Frame and patch design for occluder with access channel

Abstract

A woven occlusion device with an access channel and methods including the device are described herein. The occlusion device includes a woven frame comprising. The frame includes an annular distal disc, a waist member, and an annular proximal disc that define a passageway through the woven frame. The woven frame is formed from a closed-end weave.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 969,561, filed February 3, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention generally relates to medical devices for use in the human body. In particular, the invention relates to frames and patch closures incorporated into a medical device delivered to a target site within the human body. More specifically, the invention relates to woven frames that facilitate uniform loading and deployment of the medical device, and reduce damage to cardiac tissue by minimizing bulging of the deployed medical device. Background Technology

[0004] Atrial septal defect (ASD) is a heart defect that allows blood to flow between the left and right atria of the heart. Figure 1A This reduces cardiac output. At least in some cases, using a device like Am platzer... TM Closure devices such as ASO (atrial septal occluder) Figure 1B Occluders are used to close atrial septal defects. Occluders are typically made of braided metal fabric or wire with a mesh. Some of these known occluders are shown in Figures 1C, 1D, and 1E. As shown, a conventional occluder 102 has a disc 104 that engages with the surface of the septal wall separating the left and right atria. Figure 1B These discs 104 can range in size from 10 mm to 54 mm in diameter and are typically formed from continuous metal fabric or wire. Therefore, these discs 104 form a substantially impermeable surface.

[0005] As more and more surgeries become percutaneous, several percutaneous procedures require access to the left atrium via the septal wall. For example, a young patient may have an occluder deployed to close an atrial septal defect, but may subsequently develop atrial fibrillation (AFIB). The physician may need to map and / or ablate tissue in the left atrium, thus potentially requiring access to the septal wall. In cases where a conventional occluder has already been deployed, the physician must navigate through a mesh of metal fabric, wire, and / or mesh to access the left atrium, and may not be able to penetrate the disc (e.g., disc 104 shown in Figures 1C-1E) to access the septal wall at the existing opening (i.e., the ASD). In such cases, the physician may need to remove the occluder to access the left atrium. Therefore, occlusion devices with interventional pathways can be used, which (i) achieve occlusion and (ii) allow for subsequent intervention via the pathway.

[0006] Tissue erosion after closure of an atrial septal defect is a known risk of occlusion medical devices. Erosion is tissue abrasion caused by friction between the occluder and the tissue. Friction can be reduced by making the occluder softer; however, softer devices are more prone to bulging into the atrium when force is applied to the waist and disc of the occluder. Occlusion devices with an access channel can be prone to bulging due to the patch closure applied to the device to achieve the occlusion effect. The patch closure can bulge from the center of the device without anything to hold it in place. In traditional occluders, a continuous metal fabric / wire mesh disc surface spans the center of the device, thereby helping to contain the patch. Bulging can occur due to blood flow or device compression / deformation. In some cases, the patch closure can help with loading and retrieval of the device, but if the patch closure has any permanent deformation or pulls away from the disc edge, it has a tendency to bulge in the center of the device.

[0007] Accordingly, it is desirable to have an occlusion device with an access channel that extends the least amount of metal into the access channel, contours to the septal defect to maximize tissue compliance of the device and minimize tissue erosion, and enables easier passage of any subsequent medical devices through the access channel. It is also desirable to reduce or eliminate bulging to reduce or eliminate erosion of heart tissue while maintaining the essential function and effectiveness of the patch closure(s) of the occluder with an access channel. To ensure endothelialization has a continuous surface and no pockets or voids that can become a source of thrombosis, it is desirable to minimize patch bulging. SUMMARY

[0008] The present invention generally relates to closure and patch designs for use in occlusion devices including an access channel. The present invention discloses such devices and methods of shaping and using them to, for example, enable uniform loading and deployment of the device and minimize bulging of the device and patch after the device has been deployed in the human body. Occluders with an access channel further facilitate the passage of medical devices through the access channel for intervention and reduce erosion of heart tissue caused by reducing the radial force exerted thereon.

[0009] In one embodiment, the present disclosure relates to an occlusive medical device comprising a woven frame. The woven frame includes an annular distal disc portion having a radially outer surface and a radially inner surface, an annular proximal disc portion having a radially outer surface and a radially inner surface, and a waist member extending between and connecting the annular distal disc portion to the annular proximal disc portion. The radially inner surface of the annular distal disc portion, the waist member, and the radially inner surface of the annular proximal disc portion define an unobstructed passageway through the woven frame. The woven frame is formed from a woven fabric with closed ends.

