Controlled shielding of shape memory polymers and foams

Abstract

An occlusive implant includes an expandable foam member in a compressed configuration and a biodegradable capsule disposed over the expandable foam member. The expandable foam member is made of a shape memory polymer and the biodegradable capsule holds the expandable foam member in the compressed configuration for a first period of time, after which the biodegradable capsule degrades to allow the expandable foam member to expand to an expanded configuration.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Applications No. 63 / 612,493, filed December 20, 2023; No. 63 / 612,507, filed December 20, 2023; No. 63 / 612,569, filed December 20, 2023; No. 63 / 612,582, filed December 20, 2023; No. 63 / 561,406, filed March 5, 2024; No. 63 / 561,415, filed March 5, 2024; No. 63 / 560,160, filed March 1, 2024; and No. 63 / 560,174, filed March 1, 2024, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to medical devices, and more specifically to medical devices suitable for use in percutaneous medical procedures in which an expandable shape memory material is inserted into the human body. Background Technology

[0004] A wide variety of medical devices have been developed for medical purposes, including, for example, devices for sealing off areas of the body. These devices can be used in various areas of the body, including aneurysms in blood vessels and the left atrial appendage (LAA). In patients with atrial fibrillation, the LAA may not contract or empty properly, causing stagnant blood to pool inside, which can lead to unwanted thrombus formation within the left atrial appendage.

[0005] Blood clots that form in the atrial fibrillation area (LAA) can detach from the area and enter the bloodstream. These clots can migrate through blood vessels and eventually block smaller downstream vessels, leading to a stroke or heart attack. Clinical studies have shown that a large proportion of blood clots in patients with atrial fibrillation originate in the LAA. As a treatment option, medical devices have been developed to deploy and close the LAA. Each of the known medical devices and methods has its own advantages and disadvantages. There has always been a need for alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention

[0006] This disclosure provides designs, materials, manufacturing methods, and alternatives for use in medical devices. An exemplary occlusive implant includes: an expandable foam member in a compressed configuration, the expandable foam member being made of a shape memory polymer; and a biodegradable capsule disposed on the expandable foam member, the biodegradable capsule holding the expandable foam member in a compressed configuration for a first time period, thereafter the biodegradable capsule degrades to allow the expandable foam member to expand into an expanded configuration.

[0007] As an alternative to or supplement to the above embodiments, biodegradable capsules cover the entire outer surface of the expandable foam component.

[0008] As an alternative to or supplement to any of the above embodiments, the biodegradable capsule includes at least one pore extending through the wall of the biodegradable capsule.

[0009] As an alternative or supplement to any of the above embodiments, when in a compressed configuration, the expandable foam member and the biodegradable capsule are elongated, having a first end and an opposing second end, wherein the biodegradable capsule covers all portions of the expandable foam member except for the second end.

[0010] As an alternative or supplement to any of the above embodiments, when in a compressed configuration, the expandable foam member and the biodegradable capsule are elongated, having a first end and an opposing second end, wherein the biodegradable capsule includes a plurality of spaced-apart pores disposed adjacent to the first end.

[0011] As an alternative to or supplement to any of the above embodiments, the first time period is a preset time period.

[0012] As an alternative or supplement to any of the above embodiments, the preset time period is 30 seconds to 4 minutes.

[0013] As an alternative or supplement to any of the above embodiments, when in a compressed configuration, the expandable foam member is elongated, having a first end and an opposing second end, the expandable foam member having a first dimension extending between the first end and the opposing second end and a second dimension transverse to the first dimension, the first dimension being longer than the second dimension, wherein when the expandable foam member is in an expanded configuration, the first dimension is shorter than the second dimension.

[0014] As an alternative to or supplement to any of the above embodiments, when in an expanded configuration, the first dimension is between 3-15 mm and the second dimension is between 20-35 mm.

[0015] As an alternative to or supplement to any of the above embodiments, the biodegradable capsule is made of one or more materials selected from the group consisting of: polyethylene glycol, polyvinyl alcohol, polyurethane, polylactic acid, poly(lactide-co-glycolic acid), poly(ε-caprolactone), sugar derivatives, salts, high specific surface area electrospun materials, and hydrogels.

[0016] As an alternative to or supplement to any of the above embodiments, the biodegradable capsules are made of a copolymer of hydrophobic and hydrophilic components.

[0017] As an alternative to or supplement to any of the above embodiments, the copolymer includes polyethylene glycol and polylactic acid.

[0018] As an alternative to or supplement to any of the above embodiments, the biodegradable capsule includes a first segment and a second segment sealed to the first segment.

[0019] As an alternative to or supplement to any of the above embodiments, the occlusive implant further includes an expandable frame configured to switch between a collapsed configuration and an expanded configuration, the expandable frame defining an interior in which an expandable foam member is disposed.

[0020] As an alternative to or supplement to any of the above embodiments, when the expandable frame is in an expanded configuration and the biodegradable capsule has degraded, the expandable foam component expands to fill at least the entire proximal region of the expandable frame.

[0021] As an alternative to or supplement to any of the above embodiments, the occlusive implant further includes an occlusive covering disposed on the proximal end region of the expandable frame.

