Systems and methods for pulmonary embolism removal - Patents.com

Abstract

A system for treating pulmonary embolism includes an aspiration catheter having a distal occlusion component and a retention catheter having a distal valve attachment. In use, expansion of the occlusion component occludes a subject's pulmonary artery and deployment of the valve attachment promotes mitral regurgitation. Suction provided by the aspiration catheter induces a reversal of blood flow throughout the targeted lung region. Reversing the direction of blood flow allows for removal of one or more pulmonary emboli.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 318,490, entitled "SYSTEM AND METHOD FOR PULMONARY EMBOLISM REMOVAL," filed March 10, 2022, which is incorporated herein by reference in its entirety.

[0002]

[0002] The present disclosure relates to catheter-based devices, systems, and methods of their use for use in removing pulmonary emboli. [Background technology]

[0003]

[0003] Acute pulmonary embolism is a significant cause of death worldwide, with over 100,000 deaths per year in the United States alone. Acute pulmonary embolism (PE) or embolus is the blockage of a pulmonary (lung) artery. In most cases, the condition is caused by a blood clot that forms in the legs or another part of the body (e.g., deep vein thrombosis, or DVT) and travels to the lungs. PE is the third leading cause of cardiovascular death after myocardial infarction and stroke. Modern medical treatments for acute PE generally fall into four categories: systemic anticoagulation, catheter-directed fibrinolysis, systemic fibrinolysis, and surgical pulmonary embolectomy. Treatment may also include a combination of these therapies.

[0004]

[0004] However, current treatments are limited and can pose significant risks to patients. Anticoagulation techniques are often ineffective, especially in complex and / or advanced disease profiles. Systemic fibrinolysis has a significant associated risk of bleeding and is often contraindicated. Contraindication means that a particular medical condition suggests or indicates that a particular technique should not be used. Surgical and catheter-based methods are limited by the size of the vessels and / or catheters and the limited maneuverability of current catheter techniques, especially due to a tortuous environment such as the human pulmonary anatomy. Thus, there exists a long-felt unmet need for techniques, devices and systems that can address these and other challenges in the art. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] The present disclosure relates to catheter-based systems, devices, and methods for the removal of pulmonary emboli. Certain embodiments of the disclosed systems, devices, and methods temporarily reverse blood flow into the pulmonary vasculature to facilitate removal of trapped emboli. Advantageously, the disclosed systems, devices, and methods enable effective removal of pulmonary emboli without necessarily requiring administration of systemic therapeutic drugs (or enabling reduced use of such drugs) and without necessarily requiring catheter navigation through small pulmonary vessels. Thus, the disclosed systems, devices, and methods enable safer and more effective treatment of PE. [Means for solving the problem]

[0006] In some embodiments, the system includes an aspiration catheter with a distal end balloon and a second catheter for holding the mitral valve open during cardiac systole. In some embodiments, the second catheter may include a distal attachment that allows the mitral valve to be held open. In some embodiments, the distal end balloon of the aspiration catheter may occlude either the right or left pulmonary artery or a subsequent pulmonary artery vessel.

[0007]

[0007] One embodiment of the disclosed method includes delivering a catheterized component through the heart via the venous system to reach the pulmonary vasculature. The method may also include occluding a subject's pulmonary arterial blood vessel to close off normal blood flow, providing suction to allow reverse flow, embolic removal, and / or blood drainage, and optionally administering a localized pharmaceutical agent into the pulmonary vasculature. The administration of pharmaceutical agents may include, for example, administration of anticoagulant, anti-inflammatory, antiplatelet, and / or other therapeutic agents. The method may further include delivering a catheterized component through the arterial system to the mitral valve to prevent the mitral valve from closing during ventricular contraction, thus allowing increased back pressure to reverse pulmonary blood flow.

[0008]

[0008] Removing emboli from blood vessels using reversed pulmonary blood flow has been used as a neuroprotective measure in the treatment of strokes that also involve the formation of blood clots or emboli. Now, creating reverse flow throughout the pulmonary vasculature can be an effective and safe method of treating PE.

[0009]

[0009] To avoid major cardiac damage, blood flow reversal is preferably limited to a single lung or to a region of lung tissue within a single lung. A device may be used to occlude blood flow in the target pulmonary artery vessel to initiate blood flow reversal in the targeted lung region. An external pump may be used to create the negative pressure required to reverse the flow and to expel retrograde blood and / or particulates. This aspirated blood may travel through an in-line filter disposed inside the aspiration catheter to remove dislodged emboli before entering the low pressure venous system, or may be expelled externally assuming hemodynamic stability (stable blood flow and good circulation).

