Balloon encapsulation and isovolumetric suction thrombectomy catheter and methods thereof

Abstract

To provide an adjustable catheter system with isovolumetric suction and restoration of fluid for removal of a thrombus and a method of use thereof.SOLUTION: A catheter system includes an inner catheter and an outer sheath surrounding at least a portion of the inner catheter. The inner catheter may include at least three lumina extending from the proximal end to the distal end of the inner catheter, at least one infusion fenestration along an infusion segment, and a distal encapsulation balloon at the distal end. The outer sheath may include at least three lumina extending from the proximal end to the distal end of the outer sheath and a proximal encapsulation balloon at the distal end. The catheter system may further include an agitator for mechanical morcellation of a thrombus.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to balloon-encapsulated aspiration thrombectomy catheters and methods of use thereof. [Background technology]

[0002] Over the past two decades, the incidence and prevalence of deep vein thrombosis (DVT) and pulmonary embolism (PE) have increased due to the increased use of central venous catheters (CVCs), inferior vena cava (IVC) filters, and venous stenting. The most common risk factors for DVT and / or PE include age, obesity, pregnancy, pharmacological contraception, malignancy, and immobility. The pathogenesis of DVT and PE is characterized by a triad of Virchow venous thrombosis, venous injury, and hypercoagulability. Under these circumstances, thrombus foci may develop and propagate to points of reduced venous outflow—behind valves or at venous bifurcations—leading to organized trains of acute thrombi. Incomplete resolution can lead to further thrombus propagation, instability, fragmentation, chronic thromboembolic pulmonary hypertension (CTEPH), and venous thromboembolism (VTE). However, even if the thrombus is stable and propagation is prevented, the resulting residual occlusive chronic DVT within the venous structure can lead to post-thrombotic syndrome (PTS). Summary of the Invention [Problem to be solved by the invention]

[0003] The 2016 American College of Chest Physicians (ACCP) recommends initial treatment of acute DVT with low-molecular-weight heparin (LMWH) followed by therapeutic anticoagulation (AC) for patients, but this does not result in thrombolysis or prevent PTS. Endovascular techniques, such as catheter-directed thrombolysis (CDT), rheolytic drug-mechanical thrombectomy, and mechanical aspiration thrombectomy, each have advantages and disadvantages for treating VTE, but all have limited efficacy for treating PE.

[0004] Currently, there are no endovascular devices specifically designed for the treatment of massive (PE causing hemodynamic compromise) and submassive PE (PE causing cardiac dysfunction). Furthermore, recent evidence from various large, multicenter, randomized, controlled trials has called into question the efficacy of CDT endovascular devices. While CDT endovascular devices have been shown to reduce PTS, ultimately, they have not altered the quality of life of patients with proximal DVT. Notably, existing technologies have the following limitations: a lack of clot removal devices tailored to the iliac venous system, ineffective local thrombolysis leading to systemic dispersion, ineffective encapsulation of the clot during lysis to avoid VTE, and atraumatic thrombectomy to avoid vein wall damage and prolonged PTS.

[0005] Therefore, there is a need for viable and translatable treatment strategies for DVT and massive and submassive PE that minimize the risk of VTE and PTS in order to reduce the high morbidity associated with this condition. [Means for solving the problem]

[0006] (overview) The present disclosure provides a catheter system for removing a thrombus. In some embodiments, the catheter system can be used to treat PE. In one aspect, the catheter system can include an inner catheter having a proximal end, an infusion segment, and a distal end. The inner catheter can include at least one infusion window along the infusion segment and a distal encapsulation balloon at its distal end. The catheter system can also include an outer sheath having a proximal end and a distal end. The outer sheath can include a proximal encapsulation balloon at its distal end. The outer sheath surrounds at least a portion of the inner catheter. In some aspects, the catheter system further includes an agitator capable of agitating the thrombus.

[0007] In one embodiment, the inner catheter further comprises at least three lumens extending from the proximal end to the distal end of the inner catheter, e.g., an inflation lumen, a guidewire lumen, and an infusion lumen. In one embodiment, the infusion segment comprises a plurality of infusion windows fluidly connected to the infusion lumens.

[0008] In another embodiment, the outer sheath can further include at least three lumens extending from the proximal end to the distal end of the outer sheath, e.g., an inflation lumen, a suction lumen, and a catheter lumen. The inner catheter can be disposed within the catheter lumen.

[0009] In one embodiment, the agitator includes multiple protrusions. The agitator can be advanced and retracted through the catheter lumen. In another embodiment, the agitator can be a rotatable wire extending from the distal end of the outer sheath. The distal encapsulation balloon and the proximal can form a treatment region. The thrombus to be removed can be contained within the treatment region. The infusion segment is within the treatment region. In one embodiment, the inner catheter further includes a manifold at its proximal end, including an infusion port, a balloon inflation port, and a guidewire access port, each port fluidly connected to at least one lumen therein of the inner catheter. In another embodiment, the outer sheath further includes a manifold at its proximal end, including an aspiration port, a balloon inflation port, and a device access port, each port fluidly connected to at least one lumen therein of the outer sheath.

[0010] Further provided herein is a method for removing a thrombus in a patient in need thereof. In one aspect, the method may include inserting the catheter system of claim 1 into a treatment area, inflating a distal encapsulation balloon through an inflation lumen of the inner catheter, inflating a proximal encapsulation balloon through an inflation lumen of the outer sheath, mechanically lysing the thrombus with an agitator, injecting an infusion solution into the treatment area through at least one infusion window, applying negative suction to the treatment area through an aspiration lumen of the outer sheath, and removing the catheter system from the patient.

[0011] In one embodiment, the infusion solution is a thrombolytic solution, saline, or a combination thereof. The thrombolytic solution may include tPA. In one embodiment, negative suction may be applied for about 2 minutes. In another embodiment, mechanically lysing the thrombus includes advancing and retracting an agitator through the lumen of the catheter. In yet another embodiment, mechanically lysing the thrombus may include rotating the agitator. In one embodiment, greater than about 90% of the treated area is restored to luminal patency.

[0012] Also provided herein is a method of treating pulmonary embolism in a patient in need thereof, the method comprising advancing a catheter system from a femoral vein cannula or an internal jugular vein cannula.

[0013] Additional embodiments and features are set forth in part in the description which follows, and will become apparent to those skilled in the art upon examination of the specification or may be learned by practice of the disclosed subject matter. A further understanding of the nature and advantages of the present disclosure may be realized by reference to the remaining portions of the specification and drawings which form a part of this disclosure. [Brief explanation of the drawings]

[0014] The present specification will be more fully understood with reference to the following figures and data graphs, which are presented as various embodiments of the present disclosure and should not be construed as a complete recitation of the scope of the present disclosure.

