Torqueable device and method for removing emboli - Patent application

Abstract

A thrombus retrieval device is provided that features a capture basket coupled to a delivery shaft. The capture basket is deployable in a blood vessel at a side of a thrombus. The capture basket is configured to allow the thrombus to enter the capture basket and surround at least a portion of the thrombus. The capture basket is torqueable by torque transmission at a proximal end of the catheter resulting in rotation of the capture basket about its longitudinal axis.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Application No. 17 / 691,914, filed March 10, 2022, and U.S. Application No. 18 / 145,691, filed December 22, 2022, the specifications of which are incorporated by reference in their entireties herein.

[0002] The present invention relates to the field of medical devices and methods for removing emboli. [Background technology]

[0003] In recent years, thrombectomy has proven to be a safe and effective treatment for patients with acute ischemic stroke. However, despite the success of thrombectomy as a treatment for acute ischemic stroke, minimal progress has been made in treating diseases caused by the presence of large clots, such as pulmonary embolism (PE). As a result, in the United States alone, over 300,000 patients are hospitalized each year for PE, and 100,000 people die from PE each year.

[0004] Pulmonary embolism often occurs when a blood clot that forms in a deep vein travels to the lungs and blocks a pulmonary artery. The presence of a pulmonary embolus can block blood to a large portion of the lungs and can be fatal. The blood clot burden is often high, causing blockages in the main pulmonary artery, the left pulmonary artery, and / or the right pulmonary artery and their branches. Emboli are particularly difficult to remove because they are often large and must travel a complex, tortuous path to be removed from the body using an endovascular approach. Pulmonary embolism often causes right heart overload, which can result in heart failure and death.

[0005] Pulmonary embolism differs from acute ischemic stroke in that the thrombus burden is often much larger. Therefore, there is a need for a medical device that can safely and quickly retrieve large emboli from the body, thereby opening the passageway for deoxygenated blood to travel to the lungs. Thus, the present invention provides a method and device for safely removing embolic masses from the pulmonary artery. Summary of the Invention [Problem to be solved by the invention]

[0006] The object of the present invention is to provide a system, a device and a method which allow retrieving a thrombus in a blood vessel as specified in the independent claims. Embodiments of the invention are set out in the dependent claims. The embodiments of the invention can be freely combined with one another if they are not mutually exclusive. [Means for solving the problem]

[0007] In some embodiments, the invention features a capture basket for capturing emboli. The capture basket includes a first basket end and a second basket end, a plurality of cells defined by struts, and at least four body markers disposed in the basket. In some embodiments, the struts have strut ends connected to the first basket end and the second basket end.

[0008] In some embodiments, the invention features a torque-transmitting thrombectomy device. The torque-transmitting thrombectomy device can include a delivery shaft (e.g., a pusher) and a capture basket. The delivery shaft (e.g., the pusher) has a delivery shaft distal end. In some embodiments, the capture basket is coupled to the delivery shaft distal end. The capture basket includes a first basket end, a second basket end, a plurality of cells defined by struts, and at least four body markers disposed in the basket. The struts can have strut ends connected to the first basket end and the second basket end. The device is configured to transmit torque from the delivery shaft to the capture basket. For example, rotating the delivery shaft also rotates the capture basket as torque is transmitted from the delivery shaft to the capture basket.

[0009] In other embodiments, the invention may also feature a thrombectomy device. The thrombectomy device may include a delivery shaft (e.g., a pusher) and a capture basket. The delivery shaft (e.g., the pusher) has a delivery shaft distal end, and in some embodiments, the capture basket is coupled to the delivery shaft distal end. The capture basket includes a first basket end, a second basket end, a plurality of cells defined by struts, and at least four body markers disposed in the basket. The struts may have strut ends connected to the first basket end and the second basket end.

[0010] One of the unique inventive technical features of the present invention is the shape and size of the multiple closed cells that make up the capture basket. Without wishing to limit the present invention to any theory or mechanism, it is believed that the technical features of the present invention advantageously provide for emboli to enter the capture basket. Additionally, the thrombectomy devices described herein are configured to withstand torque (i.e., configured to rotate). Specifically, when the distal end of the delivery shaft (e.g., pusher) described herein is manually rotated (e.g., axially rotated), torque is transferred from the delivery shaft to the capture basket, thereby causing the capture basket to rotate. Without wishing to limit the present invention to any theory or mechanism, it is believed that the technical features of the present invention advantageously allow for controlled shearing of the emboli by the capture basket, allowing the capture basket to dislodge the emboli from the vessel wall. None of the currently known prior references or studies have the unique inventive technical features of the present invention.

[0011] Briefly, the present invention describes a thrombectomy device. In some embodiments, the thrombectomy device comprises a delivery shaft and a capture basket coupled to a distal end of the delivery shaft. The capture basket can feature a plurality of cells defined by struts having strut ends connected to the ends of the capture basket, and at least four body markers disposed on the capture basket.

[0012] In some embodiments, the delivery shaft is hollow. In some embodiments, the device is configured to allow a guidewire to pass through the delivery shaft through the second basket end, and the guidewire is disposed within the capture basket. In some embodiments, the cells at the second basket end of the capture basket are smaller in size than the cells at the middle of the capture basket and the cells at the first end of the capture basket. In some embodiments, the body markers are disposed on struts of the capture basket. In some embodiments, the body markers are aligned or parallel with the struts of the capture basket. In some embodiments, the body markers are attached to the struts at a single attachment point, or the body markers are attached to the struts at two attachment points. In some embodiments, the delivery shaft is capable of withstanding torque. In some embodiments, the delivery shaft is configured to rotate. In some embodiments, the delivery shaft rotates between 2 and 50 rpm. In some embodiments, the delivery shaft rotates between 2 and 10 rpm. In some embodiments, rotating the delivery shaft causes torque to be transferred from the delivery shaft to the capture basket, and therefore the capture basket. The present invention is not limited to the above features or configurations.

[0013] The present invention includes a torqueable thrombectomy device. In some embodiments, the torqueable thrombectomy device includes a delivery shaft and a capture basket coupled to a distal end of the delivery shaft. The capture basket can feature a plurality of cells defined by struts having strut ends connected to the ends of the capture basket, and at least four body markers disposed in the capture basket. The device can be configured such that torque is transmitted from the delivery shaft to the capture basket.

[0014] In some embodiments, the delivery shaft is hollow. In some embodiments, the device is configured to allow a guidewire to pass through the delivery shaft through the second basket end, and the guidewire is disposed within the capture basket. In some embodiments, the cells at the second basket end of the capture basket are smaller in size than the cells at the middle of the capture basket and the cells at the first end of the capture basket. In some embodiments, the body markers are disposed on the struts of the capture basket. In some embodiments, the body markers are aligned or parallel with the struts of the capture basket. In some embodiments, the body markers are attached to the struts at a single attachment point, or the body markers are attached to the struts at two attachment points, or the body markers are attached to the struts as one continuous attachment. In some embodiments, rotating the delivery shaft causes the capture basket to rotate as torque is transferred from the delivery shaft to the capture basket. The present invention is not limited to the above features or configurations.

[0015] Any feature or combination of features described herein is included within the scope of the present invention, provided that the features included in any such combination are not mutually inconsistent as would be apparent from the context, the specification, and the knowledge of one of ordinary skill in the art. Further advantages and aspects of the present invention are apparent in the following detailed description and claims.

[0016] The features and advantages of the present invention will become apparent from consideration of the following detailed description, taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0017] [Figure 1A] 1 shows a schematic diagram of a thrombectomy device as described herein, including either a delivery sheath (top) or a delivery catheter (bottom). [Figure 1B] 1 illustrates a thrombectomy device as described herein; [Diagram 2] 1 shows a detailed thrombectomy device according to an embodiment herein. [Figure 3A] 1 illustrates one of various embodiments of a capture basket described herein, showing the capture basket with body markers aligned with struts of the capture basket. [Figure 3B] 1 illustrates one of various embodiments of a capture basket described herein, showing the capture basket with body markers protruding from struts of the capture basket. [Figure 4A] 1 shows how the thrombectomy devices described herein can be divided into two parts (eg, distal or proximal parts, upper side) and also shows the dimensions of the cells (lower side). [Figure 4B] FIG. 14 shows non-limiting examples of how the body markers described herein may be attached to the capture basket, for example, the body marker may be aligned with the capture basket struts (left), the body marker may be parallel to the capture basket struts (e.g., may protrude from the capture basket struts, middle / right), or the body marker may be attached to the capture basket struts at a single attachment point (right) or at two attachment points (middle) using adhesive. [Figure 4C] FIG. 1 illustrates non-limiting examples of body markers as described herein. [Diagram 5] Illustrated are abstract diagrams representing non-limiting views of capture baskets having a tapered diameter at one end (top, left), a constant diameter (top, right), or tapered diameters at both ends (bottom). [Figure 6A] FIG. 1 shows a basic diagram of how portions of a support component described herein (e.g., a support component including a first support portion, a second support portion, and an inner shaft disposed through a first lumen of the first support portion and a second lumen of the second support portion) may move according to embodiments herein. [Figure 6B]FIG. 1 shows a basic diagram of how portions of a support component described herein (e.g., a support component including a first support portion, a second support portion, and an inner shaft disposed through a first lumen of the first support portion and a second lumen of the second support portion) may move according to embodiments herein. [Figure 6C] FIG. 1 shows a basic diagram of how portions of a support component described herein (e.g., a support component including a first support portion, a second support portion, and an inner shaft disposed through a first lumen of the first support portion and a second lumen of the second support portion) may move according to embodiments herein. [Figure 6D] FIG. 1 shows a basic diagram of how portions of a support component described herein (e.g., a support component including a first support portion, a second support portion, and an inner shaft disposed through a first lumen of the first support portion and a second lumen of the second support portion) may move according to embodiments herein. [Figure 7] In accordance with the embodiments herein, a delivery catheter is shown, where the catheter shaft may include an attached hub subassembly, and in addition, a dilator may be used in conjunction with the catheters described herein. [Figure 8] 1 shows a thrombectomy device assembly including a delivery catheter. [Figure 9A] 1 shows an alternative view of the thrombectomy device, specifically the capture basket. [Figure 9B] 1 shows an alternative view of the thrombectomy device, specifically the capture basket. [Figure 10] 1 shows a thrombectomy device including a catheter. [Figure 11A] A non-limiting example of a capture basket as described herein is shown in 3D. [Figure 11B] 1 illustrates a non-limiting example of a capture basket as described herein in 2D. [Figure 12] 1 shows the distal and proximal ends of the capture basket and how the capture basket is connected to the distal end of the delivery shaft. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] 1A-12, the present invention features devices and methods for capturing and retrieving emboli.

[0019] The invention features a capture basket (120) for capturing emboli. The capture basket includes a first basket end (121) and a second basket end (122). In some embodiments, the capture basket (120) includes a plurality of cells (123) defined by struts (124) and at least four body markers (125) disposed on the basket. The struts can have strut ends connected to the first basket end (121) and the second basket end (122).

[0020] The invention may also feature a torqueable thrombectomy device (100). The torqueable thrombectomy device (100) may include a delivery shaft (110, e.g., a pusher) and a capture basket (120). The delivery shaft (110, e.g., a pusher) has a delivery shaft distal end (111). In some embodiments, the capture basket (120) is coupled to the delivery shaft distal end (111). The capture basket (120) includes a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), and at least four body markers (125) disposed on the basket (120) (e.g., the body markers (125) may be disposed on the struts (124). The struts (124) can have strut ends that are connected to a first basket end (121) and a second basket end (122). The device (100) is configured such that torque is transferred from the delivery shaft (110) to the capture basket (120). For example, rotating the delivery shaft causes the capture basket to rotate as torque is transferred from the delivery shaft to the capture basket.

