Collapsible medical device

Abstract

The present invention provides a collapsible medical device, preferably an occluder device, comprising a fabric formed of braided strands, the device having a collapsed configuration for delivery through at least a lumen in a subject, preferably a human patient, and has a generally dumbbell-shaped expanded configuration with two expanded diameter portions spaced apart by a waist portion formed between the two expanded diameter portions.

Description

COLLAPSIBLE MEDICAL DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to European Patent Application No. 24158488.7 filed on February 19, 2024. The entire contents of the above-listed application are hereby incorporated by reference for all purposes.FIELD

[0002] Embodiments of the subject matter disclosed herein relate to collapsible medical device, in particular for treatment of a cardiac defect or hole, preferably a septal defect or hole such as a septal defect or hole caused by a congenital heart disease.BACKGROUND AND SUMMARY

[0003] Cardiac defects or holes, such as septal defects or holes, represent unwanted openings formed in a heart wall. Congenital heart diseases are among the most frequent defects children are born with. The most common congenital heart defects are atrial septal defects (ASDs), ventricular septal defects (VSDs), patent foramen ovale (PFO), and patent ductus arteriosus (PDA). Defects of this kind may affect different regions of the heart, creating abnormal communication between two chambers that affects physiology of blood circulation.

[0004] Some of these such defects are treated through minimally invasive interventional techniques. Alternatively, or additionally, medical devices, in particular occlude devices, may be implanted to mechanically close the cardiac defect or hole. Medical devices, in particular occlude devices, of this kind are known in the art.

[0005] U.S. Patent 9,119,607 to Amin discloses a heart occlusion device having a selfcentering mechanism, an example of which is shown in FIGS. 1 and 2. This known device comprises two separate, uniquely-shaped wires, each forming shapes that mirror the respective wire’s shapes. In particular, each wire forms half-discs or quarter-discs that together form a distal disc and a proximal disc. The distal disc and proximal disc are separated by a self-centering waist. In another configuration, this known device includes four separate wires, each mirroring its neighboring wire and forming a proximal and a distal quarter-disc. Here, the quarter-discs of each wire together form proximal and distal discs. At least the proximal disc is attached to a hubcomprising a screw mechanism. The discs further include coverings forming a sealant to occlude an aperture in a tissue, e.g., cardiac tissue. The wires forming the discs have shape-memory capability such that they can be collapsed and distorted in a catheter during delivery, but resume and maintain their intended shape after delivery.

[0006] European Patent No. 0808138 to Amplatz discloses a medical device, in particular an intravascular occlusion device, formed of metal fabric. The device is capable of switching between an expanded configuration and a collapsed configuration. In particular, the medical device is collapsed for deployment through a catheter. Then, upon exiting the distal end of the catheter in a patient’s channel, will resiliently substantially return to its expanded configuration. This known medical device has a generally tubular middle portion and a pair of disc-shaped expanded diameter portions, with one expanded diameter portion positioned at either end of the middle portion.

[0007] Although effective, these known medical devices still have several drawbacks. Most of these issues are inherent to the self-centering nature of the device, and in particular pertain to the structure of the waist portion. A significant limitation of these known medical devices is that the two discs are completely dependent on each other. Thus, in the common case where one of the discs is fixed, the other disc will be fixed by default because it is connected with the same wires via the waist. Accordingly, if the edge of the medical device, e.g., an occlude device, is in contact with a tissue, e.g., cardiac tissue, and the device remains stuck in one orientation / configuration, a sawing effect may occur, which may significantly damage or even perforate the tissue.

[0008] Also, difficulties have been reported during device deployment, especially in ASD and VSD, mostly because the device discs and the septal angle tend to mismatch, despite improvement in attaching mechanisms (e.g., like change of angle of the clamp or discs or the connecting cable). Other complications are related to erosion and undue radial force exhibited by the waist portion of the device, which may inter alia increase arrhythmias.

[0009] The inventors herein have recognized the aforementioned drawbacks and developed a collapsible medical device that at least partially addresses these issues. In one example, a device that conforms to differences in septal tissue and morphology without increasing tension on the septum is provided herein. The device can be easily deployed and reliably maintained in place after deployment while reducing the possibility of tissue damage or perforation and / or of device prolapse.

