HK40034026B - Apparatus and method for vessel occlusion removal - Google Patents

Description

Devices and methods for removing vascular obstructions

This application is a divisional application of application number 201680031844.X (PCT application number PCT/IL2016/050763), filed on July 14, 2016, entitled "Apparatus and Method for Removing Vascular Obstructions".

Technical Field and Background Technology

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing obstructive substances from a blood vessel.

Summary of the Invention

According to one aspect of some embodiments of the present invention, an apparatus for removing obstructive material from a blood vessel is provided, the apparatus comprising:

An expandable structure, the expandable structure being sized to be inserted into the blood vessel; and

One or more portions protrude radially from a central longitudinal axis of the expandable structure, such that a space between the protrusion and a closest portion of the expandable structure contains a radial component;

The space is sized and shaped to receive an obstructive substance.

According to some embodiments of the present invention, the device includes multiple wires, wherein one or more protruding portions are part of one wire.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is tangent to the central longitudinal axis of the device.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is parallel to the central longitudinal axis of the device.

According to some embodiments of the present invention, the device includes an interlacing structure, wherein the protruding portion and the closest portion are a warp and a weft of the interlacing structure.

According to some embodiments of the present invention, the one or more protruding portions are circular.

According to some embodiments of the invention, the radial component of the space is between 0.01 and 0.2 mm.

According to some embodiments of the present invention, the central longitudinal axis of the expandable structure is a central longitudinal axis that can enclose a maximum cylindrical space within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the longest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is a cylindrical space with the largest diameter that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the largest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the expandable structure is configured to have a contracted state and a plurality of expanded shapes within a range, the structure being expandable to a maximum expanded state;

The diameter of the largest cylindrical space in the contracted state is smaller than the volume of the largest cylindrical space in the maximum expanded state.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the contraction space is 0.3 to 2 mm.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the maximum expansion state is 1 to 7 millimeters.

According to some embodiments of the present invention, when the structure is in each of a plurality of expanded states of the range, the radial component of the space is greater than a radial component of the space when the device is in the contracted state.

According to some embodiments of the present invention, the protruding portion and the nearest device portion are connected at at least two connection points, wherein an axial length of the protruding portion between the two connection points is greater than an axial length of the nearest device portion between the two connection points.

According to some embodiments of the invention, the protruding portion and the closest device portion are spatially curved to create a phase difference between the plurality of portions.

According to some embodiments of the present invention, the expandable structure includes a plurality of protruding portions.

According to some embodiments of the invention, a plurality of protruding portions are disposed at a plurality of different radial positions around an axial position of the expandable structure.

According to some embodiments of the invention, one or more of the plurality of protruding portions are distributed along the expandable structure at an axial position different from one or more other protruding portions.

According to some embodiments of the present invention, the structure includes:

Multiple wires, each wire being connected to a different radial position at a distal end and a proximal end of the structure;

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least a portion of one of the conductors includes a protrusion at which the conductor path extends radially from the surface of the tubular mesh and then extends axially to define the space between the portion and the surface of the tubular mesh.

According to some embodiments of the present invention, the path including the change of radial position is a spiral path.

According to some embodiments of the present invention, the apparatus includes:

At least one loop is attached to the proximal end of the structure and extends radially from the central longitudinal axis;

The space therein is located within the loop.

According to some embodiments of the present invention, the apparatus includes:

Multiple wire loops, each of the wire loops being attached to the proximal end of the structure;

The space described therein is located between two loops.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described herein, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

One or more of the loops protrude radially from the surface of the tubular mesh.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least one of the wires contains a protruding portion.

According to some embodiments of the invention, the shape is sized and shaped to receive at least a portion of the obstructive material.

According to one aspect of some embodiments of the present invention, a method for removing obstructive material from a blood vessel is provided, the method comprising:

A contractile expandable structure is provided near one axial direction of the obstructive material;

Connect the structure to the obstructive material, allowing the obstructive material to enter at least one space between a structurally protruding portion of the device and a central longitudinal axis; and

The obstructive substance is removed from the blood vessel by removing the structure.

According to some embodiments of the present invention, the at least one space is a plurality of spaces.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different positions along a longitudinal axis of the structure.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different radial positions.

According to some embodiments of the present invention, the connection includes connecting multiple different portions of the obstructive material such that each portion is connected to a different space among the multiple spaces.

According to some embodiments of the present invention, the connection includes: expanding the structure.

According to some embodiments of the present invention, the expansion includes increasing the size of the space in at least one dimension.

According to some embodiments of the present invention, the expansion includes: reducing the size of the space in at least one dimension.

According to some embodiments of the present invention, the at least one space is located between a structurally protruding portion and a second structural portion.

According to some embodiments of the invention, the connection includes: pulling the expandable structure through the vicinity of the obstructive material along its axis.

According to some embodiments of the present invention, the connection includes: pushing the expandable structure into the obstructive material.

According to some embodiments of the present invention, the method includes: shrinking the at least one space in at least one dimension.

According to some embodiments of the present invention, the removal includes: moving the device through multiple portions of the blood vessel by means of changes in multiple directions and geometry.

According to some embodiments of the present invention, the expansion includes: expanding the device until the device applies an external force to the plurality of blood vessel walls.

According to some embodiments of the present invention, the device applies an outward force to the plurality of blood vessel walls during the removal process.

Unless otherwise stated, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While embodiments of the invention may be implemented or tested by any methods and substances similar to or equivalent to those described in the embodiments of the invention, the embodiments, enumerated methods, and/or substances of the invention have been described below. In case of conflict, the definitions included in this specification will be used for control. Furthermore, substances, methods, and embodiments are illustrative only and are not necessarily intended to be limiting.

Attached Figure Description

Some embodiments of the present invention described herein are by way of example only and with reference to the accompanying drawings. The detailed description of the drawings and specific references emphasizes that the details shown are merely illustrative and are intended to illustrate the purpose of the embodiments of the present invention. Based on this, the embodiments of the present invention will be clearly understood by those skilled in the art in conjunction with the accompanying drawings and description.

In the attached diagram:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention;

Figure 2A is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located within a blood vessel having an obstruction;

Figure 2B is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 2E is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 3A is a simplified cross-sectional view of a clot in a blood vessel;

Figure 3B is a simplified cross-sectional schematic diagram of a clot in a blood vessel and a device delivered to the vicinity of the clot according to some embodiments of the present invention.

Figure 3C is a simplified cross-sectional schematic diagram of a device according to some embodiments of the present invention expanding and grasping the clot in a blood vessel;

Figure 3D is a simplified cross-sectional view of an axial expansion of a clot within a blood vessel by a device according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

Figure 4A is a simplified side view of an expandable device for removing and holding multiple clots in a blood vessel according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device according to some embodiments of the present invention removing a clot through a bend in a blood vessel.

Figure 4C is a simplified side view schematic diagram of an expandable device removing a clot through an expanded portion of a blood vessel according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device according to some embodiments of the present invention guiding a bend and multiple variations of a blood vessel in a cross-sectional area when removing clotted material.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device being delivered to the vicinity of a clot within a blood vessel, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot according to some embodiments of the present invention;

Figure 6A is a simplified side view of a device expanding near a clot in a blood vessel according to some embodiments of the present invention.

Figure 6B illustrates a clump of material held by a plurality of protrusions, for example, between a plurality of protrusions and the body of the device, according to some embodiments of the present invention.

Figure 7A is a simplified side view of an expandable device including a plurality of protrusions according to some embodiments of the present invention;

Figure 7B is a simplified side view of an expandable device in a blood vessel according to some embodiments of the present invention;

Figure 7C is a simplified side view of a contraction device within a blood vessel according to some embodiments of the present invention;

Figure 7D is a simplified side view of an expandable device inserted through an obstructive substance within a blood vessel, according to some embodiments of the present invention.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel.

Figure 8A is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 8B is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 9A is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention;

Figure 9B is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention.

Figure 10 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 11 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 12A is a simplified top view of a clump material and a mesh device portion according to some embodiments of the present invention.