[0010]

[0010] Once normal blood flow has been stopped at the pulmonary artery and negative pressure and / or retrograde flow drainage has been established, additional pressure may be required to establish and maintain retrograde flow. To apply additional pressure, a component may be inserted into the heart during normal heartbeats to prevent the mitral valve from closing, so that during systole pressure is transferred retrogradely into the left atrium and through the desired pulmonary vein to the target tissue lung. Thus, keeping the mitral valve open facilitates the increase of mitral regurgitation, which further contributes to maintaining the reversal of blood flow.

[0011]

[0011] Additional features and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the embodiments disclosed herein. The objects and advantages of the embodiments disclosed herein will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing brief summary and the following detailed description are merely exemplary and explanatory and are not restrictive of the embodiments disclosed or claimed herein.

[0012] A more particular description of the invention briefly described above will be made with reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are not intended to limit the scope of the invention, the invention being described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0013] [Figure 1] 1A, 1B, 1C, and 1D are schematic anatomical cross-sectional diagrams of blood flow through one embodiment of the disclosed reverse flow system, showing only one pulmonary artery and pulmonary vein. [Diagram 2]

[0014] 2A, 2B, 2C and 2D are schematic diagrams of blood flow in one embodiment of the disclosed reverse flow system. [Diagram 3]

[0015] FIG. 1 illustrates a catheter-based system for pulmonary embolus removal used in a reverse flow system. [Figure 4]

[0016] 4 illustrates a method of using a catheter-based system such as that shown in FIG. 3 to reverse blood flow through lung tissue and facilitate removal of one or more pulmonary emboli. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014]

[0017] The present disclosure relates to catheter-based systems, devices, and methods for the removal of pulmonary emboli. For example, embodiments of the disclosed systems, devices, and methods temporarily reverse blood flow into the pulmonary vasculature to facilitate removal of trapped emboli. Advantageously, the disclosed systems, devices, and methods allow for effective removal of pulmonary emboli without requiring administration of systemic therapeutic agents and without requiring navigation of catheters through small pulmonary vessels.

[0015]

[0018] In some embodiments, the system includes an aspiration catheter (also referred to herein as a first catheter, first catheter device, or aspiration catheter device) with an occlusion component such as a balloon (e.g., disposed at or near a distal end) and a retention catheter (also referred to herein as a second catheter, second catheter device, or retention catheter device) for holding the mitral valve open or at least temporarily disrupting mitral valve function to increase mitral regurgitation during cardiac systole.

[0016]

[0019] In some embodiments, the second catheter may include a valve attachment to allow engagement with the mitral valve. In some embodiments, a balloon or other occlusion component of the suction catheter is used to occlude the pulmonary artery vessel. For example, the balloon of the suction catheter may be deployed to occlude either the right or left pulmonary artery.

[0017]

[0020] One embodiment of the disclosed method includes delivering a suction catheter to the heart via the venous system to reach the pulmonary vasculature, occluding the subject's pulmonary arterial blood vessels to close off normal blood flow, providing suction with the suction catheter to allow reverse flow and embolic removal, and optionally administering a localized pharmaceutical agent into the pulmonary vasculature. For example, anticoagulant, anti-inflammatory, antiplatelet, and / or other therapeutic agents may be administered and delivered locally. The method may further include delivering a catheterized component through the heart via the arterial system to prevent the mitral valve from fully closing during ventricular contraction, thus allowing increased back pressure to reverse pulmonary blood flow.

[0018]

[0021] To avoid major cardiac damage, blood flow reversal is preferably limited to a single lung or to a region of lung tissue within a single lung. A device may be used to occlude blood flow in the subject's pulmonary artery vessels to initiate blood flow reversal. An external pump may be used to create negative pressure for the reverse flow and to expel retrograde blood and / or particulates. This aspirated blood may travel through a filter, such as an in-line filter, to remove dislodged emboli before entering the low pressure venous system, or may be expelled externally.

[0019]

[0022] Once normal blood flow has been stopped at the pulmonary artery and negative pressure / reverse flow drainage has been established, further pressure adjustments may be required to establish reverse flow, and accordingly components to prevent complete closure of the mitral valve may be utilized to transmit pressure retrogradely into the left atrium to assist in blood flow reversal.

[0020]

[0023] 1A-1D are anatomical cross-sectional schematic diagrams of blood flow through one embodiment of the disclosed reverse flow system, showing only one pulmonary artery and pulmonary vein, it being understood that the reverse flow system may be implemented in more than one pulmonary artery and pulmonary vein.

