WO2025264398A1

WO2025264398A1 - Transcatheter atrial septal closure device

Info

Publication number: WO2025264398A1
Application number: PCT/US2025/032515
Authority: WO
Inventors: Spencer Toder
Original assignee: Tavr Solutions LLC
Current assignee: Tavr Solutions LLC
Priority date: 2024-06-19
Filing date: 2025-06-05
Publication date: 2025-12-26
Anticipated expiration: 2026-12-19

Abstract

A closure device for sealing an atrial septal defect is provided. The closure device includes a distal closure portion and a proximal closure portion having a peripheral frame. The distal closure portion includes a distal membrane covering a plurality of distal fingers that extend in a distal direction. The proximal closure portion includes a proximal membrane covering a plurality of proximal fingers that extend in a proximal direction. The closure device also includes a waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers. The distal closure portion is configured to sealingly engage one of the left or right side of a septal wall, the proximal closure portion is configured to sealingly engage the other of the left or right side of the septal wall, and the waist section is configured to be positioned and centered in an atrial septal defect between the left and the right septal wall.

Description

TRANSCATHETER ATRIAL SEPTAL CLOSURE DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No. 63/661,678 filed on June 19, 2024, which is incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates to an occlusion or closure device to seal an atrial septal defect.

BACKGROUND

[0003] The heart has two sides separated by two inner dividing walls, or septa, which are known as the interatrial septum and the interventricular septum. The right side of the heart receives oxygen-poor blood from the body and pumps it into the lungs, where it is oxygenated. The left side of the heart receives the oxygen-rich blood from the lungs and pumps it to the body. The interatrial septum separates the upper chambers of the heart, and the interventricular septum separates the bottom chambers of the heart. Each septum serves to prevent the mixing of blood between the right and left sides of the heart.

[0004] Apertures, or holes, in the septa of the heart are defects that can affect the normal flow of blood through the heart. Such apertures can occur congenitally or be caused by medical procedures including puncturing by a medical device or the like. An aperture in the interatrial septum between the heart's two upper chambers is known as an atrial septal defect ("ASD"), with secundum ASDs being the most common form of ASDs. An ASD can cause the mixing of oxygen-rich blood with oxygen-poor blood. Such mixing of blood with differing oxygen contents can cause blood with high oxygen content to be pumped to the lungs rather than the body, and blood with low oxygen content to be pumped to the body rather than the lungs, which is known as blood shunting. Depending upon the size of the aperture and the amount of blood shunting, this can result in a spectrum of diseases including, without limitation, abnormal heart rhythms, abnormal elevation in blood pressure in the pulmonary arteries, and congestive heart failure, embolic phenomena and strokes.

[0005] Over the past few decades, minimally invasive treatment techniques have been developed, and transcatheter treatment techniques have become preferred techniques for treating ASDs and avoiding the adverse side effects common to other treatment techniques. Specifically, percutaneous transcatheter treatment techniques provide for a safer and less invasive medical procedure. However, occlusion or closure devices used in known percutaneous transcatheter treatment techniques are not without their disadvantages. A number of transcatheter occlusion or closure devices generally employ umbrella-like structures to occlude or close ASDs. Known occlusion or closure devices have a number of specific disadvantages, including, but not limited to, a propensity to tear or fracture, a propensity to perforate body tissue, including heart tissue, a propensity for residual leaking, an elevated risk of complications due to thrombus, a tendency to erode the atrial and aortic walls, migration and other drawbacks. Further, many known occlusion or closure devices have high profiles and include large masses of foreign material, such as nitinol, an excess amount of occlusion or closure membrane or fabric, that may impair the adaptation of the device by the patient's body.

[0006] Another disadvantage of known occlusion or closure devices is that, in cases where the patient may need a subsequent transseptal procedure, the presence of the deployed or implanted device generally inhibits the ability to transseptally puncture the device for purposes of recrossing the septum or permitting interatrial re-entry. This disadvantage results from the fact that the structure of the deployed or implanted device may block the passage of certain-sized sheathes or other medical instruments through the septum and/or comprises materials that are incapable of permitting single or repeated transseptal punctures or interatrial re-entry therethrough. Further, after such occlusion devices are punctured, they cannot be re- sealed.

[0007] Another disadvantage of known occlusion or closure devices is their limited ability, or complete inability, to occlude or close holes or apertures that are located relatively low in a heart or its septum, because of the potential interaction or interference of such occlusion or closure devices with the tricuspid or mitral valves.