[0021] The present invention may further feature a thrombectomy device (100). The thrombectomy device (100) may include a delivery shaft (110, e.g., a pusher) and a capture basket (120). The delivery shaft (110, e.g., a pusher) has a delivery shaft distal end (111). In some embodiments, the capture basket (120) is coupled to the delivery shaft distal end (111). The capture basket (120) includes a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), and at least four body markers (125) disposed on the basket (120) (e.g., the body markers (125) may be disposed on the struts (124)). The struts may have strut ends connected to the first basket end (121) and the second basket end (122).

[0022] In some embodiments, the thrombectomy device (100) can include a delivery shaft (110, e.g., a pusher), a capture basket (120), and a support component (150). The delivery shaft (110, e.g., a pusher) has a delivery shaft distal end (111). In some embodiments, the capture basket (120) is coupled to the delivery shaft distal end (111). The capture basket (120) includes a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), and at least four body markers (125) disposed on the basket (120) (e.g., the body markers (125) can be disposed on the struts (124)). The struts (124) can have strut ends connected to the first basket end (121) and the second basket end (122). In some embodiments, the support component (150) is coupled to the delivery shaft distal end (111) and disposed within the capture basket (120).

[0023] In some embodiments, the support component (150) includes a first support portion (130) having a first end (131), a second end (132), and a first lumen (133). In some embodiments, the first end (131) of the first support portion (130) is disposed within the basket (120) proximate to the first basket end (121). In some embodiments, the support component (150) includes a second support portion (140) having a first end (141), a second end (142), and a second lumen (143). In some embodiments, the second end (142) of the second support portion (140) is disposed within the basket (120) proximate to the second basket end (122). In some embodiments, the second end (132) of the first support portion (130) is adjacent to the first end (141) of the second support portion (140). In some embodiments, the second end (142) of the second support portion (140) can be secured to the second basket end (122) of the capture basket (120). In other embodiments, the support component (150) further includes an inner shaft (160) disposed through the first lumen (133) of the first support portion (130) and the second lumen (143) of the second support portion (140).

[0024] In some embodiments, the inner shaft (160) is movable. In some embodiments, the inner shaft (160) is free-floating and not fixed to either end (e.g., not fixed to the first end (131) of the first support portion (130) or the second end (142) of the second support portion (140). In some embodiments, the inner shaft (160) is free-floating within the first lumen (133) of the first support portion (130) and the second lumen (143) of the second support portion (140). In other embodiments, the inner shaft (160) is fixed to the second end (142, e.g., the distal end) of the second support portion (140). In further embodiments, the inner shaft (160) is fixed to the first end (131, e.g., the proximal end) of the first support portion (130). In certain embodiments, the inner shaft (160) is fixed to a first end (131, e.g., a proximal end) of the first support portion (130) and to a second end (142, e.g., a distal end) of the second support portion (140).

[0025] In some embodiments, the thrombectomy device (100) described herein comprises an inner shaft (160) secured to a second end (142, e.g., a distal end) of the second support portion (140) (see FIG. 6A). This allows the second support portion (140) to be movable relative to the first support portion (130) and allows the inner shaft (160) to slide within a first lumen (133) of the first support portion (130). In some embodiments, the first support portion (130) is stationary relative to the delivery shaft (110). In some embodiments, the first end (131) of the first support portion (130) is secured to the delivery shaft distal end (111) of the delivery shaft (110). As the inner shaft (160) slides distally within the first lumen (133) of the first support portion (130) and away from the first end (131) of the support portion (130), the acquisition basket (120) extends (i.e., the second basket end (122) moves (i.e., distally) away from the first basket end (121). Sliding the inner shaft distally within the first lumen (133) of the first support portion (130) also causes the second end (142) of the second support portion (140) to extend distally away from the first support portion (130). Furthermore, as the inner shaft (160) slides proximally within the first lumen (133) of the first support portion (130) toward the first end (131) of the support portion (130), the capture basket (120) retracts (i.e., the second basket end (122) moves toward (i.e., proximally) the first basket end (121).

[0026] In other embodiments, the thrombectomy device (100) described herein comprises an inner shaft (160) secured to a first end (131, e.g., a proximal end) of the first support portion (130) (see FIG. 6B). This allows the second support portion (140) to be movable relative to the first support portion (130) and allows the second lumen (143) of the second support portion (140) to slide over the inner shaft (160). In some embodiments, the first support portion (130) is stationary relative to the delivery shaft (110). In some embodiments, the first end (131) of the first support portion (130) is secured to the delivery shaft distal end (111) of the delivery shaft (110). As the second support portion (140) slides distally along the inner shaft (160) away from the first support portion (130), the capture basket (120) extends (i.e., the second basket end (122) moves away (i.e., distally) from the first basket end (121). Additionally, as the second support portion (140) slides proximally along the inner shaft (160) toward the first support portion (130), the capture basket (120) retracts (i.e., the second basket end (122) moves toward (i.e., proximally) the first basket end (121).

[0027] In certain embodiments, the thrombectomy device (100) described herein comprises an inner shaft (160) that is free-floating and not fixed at either end (i.e., not fixed to the first end (131) of the first support portion (130) or the second end (142) of the second support portion (140)) (see FIG. 6C). This allows the second support portion (140) to be movable relative to the first support portion (130). In some embodiments, the first support portion (130) is stationary relative to the delivery shaft (110). In some embodiments, the first end (131) of the first support portion (130) is fixed to the distal end (111) of the delivery shaft (110). In some embodiments, the second end (142) of the second support portion (140) is fixed to the second basket end (122) of the capture basket (120). Using the inner shaft (160) as a guide (e.g., a structure that directs the movement or positioning of something), as the second support portion (140) moves away from the first support portion (130), the capture basket (120) extends (i.e., the second basket end (122) moves away (i.e., distally) from the first basket end (121). Additionally, as the second support portion (140) slides proximally along the inner shaft (160) toward the first support portion (130), the capture basket (120) retracts (i.e., the second basket end (122) moves toward (i.e., proximally) the first basket end (121).

[0028] In a further embodiment, the thrombectomy device (100) described herein comprises an inner shaft (160) secured to both the first end (131) of the first support portion (130) and the second end (142) of the second support portion (140) (see FIG. 6D). In this embodiment, the inner shaft (160) is expandable and can be made from an elastomeric material. As the length of the inner shaft (160) increases (e.g., as the inner shaft (160) stretches), the second basket end (122) moves away (i.e., distally) from the first basket end (121), thus stretching the capture basket (120). Furthermore, as the length of the inner shaft (160) decreases (e.g., as the inner shaft (160) contracts (e.g., shortens)), the second basket end (122) moves toward (i.e., proximally) the first basket end (121), thus shortening the capture basket (120).

[0029] In certain embodiments, the support component 150 includes a telescoping shaft. In some embodiments, when the telescoping shaft of the support component 150 expands, the capture basket 120 lengthens. In some embodiments, when the telescoping shaft of the support component 150 shortens, the capture basket 120 shortens.

[0030] In some embodiments, the support component (150) is flexible or resilient. In some embodiments, the support component (150) is made from a flexible or resilient material. Such flexible or resilient materials may include, but are not limited to, polyetheretherketone (PEEK) polymers with a polytetrafluoroethylene (PTFE) coating. In certain embodiments, the support component (150) comprises an optimally flexible material, such as a PEEK / PTFE composite. Other flexible / resilient materials (e.g., the support component (150)) may be used in accordance with the present invention.

[0031] In some embodiments, the capture basket (120) has a length between 30 mm and 50 mm. In other embodiments, the capture basket (120) has a length between about 20 mm and 60 mm, or between about 20 mm and 50 mm, or between about 20 mm and 40 mm, or between about 20 mm and 30 mm, or between about 30 mm and 60 mm, or between about 30 mm and 50 mm, or between about 30 mm and 40 mm, or between about 40 mm and 60 mm, or between about 40 mm and 50 mm, or between about 50 mm and 60 mm. In further embodiments, the capture basket (120) has a length between about 20 mm, or between about 30 mm, or between about 40 mm, or between about 50 mm, or between about 60 mm. In other embodiments, the capture basket (120) has a length greater than 60 mm.

[0032] In some embodiments, the capture basket (120) can extend (e.g., the second basket end (122) moves away (i.e., distally) from the first basket end (121)) or retract (e.g., the second basket end (122) moves toward (i.e., proximally) the first basket end (121)) by approximately 20% of the original length of the capture basket (120). In other embodiments, the capture basket (120) can extend or retract by approximately 10% of the original length of the capture basket (120). In further embodiments, the capture basket (120) can extend or retract by approximately 30% of the original length of the capture basket (120).

[0033] In some embodiments, the capture basket (120) can expand or contract by between 5 mm and 10 mm. In other embodiments, the capture basket (120) can expand or contract by between about 2 mm and 18 mm, or between about 2 mm and 16 mm, or between about 2 mm and 14 mm, or between about 2 mm and 12 mm, or between about 2 mm and 10 mm, or between about 2 mm and 8 mm, or between about 2 mm and 6 mm, or between about 2 mm and 4 mm, or between about 4 mm and 18 mm, or between about 4 mm and 16 mm, or between about 4 mm and 14 mm, or between about 4 mm and 12 mm, or between about 4 mm and 10 mm, or between about 4 mm and 8 mm, or between about 4 mm and 6 mm, or between about 6 mm and 18 mm, or between about 6 mm and 16 mm, or between about 6 mm and 14 mm, or between about 6 mm and 18 mm. m to 12 mm, or about 6 mm to 10 mm, or about 6 mm to 8 mm, or about 8 mm to 18 mm, or about 8 mm to 16 mm, or about 8 mm to 14 mm, or about 8 mm to 12 mm, or about 8 mm to 10 mm, or about 10 mm to 18 mm, or about 10 mm to 16 mm, or about 10 mm to 14 mm, or about 10 mm to 12 mm, or about 12 mm to 18 mm, or about 12 mm to 16 mm, or about 12 mm to 14 mm, or about 14 mm to 18 mm, or about 14 mm to 16 mm, or about 16 mm to 18 mm.

[0034] In some embodiments, the capture basket (120) can have an unconstrained (i.e., fully expanded) diameter of 10 mm to 14 mm. In other embodiments, the capture basket (120) can have an unconstrained (i.e., fully expanded) diameter of about 2 mm to 18 mm, or about 2 mm to 16 mm, or about 2 mm to 14 mm, or about 2 mm to 12 mm, or about 2 mm to 10 mm, or about 2 mm to 8 mm, or about 2 mm to 6 mm, or about 2 mm to 4 mm, or about 4 mm to 18 mm, or about 4 mm to 16 mm, or about 4 mm to 14 mm, or about 4 mm to 12 mm, or about 4 mm to 10 mm, or about 4 mm to 8 mm, or about 4 mm to 6 mm, or about 6 mm to 18 mm, or about 6 mm to 16 mm, or about 6 mm to 14 mm, or about 6 mm to 12 mm. or about 6 mm to 10 mm, or about 6 mm to 8 mm, or about 8 mm to 18 mm, or about 8 mm to 16 mm, or about 8 mm to 14 mm, or about 8 mm to 12 mm, or about 8 mm to 10 mm, or about 10 mm to 18 mm, or about 10 mm to 16 mm, or about 10 mm to 14 mm, or about 10 mm to 12 mm, or about 12 mm to 18 mm, or about 12 mm to 16 mm, or about 12 mm to 14 mm, or about 14 mm to 18 mm, or about 14 mm to 16 mm, or about 16 mm to 18 mm. In further embodiments, the capture basket (120) can have an unconstrained (i.e., fully expanded) diameter of 6 mm, or 8 mm, or 10 mm, or 12 mm, or 14 mm, or 16 mm, or 18 mm.