[0010] In another embodiment, the present disclosure is directed to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other set of wire tails of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0011] In another embodiment, the present disclosure is directed to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other set of wire tails of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0012] In another embodiment, the present disclosure is directed to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other set of wire tails of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0013] In another embodiment, the present disclosure is directed to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other set of wire tails of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0014] In another embodiment, the present disclosure is directed to a method of eliminating or reducing cardiac tissue erosion. The method includes providing an occlusive medical device including an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between the annular distal disc and the annular proximal disc and connecting the annular distal portion to the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame. The woven frame is woven in two layers in at least one of the annular distal disc or the annular proximal disc. The method also includes confining the occlusive medical device in a reduced profile and delivering the occlusive medical device. The method also includes deploying the occlusive medical device such that the frame transitions from the reduced profile to an expanded profile and increasing a compliance of the occlusive medical device on the cardiac tissue.

[0015] In one embodiment, the present disclosure is directed to an occlusive medical device including a woven frame. The woven frame includes an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between the annular distal disc and the annular proximal disc and connecting the annular distal portion to the annular proximal disc, and at least one patch closure. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0016] In one embodiment, the present disclosure is directed to an occlusive medical device including a woven frame. The woven frame includes an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between the annular distal disc and the annular proximal disc and connecting the annular distal portion to the annular proximal disc, and a plurality of woven wire spokes of a respective set of wire attached to at least one of the annular distal disc or the annular proximal disc and a tail of a center marker band. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0017] The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be better understood from the following description and from the claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1A An atrial septal defect (ASD) is shown. Figure 1B A general closure procedure for an ASD with a plug device is shown. FIGS. 1C, 1D, and 1E show an embodiment of a conventional occluder.

[0019] Figure 2 is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with wire sets on the distal disc and the proximal disc, which terminate in marker bands.

[0020] Figure 3A is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with end screws sewn to eyelets, which are welded to each marker band. Figure 3B depicts a magnified view of the braided occluder shown in Figure 1.

[0021] Figure 4A is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with a closed end braid. Figure 4B depicts a magnified view of the braided occluder shown in Figure 3.

[0022] Figure 5A is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure including a closed end braid with loops. Figure 5B depicts a magnified view of the braided occluder shown in Figure 4.

[0023] Figure 6 is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with wire loops on the distal disc and the proximal disc.

[0024] Figure 7 is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with wire loops on the proximal disc, each wire loop connecting each tail to a central marker band.

[0025] Figure 8 is an exemplary embodiment of a polymeric coated braided occluder with an intervention channel according to the present disclosure.

[0026] Figure 9 is an exemplary embodiment of a cross-sectional view of an open cell occluder according to the present disclosure to show a rolled braid construction (dashed line indicates open cell).

[0027] Figure 10 is another exemplary embodiment of a cross-sectional view of an open cell occluder according to the present disclosure to show a rolled braid construction (dashed line indicates open cell).

[0028] Figure 11 is an exemplary embodiment of a braided occluder with an intervention channel according to the present disclosure with multiple spokes extending to the center of the intervention channel.

[0029] Figure 12is an exemplary embodiment of a braided occluder with an access channel according to the present disclosure having a plurality of braided wires extending into the center of the access channel.

[0030] Figure 13 is an exemplary embodiment of a reinforcing material sewn to the end of a braid according to the present disclosure.

[0031] Figure 14 is an exemplary embodiment of a reinforcing material built into a patch according to the present disclosure.

[0032] Figure 15 is an exemplary embodiment of a tether through the center of a patch according to the present disclosure.

[0033] Figure 16 is an exemplary embodiment of a pusher cable with a distal lumen to seat a reinforcing patch in a collapsed state according to the present disclosure.

[0034] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. It will be understood that the drawings are not necessarily to scale. DETAILED DESCRIPTION

[0035] The present invention relates generally to medical devices for use in the human body. In particular, the present invention relates generally to occluders that account for loading and deployment of the occluder that includes an access channel for intervention through the occluder (e.g., by a medical device) after the occluder is deployed in the patient’s body. The occluder also includes a patch closure that functions as an occlusion but is penetrable to allow intervention through the access channel. The patch can also enable fenestrations that can reduce right heart burden for patients with pulmonary arterial hypertension (partial defect closure). As used herein, “intervention” broadly refers to entry into and / or passage through the access channel by any medical device performing any function. Thus, “intervention” can refer to intervention by a medical device such as a catheter completely through the occluder, as well as intervention by a medical device configured to create a fenestration in the occluder, e.g., a dilator, balloon, etc.

[0036] The disclosed embodiments can result in more consistent and improved patient outcomes. However, it is contemplated that the features and methods described by the present disclosure described herein can be incorporated into any number of systems as will be appreciated by one of ordinary skill in the art based on the disclosure herein.

