Rotatable ultrasound catheter for detecting leaks of left atrial appendage closure device

Abstract

Implanting a left atrial appendage closure (LAAC) device within a left atrial appendage (LAA) of a patient may include advancing an assembly to a location proximate the LAA of the patient. The assembly includes a LAAC device releasably secured to the LAAC delivery catheter, and one or more ultrasound transducers disposed relative to the LAAC delivery catheter. Once the LAAC device is deployed, the ultrasound transducer may rotate relative to the LAAC device to find leakage between the LAAC device and the LAA. In some cases, the LAAC device may be repositioned relative to the LAA when excessive leaks are found via ultrasound.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 427,696, filed on November 23, 2022, the disclosure of which is incorporated herein by reference. Technical field

[0003] The present disclosure generally relates to medical devices and, more particularly, to medical devices adapted to detect leaks around left atrial appendage closure devices. Background art

[0004] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, as the left atrium contracts and forces blood into the left ventricle, the left atrial appendage contracts and forces blood into the left atrium. The ability of the left atrial appendage to contract helps to improve the filling of the left ventricle, thus playing a role in maintaining cardiac output. However, in patients with atrial fibrillation, the left atrial appendage may not contract or empty properly, resulting in stagnant blood pooling within it, which can lead to the formation of unwanted thrombi within the left atrial appendage.

[0005] Thrombi formed in the left atrial appendage may break free from the area and enter the bloodstream. Thrombi migrating through the blood vessels may eventually block smaller downstream blood vessels and thereby cause a stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation originate in the left atrial appendage. As a treatment method, medical devices have been developed for closing the left atrial appendage. In known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using such medical devices. Summary of the invention

[0006] The present disclosure provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example can be found in a method of implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA). The method includes advancing a component to a position adjacent to the patient's LAA, the component including an LAAC device releasably secured to an LAAC delivery catheter and one or more ultrasound transducers positioned relative to the LAAC delivery catheter. The method includes deploying the LAAC device within the LAA and then rotating the ultrasound transducer relative to the LAAC device to search for gaps and / or leaks between the LAAC device and the LAA.

[0007] Alternatively or additionally, the method may further include repositioning the LAAC device in response to detecting a gap and / or leak.

[0008] Alternatively or additionally, one or more ultrasound transducers can be part of an ultrasound catheter.

[0009] Alternatively or additionally, the ultrasound catheter can be steerable.

[0010] Alternatively or additionally, the method can further include steering the ultrasound catheter to better visualize any possible leaks between the LAAC device and the LAA.

[0011] Alternatively or additionally, rotating one or more ultrasound transducers can include rotating the ultrasound catheter around the LAAC delivery catheter.

[0012] Alternatively or additionally, rotating one or more ultrasound transducers can include rotating the ultrasound catheter in place relative to the LAAC delivery catheter.

[0013] Alternatively or additionally, one or more ultrasound transducers can be disposed on the LAAC delivery device.

[0014] Alternatively or additionally, rotating one or more ultrasound transducers can include rotating the LAAC delivery device.

[0015] Another example can be found in a component suitable for implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA). The component includes an LAAC device releasably secured to an LAAC delivery catheter and one or more ultrasound transducers disposed relative to the LAAC delivery catheter.

[0016] Alternatively or additionally, one or more ultrasound transducers can be part of an ultrasound catheter.

[0017] Alternatively or additionally, the ultrasound catheter can be steerable.

[0018] Alternatively or additionally, the ultrasound catheter can be adapted to rotate around the LAAC delivery catheter.

[0019] Alternatively or additionally, the ultrasound catheter can be adapted to rotate in place relative to the LAAC delivery catheter.

[0020] Alternatively or additionally, one or more ultrasound transducers can be disposed on the LAAC delivery catheter.

[0021] Alternatively or additionally, the LAAC delivery device can have a releasable connection between the LAAC delivery catheter and the LAAC device, and the releasable connection can be adapted to allow relative rotation therebetween without releasing the LAAC device.

[0022] Another example can be found in a component adapted for implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA). The component includes an LAAC device releasably secured to an LAAC delivery catheter, and a steerable ultrasound catheter rotatably disposed relative to the LAAC delivery catheter.

