Implantable medical device with primary and secondary covers

Abstract

An implantable medical device, such as, but not limited to, a left atrial appendage occlusion (LAAC) device, includes an expandable frame movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame including a proximal portion, a distal portion, and an intermediate portion. The expandable frame includes a plurality of anchors extending around an outer periphery of the expandable frame. A primary cover extends over the proximal portion of the expandable frame and may interact with the plurality of anchors. A secondary cover extends over a portion of the expandable frame.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 391,080, filed on July 21, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to medical devices and, more particularly, to medical devices suitable for use in percutaneous medical procedures involving implantation into the left atrial appendage (LAA) of the heart. Background Art

[0004] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, the left atrial appendage contracts and forces blood into the left atrium as the left atrium contracts and forces blood into the left ventricle. The left atrial appendage's ability to contract helps improve the filling of the left ventricle, thereby playing a role in maintaining cardiac output. However, in patients with atrial fibrillation, the left atrial appendage may not contract or empty properly, causing blood to pool inside the left atrial appendage, which may lead to the formation of unwanted blood clots within the left atrial appendage.

[0005] A thrombus that forms in the left atrial appendage may break away from the area and enter the bloodstream. A thrombus that migrates through a blood vessel may eventually block a smaller blood vessel downstream, leading to a stroke or heart attack. Clinical studies have shown that a majority of blood clots in patients with atrial fibrillation originate from the left atrial appendage. As a treatment method, medical devices that are deployed to occlude the left atrial appendage have been developed. Of the known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of making and using medical devices. Summary of the invention

[0006] The present disclosure provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example can be found in an implantable medical device. The implantable medical device includes an expandable frame that defines the outline of the implantable medical device, the expandable frame can move between a contracted configuration for delivery and an expanded configuration for deployment, the expandable frame includes a proximal portion, a distal portion, and an intermediate portion therebetween; a primary cover extends over the proximal portion of the expandable frame. A secondary cover extends over the portion of the expandable frame that is not covered by the primary cover.

[0007] Alternatively or additionally, the secondary cover may extend over the intermediate portion of the expandable frame.

[0008] Alternatively or additionally, the secondary covering may extend over the distal portion of the expandable frame.

[0009] Alternatively or additionally, the expandable frame can include a plurality of proximal anchors disposed about a first periphery of the expandable frame.

[0010] Alternatively or additionally, the expandable frame can include a plurality of distal anchors disposed about a second periphery of the expandable frame, the second periphery being axially displaced from the first periphery.

[0011] Alternatively or additionally, the primary covering can be secured in place relative to the expandable frame by interaction between the primary covering and a plurality of proximal anchors.

[0012] Alternatively or additionally, the secondary covering can be secured in place relative to the expandable frame by interaction between the secondary covering and a plurality of distal anchors.

[0013] Alternatively or additionally, the secondary covering may be secured in place relative to the expandable frame by sutures extending between the secondary covering and the expandable frame.

[0014] Alternatively or additionally, the secondary covering may be secured in place relative to the expandable frame by sutures extending between the primary covering and the secondary covering.

[0015] Alternatively or additionally, the primary covering may have one or more first characteristics and the secondary covering may have one or more second characteristics different from the one or more first characteristics.

[0016] Alternatively or additionally, the implantable medical device may include a LAAC (Left Atrial Appendage Closure) device.

[0017] Another example can be found in a left atrial appendage occlusion (LAAC) device. The LAAC device includes an expandable frame that defines the outline of the LAAC, the expandable frame being movable between a contracted configuration for delivery and an expanded configuration for deployment, the expandable frame including a proximal portion, a distal portion, and an intermediate portion therebetween. The expandable frame includes a plurality of anchors extending around the periphery of the expandable frame. A primary covering extends over the proximal portion of the expandable frame and interacts with the plurality of anchors. A secondary covering extends over portions of the expandable frame.

[0018] Alternatively or additionally, the secondary covering may also interact with multiple anchors.

[0019] Alternatively or additionally, the secondary covering may be secured in place relative to the expandable frame by sutures extending between the secondary covering and the expandable frame.

[0020] Alternatively or additionally, the secondary covering may be secured in place relative to the expandable frame by sutures extending between the primary covering and the secondary covering.

[0021] Alternatively or additionally, the primary covering may have one or more first characteristics and the secondary covering may have one or more second characteristics different from the one or more first characteristics.

[0022] Alternatively or additionally, the secondary covering may extend over the middle portion and / or the distal portion of the expandable frame.

[0023] Alternatively or additionally, the primary covering may also extend over the medial portion of the intermediate frame, and the secondary covering may extend over the proximal portion of the intermediate frame, thereby covering a portion of the primary covering.

[0024] Another example can be found in a left atrial appendage occlusion (LAAC) device. The LAAC device includes an expandable frame that defines the outline of the LAAC, the expandable frame being movable between a contracted configuration for delivery and an expanded configuration for deployment, the expandable frame including a proximal portion, a distal portion, and an intermediate portion therebetween. A proximal cover extends over the proximal portion of the expandable frame and the intermediate portion of the expandable frame. The distal cover can be fixed relative to the expandable frame to a distal periphery proximal to the proximal cover, the distal cover including sections of various thicknesses to enhance the seal between the LAAC device and tissue proximal to the LAAC device after deployment.