[0037] It should be understood that the use of the term "target site" is not meant to be limiting as the medical device can be configured to treat any target site, such as an abnormality, a blood vessel, an organ, an opening, a chamber, a passageway, a hole, a lumen, etc. located anywhere in the body. As used herein, the term "blood vessel abnormality" is not meant to be limiting as the medical device can be configured to bridge or otherwise support a variety of blood vessel abnormalities. For example, the blood vessel abnormality can be any abnormality affecting the shape of a native lumen, such as an LAA (left atrial appendage), an atrial septal defect, a lesion, a blood vessel dissection, or a tumor. As noted above, embodiments of the medical device can be used to, for example, occlude an LAA, an ASD, a VSD (ventricular septal defect), or a PDA (patent ductus arteriosus). Further, the term "lumen" is also not meant to be limiting as the blood vessel abnormality can be present at a variety of locations within the vasculature, such as a blood vessel, an artery, a vein, a passageway, an organ, a chamber, etc. As used herein, the term "proximal" refers to the portion of the medical device or delivery device closest to the operator and the term "distal" refers to the portion of the medical device or delivery device furthest from the operator at any given time while the medical device is being delivered through the delivery device.

[0038] The medical device can include one or more layers of occlusive material, where each layer can be constructed of any material configured to substantially stop or occlude blood flow to promote thrombus formation. As used herein, "substantially stop or occlude flow" functionally means that blood flow can occur for a short period of time, but after that initial period of time, the body's clotting mechanisms or proteins or other bodily deposits on the occlusive material cause the occlusion or stoppage of flow.

[0039] The present application will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the applications are shown. Indeed, the applications can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like reference numerals refer to like elements throughout. Some embodiments of the present disclosure provide a medical device, such as an occlusion device (occluder), for occluding an abnormality of a patient's body, such as an atrial septal defect (ASD), a ventricular septal defect (VSD), a patent ductus arteriosus (PDA), a patent foramen ovale (PFO), a condition resulting from a previous medical procedure, such as paravalvular leakage (PVL) after a surgical valve repair or replacement, etc. The device can also be used as a flow restrictor or aneurysm bridge or for other types of occluders placed in the vascular system. It should be understood that the use of the term "abnormality" is not meant to be limiting as the device can be configured to occlude any blood vessel, organ, opening, chamber, passageway, hole, lumen, etc. located anywhere in the body.

[0040] Some embodiments of the present invention provide an improved percutaneous catheter directed endovascular occlusion device for use in the vasculature of a patient, such as a blood vessel, passageway, lumen, hole through tissue, cavity, etc., such as an ASD or VSD. Other physiological conditions exist in the body where it is also desirable to occlude a blood vessel or other passageway to prevent blood flow into or through it. These device embodiments can be used anywhere in the vasculature where the anatomical conditions are suitable for the design.

[0041] The medical device can include one or more occlusive materials configured to substantially stop or occlude blood flow to promote thrombus formation. As used herein, "substantially stop or occlude flow" functionally means that blood flow can occur for a short period of time, but after that initial period of time, the body's clotting mechanisms or proteins or other body deposits on the occlusive material cause occlusion or flow stoppage. According to one embodiment of the present invention, the device is configured to occlude at least a portion of a blood vessel, passageway, lumen, opening, or cavity in less than about 10 minutes, or even less than about 5 minutes, with occlusion observed in testing as low as about 1 minute. Thus, in one embodiment, there is no "immediate occlusion" in that the device does not immediately occlude all blood flow, but rather slows blood flow so that occlusion occurs as described above. Such immediate occlusion can cause problems with fixation or positioning of the device in the lumen, or can cause suction or complete stoppage of flow which can not be desirable in some situations.

[0042] As Figure 2As shown, the braided occluder with intervention channels terminates approximately at the waist of the device. Each disc (distal disc 205 and proximal disc 206) has 12 groups (each group containing 12 wires) terminating at the tail and covered with a marker tape, shown as marker tape tail 200. In this embodiment, the device is a 26 mm device with a 144-wire braid, a 40 mm diameter, and 12 groups on each disc, each group containing 12 wires (and therefore 12 marker tape tails 200). In this configuration, ensuring that the tails on the proximal disc 206 completely collapse and simultaneously enter the loader or sheath may be difficult for devices with stronger / stiffer braids, and the device may not collapse uniformly. Once the wires are grouped together and secured by their respective marker tapes, the distal disc 205 may also not collapse well due to asymmetry or inhomogeneity in the braid. Another problem caused by non-uniform loading is that the tail on any disc can cross and entangle with other tails on the same disc, which may prevent the device from fully deploying or returning to its original shape. In known medical devices, strong braids (such as nickel-titanium alloy braids) are used to prevent disc bulging. Ideally, weaker / softer braids reduce the risk of tissue erosion. Once deployed, the device may also fail to conform to the anatomy. Disc bulging is undesirable because it leads to inadequate defect closure and results in a heavier mass within the anatomy (i.e., a bulky device that is not recommended). Loading and deployment of this type of device involves several operations... Figure 3A The configuration shown is as follows (for clarity, the 12 marker band tails 200 on the distal disk 205 are not shown). In this embodiment, each marker band tail 200 of the proximal disk 206 (as shown) Figure 2 (As shown) A marking strip tail with holes 304 is formed by welding holes, as shown. Figure 3B Medium magnification shown (the marker tape tail 200 of the distal disc 205 is not shown for clarity). End screws 303 are sewn to each marker tape tail using eyelets 304, facilitating passage through a delivery system (e.g., Amplatzer). TM Delivery system) delivers braided plugs.