[0023] Alternatively or additionally, the component may further include a tubular member through which both the LAAC delivery catheter and the steerable ultrasound catheter extend.

[0024] Alternatively or additionally, the steerable ultrasound catheter may be adapted to rotate about the LAAC delivery catheter within the tubular member.

[0025] Alternatively or additionally, the steerable ultrasound catheter may be adapted to rotate in place relative to the LAAC delivery catheter within the tubular member.

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

[0027] The present disclosure may be more fully understood when considered in conjunction with the following detailed description taken in conjunction with the accompanying drawings, in which:

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

[0029] Figure 2 is a side view of an illustrative left atrial appendage closure (LAAC) device delivery catheter, with the LAAC device shown in a collapsed configuration;

[0030] Figure 3 is Figure 2 a side view of the illustrative LAAC device delivery catheter of

[0031] Figure 4 with the LAAC device shown in an expanded configuration;

[0032] Figure 5 is a perspective view of an illustrative expandable frame forming part of the LAAC device;

[0033] Figure 6 is a perspective view of an illustrative LAAC device;

[0034] Figure 7 is a schematic view of a portion of an illustrative component including an LAAC device delivery catheter and an ultrasound catheter;

[0035] Figure 7A andFigure 7B is a cross-sectional view of a portion of an illustrative assembly including a LAAC device delivery catheter and an ultrasound catheter;

[0036] Figure 8 is a schematic view of an illustrative assembly including a LAAC device delivery catheter and an ultrasound catheter;

[0037] Figure 9 is a schematic view of an illustrative assembly including a LAAC device delivery catheter and an ultrasound catheter; and

[0038] Figure 10 is a schematic view of an illustrative assembly including a LAAC device delivery catheter including an ultrasound transducer disposed thereon.

[0039] While the present disclosure is capable of various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0040] The following description should be read with reference to the drawings, which are not necessarily to scale, in which like reference numerals indicate like elements throughout the several views. The detailed description and the drawings are intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings illustrate example embodiments of the present disclosure. However, for the sake of clarity and ease of understanding, while each feature and / or element may not be shown in each drawing, the (multiple) features and / or elements can be understood to be present nonetheless unless otherwise indicated.

[0041] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0042] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant digit.

[0043] A numerical range recited by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0044] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its inclusive sense of "and / or" unless the context clearly provides otherwise.

[0045] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its inclusive sense of "and / or" unless the context clearly provides otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular, although such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by the singular disclosure unless clearly stated to the contrary. For simplicity and clarity purposes, not all elements of the present disclosure are necessarily shown in each drawing or discussed in detail below. However, it should be understood that the following discussion may equally apply to any and / or all components in which there are more than one component, unless clearly stated to the contrary. Additionally, for clarity, not all instances of certain elements or features may be shown in each drawing.

[0046] Relative terms such as "proximal", "distal", "advance", "retract", their variants, and the like can generally be regarded as relating to the positioning, orientation, and / or operation of various elements relative to the user / operator / handler of the device, where "proximal" and "retract" indicate or refer to being close to or towards the user, and "distal" and "advance" indicate or refer to being further away or away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily assigned in an effort to facilitate understanding of the present disclosure, and such instances will be 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, blood vessel) or within a device. Still other relative terms, such as "axial", "circumferential", "longitudinal", "transverse", "radial", etc. and / or their variants generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0047] The terms "monolithic" and "integral" shall generally refer to one or more elements made of or consisting of a single structure or base unit / element. Monolithic and / or integral elements shall exclude structures and / or features made by assembling or otherwise combining a plurality of separate elements.

[0048] Note that in the specification, the recitation of "one embodiment", "some embodiments", "other embodiments", etc. indicates that the described (multiple) embodiments may include a particular feature, structure, or characteristic, but each embodiment does not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in connection with an embodiment, whether or not explicitly described, using that particular feature, structure, or characteristic in connection with other embodiments will be within the knowledge of those skilled in the art, unless the contrary is explicitly stated. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are still contemplated to be combinable or arrangeable with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as would be understood by a person of ordinary skill in the art.

[0049] For clarity purposes, certain identified numerical nomenclatures (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish between various described and / or claimed features. It should be understood that the numerical nomenclature is not intended to be restrictive and is merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numerical nomenclature may be changed and deviated from. 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 altogether, and / or different features may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to a skilled practitioner.

