A clot treatment system for use, for example, in removing clot material from the left atrial appendage (LAA), and related devices and methods
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- INARI MEDICAL INC
- Filing Date
- 2023-06-06
- Publication Date
- 2026-05-19
AI Technical Summary
Current methods for addressing intracardiac thrombi, such as anticoagulant medication, are risky and often ineffective, leading to delayed or canceled cardiac procedures, which can have adverse consequences.
A clot treatment system comprising a catheter with a shaped distal portion for accessing the left atrial appendage, a pressure source for aspirating clot material, and a clot capture device to prevent embolization, allowing for mechanical removal of clots without the need for anticoagulants.
The system enables safe and efficient removal of intracardiac thrombi, reducing the need for anticoagulant therapy, minimizing procedural delays, and lowering the risk of complications associated with clot presence during cardiac procedures.
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Abstract
Description
Technical Field
[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 349,969, filed on June 7, 2022, entitled "CLOT TREATMENT SYSTEMS, SUCH AS FOR USE IN REMOVING CLOT MATERIAL FROM A LEFT ATRIAL APPENDAGE (LAA), AND ASSOCIATED DEVICES AND METHODS", which is hereby incorporated by reference in its entirety.
[0002] (Field of the Invention) The present technology generally relates to clot treatment systems, including clot treatment systems for use in removing clot material from a left atrial appendage, and associated devices and methods.
Background Art
[0003] Thrombosis is the local 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. Intracardiac thrombosis is a blood clot formed in a patient's heart. An example of intracardiac thrombosis is a left atrial appendage (LAA) thrombus, which is a blood clot formed within the left atrial appendage of the heart. When an intracardiac thrombus (e.g., an LAA thrombus) breaks off (embolizes) and flows towards the extremities or the brain, it can cause organ failure, acute limb ischemia (ALI) and / or stroke.
[0004] Additionally, the presence of an intracardiac thrombus can have an adverse effect (e.g., may indicate a contraindication) on many structural cardiac procedures 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 an intracardiac thrombus is detected, the cardiac procedure is typically aborted, and the patient is often instructed to take oral anticoagulants for about 4 - 6 weeks to attempt to dissolve the intracardiac thrombus. However, the thrombus may not have completely dissipated even after this 4 - 6 week period. In this case, the physician may decide to proceed with the procedure with the thrombus present or prescribe a different anticoagulant and wait longer.
[0005] Taking oral anticoagulants can have several risks such as excessive bleeding or an increased likelihood of bleeding. Additionally, a patient may be contraindicated for anticoagulants due to their side effects, making it difficult to remove intracardiac thrombi in these patients. Moreover, delaying the procedure has its own risks, such as an increased risk of death for some procedures. Additionally, patients may not always take the prescribed anticoagulants, which can result in the clot not dissipating and / or further delay of the cardiac procedure. Summary of the Invention Means for Solving the Problems
[0006] The present technology generally relates to clot treatment systems, as well as associated devices and methods. In some embodiments, a representative clot treatment system includes a catheter having a shaped distal portion configured to facilitate insertion of the catheter into a particular portion of a patient's anatomical structure. For example, the shaped portion may be curved to facilitate access to the interior of a patient's left atrial appendage. The clot treatment system may further include a pressure source fluidly coupled to the catheter and configured to apply a negative pressure to the catheter to aspirate clot material from the patient's body. Accordingly, the shaped portion of the catheter may be aligned with and / or positioned within the patient's left atrial appendage and used to aspirate clot material from within the left atrial appendage. In some aspects of the present technology, the clot treatment system provides for mechanical removal of clot material from the left atrial appendage, thereby reducing or eliminating the need to cancel a structural heart procedure if clot material is found within the patient's left atrial appendage, reducing or eliminating the need to prescribe anticoagulants to treat the clot material, and / or increasing the rate at which a structural heart procedure can be performed.
[0007] In some embodiments, the clot treatment system further includes a clot capture and / or embolism protection device (e.g., a funnel) configured to prevent the movement or transfer of clot material away from the left atrial appendage, such as by at least partially or completely preventing the clot material from embolizing. For example, the clot capture device can be aligned with, positioned relative to, and / or at least partially inserted through the ostium of the patient's left atrial appendage such that the clot capture device "catches" some or all of any clot material that has detached from the left atrial appendage. Thus, the clot capture device can reduce the risk that clot material within the left atrial appendage will embolize and move through the patient's heart and vasculature. In some embodiments, the clot capture device can include a funnel configured to (i) allow blood or other fluid within the left atrial appendage to flow through the funnel and (ii) at least partially prevent clot material within the left atrial appendage from exiting the left atrial appendage. Additionally or alternatively, the clot capture device can be positioned downstream of the left atrial appendage (e.g., within the patient's aorta) to capture any of the clot material flowing therethrough. In these and other embodiments, the clot treatment system can further include a coiling element or other clot treatment device that can be inserted into and positioned within the left atrial appendage to engage and / or remove at least a portion of the clot material located therein.
[0008] Certain aspects of the technology are described with reference to clot treatment and / or removal procedures associated with a patient's left atrial appendage, but those skilled in the art will understand that the technology can be used to treat and / or remove clots in other parts of a patient's anatomical structure. For example, at least some embodiments of the technology can be used to treat and / or remove clots at other locations within the left side of the heart, such as within the left atrium, left ventricle, and / or mitral valve. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Many aspects of the technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Rather, emphasis has been placed on clearly illustrating the principles of the disclosure.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0010] To provide a complete understanding of various embodiments of the present technology, specific details are set forth in the following description and FIGS. 1A - 10. In other instances, well-known structures, materials, operations, and / or systems often associated with intravascular procedures, clot removal procedures, catheters, etc., are not shown in detail and are not described 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 may be practiced without one or more of the details described herein and / or with other structures, methods, components, etc.
[0011] The terms used hereinafter should be interpreted in the broadest reasonable manner even when used in conjunction with a detailed description of specific examples of embodiments of the present technology. Indeed, certain terms may even be emphasized hereinafter, however, any terms intended to be interpreted in any limited manner are clearly and specifically so defined in this section of the detailed description.
[0012] The accompanying figures depict embodiments of the present technology and are not intended to limit its scope unless explicitly indicated. The sizes of the various depicted elements are not necessarily drawn to scale, and these various elements may be enlarged to improve readability. Details of components may be abstracted in the figures to exclude details such as the position of components and specific exact connections between such components when such details are not necessary for a complete understanding of the creation and use of the present technology. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of specific embodiments of the present disclosure. Accordingly, other embodiments may have other details, dimensions, angles, and features without departing from the present technology. In addition, those skilled in the art will understand that further embodiments of the present technology can be implemented without some of the details described below.
