Floating clot retrieval device for removing clots from a blood vessel

Abstract

A clot removal device including an elongated member including a distal end; and an expandable frame including a proximal end, and one or more frame members including one or more pinching cells operable to be slidably and rotatably placed thereon, each of the pinching cells including a collapsed state within a microcatheter and an expanded state distal of the microcatheter configured to tweeze at least a portion of a clot.

Claims

1. A clot removal device, comprising: an elongated member comprising a distal end; and an expandable frame comprising: a proximal end; a distal end; and two or more frame members joined at the proximal end and the distal end of the expandable frame, the two or more frame members each comprising one or more pinching cells operable to be slidably and rotatably placed thereon, each of the one or more pinching cells comprising a collapsed state within a microcatheter and an expanded state distal of the microcatheter operable to tweeze at least a portion of a clot, wherein each of the one or more pinching cells is positioned between a respective proximal collar and a respective distal collar.

2. The clot removal device of claim 1, wherein each of the one or more pinching cells comprise: a plurality of strut members operable to actuate and tweeze the clot from a blood vessel between the plurality of strut members.

3. The clot removal device of claim 2, wherein the plurality of strut members are positioned about one or more central strut members, each strut member of the plurality of strut members joined at common respective proximal and distal ends.

4. The clot removal device of claim 2, wherein each of the one or more pinching cells is operable to tweeze the clot on movement from the collapsed state to a clot pinching state of the expanded state until the at least a portion of the clot is compressed between the plurality of strut members.

5. The clot removal device of claim 2, wherein a ratio of diameters of each of the one or more pinching cells between the collapsed state and a clot pinching state of the expanded state is from approximately 1.5:1 to 4:1.

6. The clot removal device of claim 2, wherein each of the one or more pinching cells comprises a radiopaque marker.

7. The clot removal device of claim 1, wherein each of the one or more pinching cells comprises: a pinching structure comprising a plurality of strut members and one or more central strut members; the proximal collar comprising a first collar lumen; and the distal collar comprising a second collar lumen.

8. The clot removal device of claim 7, wherein the plurality of strut members and the one or more central strut members are a network of struts operable to tweeze the at least a portion of the clot, the network of struts being configured such that in the expanded state at least a portion of the network of struts penetrate the clot.

9. The clot removal device of claim 7, wherein the first collar lumen and the second collar lumen are operable to receive the two or more frame members.

10. The clot removal device of claim 1, wherein the distal end of the elongated member is attached to the proximal end of the expandable frame.

11. The clot removal device of claim 1, wherein the one or more pinching cells are selectively aligned in a plurality of orientations on the two or more frame members.

12. The clot removal device of claim 1, wherein the expandable frame is generally a wave pattern having an increasing amplitude along its length.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The above and further aspects of this disclosure are further discussed with the following description of the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the disclosure. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation. It is expected that those of skill in the art can conceive of and combining elements from multiple figures to better suit the needs of the user.

(2) FIG. 1A depicts a close-up view of an example pinching cell.

(3) FIG. 1B illustrates the movement of an example pinching cell on a wire.

(4) FIG. 2A illustrates an example clot removal device in a deployed configuration.

(5) FIG. 2B illustrates an example clot removal device in a delivery configuration.

(6) FIG. 3 is a flowchart that illustrates a method for removing a clot.

(7) FIG. 4A depicts a close-up view of an example clot removal device penetrating a clot.

(8) FIG. 4B depicts a close-up view of an example clot removal device pinching a clot.

(9) FIG. 4C depicts a close-up view of an example clot removal device capturing a clot.

(10) FIG. 5 depicts an example frame pattern for an example clot removal device.

(11) FIG. 6 depicts an example frame pattern for an example clot removal device.

(12) FIGS. 7A-B depict an example frame pattern for an example clot removal device.

(13) FIGS. 8A-B depicts an example frame pattern for an example clot removal device.

(14) FIG. 9 illustrates an example clot fragment collection section.

(15) FIG. 10 is a flowchart that illustrates a method manufacturing a clot removal device.

(16) FIGS. 11A-C illustrates pinching cells in a) an expanded state, b) a collapsed state, c) a pinched state of the expanded state.

(17) FIGS. 12A-D illustrate example pinching cell according to aspects of this disclosure.

DETAILED DESCRIPTION

(18) Specific examples of the present disclosure are now described in detail with reference to the Figures, where identical reference numbers indicate elements which are functionally similar or identical. The examples address many of the deficiencies associated with traditional catheters, such as inefficient clot removal and inaccurate deployment of catheters to a target site.