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

[0051] Figure 1is a partial cross-sectional view of the left atrial appendage 10. In some embodiments, the left atrial appendage (LAA) 10 can have a complex geometry and / or an irregular surface area. It should be understood that the illustrated LAA 10 is merely one of many possible shapes and sizes for the LAA 10, which can vary from patient to patient. Those skilled in the art will also recognize that the medical devices, systems, and / or methods disclosed herein can be adapted as needed to various sizes and shapes of the LAA 10. The left atrial appendage 10 can include a generally longitudinal axis 12 disposed along the depth of the body 20 of the left atrial appendage 10. The body 20 can include a sidewall 14 and an opening 16 that forms a proximal mouth 18. In some examples, the lateral extent of the opening 16 and / or the sidewall 14 can be less than or fewer than the depth of the body 20 along the longitudinal axis 12, or the depth of the body 20 can be greater than the lateral extent of the opening 16 and / or the sidewall 14. In some examples, the LAA 10 can rapidly narrow along the depth of the body 20 or the left atrial appendage can maintain a generally constant lateral extent along most of the depth of the body 20. In some examples, the LAA 10 can include a most distal region that is formed or arranged as a caudal element associated with the distal portion of the body 20. In some examples, the most distal region can project radially or laterally away from the longitudinal axis 12.

[0052] Figure 2 and Figure 3 shows selected components and / or arrangements of the LAAC device delivery catheter 22, which is adapted for delivering a LAAC device for occluding the LAA 10. It should be noted that in any given drawing, for the sake of brevity, some features of the LAAC device delivery catheter 22 may not be shown, or may be shown schematically. Additional details regarding some components of the LAAC device delivery catheter 22 can be shown in more detail in other drawings.

[0053] The LAAC device delivery catheter 22 can include a delivery sheath 40 having a lumen 42 extending from a proximal opening to a distal opening, a wire 30 slidably disposed within the lumen 42, and a LAAC device 100 for occluding the LAA 10. The LAAC device 100 can include an expandable frame 110 (e.g. Figure 4 ), which is configured to shift between a fully constrained configuration (e.g. Figure 2 ) in which the LAAC device 100 is disposed within the lumen 42 near the distal opening in the delivery configuration) and a fully unconstrained configuration (e.g. Figure 3 ), wherein the LAAC device 100 and / or the expandable frame 110 are configured to shift between the fully constrained configuration and the fully unconstrained configuration as the LAAC device 100 is translated relative to the delivery sheath 40. In at least some embodiments, the expandable frame 110 can be self-biased towards the fully unconstrained configuration.

[0054] The LAAC device 100 can be disposed at and / or releasably secured to the distal portion of the core wire 30. The core wire 30 can be slidably and / or rotatably disposed within the lumen 42 of the delivery sheath 40. In some embodiments, the proximal end of the core wire 30 can extend proximally at the proximal end of the delivery sheath 40 and / or the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the LAAC device 100 can be removably attached, coupled, secured, or otherwise connected to the distal end of the core wire 30. The core wire 30 can be configured to and / or be capable of axially translating the LAAC device 100 relative to the delivery sheath 40. In one example, the core wire 30 can be advanced distally while the delivery sheath 40 is held in a constant position. In another example, the core wire 30 can be advanced distally while the delivery sheath 40 is retracted proximally. In yet another example, the core wire 30 can be held in a constant position while the delivery sheath 40 is retracted proximally relative to the core wire 30 and / or the LAAC device 100. Other configurations are also contemplated. The delivery sheath 40 and / or the core wire 30 can have a selected level of axial stiffness and / or pushability characteristics, while also having a selected level of flexibility to allow navigation through the patient's vasculature.

[0055] Some suitable but non-limiting examples of materials for the LAAC device delivery catheter 22, the core wire 30, the delivery sheath 40, and / or the LAAC device 100, etc. are discussed below. It is contemplated that any of the exemplary LAAC devices disclosed herein can be used in accordance with and / or in association with the exemplary LAAC device delivery catheter 22 described above.