[0035] In some embodiments, the capture basket (120) has an unconstrained (i.e., fully expanded) diameter that is constant along a mid-portion of its length. For example, the capture basket (120) can resemble a cylinder or tube (see FIG. 5). In other embodiments, the capture basket (120) has an unconstrained (i.e., fully expanded) diameter that tapers continuously such that the first basket end (121) has a larger diameter compared to the second basket end (122) (see FIG. 5, e.g., the second basket end (122) has a smaller diameter compared to the first basket end (121)). In further embodiments, the capture basket (120) has an unconstrained (i.e., fully expanded) diameter that tapers at both the first basket end (121) and the second basket end (121) such that a mid-portion of the capture basket (120) has the largest diameter compared to the first basket end (121) and the second basket end (122) (see FIG. 5). Without wishing to limit the present invention to any theory or mechanism, it is believed that the smaller diameter at the second basket end (122) allows the capture basket (120) to enter a smaller diameter distal vessel, while the larger diameter at the first basket end (121) allows the capture basket (120) to be effective in a proximal, larger diameter vessel. In some embodiments, the capture basket (120) can allow for the retrieval of thrombus from two vessels simultaneously, where the distal vessel is a branch vessel of the proximal vessel.

[0036] In some embodiments, the capture basket (125) can have a constrained (i.e., compressed) diameter of between 1.5 mm and 4.0 mm. In other embodiments, the capture basket (125) can have a constrained (i.e., compressed) diameter of between about 1.0 mm and 4.5 mm, or between about 1.0 mm and 4.0 mm, or between about 1.0 mm and 3.5 mm, or between about 1.0 mm and 3.0 mm, or between about 1.0 mm and 2.5 mm, or between about 1.0 mm and 2.0 mm, or between about 1.0 mm and 1.5 mm, or between about 1.5 mm and 4.5 mm, or between about 1.5 mm and 4.0 mm, or between about 1.5 mm and 3.5 mm, or between about 1.5 mm and 3.0 mm, or between about 1.5 mm and 2.5 mm, or between about 1.5 mm and 2.0 mm, or between about 2.0 mm and 4.5 mm, or between about It may have a constrained (i.e. compressed) diameter of 2.0mm to 4.0mm, or about 2.0mm to 3.5mm, or about 2.0mm to 3.0mm, or about 2.0mm to 2.5mm, or about 2.5mm to 4.5mm, or about 2.5mm to 4.0mm, or about 2.5mm to 3.5mm, or about 2.5mm to 3.0mm, or about 3.0mm to 4.5mm, or about 3.0mm to 4.0mm, or about 3.0mm to 3.5mm, or about 3.5mm to 4.5mm, or about 3.5mm to 4.0mm, or about 4.0mm to 4.5mm.

[0037] The capture basket (120) is loaded into a fixed diameter catheter in its constrained (i.e., compressed) state. In some embodiments, the capture basket (120) has a constrained (i.e., compressed) diameter that is constant along a mid-section of its length (i.e., the constrained (i.e., compressed) diameter is not tapered).

[0038] In a preferred embodiment, the cells (123) are closed cells. In other embodiments, the cells (123) are open cells. As used herein, "closed cells" refers to cells that are completely enclosed, defined by struts.

[0039] The capture basket (125) can further include cells (123) that decrease in size from a mid-portion of the capture basket (120) toward the first basket end (121) and the second basket end (122). In some embodiments, the cells (123) at the second basket end (122, i.e., distal end) of the capture basket (120) are smaller in size than the cells (123) at the mid-portion of the capture basket (120) and the cells (123) at the first end (121) of the capture basket (120). In some embodiments, the cells (123) at the mid-portion of the capture basket (120) are largest (e.g., when compared to the cells (123) at the first end (121) or the cells (123) at the second end (122). In other embodiments, the cells (123) at the first basket end (121, i.e., the proximal end) of the capture basket (120) are the largest (e.g., compared to the cells (123) in the middle or the cells (123) at the second end (122). In some embodiments, all of the cells (123) in the capture basket (120) are equal in size.

[0040] In some embodiments, the capture basket (120) includes cells (123) of only one size. In other embodiments, the capture basket (120) includes cells (123) of various sizes (see FIGS. 11A and 11B). In some embodiments, the capture basket includes one or more cells (123) of various sizes (e.g., two regions of cells (123) of different sizes). In some embodiments, the capture basket includes two or more cells (123) of various sizes (e.g., three regions of cells (123) having different sizes). In some embodiments, the capture basket includes three or more cells (123) of various sizes (e.g., four regions of cells (123) having different sizes). In some embodiments, the capture basket includes four or more cells (123) of various sizes (e.g., five regions of cells (123) having different sizes).

[0041] Without wishing to limit the present invention to any theory or mechanism, it is believed that the smaller cells (123) at the second basket end (122, i.e., the distal end) of the capture basket (120) act as a secondary capture "device" for thrombus that is dislodged from the device or crushed into smaller pieces.

[0042] In some embodiments, the cells (123) are quadrilateral in shape. In other embodiments, the cells (123) are trapezoid in shape. As used herein, a "trapezoid" refers to a quadrilateral that is symmetrical but does not require congruent sides or angles. In other embodiments, the cells (123) are rhombus in shape. In some embodiments, the cells (123) are diamond-shaped. As used herein, "diamond-shaped" and "rhombus" are used interchangeably and can refer to a quadrilateral having four straight equal sides, with both pairs of opposite sides being parallel. In some embodiments, the cells (123) are kite-shaped. As used herein, a "kite-shaped" refers to a quadrilateral whose four sides can be divided into two pairs of equal length sides adjacent to each other.

[0043] In some embodiments, the cells (123) in the first basket end (121) are kite-shaped. In some embodiments, the cells (123) in the first basket end (121) are kite-shaped with a longer side disposed toward the first basket end (121). Without wishing to limit the present invention to any theory or mechanism, it is believed that the kite-shaped cells (123) in the first basket end (121) facilitate retrieval of the thrombus retrieval device (100) described herein that contains a thrombus (e.g., an embolus) in a catheter (e.g., an aspiration catheter).

[0044] In a preferred embodiment, the cells 123 described herein have a height of between 4 mm and 8 mm. In some embodiments, the cells 123 have a height of between about 2 mm and 10 mm, or between about 2 mm and 9 mm, or between about 2 mm and 8 mm, or between about 2 mm and 7 mm, or between about 2 mm and 6 mm, or between about 2 mm and 5 mm, or between about 2 mm and 4 mm, or between about 2 mm and 3 mm, or between about 3 mm and 10 mm, or between about 3 mm and 9 mm, or between about 3 mm and 8 mm, or between about 3 mm and 7 mm, or between about 3 mm and 6 mm, or between about 3 mm and 5 mm, or between about 3 mm and 4 mm, or between about 4 mm and 10 mm, or between about 4 mm and 9 mm, or between about 4 mm and 4 mm. In further embodiments, the cells 123 described herein have a height of about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 50 mm, 51 mm, 52 mm, 53 mm, 54 mm, 55 mm, 56 mm, 57 mm, 58 mm, 59 mm, 60 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 7 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm,

[0045] In a preferred embodiment, the cells 123 described herein have a length between 6 mm and 16 mm. In some embodiments, the cells 123 may have a length between about 4 mm and 18 mm, or between about 4 mm and 16 mm, or between about 4 mm and 14 mm, or between about 4 mm and 12 mm, or between about 4 mm and 10 mm, or between about 4 mm and 8 mm, or between about 4 mm and 6 mm, or between about 6 mm and 18 mm, or between about 6 mm and 16 mm, or between about 6 mm and 14 mm, or between about 6 mm and 12 mm, or between about 6 mm and 10 mm, or between about 6 mm and 8 mm, or between about 8 mm and 18 mm, or between about 8 mm and 12 ... In further embodiments, the cells 123 described herein have a length of about 4 mm, or about 6 mm, or about 8 mm, or about 10 mm, or about 12 mm, or about 14 mm, or about 16 mm, or about 16 mm, or about 18 ...6 mm, or about 16 mm, or about 16 mm, or about 16 mm, or about 16 mm, or about

[0046] In some embodiments, the plurality of cells (123) defined by the struts (124) exerts an outward radial force. Generally, a radial force is defined as a force exerted radially toward or away from the center. As used herein, "outward radial force" refers to the force exerted outward (i.e., away from the center) by the capture basket (120) when the capture basket (120) is compressed to 50% of its unconstrained diameter.

[0047] In a preferred embodiment, the outer radial force is between 0.10 N / mm length and 0.15 N / mm length.In some embodiments, the outer radial force is between about 0.05 N / mm and 0.02 N / mm, or between about 0.05 N / mm and 0.18 N / mm, or between about 0.05 N / mm and 0.16 N / mm, or between about 0.05 N / mm and 0.15 N / mm, or between about 0.05 N / mm and 0.14 N / mm, or between about 0.05 N / mm and 0.12 N / mm, or between about 0.05 N / mm and 0.10 N / mm, or between about 0.05 N / mm and 0.08 N / mm, or between about 0.05 N / mm and 0.06 N / mm, or between about 0.06 N / mm and 0.20 N / mm. long, or about 0.06N / mm long to 0.18N / mm long, or about 0.06N / mm long to 0.16N / mm long, or about 0.06N / mm long to 0.15N / mm long, or about 0.06N / mm long to 0.14N / mm long, or about 0.06N / mm long to 0.12N / mm long, or about 0.06N / mm long to 0.10N / mm long, or about 0.06N / mm long to 0.08N / mm long, or about 0.08N / mm long to 0.20N / mm long, or about 0.08N / mm long to 0.18N / mm long, or about 0.08N / mm long to 0.16N / mm long, or about 0.08N / mm long to 0. 15N / mm length, or about 0.08N / mm length to 0.14N / mm length, or about 0.08N / mm length to 0.12N / mm length, or about 0.08N / mm length to 0.10N / mm length, or about 0.10N / mm length to 0.20N / mm length, or about 0.10N / mm length to 0.18N / mm length, or about 0.10N / mm length to 0.16N / mm length, or about 0.10N / mm length to 0.15N / mm length, or about 0.10N / mm length to 0.14N / mm length, or about 0.10N / mm length to 0.12N / mm length, or about 0.12N / mm length to 0.20N / mm length, or about 0.12N / mm length mm long to 0.18 N / mm long, or about 0.12 N / mm long to 0.16 N / mm long, or about 0.12 N / mm long to 0.15 N / mm long, or about 0.12 N / mm long to 0.14 N / mm long, or about 0.14 N / mm long to 0.20 N / mm long, or about 0.14 N / mm long to 0.18 N / mm long, or about 0.14 N / mm long to 0.16 N / mm long, or about 0.14 N / mm long to 0.15 N / mm long, or about 0.16 N / mm long to 0.20 N / mm long, or about 0.16 N / mm long to 0.18 N / mm long, or about 0.18 N / mm long to 0.20 N / mm long.In further embodiments, the outer radial force is about 0.05 N / mm, or about 0.06 N / mm, or about 0.08 N / mm, or about 0.10 N / mm, or about 0.12 N / mm, or about 0.14 N / mm, or about 0.15 N / mm, or about 0.16 N / mm, or about 0.18 N / mm, or about 0.20 N / mm.

[0048] In some embodiments, the plurality of cells (123) defined by the struts allows emboli to enter the capture basket (120). Without wishing to limit the present invention to any theory or mechanism, it is believed that the shape and size of the plurality of cells (123) defined by the struts (124), as well as the width and thickness of the struts (124), allow emboli to enter the capture basket (120).

