Mechanical thrombectomy assemblies with embolic protection and associated devices, systems, and methods

Abstract

Disclosed herein are clot treatment systems including an integrated / systematic mechanical thrombectomy device and a clot treatment device, and associated devices and methods. In some embodiments, a method of removing clot material from a blood vessel of a patient includes inserting a catheter within the blood vessel proximate the clot material while radially constraining a clot handling device and an embolic protection device within the catheter. The method may also include moving the catheter proximally to at least partially deploy the clot treatment device to a distal side of the clot material within the blood vessel, and then further moving the catheter proximally to at least partially deploy the embolic protection device to a proximal side of the clot material.

Description

TECHNICAL FIELD

[0001] The present technology generally relates to mechanical thrombectomy assemblies (including mechanical thrombectomy assemblies with embolic protection) and associated devices, systems, and methods. BACKGROUND

[0002] Thromboembolic events are characterized by blockage of blood vessels. Thromboembolic diseases such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, atherosclerosis, etc. affect many people. These diseases are a major cause of morbidity and mortality.

[0003] When an artery is blocked by a clot, tissue ischemia develops. If the blockage persists, the ischemia will progress to tissue infarction. However, if blood flow is quickly reestablished, infarction does not develop or is greatly limited. Failure to reestablish blood flow can thus result in loss of a limb, angina, myocardial infarction, stroke, or even death.

[0004] In the venous circulation, obstructive material can also cause serious harm. Blood clots can form in the large veins of the legs and pelvis, a common condition known as deep vein thrombosis (DVT). DVT often occurs where there is a tendency for blood to stagnate (e.g., long distance air travel, immobility, etc.) and clot (e.g., cancer; recent surgery such as orthopedic surgery, etc.). DVT can impede the drainage of venous blood from the legs, leading to swelling, ulceration, pain, and infection. DVT can also create a reservoir in which blood clots can collect and then travel to other parts of the body, including the heart, lungs, brain (which can cause stroke), abdominal organs, and / or extremities.

[0005] In the arterial circulation (e.g., peripheral arterial circulation, pulmonary circulation), undesirable material can cause harm by blocking different arteries. For example, obstruction within the pulmonary arteries is a condition known as pulmonary embolism. If the obstruction is upstream, in the main stem or large branch pulmonary arteries, it can severely impair total blood flow within the lungs, and thus the entire body, leading to low blood pressure and shock. If the obstruction is downstream, in the large to medium pulmonary arterial branches, it can prevent a significant portion of the lungs from participating in gas exchange to blood, leading to low blood oxygen and accumulation of blood carbon dioxide.

[0006] Various devices exist for performing thrombectomy or removing clot material to reestablish blood flow in a patient. For example, a mechanical thrombectomy catheter is a catheter used for thrombectomy, embolectomy, or extraction and generally includes an element on a distal end for capturing thrombus, emboli, foreign matter, and / or other particulate. The element can be made of wire, laser cut metal including nitinol, loop or braided wire, or an inflatable element such as a balloon. However, the element on the distal end of the mechanical thrombectomy catheter can cause embolization of the clot material as the element is inserted and / or retracted through the clot material. The embolized clot material can flow to other parts of the body, potentially causing other medical complications. BRIEF DESCRIPTION OF DRAWINGS

[0007] 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. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0008] FIG. 1A is a partial schematic side view of a clot treatment system constructed in accordance with an embodiment of the technology.

[0009] FIG. 1B is a side view of a clot treatment system constructed in accordance with an additional embodiment of the technology.

[0010] FIG. 1C is a side view of a mechanical thrombectomy assembly of a clot treatment system constructed in accordance with an additional embodiment of the technology.

[0011] FIG. 2A and FIG. 2B are, respectively, a side view and a perspective view of a distal portion of a clot treatment system constructed in accordance with an embodiment of the technology. FIG. 1A

[0012] FIG. 3 and FIG. 4 are side views of respective clot removal elements of a clot treatment system constructed in accordance with an additional embodiment of the technology.

[0013] FIG. 5 is a perspective view of a mechanical thrombectomy assembly constructed in accordance with an additional embodiment of the technology.

[0014] FIG. 6 is a flowchart of a process or method for removing clot material from a blood vessel of a patient using a clot treatment system in accordance with an embodiment of the technology.

[0015] FIG. 7A to FIG. 7E is a perspective view of a clot treatment system constructed in accordance with an embodiment of the technology during different stages of a process or method of FIG. 6 is a side view of a distal portion of a clot treatment system during different stages of a process or method of​

[0016] FIG. 8A and FIG. 8B are side and perspective views of a distal portion of a clot treatment system constructed in accordance with additional embodiments of the present technology. FIG. 1B and FIG. 1C are side and perspective views of a distal portion of a clot treatment system constructed in accordance with additional embodiments of the present technology.

[0017] FIG. 9 is a perspective view of a distal portion of a clot treatment system constructed in accordance with additional embodiments of the present technology.

[0018] FIG. 10 is a flowchart of a procedure or method for removing clot material from a blood vessel of a patient using a clot treatment system in accordance with embodiments of the present technology.

[0019] FIG. 11A to FIG. 11E is a side view of a distal portion of a clot treatment system during different stages of a procedure or method of FIG. 10

[0020] FIG. 12 is a flowchart of a procedure or method for removing clot material from a blood vessel structure of a patient using a clot treatment system in accordance with embodiments of the present technology.

[0021] FIG. 13A to FIG. 13G is a side view of a distal portion of a clot treatment system during different stages of a procedure or method of FIG. 12 DETAILED DESCRIPTION

[0022] ​​The present technology generally relates to clot treatment systems having integrated / systemized mechanical thrombectomy devices and clot treatment devices, and associated devices and methods. In some embodiments, an integrated clot treatment system includes an embolic protection device, a clot treatment device, a first shaft, and a second shaft. The embolic protection device can be carried by the first shaft, and the clot treatment device can be carried by the second shaft. In some embodiments, the second shaft can be slidably positioned within the first shaft. During a clot removal procedure, the clot treatment device and the embolic protection device can be inserted together into a blood vessel of a patient that includes a clot material to be treated, while being radially constrained within a delivery catheter. The delivery catheter can be proximally retracted to at least partially deploy the clot treatment device distal of the clot material within the blood vessel, and then the delivery catheter can be further proximally retracted to at least partially deploy the embolic protection device proximal of the clot material. The clot treatment device can be used to mechanically engage and break up the clot material, for example, by proximally retracting the clot treatment device through the clot material and into the embolic protection device and / or the first shaft. The embolic protection device can be positioned to capture all or a portion of the clot material that embolizes or otherwise dislodges during mechanical engagement of the clot treatment device with the clot material, and / or to direct the clot material into the first shaft.

[0023] In some aspects of the present technology, the embolic protection device is integrated with the clot treatment device within the clot treatment system, such that the clot treatment system can be more easily operable as compared to other devices having separate embolic protection devices. In additional aspects of the present technology, the embolic protection device can be used to directly deploy the clot treatment device, which is expected to allow the clot treatment system of the present technology to have a reduced profile (e.g., a smaller outer diameter) and / or to be more easily navigable through relatively smaller blood vessels, stenotic blockages, and / or thrombotic occlusions.

[0024] In the following description and in the FIG. 1A to FIG. 13GCertain details are set forth in this description to provide a thorough understanding of the various embodiments of the technology. In other instances, well-known structures, materials, operations and / or systems have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the various embodiments of the technology. It will also be appreciated by those of ordinary skill in the art that one or more of the details described herein can be practiced without one or more of the details. Furthermore, although many of the examples presented herein involve removing and / or treating clot material, the technology can be used to remove and / or treat other unwanted material in addition to or instead of clot material, such as thrombus, emboli, plaque, intimal hyperplasia, post-thrombotic scar tissue, etc. As such, the terms "clot" and "clot material" as used herein can refer to any of the foregoing materials, etc.

[0025] The terms used below should be construed in their broadest reasonable manner, even if it is used in connection with a detailed description of certain embodiments of the technology. Indeed, certain terms can even be emphasized below; however, any term intended to be construed in any limited manner will be disclosed and specifically defined in the detailed description section.

[0026] The accompanying drawings depict embodiments of the technology and are therefore to be considered a part of this specification, unless explicitly indicated to the contrary otherwise. The size of various depicted elements in the drawings is not necessarily to scale, and the various elements can be enlarged or otherwise modified to improve readability of the drawings. Details of components not essential to an understanding of how to make and use the technology can be omitted in order to avoid obscuring the underlying principles of the technology. Many of the details, dimensions, angles and other features shown in the drawings are merely illustrative of particular embodiments of the present disclosure. Therefore, other embodiments can have other details, dimensions, angles and features without departing from the technology. Additionally, it is understood that other embodiments of the technology can be practiced without several of the details described below.

[0027] With respect to the terms "distal" and "proximal" in this specification, unless otherwise noted, these terms can guide the relative position of portions of the tube system relative to an operator and / or position in a vascular structure. Further, as used herein, the designations "rearward," "forward," "upward," "downward," and the like do not mean to limit the referenced component to a particular orientation. It will be appreciated that such designations refer to the orientation of the referenced component as exemplified by the drawings; the systems of the technology can be adapted for use in any orientation of the user.

[0028] In the drawings, like reference numerals refer to like or at least substantially similar elements throughout. To facilitate discussion of any particular element, the highest three digits of any reference numeral refer to the drawing figure wherein that element is first introduced. For example, 10-123 is discussed first in FIG. 10. FIG. 1A A catheter assembly is introduced and discussed 1 10.

[0029] To the extent any material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls.

