left atrial appendage closure inflatable foam delivery system

Abstract

A left atrial appendage closure device fitted to close the left atrial appendage includes a conical insert, which is formed from an inflatable foam and fitted for transseptal delivery to the LAA. A polymer cover is placed on the conical insert, which is fitted to protect the conical insert during transseptal delivery to the LAA and to be removed after transseptal delivery to the LAA. Before inflation of the conical insert, the insert lumen extends within the conical insert. A tubular support rod extends through the insert lumen and is operably connected to at least a portion of the polymer cover, and the tubular support rod itself defines a tubular support rod lumen fitted to accommodate a guidewire for advancing the insert into the LAA and / or a radiofrequency (RF) energy wire fitted for transseptal puncture.

Description

[Technical Field]

[0001] This disclosure relates in general to medical devices, and more specifically to medical devices adapted to detect leakage around a left atrial appendage closure device. [Background technology]

[0002] The left atrial appendage is a small organ attached to the left atrium of the heart. When the heart is functioning normally, the left atrial appendage contracts to pump blood into the left ventricle as the left atrium contracts. The contractility of the left atrial appendage helps to improve left ventricular filling, thereby maintaining cardiac output. However, in patients with atrial fibrillation, the left atrial appendage may not contract properly or may become empty, causing stagnant blood to accumulate inside, which can lead to the formation of undesirable blood clots within the left atrial appendage.

[0003] Thrombi that form in the left atrial appendage can detach from this area and enter the bloodstream. As these thrombi travel through the blood vessels, they can eventually block smaller vessels downstream, potentially causing stroke or heart attack. Clinical studies have shown that the majority of thrombi in patients with atrial fibrillation originate in the left atrial appendage. As a treatment, medical devices are being developed that are positioned to occlude the left atrial appendage. Known medical devices and methods each have their own advantages and disadvantages. There is an ongoing need to provide alternative medical devices, as well as alternative methods for manufacturing and using them. [Overview of the Initiative]

[0004] This disclosure provides alternative designs, materials, manufacturing methods, and uses for medical devices. One example is a left atrial appendage closure (LAAC) device adapted to close the left atrial appendage (LAA). The LAAC device includes an implant adapted for transseptal delivery to the LAA, the implant comprising an expandable foam. A polymer cover is placed on the implant and adapted to protect the implant during transseptal delivery to the LAA. The polymer cover is adapted to be removable after transseptal delivery to the LAA.

[0005] Alternatively, or in addition to the above, the LAAC device may further include an implant lumen extending within the implant before the implant is expanded, and a tubular support rod extending through the implant lumen, the tubular support rod being operably coupled to at least a portion of the polymer cover. The tubular support rod defines a tubular support rod lumen adapted to accommodate one or more of the following: a guidewire for advancing the implant into the LAA, and a radiofrequency (RF) energy wire adapted for performing transseptal puncture.

[0006] Alternatively, or in addition to the above, the implant may have a shape that facilitates transseptal delivery to the LAA. Alternatively, or in addition to the above, the implant may include an expandable foam that expands when it reaches a temperature higher than the ambient temperature.

[0007] Alternatively, or in addition to the above, the implant may include an expandable foam that expands when exposed to moisture. Alternatively, or in addition to the above, the proximal cover may include a distal region having a plurality of perforations formed within the polymer cover, the plurality of perforations being adapted to allow the polymer cover to be removed relative to the implant.

[0008] Alternatively, or in addition to the above, both the polymer cover and the tubular support rod may be fitted to be independently pulled proximal to expose the implant.

[0009] Alternatively, or in addition to the above, the LAAC device may further include a fracture point formed in the polymer cover, where pulling the tubular support rod proximal causes the polymer cover to detach at the fracture point, and a portion of the polymer cover distal to the fracture point is drawn through the implant lumen together with the tubular support rod.

[0010] Alternatively, or in addition to the above, the proximal cover may be adapted to dissolve after transseptal delivery to the LAA. Alternatively, or in addition to the above, the LAAC device may further include one or more anchoring mechanisms embedded in the implant for securing the LAAC device within the LAA.

[0011] Alternatively, or in addition to the above, the LAAC device may further include one or more tethers for temporarily securing the implant to the tubular support rod. Alternatively, or in addition to the above, the expandable foam may include a shape-memory foam.

[0012] Another example is a left atrial appendage closure (LAAC) device adapted to close the left atrial appendage (LAA). The LAAC device comprises an inflatable foam conical implant adapted for transseptal delivery to the LAA, and a conical cover positioned on the inflatable foam conical implant, the conical cover being adapted to protect the inflatable foam conical implant during transseptal delivery to the LAA, and the conical cover including a distal region having multiple perforations adapted to be torn to facilitate removal of the conical cover. When the conical implant is in a delivery configuration, an insertion lumen extends within the conical implant. A tubular support rod extends through the implant lumen, the tubular support rod being operably coupled to at least a portion of the conical cover, and the tubular support rod itself defining a tubular support rod lumen extending inward.

[0013] Alternatively, or in addition to the above, the implant lumen may be fitted such that it disappears as the expandable foam conical implant expands. Alternatively, or in addition to the above, the LAAC device may further include one or more anchoring mechanisms embedded within the expandable foam conical implant for securing the LAAC device within the LAA.

[0014] Alternatively, or in addition to the above, the LAAC device may further include one or more tethers for temporarily securing the expandable foam conical implant to the tubular support rod.

