Medical devices, systems and methods for occluding tissue openings

Abstract

The present invention provides devices, methods and systems for occluding a left atrial appendage. In one embodiment, the medical device includes a cover portion and a foam anchor portion, wherein a flexible member is connected between the cover portion and the foam anchor portion. The cover portion is configured to be positioned above the opening of the left atrial appendage. The foam anchor portion extends between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion. The foam anchor portion defines a curved outer surface extending radially relative to the axis, such that the curved outer surface extends between the proximal end and the distal end of the foam anchor portion. The foam anchor portion is configured to self-expand to provide an outward biasing force from the curved outer surface so that a circumferential surface area of ​​the curved outer surface is biased against tissue of the left atrial appendage.

Description

Technical Field

[0001] The present invention relates generally to the occlusion of tissue openings or atrial appendages, and more particularly to devices, systems and methods for occluding or otherwise structurally altering such openings and atrial appendages, including, for example, the left atrial appendage. Background Art

[0002] Each of the upper chambers of the heart, i.e., the atria, has an atrial appendage attached to it. For example, the left atrial appendage is a characteristic structure in all human heart structures. The physiological function of such atrial appendages is not fully understood, but the atrial appendages do serve to store blood during normal pumping of blood by the heart. The atrial appendages usually protrude from the atria and cover the outer portion of the atria. The atrial appendages are substantially different from each other. For example, one atrial appendage may be configured as a conical protrusion, and another atrial appendage may be configured as a concave sock-shaped hole. There is usually a septum between the inner surface of the atrial appendage and the fibers of the myocardial tissue, and one or more leaflets of the myocardial tissue fibers cross the surface of the atrial appendage.

[0003] The atrial appendages do not appear to function when the heart is pumping blood through them during normal heart function. In other words, the atrial appendages do not appear to have a significant effect on the blood pumped through them during normal heart function. However, during atrial fibrillation, blood can pool inside the atrial appendages and form clots once an arrhythmia occurs in the atria. Furthermore, if this phenomenon occurs in the left atrial appendage, it can pose a risk of stroke because once normal sinus rhythm is restored after an arrhythmic event, the clots can be pumped out of the heart and into the cranial circulation.

[0004] In the past, the atrial appendage was sometimes surgically corrected to reduce the risk of atrial fibrillation. In recent years, devices that can be delivered percutaneously into the left atrial appendage have been introduced. The basic function of these devices is to evacuate the space within the atrial appendage with an implant that then allows the blood within the atrial appendage to safely thrombose and then gradually incorporate into the heart tissue. This process is combined with the growth of the endothelium over the surface of the device, leaving a smooth endothelialized surface where the atrial appendage is located. Compared to surgical procedures used to solve problems related to the left atrial appendage, percutaneous implantation of devices for the same purpose is a less invasive method.

[0005] However, due to the wide range of variation in the orifice size and volume of the left atrial appendage, the structure of existing implantable devices often cannot meet such variations, resulting in these devices being unsuitable for most left atrial appendage anatomical structures. In addition, such implantable devices are substantially limited by the direction in which they can be successfully deployed. Furthermore, another problem with many existing implantable devices is that they are anchored with hooks of a size and length that often pose a perfusion risk to the patient. Thus, it would be advantageous to provide a percutaneous system, method, and / or device for addressing, for example, perfusion risks, implant orientation issues, variable size and shape issues of the left atrial appendage, or all of these issues, in order to improve the success rate of left atrial appendage correction.

[0006]

[0011] Various features and advantages will become apparent to those of ordinary skill in the art after reading the description of the various embodiments set forth below. Summary of the invention

[0007] Embodiments of the present invention relate to various devices, systems and methods for occluding an opening in the tissue of the body. For example, in one embodiment, a medical device for occluding the left atrial appendage of the heart is provided. The medical device includes a cover portion and a foam anchor portion. The cover portion includes a hub and a cover, the cover extending radially from the hub so that the size and configuration of the cover portion are configured to be positioned proximally along the opening of the left atrial appendage. The foam anchor portion is connected to the cover portion using a flexible member. The foam anchor portion extends between a proximal end and a distal end to define a length and an axis, which is defined along the length of the foam anchor portion. The foam anchor portion defines a curved outer surface extending radially relative to the axis, so that the curved outer surface extends between the proximal end and the distal end of the foam anchor portion. In addition, the foam anchor portion is configured to self-expand to provide an outward biasing force from the curved outer surface so that the circumferential surface area of ​​the curved outer surface is biased against the tissue of the left atrial appendage.

[0008] In another embodiment, the curved outer surface defines a total surface area, and wherein at least half of the total surface area of ​​the curved outer surface is sized and configured to grip and contact tissue within the left atrial appendage. In another embodiment, the curved outer surface of the foam anchor portion includes microprotrusions sized and configured to grip and contact tissue within the left atrial appendage with an outward biasing force.

[0009] In another embodiment, the curved outer surface of the foam anchor portion includes a raised grid pattern sized and configured to grip tissue with an outward biasing force. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of protrusions sized and configured to grip and anchor to tissue with an outward biasing force. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of recesses therein, the plurality of recesses being defined by the raised portions of the curved outer surface of the foam anchor portion. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of annular structures.

[0010] In another embodiment, the foam anchor portion expands to a shape resembling at least one of a frustoconical structure and a cylindrical structure. In yet another embodiment, the foam anchor portion extends with a variable foam density between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having a greater foam density than the proximal end portion. In another embodiment, the foam anchor portion includes variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having a greater expandability than the proximal end portion.

[0011] In another embodiment, the cover portion extends wherein the proximally facing surface has a concave configuration, the proximally facing surface facing away from the distal end of the medical device. In another embodiment, wherein the flexible member is capable of extending at an angle relative to the axis of the foam anchor member when the cover portion and the foam anchor portion are deployed.