[0025] Alternatively or additionally, the proximal covering may further include sections of various thicknesses to enhance the seal between the LAAC device and tissue proximate the LAAC device after deployment.

[0026] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention may be more fully understood from the following detailed description of various embodiments of the invention considered in conjunction with the accompanying drawings, in which:

[0028] Figure 1 It is a partial cross-sectional view of the left atrial appendage;

[0029] Figure 2 and Figure 3 is a side view of an exemplary system for closing a left atrial appendage;

[0030] Figure 4 is a perspective view of an exemplary expandable frame for a left atrial appendage occlusion device;

[0031] Figure 5 yes Figure 4 A perspective view of a portion of an exemplary expandable frame;

[0032] Figure 6 is a perspective view of an exemplary left atrial appendage closure (LAAC) device;

[0033] Figure 7 is a perspective view of an exemplary LAAC device;

[0034] Figure 8 is a perspective view of an exemplary LAAC device having a first cover;

[0035] Fig. 9 is a device having a first covering and a second covering Figure 8 A perspective view of an exemplary LAAC device;

[0036] Fig.10 is a schematic diagram of an exemplary LAAC device disposed within a LAA; and

[0037] Fig.11 is a schematic diagram of an exemplary LAAC device disposed within a LAA.

[0038] Although the present disclosure may have various modifications and alternative forms, the details thereof have been illustrated by the examples in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit the present disclosure to the specific embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0039] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals represent the same elements in several views. The detailed description and the accompanying drawings are intended to illustrate rather than limit the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the accompanying drawings illustrate exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, although each feature and / or element may not be shown in each of the accompanying drawings, unless otherwise stated, these features and / or elements may be understood to exist in any case.

[0040] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0041] Whether or not explicitly stated, it is assumed herein that all numerical values ​​are modified by the term "about". The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the stated value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0042] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0043] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0044] As used in this specification and the appended claims, the singular forms "one", "an" and "the" include plural indicators, unless otherwise expressly specified in the content. As used in this specification and the appended claims, the term "or" is generally used to include the meaning of "and / or", unless otherwise expressly specified in the content. It should be noted that, for ease of understanding, some features of the present disclosure may be described in the singular, even if these features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be included in a single disclosure, unless there is an explicit statement to the contrary. For the purpose of simplicity and clarity, not all elements of the present disclosure must be shown in each figure or discussed in detail below. However, it should be understood that the following discussion can be equally applicable to any and / or all components having more than one component, unless there is a clear contrary statement. Additionally, for clarity, not all instances of some elements or features are shown in each figure.

[0045] Relative terms, such as "proximal," "distal," "advance," "retract," and variations thereof, etc., may generally be considered to refer to the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of a device, wherein "proximal" and "retract" mean or refer to being closer to or toward a user, and "distal" and "advance" mean or refer to being farther away from or away from a user. In some cases, the terms "proximal" and "distal" may be arbitrarily designated to facilitate understanding of the present disclosure, and such cases will be apparent to one skilled in the art. Other related terms, such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of flow of a fluid within a lumen (e.g., a body cavity, a blood vessel, or a device). Still other related terms, such as "axial," "circumferential," "longitudinal," "lateral," "radial," etc., and / or variations thereof, generally refer to a direction and / or orientation relative to a central longitudinal axis of the disclosed structure or device.

[0046] The term "range" can be understood as the maximum measurement of the described or identified dimension, unless the described range or dimension is preceded by "minimum value" or is identified as "minimum value", which can be understood as the minimum dimension of the described or identified dimension. For example, "outer range" can be understood as the outer dimension, "radial range" can be understood as the radial dimension, "longitudinal range" can be understood as the longitudinal dimension, etc. Each instance of "range" can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and is obvious to those skilled in the art from the context of individual use. Generally, "range" can be considered as the maximum possible dimension measured according to the intended use, while "minimum range" can be considered as the minimum possible dimension measured according to the intended use. In some cases, "range" can generally be measured orthogonally in a plane and / or cross section, but it is obvious from the specific context that it can be measured in different ways, such as but not limited to angularly, radially, circumferentially (e.g., along an arc), etc.

[0047] The terms "integral" and "unitary" generally refer to one or more elements that are made or composed of a single structure or basic unit / element. Integral and / or unitary elements should exclude structures and / or features made by assembling or otherwise connecting multiple discrete elements together.

[0048] Note that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment must include the particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to use the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary. That is, as will be understood by those of ordinary skill in the art, the various individual elements described below are considered to be combinable or arrangable with each other, even if not explicitly shown in a particular combination, to form other additional embodiments or to supplement and / or enrich the described embodiments.