[0043] The medical device of the present invention includes a braided occlusion device with an intervention channel and (multiple) patch closure members, which at least avoids these disadvantages of known medical devices.

[0044] Loading and deployment

[0045] The embodiments described herein can improve the loading and deployment of the disclosed device, which in turn can improve device performance and treatment outcomes.

[0046] a. Braided mesh with closed end

[0047] In an example embodiment, the present disclosure is directed to an occlusive medical device comprising a braided frame. The braided frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between and connecting the annular distal disc to the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame. The braided frame is formed from a closed-end braid.

[0048] Closed-end braids are a well-known braiding manufacturing technique. The use of closed-end braids on occluder devices has not been known. While a well-known manufacturing technique, to the best of Applicant's knowledge, closed-end braids of large diameters (30 mm or greater) and large numbers of wires (72 or more) have not been manufactured and are capable of being collapsed to small diameters (14 French or less) for delivery through a sheath.

[0049] The use of closed-end braids to form the devices disclosed herein allows for symmetry and uniformity of the braid on the distal disc of the device, as well as a reduction in the number of tails and the amount of metal that protrudes into the center of the device. The removal of distal tails eliminates the possibility of the tails tangling during loading and / or deployment, and also reduces the number of attachment points that can become a source of broken wires and chafing.

[0050] The number of wires used, the PPI (i.e., the number of braided nodes per inch, or the number of weft yarns per inch), the size of the wires used to form the closed end, and the size of the pin all affect the ability of the closed end to fully collapse. Figure 4A and Figure 4B Devices formed with closed-end braids 402 are shown, therefore, with no marker band tails 200 on the distal disc 205, as compared to non-closed-end braids shown in Figure 2 , Figure 3A and Figure 3B Note that the marker band tails 200 on the distal disc 205 are not shown in Figure 3A or Figure 3B for clarity). In non-closed-end braid configurations, the braid can only collapse to a certain diameter before it inevitably locks, at which point the device can become tangled or need to be folded to continue collapsing, both of which are undesirable as they increase the loading force required to collapse the device and the profile of the delivery system. Using a closed-end braid, as in Figure 5A and Figure 5BThe closed end braid with wire loops 502 (formed, for example, by wrapping wire around a pin (not shown) and creating loops 502) allows the braid to fully collapse without locking, as further shown. This closed end braid design can be formed using any number of filaments, any loop size, or PPI.

[0051] b. Wire loop separator

[0052] In an example embodiment, the present disclosure is directed to an occlusive medical device comprising a braided frame. The braided frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other filament tail of at least one of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame.

[0053] In Figure 6 In the illustrated embodiment, the wire loops 602 are attached alternately to the tails (i.e., the loops are attached to every other tail in a clockwise or counterclockwise manner), thereby forcing the tails apart and ensuring that they do not interfere with each other during loading and / or deployment. In this embodiment, six 0.0065 inch Nitinol wire loops are used on each disc. Wire loops of any form, size, or style can be used to keep the tails separate and suitable for successful loading and deployment. Depending on the embodiment, the wire loops can be attached to the tails in many different configurations (e.g., to every group of tails, or every third group of tails, etc.).

[0054] c. Shaped wire loop extending to centering marker band

[0055] In an example embodiment, the present disclosure is directed to an occlusive medical device comprising a braided frame. The braided frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and a plurality of wire loops attached to every other filament tail of at least one of the annular distal disc or the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame.

[0056] In addition to keeping the tails separate as described above, the shaped filaments can also serve as a mechanism for loading the device while maintaining a low radial stiffness of the access device.Figure 7 A device is shown with shaped wire loops 702 that are welded into each marker band in a helical fashion and converge into the central marker band (which can be similar to or used in conjunction with end screw 303). In this embodiment, twelve 0.0065 inch nitinol wire loops are used on the proximal disc 206, each connecting a respective tail to the central marker band. The wire loops 702 that come together at the central marker band can also be used with alternative cable attachment mechanisms (e.g. ball and socket, tether, lasso) for loading and deployment. Any shape of wire that is not directly opposite one another on the device can be used to maintain the compressibility and uniformity of the device.

