Thrombectomy systems and related methods

Abstract

The present technology relates to systems and methods for removing a thrombus from a patient's blood vessel. In some embodiments, the present technology is directed to a system including an elongate catheter having a distal portion configured to be positioned within the patient's blood vessel, a proximal portion configured to reside outside the patient, and a lumen extending therebetween. The system may further include an imaging element at the distal portion, an illumination source at the distal portion, a capture element at the distal portion configured to engage the thrombus, a fluid delivery mechanism within the lumen configured to apply fluid to (1) at least partially fragment the thrombus and (2) provide an optical path for the imaging element, and a suction mechanism fluidly coupled to the lumen and configured to aspirate the fragmented thrombus.

Description

Technical Field

[0001] Cross-Reference to Related Applications

[0001] This application claims the priority of the following pending applications.

[0002] U.S. Provisional Patent Application No. 62 / 984,918 filed on March 4, 2020, and

[0003] U.S. Provisional Patent Application No. 63 / 050,039 filed on July 9, 2020.

[0002]

[0004] All the above applications are incorporated herein by reference in their entireties. Furthermore, the components and features disclosed in the applications incorporated by reference may be combined with the various components and features disclosed and claimed in the present application.

[0003]

[0005] The present technology generally relates to medical devices, and in particular relates to systems and related methods for removing thrombus from a patient's blood vessels.

Summary of the Invention

Problem to be Solved by the Invention

[0004]

[0006] Pulmonary embolism is an obstruction in one of the pulmonary arteries that supply blood to the lungs. Pulmonary embolism typically occurs when a thrombus originating from another part of the body, for example a vein in the pelvis or leg, detaches and travels to the lungs. Anticoagulation therapy is the current standard treatment for pulmonary embolism, but it may not be effective for some patients. In addition, conventional devices for removing thrombotic material may be unable to navigate the pulmonary vasculature, may not be effective in removing thrombotic material, and / or may lack the ability to provide sensor data or other feedback to a clinician during a thrombectomy procedure.

Means for Solving the Problem

[0005]

[0014] This technology generally pertains to thrombectomy systems and related methods. A system configured according to embodiments of this technology may include, for example, an elongated catheter having a distal portion configured to be positioned within a patient's blood vessel, a proximal portion configured to be located outside the patient, and a lumen extending between them. The system may further include an imaging element located in the distal portion for imaging the patient's vascular system and / or thrombus. In some embodiments, the system further includes a capture element configured to engage and draw the thrombus into the lumen, a fluid delivery mechanism configured to fragment the thrombus using a pressurized fluid, and / or an aspiration mechanism configured to aspirate the thrombus fragments. [Brief explanation of the drawing]

[0006] [Figure 1A]

[0007] This figure shows a thrombectomy system having an elongated catheter positioned within the patient's pulmonary vascular system, configured according to an embodiment of the present technology. [Figure 1B]

[0008] This figure shows the proximal portion of the elongated catheter shown in Figure 1A. [Figure 1C]

[0009] This is an enlarged view showing the distal portion of the elongated catheter in Figure 1A. [Figure 1D]

[0010] This is a side cross-sectional view showing the distal portion of Figure 1C. [Figure 1E]

[0011] This is a side cross-sectional view showing a distal portion configured according to another embodiment of the present technology. [Figure 1F]

[0012] This is a side cross-sectional view showing the distal portion configured according to another embodiment of the present technology. [Figure 1G]

[0013] This is a side cross-sectional view showing a distal portion configured according to another embodiment of the present technology. [Modes for carrying out the invention]

[0007]

[0015] The terms used in the following descriptions are intended to be interpreted in the broadest and most appropriate manner, even when used in conjunction with detailed descriptions of specific embodiments of the Art. Certain terms may be emphasized below, but any terms intended to be interpreted in some restrictive manner will be explicitly defined in the sections on embodiments for carrying out the invention. In addition, the Art may include other embodiments that fall within the scope of the examples but are not described in detail in relation to Figures 1A-1G.

[0008]

[0016] Throughout this specification, any reference to “one embodiment” or “embodiment” means that certain features, structures, or properties described in relation to an embodiment are included in at least one embodiment of the Art. Therefore, the phrases “in one embodiment” or “in an embodiment” appearing in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, certain features or properties may be combined in any suitable manner in one or more embodiments.

[0009]

[0017] Throughout this specification, references to relative terms such as "approximately," "about," and "about" are used to mean plus or minus 10% of the stated value.

[0010]

[0018] While some embodiments of this specification are described in relation to the removal of thrombi, it will be recognized that the technique may be used and / or modified for the removal of other types of embolus that may block blood vessels, such as fat, tissue, or foreign bodies. In addition, while some embodiments of this specification are described in the context of removing thrombi from the pulmonary artery (e.g., pulmonary embolization), the technique may also be applied to the removal of thrombi and / or embolus from other parts of the vascular system (e.g., neurovascular, coronary, or peripheral applications). Furthermore, while some embodiments are considered in relation to macerating thrombi using fluids, the technique may be adapted for use in conjunction with other techniques (e.g., ultrasound, machinery, enzymes, etc.) for fragmenting thrombi into smaller fragments or particles.

[0011]

[0019] The headings presented herein are for convenience only and do not describe the scope or meaning of the claimed technology. System for thrombus removal

[0020] As presented above, this technology generally relates to thrombectomy systems. Such a system includes an elongated catheter having a distal portion that can be positioned within a patient's blood vessel (e.g., an artery or a vein), a proximal portion that can be positioned outside the patient's body, and a lumen extending between the distal and proximal portions. In some embodiments, the systems described herein are configured to engage with a thrombus in a patient's blood vessel, to fragment the thrombus into smaller fragments, and to aspirate the fragments out of the patient's body. Optionally, the systems described herein may include one or more sensors (e.g., a camera) integrated with the elongated catheter (e.g., in the distal portion) for facilitating the positioning of the elongated catheter, for measuring the properties of the thrombus, and / or for providing feedback to the clinician in other ways during the thrombectomy procedure. The terms “thrombus” and “embolism” as used herein are, in various respects, interchangeable to some extent.

[0012]

[0021] Figures 1A to 1G show a thrombectomy system 100 configured according to various embodiments of the present technology. More specifically, Figure 1A shows an elongated catheter 102 of the system 100 positioned within the patient's pulmonary vascular system, Figure 1B shows the proximal portion 104b of the elongated catheter 102, Figure 1C is an enlarged view of the distal portion 104a of the elongated catheter 102, Figure 1D is a side cross-sectional view of the distal portion 104a, Figure 1E is a side cross-sectional view of several embodiments of the distal portion 104a, Figure 1F is a side cross-sectional view of another embodiment of the distal portion 104a, and Figure 1G is a side cross-sectional view of another embodiment of the distal portion 104a.