[0015] Another example is a left atrial appendage closure (LAAC) device adapted to close the left atrial appendage (LAA). The LAAC device includes a shape memory foam implant adapted for transseptal delivery to the LAA and a conical cover positioned on the shape memory foam insert, the conical cover being adapted to protect the shape memory foam implant during transseptal delivery to the LAA, and the conical cover including a distal region having multiple perforations adapted to be torn to facilitate removal of the conical cover. When the shape memory foam implant is in the delivery configuration, an implant lumen extends within the shape memory foam implant. A tubular support rod extends through the implant lumen and is operably coupled to at least a portion of the conical cover, the tubular support rod itself defining a tubular support rod lumen extending inward. The shape memory foam implant is adapted to expand in diameter when implanted in the LAA.

[0016] Alternatively, or in addition to the above, the LAAC device may further include one or more anchoring mechanisms embedded within the shape memory foam implant for securing the LAAC device within the LAA.

[0017] Alternatively, or in addition to the above, the LAAC device may further include one or more tethers for temporarily securing the shape memory foam implant to the tubular support rod. Alternatively, or in addition to the above, the shape memory foam implant may be adapted to expand within the LAA.

[0018] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of this disclosure. The drawings and the following detailed description are intended to illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0019] The present disclosure can be more fully understood by considering the following detailed description in conjunction with the accompanying drawings. [Figure 1] It is a partial cross-sectional view of the LAA (left atrial appendage). [Figure 2] It is a schematic diagram of an LAAC (left atrial appendage closure) device. [Figure 3] It is a cross-sectional view taken along line 3-3 of FIG. 2. [Figure 4] It is a schematic diagram of the state where the LAAC device in FIG. 2 is partially expanded. [Figure 5] It is a cross-sectional view taken along line 5-5 of FIG. 4. [Figure 6] It is a schematic diagram of the state where the LAAC device in FIG. 2 is further expanded. [Figure 7] It is a cross-sectional view taken along line 7-7 of FIG. 6. [Figure 8] FIGS. 8 to 11 are schematic diagrams showing the state where the degree of expansion of the LAAC device in FIG. 2 deployed in the LAA of FIG. 1 increases. <00 chemo <00 chemo [Figure 9] The same as above. <00 chemo <00 chemo [Figure 10] The same as above. <00 chemo <00 chemo [Figure 11] The same as above. <00 chemo <00 chemo [Figure 12] It is a schematic diagram of an LAAC (left atrial appendage closure) device. <00 chemo <00 chemo [Figure 13] It is a cross-sectional view taken along line 13-13 of FIG. 12. <00 chemo <00 chemo [Figure 14] It is a schematic diagram of an exemplary delivery device. <00 chemo <00 chemo

Mode for Carrying Out the Invention

[0020] <00 chemo 00 chemo The present disclosure can follow various modifications and alternative forms. However, the details are shown as examples in the drawings and will be described in detail herein. It should be understood, however, that the intention is not to limit the invention to the specific embodiments described. On the contrary, it is intended to include all modifications, equivalents, and alternatives within the spirit and scope of the present disclosure. <00 chemo 00 chemo [[ID=[]]<00 chemo 00 chemo

[0021] [[ID=[]]<00 chemo 00 chemo Detailed Description [[ID=[]]<00 chemo 00 chemo The following description should be read with reference to the drawings, although the drawings are not necessarily to scale, and similar reference numbers in some drawings indicate similar elements. The detailed description and drawings are intended to illustrate, and not limit, the present disclosure. Those skilled in the art will recognize that various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure. However, for ease of clarity and understanding, not all features and / or elements may be shown in each drawing, but unless otherwise specified, such features and / or elements should be understood to be present.

[0022] The terms defined below shall apply unless otherwise given in the claims or elsewhere herein. In this specification, all numerical values, whether expressly indicated or not, are considered to be qualified by the term “approximately.” The term “approximately” generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. Often, the term “approximately” may include numerical values ​​rounded to the nearest significant figure.

[0023] When specifying a numerical range with upper and lower limits, all numbers within that range are included (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used herein and in the appended claims, the singular forms “one,” “it,” and “the foregoing” refer to multiple subjects unless the context clearly indicates otherwise. As used herein and in the appended claims, the term “or” is used collectively to mean “and / or” unless the context clearly indicates otherwise.

[0024] Where used herein and in the appended claims, the singular forms “one,” “it,” and “the foregoing” refer to multiple subjects unless the context clearly indicates otherwise. Where used herein and in the appended claims, the term “or” is used generally to include “and / or” unless the context clearly indicates otherwise. For ease of understanding, note that certain features of this disclosure may be described in the singular form even if they are plural or repeated within the disclosed embodiments. Each example of a feature may include a single disclosure and / or be encompassed by a single disclosure unless expressly stated to the contrary. For the purposes of simplification and clarity, not all elements of this disclosure are necessarily shown in each figure or described in detail below. However, unless expressly stated to the contrary, it will be understood that the following descriptions may apply equally to any and / or all of the multiple components. Furthermore, for clarity, not all examples of some elements or features are shown in each figure.

[0025] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations are typically considered in relation to the positioning, orientation, and / or manipulation of various elements of a device relative to the user / operator / manipulator. Here, “proximal” and “backward” indicate or refer to being close to or toward the user, while “distal” and “forward” indicate or refer to being far from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and such examples will be readily apparent 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, such as a body lumen, a blood vessel, or within a device. Further relative terms such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or their variations are typically referred to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0026] The terms “monolithic” and “single” generally refer to an element made from or consisting of a single structure or basic unit / element. Monolithic and / or single elements do not include structures and / or features made by assembling or combining multiple individual elements.