Figure 12B is a simplified top view of the device portion after device expansion according to some embodiments of the present invention;

Figures 12C and 12D show side views of the clump of material held between a meridian and a parallel during the expansion of the device;

Figure 12E is a simplified side view of a clump of material between multiple conductors according to some embodiments of the present invention;

Figure 13A is a simplified side view of an expandable device according to some embodiments of the present invention, comprising a conductor having multiple connections between multiple conductors.

Figure 13B is a simplified side view of the device of Figure 13A after the space between the wires has been expanded, according to some embodiments of the present invention.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions, and the shrinking device being spatially positioned with a phase difference between the plurality of portions;

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions, and the expandable device being spatially positioned with a phase difference between the plurality of portions;

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions, and the device being arranged in space with a phase difference between the plurality of portions;

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including multiple additional wires connected to multiple baselines; and

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer bar holds a space between two portions of the apparatus.

Specific Implementation

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing multiple obstructions from multiple blood vessels.

Overview:

A broad aspect of some embodiments of the present invention relates to various expandable apparatuses and methods for removing multiple obstructions from multiple blood vessels. In some embodiments, an apparatus is engaged with an obstruction, and then the apparatus is removed from the blood vessel along the obstruction.

In some embodiments, the engagement between the device and the obstruction is maintained at least partially when the device changes dimension (e.g., along a radial direction perpendicular to the longitudinal axis of the device) and/or when the device bends and/or contracts. For example, during device removal, the device passes through multiple changes in blood vessel direction (e.g., bending) and/or geometry.

One aspect of some embodiments of the invention involves engaging the device with the blockage by holding at least a portion of the blockage (e.g., a clump of material) beneath a portion of the expandable device. For example, holding at least a portion of the blockage within a space in the device, the space having a radial component (e.g., the space comprising a dimension in a radial direction of a central longitudinal axis of the device). For example, holding at least a portion of the blockage within a space between a protruding portion (also referred to as a "protrusion") and the closest portion of the protruding portion (e.g., having the shortest vector connecting the two portions).

In some embodiments, the clump material is held below a radially projecting portion of the device, wherein the radial direction is measured from a central longitudinal axis of the device. For example, the clump material is held between a longitudinal central axis of the device and the projecting portion (in a radial direction).

In some embodiments, a device is expanded within a blood vessel such that and/or until one or more protrusions of the device contact the vessel wall, for example, by gripping the obstructive material beneath the protrusions (e.g., when the device is pulled past the obstructive material). In some embodiments, when the device is removed, one or more protrusions remain in contact with the vessel wall, for example, during multiple geometrical changes in the blood vessel (e.g., bending and/or changes in cross-sectional area and/or shape).

In some embodiments, the device has a non-cylindrical and/or irregular shape (e.g., curved, irregularly shaped cross-section), and the central longitudinal axis is defined as a longitudinal central axis extending from the maximum volume (and/or maximum diameter and/or maximum length) enclosed by the device. Alternatively or additionally, the central longitudinal axis is defined as a line connecting the center points of a plurality of parallel circular cross-sections along a length of the device, wherein at each point along the entire length of the shape, the circular cross-section is the largest circle contained within the device. For example, in a device comprising a cylindrical intermediate portion having a tapered end, the longitudinal central axis may be defined as the central axis extending through the center of the cylindrical intermediate portion and through the tapered end of a cone. For example, in a curved and/or curved tubular device, the central longitudinal axis follows the curve of the device.

In some embodiments, the obstructive material extends over at least one protrusion, wherein the material entering below is within 30% to 95%, or 40% to 90%, or 50% to 80% or lower, or higher, or a plurality of intermediate ranges or percentages of the length of the protrusion.

In some embodiments, a protrusion is sized large enough to accommodate multiple clots beneath it. In some embodiments, the device is moved within the blood vessel to hold multiple clots beneath one or more protrusions.

In some embodiments, one or more protrusions are circular, for example, to potentially prevent damage to the blood vessel during expansion of the device within the blood vessel and/or during movement of the device.

One aspect of some embodiments of the invention relates to attaching a clump of material to at least two portions of an expandable device, for example, between two wires (e.g., multiple nitinol wires). In some embodiments, the space between the portions is large enough to accept at least a portion of a clump and/or a portion of the clump is large enough to attach the clump to the device. In some embodiments, the obstructing material is clamped between the at least two device portions.

In some embodiments, the space includes a radial component.

In some embodiments, the angle between a shortest distance between the two conductors and the central longitudinal axis is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, and the two conductors define a space and a radial straight line connecting the protruding conductors.

In some embodiments, the clump material is held between two portions, the two portions including a protruding portion and a second portion of the device (in at least one dimension) closest to the protruding portion.

In some embodiments, one or more portions define a space having a radial separation different from the central axis of the device. Alternatively, in some embodiments, one or more portions define a space having an angular orientation different from the central axis of the device, for example, a different circumferential position on an outer surface of the device.

In one exemplary embodiment, the device expands to increase a radial space between two device portions as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

In some embodiments, once the clump material has entered a space within the device (e.g., between two sections and/or under a protrusion), the space is reduced (e.g., one or more dimensions) to accommodate the clump within the device, for example.

In some embodiments, the clump material is held between two or more portions, such as 3, 4, 5, or 3 to 10, or smaller, larger, or a plurality of intermediate portions.

Optionally, in some embodiments, the device is delivered to a clot site within a patient's body and expanded, for example, to expand the space below and/or between multiple portions of the device. Additionally or alternatively, in some embodiments, the multiple spaces are expanded by bending and/or twisting and/or rotating the device.

In one exemplary embodiment, a device includes a plurality of wire pairs, and the expansion (and/or bending and/or rotation) of the device causes one of the wires in the wire pairs to protrude axially from a central axis of the device beyond the other wires in the wire pairs.

In some embodiments, once the clotted material is held within the device, the device is moved within the blood vessel to move the clotted material contained between the device and the vessel wall.

In some embodiments, as the device is moved within the blood vessel, a shape of the device is altered and/or has been altered to maintain contact and/or engagement between the device and the clot material within the changing geometry of the blood vessel.

In some embodiments, the dimensions of multiple spaces below multiple protrusions and/or between multiple portions of the device are adapted to grip clot material in a range of device dimensions, potentially allowing clot removal from a range of multiple vessel dimensions.

In some embodiments, the size of a space in one or more dimensions (e.g., suitable for holding clumps of material) is 0.005 to 0.5 mm, or 0.01 to 0.2 mm, or 0.5 to 0.1 mm, or lower, or higher, or a plurality of intermediate ranges or sizes.

In some embodiments, the device can be expanded to a range or size with a diameter (e.g., a device suitable for use within the diameter of a blood vessel) of 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher, or intermediate. The term "diameter" refers to the diameter of a cylindrical portion of the device, and/or the average diameter of the expandable portion of the device, and/or the diameter of a cylinder completely enclosing the expandable device.

In some embodiments, the device includes a plurality of ranges or sizes with a contracted and/or unexpanded diameter of 0.3 to 2 mm, or 0.3 to 1.5 mm, or 0.4 to 1 mm, or lower, or higher, or intermediate.

In some embodiments, a device may be expanded to a range of different diameters, wherein a maximum diameter of the device (e.g., the diameter of the cylinder having the largest volume and/or diameter in the device) is 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher or intermediate ranges or sizes.

In some embodiments, a pair of conductors comprises at least two portions (e.g., multiple elongated components) joined together at two points, wherein the lengths of a first portion and a second portion between the two joint points are different. In some embodiments, changing a shortest distance between the two points (e.g., during device expansion) increases the space between the conductors.

In some embodiments, a wire pair comprises at least two parts (e.g., multiple elongated components), each part including a curved portion, wherein the multiple curved portions are spatially arranged with a phase difference, the phase difference forming a space between the portions in at least one dimension.

Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of its construction and the arrangement of components and/or methods illustrated in the following description and/or figures and/or embodiments. The present invention can be implemented or applied in other embodiments or in various methods.

Several exemplary methods for removing blocking:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention.