[0013]

[0022] Referring first to Figure 1A, the patient's pulmonary vascular system has a pulmonary valve (PV) that separates the right ventricle of the heart (not shown) from the main pulmonary artery or pulmonary trunk (PT). The pulmonary trunk (PT) divides into the left pulmonary artery (LPA) and the right pulmonary artery (RPA), which connect to the left and right lungs (not shown), respectively. The diameter of the pulmonary trunk (PT) can vary considerably during systole and diastole, for example, between 22 mm and about 43 mm. The left pulmonary artery (LPA) and the right pulmonary artery (RPA) can each have a diameter ranging from 16 mm to 49 mm and a length ranging from about 80 mm to about 100 mm. Pulmonary embolism occurs when one or more parts of the pulmonary vascular system are blocked by a thrombus (T). For example, in the shown embodiment, a thrombus (T) is blocking the left pulmonary artery (LPA).

[0014]

[0023] Referring together to Figures 1A and 1B, a thrombectomy system 100 may be used to remove a thrombus T from a patient's vascular system. The system 100 has an elongated catheter 102 having a lumen 106 extending through the elongated catheter 102 between a distal portion 104a and a proximal portion 104b. The distal portion 104a is configured to be positioned within a blood vessel near or adjacent to the thrombus T. The elongated catheter 102 or at least a portion of the elongated catheter 102 (e.g., the distal portion 104a) may be introduced into the patient's body (e.g., via a delivery sheath not shown) and advanced to the site of the thrombus T. For example, in the shown embodiment, the elongated catheter 102 is advanced through the pulmonary valve PV into the pulmonary trunk PT, and further at least partially into the left pulmonary artery LPA or the right pulmonary artery RPA, so that the distal portion 104a is adjacent to the thrombus T. The proximal portion 104b is configured to remain outside the patient's body, as will be described in more detail later. The proximal portion 104b may have, or may be connected to, a handle (not shown) for controlling the movement and / or other functions of the elongated catheter 102. Although described in relation to procedures within the pulmonary artery, it will be recognized from the description herein that the systems, devices, and methods described may also be applicable to other locations in the body and other diseases. For example, the systems and devices may be used to remove thrombi from any kind of occluded artery, vein, or prosthesis (e.g., artificial blood vessel). The systems, devices, and methods may be used as adjunctive therapy or as monotherapy. In various embodiments, the system is configured to remove pulmonary embolism, iliofemoral embolism, and / or deep vein thrombosis.

[0015]

[0024] In some embodiments, the elongated catheter 102 or a portion of the elongated catheter 102 (e.g., a distal portion 104a, an intermediate portion between the distal portion 104a and the proximal portion 104b (not shown)) has a relatively small outer diameter suitable for introduction into the patient's vascular system (e.g., the pulmonary vascular system). The outer diameter may be smaller than the diameter of the target vessel, so as a result, the vessel will not be completely occluded when the elongated catheter 102 is introduced into the vessel. For example, the outer diameter may be about 10 mm or less, about 9 mm or less, about 8 mm or less, about 7.5 mm or less, about 7 mm or less, about 6.5 mm or less, about 6 mm or less, about 5.5 mm or less, about 5 mm or less, about 4.5 mm or less, about 4 mm or less, about 3.5 mm or less, about 3 mm or less, about 2.5 mm or less, about 2 mm or less, about 1.5 mm or less, or about 1 mm or less. In some embodiments, the outer diameter is 21 French (Fr) or less, 10 Fr or less, or in the range of about 10 Fr to about 4 Fr. The distal portion 104a of the elongated catheter 102 may be configured to facilitate navigation through the patient's vascular system. For example, the catheter may be maneuverable. The catheter may have relatively high flexibility to be guided on a guidewire, or it may have a tip configured to be pushed through the vascular system. Optionally, the elongated catheter 102 or a portion of the elongated catheter 102 may have sufficient rigidity to reduce or prevent twisting, compression, etc., when the elongated catheter 102 is introduced to pass through bends, curves, bifurcations, or other tortuous portions of the vascular structure.

[0016]

[0025] Referring to Fig. 1C, in some embodiments, a distal portion 104a of an elongated catheter 102 comprises an imaging element 108 (e.g., a camera, such as a CCD camera or a CMOS camera). The imaging element 108 may be operatively coupled to an outer surface of the distal portion 104a, operatively coupled to an inner surface of the distal portion 104a (e.g., within the lumen 106), or embedded within a wall of the distal portion 104a surrounding the lumen 106. The imaging element 108 may be configured to generate images and / or data representative of the patient's vasculature and / or a thrombus (not shown in Fig. 1C) to guide a clinician when performing a thrombectomy procedure. For example, image data may be displayed to assist the clinician in positioning the distal portion 104a near the thrombus. The image data can further assist the clinician in determining an appropriate procedure and / or tool for removing the thrombus by assessing the thrombus type (e.g., soft and acute, slightly organized with some fibrin, highly organized and fibrous, etc.). Optionally, the imaging element 108 can generate image data before, during, and / or after the thrombectomy procedure, so that the clinician can evaluate whether the thrombus has been completely removed, whether a portion or other thrombus remains in the blood vessel, whether other treatment procedures would be beneficial, and the like.

[0017]

[0026] The system 100 may have additional components configured to facilitate visualization of the treatment site using the imaging element 108. For example, the system 100 may have an illumination source (e.g., one or more LEDs (not shown)) in or near the distal portion 104a. The system 100 may further be configured to deliver a fluid (e.g., a fluid that is transparent in the visible spectrum) to provide an optical path to the location of interest. The fluid may be delivered from the distal portion 104a to displace opaque blood away from the treatment site to provide an optically transparent medium for imaging. In some embodiments, the fluid for imaging is the same fluid used to fragment the thrombus, as will be further described below. In other embodiments, the fluid for imaging is different from the fluid used to fragment the thrombus.

[0018]

[0027] Referring together to Figures 1C and 1D, in some embodiments, the distal portion 104a of the elongated catheter 102 has an expandable chamber 109. The internal space within the expandable chamber 109 may be part of or connected to the lumen 106, as a result allowing material to enter the elongated catheter 102 through the expandable chamber 109 and / or exit the elongated catheter 102. The expandable chamber 109 can be deformed between a deployed configuration (e.g., the expanded configuration and / or a generally cylindrical configuration shown in Figures 1C and 1D) and a low-profile configuration (e.g., a folded, contracted, and / or flattened configuration (not shown)). The expandable chamber 109 may take a low-profile configuration to allow the distal portion 104a of the elongated catheter 102 to be introduced into the patient's body intravascularly via a delivery sheath or other minimally invasive technique. Once the distal portion 104a is positioned at the target site within the blood vessel, the expandable chamber 109 may be deformed into a deployed configuration for capturing and macerating the thrombus, as will be described in more detail later. The expandable chamber 109 may be self-expanding, so that it automatically deforms into the deployed configuration when released from the delivery sheath. After the thrombectomy procedure is complete, the expandable chamber 109 can be deformed back to a low profile and withdrawn into the delivery sheath for removal from the patient's body. Alternatively, or in addition, the expandable chamber 109 may be inflatable (e.g., by fluid or gas) to deform from a low profile to a deployed configuration.

