Clot processing systems, such as for removal of clot substances from level atrial audial laa, and associated

Abstract

CLOT PROCESSING SYSTEMS, AND ASSOCIATED DEVICES AND METHODS, are disclosed herein. In some embodiments, a clot treatment system includes a catheter having a shaped distal portion configured to enter a left atrial appendage of a patient. The shaped distal portion of the catheter may be aligned with and / or positioned within the patient's left atrial appendage and used to aspirate clot material therefrom. The clot treatment system may also include a clot capture device configured to at least partially cover the opening of the left atrial appendage. For example, the clot capture device may be aligned with, positioned against, and / or inserted at least partially through an aperture of a left auricle of the patient to capture any clot material detached from the left auricle.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. patent application No. 63 / 349,969, filed on June 7, 2022, and entitled “CLOT TREATMENT SYSTEMS, SUCH ASFOR USE IN REMOVING CLOT MATERIAL FROM ALEFT ATRIAL APPENDAGE (LAA), AND ASSOCIATED DEVICES AND METHODS,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology generally relates to clot management systems, including clot management systems for removing clot material from the left atrial appendage, and associated devices and methods. Background Art

[0004] Thrombosis is the localized coagulation or clotting of blood in a part of the circulatory system, and a thrombus is a blood clot formed in situ within the vascular system. An intracardiac thrombus is a blood clot formed in the patient's heart. An example of an intracardiac thrombus is a left atrial appendage LAA thrombus, which is a blood clot formed in the left atrial appendage of the heart. If an intracardiac thrombus (e.g., a LAA thrombus) breaks off (embolizes) and travels to the limbs or brain, it may cause organ failure, acute limb ischemia (ALI), and / or stroke.

[0005] In addition, the presence of intracardiac thrombus may adversely affect (e.g., contraindicate) many structural heart surgeries, such as ablation, left atrial appendage closure (LAAC), mitral valve repair / replacement (TMVR), aortic valve repair / replacement (TAVR), and patent foramen ovale (PFO) closure. When intracardiac thrombus is detected, cardiac surgery is usually canceled, and patients are usually instructed to take oral anticoagulants for about 4 to 6 weeks to try to break down the intracardiac thrombus. However, there may be situations where the thrombus has not completely resolved after these 4 to 6 weeks. In this case, the doctor may decide to proceed with the operation in the presence of the thrombus, or wait longer and prescribe a different anticoagulant.

[0006] Taking oral anticoagulants may have several risks, such as increasing the likelihood of excessive bleeding or hemorrhage. In addition, patients may be contraindicated from taking anticoagulants due to their side effects, making it difficult to remove intracardiac clots in these patients. Furthermore, postponing surgery has its own risks, such as an increased risk of death from certain surgeries. In addition, patients may not always take the prescribed anticoagulants, which can result in clots not resolving and / or further delaying cardiac surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Many aspects of the present invention may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0008] Figure 1A is a partially schematic side elevational view of a clot handling system constructed in accordance with an embodiment of the present technology.

[0009] Figure 1B According to the implementation scheme of the present technology Figure 1A End view of a formed portion of a clot handling system.

[0010] Figure 2 According to the implementation scheme of the present technology Figure 1A and Figure 1B A side cross-sectional view of a formed portion of a clot handling system.

[0011] Figure 3 , Figure 4 , Figure 5A , Figure 5B , Fig. 6A , Figure 6B and Figure 6C is a side view of a corresponding clot capture and / or embolic protection device constructed in accordance with an embodiment of the present technology.

[0012] Figure 7 is a side view of a clot management device positioned within a left atrial appendage according to an embodiment of the present technology.

[0013] Figure 8 is a side cross-sectional view of a patient's heart and a clot capture and / or embolic protection device positioned downstream of the heart in accordance with an embodiment of the present technology.

[0014] Fig. 9 is an embodiment according to the present technology Figure 1B A side cross-sectional view of a patient's heart with a shaped portion positioned within the left atrium.

[0015] Fig.10 is positioned according to an embodiment of the present technology Figure 3 A side cross-sectional view of a patient's heart with a clot capture device. DETAILED DESCRIPTION

[0016] The present technology as a whole relates to clot handling systems and associated devices and methods. In some embodiments, a representative clot handling system includes a catheter having a shaped distal portion that is configured to facilitate insertion of the catheter into a specific portion of a patient's anatomical structure. For example, the shaped portion can be curved to facilitate access to the interior of the patient's left atrial appendage. The clot handling system may also include a pressure source that is fluidly connected to the catheter and is configured to apply negative pressure to the catheter to aspirate clotted material from the patient's body. Therefore, the shaped portion of the catheter can be aligned with and / or positioned within the patient's left atrial appendage and used to aspirate clotted material from the left atrial appendage. In some aspects of the present technology, the clot handling system provides the function of mechanically removing clotted material from the left atrial appendage, thereby reducing or eliminating the need to cancel structural heart surgery if clotted material is found in the patient's left atrial appendage, reducing or eliminating the need to prescribe anticoagulants to treat clotted material, and / or increasing the speed at which structural heart surgery can be performed.

[0017] In some embodiments, the clot handling system also includes a clot capture and / or embolic protection device (e.g., a funnel) that is configured to inhibit the movement or migration of clot material away from the left atrial appendage, such as by at least partially or completely inhibiting embolism of clot material. For example, the clot capture device can be aligned with the orifice of the patient's left atrial appendage, positioned against the orifice of the patient's left atrial appendage, and / or inserted at least partially through the orifice of the patient's left atrial appendage, so that the clot capture device "captures" part or all of any clot material that detaches from the left atrial appendage. Therefore, the clot capture device can reduce the risk of clot material in the left atrial appendage embolizing and moving through the patient's heart and vascular system. In some embodiments, the clot capture device may include a funnel that is configured to (i) allow blood or other fluids in the left atrial appendage to flow through the funnel, and (ii) at least partially prevent clot material in the left atrial appendage from leaving the left atrial appendage. Additionally or alternatively, the clot capture device can be positioned downstream of the left atrial appendage, such as within the patient's aorta, to capture any clot material flowing therethrough. In these and other embodiments, the clot handling system can also include a coring element or other clot handling device that can be inserted into the left atrial appendage to engage and / or remove at least a portion of the clot material positioned therein.

[0018] Although certain aspects of the present technology are described with reference to clot treatment and / or removal procedures associated with a patient's left atrial appendage, one of ordinary skill in the art will appreciate that the present technology can be used to treat and / or remove clots in other parts of a patient's anatomy. For example, at least some embodiments of the present technology can be used to treat and / or remove clots in other locations within the left side of the heart, such as clots within the left atrium, left ventricle, and / or mitral valve.

[0019] In the following description and in Figures 1A to 10 Certain details are set forth in order to provide a thorough understanding of various embodiments of the present technology. In other cases, well-known structures, materials, operations, and / or systems that are typically associated with endovascular procedures, clot removal procedures, catheters, etc. are not shown or described in detail in the following disclosure to avoid unnecessarily obscuring the description of various embodiments of the present technology. However, one of ordinary skill in the art will recognize that the present technology can be practiced without one or more of the details set forth herein and / or with other structures, methods, components, etc.

[0020] The terminology used below should be interpreted in its broadest reasonable manner, even though it is used in conjunction with the detailed description of certain examples of the embodiments of the present disclosure. In fact, certain terms may even be emphasized below; however, any term intended to be interpreted in any limited manner will be openly and specifically defined in this detailed description section.

[0021] The accompanying drawings depict embodiments of the present technology, and are not intended to limit their scope unless explicitly stated. The sizes of the various depicted elements are not necessarily drawn to scale, and these various elements may be amplified to improve readability. Component details may be separated in the drawings to exclude these details when it is not necessary to fully understand how to make and use the present technology in details such as the position of the components and certain precise connections between such components. Many details, sizes, angles and other features shown in the drawings are only specific embodiments of the present disclosure. Therefore, without departing from the present technology, other embodiments may have other details, sizes, angles and features. In addition, it will be appreciated by those of ordinary skill in the art that other embodiments of the present technology may be implemented without some details described below.