[0056] The LAAC device 100 can include an expandable frame 110 that is configured to axially and / or radially displace between a fully constrained configuration and a fully unconstrained configuration along a central longitudinal axis. In the fully constrained configuration, the expandable frame 110 can be axially elongated and / or radially compressed. In the fully unconstrained configuration, the expandable frame 110 can be axially shortened and / or radially expanded.

[0057] As Figure 4 shown, which illustrates selected features of the LAAC device 100 in the fully unconstrained configuration, the expandable frame 110 can have a plurality of struts disposed about the central longitudinal axis. In some embodiments, the plurality of struts can define a plurality of cells. In some embodiments, the plurality of cells can be a plurality of closed cells. In some embodiments, the plurality of cells can be a plurality of open cells. In some embodiments, the plurality of cells can include a plurality of open cells and a plurality of closed cells in various combinations and / or arrangements.

[0058] The expandable frame 110 may include a proximal hub 112 and a distal hub 114. In some embodiments, the proximal hub 112 and / or the distal hub 114 may be centered about and / or coaxial with a longitudinal axis. A plurality of struts are joined together and / or fixedly attached to the proximal hub 112 and / or the distal hub 114 at the proximal hub 112 and / or the distal hub 114. The proximal hub 112 may be configured to releasably connect, secure, and / or attach the LAAC device 100 and / or the expandable frame 110 to the core wire 30. In some embodiments, the proximal hub 112 may include internal threads configured to rotatably and / or threadedly engage the external threaded distal end of the core wire 30. Other configurations for releasably securing the LAAC device 100 to the core wire 30 are also contemplated. As noted herein, certain features are not shown in each drawing for purposes of clarity.

[0059] The expandable frame 110 and / or the plurality of struts may be formed from and / or cut from tubular members. In some embodiments, the expandable frame 110 and / or the plurality of struts may be integrally formed and / or cut from a monolithic member. In some embodiments, the expandable frame 110 and / or the plurality of struts may be integrally formed and / or cut from a monolithic tubular member and then formed and / or heat set into a desired shape in a completely unconstrained configuration. In some embodiments, the expandable frame 110 and / or the plurality of struts may be integrally formed and / or cut from a monolithic flat member or sheet and then rolled or formed into a tubular structure and then formed and / or heat set into a desired shape. Some exemplary means and / or methods for manufacturing and / or forming the expandable frame 110 and / or the plurality of struts include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and / or methods are also contemplated.

[0060] As will be appreciated by those skilled in the art, anatomical features may vary in size and / or shape. In some embodiments, the left atrial appendage may have an irregular (e.g., elongated and / or oval) cross-sectional shape. In some embodiments, the expandable frame 110 may be compliant and substantially conform to the shape and / or geometry of the sidewall of the LAA 10 and / or sealably engage the shape and / or geometry of the sidewall of the LAA 10 when deployed and / or inflated therein. In some embodiments, the LAAC device 100 may be inflated to a size, extent, or shape that is less than or different from a completely unconstrained configuration, as determined by the surrounding tissue and / or sidewall of the LAA 10. In some embodiments, the expandable frame 110 may be configured to shape and / or stretch the tissue of the LAA 10 such that the sidewall of the LAA 10 substantially conforms to the external shape of the expandable frame 110. Other configurations are also contemplated.

[0061] In some embodiments, the expandable frame 110 may include at least one anchoring member 116 that extends radially outwardly therefrom in a completely unconstrained configuration. In some embodiments, the expandable frame 110 may include at least one anchoring member 116 that extends radially outwardly from the expandable frame 110. In some embodiments, the expandable frame 110 may include at least one anchoring member 116 that extends radially outwardly from a location on the expandable frame 10 proximate the proximal shoulder of the expandable frame 110. In some embodiments, the expandable frame 110 may include at least one anchoring member 116 that extends radially outwardly from a location on the expandable frame 110 proximate the middle portion of the expandable frame 110. In some embodiments, at least one anchoring member 116 may be configured to engage the sidewall of the body of the left atrial appendage. In some embodiments, at least one anchoring member 116 may be formed as a J-shaped hook having a free end that extends and / or is directed in a proximal direction relative to the central longitudinal axis of the left atrial appendage closure device 100 and / or the expandable frame 110. Other configurations are also contemplated.