[0019]

[0028] The geometry (e.g., size, shape) of the expandable chamber 109 can be constructed in a number of different ways. For example, the expandable chamber 109 may have a circular cross-sectional shape, an elliptical cross-sectional shape, a square cross-sectional shape, a rectangular cross-sectional shape, a polygonal cross-sectional shape, a curved cross-sectional shape, a star cross-sectional shape, or other cross-sectional shapes. In some embodiments, the expandable chamber 109 has a uniform cross-sectional shape along its entire length (e.g., the expandable chamber 109 is generally cylindrical), while in other embodiments, the expandable chamber 109 has a variable cross-sectional shape (e.g., the expandable chamber 109 is funnel-shaped). The expandable chamber 109 may have a length of at least about 5 cm, at least about 6 cm, at least about 7 cm, at least about 7.5 cm, at least about 8 cm, at least about 8.5 cm, at least about 9 cm, at least about 9.5 cm, at least about 10 cm, at least about 10.5 cm, at least about 11 cm, or at least about 12 cm. In some embodiments, the length of the expandable chamber 109 is in the range of about 8 cm to about 10 cm. When in the deployed configuration, the expandable chamber 109 can have an outer diameter of at least about 5 mm, at least about 5.5 mm, at least about 6 mm, at least about 6.5 mm, at least about 7 mm, at least about 7.5 mm, at least about 8 mm, at least about 8.5 mm, at least about 9 mm, at least about 9.5 mm, at least about 10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm, at least about 30 mm, at least about 35 mm, or at least about 40 mm. When in the low profile configuration, the expandable chamber 109 can have an outer diameter of up to about 7 mm, up to about 6.5 mm, up to about 6 mm, up to about 5.5 mm, up to about 5 mm, up to about 4.5 mm, up to about 4 mm, up to about 3.5 mm, up to about 3 mm, up to about 2.5 mm, up to about 2 mm, up to about 1.5 mm, or up to about 1 mm.The cross-sectional dimension (e.g., area, diameter, width, etc.) of the expandable chamber 109 in the deployed configuration may be at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100%, at least about 150%, at least about 200%, at least about 250%, at least about 300%, at least about 400%, at least about 500%, at least about 600%, at least about 700%, at least about 800%, at least about 900%, or at least about 1000% greater than the cross-sectional dimension of the expandable chamber 109 in the low-profile configuration. In some embodiments, when in the deployed configuration, the cross-sectional dimension of the expandable chamber 109 may be at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100%, at least about 150%, at least about 200%, at least about 250%, at least about 300%, at least about 400%, or at least about 500% greater than the cross-sectional dimension of the remaining portion of the elongated catheter 102 (e.g., the intermediate portion between the distal portion 104a and the proximal portion 104b).

[0020]

[0029] Optionally, when in the deployed configuration, the cross-sectional dimension of the expandable chamber 109 may be smaller than the cross-sectional dimension of the blood vessel in which the expandable chamber 109 is positioned. For example, the diameter of the expandable chamber 109 may be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, or about 90% of the diameter (e.g., the minimum diameter or the maximum diameter) of the blood vessel. In some embodiments, during deployment, the expandable chamber 109 is configured to engage the thrombus and form a seal against the thrombus while allowing blood to flow around the outside of the expandable chamber 109 and / or the thrombus to maintain a perfusion state. Sealing the expandable chamber 109 against the thrombus may enable delivery, containment, and aspiration of fluid (e.g., for imaging and / or fragmenting the thrombus) from the expandable chamber 109 with little or no leakage into the patient's bloodstream, as will be further described later.

[0021]

[0030] Alternatively, when in the deployed configuration, the cross-sectional dimensions of the expandable chamber 109 may be equal to or approximately equal to the cross-sectional dimensions of the blood vessel, resulting in the expandable chamber 109 partially or completely blocking the flow of fluid through it. For example, an expandable chamber 109 in the deployed configuration can form a fluid seal against the blood vessel wall around the periphery of the expandable chamber 109. The seal may be a partial fluid seal or a complete fluid seal (clinically and / or functionally complete seal). This approach may be used in situations where a thrombus fragment is designed to prevent migration of thrombus fragments to other parts of the patient's body during a thrombectomy procedure, where tissue downstream of the expandable chamber 109 is to be continuously perfused by other blood vessels, and / or where a temporary upstream blockage by the expandable chamber 109 can be tolerated. In some embodiments, the expandable chamber 109 may have one or more valves (not shown) configured to selectively allow fluid flow along the outer portion of the system 100. For example, one or more valves may be located around the periphery of the expandable chamber 109. This approach may be advantageous in situations where tissue perfusion downstream of the expandable chamber 109 may be impaired in cases of complete or near-complete occlusion by the expandable chamber 109.

[0022]

[0031] An expandable chamber 109 may be used to house one or more components of the system 100. In some embodiments, for example, the system 100 has a capture element 110 located in the distal portion 104a, at least partially within the expandable chamber 109. The capture element 110 may be configured to contact and engage with a thrombus in order to draw the thrombus at least partially into the lumen 106 and the expandable chamber 109. Various types of capture elements are suitable for use in the embodiments described herein. For example, as best seen in Figure 1D, the capture element 110 may be configured as an auger, screw (e.g., Archimedes' spiral), or other spiral structure, configured to rotate (e.g., along direction D1) to enter into the thrombus and / or progressively draw the thrombus into the lumen 106. The geometry (e.g., size, shape) of the capture element 110 can be configured in a number of different ways. In some embodiments, the capture element is formed to have an outer diameter (e.g., profile) that is substantially uniform along its axial length (e.g., along direction D2). In some embodiments, the capture element 110 has a variable profile. For example, the capture element 110 may have a conical profile that tapers distally and / or proximal. Alternatively to rotation, or in combination with rotation, the capture element 110 may be movable longitudinally (e.g., direction D2) to engage with a thrombus and progressively draw the thrombus into the lumen 106 and the expandable chamber 109. In some embodiments, the capture element 110 is movable along a distance of at least about 10%, at least 20%, at least about 30%, at least 40%, at least about 50%, at least 60%, at least about 70%, at least 80%, at least about 90%, or at least 100% of the length of the capture element 110. The longitudinal movement of the capture element 110 (for example, out of the lumen 106 and expandable chamber 109) can also be used to release the capture element 110 if it becomes immobile or jammed.

[0023]

[0032] The rotational and / or longitudinal movement of the capture element 110 relative to the distal portion 104a may be actuated by a drive shaft 112 extending through the elongated catheter 102 into the expandable chamber 109. The drive shaft 112 may operably connect the capture element 110 to a motor, cam, and / or other actuation mechanism located in the proximal portion of the elongated catheter 102 (not shown). In some embodiments, the rotational speed of the capture element 110 is adjustable to facilitate engagement with various types of thrombi (e.g., between high, medium, and low speeds). For example, a lower rotational speed may be used to capture softer, less organized, and / or less fibrous thrombi, while a higher rotational speed may be used to capture harder, more organized, and / or more fibrous thrombi.