[0015] [Figure 1] FIG. 1 is a perspective view of an intravascular catheter system relative to an intraluminal guidewire, in one embodiment. [Figure 2A] FIG. 2A is a side view of one embodiment of a catheter system positioned intraluminally with the agitator retracted. [Figure 2B]FIG. 2B is a side view of an intraluminal catheter system with an agitator positioned in the treatment area, according to one embodiment. [Figure 3] 3 is a side view of an inner catheter with an infusion port, a balloon inflation port, and a guidewire access port, according to one embodiment. The inner catheter also comprises an infusion segment with an infusion window and a distal encapsulation balloon. [Figure 4A] FIG. 4A is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4B] FIG. 4B is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4C] FIG. 4C is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4D] FIG. 4D is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4E] FIG. 4E is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4F] FIG. 4F is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 4G] FIG. 4G is a cross-sectional view of an inner catheter multi-lumen design with an infusion lumen, a guidewire lumen, and an inflation lumen in one embodiment. [Figure 5A] FIG. 5A is an end view of the infusion segment of the inner catheter. [Figure 5B] FIG. 5B is an isometric view of the infusion segment of the inner catheter. [Figure 6A] FIG. 6A is a side view of the distal encapsulation balloon of the inner catheter. [Figure 6B] FIG. 6B is a cross-sectional view of the distal encapsulation balloon of the inner catheter. [Figure 7] FIG. 7 is a side view of an outer sheath including a sheath body, an agitator, a proximal balloon, and an outer manifold with suction ports, balloon inflation ports, and device access ports, in one embodiment. [Figure 8A] FIG. 8A is a cross-sectional view of an outer sheath multi-lumen design with an inflation lumen, an aspiration lumen, and a catheter lumen in one embodiment. [Figure 8B] FIG. 8B is a cross-sectional view of an outer sheath multi-lumen design with an inflation lumen, an aspiration lumen, and a catheter lumen in one embodiment. [Figure 8C] FIG. 8C is a cross-sectional view of an outer sheath multi-lumen design with an inflation lumen, an aspiration lumen, and a catheter lumen in one embodiment. [Figure 9A] FIG. 9A is a side view of the distal encapsulation balloon of the inner catheter. [Figure 9B] FIG. 9B is a cross-sectional view of the distal encapsulation balloon of the inner catheter. [Figure 10] FIG. 10 is a side view of an intravenous catheter system with a cross-sectional view along the length of the catheter. [Figure 11] FIG. 11 is a side view of a combined manifold for an inner catheter and outer sheath. [Figure 12A] FIG. 12A is a side view of an agitator in one embodiment. [Figure 12B] FIG. 12B is a cross-sectional view of an agitator in one embodiment. [Figure 12C] FIG. 12C is a side view of an agitator in one embodiment. [Figure 12D] FIG. 12D is a cross-sectional view of an agitator in one embodiment. [Figure 12E] FIG. 12E is a side view of an agitator in one embodiment. [Figure 12F] FIG. 12F is a cross-sectional view of an agitator in one embodiment. [Figure 12G] FIG. 12G is an isometric view of an agitator in one embodiment. [Figure 12H] FIG. 12H is a perspective view of an agitator in one embodiment. [Figure 12I] FIG. 12I is a perspective view of an agitator in one embodiment. [Figure 12J] FIG. 12J is a side view of an agitator in one embodiment. [Figure 12K] FIG. 12K is a perspective view of an agitator in one embodiment. [Figure 13A] FIG. 13A is a cross-sectional view of an agitator designed to advance and retract through an outer device sheath lumen that houses an inner device catheter in one embodiment. [Figure 13B] FIG. 13B is a cross-sectional view of an agitator designed to advance and retract through an outer device sheath lumen that houses an inner device catheter in one embodiment. [Figure 13C] FIG. 13C is a perspective view of an agitator in one embodiment. [Figure 14] FIG. 14 is an isometric view of a catheter system in one embodiment. [Figure 15] Figure 15 is a graph comparing the catheter system with the Indigo® Penumbra catheter, showing that the catheter system can more efficiently remove thrombus in benchtop thrombectomy experiments. *p<0.01 [Figure 16A] Figure 16A is a graph of a fluent flow simulation of drag coefficients at various bristle angles. *p<0.01 [Figure 16B] Figure 16B is a graph of the fluent flow simulation of applied force at various bristle angles. *p<0.01 [Figure 16C] FIG. 16C shows benchtop testing of a 5-degree offset agitator, demonstrating clot drag and retention with a single pass of the agitator through the clot. DETAILED DESCRIPTION OF THE INVENTION

[0016] Detailed Description The present disclosure can be understood by reference to the following detailed description in conjunction with the drawings described below: It should be noted that, for clarity of illustration, certain elements in the various drawings may not be drawn to scale.

[0017] CDT and PCDT have ineffective local thrombolysis and result in systemic bleeding side effects. Another major limitation of CDT and PCDT compared with AC alone is a 1.5-fold increased risk of PE and a 2-fold increased need for an adjunctive IVC filter placement to avoid thromboembolism during treatment. Therefore, CDT and PCDT do not effectively encapsulate the treatment zone to avoid dangerous thromboembolism during the procedure. Mechanical aspiration thrombectomy aims to reduce the risk of PE. However, current aspiration thrombectomy devices have inappropriate calibers and lack proven efficacy for the treatment of DVT. The balloon encapsulation and isovolumic aspiration thrombectomy catheter provided herein overcomes all major gaps in current endovascular thrombectomy devices for the treatment of "large-volume" iliac vein DVT and massive and submassive PE. Therefore, the balloon encapsulation aspiration thrombectomy catheter can be used to efficiently remove venous clots from the pulmonary artery, vena cava, and iliac veins.

[0018] Disclosed herein are balloon-encapsulated aspiration thrombectomy catheter systems and methods for the treatment of extensive and sub-extensive PE, IVC, and iliac vein DVT. In one embodiment, the catheter system provides a minimally invasive solution for efficient and complete removal of "massive" thrombus from the pulmonary artery. The catheter system may include chemical, mechanical, and / or aspiration capabilities for maximum thrombus removal efficiency. In one embodiment, the catheter system may be less invasive than existing procedures and devices. For example, a percutaneously delivered 20Fr catheter system with isovolumic infusion and thrombus aspiration may provide less invasive manipulation of the pulmonary artery. The catheter system may reduce surgical risk to the patient by maintaining vascular integrity.

[0019] In one embodiment, the catheter system may have proximal and distal balloons for encapsulating thrombus in the treatment region. In some instances, proximal and distal thrombus balloon encapsulation of thrombus may reduce or prevent distal embolization. The distance between the proximal and distal balloons may be adjustable, thus creating an adjustable treatment region that can be used to accommodate a wide range of venous treatment lengths. In another embodiment, the catheter system may perform local isovolumic aspiration thrombectomy. The catheter system may provide localized catheter-based thrombolysis in the treatment zone, which may reduce the risk of bleeding. The catheter system may also provide localized mechanical thrombectomy using an agitator. In yet another embodiment, the catheter system may provide mechanical agitation of thrombus with an agitator to facilitate removal via isovolumic aspiration and restoration of fluid in the treatment region.