[0049] In a preferred embodiment, the struts (124) have a width between 0.007 inches and 0.010 inches. As used herein, "width" refers to a measurement taken between two sides of the strut (see FIG. 4A, i.e., a measurement taken parallel to the support component (150)). In some embodiments, the struts 124 may be between about 0.005 inches and 0.014 inches, or between about 0.005 inches and 0.013 inches, or between about 0.005 inches and 0.012 inches, or between about 0.005 inches and 0.011 inches, or between about 0.005 inches and 0.011 inches. inch) to 0.0254 cm (0.010 inches), or about 0.005 inches to 0.009 inches, or about 0.005 inches to 0.02032 cm (0.008 inches), or about 0.005 inches to 0.007 inches, or about 0.005 inches to 0.01524 cm (0.006 inches), or about 0.00 0.006 inch to 0.014 inch, or about 0.006 inch to 0.013 inch, or about 0.006 inch to 0.012 inch, or about 0.006 inch to 0.011 inch, or about 0.006 inch to 0.010 inch, or about 0.01524 cm (about 0.006 inches) to 0.02286 cm (0.009 inches), or about 0.01524 cm (about 0.006 inches) to 0.02032 cm (0.008 inches), or about 0.01524 cm (about 0.006 inches) to 0.01778 cm (0.007 inches), or about 0.01778 cm (about 0.007 inches) to 0.03556 cm (0.014 inches), or about 0.01778 cm (about 0.007 inches) to 0.03302 cm (0.013 inches), or about 0.0.01778cm (about 0.007 inches) to 0.03048cm (0.012 inches), or about 0.01778cm (about 0.007 inches) to 0.02794cm (0.011 inches), or about 0.01778cm (about 0.007 inches) to 0.0254cm (0.010 inches), or about 0.01778cm (about 0.007 inches) to 0.02286cm (0.009 inches), or about 0.01778cm (about 0.007 inches) to 0.02032cm (0.008 inches), or about 0.02032cm (about 0.008 inches) to 0.03556cm ( 0.014 inches), or about 0.008 inches to 0.03302 cm (0.013 inches), or about 0.008 inches to 0.012 inches, or about 0.008 inches to 0.02794 cm (0.011 inches), or about 0.008 inches to 0.010 inches, or about 0.008 inches to 0.02286 cm (0.00 9 inches) to 0.03556 cm (0.014 inches), or about 0.02286 cm (about 0.009 inches) to 0.03302 cm (0.013 inches), or about 0.02286 cm (about 0.009 inches) to 0.03048 cm (0.012 inches), or about 0.02286 cm (about 0.009 inches) to 0.02794 cm (0.011 inches), or about 0.02286 cm (about 0.009 inches) to 0.0254 cm (0.010 inches), or about 0.0254 cm (about 0.010 inches) to 0.03556 cm (0.014 inches), or about .0254 cm (about 0.010 inches) to 0.03302 cm (0.013 inches), or about 0.0254 cm (about 0.010 inches) to 0.03048 cm (0.012 inches), or about 0.0254 cm (about 0.010 inches) to 0.02794 cm (0.011 inches), or about 0.02794 cm (about 0.011 inches) to 0.03556 cm (0.014 inches), or about 0.02794 cm (about 0.011 inches) to 0.03302 cm (0.013 inches), or about 0.02794 cm (about 0.011 inches) to 0.03048 cm (0.0.012 inches, or about 0.012 inches to 0.014 inches, about 0.012 inches to 0.013 inches, or about 0.013 inches to 0.014 inches.

[0050] In a preferred embodiment, the struts (124) have a thickness of 0.007 inches to 0.010 inches. As used herein, "thickness" refers to a measurement taken from the outer surface of the strut to the inner surface of the strut (see FIG. 4A, i.e., a measurement taken perpendicular to the support component (150)). In some embodiments, the struts 124 may be between about 0.005 inches and 0.014 inches, or between about 0.005 inches and 0.013 inches, or between about 0.005 inches and 0.012 inches, or between about 0.005 inches and 0.011 inches, or between about 0.005 inches and 0.011 inches. 0.05 inches to 0.0254 cm (0.010 inches), or about 0.005 inches to 0.02286 cm (0.009 inches), or about 0.005 inches to 0.02032 cm (0.008 inches), or about 0.005 inches to 0.01778 cm (0.007 inches), or about 0.005 inches to 0.006 inches, or about 0.01524 cm (about 0.006 inches) to 0.03556 cm (0.014 inches), or about 0.006 inches) to 0.03302 cm (0.013 inches), or about 0.006 inches) to 0.03048 cm (0.012 inches), or about 0.006 inches) to 0.011 inches), or about 0.006 inches) to 0.02794 cm (0.010 inches), or From about 0.01524 cm (about 0.006 inches) to 0.02286 cm (0.009 inches), or from about 0.01524 cm (about 0.006 inches) to 0.02032 cm (0.008 inches), or from about 0.01524 cm (about 0.006 inches) to 0.01778 cm (0.007 inches), or from about 0.01778 cm (about 0.007 inches) to 0.03556 cm (0.014 inches), or from about 0.01778 cm (about 0.007 inches) to 0.03302 cm (0.0.013 inches), or about 0.007 inches to 0.012 inches, or about 0.007 inches to 0.011 inches, or about 0.007 inches to 0.010 inches, or about 0.007 inches to 0.009 inches, or about 0.007 inches to 0.008 inches, or about 0.008 inches to 0.02032 cm 0.03556 cm (0.014 inches), or about 0.008 inches to 0.03302 cm (0.013 inches), or about 0.008 inches to 0.03048 cm (0.012 inches), or about 0.008 inches to 0.02794 cm (0.011 inches), or about 0.008 inches to 0.0254 cm (0.010 inches), or about 0.008 inches to 0.02286 cm (0.009 inches), or about 0.02 286 cm (about 0.009 inches) to 0.03556 cm (0.014 inches), or about 0.02286 cm (about 0.009 inches) to 0.03302 cm (0.013 inches), or about 0.02286 cm (about 0.009 inches) to 0.03048 cm (0.012 inches), or about 0.02286 cm (about 0.009 inches) to 0.02794 cm (0.011 inches), or about 0.02286 cm (about 0.009 inches) to 0.0254 cm (0.010 inches), or about 0.0254 cm (about 0.010 inches) to 0.03556 cm (0.01 4 inches), or about 0.010 inches to 0.013 inches, or about 0.010 inches to 0.012 inches, or about 0.010 inches to 0.011 inches, or about 0.011 inches to 0.014 inches, or about 0.011 inches to 0.013 inches, or about 0.011 inches to 0.013 inches.The thickness is about 0.012 inches, or about 0.012 inches to 0.014 inches, about 0.012 inches to 0.013 inches, or about 0.013 inches to 0.014 inches.

[0051] In some embodiments, the ratio of width to thickness of the struts (124) can be at least 1. The width and thickness of the struts can vary based on the size of the cell they define. For example, for smaller cells (e.g., at the second basket end (122)), the struts can be thinner and for larger cells (e.g., at the first basket end (121)), the struts can be wider and thicker.

[0052] The struts (124) may have surface unevenness as described herein. As used herein, "surface unevenness" refers to small (i.e., less than 0.5 mm) irregularities in a surface that make the surface rough (i.e., not smooth). In some embodiments, the surface unevenness is on an inner surface of the struts (124). In other embodiments, the surface unevenness is on a side surface of the struts (124). In further embodiments, the surface unevenness is on an outer surface of the struts (124). In some embodiments, the surface unevenness includes grooves, protrusions, or a combination thereof. In certain embodiments, the protruding surface unevenness can be used as a body marker (125), and a radiopaque marker is added to the protrusion. In some embodiments, the surface unevenness in the surface of the struts (124) is created by using a laser (e.g., laser cutting) or other means.

[0053] Without wishing to limit the present invention to any theory or mechanism, it is believed that the surface unevenness in the struts 124 described herein aids in retaining emboli and keeping them captured (i.e., retaining) within the capture basket 120. The surface unevenness can be created using a laser or other means.

[0054] The entire capture basket 120 can be fabricated by laser cutting from a tube and shaping to the final shape. In various embodiments, the capture basket 120 is fabricated by layer deposition using 3D printing. Also, in various embodiments, deposition can be used to fabricate the capture basket.

[0055] Without wishing to limit the present invention to any theory or mechanism, it is believed that the use of a laser cut capture basket (120) is important to the present invention because it allows for optimal radial force and cell size in the capture basket (120), which allows the capture basket (120) to dislodge the thrombus from the vessel wall and shear the thrombus before it can enter the cells.

[0056] In some embodiments, the capture basket (120) can contain less metal, which allows more space for the thrombus to be retrieved, thereby increasing the efficiency of the retrieval.

[0057] In some embodiments, the capture basket (120) includes at least six body markers (125). In other embodiments, the capture basket (120) includes at least eight body markers (125). In further embodiments, the capture basket (120) includes at least ten body markers (125). In some embodiments, the capture basket (120) includes more than ten body markers (125).

[0058] The capture basket (120) may be split along a transverse plane (e.g., split perpendicular to the support structure (150), see FIG. 4A). Splitting the capture basket (120) along a transverse plane results in two portions (e.g., a distal portion and a proximal portion). In some embodiments, the body markers (125) are evenly distributed between the two portions (e.g., the distal portion and the proximal portion) of the capture basket (120) created by the transverse plane.

[0059] In some embodiments, the body markers (125) described herein are equiangularly distributed around the capture basket (120). In some embodiments, the body markers (125) described herein are equiangularly distributed around the capture basket (120) within a single portion (e.g., distal portion or proximal portion). In some embodiments, the body markers (125) within a single portion (e.g., distal portion or proximal portion) of the capture basket are 120° apart from each other.

[0060] The body markers (125) described herein are disposed on the struts (124) of the capture basket (120). In some embodiments, the body markers (125) are aligned with the struts (124) of the capture basket (120) (see FIG. 4B, left side). In other embodiments, the body markers (125) are parallel to the struts (124) of the capture basket (120) (see FIG. 4B, middle / right side). In other embodiments, the body markers (125) protrude from the struts (124) of the capture basket (120) (see FIG. 4B, middle / right side). In some embodiments, the body markers (125) are attached to the struts (124) at a single attachment point (e.g., a single protrusion on the strut (124) (FIG. 4B, right side)). In some embodiments, the body marker (125) is attached to the strut (124) at two attachment points (e.g., two protrusions on the strut (124)) (FIG. 4B, middle). In some embodiments, the body marker (125) is attached to the strut (124) at one or more or more attachment points (e.g., protrusions) on the strut (124). In other embodiments, the body marker (125) is attached to the strut (124) continuously as one continuous attachment (e.g., the body marker is connected along its entire length as a continuous joint).

[0061] The protrusions may act as cushions (e.g., pillows) for the body markers (125), provide additional support and / or structural integrity to the body markers (125), allow for proper positioning of the body markers (125) on the struts (124), help maintain proper positioning of the body markers (125), and / or help maintain the structural integrity of the body markers (125), etc. In some examples, the distal protrusions may be lower (e.g., smaller) than the proximal protrusions (i.e., the proximal protrusions may be higher (e.g., larger) than the distal protrusions (see FIG. 4C). The present invention is not limited to the configurations shown or described herein.

[0062] In some embodiments, the body marker 125 is a radiopaque marker, hi some embodiments, the radiopaque marker comprises tantalum, platinum, or other radiopaque material.

[0063] In some embodiments, the body markers (125) described herein are attached to the struts (124) by a bonding agent. Bonding agents that may be used to attach the body markers (125) to the struts (124) include, but are not limited to, adhesives, soldering, or welding.

[0064] Without wishing to limit the present invention to any theory or mechanism, it is believed that the body markers described herein allow visualization to be used as an aid to see when a thrombus has been captured or missed, and to improve thrombus retention during retrieval.