[0030] FIG. 1A is a partial, schematic side view of a clot treatment system 100 (“system 100”) constructed in accordance with embodiments of the present technology. The system 100 can also be referred to as a suction assembly, a vascular access system, a clot removal system, and / or a thrombectomy system, among others. In the illustrated embodiment, the system 100 includes a catheter assembly 110 fluidically coupled to a catheter 120 via a valve 102. In some embodiments, the catheter 120 is an elongated member (e.g., a sheath, a shaft) that is configured to be inserted into and pass through a vascular structure of a patient and used, for example, to remove or otherwise treat clot material in the vascular structure. In other embodiments, the catheter 120 can be an introducer sheath that is configured to be inserted through a skin and tissue tract of a patient to provide an access site through which other components (e.g., other catheters used to treat clot material) can pass to easily access the vascular structure. Thus, when referred to as a “catheter 120,” the catheter 120 can include an introducer sheath, an access sheath, and / or another type of elongated member that is configured to be inserted through a skin and tissue tract and / or configured to pass through a vascular structure of a patient. Generally, the system 100 (i) can include features that are structurally and / or functionally substantially similar or identical to those of the clot treatment systems described in detail in U.S. Patent Application 16 / 536,185, filed August 8, 2019, and entitled SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS, which is incorporated by reference herein in its entirety, and / or (ii) can be used to treat clot material / remove clot material from a patient (e.g., a human patient) using any of the methods described therein.

[0031] The catheter 120 also defines a lumen 122 that extends completely therethrough (e.g., from the valve 102 to a distal tip 124 of the catheter 120) (in FIG. 1AThe catheter 120 can have varying lengths, flexibilities, shapes, thicknesses, and / or other properties in / along the various regions 122a-d (shown in dashed lines). For example, the catheter 120 can include one or more coils, braids, and / or other structures positioned between one or more gasket layers (e.g., an inner gasket layer and an outer gasket layer). In some embodiments, the catheter 120 can include several features that are substantially 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,” U.S. Patent Application No. 17 / 529,064, filed November 17, 2021, entitled “CATHETERS HAVING STEERABLE DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” and / or U.S. Patent Application No. 18 / 159,507, filed January 25, 2023, entitled “ASPIRATION CATHETERS HAVING GROOVED INNER SURFACE, AND ASSOCIATE SYSTEM AND METHODS,” each of which is incorporated by reference herein in its entirety.

[0032] Valve 102 is fluidly coupled to lumen 122 of catheter 120 and can be integral with or coupled to catheter 120 such that the components move together. In some embodiments, valve 102 is a hemostasis valve configured to maintain hemostasis during a clot treatment procedure by preventing fluid flow in a proximal direction through valve 102 as various components (such as dilators, delivery sheaths, pull members, guidewires, interventional instruments, other aspiration catheters, etc.) are inserted through valve 102 for delivery into a treatment site in a blood vessel by catheter 120. Valve 102 can include a branch or side port 104 configured to fluidly couple lumen 122 of catheter 120 to tubing assembly 110. In some embodiments, valve 102 can be a valve of the type disclosed in U.S. Patent No. 11,000,682, entitled “HEMOSTASIS VALVES AND METHODS OF USE,” filed August 30, 2018, which is incorporated by reference herein in its entirety.

[0033] In the illustrated embodiment, tubing assembly 110 fluidly couples catheter 120 to a pressure source 106, such as a syringe. Pressure source 106 can be configured to generate (e.g., create, produce, fill, accumulate) a vacuum (e.g., negative relative pressure) and store the vacuum for subsequent application to catheter 120. Tubing assembly 110 can include one or more tubing segments 112 (each labeled as first tubing segment 112a and second tubing segment 112b), at least one fluid control device 114 (e.g., a valve), and at least one connector 116 (e.g., a Toomey tip connector) for fluidly coupling tubing assembly 110 to pressure source 106 and / or other suitable components. In some embodiments, fluid control device 114 is a stopcock valve that is (i) fluidly coupled to side port 104 of valve 102 via first tubing segment 112a and (ii) fluidly coupled to connector 116 via second tubing segment 112b. Fluid control device 114 is externally operable by a user to regulate fluid flow therethrough, specifically, to regulate fluid flow from lumen 122 of catheter 120 to pressure source 106. In some embodiments, connector 116 is a quick release connector (e.g., a quick disconnect fitting) that enables quick coupling and decoupling of catheter 120 and fluid control device 114 to / from pressure source 106.

[0034] The system 100 also includes a mechanical thrombectomy assembly 130 that is shown positioned at least partially within the lumen 122, with a portion of the mechanical thrombectomy assembly extending beyond the distal tip 124 of the catheter 120. The mechanical thrombectomy assembly 130 can include a proximal or first actuation component 132, a distal or second actuation component 134, one or more embolic protection devices 136, and one or more clot treatment devices 138. In some embodiments, the second actuation component 134 is operably coupled to the embolic protection devices 136 via a first catheter or shaft 140. The second actuation component 134 can be an access port or valve, such as a hemostatic valve, that can include similar or identical features as the valve 102 described in detail above, and that can selectively provide access to a lumen of the first shaft 140. The second actuation component 134 can be fluidly coupled to the tubing segment 111, an additional tubing segment, a fluid control device, a pressure source, etc., to facilitate suction through the first shaft 140, for example. Moving the second actuation component 134, such as in a proximal or distal direction, can cause corresponding movement of the embolic protection devices 136.

[0035] In some embodiments, the first actuation component 132, e.g., a proximal hub or handle, is operably coupled to the clot treatment devices 138 via a second catheter or shaft 142. Thus, moving the first actuation component 132, such as in a proximal or distal direction, can cause corresponding movement of the clot treatment devices 138. The second shaft 142 can be positioned within and / or extend through the first shaft 140, e.g., a lumen of the first shaft 140, such that all or at least a portion of the first shaft 140 is positioned radially outward from the second shaft 142. In some embodiments, at least a portion of an outer surface of the second shaft 142 can be in sliding contact with an interior or lumen of the first shaft 140. The first and second actuation components 132, 134 can be moved together and / or relative to one another, e.g., to insert the embolic protection devices 136 and / or the clot treatment devices 138 through and / or distally beyond the distal tip 124 of the catheter 120. In the illustrated embodiment, the clot treatment devices 138 and the embolic protection devices 136 are each configured to be deployed from the catheter 120. For example, the catheter 120 can be proximally retracted over the first shaft 140 to deploy the embolic protection devices 136, and / or the catheter 120 and / or the first shaft 140 can be proximally retracted over the second shaft 142 to deploy the clot treatment devices 138. Such deployment is described in further detail below with reference to FIGS. 2-4. FIG. 2A 、 FIG. 2B and FIG. 6 to FIG. 7E Such deployment is described in further detail below with reference to FIGS. 2-4.

[0036] During a clot removal procedure, at least a portion of the system 100, including the catheter 120, the embolic protection device 136, and the clot treatment device 138, can be inserted through a patient's vascular structure. In some embodiments, the system 100 is inserted through a guide sheath that traverses the patient's skin and tissue to provide an access site. The clot treatment device 138 and / or the embolic protection device 136 can be constrained (e.g., radially constrained) within the catheter 120 during insertion of the system 100. For example, an inner surface of the catheter 120 can directly contact one or both of the clot treatment device 138 and the embolic protection device 136 to, for example, hold the clot treatment device 138 and / or the embolic protection device 136 in a radially constrained configuration. The clot treatment device 138 can then be at least partially deployed from the catheter 120 (and / or the deployment shaft 141) distally of the clot material in a blood vessel of the vascular structure, such as via proximal retraction of the catheter 120. The embolic protection device 136 can then be deployed from the catheter 120 proximally of the clot material, such as via further proximal retraction of the catheter 120. The clot treatment device 138 can engage the clot material to fragment, capture, and / or core the clot material, while the embolic protection device 136 can inhibit or even block embolization and / or capture any of the clot material that dislodges (e.g., emboli) during engagement of the clot material by the clot treatment device 138, and / or redirect all or a portion of the dislodged clot material into the first shaft 140. In some embodiments, the embolic protection device 136 can inhibit or even block blood flow from traversing, passing, and / or bypassing the embolic protection device 136 within a blood vessel in which the embolic protection device 136 is deployed. Finally, the embolic protection device 136 and the clot treatment device 138 can be retracted into the catheter 120, and the clot treatment system 100 can be retracted from the patient.

[0037] In some embodiments, the catheter 120 can be aspirated during, before, and / or after use of the clot treatment device 138. For example, when positioning the catheter 120 at a target treatment location proximate to a clot material, the user / operator can first close the fluid control device 114 and then create a vacuum in the pressure source 106 (e.g., by retracting a plunger of a syringe coupled to the connector 116). In this manner, the pressure source 106 is filled with a vacuum (e.g., a negative pressure) before the pressure source 106 is fluidly connected to the lumen 122 of the catheter 120. To aspirate the lumen 122 of the catheter 120, the user can open the fluid control device 114 to fluidly connect the pressure source 106 to the catheter 120, thereby applying or releasing the vacuum stored in the pressure source 106 to the lumen 122 of the catheter 120. Opening the fluid control device 114 instantaneously or nearly instantaneously applies the stored vacuum pressure to the catheter assembly 110 and the catheter 120, creating a suction pulse across the catheter 120 that can aspirate the clot material into the catheter 120. In some embodiments, with the fluid control device 114 in the open position, a vacuum from the pressure source 106 is applied (e.g., to provide a continuous vacuum). That is, the user can create a vacuum in the pressure source 106 while the fluid control device 114 is open (e.g., while the pressure source 106 is fluidly connected to the lumen 122 of the catheter 120), thereby aspirating the clot material while also creating a vacuum (e.g., without or substantially without storing the vacuum in the pressure source 106). In other embodiments, the catheter 120 can be continuously and / or intermittently aspirated via a vacuum pump (e.g., an electrically powered vacuum pump) or other source of suction.

[0038] Although in FIG. 1A some embodiments, the pressure source 106 is fluidly coupled to the lumen of the first shaft 140 and / or the lumen of the second shaft 142 via the tubing segment 111, in some embodiments, the pressure source 106 (or a separate pressure source) is fluidly coupled to the lumen of the first shaft 140 and / or the lumen of the second shaft 142. Thus, a vacuum created within the pressure source 106 can be applied into the lumen 122 of the catheter 120 and / or into the respective lumens of the first shaft 140, the second shaft 142, and / or the deployment shaft 141 to aspirate clot material.