[0024]

[0033] Optionally, the characteristics of the capture element 110 (e.g., screw size, screw pitch, and / or durometer) may be selected based on the type and / or properties of the thrombus (e.g., stiffness, density, degree of organization, fibrin content, size, etc.). In some embodiments, the capture element 110 has at least one sensor 113 (e.g., located on the distal portion of the capture element 110) for sensing one or more properties of the thrombus. For example, the sensor 113 may be configured to measure strain, stiffness, and / or other mechanical properties of the thrombus. In another embodiment, the sensor 113 may be configured to measure current, impedance, and / or other electrical properties of the thrombus (e.g., while the capture element 110 is rotating). Other types of sensors suitable for use with the embodiments herein include pressure sensors, accelerometers, temperature sensors, flow sensors, optical sensors, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpO2 sensors, electrical impedance sensors, and other sensors adapted to measure tissue and / or blood gas levels, blood volume sensors, as well as other sensors known to those skilled in the art. Sensor data generated by sensor 113 may be transmitted to an external computing device via wired or wireless communication, and as a result, the sensor data may be processed and / or displayed to a clinician.

[0025]

[0034] In some embodiments, the capture element 110 is expandable (e.g., inflatable) and can be transformed between a low-profile configuration (e.g., a flattened and / or folded configuration (not shown)) and an unfolded configuration (e.g., an operational configuration for engaging with a thrombus and / or an expanded configuration, as shown in Figures 1C and 1D). For example, to be introduced into a patient's blood vessel, the capture element 110 may be transformed into a low-profile configuration while the expandable chamber 109 is also in a low-profile configuration. Once the distal portion 104a is properly positioned in the blood vessel, the capture element 110 may be transformed into an unfolded configuration simultaneously with, or after, the expandable chamber 109 is transformed into an unfolded configuration. In some embodiments, a portion or all of the capture element 110 is inflatable using a delivered fluid and / or gas. A portion may include a) one or more blades (e.g., an impeller), or b) one or more blade portions (e.g., peripheral edges of a given blade). In some embodiments, the body of the capture element comprises a membrane having an inflatable outer portion (e.g., an edge). In some embodiments, the capture element 110 is configured to self-expand, so that when not covered by the sheath and / or unrestrained, the capture element 110 automatically deforms into an expanded configuration together with the expandable chamber 109. The capture element 110 can then be used to engage with a thrombus and draw the thrombus into the expandable chamber 109, as described herein. For example, after the thrombus has been retrieved and / or simultaneously with the expansionable chamber 109 deforming into a low-profile configuration, the capture element 110 can be deformed back into a low-profile configuration.

[0026]

[0035] Referring to Figure 1D, the system 100 may further have a fluid delivery mechanism 114 located in the distal portion 104a and at least partially within the expandable chamber 109. The fluid delivery mechanism 114 may be configured to apply a fluid 116 (e.g., saline solution) for the purpose of fragmenting, macerating, cutting, breaking down, and / or otherwise breaking down the thrombus into a plurality of smaller particles. For example, the delivery mechanism 114 may be positioned proximal to the capture element 110, so that as a result the capture element 110 draws a portion of the thrombus proximal to the expandable chamber 109, the fluid delivery mechanism 114 uses the fluid 116 to fragment the portion of the thrombus. In some embodiments, the fluid 116 is pressurized to contact the thrombus with sufficient force to fragment it. The fluid 116 may be delivered as a continuous flow or jet, or intermittently at specified timings, frequencies, etc. The pressure and / or flow rate of the fluid 116 may be high enough to fragment the thrombus, but low enough that little or no fluid 116 leaks from the lumen 106 into the patient's bloodstream. In some embodiments, the applied fluid 116 is delivered proximal to the seal formed by the expandable chamber 109. Advantageously, the applied fluid 116 delivered proximal to the seal is expected to improve the effectiveness and / or efficiency of a) maceration / fragmentation of the thrombus, and / or b) aspiration of the thrombus fragments. Optionally, the pressure and / or flow rate may be selectively adjusted based on the type and / or nature of the thrombus (e.g., higher pressure and / or higher flow rate for harder, more organized, and / or more fibrous thrombi, and lower pressure and / or lower flow rate for softer, less organized, and / or less fibrous thrombi).In some embodiments, the fluid 116 to be applied is delivered at a pressure of at least about 345 kPa (about 50 pounds-force per square inch (psi)), at least 483 kPa (about 70 psi), at least 621 kPa (about 90 psi), at least 758 kPa (about 110 psi), at least 896 kPa (about 130 psi), or at least 1034 kPa (about 150 psi). In some embodiments, the fluid 116 to be applied may be delivered at a pressure ranging from at least 345 kPa (approximately 50 psi) to at least 6895 kPa (approximately 1000 psi), such as at least 345 kPa (approximately 50 psi), at least 689 kPa (approximately 100 psi), at least 1379 kPa (approximately 200 psi), at least 2068 kPa (approximately 300 psi), at least 2758 kPa (approximately 400 psi), at least 3447 kPa (approximately 500 psi), at least 4137 kPa (approximately 600 psi), at least 4826 kPa (approximately 700 psi), at least 5516 kPa (approximately 800 psi), at least 6205 kPa (approximately 900 psi), or at least 6895 kPa (approximately 1000 psi). The fluid 116 to be applied may be delivered at any pressure within the pressure range mentioned above. In some embodiments, the fluid to be applied 116 is delivered for a given duration, such as at least about 100 milliseconds (ms), at least about 200 ms, at least about 300 ms, at least about 400 ms, at least about 500 ms, at least about 600 ms, at least about 700 ms, at least about 800 ms, at least about 900 ms, or at least about 1 second. The fluid to be applied 116 may be delivered for any duration within the range of durations mentioned above. In some embodiments, the fluid to be applied 116 is delivered intermittently and / or periodically (e.g., as pulses) for a given duration. Advantageously, pulsing the fluid to be applied 116 can reduce the total volume of fluid delivered to the patient. For example, the fluid to be applied 116 may be delivered periodically at an (applied) frequency of about 0.1 Hz, about 0.3 Hz, about 0.5 Hz, about 0.7 Hz, about 1 Hz, about 2 Hz, about 3 Hz, about 4 Hz, or about 5 Hz.The delivery of the fluid 116 to be applied may be at any frequency within the frequency range mentioned above. In some embodiments, the frequency at which the fluid 116 to be applied is delivered may be changed, for example, before, during, and / or after the application of the delivery fluid to a given pulse.

[0027]

[0036] The fluid delivery mechanism 114 can be composed of a number of different methods. In the embodiment shown, for example, the fluid delivery mechanism 114 has a single elongated tube 118 terminating at an opening 120 (e.g., a fluid port or fluid nozzle). The opening 120 may be positioned proximal to the capture element 110, spaced apart from the capture element 110, and within the expandable chamber 109, so that a thrombus or a portion of a thrombus can be received within the expandable chamber 109 between the opening 120 and the capture element 110. The elongated tube 118 and the opening 120 are oriented along the longitudinal axis of the distal portion 104a, so that the fluid 116 is guided distally toward the capture element 11. Thus, when the thrombus is drawn proximal to the expandable chamber 109 by the capture element 110, the fluid 116 is applied distally toward the thrombus to fragment it.

