WO2025050040A1 - Thrombus removal systems and methods - Google Patents

Abstract

Thrombectomy systems and methods are provided for acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time, deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time, removing at least one occlusion or partial occlusion in the pulmonary artery branch, after removing the at least one occlusion or partial occlusion, acquiring a post-treatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time, deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time, and providing a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

Description

THROMBUS REMOVAL SYSTEMS AND METHODS

PRIORITY CLAIM

[0001] This patent application claims priority to U.S. provisional patent application no. 63/579,679, titled “INTRODUCER CATHETER SYSTEMS AND METHODS,” filed on August 30, 2024, which is incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] The present technology generally relates to medical devices and, in particular, to systems including aspiration and fluid delivery mechanisms and associated methods for removing a thrombus from a mammalian blood vessel and measuring or estimating hemodynamic parameters for clinical decision making during and after the methods.

BACKGROUND

[0004] Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms (PEs) typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs, relodging into the pulmonary artery and raising pulmonary artery and right ventricular pressures.

Anti coagulation therapy is the current standard of care for treating pulmonary embolisms, but may not be effective in some patients, requiring mechanical intervention. Hemodynamic data such as pressures in the pulmonary artery may be readily measured during thrombectomy. [0005] Problematically, changes in right heart strain and the magnitude of reduction in pulmonary artery pressure after thrombectomy and afterload relief may be variable among patients and there are not clear mechanisms in place for assessing treatment efficiency and outcomes based on the hemodynamic data that may be gathered during and after thrombectomy methods. [0006] What is needed are systems and methods for assessing treatment outcomes including treatment progress and efficiency during thrombectomy procedures based on patient-specific hemodynamic data gathered during the procedures.

SUMMARY OF THE DISCLOSURE

[0007] A method for patient assessment during and/or following thrombotic treatment is provided, comprising: advancing a thrombectomy catheter system into a pulmonary artery branch of a subject; acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time; removing at least one occlusion or partial occlusion in the pulmonary artery branch with the thrombectomy catheter system; after removing the at least one occlusion or partial occlusion, acquiring a post-treatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time; and providing a signal recommending a CTEPH procedure based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

[0008] In some aspects, the baseline hemodynamics assessment comprises a baseline dP/dt versus pressure curve and wherein the post-treatment hemodynamics assessment comprises a post-treatment dP/dt versus pressure curve.

[0009] In other aspects, the post-treatment hemodynamics assessment is derived while the thrombectomy catheter system is within the subject.

[0010] In some aspects, the post-treatment hemodynamics assessment is derived within 30 minutes of removing the at least one occlusion or partial occlusion.

[0011] In one aspect, the post-treatment hemodynamics assessment is derived within 60 minutes of removing the at least one occlusion or partial occlusion.

[0012] In additional aspects, deriving the baseline hemodynamics assessment comprises generating a baseline dP/dt versus pressure curve; and deriving the post-treatment hemodynamics assessment comprises generating a post-treatment dP/dt versus pressure curve.

[0013] In one aspect, the correlation is based on a change in amplitude in a region of the post-treatment dP/dt versus pressure curve representing diastolic drop. [0014] In another aspect, the correlation is based on a shift in mean pressure between the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve.

[0015] In additional aspects, the correlation is based on a change in maximum baseline dP/dt and maximum post-treatment dP/dt.

[0016] In one aspect, the correlation is based on a change in a maximum baseline dP/dt delta and a maximum post-treatment dP/dt delta.

[0017] In some aspects, the correlation is based on a shift in a mean pressure of the baseline dP/dt versus pressure curve and a mean pressure of the post-treatment dP/dt versus pressure curve

[0018] In other aspects, the correlation is based on a distribution of pressures at a given value of dP/dt (e.g., zero) of the baseline and post-treatment dP/dt versus pressure curves.

[0019] In some aspects, the distribution is associated with a systolic phase of the subject’s cardiac cycle.

[0020] In one aspect, the correlation is based on a post-treatment area within the posttreatment dP/dt versus pressure curve relative to a baseline area within the baseline dP/dt versus pressure curve.

[0021] In another aspect, the method includes displaying the signal to a user of the thrombectomy catheter system.

[0022] In other aspects, the method includes displaying the baseline hemodynamics assessment to a user of the thrombectomy catheter system.

[0023] In other aspects, the method includes displaying the post-treatment hemodynamics assessment to a user of the thrombectomy catheter system.

[0024] In some aspects, the method includes displaying the baseline hemodynamics assessment and the post-treatment hemodynamics assessment to a user of the thrombectomy catheter system.

[0025] In additional aspects, the method includes displaying the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0026] In some aspects, the method includes displaying the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0027] In additional aspects, the method includes displaying the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0028] In some aspects, the method includes displaying at least a portion of the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system. [0029] In additional aspects, the method includes displaying at least a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0030] In additional aspects, the method includes displaying at least a portion of the baseline dP/dt versus pressure curve and at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0031] In another aspect, the method includes displaying at least one numerical representation of a portion of the baseline dP/dt versus pressure curve or a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0032] In some aspects, a thrombectomy system is provided, comprising: an introducer sheath; a thrombectomy device adapted to be inserted into the introducer sheath to place the thrombectomy device within a pulmonary artery of a subject, the thrombectomy device including an aspiration lumen coupled to an aspiration source; a pressure sensor disposed on the introducer sheath and/or the thrombectomy device and configured to continuously or periodically measure a pulmonary artery pressure and/or a change in the pulmonary artery pressure over time for the subject; one or more processors configured to derive a baseline hemodynamics assessment from the measured pulmonary artery pressure and change in pulmonary artery pressure over time prior to removing an occlusion or partial occlusion from the subject, the one or more processors being configured to derive a post-treatment hemodynamics assessment from the measured pulmonary artery pressure and change in pulmonary artery pressure over time after removing the occlusion or partial occlusion from the subject, the one or more processors being further configured to provide a signal recommending a CTEPH procedure based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

[0033] In some aspects, the one or more processors are configured to display the signal on the display.

[0034] In one aspect, the signal comprises a dP/dt versus pressure curve.

[0035] In other aspects, the signal comprises a data representation of one or more components of a dp/dt versus pressure curve.

[0036] In some aspects, the baseline hemodynamics assessment comprises a baseline dP/dt versus pressure curve and wherein the post-treatment hemodynamics assessment comprises a post-treatment dP/dt versus pressure curve.

[0037] In some aspects, the one or more processors are configured to derive the posttreatment hemodynamics assessment while the thrombectomy catheter system is within the subject. [0038] In other aspects, the one or more processors are configured to derive the posttreatment hemodynamics assessment within 30 minutes of removing the at least one occlusion or partial occlusion.

[0039] In some aspects, the one or more processors are configured to derive the posttreatment hemodynamics assessment within 60 minutes of removing the at least one occlusion or partial occlusion.

[0040] In another aspect, the one or more processors are configured to derive the baseline hemodynamics assessment comprises by generating a baseline dP/dt versus pressure curve; and the one or more processors are configured to derive the post-treatment hemodynamics assessment comprises by generating a post-treatment dP/dt versus pressure curve.

[0041] In one aspect, the correlation is based on a change in amplitude in a region of the post-treatment dP/dt versus pressure curve representing diastolic drop.

[0042] In another aspect, the correlation is based on a shift in mean pressure between the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve.

[0043] In other aspects, the correlation is based on a change in maximum baseline dP/dt and maximum post-treatment dP/dt.

[0044] In one aspect, the correlation is based on a change in a maximum baseline dP/dt delta and a maximum post-treatment dP/dt delta.

[0045] In other aspects, the correlation is based on a shift in a mean pressure of the baseline dP/dt versus pressure curve and a mean pressure of the post-treatment dP/dt versus pressure curve.

[0046] In additional aspects, the correlation is based on a distribution of pressures at a given value of dP/dt (e.g., zero) of the baseline and post-treatment dP/dt versus pressure curves.

[0047] In one aspect, the distribution is associated with a systolic phase of the subject’s cardiac cycle.

[0048] In additional aspects, the correlation is based on a post-treatment area within the post-treatment dP/dt versus pressure curve relative to a baseline area within the baseline dP/dt versus pressure curve.

[0049] In another aspect, the signal comprises the baseline hemodynamics assessment to a user of the thrombectomy device.

[0050] In some aspects, the signal comprises the post-treatment hemodynamics assessment to a user of the thrombectomy device.

[0051] In other aspects, the signal comprises the baseline hemodynamics assessment and the post-treatment hemodynamics assessment to a user of the thrombectomy device. [0052] In some aspects, the signal comprises the baseline dP/dt versus pressure curve to a user of the thrombectomy device.

[0053] In an additional aspect, the signal comprises the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0054] In one aspect, the signal comprises the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve to a user of the thrombectomy device.

[0055] In another aspect, the signal comprises at least a portion of the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0056] In some aspects, the signal comprises at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0057] In other aspects, the signal comprises at least a portion of the baseline dP/dt versus pressure curve and at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0058] In one aspect, the signal comprises at least one numerical representation of a portion of the baseline dP/dt versus pressure curve or a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

[0059] A method for patient assessment following thrombotic treatment is provided, comprising: advancing a thrombectomy system into a pulmonary artery of a subject; periodically or continuously measuring one or more of: pulmonary artery pressure and a change in the pulmonary artery pressure over a change in time with the thrombectomy system; advancing a P-V catheter into a right ventricle of the subject; periodically or continuously measuring right ventricular pressure, and a change in the right ventricular pressure over the change in time; initiating a thrombectomy procedure with the thrombectomy system; and determining a treatment effectiveness or treatment completion state based on a correlation between a change in the measured pulmonary artery pressure and the measured change in right ventricular pressure over the change in time.

[0060] In one aspect, the method further comprises providing an output of the system state to a user of the thrombectomy system, wherein the output provides guidance for clinical decision making based on assessment of one or more of: (i) original thrombus size and extent of obstruction, (ii) original or present thrombus location, (iii) extent of clot removed, (iv) systemic damage from the thrombus, (v) patient prognosis, (vi) a need for medical monitoring, (vii) recovery and treatment outcomes including extent of reperfusion, inflammatory responses, and reperfusion injury, and (viii) arterial compliance. [0061] In some aspects, the method comprises performing a pressure-volume loop analysis with the right ventricular pressure, right ventricular conductance, and/or a right ventricular admittance.

[0062] In some aspects, the measuring and correlation is further based on a relationship between one or more of: (i) right ventricular strain/function, (ii) stroke volume, (iii) ventilation, (iv) perfusion, (v) indicators of elastin quantity and quality, (vi) imaging including fluoroscopy and CT pulmonary angiogram, (vii) flow rates, (viii) oxygenation, (ix) pH, and (x) shock state, including obstructive shock.

[0063] In one aspect, the method includes determining the system state algorithmically based on a change in onboard catheter data exceeding a predetermined threshold.

[0064] In another aspect, the method comprises determining the system state with a machine learning model.

[0065] In some aspects, the machine learning model is trained by tagging the system state with one or more training data sets.

[0066] In another aspect, the system state comprises a label that describes clot engagement.

[0067] In one aspect, the label is selected from the group consisting of clear, partially engaged, and engaged.

[0068] A thrombectomy system is provided, comprising: an introducer sheath; a thrombectomy device adapted to be inserted into the introducer sheath to place the thrombectomy device within a pulmonary artery of a subject, the thrombectomy device including an aspiration lumen coupled to an aspiration source; a pressure sensor disposed on the introducer sheath and/or the thrombectomy device and configured to continuously or periodically measure a pulmonary artery pressure and/or a change in the pulmonary artery pressure over time of the subject; one or more processors; a memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer-implemented method comprising: acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time; removing at least one occlusion or partial occlusion in the pulmonary artery branch with the thrombectomy catheter system; after removing the at least one occlusion or partial occlusion, acquiring a post-treatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time; and providing a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

[0069] In some aspects, a method of performing a CTEPH procedure is provided, comprising advancing a sheath or introducer catheter into the pulmonary vasculature of a patient, navigating a distal end of the sheath to a treatment location by steering the distal end, and introducing a therapeutic through the sheath to the treatment location.

[0070] In some aspects, the therapeutic includes a balloon angioplasty catheter.

