Patent Application
20240188948
The present disclosure generally relates to the field of medical implant devices.
Openings and/or other defects can form or otherwise be present in certain biological tissue walls, such as cardiac septa. Such defects can negatively impact physiological function and/or health in some patients and cases.
Described herein are one or more methods and/or devices to facilitate the treatment of defects in biological tissue, including inventive occluder devices and associated delivery systems and procedures for delivering and deploying the same.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and/or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.
Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.
Although certain preferred examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
Certain reference numbers are re-used across different figures of the figure set of the present disclosure as a matter of convenience for devices, components, systems, features, and/or modules having features that may be similar in one or more respects. However, with respect to any of the examples disclosed herein, re-use of common reference numbers in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one having ordinary skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply similarity between referenced subject matter. Use of a particular reference number in the context of the description of a particular figure can be understood to relate to the identified device, component, aspect, feature, module, or system in that particular figure, and not necessarily to any devices, components, aspects, features, modules, or systems identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with common reference numbers can be interpreted to share characteristics or to be entirely independent of one another.
Certain standard anatomical terms of location are used herein to refer to certain device components/features and to the anatomy of animals, and namely humans, with respect to the preferred examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” “under,” “over,” “topside,” “underside,” and similar terms, are used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.
The present disclosure relates to systems, devices, and methods for occluding a defect in biological tissue using a septal occluder device having rotationally expansive and compressive cover(s) that provide for a desirably large ratio (e.g., 5:1) between expanded and compressed configurations. In some implementations, the present disclosure relates to occluder devices that include a core form/structure associated with two (e.g., identical) mirrored self-expanding covers including individual radially and/or circumferentially-/rotationally-projecting wires coupled to or otherwise associated with respective coverings (e.g., cloth). Such covers can be configured to progressively transition between and/or assume cylindrical, dish, and/or disc-type forms/configurations through the rotational folding of the cover about an axis of the device. The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.
Occluder devices of the present disclosure include opposing defect covers coupled by a core form/structure configured to traverse a target defect when the occluder device is deployed/implanted. The use of rotationally-expandable covers in connection with occluder devices as disclosed herein can provide improved compression for reduced delivery configuration profile for transcatheter transportation, as well as sufficient expansion profile/coverage to accommodate coverage of relatively large areas of tissue and/or defects. Furthermore, implementation of partial expansion of such devices/covers, wherein alternating radially-expanding wires of the relevant covers lie in angularly-offset planes, can facilitate conforming of the shape/form of the devices/covers to concave topologies, thereby providing improved fit/sealing. Certain examples of occluder devices are disclosed herein in the context of cardiac implant devices. However, although certain principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that occluder implant devices in accordance with the present disclosure may be implanted in, or configured for implantation in, any suitable or desirable anatomy.
The anatomy of the heart is described below to assist in the understanding of certain inventive concepts disclosed herein. In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the flow between chambers and vessels associated therewith is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. The valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to blood vessels (e.g., pulmonary, aorta, etc.).
In addition to the pulmonary valve, the heart 1 includes three additional valves for aiding the circulation of blood therein, including the tricuspid valve 8, the aortic valve (not shown in
The heart valves may generally comprise a relatively dense fibrous ring, referred to as the annulus, as well as a plurality of leaflets or cusps attached to the annulus. Generally, the size of the leaflets/cusps may be such that when the heart contracts the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or blood vessel may become dominant and press back against the leaflets. As a result, the leaflets/cusps come in apposition to each other, thereby closing the flow passage. Disfunction of a heart valve and/or associated leaflets (e.g., pulmonary valve disfunction) can result in valve leakage and/or other health complications.
The atrioventricular (i.e., mitral and tricuspid) heart valves may further comprise a collection of chordae tendineae 7 and papillary muscles 9 for securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles 9, for example, may generally comprise finger-like projections from the ventricle wall. The valve leaflets are connected to the papillary muscles by the chordae tendineae 7.
A wall of muscle, referred to as the septum, separates the left-side chambers from the right-side chambers. In particular, an atrial septum wall portion 18 (referred to herein as the “atrial septum,” “interatrial septum,” or “septum”) separates the left atrium 2 from the right atrium 5, whereas a ventricular septum wall portion 17 (referred to herein as the “ventricular septum,” “interventricular septum,” or “septum”) separates the left ventricle 3 from the right ventricle 4. The atrial septum 18 is generally a relatively thin wall tissue, whereas the ventricular septum 17 is typically thicker than they atrial septum 18.