[0049] For the sake of clarity, the digital designations of certain identifiers (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish the various described and / or claimed features. It should be understood that the digital terms are not restrictive, but exemplary only. In some embodiments, for the sake of simplicity and clarity, the digital designations previously used may be changed and deviated. That is, the feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., and / or different features may be referred to as a "first" element. The meaning and / or name in each case will be apparent to a skilled practitioner.

[0050] The following figures illustrate selected components and / or arrangements of an implant for closing the left atrial appendage, a system for closing the left atrial appendage, and / or methods of using the implant and / or system. It should be noted that in any given figure, some features may not be shown, or may be shown schematically, for simplicity. Other details about some components of the implant and / or system may be shown in more detail in other figures. Although discussed in the context of closing the left atrial appendage, the implant and / or system may also be used for other interventional and / or percutaneous medical procedures in a patient. Similarly, the devices and methods described herein for percutaneous deployment may be appropriately used in other types of surgical procedures. For example, in some examples, the device may be used in non-percutaneous surgery. The devices and methods according to the present disclosure may also be modified and configured for other uses within anatomical structures.

[0051] Figure 11 is a partial cross-sectional view of the left atrial appendage 10. In some embodiments, the left atrial appendage (LAA) 10 may have a complex geometry and / or an irregular surface area. It should be understood that the illustrated LAA 10 is only one of many possible shapes and sizes of the LAA 10, which may vary from patient to patient. Those skilled in the art will also recognize that the medical devices, systems and / or methods disclosed herein may be applicable to LAA 10 of various sizes and shapes, as needed. The left atrial appendage 10 may include a substantially longitudinal axis 12 arranged along the depth of the body 20 of the left atrial appendage 10. The body 20 may include lateral walls 14 and an orifice 16 forming a proximal mouth 18. In some examples, the lateral extent of the orifice 16 and / or the lateral wall 14 may be less than or less than the depth of the body 20 along the longitudinal axis 12, or the depth of the body 20 may be greater than the lateral extent of the orifice 16 and / or the lateral wall 14. In some examples, the LAA 10 can narrow rapidly along the depth of the body 20, or the left atrial appendage can maintain a substantially constant lateral extent along most of the depth of the body 20. In some examples, the LAA 10 can include a distal-most region formed or arranged as a tail-like element associated with a distal portion of the body 20. In some examples, the distal-most region can protrude radially or laterally away from the longitudinal axis 12.

[0052] Figure 2 and Figure 3 is a side view of an exemplary medical device system 22. It should be noted that in any given figure, some features of the medical device system 22 may not be shown, or may be shown schematically, for the sake of brevity. Additional details about some components of the medical device system 22 may be shown in more detail in other figures. The medical device system 22 can be used to deliver and / or deploy various medical implants (e.g., cardiovascular medical implants, closed medical implants, replacement heart valve implants, etc.) to one or more locations within the anatomical structure, including but not limited to the heart and / or LAA10 in some embodiments. For clarity, the following discussion relates to closed medical implants, but other medical implants may be used and / or considered with the medical device system 22.

[0053] The medical device system 22 may include a catheter 24 having a lumen 26 extending from a proximal opening to a distal opening, a core wire 28 slidably and / or rotatably disposed within the lumen 26, and a closed medical implant 30 for implantation within a left atrial appendage, such as the LAA 10, releasably attached at and / or to the distal end of the core wire 28. In some embodiments, the closed medical implant 30 may be considered a left atrial appendage (LAAC) device.

[0054] In some embodiments, the core wire 28 can be non-rotatably fixed to the closed medical implant 30. In some embodiments, the core wire 28 can rotate relative to the closed medical implant 30. Other configurations are also considered. In some embodiments, the proximal end of the core wire 28 can extend proximally to the proximal end of the catheter 24 and / or the proximal opening of the lumen 26 for manual manipulation by a clinician or practitioner. Some suitable but non-limiting examples of materials for the medical device system 22, core wire 28 and / or catheter 24, etc. will be discussed below, including but not limited to metallic materials, polymeric materials, etc. It is conceivable that any and / or all exemplary closed medical implants disclosed herein can be used according to the above-mentioned medical device system 22 and / or be associated with the above-mentioned medical device system.

[0055] The closed medical implant 30 may include an expandable frame 32 (e.g., Figure 4 ), the expandable frame is configured to be able to be adjusted from a collapsed configuration (e.g., Figure 2 ), such as when the closed medical implant 30 is disposed within the lumen 26 near the distal opening, self-expands to an expanded configuration (e.g., Figure 3 and Figure 4 ), at which point the closed medical implant 30 is not constrained by the catheter 24. In at least some embodiments, at least a portion of the expandable frame 32 can be moved from an expanded configuration (e.g., Figure 3-Figure 4 ) mechanically expanded to a fixed structure as described herein.

[0056] Figure 4 Selected features of the expandable frame 32 are shown in a fully unconstrained configuration. The expandable frame 32 can have a plurality of struts 42 arranged about a central longitudinal axis. In some embodiments, the plurality of struts 42 can define a plurality of cells. In some embodiments, the plurality of cells can be a plurality of occluding cells. In some embodiments, the plurality of cells can be a plurality of open cells. In some embodiments, the plurality of cells can include a plurality of open cells and a plurality of occluding cells in various combinations and / or arrangements.