[0065] In some embodiments, the capture basket (120) is configured to rotate. In some embodiments, the capture basket (120) is configured to rotate axially. In some embodiments, the capture basket (120) can rotate bidirectionally. In some embodiments, the capture basket (120) rotates at low revolutions per minute (rpm). The capture basket can rotate at a rate of about 2 rpm to 50 rpm, or about 2 rpm to 40 rpm, or about 2 rpm to 30 rpm, or about 2 rpm to 25 rpm, or about 2 rpm to 20 rpm, or about 2 rpm to 15 rpm, or about 2 rpm to 10 rpm, or about 2 rpm to 8 rpm, or about 2 rpm to 6 rpm, or about 2 rpm to 4 rpm, or about 4 rpm to 50 rpm, or about 4 rpm to 40 rpm, or about 4 rpm to 30 rpm, or about 4 rpm to 25 rpm. pm, or about 4 rpm to 20 rpm, or about 4 rpm to 15 rpm, or about 4 rpm to 10 rpm, or about 4 rpm to 6 rpm, or about 6 rpm to 50 rpm, or about 6 rpm to 40 rpm, or about 6 rpm to 30 rpm, or about 6 rpm to 25 rpm, or about 6 rpm to 20 rpm, or about 6 rpm to 15 rpm, or about 6 rpm to 10 rpm, or about 6 rpm to 8 rpm, or about 8 rpm to 50 rpm, or about 8 rpm to 40 rpm, or is about 8 rpm to 30 rpm, or about 8 rpm to 25 rpm, or about 8 rpm to 20 rpm, or about 8 rpm to 15 rpm, or about 8 rpm to 10 rpm, or about 10 rpm to 50 rpm, or about 10 rpm to 40 rpm, or about 10 rpm to 30 rpm, or about 10 rpm to 25 rpm, or about 10 rpm to 20 rpm, or about 10 rpm to 15 rpm, or about 15 rpm to 50 rpm, or about 15 rpm to 40 rpm, or about 15 rpm It can be rotated at about 15 rpm to 25 rpm, or about 15 rpm to 20 rpm, or about 20 rpm to 50 rpm, or about 20 rpm to 40 rpm, or about 20 rpm to 30 rpm, or about 20 rpm to 25 rpm, or about 25 rpm to 50 rpm, or about 25 rpm to 40 rpm, or about 25 rpm to 30 rpm, or about 30 rpm to 50 rpm, or about 30 rpm to 40 rpm, or about 40 rpm to 50 rpm.

[0066] To remove large thrombi, it may be useful to shear the thrombi into smaller pieces without causing uncontrolled embolic debris (e.g., debris that is dislodged and migrates to undesired locations). Without wishing to limit the present invention to any theory or mechanism, it is believed that rotating the capture basket allows for controlled shearing of the emboli and also helps to remove the emboli from the vessel wall. As described herein, "controlled shearing" may refer to breaking up an object (e.g., a thrombus) into several chunks (e.g., breaking up circumferentially), and does not refer to macerating or pulverizing an object (e.g., a thrombus) (e.g., reducing it to fine particles by grinding or crushing).

[0067] The capture basket (120) can be attached to a delivery shaft (i.e., pusher or push wire, 110), which is a wire that delivers the capture basket (120) through the vasculature to the location of the embolus and pushes the capture basket (120) through the catheter to the side of the embolus.

[0068] In certain embodiments, the delivery shaft (i.e., pusher, 110) is braided. In preferred embodiments, the delivery shaft (i.e., pusher, 110) is hollow. In some embodiments, the delivery shaft (i.e., pusher, 110) is hollow over at least a section of the shaft. In other embodiments, the delivery shaft (i.e., pusher, 110) is hollow over the entire length of the delivery shaft (110). In further embodiments, the delivery shaft (i.e., pusher, 110) has a hollow distal end. In certain embodiments, the delivery shaft (i.e., pusher, 110) is solid.

[0069] In some embodiments, a guidewire can be threaded through the delivery shaft (110). In some embodiments, the guidewire can be threaded through the first basket end (121) and the second basket end (122) such that the guidewire is disposed within the capture basket. In other embodiments, the device is configured such that the guidewire can be threaded through the delivery shaft (110) via the second basket end (122) such that the guidewire is disposed within the capture basket (120).

[0070] The delivery shaft (i.e., pusher, 110) can be rotated. In some embodiments, the delivery shaft (i.e., pusher, 110) can be rotated axially. In other embodiments, the delivery shaft (i.e., pusher, 110) can be rotated by hand. In some embodiments, the delivery shaft (i.e., pusher, 110) can be rotated bidirectionally. In some embodiments, the delivery shaft (i.e., pusher, 110) can withstand torque. In some embodiments, the delivery shaft (i.e., pusher, 110) allows for torque transmission. In some embodiments, the delivery shaft (i.e., pusher, 110) allows for 1:1 torque transmission. For example, when the proximal end of the delivery shaft (i.e., pusher, 110) (e.g., the end opposite the distal end (111) of the delivery shaft (110)) is rotated (e.g., rotated by hand), an equivalent torque is transmitted from the delivery shaft (i.e., pusher, 110) to the capture basket (120), and therefore the capture basket (120) also rotates. In some embodiments, rotating the delivery shaft (110) also rotates the capture basket (120) as torque is transferred from the delivery shaft (110) to the capture basket (120).

[0071] In certain embodiments, the delivery shaft (i.e., pusher, 110) can withstand low revolutions per minute (rpm). In certain embodiments, the delivery shaft (i.e., pusher, 110) can withstand revolutions per minute (rpm) of about 2-10 rpm. In other embodiments, the delivery shaft (i.e., pusher, 110) can withstand revolutions per minute (rpm) of about 2-50 rpm, or about 2-40 rpm, or about 2-30 rpm, or about 2-25 rpm, or about 2-20 rpm, or about 2-15 rpm, or about 2-10 rpm, or about 2-8 rpm, or about 2-6 rpm, or about 2-4 rpm, or about 4-50 rpm, or about 4-40 rpm, or about 4-30 rpm. m, or about 4 rpm to 25 rpm, or about 4 rpm to 20 rpm, or about 4 rpm to 15 rpm, or about 4 rpm to 10 rpm, or about 4 rpm to 6 rpm, or about 6 rpm to 50 rpm, or about 6 rpm to 40 rpm, or about 6 rpm to 30 rpm, or about 6 rpm to 25 rpm, or about 6 rpm to 20 rpm, or about 6 rpm to 15 rpm, or about 6 rpm to 10 rpm, or about 6 rpm to 8 rpm, or about 8 rpm to 50 rpm, or about 8 rpm to 4 0 rpm, or about 8 rpm to 30 rpm, or about 8 rpm to 25 rpm, or about 8 rpm to 20 rpm, or about 8 rpm to 15 rpm, or about 8 rpm to 10 rpm, or about 10 rpm to 50 rpm, or about 10 rpm to 40 rpm, or about 10 rpm to 30 rpm, or about 10 rpm to 25 rpm, or about 10 rpm to 20 rpm, or about 10 rpm to 15 rpm, or about 15 rpm to 50 rpm, or about 15 rpm to 40 rpm, or about 15 rpm to 3 The rotor can withstand a revolutions per minute (rpm) of 0 rpm, or about 15 rpm to 25 rpm, or about 15 rpm to 20 rpm, or about 20 rpm to 50 rpm, or about 20 rpm to 40 rpm, or about 20 rpm to 30 rpm, or about 20 rpm to 25 rpm, or about 25 rpm to 50 rpm, or about 25 rpm to 40 rpm, or about 25 rpm to 30 rpm, or about 30 rpm to 50 rpm, or about 30 rpm to 40 rpm, or about 40 rpm to 50 rpm.

[0072] In some embodiments, the devices described herein further comprise a first marker (126) and a second marker (127). In some embodiments, the first marker (126) is disposed at the first basket end (121) and the second marker (127) is disposed at the second basket end (122). In certain embodiments, the first marker (126) and the second marker (127) are radiopaque markers. The radiopaque markers may be positioned to reveal the thrombus under fluoroscopy. In some embodiments, the radiopaque markers include tantalum, platinum, or other radiopaque materials.

[0073] For improved radiopacity and visualization, radiopaque markers made from tantalum, platinum, or other radiopaque materials may be provided on various portions of the capture basket.

[0074] In some embodiments, the radiopaque markers described herein can be textured to provide additional emboli retention. The textured radiopaque markers can be positioned in multiple radial directions around the capture basket (120) to retain dislodged fragments of emboli in any portion of the capture basket.

[0075] In some embodiments, the device is rotatable. In other embodiments, the device is configured to rotate. For example, rotating the proximal end (e.g., the end opposite the distal end (111) of the delivery shaft (110)) of the delivery shaft (i.e., pusher, 110) transmits torque from the delivery shaft (110) to the capture basket (120), thereby causing the capture basket (120) to rotate. In some embodiments, the device rotates axially. In some embodiments, the device is rotated by hand. In some embodiments, the device can be rotated bidirectionally.

[0076] In certain embodiments, the device (100) can withstand low revolutions per minute (rpm). In certain embodiments, the device (100) can withstand revolutions per minute (rpm) of about 2-10 rpm. In other embodiments, the device (100) can withstand revolutions per minute (rpm) of about 2-50 rpm, or about 2-40 rpm, or about 2-30 rpm, or about 2-25 rpm, or about 2-20 rpm, or about 2-15 rpm, or about 2-10 rpm, or about 2-8 rpm, or about 2-6 rpm, or about 2-4 rpm, or about 4-50 rpm, or about 4-40 rpm, or about 4-30 rpm, or about 4 rpm. m to 25 rpm, or about 4 rpm to 20 rpm, or about 4 rpm to 15 rpm, or about 4 rpm to 10 rpm, or about 4 rpm to 6 rpm, or about 6 rpm to 50 rpm, or about 6 rpm to 40 rpm, or about 6 rpm to 30 rpm, or about 6 rpm to 25 rpm, or about 6 rpm to 20 rpm, or about 6 rpm to 15 rpm, or about 6 rpm to 10 rpm, or about 6 rpm to 8 rpm, or about 8 rpm to 50 rpm, or about 8 rpm to 40 rpm, or is about 8 rpm to 30 rpm, or about 8 rpm to 25 rpm, or about 8 rpm to 20 rpm, or about 8 rpm to 15 rpm, or about 8 rpm to 10 rpm, or about 10 rpm to 50 rpm, or about 10 rpm to 40 rpm, or about 10 rpm to 30 rpm, or about 10 rpm to 25 rpm, or about 10 rpm to 20 rpm, or about 10 rpm to 15 rpm, or about 15 rpm to 50 rpm, or about 15 rpm to 40 rpm, or about 15 rpm to 30 rpm m, or about 15 rpm to 25 rpm, or about 15 rpm to 20 rpm, or about 20 rpm to 50 rpm, or about 20 rpm to 40 rpm, or about 20 rpm to 30 rpm, or about 20 rpm to 25 rpm, or about 25 rpm to 50 rpm, or about 25 rpm to 40 rpm, or about 25 rpm to 30 rpm, or about 30 rpm to 50 rpm, or about 30 rpm to 40 rpm, or about 40 rpm to 50 rpm.

[0077] As used herein, "low rpm" may refer to a speed that prevents tachycardia and hemolysis of red blood cells. Without wishing to limit the present invention to any theory or mechanism, it is believed that spinning the device at a low rpm prevents red blood cells (RBCs) from hemolyzing and also prevents tachycardia, both of which can occur when using high rpm devices.

[0078] In some embodiments, the devices described herein further comprise a delivery sheath (170). In some embodiments, the thrombectomy device (100) is loaded into the delivery sheath (170) prior to delivery. In some embodiments, the delivery sheath (170) containing the thrombectomy device (100) is advanced through a catheter (180, e.g., an aspiration catheter) to reach the target location (i.e., the target lesion, e.g., a thrombus). In some embodiments, the devices described herein further comprise a delivery catheter (180).

[0079] The devices described herein may further comprise a catheter (e.g., a suction catheter). Suction at the proximal end of the catheter while the thrombus-containing thrombectomy device (100) is drawn into the catheter and withdrawn from the body may increase the efficiency of thrombectomy. Suction may be accomplished manually or using a pump. The devices described herein (100) may be operated with or without suction assistance.