[0020] In one embodiment, the agitator and suction features of the catheter system can facilitate complete thrombus removal, hi some embodiments, the catheter system can facilitate at least 90%, at least 95%, at least 98%, at least 99%, or at least 100% thrombus removal.

[0021] In one embodiment, the catheter system can minimize the length and uncertainty of a procedure. In some embodiments, the length of a procedure using the catheter system can be up to 30 minutes, up to 45 minutes, up to 1 hour, or up to 2 hours. In various embodiments, the catheter system can be used in multiple blood vessels throughout the body, including, but not limited to, the pulmonary artery, vena cava, iliac vein, femoral vein, right atrium, jugular vein, and / or popliteal vein.

[0022] Catheter System In some examples, the catheter system includes an inner catheter, an outer sheath, and / or an agitator. The inner catheter has a proximal end, an infusion segment, and a distal end. The inner catheter further has at least one infusion window along the infusion segment and a distal encapsulation balloon at the distal end. The outer sheath has a proximal end and a distal end. The outer sheath further includes a proximal encapsulation balloon at the distal end. In some examples, the outer sheath surrounds at least a portion of the inner catheter, and the distal encapsulation balloon and the proximal encapsulation balloon are separated by a distance along the infusion segment.

[0023] FIG. 1 shows the distal end of a catheter system 100 relative to an intraluminal guidewire 112. The catheter system 100 includes an inner catheter 101, a distal balloon 104, an outer sheath 106, a proximal balloon 108, and an agitator 110. FIG. 2A is a side view of the intravascular catheter system 100 with the proximal balloon 108 and distal balloon 104 deployed to create a treatment area with an infusion segment 102, and the agitator retracted within the outer sheath 106. FIG. 2B is a side view of the intravascular catheter system 100 with the proximal balloon 108 and distal balloon 104 deployed to create a treatment area with an infusion segment 102, and the agitator 110 deployed intraluminally.

[0024] Figure 3 shows an inner catheter 101 having a manifold 114, a distal encapsulation balloon 104, and an infusion segment 102 with infusion windows 116. The manifold 114 includes an infusion port 115, a balloon inflation port 117, and a guidewire access port 119. Figures 4A-4G are optional cross-sectional views of the multi-lumen design of the inner catheter 101 with an infusion lumen 103, a guidewire lumen 105, and an inflation lumen 107. Figures 5A and 5B show the infusion segment 102 of the inner catheter 101 with a staggered arrangement of infusion windows 116.

[0025] FIG. 7 shows the outer sheath 106, including the outer manifold 118, sheath body 120, agitator 110, and proximal balloon 108. The outer manifold 118 can include an aspiration port 121, a balloon inflation port 123, and a device access port 125. FIGS. 8A-8C are cross-sectional views of the multi-lumen design of the outer sheath 106, with an inflation lumen 109, an aspiration lumen 111, and a catheter lumen 113. FIGS. 3A-3G are examples of the agitator 110 advancing and retracting through the outer sheath lumen that houses the inner catheter. FIG. 10 shows a catheter system within a blood vessel, providing cross-sections of the inner catheter and outer sheath at various points along the catheter system.

[0026] In some instances, the manifold 114 for the inner catheter and the outer manifold 118 for the outer sheath can be connected together to form one combined manifold, as shown in FIG. 11 . The various ports can be operated as follows: A guidewire is advanced through the thrombus in front of the catheter system and through the guidewire port. With all ports sealed, the catheter system is moved to a location proximal to the thrombus. The proximal balloon inflation port 123 is opened and the proximal encapsulation balloon 108 is inflated. The proximal balloon inflation port 123 is then closed. The Tuohy valve sealing the inner catheter is released and the inner catheter is advanced distal to the thrombus (4 cm length of treatment zone). The inner catheter Tuohy valve is then sealed. The valve at the distal balloon inflation port 117 is opened and the distal balloon 104 is inflated. The distal balloon inflation valve is then closed.

[0027] The sequence of the following operations can be based on the operator's discretion, using available options for mechanically and / or chemically agitating the clot. The valves for the injection port 115 and the aspiration port 121 can be opened, and lytics can be injected through the injection port 115, while an equal amount of fluid can be removed through the aspiration port 121 to maintain isovolumic conditions within the treatment area. Both the aspiration and injection ports 121, 115 can be closed, and the mechanical agitator 110 can be moved along the treatment area through the device access port 125. In some examples, the device access port can be a push-rod Tuohy valve.

[0028] At the operator's discretion, these steps can be repeated any number of times, possibly with saline injection through the injection port to ensure no lytics remain in the patient after removal of the catheter system. The inflation port 117 is opened and the distal balloon 104 is deflated. The distal balloon inflation port 117 is then closed. The Tuohy valve at the device access port 125 is opened and the inner catheter 101 is retracted into the outer sheath 106. The Tuohy valve is then closed. The proximal balloon inflation port 123 is opened, the proximal balloon 108 is deflated, and the proximal balloon inflation port 123 is closed. The catheter system is retracted over the guidewire and removed from the patient. The guidewire is then removed, completing the procedure.

[0029] The catheter system may be operated percutaneously and introduced into a vein using the Seldinger technique (a method of introducing catheters and catheter-based devices into blood vessels from outside the body over a wire). In one embodiment, the catheter system may be flexible to facilitate advancement from either a femoral vein cannula or an internal jugular vein cannula.

[0030] Micro- and macroemboli during venous thrombectomy procedures are particularly dangerous and can lead to fatal PE. Use of a typical thrombectomy device has been shown to generate more than 300,000 particles between 10 and 100 μm in size, fewer than 1,000 particles between 100 and 1,000 μm in size, and fewer than 20 particles larger than 1 mm. In one embodiment, the proximal and distal balloon encapsulation design of the catheter system minimizes embolism of thrombus particles.

[0031] As seen in Figures 1, 2A, and 2B, the catheter system has a tandem balloon encapsulation design with proximal and distal encapsulation balloons that conform around the intraluminal thrombus. This adjustable dual-balloon design maintains cradle and capture of the intraluminal thrombus, thereby reducing the risk of thromboembolism during the procedure, facilitating thrombus containment within the device's proximal aspiration port, reducing the risk of imprecise treatment of specific venous segments and systemic leakage of thrombolytic agents, and minimizing trauma to the vessel wall.

[0032] Adjusting the distance between the proximal and distal encapsulation balloons allows for the adjustment of the thrombolytic treatment region between the balloons. In some instances, the distance between the proximal and distal encapsulation balloons is determined based on how far the inner catheter can extend beyond the outer sheath. The treatment region is then established by inflation of both the proximal and distal encapsulation balloons. This secures the catheter system in place within the vessel. In various instances, the length of the treatment region can range from approximately 1 cm to approximately 25 cm. In one example, the treatment region can be approximately 4 cm long. The thrombus being removed is contained within the thrombolytic treatment region. Furthermore, the infusion segment of the inner catheter is within the thrombolytic treatment region. The variable length of the treatment region can accommodate various clot shapes and provides the freedom to treat clots in stages.