[0071] In any of the methods described herein the method can comprise continuously or periodically obtaining a pressure measurement within the pulmonary artery with the sheath. [0072] In some aspects, the method comprises establishing a baseline pressure of the pulmonary artery, advancing a balloon angioplasty catheter out of the sheath, expanding the balloon angioplasty catheter to treat a target location within the pulmonary artery, and identifying when the pressure measurement within the pulmonary artery falls below a treatment threshold.

[0073] In some aspects, the baseline pressure comprises 14 +/- 3 mmHg.

[0074] In other aspects, the treatment threshold is selected from the group comprising 8, 9, 10, 11, 12, 13, 14, 15, and 16 mmHg.

[0075] In one aspect, a CTEPH treatment system is provided, comprising: an elongate, steerable introducer catheter shaft adapted for insertion into a pulmonary artery of a subject, at least one pressure sensor disposed on the catheter shaft, the pressure sensor being configured to continuously or periodically measure a pressure within the pulmonary artery, and a balloon angioplasty catheter insertable into a lumen of the catheter shaft, the balloon angioplasty catheter being adapted to expand within the pulmonary artery to treat a target location within the pulmonary artery.

[0076] A method of performing a CTEPH procedure is provided, comprising advancing an introducer catheter into a pulmonary artery of a subject, continuously or periodically obtaining a pressure measurement within the pulmonary artery with the introducer catheter, establishing a baseline pressure of the pulmonary artery, advancing a balloon angioplasty catheter out of the introducer catheter, expanding the balloon angioplasty catheter to treat a target location within the pulmonary artery, and identifying when the pressure measurement within the pulmonary artery falls below a treatment threshold. [0077] Any of the methods described herein or above can be implemented in the computer implemented method.

BRIEF DESCRIPTION OF THE DRAWINGS

[0078] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0079] FIGS. 1-1L illustrate various views of a portion of a thrombus removal system including a distal portion of an elongated catheter configured in accordance with an embodiment of the present technology.

[0080] FIGS. 2A-2E illustrate plan views of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0081] FIGS. 3A-3H illustrate an elevation view of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0082] FIGS. 4A-4C illustrate various embodiments of a thrombus removal system including a saline source, an aspiration system, and one or more controls for controlling irrigation and/or aspiration of the system.

[0083] FIGS. 5A-5N illustrate a thrombectomy method that can include measuring cardiovascular pressures and performing PV loop analysis.

[0084] FIG. 6A is an example of a pressure vs. rate of change of pressure loop plot pre- PE treatment and post-PE treatment.

[0085] FIG. 6B is an acceleration-deceleration rate of pulmonary artery pressure plot pre- PE treatment and post-PE treatment.

[0086] FIG. 6C is another example of a pressure vs. rate of change of pressure loop plot.

[0087] FIG. 7A is a flow chart depicting a method for patient assessment during and/or following thrombotic treatment.

[0088] FIG. 7B is a flow chart depicting another method for patient assessment following thrombotic treatment.

[0089] FIG. 8 is a system schematic of a thrombus removal system.

[0090] FIG. 9 is an example of a thrombectomy system including a console and a display. [0091] FIGS. 10A-10B illustrate a thrombus removal system including a saline source, an aspiration system, and one or more controls for controlling irrigation and/or aspiration of the system.

[0092] FIGS. 11A-11G illustrate a sequence of advancing a delivery catheter and dilator to a target thrombus location within a patient.

[0093] FIG. 12 is an example of an introducer catheter and a dilator.

DETAILED DESCRIPTION

[0094] This application is related to disclosure in International Application No. PCT/US2021/020915, filed March 4, 2021 (the ‘915 application), and International Application No. PCT/US2022/033024, filed June 10, 2022 (the ‘024 application), and U.S. Provisional Patent Application No. 63/513,531, filed July 13, 2023, the disclosures of which are incorporated by reference herein for all purposes. The ‘915 and ‘024 applications describe general mechanisms for capturing and removing a clot. By example, multiple fluid streams are directed toward the clot to fragment the material.

[0095] The present technology is generally directed to thrombus removal systems and associated methods. A system configured in accordance with an embodiment of the present technology can include, for example, an elongated catheter having a distal portion configured to be positioned within a blood vessel of the patient, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion.

[0096] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to the figures.

[0097] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0098] Reference throughout this specification to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean the stated value plus or minus 10%.

[0099] Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and/or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and/or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, within chambers of the heart, or peripheral applications). Moreover, although some embodiments are discussed in terms of maceration of a thrombus with a fluid, the present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).

[0100] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.

Systems for Thrombus Removal and Treatment Assessment

[0101] As provided above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the systems herein are configured to engage a thrombus in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid streams (e.g., jets) function to cut or macerate thrombus, before, during, and/or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated. As used herein, “thrombus” and “embolism” are used somewhat interchangeably in various respects. Typically a thrombus is a portion of clotted blood that has stopped moving through the vasculature and is lodged or stuck and the emboli is a portion of clotted blood that is moving in the vasculature that can eventually become a thrombus and additionally seed a larger thrombus either by collecting other emboli or blood clotting on the thrombus.

[0102] It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.

[0103] According to embodiments of the present technology, a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and/or urging thrombus to be removed from a proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source). In operation, the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion to the proximal portion.

[0104] According to certain embodiments, there is a thrombectomy system, including: an introducer sheath; a thrombectomy device adapted to be inserted into the introducer sheath to place the thrombectomy device within a pulmonary artery of a subject, the thrombectomy device including an aspiration lumen coupled to an aspiration source; a pressure sensor disposed on the introducer sheath and/or the thrombectomy device and configured to measure a pulmonary artery pressure and a change in the pulmonary artery pressure over a change in time for the subject; one or more processors; and memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer-implemented method including: determining a treatment progress or treatment completion state based on a correlation between the measured pulmonary artery pressure and/or the change in the pulmonary artery pressure over a change in time for the subject.

[0105] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. FIG. 1 A Section A-A illustrates an elevation sectional view of the distal portion. The example section A-A in FIG. 1 A depicts a funnel 20 that is positioned at the distal end of the distal portion 10, the funnel adapted to engage with thrombus and/or a tissue (e.g., vessel) wall to aid in thrombus collection, fragmentation, and/or removal. The funnel can have a variety of shapes and constructions as would be understood by one of skill from the description herein. The example section A-A in FIG. 1 A depicts a double walled thrombus removal device construction having an outer wall/tube 40 and an inner wall/tube 50. An aspiration lumen 55 is formed by the inner wall 50 and is centrally located. A generally annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50. The fluid lumen 45 is adapted for fluid communication with the fluid delivery mechanism. One or more apertures (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system to be in fluid communication with the fluid lumen 45 and an irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., pressurized) fluid toward thrombus that is engaged with the distal portion 10 of the thrombus removal system.

[0106] In various embodiments, the system can have an average flow velocity within the fluid lumen of up to 20 m/s to achieve consistent and successful aspiration of clots. In some embodiments, the fluid source itself can be delivered in a pulsed sequence or a preprogrammed sequence that includes some combination of pulsatile flow and constant flow to deliver fluid to the jets. In these embodiments, while the average pulsed fluid velocity may be up to 20 m/s, the peak fluid velocity in the lumen may be up to 30 m/s or more during the pulsing of the fluid source. In some embodiments, the jets or apertures have an aperture size ranging between 0.005” to 0.020” to avoid undesirable spraying of fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 15 inHg, to remove target clots after they have been macerated or broken up with the jets described above.

[0107] The thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient’s body. It should be understood that while the dimensions of the system may vary depending on the target location, generally similar features and components described herein may be implemented in the thrombus removal system regardless of the application. For example, a thrombus removal system configured to remove pulmonary embolism (PE) from a patient may have an outer wall/tube with a size of approximately 11-13 Fr, or preferably 12 Fr, and an inner wall/tube with a size of 7-9 Fr, or preferably 8 Fr. A deep vein thrombosis (DVT) device, on the other hand, may have an outer wall/tube with a size of approximately 9-11 Fr, or preferably 10 Fr, and an inner wall/tube with a size of 6-9 Fr, or preferably 7.5 Fr. Applications are further provided for ischemic stroke and peripheral embolism applications.

[0108] Section B-B of FIG. IB illustrates in plan view a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Section B-B depicts an outer wall 140, an inner wall 150, an aspiration lumen 155 and a fluid lumen 145. In some embodiments, in cross-section the aspiration lumen 155 is generally circular and the fluid lumen 145 is generally annular in shape (e.g., cross-section 70). It will be appreciated that alternative constructions and/or arrangements of the inner wall 150 and the outer wall 140 produce variations in cross-sectional shape of the aspiration and fluid lumens 155 and 145. For example, the inner wall 150 can be shaped to form an aspiration lumen 155 that, in crosssection, is generally oval, circular, rectilinear, square, pentagonal, or hexagonal. The inner and outer walls 150 and 140 can be shaped and arranged to form a fluid lumen 145 that, in cross-section, is generally crescent-shaped, diamond shaped, or irregularly shaped. For example, referring to FIG. 1C Section B-B, the region between the inner wall 150 and the outer wall 140 can include one or more wall structures 165 that form respective fluid lumens 145 (e.g., as in cross-section 80). The wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi -lumen extrusion that forms a plurality of the wall structures.

[0109] Section B-B of FIGS. 1D-1H illustrate additional examples of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the portion in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. Additionally, the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. The middle wall 170 enables further segmentation of the annular space between the inner wall and outer wall into a plurality of distinct fluid lumens and/or auxiliary lumens. For example, referring to FIG. ID, the middle wall can be generally hexagon shaped, and the annular space can include a plurality of fluid lumens 145a- 141 and a plurality of auxiliary lumens 175a-175f. As shown in FIG. ID, the fluid lumens can be formed by some combination of the outer wall 140 and the middle wall 170, or between the middle wall 170, the inner wall 150, and two of the auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and middle wall 170. However, fluid lumen 145g is formed in the space between middle wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b. Generally, the fluid lumens are configured to carry a flow of fluid such as saline from a saline source of the system to one or more ports/apertures/orifices of the system. The auxiliary lumens can be configured for a number of functions. In some embodiments, the auxiliary lumens can be coupled to the fluid/saline source and to the apertures to be used as additional fluid lumens. In other embodiments, the auxiliary lumens can be configured as steering ports and can include a guide wire or steering wire within the lumen for steering of the thrombus removal system. Additionally, in other embodiments, the auxiliary lumens can be configured to carry electrical, mechanical, or fluid connections to one or more sensors. For example, the system may include one or more electrical, optical, or fluid based sensors disposed along any length of the system. The sensors can be used during therapy to provide feedback for the system (e.g., sensors can be used to detect clogs to initiate a clog removal protocol, or to determine the proper therapy mode based on sensor feedback such as jet pulse sequences, aspiration sequences, and or proper functioning of the system, etc.). The auxiliary ports can therefore be used to connect to the sensors, e.g., by electrical connection, optical connection, mechanical/wire connection, and/or fluid connection. It is also contemplated that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytics or radio-opaque contrast injections to the target tissue site during treatment.

[0110] It should be understood that in some embodiments, all the fluid lumens are fluidly connected to all of the jets or apertures of the thrombus removal device. Therefore, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all jets are activated with a jet of fluid at once. However, it should also be understood that in some embodiments, the fluid lumens are separate or distinct, and these distinct fluid lumens may be fluidly coupled to one or more jets but not to all jets of the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to that subset of jets. This enables additional functionality in the device, in which specific jets can be activated in a user defined or predetermined order.

[OHl] In various embodiments, the fluid pressure is generated at the pump (at the console or handle). The fluid is accelerated as it exits through the ports at the distal end and is directed to the target clot. In this way a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly-effective device for clot removal. Additional details are provided below.

[0112] Section B-B of FIG. IE illustrates another embodiment of the portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiment of FIG. ID, this embodiment also includes a middle wall 170. However, the middle wall in this example is generally square shaped, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example illustrated in section B-B of FIG. IF is similar to that of the embodiment of FIG. IE, however this embodiment includes only fluid lumens 145a-145d. The fluid lumens 145e-145k from the embodiment of FIG. IE are not used as fluid lumens in this embodiment. They can be, for example, empty lumens, vacuum, filled with an insulative material, and/or filled with a radio-opaque material or any other material that may help visualize the thrombus removal system during therapy. The embodiment IF includes the same four auxiliary reports as illustrated and described in the embodiment of FIG. IE. [0113] Section B-B of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. However, this embodiment includes four distinct fluid lumens 145a-145d formed by wall structures 165. As with the embodiment of FIG. 1C, the wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi-lumen extrusion that forms a plurality of the wall structures. As shown, this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or for sensor connections as described above.