[0010] It should be understood that the brief description above is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined uniquely by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The present disclosure will be better understood from reading the following description of non-limiting embodiments, with reference to the attached drawings, wherein below:

[0012] FIG. 1 shows a perspective view of a conventional medical device;

[0013] FIG. 2 shows a top down view of the conventional medical device of FIG. 1;

[0014] FIG. 3 shows a collapsible medical device in a relaxed position before deployment, according to one or more embodiments of the present disclosure;

[0015] FIG. 4 shows a cross-sectional view of the collapsible medical device of FIG. 3, according to one or more embodiments of the present disclosure;

[0016] FIG. 5 shows the collapsible medical device of FIG. 3 in a compressed position during deployment, according to one or more embodiments of the present disclosure;

[0017] FIG. 6 shows the collapsible medical device of FIG. 3 in a deployed, expanded position, according to one or more embodiments of the present disclosure;

[0018] FIG. 7 shows a perspective view of a first expanded diameter portion of the collapsible medical device of FIGS. 3-6, according to one or more embodiments of the present disclosure;

[0019] FIG. 8 shows a perspective view of a second expanded diameter portion of the collapsible medical device of FIGS. 3-6, according to one or more embodiments of the present disclosure;

[0020] FIG. 9 shows a waist portion of the collapsible medical device of FIGS. 3-6, according to one or more embodiments of the present disclosure;

[0021] FIG. 10 shows one of a plurality of waist elements forming the waist portion of FIG. 9, according to one or more embodiments of the present disclosure;

[0022] FIG. 11 shows an exemplary wire loop of the one of the plurality of waist elements of FIG. 10, according to one or more embodiments of the present disclosure; and

[0023] FIG. 12 shows an exploded view of the collapsible medical device, according to one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0024] The following description relates to various embodiments of a collapsible medical device. In particular, systems and methods for a collapsible medical device are herein provided. Intervention for various cardiac defects, such as atrial septal defects (ASDs), ventricular septal defects (VSDs), patent foramen ovale (PFO), and the like, may include minimally invasive procedures such as inserting an occluding collapsible medical device for closure of the cardiac defect through a catheter. For example, endovascular closure of an ASD may comprise using an intravascular catheter to place a collapsible device, wherein the device is in a collapsed state during deployment and returns to an expanded state once deployed. However, such collapsible devices may not match the angle of the septum, thus making deployment more difficult and potentially resulting in tissue damage.

[0025] FIGS. 1 and 2 demonstrate an example of a conventional collapsible device 100 for such cardiac defect closures. FIG. 1 shows a perspective view of the conventional collapsible device 100 and FIG. 2 shows a top-down view of the conventional collapsible device 100. The collapsible device 100 comprises two separate wires 102, including a first wire 104 and a second wire 106. The first and second wires 104, 106 may mirror each other in shape and orientation. For example, the first wire 104 may form a first side half of the device and the second wire 106 may form a second side half of the device. In particular, each wire may form half-discs or quarter-discs that together form a distal disc 108 and a proximal disc 110.

[0026] The distal disc 108 and proximal disc 110 are separated by a self-centering waist 112. The self-centering waist 112 may comprise four sections of wire, a first from the distal region of the first wire 104, a second from the proximal region of the first wire 104, a third from the distal region of the second wire 106, and a fourth from the proximal region of the second wire 106. While not shown in FIGS. 1 and 2, the discs further include coverings forming a sealant to occlude an aperture in a tissue, e.g., cardiac tissue. The wires forming the discs have shape-memory capability such that they can be collapsed and distorted in a catheter during delivery, but resume and maintain their intended shape after delivery.

[0027] In operation, the collapsible device 100 is collapsed to conform to inner shape of a delivery catheter. During deployment, the distal disc 108 exits the delivery catheter first, expanding to its original shape as it exits. The waist 112 then exits second and the proximal disc 110 exits third. The waist 112 is designed to expand such that each of the wires forming the waist are urged against the aperture in the heart (e.g., the defect of interest). Once deployed, the collapsible device 100 fully expands to its intended shape to form a seal over the aperture.

[0028] However, as discussed herein, the two discs are completely dependent on each other. Thus, in the common case where one of the discs is fixed, the other disc will be fixed by default because it is connected with the same wires via the waist. Accordingly, if the edge of the medical device, e.g., an occluding device, is in contact with a tissue, e.g., cardiac tissue, and the device remains stuck in one orientation / configuration, a sawing effect may occur, which may significantly damage or even perforate the tissue. Further, during device deployment, especially in ASD and VSD, the device discs may not may the septal angle, which may result in inadequate closure of the aperture.

[0029] Turning now to FIG. 3, a collapsible medical device 300 according to the present disclosure is shown. The collapsible medical device 300 is shown in FIG. 3 in a relaxed position prior to deployment. In some examples, the collapsible medical device 300 may be an occluder device that is adapted for closing apertures, such as cardiac defects like ASDs, VSDs, PFOs, and more. For example, the collapsible medical device 300 may be adapted for use in a subject, such as a human patient, affected by a congenital heart disease that includes an abnormal aperture.

[0030] The collapsible medical device 300 may comprise a first expanded diameter portion 12 and a second expanded diameter portion 14, each formed of a fabric formed of braided strands 10. The braided strands 10 may comprise a nitinol-based wiring system, in some examples. The first and second expanded diameter portions 12 and 14 may be positioned at opposing sides of the device. In some examples, the first and second expanded diameter portions 12 and 14 may have a double-layered configuration.