[0013] Regarding the terms "distal" and "proximal" within this description, unless otherwise specified, these terms can refer to the relative position of a portion of the catheter subsystem with respect to the operator and / or a location within the vasculature. Also, as used herein, designations such as "rearward," "forward," "upward," "downward," etc. do not mean to limit the referenced component to a particular orientation. Such designations are understood to refer to the orientation of the referenced component as illustrated in the figures, and the system of the present technology can be used in any orientation suitable for the user.
[0014] In the figures, the same reference numbers identify the same or at least generally similar elements. To facilitate the description of any particular element, the most significant digit(s) of any reference number refer to the figure in which the element was first introduced. For example, element 110 was first introduced and described with reference to FIG. 1A.
[0015] To the extent that materials incorporated herein by reference conflict with the present disclosure, the present disclosure prevails.
[0016] Figure 1A is a partial schematic side view of a clot treatment system 100 (the "system 100") configured in accordance with an embodiment of the present technology. The system 100 may also be referred to as a suction assembly, a vascular access system, a clot removal system, a thrombus removal system, a left atrial appendage (LAA) thrombus removal system, and / or the like. In the illustrated embodiment, the system 100 includes a tubing assembly 110 fluidly coupled to a catheter 120 via a valve 106. The catheter 120 is in a relaxed, unconstrained configuration in Figure 1A. In some embodiments, the catheter 120 is an elongate member configured to be inserted into and through a patient's vasculature, for example, to treat clot material therein. In other embodiments, the catheter 120 can be an introducer sheath configured to be inserted through a patient's skin and tissue tract to provide an access site through which other components (e.g., other catheters used to treat clot material) can easily access the vasculature. Thus, although referred to as the "catheter 120", the catheter 120 can include an introducer sheath, an access sheath, and / or another type of elongate member configured to be inserted through and / or across a patient's skin and tissue tract and / or across a patient's vasculature. Generally, the system 100 can include features that are generally similar in structure and / or function to, or are identical in structure and / or function to, the structure and / or function of the clot treatment system described in detail in U.S. Patent Application No. 16 / 536,185, entitled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS", filed on August 8, 2019, which is hereby incorporated by reference in its entirety, and / or can be used to treat / remove clot material from a patient (e.g., a human patient) using any of the methods described in detail therein.
[0017] In the illustrated embodiment, the catheter 120 includes (i) a proximal region or portion 122a, (ii) an intermediate region 122b adjacent to and distal of the proximal region 122a, (iii) a distal region 122c adjacent to and distal of the intermediate region 122b, and (iv) a distal tip region 122d adjacent to and distal of 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 further defines a lumen 124 (shown using a dashed line in FIG. 1A) that extends completely therethrough from the proximal region 122a to the distal tip region 122d. In some embodiments, the lumen 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, a maximum of 25 Fr (e.g., corresponding to the inner diameter of the catheter 120). For example, the lumen 124 can have a diameter of 20.6 Fr. However, in other embodiments, the lumen 124 can have a diameter of 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.
[0018] The proximal region 122a can be at least generally linear and can define a longitudinal axis Z. The intermediate region 122b, the distal region 122c, and / or the distal tip region 122d can define a shaped distal portion 128 (the "shaped portion 128") that is curved relative to the longitudinal axis Z. FIG. 1B is an end view of the shaped portion 128 along line 1B-1B of FIG. 1A. Referring to FIGS. 1A and 1B together, the intermediate region 122b can be curved relative to the longitudinal axis Z about a first radius R1 at a first angle A1, and the distal region 122c can be curved relative to the longitudinal axis Z about a second radius R2 at a second angle A2 (as shown in FIG. 1B). The first radius R1 can be in a first plane that includes the longitudinal axis Z, and the second radius R2 can be in a second plane that is different from the first plane (e.g., perpendicular to the first plane, not parallel to the first plane, angled with respect 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 about 0.5 to 5.0 inches, the first angle A1 can be about 60 to 120 degrees, the second radius R2 can be about 0.5 to 2.5 inches, and the second angle A2 can be about 10 to 60 degrees. The distal tip region 122d can be at least generally linear and can extend a length L from the distal region 122c. In the illustrated embodiment, the length L is 1.0 inch. In other embodiments, the length L can be about 0.25 inch to about 2 inches, such as at least 0.25 inch, 0.5 inch, 1.25 inch, 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 at least in part based on whether the dilator is positioned within the catheter 120 (e.g., within the shaped 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 second value that is different (e.g., greater than or less than the first value) from the respective first value when the dilator is not positioned within the shaped portion 128 and a first value when the dilator is positioned within the shaped portion 128.For example, the first radius R1 can be 2 inches without an expander and 2.1 inches with an expander, the first angle A1 can be 90 degrees without an expander and 85 degrees with an expander, the second radius R2 can be 1 inch without an expander and 2 inches with an expander, and / or the second angle A2 can be 30 degrees without an expander and 15 degrees with an expander. In other embodiments, any one 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 described hereinabove.
[0019] In some aspects of the present technology, the curvature of the shaped portion 128 is expected to improve access to selected portions of the patient's biological structures such as the left atrial appendage as will be described in detail below with reference to FIG. 2 and / or the left atrium as will be described in detail below with reference to FIGS. 9 and 10. The shaped portion 128 has specific dimensions and / or curvatures in the embodiments illustrated in FIGS. 1A and 1B, but in other embodiments, the shaped portion 128 can have other dimensions and / or curvatures, for example, to facilitate the placement of the distal tip region 122d proximate to a desired location within the patient's heart. For example, in the illustrated embodiments, the catheter 120 includes two curved regions (e.g., the intermediate region 122b and the distal region 122c) between the proximal end 126a and the distal end 126b, but in other embodiments, the catheter 120 can include more or fewer curved regions. In at least some embodiments, for example, the shaped portion 128 can include at least one, three, four, or another suitable number of curved regions, and any one of the individual curved regions can have the same or different curvatures as the intermediate 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 can be curved and / or otherwise configured to deviate from a generally linear configuration, as will be described in more detail below.
[0020] Catheter 120 can have various lengths, flexibilities, shapes, thicknesses, and / or other characteristics in and along various regions 122a - d. For example, catheter 120 can include one or more coils, braids, and / or other structures positioned between one or more liner layers (e.g., an inner liner layer and an outer liner layer). In some embodiments, catheter 120 can include some features that are generally similar or identical in structure and / or function to any of the catheters described in U.S. Patent Application No. 17 / 529,018, filed November 17, 2021, entitled "CATHETERS HAVING SHAPED DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS," and / or U.S. Patent Application No. 17 / 529,064, filed November 17, 2021, entitled "CATHETERS HAVING STEERABLE DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS," each of which is hereby incorporated by reference in its entirety.
[0021] In some embodiments, the shaped portion 128 can be configured to move between (i) a relaxed configuration, illustrated in FIGS. 1A and 1B, 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 intermediate region 122b and / or the distal region 122c can be configured (e.g., heat set) to deflect away from the longitudinal axis Z of the catheter 120 relative to the proximal region 122a. In the constrained configuration, the intermediate 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 intermediate region 122b, the distal region 122c, and / or the distal tip region 122d are at least generally aligned (e.g., in a straight line) with the proximal region 122a and / or the longitudinal axis Z.