[0114] Section B-B of FIG. 1H is another similar embodiment in which the middle wall and outer wall can be used to form fluid lumens 145a and 145b. Auxiliary lumens 175a and 175b can be formed in the space between the middle wall and the inner wall. It should be understood that the middle wall can contact the outer wall to create independent fluid lumens 145a and 145b. However, in other embodiments, it should be understood that the middle wall may not contact the outer wall, which would facilitate a single annular fluid lumen, such as is shown by fluid lumen 145 in Section B-B of FIG. II. In another embodiment, as shown in Section B-B of FIG. 1 J, the inner wall 150 and the outer wall 140 may not be concentric, which facilitates formation of an annular space and/or fluid lumen 145 that is thicker or wider on one side of the device relative to the other side. As shown in FIG. 1 J, a distance between the exemplary outer wall 140 and inner wall at the top (e.g., 12 o’clock) portion of the device is larger than a distance between the outer wall and inner wall at the bottom (e.g., 6 o’clock) portion of the device.

[0115] Section C-C of FIG. IK illustrates in plan view a portion of the thrombus removal system comprising an irrigation manifold 225. Section C-C depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing respective fluid streams 210.

[0116] Detail View 101 of FIG. IL illustrates a section view in elevation of a portion of the irrigation manifold 25 that includes a plurality of ports 230 that are formed within an inner wall 250. In some embodiments, a thickness of one or more walls of the thrombus removal system may be varied along its axial length and/or its circumference. As shown in Detail View 101, inner wall 250 has a first thickness 265 in a region 250 that is proximal to the irrigation manifold 25, and a second thickness 270 in a region 235 that includes the ports 230. In some embodiments, the second thickness 270 is greater than the first thickness 265. The first thickness 265 can correspond to a general wall thickness of the inner wall 50 and/or of the outer wall 40, which can be from about 0.10 mm to about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be from about 0.20 mm to about 0.70 mm, from about 0.70 mm to about 0.90 mm, or from about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned range. The dimension of the second thickness 270 can be selected to provide a fluid path through the ports 230 that produces a generally laminar flow for a fluid stream that is directed therethrough, when the fluid delivery mechanism supplies fluid via the fluid lumen 245 at a typical operating pressure. Such operating pressure can be from about 10 psi to about 60 psi, from about 60 psi to about 100 psi, or from about 100 psi to about 150 psi. The operating pressure of the fluid delivery mechanism can be any value within the aforementioned range of values. In some embodiments, the fluid delivery mechanism is operated in a high pressure mode, having a pressure from about 150 psi to about 250 psi, from about 250 psi to about 350 psi, from about 350 psi to about 425 psi, or from about 425 psi to about 500 psi, or up to 1,000 psi. The operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned range of values.

[0117] The manifold is configured to increase a fluid pressure and/or flow rate of the fluid. When fluid is provided by the fluid delivery mechanism to the fluid lumen(s) at a first pressure and/or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and/or is configured to increase the flow rate of the fluid to a second flow rate. The second pressure and/or second fluid rate can be higher than the first pressure and/or first flow rate. As a result, the manifold can be configured to increase the relatively low operating pressures and/or flow rates generated by the fluid delivery mechanism to the relatively high pressures and/or high flow rates generated by the ports/fluid streams.

[0118] In some embodiments, a profile (cross-sectional dimension) of a port 230 varies along its length (e.g., is non-cylindrical). A variation in the cross-sectional dimension of the port may alter and/or adjust a characteristic of fluid flow along the port 230. For example, a reduction in cross-sectional dimension may accelerate a flow of fluid through the port 230 (for a given volume of fluid). In some embodiments, a port 230 may be conical along its length (e.g., tapered), such that its smallest dimension is positioned at the distal end of the port 230, where distal is with respect to a direction of fluid flow.

[0119] In some embodiments, the port 230 is formed to direct the fluid flow along a selected path. FIGS. 2A-2E illustrate various embodiments of arrangements of ports 230 for directing respective fluid streams 210. In some embodiments, such as those shown in FIGS. 2A and 2B, at least two ports 230 are arranged to produce (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the thrombus removal system. An intersection region 237 can be a region of increased fluid momentum, turbulence, shear, and/or energy transfer, which multiply with respect to individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and/or energy transfer at an intersection may advantageously fragment thrombus more efficiently and/or quickly. As described above, the fluid streams can be configured to accelerate and cause cavitation and/or other effects to further add to breaking up of the target clot. In some embodiments, an intersection region can be formed from at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 fluid streams 210. An intersection region can be generally near a central axis 290 of the thrombus removal system (e.g., 237), or away from the central axis (e.g., 238 and 239 in the embodiment of FIG. 2D). In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are arranged to direct a fluid stream 210 along an oblique angle with respect to the central axis of the thrombus removal system. An operating pressure of the fluid delivery mechanism may be selected to approach a minimum targeted fluid velocity for a fluid stream 210 that is delivered from a port 230. The targeted fluid velocity for a fluid stream 210 can be about 5 meters/second (m/s), about 8 m/s, about 10 m/s, about 12 m/s, or about 15 m/s. Additionally, the targeted fluid velocities in some embodiments can be in the range above 15m/s to up tol50 m/s. At these higher velocities (e.g. above 15m/s, or alternatively above 20m/s), the fluid streams may be configured to generate cavitation in a target thrombus or tissue. It has been found that with fluid exiting from the ports to these flow rates a cavitation effect can be created in the focal area of the intersecting or colliding fluid streams, or additionally at a boundary of one or more of the fluid streams. While the exact specifications may change based on the catheter size, in general, at least one of the fluid streams should be accelerated to such a high velocity to create cavitation as described in detail below. The targeted fluid velocity for fluid stream 210 can be any value within the range of aforementioned values. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at different fluid velocities (i.e. speed and direction), for a given pressure of the fluid delivery mechanism. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at the substantially the same fluid velocities, for a given pressure of the fluid delivery mechanism. In some embodiments, one port is adapted to deliver fluid at high velocity and the respective one or more other ports is adapted to deliver fluid at relatively lower velocities. Advantageously, an increased cross-sectional area of the fluid lumen 145 reduces a required operating pressure of the fluid delivery mechanism to achieve a targeted fluid velocity of the fluid streams. [0120] In some embodiments, the fluid streams are configured to create angular momentum that is imparted to a thrombus. In some examples, angular momentum is imparted on the thrombus by application of a) at least one fluid stream 210 that is directed at an oblique angle from a port 230, and/or b) at least two fluid streams 210 that have different fluid velocities. For example, fluid streams that cross near each other but do not necessarily intersect may create a “swirl” or rotational energy on the clot material. Advantageously, angular momentum produced in a thrombus may impart a (e.g., centrifugal) force that assists in fragmentation and removal of the thrombus. Rotating of the clot may enhance delivery of the clot material to the jets. By example, with a large, amorphous clot the soft material may be easily aspirated or broken up by the fluid streams whereas tough fibrin may be positioned away from the fluid streams. Rotating or swirling of the clot moves the material around so the harder clot material is presented to the jets. The swirling may also further break up the clot as it is banged inside the funnel.

[0121] FIGS. 3A-3H depict various configurations of fluid streams 410 that are directed from respective ports 430. A fluid stream 410 can be directed along a path that is substantially orthogonal, proximal, and/or distal to the flow axis 405 (which is like to flow axis 305). In some embodiments, at least two fluid streams are directed in different directions with respect to the flow axis 405. In some embodiments, at least two fluid streams are directed in a same direction (e.g., proximally) with respect to the flow axis 405. In some embodiments, at least a first fluid stream is directed orthogonally, at least a second fluid stream is directed proximally, and at least a third fluid stream is directed distally with respect to the flow axis 405. An angle a may characterize an angle that a fluid stream 410 is directed with respect to an axis that is orthogonal to the flow axis 405 (e.g., as shown in section D-D of FIGS. 3G and 3H). An intersection region of fluid streams can be within an interior portion of the thrombus removal system, and/or exterior (e.g., distal) to the thrombus removal system. In some embodiments, a fluid stream that is directed by a port 430 in a nominal direction (e.g., distally) is deflected along an altered path (e.g., proximally) by (e.g., suction) pressure generated by the aspiration mechanism during operation.

[0122] FIGS. 4A-4C illustrate various configurations of a thrombus removal system 600, including a thrombus removal device, 602, a vacuum source and cannister 604, and a fluid source 606. In some embodiments, the vacuum source and cannister and the fluid source are housed in a console unit that is detachably connected to the thrombus removal device. A fluid pump can be housed in the console, or alternatively, in the handle of the device. The console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system. The thrombus removal device 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controls 614 and 616. For example, in the embodiment shown in FIG. 4 A, the device can include a finger switch or trigger 614 and a foot pedal or switch 616. These can be used to control aspiration and irrigation, respectively. Alternatively, as shown in the embodiment of FIG. 4B, the device can include only a foot switch 614, which can be used to control both functions, or in FIG. 4C, the device can include only an overpedal 616, also used to control both functions. It is also contemplated that an embodiment could include only a finger switch to control both aspiration and irrigation functions. As shown in FIG. 4A, the vacuum source can be coupled to the aspiration lumen of the device with a vacuum line 618. Any clots or other debris removed from a patient during therapy can be stored in the vacuum cannister 604. Similarly, the fluid source (e.g., a saline bag) can be coupled to the fluid lumens of the device with a fluid line 620.

[0123] Still referring to FIG. 4A, electronics line 622 can couple any electronics/sensors, etc. from the device to the console/controllers of the system. The system console including the CPUs/electronic controllers can be configured to monitor fluid and pressure levels and adjust them automatically or in real-time as needed. In some embodiments, the CPUs/electronic controllers are configured to control the vacuum and irrigation as well as electromechanically stop and start both systems in response to sensor data, such as pressure data, flow data, etc.

[0124] As is described above, aspiration occurs down the central lumen of the device and is provided by a vacuum pump in the console. The vacuum pump can include a container that collects any thrombus or debris removed from the patient.

Real-Time Hemodynamics Analysis for Determining Treatment Efficacy and Patient Outcomes

[0125] Systems and methods are also provided herein that include measuring various patient parameters and performing real-time hemodynamics analysis based on the measured parameters before, during, and/or after thrombectomy procedures to characterize ventricular systolic and diastolic properties independent of loading conditions and assess procedure completion. The systems and methods herein can measure, calculate, and use the various pressures, flows, and resistance within a patient’s heart that contribute to the efficient functioning of the heart and the circulation of blood throughout the heart. to inform a physician of treatment progress and/or treatment completion.

[0126] Thrombectomy systems provided herein can include the system components described above, including a thrombectomy catheter that may include a flexible shaft, a distal expandable funnel, an aspiration lumen coupled to an aspiration source, and optionally two or more fluid apertures for producing jets or fluid streams at or within the distal expandable funnel. The system can further include a delivery system configured to delivery and position the thrombectomy catheter at a target location, such as within the pulmonary artery in proximity to one or more pulmonary embolisms or clots. The delivery system can include a guidewire, an introducer catheter or sheath and a dilator. In some aspects, the introducer catheter can include one or more sensors such as pressure sensors configured to measure parameters of the patient (e.g., pulmonary artery pressure).

[0127] FIGS. 5A-5L illustrate a thrombectomy method that can include measuring cardiovascular parameters such as pressures, volumetric flow rates, blood flow velocities, heart rate, vascular resistance, admittance, conductance, etc., and performing real-time hemodynamics analysis. The hemodynamics analysis can be used to determine treatment progress and/or completion.

[0128] In FIG. 5 A, a guidewire 524 can be advanced into the right atrium (RA), through the right ventricle (RV), and into the pulmonary artery (PA). Typically a femoral approach is used, however other approaches such as the jugular approach can also be considered. In FIG. 5B, at least one thrombus is shown in the PA, and an introducer catheter/sheath 526 and dilator 528 are advanced over the guidewire. Here, the dilator is shown extending into the RV.