[0033] The catheter system may further facilitate the release of fluid through the infusion segment of the inner catheter. In some examples, the fluid may include a thrombolytic agent and / or a contrast agent. In one embodiment, the thrombolytic agent may be injected through an injection window in the infusion segment of the inner catheter of the catheter system.

[0034] The inner catheter and outer sheath are operable to provide isovolumic aspiration and recovery of fluid within the thrombolytic treatment area. For example, the catheter system further utilizes isovolumic aspiration for the removal of thrombus from the treatment area. The catheter system includes both an inner catheter infusion port (FIG. 3) and an outer sheath negative suction port (FIG. 7), which allow fluid access to and from the treatment area. The inner catheter infusion port is intended to facilitate both the administration of thrombolytic drugs and to provide an inflow saline circuit to prevent venous wall collapse during negative suction of the outer sheath. In one embodiment, the inner catheter can be used as both a thrombolytic infusion catheter and a saline infusion port to facilitate isovolumic aspiration of thrombus from the venous treatment area. The outer sheath aspiration port may include a large aspiration lumen to rapidly remove clot debris and accommodate various negative suction strengths.

[0035] The catheter system further includes an agitator, such as a bristle morcellator, for mechanically agitating the thrombus. The built-in agitator / morcellator design can increase the efficiency of the catheter system in fragmenting and expelling the thrombus. The agitator can be used to bind the thrombus, fragment the thrombus, and draw the thrombus into the mechanical aspiration thrombectomy port. Agitating the thrombus can avoid contact with and damage to the vessel wall.

[0036] Inner Catheter The catheter system 100 includes an inner catheter 101. The inner catheter has a proximal end, an infusion segment, and a distal end. In one embodiment, the inner catheter includes at least three lumens, at least one infusion window along the infusion segment, and a distal encapsulation balloon at the distal end of the inner catheter. The inner catheter may further include a manifold at its proximal end including an infusion port, a balloon inflation port, and a guidewire access port, each port fluidly connected to at least one of the lumens in the inner catheter.

[0037] As seen in Figures 4A-4G, the at least three lumens of the inner catheter can include, but are not limited to, an inflation lumen 107, a guidewire lumen 105, and an infusion lumen 103. These lumens extend from the proximal end to the distal end of the inner catheter, and each is fluidly connected to one of the ports at the proximal end of the inner catheter. For example, the inflation lumen is fluidly connected to a balloon inflation port, the guidewire lumen is fluidly connected to a guidewire access port, and the infusion lumen is fluidly connected to an infusion port. In some examples, as shown in Figure 11, a manifold with a balloon inflation port, a guidewire access port, and an infusion port can be combined with an outer manifold of the outer sheath.

[0038] Figures 4A-4G show example cross sections of the inner catheter. Generally, the infusion lumen is the largest of the three lumens within the inner catheter. In some instances, the inner catheter includes a large "D-shaped" infusion lumen and, below that, twin lumens for the guidewire and inflation of the distal balloon. The guidewire may be the only lumen exiting the inner catheter along the centerline and passing through the distal balloon.

[0039] The inner catheter may have an outer diameter of about 4 French to about 7 French. In one embodiment, the inner catheter may have an outer diameter of about 5.5 French. The inner catheter may have a length ranging from about 60 cm to about 160 cm. In one embodiment, the inner catheter has a length of about 100 cm from the distal end of the manifold to the distal end of the distal encapsulation balloon.

[0040] The infusion segment 102 of the inner catheter 101 includes at least one window 116 fluidly connected to an infusion lumen to allow infusion of a fluid into the treatment area. In some examples, the fluid is an infusion solution. In one embodiment, infusion solution introduced into the infusion port travels through the infusion lumen and exits the inner catheter at the at least one window. In some embodiments, the infusion solution is a thrombolytic solution, saline, or a combination thereof. In one embodiment, the infusion solution can be introduced into the inflation port using a syringe.

[0041] In one embodiment, the infusion window has a diameter of about 0.01 inches to about 0.5 inches. In one example, the window has a diameter of about 0.02 inches. In some examples, the window has a diameter of less than 0.5 mm. In another example, the window diameter is about 0.4 mm. The number of infusion windows along the length of the infusion segment can vary from about 1 to about 5 windows per cm of infusion segment. In some examples, the windows can be spaced about 2 mm apart. In one example, a treatment area of ​​about 4 cm with 0.4 mm diameter windows spaced 2 mm apart in a staggered pattern would result in a total of 21 windows.

[0042] The windows may be in a staggered formation or in an ordered formation. An infusion segment may include infusion windows along the right, top, and left faces of the inner catheter. In one example, the infusion windows are separated from each other along each face at equal distances from each other and alternate among the three faces by starting the spacing pattern slightly further on each face.

[0043] In one embodiment, lytics may be infused into a 4 cm long treatment area along three lines of 0.4 mm outer diameter infusion windows oriented along the top, right, and left faces of the inner catheter's infusion segment. Along each of the three lines, each window may be approximately 6 mm apart along its centerline, while each window may be approximately 2 mm apart from its counterpart on the adjacent face. For example, windows may be present on the right face and on the top face, spaced approximately 2 mm apart along the length of the inner catheter. This allows infusion along three faces while maintaining the structural integrity of the inner catheter. These windows span the entire length of the infusion segment of the treatment area and, together with the aspiration lumen of the outer sheath, help maintain isovolumic conditions by regulating the fluid volume throughout the treatment area.

[0044] The guidewire lumen is configured to accept a guidewire so that the catheter system can be inserted into a patient using standard catheter introduction techniques. In various embodiments, the guidewire lumen has a diameter of about 0.02 inches to about 0.1 inches. In one embodiment, the guidewire lumen has a diameter of about 0.038 inches. In one example, as seen in FIGS. 4A-B and 4E-4G, the guidewire lumen 105 can be concentric with or centrally located within the inner catheter 101. In other examples, the guidewire lumen 105 can be off-center within the inner catheter 101.

[0045] The inflation lumen 107 may be fluidly connected to the distal encapsulation balloon 104 at the distal end of the inner catheter. For example, fluid may be introduced through the inflation port, travel through the inflation lumen, and inflate the distal encapsulation balloon. In some embodiments, the fluid may be saline, a biocompatible fluid, atmosphere, and / or pressurized air. In one embodiment, the fluid may be introduced into the inflation port using a syringe.