[0022] Valve 106 is fluidly coupled to the lumen 124 of catheter 120 and may be integrated with or coupled to the proximal region 122a of catheter 120, such that these components move together. In some embodiments, valve 106 is a hemostatic valve configured to maintain hemostasis during a clot treatment procedure by preventing fluid flow in the proximal direction P through valve 106 when various components such as dilators, delivery sheaths, tension members, guidewires, intervention devices, other aspiration catheters, etc. are inserted through valve 106 and delivered through catheter 120 to a treatment site in a blood vessel. Valve 106 may include a branch or side port 102 configured to fluidly couple the lumen 124 of catheter 120 to tubing assembly 110. In some embodiments, valve 106 may be of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed August 30, 2018, and titled "HEMOSTASIS VALVES AND METHODS OF USE", which is hereby incorporated by reference in its entirety.
[0023] In the illustrated embodiment, the tubing assembly 110 fluidly couples the catheter 120 to a pressure source 104, such as a syringe. The pressure source 104 can be configured to generate (e.g., form, create, fill, accumulate) a vacuum (e.g., a negative relative pressure) and store the vacuum for subsequent application to the catheter 120. The tubing assembly 110 includes one or more tubing sections 112 (individually labeled as a first tubing section 112a and a second tubing section 112b) for fluidly coupling the tubing assembly 110 to the pressure source 104 and / or other suitable components, at least one fluid control device 114 (e.g., a valve), and at least one connector 116 (e.g., a Toomey tip connector). In some embodiments, the fluid control device 114 is a stopcock fluidly coupled (i) to the side port 102 of the valve 106 via the first tubing section 112a and (ii) to the connector 116 via the second tubing section 112b. The fluid control device 114 is externally operable by a user to regulate the flow of fluid through it, specifically, from the lumen 124 of the catheter 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 rapid connection / disconnection of the catheter 120 and the fluid control device 114 to / from the pressure source 104.
[0024] During clot treatment procedures, 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 near a clot material (e.g., left atrial appendage thrombus, pulmonary embolism, deep vein thrombosis, etc.) within the patient, the user can first close the fluid control device 114, for example, by withdrawing the plunger of a syringe coupled to the connector 116, before generating a vacuum within the pressure source 104. In this way, the vacuum is filled (e.g., a negative pressure is maintained) within the pressure source 104 before the pressure source 104 is fluidly connected to the lumen 124 of the catheter 120. To aspirate the lumen 124 of the catheter 120, the user opens the fluid control device 114 to fluidly connect the pressure source 104 to the catheter 120, thereby applying or releasing the vacuum accumulated in the pressure source 104 to the lumen 124 of the catheter 120. The opening of the fluid control device 114 instantaneously or nearly instantaneously applies the accumulated vacuum pressure to the tubing assembly 110 and the catheter 120, thereby generating a suction pulse throughout the catheter 120, which can aspirate the clot material into the catheter 120. In particular, the suction is applied to the distal tip region 122d of the catheter 120 to aspirate / suction at least a portion of the clot material proximate to the distal tip region 122d into the lumen 124 of the catheter 120. Additionally, or alternatively, the catheter 120 can act as an introducer sheath and be partially inserted into a blood vessel through the patient's skin and tissue to provide an access point through which other medical devices can be delivered and / or otherwise used to treat the patient.In these and other embodiments, the user may generate a vacuum within the pressure source 104 while the fluid control device 114 is open (e.g., while the pressure source 104 is in fluid connection with the lumen 124 of the catheter 120), thereby aspirating clot material in cooperation with and / or further simultaneously with generating the vacuum, e.g., without or substantially without storing the vacuum within the pressure source 104.
[0025] FIG. 2 is a side cross-sectional view of the shaped distal portion 128 of the clot treatment system 100 of FIGS. 1A and 1B inserted into a human heart H (“heart H”) according to an embodiment of the present technology. The heart H includes a left atrium LA, which includes a left atrial appendage LAA. The left atrial appendage LAA may be fluidly coupled to the left atrium LA by a small aperture O such that fluid can flow between the left atrium LA and the left atrial appendage LAA. In some patients, blood and / or other clot material 201 (shown schematically) may accumulate within the left atrial appendage LAA and form a clot or thrombus therein. Referring together to FIGS. 1A, 1B, and 2, in the illustrated embodiment, the catheter 120 has been inserted into and advanced through a patient's right atrial vein (not shown) and enters the left atrium LA septum-crossing through an opening 203 formed within a septum S between the left atrium LA and the right atrium of the heart H (not shown).
[0026] The shaped portion 128 of the catheter 120 is curved such that the distal tip region 122d can be aligned with the left atrial appendage LAA. For example, the distal end 126b may be positioned proximate to and / or extend at least partially through the small aperture O into the left atrial appendage LAA. When so positioned, the catheter 120 can be used to aspirate clot material 201 from the left atrial appendage LAA as described in detail above with reference to FIGS. 1A and 1B. In some embodiments, one or more clot treatment and / or removal devices, such as the clot treatment device of FIG. 7, may be inserted through the catheter 120 to assist in the treatment of the clot material 201.
[0027] Figures 3 through 6C are side views of respective clot capture and / or embolic protection devices 330, 430, 530a, 530b, 630 (collectively referred to as "devices 330 - 630") configured in accordance with embodiments of the present technology. In some embodiments, one or more of devices 330 - 630 may be used in clot treatment system 100 described in detail with reference to FIGS. 1A - 2. For example, devices 330 - 630 may be coupled to catheter 120 or may be advanced through catheter 120. At least some aspects of one or more of devices 330 - 630 may be generally similar or identical in structure and / or function to one or more of the other devices 330 - 630. Accordingly, like names and / or reference numerals are used to denote aspects of devices 330 - 630 that may be generally similar or identical.
[0028] Referring to FIG. 3, device 330 includes a funnel 332 having a proximal end portion 334a and a distal end portion 334b. The distal end portion 334b may define a distal edge or terminus 336 of the funnel 332. Referring to FIGS. 2 and 3 together, the distal edge 336 may be configured to contact or engage at least a portion of the patient's left atrial appendage LAA, such as the ostium O of the left atrial appendage LAA and / or one or more inner surfaces. The distal end portion 334b and / or the distal edge 336 may define an outer dimension D (e.g., diameter, width) of the funnel 332. The outer dimension D may be about 15 mm to 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 a corresponding inner dimension of the left atrial appendage LAA, such as the diameter of the ostium O. The proximal end portion 334a may be coupled to the distal tip 340 of an elongate member 338, such as a shaft or catheter. In the illustrated embodiment, the elongate member 338 is positioned within catheter 120 and the funnel 332 extends distally beyond the distal terminus 126b of the catheter 120. In some embodiments, the elongate member 338 may be shapeable and / or steerable. For example, the elongate member 338 may include at least some aspects that are generally similar or identical in structure and / or function to one or more of the catheters described in U.S. Patent Application No. 17 / 529,018, filed November 17, 2021, entitled "CATHETERS HAVING SHAPED DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS," and / or U.S. Patent Application No. 17 / 529,064, filed November 17, 2021, entitled "CATHETERS HAVING STEERABLE DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS," each of which is hereby incorporated by reference in its entirety.