SUMMARY

[0008] The present disclosure relates to a device for closing an opening in a bodily tissue wall (also referred to herein as a “closure device”). The device can be used to treat abnormal openings, either man-made, congenital, or acquired, for example. In an aspect, a closure device is provided that comprises a continuous unitary frame. The continuous unitary frame has a plurality of radially extendible distal fingers extending in a distal direction and a plurality of radially extendible proximal fingers extending in a proximal direction. The proximal direction extends in a direction different than the distal direction. The continuous unitary frame further includes a waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers. The device further includes a pre-shaped distal peripheral frame attached to or integral with the plurality of distal fingers and/or a pre- shaped proximal peripheral frame attached to or integral with the plurality of proximal. The closure device also includes a distal membrane covering at least one side of the plurality of distal fingers and/or a proximal membrane covering at least one side of the plurality of proximal fingers. The closure device is expandable from a radially collapsed configuration in which the continuous unitary frame is elongated axially to a radially expanded configuration in which the continuous unitary frame is shortened axially. In the radially expanded configuration, the waist section is configured to be positioned within the opening in the tissue wall, the plurality of distal fingers is configured to engage one side of the tissue wall defining the opening, and the plurality of proximal fingers is configured to engage the other side of the tissue wall defining the opening such that the distal and/or proximal membranes are pressed against the sides of the tissue wall to seal the opening. The closure device has a reduced propensity for tearing or rupturing, permits transseptal punctures or interatrial re-entry, and is configured to not interact or interfere with adjacent tissue, such as the aorta, tricuspid or mitral valves of the heart or other adjacent tissue where it would be undesirable to have such interference or interaction. Further, the closure device has very little amount of metal, which makes the device more malleable.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a schematic illustration of a human heart including an ASD.

[0010] FIG. 2 is a top view of a frame of a closure device according to an aspect of the present disclosure.

[0011] FIG. 3 is a perspective view of the frame of FIG. 2.

[0012] FIG. 4 is a side view of the frame of FIG. 2.

[0013] FIG. 5 is a perspective view of closure device according to an aspect of the present disclosure.

[0014] FIG. 6 is a schematic illustration of a cardiac septum including an ASD.

[0015] FIG. 7 is a schematic illustration of a closure device placed against the cardiac septum of FIG. 6.

[0016] FIG. 8 is a side view of FIG. 7.

[0017] FIG. 9 is a schematic illustration of a closure device in an elongated position prior to loading into a delivery device according to an aspect of the present disclosure. [0018] FIG. 10 is a schematic illustration of a distal and/or proximal membrane of a closure device according to an aspect of the present disclosure.

[0019] FIG. 11 is a schematic illustration of the distal and/or proximal membrane of FIG. 10 with a pulling thread attached to the membrane.

[0020] FIG. 12 is a schematic illustration illustrating a side view of the closure device of FIG. 9.

[0021] FIG. 13 is a schematic view of the closure device of FIG. 9 loaded into a catheter.

[0022] FIG. 14 is a schematic illustration of the closure device of FIG. 9 prior to insertion into a ASD of a cardiac septum with the cardiac septum represented by a silicone sheet and the aperture in the silicone sheet representing the ASD.

[0023] FIG. 15 is a schematic illustration of the closure device of FIG. 9 inserted through the ASD.

[0024] FIG. 16 is a schematic illustration of a distal closure portion of the closure device of FIG. 9 deployed on the left side of the cardiac septum.

[0025] FIG. 17 is a schematic illustration of the proximal portion of the closure device of FIG. 9 deployed and positioned against the right side of the cardiac septum.

[0026] FIG. 18 is a schematic illustration of the closure device of FIG. 9 in a fully deployed position

[0027] FIG. 19 is a perspective view of a frame of a closure device according to an aspect of the present disclosure.

[0028] FIG. 20 is a top view of the frame of FIG. 19.

[0029] FIG. 21 is a side view of the frame of FIG. 19.

[0030] FIG. 22 is a perspective view of a frame of a closure device according to an aspect of the present disclosure.

[0031] FIG. 23 is a top view of the frame of FIG. 22.

[0032] FIG. 24 is a side view of the frame of FIG. 22.

[0033] FIG. 25 is a top view of a closure device according to an aspect of the present disclosure.

[0034] FIG. 26 is a perspective view of a closure device according to an aspect of the present disclosure.

[0035] FIG. 27 is a top view of the closure device of FIG. 26.

[0036] FIG. 28 is a side view of the closure device of FIG. 26.

[0037] FIG. 29 is a top view of a distal peripheral frame attached to a distal plurality of fingers according to an aspect of the present disclosure. [0038] FIG. 30 is a perspective view of a closure device with a distal peripheral frame attached to a distal membrane and a distal plurality of fingers and a proximal peripheral frame attached to a peripheral membrane and a proximal plurality of fingers according to an aspect of the present disclosure.

[0039] FIG. 31 is a top view of FIG. 30.

[0040] FIG. 32 is a top view of a closure device according to an aspect of the present disclosure.

[0041] FIG. 33 is a top view of a closure device with the distal side of the device pressed against a septal wall according to an aspect of the present disclosure.

[0042] FIG. 34 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0043] FIG. 35 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0044] FIG. 36 is a plan view of the continuous one-piece unitary frame of FIG. 35.

[0045] FIG. 37 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0046] FIG. 38 is a plan view of the continuous one-piece unitary frame of FIG. 37.

[0047] FIG. 39 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0048] FIG. 40 is a plan view of the continuous one-piece unitary frame of FIG. 39.

[0049] FIG. 41 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0050] FIG. 42 is a plan view of the continuous one-piece unitary frame of FIG. 41.

[0051] FIG. 43 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0052] FIG. 44 is a side cross-sectional view of the continuous one-piece unitary frame of FIG. 43.

[0053] FIG. 45 is a perspective view of a continuous one-piece unitary frame of a closure device according to an aspect of the present disclosure.

[0054] FIG. 46 is a side cross-sectional view of the continuous one-piece unitary frame of FIG. 45. DETAILED DESCRIPTION

[0055] The present disclosure relates to medical devices for occluding or closing an opening in body tissue, including congenital heart defects. Such medical devices include collapsible and deployable atrial septal occlusion or closure devices that can be delivered through a catheter or sheath.