[0046] The distal encapsulation balloon may have an average diameter of about 5 mm to about 30 mm. In one embodiment, the distal encapsulation balloon may have a diameter of about 15 mm. The distal encapsulation balloon may have a cylindrical, conical, elliptical, or circular shape. For example, the distal encapsulation balloon 104 may have a substantially cylindrical shape with tapered ends, as seen in FIGS. 6A and 6B. In some aspects, the distal encapsulation balloon may have a combination of shapes. For example, as seen in FIG. 3, the proximal portion of the distal encapsulation balloon may be substantially cylindrical, and the distal portion of the distal encapsulation balloon may have a tapered or conical shape. In various embodiments, the distal encapsulation balloon may have a length of about 1 cm to about 5 cm. In one embodiment, the distal encapsulation balloon may have an overall length of about 1.5 cm. In one embodiment, the proximal end of the distal encapsulation balloon may be concave. The distal encapsulation balloon may have a proximal concavity of about 5° to about 15°. In one embodiment, the distal encapsulation balloon may have a concavity of about 10°.

[0047] The distal encapsulation balloon may be a compliant balloon operable to accommodate various vessel sizes and minimize vessel trauma or damage. The distal encapsulation balloon may be made of polyethylene terephthalate (PET), polyurethane, or any other biocompatible polymer that can be expanded to an appropriate diameter.

[0048] Outer sheath The catheter system 100 further includes an outer sheath 106 with a proximal encapsulation balloon 108, as seen in FIG. 7 . The outer sheath has a proximal end and a distal end. In one embodiment, the outer sheath includes at least three lumens extending from the proximal end to the distal end of the outer sheath, with the proximal encapsulation balloon 108 at the distal end. The outer sheath also includes a manifold 118 at its proximal end, with a suction port 121, a balloon inflation port 123, and a device access port 125, each fluidly connected to at least one of the lumens in the outer sheath. The outer sheath may have an approximate "power symbol" design, with a consistent wall thickness for structural stability and larger lumens for the balloons within "rails" that ride along the length of the outer sheath.

[0049] 8A-8C, the outer sheath can include an inflation lumen 109, an aspiration lumen 111, and a catheter lumen 113. These lumens extend from the proximal end to the distal end of the outer sheath and are each fluidly connected to one of the ports at the proximal end of the outer sheath. For example, the inflation lumen is fluidly connected to a balloon inflation port, the aspiration lumen is fluidly connected to an aspiration port, and the catheter lumen is fluidly connected to a device access port.

[0050] The outer sheath can have an outer diameter of about 10 French to about 26 French. In one embodiment, the outer sheath has an outer diameter of about 20 French. In another embodiment, the outer sheath can have an inner diameter of about 18 French. The outer sheath can have a length ranging from about 50 cm to about 150 cm. In one embodiment, the outer sheath has a length of about 65 cm from the distal end of the manifold to the distal end of the proximal encapsulation balloon. In some embodiments, the outer sheath has a length shorter than that of the inner catheter. For example, only a portion of the inner catheter is covered by the outer sheath. This allows the distal encapsulation balloon on the inner catheter and the proximal encapsulation balloon on the outer sheath to surround the thrombus in the treatment area.

[0051] The catheter lumen is configured to receive the inner catheter such that at least a portion of the inner catheter is surrounded by the outer sheath. In this embodiment, the proximal portion of the inner catheter prior to the infusion segment is covered by the outer sheath. In various embodiments, the catheter lumen has a diameter of about 4 French to about 22 French. In one embodiment, the catheter lumen has an inner diameter of about 5.5 French. The catheter lumen may have an outer diameter of about 7.5 French. In one embodiment, the catheter lumen may be concentric with or centrally located within the outer diameter of the outer sheath, as seen in Figures 8A-8C. The inner catheter may be inserted into the catheter lumen at the device access port.

[0052] The inflation lumen can be fluidly connected to the proximal encapsulation balloon at the distal end of the outer sheath. For example, fluid can be introduced through the inflation port, travel through the inflation lumen, and inflate the proximal encapsulation balloon. In some embodiments, the fluid can be saline, a biocompatible fluid, atmosphere, or pressurized air. In one embodiment, the fluid can be introduced into the inflation port using a syringe. In various embodiments, the inflation lumen can have a diameter of about 1 French to about 4 French. In one embodiment, the inflation lumen has a diameter of about 2 French.

[0053] The proximal encapsulation balloon can have an average diameter of about 10 mm to about 30 mm. In one embodiment, the proximal encapsulation balloon has a diameter of about 15 mm. The proximal encapsulation balloon can have a cylindrical, conical, elliptical, or circular shape. In some aspects, the proximal encapsulation balloon can have a combination of shapes. For example, as seen in FIGS. 9A and 9B, the distal portion of the proximal encapsulation balloon 108 can be cylindrical in shape, while the proximal portion of the proximal encapsulation balloon can be tapered or conical. In various embodiments, the proximal encapsulation balloon can have a length of about 1 cm to about 3 cm. In one embodiment, the proximal encapsulation balloon can have an overall length of about 1.5 cm. In one embodiment, the distal end of the proximal encapsulation balloon can be concave. The distal encapsulation balloon can have a proximal concavity of about 5° to about 15°. In one embodiment, the distal encapsulation balloon can have a proximal concavity of about 10°. The proximal encapsulation balloon may be made of polyethylene terephthalate (PET), polyurethane, or any other biocompatible polymer that can be expanded to an appropriate diameter.

[0054] The suction lumen can surround the catheter lumen. In various embodiments, the suction lumen can have a diameter of about 11 French to about 22 French. In one embodiment, the suction lumen has a diameter of about 18 French. The suction lumen is fluidly connected to the suction port so that negative suction can be applied to the suction port to draw up material in the treatment area at the opening of the suction lumen at the distal end of the outer sheath. In various embodiments, the applied suction can range from about 0 kPa to about 150 kPa. In some instances, the applied suction can range from about 0 kPa to about 15 kPa. The suction applied through the suction lumen is balanced with the infusion of infusion solution through the infusion window.

[0055] Mixer The catheter system may provide localized mechanical thrombolysis using an agitator operable to agitate or morcellate the thrombus. Morcellation may be used to locally fragment the thrombus. The agitator may be used to mechanically break down large thrombi so that they can be aspirated through the aspiration lumen or contained between the proximal and distal encapsulation balloons when the catheter system is removed from the patient.

[0056] As seen in Figures 1 and 2B, the agitator can extend from the distal end of the outer sheath into the treatment area to morsel the thrombus. In some embodiments, the outer sheath surrounds the agitator. In one embodiment, the agitator advances and retracts across the catheter lumen of the outer sheath. For example, the agitator can be railed to the catheter lumen and the outside of the inner catheter to maintain its movement along the centerline of the vasculature. In this example, the agitator can be within the aspiration lumen when retracted within the outer sleeve. In some examples, the agitator can be manipulated for use without touching the vessel wall. Figures 13A-13E show end or cross-sectional views of various agitators 110 railed onto the outer diameter of the catheter lumen 113 of the outer sheath so that they are inside the aspiration lumen 111 when retracted.