(19) Accessing the various vessels within the vascular, whether they are coronary, pulmonary, or cerebral, involves well-known procedural steps and the use of a number of conventional, commercially-available accessory products. These products, such as angiographic materials and guidewires are widely used in laboratory and medical procedures. When these products are employed in conjunction with the system and methods of this disclosure in the description below, their function and exact constitution are not described in detail.

(20) The following detailed description is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. Although the description of the disclosure is in many cases in the context of treatment of intracranial arteries, the disclosure may also be used in other body passageways as previously described.

(21) It will be apparent from the foregoing description that, while particular embodiments of the present disclosure have been illustrated and described, various modifications can be made without departing from the spirit and scope of the disclosure. For example, while the embodiments described herein refer to particular features, the disclosure includes embodiments having different combinations of features. The disclosure also includes embodiments that do not include all of the specific features described. Specific embodiments of the present disclosure are now described in detail with reference to the figures, wherein identical reference numbers indicate identical or functionality similar elements. The terms “distal” or “proximal” are used in the following description with respect to a position or direction relative to the treating physician. “Distal” or “distally” are a position distant from or in a direction away from the physician. “Proximal” or “proximally” or “proximate” are a position near or in a direction toward the physician.

(22) Accessing cerebral, coronary and pulmonary vessels involves the use of a number of commercially available products and conventional procedural steps. Access products such as guidewires, guide catheters, angiographic catheters and microcatheters are described elsewhere and are regularly used in catheter lab procedures. It is assumed in the descriptions below that these products and methods are employed in conjunction with the device and methods of this disclosure and do not need to be described in detail.

(23) The following detailed description is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. Although the description of the disclosure is in many cases in the context of treatment of intracranial arteries, the disclosure may also be used in other body passageways as previously described.

(24) FIG. 1A depicts a close-up view of an example pinching cell 100. Pinching cell 100 can be configured to embed and/or engage with and grip a clot to retain it securely for retraction. It is understood that each of the herein described pinching cells can be used interchangeably with clot retrieval devices as needed or required. Pinching cell 100 can include a first collar 102, a first lumen 104, a second collar 106, and a second lumen 108 between which a pinching structure 110 is positioned (e.g., between the first collar and second collar). The pinching structure 110 can include strut members 112a, 112b, 112c and 112d. One or more of strut members 112a, 112b, 112c and 112d can be configured as bowed or otherwise including tensioned flex so as to be capable of embedding in a clot and then being actuated to grip and/or pinch the clot during use. The terms “bowed” is intended to refer to a strut that is generally a shape of an arc, while “tension flex” is intended to refer to a strut that has been placed in tension and plastically deformed into a desired shape.

(25) In some examples, pinching cell 100 can be actuated into a pinched state of an expanded state by being unsheathed from a sheath (e.g., a microcatheter), by being pulled, or actuated by one or more pull members, delivering a current to one or more of strut members 112a, 112b, 112c and 112d to cause at least a first portion of the one or more of strut members 112a, 112, 112c and 112d to change from an expanded state to pinched state. The pinching cell 100 can be configured to embed and grip, pinch, and/or “tweeze” the clot, as shown and described more particularly in FIGS. 11A-C. As discussed herein, the term “tweeze” or “tweezing” is intended to refer to the sheathing of the pinching or squeezing cells that causes respective struts to come together and tweeze or grip at least a portion of clot. In this respect, while the numbers of struts in a respective cell need not be limited, at least two strut surfaces can be included so as to tweeze corresponding clot material. One or more of strut members 112a, 112b, 112c, and 112d can also have one or more radiopaque bands to indicate to the user when the pinching cell 100 is pinched, as the distance between struts is decreased when the pinching cell 100 transitions from the expanded state to the pinched state of the expanded state.

(26) The diameter of pinching cell 100 can range between approximately 2-10 millimeters depending on how much the design profile allows. One preferred diameter can be approximately 2.25 millimeters. In some examples, pinching cells 100 can be small enough to fit in a 0.021 or 0.018 inch ID microcatheter.

(27) The pinching cell 100 can be constructed from a superelastic material such as Nitinol or an alloy of similar properties. The material could be in many forms such as wire or strip or sheet or tube. A particularly suitable manufacturing process is to laser cut a Nitinol tube and then heat set and electropolish the resultant structure to create a framework of struts. This framework can be any of huge range of shapes as disclosed herein and may be rendered visible under fluoroscopy through the addition of alloying elements (e.g., Platinum) or through a variety of other coatings or marker bands. Pinching cell 100 can include a collapsed state for delivery and an expanded state distal of a microcatheter for clot retrieval, flow restoration and/or fragmentation protection. To move between the collapsed state and the expanded state, the pinching cell 100 can be configured to self-expand upon delivery from a microcatheter (e.g., release from the microcatheter) to an expanded diameter, as discussed in detail in FIGS. 11A-C.