[0056] As used herein with respect to a described element, the terms "a," "an," and "the" include at least one or more of the described element(s) including combinations thereof unless otherwise indicated. Further, the terms "or" and "and" refer to "and/or" and combinations thereof unless otherwise indicated. By "substantially" is meant that the shape or configuration of the described element need not have the mathematically exact described shape or configuration of the described element but can have a shape or configuration that is recognizable by one skilled in the art as generally or approximately having the described shape or configuration of the described element. The terms "first," "second," etc. are used to distinguish one element from another and not used in a quantitative sense unless indicated otherwise. By "integral" or "integrated" is meant that the described components are fabricated as one piece and not as multiple components assembled together. As used herein a "patient" includes a mammal such as a human being. All closure devices as described herein are used for medical purposes and are therefore sterile. Although the drawings show certain elements of a closure device in combination, it should be noted that such elements can be included in other embodiments or aspects illustrated in other drawings or otherwise described in the specification. In other words, each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments of the disclosure including patent applications incorporated by reference herein. [0057] FIG. 1 illustrates a human heart 10, having a right atrium 12, a left atrium 14, an atrial septum 16, and a septal aperture 22. The atrial septum 16 generally comprising a septum primum 18 and septum secundum 20. The anatomy of the septum 16 can vary widely within a population. For example, in some people, the septum primum 18 may be quite thin. As used herein, "left" refers to the left chambers of the heart 10, including the left atrium 14 and left ventricle, and "right" refers to the right chambers of the heart 10, including the right atrium 12 and right ventricle.

[0058] Referring to FIGs. 2-5, a closure device 24 is provided that comprises a continuous unitary frame 26. Frame 26 can comprise a plurality of radially extendible distal fingers 28 extending in a distal direction Pl and a plurality of radially extendible proximal fingers 30 extending in a proximal direction P2. As can be seen be FIG. 5, direction Pl and direction P2 extend in different, non-parallel directions. Such a non-parallel alignment can result in greater compressive forces exerted by the plurality of fingers against the respective lateral faces of tissue defining the bodily opening to secure the device to the lateral faces of the tissue to sufficiently seal the bodily opening and inhibit the flow of liquids therethrough. Because the frame can be a continuous unitary structure, the plurality of proximal fingers and the plurality of distal fingers are not mechanically separate and are integrally connected or continuously attached. For example, the frame can comprise a one-piece single wire or tubular structure. In certain aspects, the plurality of distal fingers and the plurality of proximal fingers alternate such that a distal finger is immediately adjacent to a proximal finger and vice versa. In such an aspect, every other finger is a distal finger and the remaining fingers are proximal fingers. FIGs. 1 and 2 illustrate such an alternating pattern where distal finger 28a (for example) is immediately adjacent to proximal finger 30a (for example) because there are no intervening fingers between distal finger 28a and proximal finger 30a. In other words, for any given distal finger, such finger can be immediately adjacent to a proximal finger such that there are no intervening distal finger(s) between the given distal finger and the immediately adjacent proximal finger. Similarly, for any given proximal finger, such finger can be immediately adjacent to a distal finger such there are no intervening proximal finger(s) between the given proximal finger and the immediately adjacent distal finger. Such a configuration where this alternating pattern is repeated for all distal and proximal fingers is best illustrated in FIGs. 3 and 5. However, the number of distal fingers can be more than the number of proximal fingers and vice versa. As shown in FIG. 4, frame 26 includes a waist section 34 between the plurality of distal fingers 28 and the plurality of proximal fingers 30. The waist section 34 is defined by a plurality of vertices 32 between immediately adjacent fingers and is configured to be positioned within the bodily opening and can, for example, contact the walls of the tissue defining the bodily opening to sealingly engage the bodily opening.

[0059] The device should be appropriately sized or oversized to the aperture of the defect. The size and shape of the plurality of fingers and the waist section can correspond with the size of the bodily opening and adjacent tissue and can vary depending on the location of the bodily opening. For example, the size and shape of the plurality of fingers can be such that they sealingly engage the lateral faces of the bodily opening to occlude the bodily opening and the size and shape of the waist section can be such that it can be positioned within the bodily opening. The shape and design of the fingers can also be such that they avoid any potential interaction or interference with surrounding bodily and/or medical structure such as, for example, the mitral valve, tricuspid valve and pulmonary veins. The plurality of distal fingers and the plurality of proximal fingers can each have an arcuate tip as best illustrated in FIGs. 2, 3 and 5. In certain aspects, each of the fingers are substantially the same size. In other aspects, one or more of the fingers can be different sizes. In either case, the shape of the fingers defines a shape that allows the fingers to engage the lateral tissue faces defining the bodily opening, such as the septum of the heart having an ASD, in a clasp or clamp-like manner. Referring to FIG. 19-21, in certain aspects, a closure device 27 has fingers 29 with a petal shape. Such petal shaped fingers can extend in different directions s such that the frame’s petals on one side would all sit radially along the surface of a shallow cone when deployed. In particular, fingers 29 from one side cross over an imaginary plane (depicted by reference character P in FIG. 21) in an unbound state acting similar to an unstretched/uncompressed spring. Once the crossing fingers are placed between the septum, for example, the fingers will deflect. This deflection from an unbound state provides a clamping force to keep the frame secured in place and maintains the membrane close to the septum’s surface for less leakage. In other words, such “crisscrossing” of the fingers preloads the fingers to better clamp on the septum & pull in the sealing membrane to sit against the septal wall to minimize leakage.