[0062] In some embodiments, the LAAC device 100 may optionally include an occlusion element 120 that is connected to at least a portion of the expandable frame 110 and / or a plurality of struts, disposed on at least a portion of the expandable frame 110 and / or a plurality of struts, disposed above at least a portion of the expandable frame 110 and / or a plurality of struts, disposed around at least a portion of the expandable frame 110 and / or a plurality of struts, and / or disposed radially outward of at least a portion of the expandable frame 110 and / or a plurality of struts, as Figure 5 shown. In some embodiments, the occlusion element 120 may be attached to the proximal hub 112 and / or may be attached to the expandable frame at the proximal hub 112. In some embodiments, the occlusion element 120 may extend radially outwardly from the proximal hub 112 and / or may extend distally from the proximal hub 112. In some embodiments, the occlusion element 120 may be attached and / or secured to the expandable frame 110 at a plurality of discrete locations. In some embodiments, one, some, and / or all of the at least one anchoring member 116 may extend through the occlusion element 120, if present.

[0063] In some embodiments, the occluding element 120 may include a membrane, fabric, mesh, tissue element, or another suitable structure. In some embodiments, the occluding element 120 may be porous. In some embodiments, the occluding element 120 may be non-porous. In some embodiments, the occluding element 120 may be permeable to selected gases and / or fluids. In some embodiments, the occluding element 120 may be substantially impermeable to selected gases and / or fluids (such as blood, water, etc.). In some embodiments, the occluding element 120 may be designed, sized, and / or configured to prevent thrombus and / or embolization material from passing out of the left atrial appendage into the left atrium and / or the patient's bloodstream. In some embodiments, the occluding element 120 may be configured to promote endothelization after implantation, thereby effectively removing the targeted site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable but non-limiting examples of materials for the occluding element 120 are discussed below.

[0064] The LAAC device delivery catheter 22 discussed above can be used to deliver and deploy the LAAC 100. Since the LAA 10 in one patient is likely to be different from the LAA 10 in another patient, it will be appreciated that each implantation may not be perfect. Depending on how exactly the LAAC device 100 is deployed relative to the LAA 10, there may be one or more gaps between the LAAC device 100 and the LAA 10. In some cases, leakage or blood flowing through these one or more gaps can limit the effectiveness of the LAAC device 100 and should be minimized if not eliminated. In some cases, ultrasound can be used in conjunction with the LAAC device delivery catheter 22 to look for gaps and / or leaks before the LAAC device delivery catheter 22 is withdrawn. If a gap and / or leak is found, the LAAC device 100 can be repositioned. Repositioning the LAAC device 100 may include re-sheathing the LAAC device 100 to fold the LAAC device 100 into its folded configuration and then repositioning the LAAC device delivery catheter 22 before redeploying the LAAC device 100.

[0065] Figure 6is a perspective view of an illustrative assembly 150 that includes a LAAC device delivery catheter 152 and an ultrasound catheter 154. In some cases, for example, the ultrasound catheter 154 is an intravascular cardiac echography (ICE) catheter. The assembly 150 includes a LAAC device 100 that is secured to the LAAC device delivery catheter 152 via the proximal hub 112 of the LAAC device 100. For example, the LAAC device delivery catheter 152 can be considered an example of the LAAC device delivery catheter 22. In some cases, the LAAC device delivery catheter 152 can include or otherwise represent the core wire 30 shown with respect to Figure 2 and Figure 3 Any features attributed to the LAAC device delivery catheter 22 can be considered applicable to the LAAC device delivery catheter 152.

[0066] The ultrasound catheter 154 is shown as including an ultrasound transducer 156. Although a single ultrasound transducer 156 is shown, this is merely illustrative as the ultrasound catheter 154 can include any number of different ultrasound transducers 156. Figure 6 A field 158 is schematically shown that represents what the ultrasound transducer 156 potentially can see. It can be seen that the field 158 extends far enough in the radial direction so as to be able to see beyond the periphery of the LAAC device 100. Thus, this means that the field 158 should extend into any space or void that exists between the LAAC device 100 and the LAA 10 in which the LAACC device 100 is implanted. By rotating the ultrasound transducer 156 in a 360-degree circle, all paths around the LAAC device 100 can be seen and thus any potential gaps and / or leaks that are present. Ultrasound may be able to visualize any gaps and / or leaks that exist between the LAAC device 100 and the LAA 10, and in some cases Doppler can be used to confirm possible leaks.