(28) Turning to FIG. 1B, an example pinching cell 100 is shown placed on a wire 114 that can pass through the first lumen 104 and the second lumen 108. Passing wire 114 in this respect can permit pinching cell 100 to slide along the A-axis, as depicted by arrow S, and rotate about the A-axis, as depicted by arrow R. The A-axis can be defined, for example, aligned with wire 114 or similar implements.

(29) FIG. 2A illustrates an example clot removal device 200 in a deployed configuration. The example device 200 can include a microcatheter 202 having a lumen 204, a distal end 206, and a proximal end 208. Device 200 can include an expandable frame 210 having a distal end 212, a proximal end 214, and one or more frame members 216a, 216b, and 216c. The one or more frame members 216a, 216b, and 216c can have one or more pinching cells 100 slidably and/or rotatably placed thereon, as discussed in FIG. 1B. Device 200 can include an elongated member 218 having a distal end 219. The distal end 219 of the elongated member 218 can be attached to the proximal end 214 of the expandable frame 210. The expandable frame 210 can be constructed from a superelastic material such as Nitinol or an alloy of similar properties.

(30) The material could be in many forms such as wire, strip, sheet and/or tube. A particularly suitable manufacturing process is to laser cut a Nitinol tube and then heat set and electropolish the resultant structure to create a framework of frame members. This framework can be any of huge range of shapes as disclosed herein and may be rendered visible under fluoroscopy through the addition of alloying elements (e.g., Platinum) or through a variety of other coatings or marker bands. The elongated member 218 can be a tapered wire shaft, and may be made of stainless steel, MP35N, Nitinol or other material of a suitably high modulus and tensile strength. As noted, device 200 can include a delivery configuration for delivery and a deployed configuration for clot retrieval, flow restoration and/or fragmentation protection. To move between the delivery to the deployed configurations, expandable frame 210 can be configured to self-expand upon delivery from the microcatheter 202 (e.g., release from the microcatheter) to a diameter larger than that of the lumen 204 of the microcatheter 202. In the deployed configuration, the expandable frame 210 can be distal to the distal end 206 of the microcatheter 202. The pinching cells 100 can be in an expanded state and a collapsed state, as discussed in greater detail in FIGS. 11A-C. In the delivery configuration, the expandable frame 210 can be within the lumen 204 of the microcatheter 202. Turning to FIG. 2B, device 200 is shown in a delivery configuration collapsed within the lumen 204 of the microcatheter 202. Further, the pinching cells 100, can be in a collapsed state, as discussed in detail in FIGS. 11A-C.

(31) FIG. 3 is a flow diagram illustrating a method of removing a clot, according to aspects of the present disclosure. The method steps in FIG. 3 can be implemented by any of the example means described herein or by similar means, as will be appreciated. Referring to method 300 as outlined in FIG. 3, in step 302, deploying an expandable frame into a deployed configuration from a delivery configuration within a blood vessel and proximate a clot, the expandable frame can include one or more frame members and one or more pinching cells located on one or more frame members. Each of the pinching cells can include a collapsed state within a microcatheter and an expanded state distal of the microcatheter configured to pinch at least a portion of the clot, the expandable frame can be deployed such that one or more pinching cells are in contact with the clot. In step 304, advancing a lumen of the microcatheter over the expandable frame such that a portion of the expandable frame at least partially collapses into the lumen of the microcatheter, and one or more pinching cells at least partially collapses into the lumen of the microcatheter. In step 306, pinching the one or more pinching cells in contact with the portion of the clot on movement from the collapsed state to a clot pinching state of the expanded state until a portion of the clot is compressed between at least a pair of struts of the one or more pinching cells. Additionally, or alternatively, the pair of strut members can be operable to actuate and tweeze the clot from a blood vessel between the plurality of strut members. Additionally, or alternatively, the pair of strut members are positioned about a central strut member, each of the strut members joined at common respective proximal and distal ends. In step 308, withdrawing the microcatheter, the expandable frame, and the clot, while pinching the one or more pinching cells withdrawing the microcatheter. Method 300 can end after step 308. In other embodiments, additional steps according to the examples described above can be performed.