[0057] Expandable framework 32 can include proximal hub 34 and distal hub 36. In certain embodiments, proximal hub 34 and / or distal hub 36 can be centered on the longitudinal axis and / or coaxial with the longitudinal axis. A plurality of pillars can be coupled together and / or fixedly attached to the proximal hub and / or distal hub at proximal hub 34 and / or distal hub 36. Proximal hub 34 can be configured to releasably connect, affix and / or attach to core wire 28 closed medical implant 30 and / or expandable framework 32. In certain embodiments, proximal hub 34 can include internal threads, which are configured to rotatably and / or threadably engage the external threaded distal end of core wire 28. Other configurations for releasably affixed to core wire 30 for closed medical implant 30 are also considered. As described herein, for clarity, some features are not shown in each figure.

[0058] The expandable frame 32 and / or multiple pillars can be formed from a tubular member and / or cut from a tubular member. In some embodiments, the expandable frame 32 and / or multiple pillars can be integrally formed from a single member and / or cut from a single member. In some embodiments, the expandable frame 32 and / or multiple pillars can be integrally formed from a single tubular member and / or cut from a single tubular member, and then formed and / or heat-set to the desired shape of a completely unconstrained structure. In some embodiments, the expandable frame 32 and / or multiple pillars can be integrally formed from a single flat member or sheet and / or cut from a single flat member or sheet, then rolled or formed into a tubular structure, and then formed and / or heat-set to the desired shape of a completely unconstrained structure. Some exemplary ways and / or methods of manufacturing and / or forming the expandable frame 32 and / or multiple pillars include laser cutting, machining, stamping, molding, electrical discharge machining (EDM), chemical dissolution, etc. Other ways and / or methods are also considered.

[0059] As reference Figure 1 As described, for example, anatomical features of the LAA 10 may vary in size and / or shape. In some embodiments, when deployed and / or expanded in the LAA 10, the expandable frame 32 may be compliant and substantially conform to and / or sealingly engage the shape and / or geometry of the lateral walls of the LAA. In some embodiments, the closed medical device 30 may expand to a size, range, or shape that is smaller than or different from a completely unconstrained structure, which is determined by the surrounding tissue and / or the lateral walls of the LAA 10. In some embodiments, the expandable frame 32 may be configured to shape and / or stretch the tissue of the LAA 10 so that the lateral walls of the LAA 10 substantially conform to the outer shape of the expandable frame 32. Other configurations are also contemplated.

[0060] In some embodiments, the expandable frame 32 may include at least one anchoring member 38 extending radially outward from the expandable frame in a fully unconstrained configuration. In some embodiments, the expandable frame 32 may include at least one anchoring member 38 extending radially outward from the expandable frame 32. In some embodiments, the expandable frame 32 may include at least one anchoring member 38 extending radially outward from the expandable frame 32 near a proximal shoulder of the expandable frame 32. In some embodiments, the expandable frame 32 may include at least one anchoring member 38 extending radially outward from the expandable frame 32 near a middle section of the expandable frame 32. In some embodiments, at least one anchoring member 38 may be configured to engage with the lateral wall 14 of the body 20 of the LAA 10. In some embodiments, at least one anchoring member 38 may be formed as a J-shaped hook having a free end extending in a proximal direction and / or toward a proximal direction relative to a central longitudinal axis of the closed medical device 30 and / or the expandable frame 32. Other configurations are also contemplated.

[0061] Figure 5 An enlarged view of an anchoring member 38 is provided. As shown, the anchoring member 38 may include a base portion 40 attached to one of the struts 42, an end portion 44, and a body portion 46 extending from the base portion 40 to the end portion 44. The body portion 46 at least partially defines a void 48. In some embodiments, the end portion 44, the body portion 46, and the void 48 may together provide an anchor for an occlusive covering that engages one or more anchoring members 38. In some embodiments, the end portions 44 of each, some, or one of the plurality of anchoring members 38 may be radially aligned (e.g., on a common circumference) with a plurality of interconnected struts 42. In some embodiments, the body portions 46 and / or the end portions 44 of the plurality of anchoring members 38 may be oriented substantially parallel to the plurality of interconnected struts 42. In some embodiments, the end portions 44 of each, some, or one of the plurality of anchoring members 38 do not extend radially outward from the plurality of interconnected struts 42. Thus, the plurality of anchoring members 38 and / or the end portions 44 of the plurality of anchoring members 38 may not be able to engage, extend into and / or pierce natural tissue disposed outside (e.g., radially outside, etc.) the expandable frame 32 and / or the plurality of interconnected struts 42. Some suitable but non-limiting examples of materials for the closed medical implant 30, the expandable frame 32, the plurality of interconnected struts 42, etc. (including but not limited to metallic materials, polymeric materials, etc.) are discussed below.