[0022] Another exemplary occlusive implant includes: an expandable foam member in a compression configuration, the expandable foam member being made of a shape memory polymer that expands upon exposure to water, elevated temperature, pH changes, or electrical stimulation; and a biodegradable capsule disposed on the expandable foam member, the biodegradable capsule holding the expandable foam member in a compression configuration for a first time period thereafter, the biodegradable capsule degrading to allow the expandable foam member to expand into an expanded configuration, wherein, when in the compression configuration, the expandable foam member is elongated, having a first end and an opposing second end, the expandable foam member having a first dimension extending between the first end and the opposing second end and a second dimension transverse to the first dimension, the first dimension being longer than the second dimension, wherein, when the expandable foam member is in an expanded configuration, the first dimension is shorter than the second dimension.

[0023] As an alternative or supplement to the above embodiments, the occlusive implant further includes an expandable frame configured to switch between a collapsed configuration and an expanded configuration, the expandable frame defining an interior in which an expandable foam member is disposed.

[0024] As an alternative to or supplement to any of the above embodiments, when the expandable frame is in an expanded configuration and the biodegradable capsule has degraded, the expandable foam component expands to fill at least the entire proximal region of the expandable frame.

[0025] An exemplary method for occluding a body cavity includes the following steps: inserting an expandable foam member in a compressed configuration into a self-expanding frame, the expandable foam member being made of a shape memory polymer and encapsulated by a biodegradable capsule that holds the expandable foam member in the compressed configuration, the self-expanding frame being configured to switch between a collapsed configuration and an expanded configuration; compressing the self-expanding frame to a collapsed configuration (where the expandable foam is located internally); delivering the self-expanding frame into the body cavity, causing the self-expanding frame to expand; and degrading the biodegradable capsule in the presence of moisture and / or heat in the body cavity, thereby causing the expandable foam member to expand, wherein the expandable foam member expands to fill at least a proximal region of the expanded self-expanding frame.

[0026] The above overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of this disclosure. These embodiments are illustrated in more detail in the following accompanying drawings and detailed description.

[0027] Brief description of the attached figures

[0028] This disclosure will be more fully understood in light of the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which:

[0029] Figures 1-2 This is a side view showing selected aspects of an occlusive implant system for occluding the left atrial appendage;

[0030] Figures 3-4 The selection of occlusive implants for occlusion of the left atrial appendage is shown;

[0031] Figure 5A and Figure 5B These are cross-sectional views of exemplary occlusive implants in compression and expansion configurations, respectively.

[0032] Figure 6A and Figure 6B This is another example of an occlusive implant in both a compression configuration and a partially expanded configuration, in cross-sectional views.

[0033] Figure 7AThis is a side view of another example of an occlusive implant;

[0034] Figure 7B and Figure 7C yes Figure 7A Cross-sectional views of the occlusive implant taken along line 7B-7B in both the compression and partial expansion configurations;

[0035] Figure 8 This is a cross-sectional view of another exemplary occlusive implant;

[0036] Figure 9A This is a side cross-sectional view of another exemplary occlusive implant in a delivery sheath; and

[0037] Figure 9B yes Figure 9B The occlusive implant is shown in a side cross-sectional view in an unfolded, expanded configuration.

[0038] While various modifications and alternatives may be made to aspects of this disclosure, details have been illustrated by example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit aspects of this disclosure to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[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 indicate the same elements in several views. The detailed description and drawings are intended to illustrate the present disclosure and not to limit it. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure.

[0040] The following definitions shall apply to the terms, unless otherwise defined in the claims or elsewhere in this specification.

[0041] All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly indicated or not. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their common and conventional definitions, as understood and consistent with the context of the specification.

[0042] The representation of a numerical range by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values ​​associated with various components, features, and / or specifications are disclosed, those skilled in the art will understand, inspired by this disclosure, that desired dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0043] As used in this specification and the appended claims, the singular forms “a (an)” and “the” include plural referents unless the content expressly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless the content expressly indicates otherwise. It should be noted that, for ease of understanding, certain features of this disclosure can be described in the singular, even if such features may be plural or repeated within the disclosed embodiments. Each instance of a feature may include and / or be covered by a single disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of this disclosure need to be shown in every drawing or discussed in detail below. However, it should be understood that the following discussion can be equally applied to any and / or all components that exist in more than one form, unless expressly stated to the contrary. Furthermore, for clarity, not all instances of some elements or features can be shown in every drawing.

[0044] For example, relative terms such as “proximal,” “distal,” “advance,” “retract,” and their variations are generally considered in relation to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device. “Proximal” and “retract” indicate or refer to being closer to or towards the user, while “distal” and “advance” indicate or refer to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily designated to facilitate understanding of this disclosure, and such cases will be clear to those skilled in the art. Other relative terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a lumen (e.g., body cavity, blood vessel) or within the device.

[0045] The term "range" can be understood as referring to the maximum measurement of the stated or identified dimension, unless the range or dimension in question is preceded by "minimum" or is identified as "minimum," in which case "minimum" can be understood as referring to the minimum measurement of the stated or identified dimension. For example, "outer range" can be understood as referring to the maximum outer dimension, "radial range" can be understood as referring to the maximum radial dimension, "longitudinal range" can be understood as referring to the maximum longitudinal dimension, and so on. Each instance of "range" can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.), and will become clear to those skilled in the art from the context of its individual use. Generally, "range" can be considered as the maximum possible dimension measured according to its intended use, while "minimum range" can be considered as the minimum possible dimension measured according to its intended use. In some cases, "range" can typically be measured orthogonally within a plane and / or cross-section, but it will be clear 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. Additionally, the term "substantially" when used to refer to two sizes being "substantially the same" should generally refer to a difference of less than or equal to 5%.