[0039] FIG. 1Bis a side view of system 100 constructed in accordance with additional embodiments of the present technology. In the illustrated embodiment, mechanical thrombectomy assembly 130 further includes: (i) an additional delivery and / or deployment shaft 141 (which can also be referred to as a “delivery shaft,” an “intermediate shaft,” a “third shaft,” and / or a “catheter,” among other possibilities) that is configured to extend through first shaft 140 and over clot treatment device 138 to constrain clot treatment device 138; and (ii) a third actuation component 139 coupled to deployment shaft 141 for moving deployment shaft 141 relative to clot treatment device 138, e.g., to deploy clot treatment device 138 from within deployment shaft 141. That is, clot treatment device 138 can be positioned within or at least partially positioned within deployment shaft 141 such that deployment shaft 141 maintains a collapsed or undeployed configuration / state of clot treatment device 138, and third actuation component 139 can be retracted over and / or relative to second shaft 142 (e.g., proximally) to deploy clot treatment device 138. For example, first actuation component 132 can be pinned in place, and third actuation component 139 can be retracted relative to first actuation component 132. Third actuation component is shown being retracted over second shaft 142 and / or relative to second shaft 142 (e.g., proximally) to deploy clot treatment device 138. FIG. 1B completely retracted and / or retracted into contact with first actuation component 132 such that clot treatment device 138 is deployed. Such deployment is described in further detail below with respect to FIGS. 6-8. FIG. 8A to FIG. 13G completely retracted and / or retracted into contact with first actuation component 132 such that clot treatment device 138 is deployed. Such deployment is described in further detail below with respect to FIGS. 6-8. FIG. 1A In the illustrated embodiment, third actuation component 139 is a valve assembly that includes a connector 135 for attachment to one or more tubing segments, a fluid control device (which can be similar or identical to fluid control device 114 of FIG. 1), a pressure source (which can be similar or identical to pressure source 106 of FIG. 1), among other possibilities, to facilitate suction through deployment shaft 141, for example. FIG. 1A In the illustrated embodiment, third actuation component 139 is a valve assembly that includes a connector 135 for attachment to one or more tubing segments, a fluid control device (which can be similar or identical to fluid control device 114 of FIG. 1), a pressure source (which can be similar or identical to pressure source 106 of FIG. 1), among other possibilities, to facilitate suction through deployment shaft 141, for example.

[0040] FIG. 1Cis a side view of a system 100 configured in accordance with additional embodiments of the technology. In the illustrated embodiment, the third actuation component 139 is a handle that includes a trigger 144 positioned at least partially within the housing 131. The housing 131 can include a connector 133 (e.g., at least substantially similar or identical in structure and / or function to the connector 135). The trigger 144 is operably coupled to the deployment shaft 141 via a carriage or slider 145 such that movement of the trigger 144 relative to the housing 131 (e.g., proximally or distally) can cause corresponding movement of the deployment shaft 141. The second shaft 142 extends through the deployment shaft 141, and in the illustrated embodiment, the first actuation component 132 is coupled (e.g., fixed, pinned) to a proximal portion of the housing 131 such that movement of the trigger 144 moves the deployment shaft 141 relative to the second shaft 142 and the clot treatment device 138. The trigger 144 can include one or more first engagement features or teeth 146, the intermediate actuation component 139 can include one or more second engagement features or recesses 148, and each of the recesses 148 can be configured to receive a corresponding one of the teeth 146. When the teeth 146 are received and / or contacted by one or more of the recesses 148, mechanical interference between the teeth 146 and the recesses 148 can inhibit or even prevent movement of the trigger 144 relative to the housing 131. The trigger 144 can be pivotally coupled to the carriage 145 and pivoted (e.g., in the direction indicated by arrow P in the enlarged view) to space the teeth 146 and the recesses 148 apart, for example, to allow movement of the trigger 144 relative to the housing 131 (e.g., to slide proximally or distally). In some embodiments, the trigger 144 can be biased (e.g., via a spring) to pivot in a direction opposite to that indicated by arrow P such that the teeth 146 engage the recesses 148 to inhibit or even prevent movement of the trigger without an external force (e.g., a force applied by an operator / user’s finger). In some aspects of the technology, the configuration of the third actuation component 139 can allow for more precise deployment of the clot treatment device 138 from the deployment shaft 141.

[0041] FIG. 2A and FIG. 2B are, respectively, a FIG. 1ASide and perspective views of the distal portion of the clot treatment system 100. In an illustrated embodiment, the embolism protection device 136 includes a conical member or funnel 250 having a first or proximal end portion 252 and a second or distal end portion 254 opposite the proximal end portion 252. In these and / or other embodiments, the embolism protection device 136 may include a balloon, a disc, a braided structure, and / or another suitable embolism protection device 136. In an illustrated embodiment, the funnel 250 includes a conical polymer layer. The funnel 250 may additionally or alternatively include a coil, one or more wires, a mesh, a braided structure, a structure at least partially coated and / or impregnated, and / or another suitable structure. The coils, wires, meshes, etc., used to form the funnel 250 may be radiopaque and / or coated with a radiopaque material, for example, to improve imaging / visualization of the funnel 250 within the patient. In these and / or other embodiments, the funnel 250 may be configured to inhibit or even block the flow of fluid (e.g., blood) when deployed. That is, the funnel 250 may be impermeable to blood flow. For example, in some embodiments, the funnel 250 includes a braided fabric that has been impregnated to form a membrane that is at least partially fluid-impermeable around all or at least a portion of the braided fabric. The distal end portion 254 of the funnel 250 may define an opening 256 leading to the interior 258 of the funnel 250. The diameter of the funnel 250 (e.g., outer diameter and / or inner diameter) may increase from a first diameter at the proximal end portion 252 to a second diameter at the distal end portion 254 that is larger than the first diameter. At least a portion of the funnel 250 (e.g., the proximal end portion 252) may be coupled to a first shaft 140 (such as the distal end of the first shaft 140). Therefore, all or at least a portion of the fluid entering the interior 258 of the funnel 250 (e.g., via passive flow, during suction, etc.) can be guided into the cavity of the first shaft 140.

[0042] The funnel 250 can be self-expanding and is configured to transition from a collapsed or unexpanded configuration to an expanded or unfolded configuration (e.g., FIG. 2A and FIG. 2B (As shown). For example, when positioned within a larger delivery catheter (such as catheter 120), the funnel 250 may be in a collapsed configuration, and when catheter 120 (or other delivery catheters) retracts and / or the first axis 140 travels, the funnel 250 may expand to an expanded configuration such that the funnel 250 is no longer constrained by catheter 120 (e.g., positioned distal to the distal end 124 of catheter 120).

[0043] FIG. 2A and FIG. 2B The illustrated clot processing device 138 has a... FIG. 1A to FIG. 1CThe clot treatment device 138 is illustrated in different configurations. In the illustrated embodiment, the clot treatment device 138 includes an expandable clot removal element 260 coupled to a second shaft 142 extending through the first shaft 140. For example, the clot removal element 260 can be a single (e.g., unitary) laser cut metal (e.g., nitinol) element formed from a plurality of interconnected struts 267 configured to self-expand. The clot removal element 260 has a proximal end portion 262 and a distal end portion 264. The proximal end portion 262 can be fixed to the second shaft 142, and the distal end portion 264 can include (e.g., be joined at) a hub or tube 265 that is slidable over the second shaft 142. In other embodiments, the proximal end portion 262 can be slidable over the second shaft 142, and the distal end portion 264 can be fixed to the second shaft, both the proximal end portion 262 and the distal end portion 264 can be fixed to the second shaft 142, or both the proximal end portion 262 and the distal end portion 264 can be slidably positioned over the second shaft 142. The proximal portion of the clot removal element 260 can include / define one or more proximal ports or holes 266 (e.g., relatively larger open holes formed / defined by the struts 267), and the distal portion of the clot removal element 260 can be relatively more closed (e.g., include smaller open holes 268 formed / defined by the struts 267). In some aspects of the technology, the slidable distal end portion 264 allows the clot removal element 260 to longitudinally elongate / shorten and radially collapse / expand in a corresponding manner.

[0044] The clot removal element 260 can be self-expanding and configured to transition from a collapsed or un-deployed configuration to an expanded or deployed configuration (as FIG. 2A and FIG. 2B illustrated). For example, when positioned within a larger delivery catheter, such as the delivery catheter 120, the clot removal element 260 can be in a collapsed configuration, and when the delivery catheter 120 (or other delivery catheter) is retracted and / or the second shaft 142 is advanced, the clot removal element 260 can expand to an expanded configuration such that the clot removal element 260 is no longer constrained by the first shaft 140 and / or the funnel 250 (e.g., when positioned distal to the distal tip of the first shaft 140 and / or distal to the opening 256 of the funnel 250).

[0045] In some embodiments, the second shaft 142 includes an atraumatic tip 243 defining a distal-most end of the mechanical thrombectomy assembly 130. When the clot removal element 260 is in a collapsed configuration, the distal end portion 264 of the clot removal element 260 can contact at least a portion of the atraumatic tip 243.

[0046] As described below with reference to FIG. 6 to FIG. 7EIn greater detail, the same delivery catheter (e.g., catheter 120) can be used to deploy both the clot treatment device 138 and the embolic protection device 136. For example, the catheter 120 can be proximally retracted to pull out and deploy the clot treatment device 138 and the embolic protection device 136. Thus, the assembly 130 is expected to have a reduced profile or outer diameter as compared to other mechanical thrombectomy assemblies that use another catheter or shaft positioned between the first shaft 140 and the second shaft 142 to deploy the clot treatment device 138. In such embodiments, the system 100 can be an integrated system for both mechanical thrombectomy and embolic protection.