[0062] In some cases, the anchoring member 38 may also be involved in helping to fix one or more closed covers to the expandable frame 32 to form a closed medical implant 30. As shown in the subsequent figures, the closed medical implant 30 may include one or more closed covers, each of which covers at least a portion of the closed medical implant 30. In some embodiments, one or more closed elements may be connected to at least a portion of the expandable frame 32 and / or a plurality of struts 42, disposed on at least a portion of the expandable frame and / or a plurality of struts, disposed above at least a portion of the expandable frame and / or a plurality of struts, disposed around at least a portion of the expandable frame and / or a plurality of struts, and / or disposed radially outside at least a portion of the expandable frame and / or a plurality of struts. In some embodiments, one or more closed elements may be attached to the proximal hub 34 and / or may be attached to the expandable frame 32 at the proximal hub 34. In some embodiments, one or more closed elements may extend radially outward from the proximal hub 34 and / or may extend distally from the proximal hub. In some embodiments, one or more closure elements can be attached and / or secured at multiple discrete locations to the expandable frame 32. In some embodiments, one, some, and / or all of the at least one anchoring member 38 can extend through the closure element, if present.

[0063] In some embodiments, each of one or more closure elements may include a membrane, a fabric, a net, a tissue element or another suitable structure. In some embodiments, each of one or more closure elements may be porous. In some embodiments, one or more closure elements may be non-porous. In some embodiments, one or more closure elements may be permeable to selected gases and / or fluids. In some embodiments, one or more closure elements may be substantially impermeable to selected gases and / or fluids, such as blood, water, etc. In some embodiments, one or more closure elements may be designed, sized and / or configured to prevent thrombus and / or embolic materials from flowing out of the left atrial appendage into the left atrium and / or the patient's blood flow. In some embodiments, one or more closure elements may be configured to promote endothelialization after implantation, thereby effectively removing a target site (e.g., left atrial appendage, etc.) from the patient's circulatory system. Some suitable but non-limiting examples of materials for one or more closure elements are discussed below.

[0064] Figure 6is a perspective view of an exemplary LAAC device 50. The exemplary LAAC device 50 includes an expandable frame 32. The expandable frame 32 can be considered to include a proximal portion 52, a distal portion 54, and a middle portion 56 disposed between the proximal portion 52 and the distal portion 54. In some cases, as shown, the LAAC device 50 includes a primary cover 58 extending at least over the proximal portion 52 of the expandable frame 32. The LAAC device 50 includes a secondary cover 60, which can cover portions of the expandable frame 32 that are not covered by the primary cover 58. The primary cover 58 and the secondary cover 60 are translucent, which is why the expandable frame 32 beneath the primary cover 58 and the secondary cover 60 can be seen. In some embodiments, as shown, the secondary cover 60 extends over the distal portion 54 of the expandable frame 32 and the middle portion 56 of the expandable frame 32. In some embodiments, the secondary cover 60 partially overlaps the primary cover 58. In some embodiments, the primary cover 58 partially overlaps the secondary cover 60, which facilitates being able to recapture the LAAC device 50 without affecting the edge of the secondary cover 60, as the edge is protected by the primary cover 58. The primary cover 58 and the secondary cover 60 can be considered examples of occlusive covers.

[0065] The LAAC device 50 includes a plurality of anchoring members 38. In some embodiments, the anchoring members 38 can be considered to be divided into a plurality of proximal anchoring members 38a disposed around a first periphery 62 of the expandable frame 32, the first periphery extending circumferentially all the way around the expandable frame 32, and a plurality of distal anchoring members 38b disposed around a second periphery 64 of the expandable frame 32, the second periphery extending circumferentially all the way around the expandable frame 32. The second periphery 64 can be considered to be axially spaced from the first periphery 62. For example, the relative distance between the first periphery 62 and the second periphery 64 can vary. It should be understood that the proximal anchoring members 38a are all disposed along the first periphery 62 and the distal anchoring members 38b are all disposed along the second periphery 64, even though only a few of the proximal anchoring members 38a and a few of the distal anchoring members 38b are labeled.

[0066] In some cases, the primary covering 58 can be fixed in place relative to the expandable frame 32 by the interaction between the primary covering 58 and at least some of the proximal anchoring members 38a. In some embodiments, the interaction between the primary covering 58 and at least some of the proximal anchoring members 38a can include the proximal anchoring members 38a extending through the primary covering 58. In some embodiments, the interaction between the primary covering 58 and at least some of the proximal anchoring members 38a can include the primary covering 58 being captured within the void 48, which is at least partially defined by the body portion 46 ( Figure 5 ). In some cases, the primary covering 58 can also interact with at least some of the distal anchoring members 38b, depending on the extent to which the primary covering 58 extends over the expandable frame 32. In some cases, the secondary covering 60 can be secured in place relative to the expandable frame 32 by interaction between the secondary covering 60 and at least some of the distal anchoring members 38b.

