Occlusive medical device with sensing capabilities

Abstract

Example occlusive implants are disclosed. One example occlusive implant includes an expandable framework configured to transition between a collapsed configuration and an expanded configuration, an occlusive member disposed along at least a portion of the expandable framework, and a first collar attached to the expandable framework. The occlusive implant also includes a sensor housing coupled to the first collar, the sensor housing having a first end and a second end opposite the first end, and the occlusive implant includes a second collar slidably disposed along an outer surface of the sensor housing. Further, the second collar is coupled to the expandable framework via a spring. The occlusive implant also includes a sensor disposed along the second end of the sensor housing.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 127,573, filed December 18, 2020, the entire disclosure of which is incorporated herein by reference. Background Technology

[0003] The left atrial appendage (LAA) is a small, pouch-like organ attached to the left atrium of the heart. In patients with atrial fibrillation, the LAA may not contract properly with the left atrium, causing stagnant blood to pool within it, potentially leading to unwanted blood clot formation. A blood clot formed in the LAA can break free from the area and enter the bloodstream. This clot, migrating through blood vessels, can eventually block smaller downstream vessels, resulting in a stroke or heart attack. Clinical studies have shown that a large proportion of blood clots in patients with atrial fibrillation are found in the LAA. As a treatment approach, medical devices have been developed that are positioned within the LAA and deployed to close the opening of the LAA. Over time, the exposed surface across the opening of the LAA is covered with tissue (a process known as endothelialization), effectively removing the LAA from the circulatory system and reducing or eliminating the number of blood clots that could potentially enter the bloodstream from the LAA. There is a ongoing need for improved medical devices and methods to monitor and control thrombus formation in the left atrial appendage of patients with atrial fibrillation. Summary of the Invention

[0004] An example occlusive implant includes an expandable frame configured to switch between a collapsed configuration and an expanded configuration, an occlusive member disposed along at least a portion of the expandable frame, and a first collar attached to the expandable frame. The occlusive implant also includes a sensor housing coupled to the first collar, the sensor housing having a first end and a second end opposite the first end, and a second collar slidably disposed along an outer surface of the sensor housing. Furthermore, the second collar is spring-coupled to the expandable frame. The occlusive implant also includes a sensor disposed along the second end of the sensor housing.

[0005] Additionally or alternatively, the extension of the spring is configured to shift the second collar from a first position adjacent to the first collar to a second position adjacent to the sensor.

[0006] Additionally or alternatively, the spring is wound around the outer surface of the sensor housing.

[0007] Additionally or alternatively, the spring includes a first end coupled to a first collar and a second end coupled to a second collar.

[0008] Additionally or alternatively, the spring includes a first end coupled to the sensor housing and a second end coupled to the second collar.

[0009] Alternatively or additionally, the first collar includes a hole, and the sensor housing extends within the hole of the first collar.

[0010] Additionally or alternatively, the first collar extends circumferentially around the outer surface of the sensor housing.

[0011] Additionally or alternatively, the first collar and the expandable frame are formed from a single piece of material.

[0012] Additionally or alternatively, the expandable frame may further include a plurality of struts attached to the first collar.

[0013] Additionally or alternatively, the expandable frame may further include multiple struts attached to the sensor housing.

[0014] Additionally or alternatively, the first collar is configured to remain stationary relative to the sensor housing when the expandable frame transitions between a collapsed configuration and an expanded configuration.

[0015] Additionally or alternatively, the first collar is configured to remain stationary relative to the sensor housing as the second collar moves along the outer surface of the sensor housing.

[0016] Additionally or alternatively, the sensor is positioned within an expandable frame such that the sensor is away from the occlusive member.

[0017] Additionally or alternatively, a first portion of the occlusive member is attached to the expandable frame, while a second portion of the occlusive member is attached to the second collar.

[0018] Another example of an occlusive implant includes an expandable framework configured to switch between a collapsed configuration and an expanded configuration, the expandable framework including a plurality of struts spaced apart around a longitudinal axis of the expandable framework. The occlusive implant also includes an occlusive member disposed along at least a portion of the expandable framework and a first collar attached to the plurality of struts of the expandable framework, the first collar defining an aperture wherein a central region of the aperture is aligned with the longitudinal axis of the expandable framework. The occlusive collar also includes a sensor housing coupled to the first collar and extending along the longitudinal axis of the expandable framework, the sensor housing having a first end and a second end opposite to the first end. The occlusive implant also includes a second collar slidably disposed along an outer surface of the sensor housing, wherein the second collar is spring-coupled to the expandable framework. Furthermore, the occlusive implant includes a sensor disposed along the second end of the sensor housing.

[0019] Additionally or alternatively, the extension of the spring is configured to shift the second collar from a first position adjacent to the first collar to a second position adjacent to the sensor.

[0020] Additionally or alternatively, the spring is wound around the outer surface of the sensor housing.

[0021] Additionally or alternatively, the spring includes a first end coupled to a first collar and a second end coupled to a second collar.

[0022] Additionally or alternatively, the first collar is configured to remain stationary relative to the sensor housing as the second collar moves along the outer surface of the sensor housing.

[0023] An example method for occluding the left atrial appendage includes advancing an occlusive implant into the left atrial appendage. The occlusive implant includes an expandable framework configured to switch between a collapsed configuration and an expanded configuration. The occlusive implant also includes an occlusive member disposed along at least a portion of the expandable framework and a first collar attached to the expandable framework. The occlusive implant also includes a sensor housing coupled to the first collar, the sensor housing having a first end and a second end opposite the first end. The occlusive implant also includes a second collar slidably disposed along an outer surface of the sensor housing, wherein the second collar is spring-coupled to the expandable framework. The occlusive implant also includes a sensor disposed along the second end of the sensor housing. The method further includes expanding the expandable framework within the left atrial appendage.

[0024] The foregoing overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of this disclosure. The accompanying drawings and the following detailed description illustrate these embodiments in more specific terms. Attached Figure Description

[0025] This disclosure can be more fully understood in light of the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which:

[0026] Figure 1 This is a plan view of an example occlusive implant;

[0027] Figure 2 An example occlusive implant positioned in the heart is shown;

[0028] Figure 3 An example occlusive implant positioned in the left atrial appendage is shown;

[0029] Figure 4 This is a plan view of another example of an occlusive implant;

[0030] Figure 5 This is a plan view of another example of an occlusive implant;

[0031] Figure 6 This is a plan view of another example of an occlusive implant;

[0032] Figure 7 This is a plan view of another example of an occlusive implant;

[0033] Figure 8 This is a plan view of another example of an occlusive implant;

[0034] Figure 9 This is a plan view of another example of an occlusive implant;

[0035] Figure 10 yes Figure 9 A perspective view of a portion of the example sensor shown;

[0036] Figure 11 yes Figure 9 Another perspective view of a portion of the example sensor shown;

[0037] While various aspects of this disclosure are applicable to a variety of modifications and alternatives, their details have been shown by way of example in the drawings and will be described in detail. However, it should be understood that this disclosure is not intended to limit its aspects to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0038] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals denote the same elements in several views. The detailed description and drawings are intended to illustrate the claimed 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 this disclosure. The detailed description and drawings illustrate exemplary embodiments of the claimed disclosure. However, for clarity and ease of understanding, although each feature and / or element may not be shown in every drawing, such feature and / or element can be understood to be present in any way unless otherwise stated.