A septal defect or orifice (e.g., atrial septal defect 16) can form in a septal wall in the form of a perforation, aperture, or other hole or passage through the tissue wall. A septal defect can occur congenitally or by puncturing the septum with a medical device to access a location (e.g., left atrium 2) within the heart. While some septal defects can be relatively benign and have relatively little impact on a patient's health, other septal defects can be more serious. Septal defects can result in left-to-right shunting of blood, wherein oxygen-rich blood is shunted to the relatively oxygen-depleted right-side chamber(s) (e.g., right atrium 5). In some cases, such shunting can cause volume overload in the right side of the heart and/or insufficient oxygenated blood being delivered to the body. In some cases, a thrombus or other embolus can travel from the right to the left, potentially causing various health complications, such as migraines and/or stroke.
In some instances, an atrial defect is formed in the area of the fossa ovalis 15, which is a depression in the right atrium 5 of the heart, at the level of the interatrial septum 18. For example, one type of septal defect is a patent foramen ovale (PFO), which is an opening in the area of the fossa ovalis 15. Because the fetal lungs do not provide air prior to birth, fetal blood is oxygenated by the mother in utero via the umbilical cord and placenta. To provide for circulation of such oxygenated blood, the fetal blood circulation system includes certain vessels and openings that are open during fetal development but typically close soon after birth. One such opening is the foramen ovale, a central location in the interatrial septum where the septum primum and the septum secundum overlap, which permits blood to flow from the right atrium into the left atrium in a fetal heart, thereby allowing blood to bypass the fetal lungs and flow directly from the venous circulation to the arterial circulation. After birth, the infant's lungs typically provide oxygenation to the blood, and it is generally undesirable to continue having blood shunt/flow from the venous circulation to the arterial circulation without first passing through the lungs. At birth, left atrial pressure increases as the pulmonary circulation is established. This pressure increase typically causes the closure of a flap of tissue which occludes the foramen ovale and then heals/fixes in the occluded position shortly after birth. The foramen ovale becomes the fossa ovalis depression as the foramen closes.
In some individuals, however, the tissue flap does not heal to permanently occlude the foreman ovale. This condition is known as a patent (i.e., open) foramen ovale (PFO). While a PFO can be a relatively benign condition in some cases, PFOs can lead to migraines and other conditions in some individuals. In some cases, a PFO can cause a stroke by permitting blood containing small thrombi/embolus to bypass the lungs (which would otherwise filter out such small thrombi) and flow directly from the venous circulation to the arterial circulation and ultimately into the brain.
In addition to patent foramen ovale, septal defects can be caused in connection with certain medical interventions. For example, the atrial septum can serve as an access point for certain catheterization procedures for accessing the left atrium from the venous system (i.e., right atrium and inferior or superior vena cava). For example, the atrial septum can serve as a point of percutaneous access for atrial fibrillation therapy, left atrial appendage closure, percutaneous mitral valve repair, and percutaneous mitral valve replacement. In such procedures, devices may traverse across the atrial septum and, by doing so, may leave a defect/opening in the atrial septum that does not close spontaneously.
Health Conditions and Treatments Associated with Septal Defects
As referenced above, defects in cardiac tissue walls, such as patent foramen ovale or other septal defects, can adversely affect the health of an individual. For example, atrial septal defects can cause ischemic stroke due to embolism of venous emboli passing to the arterial circulation from thrombus traversing a patent foramen ovale. In addition, patent foramen ovale can cause migraine headaches in some individuals.
Treatments for patent foramen ovale (PFO) and other septal defects can include open-heart surgery, as well as percutaneous (e.g., transcatheter) procedures. Open-heart surgery for septal defect closure can involve suturing the opening/defect closed. Such open-heart surgical treatment can be associated with a variety of risks typically associated with cardiac surgery. Percutaneous methods can involve deploying mesh, clamshell, plug, or other similar implanted devices to close the opening. Other treatments can include using heat, laser, RF, or other energy to treat the tissue of (or adjacent to) the septal defect to induce the tissue to permanently close the opening. Such percutaneous methods can be complicated and/or involve relatively large implant devices or uncertain tissue treatments. In some cases, the implantation of a septal defect closure device forecloses the ability to re-cross the septum in connection with a subsequent intervention. Septal defect closure devices can be implanted percutaneously, such as through femoral venous puncture/access. Such procedures can be guided by echocardiography.
