# Patent

## Title
Heart-shaped PFO closure device

## Abstract

Patent foramen ovale (PFO) closure clip include two closure members, which may be heart shaped, joined by at least two spaced central connecting members. Each of the at least two spaced central connecting members is attached to each closure member at a location on the periphery of the closure member. The connecting member may be generally square shaped or include other shapes. The clips of the present invention may be formed of various materials, including metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, or combinations thereof. The clips can take various forms depending, in part, upon the distribution of force required to close a given PFO. At least one of the closure members can include a tissue scaffold.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims priority to provisional application Ser. No. 60/565,285, filed Apr. 26, 2004, which is incorporated herein by reference.


FIELD OF THE INVENTION
The present invention relates to devices and methods that are used to close defects, and particularly for closing a patent foramen ovale (PFO).
BACKGROUND
A PFO, illustrated in FIG. 1, is a persistent, one-way, usually flap-like opening in the wall between the right atrium 10 and left atrium 12 of the heart. Because left atrial pressure is normally higher than right atrial pressure, the flap formed by septum primum 14 and septum secundum 16 usually stays closed. Under certain conditions, however, right atrial pressure can exceed left atrial pressure, which creates the possibility that blood could pass from the right atrium to the left atrium through a PFO tunnel 18 and allow blood clots to enter the systemic circulation. It would be desirable to avoid this situation.
SUMMARY
Embodiments of the present invention provide a device for closing septal defects, such as a patent foramen ovale (PFO). The device has substantially circular proximal and distal configurations connected with a center joint. In most embodiments, the center joint has a generally square configuration. The shape of the center joint provides for centering of the device in the defect. The device can be made from wire, such as nitinol wire. Pieces of wire can be connected with tubes, welds, or other joining techniques. The device can be retrieved after deployment and repositioned if needed. Either the distal (left atrial) clip, proximal (right atrial) clip, or both can be covered with a tissue scaffold to help the defect seal and to encourage tissue ingrowth.
Embodiments of the closure device can have one or more of the following advantages: an atraumatic shape, good embolization resistance, an ability to conform to the anatomy (instead of the anatomy conforming to the device, especially in the defect tunnel), repositionable or/and removable during delivery, and a small profile after deployment. Other benefits include small diameter delivery sheath, ease of manufacturing, cost effectiveness, and overall simplicity. Other features and advantages will become apparent from the following detailed description and drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional side view showing a patent foreman ovale (PFO).
FIGS. 2A and 2B are front elevational and top plan views of a device according to the present invention.
FIGS. 3A and 3B are right side elevational views of the device as made and as positioned in a PFO, respectively.
FIG. 4 is a prospective view and FIGS. 5 and 6 are front and rear elevational views showing the device of FIG. 2A as positioned in a PFO.
FIGS. 7 and 8 are views of the device in an elongated form and shown within a catheter for delivery, and FIG. 7A is a perspective view of an alternative embodiment to FIG. 7.
FIGS. 9 and 9A are a perspective view of the device according to another embodiment of the present invention, and an enlarged detailed view of a portion of a that device, respectively. FIG. 9B is a perspective view of an alternative embodiment to that in FIG. 9.
FIG. 10 is a front elevational view of a device according to get another embodiment of the present invention.
FIGS. 10A-10C are elevational views of alternative configurations for a center joint in the device of FIG. 10.
FIGS. 11A-11F are fragmentary front elevational views showing alternative loop designs.