[0057] In one embodiment, the agitator may include multiple protrusions extending radially from a central ring. The protrusions may be fins, bristles, rods, cylinders, rectangular, or curved. In one embodiment, as seen in Figures 12A-12K, the agitator protrusions may be fins, rods, or cylinders. The protrusions may be distributed in a spiral pattern along the length of the agitator. In one embodiment, the central ring is a partial ring that partially surrounds the catheter lumen to allow for rail mounting of the agitator. In some examples, the protrusions are located at the distal end of the central ring, and the central ring extends a length along the outer sheath to allow for actuator activation or deployment, as seen in Figure 14. In some examples, the agitator may have a length of at least about 15 cm.

[0058] The projections can have a radial extension length of about 1 mm to about 5 mm. In some examples, the projections can be at a pitch angle operable to reduce shear stress on the vessel. The pitch angle can range from about 5 degrees to about 65 degrees. In one example, the pitch angle can be about 30 degrees. In another example, the pitch angle can be about 15 degrees. In one embodiment, the density and angle of the projections can be optimized so that the projections exert increased mechanical traction on the thrombus to enhance its morcellation.

[0059] In some examples, the protrusions can be fins extending along the length of the central ring, as seen in Figures 12A-12G. In some examples, the fins can be tapered or have a conical appearance toward the distal end of the agitator, as seen in Figures 12C-12F. The agitator fins can be at 5, 10, 15, 20, 25, 30, or 90 degrees relative to the central curve of the vertical axis. For example, Figures 12A-12D show fins with a pitch angle of 0 degrees, while Figures 12E-12F show fins with a pitch angle of 30 degrees. In some examples, as seen in Figures 12H-12I, the fins can be rounded to form a semi-spiral along the length of the central ring. In an additional example, as seen in Figure 12J, the rod-like protrusions can be offset along the length of the central ring. The agitator can include variations of the finned (bolt) design and can be lined with reinforcing regions of similar material. This region may include a "strain relief" section, allowing the agitator to rest on rails within the outer sheath even when fully extended into the treatment area, while also allowing flexibility of the catheter that may be hindered by a solid agitator longer than 15 cm.

[0060] In one example, a mechanical agitator consists of seven fins, each 0.4 mm wide and 1 mm high, radiating from a central ring. The fin portion of the agitator can be 1 cm long, with the front of each fin at a 20-degree angle. Each fin is "rotated" at 5 degrees from the agitator's centerline, and this angle combination has been shown to improve engagement with thrombus. The agitator can be connected to an inner catheter that runs along the catheter lumen of the outer sheath by three wires attached to the left, right, and bottom surfaces of the agitator. This allows the agitator to follow the curves of the catheter, allowing for flexibility in the overall catheter system.

[0061] In another embodiment, the agitator is at least one protrusion or rod that extends into the treatment area. For example, the agitator can be a single curved rod or wire, as seen in Figure 12K. For example, a cleaner wire can be threaded through the device access port. In this embodiment, the catheter system can have only an outer sheath or catheter, a proximal balloon, and a cleaner wire.

[0062] Methods for removing blood clots Provided herein is a method of treatment using a catheter system. In one embodiment, the catheter system is used to treat PE. For example, the catheter system can be advanced from a femoral vein cannula or an internal jugular vein cannula. The catheter system can then be deployed to inflate an encapsulation balloon, agitate the thrombus, and remove the thrombus by using isovolumic suction and fluid restoration.

[0063] Also provided herein is a method for removing a thrombus in a patient in need thereof. The method can include inserting a catheter system into a treatment area containing a thrombus. The distal encapsulation balloon can then be inflated through an inflation lumen of the inner catheter, and the proximal encapsulation balloon can then be inflated through an inflation lumen of the outer sheath. The inflated distal and proximal encapsulation balloons expand such that they encapsulate or surround the thrombus to be removed.

[0064] To aid in the removal of the thrombus, the method may include localized mechanical thrombolysis using an agitator. Morcellation may be used to locally fragment the thrombus. This may involve mechanically moving an agitator in, out of, and / or around the treatment area to break up the thrombus. In one embodiment, morcellating involves advancing and retracting an agitator across the catheter lumen so that the agitator prongs move within the treatment area. The agitator of the catheter system may be advanced into the thrombus segment in a controlled manner.

[0065] The method may further include applying isovolumic suction and fluid restoration to the treatment area. Local negative suction may be applied to the treatment area through the suction lumen of the outer sheath. The negative suction may provide at least partial removal of the thrombus through the suction lumen. The negative suction may also allow for retention of the thrombus within the treatment area, i.e., between the encapsulation balloons. The suction port may be attached to a negative suction pump capable of delivering a pure vacuum of approximately 5-40 inHg or approximately 17-135 kPa. The negative suction pump may be attached to a reservoir canister / bag to collect the thrombus. In one embodiment, the reservoir canister / bag may be 1,000 mL.

[0066] In various embodiments, negative suction can be applied for less than about 30 seconds, about 30 seconds, about 1 minute, about 2 minutes, about 5 minutes, or more than 5 minutes. In one embodiment, negative suction is applied for about 2 minutes. To counteract the negative suction within the treatment area, the method can also include injecting an infusion solution into the treatment area through at least one infusion window. The infusion solution can be a thrombolytic solution, saline, or a combination thereof. The infusion solution can also work in combination with an agitator to break up the thrombus for removal.

[0067] The method may optionally include infusing a thrombolytic agent through the inner catheter for localized chemical thrombolysis. An infusion window in the inner catheter may facilitate release of the thrombolytic agent at the infusion segment or distal end of the inner catheter. In one embodiment, the thrombolytic agent may be tissue plasmogen activator (tPA). The concentration of the thrombolytic agent may range from about 1 mg / mL to about 40 mg / mL. In various embodiments, the concentration of the thrombolytic agent released by the catheter system may be about 1 mg / mL, about 5 mg / mL, about 10 mg / mL, about 20 mg / mL, about 30 mg / mL, or about 40 mg / mL. For example, the tPA concentration may be about 5-20 mg / mL in about 20-200 mL of blood.

[0068] The method may further include removing the catheter system from the patient. When the catheter system is removed, the proximal and distal encapsulation balloons may remain inflated so that the remaining portion of the thrombus remains encapsulated between the balloons when the system is removed from the patient. In various embodiments, after removing the thrombus with the catheter system, greater than about 80% lumen patency is restored, greater than about 85% lumen patency is restored, greater than about 90% lumen patency is restored, greater than about 95% lumen patency is restored, or greater than about 99% lumen patency is restored in the treatment area. In one embodiment, greater than about 90% lumen patency is restored in the treatment area.