As referenced above, the treatment of septal defects can involve the implantation of devices designed to occlude, or cover, the septal defect. Disclosed herein are novel occluder devices including rotationally foldable septal defect covers configured to be transported to a target treatment site in a folded configuration within a delivery sheath or catheter and expanded upon deployment from the delivery sheath/catheter. Such foldable covers can be configured to form radial/transverse pleats or other types of corrugations that can be circumferentially/rotationally wrapped around an axis of the cover, wherein such pleats/corrugations are formed by alternating ‘mountain’ (e.g., ‘peak,’ ‘crest,’ or the like) and ‘valley’ (e.g., ‘trough,’ or the like) radial and/or circumferentially/rotationally curved folds/creases in the cover. The folds can be along individual wires or wire segments, as described in detail herein.
Certain septal defect cover solutions can include wireframe designs that are relatively intricate and/or bulky, wherein such covers have difficulty adapting to the curvature/topology of the septum or other tissue wall. In some examples, each of the wire segments 31 are separate wires and/or configured to be independently or individually manipulable/movable. Use of individual radiating wires can advantageously allow for the cover 30 to contour the septum or other tissue wall. The wires 31 are fixed at their base to the central/core portion 39 and configured to twist/wrap around the axis A1 of the cover 30. Such system of wires can provide desirable flexibility to allow the cover 30 to adapt to various shapes and surfaces.
The covering 38 can be a single cloth or can be made up of multiple at least partially fluid-tight segments/cloths. In the image of
The cover 30 includes a central portion 39, which may be hexagonal in shape, or have any other shape or size/area. The central portion 39 of the cover 30 may be part of the cloth or other material of the covering 38; that is, the central portion 39 may be a central portion of the covering 38 of the cover 30. The central portion 39 may be an axial end of a core form associated with the cover 30. In some examples, the central portion 39 does not include any folds, but rather the ‘petals’ of the folding pattern of the covering 38 fold according to right- or left-handed chirality around the central portion 39, wherein the term ‘petals’ may be used to refer to one or more of the wires 31 and interposed or adjacent segments 37 of the covering 38. For example, a ‘petal,’ or ‘wire,’ as described herein, may refer to either a mountain 31m or valley 31v wire together with one or both adjacent covering segments 37. In examples including more (or fewer) petals/wires than shown in
The cover 30 can expand to a really large diameter d1 and can also be compressed to a much smaller profile in a folded, cylindrical configuration for delivery. For example, the cover 30 may advantageously be configured to expand to an expanded, substantially flat configuration, as shown in
The cover 30 includes a cloth, polymer, and/or tissue covering material 38, which may be fluid tight in some implementations. In some examples, the covering 38 comprises a mesh, such as a wire mesh, suture mesh, mesh of polymer fibers/strands, and/or the like. Generally, the covering 38 may serve to occlude the defect/feature over which it is placed, thereby at least partially preventing or reducing the passage of fluid through the defect when the cover 30 is in place.
The cover 30 can include a plurality of wires 31. Although described as wires herein, it should be understood that such features of a cover in accordance with aspects of the present disclosure may be or comprise any type of elongate arm structure, such as a wire, band, suture, rod, pole, stick, line, shaft, or the like, wherein such arms are attached to and/or otherwise associated with the covering 38 in some manner. For example, the wires 31 may be threaded/woven through portions of the covering 38 in a generally radial direction, or may be sutured, adhered, or otherwise coupled to the covering 38. In some examples, the wires 31 are attached to the covering 38 only at distal ends thereof and/or proximal ends thereof. For example, the distal end of a wire 31 may be coupled to a portion of the perimeter 35 of the covering 38.