[0022] With respect to the terms "distal" and "proximal" in this specification, unless otherwise specified, these terms may guide the relative position of the various parts of the tube system with respect to the operator and / or the position in the vascular structure. In addition, as used herein, the designations "rearward", "forward", "upward", "downward", etc. are not intended to limit the referenced components to a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the accompanying drawings; the system of the present technology can be used in any orientation suitable for the user.

[0023] In the drawings, the same reference numerals indicate the same or at least substantially similar elements. To facilitate discussion of any particular element, the most significant digit of any reference numeral refers to the drawing in which the element is first introduced. Figure 1A Introduce and discuss components 1 10.

[0024] If anything incorporated by reference conflicts with the present disclosure, the present disclosure controls.

[0025] Figure 1A 1 is a partially schematic side view of a clot management system 100 ("system 100") constructed in accordance with an embodiment of the present technology. System 100 may also be referred to as an aspiration assembly, a vascular access system, a clot removal system, a thrombectomy system, a left atrial appendage ("LAA") thrombectomy system, etc. In the illustrated embodiment, system 100 includes a tubing assembly 110 fluidly coupled to a catheter 120 via a valve 106. The catheter 120 is disposed in a manner that allows the catheter 120 to be positioned adjacent to the catheter 120. Figure 1A In some embodiments, catheter 120 is an elongated member configured to be inserted into and through a patient's vascular structure and used, for example, to treat clotted material therein. In other embodiments, catheter 120 may be an introducer sheath configured to be inserted through the skin and tissue tract of a patient to provide an access site through which other components (e.g., other catheters for treating clotted material) may be passed to easily access the vascular structure. Thus, when referred to as "catheter 120," catheter 120 may include an introducer sheath, an access sheath, and / or another type of elongated member configured to be inserted through the skin and tissue tract and / or configured to pass through a patient's vascular structure. In general, system 100 (i) may include features that are substantially similar in structure and / or function or are identical in structure and / or function to those features of the clot handling system described in detail in U.S. patent application Ser. No. 16 / 536,185, filed on August 8, 2019, and entitled “SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS,” which is incorporated herein by reference in its entirety, and / or (ii) may be used to treat clotted material / remove clotted material from a patient (e.g., a human patient) using any of the methods described in detail therein.

[0026] In the illustrated embodiment, the catheter 120 includes (i) a proximal region or portion 122a, (ii) an intermediate region 122b adjacent to and distal to the proximal region 122a, (iii) a distal region 122c adjacent to and distal to the intermediate region 122b, and (iv) a distal tip region 122d adjacent to and distal to the distal region 122c. In some embodiments, the catheter 120 has an outer diameter of at least 20 Fr, such as at least 21 Fr, 22 Fr, 23 Fr, 24 Fr, etc., up to, for example, 30 Fr. However, in other embodiments, the catheter 120 has an outer diameter of less than 20 Fr or another suitable outer diameter. The catheter 120 also defines an inner cavity 124 (at least 100 mm) extending completely therethrough from the proximal region 122a to the distal tip region 122d. Figure 1A124 is shown using dashed lines. In some embodiments, the inner cavity 124 has a diameter of at least 15 Fr, such as at least 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, etc., up to, for example, 25 Fr (e.g., corresponding to the inner diameter of the catheter 120). For example, the inner cavity 124 can have a diameter of 20.6 Fr. However, in other embodiments, the inner cavity 124 can have a diameter less than 15 Fr or another suitable diameter. The proximal region 122a defines the proximal end 126a of the catheter 120, and the distal tip region 122d defines the distal end 126b of the catheter 120.

[0027] The proximal region 122a may be at least generally linear and define a longitudinal axis Z. The intermediate region 122b, the distal region 122c, and / or the distal tip region 122d may define a shaped distal portion 128 ("shaped portion 128") that is curved relative to the longitudinal axis Z. Figure 1B is along Figure 1A An end view of the formed portion 128 taken along line 1B-1B in FIG. Figure 1A and Figure 1B , the middle region 122b can be bent at a first angle A1 around a first radius R1 relative to the longitudinal axis Z, and the distal region 122c can be bent at a second angle A2 around a second radius R2 relative to the longitudinal axis Z (eg, Figure 1B). The first radius R1 can be in a first plane including the longitudinal axis Z, and the second radius R2 can be in a second plane different from the first plane (e.g., perpendicular to the first plane, not parallel to the first plane, angled relative to the first plane, etc.). In the illustrated embodiment, the first radius R1 is 2 inches, the first angle A1 is 90 degrees, the second radius R2 is 1.25 inches, and the second angle A2 is 30 degrees. In other embodiments, the first radius R1 can be between about 0.5 inches and 5.0 inches, the first angle A1 can be between about 60 degrees and 120 degrees, the second radius R2 can be between about 0.5 inches and 2.5 inches, and the second angle A2 can be between about 10 degrees and 60 degrees. The distal tip region 122d can be at least substantially linear and can extend a length L from the distal region 122c. In the illustrated embodiment, the length L is 1.0 inches. In other embodiments, the length L can be between about 0.25 inches and about 2 inches, such as at least 0.25 inches, 0.5 inches, 1.25 inches, or another suitable length. One or more of the first radius R1, the second radius R2, the first angle A1, and / or the second angle A2 can vary based at least in part on whether the dilator is positioned within the catheter 120 (e.g., within the forming portion 128 of the catheter 120). In at least some embodiments, one or more of the first radius R1, the second radius R2, the first angle A1, and / or the second angle A2 can have a corresponding first value when the dilator is not positioned within the forming portion 128, and have a second value different from (e.g., greater than or less than) the first value when the dilator is positioned within the forming portion 128. For example, the first radius R1 can be 2 inches without the expander and 2.1 inches with the expander, the first angle A1 can be 90 degrees without the expander and 85 degrees with the expander, the second radius R2 can be 1 inch without the expander and 2 inches with the expander, and / or the second angle A2 can be 30 degrees without the expander and 15 degrees with the expander. In other embodiments, each of the first radius R1, the second radius R2, the first angle A1, and / or the second angle A2 can vary between any two of the other values ​​previously described herein.

[0028] In some aspects of the present technology, the curvature of the shaped portion 128 is expected to be improved to a selected portion of the patient's anatomy (such as described below with reference to Figure 2 The left atrial appendage described in detail and / or as referenced below Fig. 9 and Fig.10 The left atrium is described in detail. Figure 1A and Figure 1BIn the embodiment shown, the shaped portion 128 has a specific size and / or curvature, but in other embodiments, the shaped portion 128 may have other sizes and / or curvatures, for example, to facilitate the placement of the distal tip region 122d near the desired position in the patient's heart. For example, although in the illustrated embodiment, the catheter 120 includes two curved regions (e.g., the middle region 122b and the distal region 122c) between the proximal end 126a and the distal end 126b, in other embodiments, the catheter 120 may include more or less curved regions. In at least some embodiments, for example, the shaped portion 128 may include at least one, three, four or another suitable number of curved regions, wherein each curved region may have a curvature that is the same or different from the middle region 122b and / or the distal region 122c. In these and other embodiments, one or both of the proximal region 122a and / or the distal tip region 122d may be curved and / or otherwise configured to deviate from a substantially linear configuration, as described in further detail below.

[0029] The catheter 120 can have varying lengths, flexibility, shapes, thicknesses, and / or other properties in / along the various regions 122a-d. For example, the catheter 120 can include one or more coils, braids, and / or other structures positioned between one or more cushioning layers (e.g., an inner cushioning layer and an outer cushioning layer). In some embodiments, the catheter 120 can include several features that are structurally and / or functionally substantially similar or identical to any of the catheters described in U.S. patent application Ser. No. 17 / 529,018, filed on November 17, 2021, entitled “CATHETERS HAVING SHAPEDDISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” and / or U.S. patent application Ser. No. 17 / 529,064, filed on November 17, 2021, entitled “CATHETERS HAVING STEERABLE DISTALPORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” each of which is incorporated herein by reference in its entirety.