[0027] References in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include certain features, structures, or characteristics, but it should be noted that not all embodiments necessarily include those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, if a particular feature, structure, or characteristic is described in relation to an embodiment, it is within the knowledge of those skilled in the art to use that particular feature, structure, or characteristic in relation to other embodiments, whether or not it is explicitly stated, unless otherwise explicitly stated. In other words, the various individual elements described below can be combined or arranged to form other additional embodiments or to supplement and / or enhance the embodiments described, even if they are not explicitly shown in specific combinations, as can be understood by those skilled in the art.

[0028] For clarity, specific numerical nomenclature (e.g., First, Second, Third, Fourth, etc.) may be used throughout this specification and / or claims to name and / or distinguish the various features described and / or claimed. It should be understood that numerical nomenclature is not intended to be limiting, but merely illustrative. In some embodiments, for brevity and clarity, modifications and deviations from previously used numerical nomenclature may be made. That is, a feature identified as the “First” element may later be referred to as the “Second” element, the “Third” element, etc., or may be omitted entirely, and / or a different feature may be referred to as the “First” element. The meaning and / or names in each example will be obvious to those skilled in the art.

[0029] The following figures illustrate selected components and / or arrangements of an implant for closing the left atrial appendage, a system for closing the left atrial appendage, and / or a method of using the implant and / or system. Note that in any figure, for simplification, some features may be omitted or shown schematically. Additional details regarding some components of the implant and / or system may be shown in more detail in other figures. Although left atrial appendage closure is described, the implant and / or system may also be used in other interventional and / or percutaneous medical procedures in patients. Similarly, the devices and methods described herein with respect to percutaneous deployment may be used in other types of surgical procedures as needed. For example, in some cases, the devices may be used in non-percutaneous procedures. The devices and methods according to this disclosure may also be adapted and configured for other use within anatomical structures.

[0030] Figure 1 is a partial cross-sectional view of the left atrial appendage 10. In some embodiments, the left atrial appendage (LAA) 10 may have a complex shape and / or irregular surface area. It will be understood that the illustrated LAA 10 is only one of many possible shapes and sizes of the LAA 10, and will vary from patient to patient. Those skilled in the art will also recognize that the medical devices, systems, and / or methods disclosed herein may be adapted to various sizes and shapes of the LAA 10 as needed. The left atrial appendage 10 may include a substantially longitudinal axis 12 positioned along the depth of the body 20 of the left atrial appendage 10. The body 20 may include side walls 14 and a small hole 16 forming a proximal opening 18. In some examples, the lateral extent of the small hole 16 and / or side walls 14 may be less than the depth of the body 20 along the longitudinal axis 12, i.e., the depth of the body 20 may be greater than the lateral extent of the small hole 16 and / or side walls 14. In some cases, the LAA10 may narrow rapidly along the depth of the body 20, or the left atrial appendage may maintain a nearly constant lateral range along most of the depth of the body 20. In some cases, the LAA10 may include a most distal region formed or positioned as a caudate element associated with the distal portion of the body 20. In some cases, the most distal region may project radially or laterally from the longitudinal axis 12.

[0031] In some cases, the LAA10 may be reached via a transseptal approach, in which case it is reached by passing from the right atrium through the atrial septum into the left atrium. This is considered an endocardial approach and is understood to be less invasive than an epicardial approach. In some cases, the transseptal approach reaches the right atrium, and then the atrial septum is punctured using a guidewire or RF (radiofrequency) energy wire. From there, the LAA10 can be reached by passing through the atrial septum into the left atrium. Figure 2 is a schematic diagram of an exemplary LAAC (left atrial appendage closure) device 22 delivered by a transseptal approach and used to occlude the LAA10. Figure 3 is a cross-sectional view of the LAAC device 22 along line 3-3 in Figure 2. In some cases, the LAAC device 22 may be advanced along a guidewire 24 through the right atrium, atrial septum, and left atrium to the LAA10. In some cases, the guidewire 24 may be fitted to provide a non-traumatic distal end by forming a pigtail 26. In some cases, the guidewire 24 may not form a pigtail 26 and therefore may not be considered to include a non-traumatic distal tip.

[0032] The LAAC device 22 includes an implant 28 adapted for transseptal delivery to the LAA 10. In some cases, the implant 28 may have a shape or overall profile that facilitates transseptal delivery to the LAA 10. In some cases, the implant 28 may have a tapered profile, having its minimum diameter at its distal end and expanding to a larger diameter towards its proximal end. An example of a tapered profile is a conical shape. Since the implant 28 would lose this characteristic shape upon expansion, references to the profile of the implant 28 should generally be understood as referring to the collapsed configuration of the implant 28.

[0033] In some cases, the implant 28 may be formed from or contain an expandable foam. In some cases, the expandable foam may be a shape-memory foam that can be adapted to return to a memorized shape upon application of or exposure to one or more appropriate stimuli, or may contain a shape-memory foam. For example, a shape-memory foam may expand to a memorized expanded configuration when exposed to moisture (such as blood) or temperature (such as body temperature) that is higher than the ambient temperature outside the patient. In some cases, a shape-memory foam may expand when exposed to a combination of moisture and high temperature. In some cases, a shape-memory foam may expand to a diameter up to 10 times or more its original diameter, which is sometimes called a 1:10 expansion. In some cases, a shape-memory foam may expand much more than this.

[0034] In some cases, the implant 28 itself may be rigid enough to withstand septal transposition. In some cases, the LAAC device 22 may include a polymer cover 30 that covers the implant 28. The polymer cover 30 may be fitted to provide additional rigidity to the LAAC device 22. In some cases, the polymer cover 30 may be fitted to prevent the implant 28 from being exposed to blood when the LAAC device 22 is advanced into the LAA 10. The polymer cover 30 may be formed from any suitable polymer material. Specific examples include semi-crystalline or crystalline polymers such as polyethylene terephthalate (PET), polypropylene (PP), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), and polyamide (nylon); thermoplastic polyesters such as polylactic acid (PLA, PLLA, PLGA); amorphous polymers such as polycarbonate (PC) and polymethyl methacrylate (PMMA); or complex thermoplastic elastomers such as polyurethane (PUR - various suitable compositions) and polyether block amide (PEBAX).