The wires 31 may further be coupled at proximal ends thereof to a core form or other component/feature of an occluder device. With respect to the description of the wires 31, ‘proximal’ refers to an innermost portion or end of a wire, such as a portion of the wire that is at or near the central axial portion/core 39 of the cover 30. For example, the wires 31 may be configured to hook onto the core/portion 39 in some manner. For example, the proximal portions of the wires 31 may include hooks that are configured to couple to corresponding loops or other features associated with a core component/form (see, e.g.,
The wires 31 may each be independent wires or wire segments. For example, each of the wires 31 may be configured to move independently of any of the other wires/segments 31. In some examples, multiple wire segments may be formed of a single wire. That is, different wire segments may be segments of the same wire. For example, with further reference to
As described above, the central portion 39 of the cover may be, or be associated with, an axial end of a core form, which may have a polygonal shape, as shown. Generally, the wire segments 31 may emanate radially outward from a perimeter 36 of the end/portion 39 of the core 40 (see, e.g.,
In some examples, such as in the example of
The covering 38 may be disposed over one or more of the wires 31 and/or the end 39 of the core 40. Alternatively, the covering 38 may be disposed at least partially under the wires 31 and/or around the core 40 without covering the end the core 40. In some examples, the valley fold wires 31v are disposed over the covering 38, whereas the mountain fold wires 31m are disposed under the covering 38, or vice versa, which may allow the covering 38 to fold around the wires as desired.
As referenced above, the wires/segments 31 may facilitate folding/compression of the cover 30 about the core 40. In order to facilitate such folding, alternating ones 31v of the wires 31 may serve as valley fold wires, wherein such wires are wrapped circumferentially around the core 40 during compression in or relatively near a plane P1 (e.g., a plane in which the expanded/flat cover 30 lies when expanded as shown in
The segments 37 of the covering/cloth 38, at the outer perimeters thereof, may be substantially straight between the adjacent wires 31, as shown in the illustrated example of
Although the cover 30 is described with respect to the configuration of
With respect to foldable defect covers disclosed herein, references herein to a topside thereof may generally refer to an axial side of the cover associated with the concavity of the cover when folding. That is, as described in detail herein, when folded/compressed, a cover in accordance with aspects of the present disclosure may include mountain fold wire segments 31m that project axially away from a center/core 39 of the cover in a given axial direction. The topside of the cover may be considered to be the side of the cover associated with the axial direction of bending/folding of the mountain fold wires 31m. With respect to dual-cover occluder devices in accordance with aspects of the present disclosure, the topside of such covers refers to the sides of the covers that face axially outward, away from an axial center of a core of the device. Conversely, the underside of a defect cover as described herein may generally refer to an opposite axial side of the cover from the topside. That is, the underside of a cover may generally be associated with the convexity of the cover as it folds, such that the underside is a perspective from a side of the cover away from which the mountain fold wires project as they are folded/wrapped circumferentially around the core 39 and project radially away from the core. With respect to dual-cover occluder devices in accordance with aspects of the present disclosure, the underside of such covers refers to sides of the covers that face axially inward, in the direction of an axial center of a core of the device.
As is apparent in the images of
Generally, the valley fold wires 31˜ may wrap circumferentially around the central portion/core 39 generally in plane with the center/core 39 when fully compressed as shown in
In the partially-expanded configuration of
Although the images of
As the cover 30 is gradually compressed, the covering 38 is folded over/around the wires 31 to form radially- and/or circumferentially-oriented pleats, corrugations, grooves, crimps, ridges, flutes, or similar features that collapse together as they wrap around the axis A1 of the cover 30. The apices of the pleats alternate between mountain 301 and valley 302 points, as shown, creating a chevron, or zig-zag, circumference/perimeter 35 with reducing angles as the pleats wrap tighter around the core.
A slightly- or partially-compressed defect cover, such as shown in
Because the size of the atrial septum can vary significantly across patients, deploying occluder devices in accordance with aspects of the present disclosure in configurations in which one or more of the covers thereof is partially compressed/folded, as in some of the images of
In some implementations, septal closure/occluder devices in accordance with the present disclosure include two covers configured to be folded/pleated as shown in
The core 40 includes a mass or form that includes distal 42d and proximal 42p ends associated with respective axially-narrowing/expanding bulbous, conical, and/or pyramidal (e.g., hexagonal pyramidal) structures 44 that are connected at a relatively narrow neck portion 45. The narrowing/expanding structures 44 can be opposing forms in that they expand, narrow, and/or face in opposite axial directions.