DETAILED DESCRIPTION
Embodiments of the devices described here are intended to clip together tissue flaps, and particularly to clip together septum primum and septum secundum to minimize the flow of blood from the right atrium to the left atrium, thereby helping to reduce the risk of stroke. To accomplish this, the devices apply a compressive force between septum primum and septum secundum to bring septum primum and septum secundum together to provide a closing effect. In at least some embodiments, the applied compressive force draws the more flexible septum primum toward septum secundum, thereby closing the PFO without significantly distorting the septum. The clip can provide mechanical closure at points of contact along the PFO such that the largest remaining opening is reduced to a size deemed small enough to block stroke-inducing embolic particles from crossing through the PFO tunnel. In other embodiments, the clip provides substantially complete closure along the entire PFO length. Because the clips do not distort the defect in preferred embodiments, the overlapping layers of septal tissues may themselves be used to close the defect as they are compressed by the clip.
Referring to FIGS. 2A and 2B, a closure device 20 has a distal loop 22, a proximal loop 24, and a center joint 26 connecting loops 22 and 24. In this embodiment, the loops are each generally “heart-shaped” and have two lobes that come together. As shown in FIG. 2A, there are several points in the device where wires or portions of a wire meet. At these points, the wires can be welded and/or clamped with a collar 28, 30, 32, and 34. Collars 28 and 30 are formed at outer vertices of loops 24 and 22, respectively; collars 32 and 34 are provided where the lobes of the loops come together at center joint 26.
Center joint 26 has generally four sides and is preferably generally rectangular in shape in that it has basically four sides with two sets of parallel sides coming together at roughly right angles. While “rectangular” strictly might imply sharp corners, it should be understood that the corners here can be rounded or have other configurations as are present at the location of collars 32 and 34 as shown in FIG. 2A. The sides can be straight, but can also have some bends or curves while the overall look is still generally rectangular. More preferably, the center joint is generally square. Other shapes could be used, including circular, polygonal, or some combination of straight and curved segments. The two wire paths from collar 32 to collar 34 preferably have about the same length, thus making it easier to load the device in a catheter or sheath.
FIG. 2B shows a top plan view with loops 22 and 24 that are in substantially parallel configuration and parallel to center joint 26 from this view. The device could have this configuration, although it could be formed such that, in its non-deployed configuration, loops 22 and 24 are curved in the vertical plane such that the ends, shown at collars 28 and 30, bend to an opposite side of a center line 31 that runs through center joint 26. In other words, as shown by the arrows in FIG. 2B, loop 24 could start one side of center line 31 and have its outer vertex at collar 28 on the other side of line 31, and similarly for loop 22. This overlapping effect can help provide good compressive force, especially for materials with less recovery. For materials with very high recovery, such as nitinol, such a configuration might not be desirable.
Referring to FIGS. 3A, 3B and 4-6, device 20 is shown in a non-deployed configuration (FIG. 3A), and as deployed (FIGS. 3B and 4-6). As indicated in these views, loops 22 and 24 each have a respective upper portion or top lobe in contact with septum secundum 16 and a lower portion or lower lobe in contact with septum primum 14. The loops generally define a plane that is generally parallel to each of septum primum and septum secundum. This configuration helps distribute compressive forces across the applicable septum and makes the pressure less traumatic.
As shown particularly in FIGS. 5 and 6, which represent views from the right atrium (FIG. 5) and left atrium (FIG. 6), center joint 26 is partially on the right atrial side, partially on the left atrial side, and partially within PFO tunnel 18 (FIG. 1) where the flaps of septum secundum 16 (FIG. 4) and septum primum 14 (FIG. 4) overlap. The center joint could be completely within the overlapping portions of septum primum and septum secundum.
The loops and center joint are formed with appropriate dimensions and materials, and in such a configuration, such that when deployed, the loops provide a compressive force that holds together septum primum 14 and septum secundum 16.
Referring to FIGS. 7 and 8, the device can be deployed with a delivery sheath in the generally conventional manner. FIGS. 7 and 8 show device 20 in an elongated form for delivery purposes. Device 20 can be provided with a low profile to fit within a sheath 40 and have an end, such as at collar 28, in a contact with a connector 42 at the end of a wire 44 that is used by an operator to push the device or hold the device as sheath 40 is retracted, i.e., the connection allows relative movement between device 20 and sheath 40. Typically, device 20 is deployed by providing sheath 40 within the left atrium and withdrawing sheath 40 while wire 44 and connector 42 hold device 20 in place. As sheath 40 is withdrawn, loop 22 opens and assumes the shape shown in FIG. 6. Sheath 40 is further drawn back within the PFO tunnel to release center joint 26, and then is further drawn back into the right atrium to allow loop 24 to open in the right atrium. Connector 42 can stay in contact until the device is at a desired positioning of device 20. If the operator is not satisfied with the positioning of device 20, the connector can be used to pull the device or hold the device while the sheath is pushed forward to draw the device back into the sheath to be removed or redeployed.
FIG. 7A shows an embodiment that is similar to that of FIG. 7, except that rather than a collar 28, there is a curved portion 28′ in the wire used to form loop 24. While shown as a more gradual bend, it could have a sharper bend, such as a hairpin turn. A curved portion without a collar could be used on the other side where collar 30 is, and in other embodiments where a collar is shown.
FIGS. 9 and 9A show another embodiment of the present invention. In this embodiment, device 90 has a loop 92 for use in the left atrium and loop 94 for use in the right atrium. A tissue scaffold 96 is shown within loop 92 for deployment in the left atrium, and a scaffold is shown connected to loop 94 to be released in the right atrium. As shown in FIG. 9A, where two portions of wire come together in loop 92, a weld 99 is formed to hold the wires together. As also indicated here, tissue scaffold 96 is shown attached to the wire over most of its distance up to where the wires come together. This device would be delivered in a manner similar to that shown in FIGS. 7 and 8 above. FIG. 9B shows a variation of FIG. 9 in which the weld 99 between two wires is replaced with a curved wire 99′ without the weld.