[0012] According to another embodiment of the present invention, a medical device system for occluding the left atrial appendage of a heart is provided. The medical device system includes a delivery device and a medical device. The delivery device includes a handle and a catheter extending between a proximal end and a distal end, the proximal end being coupled to the handle, the catheter defining a lumen extending longitudinally through the catheter between the proximal end and the distal end of the catheter. The medical device is operably coupled to the handle. In addition, the size and configuration of the medical device are configured to move between a contracted state and an expanded state, so that in the contracted state, the medical device is within the distal end portion of the catheter, and in the expanded state, the medical device is advanced from the catheter. The medical device includes a cover portion and a foam anchor portion. The cover portion includes a hub and a cover, the cover extending radially from the hub. The size and configuration of the cover portion are configured to be positioned proximally along the mouth of the left atrial appendage. The foam anchor portion is coupled to the cover portion using a flexible member. In addition, the foam anchor portion extends between the proximal end and the distal end to define a length and an axis, which is defined along the length of the foam anchor portion. The foam anchor portion defines a curved outer surface extending radially relative to the axis such that the curved outer surface extends between a proximal end and a distal end of the foam anchor portion. The foam anchor portion is configured to self-expand along the curved outer surface to provide an outward biasing force such that a circumferential surface area of ​​the curved outer surface is biased against tissue of the left atrial appendage.

[0013] In another embodiment, the curved outer surface defines a total surface area, and wherein at least half of the surface area of ​​the curved outer surface is sized and configured to grasp and contact tissue within the left atrial appendage with an outward biasing force. In another embodiment, the curved outer surface of the foam anchor portion includes microprotrusions sized and configured to grasp and contact tissue within the left atrial appendage with an outward biasing force. In another embodiment, wherein the flexible member is capable of extending at an angle relative to the axis of the foam anchor member when the cover portion and the foam anchor portion are deployed.

[0014] According to another embodiment of the present invention, a method for occluding the left atrial appendage of a heart is provided. The method steps include: using a catheter of a delivery system to advance a medical device through the vascular system and into the left atrial appendage of the heart, the medical device is positioned in a contracted state in the distal end portion of the catheter, the medical device includes a cover portion and a foam anchor portion, wherein a flexible member is connected between the cover portion and the foam anchor portion, the foam anchor portion has a length extending between the proximal end and the distal end, and the foam anchor portion defines an axis extending axially along the length; the anchor portion of the medical device is deployed from the distal end portion of the catheter to self-expand, so that the circumferential surface area of ​​the curved outer surface of the foam anchor portion contacts and abuts against tissue within the left atrial appendage with an outward biasing force; the cover portion of the medical device is deployed from the distal end portion of the catheter so that the cover portion self-expands to an expanded state; and the cover portion of the medical device is tightened against the mouth of the left atrial appendage to shorten the length of the flexible member connected between the foam anchor portion and the cover portion.

[0015] In another embodiment, the method step of tightening includes extending the flexible member tautly from the foam anchor portion so that the flexible member extends at an angle relative to the axis of the foam anchor portion. In another embodiment, the method step of deploying the anchor portion includes anchoring the foam anchor portion, the foam anchor portion having a circumferential band region of a curved outer surface and having micro-protrusions defined along the curved outer surface of the foam anchor portion. In yet another embodiment, the method step of deploying the cover portion includes deploying the cover portion with spokes extending radially from the hub of the cover portion. In another embodiment, the method also includes releasing the catheter from the medical device and removing the delivery system from the heart to permanently retain the medical device in the left atrial appendage.

[0016] According to another embodiment of the present invention, a medical device for occluding the left atrial appendage of a heart is provided. The medical device includes a foam anchor extending between a proximal end and a distal end to define a length, and an axis defined along the length of the foam anchor, the foam anchor defining a curved outer surface extending radially relative to the axis, such that the curved outer surface extends between the proximal end and the distal end of the foam anchor, and the foam anchor is configured to self-expand to provide an outward biasing force from the curved outer surface, such that a circumferential surface area of ​​the curved outer surface is biased against tissue of the left atrial appendage.

[0017] In another embodiment, the foam anchor extends between the proximal end and the distal end to exhibit at least one of a truncated cone structure and a cylindrical structure. In another embodiment, the curved outer surface defines a total surface area, and wherein at least half of the total surface area of ​​the curved outer surface is sized and configured to grasp and contact tissue within the left atrial appendage. In another embodiment, the curved outer surface of the foam anchor portion includes microprotrusions that are sized and configured to grasp and contact tissue within the left atrial appendage with an outward biasing force.

[0018] In another embodiment, the curved outer surface of the foam anchor portion includes a raised grid pattern sized and configured to grip tissue with an outward biasing force. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of protrusions sized and configured to grip and anchor to tissue with an outward biasing force. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of recesses therein, the plurality of recesses being defined by the raised portions of the curved outer surface of the foam anchor portion. In another embodiment, the curved outer surface of the foam anchor portion defines a plurality of annular structures.

[0019] In yet another embodiment, the foam anchor portion extends with a variable foam density between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having a greater foam density than the proximal end portion. In another embodiment, the foam anchor portion includes variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having a greater expandability than the proximal end portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The foregoing and other advantages of the present invention will become apparent upon reading the following detailed description and referring to the accompanying drawings, in which:

[0021] Figure 1 is a perspective rear view of a medical device according to one embodiment of the present invention;

[0022] Figure 2 is a perspective front view of a medical device according to another embodiment of the present invention;

[0023] Figure 3 is a side view of a medical device according to another embodiment of the present invention;

[0024] Figure 4 is a perspective view of a delivery system for a medical device according to another embodiment of the present invention;

[0025] Figure 5is a side view of a distal portion of a delivery system according to another embodiment of the present invention, depicting the distal portion of the delivery system adjacent to a left atrial appendage of the heart;

[0026] Figure 6 is a side view of a distal portion of a delivery system according to another embodiment of the present invention, depicting a medical device partially advanced from the distal portion of the delivery system in a left atrial appendage;

[0027] Figure 7 is a side view of a distal portion of a delivery system according to another embodiment of the present invention, depicting an anchor portion of the medical device in an expanded state in a left atrial appendage;

[0028] Figure 8 is a side view of a distal portion of a delivery system depicting a cover portion of a medical device partially advanced from the distal portion of the delivery system adjacent a left atrial appendage;

[0029] Fig. 9 is a side view of a distal portion of a delivery system and a medical device according to another embodiment of the present invention, depicting a fully extended cover portion of the delivery system coupled to the medical device using a flexible member;

[0030] Fig.10 is a side view of a distal portion of a delivery system and a medical device according to another embodiment of the present invention, depicting the distal portion of the delivery system tightening a cover portion against a left atrial appendage using a flexible member;

[0031] Fig.11 is a side view of a distal portion of a delivery system and a medical device according to another embodiment of the present invention, depicting an anchor portion anchoring the medical device in a left atrial appendage, wherein the cover portion is positioned above the ostium of the left atrial appendage;

[0032] Fig.12 is a perspective view of another embodiment of a medical device according to the present invention, depicting an anchor portion having a frustoconical structure with a plurality of recesses defined in an outer surface of the anchor portion.