[0057] d. Polymer coating

[0058] In an example embodiment, the present disclosure relates to an occlusive medical device comprising a braided frame. The braided frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between and connecting the annular distal disc to the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame. The braided frame is coated with at least one polymeric coating.

[0059] Interventional access occlusion devices made from high PPI braid and low PPI braid deform when loaded, particularly when the distal disc 205 collapses into a sheath. Deformation is worse in devices with lower PPI, the wires take a more direct path around the device, so the device is more rigid and difficult to pull down. As a result, these wires tend to shift position relative to one another when the device collapses into a loader or sheath, resulting in wire bunching and deformation (e.g. “cobra deformation”). Adding a thin polymeric coating to the wires in the device, particularly at the disc edges, locks these wires in place relative to one another, reducing the amount of deformation that occurs. Figure 8 A thin layer of polyurethane coating 802 is shown applied over the braided device. Depending on the embodiment, any suitable polymer can be used to achieve the desired amount of wire / braid immobilization.

[0060] e. Rolled up braided mesh

[0061] In an example embodiment, the present disclosure relates to an occlusive medical device comprising a braided frame. The braided frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between and connecting the annular distal portion to the annular proximal disc. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame. The braided frame is rolled over on itself to form two layers of braid in at least one of the annular distal disc or the annular proximal disc.

[0062] The use of a rolled braid to form the device of the present disclosure allows for symmetry and uniformity of the braid on the distal disc of the device, as well as a reduction in the number of tails and the amount of metal protruding into the center of the device. The symmetry of the braid throughout the device allows for better, more uniform collapse of the device. Figure 9 and Figure 10 Potential braid path configurations relative to the marker band tails 200 are shown for making and using a rolled braid. Increasing the PPI in the braid starting from the disc edge or closer to the interior of the device will accommodate the difference in braid layer length as the device collapses (e.g., the reduced profile of the device), so the distal disc edge collapses into the sheath last. Additionally, returning the braid to the center and toward the opposite disc can minimize bulging, thereby reducing the risk of tissue erosion upon deployment of the device.

[0063] f. Method of using device

[0064] According to the present disclosure, the occlusive medical device disclosed herein relates to a method of eliminating or reducing cardiac tissue erosion. The method comprises providing an occlusive medical device comprising a braided frame, the braided frame comprising an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between and connecting the annular distal portion to the annular proximal disc; wherein the radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame; constraining the occlusive medical device from a pre-set expanded profile to a reduced profile; delivering the occlusive medical device; deploying the occlusive medical device such that the frame returns to the pre-set expanded profile; and increasing the compliance of the occlusive medical device on the cardiac tissue.

[0065] Mitigation of patch ballooning

[0066] The embodiments disclosed herein mitigate bulging of the patch enclosure in the middle of the device through the patch design and / or the patch support of the device, while maintaining a majority of the non-braided surface area in the middle of the device (i.e., within the interventional passageway).

[0067] In exemplary embodiments of an interventional access occluder, such as those shown in Figures 2-8 and Figure 11 at least one patch or patch closure (not shown) is attached to the frame of the occlusion device to close or limit inflow (e.g., bodily fluids) through the passage of the occluder (i.e., the interventional access). In this way, the patch closure(s) ensure that the occluder performs its occlusive function, as described herein above. However, the patch closure is formed of an occlusive yet still penetrable material, thereby leaving the passage of the medical device through the occluder unencumbered. In exemplary embodiments, the "penetrable" material is more easily punctured, separated, cut, pierced, or otherwise penetrated than the material forming the frame.

[0068] In some embodiments, the patch closure(s) can operate in tandem with the woven frame of the device during deployment (including loading, advancement, and / or retrieval) of the occluder, such that the patch closure(s) collapse and expand with the collapsing and expanding of the frame (i.e., as the frame transitions between the collapsed and expanded configurations). In exemplary embodiments, the patch closure(s) are flexible, thereby simplifying deployment of the occluder and increasing the penetrability of the patch closure(s) (particularly when compared to the more rigid, denser traditional wire mesh forming the distal and proximal discs 205, 206, respectively).

[0069] a. Patch design

[0070] In exemplary embodiments, the present disclosure is directed to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between and connecting the annular distal disc to the annular proximal disc, and at least one patch closure. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passage through the woven frame.