[0028]

[0037] Referring to Figure 1E, in another embodiment, the system 100 may have a fluid delivery mechanism 124 configured to produce two or more fluid jets or fluid flows (e.g., two fluid jets 126a-b). The fluid delivery mechanism 124 may have two elongated tubes 128a-b, each terminating at their respective openings 129a-b. The elongated tubes 128a-b may extend along opposing inner surfaces of the expandable chamber 109, with the openings 129a-b positioned adjacent to or near the proximal portion of the capture element 110. The distal portions of the openings 129a-b and / or the elongated tubes 128a-b may be oriented proximal toward the central longitudinal axis of the expandable chamber 109. As a result, the fluid jets 126a-b are guided proximal away from the capture element 110 and toward the center of the expandable chamber 109. As the thrombus is drawn proximal to the expandable chamber 109 by the capture element 110, fluid jets 126a-b are applied proximal to the thrombus to fragment it.

[0029]

[0038] It will be recognized that system 100 may have a fluid delivery mechanism different from the embodiments shown in Figures 1D, 1E, and 1G. For example, the fluid delivery mechanism may have any suitable number of elongated tubes or similar structures for transporting fluid (e.g., one, two, three, four, five, ten, twenty, thirty, or more elongated tubes). The fluid delivery mechanism may have any number of structures within the range mentioned above. Each elongated tube may have one or more openings (e.g., one, two, three, four, five, or more openings) for delivering fluid through it. In some embodiments, a single elongated tube has multiple openings at different locations along the length of the tube to apply fluid to different parts of the captured thrombus. The fluid may be guided proximally, distally, toward the central longitudinal direction (e.g., 141 in Figure 1G), in a combination of the above, or in any other direction suitable for fragmenting the thrombus. In some embodiments, the opening is positioned to guide the fluid flow so as to follow the inner wall of the distal portion 104a.

[0030]

[0039] In some embodiments, the pressure at which the fluid is delivered in a given flow is selected such that the flow dissipates before it hits the inner wall of the distal portion 104a. For example, the pressure may be low enough that the fluid flow dissipates before it hits the second wall portion at the opening that guides the fluid flow in a path from the first wall portion to the second wall portion. In some embodiments, the second wall portion faces the first wall portion. Dissipation may include loss of cohesiveness of the fluid flow, reduction of the momentum of the fluid flow, or a change in the momentum of the fluid flow (e.g., becoming proximal). Dissipation of the fluid flow may include a reduction of up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 20%, up to about 10%, up to about 5%, or up to about 1% of the magnitude of the momentum (e.g., initial momentum) when the fluid flow is delivered to its given opening. The reduction of momentum may be any reduction within the range of reduced momentum mentioned above. Optionally, in some embodiments, some or all of the elongated tubes may be used to deliver fluid to create a clear optical path for imaging, in addition to delivering fluid to fragment a thrombus, for example.

[0031]

[0040] Referring together to Figures 1B and 1D, the system 100 further comprises a suction mechanism 140 (best seen schematically in Figure 1B) fluid-connected to the lumen 106. The suction mechanism 140 may be an active or passive suction mechanism and may have any device suitable for generating a vacuum (e.g., a vacuum pump). During operation, the suction mechanism is fluid-connected to the distal portion 104a (e.g., via the lumen 106). The suction mechanism 140 may be configured to suction fragmented thrombi from the distal portion 104a of the elongated catheter 102 (e.g., from the expandable chamber 109) to the proximal portion 104b, and optionally to a collection container 142. In some embodiments, the suction mechanism 140 may be configured to complement and / or replace the capture element 110 to draw the thrombi into the lumen 106 (best seen most clearly in Figure 1G). For example, when the distal portion 104a is near a thrombus and / or in contact with a thrombus, the suction mechanism 140 may be activated to reduce (e.g., lower) the pressure within the distal portion 104a. For example, the suction mechanism 140 may be a Venturi vacuum pump, in which, as is known to those skilled in the art, a pumped fluid (e.g., water) is passed through the pump to create a vacuum in the side port. The pumped fluid and aspirated material may be recovered in the container 142. Optionally, the recovered fluid may be filtered and reused to keep the pump running.

[0032]

[0041] The amount of vacuum pressure applied by the suction mechanism 140 can be selected to effectively aspirate the thrombus through the length of the elongated catheter 102 (e.g., sufficiently high). The vacuum pressure can further be selected to ensure that most or all of the fluid 116 produced by the fluid delivery mechanism (e.g., fluid delivery mechanism 114 in Figure 1D or fluid delivery mechanism 124 in Figure 1E) is aspirated and does not accumulate in the patient's bloodstream (e.g., sufficiently high). However, the vacuum pressure can further be selected to ensure that the suction mechanism 140 aspirates little or no blood from the patient's body (e.g., sufficiently low). In some embodiments, the system 100 includes one or more sensors (e.g., pressure sensors, flow sensors, etc. (not shown)) configured to monitor the flow, volume, and / or pressure of fluid moving into or out of the patient's bloodstream. Based on sensor data, the operating parameters of the fluid delivery mechanism (e.g., fluid delivery mechanism 114 in Figure 1D or fluid delivery mechanism 124 in Figure 1E) and / or the suction mechanism 140 can be adjusted to increase or decrease the amount of fluid flowing into and / or out of the patient's bloodstream.

[0033]

[0042] In some embodiments, system 100 has an expandable housing. The expandable housing may comprise, for example, an expandable scaffold or frame, an inflatable shroud, or a balloon. In some embodiments, system 100 has a plurality of imaging elements and / or a plurality of illumination elements. In some embodiments, one or more imaging elements and / or illumination elements are housed within the expandable housing. The expandable housing may be at least partially transparent to the light produced by the illumination elements and / or the light detected by the imaging elements. The inflatable shroud may be positioned on the distal portion of an elongated catheter (e.g., 104a). In some embodiments, the inflatable shroud at least partially (e.g., completely) surrounds the chamber 109. The inflatable shroud may be expandable by filling it with a fluid or gas. For example, the inflatable shroud may be expanded with brine, oil, CO2, and / or a substantially inert gas. In some embodiments, the suction fluid and the fluid filling the inflatable shroud are the same. In some embodiments, the inflatable shroud is reversibly adjustable from a first folded configuration to a second expanded configuration. In some embodiments, the inflatable shroud can be folded so as to change axially, where the first axial portion of the inflatable shroud folds at a different time than the second axial portion of the inflatable shroud. For example, the inflatable shroud can be folded from distal to proximal (e.g., foldable distally). In some embodiments, the inflatable shroud can be folded from proximal to distal. Advantageously, by folding the inflatable shroud to change axially, a) fragmentation of the thrombus and / or b) initiation of movement of the thrombus and / or thrombus fragments proximal to the thrombus can be facilitated. In some embodiments, fluid delivery openings (e.g., 129a-b) supported by the inflatable shroud can be guided to deform into a selected geometry and / or configuration by the inflation of the inflatable shroud (e.g., targeted).For example, the angle at which one or more fluid flows are guided toward the thrombus may be selected or modified according to the pressure required to inflate the inflatable shroud. Advantageously, a folded configuration can improve the translation of the catheter during advancement and retraction, while an expanded configuration can improve the illumination / imaging pathway during material removal.