[0047] FIG. 3 and FIG. 4 are side views of respective clot removal elements 360, 460 constructed in accordance with additional embodiments of the present technology. Referring to FIG. 3 , the clot removal element 360 is at least generally similar in structure and / or function to the clot removal element 260 of FIG. 2A and FIG. 2B but includes smaller open holes 368 positioned proximally and distally of one or more larger open holes 366. Referring to FIG. 4 , the clot removal element 460 is at least generally similar in structure and / or function to the clot removal element 360 of FIG. 3 but includes larger open holes 466 that are smaller in size as compared to the larger open holes 366 of FIG. 3 In some embodiments, the clot removal element 260, the clot removal element 360, and / or the clot removal element 360 can include some features that are generally similar or identical to any of the clot removal elements described in detail in U.S. Patent Application No. 17 / 072,909, entitled “SYSTEMS, DEVICES, AND METHODS FOR TREATING VASCULAR OCCLUSION,” filed on October 16, 2020, and U.S. Patent Application No. 17 / 125,397, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” filed on December 17, 2020, each of which is incorporated by reference herein in its entirety, and can function in a generally similar or identical manner.

[0048] FIG. 5 is a perspective view of a mechanical thrombectomy assembly 530 (“assembly 530”) constructed in accordance with additional embodiments of the present technology. At least some aspects of the assembly 530 can be at least generally similar in structure and / or function to the assembly 100 of FIG. 1A , FIG. 2A andFIG. 2B The mechanical thrombectomy assembly 130 is at least substantially similar or identical to the one described above. For example, the mechanical thrombectomy assembly 530 includes an embolism protection device 536 comprising a funnel 550 and a clot treatment device 538 comprising a clot removal element 560. The funnel 550 includes a braided structure 551 and a material layer 553 coupled to (e.g., within) the braided structure 551. The braided structure 551 may be formed of nitinol and / or other suitable materials. In some embodiments, the material layer 553 may be impermeable or at least substantially impermeable to clot material, blood, fluids, emboli, and / or other substances. The braided structure 551 may be deformable (e.g., configured to deform elastically). In at least some embodiments, the funnel 550 may expand from and / or retract into another funnel and / or cone structure, for example, the other funnel and / or cone structure being configured to constrain the braided structure 551 and / or material layer 553 in a collapsed or delivered configuration. The clot removal element 560 includes a plurality of expandable discs or disc portions 561 (identified as a first or proximal disc portion 561a and a second or distal disc portion 561b, respectively) and narrowing portions 563 positioned between the respective discs within the discs 561. In some embodiments, the clot removal element 560 may be at least substantially similar or identical in structure and / or function to one or more clot treatment devices described in the following: U.S. Patent No. 10,709,471, filed April 10, 2018, entitled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” the entire contents of which are incorporated herein by reference.

[0049] FIG. 6 This is a flowchart of a process or method 670 for removing clot material from a patient's vascular structures using a clot removal system, according to an embodiment of the present technology. Although for illustrative purposes, in FIG. 1A , FIG. 2A and FIG. 2B Some features of method 670 are described in the context of the illustrated clot treatment system 100, but those skilled in the art will readily understand that method 670 can be used with other suitable systems and / or apparatuses described herein (including...). FIG. 3 360-degree clot removal element FIG. 4 clot removal element 460 and / or FIG. 5 The mechanical thrombectomy component 530 is used to perform the procedure. FIG. 7A to FIG. 7E This refers to the different stages of method 670 according to the implementation scheme of this technology. FIG. 1A , FIG. 2A and FIG. 2BFIG. 6 shows a partial schematic side view of a distal portion of a clot treatment system 100. The following describes one or more blocks 671-676 of the method 670 with reference to FIG. 6. FIG. 7A to FIG. 7E

[0050] At block 671, the method 670 can include inserting a mechanical thrombectomy assembly of a clot treatment system into a patient via skin such that at least a distal portion of the mechanical thrombectomy assembly is positioned within a blood vessel to be treated. For example, FIG. 7A FIG. 6 shows a partial schematic side view of a distal portion of a clot treatment system 100. The following describes one or more blocks 671-676 of the method 670 with reference to FIG. 6.

[0051] In some embodiments, at least a portion of the assembly 130 can be positioned within the clot material 781 or extend distally beyond the clot material such that, for example, the atraumatic tip 243 is fully inserted through the clot material 781. To position the assembly 130 at least proximate to and / or at least partially through the clot material 781, the first actuation member 132 and the second actuation member 134 FIG. 1A ) can be advanced into and / or through the blood vessel 780 with the catheter 120. In some cases, the clot material 781 can substantially occlude the blood vessel 780 (such as shown in FIG. 6) or can partially occlude the blood vessel 780. FIG. 7A

[0052] At block 672, the method 670 can include deploying a clot treatment device of the mechanical thrombectomy assembly from within a delivery catheter of the clot treatment system at least distally of clot material in the blood vessel. For example, FIG. 7B FIG. 6 shows a partial schematic side view of a distal portion of a clot treatment system 100. The following describes one or more blocks 671-676 of the method 670 with reference to FIG. 6. FIG. 1A ​​trigger 144 and cause the trigger 144 and the carriage 145 to travel distally, e.g., to cause the second shaft 142 to move relative to the catheter 120 (e.g., distally) to at least partially position the clot treatment device 138 outside of the catheter 120. The embolic protection device 136 can remain un-deployed / encased within the catheter 120 while the clot treatment device 138 is deployed in the blood vessel 780.

[0053] At block 673, the method 670 can include deploying, from within the delivery catheter, an embolic protection device of the mechanical thrombectomy assembly at least proximally of the clot material in the blood vessel. For example, FIG. 7C The embolic protection device 136 is shown deployed / expanded within the blood vessel 780 including the funnel 250, with at least a portion of the funnel 250 positioned proximally of the clot material 781. The embolic protection device 136 can be deployed / expanded by causing the catheter 120 to retract (e.g., proximally). Additionally or alternatively, the embolic protection device 136 can be deployed / expanded by causing the second actuation member 134 to travel distally, e.g., to cause the first shaft 140 to move relative to the catheter 120 (e.g., distally) to at least partially position the embolic protection device 136 outside of the catheter 120. When expanded / deployed, the embolic protection device 136 can span all or a portion of the width / diameter of the blood vessel 780. Notably, together with reference to blocks 672 and 673, the outer delivery catheter 120 can be retracted proximally (e.g., in stages or in a continuous motion) to deploy both the clot treatment device 138 and the embolic protection device 136. When expanded, the embolic protection device 136 can substantially or completely block blood flow through the blood vessel 780.

[0054] At block 674, the method 670 can include mechanically fragmenting the clot material in the blood vessel with the clot treatment device. For example, FIG. 7DThe clot treatment device 138 (e.g., the clot removal element 260) is shown retracted (e.g., proximally) to capture at least a portion 782 of the clot material 781. The proximal mouth 266 of the clot removal element 260 can receive at least the portion 782 of the clot material 781, and the relatively more closed distal portion (e.g., the smaller open bore 268) of the clot removal element 260 can retain the received portion 782 within or at least partially within the clot removal element 260. The clot treatment device 138 can be retracted toward the embolic protection device 136 through / against the clot material 781 and / or at least partially into the interior 258 of the funnel 250. For example, the trigger 144 can be depressed, and the trigger 144 and the carriage 145 can be retracted proximally relative to the housing of the first actuation member 132 to pull the clot removal element 260 through the clot material 781 and / or at least partially into the interior 258 of the funnel 250 toward the embolic protection device 136. Additionally or alternatively, the trigger 144 can be locked to the housing of the first actuation member 132 (e.g., by mechanical interference between the teeth 146 and the recesses 148 when the teeth 146 are positioned in contact with one of the recesses 148), and the first actuation member 132 can be retracted proximally relative to the housing of the first actuation member 132 to pull the clot removal element 260 through the clot material 781 and / or at least partially into the interior 258 of the funnel 250 toward the embolic protection device 136.

[0055] The embolic protection device 136 (e.g., the funnel 250) is positioned proximally of the clot material 781 and is configured to direct the clot removal element 260 and the received portion 782 contained within the clot removal element 260 into the first shaft 140. Blood in the blood vessel 780 can flow in the direction indicated by arrow B. However, when deployed proximally of the clot material 781, the funnel 250 can inhibit or even prevent blood from flowing distally past and / or through the funnel 250 and flow through the clot material 781. In some aspects of the technology, such stopping of blood flow provided by the funnel 250 is expected to inhibit or even prevent clot material fragments 783 from embolizing and further downstream into the patient’s vascular structure in the direction of arrow B. In some embodiments, after the clot material 781 is sufficiently fragmented, the block 674 can include removing the mechanical thrombectomy assembly 130 from the patient, for example, by retracting one or both of the first shaft 140 and the second shaft 142 (e.g., proximally) into and / or through the catheter 120.

[0056] In some embodiments, at block 675, the method 670 can include aspirating the clot material from the blood vessel through the lumen of the clot treatment system 100. The aspirated clot material can include all or a portion of the clot material maintained in the blood vessel after the mechanical fragmentation in block 674. For example, FIG. 7E Aspiration of the remaining clot material 784 from the blood vessel 780 through the lumen 122 of the catheter 120 is shown. In other embodiments, the lumen of the first shaft 140 and / or the lumen of the second shaft 142 can be used to aspirate material from the blood vessel 780. In some embodiments, blocks 674 and 675 can be repeated until all or at least a sufficient amount of material in the blood vessel structure has been removed via one or both of mechanical fragmentation (e.g., block 674) and aspiration (e.g., block 675). A sufficient amount can be at least 50%, 60%, 70%, 80%, 90%, 95%, 99%, etc. of the clot material at a given location in the patient. Although block 675 is shown as occurring after block 674, in other embodiments, block 675 can occur before and / or concurrently with block 674. After the clot material has been sufficiently removed, the method 670 can include removing the clot treatment system 100 from the patient (block 676). FIG. 6

[0057] FIG. 8A and FIG. 8B are perspective and side views, respectively, of a distal portion of a clot treatment system 100 constructed in accordance with additional embodiments of the present technology. FIG. 1B and / or FIG. 1C In the illustrated embodiment, the mechanical thrombectomy assembly 130 further includes an (e.g., intermediate) deployment shaft 141. The deployment shaft 141 can be positioned at least partially between the first shaft 140 and the second shaft 142 (e.g., radially between the first shaft and the second shaft). In the illustrated embodiment, for example, the deployment shaft 141 is positioned within the first shaft 140 and is configured to slidably receive the second shaft 142. The deployment shaft 141 can be positioned over the clot removal element 260 to collapse and constrain the clot removal element 260 in a collapsed configuration. Thus, during a clot removal procedure, the deployment shaft 141 can be retracted proximally relative to the clot removal element 260 (and / or can cause the clot removal element 260 to travel distally relative to the deployment shaft 141) to pull out and deploy the clot removal element 260. The catheter 120 can then be retracted to pull out and deploy the funnel 250 (as previously described herein). In such embodiments, the system 100 is systematized for both mechanical thrombectomy and embolic protection.