[0046] The terms "integral" and "single" should generally refer to one or more elements made or constituted by a single structural or basic unit / element. Integral and / or single elements should exclude structures and / or features made by assembling or otherwise connecting multiple discrete elements together.

[0047] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, that specific feature, structure, or characteristic is within the knowledge of those skilled in the art to be implemented in conjunction with other embodiments, whether explicitly described or not, unless otherwise expressly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0048] For clarity, certain identifying numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designations are not intended to be limiting, but are merely exemplary. In some embodiments, for the sake of brevity and clarity, previously used numerical designations may be modified and deviated from. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or name in each case will be clear to a skilled practitioner.

[0049] Figures 1-2 Selected components and / or arrangements of a prior art occlusive implant system 10 for occluding the left atrial appendage are shown. It should be noted that, for simplicity, some features of the occlusive implant system 10 may not be shown, or may be shown schematically. Additional details regarding some components of the occlusive implant system 10 can be shown in more detail in other figures. The occlusive implant system 10 can be used for the percutaneous delivery and / or deployment of various medical implants (e.g., cardiovascular implants, occlusive implants, replacement heart valve implants, etc.) to one or more locations within anatomical structures (including, in some embodiments, the heart).

[0050] The occlusive implant system 10 may include a core wire 30. The occlusive implant system 10 may include an occlusive implant 20 releasably coupled to and / or disposed at the distal end 32 of the core wire 30. In at least some embodiments, the occlusive implant 20 may be configured to occlude the left atrial appendage. The left atrial appendage is attached to and in fluid communication with the left atrium of a patient's heart. The left atrial appendage may have a complex geometry and / or an irregular surface area.

[0051] In some embodiments, the occlusive implant system 10 may include a delivery sheath 40 having a lumen 42 extending from a proximal opening to a distal opening (e.g., Figure 2In some embodiments, the core wire 30 may be slidably disposed within the lumen 42 of the delivery sheath 40. The core wire 30 may have a proximal end 34 disposed proximal to the delivery sheath 40. In some embodiments, the proximal end 34 of the core wire 30 may include a knob and / or handle configured to manipulate and / or move the core wire 30 and / or the occlusive implant 20. In some embodiments, the proximal end 34 of the core wire 30 may include a knob and / or handle configured to manipulate and / or move the core wire 30 and / or the occlusive implant 20 relative to the delivery sheath 40. In some embodiments, the delivery sheath 40 may be sized and configured to deliver the occlusive implant 20 to the left atrial appendage.

[0052] The occlusive implant 20 may include an expandable frame 22 (e.g., Figures 3-4 The extensible framework is configured to operate in a collapsed configuration (e.g., Figure 2 ) and expanded configuration (e.g., Figure 1 The occlusive implant 20 can be configured to switch between a collapsed configuration and an expanded configuration when the occlusive implant 20 is disposed within the lumen 42 near the distal opening, in some embodiments. In some embodiments, the delivery sheath 40 can constrain the occlusive implant 20 and / or the expandable frame 22 in the collapsed configuration. In some embodiments, the occlusive implant 20 and / or the expandable frame 22 can be configured to switch between a collapsed configuration and an expanded configuration when the occlusive implant 20 is disposed distal to the distal opening of the delivery sheath 40 and / or the lumen 42, and / or when the occlusive implant 20 is unconstrained. In some embodiments, the occlusive implant 20 and / or the expandable frame 22 can be configured to switch between a collapsed configuration and an expanded configuration when the occlusive implant 20 is unconstrained by the delivery sheath 40. In at least some embodiments, the expandable frame 22 can be self-biased toward the expanded configuration.

[0053] In some embodiments, the core wire 30 may be slidably and / or rotatably disposed within the lumen 42 of the delivery sheath 40. In some embodiments, the proximal end 34 of the core wire 30 may extend proximally to the proximal end of the delivery sheath 40 and / or the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the occlusive implant 20 may be removably attached, coupled, secured, or otherwise connected to the distal end 32 of the core wire 30. The core wire 30 may be configured and / or may be capable of axially translating the occlusive implant 20 relative to the delivery sheath 40. The delivery sheath 40 and / or the core wire 30 may have a selected level of axial stiffness and / or maneuverability, while also having a selected level of flexibility to allow guidance through the patient's vascular system.

[0054] Suitable, but non-limiting, examples of materials for occlusive implant systems 10, core wires 30, delivery sheaths 40, and / or occlusive implants 20 are discussed below.

[0055] Figure 3 and Figure 4 Selected components and / or arrangements of a prior art occlusive implant 20 for occluding the left atrial appendage are shown. The occlusive implant 20 may include an expandable frame 22 configured along a longitudinal axis 21 (e.g., Figure 4 The expandable frame 22 can switch between a collapsed configuration and an expanded configuration. In the collapsed configuration, the expandable frame 22 can be axially elongated and / or radially compressed. In the expanded configuration, the expandable frame 22 can be axially shortened and / or radially expanded. The expandable frame 22 may include a plurality of interconnecting struts defining a plurality of mesh openings. In some embodiments, the plurality of mesh openings may be a plurality of closed mesh openings. In some embodiments, the plurality of mesh openings may be a plurality of open mesh openings and a plurality of closed mesh openings in various combinations and / or arrangements. In some embodiments, the plurality of interconnecting struts may converge, connect, and / or link at intersections or nodes.