In step 100, in some embodiments, the location of a vascular obstruction (also referred to herein as an obstruction) is confirmed using images, for example using ultrasound (e.g., Doppler ultrasound) and/or magnetic resonance imaging (MRI) and/or computed tomography (CT) and/or X-ray imaging.

In step 102, a device is positioned near (also referred to herein as "in the vicinity") the blockage, for example, at a location within the blood vessel, such that at least a portion of the device overlaps with the clot in an axial direction of the blood vessel. For example, the device is positioned at a distance of 0 to 30 mm, or 0 to 10 mm, or 0.5 to 10 mm, or 1 to 10 mm, or lower, or higher, or in between from the blockage.

In some embodiments, a device is introduced into a blood vessel at a distance from the obstruction, for example, by pushing it in through an inlet (e.g., an incision) (e.g., using a sufficiently long elongated component attached to the device), until the device approaches the obstruction, for example, at the location of the obstruction. In some embodiments, such as in the case of a large obstruction extending a length through the blood vessel, the device is positioned in a desired location, for example, selected by a physician.

In some embodiments, the device is guided to the location of the obstruction by using imaging (e.g., computed tomography, X-ray, ultrasound, magnetic resonance imaging), and optionally a contrast agent is used to guide it into the blood vessel.

In one exemplary embodiment, a lead wire is first set up, then a conduit is inserted into the lead wire, and then the device is inserted through the conduit.

In some embodiments, the device is positioned near the obstruction such that at least a portion of the obstruction is connected to the device, wherein, for example, at least a portion of the obstruction enters a space within the device. In some embodiments, at least a portion of the obstruction radially enters a space below a portion of the device (e.g., as described herein).

In some embodiments, a portion of the device (e.g., at least a portion of an expandable structure) is pushed into and/or through an obstructing material before being removed. In an exemplary embodiment, at least a portion of an expandable structure is pushed into and/or through an obstructing material to be removed in a contracted configuration. In some embodiments, the structure is then expanded before being removed. In some embodiments, as the expandable structure is removed, one or more protrusions are highlighted and the obstructing material is removed (e.g., "scraped").

In step 104, the device is expanded. In some embodiments, the device is expanded to engage the device with at least a portion of the obstructive material.

In some embodiments, the device is expanded to form and/or expand at least a space below at least a portion of the device. In some embodiments, the device is expanded to form a space sized to allow obstructive substances to enter.

In some embodiments, one or more spaces are created and/or expanded within the device by twisting and/or bending and/or rotating the device.

In some embodiments, an elongated component connected to the device is pulled and/or pushed and/or rotated to expand the device and/or one or more spaces within the device (e.g., device diameter and/or maximum radial range).

In some embodiments, a space is formed and/or expanded by a separation of a portion of the device from a central axial axis of the device, thereby increasing the size of at least one radial space in the device.

In some embodiments, a space is formed and/or expanded by a separation between one or more parts of the device, increasing in at least one dimension, and in an exemplary embodiment, at least one radial dimension.

In some embodiments, the expansion of the device between one or more portions of the device adds one or more spaces to the surface of the device (e.g., tangential to and/or parallel to the central longitudinal axis).

In some embodiments, expanding the device may include, for example, increasing multiple radial dimensions of the device and/or one or more cross-sectional areas of the device perpendicular to its long axis (e.g., the average cross-sectional area of the device). In some embodiments, one or more radial dimensions of the device are increased and the longitudinal length of the device is correspondingly reduced.

In step 106, at least a portion of the obstruction enters below at least a portion of the device.

In some embodiments, expanding the device causes at least a portion of the obstruction to enter the device, for example, axially into a space below a portion of the device (e.g., a space axially approaching a longitudinal central axis of the device).

In some embodiments, expanding the device results in a separation between two parts of the device to increase the entry of obstructive substances into the device (e.g., as described above according to FIG. 2B).

Alternatively or additionally, in some embodiments, the insertion device allows material to enter beneath one or more portions of the device.

Alternatively or optionally, in some embodiments, during and/or after the expansion and/or insertion of the device, the device is moved (e.g., rotated about the central longitudinal axis and/or moved axially within the blood vessel) to allow obstructive material to enter one or more spaces within the device.

Optionally, in some embodiments, the device is then contracted (e.g., partially contracted) to reduce one or more spaces suitable for the entry of the clump material (e.g., at least in one dimension), for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before and/or during its removal.

In step 106, in some embodiments, the device is removed (e.g., by pulling an elongated component connected to the device). In some embodiments, removal of the device reduces the size of one or more spaces that could potentially contain obstructive material. Optionally, in some embodiments, the device conforms to the shape of the blood vessel wall, for example, by altering the cross-sectional area and/or conforming to multiple bends in the blood vessel, potentially retaining a clot between the device and the blood vessel wall.

Space of one or more exemplary devices:

Please now refer to Figures 2A and 2B. Figure 2A is a simplified cross-sectional schematic diagram of two parts 212, 214 of a device according to some embodiments of the present invention located within a blood vessel 204 having a blockage 202.

Embodiments of multiple spaces within a variety of exemplary devices include:

Figure 6A shows a space formed between multiple parts of the device body 610 and the protrusions 610 of the device body 610.

Figure 7A shows multiple spaces formed within and/or between multiple loops 708 and/or between a single loop and the device body 710.

Figure 8B shows the location where a space is formed, for example, between multiple conductors 812 and 814.

Figures 2A to 2C show schematic cross-sectional views of the device, wherein the cross-section is perpendicular to a longitudinal axis of the device, and only a portion of the vessel wall 204 is shown.

In some embodiments, expansion of the device causes an increase in the separation between the plurality of portions 212, 214 in one or more dimensions. For example, in some embodiments, when the device expands, a space between two portions of the device increases along a direction perpendicular to the central longitudinal axis of the device and along the surface of the device (e.g., tangentially and/or parallel to the central longitudinal axis).

In some embodiments, the expansion of the device causes an increase in separation between the plurality of portions 212, 214 in one dimension and a decrease in another dimension, as illustrated, for example, in Figures 12A to 12C.

Figure 2B is a simplified cross-sectional schematic diagram of two portions of a device according to some embodiments of the present invention located behind an intravascular dilation device having an obstruction. In an exemplary embodiment, the dilation of the device increases radial separation T', 1014: T' > T between multiple portions 212 and/or tangential separation D1', D1' > D1 between multiple portions.

As previously described, in some embodiments, the device is inserted into the obstructing material and/or placed near the obstructing material such that the material enters beneath one or more portions of the device. Referring now to FIG2A, in some embodiments, upon insertion of the device, the clump material 202 enters a space between two portions 212, 214 of the device (e.g., a pair of wires). In some embodiments, the plurality of portions 212, 214 are separated by one or more dimensions. For example, as shown in FIG2A, in an exemplary embodiment, the plurality of portions 212, 214 are axially separated (relative to a longitudinal axis of the device) by a distance D1 and tangentially separated (relative to the longitudinal axis of the device) by a distance T.

As previously described, in some embodiments (e.g., after the device expands), the device is then contracted (e.g., partially contracted) to reduce the space of one or more spaces into which the clump material (e.g., in at least one dimension) has entered, for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before it is removed and/or before the device is removed.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction. In some embodiments, after contraction, the separation between the multiple parts is reduced by one or more dimensions, for example: T" < T'; and/or D" < D'.

Although in Figure 2C, the space between the plurality of portions 212, 214 is radially reduced due to the movement of portion 214 away from blood vessel 204, in some embodiments, for example, a radial dimension of the space is reduced, for example, when clamping material between the plurality of portions of the device, by moving portion 212, for example, along the radial direction, while, for example, maintaining radial pressure of portion 214 on obstructive material 202.

In some embodiments, as described elsewhere in more detail (e.g., Figures 12A-D), the device expands to increase a radial space between portions of the two devices as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus 200 according to some embodiments of the present invention, including a protruding portion 214.

In some embodiments, the protruding portion 214 protrudes above a body of the device 242. The largest circular cross-section 242, which completely encloses the plurality of portions of the device (circles with solid outlines as shown in Figures 2D and 2E), may define the body of the device.