[0031] For example, each of the first and second expanded diameter portions 12, 14 may be fabricated from 32 braided nitinol wires having a diameter ranging from 0.0015-0.008 inches (e.g., 0.0381-0.203mm). The number of wires that are braided may range from four to two hundred in some examples, depending on the particular device characteristics desired. A typical pitch angle may range from 30 to 70 degrees from a longitudinal axis of the braided portion. The first andsecond expanded diameter portions 12, 14 may be shaped as discs, for example with one or more concave surfaces. For example, inner surfaces (e g., those facing the space between the first and second expanded diameter portions) may be concave.

[0032] FIG. 4 shows a cross-sectional view of the collapsible medical device 300. The first and second expanded diameter portions 12, 14 may be separated by a waist portion 16. The waist portion 16 may be formed between the first and second expanded diameter portions 12 and 14. For example, the waist portion 16 may be arranged equidistant from the first and second expanded diameter portions 12 and 14 so as to be arranged in the middle of the two.

[0033] As described herein, the first and second expanded diameter portions 12 and 14 may be shaped as discs. The first and second expanded diameter portions 12 and 14 may mirror each other at opposite sides of the waist portion 16. In the expanded configuration as shown in FIGS. 3 and 4, the first and second expanded diameter portions 12 and 14 may not overlap, such that they occupy opposite sides of the collapsible medical device, separated by the waist portion 16.

[0034] The waist portion 16 may be configured such that the first and second expanded diameter portions 12 and 14 may act independently of each other during deployment. For example, the first and second expanded diameter portions 12 and 14 may be deployed, attached to a body wall, and may reside in positions long term independent of one another.

[0035] Each of the first and second expanded diameter portions 12 and 14 may comprise a waist element. For example, the first expanded diameter portion 12 may comprise a first waist element 18 and the second expanded diameter portion 14 may comprise a second waist element 20. The first and second waist elements 18, 20 may thus form the waist portion 16. The first and second waist elements 18 and 20 may be constructed of wires from the respective diameter portion. For example, the first and second waist elements 18 and 20 may be formed as part of the first and second expanded diameter portions 12 and 14, respectively, at attachment points.

[0036] In some examples, the first and second waist elements 18 and 22 may directly connect with each other or through separate circular connection elements 24. The circular connection elements 24 may be configured as rings that are positioned around the waist elements 18, 20. In another example, the connection elements 24 may be loosely attached to the waist elements 18, 20.

[0037] Turning briefly to FIG. 12, portions of the collapsible medical device 300 are shown in an exploded, cross-sectional schematic view. In particular, FIG. 12 illustrates the first expanded diameter portion 12, the second expanded diameter portion 14, and the waist 16.

[0038] As described herein, the waist 16 may comprise the first waist element 18 and the second waist element 20. The first waist element 18 may be formed with or otherwise coupled to the first expanded diameter element 12. For example, attachment points 22 of the first expanded diameter element 12 and the first waist element 18 may illustrate where the diameter element 12 is coupled to or formed with the first waist element 18. Similarly, the second waist element 20 may be formed with or otherwise coupled to the second expanded diameter element 14 at attachment points 22.

[0039] The first and second waist elements 18, 20 may be coupled together, for example via connection elements 24. As shown in FIG. 4, and further described below with respect to FIG. 9, the connection elements 24, which are not shown in FIG. 12, may loosely couple the first and second waist elements 18, 20, thereby allowing the first and second expanded diameter portions 12, 14 to move semi -independently.

[0040] In the present embodiment, the first expanded diameter portion 12 has a larger diameter than the second expanded diameter portion 14. However, in other examples, the first and second expanded diameter portions 12, 14 may as well be configured to have the same diameter. Further, in some examples, the second expanded diameter portion 14 may have a larger diameter than the first expanded diameter portion 12. In some examples, the first and second expanded diameter portions 12, 14 may both have larger diameters than the waist portion 16. In principle, it is preferable that the waist portion 16 has a dimension that is generally equal in size of the cardiac defect to allow for sufficient plug closure.

[0041] The waist portion 16 may be substantially circular, ovular, or lunar in shape. In particular, a lunar shape may be convenient when the collapsible medical device 300 is used for the treatment of a cardiac defect generated by a muscular ventricular septal defect.

[0042] Returning to FIG. 4, the connection elements 24 are illustrated as rings. In some examples, the first and second waist elements 18, 20 may be configured as rings, whereby the attachment points are spaced apart circumferentially about the waist elements, thereby affixing the waist elements to the corresponding discs (e.g., the expanded diameter portions). The connection elements 24 may similarly by arranged at various positions about the waist 16. For example, aplurality of connection elements 24, such as four, six, eight, or other number of connection elements, may be positioned equidistant from each other about the ring of the waist elements 18, 20. In this way, the waist 16 may be configured for some amount of shear angling, wherein the first waist element 18 can be translated (e.g., side to side) with respect to the second waist element 20 by tilting of the connection elements 24. In this way, the angle of a target defect may be matched by the waist 16.