[0056] Multiple interconnect pillars may be formed and / or cut from tubular members. In some embodiments, multiple interconnect pillars may be integrally formed and / or cut from a single member. In some embodiments, multiple interconnect pillars may be integrally formed and / or cut from a single tubular member, and subsequently formed and / or heat-set into a desired shape in an unfolded configuration. In some embodiments, multiple interconnect pillars may be integrally formed and / or cut from a single flat member or sheet, and then rolled or formed into a tubular structure, and subsequently formed and / or heat-set into a desired shape in an unfolded configuration. Some exemplary means and / or methods for manufacturing and / or forming multiple interconnect pillars include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical etching, etc. Other means and / or methods are also contemplated.

[0057] In some embodiments, the expandable frame 22 may be compliant and substantially conform to and / or seal the shape and / or geometry of the wall of the left atrial appendage in an expanded configuration. In some embodiments, the occlusive implant 20 may expand to a size, extent, or shape smaller than or different from a maximum unconstrained extent determined by the surrounding tissue and / or wall of the left atrial appendage. In some embodiments, reducing the thickness of the individual elements of the expandable frame 22 may increase the flexibility and compliance of the expandable frame 22 and / or the occlusive implant 20, thereby allowing the expandable frame 22 and / or the occlusive implant 20 to conform to the surrounding tissue, rather than forcing the tissue to conform to the expandable frame 22 and / or the occlusive implant 20. In some embodiments, the expandable frame 22 and / or the occlusive implant 20 may be more rigid and / or less compliant, so that the expandable frame 22 and / or the occlusive implant 20 may force the tissue of the left atrial appendage to conform to the expandable frame 22 and / or the occlusive implant 20 in an expanded configuration. Other configurations are also contemplated.

[0058] In some embodiments, the occlusive implant 20 and / or expandable frame 22 may include a plurality of anchoring elements 25. In some embodiments, the plurality of anchoring elements 25 may extend radially outward from the expandable frame 22 in an deployed configuration. In at least some embodiments, the plurality of anchoring elements 25 may be configured to engage with tissue and / or may be configured to secure the occlusive implant 20 and / or expandable frame 22 to tissue at a target site (e.g., left atrial appendage, etc.). In some embodiments, the plurality of anchoring elements 25 may be configured to prevent displacement and / or dislodgement of the occlusive implant 20 from the target site.

[0059] In some embodiments, the occlusive implant 20 and / or expandable frame 22 may include a proximal hub 24 and / or a distal hub 26. A longitudinal axis 21 of the expandable frame 22 may extend from the proximal hub 24 to the distal hub 26. In at least some embodiments, the proximal hub 24 and / or distal hub 26 may be centered on and / or coaxial with the longitudinal axis 21. Multiple interconnecting struts may be joined together and / or securely attached to the proximal hub 24 and / or the distal hub 26. In some embodiments, the proximal hub 24 and / or distal hub 26 may be securely attached to the expandable frame 22 and / or the multiple interconnecting struts, for example, by welding, adhesive bonding, brazing, soldering, etc. The proximal hub 24 may be configured to releasably connect, couple, and / or attach the occlusive implant 20 and / or expandable frame 22 to the distal end 32 of the core wire 30 (e.g., Figures 1-2In some embodiments, the proximal hub 24 may include an internal thread configured to rotatably and / or threadedly engage an external thread formed on the distal end 32 of the core wire 30 and / or at the distal end of the core wire. Other configurations for releasably securing the occlusive implant 20 to the core wire 30 are also contemplated.

[0060] In some embodiments, the occlusive implant 20 may optionally include an occlusive cover 28 that is connected to, disposed on, disposed over, surrounding, and / or configured to extend radially outward from a proximal portion of a plurality of interconnecting struts and / or expandable frame 22. In some embodiments, the occlusive cover 28 may be attached to a proximal hub 24 and / or may be attached at the proximal hub 24 to the expandable frame. In some embodiments, the occlusive cover 28 may extend radially outward from the proximal hub 24 and / or may extend distally from the proximal hub. In some embodiments, the occlusive cover 28 may be attached and / or secured to the expandable frame 22 at a plurality of discrete locations. In some embodiments, one or more of a plurality of anchoring elements 25 may extend through the occlusive cover 28. In some embodiments, one or more of the plurality of anchoring elements 25 extending through the occlusive cover 28 may attach and / or secure the occlusive cover 28 to the expandable frame 22.

[0061] In some embodiments, the occlusive covering 28 may include a membrane, fabric, mesh, tissue element, or other suitable construction. In some embodiments, the occlusive covering 28 may be porous. In some embodiments, the occlusive covering 28 may be non-porous. In some embodiments, the occlusive covering 28 may be permeable or impermeable to blood and / or other fluids (such as water). In some embodiments, the occlusive covering 28 may be designed, sized, and / or configured to prevent thrombus and / or embolic material from flowing from the left atrial appendage into the left atrium and / or the patient's bloodstream. In some embodiments, the occlusive covering 28 (e.g., a membrane, fabric, or tissue element, etc.) promotes post-implantation endothelialization, thereby effectively and / or permanently removing the target site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive covering 28 are discussed below.