[0060] As stated above, the frame can comprise a wire or tubular structure. The diameter or thickness of the wire or tubular structure can be generally proportional to the size of the closure device. For example, the diameter or thickness of the wire or tubular structure can be between about 50 pm and about 2000 pm. In other aspects, the diameter can be between about 200 pm and about 1000 pm. In other aspects, the diameter can be between about 200 pm and about 300 pm. In yet other aspects, the diameter can be approximately 300 pm. [0061] As described in more detail below, the closure device is flexible and is configured to assume both a radially collapsed configuration in which the frame is elongated axially and a radially expanded configuration in which the frame is shortened axially. The flexibility of the frame allows for the device to be expanded, contracted, and positionally adjusted to accommodate bodily openings and adjacent tissue of varying shapes and sizes. Further, the frame can be collapsible or capable of being distorted so that the device can be, among other things, deployed via transcatheter techniques. As such, the frame can be fabricated from a flexible and manipulatable material (e.g. metals or polymers) such as, for example, iron, magnesium, platinum, stainless steel, cobalt-chromium-nickel allow or nickel titanium metal alloy (such as nitinol). In certain aspects, the frame is fabricated from a selfexpanding shape memory material, such as nitinol for example, that can maintain the device’s intended shape once it is released from a delivery device or otherwise deployed. The frame can also include biodegradable materials, PLA, PLLA, other magnesium-based materials, or suitable combinations thereof. The frame can be fabricated by laser cutting a flat sheet of a flexible material such as nitinol or by forming the frame from a flexible material.

[0062] Referring to FIG. 5, in an embodiment, closure device 24 further includes a distal membrane 36 covering at least one side of the plurality of distal fingers 28 (collectively referred to as the “distal closure portion 48”) and/or a proximal membrane 38 covering at least one side of the plurality of proximal fingers 30 (collectively referred to as the proximal closure portion 50”). Alternatively or in addition to, referring to FIG. 22-24, a closure device 31 can include a single membrane 33 or other occlusion member that occludes blood flow through expandable waist section 35 to provide blood clotting functionalities. The membranes are adapted to sealingly engage lateral tissue faces defining the bodily opening that is to be sealed. The plurality of fingers can hold the respective membrane substantially taut. Referring to FIGs. 25-27, in certain aspects, a closure device is provided that includes an aperture within the membrane to alleviate too high of pressure in one atrium. Such an aperture can shunt the blood to the other atrium, which is at a lower pressure. FIG. 25 illustrates a closure device 37 where the aperture 41 is located within membrane 39. FIGs. 26-28 illustrate a closure device 43 with a sealing membrane 47 covering frame 45. Fingers 49 of closure device 43 have a broader petal shape with an alternating & more secure attachment of membrane 47 to the frame.

[0063] The membranes can be fabricated from a material that is sufficiently resilient and flexible and is sufficiently durable to allow post-deployment medical punctures without jeopardizing the integrity of the membranes. For example, the membranes can be fabricated from an expanded polytetrafluoroethylene or a bioremodelable material, such as polytetrafluoroethylene (PTFE); expanded polytetrafluoroethylene (ePTFE); a fabric such as a polyester fabric; Teflon-based materials; pericardium tissue; other biocompatible or bioabsorbable materials; or suitable combinations thereof. In certain aspects, the membrane can comprise a silk, nylon, silicone, polyethylene, polypropylene, or fluoropolymer membrane. However, the membrane preferably comprises a biocompatible material that does not produce a significant inflammatory response or calcification response, including a PTFE, ePTFE, polyethylene terephthalate (PET), or other polyethylene membrane, pericardium, or other polymer. Preferably, the membrane is fabricated from a material that inhibits the passage of blood while also permitting post-deployment transseptal punctures and interatrial re-entry. The membrane can be a PET mesh, a PTFE laminate baked by PET (discussed below) or other suitable materials. The membranes can be attached to the respective plurality of fingers by sutures or other suitable attachment devices and methods such as an adhesive, gluing, heat sealing, through the use of electricity, polymerization, welding or the like. The plurality of proximal fingers and the plurality of distal fingers can each comprise an attachment point for the respective proximal membrane and distal membrane. For example, the attachment point be an eyelet 62 sized to receive a suture(s). The eyelets can be located at the distal end of the fingers. As illustrated in FIG. 10, suture knots 64 can be tied to the eyelets. The eyelets can provide robust anchoring of the membrane 65 to the frame as the suture(s) will not slide out of place on the frame. It should be noted that in certain aspects, the closure device does not include any membranes.