The narrowness of the neck 45 may be designed to accommodate the defect into which the core may be placed/disposed. For example, by having a neck portion 45 that is relatively narrow compared to the distal ends 42 of the core 40, the tissue around the defect may be permitted to enter into the radial space of the core in the area of the neck portion 45. The distal ends 42, which may have associated axial faces, can have any suitable or desirable diameter, such as approximately 7 mm (e.g., about 0.25″) or less. Furthermore, the neck portion 45 may have a diameter d4 that is less than the diameter d3. For example, the diameter d4 of the neck portion 45 may be approximately 3 mm (e.g., about 0.125″) or less.
In the illustrated example of
In the illustrated delivery configuration of the occluder device 50, the proximal cover 30p is folded/compressed in a manner such that the peaks 39 associated with the mountain folds 31m of the cover 30p, as described in detail herein, project in a proximal direction (e.g., in the direction toward the operator when the device 50 is disposed in a delivery system and delivered to target anatomy in accordance with a relevant procedure), whereas the distal cover 30d is folded such that the peaks 39 associated with the mountain folds 31m thereof project in a distal direction (e.g., opposite of the proximal direction). That is, in the delivery configuration, the covers 30p, 30d may advantageously fold and project in opposite directions, and in particular project in opposite directions away from the core 40. Such configuration can prevent the covers 30 from overlapping one another in the delivery configuration. For example, overlapping of the covers 30 may otherwise occur if one or both of the covers 30 compresses inward (as opposed to the outwardly-folding/compressing implementation shown in
The compressed delivery configuration shown in
With both of the covers 30 in the fully compressed configuration shown in
As described above, intermediate expansion of the cover(s) 30 can allow for different sizes and shapes/contours of the cover(s) with respect to the expanded diameter thereof; different states of expansion of the covers can produce different diameters, shapes, contours, and/or topology of the covers in the various states of expansion. In some implementations, it may be desirable to deploy/implant the device 50 such that at least one of the covers 30 is in an intermediate state of expansion. However, such intermediate expansion states can present certain contours/angles of the various portions/segments of the covers that can lead to risk of pooling/stagnation of blood and/or embolism formation due to blood trapping. However, depending on the particular anatomy in which the device 50 is implanted, the relevant pressure levels may serve to prevent embolism formation, and therefore intermediate-expansion deployment may be tenable or suitable in some cases.
In some examples, the defect covers 30 comprise twelve (or other number) thin, flexible nitinol wires arranged in a spiral and connected to a hexagonally-shaped core 40. In some examples, the sides of the covers touching the tissue wall 18 are covered in a biocompatible cloth as scaffolding for tissue growth and to provide sealing functionality. The spiral, flat design of the disc-type covers 30 can allow the device to furl down to a much smaller profile relative to the structure's expanded size. With memory metal shape memory, the covers can be configured to self-expand into a relatively flatter disc shape once released from the delivery catheter.
The partially-expanded/folded state shown in
The ability to expand the covers 30 to various intermediate states of expansion can allow for configurations of the covers having varying diameters. That is, a fully expanded configuration of a defect cover in accordance with aspects of the present disclosure may have a greater diameter than a configuration of the same cover in a partially-expanded state, which may have a relatively smaller diameter. Therefore, occluder devices in accordance with aspects of the present disclosure may be suitable for implantation in patients having varying anatomies. For example, an occluder device in accordance with the present disclosure may be configurable to multiple diametrical sizes, wherein a particular size/expansion state may be implemented to fit/suit the particular anatomy of the patient. That is, the angle θ1 of the concavity of one or more of the covers 30 can provide a convex tissue-facing surface that allows the cover to sit relatively deeper in the fossa ovalis and/or defect associated with the tissue wall 18.
Control of the degree of expansion of the covers 30 can be controlled using suture tensioning or other mechanism to hold a cover and/or one or more wires associated therewith in a desired state of expansion. For example, in some implementations, one or more sutures 76 (see
At block 1002, the process 1000 involves providing a delivery system 70 with an occluder device 50 disposed therein in a delivery configuration. Image 1102 of
With respect to implantation processes for dual-cover occluder devices in accordance with aspects of the present disclosure, generally, one cover may first be deployed in the left atrium in front of the atrial defect in the left atrial chamber, after which the delivery catheter is withdrawn through the septal defect and the second cover is placed on the right atrial side of the defect/wall. Both covers advantageously can have at least one diameter dimension, or an area, that is larger than that of the defect opening in order to fully cover the opening. The two covers of the dual-cover device can face in opposite directions, as shown in image 1102, or may both face in the same direction.