[0080] In some embodiments, the delivery catheter (180) is an aspiration catheter. In some embodiments, the delivery catheter (180, e.g., an aspiration catheter) comprises a 24 Fr catheter, a 20 Fr catheter, a 16 Fr catheter, or a 12 Fr catheter. In other embodiments, the delivery catheter (180, e.g., aspiration catheter) is about 10 Fr to 26 Fr, or about 10 Fr to 24 Fr, or about 10 Fr to 22 Fr, or about 10 Fr to 20 Fr, or about 10 Fr to 18 Fr, or about 10 Fr to 16 Fr, or about 10 Fr to 14 Fr, or about 10 Fr to 12 Fr, or about 12 Fr to 26 Fr, or about 12 Fr to 24 Fr, or about 12 Fr to 22 Fr, or about 12 Fr to 20 Fr, or about 12 Fr to 18 Fr, or about 12 Fr to 16 Fr, or about 12 Fr to 14 Fr, or about 14 Fr to 26 Fr, or about 14 Fr to 24 Fr, or Catheters of about 14Fr to 22Fr, or about 14Fr to 20Fr, or about 14Fr to 18Fr, or about 14Fr to 16Fr, or about 16Fr to 26Fr, or about 16Fr to 24Fr, or about 16Fr to 22Fr, or about 16Fr to 20Fr, or about 16Fr to 18Fr, or about 18Fr to 26Fr, or about 18Fr to 24Fr, or about 18Fr to 22Fr, or about 18Fr to 20Fr, or about 20Fr to 26Fr, or about 20Fr to 24Fr, or about 20Fr to 22Fr, or about 22Fr to 26Fr, or about 22Fr to 24Fr, or about 24Fr to 26Fr.

[0081] In some embodiments, the delivery catheter (180, e.g., aspiration catheter) includes an attached hub subassembly. In some embodiments, the delivery catheter (180, e.g., aspiration catheter) includes a valve. In some embodiments, a large size engineered valve in the proximal hub allows for high aspiration efficiency. For example, the valve allows for the clot to be aspirated through a side port while the main port can be opened and closed to a desired opening diameter by the rotating valve. The rotating valve can withstand suction forces and remain sealed around any device (e.g., thrombectomy device (100)) inserted through the rotating valve to allow aspiration through the side port.

[0082] In some embodiments, the delivery catheter (180, e.g., aspiration catheter) comprises a syringe. In some embodiments, the syringe comprises a 60cc Vac-Lok syringe or a 30cc Vac-Lok syringe.

[0083] The capture basket (120) may be configured to be delivered by a delivery catheter (180) from an upstream direction in a blood vessel. In some embodiments, the distal opening of the delivery catheter has one or more extrusions extending from an inner surface of the delivery catheter, the one or more extrusions having sharp edges. The capture basket (120) may be configured to be delivered by a delivery catheter (180) from an upstream direction in a blood vessel and then retrieved by the delivery catheter (180), the distal opening of the delivery catheter (180) being configured to increase in size to retrieve the capture basket (120).

[0084] In some embodiments, the distal opening of the delivery catheter (180) can have one or more extrusions extending from an inner surface of the delivery catheter (180), the one or more extrusions having sharp edges, the one or more extrusions being retractable, and the one or more extrusions having sharp edges configured to shear the thrombus as the capture basket (120) is retrieved by the distal end of the delivery catheter (180). The delivery catheter (180) can have one or more slits at the distal opening of the delivery catheter (180), the distal opening of the delivery catheter (180) configured to increase in size to retrieve the capture basket.

[0085] The thrombectomy device (100) can further include a balloon catheter located near the distal opening of the delivery catheter (180) that has a funnel shape when inflated. The balloon catheter can have pores that allow blood to flow through the balloon catheter when the balloon catheter is inflated and prevent large thrombus from flowing through the balloon catheter. The proximal end of the delivery catheter (180) can be configured to be suctioned to aid in the capture of the capture basket into the distal end of the delivery catheter.

[0086] The catheter may include a balloon that, when inflated, increases the opening at the distal end of the catheter. The balloon may have a funnel shape that facilitates the capture of the capture basket into the catheter after it captures the emboli. The balloon may further include a lattice structure that, when the balloon is inflated, allows the open areas of the balloon to allow blood to pass through the balloon. In various embodiments, the balloon is not limited to a funnel shape. The balloon may be of various shapes, such as a disk or cylinder. External suction may be used with the device to aid in retrieving the emboli.

[0087] In one embodiment, suction at the proximal end of the catheter can be used to increase the efficiency of emboli removal. Suction can be performed while the emboli are captured in the capture basket and drawn into the catheter. In various embodiments, suction is not used to retrieve the emboli.

[0088] In some embodiments, the invention features a method of removing a thrombus. The method includes loading a thrombus retrieval device (100) into a delivery sheath (170). The delivery sheath (170) is then advanced inside a previously delivered catheter (180, e.g., an aspiration catheter). Once the thrombus retrieval device (100) reaches the target lesion, the delivery sheath (170) is withdrawn (i.e., removed from the body). The thrombus retrieval device (100), and more specifically, the capture basket (120), can help break the thrombus from the vessel wall if necessary. For example, the capture basket (120) can be rotated (at a low rpm, such as 2-10 rpm) to dislodge the thrombus from the vessel wall. The capture basket (120) can then be used to capture the thrombus and bring it near the tip of the catheter (180, e.g., an aspiration catheter). In some embodiments, suction and retrieval of the thrombus by the capture basket (120) work together to remove the thrombus from the lesion and out of the body.

[0089] The invention may feature a method of capturing a thrombus. The method includes deploying a thrombus removal device (100) as described herein and expanding a capture basket (120) on the side of the thrombus between the vessel wall and the thrombus. In some embodiments, expanding the capture basket (120) of the thrombus retrieval device (100) allows the thrombus to laterally enter the capture basket (120) of the thrombus retrieval device (100), thus capturing the thrombus. In some embodiments, the thrombus comprises an embolus.

[0090] The invention may also feature a method of retaining a thrombus. The method includes capturing a thrombus in a thrombus retrieval device (100) as described herein and visualizing and monitoring the distance between the body markers (125) in a portion of the capture basket (120). In some embodiments, the thrombus is retained in the capture basket (120) when the distance between the body markers (125) in a portion of the capture basket (120) does not change, and the thrombus has escaped when the distance between the body markers (125) in a portion of the capture basket (120) changes. In some embodiments, the thrombus includes an embolus.

[0091] The invention may further feature a method of capturing and retaining a thrombus. The method includes deploying a thrombus retrieval device (100) as described herein on the side of the thrombus. In some embodiments, the method includes expanding a capture basket (120) on the side of the thrombus between the vessel wall and the thrombus. In some embodiments, expanding the capture basket (120) of the thrombus retrieval device (100) allows the embolus to enter the capture basket (120) of the embolus retrieval device (100) laterally, thus capturing the thrombus. The method may further include visualizing and monitoring a distance between the body markers (125) on a portion of the capture basket (120). In some embodiments, when the distance between the body markers (125) on a portion of the capture basket (120) does not change, the thrombus is retained in the capture basket (120), and when the distance between the body markers (125) on a portion of the capture basket (120) changes, the thrombus has escaped. In some embodiments, the thrombus includes an embolus. In some embodiments, the distance of the body markers 125 in the portion of the capture basket 120 increases, while in other embodiments the distance of the body markers 125 in the portion of the capture basket 120 decreases.

[0092] In some embodiments, the distance between the body markers (125) in a single portion of the capture basket (120) (e.g., the distal portion or the proximal portion) increases. For example, if a thrombus is moving from outside the capture basket (120) into the capture basket (120), the distance between the body markers (125) may increase. In some embodiments, the distance between the body markers (125) in a single portion of the capture basket (120) (e.g., the distal portion or the proximal portion) decreases. For example, if a thrombus is moving from inside the capture basket (120) to outside the capture basket (120), the distance between the body markers (125) may decrease.

[0093] In some embodiments, the distance between the body markers (125) in each of the two portions (e.g., the distal portion or the proximal portion) of the capture basket (120) both increases. In some embodiments, the distance between the body markers (125) in each of the two portions (e.g., the distal portion or the proximal portion) of the capture basket (120) both decreases. In certain embodiments, the distance between the body markers (125) in each of the two portions (e.g., the distal portion or the proximal portion) changes independently of one another.

[0094] The invention may feature a method of indirectly visualizing a captured thrombus. The method includes capturing a thrombus with a capture basket (120) as described herein and monitoring a distance between body markers (125) on a portion of the capture basket (120). In some embodiments, the thrombus is captured and retained within the capture basket (120) when the distance between the body markers (125) on a portion of the capture basket (120) does not change, and the thrombus is released from the capture basket (120) when the distance between the body markers (125) on a portion of the capture basket (120) changes.

[0095] In some embodiments, the invention described above (e.g., the devices described herein) are intended to treat pulmonary embolism, however, the devices described herein may be applicable in whole or in part to treat other peripheral vascular diseases, including, but not limited to, deep vein thrombosis (DVT) or peripheral arterial thrombosis.

[0096] Real-life examples The following are non-limiting examples of the present invention. It should be understood that the examples are not intended to limit the present invention in any way. Equivalents or substitutes are within the scope of the present invention.

[0097] A common medical condition is pulmonary embolism, where an embolus is trapped in the pulmonary artery. Most emboli originate deep in the veins of the body, such as the legs. From the legs, the embolus may travel through the inferior vena cava to the right atrium and right ventricle of the heart. From the right ventricle, the embolus may travel to the pulmonary artery. The pulmonary artery branches into the right and left pulmonary arteries. The right and left pulmonary arteries successively branch further to the lungs to provide oxygen to the blood. As the right and left pulmonary arteries branch, they become successively smaller, so that an embolus traveling in the right and left pulmonary arteries may get stuck or become lodged, blocking or reducing blood flow downstream from the embolus. A device (100) as described herein is advanced through the pulmonary artery and delivered to the site of the embolism. The thrombus retrieval device (100) can capture the embolus so that it can be retrieved from the body.

[0098] Example 1: Use of a thrombectomy device to capture and remove a thrombus from the body A surgeon uses a guidewire to guide a catheter (180, e.g., an aspiration catheter) through the patient's vasculature toward the embolus. The surgeon then loads a delivery sheath (170) containing the thrombectomy device (100) into a previously delivered catheter (180, e.g., an aspiration catheter) and pushes the delivery sheath (170) through the catheter (180). Once the delivery sheath (170) containing the thrombectomy device (100) reaches the target lesion (e.g., an embolus), the surgeon can then push the thrombectomy device (100) out of the distal end of the delivery sheath (170) using the delivery shaft (110). Once the thrombectomy device (100) is out of the delivery sheath (170), the surgeon then withdraws the delivery sheath (170) from the body through the catheter (180). Once the capture basket (120) is out of the delivery sheath (170), it expands, allowing emboli to enter the capture basket (120) of the thrombectomy device (100) from the side, thus capturing the emboli. To ensure that the emboli are completely removed from the vessel wall, the surgeon rotates the distal end of the delivery shaft (110) to rotate the capture basket (120). Once the emboli are captured within the capture basket (120), the surgeon uses the delivery shaft (110) to pull the capture basket (120) towards the catheter (180). Using the body markers (125) placed on the capture basket (120), the surgeon monitors any changes in the distance between the markers. While the surgeon is pulling the delivery shaft (110), the distance between the body markers (125) on the capture basket (120) begins to increase. To prevent emboli from escaping from the capture basket (120), the surgeon slows down the speed at which the capture basket (120) is pulled by the delivery shaft (110). If the distance of the body markers (125) at the capture basket (120) does not change, the surgeon knows that the thrombus has been captured and retained within the capture basket (120), and therefore pulls the delivery shaft (110) at a newly adjusted speed. Once the capture basket (120) reaches the distal end of the catheter (180), the surgeon uses suction to help pull the emboli and / or the capture basket (120) into the catheter (180).Once the capture basket (120) and emboli are within the catheter (180), the surgeon then removes the catheter from the body. EXAMPLES

[0099] The following examples are intended to be merely illustrative and not limiting in any way.

[0100] Example Set A Example 1A: A capture basket (120) for capturing emboli, the capture basket (120) comprising: (a) a first basket end (121) and a second basket end (122); (b) a plurality of cells (123) defined by struts (124), the struts having strut ends connected to the first basket end (121) and the second basket end (122); and (c) at least four body markers (125) disposed on the capture basket (120).