[0039] The terms defined below shall be used unless otherwise defined in the claims or elsewhere in this specification.

[0040] Whether explicitly stated or not, all numerical values ​​assumed herein are modified by the term "approximately". In the context of numerical values, the term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant digit. Unless otherwise stated, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their common and conventional definition, as understood from and consistent with the context of the specification.

[0041] The representation of an endpoint to a range of numbers includes all numbers in that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0042] While some suitable dimensions, ranges and / or values ​​relating to 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 expressly stated otherwise. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless expressly stated otherwise. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by a single disclosure unless expressly stated otherwise. For simplicity and clarity, not all elements of this disclosure need to be shown in every figure or discussed in detail below. However, it should be understood that the following discussion can be equally applied to any and / or all components having more than one component, unless expressly stated otherwise. Furthermore, for clarity, not all instances of some elements or features can be shown in every figure.

[0044] Terms such as “proximal,” “distal,” “advancing,” “retracting,” and their variations can generally be considered relative to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device. “Proximal” and “retracting” indicate or refer to being closer to or towards the user, while “distal” and “advancing” indicate or refer to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to aid in understanding this disclosure, and these cases will be readily apparent to those skilled in the art. Other related terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within an internal lumen (such as a body cavity or blood vessel) or within the device.

[0045] The term "range" can be understood as referring to the maximum measured value 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 measured value 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 longitudinal dimension, and so on. Each instance of "range" can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.), and this will be 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 is clear from the specific context that it can be measured in different ways—such as, but not limited to, angular measurement, radial measurement, circumferential measurement (e.g., along an arc), etc.

[0046] The terms “single” and “monolithic” should generally refer to elements made or constituted by a single structural or basic unit / element. Single and / or monolithic elements should exclude structures and / or features formed by assembling multiple discrete elements together or otherwise connecting multiple discrete elements together.

[0047] Note 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 connection with an embodiment, unless expressly stated to the contrary, implementing that specific feature, structure, or characteristic in conjunction with other embodiments will be within the knowledge of those skilled in the art, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangeable 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 designated numerical names (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish the various described and / or claimed features. It should be understood that the numerical names are not intended to be limiting and are merely exemplary. In some embodiments, for brevity and clarity, the previously used numerical names may be modified and deviated from. That is, a feature designated as a “first” element may subsequently 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 naming in each case will be clear to a person skilled in the art.

[0049] Thrombosis in the left atrial appendage (LAA) during atrial fibrillation may be due to stagnation of blood pooling within the LAA. While the pooled blood can still be pumped out of the left atrium by the left ventricle, this is less effective due to the irregular contractions of the left atrium caused by atrial fibrillation. Therefore, left ventricular filling may depend primarily or solely on the suction effect produced by the left ventricle, rather than on the active support of blood flow by the contracting left atrium and left atrial appendage. However, the contraction of the left atrial appendage may be out of sync with the left ventricular cycle. For example, the contraction of the left atrial appendage may be up to 180 degrees out of phase with the left ventricle, which can significantly impede desired blood flow. Furthermore, the geometry of most left atrial appendages is complex and highly variable compared to their depth, with a large irregular surface area and narrow orifices or openings. These aspects, along with others (individually or in various combinations), may contribute to high flow resistance to blood outflow from the left atrial appendage.

[0050] To reduce the occurrence of thrombus formation in the left atrial appendage (LAA) and prevent thrombi from entering the bloodstream from the LA, it may be necessary to develop medical devices and / or occlusive implants that close the LA from the heart and / or circulatory system, thereby reducing the risk of stroke due to thrombolytic substances entering the bloodstream from the LA. Furthermore, in some cases, it may be necessary to develop medical devices and / or occlusive implants that provide diagnostic functionality to implantable medical devices. For example, it may be necessary to design medical devices that include sensors capable of sensing various diagnostic information, such as left atrial pressure, temperature, oxygen levels, etc. This document discloses example medical devices and / or occlusive implants designed to seal the left atrial appendage (or other similar opening) while also possessing diagnostic sensing capabilities.

[0051] Figure 1 An example occlusive implant 10 is shown; the occlusive implant 10 may include an expandable framework 12. The occlusive implant 10 may also include an occlusive member 14 disposed on at least a portion of the expandable framework 12, disposed above at least a portion of the expandable framework, disposed around at least a portion of the expandable framework, or covering at least a portion of the expandable framework. In some embodiments, the occlusive member 14 may be disposed on at least a portion of the outer surface (or outward-facing surface) of the expandable framework 12, disposed above at least a portion of the outer surface of the expandable framework, disposed around at least a portion of the outer surface of the expandable framework, or covering at least a portion of the outer surface of the expandable framework. Figure 1 It is further shown that the occlusion member 14 may extend only partially along the longitudinal extent (e.g., the longitudinal axis) of the expandable frame 12. However, this is not intended to be restrictive. Rather, the occlusion member 14 may extend to any extent along the longitudinal extent of the expandable frame (e.g., the entire longitudinal extent of the expandable frame 12).

[0052] In some embodiments, the occlusive member 14 may be permeable or impermeable to blood and / or other fluids (such as water). In some embodiments, the occlusive member 14 may comprise woven, braided, and / or knitted materials, fibers, sheet materials, fabrics, polymer membranes, metal or polymer meshes, porous filter-like materials, or other suitable constructions. In some embodiments, the occlusive member 14 may prevent thrombi (i.e., blood clots, etc.) from passing through the occlusive member 14 and exiting the left atrial appendage into the bloodstream. In some embodiments, the occlusive member 14 may promote endothelialization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable but non-limiting examples of materials for the occlusive member 14 are discussed below.

[0053] Figure 1Further illustrated, the expandable frame 12 may include a plurality of anchoring members 16 disposed around the periphery of the expandable frame 12. The plurality of anchoring members 16 may extend radially outward from the expandable frame 12. In some embodiments, at least some of the plurality of anchoring members 16 may each have and / or include a body portion and a circumferentially projecting tip portion from the body portion, such as... Figure 1 As shown in the figure. Some suitable, but non-limiting, examples of materials for the expandable frame 12 and / or the plurality of anchoring members 16 are discussed below.