(32) FIGS. 4A-C depict a close up of an example clot removal device 200 penetrating, pinching capturing a clot 1. In FIG. 4A, device 200 is shown in a deployed configuration with the expandable frame 210 located proximate the clot 1 (e.g., embedding with or otherwise contacting the clot). The pinching cell 100 can penetrate the clot 1. In FIG. 4B, the microcatheter 202, is now sheathed over the expandable frame 210 and the pinching cell 100 causing the pinching cell 100 to pinch a portion of the clot 1. Each pinching cell 100 provides enhanced grip on a clot 1, and any fragments thereof. Each of the pinching cells 100 can be particularly advantageous in capturing clots which may have fibrin core in the center, distal, or proximal location in the clot 1. Moreover, in use, if grip on some of a clot 1 is missed by one pinching cell 100, one or more pinching cells 100 distal thereof can engage and/or grip the clot 1. In an example, a portion of the clot 1 can be pinched between the distal end 206 of the microcatheter 202 and the expandable frame 210. In FIG. 4C, the clot 1 is captured by the device 200. At least a portion of the clot 1 can be secured by the pinching cells 100 within the lumen 204 of the microcatheter 202, now sheathed over the expandable frame 210 and the pinching cell 100. The device 200 can be in the delivery configuration. Additionally or alternatively, the device 200 can be in a securing configuration of the deployed configuration. Additionally or alternatively, the device 200 can be in the pinching configuration of the deployed configuration. Each pinching cell 100 provides enhanced grip on a clot 1, and any fragments thereof. Each of the pinching cells 100 can be particularly advantageous in capturing clots which may have fibrin core in the center, distal, or proximal location in the clot 1. Moreover, in use, if grip on some of a clot 1 is missed by one pinching cell 100, one or more pinching cells 100 distal thereof can engage and/or grip the clot 1.

(33) FIG. 5 illustrates an example pattern of an example expandable frame. The example expandable frame 500 can be helical and include a frame member 502, a distal end 504 and a proximal end 506. The proximal end 506 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and/or rotatably disposed on the frame member 502. The expandable frame 500 can be constructed from Nitinol or other suitable materials.

(34) FIG. 6 illustrates an example pattern of an example expandable frame. The example expandable frame 600 can be a double-helix and include a first frame member 602, a second frame member 604, a distal end 606 and a proximal end 608. The first and second frame members 602, 604 can connect to one another at the distal end 606 and the proximal end 608. The proximal end 608 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and/or rotatably disposed on the first and second frame members 602, 604. The expandable frame 600 can be constructed from Nitinol or other suitable materials.

(35) FIGS. 7A-B depict example expandable, non-tubular curved, atraumatic frame patterns capable of being actuated to grip and/or pinch, as between one or more peaks of the frame pattern, clot or fragments thereof. FIG. 7A illustrates an example expandable frame 700 having a frame member 702, a distal end 704, a proximal end 706. The wave pattern can be defined by a wavelength L1 and an amplitude H1 generally consistent between proximal and distal ends. The proximal end 706 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 702. FIG. 7B illustrates an example expandable frame 750 having a frame member 752, a distal end 754, a proximal end 756. The wave pattern can be defined by a wavelength L2 and a first amplitude H2 that can transition into a second amplitude H3 generally larger than first amplitude H2. The proximal end 756 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 752. The example expandable frames 700, 750 can be constructed from Nitinol or other suitable materials.

(36) FIGS. 8A-B also depict example expandable, non-tubular frame patterns capable of being actuated to grip and/or pinch, as between one or more peaks of the frame pattern, clot or fragments thereof. FIG. 8A illustrates an example expandable frame 800 having a frame member 802, a distal end 804, a proximal end 806. The relatively sharp, non-curved pattern can be defined by a wavelength L3 and an amplitude H4 that is generally consistent between proximal and distal ends. The proximal end 806 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 802. FIG. 8B illustrates an example expandable frame 850 having a frame member 852, a distal end 854, a proximal end 856. The pattern can be defined by a wavelength L4 and a first amplitude H5 that can transition into a second amplitude H6 generally larger than first amplitude H5. The proximal end 756 can be configured to connect to the distal end 219 of the elongated member 218. One or more pinching cells 100 can be slidably and rotatably disposed on the frame member 852. The example expandable frames 800, 850 can be constructed from Nitinol or other suitable materials.

(37) FIG. 9 illustrates an example clot removal device 900. The device 900 can include a clot fragment collection section 902 located at the distal end 212 of the expandable frame 210. The clot fragment collection section 902 (e.g., a distal net, mesh, or the like) can be configured to entangle clot fragments that break off the clot 1.