[0067] In some cases, a gap can be seen between the LAAC device 100 and the tissue of the LAA 10. In some cases, blood flowing through the gap between the LAAC device 100 and the tissue of the LAA 10 can be visible via ultrasound. If a leak and / or gap is detected, various different actions can be taken. As an example, the physician can decide to implant the LAAC device 100 in the position where the LAAC device 100 currently is, or the physician can decide to reposition the LAAC device 100 before releasing the LAAC device 100. In some cases, the physician can decide to abort the procedure. In some cases, the physician can decide to remove the LAAC device 100 and implant a different sized device. In some cases, the physician can decide to add an additional device to address the leak, for example, such as adding an embolization coil or a foam plug.

[0068] Component 150 includes a tubular member 160 that is configured to hold close to the LAAC device delivery catheter 152 and the ultrasound catheter 154. In some cases, such as, for example, in Figure 6 as shown, the tubular member 160 can be a short element that fits closely around the LAAC device delivery catheter 152 and the ultrasound catheter 154. In some cases, the tubular member 160 can be a longer tubular element and / or may not fit closely around the LAAC device delivery catheter 152 and the ultrasound catheter 154. In some cases, the tubular member 160 can be an extruded member having two or more lumens extending therethrough, where the LAAC device delivery catheter 152 extends through one lumen and the ultrasound catheter 154 extends through another lumen. So long as the ultrasound catheter 154 is able to rotate relative to the LAAC device delivery catheter 152, the tubular member 160 can take any of a variety of forms.

[0069] Figure 7A is a schematic cross-sectional view showing the LAAC device delivery catheter 152 and the ultrasound catheter 154 inside the tubular member 162. As Figure 7A shown, the ultrasound catheter 154 is able to rotate around the LAAC device delivery catheter 152 in a planetary motion inside the tubular member 162. Figure 7B is a schematic cross-sectional view showing the LAAC device delivery catheter 152 and the ultrasound catheter 154 inside the tubular member 162. As Figure 7B shown, the ultrasound catheter 154 does not rotate around the LAAC device delivery catheter 152, but instead rotates in place next to the LAAC device delivery catheter 152. It should be understood that for either form of motion of the ultrasound catheter 154, the ultrasound catheter 154 is able to "see" all paths around the LAAC device 100, except for areas that may be blocked, at least in part, by any components or portions of the LAAC device delivery 152 that are at least partially radiopaque.

[0070] Figure 8 and Figure 9 are schematic views of an illustrative component 164. The illustrative component 164 includes an LAAC device delivery catheter 166 and a steerable ultrasound catheter 168. The LAAC device delivery catheter 166 and the steerable ultrasound catheter 168 are coupled together via a tubular member 170. The steerable ultrasound catheter 168 includes an ultrasound transducer 172. Although a single ultrasound transducer 172 is shown, this is merely illustrative, as the steerable ultrasound catheter 168 can include any number of different ultrasound transducers 172. Figure 8 and Figure 9Field 174 is schematically shown representing what the ultrasonic transducer 172 can potentially see. It can be seen that the field 174 extends far enough in the radial direction to be able to see beyond the periphery of the LAAC device 100. Thus, this means that the field 174 should extend into any space or void existing between the LAAC device 100 and the LAA 10 in which the LAACC device 100 is implanted. By rotating the ultrasonic transducer 172 in a 360-degree circle, all paths around the LAAC device 100 can be seen and thus any potential leaks present. The ultrasound may be able to visualize any gaps existing between the LAAC device 100 and the LAA 10, and in some cases Doppler can be used for confirmation. The LAAC device delivery catheter 166 and the steerable ultrasound catheter 168 extend through the guiding catheter 176.

[0071] The steerable ultrasound catheter 168 has a distal region 178 that can be steered to provide an improved image. In some cases, Figure 8 the field 174 shown in may not be able to satisfactorily fully see any gaps existing between the LAAC device 100 and the LAA 10 in which the LAAC device 100 is implanted. In some cases, bending the distal region 178 (which effectively changes the direction at which the ultrasonic transducer 172 is aimed) can provide a field 174' that provides a better view, as Figure 9 shown. In some cases, the steerable ultrasound catheter 168 may include an elongate member that extends proximally within the steerable ultrasound catheter 168 from the distal region 178, and the elongate member can be manipulated to cause the distal region 178 to bend or curve.