[0035] As illustrated in Figure 3, in a non-expanding configuration, the implant 28 defines an insertion lumen 32 extending axially within the conical implant 28. In some cases, it will be understood that as the implant 28 begins to expand, the expansion of the form forming the implant 28 may obscure or bury the implant lumen 32. The tubular support rod 34 is fitted to extend within the implant lumen 32 and itself defines a tubular support rod lumen 36 extending within the tubular support rod 34. The tubular support rod 34 may be formed from any suitable metallic or polymer material. As an example, the tubular support rod 34 may include or be formed from a hypotube or a more flexible polymer tube. The tubular support rod 34 may be considered fitted to accommodate a guidewire 24 extending through the tubular support rod lumen 36 when placed within the implant lumen 32. If the guidewire 24 is not positioned within the lumen 36 of the tubular support rod, it will be understood that an RF energy wire (not shown) may extend through the lumen 36 of the tubular support rod to puncture the atrial septum.

[0036] In some cases, the LAAC device 22 may include one or more tethers 38 extending from the implant 28 to the tubular support rod 34. The one or more tethers 38 can be formed from any suitable material, such as surgical suture, and may be adapted to hold the implant 28 in place relative to the tubular support rod 34, for example, until the tubular support rod 34 is pulled back proximal. As will be described later, in some cases, the LAAC device 22 may include one or more anchors or fixation members (not shown in Figures 2 and 3) that help hold the LAAC device 22 in place before the implant 28 fully expands.

[0037] In some cases, the LAAC device 22 has a polymer cover 30 (and the implant 28 within it) that defines a constant diameter region 40, a tapered region 42, and a distal tip region 44. The tapered region 42 narrows distally from the constant diameter region 40 to the distal tip region 44. In some cases, a tubular support rod 34 may be fixed to the polymer cover 30 within the distal tip region 44. It will be understood that the distal tip region 44 has the minimum diameter to accommodate the tubular support rod 34, while still providing (together with the tapered region 42) the minimum surface area for advancing the LAAC device 22 through the vascular system to reach the LAA 10.

[0038] In some cases, as shown in Figure 2, for example, the polymer cover 30 may include a pattern of perforations 46 adapted to allow the implant 28 to be exposed to body temperature blood in the LAA 10 by cutting open the polymer cover 30 and pulling it back proximal. In some cases, the perforation pattern 46 includes a first set of perforations 48 located within a tapered region 42 and a second set of perforations 50 located within a distal tip region 44. In some cases, the perforations 46 may extend across the entire thickness of the polymer cover 30. In some cases, the perforations 46 may extend only partway across the thickness of the polymer cover 30, creating a weak point where the polymer cover 30 will preferentially break when sufficient force is applied. Alternatively, in some cases, the polymer cover 30 may be adapted to dissolve after being exposed to blood for a certain period of time, or a solution that dissolves the polymer cover 30 may be injected into the LAA 10.

[0039] It will be understood that only the distal portion of the LAAC device 22 is shown. In some cases, the LAAC device 22 may include a proximal handle that has the function of controlling the deployment of the conical implant 28. The proximal handle may also have the function of enabling the removal of the conical implant 28. In some cases, the proximal handle enables the engagement of the anchoring mechanism. The delivery system may include such a proximal handle and may also include the function of enabling, for example, flushing of the system or injection of contrast agent. For example, the delivery system may be maneuverable. An example of a delivery system is shown in Figure 14.

[0040] In some cases, the implant 28 can be exposed by pulling both the proximal cover 30 and the tubular support rod 34 back proximal, thereby exposing the form forming the implant 28 to the body temperature blood in the LAA 10. In Figure 4, a schematic diagram of the LAAC device 22, and in Figure 5, a cross-sectional view along line 5-5 in Figure 4, it can be seen that the polymer cover 30 is detached at the first set of perforations 48. The second set of perforations 50 is also detached, thereby freeing the tubular support rod 34 from the distal tip region 44. In some cases, applying tensile force to the polymer cover 30 can detach the perforations 48. As shown, the tapered region 42 is distal to the rest of the polymer cover 30, so the conical implant 28 is beginning to be exposed to the environment outside the polymer cover 30.

[0041] Figure 6 is a schematic diagram of the LAAC device 22, and Figure 7 is a cross-sectional view of the LAAC device 22 along line 7-7 in Figure 6. In Figure 6, it can be seen that the diameter is beginning to expand where it was previously a tapered region 42. The tubular support rod 34 has been pulled back somewhat but remains in the insertion lumen 32, as does the guidewire 24. One or more tethers 38 still secure the implant 28 to the tubular support rod 34. Figure 8 is similar to Figure 6 but shows the LAAC device 22 positioned near the LAA 10. As shown, the LAAC device 22 includes a bulge 60 resulting from the expansion of a portion of the implant 28 as a result of exposure to body temperature blood in and around the LAA 10. In some cases, as shown, the LAAC device 22 includes an anchor 62 extending distally from the bulge 60. A single anchor 62 is shown, but in some cases there may be two, three, or more anchors 62. In some cases, the anchor 62 may be embedded within the conical implant 28, and as the implant 28 expands, the anchor 62 may extend outward from the expanded portion 60.