[0030] In some embodiments, the forming portion 128 can be configured to: Figure 1A and Figure 1BThe shaped portion 128 can be configured to move between (i) a relaxed configuration as shown, in which the shaped portion 128 has a curved shape, and (ii) a constrained position, in which the shaped portion 128 is more closely aligned with the longitudinal axis Z. For example, in the relaxed configuration, the middle region 122b and / or the distal region 122c can be configured (e.g., heat set) to deviate from the longitudinal axis Z of the catheter 120 relative to the proximal region 122a. In the constrained configuration, the middle region 122b and / or the distal region 122c can be configured to deflect toward the longitudinal axis Z, such that one or more of the middle region 122b, the distal region 122c, and / or the distal tip region 122d are at least approximately aligned (e.g., co-linear) with the proximal region 122a and / or the longitudinal axis Z.

[0031] The valve 106 is fluidly coupled to the lumen 124 of the catheter 120 and may be integral with or coupled to the proximal region 122a of the catheter 120 such that these components move together. In some embodiments, the valve 106 is a hemostatic valve configured to maintain hemostasis during a clot management procedure by preventing fluid from flowing through the valve 106 in a proximal direction P when various components (such as dilators, delivery sheaths, pull members, guidewires, interventional devices, other aspiration catheters, etc.) are inserted through the valve 106 for delivery to a treatment site in a blood vessel through the catheter 120. The valve 106 may include a branch or side port 102 configured to fluidly couple the lumen 124 of the catheter 120 to the tubing assembly 110. In some embodiments, the valve 106 can be a valve of the type disclosed in U.S. patent application 16 / 117,519, filed on August 30, 2018, and entitled “HEMOSTASIS VALVES AND METHODS OF USE,” which is incorporated herein by reference in its entirety.

[0032] In the illustrated embodiment, the tubing assembly 110 fluidly couples the conduit 120 to a pressure source 104, such as a syringe. The pressure source 104 may be configured to generate (e.g., form, generate, fill, accumulate) a vacuum (e.g., a negative relative pressure) and store the vacuum for subsequent application to the conduit 120. The tubing assembly 110 may include one or more tubing segments 112 (each labeled as a first tubing segment 112a and a second tubing segment 112b), at least one fluid control device 114 (e.g., a valve), and at least one connector 116 (e.g., a Toomey head connector) for fluidly coupling the tubing assembly 110 to the pressure source 104 and / or other suitable components. In some embodiments, the fluid control device 114 is a stopcock that (i) is fluidly coupled to the side port 102 of the valve 106 via the first tubing segment 112a, and (ii) is fluidly coupled to the connector 116 via the second tubing segment 112b. The fluid control device 114 is externally operable by a user to regulate the flow of fluid therethrough, and in particular, to regulate the flow of fluid from the lumen 124 of the conduit 120 to the pressure source 104. In some embodiments, the connector 116 is a quick release connector (e.g., a quick disconnect fitting) that enables the conduit 120 and the fluid control device 114 to be quickly coupled to / disconnected from the pressure source 104.

[0033] During a clot management procedure, at least a portion of the system 100, such as the distal end 126b and / or the distal tip region 122d of the catheter 120, can be inserted through the patient's vasculature. In some embodiments, the system 100 is inserted through an introducer sheath that traverses the patient's skin and tissue to provide an access site. When the catheter 120 is positioned at a target treatment location in the patient's body near a clotted material (e.g., a left atrial appendage thrombus, a pulmonary embolism, a deep vein thrombosis, etc.), the user can first close the fluid control device 114, for example, by withdrawing the plunger of a syringe connected to the connector 116, before creating a vacuum in the pressure source 104. In this way, the pressure source 104 is filled with a vacuum (e.g., maintaining a negative pressure) before the pressure source 104 fluid is connected to the inner cavity 124 of the catheter 120. To aspirate the lumen 124 of the catheter 120, the user may open the fluid control device 114 to fluidly connect the pressure source 104 to the catheter 120, thereby applying or releasing the vacuum stored in the pressure source 104 to the lumen 124 of the catheter 120. Opening the fluid control device 114 instantaneously or nearly instantaneously applies the stored vacuum pressure to the tubing assembly 110 and the catheter 120, thereby generating a suction pulse throughout the catheter 120 that may draw clot material into the catheter 120. Specifically, suction is applied at the distal tip region 122d of the catheter 120 to aspirate / draw at least a portion of the clot material proximate the distal tip region 122d into the lumen 124 of the catheter 120. Additionally or alternatively, the catheter 120 may function as an introducer sheath and may be inserted through the patient's skin and tissue and then partially inserted into a blood vessel to provide an access point through which other medical devices may be delivered and / or otherwise used to treat the patient. In these and other embodiments, a user can create a vacuum in the pressure source 104 when the fluid control device 114 is open (e.g., when the pressure source 104 fluid is connected to the inner cavity 124 of the catheter 120), thereby aspirating clot material consistent with and / or simultaneously with the creation of the vacuum, for example, without storing a vacuum in the pressure source 104 or substantially in the pressure source.

[0034] Figure 2 is a device inserted into a human heart H ("heart H") according to an embodiment of the present technology Figure 1A and Figure 1B 1 is a side cross-sectional view of a shaped distal portion 128 of a clot management system 100. The heart H includes a left atrium LA, and the left atrium LA includes a left atrial appendage LAA. The left atrial appendage LAA can be fluidly coupled to the left atrium LA via an orifice O so that fluid can flow between the left atrium LA and the left atrial appendage LAA. In some patients, blood and / or other clotting material 201 (shown schematically) can accumulate within the left atrial appendage LAA and form a clot or thrombus therein. Figure 1A , Figure 1B and Figure 2 In the illustrated embodiment, the catheter 120 has been inserted into and advanced through the patient's right atrial vein (not shown), and has percutaneously entered the left atrium LA via an opening 203 formed in the septum S between the left atrium LA and the right atrium (not shown) of the heart H.

[0035] The shaped portion 128 of the catheter 120 is curved so that the distal tip region 122d can be aligned with the left atrial appendage LAA. For example, the distal end 126b can be positioned near the orifice O and / or extend at least partially through the orifice O into the left atrial appendage LAA. When so positioned, the catheter 120 can be used to aspirate the clotted material 201 from the left atrial appendage LAA, as described above with reference to Figure 1A and Figure 1B In some embodiments, one or more clot handling and / or removal devices (such as Figure 7 A clot handling device) can be inserted through catheter 120 to assist in handling clot material 201.

[0036] Figures 3 to 6C is a side view of a respective clot capture and / or embolic protection device 330, 430, 530a, 530b, 630 (collectively referred to as "devices 330-630") constructed in accordance with embodiments of the present technology. In some embodiments, one or more of devices 330-630 may be used in reference to Figure 1A to Figure 2 Detailed description of the clot management system 100. For example, the devices 330-630 may be coupled to or advanced through the catheter 120. At least some aspects of one or more of the devices 330-630 may be substantially similar or identical in structure and / or function to one or more of the other devices 330-630. Therefore, similar names and / or reference numerals are used to indicate aspects of the devices 330-630 that may be substantially similar or identical.

[0037] refer to Figure 3 , the device 330 includes a funnel 332 having a proximal end portion 334a and a distal end portion 334b. The distal end portion 334b ​​can define a distal edge or tip 336 of the funnel 332. Figure 2 and Figure 3, the distal edge 336 may be configured to contact or otherwise engage at least a portion of the patient's left atrial appendage LAA, such as the orifice O and / or one or more inner surfaces of the left atrial appendage LAA. The distal end portion 334b ​​and / or the distal edge 336 may define the outer dimension D (e.g., diameter, width) of the funnel 332. The outer dimension D may be between about 15 mm and about 50 mm, such as at least 35 mm or another value therebetween. In these and other embodiments, the outer dimension D may be equal to or greater than the corresponding inner dimension of the left atrial appendage LAA, such as the diameter of the orifice O. The proximal end portion 334a may be coupled to the distal tip 340 of an elongated member 338 (such as a shaft or catheter). In the illustrated embodiment, the elongated member 338 is positioned within the catheter 120, wherein the funnel 332 extends distally beyond the distal end 126b of the catheter 120. In some embodiments, the elongated member 338 may be shaped and / or steerable. For example, the elongated member 338 may include at least some aspects that are structurally and / or functionally substantially similar or identical to one or more of the catheters described in U.S. patent application Ser. No. 17 / 529,018, filed on November 17, 2021, and entitled “CATHETERSHAVING SHAPEDDISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” and / or U.S. patent application Ser. No. 17 / 529,064, filed on November 17, 2021, and entitled “CATHETERS HAVING STEERABLE DISTALPORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” each of which are incorporated herein by reference in their entirety.