[0129] FIG. 5C shows the introducer sheath 526 and dilator 528 advanced into the PA, proximal to the targeted thrombi. In FIG. 5D, the dilator can be retracted proximally into the sheath and optionally out of the patient, leaving only the introducer sheath in the PA. In FIG. 5D, it’s also shown that the introducer sheath 526 can include any number of sensors, such as a pressure sensor 530 and a flow sensor 531. The pressure sensor can comprise, for example, a fiber optic pressure sensor. In some embodiments, the pressure sensor is integrated into the sheath to measure a blood pressure parameter in the patient. The flow sensor 531 may measure flow rates in the PA or other vessels or chambers of the heart and may also be integrated into the introducer sheath. When the introducer sheath is positioned in the PA, the pressure sensor can be configured to measure pulmonary artery pressure. Any pressure sensor known in the art can be integrated into the introducer sheath, either externally or internally to the introducer sheath.

[0130] In FIG. 5E, a thrombectomy catheter 502, such as any of the thrombectomy catheters or devices described herein, can be inserted into the introducer catheter 526 and advanced into the pulmonary artery. When the thrombectomy catheter 502 is advanced distally beyond the distal end of the introducer sheath 526, an expandable funnel 508 of the thrombectomy catheter can assume an expanded configuration as shown. In FIG. 5F, the introducer sheath and thrombectomy catheter can be further advanced and positioned adjacent to the one or more thrombi. Proper positioning can be confirmed with real-time imaging and/or contrast injections into the vasculature (e.g., by injecting contrast through the introducer sheath into the pulmonary artery in the directions of the target thrombi). The pressure sensor 530 of the introducer sheath can continuously or periodically measure pressure in the pulmonary artery when the thrombectomy catheter is in position. Likewise, flow sensor 531 can measure flow rates in the pulmonary artery when the thrombectomy catheter is in position. In some embodiments, a user or physician of the system can provide an input to the system (e.g., press a button) to take an on-demand pressure sensor measurement. Alternatively, the system can be configured to constantly or periodically take pressure and/or flow rate measurements during a procedure.

[0131] In FIG. 5G, the thrombectomy catheter 502 can be advanced towards a clot. In some examples, aspiration can be activated on the thrombectomy catheter to engage with the clot in the funnel. Optionally, the thrombectomy catheter can administer jets or fluid streams into the clot to help break up and remove the clot via the catheter aspiration. The pressure sensor 530 can continuously or periodically obtain pressure, change in pressure over time, conductance, and/or admittance measurements during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot. Flow sensor 531 can also obtain flow rate information during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot.

[0132] Before, during, or after a thrombectomy procedure, the systems described herein can measure patient parameters and perform real-time hemodynamics analysis of the patient. For example, after removing the first clot or thrombus as shown in FIG. 5G, a real-time hemodynamics analysis may indicate to a user or medical provider that treatment is progressing by noticing a large change in hemodynamics and/or pressure, flow, or velocity after removal if the first clot. The thrombectomy system and device described herein can employ algorithms and software to perform real-time hemodynamics analysis based on sensed parameters such as PA pressure, volumetric flow measurements, flow velocity measurements, and other measurements in the heart including but not limited to RV including conductance, admittance, RV pressure, and/or pressure-volume loop analysis. The hemodynamics analysis can be used to inform and provide treatment progress or completion, as well as patient outcomes and assessment. For example, the analysis can use the measurements from the system to determine or quantify how the treatment is progressing. In some examples, the analysis can be between pressure, flow, and velocity in the pulmonary artery. In some examples, the treatment progress/completion is algorithmically determined (e.g., a change in the PA pressure, change in RV function, change in conductance/admittance, and/or the pressure-volume loop analysis exceeds a pre-determined threshold) and the user or physician can be notified or alerted of a treatment progression state or system state (e.g., with an alert, light, indicator, or icon on a display, or with a sound from the system console). For example, a change in one or more of the measured parameters that exceeds a first threshold may indicate that a first (of one or more) clots has been removed. Alternatively, a change in one or more of the measured parameters that exceeds a second threshold may indicate treatment completion and return to normal or acceptable vascular and/or RV function.

[0133] FIG. 5H shows continued clot removal, this time with the thrombectomy catheter 502 moved to a new clot location and engaged with the clot. As described above, the pressure sensor 530 can continuously or periodically obtain pressure measurements, change in pressure over time, volumetric flow information, blood flow velocity information, conductance, and/or admittance measurements during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot. Flow sensor 531 can also obtain volumetric flow rate information and/or blood flow velocity information during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot.

[0134] FIGS. 5I-5J show a similar sequence to that of FIGS. 5G-5H, with the addition of a P-V catheter 532 inserted into the RV through a port 534 in the sheath of the thrombectomy system. The P-V catheter can measure additional patient parameters such as admittance and conductance with one or more electrodes 536.

[0135] In FIG. 51, the thrombectomy catheter 502 can be advanced towards a clot. In some examples, aspiration can be activated on the thrombectomy catheter to engage with the clot in the funnel. Optionally, the thrombectomy catheter can administer jets or fluid streams into the clot to help break up and remove the clot via the catheter aspiration. The pressure sensor 530 and P-V catheter 532 can continuously or periodically obtain pressure, change in pressure over time, conductance, and/or admittance measurements during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot. In some examples, as described above, the P-V catheter measurements can be used to perform a pressure-volume loop analysis. Flow sensor 531 can also obtain flow rate information during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot.

[0136] FIG. 5J shows continued clot removal, this time with the thrombectomy catheter 502 moved to a new clot location and engaged with the clot. As described above, the pressure sensor 530 and P-V catheter 532 can continuously or periodically obtain pressure, change in pressure over time, conductance, and/or admittance measurements during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot. In some examples, as described above, the P-V catheter measurements can be used to perform a pressure-volume loop analysis. Flow sensor 531 can also obtain flow rate information during the thrombectomy procedure, including prior to engagement with the clot, during engagement with the clot, and removal of the clot. [0137] The system can perform real-time hemodynamics analysis before, during, and after the procedural steps shown in FIGS. 5I-5J. As described above, this analysis can inform the user or medical provider regarding treatment progress and patient outcomes. In some examples, the hemodynamics analysis can identify an improvement in cardiac output or performance after the first clot is removed (FIG. 51), and a second additional improvement when the second clot is removed (FIG. 5J).

[0138] FIG. 5K shows the introducer sheath still inserted into the PA after removal of the two target clots from FIGS. 51 and 5J. In this example, the thrombectomy catheter 502 can be seen retracted into the sheath but still positioned near the distal end of the sheath. After the clots have been removed, the pressure sensor 530 can continuously or periodically obtain pressure, conductance, and/or admittance measurements. In certain embodiments, flow sensor 531 can also continuously or periodically obtain flow rate information.

[0139] FIG. 5L shows an embodiment similar to that of FIG. 5K, with the introducer sheath still inserted into the PA after removal of the two target clots from FIGS. 51 and 5 J. This example includes a P-V catheter 532 positioned in the RV. In this example, the thrombectomy catheter 502 can be seen retracted into the sheath but still positioned near the distal end of the sheath. After the clots have been removed, the pressure sensor 530 can continuously or periodically obtain pressure, conductance, and/or admittance measurements. In certain embodiments, P-V catheter 532 may also be present after clot removal and continuously or periodically obtain pressure and other readings from the right ventricle. In some examples, as described above, the P-V catheter measurements can be used to perform a pressure-volume loop analysis. In certain embodiments, flow sensor 531 can also continuously or periodically obtain flow rate information.

[0140] The embodiments above discuss taking one or more (e.g., discrete or continuous) pressure measurements within the main pulmonary artery before, during, and/or after a thrombectomy procedure. However, referring to FIGS. 5M and 5N, additional embodiments described herein can include taking pressure measurements (or other sensor measurements) at other locations within the pulmonary vasculature. The pressure measurements can be continuous or periodic, and can comprise measurements of a pulmonary artery pressure and/or a change in the pulmonary artery pressure over time for the subject. In some examples, these sensor/pressure measurements can be used to derive dP/dt versus pressure curves at discrete, targeted locations within the pulmonary vasculature, before, during, and/or after a thrombectomy procedure or procedures. In some examples, the measurements and/or dP/dt versus pressure curves can be analyzed, and results before/during/after a procedure can be compared to enable stratification of the sensed signals and derived dP/dt versus pressure curves into data signatures or indications that can be used (e.g., by a physician) to provide an assessment of the patient’s disease state and/or predicted outcomes. Additionally, aspects of the curves can give insights into the progress of the procedure in real-time.

[0141] Referring to FIG. 5M, the pulmonary vasculature can include the main pulmonary artery, described above, which branches into the right pulmonary artery and the left pulmonary artery. As these branches of the pulmonary artery descend further into the lungs, the arterial branches split into smaller arteries that divide and become arterioles, eventually narrowing into the capillary microcirculation of the lungs where gas exchange occurs.

[0142] FIG. 5N is a zoomed-in view of the left pulmonary artery, divided into three segments X, Y, and Z. X can represent a proximal section of the left pulmonary artery near the bifurcation between the left and right pulmonary arteries, Y can represent a medial section of the left pulmonary artery, and Z can represent a distal section of the left pulmonary artery near the apical posterior branch. In some aspects of the present disclosure, methods and techniques are provided in which pressure measurements are taken in more than one section of the left or right pulmonary arteries before, during, and/or after a thrombectomy procedure, in some embodiments, this technique can be used when clots or thrombi deep in the lungs, (e.g., within or beyond the left or right pulmonary arteries) are targeted. In addition to taking pressure measurements at more than one location within the left or right pulmonary arteries before, during, or after a thrombectomy procedure, the present disclosure also provides for analyzing this data and/or deriving dP/dt versus pressure curves at each of these discrete locations before/during/after a thrombectomy procedure.

[0143] For example, a method of the present disclosure may include: 1) targeting one or more clots, occlusions, or portions of occlusions within the left or right pulmonary arteries, or beyond (deeper) into the lungs from the left or right pulmonary arteries; 2) navigating a thrombectomy device or system to the left or right pulmonary artery; 3) taking at least one pressure measurement in at least two (and optionally three or more) discrete locations within the left or right pulmonary artery; 4) taking the pressure measurements before, during, and/or after a thrombectomy procedure; and 5) comparing pressure measurements and/or analysis of the pressure measurements before/during/after the procedure.

[0144] In some aspects, comparing pressure measurements can include deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time, deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time, and providing a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

[0145] As described above, the analysis can include deriving a dP/dt versus pressure curve at each of the discrete locations where the pressure measurements are taken. Therefore, if pressure measurements are taken at X, Y, and Z locations in FIG. 5N, then dP/dt versus pressure curves can be derived for measurements at any of these locations. Similarly, the method can include taking measurements and deriving dP/dt versus pressure curves before, during, and/or after the thrombectomy procedure, to establish baseline dP/dt versus pressure curves and/or post-treatment dP/dt versus pressure curves. It is therefore an object of this disclosure to enable a comparison of the baseline dP/dt versus pressure curves derived before a thrombectomy procedure to the post-treatment dP/dt versus pressure curves derived during or after a thrombectomy procedure.

[0146] In some aspects, the dP/dt versus pressure curves can be gated at selected times/phases within the pulmonary or cardiac cycles to improve the accuracy of the data collection and resulting curves. For example, the pressure measurements could be optionally gated according to the breathing cycle to normalize pressure contributed to the cardiac cycle by the breathing cycle, which affects vessel pressures. In one specific example, the patient or subject, who would typically be awake during a thrombectomy procedure, could be instructed to hold his or her breath to facilitate gated pressure measurements at the desired sections within the lungs.

[0147] The derived dP/dt versus pressure curves taken before, during, and/or after a thrombectomy procedure could then be analyzed to enable stratification of the measurements and analysis into data signatures or indications that can be used (e.g., by a physician) to provide a characterization of the patient disease state. Alternatively, the analysis can be used to assess the clot burden for a particular patient. Many factors can be used to make the disease state characterization, including the dP/dt versus pressure curve prior to therapy, the dP/dt versus pressure curve after therapy, individual or collective parameters of the dP/dt versus pressure curve(s), the level of “improvement” seen in the dP/dt versus pressure curves after the thrombectomy procedure, etc. Additionally, trained machine learning models can be used to analyze the data, including the raw pressure measurements and the dP/dt versus pressure curves, and output a data signature or indication that can be used (e.g., by a physician) to provide characterization of patient disease state.