[0029] The funnel 332 can be configured to transition between an expanded state (shown in FIG. 3) and a folded or low-profile delivery state. In the illustrated embodiment, the elongate member 338 can be moved relative to the catheter 120 to transition the funnel 332 between the expanded and folded states. For example, the elongate member 338 can be retracted proximally within the catheter 120 to move the funnel 332 toward and / or into the distal end 126b of the catheter 120 to transition the funnel 332 from the expanded state to the folded state. Additionally or alternatively, the catheter 120 can be advanced proximally over the elongate member 338 to drive the distal end 126b toward and / or against the funnel 332 to transition the funnel 332 from the expanded state to the folded state. To transition the funnel 332 from the folded state to the expanded state, the catheter 120 can be retracted proximally relative to the elongate member 338 to expose the funnel 332 and allow the funnel 332 to expand toward and / or into the expanded state. Additionally or alternatively, the elongate member 338 can be advanced distally out of the catheter 120 to extend distally beyond the distal end 126b, thereby exposing the funnel 332 out of the catheter 120 and allowing the funnel 332 to expand from the folded state to the expanded state.
[0030] The funnel 332 can include a plurality of braided filaments such as a plurality of shape memory wires heat set to expand to the expanded state shown in FIG. 3. The funnel 332 can further define one or more openings or pores 333 (schematically shown in FIG. 3). In the embodiment illustrated in FIG. 3, eight pores 333 are shown, but in other embodiments, the funnel 332 can include more or fewer pores, such as at least 1, 5, 10, 20, 30, 50, 100, a number between them, or another suitable number of pores 333. Each individual one of the pores 333 can have a cross-sectional dimension (e.g., width) or area of about 100 μm to about 500 μm (e.g., 150 μm or less), or another suitable dimension or area. Referring to FIGS. 2 and 3 together, the pores 333 of the funnel 332 can be sized and shaped such that (i) blood and / or other fluid within the left atrial appendage LAA can flow substantially through the funnel 332, and (ii) clot material 201 within the left atrial appendage LAA is blocked from flowing through the funnel 332.
[0031] The funnel 332 can be configured such that clot material 201 (FIG. 2) within the left atrial appendage LAA is blocked from embolizing and flowing through the patient's heart H and vasculature during clot treatment and / or removal procedures. For example, during the procedures described in detail with reference to FIGS. 1A, 1B, and 2, the device 330 can be deployed from the catheter 120 and used to prevent or prevent clot material 201 from passing out (e.g., embolizing) from the small aperture O of the left atrial appendage LAA during aspiration of the catheter 120. More specifically, the distal edge 336 of the funnel 332 can be aligned with and / or positioned relative to the small aperture O such that the funnel 332 can "catch" the clot material 201 when the clot material 201 is released from the left atrial appendage LAA, such as in response to aspiration, and at least partially covers / occludes the small aperture O. Additionally or alternatively, the funnel 332 can be at least partially positioned / deployed within the left atrial appendage LAA, whereby 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.
[0032] In some embodiments, in addition to, or alternatively to, aspirating the lumen 124 of the catheter 120, the lumen of the elongate member 338 can be used to aspirate the clot material 201. For example, a pressure source and tubing system similar or identical to the pressure source 104 and tubing assembly 110 of FIG. 1A can be coupled to the elongate member 338 and used to aspirate the elongate member 338. In these and other embodiments, one or more other clot treatment and / or removal devices can be positioned within and / or delivered through the elongate member 338 and / or the catheter 120 to aspirate and / or engage the clot material 201.
[0033] Referring to FIG. 4, the device 430 can include a funnel 432 that is generally similar to the funnel 332 of FIG. 3. For example, the funnel 432 can be configured to "capture" the clot material 201 and / or at least partially or fully prevent the clot material from embolizing, as described above with reference to FIG. 3. However, in the illustrated embodiment, the funnel 432 has a shorter length such that the distal edge 436 of the funnel 432 is in substantially the same plane as the distal tip 340 of the elongate member 338 and / or 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 elongate member 338 proximal to the distal tip 340. Thus, referring to FIGS. 2 and 4 together, when used during a clot treatment procedure to treat the clot material 201 within the small aperture O of the left atrial appendage LAA, the distal tip 340 of the elongate member 338 can extend through the small aperture O of the left atrial appendage LAA and / or be positioned closer to the clot material 201 located therein otherwise. In some aspects, positioning the distal tip 340 of the elongate member 338 closer to the clot material 201 is expected to improve the suction force applied to the clot material 201 and / or increase the amount of clot material 201 removed during a given suction pulse (e.g., applied through the elongate member 338). However, in other embodiments, the distal edge 436 can be positioned proximal or distal to the distal tip 340.
[0034] Referring to FIG. 5A, the device 530a may include a funnel 532a having a plurality of support elements or struts 535a and a filtration layer 537 coupled thereto. The funnel 532a may be coupled to the elongate member 338. An individual one of the struts 535a may be formed from 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 may be configured to automatically transition from a low-profile delivery state to an expanded state (shown in FIG. 5A). The filtration layer 537 may cover one or more or all of the struts 535a and may be formed from expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) mesh, a silicone coating, and / or another suitable material. Additionally, the filtration layer 537 may include / delineate a plurality of pores 533 such that the funnel 532a is configured to (i) substantially enable blood and / or other fluid within the left atrial appendage LAA to flow through the funnel 532a and (ii) prevent clot material 201 within the left atrial appendage LAA from flowing through the funnel 532a.
[0035] Referring to FIG. 5B, the device 530b may include a funnel 532b that is generally similar to the funnel 532a of FIG. 5A. In the illustrated embodiment, the funnel 532b includes one or more struts 535b that extend radially outwardly in a distal direction from a central hub 539. The central hub may be coupled to the elongate member 338 such that each of the struts 535b may extend distally beyond the distal tip 340 of the elongate member 338 in a direction generally parallel to the longitudinal axis of the elongate member 338. An individual one of the struts 535b may be formed from a shape memory material such as nitinol such that the funnel 532b is configured to self-expand and / or automatically transition from a low-profile delivery state to an expanded state (shown in FIG. 5B). The filtration layer 537 may cover one or more or all of the struts 535b.