[0054] In some examples, the expandable frame 12, the plurality of anchoring members 16, and / or other components / parts of the expandable frame 12 disclosed herein may be integrally formed and / or cut from a single (e.g., monolithic) member. In some embodiments, the expandable frame 12 and the plurality of anchoring members 16 may be integrally formed and / or cut from a single tubular member, and subsequently formed and / or heat-set into the desired shape in the expandable configuration. In some embodiments, the expandable frame 12 and the plurality of anchoring members 16 may be integrally formed and / or cut from a single flat member, then rolled or formed into a tubular structure, and subsequently formed and / or heat-set into the desired shape in the expandable configuration. Some exemplary ways and / or methods of manufacturing and / or forming the expandable frame 12 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical melting, etc. Other ways and / or methods are also contemplated.

[0055] like Figure 1 As shown, the plurality of anchoring members 16 arranged along the expandable frame 12 may include two rows of anchoring members 16. However, this is not intended to be limiting. Rather, the expandable frame 12 may include a single row of anchoring members 16. In other examples, the expandable frame 12 may include more than two rows of anchoring members 16. For example, in some cases, the expandable frame 12 may include one, two, three, four, or more rows of anchoring members 16.

[0056] Figure 1 The occlusive implant 10 is further illustrated, which may include a sensor housing 26 coupled to the framework 12. The sensor housing 26 may include a first end 27 and a second end 29 opposite to the first end 27. (As shown) Figure 1 As shown, the frame 12 may include one or more supports 15 that are securely attached (e.g., welded, glued, brazed, crimped, etc.) to a cylindrical collar 34 (e.g., a cylindrical belt, a cylindrical ring) designed to be circumferentially positioned around the outer surface of the sensor housing 26. The collar 34 may include a hole whose center may be substantially aligned with the longitudinal axis of the expandable frame 12. However, although... Figure 1The occlusive implant 10 shown is illustrated with a strut 15 welded to the collar 34, but it is conceivable that in other examples, the strut 15 could be welded directly to the sensor housing 26.

[0057] In some examples, the collar 34 may comprise a cylindrical metal ring (e.g., a metal collar) designed to allow the sensor housing 26 to extend through it. In some examples, the collar 34 may be fully or partially embedded in the sensor housing 26. For example, the sensor housing 26 may be overmolded on top of the collar 34. However, it is conceivable that the collar 34 may be securely attached to the sensor housing 26 via a variety of different attachment techniques. For example, the collar 34 may be attached to the sensor housing 26 using one or more of the following attachment techniques: helical thread, snap-fit, crimp, weld, press fit, C-clamp, snap ring, snap-fit, adhesive, glue, brazing, or any other suitable attachment technique.

[0058] The collar 34 can be constructed from a variety of materials. For example, the collar 34 can be formed from metal, metal alloy, polymer, ceramic, or any combination thereof. Furthermore, in some cases, the collar 34 can be constructed from the same material as the frame 12. For example, the frame 12 (including the support column 15) and the collar 34 can be a single structure, whereby the frame 12, support column 15, and collar 34 can be formed from the same single substrate. However, it is understood that in some examples, the frame 12 and the collar 34 can be constructed as separate components, whereby the support column 15 of the frame 12 can be fixed to the collar 34. Figure 1 It is shown that the strut 15 can be fixed around the outer surface of the collar 34, thereby extending along the entire outer circumference of the collar 34. In other words, the strut 15 can be attached to the belt by extending 360 degrees around the outer circumference of the collar 34 at uniform (or non-uniform) intervals.

[0059] As described above, the collar 34 may be designed to include a central bore (e.g., an opening) that allows the sensor housing 26 to extend through it. It is understood that the central bore of the collar 34 may include an inner diameter. It is further understood that the sensor housing 26 may include an outer diameter sized to fit within the inner diameter of the collar 34. Figure 1 The first end 27 of the sensor housing 26 is shown to be aligned such that when the occlusive implant 10 is positioned in the opening of the left atrial appendage, the first end 27 of the sensor housing 26 is oriented (e.g., pointing) toward the left atrial appendage. Furthermore, Figure 1 The second end 29 of the sensor housing 26 is shown to be aligned such that when the occlusive implant 10 is positioned in the opening of the left atrial appendage, the second end 29 of the sensor housing 26 can point towards the left atrium of the heart. Reference will be made below. Figure 2The orientation of the sensor housing 26 is described in more detail when the occlusive implant 10 is positioned within the opening of the left atrial appendage.

[0060] Figure 1 Further illustration shows that the sensor housing 26 may include a sensor 30 disposed along a second end 29 of the sensor housing 26. The sensor 30 may include a variety of different sensors. For example, the sensor 30 may include a pressure sensor, a temperature sensor, an oxygen sensor, an electrical sensor (e.g., an EKG sensor), an impedance sensor, etc. Furthermore, the sensor contemplated herein may be configured to sense heart rhythm, blood chemistry tests (e.g., NT-proBNP test), or other similar tests. Moreover, it is understood that the sensor 30 (and the components defining the sensor 30) may be integrated into the sensor housing 26. For example, in some cases, the sensor 30 (and its components) may be fixedly attached to the second end 29 of the sensor housing. In some examples, the sensor 30 may be wholly or partially embedded in the material used to construct the sensor housing 26.

[0061] Understandably, in some examples, collar 34 may include one or more retaining members designed to allow the occlusive member 14 to be attached thereto. For example, collar 34 may include hooks, holes, teeth, etc., designed to allow the occlusive member 14 to be attached thereto. As mentioned above, in some examples, the occlusive member 14 may be constructed of fabric, and therefore the occlusive member can hook onto one or more of the hooks, holes, teeth, etc., located on collar 34.

[0062] The sensor housing 26 can be formed from a variety of materials. For example, the sensor housing can be formed from glass, acrylic, polymer, metal, metal alloy, ceramic, or any combination thereof. In addition, the sensor housing 26 (including the sensor 30) can be formed from a biocompatible material.

[0063] Figure 2 The occlusive implant 10 is shown to be inserted and advanced through the body cavity via the occlusive implant delivery system 20. Figure 2 The occlusive implant 10, delivered and positioned within the left atrial appendage 50, is further illustrated. In some cases, the occlusive implant delivery system 20 may include a delivery catheter 24 that is guided toward the left atrium 51 and adjacent to the left atrial appendage 50 via the various chambers and lumens of the heart (e.g., the inferior vena cava, right atrium, etc.).

[0064] Delivery system 20 may include a hub 22 coupled to a proximal region of delivery catheter 24. Hub 22 may be manipulated by a clinician to guide a distal region of delivery catheter 24 to a location adjacent to the left atrial appendage 50. In some embodiments, the occlusive implant delivery system may include a core wire 18. Furthermore, the proximal end of expandable frame 12 may be configured to releasably attach, engage, interlock, engage, or otherwise connect to the distal end of core wire 18. In some embodiments, the end region of expandable frame 12 may include a threaded insert coupled thereto. In some embodiments, the threaded insert may be configured and / or adapted to engage, interlock, mate, or otherwise engage with the threaded insert located at the distal end of core wire 18. Other methods of releasably engaging and / or engaging the proximal end of expandable frame 12 to the distal end of core wire 18 may also be considered.