[0062] Figure 5A and Figure 5BThis is a cross-sectional view of an occlusive implant 100 for use in occluding body cavities (such as aneurysms or laminar aneurysms) according to the present disclosure. The occlusive implant 100 may contain an expandable foam member 110 in a compressed configuration within a layer 120 of bioabsorbable or biodegradable material, which temporarily restrains or holds the expandable foam member in a compressed configuration for a first time period, thereafter the biodegradable capsule degrades to allow the expandable foam member to expand into an expanded configuration. In some embodiments, the expandable foam member 110 may be made of a shape memory polymer that can change from a compressed shape to a preset expanded shape in response to stimulation in the form of moisture, heat, pH changes, or electrical current. The biodegradable material may be in the form of a biodegradable capsule 120 that protects the expandable foam member 110 from stimulation until the expandable foam member is ready to expand within an anatomical structure. The biodegradable capsule 120 may cover the entire outer surface of the expandable foam member 110. The biodegradable capsule 120 allows the expandable foam component 110 to be loaded into a delivery device, sterilized, and delivered to the desired anatomical location before full expansion. The biodegradable capsule 120 may begin to degrade during the implantation process, such as during exposure to water or other fluids while being loaded into the delivery catheter before delivery, during delivery through the body, and during exposure to blood while implanted in the body. The biodegradable capsule 120 completes its degradation after implantation in the body. A first time period (in which the biodegradable material 120 temporarily restrains or holds the expandable foam component in a compressed configuration) may be a preset time period, and the thickness and composition of the biodegradable capsule 120 may be designed to achieve a desired level of degradation after the preset first time period. The desired level of degradation may be partial or complete. The first time period may be from 30 seconds to 5 hours. In some embodiments, the time period may be less than 5 minutes, for example, from 30 seconds to 4 minutes. In some embodiments, the thickness of the biodegradable capsule 120 may be between 0.02 mm and 2 mm, for example, from 0.025 mm to 1 mm. These thick biodegradable capsules 120 can be made of polyethylene glycol (PEG), gelatin, cellulose, starch, or combinations thereof.

[0063] In some embodiments, when in a compressed configuration, the expandable foam member 110 is elongated, having a first end 112, an opposing second end 114, a first dimension D1 extending between the first end 112 and the opposing second end 114, and a second dimension D2 transverse to the first dimension D1, as shown below. Figure 5AAs shown. The first dimension D1 and the second dimension D2 are taken only from the expandable foam component 110, excluding the biodegradable capsule 120. The first dimension D1 may be longer than the second dimension D2. In some examples, when the biodegradable capsule 120 has completely degraded and the expandable foam component 110 is in a fully expanded configuration, the first dimension D1 may be shorter than the second dimension D2, such as... Figure 5B As shown. When in compressed configuration ( Figure 5A When in an expanded configuration, the first dimension D1 can be between 5mm and 40mm, and the second dimension D2 can be between 1mm and 10mm. Figure 5B When the implant 100 is moved from a compression configuration to an expansion configuration, the first size D1 can be between 0.5 mm and 15 mm, and the second size D2 can be between 15 mm and 35 mm, resulting in a shrinkage ratio of at least 10 times (e.g., at least 10:1). The shrinkage ratio can be achieved using a variety of different sizes. For example, a 10:1 ratio can occur only in one direction, where only D2 expands while D1 remains unchanged as the implant 100 moves from a compression configuration to an expansion configuration. In other examples, one of D1 or D2 may shrink while the other expands as the implant moves from a compression configuration to an expansion configuration. In other embodiments, such as when the implant 100 needs to be inserted into and substantially fill the LAA when in an expansion configuration, D1 in the expansion configuration can be up to 75 mm, and D2 can be up to 60 mm. These sizes can also be achieved using multiple separate implants 100. In addition to… Figure 5A and Figure 5B In addition to the basically stadium-shaped implant 100 shown, the implant 100 may be elliptical, circular, polygonal, or have an uneven shape (such as a star) or uneven protrusions or leaflets.

[0064] Other configurations are also conceivable, including configurations in which the first size D1 and the second size D2 are substantially the same in either or both of the compression and expansion configurations, such that the ratio of D1 to D2 remains substantially the same in both configurations. In some embodiments, instead of a single monolithic implant 100, multiple separate occlusive implants 100 may be used to fill the desired space. It should be understood that the dimensions described in conjunction with the above figures are merely illustrative, and other device dimensions are conceivable. As will be discussed below, this embodiment may be particularly suitable for delivery and implantation in the LAA via a sheath delivery and for occluding the left atrial appendage.

[0065] In another embodiment of the occlusive implant 200, the biodegradable capsule 220 may include at least one aperture 226 extending through a wall 228 defining the biodegradable capsule 220. The aperture 226 extends fully through the wall 228, exposing the expandable foam member 210 to the environment outside the biodegradable capsule 220. One or more apertures 226 may be strategically placed to leave certain areas of the expandable foam member 210 unprotected to facilitate expansion at specific locations or to initiate shape changes prematurely, but to prevent full expansion for a period of time.