The illustrated delivery system 70 includes an inner sheath/catheter 91, which may be disposed at least partially within the outer sheath 71 during one or more periods of the process 1000. In some examples, the delivery system 70 may be configured such that a guidewire may be disposed at least partially therein. For example, the guidewire may run in the area of an axis of the sheath 71 and/or inner catheter 91, such as within the inner catheter 91. The delivery system 70 may be configured to be advanced over the guidewire to guide the delivery system 70 to a target implantation site.
The outer sheath 71 may be used to transport the occluder device 50 to the target implantation site. That is, the occluder device 50 may be advanced to the target implantation site at least partially within a lumen of the outer sheath 71 and/or inner sheath 91, such that the occluder device 50 is held and/or secured at least partially within a distal portion of the outer sheath 71 and/or inner sheath 91. The terms “catheter” and “sheath” are used herein according to their broad and ordinary meanings and may refer to any type of tube suitable for insertion in the body. “Catheter” and “sheath” may be used substantially interchangeably is some contexts herein. Similarly, the terms “catheter,” “tube,” “shaft” (e.g., inner/outer shaft), “sheath,” “delivery sheath,” “steerable sheath,” and/or “steerable catheter” are used herein according to their plain and ordinary meanings and can refer or apply generally to any type of elongate and/or tubular delivery devices.
At block 1004, the process 1000 involves accessing a target site/anatomy with the delivery system 70. For example, such access may be made through a transcatheter access path, as described herein. In some examples, the target anatomy is a chamber of the heart of the patient, for example. In some implementations, access to the target implantation site may be facilitated using a guidewire. For example, a guidewire may be disposed within the delivery system 70, such as within the outer sheath 71. In some implementations, the guidewire may pass through the pusher 80 and/or the occluder device 50. For example, the core 40 of the occluder device 50 can have an axial hole through which a guidewire can pass.
At block 1006, the process 1000 involves deploying the distal cover 30d from the inner sheath 91 on a distal (e.g., left atrial) side of the tissue wall 18. For example, the tissue wall 18 may be an atrial septum having a defect 16 formed therein. Deploying the distal cover 30d from the inner sheath 91 may be performed after first deploying the inner sheath 91 from the outer sheath 71, as shown in image 1106. Deploying the distal cover 30d may involve proximally pulling back the inner sheath 91 and/or distally pushing the occluder device 50, such as by distally pushing the pusher/catheter 80 to move the core 40 and/or other aspect(s) of the device 50 relative to one or more components of the delivery system 70 (e.g., the inner catheter 91). Relative movement of the inner sheath 91 proximally with respect to the implant device 50 can cause the cover 30d to be deployed from the inner sheath 91, wherein upon deployment from the inner sheath 91, the cover 30d and/or wires 31 thereof may have shape memory that causes the cover to expand outward radially to form a disc and/or dish-type shape/form configured to cover over the defect 16.
At block 1008, the process 1000 involves deploying the proximal cover 30p on the proximal/opposite side of the defect wall 18. Such deployment of the cover 30p may be implemented by further withdrawing proximally the inner sheath 91 relative to the implant device 50 and/or distally pushing the implant device 50 relative to the inner sheath 91. For example, a pusher or catheter 80 may be coupled to the core 40 of the implant device 50 during one or more periods of the implantation process, such that distally moving or applying pressure to the pusher/catheter 80 can cause the implant device 50 to be distally moved accordingly. The pusher/catheter 80 may be coupled to a proximal portion of the core 40 and/or any other component(s) of the device 50 using any suitable or desirable means or mechanism. For example, the pusher 80 may be coupled to the core 40 using one or more sutures, which may be looped through one or more hook or hoop features of the core 40 and/or other component(s) of the device 50, wherein such suture(s) may be withdrawn from such coupling to thereby release the pusher 80, and therefore the delivery system 70, from the device 50 after placement thereof.
When the cover 30, is deployed from and/or moved out of the inner sheath 91 on the proximal (e.g., right atrial) side of the tissue wall 18, the shape memory of the cover 30p and/or wires 31 thereof may cause the cover 30p to expand radially outwardly, as described in detail herein.