[0038] The funnel 332 can be configured to be in an expanded state (eg Figure 3In the illustrated embodiment, the elongated member 338 can be moved relative to the catheter 120 to convert the funnel 332 between the expanded state and the contracted state. For example, the elongated member 338 can be pulled back proximally within the catheter 120 to withdraw the funnel 332 toward the distal end 126b of the catheter 120 and / or enter the catheter 120 to convert the funnel 332 from the expanded state to the contracted state. Additionally or alternatively, the catheter 120 can be advanced proximally on the elongated member 338 to drive the distal end 126b toward and / or against the funnel 332 and convert the funnel 332 from the expanded state to the contracted state. In order to convert the funnel 332 from the contracted state to the expanded state, the catheter 120 can be pulled back proximally relative to the elongated member 338 to expose the funnel 332 and allow the funnel 332 to expand toward and / or to the expanded state. Additionally or alternatively, the elongate member 338 can be advanced distally from within the catheter 120 to extend distally beyond the distal tip 126b, thereby exposing the funnel 332 from within the catheter 120 and allowing the funnel 332 to expand from a contracted state to an expanded state.

[0039] The funnel 332 may include a plurality of braided filaments, such as a plurality of shape memory filaments, which are heat set to expand to Figure 3 The funnel 332 may also define one or more openings or holes 333 (in Figure 3 ). Although Figure 3 In the illustrated embodiment, eight holes 333 are shown, but in other embodiments, the funnel 332 may include more or fewer holes, such as at least 1, 5, 10, 20, 30, 50, 100, a number therebetween, or another suitable number of holes 333. Each of the holes 333 may have a cross-sectional dimension (e.g., width) or area between about 100 μm and about 500 μm (such as less than or equal to 150 μm), or another suitable dimension or area. Figure 2 and Figure 3 The size and shape of the hole 333 of the funnel 332 can be set to (i) substantially allow blood and / or other fluids within the left atrial appendage LAA to flow through the funnel 332, and (ii) inhibit the clot material 201 within the left atrial appendage LAA from flowing through the funnel 332.

[0040] The funnel 332 can be configured to contain clotted material 201 ( Figure 2 ) embolizes and flows through the patient's heart H and vasculature. For example, in reference Figure 1A , Figure 1B and Figure 2During the detailed procedure, the device 330 can be deployed from the catheter 120 and used to inhibit or prevent the clot material 201 from leaving the orifice O of the left atrial appendage LAA (e.g., embolization) during aspiration of the catheter 120. More specifically, the distal edge 336 of the funnel 332 can be aligned with and / or positioned against the orifice O so that when the clot material 201 breaks away from the left atrial appendage LAA, such as in response to aspiration, the funnel 332 can at least partially cover / block the orifice O and "catch" the clot material 201. Additionally or alternatively, the funnel 332 can be at least partially positioned / deployed within the left atrial appendage LAA so that at least a portion of the funnel 332 (e.g., the distal edge 336) can contact the inner surface of the left atrial appendage LAA.

[0041] In some embodiments, the lumen of the elongated member 338 can be used to aspirate the clotted material 201 in addition to or in lieu of the lumen 124 of the aspiration catheter 120. Figure 1A A pressure source and tubing system similar or identical to the pressure source 104 and tubing assembly 110 of the embodiment of the present invention can be coupled to the elongated member 338 and used to aspirate the elongated member 338. In these and other embodiments, one or more other clot handling and / or removal devices can be positioned within and / or delivered through the elongated member 338 and / or catheter 120 to aspirate and / or engage the clotted material 201.

[0042] refer to Figure 4 , the device 430 may include Figure 3 The funnel 332 is substantially similar to the funnel 432. For example, the funnel 432 can be configured to "catch" the clotted material 201 and / or at least partially or completely prevent the clotted material from embolizing, as previously described with reference to Figure 3 However, in the illustrated embodiment, the funnel 432 has a shorter length and is positioned such that the distal edge 436 of the funnel 432 is substantially coplanar with the distal tip 340 of the elongated member 338 and / or such that the distal tip 340 extends distally beyond the distal edge 436 of the funnel 432. More specifically, for example, the proximal end portion 434a of the funnel 432 can be coupled to the elongated member 338 proximal to the distal tip 340. Therefore, referring to Figure 2 and Figure 4, when used to treat a clotted material 201 within the orifice O of the left atrial appendage LAA during a clot handling procedure, the distal tip 340 of the elongated member 338 may extend through the orifice O of the left atrial appendage LAA and / or otherwise be positioned closer to the clotted material 201 located therein. In some aspects, positioning the distal tip 340 of the elongated member 338 closer to the clotted material 201 is expected to increase the suction applied to the clotted material 201 and / or increase the amount of clotted material 201 removed during a given suction pulse (e.g., applied by the elongated member 338). However, in other embodiments, the distal edge 436 may be positioned proximally or distally relative to the distal tip 340.

[0043] refer to Figure 5A , the device 530a may include a funnel 532a having a plurality of support elements or struts 535a and a filter layer 537 coupled thereto. The funnel 532a may be coupled to the elongated member 338. Individual struts in the struts 535a may be formed of a shape memory material such as nitinol and may be interconnected with one or more of the other struts 535a. In at least some embodiments, the funnel 532a may be self-expanding and / or configured to automatically transition from a low-profile delivery state to an expanded state (in Figure 5A ). The filter layer 537 can cover one or more or all of the struts 535a and can be formed of expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) mesh, silicone coating and / or another suitable material. In addition, the filter layer 537 may include / define a plurality of holes 533 so that the funnel 532a can be configured to (i) substantially allow blood and / or other fluids within the left atrial appendage LAA to flow through the funnel 532a, and (ii) inhibit the clotted material 201 within the left atrial appendage LAA from flowing through the funnel 532a.

[0044] refer to Figure 5B , the device 530b may include Figure 5A The funnel 532a is substantially similar to the funnel 532b. In the illustrated embodiment, the funnel 532b includes one or more struts 535b extending radially outward in the distal direction from the central hub 539. The central hub can be coupled to the slender member 338 so that each of the struts 535b can extend distally beyond the distal tip 340 of the slender member 338 in a direction substantially parallel to the longitudinal axis of the slender member 338. Each of the struts 535b can be formed of a shape memory material such as nitinol, so that the funnel 532b can be self-expanding and / or be configured to automatically transition from a low-profile delivery state to an expanded state (in a Figure 5B ). The filter layer 537 may cover one or more or all of the pillars 535b.

[0045] Reference together FIG. 6A to FIG. 6C , the device 630 includes an adjustable structure 642 having a first (e.g., proximal) end portion 644a and a second (e.g., distal) end portion 644b. The second end portion 644b can be coupled to the elongated member 338, for example, at or near the distal tip 340. The first end portion 644a can be coupled to a catheter, such as FIG. 6A to FIG. 6C The catheter 120 shown or another suitable catheter. In the illustrated embodiment, the adjustable structure 642 includes a shape memory wire structure. In other embodiments, the adjustable structure 642 may include a mesh or other suitable structure. The elongated member 338 is slidably disposed within the catheter 120 so that one or both of the elongated member 338 and the catheter 120 can move relative to each other.