[0071] The patch closure can be formed of any suitable material. It is contemplated that a bioabsorbable material that promotes endothelialization can be used to form the patch closure. After the occluder is deployed, the bioabsorbable material will be absorbed while tissue grows over the occluder. Thus, the passageway (or access channel) will be accessible through a relatively soft, thin layer of tissue. Such bioabsorbable materials can include polylactic acid (PLA), poly-L-lactic acid (PLLA), poly-lactic-co-glycolic acid (PLGA), polycaprolactone (PCL), combinations thereof, and / or any suitable bioabsorbable material. Alternatively, the patch closure is at least partially non-bioabsorbable and can be formed of polyesters, polyethylene terephthalate (PET), silicone, polyurethane, combinations thereof, other polymers, and / or the like. In some embodiments, the patch closure can be formed partially of a bioabsorbable material and partially of a non-bioabsorbable material. The patch closure can be formed of woven, knitted, or braided materials, printed materials, molded materials, and / or the like. In an exemplary embodiment, laser cutting a diamond or auxetic pattern into the patch will enable additional stretching, thus not requiring a high-elasticity material.

[0072] In some embodiments, at least one polymeric coating is applied to the patch to reinforce the patch. Depending on the embodiment, the polymeric coating is applied to a portion of the patch, to multiple portions of the patch, or to the entire patch. The reinforcing polymeric coating can be applied by spraying or dip coating.

[0073] The use of an elastic polymeric patch and sewing, suturing, or otherwise securing it in a stretched state into the device can help prevent some patches from ballooning after the device is deformed. Other methods for securing / attaching the patch closure to the device frame can include any suitable method, such as by suturing, bonding (with other polymers, thermal bonding, by lamination, etc.), welding, adhesion, folding and / or recycling the patch closure within the frame material, overmolding, any combination thereof, and / or any other suitable attachment mechanism.

[0074] In some embodiments, a suitable suture, thread, or yarn type of material is applied / affixed to the patch using a needle to reinforce the patch. Depending on the embodiment, the material is sewn, stitched, adhered, and / or attached to the patch at a point, multiple points, at a section, at multiple sections, or across the entire patch. Suitable suture, thread, or yarn type of material for reinforcing the patch can be any suitable biocompatible polymer, or biodegradable / bioabsorbable material. In alternative embodiments, the suture (or similar material) can be wrapped around a series of pins to form a suitable patterned structure (e.g., a star pattern, a cross-hatch pattern, a zig-zag pattern, etc.). This would span a desired section (e.g., in the middle of the patch and / or at a distance or distances from the center) or across the entire patch in order to provide the desired reinforcement to the patch upon attachment. In some embodiments, the reinforcing material (e.g., the patterned structure) is attached to the patch on the inner surface of the patch (e.g., for a patch positioned within the proximal disc, the inner surface of the patch would be considered the surface of the patch facing the device waist, as opposed to the surface of the patch facing the proximal disc of the device), such that the material can or can not be fully adhered to the patch. That is, in certain areas / points, the reinforcing material can be tightly attached to the patch, while in other areas / points, the reinforcing material can be more loosely attached. In some embodiments, the patterned structure can be sewn, stitched (e.g., stitched using a flat stitch, a loop stitch, a whip stitch, and any combination thereof), adhered, and / or otherwise attached to the patch material using any suitable method in order to reinforce the patch.

[0075] This can be used in cases where lamination and adhesive bonding or clamping it between the patch and another material does not work.

[0076] b. Patch support

[0077] In some embodiments, the disclosure relates to an occlusive medical device comprising a woven frame. The woven frame comprises an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, a waist member extending between the annular distal disc and the annular proximal disc and connecting the annular distal portion to the annular proximal disc, and a plurality of woven wire spokes of a respective set of wire attached to at least one of the annular distal disc or the annular proximal disc, a tail of the respective set of wire, and a centering marker band. The radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame.

[0078] As Figure 11As shown, the (3 or more spokes) spokes (e.g. Nitinol spokes) 1102 formed from braided wire can be used to house the patch closure and prevent it from bulging. The Nitinol spokes formed from braided wire increase the radial stiffness of the disc, which can increase the risk of atrial erosion. Therefore, to reduce the radial stiffness, a smaller diameter and / or less Nitinol wire or strut can be welded or adhered to the end of the braid tail before terminating in the center of the device. The shape of the wire can also help reduce the radial stiffness of the disc(s) (see also Figure 7 ).

[0079] It is also possible to braid a number (2 or more) of braided wires 1202 from the braid to the middle of the device Figure 12 ). This can be performed on the braid with closed end (distal end) and the braid tail (proximal end). The purpose of these wires 1202 is to house the patch closure; however, they must have the ability to collapse into the loader or sheath. The tail of the braid (e.g. Nitinol braid tail) is fixed to the patch closure and the few braided wires 1202 extending to the middle of the device are only used to prevent the patch closure from bulging when deployed.