[0064] A thread, cable or other resistant elongated material 40, illustrated in FIG. 9, can be attached to the proximal membrane 38A (but could also be attached to the distal membrane 36A). The thread can be, for example, a polymeric fiber or a wire. The thread can be attached to the center of the proximal membrane or the distal membrane. As described in detail below, the thread can facilitate the release or deployment of the device and can be used to pull the device into a delivery device prior to the delivery or deployment of the device. As stated above, the suture knots can be attached to the eyelets of the frame, which can be located at the distal end of the fingers. By attaching the sutures (and thus the membrane(s)) only at the distal end of the fingers, when the thread is pulled proximally from the center of the proximal membrane or the distal membrane, the membrane is allowed to pivot away from the frame. This may not be possible if the membrane were attached at other portions of the frame. This can be advantageous because it allows the closure device to load into a delivery catheter having a smaller diameter. The smaller the delivery catheter diameter is, the easier the procedure can be on the patient and a larger patient population can be treated.

[0065] Referring to FIGs. 11 and 12, in certain aspects, first and second reinforcing filaments 72 and 74 can criss-cross at a central intersection point 76. First reinforcing filament 72 can have ends 78a and 78b attached to opposing fingers of frame 80 and second reinforcing filament 74 can have ends 82a and 82b attached to opposing fingers of frame 80. In particular, the first and second filaments 72 and 74 can carry the loading and retrieval loads of the frame. As seen in FIG. 11 , ends of the reinforcing filaments can be tied to the frame’ s eyelets to provide requisite anchoring knots. In embodiments with membrane(s), the crisscrossing first and second reinforcing filaments can be embedded in the membrane or on the outer or inner surface of the membrane. The closure device can also include more than one set of criss-crossing filaments that attach to opposing ends of the unitary frame. As shown in FIG. 12, thread 40A can be attached to the first and second reinforcing filaments at central intersection point 76. When thread 40 A is looped through at central intersection point 76, thread 40A can be pulled proximally, transferring pulling forces from the thread to the crisscrossing filaments, to the sides or comers of the frame to assist in pulling in the frame uniformly and ensuring that the frame does not load in a manner that may deform the frame or in a manner in which the frame does not fit in a delivery catheter. The thread can be one or more threads.

[0066] Referring to FIG. 13, in certain aspects a closure device 90 comprises a reinforcing material 92 attached to the proximal membrane or the distal membrane 94. A thread as described above can be attached to (e.g. looped through) the center of reinforcing material 92. As described above, the thread can facilitate the release or deployment of the device and can be used to pull the device into a delivery device prior to the delivery or deployment of the device.

[0067] The closure device is configured to transition from a series of shapes. For example, in a radially collapsed configuration, the frame is elongated axially. Such an elongated shape can allow the closure device to be loaded into a deliver}' device so that it can be delivered percutaneously to the target site. When transitioning to the radially expanded configuration, the frame is shortened axially. In such a radially expanded configuration, the waist section is positioned in the bodily opening, the plurality of distal fingers engages one side of the tissue wall defining the bodily opening, and the plurality of proximal fingers engages the other side of the tissue wall defining the bodily opening such that the distal and proximal membranes are pressed against the sides of the tissue wall to seal the bodily opening. In a radially expanded configuration, the distal and proximal directions can be maintained in a specified spaced relationship, including for example, an axially spaced relationship. In certain aspects, the closure device is configured so that it is biased to assume its intended shape while in the radially expanded configuration when the device is free from any restraining forces caused by the delivery device or the like.

[0068] In certain aspects, the closure device is used to treat an ASD. FIG. 6 illustrates an ASD 42 between a left septal wall 44 and a right septal wall 46. FIG. 7 illustrates closure device 24 in a deployed position where the distal closure portion 48 sealingly engages left septal wall 44 and proximal closure portion 50 sealingly engages right septal wall 46. Of course, it is understood that depending on the direction of entry, distal closure portion 48 can sealingly engage right septal wall 46 and proximal closure portion 50 can sealingly engage left septal wall 46. The alternating pattern of the distal and proximal fingers can facilitate the fingers gripping the septum across the ASD to hold the closure device in place. Such a clamping action can also hold the membranes of the closure device against the respective sides of the cardiac septum. The alternating pattern also minimizes the amount of metal or other fabrication material that could interfere with a potential subsequent procedure that would require puncturing through the closure device. As illustrated in FIG. 8, waist section 34 is positioned within ASD 42. The waist section of the closure device functions to selfcenter the device in the ASD, which in turn centers the proximal and distal membranes over the ASD to provide sufficient sealing of the ASD.

[0069] FIGs. 9 and 14-19 provide a schematic depiction of a method of using closure device 24A. FIG. 9 illustrates closure device 24A in a radially collapsed configuration where the frame is elongated axially. To transition closure device 24A into a radially expanded configuration, thread 40, which is shown looped through the center of membrane 38A of proximal closure portion 50A, can be pulled in a proximal direction. To load closure device 24A into a delivery device, thread 40 can be pulled through the distal end of the delivery device. By drawing membrane 38A in at the center, the closure device has the capability to be retrieved and reloaded into the delivery device if necessary. FIG. 14 illustrates closure device 24A loaded into a catheter 52. It should be noted that catheter 52 is shown as being clear in order to better illustrate the components loaded in catheter 52. FIG. 15 illustrates catheter 52 being positioned towards a right cardiac septal wall 54. FIG. 16 illustrates catheter 52 being guided through the ASD 56 of the cardiac septum 58. Catheter 52 can be retracted to deploy the distal closure portion 48 A as illustrated in FIG. 17. Catheter 52 can then be further retracted so that proximal closure portion 50A is on the right cardiac septal wall 54 as illustrated in FIG. 18. The device is now fully deployed with the distal closure portion 48A sealingly engaging the left septal wall 60 and proximal closure portion 50A sealingly engaging the right septal wall. Again, depending on the direction of entry, the position of the distal closure portion and the proximal closure portion can be reversed. Prior to full release, the closure device can be repositioned or retrieved. In a fully deployed and implanted configuration, the device straddles across the septum and the waist section of the closure device is positioned and centered in the ASD. The proximal and distal closure portions can be placed on top of each other and still seal allowing for resealing the opening if necessary.