In some embodiments, a space between the protruding portion 214 of the device 212 and a closest other portion of the device 212 includes a radial component: in some embodiments, an angle θ1 between a radial line extending from a central longitudinal point of the device 236 and a radial line from the closest portion 212 of the device to the protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

In some embodiments, a central longitudinal axis of a device (e.g., non-cylindrical) is defined as extending from the longitudinal central axis of the largest cylinder completely enclosing the device. FIG2E is a simplified cross-sectional view of a device 200 including a protruding portion 214 according to some embodiments of the invention. In some embodiments, one or more portions of the device comprise a non-circular cross-section, such as the elliptical cross-section shown in FIG2E (multiple device portions are represented by multiple solid-outline circles). Circle 242 represents a largest circular cross-section enclosed by the device at this point and defines a central longitudinal point 236 (the largest circular cross-section completely enclosed by the device defines multiple defining longitudinal points and a central longitudinal axis).

In some embodiments, an angle θ2 between a radial line extending from a central longitudinal point of the device 236 and a radial line from a closest portion 212 of the device to a protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

An exemplary insertion and expansion of a device:

In one exemplary embodiment, the obstruction is a blood clot blocking a blood vessel.

Figure 3A is a simplified cross-sectional view of a clot 302 in a blood vessel 304, the clot 300 substantially blocking the entire portion of the blood vessel (e.g., the blockage substantially fills at least a portion of the cross-section of the blood vessel).

Figure 3B is a simplified cross-sectional schematic diagram of a clot 302 in a blood vessel 304 and an expandable device 300 delivered to the vicinity of the clot 302 according to some embodiments of the present invention. In some embodiments, insertion of the device 300 displaces at least a portion of the clot, for example, by displacing a portion of the clot 302 from a blood vessel wall. In some embodiments, insertion of the device 300 causes multiple portions 306 of the clot 302 to enter the device 300, for example, into multiple spaces within the device (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device).

In some embodiments, the device 300 is expanded such that at least a portion of the clot 302 enters at least one space within the device 300. Figure 3C is a simplified cross-sectional schematic diagram of a device 300 expanding within a blood vessel 304 and grasping the clot 302 according to some embodiments of the present invention.

Figure 3D is a simplified cross-sectional view of an axial expansion of a device 300 within a blood vessel 303 of a clot 302 according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

In some embodiments, FIG3D is a cross-section taken at plane A-A as shown in FIG3C. In some embodiments, the clump material 302a enters at least one space within the expanded device 300.

An example of removing an obstruction:

As previously described, in some embodiments, during the removal of the obstruction, including during the period when the blood vessel changes direction and/or dimensional position, a device holds an obstruction (e.g., a clot) against a blood vessel wall.

In some embodiments, during the period when the device holds obstructive material between the device and multiple vessel walls and/or within the space of one or more devices, one or more portions of the device (e.g., one or more protrusions) maintain sufficient outward force on the obstructive material, optionally causing the obstructive material to move with the device within the vessel during changes in the geometry and size of the vessel.

For example, in some embodiments, one or more protrusions (e.g., protruding portion 608) remain in contact with the vessel wall in various cross-sectional areas of the blood vessel.

Figure 4A is a simplified side view of an expandable device 400 and a grasped clot 402 in a blood vessel 404 according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device 400 according to some embodiments of the present invention removing a clot 402 through a bend in a blood vessel 404.

Figure 4C is a simplified side view schematic diagram of an expandable device 400 removing a clot through an expanded portion of a blood vessel 404 according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device 400 according to some embodiments of the present invention guiding a bend and a blood vessel 404 in a cross-sectional area during the removal of clotted material 402.

Exemplary interaction between device insertion and obstruction:

In some embodiments, the insertion and/or placement of the device places the device between an obstruction and a wall of the blood vessel (e.g., as shown in Figures 3B and 3C).

In some embodiments, a device is inserted into an obstruction. In some embodiments, the device is inserted into an obstruction and obstructive material is pushed away from the device. Alternatively or additionally, in some embodiments, the device is inserted into an obstruction such that some of the obstructive material enters the space of one or more of the devices (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device (e.g., 610, 810)). In some embodiments, the obstructive material at least partially covers the walls of the plurality of blood vessels, for example, as shown in FIG6A.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device 500 being delivered to a vicinity of a clot 502 within a blood vessel 504, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot 504 according to some embodiments of the present invention.

Several exemplary devices:

Figure 6A is a simplified side view of a device 600 expanding near an obstruction 602 of a blood vessel 604 according to some embodiments of the present invention.

In an exemplary embodiment (e.g., as shown in FIG6A), a device (e.g., under uniform external pressure) includes: a central portion having a cylindrical shape; and a plurality of ends having tapered shapes.

Alternatively or additionally, in some embodiments, the device includes an elliptical cross-sectional portion (e.g., a central portion). Alternatively or additionally, in some embodiments, the device includes an irregular shape.

In some embodiments, the device 600 includes an expandable structure consisting of a plurality of wires, wherein one or more of the plurality of wires are connected at different radial locations at a distal end and a proximal end of the structure.

In some embodiments, an apparatus includes a plurality of conductors, each of which extends a path from the distal end to the proximal end, the path including multiple variations in the radial position (e.g., the angle from a central longitudinal axis) of the conductor (e.g., a helical path). In some embodiments, a single conductor passes through other conductors along the path of the single conductor and below the single conductor. In an exemplary embodiment, for example, as shown in Figures 6A-6B, the plurality of conductors may alternatively pass below and above multiple consecutive lines along the path of the plurality of conductors, for example forming a grid.

In some embodiments, one or more wires are connected at the distal and/or proximal ends of one or more other wires. In some embodiments, the multiple wires are connected by, for example, soldering and/or gluing together.

In some embodiments, the plurality of wires are connected to one or more ends via one or more components. For example, in some embodiments, the plurality of wires are connected to a proximal end of an elongated component 616 by a user applying force to the device (by pushing and/or pulling the device by applying force to the elongated component). In some embodiments, the plurality of wires are connected to a distal end of an expandable structure via a capped end 620.

In some embodiments, more than one wire extends from the proximal end to the distal end, the wire being composed of a single wire that passes from a proximal end to the distal end more than once.

In some embodiments, a plurality of wires forming the device form a tubular mesh surface between the distal end and the proximal end, and a body of the device 610.

In some embodiments, the expandable structure is expanded, for example, by reducing a longitudinal distance between the end 620 and the elongated component 616, for example by using a component to connect the end 620 (e.g., as shown in FIG8B, component 824 is connected to the end 820).

Several exemplary protrusions:

In some embodiments, a device (e.g., 600, 700, 800) includes one or more protruding portions (e.g., 608, 708, 812) that (e.g., as previously described) hold the clump material below the one or more protruding portions.

In some embodiments, as the device is removed, the protruding portion (e.g., 608) remains protruding, for example, non-flat and/or folded back (e.g., opposite the body 610 of the device). In some embodiments, one or more protruding portions consist of multiple conductors selected to be strong enough to remain protruding when the device is removed. For example, in some embodiments, one or more protruding portions consist of conductors having multiple dimensions of cross-section (e.g., as described below), wherein the dimensions of the cross-sections are selected to provide sufficient drag and/or moment of inertia.

In some embodiments, one or more protrusions exert an outward (e.g., elastic) force on the blood vessel, potentially maintaining contact between the one or more protrusions and the vessel wall as the cross-section of the blood vessel changes in multiple dimensions. In an exemplary embodiment, a dimension of the elastically released cross-section of the device includes the plurality of protrusions larger than the largest blood vessel through which the device travels to remove the clot (e.g., the plurality of protrusions maintain elastic force on the obstructive material and/or the vessel wall, and do not elastically relax during the removal of the obstructive material by the device and/or during the removal of the device).

In one exemplary embodiment, the plurality of protruding portions 608 are circular, which potentially reduces the risk of damage (e.g., to multiple vessel walls) during use of the device, such as when the device is expanded and/or moved through the vessel wall.