[0034]

[0043] Figure 1F is similar to the embodiments depicted in Figures 1D and 1E, but further includes multiple imaging elements 108 (e.g., cameras such as CCD or CMOS cameras) and / or illumination devices 115 located within an expandable housing 117 in the distal portion 104a of the elongated catheter 102. The imaging elements and illumination devices may be collectively referred to as “visualization elements”. The expandable housing 117 substantially encloses the expandable chamber 109. The multiple imaging elements 108 and / or illumination devices 115 may be 1) operably connected to the distal end of the expandable housing 117, 2) operably connected to the external surface of the expandable housing 117, 3) operably connected to the internal surface of the expandable housing 117, and / or 4) embedded within the wall of the expandable housing 117. The multiple imaging elements 108 and / or illumination devices 115 may be arranged in a variety of ways. For example, this arrangement may be a) single, b) paired, c) triple, d) quadruple, e) quintuple, and / or f) sextuple. In some embodiments, at least one imaging element and / or illumination device 115 is maneuverable (in other words, movable). In some embodiments, the expandable configuration of the expandable housing 117 can advantageously assist in fixing the outer peripheral portion of the distal portion 104a to the lumen wall (e.g., forming a seal with the lumen wall). In some embodiments, the expandable housing 117 has a generally annular cross-section (e.g., the cross-section of modified form 1F-A). In some embodiments, the expandable housing 117 has a radially outermost wall that is generally undulating (e.g., the cross-section of modified form 1F-B). The undulating outermost wall region 121, which is radially farther from the central axis of the catheter, can contact the vessel wall, while the region 123, which is radially closer to the central axis, can provide a path for fluid flow. In some embodiments, maintaining fluid flow can advantageously facilitate the continuation of the patient's perfusion state during thrombectomy.

[0035]

[0044] In some embodiments, at least one visualization element is maneuverable. Maneuvering may be achieved by an inflatable channel. In some embodiments, the inflatable channel for maneuvering is the same as (or forms part of) the inflatable channel for inflating the expandable housing 117. In some embodiments, a separate (e.g., dedicated) inflatable channel is provided for maneuvering. In various embodiments, any gas or fluid described herein for inflating the expandable shroud may be used for the inflatable channel for maneuvering. In some embodiments, the maneuvering of the visualization element may be responsive to pressure (e.g., passively), such as the pressure within the expandable shroud 117. In some embodiments, the maneuvering of the visualization element may be via mechanical means, such as a wire.

[0036]

[0045] In some embodiments, the system 100 can capture, macerate, and / or fragment a thrombus using irrigation alone. Figure 1G is similar to the embodiment depicted in Figure 1E, but without the capture element 110. In the embodiment of Figure 1G, the openings 139a-b of the fluid delivery mechanism 124 are arranged to guide fluid flows 136a-b along a given path of movement. In some embodiments, at least two openings 139a-b (e.g., fluid ports) are arranged to guide the fluid flows so that they intersect each other (e.g., at a fluid intersection point 137). Advantageously, the intersecting fluid flows may collide, allowing a greater force to be applied to the portion of the thrombus near the point of collision. As used herein, “intersection” does not necessarily mean a physical intersection. Intersection is intended to be its most common sense. Intersection can include the guidance of fluids toward a common area or common volume rather than toward a specific point. In addition, or by alternative means, the intersection or crossing region may be within or behind the thrombus, resulting in the fluid flow striking the target thrombus before it can physically intersect with each other. A greater force may be based on the force exerted by a similar fluid flow that contacts the thrombus alone, i.e., does not collide with the fluid flow. In some embodiments, the openings 139a-b are positioned so that the fluid flow is directed at least partially proximal (e.g., posteriorly). In some embodiments, the openings 139a-b are positioned so that the fluid flow is directed at an angle that is either a) substantially perpendicular to the central axis 141 of the chamber 109, or b) at least partially distal (e.g., in the direction of the distal opening). Although the intersection 137 is depicted near the central region of the expandable chamber 109, it will be recognized that the intersection of the fluid flow can be located at a variety of locations within the chamber 109. The forces generated by the fluid flow 136a-b at the intersection 137 may be large enough to 1) macerate / fragment the thrombus, and 2) facilitate the expulsion of the thrombus fragments proximal along the catheter 102.

[0037]

[0046] System 100 may have a console 130 (best seen schematically in Figure 1B) having various components for controlling the operation of System 100. For example, console 130 may have a suction mechanism 140 which may be connected to a recovery container 142. Console 130 may further have a fluid source 144 fluid-connected to a fluid delivery mechanism (e.g., fluid delivery mechanism 114 in Figure 1D or fluid delivery mechanism 124 in Figure 1E). Fluid source 144 may be configured to pressurize the fluid contained within (e.g., saline solution) to a pressure high enough to macerate a thrombus. Console 130 may optionally have, or be connected to, a gas source (not shown) fluid-connected to a gas delivery mechanism (not shown) configured to inflate one or more components of the system.

[0038]

[0047] The console 130 may further include a control device 146 for controlling the movement of the capture element 110 (e.g., rotational and / or longitudinal movement). In some embodiments, the console 130 further includes an actuation mechanism (e.g., a motor, a cam, etc. (not shown)) for actinguating the movement of the capture element 110. Alternatively, the actuation mechanism may be located in, at, or near the proximal portion 104b of the elongated catheter 102, and the control device 146 may be operably coupled to the actuation mechanism to control its operation.

[0039]

[0048] Console 130 may have a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and / or firmware that drives the operation of System 100 or components of System 100; memory such as RAM or ROM for storing data and / or software / firmware; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, Wi-Fi, or other protocols as will be understood by those skilled in the art from the description herein; a display, monitor, or other user interface element; and / or other electronic components 148 for powering System 100 and / or controlling the operation of System 100, such as one or more sensors. For example, the electronic components 148 may be configured to control the operation of the capture element 110, a fluid delivery mechanism (e.g., fluid delivery mechanism 114 in Figure 1D, or fluid delivery mechanism 124 in Figure 1E), one or more sensors (e.g., sensor 113, imaging element 108 in Figure 1C), a suction mechanism 140, a fluid source 144, and / or a control device 146.

[0040]

[0049] The console 130 may be connected to the proximal portion 104b of the elongated catheter 102. In some embodiments, the console 130 is connected to the proximal portion 104b via a hub or adapter 150. The hub 150 may have several different connectors for operably connecting various components of the console 130 to components of the elongated catheter 102. For example, the hub 150 may have a vacuum connection between the suction mechanism 140 and the lumen 106. The hub 150 may further have a fluid connection between the fluid source 144 and the fluid delivery mechanism (e.g., the fluid delivery mechanism 114 in Figure 1D, or the fluid delivery mechanism 124 in Figure 1E). In some embodiments, the hub 150 has one or more components (e.g., tubes, connectors, fittings, etc.) configured to withstand the large vacuum pressure and / or fluid pressure created by the suction mechanism 140 and the fluid source 144, respectively. The hub 150 may further have an electronic connection between the control device 146 and the actuation mechanism for the capture element 110. The hub 150 can further electrically connect the electronic components 148 of the console 130 to other components of the system 100 (e.g., sensors).

