Patent Application
20220387042
The present technology relates to implantable therapeutic devices and methods for endovascular placement of devices at a target site, such as an opening at a neck of an aneurysm. cl BACKGROUND
Many of the currently available surgical approaches for closing openings and repairing defects in anatomical lumens and tissues (e.g., blood vessels), septal defects, and other types of anatomical irregularities and defects are highly invasive. Surgical methods for clipping brain aneurysms, for example, require opening the skull, cutting or removing overlying brain tissue, clipping and repairing the aneurysm from outside the blood vessel, and then reassembling tissue and closing the skull. Surgical techniques for repairing septal defects are also highly invasive. The risks related to anesthesia, bleeding, and infection associated with these types of procedures are high, and tissue that is affected during the procedure may or may not survive and continue functioning.
Minimally invasive surgical techniques have been developed to place occlusive devices within or across an opening or cavity in the body, such as in the vasculature, spinal column, fallopian tubes, bile ducts, bronchial and other air passageways, and the like. In general, an implantable device is guided along a delivery catheter and through a distal opening of the catheter using a pusher or delivery wire to deploy the device at a target site in the vasculature. Once the occlusive device has been deployed at the target site, it is detached from the pusher mechanism without disturbing placement of the occlusive device or damaging surrounding structures.
Minimally invasive techniques are also highly desirable for treating aneurysms. In general, the minimally invasive therapeutic objective is to prevent material that collects or forms in the cavity from entering the bloodstream and to prevent blood from entering and collecting in the aneurysm. This is often accomplished by introducing various materials and devices into the aneurysm. One class of embolic agents includes injectable fluids or suspensions, such as microfibrillar collagen, various polymeric beads, and polyvinylalcohol foam. Polymeric agents may also be cross-linked to extend their stability at the vascular site. These agents are typically deposited at a target site in the vasculature using a catheter to form a solid space-filling mass. Although some of these agents provide for excellent short-term occlusion, many are thought to allow vessel recanalization due to their absorption into the blood. Other materials, such as hog hair and suspensions of metal particles, have also been proposed and used to promote occlusion of aneurysms. Polymer resins, such as cyanoacrylates, are also employed as injectable vaso-occlusive materials. These resins are typically mixed with a radiopaque contrast material or are made radiopaque by the addition of a tantalum powder. Accurate and timely placement of these mixtures is crucial and very difficult because it is difficult or impossible to control them once they have been placed in the blood flow.
Implantable vaso-occlusive metallic structures are also well known and commonly used. Many conventional vaso-occlusive devices have helical coils constructed from a shape memory material or noble metal that forms a desired coil configuration upon exiting the distal end of a delivery catheter. The function of the coil is to fill the space formed by an anatomical defect and to facilitate the formation of an embolus with the associated allied tissue. Multiple coils of the same or different structures may be implanted serially in a single aneurysm or other vessel defect during a procedure. Implantable framework structures are also used in an attempt to stabilize the wall of the aneurysm or defect prior to insertion of filling material such as coils.
Techniques for delivering conventional metallic vaso-occlusive devices to a target site generally involve a delivery catheter and a detachment mechanism that detaches the devices, such as a coil, from a delivery mechanism after placement at the target site. For example, a microcatheter can be initially steered through the delivery catheter into or adjacent to the entrance of an aneurysm either with or without a steerable guidewire. If a guidewire is used, it is then withdrawn from the microcatheter lumen and replaced by the implantable vaso-occlusive coil. The vaso-occlusive coil is advanced through and out of the microcatheter and thus deposited within the aneurysm or other vessel abnormality. It is crucial to accurately implant such vaso-occlusive devices within the internal volume of a cavity and to maintain the device within the internal volume of the aneurysm. Migration or projection of a vaso-occlusive device from the cavity may interfere with blood flow or nearby physiological structures and poses a serious health risk.
In addition to the difficulties of delivering implantable occlusion devices, some types of aneurysms are challenging to treat because of structural features of the aneurysm or because of particularities of the site. Wide-neck aneurysms, for example, are known to present particular difficulty in the placement and retention of vaso-occlusive coils. Aneurysms at sites of vascular bifurcation are another example where the anatomical structure poses challenges to methods and devices that are effective in treating the typical sidewall aneurysms.