[0046] The relative movement between the elongated member 338 and the catheter 120 can cause the adjustable structure 642 to be moved between a variety of shapes or states (such as Fig. 6A The first state 646a shown (eg, a spherical, disk, or ball shape), Figure 6B The second state 646b shown (eg, a flat or disk-like shape) and Figure 6C The adjustable structure 642 may be configured to be configured to be movable between the first and second states 644a and 644b of the adjustable structure 642 and the third state 646c (e.g., a cone or funnel shape) shown in the figure. For example, moving the elongated member 338 relative to the catheter 120 and / or moving the catheter 120 relative to the elongated member 338 may cause the first end portion 644a and the second end portion 644b of the adjustable structure 642 to move relative to each other and cause the adjustable structure 642 to change shape. In the first state 646a, the adjustable structure 642 may be curved or arc-shaped, and the first end portion 644a and the second end portion 644b may be substantially spaced apart from each other. In the second state 646b, the adjustable structure 642 may include a vertex region 648 that defines a maximum outer dimension (e.g., width, diameter, etc.) of the adjustable structure 642, for example, the maximum outer dimension of all or a subset of the various states 646a to 646c. For example, the diameter of the adjustable structure 642 in the second state 646b may be greater than the diameter of the adjustable structure 642 in the first state 646a and / or the third state 646c. In the third state 646c, the adjustable structure 642 can define a funnel 632 including a distal edge 636 defined by a fold in the adjustable structure 642. The fold in the adjustable structure 642 can be formed by positioning the second end portion 644b within or adjacent to the first end portion 644a, as described in further detail below.

[0047] The adjustable structure 642 may be transitioned from the first state 646a to the second state 646b by decreasing the distance between the first end portion 644a and the second end portion 644b, for example, by moving the distal tip 340 of the elongated member 338 toward the catheter 120 and / or moving the catheter 120 toward the distal tip 340. The adjustable structure 642 may be transitioned from the second state 646b to the third state 646c by continuing to decrease the distance between the first end portion 644a and the second end portion 644b, for example, until the first end portion 644a and the second end portion 644b at least partially overlap each other and / or until the distal tip 340 is positioned within the catheter 120. The adjustable structure 642 may be transitioned from the third state 646c to the second state 646b and / or the first state 646a by increasing the distance between the first end portion 644a and the second end portion 644b. In these and other embodiments, the adjustable structure 642 may be configured to transition to states other than FIG. 6A to FIG. 6C For example, the adjustable structure 642 may be transitioned to the low-profile delivery state by further increasing the distance between the first end portion 644a and the second end portion 644b so that the distal tip 340 is further advanced distally away from the catheter 120 (e.g., further advancing the distal tip 340 distally away from / outwardly away from the distal end 126b of the catheter 120), thereby causing the adjustable structure 642 to lie substantially flat against the outer surface of the elongated member 338.

[0048] Reference together Figure 2 and Fig. 6A , Figure 6B and Figure 6C , the shape of the adjustable structure 642, such as shown by the first state 646a, the second state 646b, and the third state 646c, can be adjusted in vivo based on the specific geometry of the left atrial appendage LAA of a given patient. In some aspects of the present technology, this can further improve the handling of the clot material 201. For example, the first state 646a can allow the distal tip 340 to be inserted deeper into the left atrial appendage LAA and / or can center the slender member 338 within the left atrial appendage LAA, both of which can improve the suction of the clot material 201 from the left atrial appendage LAA via the catheter 120 and / or the slender member 338. In the second state 646b, the larger outer dimensions (e.g., diameter, width, radius) of the adjustable structure 642 can allow the adjustable structure 642 to cover / shield many different sizes of left atrial appendages LAA. In the third state 646c, the distance between the distal tip 340 of the slender member and the distal edge 636 of the funnel 632 can reduce or prevent the application of aspiration forces (e.g., suction) on the wall of the left atrial appendage LAA and / or other portions of the patient's anatomy.

[0049] Figure 7 is a side view of a clot management and / or removal device 750 ("device 750") positioned within a left atrial appendage LAA in accordance with an embodiment of the present technology. In some embodiments, device 750 may be used in reference to Figure 1A 6 . For example, the device 750 can be advanced and / or retracted through the elongated member 338 and / or the catheter 120 into the elongated member and / or the catheter. Generally, the device 750 can include at least some aspects that are at least substantially similar or identical in structure and / or function to one or more of the devices described in detail in U.S. Patent No. 10,098,651, filed on April 26, 2017, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” which is incorporated herein by reference in its entirety.

[0050] In the illustrated embodiment, device 750 is a mechanical thrombectomy device that includes a braided or laser cut structure coupled to a tether 752. Device 750 may be formed at least in part of a shape memory material such as nitinol. Figure 2 and Figure 7 , the device 750 can be inserted into the left atrial appendage LAA through the orifice O to capture / engage the clotted material 201 engaged therein. Then, the tether 752 can be used to withdraw the device 750 from the left atrial appendage LAA so that the device 750 can remove / detach at least a portion of the clotted material 201. In the illustrated embodiment, for example, Figure 4 At least a portion of the device 430 (such as at least a portion of the funnel 432 and / or its distal edge 436) is positioned against the orifice O, and the device 750 has been inserted into the left atrial appendage LAA through the slender member 338. After the device 750 is positioned in the left atrial appendage LAA, the device 750 can be withdrawn into the slender member 338. The device 430 (e.g., the funnel 432) can capture any clot material 201 that is disengaged before, during, and / or after the device 750 is mechanically engaged with the clot material 201, and / or otherwise prevent at least a portion of the clot material 201 from forming an embolism.

[0051] In some embodiments, a clot capture device according to the present technology can be used with Figure 1A The clot removal system is used together with a clot removal system and is positioned elsewhere in the vasculature downstream of the patient's left atrial appendage to capture clotted material removed or detached from the patient's left atrial appendage LAA, for example, to inhibit or prevent the clotted material from causing an embolic event (e.g., embolism, stroke, etc.). For example, Figure 8is a side cross-sectional view of a patient's heart H including a clot capture device 830 having a funnel 832, wherein the funnel is configured to be positioned downstream of the heart H, such as within the aorta (e.g., the ascending aorta and / or the descending aorta). The funnel 832 may include at least some aspects that are substantially similar or identical in structure and / or function to one or more of the funnels 332, 432, 532a, 532b, 632 previously described herein. For example, when one or more of the other devices 330 to 630, 750 are positioned within the heart H, the device 830 may be used in combination with one or more of the other devices 330 to 630, 750 described herein. Additionally or alternatively, the device 830 may be used with an aspiration catheter system (such as the system 100 and / or another suitable aspiration catheter system) to aspirate at least a portion of the clot material 201 away from the left atrial appendage LAA. Generally, device 830 may include at least some aspects substantially similar or identical to one or more clot handling systems described in detail in U.S. patent application Ser. No. 17 / 339,663, filed on June 4, 2021, entitled “RECAPTURABLE FUNNELCATHETERS, AND ASSOCIATED SYSTEMS AND METHODS,” which is incorporated herein by reference in its entirety.

[0052] In the illustrated embodiment, the funnel 832 is coupled to an elongated member 838 that has been inserted through the descending aorta toward the left ventricle LV. Thus, the funnel 832 can capture the left atrial appendage LAA ( Figure 2 ) and any clotted material 201 flowing downstream through the left atrium LA and / or the left ventricle LV. The funnel 832 may be configured to be in a low profile delivery state and an expanded state (in Figure 8 ). In the low-profile delivery state, funnel 832 can be configured to be inserted into one or more arteries passing through the patient's arteries, such as the femoral artery or the radial artery. For example, in the low-profile delivery state, funnel 832 can have an outer dimension (e.g., diameter) between about 6 Fr and 8 Fr. In the expanded state, funnel 832 can be configured to span all or a portion of the inner width of a blood vessel (e.g., the aorta) in which funnel 832 is positioned. For example, in the expanded state, funnel 832 can have an outer dimension (e.g., diameter) between about 30 mm and about 40 mm, or another suitable outer dimension.

[0053] In some embodiments, at least a portion of the clot management system 100 can be used to remove clotted material from one or more portions or regions of a patient's anatomy other than the left atrial appendage (LAA). Fig. 9 is positioned according to an embodiment of the present technology Figure 1A and Figure 1B 1. A side cross-sectional view of a patient's heart H with a shaped portion 128 of a catheter 120. At least a portion of the shaped portion 128 can be positioned within the left atrium LA via an opening 203 formed in the septum between the left atrium LA and the right atrium RA. In the illustrated embodiment, for example, the shaped portion 128 extends from the right atrium RA into the left atrium LA. In this position, the catheter 120 can be used to aspirate all or at least a portion of the clot material 201 within the left atrium LA. The catheter 120 can be advanced, rotated, and / or otherwise moved to position the catheter 120 at a desired location within the left atrium LA proximate to the clot material 201.