[0033] Fig.13 According to another embodiment of the present invention Fig.12 A side view of a medical device;

[0034] Fig.14 is a perspective view of another embodiment of a medical device according to the present invention, depicting an anchor portion having a cylindrical structure and a cover portion extending with a disc-like structure;

[0035] Fig.15 According to another embodiment of the present invention Fig.14A side view of a medical device;

[0036] Fig.16 is a perspective view of another embodiment of a medical device according to the present invention, depicting an anchor portion having a cylindrical structure with raised protrusions along an outer surface of the anchor portion;

[0037] Fig.17 According to another embodiment of the present invention Fig.16 A side view of a medical device;

[0038] Fig.18 is a perspective view of another embodiment of a medical device according to the present invention, depicting an anchor portion having a cylindrical structure with a ring-like configuration on an outer surface of the anchor portion; and

[0039] Fig.19 According to another embodiment of the present invention Fig.18 Side view of a medical device. DETAILED DESCRIPTION

[0040] See also Figure 1 , Figure 2 and Figure 3 , a medical device 10 is provided, the size and configuration of the medical device being configured to be delivered with a delivery system 80 ( Figure 4 ) is delivered percutaneously through the cardiovascular system. The medical device 10 and delivery system 80 can be used in interventional procedures for closing or occluding an opening or cavity within the heart (not shown), such as the left atrial appendage ("LAA"). In one embodiment, the medical device may include a cover portion 14 and an anchor portion 16, wherein a flexible member 18 is coupled between the cover portion and the anchor portion. The anchor portion 16 of the medical device 10 may be sized to self-expand so as to be atraumatically secured within the left atrial appendage without hooks or tines to minimize perfusion that may otherwise occur from anchoring in the left atrial appendage. Such atraumatic anchoring of the medical device 10 may be used in conjunction with an outward biasing force of the anchor portion 16 such that an outer surface 34 of the anchor portion remains in contact with tissue within the left atrial appendage along a relative outer surface 34 of the anchor portion 16. In this manner, the body and outer surface 34 of the anchor portion 16 of the medical device 10 may be sized to provide self-expansion and a biasing force 17 ( Figure 7 ) to atraumatically fix itself to tissue within the left atrial appendage.

[0041] As previously described, the medical device 10 may include a cover portion 14 and an anchor portion 16, wherein the flexible member 18 extends between the cover portion and the anchor portion. The medical device 10 may extend between a proximal end 20 and a distal end 22 along a length 24 of the medical device 10, and may define an axis 26 that extends longitudinally through the medical device along the length 24 of the medical device 10 and through each of the cover portion 14 and the anchor portion 16. The medical device 10 may include, for example, a distal end portion 84 of a catheter 82 (see Figure 4 and Figure 5 ) expands from a contracted state to an expanded state (e.g. Figure 1 ) structural parts.

[0042] For example, in one embodiment, the anchor portion 16 can be formed of a foam material extending between the proximal end 36 and the distal end 22 of the anchor of the medical device 10. In the expanded state, the size of the foam material can be configured to extend in a trapezoidal cylindrical or truncated cone structure, etc. Such a structure can be oriented so that the anchor portion 16 extends radially more toward the distal end 22. In addition, along the length of the anchor portion 16, the outer surface 34 of the anchor portion 16 can extend radially or in a curved or arcuate surface between the proximal end 36 and the distal end 22 of the anchor relative to the axis 26. In one embodiment, the distal end 22 of the anchor portion 16 can be a generally flat surface that extends to a circular perimeter 38 so as to define a distal end radius 40 relative to the longitudinal axis 26. Similarly, the proximal end 36 of the anchor can be a generally flat surface that extends to a circular perimeter to define a proximal end radius 42 relative to the longitudinal axis 26. In another embodiment, the distal side surface 44 and / or the proximal side surface 46 of the anchor portion 16 can be extended, wherein the convex surface or the concave surface extends radially relative to the longitudinal axis 26 .

[0043] As previously described, the anchor portion 16 may be formed of a foam material. The foam may have structural properties that may shrink and minimize size, such as within the lumen of the catheter 82 ( Figure 4), and when advanced from the catheter 82, the foam can self-expand in an immediate manner. In one embodiment, the foam of the anchor portion 16 can self-expand isotropically. In another embodiment, the foam can self-expand in an anisotropic manner. In another embodiment, the foam can expand toward the distal end 22 of the anchor portion 16 to a greater extent than toward the proximal end 36 of the anchor. In another embodiment, the foam can expand along the distal portion of the anchor portion 16 with a greater expansion force than the expansion force of the more proximal portion of the anchor portion 16. In another embodiment, the foam can define pores or pore sizes therein. The pore size of the foam of the anchor portion 16 can be in the range of about 300 to 600 microns, and is preferably about 500 microns.

[0044] In yet another embodiment, the density of the foam material can be substantially uniform. In another embodiment, the foam material can include a variable density along its length. For example, the variable density can gradually become denser from the proximal end 36 of the anchor portion 16 toward the distal end 22. In another embodiment, the variable density can gradually become denser from the distal end 22 toward the proximal end 36 of the anchor. In another embodiment, the density of the foam material of the anchor portion 16 can be variable because portions of the anchor portion 16 can exhibit different densities. Such different densities of the foam material can be, for example, two portions or three portions of the anchor portion 16. For example, the variable density foam material can be separated from a proximal anchor portion and a distal anchor portion, the distal anchor portion being denser than the proximal anchor portion. In an alternative embodiment, the variable density foam material can be separate from the proximal anchor portion, the middle anchor portion, and the distal anchor portion, the middle anchor portion and the distal anchor portion being denser than the proximal anchor portion, and the distal anchor portion being denser than the middle anchor portion. In another embodiment, the proximal portion of the anchor portion 16 can be denser than the middle anchor portion or the distal anchor portion. In this way, there are multiple embodiments of foam materials that exhibit variable density along the length of the anchor portion 16.