[0058] FIG. 9 ​is a perspective view of a distal portion of a clot treatment system 900 constructed in accordance with an embodiment of the present technology. At least some aspects of the clot treatment system 900 can be at least generally similar or identical in structure and / or function to the clot treatment system 100 of FIG. 1B to FIG. 2B 、 FIG. 8A and FIG. 8B . For example, the clot treatment system 900 includes the clot treatment device 138, the deployment shaft 141, the second shaft 142, and the clot removal element 260 previously described in detail herein. In the illustrated embodiment, however, the embolic protection device 136 includes a balloon 950 carried by the catheter 120 and configured to be inflated radially outward from the catheter 120. Accordingly, the first shaft 140 and the funnel 250 can be omitted. One or more inflation lumens 955 for the balloon 950 can be positioned at least partially within the sidewall of the catheter 120 for concentric inflation / deflation of the balloon 950. The deployment shaft 141 can be positioned over the clot removal element 260 to collapse and constrain the clot removal element 260 in a collapsed configuration. Accordingly, the deployment shaft 141 can be retracted proximally relative to the clot removal element 260 (and / or can cause the clot removal element 260 to travel distally relative to the deployment shaft 141) to pull out and deploy the clot removal element 260 during a clot removal procedure. The balloon 950 can be inflated to provide embolic protection during use of the clot removal element 260. In such embodiments, the system 100 is systematized for both mechanical thrombectomy and embolic protection.

[0059] FIG. 10 is a flowchart of a process or method 1090 for removing clot material from a vascular structure of a patient using a clot treatment system in accordance with an embodiment of the present technology. Although some features of the method 1090 are described in the context of the embodiments shown in FIG. 8A and FIG. 8B , those skilled in the art will readily understand that the method 1090 can be performed using other suitable systems and / or devices described herein, such as the system 900 of FIG. 9 . FIG. 11A to FIG. 11E are partial schematic side views of distal portions of the clot treatment system 100 during different stages of the method 1090. Each of the various blocks in FIG. 8A and FIG. 8B is described below with reference to one or more blocks 1091-1096 of the method 1090. FIG. 11A to FIG. 11E

[0060] At block 1091, the method 1090 can include inserting a mechanical thrombectomy assembly of a clot treatment system into a patient via the skin such that at least a distal portion of the mechanical thrombectomy assembly is located within a blood vessel to be treated. For example, FIG. 11A ​A mechanical thrombectomy assembly 130 is shown inserted through the patient's skin and into a blood vessel 780 of the patient that includes a clot material 1181 to be treated. The mechanical thrombectomy assembly 130 is constrained / collapsed within the catheter 120. Thus, the clot treatment system 100 can be a systemized thrombectomy and embolic protection system in which the clot treatment device 138 and the embolic protection device 136 are deliverable together within the catheter 120. In some embodiments, at least a portion of the assembly 130 can be positioned within or extend distally beyond the clot material 1181. In some cases, the clot material 1181 can substantially occlude the blood vessel 780 (such as FIG. 11A is shown), or can partially occlude the blood vessel 780.

[0061] At block 1092, the method 1090 can include deploying a clot treatment device of the mechanical thrombectomy assembly from within an inner shaft of the mechanical thrombectomy assembly at least distally of the clot material in the blood vessel. For example, FIG. 11B A clot treatment device 138 is shown including a clot removal element 260 deployed / expanded within the blood vessel 780 from within a deployment shaft 141, with at least a portion of the clot removal element 260 positioned distally of the clot material 1181. The clot treatment device 138 can be deployed / expanded by retracting (e.g., proximally) the deployment shaft 141 and / or advancing (e.g., distally) the second shaft 142 within the deployment shaft 141 after retracting the catheter 120. The embolic protection device 136 can remain un-deployed / encased within the catheter 120 while the clot treatment device 138 is deployed within the blood vessel structure.

[0062] At block 1093, the method 1090 can include deploying an embolic protection device of the mechanical thrombectomy assembly from within an outer shaft of the mechanical thrombectomy assembly at least proximally of the clot material. For example, FIG. 11C An embolic protection device 136 is shown including a funnel 250 deployed / expanded within the blood vessel 780 from within the catheter 120, with at least a portion of the funnel 250 positioned proximally of the clot material 1181. The embolic protection device 136 can be deployed / expanded by retracting (e.g., proximally) the catheter 120. In some embodiments, deploying the embolic protection device 136 includes inflating a balloon (such as FIG. 9balloon 950) is inflated. Thus, in some aspects of the technology, the embolic protection device 136 is deployed via a mechanism independent of the clot treatment device 138 (e.g., via the catheter 120 or via inflation of the balloon), while still forming part of a systematized clot treatment system that can be navigated and used together. When expanded / deployed, the embolic protection device 136 can span all or a portion of the width / diameter of the blood vessel 780 and can stop or substantially stop blood flow through the blood vessel 780 (e.g., stop blood flow through the blood vessel). Although block 1093 is shown and described as occurring after block 1092, in some embodiments, block 1093 can occur before block 1092. For example, in some embodiments, the method 1090 includes: deploying the embolic protection device (e.g., FIG. 11C , block 1093), and then deploying the clot treatment device (e.g., FIG. 11B , block 1092).

[0063] At block 1094, the method 1090 can include: mechanically fragmenting the clot material in the blood vessel with the clot treatment device. For example, FIG. 11D is shown retracted (e.g., proximally) to capture at least a portion 1182 of the clot material 1181. The proximal mouth 266 of the clot removal element 260 can receive at least the portion 1182 of the clot material 1181, and the relatively more closed distal portion of the clot removal element 260 (e.g., the smaller open bore 268) can hold the received portion 1182 within or at least partially within the clot removal element 260. The clot treatment device 138 can be retracted toward and through the embolic protection device 136, and / or at least partially into the interior 258 of the funnel 250. As described in detail above with reference to FIG. 6 to FIG. 7E The embolic protection device 136 (e.g., the funnel 250 and / or the balloon 950) is positioned proximal of the clot material 1181 to inhibit or even stop blood flow (in the direction shown by arrow B) through the blood vessel 780. In some aspects of the technology, blocking blood flow through the blood vessel 780 via the embolic protection device 136 can inhibit clot material fragments 1183 dislodged from the clot material 1181 from migrating further downstream into the patient’s vascular structure. Additionally, the embolic protection device 136 can guide the clot removal element 260 and the received portion 1182 contained within the clot removal element 260 into the first shaft 140. In some embodiments, after the clot material 1181 is sufficiently fragmented, block 1094 can include removing the mechanical thrombectomy assembly 130 from the patient, for example, by retraction (e.g., proximally) of one or both of the first shaft 140, the second shaft 142 ( FIG. 11B ), and / or the deployment shaft 141 ( FIG. 11C ).

[0064] In some embodiments, at block 1095, method 1090 may include: aspirating clot material from the blood vessel through the lumen of the clot treatment system. The aspirated clot material may include any of the clot material 1181 remaining after mechanical disruption in block 1094. For example, FIG. 11E The remaining clot material 1184 is shown being aspirated from the vessel 780 through the lumen 122 of catheter 120. In other embodiments, aspiration can be applied through the lumen of the first axis 140, the lumen of the second axis 142, and / or the lumen of the unfolding axis 141 to aspirate the clot material 1181. In some embodiments, frames 1094 and 1095 can be repeated until all or at least a sufficient amount of clot material has been removed from the vascular structure via one or both of mechanical fracturing (e.g., in frame 1094) and aspiration (e.g., in frame 1095). Although in FIG. 10 Box 1095 is shown to occur after box 1094, but in other embodiments, box 1095 may occur before and / or simultaneously with box 1094. After the clot material has been adequately removed, method 1090 may include removing the clot removal system 100 from the patient (box 1096).

[0065] FIG. 12 This is a flowchart of a process or method 1290 for removing clot material from a patient's vascular structures using a clot removal system, according to an embodiment of the present technology. At least some aspects of method 1290 are at least substantially similar to or identical to one or more of blocks 1090 to 1096 of method 1090. Although for illustrative purposes, in FIG. 1B , FIG. 8A and FIG. 8B Some features of method 1290 are described in the context of the illustrated clot treatment system 100, but those skilled in the art will readily understand that method 1290 can be used with other suitable systems and / or devices described herein (such as...). FIG. 9 The system (900) is used to execute this. FIG. 13A to FIG. 13G This refers to the different stages of method 1290 according to the implementation scheme of this technology. FIG. 1B , FIG. 8A and FIG. 8B A side view of the clot handling system 100. The following description refers to one or more blocks 1291 to 1298 of method 1290. FIG. 13A to FIG. 13G The various boxes within.

[0066] At box 1291, method 1290 may include: inserting a catheter of the clot treatment system through the skin into the patient, such that at least a distal portion of the catheter is positioned within the blood vessel to be treated. For example, FIG. 13AA catheter 120 is shown, inserted through the patient's skin and into a blood vessel 780 within the patient's body containing clotted material 1381 to be treated. In some cases, the clotted material 1381 can substantially obstruct blood vessel 780 (such as...). FIG. 13A (as shown), or may partially block blood vessel 780. Box 1291 may be at least substantially similar to box 1091 and / or referenced. FIG. 11A Describe the methods / processes.

[0067] At frame 1292, method 1290 may include: positioning the embolism protection device of the clot treatment system within the conduit. For example, FIG. 13B A first shaft 140 is shown positioned within the catheter 120. The first shaft 140 can carry the embolization protection device 136. FIG. 8A and FIG. 8B This allows the first shaft and the embolization protection device to travel distally toward the clump material 1181 via the conduit.