(38) FIG. 10 is a flow diagram illustrating a method of manufacturing a clot removal device, according to aspects of the present disclosure. The method steps in FIG. 10 can be implemented by any of the example means described herein or by similar means, as will be appreciated. Referring to method 1000 as outlined in FIG. 10, in step 1002, forming one or more pinching cells from a shape-memory alloy tube, each of the one or more pinching cells including a plurality of strut members operable to pinch a clot, the plurality of strut members positioned about one or more central strut members, each strut member joined at common respective proximal and distal ends. Forming the one or more pinching cells can further include cutting the shape-memory alloy tube into a plurality of segments, cutting a pattern into a segment of the plurality of segments, attaching a radiopaque marker to each of the one or more pinching cells, and shape setting a plurality of strut members and one or more central strut members of a pinching structure to memorize an expanded state of the pinching structure, the a ratio of diameters of each of the one or more pinching cells between a collapsed state and the expanded state is from approximately 1.5:1 to 4:1. In step 1004, forming at least a portion of an expandable frame, including a proximal end, and one or more frame members.

(39) Forming at least a portion of the expandable frame can further include constructing one or more frame members on a mandrel, shaping, based at least in part on the mandrel, one or more frame members to memorize a deployed configuration of the expandable frame, and connecting one or more frame members to form a distal end of the expandable frame. In step 1006, assembling the one or more pinching cells with at least a portion of the expandable frame. Assembling the one or more pinching cells with at least a portion of the expandable frame can further include sliding one or more pinching cells over one or more frame members, and connecting one or more frame members to form a proximal end of the expandable frame. The one or more pinching cells can be selectively aligned in a plurality of orientations. Method 1000 can end after step 1006. In other embodiments, additional steps according to the examples described above can be performed.

(40) FIGS. 11A-C illustrate example pinching cell states. An example expanded state of the pinching cell 100 is depicted in FIG. 11A. The pinching structure 110 has an expanded diameter D1 which can be realized distal of the distal end 206 of the microcatheter 202. An example collapsed state of the pinching cell 100 is depicted in FIG. 11B. The pinching structure 110 has a collapsed diameter D2 which can be realized within the lumen 204 of the microcatheter 202. An example pinched state of the expanded state of the pinching cell 100 is depicted in FIG. 11C. The pinching structure 110 having a diameter less than the expanded diameter D1, but greater than the collapsed diameter D2. Additionally or alternatively, a ratio of diameters can be calculated by, for example, dividing the expanded diameter D1 by the collapsed diameter D2. Additionally, or alternatively, a ratio of diameters can be calculated by dividing the collapsed diameter D2 by the expanded diameter D1.

(41) FIG. 12A depicts a close-up view of another example pinching cell 1200a with strut members 1202a, 1204a, and 1206a now shown with undulating edges. These undulations can be formed by being heat-set, crimped, or otherwise formed as needed or required. FIG. 12B depicts a close-up view of another example pinching cell 1200b with strut members 1202b, 1204b, and 1206b each including one or more eyelets. FIG. 12C depicts a close-up view of another example pinching cell 1200c with strut members 1202c, 1204c, and 1206c now shown with relatively straight, non-curved strut members. FIG. 12D depicts a close-up view of another example pinching cell 1200d with strut members 1202d, 1204d, and 1206d each including one or more notches or indentation. These notches or indentations can be formed by being heat-set, crimped, or otherwise formed as needed or required.

(42) The disclosure is not limited to the examples described, which can be varied in construction and detail. The terms “distal” and “proximal” are used throughout the preceding description and are meant to refer to a positions and directions relative to a treating physician. As such, “distal” or distally” refer to a position distant to or a direction away from the physician. Similarly, “proximal” or “proximally” refer to a position near to or a direction towards the physician.

(43) In describing examples, terminology is resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method can be performed in a different order than those described herein without departing from the scope of the disclosed technology. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

(44) As discussed herein, a “patient” or “subject” can be a human or any animal. It should be appreciated that an animal can be a variety of any applicable type, including, but not limited to, mammal, veterinarian animal, livestock animal or pet-type animal, etc. As an example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like).

(45) As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.

(46) By “comprising” or “containing” or “including” or “having” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

(47) It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Ranges can be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.

(48) The descriptions contained herein are examples of the disclosure and are not intended in any way to limit the scope of the disclosure. While particular examples of the present disclosure are described, various modifications to devices and methods can be made without departing from the scope and spirit of the disclosure. For example, while the examples described herein refer to particular components, the disclosure includes other examples utilizing various combinations of components to achieve a described functionality, utilizing alternative materials to achieve a described functionality, combining components from the various examples, combining components from the various example with known components, etc. The disclosure contemplates substitutions of component parts illustrated herein with other well-known and commercially-available products. To those having ordinary skill in the art to which this disclosure relates, these modifications are often apparent and are intended to be within the scope of the claims which follow.