[0065] It is understood that in some cases, the core wire 18 (or any other component of the delivery system 20) may be releasably attached to the sensor housing 26. For example, in some cases, the core wire 18 may be releasably attached, engaged, coupled, coupled, or otherwise connected to the sensor housing 26, the expandable frame 12, or any other component of the medical device 10 via various different connection methods. For example, it is conceivable that the sensor housing 26 may include threaded components configured and / or adapted to engage, coupled, mate, or otherwise engage with threaded members disposed at the distal end of the core wire 18.

[0066] Figure 3 The delivery conduit 24 (as referenced above) is shown. Figure 2 The occlusive implant 10 is positioned within the left atrial appendage 50. As described above, in some examples, the implant 10 can be configured to switch between a collapsed configuration and an expanded configuration. For example, in some cases, the occlusive implant 10 may be in a collapsed configuration during delivery via an occlusive implant delivery system, thereby expanding into an expanded configuration once deployed from the occlusive implant delivery system.

[0067] also, Figure 3 The expandable framework 12 is shown to be compliant and thus substantially conforms to and / or seals the shape and / or geometry of the lateral walls of the left atrial appendage 50 in an expanded configuration. In some embodiments, the occlusive implant 10 can expand to a size, extent, or shape smaller than or different from the maximum unconstrained extent, as defined by the surrounding tissue 52 and / or lateral walls of the left atrial appendage. Furthermore, Figure 3 The expandable frame 12 is shown to be able to hold the adjacent left atrial appendage in place by one or more anchoring members 16.

[0068] Furthermore, it is understood that the elements of the expandable framework 12 can be customized to increase the flexibility and compliance of the expandable framework 12 and / or the occlusive implant 10, thereby allowing the expandable framework 12 and / or the occlusive implant 10 to conform to the surrounding tissue, rather than forcing the tissue to conform to the expandable framework 12 and / or the occlusive implant 10. Additionally, in some cases, it may be necessary to design the aforementioned occlusive implant 10 to include various features, components, and / or constructions that improve the sealing capability of the occlusive implant 10 within the left atrial appendage. Several example occlusive devices including various sealing features are disclosed below.

[0069] As mentioned above, Figure 3 The position of the sensor housing 26 (including the sensor 30) relative to the left atrial appendage 50 and the left atrium 51 is further illustrated. For example, Figure 3 The sensor housing 26 is shown to be attached to the collar 34 such that the sensor 30 is pointed at and extends into the left atrium 51. Positioning the sensor housing 26 such that the sensor 30 is pointed at and extends into the left atrium 51 allows the sensor 30 to sense diagnostic parameters of the left atrium and / or left atrial appendage (e.g., pressure, temperature, oxygen level, etc.). Positioning the sensor 30 adjacent to the second end 29 of the sensor housing 26 allows the sensor 30 to communicate directly with the left atrium.

[0070] Figure 4 Another medical device 110 is shown, which is similar in form and function to the occlusive implant 10 discussed above. For example, the medical device 110 may include an expandable frame 112 and an occlusive member 114 disposed on at least a portion of the expandable frame 112, above at least a portion of the expandable frame, around at least a portion of the expandable frame, or covering at least a portion of the expandable frame. The expandable frame 112 and the occlusive member 114 may be similar in form and function to the expandable frame 12 and the occlusive member 14 described above. Furthermore, for the sake of brevity, Figure 4 An outline of the occlusive implant 110 in an expanded configuration is shown. It is understood that the expandable framework 112 can be configured to switch between an unexpanded configuration and an expanded configuration.

[0071] Figure 4The medical device 110 is shown to further include a sensor housing 126 coupled to a collar 134. The sensor housing 126 may include a first end 127 and a second end 129 opposite to the first end 127. The sensor housing 126 may further include a sensor 130 disposed along the second end 129 of the sensor housing 126. The sensor 130 and the collar 134 may be similar in form and function to the sensor 30 described above. For example, the sensor 130 may include various different types of sensors. For example, as described above, the sensor 130 may include a pressure sensor, a temperature sensor, an oxygen sensor, an electrical sensor (e.g., an EKG sensor), an impedance sensor, etc. Furthermore, it is understood that the sensor 130 (and the components defining the sensor 130) may be integrated into the sensor housing 126. In some cases, the sensor 130 (and its components) may be fixedly attached to the second end 129 of the sensor housing. For example, the sensor 130 may be wholly or partially embedded in the material used to construct the sensor housing 126.

[0072] Figure 4 Detailed views further show that the sensor housing 126 may include one or more features that facilitate its attachment to the collar 134. For example, Figure 4 The sensor housing 126 is shown to include one or more protrusions 137 extending radially away from the outer surface of the sensor housing 126. It will be understood that in some examples, the protrusions 137 may be one or more individual projections extending radially from the outer surface of the sensor housing 126. However, in other examples, the protrusions 137 may include a circumferential lip (e.g., a shelf, ramp, shoulder, edge, ridge, etc.) extending radially away from the outer surface of the sensor housing 126, but also extending circumferentially around the outer surface of the sensor housing 126.

[0073] Figure 4 Further illustration shows that the collar 134 may include a recess 136 designed to mate with a protrusion 137 of the sensor housing 126. In some examples, it is understood that the protrusion 137 may engage with the recess 136 (e.g., snap-fit, press-fit, press-fit, etc.) such that the sensor housing 126 is securely attached to the collar 134. It is further understood that, although Figure 4 The sensor housing 126 is shown to include a protrusion 137 that extends radially away from the outer surface of the sensor housing 126 and matches a recess 136 in the collar 134. However, it is conceivable that the collar 134 may include a protrusion that extends radially away from its surface, whereby the protrusion matches a recess located in the sensor housing 126.

[0074] Figure 4Detailed views also show that frame 112 can be securely attached to collar 134. Furthermore, Figure 4 The detailed view also shows that the occlusive member 114 can be fixedly attached to the collar 134. However, it is conceivable that in some examples, the occlusive member 114 can be fixedly attached to one or more portions of the frame 112 (and can be attached directly to the collar 134 or not directly to the collar).

[0075] Figure 5 Another medical device 210 is shown, which is similar in form and function to the occlusive implants 10 / 110 discussed above. For example, the medical device 210 may include an expandable frame 212 and an occlusive member 214 disposed on at least a portion of the expandable frame 212, above at least a portion of the expandable frame, around at least a portion of the expandable frame, or covering at least a portion of the expandable frame. The expandable frame 212 and the occlusive member 214 may be similar in form and function to the expandable frames 12 / 112 and occlusive members 14 / 114 described above. Furthermore, for the sake of brevity, Figure 5 An outline of the occlusive implant 210 in an expanded configuration is shown. It is understood that the expandable framework 212 can be configured to switch between an unexpanded configuration and an expanded configuration.