[0072] Figure 10 is a schematic diagram of an illustrative assembly 180. The illustrative assembly 180 includes a combined catheter 182 that has not only an ultrasonic transducer 184 but also a threaded engagement portion 186 that is configured to releasably engage the proximal hub 112 of the LAAC device 100. In other words, the combined catheter 182 combines the functions of the LAAC device delivery catheter and the ultrasound catheter into a single-piece device. In some cases, the threaded engagement portion 186 is adapted to allow the combined catheter 182 to rotate relative to the LAAC device 100 by at least 360 degrees without disconnecting the LAAC device 100. Thus, the ultrasonic transducer 184 that generates the field 188 is able to rotate around at least 360 degrees without prematurely releasing the LAAC device 100. In some cases, the LAAC device 100 can be intentionally disconnected by rotating the combined catheter 182 multiple turns.

[0073] Although a single ultrasound transducer 184 is shown, this is merely illustrative, as the combined catheter 182 can include any number of different ultrasound transducers 184. By rotating the ultrasound transducer 184 in a 360-degree circle, all paths around the LAAC device 100 can be seen and thus any potential leaks that are present. Ultrasound may be able to visualize any gaps that exist between the LAAC device 100 and the LAA 10, and in some cases Doppler can be used to confirm.

[0074] The materials that can be used for the devices described herein can include those commonly associated with medical devices. The devices or components thereof described herein can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low carbon steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as UNS:N06022, such as UNS:N10276, such as other alloys and the like), nickel-copper alloys (e.g., UNS:N04400, such as and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as and the like), nickel-molybdenum alloys (e.g., UNS:N10665, such as alloys ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as and the like); platinum-enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

[0075] As implied herein, within the commercially available family of nickel-titanium or nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic" which, while chemically similar to conventional shape memory and superelastic varieties, can exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol does not display a substantial "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a generally linear, or slightly but not necessarily completely linear relationship until plastic deformation begins or at least in a more linear relationship than the superelastic plateau and / or flag region seen with superelastic nitinol. Thus, for the purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0076] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol can accept strains up to about 2% to 5% while remaining substantially elastic (e.g., prior to plastic deformation), while superelastic nitinol can accept strains up to about 8% prior to plastic deformation. Both of these materials can be distinguished from other linear elastic materials (such as stainless steel), which may only accept strains of about 0.2% to 0.44% prior to plastic deformation (which can also be distinguished by their composition).

[0077] In some embodiments, linear elastic and / or non-superelastic nitinol alloys are alloys that do not display any detectable martensite / austenite phase transformation by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) over a large temperature range. For example, in some embodiments, there may be no detectable martensite / austenite phase transformation by DSC and DMTA analysis in linear elastic and / or non-superelastic nitinol alloys in the range of about -60 degrees Celsius (°C) to about 120 °C. Thus, over this very wide temperature range, the mechanical bending properties of this class of materials can be generally inert to temperature. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nitinol alloys at ambient or room temperature are substantially the same as their mechanical properties at body temperature, for example because they do not display a superelastic plateau and / or flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nitinol alloys maintain their linear elastic and / or non-superelastic characteristics and / or properties.

[0078] In some embodiments, the nickel weight percentage of a linear elastic and / or non-superelastic nickel-titanium alloy can be in the range of about 50% to about 60%, with the remainder being substantially titanium. In some embodiments, the composition is nickel in the range of about 54% to about 57% by weight. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno Materials Co., Ltd., Kanaagawa, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (available from Toyota, Japan). In some other embodiments, superelastic alloys (e.g., superelastic nitinol) may be used to achieve the desired performance.

[0079] In at least some embodiments, the devices or components thereof described herein may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the guidewire 10 to achieve the same result.

[0080] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the devices or components thereof described herein. For example, the devices or components thereof described herein may be made of materials that do not substantially distort the image and create substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in the MRI image. The devices or components thereof described herein may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as and the like), nitinol and the like, and others.