[0045] Additionally, in another embodiment, the outer surface 34 of the anchor portion 16 and the foam material may be non-smooth or slightly variable and non-uniform, such that the outer surface 34 may define microprotrusions 35 along the perimeter of the outer surface 34, such that the microprotrusions 35 may be slightly raised relative to the surrounding portions of the outer surface 34. In one embodiment, the microprotrusions 35 may be random and an inherent characteristic of the outer surface 34 of the foam material, such that the microprotrusions 35 may aid in gripping onto tissue within the left atrial appendage. In another embodiment, the microprotrusions 35 may be formed and spaced a predetermined distance relative to each other on the outer surface 34 of the foam. In another embodiment, the microprotrusions 35 may include hardened tips such that the microprotrusions 35 exhibit effective micro-teeth that are sized and configured to grip tissue.

[0046] The foam material of the anchor portion 16 can be formed of a polymer foam material. The polymer foam material can be a polyurethane foam material or any other suitable foam material, such as a polyurethane blend, such as polycaprolactone-zinc oxide. In another embodiment, the polymer foam can be hydrophilic. In another embodiment, the foam can be a reticular foam. In another embodiment, the foam can be a non-reticular foam. In another embodiment, the anchor portion can include other polymer materials, such as ePTFE and / or silicone.

[0047] Additionally, in another embodiment, the polymer foam may include a plurality of markers (not shown) embedded therein. Such markers may be positioned within the foam material to assist the physician in properly orienting and positioning the anchor portion 16 in the left atrial appendage by employing imaging techniques known in the art. These markers may be made of a radiopaque material, such as platinum, gold, tantalum, or alloys thereof, or any other suitable biocompatible radiopaque material.

[0048] The cover portion 14 of the medical device 10 may include a frame structure 48 and a cover 50. The frame structure 48 of the cover portion 14 may include a hub 52, spokes 54, and a lip portion 56. The frame structure 48 may be formed of a superelastic material (such as nitinol and / or a polymer material). The spokes 54 may extend radially from the hub 52 to the lip portion 56. The frame structure 48 may support the cover 50 so that the cover 50 may extend at least along the proximal side 57 of the frame structure 48. The cover portion 14 may extend with the disc-shaped structure to define the proximal side 57 and the distal side 58 of the cover portion 14. The proximal side 57 may extend in a concave structure. The distal side 58 may generally extend in a convex structure. Such a concave structure of the proximal side 57 of the cover portion 14 may be at least partially formed with the spokes 54 of the frame structure 48. The spokes 54 may extend from the hub 52 so as to extend radially and slightly proximally to the spoke end portion 60. At the spoke end portion 60, the spoke 54 may include a bend or curved portion 62 such that the spoke 54 is curved to extend closer to the spoke end 64. Such spoke end portions 60 and / or curved portions 62 of the spokes 54 may at least partially form a concave structure of the proximal side 57 of the cover portion 14, and the spoke end portion 60 may also at least partially form a lip portion 56 of the cover portion 14. The lip portion 56 may define an outer lip 66 and an inner lip 68. The outer lip 66 may extend radially with the annular structure and may be positioned closer than the inner lip 68. The inner lip 68 may extend radially and more distally than the outer lip 66, such that the inner lip 68 may extend less or at a smaller radius than the outer lip 66, such that the outer profile of the outer lip 66 exhibits a distal step inward relative to the outer lip 66 and the axis 26 of the medical device 10. The spoke end portions 60 can extend along the outer surface of the inner lip 68, with the spoke ends 64 positioned within or adjacent to the outer lip 66 of the lip portion 56. In this manner, the spokes 54 of the frame structure 48 can support the lip portion 56 of the cover portion 14 and the cover 50.

[0049] The size and configuration of the framework structure 48 of the cover portion 14 can be configured to self-expand from a contracted state to an expanded state. The cover portion 14 can be retracted in the distal end portion 104 of the catheter 82 so that the spokes 54 of the framework structure 48 can be folded inwardly so as to extend and fold proximally from the hub 52. In this position, the spokes 54 can extend substantially parallel within the catheter 82. When advancing from the distal end portion 84 of the catheter 82, the spokes 54 can be biased to self-expand to a radially extended expanded position so that the cover portion 14 can expand the lip portion 56 and the cover 50. In addition, in one embodiment, the spokes 54 can be designed to expand independently relative to each other, so that the spokes 54 may not be interconnected with each other, except adjacent to the hub 52 and interconnected via the cover 50 or the lip portion 56. Such independent expansion of the spokes 54 can better promote the spokes to be biased to conform to the various mouth shapes of the left atrial appendage. In another embodiment, the spokes 54 can be interconnected with adjacent extending spokes 54 at one or more locations along the length of a given spoke. Such interconnections can prevent any one spoke from becoming tangled with another spoke when the cover portion moves between the expanded and retracted positions, as described above.

[0050] The cover 50 of the cover part 14 can be a material that is sized and configured to induce tissue ingrowth therein and above the cover 50. As previously described, the cover 50 can extend at least along the proximal side 57 of the framework structure 48 and the cover part 14. In one embodiment, the cover can be formed by a polymer material, such as expanded polytetrafluoroethylene (ePTFE) or any other suitable polymer material configured to induce tissue growth. For example, the cover 50 can include a multilayer polymer material, such as ePTFE, such as two to six or more layers. The multiple layers of the cover can be formed by bonding these layers together, such as forming with an adhesive and / or heat bonding heat treatment or other suitable processes known in the art. In addition, the cover 50 can be bondedly attached to the proximal side 57 of the framework structure 48, or the cover 50 can be attached to the framework structure 48 with any other suitable technology or device, such as attached to the framework structure 48 with a heat bonding technology. In another embodiment, the material of the cover 50 can define holes or pores therein, and the size of the hole is in the range of about 50 microns to about 200 microns.