[0066] exist Figure 6A and Figure 6B In the illustrated embodiment, when in a compressed configuration, the expandable foam member 210 and the biodegradable capsule 220 are elongated, and the biodegradable capsule 220 has a first end 222 and an opposing second end 224, with a single aperture 226 located at the second end 224. Therefore, the biodegradable capsule 220 covers all of the expandable foam member 210 except for the second end 214, leaving the second end 214 without the biodegradable capsule 220. When the occlusive implant 200 is delivered into the human body, the expandable foam member 210 begins to expand out of the aperture 226 of the biodegradable capsule 220, as... Figure 6B As shown. In this embodiment, the expandable foam member 210 expands at least partially before any degradation of the biodegradable capsule 220 occurs. When an occlusive implant 200 with a single opening 226 is used in a LAA occlusion device, the single opening 226 can be located at the distal end, so the expandable foam member 210 begins to expand distally and radially, which can help secure the occlusive implant 200 to the proximal region of the LAA occlusion device.

[0067] In other embodiments, the occlusive implant 300 may have multiple pores extending through the biodegradable capsule 320. For example... Figure 7A As shown, the biodegradable capsule 320 may have a plurality of spaced-apart holes 326. The holes 326 may be uniformly arranged along the entire length of the occlusive implant (not shown), or the holes 326 may be arranged adjacent to one end. Figure 7A In the illustrated embodiment, the holes 326 are circumferentially spaced and adjacent to one end of the occlusive implant 300. Figure 7B As shown in the cross-sectional view, multiple pores 326 extend completely through the wall 328 that defines the biodegradable capsule 320. Figure 7CThe illustration shows an occlusive implant 300 immediately after delivery into the human body, with an area of ​​expandable foam member 310 expanding out through multiple orifices 326. Areas of the expandable foam exiting the orifices 326 may form bumps or protrusions that help secure the occlusive implant in place as the biodegradable capsule 320 degrades.

[0068] Figure 8 An embodiment of an occlusive implant 400 is shown, wherein an expandable foam member 410 is encapsulated by a biodegradable capsule 420, the biodegradable capsule including a first segment 421 and a second segment 423 secured to the first segment 421 at a connection 425. The connection 425 may include a heat seal or weld, or may include an adhesive. The first segment 421 and the second segment 423 may be individually assembled onto the expandable foam member 410, and the segments may subsequently be connected. The first segment 421 and the second segment 423 may be made of the same biodegradable material, or the segments may be made of different biodegradable materials. In some embodiments, the first segment 421 and the second segment 423 may have different degradation rates. For example, the second segment 423 may partially or completely degrade before the first segment 421 begins to degrade.

[0069] In any of the above embodiments, expandable foam components 110, 210, 310, and 410 may be formed individually and subsequently inserted into biodegradable capsules 120, 220, 320, and 420, which may then be sealed or crimped. In other embodiments, biodegradable capsules 120, 220, 320, and 420 may be sprayed onto expandable foam components 110, 210, 310, and 410, with any pores masked during the spraying process.

[0070] Biodegradable capsules 120, 220, 320, and 430 can be made from one or more known biodegradable or bioabsorbable materials. For example, biodegradable capsules 120, 220, 320, and 430 can be made from one or more of polyethylene glycol (PEG), polyvinyl alcohol (PVA), polyurethane, polylactic acid (PLA), poly(lactide-co-glycolic acid) (PLGA), poly(ε-caprolactone) (PCL), sugar derivatives (such as mannitol), salts, high specific surface area electrospun materials, and hydrogels. Biodegradable capsules 120, 220, 320, and 430 can also be made from copolymers of hydrophobic and hydrophilic components. For example, a copolymer of polyethylene glycol and polylactic acid can be used.

[0071] The occlusive implant 100 can be formed by compressing an expandable foam component 110 and subjecting it to electron beam sterilization, followed by encapsulating the expandable foam component 110 in a sterile environment with a biodegradable capsule 120. Options for the polymer coating and thickness used for the biodegradable capsule 120 can be selected to minimize ethylene oxide permeation into the capsule 120. The expandable foam component 110, coated with the biodegradable capsule 120, can then be placed into a delivery system or integrated with an expandable frame or other device. Ethylene oxide can be routinely used to sterilize the fully assembled product while minimizing variations in the underlying shape memory polymer of the expandable foam component 110.

[0072] Additionally, options for the polymer coating and thickness used for the biodegradable capsule 120 can be selected to control polymer degradation, ensuring that the expandable foam component 110 does not begin to expand within a controlled time period. Once the expandable foam component 110 with the biodegradable capsule 120 disposed thereon is placed in a delivery system or integrated with an expandable frame or other device, it can be rinsed or injected with brine or fluorinated dyes around the device within a specified time limit without directly affecting the shape memory polymer expansion.