[0076] Figure 5 The medical device 210 is shown to further include a sensor housing 226 coupled to a collar 234. The sensor housing 226 may include a first end 227 and a second end 229 opposite to the first end 227. The sensor housing 226 may further include a sensor 230 disposed along the second end 229 of the sensor housing 226. The sensor 230 and the collar 234 may be similar in form and function to the sensors 30 / 130 described above. For example, the sensor 230 may include various different types of sensors. For example, the sensor 230 may include a pressure sensor, a temperature sensor, an oxygen sensor, etc. Furthermore, it is understood that the sensor 230 (and the components defining the sensor 230) may be integrated into the sensor housing 226. In some cases, the sensor 230 (and its components) may be fixedly attached to the second end 229 of the sensor housing. For example, the sensor 230 may be wholly or partially embedded in the material used to construct the sensor housing 226.

[0077] Figure 5 Detailed views further show that the sensor housing 226 may include one or more features that facilitate its attachment to the collar 234. For example, Figure 5 The sensor housing 226 is shown to include one or more threads 238 disposed along the outer surface of the sensor housing 226. Figure 5 It is further shown that the collar 234 may include one or more threads 239, which are designed to engage and mate with threads 238 disposed along the sensor housing 226. This engagement of the threads 238 of the sensor housing with the threads 239 of the collar 234 securely attaches the sensor housing 226 to the collar 234.

[0078] Figure 5 Detailed views also show that frame 212 can be securely attached to collar 234. Furthermore, Figure 5 The detailed view also shows that the occlusive member 214 can be fixedly attached to the collar 234. However, it is conceivable that in some examples, the occlusive member 214 can be fixedly attached to one or more portions of the frame 212 (and may be directly attached to the collar 234 or may not be directly attached to the collar).

[0079] Figure 6-7 Another medical device 310 is shown, which is similar in form and function to the occlusive implants discussed above. For example, the medical device 310 may include an expandable frame 312 and an occlusive member 314 disposed on at least a portion of the expandable frame 312, above at least a portion of the expandable frame, around at least a portion of the expandable frame, or covering at least a portion of the expandable frame. The expandable frame 312 and the occlusive member 314 may be similar in form and function to the expandable frame and occlusive member described above. Furthermore, for the sake of brevity, Figure 6-7 An outline of the occlusive implant 310 in an expanded configuration is shown. It is understood that the expandable framework 312 can be configured to switch between an unexpanded configuration and an expanded configuration.

[0080] Figure 6-7The medical device 310 is further shown to include a sensor housing 326 coupled to a first collar 334. The sensor housing 326 may include a first end 327 and a second end 329 opposite to the first end 327. The sensor housing 326 may further include a sensor 330 disposed along the second end 329 of the sensor housing 326. The sensor 330 and the first collar 334 may be similar in form and function to the other sensors described above. For example, the sensor 330 may include various different types of sensors. For example, the sensor 330 may include a pressure sensor, a temperature sensor, an oxygen sensor, etc. Furthermore, it is understood that the sensor 330 (and the components defining the sensor 330) may be integrated into the sensor housing 326. In some cases, the sensor 330 (and its components) may be fixedly attached to the second end 329 of the sensor housing. For example, the sensor 330 may be wholly or partially embedded in the material used to construct the sensor housing 326.

[0081] Figure 6 As further shown, in some examples, the sensor housing 326 may include one or more attachment members 342, which may be designed to facilitate attachment to a medical device delivery system (in... Figure 6 Not shown in, but in Figure 2 Examples are shown and described in the text. For example... Figure 6 The sensor housing 326 is shown to include a plurality of holes 342 for attachment to a delivery system designed to transport... Figure 6 The occlusive member 310 shown. It can be further understood that, although... Figure 6 The attachment member 342 is shown as a series of holes, but this is not intended to be limiting. Rather, it is conceivable that the sensor housing 326 may include a variety of different attachment members 342 designed to engage an example occlusive member delivery system. For example, the attachment member 342 may include protrusions, hooks, pins, threads, or rip cords.

[0082] Furthermore, while the sensor housing 326 has been described as including the attachment member 342, it is further conceivable that the attachment member 342 may be positioned and / or included on any portion of the expandable frame 312. For example, the core wire ( Figure 6 Not shown in the image, but... Figure 2 (As shown in the figure) can be attached to any part of the occlusion member 310 via an attachment member 342 positioned along any part of the occlusion member 310, any part of the occlusion member including sensor housing 326, expandable frame 312, or sensor housing 326 and expandable frame 312.

[0083] like Figure 6 As shown, the attachment member 342 can be positioned along the sensor housing 326 such that the attachment member 342 is spaced apart from the sensor 330. In other words, the attachment member 342 can be spaced apart from the first end 327 of the sensor housing relative to the position of the sensor 330 on the second end 329 of the sensor housing 326. In some examples, it can be understood that the attachment members 342 can be positioned along the sensor housing 326 such that they are away from the frame 312. In other words, when positioned in the orifice of the left atrial appendage, the attachment member 342 can be positioned away from the frame 312 and the occlusive member 314 such that the attachment member 342 can access the delivery system positioned in the left atrium.

[0084] Understandably, in some examples, after the delivery system has been used to deliver and deploy the occlusive member 310 into the orifice of the left atrial appendage, the delivery system can be detached from the occlusive implant and removed from the body. Furthermore, after removal of the delivery system, it may be necessary to cover the attachment member 342. In other words, to limit potential adverse effects (such as device-related thrombosis) from the attachment member 342, it may be necessary to cover the attachment member 342 after positioning the occlusive member 310 into the orifice of the left atrial appendage. In summary, Figure 6-7 An example mechanism is shown, which is designed to cover the attachment member 342 after the occlusive member 310 is positioned in the orifice of the left atrial appendage.

[0085] Figure 6 The occlusion member 310 is shown to include a first collar 334 and a second collar 344. The first collar 334 may be similar in form and function to the other collars described above (e.g., collars 34 / 134 / 234). For example, the first collar may be fixedly engaged (e.g., fixedly attached) to the sensor housing 326 such that the collar 334 remains in a fixed position relative to the sensor housing 326 when the frame 312 is switched between an unexpanded configuration and an expanded configuration. The first collar 334 may be fixedly attached to the sensor housing 326 using a variety of attachment techniques (e.g., adhesive bonding, crimping, etc.), some of which are described above.

[0086] However, we can also imagine... Figure 6 The occlusion member 310 shown may omit the first collar 334 while still retaining the functionality of the occlusion member 310 described herein. For example, in some cases, the struts of the frame 312 may be directly coupled (e.g., welded) to the sensor housing 326. In other words, the sensor housing 326 may be directly integrated with any component of the frame 312 (e.g., struts) using a variety of different attachment techniques.