[0148] In some examples, the data signatures or indications can be used to provide patient disease state can be characterized into two or more categories or disease state groupings. For example, stratification into the patient disease state may characterize a patient as: 1) Mild Disease State, 2) Intermediate Disease State, 3) Severe Disease State, or 4) Acute/Chronic disease state. The determined disease state can be output to the patient and/or the physician. In some examples, the disease state can be used to determine post-operative care of the patient.

[0149] According to certain embodiments, other sensors may be placed during the thrombectomy method including before, during, and after clot removal, to measure and estimate various other hemodynamic parameters including one or more of: right ventricular strain/function, stroke volume, ventilation, perfusion, indicators of elastin quantity and quality, imaging including fluoroscopy and CT pulmonary angiogram, flow rates, oxygenation, pH, and shock state, including obstructive shock. Such data may provide information about the extent of PE size and obstruction, location, extent of clot removed, systemic damage from PE, prognosis, need for medical monitoring, arterial compliance, recovery/treatment outcomes including extent of reperfusion, inflammatory responses, and reperfusion injury, etc.

[0150] The thrombectomy system described herein and above in FIGS. 5A-5L can employ algorithms and software to determine a correlation between sensed parameters such as PA pressure, volumetric flow rate, blood flow velocity, measurements in the RV including conductance, admittance, RV pressure, and/or pressure-volume loop analysis, and treatment progress or completion. For example, the correlation can use the measurements from the system to determine or quantify how the treatment is progressing. In some examples, the correlation can be between pressure, volumetric flow, and flow velocity. In some examples, the treatment progress/completion is algorithmically determined (e.g., a change in the PA pressure, change in volumetric flow, change in flow velocity, change in RV function, change in conductance/admittance, and/or the pressure-volume loop analysis exceeds a predetermined threshold) and the user or physician can be notified or alerted of a treatment progression state or system state (e.g., with an alert, light, indicator, or icon on a display, or with a sound from the system console). For example, a change in one or more of the measured parameters that exceeds a first threshold may indicate that a first (of one or more) clots has been removed. Alternatively, a change in one or more of the measured parameters that exceeds a second threshold may indicate treatment completion and return to normal or acceptable vascular and/or RV function.

[0151] Alternatively, the thrombectomy system can employ machine learning and/or artificial intelligence (Al) to determine or indicate treatment progress or completion based on the derived dP/dt versus pressure curves, baseline dP/dt versus pressure curves, posttreatment dP/dt versus pressure curves, PA and/or RV measurements, including PA pressure, volumetric flow, flow velocity, RV conductance, RV admittance, and/or the pressure-volume loop analysis. The PA and/or RV measurements can be input into a trained machine learning model, and the model can output a label or determination as to the progress or completion of the thrombectomy procedure. For example, the machine learning model may use the correlation between vascular function and RV function to determine treatment progress or completion. The output can comprise, for example, a descriptor of treatment progress (e.g., untreated, partially treated, treatment completion, etc.), or a descriptor of clot status (e.g., clot removed, clot(s) remaining, clot(s) cleared, etc.). The output can also comprise an indication of treatment progress (e.g., 10% treated, 50% treated, 75% treated, 100% treated, etc.).

[0152] The machine learning model(s) can be trained by tagging treatment progress/completion state while dP/dt versus pressure curves, onboard data, and/or the PA and/or RV measurements are obtained during a procedure. For example, a user can tag a treatment state of thrombus removed, thrombus partially removed, or thrombus not removed during a procedure, and the machine learning model can be trained to correlate onboard data such as dP/dt versus pressure curves, aspiration pressure curves, or measured data such as PA pressure, RV conductance, RV admittance, and/or pressure-volume loop analysis with a given treatment progress state (e.g., note treated, partially treated, treatment complete, etc.). The trained model can then be used as described above to determine treatment progress or completion during a procedure.

[0153] The thrombectomy systems described herein can further use a trained machine learning model or Al can be used to determine or characterize system state during a thrombectomy procedure, including 1) clear (funnel not engaged with clot), 2) partially engaged (funnel is partially but not fully engaged with clot), and 3) fully engaged/clogged. The trained machine learning model can use measured parameters and/or onboard data (e.g., aspiration pressure curves) to determine system state in concert with labeled training data. [0154] In some implementations, the machine learning model(s) can be trained by tagging a system state while the onboard data and/or PA and RV measurements are obtained during a procedure. For example, a user can tag a system state of clear, partially engaged, or engaged/clogged during a procedure, and the machine learning model can be trained to correlate onboard data such as aspiration pressure curves or measured data such as PA pressure, RV conductance, RV admittance, and/or pressure-volume loop analysis with a given system state. The trained model can then be used as described above to determine system state during a procedure.

[0155] An example of an Al model may include a convolutional neural network relating to a U-net. A U-net may be a type of convolutional neural network used for data processing, according to any method described herein. A thrombectomy system may have a computer- based system operating the Al model, according to any method described herein. The Al model may process one or more data inputs into a first layer of the convolutional neural network (e.g., the U-net). The data may be processed through a series of layers. The processing layers of the Al model may be considered in one or more phases or paths of the data processing.

[0156] FIG. 6A is an example of dP/dt versus pressure curves (pressure vs. rate of change of pressure loop plot 6000) pre-treatment or baseline dP/dt versus pressure curve 6003 and post-treatment dP/dt versus pressure curve 6004. As described above, the dP/dt versus pressure curves can be obtained with pressure measurements at more than one location within the pulmonary vasculature before, during, and/or after a thrombectomy procedure. The pressure vs. rate of change of pressure loop analysis can be generated by real-time measurement of pulmonary artery pressure 6001 and change in pulmonary artery pressure over change in time 6002 within the pulmonary artery pre-treatment or baseline dP/dt versus pressure curve 6003 and post-treatment dP/dt versus pressure curve 6004 (aspiration of at least a portion of an occlusion or clot). According to certain embodiments, several physiologically relevant hemodynamic parameters such as stroke volume, cardiac output, ejection fraction, myocardial contractility, etc. may be determined from these dP/dt versus pressure curves. Shown here is an area 6005 within pre-treatment or baseline dP/dt versus pressure curve 6003 and an area 6006 within post-treatment dP/dt versus pressure curve 6004, showing a reduction in pulmonary artery pressure 6001 and a reduction in change in pressure/change in time (dP/dt) 6002 post-treatment or a migration to the left from the baseline dP/dt versus pressure curve 6003 to the post-treatment dP/dt versus pressure curve 6003. [0157] In some examples, aspects or parameters of the baseline dP/dt versus pressure curve 6003 can be compared to the post-treatment dP/dt versus pressure curve 6004. For example, mean pressure pre-treatment can be compared to mean pressure post-treatment to determine the mean pressure shifts pre

post treatment. In some examples, the pressure shifts can be characterized as an absolute pressure shift, or alternatively as a ratio or percentage pressure shift.

[0158] Similarly, the maximum rate of change dP/dt max can be compared between the pre-treatment curve 6003 and the post-treatment curve 6004. For example, pre-treatment max dP/dt can be compared to post-treatment max dP/dt versus pressure curve to determine the max dP/dt shifts pre

post treatment.

[0159] Additionally, the minimum rate of change dP/dt min can be compared between the pre-treatment curve 6003 and the post-PE treatment curve 6004. For example, pre-treatment min dP/dt (e.g., -90 in FIG. 6A) can be compared to post-treatment min dP/dt versus pressure curve (e.g., 60 in FIG. 6A) to determine the min dP/dt shifts pre

post treatment.

[0160] FIG. 6B is an acceleration-deceleration rate of pulmonary artery pressure plot 6050 pre-PE treatment 6053 and post-PE treatment 6054. As shown here, accelerationdeceleration rate axis 6051 shows a marked reduction in acceleration and deceleration rates of pulmonary artery pressure post-PE treatment 6054. According to certain embodiments, this may correlate with a reduction in elastins.

[0161] FIG. 6C is another view of a dP/dt versus pressure curve that shows individual parameters or features of the baseline and/or post-treatment curves that can be analyzed to provide insight into patient disease state, patient improvement, patient outcomes, and/or treatment completion state. As described above, the dP/dt versus pressure curve is a cardiac signal that indicates the change in pressure over time during isovolemic contraction of the cardiac ventricles, over a plurality of cardiac cycles. Each line or plot in the dP/dt versus pressure curve can be representative of a cardiac cycle. In one embodiment, the dP/dt versus pressure curve can be analyzed to identify the presence of a “notch” in region 6007 of the dP/dt versus pressure curve. The notch can be defined as an increase in amplitude in the dP/dt versus pressure curve in region 6007 over time. The amplitude 6008 of the notch, if any, can be used as an indicator or data signature for disease state. Additionally, the reduction of amplitude in the notch after a thrombectomy procedure can also be used as an indicator or data signature for disease state, and also for future patient outcomes. As described above, various parameters or features of the dP/dt versus pressure curve can be analyzed before/during/after a thrombectomy procedure (e.g., with machine learning) to characterize disease state and/or patient outcomes. The presence or lack thereof of a notch in region 6007 of the dP/dt versus pressure curve is one parameter that can be analyzed for this purpose.

[0162] Still referring to FIG. 6C, both the spread in dP/dt can be evaluated (comparing the max dP/dt to the min dP/dt, as well as the spread in pressure (comparing the minimum pressure to the maximum pressure). In some examples, these parameters can be compared before, during, and/or after a thrombectomy procedure, similar to the comparison between the pre-treatment plot and the post-treatment plot in FIG. 6A.

[0163] In some aspects, the dP/dt versus pressure curve can be divided into sections or segments that correspond to the various stages of the cardiac cycle. For example, the plot of FIG. 6C can be divided into segments or sections indicated by dividers 6009, 6010, 6011, and 6012. These segments are representative, and it should be understood that additional segments or sections can be added as needed. In some embodiments, one or more sections or segments of the plot may apply directly to a specific stage of the cardiac cycle. For example, one or more of the sections may map to diastole and one or more sections may map to systole. For example, the dP/dt versus pressure curve may be representative of pressures at diastole at section 6009 of the plot, and systole at section 6011 of the plot. Within each section, data analysis can be performed, including looking at the rate of change, the mean change (pre and post treatment, changes to the spread in pressure or dP/dt, changes to the max or min inflow/outflow pressures, or even the spread of individual cardiac cycle plots between cardiac cycles at a given section of the plot (e.g., the spread of measurements at 6008, 6009, 6010, 6011, 6012, or any other selected section of the dP/dt versus pressure curve. Additionally, the time spent in each one of the segments or stages can be analyzed and used by the system. Furthermore, additional characteristics of the curves may be used, including but not limited to the center of mass of the loop and area within each loop. Patient improvement, clot burden, disease state, and/or treatment progress may all be characterized with a particular change in the measured curves.

[0164] Collectively, any of the parameters described above in the dP/dt versus pressure curves or pressure measurements may be analyzed to provide insight or data signatures for the characterizations of patient disease state, clot burden, treatment completion, and/or patient outcomes. The dP/dt versus pressure curves can be used to establish a baseline hemodynamics assessment and/or a post-treatment hemodynamics assessment. In some aspects, the baseline hemodynamics assessment comprises a baseline dP/dt versus pressure curve and wherein the post-treatment hemodynamics assessment comprises a post-treatment dP/dt versus pressure curve. [0165] In any embodiment disclosed herein, the post-treatment hemodynamics assessment is derived while the thrombectomy catheter system is within the subject, and can be derived within 30 minutes of removing the at least one occlusion or partial occlusion, or within 60 minutes of removing the at least one occlusion or partial occlusion, or within up to 3 hours of removing the at least one occlusion or partial occlusion.

[0166] In some aspects, deriving the baseline hemodynamics assessment comprises generating a baseline dP/dt versus pressure curve, and deriving the post-treatment hemodynamics assessment comprises generating a post-treatment dP/dt versus pressure curve.

[0167] In any of the embodiments described herein, the correlation can be based on a change in amplitude in a region of the post-treatment dP/dt versus pressure curve representing diastolic drop. Additionally, the correlation can be based on a shift in mean pressure between the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve. In additional aspects, the correlation can be based on a change in maximum baseline dP/dt and maximum post-treatment dP/dt. In some embodiments, the correlation is based on a change in a maximum baseline dP/dt delta and a maximum post-treatment dP/dt delta. In some embodiments, the correlation is based on a shift in a mean pressure of the baseline dP/dt versus pressure curve and a mean pressure of the post-treatment dP/dt versus pressure curve. Additionally, the correlation can be based on a distribution of pressures at a given value of dP/dt (e.g., zero) of the baseline and post-treatment dP/dt versus pressure curves. In other examples, the distribution is associated with a systolic phase of the subject’s cardiac cycle, the diastolic phase of the subject’s cardiac cycle, or both. In one example, the correlation is based on a post-treatment area within the post-treatment dP/dt versus pressure curve relative to a baseline area within the baseline dP/dt versus pressure curve.