Referring to FIG. 10, in another embodiment of the present invention, a device 100 has two heart shaped loops 102 and 104, with a center joint 106 between them. In this case, the center joint has contact points 114, 116 for each of the loops at adjacent corners rather than being at diagonally opposite corners as shown in device 20 in FIG. 2A. This configuration can improve rotational stability compared to the diagonal configuration (i.e., the device is less likely to rotate within the PFO tunnel).
Center joint 106 has three similar sides 108a, 108b, and 108c forming a generally block-U shape. Rather than another similar side, however, a connector 110 is provided that allows for some flexing motion in the direction indicated by arrow 112, and that approximately equalizes the length of the two paths between contact points 114 and 116. These equal paths make it easier to load the device into a sheath or catheter.
Alternative connections to connection 110 are shown in FIGS. 10A, 10B, and 10C. These figures show various alternative configurations of wires that form loops and angles that allow some ability for sides 108a, 108b, 108c, and 110 to pivot with respect to one or more of the other sides, and that equalize the two path lengths of wires between contact points 114 and 116, thereby helping to make it easier to load the device into a sheath or catheter when it is elongated to a smaller profile.
FIGS. 11A-11E show alternative loop configurations. These include a generally circular configuration with two collars (FIG. 11A), a generally rectangular configuration with two collars (FIG. 11B), a heart-shape with straight lines converging on a vertex to provide a more triangular shape (FIG. 11C) than other configuration, such as that shown in FIG. 2A, a FIG. 8 (FIG. 11D), a generally circular configuration with one collars (FIG. 11E), and a generally rectangular configuration with one collar (FIG. 11F). Other shapes could be used, although it is preferred (but not required) that the wires do not cross in a way that would create rubbing contact.
In most of these embodiments, a single wire could be used with several double-backs, or multiple wires could be used and welded or crimped together with a collar at desired locations. The clips can be formed of metal or nonmetallic materials, including bioresorbable polymers, spring steel, shape memory materials (e.g. nitinol), bioresorbable shape memory polymers, or combinations of the foregoing materials.
Shape memory materials are useful for this application. These materials allow the clips to resume and maintain their intended shape following deployment in vivo. A clip may take advantage of the thermal shape memory properties of a shape memory material, the superelastic properties of a shape memory material, or some combination of the two. In other particular embodiments, the clips are cut into their desired shapes from sheets of material, such as from bioresorbable shape memory polymers.
The first and second loops are preferably made from a material or are configured to apply a compressive force to the overlapping layers of septal tissue. The movement of the at least two loops may be limited by the edges of the PFO tunnel (which is usually between 1 mm and 20 mm wide), thereby ensuring the clip device remains horizontally centered across the defect and consistently applies compressive force to the septal tissues at the locations necessary to effect closure of the defect. Accurate and consistent application of localized force can allow the use of a smaller closure device.
The closure loops of a clip may take various forms depending, in part, on the distribution of force desired to effect closure of a given defect. In this application, the term “defect” is applied to any anatomical configuration requiring treatment. In particular, the defect can be a PFO which may allow, or allows, blood to flow from the right atrium to the left atrium. The shape of each closure member determines the location(s) at which the compressive force is applied to the overlapping layers of septal tissue.
Any of the embodiments of the present invention can include a tissue scaffold on one or both closure members and/or the center joint. The tissue scaffold promotes encapsulation and endothelialization, thereby further encouraging anatomical closure of septum primum and septum secundum. A tissue scaffold can be formed of any flexible, biocompatible material capable of promoting tissue ingrowth, including but not limited to polyester fabrics, Teflon-based materials, such as ePTFE, polyurethanes, metallic materials, polyvinyl alcohol (PVA), extracellular matrix (ECM) or other bioengineered material, synthetic bioabsorbable polymeric scaffolds, other natural materials (e.g. collagen), or combinations of these materials. Also, a tissue scaffold may be formed of a thin metallic film or foil. The scaffold may be attached to one or both sides of the device. A tissue scaffold or the frame may contain drugs or biological agents to improve the defect healing process and/or to prevent clotting.
The center joint serves a horizontal centering function. Specifically, the connecting members may be designed to fit within the PFO tunnel such that there is little (or no) horizontal movement once the device is deployed. Horizontal centering is desirable because the dynamic conditions in the heart may tend to move the device. Other configurations, including bent or slightly bent wires, to position the connecting members within the PFO tunnel can be used.
The compressive force applied by the closure members of any of the various embodiments described herein can be adjusted in a variety of ways. For example, the thickness of a strand or wire can be increased or decreased to adjust the compressive force. In general (and with other design considerations similar), a thicker strand or wire will provide higher compressive force. Additionally, various closure member configurations may be chosen to increase the compressive force. Generally, bends with smaller angles will provide more compressive force. Different parts of the device can be treated in a different manner to alter stiffness and recovery, as described in applicable Ser. No. 10/702,717 filed Nov. 6, 2003, which is incorporated herein by reference.
In some general respects, such as the ability to use one wire, the devices described here have some general similarities to some devices in application Ser. No. 10/396,253, filed Mar. 25, 2003, published as 2003/0225421, which is incorporated herein be reference.
Having described embodiments of the present invention, it should be apparent that the invention is capable of other and different embodiments and may be modified in various respects, all without departing from the scope of the invention as defined by the appended claims. Accordingly, the foregoing drawings and description are to be regarded as illustrative in nature and not in a restrictive or limiting sense.