[0087] also, Figure 6This shows that the frame 312 can be securely attached to the first collar 334. Furthermore, Figure 6 The occlusion member 314 is shown to be securely attached to the second collar 344. In other words, the occlusion member 314 is securely attached to a portion of the frame 312 spaced apart from the sensor housing 326, while also disengaging from the frame 312 at a location closer to the sensor housing 326. As the occlusion member 314 approaches the sensor housing 326, it can detach from the frame 312 and extend into the second collar 344, whereby the occlusion member can be securely attached, as described above.

[0088] Figure 6 Further illustration shows that the second collar 344 of the occlusion member 310 can be spaced apart from the first collar 334 (along the longitudinal axis of the sensor housing), such that the second collar 344 is closer to the sensor 330 than the first collar 334. Furthermore, Figure 6 It is shown that the second collar 344 can be coupled to the first collar 334 via a coil (e.g., spring) member 345 (e.g., a first end of the spring 345 can be attached to the first collar 334, and a second end of the spring 345 can be attached to the second collar 344). However, it is contemplated that in other examples, the spring 345 may include a first end attached to the sensor housing 326 and a second end attached to the second collar 344. It is understood that the coil member 345 may be wound around the sensor housing 345. (See reference...) Figure 7 As described and shown in more detail, it can be further understood that the coil member 345 can freely elongate (e.g., translate, stretch, etc.) along the sensor housing 326. It can be further envisioned that... Figure 6 The spring 345 depicted may include a variety of different spring designs. For example, the spring 345 may include a linear spring, a folding spring, a linear wave spring, an expandable mesh frame, etc., some of which do not necessarily coil around the sensor housing 326.

[0089] Figure 7 This shows that the second collar 344 can move along the sensor housing 326 from the first position (in Figure 7 The dashed line in the middle corresponds to the one above. Figure 6 The second collar 344 slides freely from its initial position (described in the diagram) to a second position, thereby sliding closer to the sensor 330. Arrow 346 depicts the direction in which the second collar 344 slides along the sensor housing 326. Figure 7Further illustration shows that as the second collar 344 slides along the longitudinal axis of the sensor housing 326, it can pass over the top of the attachment member 342. Because the occlusive member 314 can be attached to the second collar 344, the occlusive member can also pass over the top of the attachment member 342 as the second collar 344 slides over it. After passing over the top of the attachment member 342, the occlusive member 314 can cover the attachment member 342, thereby reducing the likelihood of the attachment member 342 causing adverse effects (such as device-related thrombosis).

[0090] Understandably, various mechanisms can be designed to "release" the second collar 344 after the occlusive member has been delivered and deployed within the body. In some examples, the second collar 344 can be automatically released and moved proximally toward the sensor 330 as the occlusive member is deployed from the delivery system. In other words, in some examples, as soon as the occlusive implant is delivered from the delivery catheter 24 ( Figure 6 Not shown in the image, but... Figure 2 As shown in the diagram, the second collar 344 will unfold and be released. In other examples, the second collar 344 may be released via a separate mechanism. For example, the second collar 344 may be released via a tearing rope or a similar mechanism. It can be further understood that after the second collar 344 is released, the coil 345 may expand, thereby forcing the second collar 344 along the sensor housing 326 from its first position (as shown in the diagram). Figure 6 and Figure 7 (As shown by the dashed line in the image) Slide to its second position (as shown in the image) Figure 7 (As shown in the diagram). Furthermore, after sliding along the sensor housing 326 (and over the top of the attachment member 342), the second collar 344 can pull the occlusion member 314 into a tensioned configuration. In this configuration, the occlusion member 314 can resemble a tent-like configuration, whereby the occlusion member 314 is stretched from the second collar 344 to the frame 312 with minimal slack.

[0091] Figure 8 Another medical device 410 is shown, which is similar in form and function to the occlusive implants discussed above. For example, the medical device 410 may include an expandable frame 412 and an occlusive member 414 disposed on at least a portion of the expandable frame 412, above at least a portion of the expandable frame, around at least a portion of the expandable frame, or covering at least a portion of the expandable frame. The expandable frame 412 and the occlusive member 414 may be similar in form and function to the expandable frame and occlusive member described above. Furthermore, for the sake of brevity, Figure 8An outline of the occlusive implant 410 in an expanded configuration is shown. It is understood that the expandable framework 412 can be configured to switch between an unexpanded configuration and an expanded configuration.

[0092] Figure 8 The medical device 410 is shown to further include a sensor housing 426 coupled to a collar 434. The sensor housing 426 may include a first end 427 and a second end 429 opposite to the first end 427. The sensor housing 426 may further include a sensor 430 disposed along the second end 429 of the sensor housing 426. The sensor 430 and the collar 434 may be similar in form and function to other sensors described herein. For example, the sensor 430 may include various different types of sensors. For example, the sensor 430 may include a pressure sensor, a temperature sensor, an oxygen sensor, etc. Furthermore, it is understood that the sensor 430 (and the components defining the sensor 430) may be integrated into the sensor housing 426. In some cases, the sensor 430 (and its components) may be fixedly attached to the second end 429 of the sensor housing. For example, the sensor 430 may be wholly or partially embedded in the material used to construct the sensor housing 426.

[0093] Figure 8 Further illustration shows that the expandable frame 412 may further include a frame recess 431, which may be designed to receive the first end 427 of the sensor housing 426. In other words, the frame recess 431 may include a geometry designed to match and accommodate the geometry of the first end 427 of the sensor housing 426. Various attachment techniques (e.g., adhesive bonding, press-fitting, threaded connection, press fit, welding, C-clamping, snap-fitting, overmolding, etc.) can be used to attach the sensor housing 426 to the frame recess 431 of the expandable frame 412, some of which are described above. Furthermore, Figure 8 This illustrates that the occlusion member 414 can be attached to the sensor housing 426. For example, Figure 8 It is shown that the occlusion member 414 can be attached to the second end 429 of the sensor housing. However, this is not intended to be limiting, as it is conceivable that the occlusion member 414 can be attached to any part of the sensor housing 426. Furthermore, although in Figure 8 It is not shown in the image, but it can be imagined. Figure 8 The occlusion member 410 shown may include a second slidable collar (and coil member), as referenced above. Figure 6-7 As stated above.

[0094] Figure 9-11Another medical device 510 is shown, which is similar in form and function to the occlusive implants discussed above. For example, the medical device 510 may include an expandable frame 512 and an occlusive member 514 disposed on at least a portion of the expandable frame 512, above at least a portion of the expandable frame, around at least a portion of the expandable frame, or covering at least a portion of the expandable frame. The expandable frame 512 and the occlusive member 514 may be similar in form and function to the other expandable frames and occlusive members described above. Furthermore, for the sake of brevity, Figure 9 An outline of the occlusive implant 510 in an expanded configuration is shown. It is understood that the expandable framework 512 can be configured to switch between an unexpanded configuration and an expanded configuration.