In some embodiments, a circular protrusion includes a tip (the most radially protruding portion), wherein the width of the tip is at least 20%, or at least 30%, or at least 40% of the length of the protrusion, wherein the length of the protrusion is measured as the axial length of the wire from where the wire extends radially from the body of the device.

Exemplary angle relative to the protrusion of the device body:

In some embodiments, one or more protrusions are angled, wherein a distal profile of the protrusion forms an acute angle θ with the removal direction 630 of the device.

In some embodiments, during the expansion of the device 600, the angle θ increases, also increasing the axial space beneath the plurality of protrusions 608. In some embodiments, during the contraction of the device 600, the angle θ decreases, potentially retaining the clump material.

In some embodiments, during movement of the device, one or more protrusions are angled to grip the clump material, for example, one or more protrusions are angled at an acute angle to a central axis of the device and/or the direction of movement of the device.

Exemplary multiple loop protrusions:

In some embodiments, one or more protruding portions are loop structures (e.g., 608, 708). For example, a conductor forming the loop includes a distal end and a proximal end, both of which are connected to either the proximal or distal end of the device. For example, the device shown in FIG6A includes a plurality of protrusions 608, wherein the protrusions are formed by a conductor connected to both ends of an elongated assembly 616.

In some embodiments, the ends of the plurality of loops are connected to different parts of the device.

In some embodiments, multiple wires forming one or more protruding portions follow a path to and from the surface of a tubular expandable device. In some embodiments (e.g., as described elsewhere), the wires form a protrusion extending radially from the tubular surface 610. In some embodiments, the wires also extend longitudinally along the device.

Exemplary protrusions forming an integral part of the device:

In some embodiments, a protruding portion forms a main body portion of the device. For example, as shown in FIG6A, in some embodiments, a plurality of protruding portions 608 are formed by a plurality of wires, which also form part of a device body 610.

In some embodiments, one or more protrusions are formed by a conductor extending around and/or along the device (e.g., approximately 10 to 90%, 50 to 80% of the circumference of the device and/or 10 to 90% or 50 to 80% of the length of the device). For example, multiple conductors form multiple protrusions 608 comprising one or more portions that follow a path around the tubular expandable device body 610.

In some embodiments, a protrusion is formed by applying a force (e.g., tension) to the expandable device via a wire directly connected to an elongated member (e.g., protrusion 608 is connected to the elongated component 616).

Potentially, a protrusion forming a main body portion of the device can more effectively transmit the force applied to the device, for example, to apply force to the clot (e.g., to move the clot).

Exemplary locations of multiple protrusions:

In some embodiments, a plurality of protrusions 608 are each positioned at a different radial angle from a central longitudinal axis of the device, the plurality of protrusions potentially removing obstructive material from different regions of the blood vessel wall. In some embodiments, positioning a plurality of protrusions at different radial angles allows a device to be inserted between blood vessel walls within a range of rotational orientations, and allows one or more protrusions to interact with the obstruction, for example, the operation of the device is potentially unaffected by rotational positioning relative to the obstruction.

In one exemplary embodiment, the device 600 includes four protrusions, which are positioned 90° apart from their centers when viewed at an angle perpendicular to a longitudinal central axis of the device. In one exemplary embodiment, the protrusions are substantially equal in size and protrude substantially equally (assuming equal pressure on each protrusion). In one exemplary embodiment, the center of each protrusion satisfies that a surface of the device body 610 forms a plane perpendicular to a longitudinal axis of the device.

Figure 6B shows the clump material 602 being held beneath a plurality of protrusions 608, for example, between the protrusions 608 and the device body 610.

In some embodiments, the protrusions on the device have different sizes and/or orientations and/or axial positions.

Figure 7A is a simplified side view of an expandable device 700 including a plurality of protrusions 708 according to some embodiments of the present invention. In some embodiments, the plurality of protrusions 708 are distributed along a longitudinal axis of the device 700.

In some embodiments, the expandable structure 700 includes a plurality of wires connecting the distal end 701d and the proximal end 701p of the structure. In some embodiments (e.g., as shown in FIG6A), the plurality of wires form a tubular mesh.

In some embodiments, the plurality of protrusions are composed of loops 708 formed by multiple wires extending from and returning to the proximal end 701p. In some embodiments, the plurality of loops 708 pass through a tubular mesh 710 along a path (the plurality of coils pass through the interior of the tubular mesh 708) and protrude through multiple gaps in the tubular mesh. In some embodiments, each loop protrudes through the mesh at a different location, for example, each coil protrudes at a radial and longitudinal location on the mesh, such as a unique radial and/or longitudinal location on the mesh.

Figure 7B is a simplified side view of an expandable device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7C is a simplified side view of a contraction device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7D is a simplified side view of an expandable device 700 inserted and passed through an obstruction 702 within a blood vessel 704, according to some embodiments of the present invention. As previously described, in some embodiments, a device is pushed into and/or through an obstruction, then expanded, and then the obstruction is pulled to remove (e.g., rake) the obstruction 702 from its original position within the blood vessel 704.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel. In some embodiments, the obstructive substance enters between a plurality of loops 702b and/or a plurality of loops 702c. In some embodiments, the obstructive substance 702a located between the device 700 and a plurality of blood vessel walls is moved and/or removed by pulling the device through the blood vessel 704.

As previously mentioned, optionally, in some embodiments, a plurality of coils 708 apply an outward force (e.g., elastic force) to the obstructive material and/or the blood vessel wall.

In some embodiments, during and/or after the expansion of the device, clump material 702 enters into a plurality of spaces 739 between the plurality of protrusions 708. In some embodiments, the contraction of the device reduces one or more spaces between the plurality of protrusions (e.g., the plurality of spaces 739a are greater than the plurality of spaces 739b) in at least one dimension, and in some embodiments, in a radial direction.

During and/or after the expansion of the device, the clump material 702 enters into the plurality of spaces 738 between the plurality of protrusions 708. In some embodiments, during and/or after the expansion of the device, a space within a protrusion increases in one or more dimensions and/or in a radial direction. Conversely, in some embodiments, during the contraction and/or removal of the device, a space in a protrusion decreases in size in one or more dimensions and/or in a radial direction.

The exemplary device includes multiple pairs of wires protruding from the portion:

Figure 8A is a simplified side view of an expandable device 800 according to some embodiments of the present invention. Figure 8B is a simplified side view of an expandable device 800 according to some embodiments of the present invention.

Please now refer to Figure 8B, which is an enlarged view of a portion of the apparatus shown in Figure 8A:

In some embodiments, the device 800 (e.g., under uniform pressure) has an outer surface of the device that is widened at a narrowed distal end toward a longitudinal central portion of the device, and then the outer surface of the device narrows toward a proximal end of the device.

In one exemplary embodiment, device 800 includes an elongated component 816 connected to a body of the device, for example, for moving device 800 within a blood vessel. In some embodiments, the elongated component of the device (e.g., 816, 616, 716) is resilient. In some embodiments, a first end 818 of a plurality of wires constituting the device is connected to the elongated component 816.

In some embodiments, the device 800 includes an end portion 820 to which a second end portion 822 of a plurality of wires is connected. In some embodiments, a control portion 824 (e.g., a wire) is connected to the end portion 822 and passes through the device, and optionally through a hollow portion of an elongated assembly 816. In some embodiments, the control line 824 is retracted (e.g., pulled) through the elongated assembly 816 to change the geometry of the device 800. In some embodiments, the control line 824 follows a central longitudinal axis of the device.

In some embodiments, the retraction control line 824 of the elongated component is used to expand an average cross-sectional area of the device and reduce a longitudinal length of the device.

In some embodiments, the end portion 820 is located where two or more wires of the device are connected to each other (e.g., by welding). In some embodiments, the multiple wires follow a path from the elongated component 816 to the end portion 820, wherein the end portion 820 is located where each wire passes under and/or under at least one other wire. In some embodiments, one or more wires connecting the end portion 820 to the elongated component 816 have a longer length, and one or more other wires, and in some embodiments, the wire forms a protrusion (e.g., wire 812). In some embodiments, one or more wires are shaped (e.g., by heat treatment as described herein) to have a shape that includes a protrusion.