[0051] In addition, the cover 50 can extend with the spoke end portion 60 to form an inner lip 68, so that the cover 50 can be adhesively attached to the spoke end portion 60 to form the inner lip 68. The outer lip 66 can be adhesively attached to the inner lip 68 of the cover 50 and can extend radially in the annular structure so as to be supported by the spoke end 64 of the frame structure 48 and abut the cover 50. The outer lip 66 of the lip portion 56 can be an elastic polymer material, such as foam or ePTFE, or any other suitable polymer material. In another embodiment, the outer lip 66 can be a continuous extension of the cover 50. With this arrangement, the size and configuration of the lip portion 56 can be configured to be nested in a soft and conformable manner along the outer side or front side of the periphery of the left atrial appendage orifice. In one embodiment, the lip portion 56 can be biased to self-expand to an annular structure. In another embodiment, the lip portion 56 can be extended to an annular structure by the frame structure 48, which can be moved and biased to a radially expanded position. Additionally, the size and configuration of the lip portion 56 can be configured to be folded with the entire cover portion in a minimized manner for ease of installation within the conduit 82 ( Figure 4 ). In addition, similar to the anchor portion 16, the cover portion 14 may include markers. The markers may be positioned along the lip portion 56 and / or along the spokes 54 of the cover portion 14. Such markers may be formed of a radiopaque material (such as platinum, gold, tantalum, or alloys thereof) or any other suitable radiopaque material so that a physician can easily observe the orientation and positioning of the cover portion 14 and the medical device 10 relative to the left atrial appendage by using various imaging techniques as known in the art.

[0052] As previously described, the flexible member 18 may extend between the cover portion 14 and the anchor portion 16 of the medical device 10. The flexible member 18 may be an elongated flexible filament-type structure that couples the anchor portion 16 to the cover portion 14 of the medical device 10. In the accompanying drawings, the flexible member 18 is depicted as being in a tensioned state, so that in one embodiment, the flexible member 18 may be of a type that does not provide an appreciable compressive force, and if not in a tensioned state, the flexible member 18 will move to a soft position. The flexibility of the flexible member 18 may facilitate orienting the cover portion 14 relative to the anchor portion 16 so that the medical device 10 may, for example, conform to the specific anatomical structure of a given left atrial appendage.

[0053] In one embodiment, the flexible member 18 may extend between the anchor hub 70 and the hub 52 of the cover portion 14 such that a portion of the flexible member 18 may be coupled to the hub 52 of the cover portion 14. The flexible member 18 in a pre-release position of the medical device 10 relative to the delivery system 80 may continue proximally from the hub 52 and be operably coupled to the handle 108 of the delivery system 80. At the anchor hub 70, the flexible member 18 may be coupled to the anchor hub 70 such that the anchor hub 70 may include a coupling structure 72 for retaining the anchor hub 70 to the anchor portion 16. Such a coupling structure 72 may include an extension 74 extending laterally relative to the axis 26. In another embodiment, the flexible member 18 may include a structure extending directly therefrom that may extend within the anchor portion 16 so as to extend laterally relative to the longitudinal axis 26 of the anchor portion 16 to retain the flexible member 18 to the anchor portion 16.

[0054] refer to Figure 3 and Figure 4 , provides a method for placing a medical device 10 (in Figure 4 82 for delivery to, for example, the left atrial appendage. As previously described, the medical device 10 can be connected to the delivery system 82 using the flexible member 18 or another flexible element. In addition, the medical device 10 can be retained in the distal end portion 84 of the catheter 82 of the delivery system 80 by an interference fit in the contracted state. The main components of the delivery system 80 may include a catheter 82 fixedly connected to the handle 86. In addition, the size and structure of the delivery system 80 may be configured to cooperate with the sheath system 90. The sheath system 90 may be a standard sheath system, the size and structure of which are configured to be advanced through the cardiovascular system on a guidewire (not shown). In one embodiment, the sheath system 90 may include a sheath hub 92 and a sheath 94, the sheath hub 92 being positioned and connected to the proximal end of the sheath 94. The sheath system 90 may also include a sheath fluid port 96, the size and structure of which are configured to feed fluid to the lumen of the sheath 94. Such a lumen of the sheath 94 may be sized and configured to receive and advance the catheter 82 of the delivery system 80 therethrough as the sheath 94 is advanced to a desired location within the cardiovascular system, such as to the left atrial appendage of the heart.

[0055] The catheter 82 may define a lumen extending along the length of the catheter and extending along the catheter longitudinal axis 98 between a proximal end 102 and a distal end 104, the proximal end 102 being coupled to the handle 86. The handle 86 may include a switch 106 and a push rod 108 extending from the proximal end of the handle 86. The push rod 108 may include a knob 112 at the proximal end of the push rod 108 and a distal pusher portion 110 ( Figure 5). In addition, a portion of the push rod 108 can be a tubular coil (not shown) that extends within the lumen of the catheter 82 to the distal pusher portion 110 of the push rod 108, the tubular coil defining a lumen that is sized and configured to retain a portion of the flexible member 18 ( Figure 1 ). The knob 112 can be fixed to the proximal end of the push rod 108, and its size and configuration can be configured for the physician to easily grasp and move the push rod bilinearly, as shown by the bidirectional arrow 114, and / or the knob 112 can be rotationally movable, as shown by the rotation arrow 116. For example, the push rod 108 can be moved distally to deploy the medical device 10 from the distal end portion 84 of the catheter 82, and the push rod 108 can be moved proximally to recapture the medical device 10 into the distal end portion 84 of the catheter 82. In addition, the knob 112 can be rotatable for, for example, releasing the medical device 10 from the delivery system 80. In another embodiment, the switch 106 can be moved to multiple positions to control the displacement of the push rod 108 while, for example, deploying the medical device 10 or recapturing the medical device 10. In addition, the delivery system 80 may include a fluid port 118 associated with the handle 86 to advance a fluid into the lumen of the catheter 82. Further details and functionality of the various components of the delivery system 80 will be described in conjunction with a description of the delivery system 80 delivering the medical device 10 in the left atrial appendage.