[0042] In Figure 9, the LAAC device 22 is advanced distally into the LAA 10, and the anchor 62 engages with the wall of the LAA 10. In some cases, the anchor 62 helps to hold the LAAC device 22 in place relative to the LAA 10 until the implant 28 has completed its expansion. Moving to Figure 10, we can see that the expanded portion 60 has expanded further and now occupies a larger portion of the volume of the LAA 10. The tether 38 still holds the implant 28 in place relative to the tubular support rod 32 (not visible in this figure). In Figure 11, the components of the LAAC device 22 other than the implant 28 are pulled back proximal. This detaches the tether 38 that was holding the implant 28 to the tubular support rod 32, and the polymer cover 30 is pulled back proximal.

[0043] Figure 12 is a schematic diagram of an exemplary LAAC (left atrial appendage closure) device 72 that can be delivered by a transseptal approach and used to occlude the LAA10. Figure 13 is a cross-sectional view of the LAAC device 72 along the line 13-13 in Figure 12. In some cases, the LAAC device 72 may be advanced along a guidewire 24 through the right atrium, atrial septum, and left atrium to the LAA10. In some cases, the guidewire 24 may be adapted to provide a non-traumatic distal end by forming a pigtail 26. In some cases, the guidewire 24 may not form a pigtail 26 and therefore may not be considered to include a non-traumatic distal end.

[0044] The LAAC device 72 includes an implant 78 adapted for transseptal delivery to the LAA 10. In some cases, the implant 78 may be formed from or contain an expandable foam. In some cases, the expandable foam may be a shape-memory foam, or may contain a shape-memory foam, that can be adapted to return to a memorized shape upon application of or exposure to one or more appropriate stimuli. For example, a shape-memory foam may expand to a memorized expanded configuration when exposed to moisture (such as blood) or temperature (such as body temperature) that is higher than the ambient temperature outside the patient. Alternatively, a shape-memory foam may expand when exposed to a combination of moisture and high temperature. In some cases, this exposure may provide several advantages, such as significant expansion that can seal large openings, such as the LAA 10, while reducing the delivery size. In some cases, a shape-memory foam may exhibit controlled expansion initiation; that is, the shape-memory foam does not begin to expand until exposed to moisture and / or high temperature within the patient's body.

[0045] In some cases, the implant 78 itself may be rigid enough to withstand septal transposition. In some cases, the LAAC device 72 may include a polymer cover 80 that covers the implant 78. The polymer cover 80 may be fitted to provide additional rigidity to the LAAC device 72. In some cases, the polymer cover 80 may be fitted to prevent the implant 78 from being exposed to blood when the LAAC device 22 is advanced into the LAA 10. The polymer cover 80 may be formed from any suitable polymer material. A specific example is the polymer cover 30 described.

[0046] As illustrated in Figure 13, in a non-expanding configuration, the implant 78 defines an insertion lumen 82 extending axially within the implant 78. In some cases, it will be understood that as the implant 78 begins to expand, the expansion of the form forming the implant 78 may obscure or bury the implant lumen 82. The tubular support rod 84 is fitted to extend within the implant lumen 82 and itself defines a tubular support rod lumen 86 extending within the tubular support rod 84. The tubular support rod 84 may be formed from any suitable metallic or polymer material. As an example, the tubular support rod 84 may include or be formed from a hypotube or polymer tube. When the tubular support rod 84 is placed within the implant lumen 82, it may be considered fitted to accommodate a guidewire 24 extending through the tubular support rod lumen 86. If the guidewire 24 is not positioned within the lumen 86 of the tubular support rod, it will be understood that an RF energy wire (not shown) may extend through the lumen 86 of the tubular support rod to puncture the atrial septum.

[0047] In some cases, the LAAC device 22 may include one or more tethers 88 extending from the implant 78 to the tubular support rod 84. The one or more tethers 88 can be formed from any suitable material, such as surgical suture, and may be adapted to hold the implant 78 in place relative to the tubular support rod 84, for example, until the tubular support rod 84 is pulled back proximal. In some cases, the LAAC device 72 may include one or more anchors or fixation members (not shown in Figures 2 and 3) that help hold the LAAC device 22 in place before the implant 78 fully expands.

[0048] In some cases, the LAAC device 22 has a polymer cover 80 (and the implant 78 within it) that defines a constant diameter region 40, a tapered region 42, and a distal tip region 44. The tapered region 42 narrows distally from the constant diameter region 40 to the tip region 44. In some cases, a tubular support rod 84 may be fixed to the polymer cover 80 within the distal tip region 44. It will be understood that the distal tip region 44 has the minimum diameter to accommodate the tubular support rod 84, while still providing (together with the tapered region 42) the minimum surface area for advancing the LAAC device 72 through the vascular system to reach the LAA 10.

[0049] In some cases, the polymer cover 80 may include a first region 80a and a second region 80b, with a fracture point 80c located between the first region 80a and the second region 80b. In some cases, the first region 80a may be fitted to be pulled proximal along the outside of the conical implant 78, and the second region 80b may be fitted to be pulled proximal within the implant lumen 82 together with the tubular support rod 84. The second region 80b includes a first set of perforations 90, and the distal tip region 44 includes a second set of perforations 92. In some cases, the perforations 90 and 92 may extend across the entire thickness of the polymer cover 30. In some cases, the perforations 90 and 92 may only extend partway across the thickness of the polymer cover 80, becoming a weak point where the polymer cover 80 preferentially fractures when sufficient force is applied.

[0050] Figure 14 is a schematic diagram of an exemplary delivery system 100. The exemplary delivery system 100 includes an integrated introduction mechanism 102 extending on a long shaft 104. The long shaft 104 extends distally from a handle 106. It will be understood that the distal region of the long shaft 104 may be adapted to accommodate and releasably engage with the LAAC device 22. In some cases, the handle 106 may include an external flushing port 108 that allows a flushing fluid, such as saline, to be introduced outside the central lumen 32. In some cases, the handle 106 may include an internal flushing port 110 that allows a flushing fluid, such as saline, to be introduced into the central lumen 32.