[0036] Referring together to FIGS. 6A-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 elongate member 338, for example, at or near the distal tip 340. The first end portion 644a can be coupled to a catheter, such as the catheter 120 shown in FIGS. 6A-6C, 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 can include a mesh or other suitable structure. The elongate member 338 can be slidably disposed within the catheter 120 such that one or both of the elongate member 338 and the catheter 120 can move relative to each other.
[0037] Relative movement between the elongate member 338 and the catheter 120 can shift an adjustable structure 642 between a plurality of shapes or states such as a first state 646a (e.g., spherical, disc, or spherical shape) shown in FIG. 6A, a second state 646b (e.g., flat or disc shape shown in FIG. 6B), and a third state 646c (e.g., conical or funnel shape) shown in FIG. 6C. For example, moving the elongate member 338 relative to the catheter 120 and / or moving the catheter 120 relative to the elongate member 338 can move the first and second end portions 644a-b of the adjustable structure 642 relative to each other and change the shape of the adjustable structure 642. In the first state 646a, the adjustable structure 642 can be curved or arcuate, and the first and second end portions 644a-b can generally be spaced apart from each other. In the second state 646b, the adjustable structure 642 can include a vertex region 648 that defines a maximum outer dimension (e.g., width, diameter, etc.) of the adjustable structure 642, e.g., for all or a subset of the various states 646a-c. For example, the diameter of the adjustable structure 642 in the second state 646b may be larger 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 that includes a distal edge 636 defined by a crease within the adjustable structure 642. The crease of the adjustable structure 642 can be formed by positioning the second end portion 644b within or near the first end portion 644a, as will be described in more detail below.
[0038] The adjustable structure 642 can transition from the first state 646a to the second state 646b, for example, by moving the distal tip 340 of the elongate member 338 towards the catheter 120 and / or by moving the catheter 120 towards the distal tip 340, thereby reducing the distance between the first end portion 644a and the second end portion 644b. The adjustable structure 642 can transition from the second state 646b to the third state 646c by continuing to reduce the distance between the first end portion 644a and the second end portion 644b, for example, until the first and second end portions 644a - b at least partially overlap each other and / or until the distal tip 340 is positioned within the catheter 120. The adjustable structure 642 can transition 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 can be configured to transition to one or more additional states / shapes other than the shapes 646a - c illustrated in FIGS. 6A - 6C. For example, the adjustable structure 642 can further increase the distance between the first end portion 644a and the second end portion 644b, thereby advancing the distal tip 340 further distally from the catheter 120 (e.g., advancing the distal tip 340 further distally in a direction away from / towards the distal end 126b of the catheter 120) and placing the adjustable structure 642 substantially flat against the outer surface of the elongate member 338 to transition to a low profile delivery state.
[0039] Referring together to FIGS. 2 and 6A, 6B, and 6C, for example, the shape of the adjustable structure 642, 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 treatment of the clot material 201. For example, the first state 646a can allow for deeper insertion of the distal tip 340 into the left atrial appendage LAA and / or can center the elongate member 338 within the left atrial appendage LAA, both of which can improve the aspiration of the clot material 201 from within the left atrial appendage LAA via the catheter 120 and / or the elongate 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 / occlude left atrial appendages LAA of many different sizes. In the third state 646c, the distance between the distal tip 340 of the elongate member and the distal edge 636 of the funnel 632 can reduce or prevent the application of a suction force (e.g., aspiration) to the wall of the left atrial appendage LAA and / or other parts of the patient's anatomy.
[0040] FIG. 7 is a side view of a clot treatment and / or removal device 750 (the "device 750") positioned within the left atrial appendage LAA, according to an embodiment of the present technology. In some embodiments, the device 750 can be used in the clot treatment system 100 described in detail with reference to FIGS. 1A-6. For example, the device 750 can be advanced through and / or retracted within the elongate member 338 and / or the catheter 120. Generally, the device 750 can include at least some aspects that are at least generally 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 Apr. 26, 2017, entitled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION", which is hereby incorporated by reference in its entirety.
[0041] In the illustrated embodiment, device 750 is a mechanical thrombectomy device that includes a braided or laser cut structure that is coupled to tether 752. Device 750 can be at least partially formed from a shape memory material such as nitinol. Referring together to FIGS. 2 and 7, device 750 can be inserted into the left atrial appendage LAA through small aperture O and capture / engage clot material 201 that is engaged therein. Next, tether 752 can be used to retract device 750 from the left atrial appendage LAA, whereby device 750 can remove / liberate at least a portion of clot material 201. In the illustrated embodiment, for example, at least a portion of device 430 of FIG. 4, such as funnel 432 and / or at least a portion of its distal edge 436, is positioned relative to small aperture O, and device 750 is inserted into the left atrial appendage LAA through elongate member 338. After positioning device 750 within the left atrial appendage LAA, device 750 can be retracted within elongate member 338. Device 430 (e.g., funnel 432) can capture any of the clot material 201 that is liberated before, during, and / or after the mechanical engagement of device 750 with clot material 201, and / or otherwise prevent at least a portion of clot material 201 from embolizing.
[0042] In some embodiments, the clot capture device according to the present technology can be used with the clot removal system of FIG. 1A and positioned at other locations within the patient's vasculature downstream of the left atrial appendage to capture, for example, clot material removed or separated from the patient's left atrial appendage (LAA), thereby preventing or precluding the clot material from causing an embolization event (e.g., embolism, stroke, etc.). For example, FIG. 8 is a cross-sectional view of a patient's heart H including a clot capture device 830 having a funnel 832 configured to be positioned downstream of the heart H, such as within the aorta (e.g., ascending aorta and / or descending aorta). The funnel 832 can include at least some aspects that are generally similar or identical in structure and / or function to one or more of the funnels 332, 432, 532a, 532b, 632 described hereinabove. The device 830 can be used in conjunction with one or more of the other devices 330 - 630, 750 described herein, for example, while one or more of the other devices 330 - 630, 750 are positioned within the heart H. Additionally, or alternatively, the device 830 can be used with a suction catheter system, such as the system 100 and / or another suitable suction catheter system, to suction at least a portion of the clot material 201 exiting the left atrial appendage LAA. Generally, the device 830 can include at least some aspects that are at least generally similar or identical to one or more of the clot treatment systems described in detail in U.S. Patent Application No. 17 / 339,663, filed on June 4, 2021, entitled "RECAPTURABLE FUNNEL CATHETERS, AND ASSOCIATED SYSTEMS AND METHODS", which is hereby incorporated by reference in its entirety.