Several exemplary wire pairs:

In some embodiments, a device 800 includes one or more wire pairs, wherein the wire pairs include a separation, such as multiple separations D2, D4, D6, D8, at least to some extent of expansion of the device.

Please refer to an example conductor pair and a disconnect, where disconnect D2 is located between conductors 812 and 814.

Figures 9A and 9B show enlarged views of a pair of wires in a device, such as a portion of a pair of wires shown in region R of Figure 8B.

Figure 9A is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

Figure 9B is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

In some embodiments, FIG9B illustrates the conductor pair 800 of FIG9B after the cross-sectional area of the device (e.g., device 800) has been reduced (e.g., by advancing control line 824). In some embodiments, a separation between the plurality of conductors 912, 914 of the conductor pair is reduced; D2” < D'. In some embodiments, the reduction of separation is associated with a reduction in the curvature of the plurality of conductors 912 and/or 914.

Exemplary connection of the obstructive material to the device, one or more interlacing portions:

In some embodiments, the clump material is held in a mesh device portion.

In some embodiments, the clump material is held by a portion of the device comprising multiple interwoven portions (also referred to herein as a "mesh"), for example, one or more portions following a path below or above one or more portions (e.g., below and above are in a radial direction).

Figure 10 is a simplified top view of a clump material 1002 being held in a grid device portion according to some embodiments of the present invention.

In some embodiments, at least a portion of a device includes a mesh structure in which one or more conductors are interwoven with other conductors, for example, passing through some conductors and under others. In an exemplary embodiment, the device includes warp 1026 and weft 1028, wherein the warp 1026 and weft 1028 are, for example, evenly spaced apart.

In some embodiments, multiple conductor pairs are formed at multiple intersections of multiple meridians and multiple parallels (also referred to herein as multiple connections).

Figure 11 is a simplified top view schematic diagram of a clump of material being held in a mesh device portion according to some embodiments of the present invention. In some embodiments, the obstructing material within the device distorts the device structure, for example, due to the hardness of the obstructing material.

Figure 12A is a simplified top view of a lumpy material 1202 and a mesh device portion 1200 according to some embodiments of the present invention. In some embodiments, the contact (contact lengths c1, c2, c3, and c4) between the lumpy material 1202 and the device is partial, for example, the lumpy material 1202 contacts 5 to 95%, or 10 to 90%, or 50 to 80%, or lower, or higher, or a plurality of intermediate ranges or percentages of a length of a warp between multiple warps (a) and/or a length of a weft between multiple wefts (b), for example: c1 divided by a multiplied by 100% equals 50 to 90%.

In some embodiments, the expansion of the device alters an angle between one set of conductors (e.g., multiple meridians) and another set of conductors (e.g., multiple parallels). Figure 12B is a simplified top view of the device portion of Figure 12A after the expansion device, according to some embodiments of the invention. In some embodiments, during the expansion of the device, an angle between the meridians and parallels changes, for example, from 90° in Figure 12A to 45° in Figure 12A.

In some embodiments, during the expansion, a variation of the angle α between the meridians and parallels is 10° to 90°, or 20° to 70°, or 40° to 50°, or smaller, or larger, or a plurality of intermediate angles.

In some embodiments, a device includes a range of angle α, for example, corresponding to different degrees of expansion of the device, such as 5° to 175°, or 10° to 165°, or 45° to 110°, or lower, or higher, or in between, a plurality of ranges or a plurality of angles.

In some embodiments, the space decreases simultaneously in one dimension (e.g., radially between meridians and parallels) and increases simultaneously in another dimension (in the plane of meridians and parallels, as shown in Figures 12A to 12B), and the structure potentially receives and holds clump material simultaneously.

Figures 12C and 12D illustrate side views of clump material held between a meridian 1212 and a parallel 1214 as the device expands according to some embodiments of the invention.

In some embodiments, the clump material is located between multiple intersecting portions of the device, for example, where a warp crosses a weft. Figure 12E is a simplified side view of the clump material 1202 between multiple conductors 1214 according to some embodiments of the invention. In some embodiments, the clump material 1202 contacts a portion of the length of a portion below another portion, ranging from 5% to 95%, or 10% to 90%, or 50% to 80%, or lower, or higher, or in between, length c as shown in Figure 12B.

Multiple exemplary wire pairs include multiple connections:

In some embodiments, a space is created and/or expanded between two or more conductors connected at two or more points. In some embodiments, a length of a first conductor between two points is longer than the length of a second conductor connected to the same two points. In some embodiments, a distance between the two connections is reduced, while a distance between the two conductors is increased (e.g., in a space of at least one dimension).

Figure 13A is a simplified side view of an expandable device 1300 according to some embodiments of the present invention, comprising a conductor having a plurality of connections 1332, 1334 between a plurality of conductors 1312, 1314.

In some embodiments, one or more of connection points 1332, 1334 are a connection point between a plurality of wires 1312, 1314. One or more of connection points 1332, 1334 are points through which one wire passes through and/or around another wire.

Figure 13B is a simplified side view of the device of Figure 13A according to some embodiments of the present invention, after the space 1338 between the wires has been expanded.

In some embodiments, a length (from L to L’; L < L’) between the connections 1332, 1334 is reduced to increase the size of a space 1338 between the plurality of conductors 1312, 1314 in at least one dimension, where d is the radial dimension of the space 1338 and d < d’. For example, a length of the first conductor 1314 measured along a central axis of the first conductor is greater than the length of the second conductor 1312 measured along a central axis of the second conductor.

In some embodiments, a space 1338 is located between two portions protruding from the cylinder C, as shown in FIG13A, wherein the wire 1312 is bent on one surface of the cylinder C, and in FIG13B, wherein the wire 1312 is bent on the surface of the cylinder C'.

In some embodiments, the radius R of the device 1300 is increased (e.g., from R to R') to reduce the separation L (e.g., from L to L') between the plurality of connections.

As previously described, in some embodiments, the expansion of the radius R of the device (e.g., from R to R' as shown in Figures 13A to B; R < R') reduces a length of the device 1300, wherein the radius is measured from a central longitudinal axis of the device 1336. In some embodiments, the plurality of cylinders C and C' are an outer surface or a body of the device (e.g., excluding the plurality of protrusions).

In some embodiments, the device 1300 is cylindrical, as shown in Figures 13A and 13B. In some embodiments, the device, for example, has a non-cylindrical shape (e.g., as shown in Figure 6A, Figure 7B, as described herein), and the plurality of cylinders C and C' are the plurality of largest diameter cylinders completely enclosing the device.

Exemplary wire pairs including phase difference:

In some embodiments, an expandable structure includes one or more curved portions, wherein the plurality of curved portions are spatially disposed on the structure such that a space exists between the plurality of curves. In an exemplary embodiment, a conductor pair includes a first conductor and a second conductor, the first conductor having a sinusoidal portion and the second conductor having a sinusoidal portion, wherein the plurality of sinusoidal portions are disposed on the expandable structure and have a phase difference, the phase difference implying that a space exists between the conductors in at least one dimension. In some embodiments, the means is expanded (e.g., as shown in Figures 13A to 13B) to increase the space between the conductors.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions 1412, 1414, and the shrinking device being arranged in space with a phase difference between the plurality of portions.

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions 1412, 1414, and the expandable device being spatially positioned with a phase difference between the plurality of portions.

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions 1412, 1414, and the device being arranged in space with a phase difference between the plurality of portions.

In some embodiments, when the expandable structure contracts (the radius of the largest enclosed cylinder is D”, where line 1436 represents a central longitudinal axis of the cylinder), the dimension a” between the plurality of curved portions is less than the dimension a between the plurality of curved portions when the expandable structure partially expands (the radius of the largest enclosed cylinder is D), wherein the dimension a is less than a dimension a’ when the expandable structure expands (the radius of the largest enclosed cylinder is d):

A"<a<a' and D"<D<D'.