[0041]

[0050] In some embodiments, the system 100 is further configured to deliver one or more thrombolytic agents, such as tissue plasminogen activator, streptokinase, urokinase, or derivatives or combinations thereof. The thrombolytic agent may be delivered via an elongated catheter 102 (e.g., through the lumen 106, a separate channel, or an opening in the distal portion 104a) before, simultaneously with, or after capture and / or maceration of the thrombus. The thrombolytic agent may be delivered locally to the site of the thrombus in the patient's blood vessels and / or into an expandable chamber 109 to facilitate maceration of the thrombus.

[0042]

[0051] Those skilled in the art will recognize from this disclosure that various components of the thrombectomy system described above can be omitted without departing from the scope of the art. As discussed above, for example, the art can be used and / or modified for the removal of other types of embolus that may occlude blood vessels, such as fat, tissue, or foreign bodies. Furthermore, while some embodiments of this specification are described in the context of removing thrombi from pulmonary arteries, the disclosed art can also be applied to the removal of thrombi and / or embolus from other parts of the vascular system (e.g., neurovascular, coronary, or peripheral applications). Similarly, additional components not explicitly described above can be added to the thrombectomy system without departing from the scope of the art. Thus, the system described herein is not limited to the configurations explicitly shown, but rather encompasses variations and modifications of the system described. Examples

[0052] Multiple embodiments of this technology are described in the following examples.

[0043] 1. A method for removing a blood clot from a patient's blood vessels, The steps include introducing the distal end of a long, slender catheter to the location of the thrombus in the blood vessel, A step of drawing at least a portion of the thrombus toward the distal part, A step of guiding fluid toward the thrombus from at least two different points and Methods that include...

[0044] 2. The method of Example 1, wherein the step of introducing the distal portion is to introduce it into a blood vessel in a low-profile configuration, and the method further includes the step of extending the distal portion into an expanded configuration.

[0045] 3. The method of Example 2, wherein the retraction step involves retracting the distal portion using a capture element, and the method further includes a step of extending the capture element from a low-profile configuration to an expanded configuration.

[0046] 4. Any one of the methods in Examples 1 to 3, wherein the retraction step involves retracting the distal portion using a rotatable screw or auger. 5. Steps to detect the properties of the blood clot, A step of adjusting the rotational speed of a rotatable screw or auger based on the sensed properties, The method of Example 4 further includes the method of Example 4.

[0047] 6. Any one of Examples 1 to 5, further comprising the step of applying fluid through one or more nozzles in the distal portion to form at least two fluid flows. 7. The method of Example 6, further comprising the step of inducing at least two fluid flows along the intersecting paths.

[0048] 8. Any one of the methods from Examples 1 to 6, wherein the blood vessels include the pulmonary artery. 9. Any one of Examples 1 to 8, further comprising the step of imaging the thrombus using an imaging element located in the distal portion before the retraction step.

[0049] 10. The method of Example 9, wherein the imaging step is via a fluid path. 11. The method of Example 10, further comprising the step of forming a fluid path using fluids induced from at least two different points.

[0050] 12. Any one of Examples 1 to 11, further comprising the step of aspirating a thrombus fragment into the proximal portion of an elongated catheter. 13. Any one of Examples 1 to 11, further comprising the step of engaging the distal portion of the thrombus in order to form a seal against the thrombus.

[0051] 14. A system for removing blood clots from a patient's blood vessels, It comprises a long, slender catheter device, a suction mechanism, and a fluid delivery mechanism, and the long, slender catheter device is A distal portion configured to be positioned within the patient's blood vessel, comprising at least two fluid ports, the at least two fluid ports configured to guide their respective fluid flows along their respective intersecting paths, and A proximal portion configured to be positioned outside the patient, Lumen extending between the distal and proximal portions The suction mechanism has, Positioned outside the patient and fluid-connected to the lumen, the fluid delivery mechanism is configured to reduce pressure in the distal portion in order to (a) engage the thrombus and / or (b) pull the thrombus and / or thrombus fragments proximal, A system configured to supply fluid to at least two fluid ports through an elongated catheter device.

[0052] 15. The system of Embodiment 14, wherein the fluid delivery mechanism comprises at least two structures configured to be fluidly connected to at least two fluid ports. 16. The system of Embodiment 14, wherein at least two fluid ports are arranged so as to intersect within an expandable housing in the distal portion when each fluid flow is delivered.

[0053] 17. The system of Embodiment 14, wherein at least one of the at least two fluid ports is positioned to deliver its respective fluid jet to the proximal side. 18. The system of Example 14, wherein at least one fluid port is positioned to deliver each fluid jet toward the central axis of the elongated catheter device.

[0054] 19. The system of Embodiment 14, further comprising imaging elements and / or illumination sources disposed within an expandable housing located in the distal portion. 20. The system of Example 19, wherein the fluid delivery mechanism is further configured to apply fluid to provide an optical path for imaging elements and / or illumination sources.

[0055] 21. A system for removing blood clots from a patient's blood vessels, An elongated catheter having a distal portion configured to be positioned within the patient's blood vessels, a proximal portion configured to be positioned outside the patient, and a lumen extending between them, A capture element located in the distal portion, configured to engage with the thrombus, A fluid delivery mechanism located within a lumen, configured to apply fluid to at least partially fragment a thrombus, A suction mechanism is fluidly connected to the lumen and configured to aspirate fragmented thrombi. A system that includes these features.

[0056] 22. The system of Embodiment 21, wherein the capture element comprises a rotatable screw or auger. 23. The system of Example 21 or Example 22, wherein the capture element is positioned at least partially within the lumen.

[0057] 24. Any one of the systems from Examples 21 to 23, wherein the capture element is generally conical in cross-sectional area in the axial direction. 25. A system from any one of Examples 21 to 23, wherein the capture element is expandable.

[0058] 26. The system of Example 25, wherein at least a portion of the capture element is inflatable. 27. Any one of the systems from Examples 21 to 26, wherein the capture element is configured to move toward the distal portion to draw the thrombus into the lumen.

[0059] 28. Any one of the systems from Examples 21 to 26, wherein the capturing element comprises a sensing element configured to measure the properties of a thrombus. 29. Any one of the systems from Examples 21 to 28, wherein the fluid delivery mechanism is located proximal to the capture element.

[0060] 30. Any one of the systems from Examples 21 to 29, wherein the fluid is pressurized brine. 31. Any one of the systems from Examples 21 to 30, wherein the distal portion has an expandable chamber that is deformable between a low-profile configuration and an expanded configuration.

[0061] 32. The system of Example 31, wherein the elongated catheter has an intermediate portion between the proximal and distal portions, and the expandable chamber has a cross-sectional dimension greater than the cross-sectional dimension of the intermediate portion when in the deployed configuration.