[0068] At frame 1293, method 1290 may include: deploying from within the catheter, at least partially, the embolism protection device proximal to the clot material in the blood vessel. For example, FIG. 13C An embolism protection device 136 is shown, comprising a funnel 250 that expands / diffuses within a blood vessel 780, wherein at least a portion of the funnel 250 is positioned proximal to clot material 1381. (See previous reference box 1093 and...) FIG. 11C As described, the embolization protection device 136 can be deployed / expanded, for example, by retracting the catheter 120 (e.g., proximally and / or above the first axis 140) to expose the embolization protection device 136. When expanded / deployed, the embolization protection device 136 can span all or part of the width / diameter of the vessel 780 and can block or substantially block blood flow through the vessel 780.

[0069] At frame 1294, method 1290 may include: positioning the clot treatment device within the first axis of the embolism protection device. For example, FIG. 13D A deployable shaft 141 is shown that travels through and is positioned within a first shaft 140. The deployable shaft 141 may cover and / or constrain the clot processing device 138. FIG. 8A and FIG. 8B Therefore, the clumping treatment device 138 can travel together with and be constrained within the unfolding shaft 141. In some embodiments, at least a portion of the unfolding shaft 141 may extend distally beyond the first shaft 140 and / or the clumping material 1381, such as... FIG. 13D As shown. During insertion, the first actuating member 132 and the third actuating member 139 may be spaced apart from each other. For example, as referenced above. FIG. 1BAs described, the first actuating member 132 and / or the second shaft 142 can be pinned into place relative to the third actuating member 139, such that the clot processing device 138 is constrained within the unfolding shaft 141.

[0070] At frame 1295, method 1290 may include: extending the clot treatment device at least partially to the distal side of the clot material in the blood vessel. For example, FIG. 13E The expansion / dilation within the blood vessel 780 is shown. FIG. 1A to FIG. 1C The coagulation treatment device 138, wherein at least a portion of the coagulation treatment device 138 is positioned distal to the coagulated material 781. The coagulation treatment device 138 may be as previously referenced in reference frame 1092 and / or FIG. 11B The described unfolding / expansion is achieved by, for example, retracting the unfolding shaft 141 (e.g., proximally and / or over the second shaft 142) to expose the clot removal element 1360 carried by the unfolding shaft. To retract the unfolding shaft 141, the third actuating member 139 may retract over the second shaft 142 toward the first actuating member 132, thereby reducing the distance between the third actuating member 139 and the first actuating member 132 (e.g., until the third actuating member 139 contacts the first actuating member 132), as... FIG. 13E As shown.

[0071] At frame 1296, method 1290 may include: mechanically breaking up the clot material in the blood vessel using the clot treatment device. For example, FIG. 13F A clot processing device 138 is shown (e.g., FIG. 13E The clot removal element 1360 shown retracts (e.g., proximal) to capture at least a portion of the clotted material 1381. This may be at least in conjunction with reference frame 1094 and / or FIG. 11DThe described processes are generally similar or the same. For example, the clot treatment device 138 can be retracted through / against the clot material 1381 and / or at least partially into the interior 258 of the funnel 250 toward the embolic protection device 136. The embolic protection device 136 (e.g., the funnel 250) can be positioned proximal of the clot material 1381 and configured to inhibit or even block blood flow (in the direction shown by arrow B) through the blood vessel 780. In some aspects of the technology, blocking blood flow through the blood vessel 780 via the embolic protection device 136 can inhibit portions (e.g., fragments) of the clot material 1381 from migrating further downstream into the patient’s vascular structure. Additionally, the embolic protection device 136 can direct the clot removal element 1360 and the captured clot material contained within the clot removal element 1360 into the first shaft 140. Thus, it is contemplated that the embolic protection device 136 captures and / or directs all or at least a portion of the clot material 1381 into the first shaft 140. In some embodiments, after the clot material 1381 is sufficiently fragmented, the block 1296 can include removing the clot treatment device from the patient, e.g., by retracting one or both of the deployment shaft 141 and the second shaft 142 (e.g., proximally) into and / or through the first shaft 140 and / or the catheter 120. In these and / or other embodiments, the clot treatment device can be reintroduced one or more times as needed to remove additional clot material in at least generally similar or the same manner as blocks 1294 and / or 1295.

[0072] In some embodiments, at block 1297, the method 1290 includes aspirating clot material from the blood vessel through a lumen of the clot treatment system 100. The aspirated clot material can include all or a portion of the clot material maintained in the blood vessel after the mechanical fragmentation in block 1296. For example, FIG. 13G The remaining clot material 1384 is shown being aspirated from the blood vessel 780 via the first shaft 140. The embolic protection device 136 can maintain deployment aspiration, e.g., to direct the remaining clot material 1384 into the first shaft 140 and / or to inhibit or even block the remaining clot material 1384 from embolizing. In these and / or other embodiments, another shaft of the system 100 (e.g., the catheter 120) can be used to aspirate the remaining clot material 1384 and / or other material from the blood vessel 780. In some embodiments, blocks 1296 and 1297 can be repeated until all or at least a sufficient amount of material in the vascular structure has been removed via one or both of mechanical fragmentation (e.g., block 1296) and aspiration (e.g., block 1297). A sufficient amount can be at least 50%, 60%, 70%, 80%, 90%, 95%, 99%, etc. of the clot material at a given location in the patient. Although in the illustrated embodiment the aspiration is performed via the first shaft 140, in other embodiments, the aspiration can be performed via another shaft of the system 100 (e.g., the catheter 120). FIG. 12The middle frame 1297 is shown as occurring after block 1296, but in other embodiments, block 1297 can occur before and / or simultaneously with block 1296. After the clot material has been sufficiently removed, the method 1290 can include removing the clot treatment system 100 from the patient (block 1298).

[0073] Several aspects of the technology are set forth in the following embodiments:

[0074] 1. A system for removing clot material from a blood vessel of a patient, the system comprising:

[0075] a delivery catheter;

[0076] an intermediate catheter configured to extend through the delivery catheter;

[0077] an embolic protection device coupled to a distal portion of the intermediate catheter, wherein the delivery catheter and intermediate catheter are movable relative to one another to move the embolic protection device between (a) a first embolic protection device position in which the embolic protection device is constrained within the delivery catheter and (b) a second embolic protection device position in which the embolic protection device is unconstrained from the delivery catheter and is configured to expand within the blood vessel;

[0078] a deployment catheter configured to extend through the intermediate catheter;

[0079] an elongate shaft configured to extend through the deployment catheter; and

[0080] a clot treatment device coupled to the elongate shaft, wherein the deployment catheter and the intermediate catheter are movable relative to one another to move the embolic protection device between (a) a first clot treatment device position in which the clot treatment device is constrained within the deployment catheter and (b) a second clot treatment device position in which the clot treatment device is unconstrained from the deployment catheter and is configured to expand within the blood vessel.

[0081] 2. The system of embodiment 1, wherein the embolic protection device is configured to expand to a diameter of the blood vessel in the second embolic protection device position.

[0082] 3. The system of embodiment 2, wherein the embolic protection device is impermeable to blood.

[0083] 4. The system of either of embodiments 2 or 3, wherein the embolic protection device is configured to substantially block blood flow through the blood vessel in the second embolic protection device position.

[0084] 5. The system of any of embodiments 1-4, wherein the blood vessel is a peripheral artery.

[0085] 6. The system of any of embodiments 1-5, wherein the embolic protection device is a funnel having a tapered shape.

[0086] 7. The system of embodiment 6, wherein the embolic protection device is impermeable to blood.

[0087] 8. The system of any of embodiments 1-7, wherein the embolic protection device is a balloon.

[0088] 9. The system of embodiment 8, wherein the balloon is configured to expand to a diameter of the blood vessel in the second embolic protection device position to substantially block blood flow through the blood vessel.

[0089] 10. The system of any of embodiments 1-9, further comprising:

[0090] a valve assembly fixedly coupled to a proximal portion of the deployment catheter; and

[0091] a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the valve assembly is movable relative to the hub to retract the deployment catheter relative to the elongate shaft to move the clot treatment device between the first clot treatment position and the second clot treatment position.

[0092] 11. The system of any of embodiments 1-10, further comprising a handle having a housing and a trigger movable relative to the housing, wherein the deployment catheter is fixedly coupled to the trigger, and wherein the trigger is movable relative to the housing to retract the deployment catheter relative to the elongate shaft to move the clot treatment device between the first clot treatment position and the second clot treatment position.

[0093] 12. The system of embodiment 11, further comprising a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the hub is coupled to the housing.

[0094] 13. The system of any of embodiments 1-12, further comprising an aspiration source fluidly coupled to the delivery catheter.

[0095] 14. A method of removing a clot material from a blood vessel of a patient, the method comprising:

[0096] advancing a delivery catheter through the blood vessel such that a distal portion of the delivery catheter is proximate the clot material;

[0097] advancing an embolic protection device through the delivery catheter, wherein the embolic protection device is coupled to a distal portion of an intermediate catheter;

[0098] retracting the delivery catheter to allow the embolic protection device to at least partially expand within the blood vessel proximally of the clot material;

[0099] advancing a clot treatment assembly through the intermediate catheter and at least partially through the clot material;

[0100] retracting a deployment catheter of the clot treatment assembly relative to a clot treatment device of the clot treatment assembly to allow the clot treatment device to at least partially expand within the blood vessel distally of the clot material; and

[0101] proximally retracting the clot treatment device through the clot material and into the embolic protection device.

[0102] 15. The method of embodiment 14, wherein the method further comprises substantially inhibiting blood flow through the blood vessel after expanding the embolic protection device.

[0103] 16. The method of embodiment 14 or embodiment 15, wherein allowing the embolic protection device to expand comprises allowing the embolic protection device to expand to a diameter of the blood vessel.

[0104] 17. The method of any one of embodiments 14-16, wherein the embolic protection device is impermeable to blood.

[0105] 18. The system of any one of embodiments 14-17, wherein the blood vessel is a peripheral artery.

[0106] 19. The system of any one of embodiments 14-18, wherein the embolic protection device is a funnel having a conical shape.