[0043] The first disc 12 and the second disc 14 may be arranged relatively parallel to each other in orientation and may be semi-independent, whereby connection between the waist elements is what connects the first disc 12 to the second disc 14, as opposed to the first and second discs being formed of the same piece of wire as in conventional closure device. Thus, the first disc 12 and the second disc 14 may be arranged to be at least partially rotatable relatively to each other and / or at least partially slidable relatively to each other. The waist portion 16 may control the relative movement of the first and second discs 12, 14. For example, the connection elements 24 may be configured loosely coupled to the waist elements 18, 20, thus allowing the waist elements 18, 20, and therefore the first and second expanded diameter elements 12, 14, to move relative to each other. For example, the first and second expanded diameter elements 12, 14 may slide relative to each other. In an example, sliding may be allowed by tilting of the one or more connection elements 24 when the first and second waist elements 18, 20 slide relative to each other. In another example, rotation may be achieved when the waist elements 18, 20 rotate relative to a longitudinal axis, thereby allowing the first and second expanded diameter portions 12, 14 (e.g., first and second discs 12, 14) to rotate relatively to one another. In this way, the collapsible medical device 300 may conform to the anatomy / shape of the implant site upon implantation and during endothelialization, reducing potential for tissue damage from a sawing effect and / or radial forces.

[0044] Turning now to FIG. 5, the collapsible medical device 300 is shown in a collapsed configuration, for example when positioned intravascularly such as during a minimally-invasive endovascular surgical procedure. In the example shown in FIG. 5, the collapsible medical device 300 is coupled to a catheter 502. The catheter 502 and the collapsible medical device 300 may be positioned within a lumen 500, for example of a blood vessel of a human patient. In this way, the catheter 502 may be used to navigate the human patient’s vasculature to deploy the collapsible medical device 300 at a desired location, for example at an aperture corresponding to a cardiac defect.

[0045] As a non-limiting example, the catheter 502 with the collapsible medical device 300 may be introduced to the patient through a small hole made in the patient’s femoral vein. In some examples, the catheter may be introduced first and then the collapsible medical device 300 pushed through the catheter to the desired position. The collapsible medical device 300 may then be threaded from the femoral vein to the patient’s heart for placement at the intended aperture (e.g., at the defect in the atrial septum, or other depending on the procedure and abnormality). In the example shown, the lumen 500 may be a vena cava of the human patient’s heart which may provide access from the femoral vein (e.g., from the femoral vein, through the external iliac vein and to the inferior vena cava).

[0046] In the collapsed configuration as shown in FIG. 5, the first and second expanded diameter portions 12 and 14 may overlap each other. For example, the braided fabric wiring (e.g., braided strands 10) may be collapsed in on themselves to reduce the diameter of the collapsible medical device 300, which may result in the two discs (e.g., diameter portions 12 and 14), overlapping each other across a midline.

[0047] FIG. 6 shows the collapsible medical device 300 after deployment at a target site. In the deployed configuration, the collapsible medical device 300 may take on a generally dumbbell shape, with the first and second expanded diameter portions 12, 14 taking on the bell regions.

[0048] In the deployed configuration, the first and second expanded diameter portions 12, 14 may be spaced apart from one another by the waist portion 16. In some examples, the first expanded diameter portion 12 may be oriented towards a left side after implantation (e.g., an anatomical left side of the human patient in which the device is deployed), and the second expanded diameter portion 14 may be oriented towards a right side after implantation (e.g., an anatomical right side of the human patient in which the device is deployed).

[0049] The collapsible medical device 300 may be self-centering. For example, the waist portion 16 may be sized to match or slightly exceed a diameter of the aperture to be closed, ensuring frictional engagement within the aperture. As the first and second expanded diameter portions 12, 14 are expanded upon deployment, the waist may naturally align with the aperture. As the braided strands 10 may be formed of Nitinol, the device may expand into its pre-shaped expanded configuration. These elastic restoring forces of Nitinol may help to center the device by equalizing tension around the defect. As shown in FIG. 5, the first expanded diameter portion 12 may be a distal portion that is expanded first upon deployment (e.g., expanded before the secondexpanded diameter portion 14) and the second expanded diameter portion 14 may be a proximal portion that is expanded last upon deployment.

[0050] Using ASD as a use case example, the first expanded diameter portion 12 may be released and unfolded into the left atrium of the heart. The waist 16 may then be drawn into a defect 604 in septum 600 as it is released, positioned snugly within the defect 604. The second expanded diameter portion 14 may be released and unfolded to compress against the right atrial septum. The sequential expansion of the discs on both sides may ensure that the defect remains centered within the device.