[0070] Referring to FIGs. 29-33, in certain aspects, closure device 100 for closing an opening in a septal wall can comprise continuous unitary frame 102 comprising plurality of preshaped radially extendible distal fingers 104 extending in a distal direction and plurality of preshaped radially extendible proximal fingers 106 extending in a proximal direction. The proximal direction extends in a direction different than the distal direction. Each of plurality of distal fingers 104 can have attachment point end 108 and each of proximal fingers 106 can have attachment point end 110. Expandable waist section 112 can extend axially between plurality of distal fingers 104 and plurality of proximal fingers 106. Pre-shaped distal peripheral frame 114 can be attached to plurality of distal fingers 104 at attachment point ends 108 and/or pre-shaped proximal peripheral frame 1 18 can be attached to plurality of proximal fingers 106 at attachment points ends 110. For example, the attachment point ends of the plurality of proximal fingers and the plurality of distal fingers can comprise eyelets sized to receive a suture as illustrated in FIG. 32. Distal membrane 122 can cover at least one side of plurality of distal fingers 104 and/or proximal membrane 124 can cover at least one side of plurality of proximal fingers 106. For example, the membranes can be disposed on one side of the respective plurality of fingers, between the respective plurality of fingers and respective peripheral frame, or on the exterior of the respective peripheral frame. In certain aspects, the peripheral frames are not two separate distal and proximal frames but rather one unitary peripheral frame.

[0071] In certain aspects and with reference to FIG. 29, first and second reinforcing filaments 107 and 109 can criss-cross at a central intersection point 111 of peripheral frame 114. First reinforcing filament 107 can have ends 115a and 115b attached to opposing attachment points 119a and 119b respectively of peripheral frame 114 and second reinforcing filament 109 can have ends 113a and 113b attached to opposing attachment points 117a and 117b of peripheral frame 114. The criss-crossing filaments can be attached to opposing attachment points of the distal peripheral frame, the proximal peripheral frame, a unitary peripheral frame or an integral peripheral frame. Alternatively, as illustrated above, the criss-crossing filaments can be attached to opposing ends of the plurality of distal fingers or opposing ends of the plurality of proximal fingers. The reinforcing filaments can carry the loading and retrieval loads of the closure device. As seen in FIG. 29, ends of the reinforcing filaments can be tied to the peripheral frame’s eyelets to provide requisite anchoring knots. In embodiments with membrane(s), the criss-crossing first and second reinforcing filaments can be embedded in the membrane or on the outer or inner surface of the membrane. The closure device can also include more than one set of criss-crossing filaments that attach to opposing ends of the peripheral frame or unitary continous frame. A thread can be attached to the first and second reinforcing filaments at the central intersection point. When the thread is looped through at the central intersection point, the thread can be pulled proximally, transferring pulling forces from the thread to the criss-crossing filaments, to the sides or corners of the peripheral frame to assist in pulling in the peripheral frame uniformly and ensuring that the peripheral frame does not load in a manner that may deform the peripheral frame or in a manner in which the peripheral frame does not fit in a delivery catheter. The thread can be one or more threads. [0072] Device 100 can be expandable from a radially collapsed configuration in which frame 102 is elongated axially to a radially expanded configuration in which continuous unitary frame 102 is shortened axially. In the radially expanded configuration, waist section 112 can be configured to be positioned within the opening in the tissue wall. As illustrated in FIG. 33, plurality of distal fingers 104 and peripheral distal frame 114 in conjunction can be configured to press against one side of septal wall 130 defining the opening. Likewise, the plurality of proximal fingers and peripheral proximal frame in conjunction can be configured to press the other side of the tissue wall defining the opening. As mentioned above, the distal fingers, the proximal fingers, the distal peripheral frame, and the proximal peripheral frame can be pre-shaped and, in particular, can be pre-shaped (e.g. shape set/heat set) such that these components press against the septal wall in a radially expanded configuration of the device. In this respect, these components can be fabricated from a shape memory material such as nitinol, for example. Such engagement of the distal and proximal fingers and the distal and proximal peripheral frames with the septal walls results in the distal and proximal membranes sealing against the sides of the septal wall to occlude the opening in the septal wall. As illustrated in FIG. 33, pulling on one or more threads 126, which can be attached and looped at or near the center of distal membrane 122, pulls in sides 128 of distal peripheral frame 114. Distal membrane itself could also be pulled. Distal peripheral frame 114 still holds distal membrane 122 down to tissue septal wall 130 such that distal membrane 122 seals the septal wall opening even though distal membrane 122 is not taut. As such, a purpose of the peripheral frames is to press against the septal walls such that the membranes can seal the septal wall opening and not necessarily to pull the membranes into a taut shape. The peripheral frame(s) also prevent the periphery of the membrane(s) from lifting off from the septal wall, even if there is some higher pressure underneath the membrane(s). This can assist in maintaining a continuity to the septal wall e.g. there is no step change in topography due to a section of the membrane(s) being lofted of the septal wall. The peripheral frame(s) also creates additional points of connection to the membrane(s). It should be noted that all embodiments and aspects of devices described above and herein can be incorporated with device 100. [0073] In FIG. 34, continuous unitary frame 132 of a closure device is provided wherein the entire continuous unitary frame is fabricated as a one-piece frame. In other words, a tube can be laser cut prior to being shape set (or in its extended) form. In particular, continuous unitary frame 132 can comprise a plurality of pre-shaped radially extendible distal fingers 136 extending in a distal direction and a plurality of pre-shaped radially extendible proximal fingers 138 extending in a proximal direction, the proximal direction extending in a direction different than the distal direction. Continuous unitary frame 132 can also include expandable waist section 140 extending axially between the plurality of distal fingers and the plurality of proximal fingers. Continuous unitary frame 132 can also include pre-shaped peripheral frame 142 integral with the plurality of distal fingers and the plurality of proximal fingers. In this embodiment, the peripheral frame is not attached to the plurality of distal fingers and the plurality of proximal fingers at attachment points but rather integral with the plurality of distal fingers and the plurality of proximal fingers. A distal membrane (not shown) can cover at least one side of the plurality of distal fingers and/or a proximal membrane (not shown) can cover at least one side of the plurality of proximal fingers. The closure device is expandable from a radially collapsed configuration in which the device is elongated axially to a radially expanded configuration in which the device is shortened axially. In the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of distal fingers and peripheral frame are configured to press one side of the tissue wall defining the opening, and the plurality of proximal fingers and the peripheral frame are configured to press the other side of the tissue wall defining the opening such that the distal and/or proximal membranes seal the opening. FIGs. 35-46 illustrate other embodiments of a continuous one-piece unitary frame 142, 144, 146, 148, 150 and 152. It should be noted that all embodiments and aspects of devices described above and herein can be incorporated with the device comprising the continuous unitary frame of FIG. 34 and FIGs. 35-46.