[0107] 20. The system of any one of embodiments 14-19, wherein the embolic protection device is a balloon, and wherein allowing the embolic protection device to expand comprises inflating the balloon.

[0108] 21. A method of removing a clot material from a blood vessel of a patient using a clot treatment system, the method comprising:

[0109] inserting a catheter into the blood vessel adjacent to the clot material while radially constraining a clot treatment device and an embolic protection device within the catheter;

[0110] moving the catheter proximally to at least partially deploy the clot treatment device distally of the clot material within the blood vessel; and

[0111] further moving the catheter proximally to at least partially deploy the embolic protection device proximally of the clot material.

[0112] 22. The method of any of embodiments 21, further comprising mechanically fragmenting at least a portion of the clot material by retracting the clot treatment device through the clot material toward the catheter.

[0113] 23. The method of any of embodiments 21 or 22, further comprising retracting the clot treatment device through the clot material and at least partially into the embolic protection device.

[0114] 24. The method of any of embodiments 21-23, further comprising aspirating a portion of the clot material via an inner lumen at least partially defined by the clot treatment system.

[0115] 25. The method of embodiment 24, wherein the inner lumen is a catheter inner lumen defined by the catheter.

[0116] 26. The method of any of embodiments 24 or 25, wherein the clot treatment device is carried by a shaft extending through the catheter, and wherein the inner lumen is a shaft inner lumen defined by the shaft.

[0117] 27. The method of any of embodiments 24-26, wherein the embolic protection device is carried by a shaft extending through the catheter, and wherein the inner lumen is a shaft inner lumen defined by the shaft.

[0118] 28. The method of any of embodiments 21-27, wherein inserting the catheter comprises placing the clot treatment device and the embolic protection device in direct contact with an inner surface of the catheter to radially constrain the clot treatment device and the embolic protection device.

[0119] 29. A system for removing clot material from a blood vessel structure of a patient, the system comprising:

[0120] a catheter defining an inner lumen; and

[0121] a mechanical thrombectomy assembly configured to be positioned at least partially within the lumen, the mechanical thrombectomy assembly comprising:

[0122] a first shaft;

[0123] a second shaft configured to be positioned at least partially within the first shaft;

[0124] an embolic protection device coupled to the first shaft; and

[0125] a clot treatment device coupled to the second shaft and positioned distally of the embolic protection device;

[0126] wherein the clot treatment device and the embolic protection device are configured to transition between an undeployed configuration and a deployed configuration in response to proximal movement of the catheter relative to the mechanical thrombectomy assembly.

[0127] 30. The system of embodiment 29, wherein the embolic protection device comprises a funnel defining a distally-facing opening.

[0128] 31. The system of embodiment 29, wherein the embolic protection device comprises a balloon.

[0129] 32. The system of any one of embodiments 29-31, wherein at least a portion of the second shaft contacts an inner surface of the first shaft.

[0130] 33. The system of any one of embodiments 29-32, wherein the clot treatment device and the embolic protection device are configured to sequentially transition between the undeployed configuration and the deployed configuration during the proximal movement of the catheter.

[0131] 34. A method of removing clot material from a blood vessel of a patient using a clot treatment system, the method comprising:

[0132] inserting a catheter into the blood vessel proximate the clot material while radially constraining a clot treatment device and an embolic protection device within the catheter;

[0133] moving an intermediate deployment shaft of the clot treatment system proximally to at least partially deploy the clot treatment device distally of the clot material within the blood vessel, wherein the clot treatment device is carried by a first shaft of the clot treatment system, and wherein the intermediate deployment shaft is positioned radially outward of the first shaft; and

[0134] moving the catheter proximally to at least partially deploy the embolic protection device proximally of the clot material, wherein the embolic protection device is carried by a second shaft of the clot treatment system, and wherein the second shaft is configured to receive the intermediate deployment shaft.

[0135] 35. The method of embodiment 34, further comprising mechanically fragmenting at least a portion of the clot material by retracting the clot treatment device through the clot material toward the catheter.

[0136] 36. The method of embodiment 35, further comprising retracting the clot treatment device through the clot material and at least partially into the embolic protection device.

[0137] 37. The method of embodiment 36, further comprising aspirating at least a portion of the clot material via a lumen at least partially defined by the clot treatment system.

[0138] 38. The method of embodiment 37, wherein the lumen is a catheter lumen defined by the catheter.

[0139] 39. The method of embodiment 37, wherein the lumen is a deployment lumen defined by the intermediate deployment shaft.

[0140] 40. The method of any one of embodiments 34-39, wherein inserting the clot treatment system comprises placing the embolic protection device in direct contact with an inner surface of the catheter to radially constrain the embolic protection device when the catheter and embolic protection device are advanced together.

[0141] 41. The method of any one of embodiments 34-40, wherein inserting the clot treatment system comprises advancing the catheter with (a) the embolic protection device and the clot treatment device positioned in the catheter and (b) the clot treatment device positioned distally of the embolic protection device.

[0142] 42. The method of any one of embodiments 34-41, further comprising positioning the embolic protection device within the catheter prior to deploying the embolic protection device.

[0143] 43. The method of embodiment 42, further comprising positioning the clot treatment device within the second shaft prior to deploying the embolic protection device.

[0144] 44. The method according to embodiment 43, wherein positioning the embolism protection device within the catheter and deploying the embolism protection device from the catheter occurs before positioning the clot treatment device within the second shaft.

[0145] 45. The method according to embodiment 44, wherein deploying the clot treatment device comprises: deploying the clot treatment device to the distal side of the deployed embolism protection device.

[0146] 46. ​​A system for removing clotted material from a patient's blood vessels, the system comprising:

[0147] Delivery catheter;

[0148] An intermediate conduit configured to extend through the delivery conduit;

[0149] A funnel, the funnel being connected to the distal portion of the intermediate catheter, wherein the delivery catheter and the intermediate catheter are movable relative to each other to allow the funnel to move between (a) a first funnel position and (b) a second funnel position, in the first funnel position being constrained within the delivery catheter, and in the second funnel position being unconstrained by the delivery catheter and configured to expand within the blood vessel;

[0150] A deployable conduit, the deployable conduit being configured to extend through the intermediate conduit;

[0151] An elongated shaft, configured to extend through the unfolding conduit; and

[0152] A clot treatment device coupled to the elongated shaft, wherein the spreading catheter and the intermediate catheter are movable relative to each other to allow the embolization protection device to move between (a) a first clot treatment device position and (b) a second clot treatment device position, in the first clot treatment device position, the clot treatment device being constrained within the spreading catheter, and in the second clot treatment device position, the clot treatment device being unconstrained by the spreading catheter and configured to expand within the blood vessel.

[0153] 47. The system according to embodiment 46, wherein the funnel is configured to expand to the diameter of the blood vessel in the second funnel location.

[0154] 48. The system according to Example 47, wherein the funnel is impermeable to blood.

[0155] 49. The system according to embodiment 47 or embodiment 48, wherein the funnel is configured in the second funnel position to substantially prevent blood flow through the blood vessel.

[0156] 50. The system of any of embodiments 46-49, wherein the blood vessel is a peripheral artery.

[0157] 51. The system of any of embodiments 46-50, wherein the funnel has a conical shape.

[0158] 52. The system of embodiment 51, wherein the funnel is impermeable to blood.

[0159] 53. The system of any of embodiments 46-52, further comprising:

[0160] a valve assembly fixedly coupled to a proximal portion of the deployment catheter; and

[0161] a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the valve assembly is movable relative to the hub to retract the deployment catheter relative to the elongate shaft, thereby moving the clot treatment device between the first clot treatment position and the second clot treatment position.

[0162] 54. The system of any of embodiments 46-53, further comprising a handle having a housing and a trigger movable relative to the housing, wherein the deployment catheter is fixedly coupled to the trigger, and wherein the trigger is movable relative to the housing to retract the deployment catheter relative to the elongate shaft, thereby moving the clot treatment device between the first clot treatment position and the second clot treatment position.

[0163] 55. The system of embodiment 54, further comprising a hub fixedly coupled to a proximal portion of the elongate shaft, wherein the hub is coupled to the housing.

[0164] 56. The system of any of embodiments 46-55, further comprising an aspiration source fluidly coupled to the delivery catheter.

[0165] 57. A method of removing a clot material from a blood vessel of a patient, the method comprising:

[0166] advancing a delivery catheter through the blood vessel such that a distal portion of the delivery catheter is proximate the clot material;

[0167] advancing a funnel through the delivery catheter, wherein the funnel is coupled to a distal portion of an intermediate catheter;

[0168] retracting the delivery catheter to allow the funnel to at least partially expand within the blood vessel proximal of the clot material;

[0169] advancing the clot treatment assembly through the intermediate catheter and at least partially through the clot material;

[0170] retracting the deployment catheter of the clot treatment assembly relative to the clot treatment device of the clot treatment assembly to allow the clot treatment device to at least partially expand distally of the clot material within the blood vessel; and

[0171] proximally retracting the clot treatment device through the clot material and into the funnel.

[0172] 58. The method of embodiment 57, wherein the method further comprises substantially inhibiting blood flow through the blood vessel with the funnel after expanding the funnel.

[0173] 59. The method of embodiment 57 or embodiment 58, wherein allowing the funnel to expand comprises allowing the funnel to expand to a diameter of the blood vessel.

[0174] 60. The method of any one of embodiments 57-59, wherein the funnel is impermeable to blood.

[0175] 61. The system of any one of embodiments 57-60, wherein the blood vessel is a peripheral artery.

[0176] 62. The system of any one of embodiments 57-61, wherein the funnel is a funnel having a tapered shape.

[0177] The foregoing detailed description of implementations of the technology has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although the particular implementations of the technology have been described above in detail, various alternatives will be apparent to those skilled in the art. For example, although steps are presented in a given order, alternative implementations can perform steps in a different order. Various implementations of the technology described herein can also be combined in other ways to provide other implementations.