[0054] Fig.10 is positioned according to an embodiment of the present technology Figure 3 1. A side cross-sectional view of a patient's heart H with a clot capture device 330. The clot capture device 330 (e.g., funnel 332) can be positioned between a first anatomical location or body region (e.g., left atrium LA, right atrium RA, septum S) and a second anatomical location or body region (e.g., different ones or portions of the left atrium LA, right atrium RA, and septum S), for example to help guide clot material 210 into catheter 120 and / or inhibit or even prevent clot material 210 in the first anatomical location from flowing toward and / or into the second anatomical location. For example, in an expanded state, the funnel 332 can be positioned to pass through and / or contact the septum S between the left atrium LA and the right atrium RA. In the illustrated embodiment, the funnel 332 extends through the septum S into the left atrium LA to help guide the clot material 210 into the catheter, for example, during aspiration. Additionally or alternatively, the funnel 332 is pressed against the septum S such that all or at least a portion of the fluid flowing through the septum S between the left atrium LA and the right atrium RA passes through the funnel 332. This, in turn, can inhibit or even prevent the clot material 201 in the left atrium LA from flowing toward and / or into the right atrium, for example, unless or until the clot material 201 is aspirated by the catheter 120. In some embodiments, the funnel 332 can be transitioned from a low-profile delivery state to an expanded state and / or to an expanded state, wherein at least a portion of the funnel 332 is positioned through the opening 203. Additionally or alternatively, the funnel 332 can be positioned through the opening 203, transitioned toward and / or to an expanded state, and then moved toward the right atrium RA, for example, such that at least a portion of the proximal end portion 334a is positioned within the opening 203 or the right atrium RA. With the clot capture device 330 at least partially positioned within the left atrium LA, the catheter 120 can be used to aspirate all or at least a portion of the clot material 201 from within the left atrium LA. In other embodiments, the funnel 332 can be positioned entirely within the left atrium LA, e.g., not within or in contact with the septum S. Although Fig.10Clot capture device 330 is shown, but other clot capture devices 430 - 630 described herein may also be positioned and / or used in a manner at least substantially similar or identical to clot capture device 330 .

[0055] Example

[0056] Several aspects of the present technology are illustrated in the following examples:

[0057] 1. A clot management system for treating clotted material in a left atrial appendage of a human patient, comprising:

[0058] A catheter, the catheter comprising—

[0059] a proximal portion; and

[0060] a shaped distal portion that is curved relative to the proximal portion;

[0061] a pressure source fluidly coupled to the catheter and configured to aspirate at least a portion of the clot material from the left atrial appendage via the shaped distal portion; and

[0062] A clot capture device is configured to be positioned at least partially above the opening of the left atrial appendage to inhibit any of the clotted material from exiting the left atrial appendage to the exterior of the catheter.

[0063] 2. A clot handling system according to embodiment 1, wherein the clot capture device comprises a slender member and a funnel connected to the slender member, wherein the funnel is configured to transition between a low-profile delivery state and an expanded state, and wherein the clot capture device is capable of being positioned within the catheter and is configured to move relative to the catheter to enable the funnel to transition between the low-profile delivery state and the expanded state.

[0064] 3. A clot handling system according to Example 2, wherein the slender member includes a distal tip, wherein the funnel includes a distal edge, and wherein the distal tip of the slender member extends distally beyond the distal edge of the funnel.

[0065] 4. A clot handling system according to embodiment 2, wherein the slender member includes a distal tip, wherein the funnel includes a distal edge, and wherein the distal tip is coplanar with the distal edge.

[0066] 5. The clot handling system of any one of embodiments 2 to 4, wherein the funnel comprises a filtration layer and one or more shape memory struts.

[0067] 6. The clot handling system of any one of embodiments 1 to 5, wherein the clot capture device comprises an adjustable structure configured to transform between a plurality of shapes.

[0068] 7. The clot handling system of embodiment 6, wherein the adjustable structure is configured to switch between a spherical shape, a disc shape, and a funnel shape.

[0069] 8. A clot handling system according to Example 6 or Example 7, wherein the clot capture device includes a slender member configured to be positioned within the catheter, wherein the adjustable structure includes a first end portion connected to the catheter and a second end portion connected to the slender member, and wherein the slender member and the catheter are configured to move relative to each other to change the shape of the adjustable structure.

[0070] 9. A clot handling system according to embodiment 8, wherein the adjustable structure is configured to transform from a spherical shape to a funnel shape in response to proximal movement of the slender member relative to the catheter.

[0071] 10. The clot management system of any one of embodiments 1 to 9, wherein the shaped distal portion comprises:

[0072] an intermediate portion adjacent to and distal to the proximal portion; and

[0073] a distal portion adjacent to the middle portion and distal to the middle portion;

[0074] in-

[0075] The intermediate portion is curved in a first direction relative to the proximal portion, and

[0076] The distal portion is curved in a second direction relative to the proximal portion. 11. The clot management system of embodiment 10, wherein the first direction is

[0077] The longitudinal axes of the side portions are coplanar, and wherein the second direction is perpendicular to the first direction.

[0078] 12. The clot handling system of Example 10 or Example 11, wherein the proximal portion and the middle portion define a plane, and wherein the second direction is perpendicular to the plane.

[0079] 13. The clot management system of any one of embodiments 10 to 12, wherein the middle portion is curved at a first angle about a first radius, and wherein the distal portion is curved at a second angle about a second radius.

[0080] 14. The clot handling system according to embodiment 13, wherein—

[0081] The first angle is 90 degrees;

[0082] The first radius is 2 inches;

[0083] The second angle is 30 degrees; and

[0084] The second radius is 1.25 inches.

[0085] 15. A clot handling system according to any one of embodiments 1 to 14, wherein the shaped distal portion also includes a distal-most tip portion, and the distal-most tip portion is configured to be aligned with or positioned within the left atrial appendage.

[0086] 16. A clot handling system according to any one of embodiments 1 to 15, wherein the clot capture device is a first clot capture device, and the clot handling system also includes a second clot capture device, which is configured to be positioned downstream of the left atrial appendage.

[0087] 17. The clot management system of Example 16, wherein the second clot capture device is configured to be positioned within the patient's aorta.

[0088] 18. A clot management system according to any one of embodiments 1 to 17, wherein the clot capture device is configured to be at least partially positioned within the left atrial appendage.

[0089] 19. A method for treating clotted material in a left atrial appendage of a human patient, the method comprising:

[0090] positioning a shaped distal portion of the catheter proximate to the clotted material;

[0091] positioning a clot capture device to at least partially cover an opening of the left atrial appendage;

[0092] coupling a pressure source to the conduit via a fluid control device, wherein (a) opening of the fluid control device fluidly connects the pressure source to the conduit, and (b) closing of the fluid control device fluidly disconnects the pressure source from the conduit;

[0093] activating the pressure source to create a vacuum; and

[0094] The vacuum is applied to the catheter, thereby drawing at least a portion of the clot material into the shaped distal portion of the catheter.

[0095] 20. The method of embodiment 19, wherein positioning the shaped distal portion comprises inserting the shaped distal portion from the right atrium of the heart of the human patient through the septum into the left atrium of the heart.

[0096] 21. The method of embodiment 20, wherein positioning the clot capture device comprises aligning the clot capture device with the left atrial appendage.

[0097] 22. The method of any one of embodiments 19 to 21, wherein positioning the clot capture device comprises positioning the clot capture device to contact at least a portion of an ostium of the left atrial appendage.

[0098] 23. A method according to any one of embodiments 19 to 22, wherein positioning the clot capture device includes positioning a funnel of the clot capture device relative to the left atrial appendage so that the funnel (i) at least partially prevents the clot material from leaving the left atrial appendage and (ii) substantially allows blood within the left atrial appendage to flow out of the left atrial appendage through the funnel.