In some implementations, the process 1000 may involve controlling a degree of expansion of one or more of the covers 30, such as through the use of one or more tensioning sutures coupled to one or more of the wires or other components of a cover, wherein such suture(s) may be configured to permanently hold a desired and/or locked tension therein, thereby retaining one or more of the covers in a desired state of expansion, or the suture(s) may be utilized only temporarily during implantation and withdrawn and/or disengage from the device 50 after/during deployment. One or more of the covers 30 may advantageously be deployed to a partially-expanded, rather than fully-expanded, state in some implementations in order to provide a custom fit to the target anatomy (e.g., tissue wall 18), and/or to better fit within the topology (e.g., concavity) of the tissue wall 18. For example, the covers 30 may be expanded to form a concavo-convex disc form, which may have certain radial ridges/pleats therein formed by the folds around the respective radial folding wires 31. The convex side of such forms may be placed against the respective sides of the tissue wall 18 in a manner such that the tapering of such covers lies desirably against the thinning/concave portions of the wall 18.
At block 1010, process 1000 involves withdrawing the delivery system, leaving the implant device 50 in place to provide occlusion functionality with respect to the defect 16. That is, the implanted device 50 may prevent shunting of blood between the atria 2, 5, such as may occur predominantly from the left atrium 2 to the right atrium 5 due to the pressure gradient that may be present in certain periods of the cardiac cycle.
Although access to the atrial septum 18 is illustrated and described in connection with certain examples as being via the right atrium 50 and/or vena cavae, such as through a transfemoral or other transcatheter procedure, other access paths/methods may be implemented in accordance with examples of the present disclosure. For example, alternatives to transseptal access can include transaortic access, wherein a delivery catheter 111c is passed through the descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7, and into the left atrium 2 through the mitral valve 6. Alternatively, transapical access may be implemented to access the target anatomy, as shown by delivery catheter 111d.
Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.
Example 1: An occluder device comprising a core form having first and second axial ends, a first plurality of wires emanating radially from the first axial end of the core form, the first plurality of wires being configured to circumferentially wrap around an axis of the core form, a first covering coupled to at least one of the first plurality of wires or the first axial end of the core form, a second plurality of wires emanating radially from the second axial end of the core form, the second plurality of wires being configured to circumferentially wrap around the axis of the core form, and a second covering coupled to at least one of the second plurality of wires or the second axial end of the core form.
Example 2: The occluder device of any example herein, in particular example 1, wherein the first covering is configured to fold at each of the first plurality of wires to form radial pleats.
Example 3: The occluder device of any example herein, in particular example 2, wherein the first plurality of wires includes first and second alternating sets of wires, the first set of wires is configured to wrap circumferentially around the axis of the core form at a first angle with respect to an axial plane associated with the core form, and the second set of wires is configured to wrap circumferentially around the axis of the core form at a second angle with respect to the axial plane, the second angle being greater than the first angle.
Example 4: The occluder device of any example herein, in particular example 3, wherein the first set of wires is disposed on a first side of the first covering, and the second set of wires is disposed on a second side of the first covering that is opposite the first side.
Example 5: The occluder device of any example herein, in particular examples 1-4, wherein the core form has a polygonal axial cross section at the first axial end.
Example 6: The occluder device of any example herein, in particular example 5, wherein the core form has a hexagonal axial cross section at the first axial end.
Example 7: The occluder device of any example herein, in particular example 5, wherein the first plurality of wires consists of a number of wire segments equal to two times a number of vertices of the axial cross section.
Example 8: The occluder device of any example herein, in particular examples 1-7, wherein the core form includes two opposing forms that converge at a neck portion and expand in diameter moving away from the neck portion.
Example 9: The occluder device of any example herein, in particular example 8, wherein each of the opposing forms is a truncated pyramid.
Example 10: The occluder device of any example herein, in particular example 9, wherein the opposing forms have six lateral faces.
Example 11: The occluder device of any example herein, in particular examples 8-10, wherein each of the opposing forms is a frustoconical form.