[0074] Although the above-referenced description refers primarily to ASDs, the closure device can be used to occlude other opening in bodily tissue, such as patent foramen ovales (PFO); other arterio-venuous communications; patent ductus arteriosus; and other man-made, congenital, or acquired openings (such as openings acquired by disease for example) in a minimally invasive manner. Further, the device can be configured to be used with adult and/or child patients.

[0075] Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the disclosure. Further, while certain features of embodiments and aspects of the present disclosure may be shown in only certain figures or otherwise described in the certain parts of the disclosure, such features can be incorporated into other embodiments and aspects shown in other figures or other parts of the disclosure. Along the same lines, certain features of embodiments and aspects of the present disclosure that are shown in certain figures or otherwise described in certain parts of the disclosure can be optional or deleted from such embodiments and aspects. Additionally, when describing a range, all points within that range are included in this disclosure.

Claims

What is claimed is:

1. A device for closing an opening in a tissue wall comprising: a continuous unitary frame comprising: a plurality of pre-shaped radially extendible distal fingers extending in a distal direction, each of the plurality of distal fingers having an attachment point end; a plurality of pre-shaped radially extendible proximal fingers extending in a proximal direction, the proximal direction extending in a direction different than the distal direction, each of the plurality of proximal fingers having an attachment point end; an expandable waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers; a pre-shaped distal peripheral frame attached to the plurality of distal fingers at the attachment point ends of the plurality of distal fingers; a pre-shaped proximal peripheral frame attached to the plurality of proximal fingers at the attachment points ends of the plurality of proximal fingers; a distal membrane covering at least one side of the plurality of distal fingers; a proximal membrane covering at least one side of the plurality of proximal fingers; wherein the device is expandable from a radially collapsed configuration in which the continuous unitary frame is elongated axially to a radially expanded configuration in which the continuous unitary frame is shortened axially; and wherein in the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of distal fingers and the peripheral distal frame in conjunction are configured to press one side of the tissue wall defining the opening, and the plurality of proximal fingers and the peripheral proximal frame in conjunction are configured to press the other side of the tissue wall defining the opening such that the distal and proximal membranes seal the opening.

2. The device of claim 1 , wherein the plurality of distal fingers and the plurality of proximal fingers alternate such that a distal finger is immediately adjacent to a proximal finger.

3. The device of claim 1, further comprising at least a first and a second reinforcing filament attached to opposing ends of the plurality of distal fingers, the plurality of proximal fingers, both the plurality of distal fingers and the plurality of proximal fingers, the proximal peripheral frame, the distal peripheral frame, or both the proximal and distal peripheral frames and criss-crossing at a central intersection point to carry the loading and retrieval loads of the device.

4. The device of claim 1 , further comprising one or more threads attached to the proximal membrane or the distal membrane, the one or more threads configured to assist in pulling in the device uniformly.

5. The device of claim 1, wherein the thread is attached to the center of the proximal membrane, the distal membrane, the proximal peripheral frame, or the distal peripheral frame.

6. The device of claim 5, further comprising a reinforcing material adhered to the proximal membrane or the distal membrane, the thread attached to the reinforcing material.

7. The device of claim 3, wherein a thread is attached to the first and second reinforcing filaments at the central intersection point.