In view of such challenges, implanting conventional embolic coils, other structures, or materials in the internal space of an aneurysm has not been an entirely satisfactory surgical approach. The placement procedure may be arduous and lengthy because it often requires implanting multiple devices, such as coils, serially in the internal space of the aneurysm. Higher risks of complication from such sources as anesthesia, bleeding, thromboembolic events, procedural stroke, and infection are associated with such longer procedures. Moreover, because placement of structures in the internal space of an aneurysm does not generally completely occlude the opening, recanalization of the original aneurysm may occur, and debris and occlusive material may escape from within the aneurysm to create a risk of stroke or vessel blockage. Blood may also flow into the aneurysm and other blood vessel irregularities after the placement of embolic devices, which may increase the risks of complication and further enlargement of the aneurysm.
Despite the numerous conventional devices and systems available for implanting embolic materials in an aneurysm and for occluding physiological defects using minimally invasive techniques, these procedures remain risky and rarely restore the physiological structure to its normal, healthy condition. It is also challenging to position conventional implantable devices during deployment, prevent shifting or migration of such devices after deployment, and preserve blood flow in neighboring vessels following after deployment.
The present disclosure describes implantable therapeutic devices and methods for endovascular placement of devices at a target site, such as an opening at a neck of an aneurysm. In several embodiments, a therapeutic aneurysm device is endovascularly deliverable to a site proximate to an arterial aneurysm. The aneurysm device comprises a closure structure having a distal-facing aspect configured to at least partially occlude the aneurysm and a proximal-facing aspect configured to arch over lumina of an artery. The device further includes a supplemental stabilizer connected to the closure structure and configured to reside in the artery and press outward against a luminal wall thereof in some embodiments, the device can also include a barrier spanning at least a portion of the distal-facing aspect of the closure structure and configured to further occlude a neck of the aneurysm.
The following description provides specific details for a thorough understanding of, and enabling description for, embodiments of the disclosure. Well-known structures, systems, and methods often associated with aneurysm treatment have not been shown or described in detail to avoid unnecessarily obscuring the description of the various embodiments of the disclosure. In addition, those of ordinary skill in the relevant art will understand that additional embodiments may be practiced without several of the details described below.
The closure structure 110 can define a distal framework portion, and the supplemental stabilizer 120 can define a proximal framework portion. Each of these portions can have one or more pairs of struts 130 (e.g., strut 130a is “paired” with strut 130f. In some embodiments, the struts 130 can curve inwardly toward the longitudinal axis L-L of the aneurysm device 100. The outline of the struts 130 is typically that of a quadrilateral form. In some embodiments, the struts 130 can have a rhombus-like configuration or diamond shape. In several embodiments, the struts 130 can bend to provide a tailored fit to a particular vasculature. In some embodiments, the struts 130 can bend or flexibly move independently of one another. For example, strut 130c may bend further into an aneurysm body than strut 130b. This independent adjustability can provide a customized fit to the particular contours of a given aneurysm, creating a more secure hold.
As discussed above, the struts 130 can be symmetrical (e.g., the same length along orthogonal axes) or asymmetrical in which one side of the rhombus-like structure can have an axis longer than the other side. Although many closure structures 110 described below have quadrilateral forms, the closure structures 110 are not limited to these shapes in that the distal-facing aspect of the distal framework portion may have other shapes, such as polygons or polygonal curvilinear shapes. In several embodiments, the rhombus-like supports 130 are concentric with a center at the longitudinal axis L-L of the aneurysm device 100. The lateral apices of the closure structure 102 are disposed at opposing ends of the lateral axis T-T of the distal framework portion. The two portions of the distal framework portion opposite each other across the longitudinal axis L-L may define lateral leaves of the distal framework portion.
In various embodiments, the closure structure 110 can be used in combination with the supplemental stabilizer 120 or independently from the supplemental stabilizer 120 at a neck of an aneurysm. The laterally-extending branches of the closure structure 110 and the supplemental stabilizer 120 hold the curved portion of the closure structure 110 at the neck of the aneurysm. However, in some embodiments, using the closure structure 110 independently of the supplemental stabilizer 120 can decrease the amount of contact the aneurysm device 100 has with a patient's vasculature. For example, in some embodiments, the closure structure 110 can be used independently of the supplemental stabilizer in the treatment of a ruptured aneurysm. In some embodiments, the supplemental stabilizer 120 can be used during placement of the closure structure 110, but then removed.