[0051] The handle 106 may also include a plurality of control elements 112, individually designated as 112a, 112b, and 112c. While a total of three control elements 112 are shown, it will be understood that in some cases the handle 106 may include fewer than three control elements 112. In some cases the handle 96 may include four, five, or more control elements 112. Each of the control elements 112 may be a knob, lever, slide, or handle that affects movement or operation at the distal end. Examples of movement or operation at the distal end include, but are not limited to, extending and retracting the outer housing mechanism, extending and retracting the central lumen 32, or moving the central lumen 32 simultaneously with the outer housing mechanism to retract the outer housing into the central lumen 32, activating the anchoring mechanism, and activating the disconnection mechanism between the delivery system 100 and the LAAC device 22. These are merely examples.

[0052] The expandable foam can transition from an initial configuration to an expanded configuration when exposed to a specific temperature or temperature range, and / or moisture, and can provide a suitable density in the expanded configuration for use within the left atrial appendage, thereby achieving a closure effect without adversely affecting the surrounding anatomical structure. This can include any suitable material, such as a suitable polymer material. In some cases, the expandable foam may be a shape memory foam. A suitable transition temperature is, for example, about 37°C to about 50°C, which includes about 37°C to about 40°C. This allows the shape memory foam to take an initial configuration before and during delivery via a delivery catheter or other delivery device, and an expanded configuration for closure after delivery and release within the left atrial appendage. The appropriate density of the shape memory foam in the expanded configuration is one in which the expanded configuration is flexible and compliant, substantially conforms to the anatomical structure of the left atrial appendage, forming a seal that prevents thrombus formation and leakage, while possessing sufficient radial force to seal the left atrial appendage without damaging or affecting the surrounding anatomical structure. In some cases, the density of the shape memory foam in the expanded configuration is about 10 kg / m³ 3 ~About 1000kg / m 3 This is approximately 10 kg / m³3 ~about 500kg / m 3 This includes approximately 10 kg / m 3 ~about 200kg / m 3 This includes approximately 20 kg / m 3 ~about 100kg / m 3 It includes.

[0053] In general, the materials that make up shape memory foam are polymer materials that are both biocompatible and substantially biostable. In some cases, biocompatibility includes meeting or exceeding the requirements of established standards for implant materials as defined in ISO 10993 and USP Class VI. Substantially biostable materials include not only materials that are not reabsorbed over the expected lifespan of the medical device (e.g., 5, 10, or more years), but also materials that are slowly reabsorbed over several months to a year, being replaced by tissue-like material with stable void volume.

[0054] In some cases, shape memory foam may contain natural and / or synthetic materials. Suitable natural materials include, for example, extracellular matrix (ECM) biopolymers such as collagen, fibronectin, hyaluronic acid, and elastin; non-ECM biomaterials such as cross-linked albumin and fibrin; and inorganic bioceramics such as hydroxyapatite and tricalcium phosphate. Suitable synthetic materials include, for example, saturated and unsaturated polyolefins such as polyethylene, polyacrylic, polyacrylate, polymethacrylate, polyamide, polyimide, polyurethane, and polyurea; polyvinyl aromatics such as polystyrene; polyisobutylene copolymers such as styrene-isobutylene-styrene tert-block copolymer (SIBS) and polyisobutylene-styrene block copolymer; copolymers of vinyl monomers such as polyvinylpyrrolidone, polyvinyl alcohol, and ethylene vinyl acetate (EVA); polyesters such as polyvinyl ether and polyethylene terephthalate; polyethers such as polyacrylamide, polyethylene glycol, polytetrahydrofuran, and polyethersulfone; silicones such as polycarbonate and siloxane polymers; fluoropolymers such as polyvinylidene fluoride; and biostable polymers such as mixtures and copolymers thereof.

[0055] In some cases, the shape memory foam may contain bioabsorbable materials, resulting in the formation of a biostable tissue matrix through absorption. Synthetic bioabsorbable polymers can be selected from, for example, the following: (a) polyester homopolymers and copolymers, e.g., polyglycolide (PGA; polyglycolic acid), poly-L-lactide, poly-D-lactide and poly-D,L-lactide-containing polylactide (PLA; polylactic acid), poly(β-hydroxybutyric acid), poly-D-gluconic acid, poly-L-gluconic acid, polygluconic acid-containing poly-D,L-gluconic acid, poly(ε-caprolactone), poly(δ- (b) valerolactone, poly(p-dioxanone), poly(lactide-co-glycolide) (PLGA), poly(lactide-co-δ-valerolactone), poly(lactide-co-ε-caprolactone), poly(lactide-co-β-malic acid), poly(β-hydroxybutyrate-co-β-hydroxyvalerate), poly[1,3-bis(p-carboxyphenoxy)propane-co-sebacic acid], and poly(sebacic acid-co-fumaric acid); (b) polycarbonate homopoly (c) Remers and copolymers, e.g., poly(trimethylenecarbonate), poly(lactide-co-trimethylenecarbonate), and poly(glycolide-co-trimethylenecarbonate); (d) Poly(orthoester) homopolymers and copolymers, e.g., those synthesized by copolymerization of various diketene acetals and diols; (e.g., poly(adipic anhydride), poly(suberic acid anhydride), poly(sebacic acid anhydride); (e) water compounds, poly(dodecanediic anhydride), poly(maleic anhydride), poly[1,3-bis(p-carboxyphenoxy)methane anhydride], and poly[α,ω-bis(p-carboxyphenoxy)alkane anhydride], e.g., poly[1,3-bis(p-carboxyphenoxy)propane anhydride] and poly[1,3-bis(p-carboxyphenoxy)hexane anhydride]; (e) polyphosphazenes, e.g., amino-substituted polyphosphazenes and alkoxy-substituted polyphosphazenes;(f) Amino acid polymers, including tyrosine polymers, such as tyrosine polyacrylates (for example, copolymers of diphenol and diacid linked by ester bonds, where the diphenol is selected from, for example, ethyl, butyl, hexyl, octyl, and benzyl esters of desaminotyrosyltyrosine, and the diacid is selected from, for example, succinic acid, glutaric acid, adipic acid, suberic acid, and sebacic acid), and tyrosine polycarbonates (for example, phosgene and, for example, ethyl, butyl, and hexyl esters of desaminotyrosyltyrosine). Examples include copolymers formed by condensation polymerization with diphenols selected from xyl, octyl, and benzyl esters, tyrosine-based iminocarbonates, tyrosine-based, leucine-based, and lysine-based polyesteramides. Specific examples of tyrosine-based polymers include polymers composed of desaminotyrosyltyrosine hexyl ester, desaminotyrosyltyrosine, and various diacids such as succinic acid and adipic acid. Suitable materials include cross-linked polycarbonates and cross-linked polyethylene glycols.