Example 12: The occluder device of any example herein, in particular examples 1-11, wherein the first covering is configured to fold along each of the first plurality of wires to form first transverse pleats that, in a partially-expanded configuration of the first covering, radiate from an axis of the core form and circumferentially curve about the axis of the core form, and the second covering is configured to fold along each of the second plurality of wires to form transverse pleats that, in a partially-expanded configuration of the second covering, radiate from the axis of the core form and circumferentially curve about the axis of the core form.
Example 13: The occluder device of any example herein, in particular example 12, wherein, in a fully compressed configuration each of the first covering and the second covering forms an open cylinder, and the first and second coverings are each open axially away from a neck region of the core form.
Example 14: The occluder device of any example herein, in particular example 12 or 13, wherein, in the partially-expanded configuration, the first covering has an axially concave form.
Example 15. A defect cover comprising a first set of wires emanating radially from a central portion of the defect cover, a second set of wires emanating radially from the central portion, the second set of wires being interleaved with the first set of wires, and a covering disposed against the first set of wires and the second set of wires and configured to fold about each of the first set of wires and the second set of wires to form folds configured to wrap around the central portion of the defect cover to assume a compressed configuration of the defect cover.
Example 16: The defect cover of any example herein, in particular example 15, wherein the defect cover is configured to assume an expanded configuration in which the covering is substantially fat.
Example 17: The defect cover of any example herein, in particular example 16, wherein, when the defect cover is in the expanded configuration, the first and second sets of wires are circumferentially curved.
Example 18: The defect cover of any example herein, in particular examples 15-17, wherein, when the defect cover is in the compressed configuration the first set of wires is wrapped circumferentially around an axis of the defect cover at a first angle with respect to an axial plane associated with the defect cover, and the second set of wires is wrapped circumferentially around the axis of the defect cover at a second angle with respect to the axial plane, the second angle being greater than the first angle.
Example 19: The defect cover of any example herein, in particular example 18, wherein, when the defect cover is in the compressed configuration, the first set of wires lie in the axial plane.
Example 20: The defect cover of any example herein, in particular examples 15-19, wherein the central portion is associated with a polygonal core.
Example 21: The defect cover of any example herein, in particular example 20, wherein the first set of wires runs alongside sides of the polygonal core, and the second set of wires emanates away from respective vertices of the polygonal core.
Example 22: The defect cover of any example herein, in particular example 20 or 22, wherein each vertex of the polygonal core has one wire of the first set of wires and one wire of the second set of wires emanating therefrom.
Example 23: The defect cover of any example herein, in particular examples 15-22, wherein the folds comprise alternating crests and troughs, the first set of wires is associated with the troughs, and the second set of wires is associated with the crests.
Example 24. A method of delivering an occluder device, the method comprising providing an occluder device comprising, a core form having first and second axial ends, a first cover including a first plurality of wires emanating radially from the first axial end of the core form and a first covering coupled to one or more of the first plurality of wires, and a second cover including a second plurality of wires emanating from the second axial end of the core form and a second covering coupled to one or more of the second plurality of wires. The method further comprises wrapping the first plurality of wires around the first axial end of the core form to compress the first cover, wrapping the second plurality of wires around the second axial end of the core form to compress the second cover, disposing the occluder device in a delivery system, advancing the delivery system through a defect in a tissue wall, deploying the first cover from the delivery system on a distal side of the tissue wall to cause a perimeter of the first cover to expand radially outward and toward the tissue wall, deploying the core form from the delivery system at least partially within the defect in the tissue wall, and deploying the second cover from the delivery system on a proximal side of the tissue wall to cause a perimeter of the second cover to expand radially outward and toward the tissue wall.
Example 25: The method of any example herein, in particular example 24, wherein said deploying the second cover involves causing the second cover to partially expand to form an inwardly-convex form.
Example 26: The method of any example herein, in particular example 25, wherein the inwardly-convex form is configured to seat in a concave portion of the tissue wall.
Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.
Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.
It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example. Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.
It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
This application is a continuation of International Patent Application No. PCT/US22/39336, filed Aug. 3, 2022 and entitled DEFECT OCCLUDER WITH WRAPPING COVER, which claims priority to U.S. Provisional Patent Application Ser. No. 63/237,475, filed on Aug. 26, 2021 and entitled DEFECT OCCLUDER WITH WRAPPING COVER, the complete disclosures of which are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63237475 | Aug 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2022/039336 | Aug 2022 | WO |
| Child | 18585926 | US |