[0168] In any of the examples provided herein, the signal and/or the treatment completion state may indicate that the thrombectomy procedure was not successful, had limited success, or did not improve the patient’s disease state in a meaningful way. In some examples, the signal provides a recommendation to perform further intervention such as a CTEPH procedure.

[0169] FIG. 7A is a flow chart depicting a method 700 for patient assessment during and/or following thrombotic treatment.

[0170] Method 700 begins at block 705.

[0171] At block 705, a thrombectomy system is advanced into a pulmonary artery branch of a subject. [0172] At block 710, the thrombectomy system periodically or continuously measures one or more of a pulmonary artery pressure and a change in the pulmonary artery pressure over a change in time. Additionally, the system can periodically or continuously measure one or more of volumetric flow and blood flow velocity. The method can include acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system.

[0173] At block 715, the method can include deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time.

[0174] At block 720, the method can include removing at least one occlusion or partial occlusion in the pulmonary artery branch with the thrombectomy catheter system.

[0175] At block 725, the method can include, after removing the at least one occlusion or partial occlusion, acquiring a post-treatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system.

[0176] At block 730, the method can include deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired posttreatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time.

[0177] At block 735, the method can include providing a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment. In any of the examples provided herein, the signal and/or the treatment completion state may indicate that the thrombectomy procedure was not successful, had limited success, or did not improve the patient’s disease state in a meaningful way. In some examples, the signal provides a recommendation to perform further intervention such as a CTEPH procedure.

[0178] According to certain embodiments, method 700 further includes providing an output related to treatment progress or treatment completion state to a user of the thrombectomy system, in which the output provides guidance for clinical decision making based on assessment of one or more of: (i) original thrombus size and extent of obstruction, (ii) original or present thrombus location, (iii) extent of clot removed, (iv) systemic damage from the thrombus, (v) patient prognosis, (vi) a need for medical monitoring, (vii) recovery and treatment outcomes including extent of reperfusion, inflammatory responses, and reperfusion injury, and (viii) arterial compliance. [0179] The output can comprise, for example, the signal of block 735, and any graphical representation of all or a portion of any of the pre-treatment/baseline or post-treatment dP/dt versus pressure curves.

[0180] According to certain embodiments, method 700 further includes performing a pressure-volume loop analysis with the right ventricular pressure, right ventricular conductance, and/or a right ventricular admittance.

[0181] According to certain embodiments, the measuring and correlation is further based on a relationship between one or more of: (i) right ventricular pressure, (ii) right ventricular strain/function, (iii) stroke volume, (iv) ventilation, (v) perfusion, (vi) indicators of elastin quantity and quality, (vii) imaging including fluoroscopy and CT pulmonary angiogram, (viii) flow rates, (ix) oxygenation, (x) pH, and (xi) shock state, including obstructive shock. [0182] According to certain embodiments, method 700 further includes determining the treatment progress or treatment completion state algorithmically based on a change in a measured parameter exceeding a predetermined threshold.

[0183] According to certain embodiments, the treatment progress or treatment completion state is determined with a machine learning model.

[0184] According to certain embodiments, the machine learning model is trained by tagging the treatment progress or treatment completion state with one or more training data sets.

[0185] According to certain embodiments, the output comprises a label of treatment progress.

[0186] According to certain embodiments, the label is selected from the group consisting of not complete, partially complete, and treatment complete.

[0187] According to certain embodiments, the label is an indicator of treatment progress.

[0188] According to certain embodiments, the label is a percentage of treatment completion.

[0189] FIG. 7B is a flow chart depicting another method 750 for patient assessment following thrombotic treatment.

[0190] Method 750 begins at block 755.

[0191] At block 755, a thrombectomy system is advanced into a pulmonary artery of a subject.

[0192] At block 760, the thrombectomy system periodically or continuously measures one or more of a pulmonary artery pressure and a change in the pulmonary artery over a change in time.

[0193] At block 765, a P-V catheter is advanced into the right ventricle of the subject. [0194] At block 770, the thrombectomy system periodically or continuously measures one or more of a right ventricular pressure and a change in the right ventricular pressure over a change in time.

[0195] At block 775, a treatment effectiveness or treatment completion state is determined based on a correlation between a change in the measured pulmonary artery pressure and a change in the measured right ventricular pressure over the change in time. [0196] According to certain embodiments, method 750 further includes providing an output of the system state to a user of the thrombectomy system, in which the output provides guidance for clinical decision making based on assessment of one or more of: (i) original thrombus size and extent of obstruction, (ii) original or present thrombus location, (iii) extent of clot removed, (iv) systemic damage from the thrombus, (v) patient prognosis, (vi) a need for medical monitoring, (vii) recovery and treatment outcomes including extent of reperfusion, inflammatory responses, and reperfusion injury, and (viii) arterial compliance.

[0197] In any of the examples provided herein, the signal and/or the treatment completion state may indicate that the thrombectomy procedure was not successful, had limited success, or did not improve the patient’s disease state in a meaningful way. In some examples, the signal provides a recommendation to perform further intervention such as a CTEPH procedure.

[0198] According to certain embodiments, method 750 further includes performing a pressure-volume loop analysis with the right ventricular pressure, right ventricular conductance, and/or a right ventricular admittance.

[0199] According to certain embodiments, the measuring and correlation is further based on a relationship between one or more of: (i) right ventricular strain/function, (ii) stroke volume, (iii) ventilation, (iv) perfusion, (v) indicators of elastin quantity and quality, (vi) imaging including fluoroscopy and CT pulmonary angiogram, (vii) flow rates, (viii) oxygenation, (ix) pH, and (x) shock state, including obstructive shock.

[0200] According to certain embodiments, method 750 further includes determining the system state algorithmically based on a change in onboard catheter data exceeding a predetermined threshold.

[0201] According to certain embodiments, the system state is determined with a machine learning model.

[0202] According to certain embodiments, the machine learning model is trained by tagging the treatment progress or treatment completion state with one or more training data sets. [0203] According to certain embodiments, the output comprises a label that describes clot engagement.

[0204] According to certain embodiments, the label is selected from the group consisting of clear, partially engaged, and engaged.

[0205] FIG. 8 is a system schematic of a thrombus removal system 800, according to aspects of the present disclosure. The system can include a thrombus removal device 802 that can include one or more sensors 830. As described herein, the sensors can include, but not be limited to, pressure sensors, flow sensors, or other sensors configured to measure conductance, admittance, or other parameters of a patient’s vascular or pulmonary system prior to, during, and after a thrombectomy procedure. The sensors can obtain measurements on demand continuously, or periodically.

[0206] The thrombus removal device 802 can be physically connected to a console 801, which can include a vacuum source and cannister 804, and a fluid source 806. One or more processors or electronic controllers 803 can be configured to control operation of the system 800 and device 802, including controlling aspiration and fluid delivery /jetting of the device. The electronic processors can be configured to execute instructions (e.g., software/firmware) stored on a non-transitory computing device readable medium to cause the system to aspirate target clots from a patient with the vacuum source and cannister 804 and deliver fluid streams/jets to a target thrombus with the fluid source 806. The one or more processors can receive measurements/sensor data from the one or more sensors 830, and use the measurements/sensor data to change a mode of operation of the thrombus removal device 802.

[0207] In some aspects, the one or more processors or electronic controllers 803 can be configured to execute instructions from one or more software modules. In the schematic of FIG. 8, the software modules can include an aspiration and jetting module 805 and a patient parameter analysis module 807. The aspiration and jetting module can provide control instructions to the vacuum source and cannister 804 and the fluid source 806. For example, the aspiration and jetting module can be configured to turn aspiration on and off, such as by controlling one or more valves in fluid communication between the vacuum source and the aspiration lumen of the thrombus removal device. Similarly, the aspiration and jetting module can be configured to turn jetting and/or irrigation on and off, such as by controlling the fluid source and any valves in fluid communication between the fluid source and the fluid lumen of the thrombus removal device. Additionally, the aspiration and jetting module can be configured to implement more advanced control schemes in both aspiration and jetting, including modulating or pulsing aspiration and/or jetting, and optionally controlling aspiration pressure and/or fluid pressure.

[0208] The patient parameter analysis module 807 can be electrically coupled to the one or more sensors 830. The patient parameter analysis module 807 can be configured to obtain and analyze the sensor data/measurements. In some aspects, the patient parameter analysis module 807 can include trained machine learning models configured to receive the sensor data as an input and provide an output that characterizes or provides insight into treatment progress and patient outcomes. For example, as described above, sensor data such as pressures (in the pulmonary artery, ventricle, atrium, etc.), volumetric flow rates, blood flow velocities, heart rate, vascular resistance, admittance, conductance, etc., can be provided as an input to the patient parameter analysis module which can then perform real-time hemodynamics analysis. The hemodynamics analysis can be used to determine treatment progress and/or completion. In some aspects, the hemodynamics analysis can be output to a user, such as on a display of the console 801. In other aspects, the hemodynamics analysis can be used by the one or more processors to change a mode of operation of the system 800 and thrombus removal device 802.

[0209] For example, in some aspects, the hemodynamics analysis may reveal that the thrombectomy procedure is complete. The output from the patient parameter analysis module 807 may trigger the aspiration and jetting module 805 to turn off aspiration and/or jetting of the thrombus removal device. In other aspects, the hemodynamics analysis may indicate or reveal that a clot is engaged with a funnel of the thrombus removal device. The output from the patient parameter analysis module 807 may trigger the aspiration and jetting module 805 to turn on jetting of the thrombus removal device when the clot is engaged. In other aspects, the hemodynamics analysis may indicate or reveal that no clot is engaged with a funnel of the thrombus removal device. The output from the patient parameter analysis module 807 may trigger the aspiration and jetting module 805 to turn off aspiration of the thrombus removal device when no clot is engaged to prevent unwanted aspiration of blood from the patient. Generally, the one or more processors 803 can use the software modules 805 and 807 to make a determination about system state, treatment progression, and/or patient outcomes, and control the thrombus removal device in a closed-feedback loop fashion based on the sensor measurements from sensor(s) 830 and the hemodynamics analysis performed by module 807.

[0210] FIG. 9 is an example of a console 902 of a thrombectomy system 900. The console can include, for example, features required for operation of a thrombectomy catheter including an aspiration or vacuum source (inside console), a fluid source (inside console), a clot catcher assembly 904, and one or more displays 906 configured for displaying one or more parameters or signals to a user, including displaying a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment. Additionally, the display(s) can display the baseline hemodynamics assessment to a user of the thrombectomy catheter system, the posttreatment hemodynamics assessment to a user of the thrombectomy catheter system, the baseline hemodynamics assessment and the post-treatment hemodynamics assessment to a user of the thrombectomy catheter system, the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system, the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system, the baseline dP/dt versus pressure curve and the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system, at least a portion of the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system, at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system, at least a portion of the baseline dP/dt versus pressure curve and at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system, and/or at least one numerical representation of a portion of the baseline dP/dt versus pressure curve or a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system. Any of the parameters or features described herein can be displayed on the console, including the dP/dt versus pressure curves, aspects or features of the dP/dt versus pressure curve, or numerical representations of the dP/dt versus pressure curves.

Systems for Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) [0211] As provided above, the present technology is generally directed to systems and methods for the treatment of CTEPH. Such systems include an elongated, steerable, introducer catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body. The introducer catheter can include one or more lumens disposed therein. One or more medical devices can be positionable within the one or more lumens of the introducer catheter. The medical devices can comprise, for example, dilators, angioplasty balloons, or thrombectomy catheters. The introducer catheter can further include one or more sensors for measuring parameters of a patient during a procedure, including but not limited to pressure sensors, flow sensors, or electrodes for measuring electrical characteristics and/or providing electrical stimulation and/or therapy.

[0212] In some embodiments, the systems herein are configured to navigate within a patient's vasculature and remove targeted clots from the patient and/or provide therapy to the vasculature including but not limited to stenting and/or balloon angioplasty. As used herein, “thrombus”, “clots”, and “embolism” are used somewhat interchangeably in various respects. It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.