[0095] Figure 9 The medical device 510 is shown to further include a sensor housing 526 coupled to a collar 534. The sensor housing 526 may include a first end 527 and a second end 529 opposite to the first end 527. However, as... Figure 9-11 As shown, the sensor housing 526 may include a first housing member 552 that engages with the second housing member 554. In some examples, the second housing member 554 may be threadedly engaged with the first housing member 552. In other words, the second housing member 554 can be unscrewed from and separated from the first housing member 552. Reference will be made below. Figure 10-11 The disengagement of the second housing member 554 from the first housing member 552 is described in more detail.

[0096] The second housing member 554 may further include a sensor 530 disposed along a second end 529 of the second housing member 554 of the sensor housing 526. For example, the sensor 530 may include various different types of sensors. For example, the sensor 530 may include a pressure sensor, a temperature sensor, an oxygen sensor, etc. Furthermore, it is understood that the sensor 530 (and the components defining the sensor 530) may be integrated into the second housing member 554 of the sensor housing 526. In some cases, the sensor 530 (and its components) may be fixedly attached to an end of the second housing member 554 (corresponding to the second end 529 of the sensor housing 526). For example, the sensor 530 may be wholly or partially embedded in the material used to construct the second housing member 554 of the sensor housing 526.

[0097] In some cases, the collar 534 can be securely attached to the first housing member 552 using various attachment techniques. For example, the collar 534 can be welded, forged, pressed, glued, press-fitted, overmolded, threaded, etc., to the first housing member 552. Furthermore, Figure 9It is shown that the expandable frame 512, the occlusion member 514, or both the frame 512 and the occlusion member 514 can be directly attached to the collar 534. Furthermore, although... Figure 9 A collar 534 attached to a first housing member 552 is shown, but it is conceivable that in other embodiments, the collar 534 may be attached to a second housing member 554.

[0098] Figure 10 This is a perspective view of a portion of the aforementioned occlusive member 510. Specifically, Figure 10 A sensor housing 526 is shown, which includes a first housing member 552 that is threadedly attached to a second housing member 554. Figure 10 The second housing member 554 is shown to include a plurality of threads 555 that extend into a cavity located in the first housing member (the cavity of the first housing member is located in...). Figure 11 (as shown in the figure) in one or more matching threads and engaging the one or more matching threads.

[0099] Figure 10 A collar 534 extending circumferentially around the outer surface of the first housing member 552 is further shown. Additionally, Figure 10 The struts of the expandable frame 512, which are directly attached to the collar 534, are shown. Figure 10 A sensor 530 is also shown positioned on the second housing member 554.

[0100] Figure 11 The occlusion member 510 is shown, thereby the second housing member 554 has been detached from the first housing member 552. Specifically, Figure 11 This shows that the second housing member 554 has been unscrewed from and separated from the first housing member 554. As described above, Figure 11 A threaded cavity 556 is shown, into which the thread 555 of the second housing member 554 can extend and threadly engage with the threaded cavity.

[0101] Although Figure 9-11 Not shown, but in some examples, it is conceivable that the occlusion member 514 can be attached to the sensor housing 526 by clamping the occlusion member 514 between the first housing member 552 and the second housing member 554. In other words, the attachment of the occlusion member 514 to the sensor housing 526 may include fixing the occlusion member 514 to the surface of the first housing member 552 and then screwing the second housing member 554 into the first housing member 552, thereby clamping the occlusion member 514 between the first housing member 552 and the second housing member 554.

[0102] Materials that can be used for various components (and variations, systems, or components disclosed herein) and elements of the occlusive implant 10 may include materials commonly associated with medical devices. For the sake of brevity, the following discussion refers to the occlusive implant 10 (and variations, systems, or components disclosed 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.

[0103] In some embodiments, the occlusive implant 10 (and its variations, systems, or components disclosed herein) may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include: stainless steel, such as 444V, 444L, and 314LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic nickel-titanium and / or hyperelastic nickel-titanium; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, for example...). 625, UNS: N06022, for example UNS: N10276, for example other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, for example). 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, for example). (etc.), nickel-molybdenum alloys (e.g., UNS: N10665, for example) ALLOY 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: R44003, for example). (etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0104] As implied herein, within the family of commercially available nickel-titanium or nitinol alloys, there exists a class referred to as “linearly elastic” or “non-hyperelastic” alloys, which, while chemically similar to conventional shape memory and hyperelastic types, may exhibit unique and useful mechanical properties. The difference between linearly elastic and / or non-hyperelastic nitinol and hyperelastic nitinol lies in the fact that linearly elastic and / or non-hyperelastic nitinol does not exhibit a significant “hyperelastic plateau” or “marked region” in its stress / strain curve, as hyperelastic nitinol does. Instead, in linearly elastic and / or non-hyperelastic nitinol, stress continues to increase substantially linearly with increasing recoverable strain, or to some extent, but not necessarily, linearly, until plastic deformation begins, or at least in a more linear relationship than the hyperelastic plateau and / or marked region observed in hyperelastic nitinol. Therefore, for the purposes of this disclosure, linearly elastic and / or non-hyperelastic nitinol may also be referred to as “substantially” linearly elastic and / or non-hyperelastic nitinol.

[0105] In some cases, linear elastic and / or non-hyperelastic nitinol can also be distinguished from hyperelastic nitinol because linear elastic and / or non-hyperelastic nitinol can accept up to about 2-5% strain while maintaining basic elasticity (e.g., before plastic deformation), while hyperelastic nitinol can accept up to about 8% strain before plastic deformation. Both of these materials can also be distinguished from other linear elastic materials, such as stainless steel (which can also be differentiated based on its composition), which can accept only about 0.2% to 0.44% strain before plastic deformation.

[0106] In some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys are alloys that do not exhibit martensitic / austenitic phase transformations detectable by differential scanning calorimetry (DSC) and dynamic metallographic analysis (DMTA) over a wide temperature range. For example, in some embodiments, in linear elastic and / or non-hyperelastic nickel-titanium alloys, martensitic / austenitic phase transformations detectable by DSC and DMTA analysis may not be present in the range of approximately -60°C to approximately 120°C. Therefore, the mechanical bending properties of such materials are generally inert to temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-hyperelastic nickel-titanium alloys are substantially the same at ambient temperature or room temperature as at body temperature, for example, because they do not exhibit hyperelastic plateaus and / or marker regions. In other words, linear elastic and / or non-hyperelastic nickel-titanium alloys retain their linear elastic and / or non-hyperelastic characteristics and / or properties over a wide temperature range.