[0080] At the proximal end of the braid, a relatively strong patch material (woven or knit) can be employed, or a reinforced patch can be used that is reinforced from the center of the device to each tail to facilitate loading and retrieval of the device. The reinforced portion of the patch can include any biocompatible polymer or bioabsorbable material. The reinforced patch provides the ability to use a non-woven thin patch similar to the patch currently used on the Amplatzer TM device while reinforcing the areas needed for collapsing the device. The reinforcing material can be attached to the inside of the patch so that the endothelial reaction is not affected, or it can be attached on the outside of the patch if manufacturability is deemed necessary. Furthermore, the tail of the Nitinol braid can be stuffed into the patch to provide a continuous surface to achieve a uniform healing reaction. Furthermore, the reinforcing section can be attached to the patch material using any suitable method (e.g. but not limited to lamination, adhesion, or ultrasonic welding to the patch material), and it can extend from the center of the patch all the way to the outer diameter of the patch, or only to the termination point of the braid. Furthermore, the reinforcing material 1303 itself Figure 13 ) or using a separate piece of suture (not shown) can be sutured to the braid termination point. In Figure 14In the illustrated embodiment, slits 1401 are formed in the patch 1402, and reinforcing material 1403 extends radially from the center and surrounds each slit (thus forming an elliptical reinforcing material 1403 surrounding each slit 1401), such that each braid termination point (not shown) is tucked into the slit 1401 to provide a continuous surface for the deployed occluder to achieve a uniform healing response. The elliptical shape of the reinforcing material 1403 provides a reinforced area around each tail and provides something that can be tied to prevent the patch from tearing during device loading. A separate suture piece (not shown) can be used near the slit 1401 at location 1405 to attach the reinforcing material 1403 to the braid termination point.

[0081] The delivery system attached to the reinforcing patch may include a suture loop or hub (e.g., an end screw, ball socket, etc., similar to end screw 303) at the center of the reinforcing patch, which is sutured, bonded, laminated, or ultrasonically welded to the reinforcing patch. Furthermore, the delivery system may include a tether 1501 encircling the center of the reinforcing patch, which does not require any external features of the patch itself. Figure 15 Finally, since the reinforcing patch is likely to extend beyond the device frame in its collapsed state and has little column strength for maneuverability, the delivery system may require a short lumen 1601 built into the actuator mechanism to house the patch material, allowing the actuator to engage with the braided frame during advancement. Figure 16 ).

[0082] c. Method of using device

[0083] According to this disclosure, the occlusive medical device disclosed herein relates to a method for eliminating or reducing cardiac tissue erosion. The method includes providing an occlusive medical device comprising a braided frame, the braided frame including an annular distal disc having a radially outer surface and a radially inner surface, an annular proximal disc having a radially outer surface and a radially inner surface, and a waist member extending between the annular distal disc and the annular proximal disc and connecting the annular distal portion to the annular proximal disc; wherein the radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed pathway through the braided frame; confining the occlusive medical device from a predetermined expanded form to a reduced form; delivering the occlusive medical device; deploying the occlusive medical device such that the frame returns to the predetermined expanded form; and increasing the compliance of the occlusive medical device with cardiac tissue.

[0084] It should be understood that any feature of any embodiment disclosed herein can be combined with any other feature. For example, an interventional channel occluder may include a polymer coating and a closed-end braided frame.

[0085] Further, although the occluders of the present disclosure have been described as being suitable for deployment within ASDs, these occluders are suitable for deployment in other tissues and / or defects, including for use in fenestrated ASDs, VSDs, and / or atrial shunts.

[0086] While embodiments of the application have been described, it will be apparent to those skilled in the art that many changes, modifications, substitutions, deletions, and additions can be made in the design, operation, and details of the present application without departing from the spirit and scope of the application. For example, it is contemplated that the device body portion can be cylindrical, barrel-shaped, concave, convex, conical, or combinations of shapes without departing from the present application. In addition, all directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are used only for identification in accordance with the present disclosure and do not constitute a limitation as to the position or orientation of the present disclosure. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure can be made without departing from the spirit of the disclosure as defined in the appended claims

[0087] Many modifications and other embodiments of the present application set forth herein will come to mind to one skilled in the art to which the present application pertains having the benefit of the teachings presented in the foregoing description and the associated drawings. Therefore, it is to be understood that the application is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0088] Any patent, publication, or other disclosure material identified herein that is said to be or to contain various subject matter is incorporated by reference herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material expressly set forth in this document. That is, in the event of a conflict, in determining the scope of the disclosure, the definition provided herein will control. Similarly, the material incorporated by reference herein is not intended to be disclaimed from the instant application. To the extent that any incorporated material contradicts or contradicts any disclosed aspect of the present application, such contradiction shall only be to the extent of such specific disclosure.