In some embodiments, one or more spacer components 1440 (e.g., posts) are disposed between two or more portions of the device (e.g., multiple conductors) to maintain a phase difference between the multiple conductors. In some embodiments, one or more posts are inserted into the structure, for example, during processing (e.g., heat treatment). In some embodiments, one or more posts are used in the processing to form shape memory in multiple conductors comprising a hyperelastic material (e.g., nitinol). In some embodiments, one or more spacer components 1440 are removed during manufacturing and/or before using the device.

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer post 1640 holds a space between two portions 1612, 1614 of the apparatus.

Materials and construction of several exemplary expandable devices:

In some embodiments, an expandable device (e.g., as described herein, such as Figures 6A-B and 8A-B) is constructed using multiple wires, for example, a body of the device is constructed of a wire mesh (e.g., a cross-woven mesh).

In some embodiments, at least a portion of the device comprises a flexible and/or elastic and/or biocompatible material, such as nitinol, and/or cobalt-chromium and/or stainless steel. In some embodiments, at least a portion of the device comprises a shape memory and/or hyperelastic material (e.g., nitinol).

In one exemplary embodiment, at least a portion of the device is composed of a plurality of nitinol wires.

In some embodiments, a portion of the device for grasping obstructive material (e.g., an expandable structure) is composed of multiple wires, the largest cross-sectional dimension (e.g., diameter) of which is 10 to 150 micrometers, 25 to 150 micrometers, or 12 to 100 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires with a diameter of 75 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires having a flat cross-sectional shape, such as a circular shape, having a largest cross-sectional dimension of 100 micrometers, and a cross-sectional dimension perpendicular to the largest cross-sectional dimension of 50 micrometers (e.g., a "band" with a cross-section of 50 × 100 micrometers).

In some embodiments, additional material is added to the mesh apparatus after it has been constructed (e.g., by weaving). In some embodiments, one or more additional threads are woven into an existing structure; for example, in some embodiments, one or more additional wires are wrapped around an existing wire.

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including a plurality of additional conductors 1544 connected to a plurality of baselines 1546. In some embodiments, a plurality of spaces 1538 (e.g., as described herein) are formed between the additional conductors 1544 and the baselines 1546.

Several exemplary treatments:

In some embodiments, the device (e.g., as described herein) is used to remove blood clots from a blood vessel. In an exemplary embodiment, the device (e.g., as described herein) is used to remove an obstruction (e.g., a clot) from a blood vessel in the brain, such as in a stroke.

In some embodiments, additional or alternative substances other than clot material, such as fatty deposits and/or plaques and/or thrombi and/or platelet aggregates and/or foreign matter and/or calcified deposits. In this context, the terms "clot" or "clot material" are used to indicate any obstructive substance within a blood vessel that completely and/or partially blocks said blood vessel.

In some embodiments, the device (e.g., as described herein) is used to remove pulmonary embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove peripheral embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove cardiovascular embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used for revascularization in postoperative restenosis.

General Discussion:

As used and referenced in this document, the terms “about” and “approximately” indicate ±20%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”, and their morphological variations refer to “including but not limited to”.

The term "consisting of" means "including and not limited to".

The term "consisting essentially of" means that the composition, method, or structure may include additional ingredients, steps, and/or components, but only if the additional ingredients, steps, and/or components do not substantially alter the essential or novel characteristics of the claimed composition, method, or structure.

As used herein, the singular forms “a,” “an,” and “the” may include multiple references unless explicitly indicated by the context. For example, the terms “a compound” or “at least one compound” may include multiple compounds, including mixtures thereof.

Throughout this application, various embodiments of the invention may be presented in a range format in conjunction with the references. It should be understood that the range format description is merely for convenience and brevity and should not be construed as a strict limitation on the scope of the invention. Therefore, the description of a range should be considered as all possible possible sub-ranges specifically disclosed, as well as the various numerical values within the range. For example, describing a range as "from 1 to 6" should be understood as disclosing multiple sub-ranges such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc.; and also disclosing various numbers within this range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

Unless the context explicitly indicates a numerical range, it means any number (fraction or integer) included within the indicated range. The phrases “ranging” or “ranges between” for the first and second indicated numbers, and “ranging” or “ranges from” for the first indicated number and “to” the second indicated number, are used interchangeably herein and mean including the first and second indicated numbers and all fractions and integers between them.

As used herein, the term "method" refers to the manner, means, technique, and procedures used to accomplish a particular task, including but not limited to those manner, means, techniques, and procedures that are known or readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine from known manner, means, techniques, or procedures.

As used in this article, the term "treatment" includes terminating, substantially inhibiting, slowing or reversing the progression of a disease, substantially improving the clinical or psychological symptoms of a disease, or substantially preventing the occurrence of the clinical or psychological symptoms of a disease.

It is understood that certain features of the invention, for clarity, are described in the context of independent embodiments, or may be provided in combination in a single embodiment. Conversely, various features of the invention, for brevity, are described in the context of a single embodiment, or may be provided individually or in any suitable sub-combination or in embodiments suitable for any other description of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments do not function without these components.

While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that numerous alternatives, modifications, and variations will be readily apparent. Therefore, the invention is intended to cover all such alternatives, modifications, and variations falling within the spirit and scope of the claims.

All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety as if each independent publication, patent, or patent application were expressly and individually indicated as being incorporated herein by reference. Furthermore, any reference or endorsement in this application should not be construed as an admission that such reference is prior art to the invention. Heading portions in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations.

Devices and methods for removing vascular obstructions

This application is a divisional application of application number 201680031844.X (PCT application number PCT/IL2016/050763), filed on July 14, 2016, entitled "Apparatus and Method for Removing Vascular Obstructions".

Technical Field and Background Technology

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing obstructive substances from a blood vessel.

Summary of the Invention

According to one aspect of some embodiments of the present invention, an apparatus for removing obstructive material from a blood vessel is provided, the apparatus comprising:

An expandable structure, the expandable structure being sized to be inserted into the blood vessel; and

One or more portions protrude radially from a central longitudinal axis of the expandable structure, such that a space between the protrusion and a closest portion of the expandable structure contains a radial component;

The space is sized and shaped to receive an obstructive substance.

According to some embodiments of the present invention, the device includes multiple wires, wherein one or more protruding portions are part of one wire.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is tangent to the central longitudinal axis of the device.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is parallel to the central longitudinal axis of the device.

According to some embodiments of the present invention, the device includes an interlacing structure, wherein the protruding portion and the closest portion are a warp and a weft of the interlacing structure.

According to some embodiments of the present invention, the one or more protruding portions are circular.

According to some embodiments of the invention, the radial component of the space is between 0.01 and 0.2 mm.

According to some embodiments of the present invention, the central longitudinal axis of the expandable structure is a central longitudinal axis that can enclose a maximum cylindrical space within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the longest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is a cylindrical space with the largest diameter that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the largest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the expandable structure is configured to have a contracted state and a plurality of expanded shapes within a range, the structure being expandable to a maximum expanded state;

The diameter of the largest cylindrical space in the contracted state is smaller than the volume of the largest cylindrical space in the maximum expanded state.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the contraction space is 0.3 to 2 mm.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the maximum expansion state is 1 to 7 millimeters.

According to some embodiments of the present invention, when the structure is in each of a plurality of expanded states of the range, the radial component of the space is greater than a radial component of the space when the device is in the contracted state.

According to some embodiments of the present invention, the protruding portion and the nearest device portion are connected at at least two connection points, wherein an axial length of the protruding portion between the two connection points is greater than an axial length of the nearest device portion between the two connection points.

According to some embodiments of the invention, the protruding portion and the closest device portion are spatially curved to create a phase difference between the plurality of portions.

According to some embodiments of the present invention, the expandable structure includes a plurality of protruding portions.

According to some embodiments of the invention, a plurality of protruding portions are disposed at a plurality of different radial positions around an axial position of the expandable structure.

According to some embodiments of the invention, one or more of the plurality of protruding portions are distributed along the expandable structure at an axial position different from one or more other protruding portions.