[0051] As described herein, the first and second expanded diameter portions 12, 14 may be independent from the waist portion, thus mitigating mismatch in angles of the waist and the septum. Further, the collapsible medical device may be more easily deployed and maintained in place after implantation, thereby mitigating the possibility of tissue erosion and / or device prolapse. In particular, the semi-independent movement of the expanded diameter portions 12 and 14, especially during endothelialization (e.g., growth of tissue around and through the collapsible device), allows for further mitigation of potential tissue damage.

[0052] Turning now to FIG. 7, a ventral, or underside, aspect of the first expanded diameter portion 12 is shown. As described above, the first expanded diameter portion 12 may be coupled to the first waist element 18 at attachment points 22. For example, grouped end points of the braided wires 10 that form the disc 12 may be coupled to the first waist element 18 at attachment points 22. In some examples, the first waist element 18 may be formed of the wires from the first expanded diameter portion 12. In this way, these converging wires may maintain the self-centering nature of the device 300. The first waist element 18 may directly connect to the second waist element 20 as described above.

[0053] In the example shown in FIG. 7, the connection elements 24 are provided on the first waist element 18 of the first expanded diameter portion 18. The connection elements 24 may be loosely attached to the first waist element 18 of the first expanded diameter portion 12, and thereby arranged to be rotatable.

[0054] FIG. 8 shows a similar ventral, or underside, aspect of the second expanded diameter portion 14. Similar to the first expanded diameter portion 12, the second expanded diameter portion 14 may be coupled to the second waist element 20 at attachment points 22. For example, grouped end points of the braided wires 10 that form the disc 14 may be coupled to the secondwaist element 20 at attachment points 22. In some examples, the second waist element 20 may be formed of the wires from the second expanded diameter portion 14.

[0055] Turning now to FIG. 9, the waist portion 16 is shown in greater detail. As described herein, the waist portion 16 comprises the first and second waist elements 18, 20 corresponding to the first and second expanded diameter portions 12, 14, respectively. The waist elements 18, 20 form the waist portion 16 when joined to one another, for example via the connection elements 24. In one embodiment, the waist elements 18, 20 may be formed of the same braided strands 10 that form the first and second expanded diameter portions 12, 14. Each of the waist elements 18, 20 may be connected to its respective expanded diameter portion 12, 14 at one or more attachment points 22, as shown and described herein.

[0056] One or more connection elements 24 are provided to connect the waist elements 18, 20 of the expanded diameter portions 12, 14 to one another to form the waist portion 16. In some examples, the connection elements 24 may be loosely attached to the first waist element 18 of the disc 12. The number of connection elements 24 may vary depending on the diameter of the waist elements 18, 20. For example, a smaller diameter waist element may correspond to a first number of connection elements 24 while a larger diameter waist element may correspond to a second, larger number of connection elements 24. Further, in some examples the type, size, shape, and configuration of the connection elements 24 may depend on the particular application. For example, for a muscular ventricular septal defect closure device, the connection elements 24 may be configured for between 6 and 9 mm of separation between the first disc 12 and the second disc 14. As another example, for a PFO closure device, the connection elements 24 may be configured as ovular shaped rings to allow for more sliding of the discs relative to each other for closure of a tunnel type PFO.

[0057] In the shown embodiment of FIG. 9, the connection elements are substantially circular in cross-section. However, different shapes for the connection elements 24 are also possible according to the invention. For instance, not shown is that the connection elements 24 may be partially rectangular, oval, triangular, or quadratic in cross-section. In some examples, the connection elements 24 may have rounded edges. The rounded edges may mitigate potential of damage to surrounding tissues, such as the septum, during and / or after deployment of the device 300. Further, in some examples, the connection elements 24 can be string-shaped, substantially in the shape of an elongated “8”.

[0058] Turning now to FIG. 10, a detail of one of the waist elements 18, 20 that form the waist portion 16 is shown. In the example shown, the waist element includes a plurality of wire loops 26. The wire loops 26 may be rings. One of said wire loops 26 is illustrated in greater detail in FIG. 11. In the shown configuration, the wire loops 26 are substantially oval. In another example, different shapes for the wire loops, such as a substantially rectangular shape, are also possible.

[0059] In a non-limiting example, the wire loops 26 may be the connection elements 24. In the example shown, the wire loops 26 may be formed with one of the waist elements 18, 20, and may be loosely coupled to the other of the waist elements 18, 20, thus allowing for relative rotation between the waist elements 18, 20.

[0060] In the present embodiment, the waist portion 16 comprises a mesh, preferably a double-layered mesh, made of polymeric material such as Polyester. The waist portion 16 may have a variable length. In particular, the waist portion 16 may have an overall length ranging from 3mm to 40mm. In a possible configuration of the collapsible medical device 300 as herein disclosed, the second expanded diameter portion 14 may be configured and arranged to entirely cover a cardiac defect, while the first expanded diameter portion 12 is configured and arranged to act as an anchor element, securing the collapsible medical device 300 to a surrounding tissue after implantation. For instance, said body cavity can be the inner aortic wall.