[0213] Alternatively, according to additional embodiments of the present technology, the introducer catheter can provide one or more contrast-containing fluid streams for the introduction of a contrast agent or dye into the patient. The contrast-containing fluid streams can serve the purpose of providing visualization of the catheter procedure and clot(s) (e.g., in real-time during the procedure). For example, the contrast containing fluid streams can comprise a concentration of radiopaque material.

[0214] FIGS. 10A-10B illustrate a vascular access and treatment system 1000 that can include an introducer catheter 1002 and a medical device 1004 disposed within a lumen of the introducer catheter. The introducer catheter can include an elongate, steerable, flexible shaft and a distal end 1003 at the end of one or more lumens that runs along the shaft of the introducer catheter. The introducer catheter can include one or more sensors 1005 disposed along, in, or within the shaft 1001, including but not limited to pressure sensors, flow sensors, electrical sensors (electrodes), or any other sensor useful for measuring patient parameters during an intravascular procedure. In the example of FIGS. 10A-10B, the sensor 1005 can comprise a pressure sensor disposed near the distal end 1003.

[0215] The medical device 1004 can comprise any elongate medical device insertable into the lumen of the introducer catheter, including but not limited to balloon angioplasty catheters, dilators, or thrombectomy devices. As shown in FIG. 10 A, the medical device 1004 comprises a balloon angioplasty catheter with an elongate shaft 1006 and an expandable element or balloon 1008 on a distal end of the shaft. The balloon and/or shaft can include one or more lumens, e.g., for advancing the device 1004 along a guidewire. The balloon can be advanced out of the distal end 1003 of the introducer catheter and expanded within a target vasculature location to open blocked or narrowed arteries or veins. The balloon is shown inflated or partially inflated in FIGS. 10A-10B for ease of illustration, however it should be understood that in various embodiments, the balloon can be carried by the introducer catheter in a collapsed or uninflated state so as to reduce the profile of the balloon during delivery.

[0216] In FIG. 10A, a hub assembly 1010 such as a Touhy Borst is shown which can provide access for the medical device 1004 into the lumen of the steerable introducer catheter 1002 and include an injection port for fluidic connection a fluid or contrast source 1012. The injection port can direct the fluid or contrast into the lumen(s) of the introducer catheter. In the illustrated embodiment, the fluid or contrast source 1012 can comprise a contrast injector configured to automatically or manually deliver a controlled volume (e.g., bolus) of a contrast agent into the patient’s vasculature via the introducer catheter 1002. In some examples, injection of contrast from the injector into the hub assembly 1010 provides the contrast agent into the annular space between the introducer catheter 1002 and the medical device 1004 (e.g., within the lumen of the introducer catheter, between the introducer catheter shaft and the shaft 1006 of the medical device).

[0217] FIG. 10B shows the balloon 1008 of the medical device 1004 axially disposed out of a distal end 1003 of the introducer catheter 1002. In this example, contrast delivered by the fluid or contrast source 1012 into the lumen of the introducer catheter can still be delivered into the patient, even when the balloon is in an inflated state. In some examples, the balloon can disperse the contrast agent as it’s delivered past the balloon from the introducer catheter. Alternatively, a dilator device or other medical device can be inserted into the introducer catheter, as will be described below.

[0218] The fluid or contrast source 1012 (e.g., contrast injector) can be configured to automatically inject or deliver selected volumes or boluses of any contrast agent into the thrombus removal system to assist with imaging of the thrombus removal device and/or a target thrombus. In some embodiments, while the volumes and timing of contrast to be delivered by the injector are selected by a user or pre-selected, the injector can be configured to automatically and/or continuously deliver contrast at the selected volumes and frequency. In the illustrated embodiment, the fluid or contrast source can comprise a cradle assembly configured to receive one or more contrast injection syringe(s). The cradle assembly can include an automatic pusher or other mechanism configured to engage with the syringe to inject a contrast agent into the lumen(s) of the introducer catheter.

[0219] The system 1000 can employ control algorithms or protocols to provide consistent or controlled injection of fluid or contrast agent near the distal end of the introducer catheter. In some embodiments, the fluid or contrast source can be configured to inject a predetermined or pre-selected bolus or volume of fluid or contrast agent into the patient at the target location within the vasculature. For example, the fluid or contrast source may be configured to deliver a bolus of contrast agent (e.g., a 5ml bolus or “shot” of contrast) at a pre-determined time interval (e.g., every 3-5 seconds).

CTEPH Procedure

[0220] FIGS. 11A-11G illustrate a sequence of advancing a vascular access and treatment system into a subject’s vasculature for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The system can include the components described above, including an introducer catheter 1102 and a medical device 1104 carried by the introducer catheter. In some embodiments, access to the target treatment location can be aided by inserting a dilator device 1116 into the introducer catheter. The dilator device can optionally be removed from the introducer catheter to facilitate insertion of the medical device (e.g., balloon angioplasty catheter) into the introducer catheter. In the illustrated examples, CTEPH can be characterized in the subject by one or more pulmonary embolisms (PE) located in the pulmonary artery (PA) and/or narrowing of the pulmonary artery, segmental, and sub segmental branches of the PA.

[0221] In some embodiments, the sequence described in FIGS. 11 A-l 1G is performed immediately following a thrombectomy procedure in which at least a portion of one or more clots or obstructions are removed from the pulmonary arteries of the patient. In some embodiments, the thrombectomy system can provide a signal indicative of a treatment completion state after removing at least the portion of one or more clots or obstructions. In some examples, the signal provides an indication that the thrombectomy procedure was not successful or provided limited improvement in the patient disease state. In some embodiments, the signal provides a recommendation to follow the thrombectomy procedure with a CTEPH procedure.

[0222] Furthermore, in some embodiments, the sequence described in FIGS. 11 A-l 1G can be modified to use the same sheath to deliver a thrombectomy catheter to the pulmonary arteries prior to or after the CTEPH procedure. For example, the sheath can be navigated to the pulmonary arteries, and the thrombectomy catheter can be advanced through the sheath into the pulmonary arteries. If the system makes a determination that further intervention is required, the angioplasty balloon catheter of FIGS. 11 A-l 1G can then be advanced through the sheath to the same location, and navigated further distally within the pulmonary arteries to distal branches for the CTEPH procedure.

[0223] In FIG. 11 A, a guidewire 1114 can be inserted into the patient’s vasculature and advanced towards the PA in the patient. For example, the guidewire may be inserted into a femoral vein of the patient, and routed into the pulmonary artery via the right atrium (RA) and the right ventricle (RV). In some examples, the guidewire 1114 is passed through one or more thrombi or narrowed arteries in the subject.

[0224] Next, referring to FIG. 1 IB, a dilator 1116 can be inserted into the introducer catheter 1102, and the pair can be advanced into the patient over the guidewire. In FIG. 1 IB, the dilator 1116 is shown in the RV prior to being advanced into the PA.

[0225] FIG. 11C shows the dilator 1116 and introducer catheter 1102 advanced further over the guidewire into the pulmonary circulatory system, such as the pulmonary artery (PA). When the dilator and introducer catheter are in the pulmonary artery, a contrast media or agent can be delivered into the pulmonary artery, as shown. The contrast media can be, for example, a “puff’ or bolus of contrast media that can disperse within the pulmonary artery to provide imaging of any thrombi in the vicinity and/or any narrowed segments of the pulmonary artery or branches. In another embodiment, the contrast can be delivered continuously or in a “stream” such as to characterize blood flow as opposed to highlighting a clot.

[0226] In one embodiment, the contrast can be injected directly by the introducer catheter 1102 through one or more spaces between the dilator 1116 and the introducer catheter. As described above, a contrast injector can be fluidly coupled or connected to the annular space between the thrombus removal device shaft and the introducer catheter or sheath. The contrast injector can be configured to automatically and/or continuously deliver selected volumes of contrast agent into this annular space and through the dilator. Referring to FIG. 12, in one implementation, the dilator 1216 can include grooves 1218, slits, or ports, or openings in fluid communication with a contrast source to facilitate contrast injection from the introducer catheter 1202 when the dilator is in place. For example, contrast can be delivered through the lumen of the introducer catheter and between the dilator and the introducer catheter.

[0227] Referring back to FIG. 1 ID, the dilator can be removed from the introducer catheter 1102, leaving only the introducer catheter 1102 positioned at a location within the PA. In some embodiments, the introducer catheter can include one or more sensors 1105 (e.g., pressure, flow, etc.), positioned near a distal end of the introducer catheter. The sensor(s) 1105 can be configured to continuously or periodically obtain measurements from within the vasculature, such as within the PA.

[0228] In some embodiments, the sensor(s) can comprise pressure sensors configured to provide a baseline pulmonary artery pressure prior to a treatment procedure. In some examples, prior to performing a thrombectomy procedure, the pressure sensors can acquire a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system, which can be used by the system to derive a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time. After removing the at least one occlusion or partial occlusion, the system and sensor(s) can acquire a post-treatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system, and derive a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the post-treatment change in pulmonary artery pressure over time. In further examples, the system can provide a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment. The treatment completion state may indicate that the thrombectomy procedure was not successful or did not improve the patient’s disease state. In some examples, the signal provides a recommendation to perform further intervention such as a CTEPH procedure.

[0229] The pressure sensor can comprise, for example, a fiber optic pressure sensor. Other pressure sensor types are contemplated, including fluid column sensors. In some embodiments, the pressure sensor can be configured to continually or periodically monitor the PA pressure. During treatment (e.g., clot removal and/or balloon angioplasty), the pressure sensor can provide useful information on the status of the procedure. For example, during removal, the pressure sensor can be used to monitor blood pressure in the vessel to characterize the effectiveness of the procedure. Typically, the baseline pressure when the clot is present will be elevated because blood cannot pass the clot. The pressure can continually be monitored during the procedure, and as the pressure drops it provides an indication to the user that the treatment has been partially or fully successful. In one implementation, the system and sensor(s) can establish a baseline pressure within the patient and take measurements within the PA continuously or periodically. For example, a normal mean pulmonary artery pressure (mPAP) can be 14 +/- 3 mmHg with an upper limit of 20 mmHg. The sensor(s) of the system can be used to monitor the PA pressure during a procedure, and alert the user when the pressure falls below a treatment threshold (e.g., below 8, 10, 12, 14, or 16 mmHg) to suggest that the treatment is effective or partially effective. For example, pressures falling below the treatment threshold can indicate that the obstruction(s) have been cleared or normal blood flow has been restored.

[0230] The measured pressures can be indicated to a user, such as on a display of the system. For example, the display can present real-time pressure waveforms to guide the user/physician during the procedure. The display can further indicate an alert that indicates to the user/physician when the pressure has been restored to an acceptable level (e.g., below the threshold). The information can be presented to the user in other ways, including but not limited to audio signals and/or vibrations.

[0231] In FIG. 1 IE, a medical device 1104 can be advanced within the introducer catheter and passed through a distal opening of the introducer catheter 1102. In this example, a balloon angioplasty catheter is shown advanced out of the introducer catheter. The balloon 1108 is shown in an expanded or partially expanded view for ease of illustration. However, one of skill in the art understands that typically a balloon angioplasty catheter is only expanded when it is at the target location (e.g., a vessel or artery that is to be expanded). The medical device and the introducer catheter can be further advanced and steered towards the thrombi or narrowed arteries, as shown in FIG. 1 IF. While the example of FIG. 1 IF is shown in the left branch of the pulmonary artery, it should be understood that in a CTEPH procedure, the balloon angioplasty catheter would be advanced to narrower and more distal branches of the pulmonary arteries. In this example, the balloon of the medical device can be expanded in the desired branch of the pulmonary arteries to assist in the clot removal and/or to expand the narrowed arteries or vasculature. Pressure can be continuously or periodically monitored with the sensor(s) of the system during the procedure, as discussed above.

[0232] At this stage in the procedure, the user can optionally inject additional “puffs” or boluses of contrast agent into the vessel near the target location to visualize the clot, the narrowed arteries, and/or the position of the introducer catheter and/or medical device. The contrast agent can be delivered in the annular space between the thrombus removal device catheter and the introducer catheter. With the balloon 208 of the medical device deployed, the funnel can act to disperse the contrast agent near the thrombi. It should be noted that pressure measurements can be continuously or periodically taken within the PA during this and all other steps of the procedure.