8. The device of claim 1, wherein the attachment point ends of the plurality of proximal fingers and the plurality of distal fingers comprise eyelets sized to receive a suture.

9. The device of claim 1 , wherein the continuous unitary frame, the distal peripheral frame and the proximal peripheral frame are fabricated from a shape memory material.

10. The device of claim 1, wherein at least some of the plurality of distal fingers, the plurality of proximal fingers, or both have a petal shape.

11. The device of claim 1 , wherein the proximal membrane and the distal membrane each define an opening extending therethrough.

12. The device of claim 1, wherein the plurality of distal fingers, distal membrane, and the distal peripheral frame are sized and shaped to sealingly engage one of the left or right side of the septal wall, the plurality of proximal fingers, proximal membrane and the proximal peripheral frame are sized and shaped to sealingly engage the other of the left or right side of the septal wall, and the waist section is sized and shaped to be positioned and centered in an atrial septal defect between the left and the right septal wall.

13. The device of claim 1 , wherein the expandable waist section has a membrane or occluder disposed therein to occlude blood flow therethrough.

14. A device for closing an opening in a tissue wall comprising: a continuous unitary frame comprising: a plurality of pre-shaped radially extendible distal fingers extending in a distal direction, each of the plurality of distal fingers having an attachment point end; a plurality of pre-shaped radially extendible proximal fingers extending in a proximal direction, the proximal direction extending in a direction different than the distal direction, each of the plurality of proximal fingers having an attachment point end; an expandable waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers; a pre-shaped distal peripheral frame attached to the plurality of distal fingers at the attachment point ends of the plurality of distal fingers; a distal membrane covering at least one side of the plurality of distal fingers; wherein the device is expandable from a radially collapsed configuration in which the continuous unitary frame is elongated axially to a radially expanded configuration in which the continuous unitary frame is shortened axially; and wherein in the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of distal fingers and the distal peripheral frame in conjunction are configured to press one side of the tissue wall defining the opening such that the distal membrane seals the opening, and the plurality of proximal fingers is configured to press the other side of the tissue wall defining the opening.

15. A device for closing an opening in a tissue wall comprising: a continuous unitary frame comprising: a plurality of pre-shaped radially extendible distal fingers extending in a distal direction, each of the plurality of distal fingers having an attachment point end; a plurality of pre-shaped radially extendible proximal fingers extending in a proximal direction, the proximal direction extending in a direction different than the distal direction, each of the plurality of proximal fingers having an attachment point end; an expandable waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers; a pre-shaped proximal peripheral frame attached to the plurality of proximal fingers at the attachment points ends of the plurality of proximal fingers; a proximal membrane covering at least one side of the plurality of proximal fingers; wherein the device is expandable from a radially collapsed configuration in which the continuous unitary frame is elongated axially to a radially expanded configuration in which the continuous unitary frame is shortened axially; and wherein in the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of peripheral fingers and the proximal peripheral frame in conjunction are configured to press one side of the tissue wall defining the opening such that the proximal membrane seals the opening, and the plurality of distal fingers is configured to press the other side of the tissue wall defining the opening.

16. A device for closing an opening in a tissue wall comprising: a continuous unitary frame comprising: a plurality of pre-shaped radially extendible distal fingers extending in a distal direction, each of the plurality of distal fingers having an attachment point end; a plurality of pre-shaped radially extendible proximal fingers extending in a proximal direction, the proximal direction extending in a direction different than the distal direction, each of the plurality of proximal fingers having an attachment point end; an expandable waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers; a pre-shaped peripheral frame attached to the plurality of distal fingers at the attachment point ends of the plurality of distal fingers and attached to the plurality of proximal fingers at attachment points ends; a distal membrane covering at least one side of the plurality of distal fingers and/or a proximal membrane covering at least one side of the plurality of proximal fingers; wherein the device is expandable from a radially collapsed configuration in which the continuous unitary frame is elongated axially to a radially expanded configuration in which the continuous unitary frame is shortened axially; and wherein in the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of distal fingers and peripheral frame in conjunction are configured to press one side of the tissue wall defining the opening, and/or the plurality of proximal fingers and the peripheral frame in conjunction are configured to press the other side of the tissue wall defining the opening such that the distal and/or proximal membranes seal the opening.

17. A device for closing an opening in a tissue wall comprising: a continuous one-piece unitary frame comprising: a plurality of pre-shaped radially extendible distal fingers extending in a distal direction; a plurality of pre-shaped radially extendible proximal fingers extending in a proximal direction, the proximal direction extending in a direction different than the distal direction; an expandable waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers; a pre-shaped peripheral frame integral with the plurality of distal fingers and the plurality of proximal fingers; a distal membrane covering at least one side of the plurality of distal fingers and/or a proximal membrane covering at least one side of the plurality of proximal fingers; wherein the device is expandable from a radially collapsed configuration in which the device is elongated axially to a radially expanded configuration in which the device is shortened axially; and wherein in the radially expanded configuration, the waist section is configured to be positioned within the opening in the septal wall, the plurality of distal fingers and peripheral frame are configured to press one side of the tissue wall defining the opening, and the plurality of proximal fingers and the peripheral frame are configured to press the other side of the tissue wall defining the opening such that the distal and/or proximal membranes seal the opening.

1