[0099] 24. The method of any one of embodiments 19 to 23, wherein positioning the clot capture device comprises positioning an elongated member of the clot capture device at least partially within the left atrial appendage.

[0100] 25. A method according to embodiment 24, wherein the slender member is positioned within the catheter and fluidly connected to the pressure source, such that opening the fluid control device to apply the vacuum to the catheter includes opening the fluid control device to apply the vacuum to the slender member, thereby aspirating at least the portion of the clot material.

[0101] 26. The method of any one of embodiments 19 to 25, wherein positioning the clot capture device comprises extending the clot capture device from within the catheter.

[0102] 27. The method of any one of embodiments 19 to 26, wherein positioning the clot capture device comprises transitioning the clot capture device from a low-profile delivery state to an expanded state.

[0103] 28. The method of any one of embodiments 19 to 26, wherein positioning the clot capture device comprises changing a shape of the clot capture device by moving an elongated member of the clot capture device relative to the catheter.

[0104] 29. The method of Example 28, wherein moving the elongated member relative to the catheter comprises moving the elongated member proximally or distally relative to the catheter.

[0105] 30. The method of Example 28 or Example 29, wherein changing the shape of the clot capture device comprises switching the clot capture device between at least two shapes of a sphere shape, a disk shape, and a funnel shape.

[0106] 31. The method of any one of Examples 19 to 30, wherein the clot capture device is a first clot capture device, the method further comprising positioning a second clot capture device downstream of the left atrial appendage.

[0107] 32. The method of any one of embodiments 19 to 31, further comprising positioning a clot handling device to at least partially contact the clot material.

[0108] 33. The method of embodiment 32, wherein positioning the clot handling device comprises inserting the clot handling device through the shaped distal portion of the catheter or the clot capture device.

[0109] 34. A method according to Example 32 or Example 33, wherein positioning the clot handling device includes inserting the clot handling device at least partially into the left atrial appendage of the patient.

[0110] 35. The method of any one of embodiments 32 to 34, wherein positioning the clot handling device comprises positioning a mechanical thrombectomy device to contact at least a portion of the clot material.

[0111] 36. A method according to any one of embodiments 19 to 35, wherein activating the pressure source to generate the vacuum includes activating the pressure source to generate the vacuum when the fluid control device is closed, and wherein applying the vacuum to the conduit includes opening the fluid control device.

[0112] 37. A method according to any one of embodiments 19 to 35, wherein activating the pressure source to generate the vacuum includes activating the pressure source to generate the vacuum when the fluid control device is open, thereby applying the vacuum to the catheter and aspirating at least the portion of the clot material.

[0113] 38. A clot management system for treating clotted material within the heart of a human patient, comprising:

[0114] A catheter, the catheter comprising—

[0115] a proximal portion; and

[0116] a shaped distal portion that is curved relative to the proximal portion;

[0117] a pressure source fluidly coupled to the catheter and configured to draw at least a portion of the clot material from the heart via the shaped distal portion; and

[0118] A clot capture device is configured to be positioned at least partially within the heart to inhibit any of the clotted material from exiting the heart to exterior of the catheter.

[0119] 39. The clot handling system of embodiment 38, wherein the clot capture device is configured to at least partially inhibit the clot material from causing an embolic event.

[0120] 40. The clot management system of Example 38 or Example 39, wherein the heart includes a left atrium, and wherein the clot capture device is configured to be at least partially positioned within the left atrium of the heart.

[0121] 41. A clot management system for treating clotted material within the heart of a human patient, the clot management system comprising:

[0122] a first conduit carrying a first clot capture device configured to be positioned at a first location downstream of the clot material and to at least partially prevent at least a first portion of the clot material from moving downstream;

[0123] a second conduit carrying a second clot capture device configured to be positioned at a second location downstream of the first clot capture device and to at least partially prevent at least a second portion of the clot material from moving further downstream; and

[0124] A pressure source is fluidly coupled to the first conduit or the second conduit and is configured to aspirate at least a third portion of the clot material.

[0125] 42. A clot management system according to embodiment 41, wherein the first location is located at or near the left atrial appendage of the human patient.

[0126] 43. A clot management system according to Example 41 or Example 42, wherein the second location is at least partially located within the left atrium, left ventricle, or aorta of the human patient.

[0127] 44. The clot management system of embodiment 41, wherein the first location is at least partially located within the left atrium of the human patient.

[0128] 45. The clot management system of embodiment 44, wherein the second location is at least partially located within the left ventricle or aorta of the human patient.

[0129] 46. ​​The clot handling system of any one of embodiments 41 to 45, wherein the first clot capture device or the second clot capture device comprises a funnel.

[0130] 47. The clot handling system of any one of embodiments 41 to 46, wherein the first clot capture device or the second clot capture device is configured to transform between at least two different shapes.

[0131] 48. The clot management system of any one of embodiments 41 to 47, wherein:

[0132] The first clot capture device includes a first distal edge, the first catheter includes a first distal tip positioned proximally from the first distal edge, and / or

[0133] The second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned proximally from the second distal edge.

[0134] 49. The clot management system of any one of embodiments 41 to 47, wherein:

[0135] The first clot capture device comprises a first distal edge, and the first catheter comprises a first distal tip positioned distally from the first distal edge, and / or

[0136] The second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned distally from the second distal edge.

[0137] 50. The clot management system of any one of embodiments 41 to 47, wherein:

[0138] The first clot capture device includes a first distal edge and the first catheter includes a first distal tip positioned coplanar with the first distal edge, and / or the second clot capture device includes a second distal edge and the second catheter includes a second distal tip positioned coplanar with the second distal edge.

[0139] 51. The clot handling system of any one of embodiments 41 to 50, wherein the third portion of the clot material includes at least a portion or all of the first portion or the second portion of the clot material.

[0140] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, those skilled in the relevant art will recognize that various equivalent modifications may be made within the scope of the present technology. For example, although the steps are given in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0141] From the above, it should be understood that the specific embodiments of the technology have been described herein for illustrative purposes, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0142] In addition, unless the word "or" is expressly limited to mean only a single item in a list involving two or more items that excludes other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" refers to at least including the mentioned features from beginning to end, so that any greater number of the same features and / or other types of features are not excluded. It should also be understood that specific embodiments have been described here for illustrative purposes, but various modifications can be made without departing from the present technology. In addition, although the advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to belong to the scope of the present technology. Therefore, the present disclosure and related technologies may include other embodiments not explicitly shown or described herein.

Claims

1. A clot management system for treating clotted material in a left atrial appendage of a human patient, comprising: A catheter, the catheter comprising— proximal part; as well as a shaped distal portion that is curved relative to the proximal portion; a pressure source fluidly coupled to the catheter and configured to aspirate at least a portion of the clot material from the left atrial appendage via the shaped distal portion; as well as A clot capture device is configured to be positioned at least partially above the opening of the left atrial appendage to inhibit any of the clotted material from exiting the left atrial appendage to the exterior of the catheter.

2. A clot handling system according to claim 1, wherein the clot capture device includes a slender member and a funnel connected to the slender member, wherein the funnel is configured to transition between a low-profile delivery state and an expanded state, and wherein the clot capture device is capable of being positioned within the catheter and is configured to move relative to the catheter to enable the funnel to transition between the low-profile delivery state and the expanded state.

3. A clot handling system according to claim 2, wherein the slender member includes a distal tip, wherein the funnel includes a distal edge, and wherein the distal tip of the slender member extends distally beyond the distal edge of the funnel.

4. A clot handling system according to claim 2, wherein the slender member includes a distal tip, wherein the funnel includes a distal edge, and wherein the distal tip is coplanar with the distal edge.

5. The clot handling system of claim 2, wherein the funnel comprises a filter layer and one or more shape memory struts.

6. The clot handling system of claim 1, wherein the clot capture device comprises an adjustable structure configured to transition between a plurality of shapes.

7. The clot handling system of claim 6, wherein the adjustable structure is configured to transition between a sphere shape, a disk shape, and a funnel shape.