[0056] Reference now Figures 4 to 11 , one embodiment of delivering the medical device 10 to the left atrial appendage 5 of the heart using the delivery system 80 will now be described. Figure 4 and Figure 5 , the medical device 10 may be pre-positioned or prepared for positioning within the distal end portion 84 of the catheter 82. When the medical device 10 is positioned adjacent to the distal end portion 84 of the catheter 82, the physician may prepare to position the distal end 120 of the sheath 94 adjacent to the left atrial appendage 5. This may be used by typical interventional techniques known in the art, such as with a guidewire and a sheath. Once the sheath 94 has been appropriately advanced adjacent to the left atrial appendage 5, the catheter 82 of the delivery system 80 may be advanced through the sheath 94 so that the distal end portion 84 of the catheter 82 is positioned adjacent to the left atrial appendage 5. Once positioned, the sheath 94 may be completely or slightly removed from the distal end portion 84 of the catheter 82 so that the distal end portion 84 may be positioned within the left atrial appendage 5, as shown in FIG. Figure 5 Depicted.

[0057] refer to Figures 4 to 7Once the physician is satisfied with the position of the distal end portion 84 of the catheter 82, the physician can advance the anchor portion 16 into the left atrial appendage 5, wherein the push rod 108 can be actuated at the handle 86. The push rod 108 can extend from the knob 112 and continue distally through the handle and lumen of the catheter 82 to the proximal and vicinity of the medical device 10 at the distal end portion 84 of the catheter 82. The physician can move the push rod 108 distally to the first hard stop to deploy the anchor portion 16 of the medical device 10 by moving the knob 112 distally, as shown by the double-headed arrow 114. When the knob 112 and the push rod 108 are moved distally, the distal pusher portion 110 of the pushing member 108 can push the medical device 10 from the distal end 104 of the catheter 82, so that the anchor portion 16 is advanced from the catheter 82. As the anchor portion 16 is advanced from the catheter 82, the structural properties of the anchor portion 16 may allow for immediate expansion so as to self-expand, e.g. Figure 6 and Figure 7 Depicted.

[0058] Because the size and configuration of the anchor portion can be configured to be larger than the left atrial appendage 5, a majority of the outer surface 34 of the anchor portion 16 can self-expand and bias against tissue 7 within the left atrial appendage 5 with an outward biasing force 17, such that opposing surfaces or sides along the periphery of the outer surface 34 maintain contact with tissue in the left atrial appendage 5. In addition, the curved outer surface 34 can utilize the outward biasing force 17 to bias against tissue along a circumferential surface area of ​​the anchor portion, which is defined by a band-like length 75 that can extend around the periphery or circumference of the anchor portion 16, as shown in FIG. Figure 7 as depicted. The band-like length 75 of the anchor portion 16 that is in biased contact with the tissue 7 in the left atrial appendage 5 defines a band-like portion or circumferential surface area of ​​the outer surface 34 of the anchor portion 16 that is in biased contact with the tissue 7, such that the opposing surface of the anchor portion 16 is inserted into the left atrial appendage 5. Depending on the size of the anchor portion 16 or the left atrial appendage 5, the band-like length 75 may extend further, such as the full length 77 of the anchor portion 16, or a length shorter than the length depicted. Thus, the band-like length 75 may be any length along the length 77 of the anchor portion 16, but preferably the band-like length 75 is greater than half of the length 77 of the anchor portion 16. In addition, as the outer surface 34 of the anchor portion 16 is biased against the tissue 7 in the left atrial appendage 5, the outer surface 34 of the anchor portion 16 may define microprotrusions 35 ( Figure 1 ) or other structures that can help effectively engage and grasp tissue to maintain the anchor portion 16 in the left atrial appendage 5. In this way, the anchor portion 16 can be advanced from the catheter 82 and secured within the left atrial appendage 5, with the cover portion 14 still retracted in the distal end portion 84 of the catheter 82.

[0059] refer to Figures 7 to 9Once the anchor portion 16 is positioned and anchored within the left atrial appendage 5, the physician may, for example, move or depress the switch 106 to subsequently allow the pusher member 108 to move distally to the second hard stop for advancing the cover portion 14 from the distal end portion 84 of the catheter 82. Figure 8 As depicted, the cover portion 14 is shown partially advanced from the distal end 104 of the catheter 82. Once the cover portion 14 is fully advanced from the catheter 82, as shown in FIG. Fig. 9 As depicted, the cover portion 14 of the medical device 10 can immediately self-expand to be positioned against the ostium 9 of the left atrial appendage 5 or spaced proximally of the ostium 9 of the left atrial appendage 5, as depicted. As previously described, the cover portion can self-expand via, for example, the expansion characteristics of the spokes 54 or the outer lip 66 of the cover member.

[0060] refer to Figure 4 , Fig. 9 , Fig.10 and Fig.11 , if the cover portion 14 is spaced apart from the ostium 9, the physician can tighten the cover portion 14 against the tissue 7 defined by the ostium 9 of the left atrial appendage 5 via, for example, a sliding knot 122 associated with the flexible member 18. The physician can actuate the switch 106 on the handle 86 and pull the pusher member 108 proximally, as indicated by the bidirectional arrow 114. When the physician moves the pusher member 108 proximally, the cover portion 14 of the medical device 10 can be tightened against the ostium 9 of the left atrial appendage 5. Through this process, the distal end 104 of the catheter 82 can also push the cover portion 14 against the ostium 9, so that the cover portion 14 is positioned on the outside of the left atrial appendage 5, or proximal to the ostium 9 of the left atrial appendage 5. Once the physician has sufficiently tightened the cover portion 14 of the medical device 10 against the port 9 in a somewhat sealing manner, the switch 106 may be actuated so that the knob 112 of the pusher member 108 may be rotated (as indicated by the rotation arrow 116) to release the medical device 10 from the delivery system 80. For example, upon rotating the knob 112, a cutting or slicing mechanism (not shown) may be actuated to cut the medical device 10 adjacent to the hub 52 ( Figure 2 ) at a point proximal to the cover portion 14, such as Fig.11 The physician may then remove catheter 82 from the heart and the patient.