[0073] Figure 9A and Figure 9B Another embodiment is shown, wherein the implant 500 further includes an expandable frame 522, which is configured to be in a collapsed configuration ( Figure 9A ) and extended configuration ( Figure 9B The expandable frame 522 defines an interior 521 into which a compressed occlusive implant 100 (including an expandable foam member 110 covered with a biodegradable capsule 120) is disposed. The expandable frame 522 can collapse over the compressed occlusive implant 100 for delivery. The expandable frame 522 has a proximal hub 524 and a distal hub 526, is self-expanding, is made of shape memory material, and can be delivered using a core wire 30 via a delivery sheath 40, as described above regarding... Figures 1-2 As shown in the occlusive implant system 10. The proximal hub 524 can be removably coupled to the distal end of the core wire 30. When the expandable frame 522 has been deployed in the body and is in an expanded configuration, the biodegradable capsule 120 begins to degrade. When the biodegradable capsule 120 has completely degraded, the expandable foam member 110 fully expands to fill at least the entire proximal region of the expandable frame 522, as... Figure 9B As shown. In some embodiments, the implant 500 further includes an occlusive covering 528 disposed on the proximal end region of the expandable frame 522. Figure 9A and Figure 9BThe shape of the expandable foam component 110 is shown from Figure 9A Compression configuration in Figure 9B The fully expandable configuration changes. The expandable foam member 110 may have a first end 112, a second end 114, and as described above regarding Figure 5A and Figure 5B The illustrated embodiments describe similar dimensions D1 and D2.

[0074] In some embodiments, in the expanded configuration, the expandable foam member 110 may be configured to fill at least 40% of the interior 521 of the expanded frame 522 in the unfolded configuration. In other embodiments, in the expanded configuration, the expandable foam member 110 may be configured to fill at least 80% of the interior 521 of the expanded frame 522 in the unfolded configuration. In some embodiments, in the expanded configuration, the expandable foam member 110 may be configured to fill at least 85% of the interior 521 of the expanded frame 522 in the unfolded configuration. In some embodiments, in the expanded configuration, the expandable foam member 110 may be configured to fill at least 90% of the interior 521 of the expanded frame 522 in the unfolded configuration. In some embodiments, in the expanded configuration, the expandable foam member 110 may be configured to fill at least 95% of the interior 521 of the expanded frame 522 in the unfolded configuration.

[0075] In some embodiments, the expandable foam member 110 may be configured to be permanently retained within the interior 521 of the expandable frame 422 (e.g., the expandable foam member 110 is never removed from the interior 521 of the expandable frame 422 by a worker). In some embodiments, the expandable foam member 110 may be configured to be biodegradable over time. In some embodiments, the expandable foam member 110 may be configured to be biodegradable for at least 30 days. In some embodiments, the expandable foam member 110 may be configured to be biodegradable for at least 60 days. In some embodiments, the expandable foam member 110 may be configured to be biodegradable for at least 90 days. In some embodiments, the expandable foam member 110 may be configured to be biodegradable for at least 180 days. In some embodiments, the expandable foam member 110 may be configured to be biodegradable for at least 365 days. Other configurations are also contemplated.

[0076] In some embodiments, the expandable foam member 110 may be configured to prevent thrombus formation (e.g., within the left atrial appendage). In some embodiments, the expandable foam member 110 may include an antithrombotic drug. In some embodiments, the expandable foam member 110 may be configured to absorb blood and / or body fluids. In some embodiments, the expandable foam member 110 may be configured to capture thrombi. In some embodiments, the expandable foam member 110 may be configured to promote tissue inward growth and / or endothelialization. Other configurations are also contemplated.

[0077] In at least some embodiments, the expandable foam component 110 may include a shape memory polymer and / or shape memory foam and / or may be formed from a shape memory polymer and / or shape memory foam. In at least some embodiments, the expandable foam component 110 may be configured as an open-cell foam. When exposed to temperature, humidity, and / or chemical environments and / or variations thereof, the shape memory polymer and / or shape memory foam may have a variety of geometries and / or mechanical properties. In some embodiments, the shape memory polymer and / or shape memory foam may have a high shrinkage rate. The shrinkage rate is the ratio between the expanded size and the collapsed size. In some examples, the shrinkage rate of the shape memory polymer and / or shape memory foam may be at least 5 times, at least 7 times, at least 8 times, at least 9 times, at least 10 times, at least 12 times, or more.

[0078] A method for occluding a body cavity using an occlusive implant 100 and an expandable frame 522 may include the following steps: inserting an expandable foam member 110 in a compressed configuration into the self-expanding frame 522, wherein the expandable foam member 110 is made of a shape memory polymer and is encapsulated by a biodegradable capsule 120. The biodegradable capsule 120 holds the expandable foam member 110 in a compressed configuration, and the self-expanding frame 522 is configured to switch between a deflated configuration and an expanded configuration. The method further includes the step of compressing the self-expanding frame 522 into a deflated configuration, wherein the expandable foam member 110 is located internally. After compressing the self-expanding frame 522 around the expandable foam member 100, the method includes the steps of: delivering the self-expanding frame 522 into a body cavity, causing the self-expanding frame 522 to expand, and degrading the biodegradable capsule 120 in the presence of moisture and / or heat in the body cavity, thereby causing the expandable foam member 110 to expand, wherein the expandable foam member 110 expands to fill at least a proximal region of the expanded self-expanding frame 552. In some embodiments, the body cavity is a laminar flow area (LAA).

[0079] The materials that can be used in the various components (and / or other elements disclosed herein) of the systems disclosed herein and their various components may include materials commonly associated with medical devices and / or systems. For simplicity, the following discussion refers to the systems described herein. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, occlusive implants, delivery sheaths, cored wires, expandable frames, occlusive elements, capsules, elongated fingers, filaments, etc., and / or their elements or parts.

[0080] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer, metal-polymer composite, ceramic, combinations thereof, or other suitable materials.