[0107] In some embodiments, the linear elastic and / or non-hyperelastic nickel-titanium alloy may be nickel in the range of about 50 to about 60 weight percent, with the remainder being substantially titanium. In some embodiments, the weight percentage of nickel in the composition is in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, which is commercially available from Furukawa Techno Material Co., Ltd. in Kanagawa, Japan. Other suitable materials may include ULTANIUM. TM (Available from Neo-Metrics) and GUM METAL TM (Available from Toyota). In some other embodiments, a superelastic alloy (e.g., superelastic nitinol) can be used to achieve the desired properties.

[0108] In at least some embodiments, part or all of the occlusive implant 10 (and its variants, systems, or components disclosed herein) 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 fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user determine the location of the occlusive implant 10 (and its variants, systems, or components disclosed herein). 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. Furthermore, other radiopaque marking strips and / or coils may also be incorporated into the design of the occlusive implant 10 (and its variants, systems, or components disclosed herein) to achieve the same effect.

[0109] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the occlusive implant 10 (and its variants, systems, or components disclosed herein). For example, the occlusive implant 10 (and its variants, systems, or components disclosed herein) and / or its components or portions may be made of materials that do not significantly distort the image or produce significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in (MRI) images. The occlusive implant 10 (and its variants, systems, or components disclosed herein) or portions thereof may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, etc.). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as...) (etc.), nickel-titanium, and other materials.

[0110] In some embodiments, the occlusive implant 10 (and its variants, systems, or components disclosed herein) and / or portions thereof may be made of or comprise polymers or other suitable materials. Some examples of suitable polymers may include copolymers, polyisobutylene-polyurethane, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), for example, those available from DuPont. Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., those available from DSM Engineering Plastics). ), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont) ), polyamide (e.g., available from Bayer). Or it may be available from Elf Atochem. ), elastic polyamide, block polyamide / ether, polyether block amide (PEBA, for example, capable of... ... (obtained under trademark), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g.) Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene diamine) (e.g., Polysulfone, nylon, nylon-12 (e.g., those available from EMS AmericanGrilon) Perfluoropropyl vinyl ether (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, polyurethane silicone copolymers (e.g., from Aortech Biomaterials) Or from AdvanSource Biomaterials Biocompatible polymers, other suitable materials, or mixtures thereof, compositions, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6 percent LCP.

[0111] In some embodiments, the occlusive implant 10 (and its variants, systems, or components disclosed herein) may comprise a textile material. Some examples of suitable textile materials may comprise synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked, or unshrinked. Suitable synthetic biocompatible yarns for use in this disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, ethylene polymers, polymethyl methacrylate, polyamides, polyethylene naphthalate derivatives, natural silks, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn, a glass yarn, a ceramic yarn, or a 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 comprise 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, or more specifically, in a way that forms a vascular structure with the desired properties.

[0112] In some embodiments, the occlusive implant 10 (and its variants, systems, or components disclosed herein) may include and / or be treated with a suitable therapeutic agent. Examples of suitable therapeutic agents 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 block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, epoch-forming alkaloids, epoch-forming alkaloids, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Ar). γ-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 promoters (e.g., growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, and translational repressors); angiogenesis inhibitors (e.g., growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational 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 the synergistic mechanism of endogenous angiogenesis.

[0113] While the above discussion generally pertains to occlusive implants used in the left atrial appendage of the heart, the aforementioned features can also be used in other types of medical implants in which fabric or membrane is attached to a frame or support structure. These medical implants include, but are not limited to, implants for treating aneurysms (e.g., abdominal aortic aneurysms, thoracic aortic aneurysms, etc.), valve replacement implants (e.g., heart valve replacement implants, aortic valve replacement implants, mitral valve replacement implants, vascular valve replacement implants, etc.), and / or other types of occlusive devices (e.g., atrial septal occluders, cerebral aneurysm occluders, peripheral artery occluders, etc.). Other useful applications of the disclosed features are also considered.

[0114] It should be understood that this disclosure is illustrative in many respects only. Changes in detail may be made, 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 example 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 framework, configured to switch between collapse and expansion structures; A blocking member disposed along at least a portion of the expandable frame; A first collar is attached to the expandable frame; A sensor housing connected to the first collar, the sensor housing having a first end and a second end opposite to the first end; A second collar, slidably disposed along the outer surface of the sensor housing, wherein the second collar is spring-connected to the expandable frame; and A sensor is disposed along a second end of the sensor housing, wherein the extension of the spring is configured to shift the second collar from a first position to a second position, in the first position being adjacent to the first collar, and in the second position being adjacent to the sensor.

2. The occlusive implant according to claim 1, wherein, The spring is wound around the outer surface of the sensor housing.

3. The occlusive implant according to claim 1, wherein, The spring includes a first end connected to the first collar and a second end connected to the second collar.

4. The occlusive implant according to claim 1, wherein, The spring includes a first end connected to the sensor housing and a second end connected to the second collar.

5. The occlusive implant according to any one of claims 1-4, wherein, The first collar includes a hole, and the sensor housing extends within the hole of the first collar.

6. The occlusive implant according to any one of claims 1-4, wherein, The first collar extends circumferentially around the outer surface of the sensor housing.

7. The occlusive implant according to any one of claims 1-4, wherein, The first collar and the expandable frame are formed from a single piece of material.

8. The occlusive implant according to any one of claims 1-4, wherein, The expandable frame further includes a plurality of struts attached to the first collar.

9. The occlusive implant according to any one of claims 1-4, wherein, The expandable structure further includes a plurality of pillars attached to the sensor housing.

10. The occlusive implant according to any one of claims 1-4, wherein, The first collar is configured to remain stationary relative to the sensor housing when the expandable frame transitions between a collapsed configuration and an expanded configuration.

11. The occlusive implant according to any one of claims 1-4, wherein, The first collar is configured to remain stationary relative to the sensor housing as the second collar is displaced along the outer surface of the sensor housing.

12. The occlusive implant according to any one of claims 1-4, wherein, The sensor is positioned within the expandable frame such that it is positioned away from the occlusive member.

13. The occlusive implant according to any one of claims 1-4, wherein, The first portion of the occlusive member is attached to the expandable frame, while the second portion of the occlusive member is attached to the second collar.

14. An occlusive implant comprising: An expandable frame configured to switch between a collapsed structure and an expanded structure, the expandable frame comprising a plurality of struts spaced apart around a longitudinal axis of the expandable frame; A blocking member disposed along at least a portion of the expandable frame; A first collar is attached to a plurality of supports of the expandable frame, the first collar defining a hole, wherein the central region of the hole is aligned with the longitudinal axis of the expandable frame; A sensor housing, which is coupled to the first collar and extends along the longitudinal axis of the expandable frame, the sensor housing having a first end and a second end opposite to the first end; A second collar, slidably disposed along the outer surface of the sensor housing, wherein the second collar is spring-connected to the expandable frame; and The sensor is disposed along the second end of the sensor housing. The extension of the spring is configured to shift the second collar from a first position to a second position, in which the second collar is adjacent to the first collar, and in the second position, the second collar is adjacent to the sensor.

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