[0056] In some cases, the shape memory foam may include thermosetting polyurethanes containing oxidizable bonds in the soft segments, including but not limited to tertiary amines and polyethers. The shape memory foam may optionally contain hydrolyzable soft segment components such as polycaprolactones and esters.

[0057] Shape memory forms have a heat transition point (transition temperature), and below that temperature, residual stress is maintained even without load restraint. Thermal activation (causing shape memory) can be achieved by the target material breaking through the semi-crystalline melting point or glass transition temperature between the first configuration and the expanded configuration. Several suitable thermal activation processes are known in the art and are also useful herein. In one example, a temperature-activated memory shape form can be formed for use as a medical device by first shaping a shape memory form formed from a suitable material into the final expanded configuration, i.e., the configuration that provides the desired closure effect when the shape memory form is inserted into the left atrial appendage. In this expanded configuration, the shape memory form can typically have a diameter in the range of about 10 millimeters to about 50 millimeters and a length in the range of about 1 centimeter to about 5 centimeters, although other diameters and lengths are also within the scope of the present disclosure. Once this is complete, the form can be heated above the transition temperature of the material, i.e., the temperature at which the desired expansion occurs. As described above, a suitable transition temperature can be from about 37°C to about 50°C. Once the desired transition temperature is reached, the shape memory form is held at a constant temperature and re-shaped into the initial (unexpanded) configuration. This re-shaping is appropriately carried out within a forming element of suitable size and can be of any suitable shape. In this collapsed configuration, the shape memory form typically has a diameter of less than 4.7 millimeters and a length in the range of about 2 centimeters to about 5 centimeters, although other diameters and lengths are also within the scope of the present disclosure. After insertion into the forming element, a new shape is set by lowering the temperature below the transition temperature. For example, a new shape can be set by lowering the temperature to room temperature. Once this is complete, the shape memory form remains in its initial configuration until exposed to a temperature above the transition temperature, at which point it expands to the expanded, i.e., remembered, configuration. In some cases, exposure to moisture in the blood causes a change in the glass transition temperature of the form. As an example, the T g (glass transition temperature) of the shape memory form can be above body temperature and the T g when wet after exposure to moisture can be below body temperature.

[0058] The materials that can be used in the devices described herein may include those commonly associated with medical devices. The devices or their components described herein may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Examples of suitable metals and alloys include stainless steel, e.g., 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys, e.g., linear elastic and / or superelastic Nitinol; other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS:N06625, e.g., INCONEL® 625, UNS:N06022, e.g., HASTELLOY® C-22, UNS:N10276, e.g., HASTELLOY® )C276, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, e.g., MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, e.g., MP35-N, etc.), nickel-molybdenum alloys (e.g., UNS:N10665, e.g., HASTELLOY® ALLOY Examples include 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, e.g., ELGILOY®, PHYNOX®, etc.); platinum-high stainless steel; titanium; combinations thereof; etc.; or other suitable materials.

[0059] In at least some embodiments, the devices or components disclosed herein may be doped with radiopaque materials, made of radiopaque materials, or otherwise contain radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopic screen or other imaging techniques during medical procedures. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials filled with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils can also be incorporated into the design of the guidewire 10 to achieve the same result.

[0060] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is provided to the devices or components described herein. For example, the devices or components described herein may be made of materials that do not substantially distort images and do not produce substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials may not be suitable because they can produce artifacts in MRI images. The devices or components described herein may be made of materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), and nitinol.

[0061] To define a generally smooth outer surface, a sheath or cover (not shown) may be placed over some or all of the devices described herein. However, in other embodiments, such a sheath or cover may not be present. The sheath may be made from a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, e.g., HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer). CRISTAMID® (available from Atochem), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, available as trade name PEBAX®, for example), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanExamples include GRILAMID® (available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the sheath can be blended with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.