[0061] As mentioned, the collapsible medical device 300 is preferably an occlude device 300. The characteristics of the device 300 may render it suitable for the effective treatment of cardiac defects or holes of different shapes and kinds, e.g., caused by congenital heart diseases such as ASD, VSD, PFO, and / or PDA, without inherent risk of tissue erosion and / or device prolapse.

[0062] In this way, the waist portion can be configured and arranged to at least partially control the movement of the expandable diameter portions. For example, in an example embodiment of the device, which is fully deployable or deployed to or in a patient, the waist portion may control at least partially the movement of the expandable diameter portions. Accordingly, self-centering properties of the medical device can be maintained, at the same time allowing for an easier deployment, causing less tissue friction and / or trauma.

[0063] Also, due to its improved adaptability to the surrounding anatomy, the medical device can be reliably used for treatment of every type of cardiac defect or hole, e.g., as those caused by ASD, VSD, PFO, and / or PDA. The waist portion may be configured to connect the expandablediameter portions to one another. Thus, in an example embodiment of the device, which is fully deployable or deployed to or in a patient, the waist portion is connecting the expandable diameter portions to one another. This allows the waist portion to directly control the movement, preferably semi-independent movement, of the expandable diameter portions.

[0064] The waist portion may be made of fabric, like Dacron ® (medical grade fabric polyethyleneterephthalate (PET), provided by Dupont), polytetrafluorethylene (PTFE), polyamide (PA), or any other suitable material. The waist portion can also be formed mainly be several rings. The waist portion may be configured and arranged to be placed in a cardiac defect or hole. Preferably, said cardiac defect or hole is a septal defect or hole caused by a congenital heart disease such as ASD, VSD, and the like. Preferably, the waist portion may be configured and arranged to be at least partially self-centering in said cardiac defect or hole, e.g., a septal defect or hole. This allows obtaining an enhanced adaption to a surrounding anatomy.

[0065] Partial-self centering is convenient when the medical device is used for treatment of a cardiac defect or hole caused by muscular VSD. Alternatively, the waist portion can be fully selfcentering. The two expanded diameter portions may be configured and arranged to be slidable relatively to each other, controlled in their relative movement by the waist portion. This allows for easier deployment at the target site, further reducing the risk of tissue damage and / or unwanted device displacement. The two expanded diameter portions may be configured and arranged to be at least partially rotatable relative to each other, controlled in their relative movement by the waist portion.

[0066] In an example embodiment of the device, which is fully deployable or deployed to or in a patient, the two expanded diameter portions are at least partly rotatable relatively to each other, controlled in their relative movement by the waist portion. For example, the expanded diameter portions may be partly rotatable relatively to each other. Alternatively, the expanded diameter portions may be fully rotatable relatively to each other. This allows avoiding the occurrence of a sawing effect to a surrounding tissue at the implantation site, thereby preventing tissue trauma. Unwanted erosion of the heart tissue and also a perforation of the heart can be prevented. The two expanded diameter portions may be configured and arranged to adjust their distance relatively to each other, controlled in their relative movement by the waist portion. This may allow for better adaption to the surrounding anatomy at the implantation site.

[0067] The braided strands forming the fabric can be made of metal. For instance, said metal may include Nitinol or Steel. Alternatively, the braided strands forming the fabric can be made of a polymeric material. For instance, said polymeric material can be Polyester. Further, it can be any fabric like Dacron ®, as noted above. Optionally, said polymeric material, e.g. Polyester, can be provided with a metal covering. For instance, said metal covering may comprise Nitinol or Steel.

[0068] Each of the two expanded diameter portions may include a respective waist element. In particular, the waist elements of the expanded diameter portions are made of the same braided strands forming the expanded diameter portions. The waist elements of the two expanded diameter portions form the waist portion, when joined to one another. Each of the waist elements is connected to the respective expanded diameter portion at one or more attachment points. This configuration allows further ensuring the self-centering characteristics of the medical device.

[0069] The technical effect of the collapsible medical device herein disclosed is that the collapsible medical device is adaptable, rotatable, slidable, and dislocatable. In particular, the discs (e.g., the first and second expanded diameter portions) may be partially flexible, at least semiindependent of one another, and / or partially slidable and / or partially rotatable, thus allowing the device to conform to the anatomy of the patient, such as the angle and / or thickness of the septal wall. For example, during deployment, the first disc may be deployed at the left side of the atrial septum at a first angle, the waist portion may be arranged within a septal defect, and the second disc may be deployed at the right side of the atrial septum at a second, different angle because the waist portion allows for semi-independent movement of the discs. In this way, the device may conform to the patient’s anatomy, reducing potential for tissue damage from stretch or sawing effects.