[0043] In the illustrated embodiment, the funnel 832 is coupled to an elongate member 838 inserted through the descending aorta and toward the left ventricle LV. Thus, the funnel 832 can capture any of the clot material 201 flowing downstream out of the left atrial appendage LAA (FIG. 2) and through the left atrium LA and / or the left ventricle LV. The funnel 832 can be configured to transition between a low-profile delivery state and an expanded state (shown in FIG. 8). In the low-profile delivery state, the funnel 832 can be configured to be inserted through one or more of the patient's arteries, such as the femoral artery or the radial artery. For example, in the low-profile delivery state, the funnel 832 can have an outer dimension (e.g., diameter) of about 6Fr to 8Fr. In the expanded state, the funnel 832 can be configured to span all or a portion of the inner width of the blood vessel (e.g., the aorta) in which the funnel 832 is positioned. For example, in the expanded state, the funnel 832 can have an outer dimension (e.g., diameter) of about 30 mm to about 40 mm, or another suitable outer dimension.
[0044] In some embodiments, at least a portion of the clot treatment system 100 can be used to remove clot material from one or more portions or regions of the patient's anatomical structure other than the left atrial appendage LAA. For example, FIG. 9 is a side cross-sectional view of a patient's heart H having the shaped portion 128 of the catheter 120 of FIGS. 1A and 1B positioned in accordance with an embodiment of the present technique. At least a portion of the shaped portion 128 can be positioned within the left atrium LA through 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 the clot material 201.
[0045] FIG. 10 is a cross-sectional view of a patient's heart H with the clot capture device 330 of FIG. 3 positioned in accordance with an embodiment of the present technique. The clot capture device 330 (e.g., the funnel 332) is positioned between a first anatomical location or body region (e.g., the left atrium LA, the right atrium RA, the septum S) and a second anatomical location or body region (e.g., a different one or portion of the left atrium LA, the right atrium RA, and the septum S) to, for example, assist in guiding clot material 210 into the catheter 120 and / or prevent or further prevent the clot material 210 in the first anatomical location from flowing towards and / or into the second anatomical location. For example, in an expanded state, the funnel 332 can be positioned through and / or in contact with the septum S between the left atrium LA and the right atrium RA. In the illustrated embodiment, the funnel 332 extends into the left atrium LA through the septum S to, for example, assist in guiding the clot material 210 into the catheter during aspiration. Additionally or alternatively, the funnel 332 presses against the septum S such that all or at least a portion of the fluid flow between the left atrium LA and the right atrium RA through the septum S passes through the funnel 332. This can then prevent or further prevent the clot material 201 in the left atrium LA from flowing towards and / or into the right atrium, for example, until the clot material 201 is not or is aspirated by the catheter 120. In some embodiments, the funnel 332 can transition from a low-profile delivery state to an expanded state and / or to the expanded state, together with at least a portion of the funnel 332 positioned through the opening 203. Additionally or alternatively, the funnel 332 is positioned through the opening 203, transitions towards and / or to the expanded state, and then can move towards the right atrium RA such that at least a portion of the proximal end portion 334a is positioned in the opening 203 or in the right atrium RA. With the clot capture device 330 at least partially positioned within the left atrium LA, all or at least a portion of the clot material 201 can be aspirated from within the left atrium LA using the catheter 120. In other embodiments, the funnel 332 can be positioned entirely within the left atrium LA, for example, within or in contact with the septum S.FIG. 10 illustrates clot capture device 330, but other clot capture devices 430-630 described herein may also be positioned and / or used in at least generally the same or identical manner as clot capture device 330.
Examples
[0046] Some aspects of the present technology are described in the following examples. 1. A clot treatment system for treating clot material in the left atrial appendage of a human patient, comprising: A catheter, A proximal portion, and A catheter including a shaped distal portion curved with respect 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 through the shaped distal portion; A clot capture device positioned to at least partially cover the opening of the left atrial appendage and configured to prevent any of the clot material from exiting the left atrial appendage outside the catheter. 2. The clot treatment system according to Example 1, wherein the clot capture device includes an elongate member and a funnel coupled to the elongate member, the funnel being configured to transition between a low-profile delivery state and an expanded state, the clot capture device being positionable within the catheter and movable relative to the catheter to transition the funnel between the low-profile delivery state and the expanded state. 3. The clot treatment system according to Example 2, wherein the elongate member includes a distal tip, the funnel includes a distal edge, and the distal tip of the elongate member extends distally beyond the distal edge of the funnel. 4. The clot treatment system according to Example 2, wherein the elongate member includes a distal tip, the funnel includes a distal edge, and the distal tip is in the same plane as the distal edge. 5. The clot treatment system according to any one of Examples 2-4, wherein the funnel includes a filtration layer and one or more shape memory struts. 6. The clot treatment system according to any one of Examples 1 to 5, wherein the clot capture device includes an adjustable structure configured to transition between a plurality of shapes. 7. The clot treatment system according to Example 6, wherein the adjustable structure is configured to transition between a spherical shape, a disc shape, and a funnel shape. 8. The clot capture device includes an elongated member configured to be positioned within a catheter, and the adjustable structure includes a first end portion coupled to the catheter and a second end portion coupled to the elongated member, and the elongated member and the catheter are configured to be moved relative to each other to change the shape of the adjustable structure. The clot treatment system according to Example 6 or Example 7. 9. The clot treatment system according to Example 8, wherein the adjustable structure is configured to transition from a spherical shape to a funnel shape in response to proximal movement of the elongated member relative to the catheter. 10. The shaped distal portion includes an intermediate portion adjacent to and distal from the proximal portion, and a distal portion adjacent to and distal from the intermediate portion, the intermediate portion is curved in a first direction with respect to the proximal portion, and the distal portion is curved in a second direction with respect to the proximal portion. The clot treatment system according to any one of Examples 1 to 9. 11. The clot treatment system according to Example 10, wherein the first direction is in the same plane as the longitudinal axis of the proximal portion, and the second direction is perpendicular to the first direction. 12. The proximal portion and the intermediate portion define a plane, and the second direction is perpendicular to the plane. The clot treatment system according to Example 10 or Example 11. 13. The intermediate portion is curved at a first angle around a first radius, and the distal portion is curved at a second angle around a second radius. The clot treatment system according to any one of Examples 10 to 12. 14. The first angle is 90 degrees, the first radius is 2 inches, the second angle is 30 degrees, The clot treatment system according to Example 13, wherein the second radius is 1.25 inches. The clot treatment system according to any one of Examples 1 to 14, further comprising a most distal tip portion configured such that the shaped distal portion is aligned with or positioned within the left atrial appendage. The clot treatment system according to any one of Examples 1 to 15, wherein the clot capture device is a first clot capture device, and the clot treatment system further comprises a second clot capture device configured to be positioned downstream of the left atrial appendage. The clot treatment system according to Example 16, wherein the second clot capture device is configured to be positioned within the patient's aorta. The clot treatment system according to any one of Examples 1 to 17, wherein the clot capture device is configured to be at least partially positioned within the left atrial appendage. A method for treating a clot material within the left atrial appendage of a human patient, the method comprising: positioning a shaped distal portion of a catheter in proximity to the clot material; positioning a clot capture device so as to at least partially cover an opening of the left atrial appendage; coupling a pressure source to the catheter via a fluid control device, wherein (a) the pressure source is fluidly connected to the catheter by opening the fluid control device, and (b) the pressure source is fluidly disconnected from the catheter by closing the fluid control device; activating the pressure source to generate a vacuum; applying the vacuum to the catheter, thereby sucking at least a portion of the clot material into the shaped distal portion of the catheter. The method according to Example 19, wherein positioning the shaped distal portion comprises inserting the shaped distal portion transseptally from the right atrium of the heart to the left atrium of the heart of a human patient. The method according to Example 20, wherein positioning the clot capture device comprises aligning the clot capture device with the left atrial appendage. 