[0101] Example 2A: The basket of Example 1A, wherein the diameter of the capture basket (120) is between 10 mm and 14 mm.

[0102] Example 3A: The basket of Example 1A or Example 2A, wherein the diameter of the capture basket (120) tapers between the first basket end (121) and the second basket end (122).

[0103] Example 4A: The basket of Example 3A, wherein the first basket end (121) has a larger diameter than the second basket end (122).

[0104] Example 5A: The basket of any one of Examples 1A to 4A, wherein the cell (123) is a closed cell.

[0105] Example 6A: The basket of any one of Examples 1A to 5A, wherein the cells (123) are quadrilateral in shape.

[0106] Example 7A: The basket of any one of Examples 1A to 6A, wherein the cells (123) are diamond shaped.

[0107] Example 8A: The basket of any one of Examples 1A to 7A, wherein the struts (124) have surface irregularities.

[0108] Example 9A: The basket of any one of Examples 1A to 8A, wherein the surface unevenness is on an inner surface of the strut (124).

[0109] Example 10A: The basket of any one of Examples 1A to 8A, wherein the surface unevenness is on a side of the strut (124).

[0110] Example 11A: The basket of Example 9 or Example 10A, wherein the surface irregularities include grooves, protrusions, or a combination thereof.

[0111] Example 12A: The basket of any one of Examples 1A to 11A, wherein the plurality of cells (123) defined by the struts (124) exert an outward radial force.

[0112] Example 13A: A basket described in any one of Examples 1A to 12A, wherein the plurality of cells (123) defined by the struts (124) allow emboli to enter the capture basket (120).

[0113] Example 14A: The basket of any one of Examples 1A to 13A, wherein the capture basket (120) includes at least six body markers (125).

[0114] Example 15A: The basket of any one of Examples 1A to 14A, wherein the capture basket (120) includes at least eight body markers (125).

[0115] Example 16A: The basket of any one of Examples 1A to 15A, wherein the body markers (125) are evenly distributed between the two portions of the capture basket (120) provided by the cross section.

[0116] Example 17A: The basket of Example 16A, wherein the two portions of the capture basket (120) include a distal portion and a proximal portion.

[0117] Example 18A: The basket of Example 17A, wherein the body markers (125) are evenly distributed around the distal and / or proximal portions of the capture basket (120).

[0118] Example 19A: The basket of Example 18A, wherein the body markers (125) at the distal and / or proximal portions of the capture basket (120) are spaced 120° apart from each other.

[0119] Example 20A: The basket of any one of Examples 1A to 19A, wherein the body marker (125) is disposed on a strut (124) of the capture basket (120).

[0120] Example 21A: The basket of Example 20A, wherein the body marker (125) is aligned with the struts (124) of the capture basket (120).

[0121] Example 22A: The basket of Example 20A, wherein the body marker (125) protrudes from the struts (124) of the capture basket (120).

[0122] Example 23A: The basket of any one of Examples 1A to 22A, wherein the body marker (125) is a radiopaque marker.

[0123] Example 24A: The basket of any one of Examples 1A to 23A, wherein the capture basket (120) is configured to rotate.

[0124] Example 25A: The basket of any one of Examples 1A to 24A, wherein the capture basket (120) rotates at a low revolutions per minute (rpm).

[0125] Example 26A: The basket of any one of Examples 1A to 25A, wherein the capture basket (120) rotates at 2 to 10 rpm.

[0126] Example 27A: The basket of any one of Examples 1A to 26A, wherein rotating the capture basket (120) allows for controlled shearing of the emboli.

[0127] Example 28A: The basket of any one of Examples 1A to 27A, wherein rotating the capture basket (120) dislodges emboli from the vessel wall.

[0128] Example 29A: The basket of any one of Examples 1A to 28A, wherein the capture basket (120) is configured to retrieve emboli from two blood vessels simultaneously.

[0129] Example Set B Example 1B: (a) a thrombus retrieval device (100), comprising: (a) a delivery shaft (110) having a delivery shaft distal end (111); (b) a capture basket (120) coupled to the delivery shaft distal end (111), the capture basket (120) including a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), the struts (124) having strut ends connected to the first basket end (121) and the second basket end (122), and at least four body markers (125) disposed in the capture basket (120); and (c) a support component (150) coupled to the delivery shaft distal end (111) and disposed within the capture basket (120).

[0130] Example 2B: The device (100) described in Example 1B, wherein the support component (150) includes: (a) a first support portion (130) having a first end (131), a second end (132), and a first lumen (133), wherein the first end (131) of the first support portion (130) is positioned adjacent to the first basket end (121) within the basket (120); and (b) a second support portion (140) having a first end (141), a second end (142), and a second lumen (143), wherein the second end (142) of the second support portion (140) is positioned adjacent to the second basket end (122) within the basket (120).

[0131] Example 3B: The device (100) of Example 2B, wherein the first support portion (130) is stationary relative to the delivery shaft distal end (111).

[0132] Example 4B: The device (100) described in Example 2B, wherein the support component (150) further includes an inner shaft (160) disposed through the first lumen (133) of the first support portion (130) and the second lumen (143) of the second support portion (140).

[0133] Example 5B: The device (100) of any one of Examples 2B to 4B, wherein the inner shaft (160) is fixed to the second end (142) of the second support portion (140).

[0134] Example 6B: The device (100) of any one of Examples 2B to 5B, wherein the inner shaft (160) slides within the first lumen (133) of the first support portion (130).

[0135] Example 7B: The device (100) described in Example 6B, wherein the capture basket (120) extends when the inner shaft (160) slides distally within the first lumen (133) of the first support portion (130), away from the first end (131) of the support portion (130).

[0136] Example 8B: A device (100) as described in Example 6B, wherein the capture basket (120) retracts when the inner shaft (160) slides proximally within the first lumen (133) of the first support portion (130) toward the first end (131) of the support portion (130).

[0137] Example 9B: The device (100) of Example 1B, wherein the support component (150) comprises a telescoping shaft.

[0138] Example 10B: The device (100) of Example 9B, wherein the capture basket (120) extends when the telescoping shaft of the support component (150) expands.

[0139] Example 11B: The device (100) of Example 9B, wherein the capture basket (120) retracts when the telescoping shaft of the support component (150) shortens.

[0140] Example 12B: The device (100) of any one of Examples 1B to 11B, wherein the support component (150) is flexible.

[0141] Example 13B: The device (100) of any one of Examples 1B to 12B, wherein the diameter of the capture basket (120) is between 10 mm and 14 mm.

[0142] Example 14B: The device (100) of any one of Examples 1B to 13B, wherein the diameter of the capture basket (120) tapers between the first basket end (121) and the second basket end (122).

[0143] Example 15B: The device of Example 14B, wherein the first basket end (121) has a larger diameter than the second basket end (122).

[0144] Example 16B: The device (100) of any one of Examples 1B to 15B, wherein the cell (123) is a closed cell.

[0145] Example 17B: The device (100) of any one of Examples 1B to 16B, wherein the cell (123) is quadrilateral in shape.

[0146] Example 18B: The device (100) of any one of Examples 1B to 17B, wherein the cell (123) is diamond shaped.

[0147] Example 19B: The device (100) of any one of Examples 1B to 18B, wherein the struts (124) have surface irregularities.

[0148] Example 20B: The device (100) of any one of Examples 1B to 19B, wherein the surface unevenness is on an inner surface of the strut (124).

[0149] Example 21B: The device (100) of any one of Examples 1B to 19B, wherein the surface unevenness is on a side of the strut (124).

[0150] Example 22B: The device (100) of Example 20B or Example 21B, wherein the surface unevenness comprises grooves, protrusions, or a combination thereof.

[0151] Example 23B: The device (100) of any one of Examples 1B to 22B, wherein the plurality of cells (123) defined by the struts (124) exert an outward radial force.

[0152] Example 24B: A device (100) described in any one of Examples 1B to 23B, wherein the multiple cells (123) defined by the struts (124) allow emboli to enter the capture basket (120).

[0153] Example 25B: The device (100) of any one of Examples 1B to 24B, wherein the capture basket (120) includes at least six body markers (125).

[0154] Example 26B: The device (100) of any one of Examples 1B to 25B, wherein the capture basket (120) includes at least eight body markers (125).

[0155] Example 27B: A device (100) according to any one of Examples 1B to 26B, wherein the body markers (125) are evenly distributed between the two portions of the capture basket (120) provided by the cross-section.

[0156] Example 28B: The device (100) of Example 27B, wherein the two portions of the capture basket (120) include a distal portion and a proximal portion.

[0157] Example 29B: The device (100) described in Example 28B, wherein the body markers (125) are uniformly distributed around the distal and / or proximal portions of the capture basket (120).

[0158] Example 30B: A device (100) as described in Example 28B or Example 29B, wherein the body markers (125) at the distal and / or proximal portions of the capture basket (120) are 120° apart from each other.

[0159] Example 31B: The device (100) of any one of Examples 1B to 30B, wherein the body marker (125) is disposed on a strut (124) of the capture basket (120).

[0160] Example 32B: The device (100) of Example 31B, wherein the body marker (125) is aligned with the struts (124) of the capture basket (120).

[0161] Example 33B: The device (100) of Example 31B, wherein the body marker (125) protrudes from the strut (124) of the capture basket (120).

[0162] Example 34B: The device (100) of any one of Examples 1B to 33B, wherein the body marker (125) is a radiopaque marker.

[0163] Example 35B: The device (100) of any one of Examples 1B to 34B, wherein the capture basket (120) is deployable on the side of the thrombus in the blood vessel.

[0164] Example 36B: The device (100) of any one of Examples 1B to 35B, wherein the capture basket (120) is configured to rotate.

[0165] Example 37B: The device (100) of any one of Examples 1B to 36B, wherein the capture basket (120) rotates at a low revolutions per minute (rpm).

[0166] Example 38B: The device (100) of any one of Examples 1B to 37B, wherein the capture basket (120) rotates at 2 to 10 rpm.

[0167] Example 39B: The device (100) of any one of Examples 1B to 38B, wherein rotating the capture basket (120) allows for controlled shearing of the embolus.

[0168] Example 40B: The device (100) of any one of Examples 1B to 39B, wherein rotating the capture basket (120) dislodges the emboli from the vessel wall.

[0169] Example 41B: The device (100) of any one of Examples 1B to 40B, wherein the capture basket (120) is configured to retrieve emboli from two blood vessels simultaneously.

[0170] Example 42B: The device of any one of Examples 1B to 41B, wherein the delivery shaft (110) is braided.

[0171] Example 43B: The device of any one of Examples 1B to 42B, wherein the delivery shaft (110) is hollow.

[0172] Example 44B: The device of any one of Examples 1B to 43B, wherein the delivery shaft (110) is capable of withstanding torque.

[0173] Example 45B: The device (100) of Example 44B, wherein the delivery shaft (110) is configured to rotate.

[0174] Example 46B: The device (100) of Example 45B, wherein the delivery shaft (110) is rotated by hand.

[0175] Example 47B: The device (100) described in Example 45B or Example 46B, wherein the delivery shaft (110) rotates at a low revolutions per minute (rpm).

[0176] Example 48B: The device (100) of Example 47B, wherein the delivery shaft (110) rotates at 2 to 10 rpm.

[0177] Example 49B: A device (100) described in any one of Examples 44B to 48B, wherein when the delivery shaft (110) is rotated, torque is transmitted from the delivery shaft (110) to the capture basket (120), thereby causing the capture basket (120) to also rotate.

[0178] Example 50B: A device described in any one of Examples 1B to 49B, further comprising a first end marker (126) and a second end marker (127).

[0179] Example 51B: A device (100) as described in Example 50B, wherein a first end marker (126) is positioned at the first basket end (121) and a second end marker (127) is positioned at the second basket end (122).

[0180] Example 52B: A device described in Example 50B or Example 51B, wherein the first end marker (126) and the second end marker (127) are radiopaque markers.