[0081] A sheath or covering (not shown) may be provided over some or all of the devices described herein to define a generally smooth outer surface. However, in other embodiments, such a sheath or covering may be absent. The sheath may be made of a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., ) available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ) available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as ) available from DuPont), polyamide (e.g., ) available from Bayer or ) available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name ), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as ) available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites and the like. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0082] In some embodiments, the outer surface of the devices described herein can be sandblasted, bead blasted, soda blasted, electropolished, etc. In these and some other embodiments, a coating can be applied, such as a smooth, hydrophilic, protective, or other type of coating. Alternatively, the sheath can include a smooth, hydrophilic, protective, or other type of coating. Hydrophobic coatings, such as fluoropolymers, provide dry lubricity, which improves guidewire handling and device exchange. Smooth coatings improve maneuverability and the ability to cross lesions. Suitable smooth polymers are well known in the art and can include siloxanes and the like, hydrophilic polymers such as high density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkylcellulose, alginates, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed with each other or with a formulated amount of water-insoluble compounds, including some polymers, to produce a coating with suitable lubricity, adhesion, and solubility. Some other examples of such coatings, as well as materials and methods for creating such coatings, can be found in U.S. Patent Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.

[0083] Portions of the devices described herein can be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or end-to-end fusing of several segments. The layer can have a uniform stiffness or a stiffness that gradually decreases from its proximal end to its distal end. The gradual decrease in stiffness can be continuous, such as by ILC, or can be stepwise, such as by fusing together separate extruded tubular segments. The outer layer can be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without departing from the scope of the present disclosure.

[0084] It should be understood that the present disclosure is illustrative in many respects. Changes can be made in the details, particularly in the arrangement of shape, size, and steps, without departing from the scope of the present disclosure. This can include, to the extent appropriate, using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined in the language of the appended claims.

Claims

1. A method of implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA), the method comprising: Advancing a component to a position proximal to the patient's LAA, the component comprising: An LAAC device releasably securable to an LAAC delivery catheter; and One or more ultrasonic transducers disposed relative to the LAAC delivery catheter; Deploying the LAAC device within the LAA; and Rotating the ultrasonic transducer(s) relative to the LAAC device to find gaps and / or leaks between the LAAC device and the LAA.

2. The method according to claim 1, wherein The one or more ultrasonic transducers are part of an ultrasonic catheter.

3. The method according to claim 2, wherein The ultrasonic catheter is steerable.

4. The method according to claim 3, further comprising steering the ultrasonic catheter to better view any possible leaks between the LAAC device and the LAA.

5. The method according to any one of claims 2 to 4, wherein Rotating the one or more ultrasonic transducers comprises rotating the ultrasonic catheter about the LAAC delivery catheter.

6. The method according to any one of claims 2 to 4, wherein Rotating the one or more ultrasonic transducers comprises rotating the ultrasonic catheter relative to the LAAC delivery catheter in place.

7. The method according to claim 1, wherein The one or more ultrasonic transducers are disposed on the LAAC delivery device.

8. The method according to claim 7, wherein Rotating the one or more ultrasonic transducers comprises rotating the LAAC delivery device.

9. A component suitable for implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA), the component comprising: An LAAC device releasably securable to an LAAC delivery catheter; And One or more ultrasonic transducers disposed relative to the LAAC delivery catheter.

10. The component according to claim 9, wherein, The one or more ultrasonic transducers are part of an ultrasonic catheter.

11. The component according to claim 9, wherein, The one or more ultrasonic transducers are disposed on the LAAC delivery catheter.

12. A component suitable for implanting a left atrial appendage closure (LAAC) device within a patient's left atrial appendage (LAA), the component comprising: An LAAC device releasably securable to an LAAC delivery catheter; And A steerable ultrasonic catheter rotatably disposed relative to the LAAC delivery catheter.

13. The component according to claim 12 further includes a tubular member, wherein, Both the LAAC delivery catheter and the steerable ultrasonic catheter extend through the tubular member.

14. The component according to claim 13, wherein, The steerable ultrasonic catheter is adapted to rotate about the LAAC delivery catheter within the tubular member.

15. The component according to claim 13, wherein The steerable ultrasonic catheter is adapted to rotate relative to the LAAC delivery catheter in place within the tubular member.

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