[0233] In FIG. 11G, once the clot(s) have been removed or the narrowed arteries have been expanded, the balloon angioplasty catheter can be removed or retracted within the introducer catheter, and the introducer catheter can be retracted proximally within the patient. Another optional “puff’ or bolus of contrast agent can be delivered into the PA and former thrombus location or narrowed artery to confirm that the treatment has been effective. Pressure measurements can be made with pressure sensor 205 as needed. Once treatment is completed, the entire system including the introducer catheter can be removed from the patient.

Conclusion

[0234] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0235] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0236] Unless the context clearly requires otherwise, throughout the description and the examples, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to." As used herein, the terms "connected," "coupled," or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase "and/or" as in "A and/or B" refers to A alone, B alone, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may 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 associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS What is claimed is:

1. A method for patient assessment during and/or following thrombotic treatment, comprising: advancing a thrombectomy catheter system into a pulmonary artery branch of a subject; acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time; removing at least one occlusion or partial occlusion in the pulmonary artery branch with the thrombectomy catheter system; after removing the at least one occlusion or partial occlusion, acquiring a posttreatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the posttreatment change in pulmonary artery pressure over time; and providing a signal recommending a CTEPH procedure based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

2. The method of claim 1, wherein the baseline hemodynamics assessment comprises a baseline dP/dt versus pressure curve and wherein the post-treatment hemodynamics assessment comprises a post-treatment dP/dt versus pressure curve.

3. The method of claim 1, wherein the post-treatment hemodynamics assessment is derived while the thrombectomy catheter system is within the subject.

4. The method of claim 1, wherein the post-treatment hemodynamics assessment is derived within 30 minutes of removing the at least one occlusion or partial occlusion.

5. The method of claim 1, wherein the post-treatment hemodynamics assessment is derived within 60 minutes of removing the at least one occlusion or partial occlusion.

6. The method of claim 1, wherein: deriving the baseline hemodynamics assessment comprises generating a baseline dP/dt versus pressure curve; and deriving the post-treatment hemodynamics assessment comprises generating a posttreatment dP/dt versus pressure curve.

7. The method of claim 6, wherein the correlation is based on a change in amplitude in a region of the post-treatment dP/dt versus pressure curve representing diastolic drop.

8. The method of claim 6, wherein the correlation is based on a shift in mean pressure between the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve.

9. The method of claim 6, wherein the correlation is based on a change in maximum baseline dP/dt and maximum post-treatment dP/dt.

10. The method of claim 6, wherein the correlation is based on a change in a maximum baseline dP/dt delta and a maximum post-treatment dP/dt delta.

11. The method of claim 6, wherein the correlation is based on a shift in a mean pressure of the baseline dP/dt versus pressure curve and a mean pressure of the post-treatment dP/dt versus pressure curve.

12. The method of claim 6, wherein the correlation is based on a distribution of pressures at a given value of dP/dt (e.g., zero) of the baseline and post-treatment dP/dt versus pressure curves.

13. The method of claim 12, wherein the distribution is associated with a systolic phase of the subject’s cardiac cycle.

14. The method of claim 6, wherein the correlation is based on a post-treatment area within the post-treatment dP/dt versus pressure curve relative to a baseline area within the baseline dP/dt versus pressure curve.

15. The method of claim 1, further comprising displaying the signal to a user of the thrombectomy catheter system.

16. The method of claim 1, further comprising displaying the baseline hemodynamics assessment to a user of the thrombectomy catheter system.

17. The method of claim 1, further comprising displaying the post-treatment hemodynamics assessment to a user of the thrombectomy catheter system.

18. The method of claim 1, further comprising displaying the baseline hemodynamics assessment and the post-treatment hemodynamics assessment to a user of the thrombectomy catheter system.

19. The method of claim 6, further comprising displaying the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system.

20. The method of claim 6, further comprising displaying the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

21. The method of claim 6, further comprising displaying the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

22. The method of claim 6, further comprising displaying at least a portion of the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system.

23. The method of claim 6, further comprising displaying at least a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

24. The method of claim 6, further comprising displaying at least a portion of the baseline dP/dt versus pressure curve and at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

25. The method of claim 6, further comprising displaying at least one numerical representation of a portion of the baseline dP/dt versus pressure curve or a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

26. A thrombectomy system, comprising: an introducer sheath; a thrombectomy device adapted to be inserted into the introducer sheath to place the thrombectomy device within a pulmonary artery of a subject, the thrombectomy device including an aspiration lumen coupled to an aspiration source; a pressure sensor disposed on the introducer sheath and/or the thrombectomy device and configured to continuously or periodically measure a pulmonary artery pressure and/or a change in the pulmonary artery pressure over time for the subject; one or more processors configured to derive a baseline hemodynamics assessment from the measured pulmonary artery pressure and change in pulmonary artery pressure over time prior to removing an occlusion or partial occlusion from the subject, the one or more processors being configured to derive a post-treatment hemodynamics assessment from the measured pulmonary artery pressure and change in pulmonary artery pressure over time after removing the occlusion or partial occlusion from the subject, the one or more processors being further configured to provide a signal recommending a CTEPH procedure based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

27. The system of claim 26, further comprising a display, wherein the one or more processors are configured to display the signal on the display.

28. The system of claim 26, wherein the signal comprises a dP/dt versus pressure curve.

29. The system of claim 26, wherein the signal comprises a data representation of one or more components of a dp/dt versus pressure curve.

30. The system of claim 26, wherein the baseline hemodynamics assessment comprises a baseline dP/dt versus pressure curve and wherein the post-treatment hemodynamics assessment comprises a post-treatment dP/dt versus pressure curve.

31. The system of claim 26, wherein the one or more processors are configured to derive the post-treatment hemodynamics assessment while the thrombectomy catheter system is within the subject.

32. The system of claim 26, wherein the one or more processors are configured to derive the post-treatment hemodynamics assessment within 30 minutes of removing the at least one occlusion or partial occlusion.

33. The system of claim 26, wherein the one or more processors are configured to derive the post-treatment hemodynamics assessment within 60 minutes of removing the at least one occlusion or partial occlusion.

34. The system of claim 26, wherein: the one or more processors are configured to derive the baseline hemodynamics assessment comprises by generating a baseline dP/dt versus pressure curve; and the one or more processors are configured to derive the post-treatment hemodynamics assessment comprises by generating a post-treatment dP/dt versus pressure curve.

35. The system of claim 34, wherein the correlation is based on a change in amplitude in a region of the post-treatment dP/dt versus pressure curve representing diastolic drop.

36. The system of claim 34, wherein the correlation is based on a shift in mean pressure between the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve.

37. The system of claim 34, wherein the correlation is based on a change in maximum baseline dP/dt and maximum post-treatment dP/dt.

38. The system of claim 34, wherein the correlation is based on a change in a maximum baseline dP/dt delta and a maximum post-treatment dP/dt delta.

39. The system of claim 34, wherein the correlation is based on a shift in a mean pressure of the baseline dP/dt versus pressure curve and a mean pressure of the post-treatment dP/dt versus pressure curve.

40. The system of claim 34, wherein the correlation is based on a distribution of pressures at a given value of dP/dt (e.g., zero) of the baseline and post-treatment dP/dt versus pressure curves.

41. The system of claim 34, wherein the distribution is associated with a systolic phase of the subject’s cardiac cycle.

42. The system of claim 26, wherein the correlation is based on a post-treatment area within the post-treatment dP/dt versus pressure curve relative to a baseline area within the baseline dP/dt versus pressure curve.

43. The system of claim 27, wherein the signal comprises the baseline hemodynamics assessment to a user of the thrombectomy device.

44. The system of claim 27, wherein the signal comprises the post-treatment hemodynamics assessment to a user of the thrombectomy device.

45. The system of claim 27, wherein the signal comprises the baseline hemodynamics assessment and the post-treatment hemodynamics assessment to a user of the thrombectomy device.

46. The system of claim 27, wherein the signal comprises the baseline dP/dt versus pressure curve to a user of the thrombectomy device.

47. The system of claim 27, wherein the signal comprises the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

48. The system of claim 27, wherein the signal comprises the baseline dP/dt versus pressure curve and the post-treatment dP/dt versus pressure curve to a user of the thrombectomy device.

49. The system of claim 27, wherein the signal comprises at least a portion of the baseline dP/dt versus pressure curve to a user of the thrombectomy catheter system.

50. The system of claim 27, wherein the signal comprises at least a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

51. The system of claim 27, wherein the signal comprises at least a portion of the baseline dP/dt versus pressure curve and at least a portion of the post-treatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

52. The system of claim 27, wherein the signal comprises at least one numerical representation of a portion of the baseline dP/dt versus pressure curve or a portion of the posttreatment dP/dt versus pressure curve to a user of the thrombectomy catheter system.

53. A method for patient assessment following thrombotic treatment, comprising: advancing a thrombectomy system into a pulmonary artery of a subject; periodically or continuously measuring one or more of: pulmonary artery pressure and a change in the pulmonary artery pressure over a change in time with the thrombectomy system; advancing a P-V catheter into a right ventricle of the subject; periodically or continuously measuring right ventricular pressure, and a change in the right ventricular pressure over the change in time; initiating a thrombectomy procedure with the thrombectomy system; and determining a treatment effectiveness or treatment completion state based on a correlation between a change in the measured pulmonary artery pressure and the measured change in right ventricular pressure over the change in time.

54. The method of claim 53, further comprising providing an output of the system state to a user of the thrombectomy system, wherein the output provides guidance for clinical decision making based on assessment of one or more of: (i) original thrombus size and extent of obstruction, (ii) original or present thrombus location, (iii) extent of clot removed, (iv) systemic damage from the thrombus, (v) patient prognosis, (vi) a need for medical monitoring, (vii) recovery and treatment outcomes including extent of reperfusion, inflammatory responses, and reperfusion injury, and (viii) arterial compliance.

55. The method of claim 53, further comprising performing a pressure-volume loop analysis with the right ventricular pressure, right ventricular conductance, and/or a right ventricular admittance.

56. The method of claim 53, wherein the measuring and correlation is further based on a relationship between one or more of: (i) right ventricular strain/function, (ii) stroke volume, (iii) ventilation, (iv) perfusion, (v) indicators of elastin quantity and quality, (vi) imaging including fluoroscopy and CT pulmonary angiogram, (vii) flow rates, (viii) oxygenation, (ix) pH, and (x) shock state, including obstructive shock.

57. The method of claim 53, further comprising determining the system state algorithmically based on a change in onboard catheter data exceeding a predetermined threshold.

58. The method of claim 53, further comprising determining the system state with a machine learning model.

59. The method of claim 17, wherein the machine learning model is trained by tagging the system state with one or more training data sets.

60. The method of claim 13, wherein the system state comprises a label that describes clot engagement.

61. The method of claim 19, wherein the label is selected from the group consisting of clear, partially engaged, and engaged.

62. A thrombectomy system, comprising: an introducer sheath; a thrombectomy device adapted to be inserted into the introducer sheath to place the thrombectomy device within a pulmonary artery of a subject, the thrombectomy device including an aspiration lumen coupled to an aspiration source; a pressure sensor disposed on the introducer sheath and/or the thrombectomy device and configured to continuously or periodically measure a pulmonary artery pressure and/or a change in the pulmonary artery pressure over time of the subject; one or more processors; and memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer-implemented method comprising: acquiring a baseline pulmonary artery pressure and a baseline change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a baseline hemodynamics assessment of the subject from one or more characteristics of a relationship between the acquired baseline pulmonary artery pressure and the baseline change in pulmonary artery pressure over time; removing at least one occlusion or partial occlusion in the pulmonary artery branch with the thrombectomy catheter system; after removing the at least one occlusion or partial occlusion, acquiring a posttreatment pulmonary artery pressure and a post-treatment change in the pulmonary artery pressure over time with the thrombectomy catheter system; deriving a post-treatment hemodynamics assessment from one or more characteristics of a relationship between the acquired post-treatment pulmonary artery pressure and the posttreatment change in pulmonary artery pressure over time; and providing a signal indicative of a treatment completion state based a correlation between the baseline hemodynamics assessment and the post-treatment hemodynamics assessment.

63. The system of claim 62, further comprising performing a computer-implemented method that includes any of the method steps of claims 2-25.