[0061] In this manner, the delivery system 80 can release the medical device 10 within the left atrial appendage 5 of the heart so that the anchor portion 16 can secure the medical device 10 in the left atrial appendage 5, wherein the size and structure of the cover portion 14 are configured to seal and cover the ostium 9 of the left atrial appendage 5. Due to the outward biasing force 17 of the anchor portion 14 against the tissue within the left atrial appendage 5, such a cover portion 14 can be held against the ostium 9 of the left atrial appendage 5, so that the anchor portion 14 is maintained in contact against the tissue along the relative surface along the periphery of the outer surface 34 of the anchor portion, so that the anchor portion 16 remains anchored in the left atrial appendage 5. In addition, due to the flexible nature of the flexible member 18, the cover portion 14 can be oriented to different positions of the ostium 9 of the left atrial appendage 5, so that the flexible member 18 can be stretched tautly at an angle 78 relative to the axis 26 of the anchor portion 16. With this arrangement, since the anchor is partially anchored in the left atrial appendage 5 without hooks or tines, the medical device 10 can close the opening of the left atrial appendage 5 in an atraumatic manner, thereby preventing perfusion that might otherwise occur.

[0062] refer to Fig.12 and Fig.13 , another embodiment of a medical device 130 is provided. This embodiment of the medical device 130 may include similar structural features of the previously described medical devices and may be used in a similar manner with the delivery system 80 ( Figure 4 ) as previously described. Similar to the previous embodiments, the medical device 130 may include an anchor portion 132 and a cover portion 134, wherein a flexible member 136 is coupled between the anchor portion and the cover portion. The anchor portion 132 may extend in a truncated cone structure, except in this embodiment, the outer surface 138 of the anchor portion 132 may extend in a raised grid pattern 140. The raised grid pattern 140 may extend over the curved portion of the truncated cone structure between the proximal anchor end 142 and the distal end 144 of the medical device 130. Such a raised grid pattern 140 may be integrally formed with the foam material of the anchor portion 132. In one embodiment, the raised grid pattern 140 may be a continuation of the foam material. In another embodiment, the raised grid pattern 140 may be another polymer material of the underlay or core portion coupled to the foam material of the anchor portion 132. As in the previous embodiments, the foam material of the anchor portion 132 can include microprotrusions along the outer surface 138 of the anchor portion 132, including along the raised grid pattern 140. The raised grid pattern 140 of the anchor portion 132 can extend so that when anchored in the left atrial appendage, the raised grid pattern 140 can facilitate gripping the portion of the outer surface 138 that contacts the tissue of the left atrial appendage. In this way, and as in the previous embodiments, the anchor portion 132 having the raised grid pattern 140 can be conformable and resilient so that the anchor portion 132 can be effectively anchored within the left atrial appendage.

[0063] refer to Fig.14 and Fig.15 , another embodiment of a medical device 150 is provided. Similar to the previous embodiments, the medical device 150 can define an axis 152 having an anchor portion 154 and a cover portion 156, with a flexible member 158 extending between the anchor portion and the cover portion. The flexible member 158 can include similar structural features as described in the previous embodiments.

[0064] In this embodiment, the anchor portion 154 may be a cylindrical structure whose size and configuration are configured to be anchored in the left atrial appendage similar to the previous embodiment. Such a cylindrical structure may be formed of a foam material. The cylindrical structure may include a length 160 extending between a proximal anchor end 162 and a distal end 164. The cylindrical structure may define an outer surface 165 extending radially between the proximal anchor end 162 and the distal end 164 so as to define an anchor portion radius 166 along the length 160. As in the previous embodiment, the foam material of the anchor portion 154 may include micro-protrusions along the outer surface 165 of the anchor portion 132 to help the anchor portion grasp tissue and fix in the left atrial appendage using the outward biasing force of the foam material.

[0065] The cover portion 156 of this embodiment can be a disc-shaped structure defining a cover portion radius 168. The cover portion radius 168 can be equal to or greater than the anchor portion radius 166. The cover portion 156 can include a hub 170, a cover 172, and a lip 174. The hub 170 can be aligned with the flexible member 158, wherein the cover 172 extends radially from the hub 170. The lip 174 can extend with the annular structure and can extend along the outer periphery 176 of the cover 172. The lip 174 and the cover 172 can include materials similar to those described in the previous embodiment. The size and configuration of the lip 174 can be configured to self-expand from a contracted state to an expanded state, as depicted in the figure. In another embodiment, the cover portion 156 can include spokes extending from the hub 170, so that the spokes can extend radially relative to the hub 170 to the lip 174 of the cover portion 156. The spokes can operate similarly to the spokes described in the previous embodiment, providing structural support and self-expanding properties.

[0066] Reference now Fig.16 and Fig.17, the size and configuration of another embodiment of the medical device 180 are configured to occlude an opening, such as a left atrial appendage. The medical device 180 of this embodiment is similar to the previous embodiment, including an anchor portion 182 and a cover portion 184, wherein a flexible member 186 extends between the anchor portion and the cover portion. In this embodiment, the anchor portion 182 may include a foam material defining a cylindrical structure, wherein an outer surface 188 extends above the cylindrical structure together with a plurality of annular structures 189. As in the aforementioned embodiment, the foam material of the cylindrical structure and the annular structure may include micro-protrusions along the outer surface 188 of the foam material to help grasp tissue in, for example, the left atrial appendage. The annular structure 189 may extend around the cylindrical structure in a uniformly spaced manner. In another embodiment, the annular structure 189 may extend around cylindrical structures adjacent to each other side by side. In another embodiment, the annular structure 189 may extend with a gap or interval between each annular structure 189. Such annular structures 189 may also help grasp tissue using the outward biasing force of the foam material. The cover portion 184 and the flexible member 186 may exhibit similar structural characteristics as described in the previous embodiments.