[0181] Example 53B: The device (100) of any one of Examples 1B to 52B, further comprising a delivery sheath (170).

[0182] Example 54B: The device (100) of any one of Examples 1B to 53B, further comprising a delivery catheter (180).

[0183] Example 55B: The device (100) of any one of Examples 1B to 54B, wherein the device is rotatable.

[0184] Example 56B: The device (100) of Example 55B, wherein the device rotates at 2 to 10 rpm.

[0185] Example 57B: The device (100) of Example 55B or 56B, wherein rotating the device allows for controlled shearing of the embolus.

[0186] Example 58B: The device (100) of Example 55B or 56B, wherein rotating the device enables the capture basket (120) to dislodge the embolus from the vessel wall.

[0187] Example 59B: A device (100) described in any one of Examples 1B to 58B, wherein the capture basket (120) is configured to be retrieved by a distal opening of the catheter after the thrombus enters the capture basket (120).

[0188] Example Set C Example 1C: A method for capturing a thrombus, the method comprising: (a) deploying a thrombus retrieval device (100) according to Example Set B; and (b) expanding a capture basket (120) on the side of the thrombus between the vessel wall and the thrombus, wherein expanding the capture basket (120) of the thrombus retrieval device (100) allows the thrombus to enter the capture basket (120) of the thrombus retrieval device (100) from the side, thus capturing the thrombus.

[0189] Example 2C: A method for retaining a thrombus within a thrombus retrieval device (100) while the thrombus retrieval device (100) is being pulled towards a catheter, the method comprising: (a) capturing a thrombus within a thrombus retrieval device (100) according to Example Set B; and (b) visualizing and monitoring the distance between body markers (125) in a portion of a capture basket (120), wherein if the distance between the body markers (125) in a portion of the capture basket (120) does not change, the thrombus is retained within the capture basket (120), and if the distance between the body markers (125) in a portion of the capture basket (120) changes, the thrombus has escaped.

[0190] Example 3C: A method for capturing and retaining a thrombus, the method comprising: (a) deploying a thrombus retrieval device (100) according to Example Set B on a side of the thrombus; (b) expanding a capture basket (120) on a side of the thrombus between the vessel wall and the thrombus, wherein expanding the capture basket (120) of the thrombus retrieval device (100) allows the embolus to enter the capture basket (120) of the embolus retrieval device (100) from the side, thus capturing the thrombus; and (c) further comprising visualizing and monitoring a distance between body markers (125) on a portion of the capture basket (120), wherein when the distance between the body markers (125) on a portion of the capture basket (120) does not change, the thrombus is retained within the capture basket (120), and when the distance between the body markers (125) on a portion of the capture basket (120) changes, the thrombus has escaped.

[0191] Example 4C: The method of example 2C or example 3C, wherein the distance of the body markers (125) in a portion of the capture basket (120) is increased.

[0192] Example 5C: The method of example 2C or example 3C, wherein the distance of the body markers (125) in a portion of the capture basket (120) is decreased.

[0193] Example 6C: The method of any one of Examples 1C to 5C, wherein the thrombus comprises an embolus.

[0194] Example 7C: A method for indirectly visualizing a captured embolus, the method comprising capturing an embolism with a capture basket (120) according to Example Set A and monitoring a distance between body markers (125) in a portion of the capture basket (120), wherein when the distance between the body markers (125) in a portion of the capture basket (120) does not change, the thrombus is captured and retained within the capture basket (120), and when the distance between the body markers (125) in a portion of the capture basket (120) changes, the thrombus escapes from the capture basket (120).

[0195] Example 8C: The method of example 7C, wherein the distance of the body marker (125) in a portion of the capture basket (120) is increased.

[0196] Example 9C: The method of Example 7C, wherein the distance of the body marker (125) on the side of the capture basket (120) is decreased.

[0197] Example 10C: The method of any one of Examples 7C to 9C, wherein the thrombus comprises an embolus.

[0198] Example Set D Example 1D: A thrombus retrieval device (100) comprising: (a) a delivery shaft (110) having a delivery shaft distal end (111); a capture basket (120) connected to the delivery shaft distal end (111), the capture basket (120) including a first basket end (121), a second basket end (122), and a plurality of cells (123) defined by struts (124), the struts (124) having strut ends connected to the first basket end (121) and the second basket end (122); and at least four body markers (125) disposed on the capture basket (120).

[0199] Example 2D: The device (100) of Example 1D, wherein the device (100) is configured such that torque is transmitted from the delivery shaft (110) to the capture basket (120).

[0200] Example 3D: A torque-transmitting thrombectomy device (100) comprising: (a) a delivery shaft (110) having a delivery shaft distal end (111); and a capture basket (120) coupled to the delivery shaft distal end (111), the capture basket (120) including a first basket end (121), a second basket end (122), and a plurality of cells (123) defined by struts (124), the struts (124) having strut ends connected to the first basket end (121) and the second basket end (122), and at least four body markers (125) disposed on the capture basket (120), wherein the device (100) is configured such that torque is transmitted from the delivery shaft (110) to the capture basket (120).

[0201] Example 4D: The device (100) of any one of Examples 1D to 3D, wherein the delivery shaft (110) is hollow.

[0202] Example 5D: A device (100) described in any one of Examples 1D to 4D, wherein the device is configured so that a guidewire can pass through the delivery shaft (110) via the second basket end (122), and the guidewire is positioned within the capture basket (120).

[0203] Example 6D: A device (100) described in any one of Examples 1D to 5D, wherein the cells (123) at the second basket end (122) of the capture basket (120) are smaller in size than the cells (123) at the middle of the capture basket (120) and the cells (123) at the first end (121) of the capture basket (120).

[0204] Example 7D: The device (100) of any one of Examples 1D to 6D, wherein the body marker (125) is disposed on a strut (124) of the capture basket (120).

[0205] Example 8D: The device (100) of Example 7D, wherein the body marker (125) is aligned with the struts (124) of the capture basket (120).

[0206] Example 9D: The device (100) of Example 7D, wherein the body markers (125) are parallel to the struts (124) of the capture basket (120).

[0207] Example 10D: The device (100) of Example 9D, wherein the body marker (125) protrudes from the struts (124) of the capture basket (120).

[0208] Example 11D: The device (100) of Example 9D or Example 10D, wherein the body marker (125) is attached to the strut at a single attachment point.

[0209] Example 12D: The device (100) of Example 9D or Example 10D, wherein the body marker (125) is attached to the strut at two attachment points.

[0210] Example 13D: The device (100) of any one of Examples 1D to 12D, wherein the delivery shaft (110) is capable of withstanding torque.

[0211] Example 14D: The device (100) of Example 13D, wherein the delivery shaft (110) is configured to rotate.

[0212] Example 15D: The device (100) of Example 14D, wherein the delivery shaft (110) rotates at 2 to 50 rpm.

[0213] Example 16D: The device (100) of Example 14D, wherein the delivery shaft (110) rotates at 2 to 10 rpm.

[0214] Example 17D: A device described in any one of Examples 1D to 16D, wherein when the delivery shaft (110) is rotated, torque is transmitted from the delivery shaft (110) to the capture basket (120), thereby causing the capture basket (120) to also rotate.

[0215] As used herein, the term "about" refers to plus or minus 10% of the stated number.

[0216] While preferred embodiments of the present invention have been shown and described, it will be readily apparent to one skilled in the art that modifications may be made without departing from the scope of the appended claims. Accordingly, the scope of the present invention should be limited only by the following claims. In some embodiments, the figures presented in this application are drawn to scale, including angles, dimensional ratios, etc. In some embodiments, the figures are merely representative, and the claims are not limited by the dimensions of the figures. In some embodiments, the description of the invention described herein using the phrase "comprising" includes embodiments that may be described as "consisting essentially of" or "consisting of," and thus, the description requirement for claiming one or more embodiments of the invention using the phrase "consisting essentially of" or "consisting of" is satisfied.

[0217] The reference numbers set forth in the following claims are merely for ease of review of this patent application, are exemplary, and are in no way intended to limit the scope of the claims to the particular features having corresponding reference numbers in the drawings. [Explanation of symbols]

[0218] 100 Thrombectomy Device 110 Delivery shaft 111 Delivery shaft distal end 120 Catch Basket 121 First basket end 122 Second basket end 123 Cell 124 Strut 125 Body Marker 126 First Marker 127 Second Marker 150 Supporting components 130 First support part 131 First Edge 132 Second End 133 First Lumen 140 Second Support Part 141 First Edge 142 Second End 143 Second Lumen 160 Inner Shaft 170 Delivery Sheath 180 Delivery Catheter

Claims

1. A thrombectomy device (100), comprising: a) a delivery shaft (110) having a delivery shaft distal end (111); b) a capture basket (120) coupled to the delivery shaft distal end (111), the capture basket (120) including a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), the struts (124) having strut ends connected to the first basket end (121) and the second basket end (122), and at least four body markers (125) disposed on the capture basket (120); A thrombus retrieval device (100) comprising:

2. The device (100) of claim 1 , wherein the delivery shaft (110) is hollow.

3. The device (100) of claim 1, wherein the device is configured such that a guidewire can pass through the delivery shaft (110) via the second basket end (122), the guidewire being disposed within the capture basket (120).

4. 2. The device (100) of claim 1, wherein the cells (123) at the second basket end (122) of the capture basket (120) are smaller in size than the cells (123) in the middle of the capture basket (120) and the cells (123) at the first end (121) of the capture basket (120).

5. The device (100) of claim 1, wherein the body marker (125) is disposed on the strut (124) of the capture basket (120).

6. The device (100) of claim 5, wherein the body markers (125) are aligned or parallel with the struts (124) of the capture basket (120).

7. The device (100) of claim 6, wherein the body marker (125) is attached to the strut at a single attachment point, or the body marker (125) is attached to the strut at two attachment points.

8. The device (100) of claim 1, wherein the delivery shaft (110) is capable of withstanding torque.

9. The device of claim 8 , wherein the delivery shaft is configured to rotate.

10. The device (100) of claim 9, wherein the delivery shaft (110) rotates at 2 to 50 rpm.

11. The device (100) of claim 10, wherein the delivery shaft (110) rotates at 2 to 10 rpm.

12. The device (100) of claim 1, wherein rotating the delivery shaft (110) transfers torque from the delivery shaft (110) to the capture basket (120), thereby causing the capture basket (120) to also rotate.

13. A torqueable thrombectomy device (100), comprising: a) a delivery shaft (110) having a delivery shaft distal end (111); b) a capture basket (120) coupled to the delivery shaft distal end (111), the capture basket (120) including a first basket end (121), a second basket end (122), a plurality of cells (123) defined by struts (124), the struts (124) having strut ends connected to the first basket end (121) and the second basket end (122), and at least four body markers (125) disposed on the capture basket (120); The device (100) is a torqueable thrombectomy device (100) configured such that torque is transmitted from the delivery shaft (110) to the capture basket (120).

14. The device (100) of claim 13, wherein the delivery shaft (110) is hollow.

15. The device (100) of claim 13, wherein the device is configured so that a guidewire can pass through the delivery shaft (110) via the second basket end (122), the guidewire being disposed within the capture basket (120).

16. 14. The device (100) of claim 13, wherein the cells (123) at the second basket end (122) of the capture basket (120) are smaller in size than the cells (123) in the middle of the capture basket (120) and the cells (123) at the first end (121) of the capture basket (120).

17. The device (100) of claim 13, wherein the body marker (125) is disposed on the strut (124) of the capture basket (120).

18. 20. The device (100) of claim 17, wherein the body markers (125) are aligned or parallel with the struts (124) of the capture basket (120).

19. 20. The device (100) of claim 17, wherein the body marker (125) is attached to the strut at a single attachment point, or the body marker (125) is attached to the strut at two attachment points.

20. 14. The device (100) of claim 13, wherein rotating the delivery shaft (110) transfers torque from the delivery shaft (110) to the capture basket (120), thereby causing the capture basket (120) to also rotate.

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