The distal-facing aspect or back of the proximal-facing surface generally aligns against the luminal surfaces of the bifurcating arteries, the sides of the arch extending down into the parent artery and aligned against the luminal surface thereof. The proximal face of the arch is generally and substantially transverse (perpendicular or orthogonal) to the lateral axis of the proximal framework. The arch spans unobtrusively over the lumina of the bifurcating arteries, forming no incursion into the vascular flow path. More particularly, the arch can be a non-enclosed opening or hole, but instead a structure entirely open in the proximal direction. In further embodiments, as will be discussed in more detail below, the closure structure 110 can include a cover or barrier portion spanning across one or more distal framework struts and configured to occlude the neck of the aneurysm.
In the illustrated embodiment, the closure structure 210 includes perimeter struts 232 and curved inner arms 230 that meet the perimeter struts 232 at longitudinal corner points 217. The closure structure 210 is capable of temporary or permanent attachment to a supplemental stabilizer (such as the supplemental stabilizer 120 described above with reference to
The barrier 240 can be formed with or permanently or removably attached to the perimeter and inner arms 232, 230. The barrier 240 can comprise one or more permeable or semi-permeable membranes, covers, sheets, panels, mesh, or other structures that form an occlusive or semi-occlusive covering that (a) restricts, diverts, redirects, or inhibits vascular flow into the cavity of the aneurysm and/or (b) prevents materials from escaping the cavity. In this aspect, devices and methods of the described technology may provide repair and reconstruction of a blood vessel or a junction of blood vessels by placement and retention of the closure structure 210 across the neck of the aneurysm that diverts blood flow away from the aneurysm. Following placement and deployment, the barrier 240 may substantially cover the aneurysm neck and the closure structure 210 can form a structure that substantially conforms to the tissue surrounding the aneurysm and/or the neighboring vessel walls. The highly conforming fit generally restores the vascular anatomical neighborhood to a normal or more normal configuration, thereby supporting a normal vascular flow pattern and overall function. In the illustrated embodiments, the barrier 240 includes a barrier aperture 242 configured to provide access to the aneurysm (e.g., access for a catheter, access to deliver coils, etc.) As will be described in further detail below, the barrier 240 can comprise a single sheet or panel, or can comprise a plurality of sheets or panels layered and/or otherwise arranged on the device to achieve a desired barrier pattern and/or structure.
The illustrated configurations are merely representative of the numerous arrangements the struts 430 and barrier 440 could take. For example, there could be more or fewer than three sets of nested struts 430, and the barrier 440 could cover more or fewer areas or parts of areas between the struts 430. In some embodiments, the degree of barrier coverage across the struts can be selected based on a desired degree of occlusion, type or characteristics of the aneurysm, and/or desired access to the body of the aneurysm.
The closure structure 510 further includes flexible anchor legs 552 distally coupled to the perimeter struts 530. While two legs 552 are shown descending from the illustrated side of the closure structure 510, there can be more or fewer legs 552, of the same or different dimensions, in further embodiments of the technology. The anchor legs 552 can provide pivotable movement (or shock absorption) between the closure structure 510 and a supplemental stabilizer, such as the supplemental stabilizer 120 described above with reference to
In several embodiments, at least one of the distal arms 630 or proximal arms 660 are curved or parabolic shaped to better conform to the shape of the aneurysm or the vasculature to provide the desired degree of aneurysm occlusion and device stability. For example, in the illustrated embodiment, the distal arms 630 extend distally but have a lateral, proximally-dipping curve, while the proximal arms 660 have an approximately 180-degree distal curve before projecting laterally. As best shown in
The panels 730 can be individually covered by the barrier 740, or pairs of struts (e.g., forming a V-shape) can be covered. One or more panels 730 can include an opening or hole 742. For example, in the illustrated embodiment, the closure structure 710 includes a central hole 742 that extends longitudinally through each pair of adjacent panels 730, thereby providing access from a proximal side of the closure structure 710 to the interior of the aneurysm. While the panels 730 are discussed as triangles, in further embodiments the panels 730 can be shaped as rectangles, circles, squares, or other polygonal or curved shapes. The panels 730 can laterally overlap and can be used to control, contain, and/or divert flow. The panels 730 can function as baffles that can pivotably bend or otherwise move relative to one another to adjust from an open state to a closed state. In various embodiments of use, one or more of the panels 730 can be inside the aneurysm while other panels 730 can be outside the aneurysm. In further embodiments, all of the panels 730 can be inside or outside the aneurysm.