[0021]

[0024] FIG. 1A shows normal blood flow through the heart and lungs, where deoxygenated blood flows from the right atrium (RA) and right ventricle (RV) through the pulmonary artery (PA) to the lungs and alveoli where it is oxygenated, through the pulmonary veins (PV) to the left atrium (LA) and left ventricle (LV), and then through the aorta (AO) for distribution throughout the body.

[0022]

[0025] Deoxygenated blood enters the right atrium of the heart from the venous system. It then passes through the tricuspid valve into the right ventricle of the heart, through the pulmonary artery as shown, and into pulmonary structures (e.g., the alveolar capillary bed) where the blood becomes oxygenated. Fresh oxygenated blood leaves the lungs through the pulmonary veins and enters the left atrium of the heart. The oxygenated blood then travels through the mitral valve into the left ventricle before proceeding to the aorta for delivery throughout the body.

[0023]

[0026] 1B, a first catheter device 102 may be inserted (e.g., via a transfemoral approach, a transradial approach, or other suitable approach) into the right atrium and through the right ventricle into the subject's pulmonary artery. Deploying an occlusion component 106 (e.g., a balloon) in the subject's pulmonary artery disrupts flow through that pulmonary vessel and its associated downstream pulmonary vasculature.

[0024]

[0027] 1C illustrates the use of the first catheter device 102 to effect suction that reverses the flow of blood through the subject's pulmonary artery. The negative pressure created by the suction from the catheter device induces a reversal of blood flow. In an alternative embodiment, a separate suction catheter, distinct from the first catheter 102, may be routed to an area near where the occlusion component 106 is deployed (e.g., with a distal end just distal to the occlusion component 106) and utilized to effect suction.

[0025]

[0028] 1D further shows a second catheter device 104 that is inserted (e.g., by a transfemoral, transradial, transseptal, or other suitable approach) into the left ventricle and then into the mitral valve. The second catheter device 104 can be deployed to hold the mitral valve open, or at least to increase the degree of regurgitation. Combined with negative pressure and suction from the pulmonary side, holding the mitral valve open smoothes mitral regurgitation and also allows for reversal of blood flow (i.e., blood flow from the left side of the heart to the right side of the heart).

[0026]

[0029] 2A-2D show a schematic overview of blood flow according to one embodiment of the disclosed reverse flow system. FIG. 2A shows normal blood flow through the heart and lungs. Deoxygenated blood enters the right side of the heart from the venous system. The deoxygenated blood travels through the right ventricle (RV) of the heart, through the left and right pulmonary arteries, and into the pulmonary structures where the blood becomes oxygenated (e.g., to the alveoli in both the left and right lungs). Fresh oxygenated blood leaves the lungs through the left and right pulmonary veins and enters the left atrium (LA) of the heart. The oxygenated blood then travels through the left atrium, via the mitral valve, into the left ventricle (LV), and through the aorta for delivery throughout the body.

[0027]

[0030] As shown in Figure 2B, a first catheter-based device 102 can be inserted into the right ventricle and deployed (e.g., by deploying occlusion component 106) to block the right pulmonary artery. Blocking the right pulmonary artery disrupts the normal flow of blood to the right lung. As shown, blood continues to flow normally through the left lung.

[0028]

[0031] 2C shows the first catheter device 102 providing suction to reverse the flow of blood through the right pulmonary artery while continuing to block the normal flow of blood through the right pulmonary artery. The negative pressure created by the suction from the first catheter device 102 induces a reversal of blood flow. As shown, blood continues to flow normally through the left lung.

[0029]

[0032] Figure 2D shows a second catheter device 104 being inserted into the left ventricle to increase mitral regurgitation. Combined with the negative pressure and suction from the first catheter device 102 shown in Figures 2A-2C, holding the mitral valve open facilitates mitral regurgitation, which increases backpressure within the subject's pulmonary vasculature throughout ventricular contraction and also allows for reversal of blood flow through the right lung. As shown, blood continues to flow normally through the left lung.

[0030]

[0033] 3 shows a catheter-based system for pulmonary embolus removal used in a reverse flow system. The reverse flow system may include an aspiration catheter 102 with an occlusion component 106 (e.g., a balloon) and a retention catheter 104. The aspiration catheter 102 may be placed in either the right pulmonary artery (RPA) or the left pulmonary artery (LPA), and the occlusion component 106 may, upon expansion, occlude either the right or left pulmonary artery.

[0031]

[0034] The suction catheter 102 may include an in-line filter 108 and may be routed to the right side of the heart, for example, through the femoral vein. Blood may flow through the suction catheter 102 and in-line filter 108 by a normal physiological pressure gradient or by an external pump 112, such as a mechanical pump. Additionally or alternatively, one or more external filters may be used.