## Claims

1. An occluder device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising:
first and second opposed closure members configured to be disposed on opposite sides of the septum, each of said closure members generally defining a plane with a periphery, wherein the planes are configured to be generally parallel to each of septum primum and septum secundum; and
a center joint connecting the first and second opposed closure members, the center joint comprising pairs of parallel wire paths and at least two collars having first and second opposing ends, wherein each wire path begins at the first end of a first collar and terminates at a first end of a second collar, wherein further each wire path forms a center vertex between the collars;
wherein the center joint is configured so the center vertex of each wire path extends between the overlapping layers of septum primum and septum secundum leaving the collars and closure members outside the layers, wherein further at least one of said closure members has a generally heart shape and includes two lobes that come together at the center joint, the lobes having contact points at adjacent corners to provide a compressive force to the overlapping layers of septum primum and septum secundum wherein said closure members are configured to prevent the device from moving along a longitudinal axis formed by the passage between septum primum and septum secundum when the device is deployed.

2. The device of claim 1, wherein said first closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the right atrium, and said second closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the left atrium.

3. The device of claim 1, wherein the device includes a material selected from the group consisting of metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, and combinations thereof.

4. The device of claim 3, wherein the device is constituted at least in part of nitinol.

5. The device of claim 1, wherein each of said closure members has a generally heart shape including two lobes that come together at the center joint.

6. The device of claim 1, wherein at least one of said closure members is a loop.

7. A delivery assembly comprising a catheter and the device according to claim 1, wherein the catheter contains the device in an elongated form.