The closure structure 1310 can be folded or bent into a curve along the lateral axis T-T such that the portions of the closure structure 1310 associated with corners 1317a-1317c define paired longitudinally aligned structures on either side and generally substantially orthogonal to the lateral axis T-T. The paired longitudinally aligned structures can be substantially parallel to each other and define anchors that hold the closure structure 1310 in place. The closure structure 1310 forms a vertex that is resiliently bent by a total of about 180° and is biased outward. The outward bias of the closure structure 1310 is due to the materials that form the closure structure, such as resilient metals or alloys including Nitinol and other shape memory metals. The outward biasing force is conveyed to the supplemental stabilizer 1320 from the closure structure 1310 such that the supplemental stabilizer 1320 presses outward against the lumen of a parent vessel that extends at an angle relative to the lengthwise dimension of the closure structure 1310.
Radiopaque markers 1372, 1374, 1376, and 1378 or radiopaque compounds may be associated with certain structures or portions of the device structure to facilitate accurate positioning, placement and monitoring of the deployed device in the vasculature. In one embodiment, for example, a radiopaque composition may be incorporated in the closure structure or provided as a coating on the closure structure. Variations in the marker geometry may be adopted to distinguish different segments of the device framework. For example, the proximal legs of the device may incorporate a marker with two dots, while the portion of the device closer to or in proximity to the covering may incorporate a single dot. Alternatively, different shaped markers may be used to differentiate different parts of the device. Radiopaque markers may be added anywhere along the device frame or attached materials, coverings, and membranes to provide spatial location of different device components and features under angiography. In several embodiments, for example, radiopaque markers can be added to laterally and/or longitudinally asymmetric points on the closure structure 1310 and/or supplemental stabilizer 1320 (i.e., asymmetric with reference to the lateral axis T-T, longitudinal axis L-L, or a center point 1370 at the intersection of the longitudinal and lateral axes). In the embodiment illustrated in
From the foregoing, it will be appreciated that specific embodiments of the disclosure have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the disclosure. For example, structures (such as supplemental stabilizers and/or barriers) and/or processes described in the context of particular embodiments may be combined or eliminated in other embodiments. In particular, the aneurysm devices described above with reference to particular embodiments can include one or more additional features or components, or one or more of the features described above can be omitted. Moreover, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure.
This application is a divisional of U.S. patent application Ser. No. 16/543,713 filed Aug. 19, 2019, which is a divisional of U.S. patent application Ser. No. 15/496,657, filed on Apr. 25, 2017 and entitled DEVICES, SYSTEMS AND METHODS FOR ENCLOSING AN ANATOMICAL OPENING, now U.S. Pat. No. 10,426,487, which in turn is a divisional of U.S. patent application Ser. No. 14/808,343, now U.S. Pat. No. 9,636,117, filed on Jul. 24, 2015 and entitled DEVICES, SYSTEMS AND METHODS FOR ENCLOSING AN ANATOMICAL OPENING, which in turn is a divisional of U.S. patent application Ser. No. 13/646,602, now U.S. Pat. No. 9,119,625, filed on Oct. 5, 2012 and entitled DEVICES, SYSTEMS AND METHODS FOR ENCLOSING AN ANATOMICAL OPENING, which claims the benefit of U.S. Provisional Application No. 61/543,785, filed on Oct. 5, 2011 and entitled DEVICES, SYSTEMS AND METHODS FOR ENCLOSING AN ANATOMICAL OPENING, all of which are incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 61543785 | Oct 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16543713 | Aug 2019 | US |
| Child | 17889691 | US | |
| Parent | 15496657 | Apr 2017 | US |
| Child | 16543713 | US | |
| Parent | 14808343 | Jul 2015 | US |
| Child | 15496657 | US | |
| Parent | 13646602 | Oct 2012 | US |
| Child | 14808343 | US |