[0178] In light of the above, it should be appreciated that the specific implementations of the technology described herein have been shown and described for the purposes of illustrating the more pertinent and alternative embodiments. It will be recognized by persons of ordinary skill in the art that, given the benefit of this disclosure, other changes and modifications can be made. Changes in detail of the description are not to be interpreted as disclosing the only way in which the technology can be practiced. The terminology used by the inventor should not be interpreted in any specific and / or detailed manner, merely because it is used in conjunction with a detailed description of particular embodiments. Terms such as "including", "containing", "comprising", "having", "front", "back", "upper", "lower", "beneath", "below", "above", "over", and the like, are used broadly and encompass the terms "consisting of", "consisting essentially of", "comprising of", "including of", "containing of", "having of", "front of", "back of", "upper of", "lower of", "beneath of", "below of", "above of", "over of", and the like, as well as other variations thereof.

[0179] Further, the use of "or" in such a list is to be interpreted as including (a) any single one of the items in the list, (b) any combination of two or more items in the list, or (c) any list of items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature, that thus do not exclude any additional number of the same feature or other types of features. It is further understood that the specific embodiments have been described for the purpose of exemplification only and that various modifications can be made without departing from the technology. Additionally, although advantages of certain embodiments associated with the technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and related technology can include other embodiments not expressly shown or described herein.

Claims

1. A system for removing clotted material from a patient's blood vessels, the system comprising: Delivery catheter; An intermediate conduit configured to extend through the delivery conduit; An embolization protection device is coupled to a distal portion of an intermediate catheter, wherein the delivery catheter and the intermediate catheter are movable relative to each other to allow the embolization protection device to move between (a) a first embolization protection device position and (b) a second embolization protection device position, in the first embolization protection device position being constrained within the delivery catheter, and in the second embolization protection device position being unconstrained by the delivery catheter and configured to dilate within the blood vessel; A deployable conduit, the deployable conduit being configured to extend through the intermediate conduit; An elongated shaft, configured to extend through the unfolding conduit; and A clot treatment device coupled to the elongated shaft, wherein the spreading catheter and the intermediate catheter are movable relative to each other to allow the embolization protection device to move between (a) a first clot treatment device position and (b) a second clot treatment device position, in the first clot treatment device position, the clot treatment device being constrained within the spreading catheter, and in the second clot treatment device position, the clot treatment device being unconstrained by the spreading catheter and configured to expand within the blood vessel.

2. The system according to claim 1, wherein, The embolization protection device is configured to expand to the diameter of the blood vessel in the second embolization protection device position.

3. The system according to claim 2, wherein the embolism protection device is impermeable to blood.

4. The system according to claim 2, wherein, The embolism protection device is configured to substantially block blood flow through the blood vessel in the second embolism protection device position.

5. The system according to claim 1, wherein the blood vessel is a peripheral artery.

6. The system according to claim 1, wherein the embolism protection device is a funnel having a conical shape.

7. The system of claim 6, wherein the embolism protection device is blood-impermeable.

8. The system according to claim 1, wherein the embolism protection device is a balloon.

9. The system according to claim 8, wherein, The balloon is configured to expand to the diameter of the blood vessel in the second embolization protection device position to substantially block blood flow through the blood vessel.

10. The system according to claim 1, further comprising: A valve assembly, the valve assembly being fixedly connected to the proximal portion of the deploying conduit; and A hub, which is fixedly connected to a proximal portion of the elongated shaft, wherein the valve assembly is movable relative to the hub to retract the unfolding conduit relative to the elongated shaft, thereby moving the clot treatment device between a first clot treatment position and a second clot treatment position.

11. The system of claim 1, further comprising a handle having a housing and a trigger movable relative to the housing, wherein the unfolding conduit is fixedly coupled to the trigger, and wherein the trigger is movable relative to the housing to retract the unfolding conduit relative to the elongated shaft, thereby moving the clot treatment device between a first clot treatment position and a second clot treatment position.

12. The system of claim 11, further comprising a hub fixedly coupled to a proximal portion of the elongated shaft, wherein the hub is coupled to the housing.

13. The system of claim 1, further comprising a suction source fluidly connected to the delivery conduit.

14. A method for removing clotted material from a patient's blood vessels, the method comprising: The delivery catheter is advanced through the blood vessel, with the distal portion of the delivery catheter close to the clotted material; The embolism protection device is allowed to travel through the delivery catheter, wherein the embolism protection device is coupled to the distal portion of the intermediate catheter; The delivery catheter is retracted to allow the embolization protection device to expand at least partially within the blood vessel to the proximal side of the clot material; The coagulant treatment component is made to travel through the intermediate conduit and at least partially through the coagulant material; The deploying catheter of the clot treatment assembly is retracted relative to the clot treatment device of the clot treatment assembly to allow the clot treatment device to expand at least partially within the blood vessel to the distal side of the clot material. as well as The clot treatment device retracts proximally through the clot material and enters the embolism protection device.

15. The method of claim 14, wherein the method further comprises: After the embolization protection device is expanded, blood flow through the blood vessel is essentially inhibited.

16. The method of claim 14, wherein allowing the embolism protection device to expand comprises: The embolization protection device is allowed to expand to the diameter of the blood vessel.

17. The method of claim 14, wherein the embolism protection device is impermeable to blood.

18. The method of claim 14, wherein the blood vessel is a peripheral artery.

19. The method of claim 14, wherein the embolism protection device is a funnel having a conical shape.

20. The method of claim 14, wherein the embolism protection device is a balloon, and wherein allowing the embolism protection device to expand comprises inflating the balloon.

21. A method for removing clotted material from a patient's blood vessels using a clot removal system, the method comprising: The catheter is inserted into the vicinity of the clot material within the blood vessel, while the clot removal device and embolism protection device are radially constrained within the catheter; The catheter is moved proximally to at least partially extend the clot treatment device distal to the clot material within the blood vessel; as well as The catheter is moved further proximally to at least partially deploy the embolism protection device proximally to the clotted material.

22. The method according to claim 21, further comprising: At least a portion of the clot material is mechanically broken up by retracting the clot processing device toward the conduit through the clot material.

23. The method according to claim 21, further comprising: The clot treatment device retracts through the clotted material and at least partially enters the embolism protection device.

24. The method according to claim 21, further comprising: A portion of the clump material is aspirated via an interior cavity defined at least partially by the clump treatment system.

25. The method of claim 24, wherein the lumen is a catheter lumen defined by the catheter.

26. The method of claim 24, wherein the clot treatment device is carried by a bearing extending through the conduit, and wherein the lumen is a axial lumen defined by the shaft.

27. The method of claim 24, wherein the embolism protection device is carried by a bearing extending through the conduit, and wherein the lumen is a axial lumen defined by the shaft.

28. The method of claim 21, wherein inserting the catheter comprises: The clot treatment device and the embolism protection device are brought into direct contact with the inner surface of the catheter to radially constrain the clot treatment device and the embolism protection device.

29. A system for removing clotted material from a patient's vascular structures, the system comprising: Catheter, the catheter defining an internal lumen; and A mechanical thrombectomy assembly configured to be at least partially located within the lumen, the mechanical thrombectomy assembly comprising: First axis; A second axis, configured to be at least partially located within the first axis; Embolism protection device, the embolism protection device being connected to the first shaft; and A clot treatment device, which is connected to the second shaft and positioned distal to the embolism protection device; The clot treatment device and the embolization protection device are configured to switch between an undeployed configuration and an deployed configuration in response to proximal movement of the catheter relative to the mechanical thrombectomy assembly.

30. The system of claim 29, wherein the embolism protection device includes a funnel defining an opening facing distally.

31. The system of claim 29, wherein the embolism protection device comprises a balloon.

32. The system of claim 29, wherein at least a portion of the second shaft contacts the inner surface of the first shaft.

33. The system of claim 29, wherein the clot treatment device and the embolism protection device are configured to sequentially switch between the unexpanded configuration and the expanded configuration during the proximal movement of the catheter.

34. A method for removing clotted material from a patient's blood vessels using a clot removal system, the method comprising: The catheter is inserted into the vicinity of the clot material within the blood vessel, while the clot removal device and embolism protection device are radially constrained within the catheter; The intermediate unfolding axis of the clot treatment system is moved proximally to at least partially unfold the clot treatment device to the distal side of the clot material within the blood vessel, wherein the clot treatment device is carried by a first bearing of the clot treatment system, and wherein the intermediate unfolding axis is radially positioned outside the first axis. as well as The catheter is moved proximally to at least partially deploy the embolism protection device to the proximal side of the clot material, wherein the embolism protection device is carried by a second shaft of the clot treatment system, and wherein the second shaft is configured to receive the intermediate deployment shaft.

35. The method according to claim 34, further comprising: At least a portion of the clot material is mechanically broken up by retracting the clot processing device toward the conduit through the clot material.

36. The method according to claim 35, further comprising: The clot treatment device retracts through the clotted material and at least partially enters the embolism protection device.

37. The method according to claim 36, further comprising: At least a portion of the clump material is aspirated via an interior cavity defined at least partially by the clump treatment system.

38. The method of claim 37, wherein the lumen is a catheter lumen defined by the catheter.

39. The method of claim 37, wherein the inner cavity is an unfolded inner cavity defined by the intermediate unfolding axis.

40. The method of claim 34, wherein inserting the clot treatment system comprises: The embolization protection device is brought into direct contact with the inner surface of the catheter to radially constrain the embolization protection device as the catheter and the embolization protection device travel together.

41. The method of claim 34, wherein inserting the clot treatment system comprises advancing the catheter when: (a) the embolism protection device and the clot treatment device are positioned in the catheter, and (b) the clot treatment device is positioned distal to the embolism protection device.

42. The method according to claim 34, further comprising: Before deploying the embolization protection device, position the embolization protection device inside the catheter.

43. The method according to claim 42, further comprising: Before deploying the embolism protection device, the clot treatment device is positioned within the second shaft.

44. The method of claim 43, wherein positioning the embolization protection device within the catheter and deploying the embolization protection device from the catheter occurs before positioning the clot treatment device within the second shaft.

45. The method of claim 44, wherein the agglomerate processing apparatus comprises: The clot treatment device is deployed to the distal side of the deployed embolism protection device.

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