[0069] In another embodiment, a catheter system including an outer sheath / catheter, a proximal balloon, and an agitator can be utilized. In this embodiment, the outer catheter can be advanced proximal to the thrombus. The proximal balloon can then be inflated for proximal fixation and cessation of PA inflow. An agitator (such as a cleaner wire) can then be advanced from the device access port. Negative retrograde suction can then be initiated with rotation of the cleaner wire to initiate fragmentation of the thrombus.

[0070] In one embodiment, the catheter system provides minimally invasive and efficient removal of "high-volume" thrombi from iliac vein segments. In some embodiments, the catheter system provides recovery of at least about 90%, at least about 95%, at least about 98%, at least about 99%, or nearly 100% of intravenous thrombi. In one embodiment, the catheter system can minimize the risk of trauma to the venous lumen and endothelium. The catheter system may also be compatible with existing catheter-based platforms and technologies. In one embodiment, the catheter system has the ability to effectively fragment and expel intraluminal thrombi. For example, the following example demonstrates that the design of the catheter system is superior to the Indigo® catheter in engaging and expelling thrombi (Figure 15). [Example]

[0071] Example Example 1: Preliminary comparative analysis of prototype aspiration thrombectomy efficiency A balloon-encapsulated endovascular thrombectomy catheter system (referred to herein as Hydra) was tested using the methods of the following example. A custom morphing polyethylene terephthalate (PET) balloon was developed. A bench-top IVC luminal thrombosis model was developed for initial comparative testing of the Hydra catheter and the Indigo® Penumbra catheter. 5 cm 3Subacute thrombi were captured using a Hydra catheter and an Indigo® Penumbra catheter with negative suction of 70 kPA. Over a 1-minute period, the Hydra catheter was more effective at removing thrombi (p<0.01; Figure 15).

[0072] Example 2: Stirrer Analysis To test several designs of agitator and agitator fins, the angle was varied at 5, 10, 15, and 30 degrees relative to the agitator's longitudinal axis, as shown in Figures 12A-12F. Each agitator variation was analyzed using flow simulation, with all other variables held constant. The force exerted by the front face of the agitator was determined, and the C for each fin angle design was calculated. d , which is used to calculate the drag coefficient. Figure 16A provides the calculated drag coefficient results for various fin angle offsets. Figure 16B provides the calculated applied force results for various fin angle offsets. In general, the drag coefficient and applied force were greatest at a 5 degree bristle offset angle. Benchtop testing of the 5 degree offset agitator showed clot drag and retention with a single pass of the agitator through the clot, as seen in Figure 16C.

[0073] To test several designs of agitator and agitator fins, the angle of the agitator fins was varied at 5, 10, 15, 20, 25, 30, and 90 degrees relative to the center curve of the vertical axis, as shown in Figures 12H and 12I. Each agitator variation was analyzed using flow simulation, with all other variables held constant. The force F required to hold the agitator in place as a viscous fluid passed through the agitator at a flow rate v was determined, and the effective drag coefficient C for each fin angle design was calculated. d was used to calculate where C d = 2F / ((v^2)ρA), where ρ is the fluid density and A is the sum of the cross-sectional areas of each agitator and its fins. Table 1 provides the calculated drag coefficient results for various fin angle offsets, showing that the sharpness of the fin angle affects the drag coefficient.

[0074] [Table 1]

[0075] While several embodiments have been described, those skilled in the art will recognize that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Moreover, to avoid unnecessarily obscuring the invention, some well-known processes and elements have not been described. Therefore, the above description should not be construed as limiting the scope of the invention.

[0076] Those skilled in the art will understand that the embodiments of the present disclosure are taught by way of example and not by way of limitation. Accordingly, the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. The following claims are intended to cover all general and specific features described herein, as well as all statements of the scope of the present methods and systems that may be said to lie therebetween as a matter of language.

[0077] A number of examples are provided herein to facilitate understanding of the present disclosure. A specific set of statements is provided as follows:

[0078] Statement 1: A catheter system for removing a blood clot from a blood vessel, comprising: an inner catheter having a proximal end, an infusion segment, and a distal end, the inner catheter including at least one infusion window along the infusion segment and a distal encapsulation balloon at the distal end; and an outer sheath having a proximal end and a distal end, the outer sheath including a proximal encapsulation balloon at the distal end, wherein the outer sheath surrounds at least a portion of the inner catheter, and the distal encapsulation balloon and the proximal encapsulation balloon are separated by a distance along the infusion segment.

[0079] Statement 2: The catheter system of Statement 1, wherein the distal encapsulation balloon and the proximal encapsulation balloon are compliant balloons that can accommodate a variety of blood vessel sizes and operate to minimize damage or injury to the blood vessels.

[0080] Statement 3: The catheter system of Statement 1, wherein the distance between the distal encapsulation balloon and the proximal encapsulation balloon is adjustable.

[0081] Statement 4: The catheter system of Statement 1, wherein the distance between the distal encapsulation balloon and the proximal encapsulation balloon forms a thrombolytic treatment area, and the thrombus to be removed is contained within the thrombolytic treatment area.

[0082] Statement 5: The catheter system of statement 4, wherein the infusion segment is within the thrombolytic treatment area.

[0083] Statement 6: The catheter system of Statement 5, wherein the inner catheter is operable to inject fluid into the thrombolytic treatment area and the outer sheath is operable to provide suction to remove fluid from the thrombolytic treatment area.

[0084] Statement 7: The catheter system of Statement 6, wherein the inner catheter and outer sheath are operable to provide isovolumic aspiration and restoration of fluid within the thrombolytic treatment area.

[0085] Statement 8: The catheter system of Statement 1, wherein the inner catheter further comprises at least three lumens extending from the proximal end to the distal end of the inner catheter.

[0086] Statement 9: The catheter system of Statement 8, wherein the inner catheter includes an inflation lumen, a guidewire lumen, and an infusion lumen, and at least one infusion window along the infusion segment is connected to the infusion lumen to allow for infusion of a fluid.

[0087] Statement 10: The catheter system of Statement 9, wherein the inner catheter further includes a manifold at its proximal end including an injection port, a balloon inflation port, and a guidewire access port, each port being fluidly connected to one of the at least three lumens of the inner catheter.

[0088] Statement 11: The catheter system of Statement 1, wherein the outer sheath further includes at least three lumens extending from the proximal end to the distal end of the outer sheath.

[0089] Statement 12: The catheter system of Statement 11, wherein the outer sheath includes an inflation lumen, an aspiration lumen, and a catheter lumen, and the inner catheter is disposed within the catheter lumen of the outer sheath.

[0090] Statement 13: The catheter system of Statement 12, wherein the outer sheath further includes a manifold at its proximal end including a suction port, a balloon inflation port, and a device access port, each port fluidly connected to one of the at least three lumens of the outer sheath.

[0091] Statement 14: The catheter system of statement 12, wherein the catheter lumen is concentric with the aspiration lumen.

[0092] Statement 15: The catheter system of Statement 1, further comprising an agitator operable to agitate the thrombus.