[0081] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM; e.g., DELRIN®), polyether block copolymers, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether- or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA; e.g., PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicone, polyethylene (PE), and MARLEX® high-density polyethylene. MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), polyterephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), perfluoro(propyl vinyl ether) (PFA), vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS) 50A), polycarbonate, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the system and / or its components may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6 percent LCP.

[0082] Some examples of suitable metals and metal alloys include: stainless steels, such as 304 and 316 stainless steels and their variants; low-carbon steels; nickel-titanium alloys, such as linear elastic and / or hyperelastic nickel-titanium alloys; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0083] In at least some embodiments, part or all of the system and / or its components may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluorescent screen or another imaging technique (e.g., ultrasound) during medical procedures. This relatively bright image helps the user of the system determine their location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the system design to achieve the same result.

[0084] In some embodiments, the system and / or its components may include fabric materials. The fabric materials may consist of biocompatible materials (such as polymeric or biomaterials) suitable for promoting tissue inward growth. In some embodiments, the fabric materials may include bioabsorbable materials. 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 blends or combinations thereof.

[0085] In some embodiments, the system and / or its components may include and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrinked, or unshrinked. Suitable synthetic biocompatible yarns used in this disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, polymethyl methacrylate, polyamide, polyethylene naphthalate derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-chromium based alloys. The yarn may further include carbon, glass, or ceramic fibers. Ideally, the yarn is made of a thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be multifilament, monofilament, or spun type. The type and denier of the selected yarn can be chosen in a way that forms a biocompatible and implantable prosthesis, and more specifically, in a way that forms a vascular structure with the desired properties.

[0086] In some embodiments, the system and / or its components may include suitable therapeutic agents 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 (d-phenylalanine-proline-arginine-chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that inhibit smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); and antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, and long-acting acetylcholine). Vincristine, vincristine, epoch-producing erythromycin, 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); angiogenesis growth promoters (such as growth factor inhibitors and growth factor receptor antagonists). Drugs, transcription activators, translation promoters; angiogenic cell growth promoters (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, and bifunctional molecules composed of antibodies and cytotoxins); immunosuppressants (such as the "olimus" drug family, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactivity mechanisms.

[0087] It should be understood that this disclosure is illustrative in many respects. Variations may be made in details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. The scope of this disclosure is, of course, defined by the language expressed in the appended claims.

Claims

1. An occlusive implant, comprising: An expandable foam component in a compressed configuration, the expandable foam component being made of a shape memory polymer; as well as A biodegradable capsule is disposed on the expandable foam member, the biodegradable capsule holding the expandable foam member in the compressed configuration for a first time period, thereafter the biodegradable capsule degrades to allow the expandable foam member to expand to the expanded configuration.

2. The occlusive implant according to claim 1, wherein, The biodegradable capsule covers the entire outer surface of the expandable foam component.

3. The occlusive implant according to any one of claims 1-2, wherein, The biodegradable capsule includes at least one pore extending through the wall of the biodegradable capsule.

4. The occlusive implant according to claim 3, wherein, When in the compressed configuration, the expandable foam member and the biodegradable capsule are elongated, having a first end and an opposing second end, wherein the biodegradable capsule covers all portions of the expandable foam member except for the second end.

5. The occlusive implant according to claim 3, wherein, When in the compressed configuration, the expandable foam member and the biodegradable capsule are elongated, having a first end and an opposing second end, wherein the biodegradable capsule includes a plurality of spaced-apart pores disposed adjacent to the first end.

6. The occlusive implant according to any one of claims 1-5, wherein, The first time period is a preset time period.

7. The occlusive implant according to claim 6, wherein, The preset time period is from 30 seconds to 4 minutes.

8. The occlusive implant according to any one of claims 1-7, wherein, When in the compressed configuration, the expandable foam member is elongated, having a first end and an opposing second end, the expandable foam member having a first dimension extending between the first end and the opposing second end and a second dimension transverse to the first dimension, the first dimension being longer than the second dimension, wherein, when the expandable foam member is in the expanded configuration, the first dimension is shorter than the second dimension.

9. The occlusive implant according to any one of claims 1-8, wherein, The biodegradable capsule is made of one or more materials selected from the group consisting of: polyethylene glycol, polyvinyl alcohol, polyurethane, polylactic acid, poly(lactide-co-glycolic acid), poly(ε-caprolactone), sugar derivatives, salts, high specific surface area electrospun materials, and hydrogels.

10. The occlusive implant according to any one of claims 1-9, wherein, The biodegradable capsule is made of a copolymer of hydrophobic and hydrophilic components.

11. The occlusive implant according to claim 10, wherein, The copolymer includes polyethylene glycol and polylactic acid.

12. The occlusive implant according to any one of claims 1-11, wherein, The biodegradable capsule includes a first segment and a second segment sealed to the first segment.

13. The occlusive implant according to any one of claims 1-12, further comprising an expandable frame configured to switch between a collapsed configuration and an expanded configuration, the expandable frame defining an interior, wherein, The expandable foam component is disposed inside the interior.

14. The occlusive implant according to claim 13, wherein, When the expandable frame is in the expanded configuration and the biodegradable capsule has degraded, the expandable foam member expands to fill at least the entire proximal region of the expandable frame.

15. The occlusive implant of claim 13, further comprising an occlusive covering disposed on the proximal end region of the expandable frame.

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