8. A clot handling system according to claim 6, wherein the clot capture device includes a slender member configured to be positioned within the catheter, wherein the adjustable structure includes a first end portion connected to the catheter and a second end portion connected to the slender member, and wherein the slender member and the catheter are configured to move relative to each other to change the shape of the adjustable structure.

9. The clot management system of claim 8, wherein the adjustable structure is configured to transform from a spherical shape to a funnel shape in response to proximal movement of the elongated member relative to the catheter.

10. The clot management system of claim 1, wherein the shaped distal portion comprises: a middle portion adjacent to the proximal portion and distal to the proximal portion; as well as a distal portion adjacent to the middle portion and distal to the middle portion; in- The intermediate portion is curved in a first direction relative to the proximal portion, and The distal portion is curved in a second direction relative to the proximal portion.

11. The clot management system of claim 10, wherein the first direction is coplanar with a longitudinal axis of the proximal portion, and wherein the second direction is perpendicular to the first direction.

12. The clot management system of claim 10, wherein the proximal portion and the intermediate portion define a plane, and wherein the second direction is perpendicular to the plane.

13. The clot management system of claim 10, wherein the intermediate portion is curved at a first angle about a first radius, and wherein the distal portion is curved at a second angle about a second radius.

14. The clot handling system of claim 13, wherein— The first angle is 90 degrees; The first radius is 2 inches; The second angle is 30 degrees; and The second radius is 1.25 inches.

15. The clot management system of claim 1, wherein the shaped distal portion further comprises a distal-most tip portion configured to be aligned with or positioned within the left atrial appendage.

16. A clot handling system according to claim 1, wherein the clot capture device is a first clot capture device, and the clot handling system further comprises a second clot capture device, which is configured to be positioned downstream of the left atrial appendage.

17. The clot management system of claim 16, wherein the second clot capture device is configured to be positioned within the patient's aorta.

18. The clot management system of claim 1, wherein the clot capture device is configured to be at least partially positioned within the left atrial appendage.

19. A method for treating clotted material in a left atrial appendage of a human patient, the method comprising: positioning a shaped distal portion of the catheter proximate to the clotted material; positioning a clot capture device to at least partially cover an opening of the left atrial appendage; coupling a pressure source to the conduit via a fluid control device, wherein (a) opening the fluid control device fluidly connects the pressure source to the conduit, and (b) closing the fluid control device fluidly disconnects the pressure source from the conduit; activating the pressure source to generate a vacuum; as well as The vacuum is applied to the catheter, thereby drawing at least a portion of the clot material into the shaped distal portion of the catheter.

20. The method of claim 19, wherein positioning the shaped distal portion comprises inserting the shaped distal portion from a right atrium of a heart of the human patient through the septum into a left atrium of the heart.

21. The method of claim 20, wherein positioning the clot capture device comprises aligning the clot capture device with the left atrial appendage.

22. The method of claim 19, wherein positioning the clot capture device comprises positioning the clot capture device to contact at least a portion of an ostium of the left atrial appendage.

23. A method according to claim 19, wherein positioning the clot capture device includes positioning a funnel of the clot capture device relative to the left atrial appendage so that the funnel (i) at least partially prevents the clot material from leaving the left atrial appendage and (ii) substantially allows blood within the left atrial appendage to flow out of the left atrial appendage through the funnel.

24. The method of claim 19, wherein positioning the clot capture device comprises positioning an elongated member of the clot capture device at least partially within the left atrial appendage.

25. A method according to claim 24, wherein the slender member is positioned within the catheter and fluidly connected to the pressure source, so that opening the fluid control device to apply the vacuum to the catheter includes opening the fluid control device to apply the vacuum to the slender member, thereby aspirating at least the portion of the clot material.

26. The method of claim 19, wherein positioning the clot capture device comprises extending the clot capture device from within the catheter.

27. The method of claim 19, wherein positioning the clot capture device comprises transitioning the clot capture device from a low-profile delivery state to an expanded state.

28. The method of claim 19, wherein positioning the clot capture device comprises changing a shape of the clot capture device by moving an elongated member of the clot capture device relative to the catheter.

29. The method of claim 28, wherein moving the elongate member relative to the catheter comprises moving the elongate member proximally or distally relative to the catheter.

30. The method of claim 28, wherein changing the shape of the clot capture device comprises transitioning the clot capture device between at least two of a sphere shape, a disk shape, and a funnel shape.

31. The method of claim 19, wherein the clot capture device is a first clot capture device, the method further comprising positioning a second clot capture device downstream of the left atrial appendage.

32. The method of claim 19, further comprising positioning a clot handling device at least partially in contact with the clot material.

33. The method of claim 32, wherein positioning the clot handling device comprises inserting the clot handling device through the shaped distal portion of the catheter or the clot capture device.

34. The method of claim 32, wherein positioning the clot handling device comprises inserting the clot handling device at least partially into the left atrial appendage of the patient.

35. The method of claim 32, wherein positioning the clot handling device comprises positioning a mechanical thrombectomy device to contact at least a portion of the clot material.

36. The method of claim 19, wherein activating the pressure source to create the vacuum comprises activating the pressure source to create the vacuum while the fluid control device is closed, and wherein applying the vacuum to the conduit comprises opening the fluid control device.

37. The method of claim 19, wherein activating the pressure source to create the vacuum comprises activating the pressure source to create the vacuum when the fluid control device is open, thereby applying the vacuum to the catheter and aspirating at least the portion of the clot material.

38. A clot management system for treating clotted material within the heart of a human patient, comprising: A catheter, the catheter comprising— proximal part; as well as a shaped distal portion that is curved relative to the proximal portion; a pressure source fluidly coupled to the catheter and configured to draw at least a portion of the clot material from the heart via the shaped distal portion; as well as A clot capture device is configured to be positioned at least partially within the heart to inhibit any of the clotted material from exiting the heart to exterior of the catheter.

39. The clot management system of claim 38, wherein the clot capture device is configured to at least partially inhibit the clot material from causing an embolic event.

40. The clot management system of claim 38, wherein the heart includes a left atrium, and wherein the clot capture device is configured to be positioned at least partially within the left atrium of the heart.

41. A clot management system for treating clotted material within the heart of a human patient, the clot management system comprising: a first conduit carrying a first clot capture device configured to be positioned at a first location downstream of the clot material and to at least partially prevent at least a first portion of the clot material from moving downstream; a second conduit carrying a second clot capture device configured to be positioned at a second location downstream of the first clot capture device and to at least partially prevent at least a second portion of the clot material from moving further downstream; as well as A pressure source is fluidly coupled to the first conduit or the second conduit and is configured to aspirate at least a third portion of the clot material.

42. A clot management system according to claim 41, wherein the first location is located at or near the left atrial appendage of the human patient.

43. The clot management system of claim 41, wherein the second location is at least partially located within the left atrium, left ventricle, or aorta of the human patient.

44. The clot management system of claim 41, wherein the first location is at least partially located within the left atrium of the human patient.

45. The clot management system of claim 44, wherein the second location is at least partially located within the left ventricle or aorta of the human patient.

46. ​​The clot handling system of claim 41, wherein the first clot capture device or the second clot capture device comprises a funnel.

47. The clot management system of claim 41, wherein the first clot capture device or the second clot capture device is configured to transition between at least two different shapes.

48. The clot management system of claim 41, wherein: The first clot capture device includes a first distal edge, the first catheter includes a first distal tip positioned proximally from the first distal edge, and / or The second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned proximally from the second distal edge.

49. The clot management system of claim 41, wherein: The first clot capture device includes a first distal edge and the first catheter includes a first distal tip positioned distally from the first distal edge, and / or the second clot capture device includes a second distal edge and the second catheter includes a second distal tip positioned distally from the second distal edge.

50. The clot management system of claim 41, wherein: The first clot capture device comprises a first distal edge, and the first catheter comprises a first distal tip positioned coplanar with the first distal edge, and / or The second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned coplanar with the second distal edge.

51. The clot handling system of claim 41, wherein the third portion of the clot material comprises at least a portion or all of the first portion or the second portion of the clot material.

Images