[0062] 33. The system of Embodiment 31, wherein the expandable chamber has cross-sectional dimensions that vary along its axial length. 34. The system of Example 33, wherein the expandable chamber is generally funnel-shaped.

[0063] 35. The system of Embodiment 31, wherein the expandable chamber comprises at least one wall that is expandable by expansion with a fluid or gas. 36. Any one of the systems from Examples 31 to 35, wherein the capture element is configured to draw the thrombus into an expandable chamber.

[0064] 37. Any one of the systems from Examples 31 to 36, wherein the fluid delivery mechanism is located within an expandable chamber. 38. Any one of the systems from Examples 21 to 37, further comprising an imaging element located in the distal portion, configured to visualize at least a portion of the thrombus.

[0065] 39. The system of Example 38, wherein the fluid delivery mechanism is further configured to apply fluid to provide an optical path for imaging elements. 40. The system of Example 21, wherein the fluid is optically transparent in the visible spectrum.

[0066] 41. Any one of the systems from Examples 38 to 40, further comprising an illumination source located in the distal portion. 42. The system of Embodiment 41, wherein at least one of the imaging element and the illumination source is operable.

[0067] 43. The system of Example 42, further comprising an inflatable channel having a distal portion connected to at least one of an imaging element and an illumination source, and a proximal portion fluidly connected to a fluid delivery mechanism.

[0068] 44. Any one of the systems from Examples 21 to 43, further comprising a console operably connected to the proximal portion of an elongated catheter. 45. The system of Embodiment 44, wherein the console is configured to control one or more of the imaging element, the capture element, the fluid delivery mechanism, or the suction mechanism.

[0069] 46. ​​A method for treating a patient, The steps include delivering the distal portion of the catheter intravascularly to a location adjacent to the thrombus in the patient's vascular system, The steps include generating image data of the vascular system and / or thrombus via an imaging element carried by the distal portion of the catheter, A step of drawing at least a portion of the thrombus toward the distal part, The steps include: delivering a fluid having a selected pressure and flow rate through one or more openings in the distal portion of a catheter in order to at least partially fragment a thrombus; Includes, The selected pressure and / or selected flow rate are at least partially based on image data. method.

[0070] 47. The method of Example 46, wherein the step of generating image data includes the step of generating image data before at least partially fragmenting the thrombus, during at least partially fragmenting the thrombus, and / or after at least partially fragmenting the thrombus.

[0071] 48. The method of Example 46, wherein the image data includes information about the type and / or nature of the thrombus, and the selected pressure and / or selected flow rate is at least partially based on the type and / or nature of the thrombus.

[0072] 49. A method for treating a patient, The steps include delivering the distal portion of the catheter to the vicinity of the thrombus in the patient's vascular system, A step of generating image data of a thrombus via an imaging element supported by the distal portion of a catheter, The step involves engaging the thrombus with a capture element located on the distal portion of the catheter, wherein one or more characteristics of the capture element are at least partially based on image data of the thrombus. Methods that include...

[0073] 50. The method of Example 49, wherein the step of generating image data includes the step of generating data relating to the type of thrombus. 51. The method of Example 49, wherein one or more properties of the capture element include screw size, screw pitch, and / or durometer. conclusion

[0053] The above detailed description of embodiments of the Art is not intended to be comprehensive or to limit the Art to the exact forms disclosed above. Specific embodiments of the Art and examples for the Art are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the Art, as will be recognized to those skilled in the art. For example, the steps are presented in a given order, but alternative embodiments may carry out the steps in a different order. The various embodiments described herein may be combined to provide another embodiment.

[0074]

[0054] While specific embodiments of the Art are described herein for illustrative purposes, it will be recognized above that well-known structures and functions are not shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the Art. Where the context allows, singular or plural terms may also include plural or singular terms, respectively.

[0075]

[0055] Unless the context explicitly requires a different meaning, throughout this description and the examples, words such as “comprise” and “comprising” should be interpreted as comprehensive, not exclusive, and including, i.e., “not limited, but including.” As used herein, the terms “connected,” “linked,” or variations thereof mean any direct or indirect connection or link between two or more elements, and the linkage of connections between these elements may be physical, logical, or a combination thereof. In addition, as used herein, the words and synonyms “in this specification,” “above,” “below” refer to the entire application and not to any particular part thereof. Where the context allows, words in the above detailed description that use singular or plural may also include plural or singular, respectively. As used herein, the phrase “and / or,” such as “A and / or B,” means A only, B only, and A and B. In addition, the term “comprising” is used throughout to mean including at least the features described, and therefore does not exclude a greater number of the same features and / or other features of additional types. Furthermore, while certain embodiments have been described herein for illustrative purposes, it will be recognized that a variety of modifications can be made without departing from the Art. Furthermore, while advantages related to some embodiments of the Art are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are necessarily required to exhibit such advantages in order to be within the scope of the Art. Accordingly, this disclosure and related art may also encompass other embodiments not explicitly shown or described herein.

Claims

1. A system for removing blood clots from a patient's blood vessels, The device comprises an elongated catheter device, a suction mechanism, and a fluid delivery mechanism, and the elongated catheter device is A chamber having an outer surface defining a distal opening in a distal portion configured to be positioned within the blood vessel of the patient, wherein the outer surface of the chamber surrounds at least a first fluid port and a second fluid port. The chamber comprises a first fluid port having a first axis, a second fluid port having a second axis, the first axis physically intersecting the second axis at a fluid intersection within the chamber, and the first and second fluid ports configured to direct their respective fluid flows along the first and second axes such that they collide with each other at the fluid intersection at an angle substantially perpendicular to the central axis of the distal portion. A proximal portion configured to be positioned outside the patient, A lumen extending between the distal portion and the proximal portion, The suction mechanism has, Positioned outside the patient and fluidly connected to the lumen, the fluid delivery mechanism is configured to reduce pressure in the distal portion in order to (a) engage the thrombus and / or (b) pull the thrombus and / or thrombus fragments proximal, and the fluid delivery mechanism is A system configured to supply fluid to the at least two fluid ports through the elongated catheter device so as to form fluid flows along each of the physically intersecting paths within the lumen in order to cleave the thrombus.

2. The system according to claim 1, wherein the fluid delivery mechanism comprises at least two structures configured to be fluidly connected to at least the first fluid port and the second fluid port.

3. The system according to claim 1, wherein at least one of the at least first fluid port and the second fluid port is arranged to deliver the fluid flow to the proximal side.

4. The system according to claim 1, wherein the at least one fluid port is arranged to deliver the fluid flow toward the central axis of the elongated catheter device.

5. The system according to claim 1, further comprising an imaging element and / or illumination source disposed within the expandable chamber located in the distal portion.

6. The system according to claim 5, wherein the fluid delivery mechanism is further configured to deliver an optically transparent fluid that forms an optical path for imaging the thrombus by the imaging element.

7. The system according to claim 1, wherein the distal portion comprises an expandable funnel-shaped chamber configured to engage the thrombus when the suction mechanism reduces the pressure in the distal portion.

8. The system according to claim 1, wherein the fluid flow is guided substantially perpendicular to the longitudinal axis of the lumen.

Images