22. Positioning the clot capture device includes positioning the clot capture device to contact at least a portion of the small aperture of the left atrial appendage, the method according to any one of Examples 19-21. 23. Positioning the clot capture device includes positioning the funnel of the clot capture device relative to the left atrial appendage such that the funnel (i) at least partially prevents clot material from exiting the left atrial appendage and (ii) substantially enables blood within the left atrial appendage to flow out of the left atrial appendage through the funnel, the method according to any of Examples 19-22. 24. Positioning the clot capture device includes at least partially positioning the elongate member of the clot capture device within the left atrial appendage, the method according to any one of Examples 19-23. 25. The elongate member is positioned within the catheter and fluidly coupled to a pressure source such that opening the fluid control device and applying a vacuum to the catheter includes opening the fluid control device and applying a vacuum to the elongate member, thereby aspirating at least a portion of the clot material, the method according to Example 24. 26. Positioning the clot capture device includes extending the clot capture device from within the catheter, the method according to any one of Examples 19-25. 27. Positioning the clot capture device includes transitioning the clot capture device from a low-profile delivery state to an expanded state, the method according to any one of Examples 19-26. 28. Positioning the clot capture device includes changing the shape of the clot capture device by moving the elongate member of the clot capture device relative to the catheter, the method according to any one of Examples 19-26. 29. Moving the elongate member relative to the catheter includes moving the elongate member proximally or distally relative to the catheter, the method according to Example 28. 30. Changing the shape of the clot capture device includes transitioning the clot capture device between at least two of a spherical shape, a disc shape, and a funnel shape, the method according to Example 28 or Example 29. 31. The method according to any one of embodiments 19 to 30, wherein the clot capture device is a first clot capture device, and the method further includes positioning a second clot capture device downstream of the left atrial appendage. 32. The method according to any one of embodiments 19 to 31, further comprising positioning a clot treatment device so as to at least partially contact the clot material. 33. The method according to embodiment 32, wherein positioning the clot treatment device includes inserting the clot treatment device through a shaped distal portion of a catheter or a clot capture device. 34. The method according to embodiment 32 or 33, wherein positioning the clot treatment device includes inserting the clot treatment device at least partially into the patient's left atrial appendage. 35. The method according to any one of embodiments 32 to 34, wherein positioning the clot treatment device includes positioning a mechanical thrombectomy device so as to contact at least a portion of the clot material. 36. The method according to any one of embodiments 19 to 35, wherein operating a pressure source to generate a vacuum includes operating the pressure source to generate a vacuum while a fluid control device is closed, and applying the vacuum to the catheter includes opening the fluid control device. 37. The method according to any one of embodiments 19 to 35, wherein operating a pressure source to generate a vacuum includes operating the pressure source to generate a vacuum while the fluid control device is open, thereby applying the vacuum to the catheter and sucking at least a portion of the clot material. 38. A clot treatment system for treating clot material in the heart of a human patient, comprising: a catheter, a proximal portion, and a catheter including a shaped distal portion curved with respect to the proximal portion; a pressure source fluidly coupled to the catheter and configured to suck at least a portion of the clot material from the heart through the shaped distal portion; A clot treatment system comprising a clot capture device positioned at least partially within the heart and configured to prevent any of the clot material from exiting the heart outside the catheter. 39. The clot treatment system according to embodiment 38, wherein the clot capture device is configured to at least partially prevent the clot material from causing an embolism event. 40. The clot treatment system according to embodiment 38 or 39, wherein the heart includes a left atrium and the clot capture device is configured to be positioned at least partially within the left atrium of the heart. 41. A clot treatment system for treating clot material in the heart of a human patient, the clot treatment system comprising: A first catheter carrying a first clot capture device positioned at a first location downstream of the clot material and configured to at least partially prevent downstream movement of at least a first portion of the clot material; A second catheter carrying a second clot capture device positioned at a second location downstream of the first clot capture device and configured to at least partially prevent further downstream movement of at least a second portion of the clot material; A pressure source fluidly coupled to the first catheter or the second catheter and configured to aspirate at least a third portion of the clot material. 42. The clot treatment system according to embodiment 41, wherein the first location is in or near the left atrial appendage of the human patient. 43. The clot treatment system according to embodiment 41 or 42, wherein the second location is at least partially within the left atrium, left ventricle, or aorta of the human patient. 44. The clot treatment system according to embodiment 41, wherein the first location is at least partially within the left atrium of the human patient. 45. The clot treatment system according to embodiment 44, wherein the second location is at least partially within the left ventricle or aorta of the human patient. 46. The clot treatment system according to any one of embodiments 41 to 45, wherein the first clot capture device or the second clot capture device includes a funnel. 47. The clot treatment system according to any one of Examples 41 to 46, wherein the first clot capture device or the second clot capture device is configured to transition between at least two different shapes. 48. 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, the second catheter includes a second distal tip positioned proximally from the second distal edge, the clot treatment system according to any one of Examples 41 to 47. 49. The first clot capture device includes a first distal edge, 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, the second catheter includes a second distal tip positioned distally from the second distal edge, the clot treatment system according to any one of Examples 41 to 47. 50. The first clot capture device includes a first distal edge, the first catheter includes a first distal tip positioned on the same plane as the first distal edge, and / or The second clot capture device includes a second distal edge, the second catheter includes a second distal tip positioned on the same plane as the second distal edge, the clot treatment system according to any one of Examples 41 to 47. 51. The clot treatment system according to any one of Examples 41 to 50, wherein a third portion of the clot material includes at least a part or all of the first portion or the second portion of the clot material.
[0047] 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 exact forms disclosed above. Specific embodiments and examples of the present technology have been described above for illustrative purposes, but as will be recognized by those skilled in the art, various equivalent modifications are possible within the scope of the present technology. For example, the steps are presented in a given order, but alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
[0048] From the above, while specific embodiments of the present technology have been described herein for illustrative purposes, it will be understood that well-known structures and functions have not been shown or described in detail so as not to unnecessarily obscure the description of the embodiments of the present technology. When permitted by the context, singular or plural terms may each include the plural or singular terms, respectively.