[0032]

[0035] As shown, the retention catheter 104 may be routed through the aorta to the left ventricle (or alternatively via a transseptal approach to the left ventricle) where the valve appendages 110 may be deployed to hold the mitral valve open or at least interrupt the normal function of the mitral valve to increase regurgitation. The retention catheter 104 may include, for example, a selectively retractable stent-like device, balloon, or other expandable element configured to limit closure of the mitral valve. By limiting closure of the mitral valve, the retention catheter 104 beneficially allows for facilitation of mitral regurgitation to better allow for reversal of blood flow. The facilitation of mitral regurgitation increases left atrial pressure during ventricular contraction. Increasing left atrial pressure in conjunction with mitral regurgitation and reverse blood flow through the aspiration catheter may beneficially remove one or more pulmonary emboli.

[0033]

[0036] Figure 4 illustrates a method 400 of treating a patient with PE using a catheter-based system such as the system illustrated in Figure 3. The method may include, for example, delivering a suction catheter to either the right or left pulmonary artery (step 401). The method may also include, in step 402, expanding an occlusion component (e.g., a balloon) associated with the suction catheter (e.g., connected to a distal end of the suction catheter). In some embodiments, deployment of the occlusion device occludes blood flow through either the targeted right or left pulmonary artery.

[0034]

[0037] Alternatively, the suction catheter may be routed further into the pulmonary artery system prior to deployment of the occlusion component to target specific subregions of the lung. For example, the suction catheter may be routed into a lobar or segmental artery of interest to target a particular lobe or lung segment for reverse blood flow and embolus removal.

[0035]

[0038] Method 400 may further include providing suction through the suction catheter to create a negative pressure gradient, at step 403, and inducing a reversal of blood flow, at step 404. The method may include flowing the reversed blood flow through a filter (e.g., an in-line filter disposed within the suction catheter), and optionally back into the patient's venous system, at step 405. The method may also include using the negative pressure gradient and reversal of blood flow to remove one or more pulmonary emboli, thereby treating the patient's acute PE, at step 406.

[0036]

[0039] Method 400 may further include delivering a retention catheter to the mitral valve, in step 407, and deploying the retention catheter to prevent full closure of the mitral valve and / or otherwise increase mitral regurgitation, in step 408. Steps 407 and 408 may be performed simultaneously with any of steps 401-406.

[0037] Additional Terms and Definitions

[0040] While certain embodiments of the present disclosure have been described in detail with specific configurations, parameters, components, elements, etc., this description is illustrative and should not be construed as limiting the scope of the claimed invention.

[0038]

[0041] Furthermore, for any given element of a described embodiment, any of the possible alternatives listed for that element or component may generally be understood to be used individually or in combination with another, unless implicitly or explicitly stated otherwise.

[0039]

[0042] In addition, numbers expressing quantities, compositions, distances, or other measurements used in the specification and claims may be optionally modified by the term "about" or synonyms thereof. When terms such as "about," "approximately," and "substantially" are used in conjunction with a stated amount, value, or condition, it may be taken to mean an amount, value, or condition that deviates by less than 20%, less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated amount, value, or condition.

[0040]

[0043] All headings and sub-headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims.

[0041]

[0044] Also, it should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment referring to a singular referent (e.g., "a product") may likewise include two or more such referents.

[0042]

[0045] It will also be understood that the embodiments described herein may also include properties and / or features (e.g., materials, components, members, elements, parts, and / or portions) described in one or more separate embodiments, and are not necessarily strictly limited to the features explicitly described for that particular embodiment. Thus, various features of a given embodiment can be combined with and / or incorporated into other embodiments of the present disclosure. Thus, the disclosure of a particular feature with respect to a specific embodiment of the present disclosure should not be construed as limiting the application or inclusion of said feature to the specific embodiment described above. Rather, it will be understood that other embodiments can include such features as well.

Claims

1. 1. A system for treating a pulmonary embolism, comprising: a suction catheter including an occlusion component attached at or near a distal end of the suction catheter; a retention catheter including a valve accessory attached at or near a distal end of the retention catheter; Equipped with The system, wherein the occlusion component is configured, upon expansion, to occlude normal blood flow through one or more pulmonary artery vessels.

2. The system of claim 1 , wherein the valve accessory comprises a stented device or a balloon.

3. 10. The system of claim 1, further comprising an aspiration device configured to provide aspiration through the aspiration catheter to the one or more pulmonary arteries to induce reversal of blood flow through the aspiration catheter.

4. The system of claim 3 , wherein the inhalation device comprises an external pump.

5. The system of claim 1 , wherein the occlusion component comprises a balloon.

6. The system of claim 1 , further comprising an in-line filter disposed within the suction catheter.

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