[0067] In some embodiments, the interaction between the secondary covering 60 and at least some of the distal anchoring members 38b can include the distal anchoring members 38b extending through the secondary covering 60. In some embodiments, the interaction between the secondary covering 60 and at least some of the distal anchoring members 38b can include the secondary covering 60 being captured within a void 48 that is at least partially defined by the body portion 46. In some embodiments, the secondary covering 60 can be folded up along its edges to increase its thickness, which can help seal against the LAA 10. In some cases, the secondary covering 60 can also interact with at least some of the proximal anchoring members 38a, depending on the extent to which the secondary covering 60 extends over the expandable frame 32. In some cases, the primary covering 58 and the secondary covering 60 can be fixed in place relative to the expandable frame 32 by means of interaction with the same anchoring member 38 (such as the proximal anchoring member 38a or the distal anchoring member 38b).

[0068] In some embodiments, the primary cover 58 can be fixed in place relative to the expandable frame 32 by sutures (not shown) extending between the primary cover 58 and the expandable frame 32. In some embodiments, the secondary cover 60 can be fixed in place relative to the expandable frame 32 by sutures (not shown) extending between the secondary cover 60 and the expandable frame 32. In some embodiments, the secondary cover 60 can be fixed in place relative to the expandable frame 32 by sutures (not shown) extending between the secondary cover 60 and the expandable frame 32. In some embodiments, the secondary cover 60 can be fixed in place relative to the expandable frame 32 by sutures (not shown) extending between the secondary cover 60 and the primary cover 58. In some embodiments, an adhesive can be used instead of sutures, or in addition to sutures. In some embodiments, the primary cover 58 can be fixed in place relative to the expandable frame 32 by interaction between the primary cover 58 and at least some of the anchoring members 38 and being sutured to the expandable frame 32. In some embodiments, the secondary cover 60 can be fixed in place relative to the expandable frame 32 by interaction between the secondary cover 60 and at least some of the anchoring members 38 and being sutured to the expandable frame 32 and / or being sutured to the primary cover 58. In some embodiments, an adhesive may be used instead of or in addition to sutures.

[0069] In some embodiments, the secondary covering 60 can be adapted to occupy relatively less space when the LAAC device 50 is disposed within a delivery device, such as, but not limited to, the medical device system 22. In some embodiments, the primary covering 58 can have one or more first characteristics, and the secondary covering 60 can have one or more second characteristics different from the one or more first characteristics. As an example, the primary covering 58 can have a first thickness, and the secondary covering 60 can have a second thickness that is less than the first thickness. As another example, the primary covering 58 can have a first density, and the secondary covering 60 can have a second density that is less than the first density. As another example, the primary covering 58 can be a knitted, woven, or braided fabric formed from a thread having a first diameter, and the secondary covering 60 can be a woven or braided fabric formed from a thread having a second diameter that is less than the first diameter.

[0070] In some embodiments, the primary cover 58 and the secondary cover 60 can each be formed of a knitted, woven or braided fabric available from Aran Biomedical. In some embodiments, the primary cover 58 can be a fabric with a denier rating of 15 to 20 or possibly 20 to 25, while the secondary cover 60 can be a fabric with a denier rating of 10 to 15. In some embodiments, the secondary cover 60 can be approximately 25 percent lighter than the primary cover 58. It should be understood that the denier rating of a fabric is a unit related to the weight and thickness of a single thread used in the fabric. A fabric with a higher denier rating will be thicker and heavier than the same fabric with a lower denier rating.

[0071] In some embodiments, the primary covering 58 may have a first knitting pattern, and the secondary covering 60 may have a second knitting pattern different from the first knitting pattern. The primary covering 58 may have a first hole size, while the secondary covering 60 may have a different hole size. For example, the secondary member 60 may be knitted into a honeycomb pattern. In some embodiments, the primary covering 58 and the secondary covering 60 may vary in one or more aspects of the knitting pattern, material, and post-knitting treatment to achieve the desired hole size and mechanical properties of the primary covering 58 and the secondary covering 60. In some embodiments, the primary covering 58 may have a first elasticity, while the secondary covering 60 may have a different elasticity. The primary covering 58 may have greater elasticity than the secondary covering 60. In some embodiments, the primary covering 58 may have reduced elasticity relative to the secondary covering 60.

[0072] Figure 7is a perspective view of an exemplary LAAC device 66. The exemplary LAAC device 66 includes an expandable frame 32. As previously described, the expandable frame 32 includes a proximal portion 52, a distal portion 54, and a middle portion 56. The LAAC device 66 includes a primary cover 68 that covers the proximal portion 52 and the middle portion 56. The primary cover 68 can also be considered to cover at least a portion of the distal portion 54. The LAAC device 66 also includes a secondary cover 70 that overlaps a portion of the primary cover 68 and is disposed on the proximal portion 52 of the expandable frame 32. In some embodiments, the secondary cover 70 can be wrapped differently or can have a different porosity relative to the primary cover 68. In some embodiments, the secondary cover 70 can be formed of a different type of material relative to the primary cover 68. In some embodiments, the primary cover 68 is on the outside and the secondary cover 70 is on the inside, so that only the edges of the secondary cover 70 can only be approached from the inside of the expandable frame 32.