[0067] refer to Fig.18 and Fig.19 , another embodiment of a medical device 190 is provided. In this embodiment, the medical device 190 may be substantially similar to the previous embodiment, including an anchor portion 192 and a cover portion 194, with a flexible member 196 between the anchor portion and the cover portion. As in the previous embodiment, the anchor portion 192 may be formed of a foam material that is self-expandable and provides an outward biasing force to the tissue in the left atrial appendage. The anchor portion 192 may include a cylindrical structure, but the outer surface 198 of the cylindrical structure may include a plurality of protrusions 199 or bumps thereon, rather than an annular structure. The size and configuration of the protrusion 199 may be configured to grasp the tissue using the outward biasing force of the anchor portion 192. In addition, the protrusion and the portion of the anchor portion surrounding the protrusion may include micro-protrusions to help grasp the tissue, as described in the previous embodiment. The protrusion 199 may be positioned in an aligned manner (such as a row), and the row extends along the longitudinal length of the cylindrical structure. In another embodiment, the protrusions 199 may extend from the cylindrical structure in a random or staggered manner.

[0068] In another embodiment, the anchor portion of the various embodiments of the medical device described herein can be used without the cover portion, so that the medical device can act as a stand-alone plug to close the opening of the left atrial appendage. In this embodiment, the anchor portion may include similar structural characteristics as described for the anchor portion of the various embodiments herein. In addition, the proximal surface of the anchor portion, or the surface facing the left atrial chamber, can be smooth and its size and design can be configured to block the opening so that the proximal surface is located near the opening of the left atrial appendage.

[0069] Although the present invention may have various modifications and alternative forms, specific embodiments have been shown in the drawings by way of example and have been described in detail herein. However, it should be understood that the present invention is not intended to be limited to the specific forms disclosed. On the contrary, the present invention includes any part of an embodiment combined with another embodiment, and all modifications, equivalents and substitutes fall within the spirit and scope of the present invention as defined by the following claims.

Claims

1. A medical device for occluding the left atrial appendage of a heart, comprising: a cover portion having a hub and a cover extending radially from the hub, the cover portion being sized and configured to be positioned proximally along an ostium of the left atrial appendage; and A foam anchor portion, wherein the foam anchor portion is connected to the covering portion by a flexible member, the foam anchor portion extends between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion, the foam anchor portion defines a curved outer surface extending radially relative to the axis, so that the curved outer surface extends between the proximal end and the distal end of the foam anchor portion, the proximal end of the foam anchor portion extends to define a first radius and the distal end of the foam anchor portion extends to define a second radius, the second radius is greater than the first radius, so that the curved outer surface between the distal end and the proximal end extends in a truncated cone shape along the entire length between the distal end and the proximal end, and the foam anchor portion is configured to self-expand to provide an outward biasing force from the curved outer surface so that a circumferential surface area of ​​the curved outer surface is biased against tissue of the left atrial appendage.

2. The medical device of claim 1 , wherein the curved outer surface defines a total surface area, and wherein at least half of the total surface area of ​​the curved outer surface is sized and constructed to grasp and contact tissue within the left atrial appendage.

3. A medical device according to claim 1, wherein the curved outer surface of the foam anchor portion includes micro-protrusions, the size and structure of which are configured to grasp and contact tissue within the left atrial appendage with the outward biasing force.

4. The medical device of claim 1, wherein the curved outer surface of the foam anchor portion comprises a raised grid pattern sized and configured to grip tissue with the outward biasing force.

5. The medical device of claim 1, wherein the curved outer surface of the foam anchor portion defines a plurality of protrusions sized and configured to grasp and anchor to tissue utilizing the outward biasing force.

6. The medical device of claim 1, wherein the curved outer surface of the foam anchor portion defines a plurality of recesses therein, the plurality of recesses being defined by raised portions of the curved outer surface of the foam anchor portion.

7. The medical device of claim 1, wherein the curved outer surface of the foam anchor portion defines a plurality of annular structures.

8. The medical device of claim 1, wherein the foam anchor portion expands to a shape resembling one of a frustoconical structure and a cylindrical structure.

9. The medical device of claim 1, wherein the foam anchor portion comprises variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having a greater foam expandability than the proximal end portion.

10. The medical device of claim 1, wherein the cover is partially extended, wherein a proximally facing surface has a concave configuration, the proximally facing surface facing away from a distal end of the medical device.

11. The medical device of claim 1 , wherein upon deployment of the cover portion and the foam anchor portion, the flexible member is capable of extending at an angle relative to the axis of the foam anchor portion.

12. A medical device system for occluding the left atrial appendage of a heart, comprising: a delivery device having a handle and a catheter extending between a proximal end coupled to the handle and a distal end, the catheter defining a lumen extending longitudinally therethrough between the proximal end and the distal end of the catheter; and a medical device operably coupled to the handle, the medical device being sized and configured to move between a collapsed state and an expanded state such that in the collapsed state the medical device is within the distal end portion of the catheter and in the expanded state the medical device is advanced from the catheter, the medical device comprising: a cover portion having a hub and a cover extending radially from the hub, the cover portion being sized and configured to be positioned proximally along an ostium of the left atrial appendage; and A foam anchor portion, wherein the foam anchor portion is connected to the covering portion by a flexible member, the foam anchor portion extends between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion, the foam anchor portion defines a curved outer surface extending radially relative to the axis, so that the curved outer surface extends between the proximal end and the distal end of the foam anchor portion, the proximal end of the foam anchor portion extends to define a first radius and the distal end of the foam anchor portion extends to define a second radius, the second radius is greater than the first radius, so that the curved outer surface between the distal end and the proximal end extends in a truncated cone shape along the entire length between the distal end and the proximal end, and the foam anchor portion is configured to self-expand to provide an outward biasing force from the curved outer surface so that a circumferential surface area of ​​the curved outer surface is biased against tissue of the left atrial appendage.

13. A medical device system according to claim 12, wherein the curved outer surface defines a total surface area, and wherein at least half of the surface area of ​​the curved outer surface is sized and constructed to grasp and contact tissue within the left atrial appendage with the outward biasing force.

14. A medical device system according to claim 12, wherein the curved outer surface of the foam anchor portion includes micro-protrusions, and the size and structure of the micro-protrusions are configured to grasp and contact tissue within the left atrial appendage with the outward biasing force.

15. The medical device system of claim 12, wherein upon deployment of the cover portion and the foam anchor portion, the flexible member is angularly extendable relative to the axis of the foam anchor portion.

Images