the patient's LAA. In some implementations, the patient's volumetric shape is matched to a template MSO device that includes a prefabricated volumetric shape. In some implementations, the MSO device is fabricated specifically for the patient. The shape of the MSO device manufactured specifically for the patient's anatomy can be referred to as a patient-specific morphology template.

The method <NUM> also includes generating the MSO device (step <NUM>). In some implementations, the MSO device can be fabricated using rapid prototyping techniques, such as direct 3D printing of polyurethane materials. In other implementations, the MSO device is molding from 3D printed templates of silicone materials. In other implementations, the MSO device is manufactured using a subtractive 3D process. The MSO device can be manufactured from polyurethane, silicone, nylon, PET, or a combination thereof. Once the MSO device is manufactured, the MSO device is sterilized and packaged into a deployment catheter (step <NUM>).

The steps <NUM>-<NUM> can correspond to the deployment of the MSO device. In some implementations, the steps <NUM>-<NUM> can be completed using an implantation method similar to the implantation method described in relation to <FIG>. Also referring to <FIG>, the method <NUM> includes temporarily reducing blood flow into the LAA (step <NUM>). <FIG> illustrates the closure device during step <NUM> of method <NUM>. <FIG> illustrates the use of an inflatable balloon <NUM> to reduce blood flow into the LAA. First, the tip of the occluder system <NUM> can be deployed near the LAA using a similar strategy to the Watchman closure device, by crossing the inter-atrial septum. The catheter <NUM> is preloaded with the MSO device and the inflatable balloon <NUM>. In some implementations, the catheter <NUM> can include a hemostasis Y-adapter and a <NUM>-way stopcock to control the infusion of the pressurizing fluid into the MSO device and inflatable balloon <NUM> and the deployment of a contrast dye.

As illustrated in <FIG>, first the tip of the catheter <NUM> is delivered toward the LAA. As illustrated in the <FIG>, the inflatable balloon <NUM> can be inflated to block blood flow between the LAA and the atrium. Initially, some blood <NUM> can be trapped within the LAA <NUM>.

Referring to <FIG> and <FIG>, the method <NUM> can include flushing the LAA (step <NUM>). <FIG> illustrates the LAA after the flushing according to step <NUM> of method <NUM>. The LAA <NUM> can be flushed with a saline wash (or other medical grade fluid). The flushing can remove blood from within the LAA <NUM>. The blood removed during the flushing of the LAA can be the blood trapped between the inflated balloon <NUM> and the walls of the LAA <NUM>. Removing the blood can reduce the chances of blood being trapped in the LAA <NUM> and forming clots.

Referring to <FIG> and <FIG>, the method <NUM> can also include deploying the MSO device <NUM> into the LAA <NUM> (step <NUM>). The MSO device <NUM> can be deployed into the LAA <NUM> from the tip of the catheter <NUM>. In some implementations, the MSO device <NUM> can be deployed by flowing a fluid (such as a liquid or a gas) through the catheter <NUM> and into the MSO device <NUM>. In some implementations, the fluid is a light, temperature, or time curable fluid. Once the fluid has filled the MSO device <NUM>, the fluid can be cured such that the MSO device <NUM> maintains its patient-specific shape. <FIG> illustrates the deployed MSO device <NUM> after the retraction of the catheter <NUM>.

In some implementations, during the deployment of the MSO device <NUM>, it is important that the orientation and positioning be correct. To achieve this, radiopaque markers at the distal end of the catheter and the MSO device <NUM> can be used to visualize the catheter and/or MSO device <NUM> in situ. The markers can be designed such that the position (distance from LAA orifice) and orientation (angular alignment with LAA geometry) can be determined within an accuracy of about <NUM> using x-ray fluoroscopy techniques.

As used herein, the singular terms "a," "an," and "the" may include plural referents unless the context clearly dictates otherwise.

As used herein, relative terms, such as "above," "below," "up," "left," "right," "down," "top," "bottom," "vertical," "horizontal," "side," "higher," "lower," "upper," "over," "under," "inner," "interior," "outer," "exterior," "front," "back," "upwardly," "lower," "downwardly," "vertical," "vertically," "lateral," "laterally," and the like refer to an orientation of a set of components with respect to one another; this orientation is in accordance with the drawings, but is not required during manufacturing or use.

As used herein, the terms "connect," "connected," and "connection" refer to an operational coupling or linking. Connected components can be directly or indirectly coupled to one another, for example, through another set of components.

Claim 1:
A method comprising:
imaging, non-invasively, an anatomy of a patient using an imaging device to obtain a medical image of the anatomy of the patient, characterized by:
determining, based on the medical image, a morphology class of an atrial appendage (<NUM>) of the patient;
selecting, based on the morphology class, a shape template from among a set of predetermined shape templates; and
obtaining an inflatable implant (<NUM>) manufactured according to the selected shape template, the inflatable implant configured to have, in an inflated state, a volumetric shape corresponding to the shape template;
wherein the inflatable implant is configured for use in occluding the atrial appendage of the patient, and wherein the set of predetermined shape templates comprises at least one of:
a cactus shape (<NUM>) comprising a first main lobe that is between about <NUM> to <NUM> long and more than two secondary lobes that are each longer than about <NUM>;
a chicken wing shape (<NUM>) comprising a second main lobe that is about <NUM> to <NUM> long and a secondary lobe;
a windsock shape (<NUM>) comprising a third main lobe that is about <NUM> to <NUM> long, with a predetermined first angle between the axes of the third main lobe and a second lobe being greater than about <NUM> degrees; or
a cauliflower shape (<NUM>) comprising a fourth main lobe and two secondary lobes, each secondary lobe being smaller than the fourth main lobe.