[0073] Figure 8 and Fig. 9 is a view showing the assembly of an exemplary LAAC device 72. The exemplary LAAC device 72 includes an expandable frame 32. As previously described, the expandable frame 32 includes a proximal portion 52, a distal portion 54, and a middle portion 56. Figure 8 As shown, the LAAC device 72 includes a secondary cover 74 that is disposed on a portion of the distal portion 54 of the expandable frame 32 , but does not cover the entire distal portion 54 of the expandable frame 54 .

[0074] exist Fig. 9 , a primary covering 76 is added. The secondary covering 74 can be considered to be suitable for effectively expanding the sealing ability of the LAAC 72, particularly if the LAAC 72 is deployed in a position that is too proximal relative to the mouth 18 of the LAA 10. In some embodiments, the secondary covering 74 is fixed in place relative to the expandable frame 32 by interacting with at least some of the distal anchoring members 38b, and the primary covering 76 is fixed in place relative to the expandable frame 32 by interacting with at least some of the proximal anchoring members 38a. In some embodiments, the secondary covering 74 can be fixed relative to the expandable frame 32 by interacting with at least some of the distal anchoring members 38b and at least some of the proximal anchoring members 38a. In some embodiments, the primary covering 76 can be anchored to at least a portion of the secondary covering 74, thereby helping to anchor the secondary covering 74 in place.

[0075] In some embodiments, the secondary covering may aid in sealing by providing a gathered, rolled, or folded section of fabric that helps fill any gaps between the LAAC and the sidewalls 14 of the LAA 10 . Fig.10 is a schematic diagram of an exemplary LAAC device 78, which is shown disposed in an illustration of the LAA 10. The exemplary LAAC device 78 includes an expandable frame 80, which can be considered an example of the expandable frame 32. The LAAC device 78 includes a primary cover 82 covering at least a proximal portion of the expandable frame 80. The LAAC device 78 also includes a secondary cover 84, which is coiled into a coiled structure 86 by means of a rolling process, thereby providing a variety of thicknesses of the material. The rolling process is completed during the unfolding phase. Due to the coiled metal rope embedded in the fabric, once the secondary cover 84 is exposed from the medical device system 22, the fabric is coiled up. Alternatively, the fabric essentially has a coiled shape, but is flattened when loaded in the medical device system 22. As shown, the coiled structure 86 fills the space between the LAAC 78 and the side wall 14 of the LAA 10, thereby helping to seal the LAA 10.

[0076] In some embodiments, the secondary covering 84 can be made of a shape memory polymer. In some embodiments, the secondary covering 84 can include thin strips of shape memory material woven into the fabric of the secondary covering 84. The thin strips of shape memory material can be Nitinol, although other shape memory materials are also contemplated. In some embodiments, recapture helps straighten the secondary covering 84 to prevent bunching when the LAAC 78 is packaged into the medical device system 22 for subsequent delivery. In some embodiments, for example, when a nominal fabric is treated with a certain heat setting time and is manipulated to stretch the outer lip during assembly, a fabric "rolling back" phenomenon occurs.

[0077] In some embodiments, in addition to simply rolling up the secondary covering 84, the primary covering 82 can also be adapted to roll up. The distal edges of the primary covering 82 and the secondary covering 84 can include thin strips of shape memory material, such as nitinol woven into the primary covering 82 and the secondary covering 84. In some embodiments, both the primary covering 82 and the secondary covering 84 can include shape memory polymers, or can be treated to take advantage of the natural rewinding phenomenon. Because each fabric portion has alternating rolling points between each row of anchors 38, the rolling continues all the way around the LAAC78, thereby providing additional sealing all the way around the LAAC78. Repeatedly, recapture can straighten the distal fabric to avoid bunching in the medical device system 22.

[0078] Fig.11is a schematic diagram of an exemplary LAAC device 88, which is shown disposed in an illustration of the LAA 10. The exemplary LAAC device 88 includes an expandable frame 90, which can be considered an example of an expandable frame 32. The LAAC device 88 includes a primary covering 92 covering at least a proximal portion of the expandable frame 90. The LAAC device 88 also includes a secondary covering 94, which is adapted to return to a gathering structure 96, thereby providing a variety of thicknesses of material. As shown, the gathering structure 96 fills the space between the LAAC 88 and the sidewall 14 of the LAA 10, thereby helping to seal the LAA 10. For example, the secondary covering 94 can be formed of a shape memory polymer, or can include a thin nitinol rope shaped to be set to the gathering structure 96. The secondary covering 94 can be straightened when recaptured to avoid gathering in the medical device system 22. In some embodiments, the radiopaque material can be sewn or folded into the fabric to help identify key components of the LAAC 88 by X-ray during the implantation process.

[0079] The devices described herein and their various components can be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. In addition, the various structures can include materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material. These materials can include transparent or translucent materials to facilitate visualization during surgical procedures. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as etc.), nickel-molybdenum alloys (such as UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (such as UNS: R30003, such as etc.); platinum-rich stainless steel; combinations thereof, etc.; or any other suitable material.