[0093] Statement 16: The catheter system of statement 15, wherein the outer sheath further surrounds the agitator.

[0094] Statement 17: The catheter system of Statement 15, wherein the agitator is mounted on a rail to the outer sheath.

[0095] Statement 18: The catheter system of Statement 15, wherein the agitator includes multiple protrusions.

[0096] Statement 19: The catheter system of Statement 15, wherein the agitator is configured to protrude from a distal end of the outer sheath.

[0097] Statement 20: The catheter system of statement 15, wherein the agitator is operable to advance and retract across the catheter lumen of the outer sheath.

[0098] Statement 21: The catheter system of Statement 15, wherein the agitator is operable to be used without touching the wall of the blood vessel.

[0099] Statement 22: The catheter system of Statement 15, wherein the agitator has a pitch angle operable to reduce shear stress on the blood vessel during operation of the agitator.

[0100] Statement 23: The catheter system of Statement 15, wherein the agitator is brush-shaped and operable to remove thrombus while reducing radial stress on the inner wall of the blood vessel.

[0101] Statement 24: The catheter of claim 15, wherein the protrusion or protrusions are spirally distributed along the length of the agitator.

[0102] Statement 25: A catheter for removing a blood clot from a blood vessel, comprising: a catheter body having a proximal end and a distal end, said catheter having an encapsulation balloon at the distal end and an agitator extending from the distal end beyond the encapsulation balloon.

[0103] Statement 26: The catheter of Statement 25, wherein the agitator is operable so as not to touch the wall of the blood vessel.

[0104] Statement 27: The catheter of Statement 25, wherein the encapsulated balloon is a compliant balloon that can accommodate a variety of vessel sizes and operate to minimize damage to the vessel.

[0105] Statement 28: A method for removing a thrombus in a patient in need thereof, comprising: inserting the catheter system of claim 1 into a treatment region of a blood vessel; inflating a distal encapsulation balloon through an inflation lumen of the inner catheter; inflating a proximal encapsulation balloon through an inflation lumen of the outer sheath; mechanically lysing the thrombus with an agitator; injecting an infusion solution into the treatment region through at least one infusion window; applying negative suction to the treatment region via the aspiration lumen of the outer sheath, wherein there is isovolumic aspiration and restoration of fluid in the thrombolysis treatment region between the distal encapsulation balloon and the proximal encapsulation balloon; and removing the catheter system from the patient.

[0106] Statement 29: The method of statement 28, wherein the infusion solution is a thrombolytic solution, saline, or a combination thereof.

[0107] Statement 30: The method of statement 29, wherein the thrombolytic solution comprises tPA.

[0108] Statement 31: The method of statement 28, wherein negative suction is applied for about 1 to about 30 minutes.

[0109] Statement 32: The method of Statement 28, wherein mechanically lysing the thrombus includes advancing and retracting an agitator across the catheter lumen of the outer sheath.

[0110] Statement 33: The method of statement 28, wherein luminal patency is restored to greater than about 90% of the treated area.

[0111] STATEMENT 34: The method of STATEMENT 28, further comprising advancing the catheter system from the femoral vein cannula or the internal jugular vein cannula, wherein the pulmonary embolism is treated in the patient.

[0112] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 842,975, filed May 3, 2019, and U.S. Provisional Application No. 62 / 736,890, filed September 26, 2018, the contents of which are incorporated herein by reference in their entireties.

Claims

1. 1. A catheter system for removing a blood clot from a blood vessel, comprising: An inner catheter having a proximal end, an infusion segment, and a distal end, at least one implantation window along said implantation segment; and an inner catheter including a distal encapsulation balloon at the distal end; an outer sheath having a proximal end and a distal end, an outer sheath including a proximal encapsulation balloon at a distal end thereof; the outer sheath surrounds at least a portion of the inner catheter; and The catheter system, wherein the distal encapsulation balloon and the proximal encapsulation balloon are separated by a distance along the infusion segment.

2. 10. The catheter system of claim 1, wherein the distal encapsulation balloon and the proximal encapsulation balloon are compliant balloons operable to accommodate a variety of vessel sizes and to minimize damage or injury to vessels.

3. The catheter system of claim 1 , wherein the distance between the distal encapsulation balloon and the proximal encapsulation balloon is adjustable.

4. 2. The catheter system of claim 1, wherein a distance between the distal encapsulation balloon and the proximal encapsulation balloon defines a thrombolytic treatment region, and the thrombus being removed is contained within the thrombolytic treatment region.

5. The catheter system of claim 4 , wherein the infusion segment is within a thrombolytic treatment area.

6. 6. The catheter system of claim 5, wherein the inner catheter is operable to infuse fluid into a thrombolytic treatment area and the outer sheath is operable to provide suction to remove fluid from the thrombolytic treatment area.

7. The catheter system of claim 6 , wherein the inner catheter and the outer sheath are operable to provide isovolumic aspiration and return of fluid within a thrombolytic treatment area.

8. The catheter system of claim 1 , wherein the inner catheter further comprises at least three lumens extending from the proximal end to the distal end of the inner catheter.

9. 10. The catheter system of claim 8, wherein the inner catheter includes an inflation lumen, a guidewire lumen, and an infusion lumen, and at least one infusion window along the infusion segment is connected to an infusion lumen to allow infusion of fluid.

10. 10. The catheter system of claim 9, wherein the inner catheter further comprises a manifold at its proximal end including an injection port, a balloon inflation port, and a guidewire access port, each port being fluidly connected to one of the at least three lumens of the inner catheter.

11. The catheter system of claim 1 , wherein the outer sheath further comprises at least three lumens extending from the proximal end to the distal end of the outer sheath.

12. The catheter system of claim 11 , wherein the outer sheath includes an inflation lumen, an aspiration lumen, and a catheter lumen, and the inner catheter is disposed within the catheter lumen of the outer sheath.

13. the outer sheath further comprises a manifold at a proximal end thereof including a suction port, a balloon inflation port, and a device access port; The catheter system of claim 12 , wherein each port is fluidly connected to at least one of the lumens in the outer sheath.

14. The catheter system of claim 12 , wherein the catheter lumen is concentric with the aspiration lumen.

15. The catheter system of claim 1 , further comprising an agitator operable to agitate the thrombus.

16. The catheter system of claim 15 , wherein the outer sheath surrounds the agitator.

17. 16. The catheter system of claim 15, wherein the agitator is rail-mounted to the outer sheath and configured to protrude from a distal end of the outer sheath, and / or the agitator is operable to advance and retract across the catheter lumen of the outer sheath.

18. The catheter system of claim 15, wherein the agitator is operable to be used without touching the wall of the blood vessel.

19. The catheter system of claim 15, wherein the agitator includes a plurality of protrusions or brushes at a pitch angle operable to reduce shear stress on the blood vessel.

20. 20. The catheter system of claim 19, wherein the plurality of protrusions are distributed helically along the length of the agitator.

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