[0049] Furthermore, unless the term "or" is explicitly limited to mean only a single item exclusive of the other items in a list of two or more items, the use of "or" in such a list should be interpreted to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited features such that any more of the same features and / or additional types of other features are not excluded. While specific embodiments have been described herein for illustrative purposes, it will also be understood that various modifications can be made without departing from the present technology. Further, while the advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may exhibit such advantages, and not all embodiments necessarily exhibit such advantages in order to fall within the scope of the present technology. Accordingly, the present disclosure and related technologies may encompass other embodiments not explicitly shown or described herein.
Claims
1. A clot treatment system for treating clot material in the left atrial appendage of human patients, It is a catheter, Proximal portion, and A catheter including a molded distal portion that is curved relative to the proximal portion, A pressure source is fluidly coupled to the catheter and configured to aspirate at least a portion of the coagulated material from the left atrial appendage via the molded distal portion, A clot treatment system comprising: a clot capture device positioned to at least partially cover the opening of the left atrial appendage and configured to prevent any of the clot material from exiting the left atrial appendage outside the catheter.
2. The clot treatment system according to claim 1, wherein the clot capture device comprises an elongated member and a funnel coupled to the elongated member, the funnel being configured to transition between a low-profile delivery state and an expanded state, and the clot capture device being positionable within the catheter and configured to move relative to the catheter, causing the funnel to transition between the low-profile delivery state and the expanded state.
3. The agglutination treatment system according to claim 2, wherein the elongated member includes a distal tip, the funnel includes a distal edge, and the distal tip of the elongated member extends distally beyond the distal edge of the funnel.
4. The agglutination treatment system according to claim 2, wherein the elongated member includes a distal tip, the funnel includes a distal edge, and the distal tip lies on the same plane as the distal edge.
5. The agglutination treatment system according to claim 2, wherein the funnel includes a filtration layer and one or more shape-memory support columns.
6. The coagulation treatment system according to claim 1, wherein the coagulation capturing device includes an adjustable structure configured to transition between a plurality of shapes.
7. The agglutination treatment system according to claim 6, wherein the adjustable structure is configured to transition between a spherical shape, a disc shape, and a funnel shape.
8. The coagulation treatment system according to claim 6, wherein the coagulation capturing device includes an elongated member configured to be positioned within the catheter, and the adjustable structure includes a first end portion coupled to the catheter and a second end portion coupled to the elongated member, and the elongated member and the catheter are configured to move relative to each other to change the shape of the adjustable structure.
9. The agglutination treatment system according to claim 8, wherein the adjustable structure is configured to transition from a spherical shape to a funnel shape in response to the proximal movement of the elongated member relative to the catheter.
10. The molded distal portion, An intermediate portion adjacent to the proximal portion and distal to the proximal portion, Including a distal portion adjacent to the intermediate portion and distal to the intermediate portion, The aforementioned intermediate portion is curved in a first direction relative to the aforementioned proximal portion, The agglutination treatment system according to claim 1, wherein the distal portion is curved in a second direction relative to the proximal portion.
11. The agglutination treatment system according to claim 10, wherein the first direction is coplane with the longitudinal axis of the proximal portion, and the second direction is perpendicular to the first direction.
12. The agglutination treatment system according to claim 10, wherein the proximal portion and the intermediate portion define a plane, and the second direction is perpendicular to the plane.
13. The mass treatment system according to claim 10, wherein the intermediate portion is curved at a first angle about a first radius, and the distal portion is curved at a second angle about a second radius.
14. The first angle is 90 degrees, The first radius is 2 inches, The second angle is 30 degrees, The coagulation treatment system according to claim 13, wherein the second radius is 1.25 inches.
15. The agglutination treatment system according to claim 1, further comprising a distal tip portion configured such that the molded distal portion is aligned with or positioned within the left atrial appendage.
16. The coagulation treatment system according to claim 1, wherein the coagulation capturing device is a first coagulation capturing device, and the coagulation treatment system further comprises a second coagulation capturing device configured to be positioned downstream of the left atrial appendage.
17. The clot treatment system according to claim 16, wherein the second clot capture device is configured to be positioned within the patient's aorta.
18. The coagulation treatment system according to claim 1, wherein the coagulation capture device is configured to be at least partially positioned within the left atrial appendage.
19. A coagulation treatment system for treating coagulated material in the heart of a human patient, It is a catheter, Proximal portion, and A catheter including a molded distal portion that is curved relative to the proximal portion, A pressure source, which is fluidly coupled to the catheter and configured to aspirate at least a portion of the coagulated material from the heart via the molded distal portion, A clot treatment system comprising: a clot capture device positioned at least partially within the heart and configured to prevent any of the clot material from leaving the heart outside the catheter.
20. The coagulation treatment system according to claim 19, wherein the coagulation capture device is configured to at least partially prevent the coagulation material from causing an embolic event.
21. The coagulation treatment system according to claim 19, wherein the heart includes a left atrium, and the coagulation capture device is configured to be at least partially positioned within the left atrium of the heart.
22. A coagulation treatment system for treating coagulated material in the heart of a human patient, wherein the coagulation treatment system is A first catheter carrying a first clump-capturing device positioned at a first location downstream of the clump material and configured to at least partially prevent the downstream movement of at least a first portion of the clump material, A second catheter carrying a second clump-capturing device positioned at a second location downstream of the first clump-capturing device and configured to at least partially prevent further downstream movement of at least a second portion of the clump material, A coagulation treatment system comprising: a pressure source fluidly coupled to the first catheter or the second catheter and configured to aspirate at least a third portion of the coagulated material.
23. The coagulation treatment system according to claim 22, wherein the first location is in or near the left atrial appendage of the human patient.
24. The atrophy treatment system according to claim 22, wherein the second location is at least partially located within the left atrium, left ventricle, or aorta of the human patient.
25. The atrophy treatment system according to claim 22, wherein the first location is at least partially located within the left atrium of the human patient.
26. The atrophy treatment system according to claim 25, wherein the second location is at least partially located within the left ventricle or aorta of the human patient.
27. The clot treatment system according to claim 22, wherein the first clot capture device or the second clot capture device includes a funnel.
28. The coagulation treatment system according to claim 22, wherein the first coagulation capturing device or the second coagulation capturing device is configured to transition between at least two different shapes.
29. The first agglutination device includes a first distal edge, and the first catheter includes a first distal tip located proximal to the first distal edge, and / or The clot treatment system according to claim 22, wherein the second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned proximal to the second distal edge.
30. The first agglutination device includes a first distal edge, and the first catheter includes a first distal tip located distal to the first distal edge, and / or The coagulation treatment system according to claim 22, wherein the second coagulation capture device includes a second distal edge, and the second catheter includes a second distal tip positioned distal to the second distal edge.
31. The first agglutination 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 clot treatment system according to claim 22, wherein the second clot capture device includes a second distal edge, and the second catheter includes a second distal tip positioned coplane with the second distal edge.
32. The coagulation treatment system according to claim 22, wherein the third portion of the coagulation material comprises at least part or all of the first portion or the second portion of the coagulation material.