[0080] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available, for example, from DuPont ), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer or available from ElfAtochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name obtained), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g. ), polysulfone, nylon, nylon-12, (e.g., available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or their mixtures, compositions, copolymers, polymer / metal composites, etc.

[0081] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed on or within the structure. The fabric material may be composed of a biocompatible material (such as a polymeric material or a biomaterial) suitable for promoting tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (such as polyethylene, polypropylene, polyester, polyurethane and / or mixtures or combinations thereof).

[0082] In some embodiments, the system disclosed herein and / or other elements may include textile materials and / or be formed by textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, molded, twisted, textured, pre-contracted or uncontracted. Biocompatible yarns suitable for synthesis of the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyl alcohol, polymethyl acetate, polyamide, naphthalene dicarboxyl derivatives, natural silk and polytetrafluoroethylene. In addition, at least one synthetic yarn may be a metal yarn or glass or ceramic yarn or fiber. Useful metal yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium alloys, such as stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium alloys. Yarn may further include carbon fibers, glass or ceramic fibers. Ideally, yarns are made of thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarns may be of the multifilament type, monofilament type or staple type.The type and denier of the selected yarn may be selected in a manner to form a biocompatible and implantable prosthesis (and more specifically, a vascular structure having desired properties).

[0083] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptide, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); antineoplastic agents / antiproliferative agents / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro- Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0084] It should be understood that the present disclosure is in many respects merely exemplary. Without exceeding the scope of the present disclosure, changes may be made in detail, particularly in the arrangement of shape, size, and steps. In appropriate scopes, this may include using any feature of an example embodiment in other embodiments. Of course, the scope of the present invention is defined in the language expressed in the appended claims.

Claims

1. An implantable medical device comprising: an expandable frame defining an outline of the implantable medical device, the expandable frame being movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame comprising a proximal portion, a distal portion, and an intervening intermediate portion; a primary covering extending over a proximal portion of the expandable frame; and A secondary cover extends over portions of the expandable frame not covered by the primary cover.

2. The implantable medical device according to claim 1, wherein: The secondary cover extends over a mid-portion of the expandable frame.

3. The implantable medical device according to any one of claims 1 or 2, wherein: The secondary covering extends over a distal portion of the expandable frame.

4. The implantable medical device according to any one of claims 1 to 3, wherein: The expandable frame includes a plurality of proximal anchors disposed about a first periphery of the expandable frame.

5. The implantable medical device according to claim 4, wherein: The expandable frame includes a plurality of distal anchors disposed about a second periphery of the expandable frame, the second periphery being axially displaced from the first periphery.

6. The implantable medical device according to claim 5, wherein: The primary covering is secured in place relative to the expandable frame by interaction between the primary covering and the plurality of proximal anchors.

7. The implantable medical device according to claim 5, wherein: The secondary covering is secured in place relative to the expandable frame by interaction between the secondary covering and the plurality of distal anchors.

8. The implantable medical device according to claim 1, wherein: The secondary covering is secured in place relative to the expandable frame by sutures extending between the secondary covering and the expandable frame and / or sutures extending between the primary covering and the secondary covering.

9. The implantable medical device according to any one of claims 1 to 8, wherein: The primary covering has one or more first characteristics, and the secondary covering has one or more second characteristics different from the one or more first characteristics.

10. A left atrial appendage occlusion (LAAC) device, comprising: an expandable frame defining an outline of the LAAC, the expandable frame being movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame comprising a proximal portion, a distal portion, and an intervening intermediate portion; The expandable frame includes a plurality of anchors extending around a periphery of the expandable frame; a primary covering extending over a proximal portion of the expandable frame and interacting with the plurality of anchors; and A secondary covering extends over a portion of the expandable frame.

11. The LAAC device according to claim 10, wherein: The primary covering has one or more first characteristics, and the secondary covering has one or more second characteristics different from the one or more first characteristics.

12. The LAAC device according to any one of claims 10 or 11, wherein: The secondary covering extends over the middle portion and / or the distal portion of the expandable frame.

13. The LAAC device of claim 12, wherein: The primary covering also extends over a middle portion of the middle frame; and The secondary covering extends over a proximal portion of the intermediate frame, covering a portion of the primary covering.

14. A left atrial appendage occlusion (LAAC) device, comprising: an expandable frame defining an outline of the LAAC, the expandable frame being movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame comprising a proximal portion, a distal portion, and an intervening intermediate portion; a proximal cover extending over a proximal portion of the expandable frame and an intermediate portion of the expandable frame; and A distal cover is fixed relative to the expandable frame proximal to the distal periphery of the proximal cover, the distal cover comprising sections of various thicknesses to enhance the seal between the LAAC device and tissue proximal to the LAAC device after deployment.

15. The LAAC device according to claim 14, wherein: The proximal cover further includes sections of various thicknesses to enhance the seal between the LAAC device and tissue proximate the LAAC device after deployment.

Images