[0062] In some embodiments, the outer surface of the devices described herein may be subjected to sandblasting, bead blasting, sodium bicarbonate blasting, electropolishing, etc. In these and some other embodiments, coatings, such as lubricating, hydrophilic, protective, or other types of coatings, may be applied. Alternatively, the sheath may include lubricating, hydrophilic, protective, or other types of coatings. Hydrophobic coatings, such as fluoropolymers, improve guidewire handling and device replacement by providing dry lubrication. Lubricating coatings improve maneuverability and the ability to pass through lesions. Suitable lubricating polymers are well known in the art and include hydrophilic polymers such as silicones, such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkylcellulose, algin, sugars, caprolactone, and mixtures and combinations thereof. Hydrophilic polymers can be mixed with themselves or in compounded amounts of water-insoluble compounds (including some polymers) to produce coatings with suitable lubricity, adhesion, and solubility. Several other examples of such coatings and the materials and methods used to create such coatings are described in U.S. Patent Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.

[0063] Some of the devices described herein can be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or by fusing the ends of several segments. The layers may have uniform stiffness or their stiffness may gradually decrease from the proximal end to the distal end. The gradual decrease in stiffness may be continuous, as in the case of ILC, or stepwise, as in the case of fusing separately extruded tubular segments. The outer layer may be impregnated with radiopaque filler material to improve visibility in radiographic images. Those skilled in the art will see that these materials can be broadly modified without departing from the scope of this disclosure.

[0064] It should be understood that this disclosure is illustrative in many respects. Modifications can be made without exceeding the scope of this disclosure, particularly in terms of shape, size, and sequence of processes. This may include, to the appropriate extent, using any feature of one exemplary embodiment in other embodiments. Naturally, the scope of the invention is defined by the language expressed in the appended claims.

Claims

1. A left atrial appendage closure (LAAC) device fitted to close the left atrial appendage (LAA), wherein the LAAC device is An implant adapted for transseptal delivery to LAA, the implant comprising an expandable foam, and A polymer cover placed on the implant, which is fitted to protect the implant during transseptal delivery to the LAA and is fitted to be removable after transseptal delivery to the LAA. LAAC devices, including those mentioned above.

2. The LAAC device is Before the expansion of the implant, the implant lumen extending within the implant, and A tubular support rod extending through the lumen of the implant The tubular support rod is operably coupled to at least a portion of the polymer cover, and the tubular support rod itself is A guide wire for advancing the aforementioned implant into the LAA, and Radiofrequency (RF) energy wire adapted for transseptal puncture. The LAAC device according to claim 1, comprising defining a lumen of a tubular support rod adapted to accommodate one or more of the following.

3. The LAAC device according to claim 1 or 2, wherein the implant has a shape that facilitates transseptal delivery to the LAA.

4. The LAAC device according to any one of claims 1 to 3, wherein the implant comprises an expandable foam that expands when exposed to moisture and / or when it reaches a temperature higher than the ambient temperature.

5. The LAAC device according to any one of claims 1 to 4, wherein the proximal cover includes a distal region having a plurality of perforations formed within the polymer cover, the plurality of perforations being adapted to allow the polymer cover to be removed relative to the implant.

6. The LAAC device according to claim 3, wherein both the polymer cover and the tubular support rod are fitted to be independently pulled proximal to expose the implant.

7. The LAAC device according to claim 3, further comprising a fracture point formed in the polymer cover, wherein when the tubular support rod is pulled proximal, the polymer cover is separated at the fracture point, and a portion of the polymer cover distal to the fracture point is drawn through the implant lumen together with the tubular support rod.

8. The LAAC device according to any one of claims 1 to 4, wherein the proximal cover is adapted to dissolve after transseptal delivery to the LAA.

9. The LAAC device according to any one of claims 1 to 8, further comprising one or more anchoring mechanisms embedded in the implant for fixing the LAAC device within the LAA.

10. The LAAC device according to any one of claims 1 to 9, further comprising one or more tethers for temporarily fixing the implant to the tubular support rod.

11. The LAAC device according to any one of claims 1 to 10, wherein the expandable foam includes a shape memory foam.

12. A left atrial appendage closure (LAAC) device fitted to close the left atrial appendage (LAA), wherein the LAAC device is An expandable foam cone implant adapted for transseptal delivery to the LAA, A conical cover positioned on the expandable foam conical implant, the conical cover including a distal region having a plurality of perforations fitted to protect the expandable foam conical implant during transseptal delivery to the LAA and fitted to be torn to facilitate removal of the conical cover, When the conical implant is in a delivery configuration, the insertion lumen extends within the conical implant, A tubular support rod extending through the lumen of the implant, operably coupled to at least a portion of the conical cover, the tubular support rod itself defining the tubular support rod lumen extending inside, and the tubular support rod and LAAC devices, including those mentioned above.

13. One or more anchoring mechanisms embedded in the expandable foam conical implant for fixing the LAAC device within the LAA, and / or One or more tethers for temporarily securing the expandable foam cone implant to the tubular support rod. The LAAC device according to claim 12, further comprising:

14. A left atrial appendage closure (LAAC) device fitted to close the left atrial appendage (LAA), wherein the LAAC device is Shape memory foam implants adapted for transseptal delivery to LAA, A conical cover disposed on the shape memory foam insert, the conical cover includes a distal region having a plurality of perforations fitted to protect the shape memory foam implant during transseptal delivery to the LAA and to be torn to facilitate removal of the conical cover, When the shape memory foam implant is in a delivery configuration, the implant lumen extends within the shape memory foam implant, A tubular support rod extending through the lumen of the implant, operably coupled to at least a portion of the conical cover, the tubular support rod itself defining the tubular support rod lumen extending inside, and the tubular support rod and An LAAC device comprising a shape memory foam implant that is adapted to expand in diameter when embedded in the LAA.

15. One or more anchoring mechanisms embedded in the expandable foam conical implant for fixing the LAAC device within the LAA, and / or One or more tethers for temporarily securing the expandable foam cone implant to the tubular support rod. The LAAC device according to claim 14, further comprising:

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