Claims

1. An occlusive medical device, comprising: a woven frame, comprising: an annular distal disc having a radially outer surface and a radially inner surface; an annular proximal disc having a radially outer surface and a radially inner surface; and a waist member extending between and connecting the annular distal disc to the annular proximal disc, wherein the radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame; and wherein the woven frame is formed from a plurality of shaped wires in a closed- ended weave, each of the plurality of shaped wires being attached to a respective one of a plurality of wire sets' tails and a plurality of mid-marking bands on at least one of the annular distal disc or the annular proximal disc; and at least one patch closure coupled to the woven frame to occlude the passageway through the woven frame.

2. The occlusive medical device of claim 1, wherein, The closed end of the closed-ended weave is formed from a plurality of wire loops on the annular proximal disc, wherein each of the plurality of wire loops is circumferentially spaced apart from an adjacent wire loop.

3. The occlusive medical device of claim 1, further comprising a plurality of wire loops attached to every other wire set's tail of at least one of the annular distal disc or the annular proximal disc.

4. The occlusive medical device of claim 1, wherein, The woven frame is coated with at least one polymeric coating.

5. The occlusive medical device of claim 4, wherein, The at least one polymeric coating is a polyurethane coating.

6. The occlusive medical device of claim 1, wherein, The woven frame is formed in two layers on itself to form at least one of the annular distal disc or the annular proximal disc.

7. The occlusive medical device of claim 1, further comprising a plurality of woven wire spokes, each of the plurality of woven wire spokes being attached to a respective wire set's tail and a mid-marking band of at least one of the annular distal disc or the annular proximal disc.

8. The occlusive medical device of claim 1, wherein, The at least one patch closure is a reinforced patch closure.

9. A method of forming an occlusive medical device, the method comprising: forming a woven frame having a woven material, the woven frame comprising: an annular distal disc having a radially outer surface and a radially inner surface; an annular proximal disc having a radially outer surface and a radially inner surface; and a waist member extending between and connecting the annular distal disc to the annular proximal disc, wherein the radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the woven frame, wherein forming the woven frame comprises: forming the woven frame in a closed-ended weave from a plurality of shaped wires; and attaching each of the plurality of shaped wires to a respective one of a plurality of wire sets' tails and a plurality of mid-marking bands on at least one of the annular distal disc or the annular proximal disc; and coupling at least one patch closure to the braided frame to occlude a passageway through the braided frame.

10. The method of claim 9, wherein, forming a closed end of the braided material with a closed end includes forming an annular proximal disc with a plurality of wire loops, wherein each wire loop of the plurality of wire loops is circumferentially spaced apart from an adjacent wire loop.

11. The method of claim 9, further comprising attaching a plurality of wire loop rings to the braided frame, including attaching at least one wire loop to a tail of every other wire bundle of at least one of the annular distal disc or the annular proximal disc.

12. The method of claim 9, further comprising coating the braided frame with at least one polymer coating.

13. The method of claim 9, wherein forming a braided frame further comprises rolling the braided material with a closed end upon itself to form two layers of braided material in at least one of the annular distal disc or the annular proximal disc.

14. The method of claim 9, further comprising attaching each of a plurality of braided wire spokes to a tail of a respective wire bundle and a center marker band of at least one of the annular distal disc or the annular proximal disc.

15. An occlusive medical device, comprising: a braided frame, including: an annular distal disc having a radially outer surface and a radially inner surface; an annular proximal disc having a radially outer surface and a radially inner surface; a waist member extending between and connecting the annular distal disc to the annular proximal disc; and at least one reinforcing patch closure; wherein the radially inner surface of the annular distal disc, the waist member, and the radially inner surface of the annular proximal disc define an unobstructed passageway through the braided frame; and wherein the braided frame is formed from a plurality of shaped wires in a braided material with a closed end, each shaped wire of the plurality of shaped wires being attached to a tail of a respective wire bundle and a center marker band of a plurality of wire bundles on at least one of the annular distal disc or the annular proximal disc, each respective wire bundle tail extending radially inward beyond the braided material with a closed end on at least one of the annular distal disc or the annular proximal disc.

16. The occlusive medical device of claim 14 or 15, wherein the at least one reinforcing patch closure is made of an elastic polymer.

17. The occlusive medical device of claim 14 or 15, wherein the at least one reinforcing patch closure includes a auxetic pattern covering a surface area of the at least one reinforcing patch closure.

18. The occlusive medical device of claim 14 or 15, wherein, the at least one reinforcing patch closure is sutured into the braided frame in a stretched state.

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