[0070] The disclosure also provides support for a collapsible medical device comprising a fabric formed of braided strands, the device having a collapsed configuration for delivery through at least a lumen in a subject, wherein the device has a generally dumbbell-shaped expanded configuration with two expanded diameter portions spaced apart by a waist portion formed between the two expanded diameter portions. In a first example of the system, the waist portion is configured and arranged such that the two expanded diameter portions are semi-independent in their movement to each other. In a second example of the system, optionally including the first example, the waist portion is configured and arranged to at least partially control the movement of the two expanded diameter portions. In a third example of the system, optionally including one orboth of the first and second examples, the waist portion is configured and arranged to connect the two expanded diameter portions to one another. In a fourth example of the system, optionally including one or more or each of the first through third examples, the waist portion is configured and arranged to be placed in a cardiac defect or hole caused by a congenital heart disease such as atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), and / or patent ductus arteriosus (PDA), wherein the waist portion is further configured and arranged to be at least partially self-centering in said cardiac defect or hole. In a fifth example of the system, optionally including one or more or each of the first through fourth examples, the two expanded diameter portions are configured and arranged to be slidable relatively to each other, controlled in their relative movement by the waist portion. In a sixth example of the system, optionally including one or more or each of the first through fifth examples, the two expanded diameter portions are configured and arranged to be at least partially rotatable relatively to each other, controlled in their relative movement by the waist portion. In a seventh example of the system, optionally including one or more or each of the first through sixth examples, the two expanded diameter portions are configured and arranged to adjust their distance relatively to each other, controlled in their relative movement by the waist portion. In a eighth example of the system, optionally including one or more or each of the first through seventh examples, one of: the braided strands forming the fabric are made of metal, wherein the metal is one of Nitinol and steel, and the braided strands forming the fabric are made of a polymeric material, wherein said polymeric material is Polyester and optionally wherein the polymeric material has a metal covering comprising Nitinol or steel. In a ninth example of the system, optionally including one or more or each of the first through eighth examples, each of the two expanded diameter portions includes a respective waist element made of the same braided strands that form the expanded diameter portions, wherein the respective waist elements form the waist portion when joined together, wherein each of the waist elements is connected to a respective one of the two expanded diameter portions at one or more connection points. In a tenth example of the system, optionally including one or more or each of the first through ninth examples, the waist elements are joined to one another to form the waist portion via one or more connection elements, wherein the one or more connection elements are provided on the waist element of a first expanded diameter portion of the two expanded diameter portions. In a eleventh example of the system, optionally including one or more or each of the first through tenth examples, the one or more connection elements are arranged such that the two expandeddiameter portions are spaced apart by a distance ranging from 6mm to 9mm. In a twelfth example of the system, optionally including one or more or each of the first through eleventh examples, at least one of: the one or more connection elements are circular, partially rectangular, oval, triangular, or quadratic in cross- section, wherein the one or more attachment elements have rounded edges to facilitate implantation and / or prevent risk of injuries to a surrounding tissue during and / or after implantation, the one or more attachment elements are string-shaped, and the one or more connection elements are substantially in the shape of an elongated “8”. In a thirteenth example of the system, optionally including one or more or each of the first through twelfth examples, a first expanded diameter portion of the two expanded diameter portions has a larger diameter than a second expanded diameter portion of the two expanded diameter portions. In a fourteenth example of the system, optionally including one or more or each of the first through thirteenth examples, the two expanded diameter portions have the same diameter.

[0071] The disclosure also provides support for a method, comprising: deploying a collapsible medical device for closure of an aperture, wherein the collapsible medical device comprises: a first expanded diameter portion comprising a first waist element, a second expanded diameter portion comprising a second waist element, and a waist portion formed of the first and second waist elements, wherein the first and second waist elements are connected via one or more connection elements, wherein the first and second expanded diameter portions are configured as discs of braided wire, wherein the collapsible medical device is in a collapsed configuration prior to deployment and in an expanded configuration following deployment. In a first example of the method when the aperture is a septal defect, deploying the collapsible medical device comprises deploying the first expanded diameter portion to a left side of the septal defect, deploying the waist at the septal defect, and deploying the second expanded diameter portion to a right side of the septal defect, wherein the first and second expanded diameter portion are at least partially slidable and at least partially rotatable with respect to each other. In a second example of the method, optionally including the first example, the one or more connection elements are configured as rings loosely coupled to the first and second waist elements. In a third example of the method, optionally including one or both of the first and second examples, the waist portion is configured and arranged to at least partially control the movement of the two expanded diameter portions. In a fourth example of the method, optionally including one or more or each of the first through third examples, the braided wire is made of metal, wherein the metal is one of Nitinol and steel.

[0072] Any version of any component or method step of the present disclosure may be used with any other component or method step of the disclosure. The elements described herein can be used in any combination whether explicitly described or not. All combinations of method steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.

[0073] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural of said elements or steps, unless such exclusion is explicitly stated. Furthermore, references to “one embodiment” of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, embodiments “comprising,” “including,” or “having” an element or a plurality of elements having a particular property may include additional such elements not having that property. The terms “including” and “in which” are used as the plain-language equivalents of the respective terms “comprising” and “wherein.” Moreover, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements or a particular positional order on their objects.

[0074] This written description uses examples to disclose the invention, including the best mode, and also to enable a person of ordinary skill in the relevant art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Claims

CLAIMS1. A collapsible medical device comprising a fabric formed of braided strands, the device having a collapsed configuration for delivery through at least a lumen in a subject, wherein the device has a generally dumbbell-shaped expanded configuration with two expanded diameter portions spaced apart by a waist portion formed between the two expanded diameter portions.

2. The collapsible medical device according to claim 1, wherein the waist portion is configured and arranged such that the two expanded diameter portions are semi-independent in their movement to each other.

3. The collapsible medical device according to claim 1, wherein the waist portion is configured and arranged to at least partially control the movement of the two expanded diameter portions.

4. The collapsible medical device according to claim 1, wherein the waist portion is configured and arranged to connect the two expanded diameter portions to one another.

5. The collapsible medical device according to claim 1, wherein the waist portion is configured and arranged to be placed in a cardiac defect or hole caused by a congenital heart disease such as atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), and / or patent ductus arteriosus (PDA), wherein the waist portion is further configured and arranged to be at least partially self-centering in said cardiac defect or hole.

6. The collapsible medical device according to claim 1, wherein the two expanded diameter portions are configured and arranged to be slidable relatively to each other, controlled in their relative movement by the waist portion.

7. The collapsible medical device according to claim 1, wherein the two expanded diameter portions are configured and arranged to be at least partially rotatable relatively to each other, controlled in their relative movement by the waist portion.

8. The collapsible medical device according to claim 1, wherein the two expanded diameter portions are configured and arranged to adjust their distance relatively to each other, controlled in their relative movement by the waist portion.

9. The collapsible medical device according to claim 1, wherein one of: the braided strands forming the fabric are made of metal, wherein the metal is one of Nitinol and steel; and the braided strands forming the fabric are made of a polymeric material, wherein said polymeric material is Polyester and optionally wherein the polymeric material has a metal covering comprising Nitinol or steel.

10. The collapsible medical device according to claim 1, wherein each of the two expanded diameter portions includes a respective waist element made of the same braided strands that form the expanded diameter portions, wherein the respective waist elements form the waist portion when joined together, wherein each of the waist elements is connected to a respective one of the two expanded diameter portions at one or more attachment points.

11. The collapsible medical device according to claim 10, wherein the waist elements are joined to one another to form the waist portion via one or more connection elements, wherein the one or more connection elements are provided on the waist element of a first expanded diameter portion of the two expanded diameter portions.

12. The collapsible medical device according to claim 11, wherein the one or more connection elements are arranged such that the two expanded diameter portions are spaced apart by a distance ranging from 6mm to 9mm.

13. The collapsible medical device according to claim 11, wherein at least one of: the one or more connection elements are circular, partially rectangular, oval, triangular, or quadratic in cross-section, wherein the one or more connection elements have rounded edges to facilitate implantation and / or prevent risk of injuries to a surrounding tissue during and / or after implantation;the one or more connection elements are string-shaped; and the one or more connection elements are substantially in the shape of an elongated “8”.

14. The collapsible medical device according to claim 1, wherein a first expanded diameter portion of the two expanded diameter portions has a larger diameter than a second expanded diameter portion of the two expanded diameter portions.

15. The collapsible medical device according to claim 1, wherein the two expanded diameter portions have the same diameter.

16. A method, comprising: deploying a collapsible medical device for closure of an aperture, wherein the collapsible medical device comprises: a first expanded diameter portion comprising a first waist element; a second expanded diameter portion comprising a second waist element; and a waist portion formed of the first and second waist elements, wherein the first and second waist elements are connected via one or more connection elements, wherein the first and second expanded diameter portions are configured as discs of braided wire, wherein the collapsible medical device is in a collapsed configuration prior to deployment and in an expanded configuration following deployment.

17. The method according to claim 16, wherein, when the aperture is a septal defect, deploying the collapsible medical device comprises deploying the first expanded diameter portion to a left side of the septal defect, deploying the waist at the septal defect, and deploying the second expanded diameter portion to a right side of the septal defect, wherein the first and second expanded diameter portion are at least partially slidable and at least partially rotatable with respect to each other.

18. The method according to claim 16, wherein the one or more connection elements are configured as rings loosely coupled to the first and second waist elements.

19. The method according to claim 16, wherein the waist portion is configured and arranged to at least partially control the movement of the two expanded diameter portions.

20. The method according to claim 16, wherein the braided wire is made of metal, wherein the metal is one of Nitinol and steel.

Images