According to some embodiments of the present invention, the structure includes:

Multiple wires, each wire being connected to a different radial position at a distal end and a proximal end of the structure;

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least a portion of one of the conductors includes a protrusion at which the conductor path extends radially from the surface of the tubular mesh and then extends axially to define the space between the portion and the surface of the tubular mesh.

According to some embodiments of the present invention, the path including the change of radial position is a spiral path.

According to some embodiments of the present invention, the apparatus includes:

At least one loop is attached to the proximal end of the structure and extends radially from the central longitudinal axis;

The space therein is located within the loop.

According to some embodiments of the present invention, the apparatus includes:

Multiple wire loops, each of the wire loops being attached to the proximal end of the structure;

The space described therein is located between two loops.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described herein, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

One or more of the loops protrude radially from the surface of the tubular mesh.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least one of the wires contains a protruding portion.

According to some embodiments of the invention, the shape is sized and shaped to receive at least a portion of the obstructive material.

According to one aspect of some embodiments of the present invention, a method for removing obstructive material from a blood vessel is provided, the method comprising:

A contractile expandable structure is provided near one axial direction of the obstructive material;

Connect the structure to the obstructive material, allowing the obstructive material to enter at least one space between a structurally protruding portion of the device and a central longitudinal axis; and

The obstructive substance is removed from the blood vessel by removing the structure.

According to some embodiments of the present invention, the at least one space is a plurality of spaces.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different positions along a longitudinal axis of the structure.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different radial positions.

According to some embodiments of the present invention, the connection includes connecting multiple different portions of the obstructive material such that each portion is connected to a different space among the multiple spaces.

According to some embodiments of the present invention, the connection includes: expanding the structure.

According to some embodiments of the present invention, the expansion includes increasing the size of the space in at least one dimension.

According to some embodiments of the present invention, the expansion includes: reducing the size of the space in at least one dimension.

According to some embodiments of the present invention, the at least one space is located between a structurally protruding portion and a second structural portion.

According to some embodiments of the invention, the connection includes: pulling the expandable structure through the vicinity of the obstructive material along its axis.

According to some embodiments of the present invention, the connection includes: pushing the expandable structure into the obstructive material.

According to some embodiments of the present invention, the method includes: shrinking the at least one space in at least one dimension.

According to some embodiments of the present invention, the removal includes: moving the device through multiple portions of the blood vessel by means of changes in multiple directions and geometry.

According to some embodiments of the present invention, the expansion includes: expanding the device until the device applies an external force to the plurality of blood vessel walls.

According to some embodiments of the present invention, the device applies an outward force to the plurality of blood vessel walls during the removal process.

Unless otherwise stated, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While embodiments of the invention may be implemented or tested by any methods and substances similar to or equivalent to those described in the embodiments of the invention, the embodiments, enumerated methods, and/or substances of the invention have been described below. In case of conflict, the definitions included in this specification will be used for control. Furthermore, substances, methods, and embodiments are illustrative only and are not necessarily intended to be limiting.

Attached Figure Description

Some embodiments of the present invention described herein are by way of example only and with reference to the accompanying drawings. The detailed description of the drawings and specific references emphasizes that the details shown are merely illustrative and are intended to illustrate the purpose of the embodiments of the present invention. Based on this, the embodiments of the present invention will be clearly understood by those skilled in the art in conjunction with the accompanying drawings and description.

In the attached diagram:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention;

Figure 2A is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located within a blood vessel having an obstruction;

Figure 2B is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 2E is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 3A is a simplified cross-sectional view of a clot in a blood vessel;

Figure 3B is a simplified cross-sectional schematic diagram of a clot in a blood vessel and a device delivered to the vicinity of the clot according to some embodiments of the present invention.

Figure 3C is a simplified cross-sectional schematic diagram of a device according to some embodiments of the present invention expanding and grasping the clot in a blood vessel;

Figure 3D is a simplified cross-sectional view of an axial expansion of a clot within a blood vessel by a device according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

Figure 4A is a simplified side view of an expandable device for removing and holding multiple clots in a blood vessel according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device according to some embodiments of the present invention removing a clot through a bend in a blood vessel.

Figure 4C is a simplified side view schematic diagram of an expandable device removing a clot through an expanded portion of a blood vessel according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device according to some embodiments of the present invention guiding a bend and multiple variations of a blood vessel in a cross-sectional area when removing clotted material.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device being delivered to the vicinity of a clot within a blood vessel, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot according to some embodiments of the present invention;

Figure 6A is a simplified side view of a device expanding near a clot in a blood vessel according to some embodiments of the present invention.

Figure 6B illustrates a clump of material held by a plurality of protrusions, for example, between a plurality of protrusions and the body of the device, according to some embodiments of the present invention.

Figure 7A is a simplified side view of an expandable device including a plurality of protrusions according to some embodiments of the present invention;

Figure 7B is a simplified side view of an expandable device in a blood vessel according to some embodiments of the present invention;

Figure 7C is a simplified side view of a contraction device within a blood vessel according to some embodiments of the present invention;

Figure 7D is a simplified side view of an expandable device inserted through an obstructive substance within a blood vessel, according to some embodiments of the present invention.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel.

Figure 8A is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 8B is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 9A is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention;

Figure 9B is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention.

Figure 10 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 11 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 12A is a simplified top view of a clump material and a mesh device portion according to some embodiments of the present invention.

Figure 12B is a simplified top view of the device portion after device expansion according to some embodiments of the present invention;

Figures 12C and 12D show side views of the clump of material held between a meridian and a parallel during the expansion of the device;

Figure 12E is a simplified side view of a clump of material between multiple conductors according to some embodiments of the present invention;

Figure 13A is a simplified side view of an expandable device according to some embodiments of the present invention, comprising a conductor having multiple connections between multiple conductors.

Figure 13B is a simplified side view of the device of Figure 13A after the space between the wires has been expanded, according to some embodiments of the present invention.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions, and the shrinking device being spatially positioned with a phase difference between the plurality of portions;

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions, and the expandable device being spatially positioned with a phase difference between the plurality of portions;

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions, and the device being arranged in space with a phase difference between the plurality of portions;

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including multiple additional wires connected to multiple baselines; and

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer bar holds a space between two portions of the apparatus.

Specific Implementation

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing multiple obstructions from multiple blood vessels.

Overview:

A broad aspect of some embodiments of the present invention relates to various expandable apparatuses and methods for removing multiple obstructions from multiple blood vessels. In some embodiments, an apparatus is engaged with an obstruction, and then the apparatus is removed from the blood vessel along the obstruction.

In some embodiments, the engagement between the device and the obstruction is maintained at least partially when the device changes dimension (e.g., along a radial direction perpendicular to the longitudinal axis of the device) and/or when the device bends and/or contracts. For example, during device removal, the device passes through multiple changes in blood vessel direction (e.g., bending) and/or geometry.

One aspect of some embodiments of the invention involves engaging the device with the blockage by holding at least a portion of the blockage (e.g., a clump of material) beneath a portion of the expandable device. For example, holding at least a portion of the blockage within a space in the device, the space having a radial component (e.g., the space comprising a dimension in a radial direction of a central longitudinal axis of the device). For example, holding at least a portion of the blockage within a space between a protruding portion (also referred to as a "protrusion") and the closest portion of the protruding portion (e.g., having the shortest vector connecting the two portions).

In some embodiments, the clump material is held below a radially projecting portion of the device, wherein the radial direction is measured from a central longitudinal axis of the device. For example, the clump material is held between a longitudinal central axis of the device and the projecting portion (in a radial direction).

In some embodiments, a device is expanded within a blood vessel such that and/or until one or more protrusions of the device contact the vessel wall, for example, by gripping the obstructive material beneath the protrusions (e.g., when the device is pulled past the obstructive material). In some embodiments, when the device is removed, one or more protrusions remain in contact with the vessel wall, for example, during multiple geometrical changes in the blood vessel (e.g., bending and/or changes in cross-sectional area and/or shape).

In some embodiments, the device has a non-cylindrical and/or irregular shape (e.g., curved, irregularly shaped cross-section), and the central longitudinal axis is defined as a longitudinal central axis extending from the maximum volume (and/or maximum diameter and/or maximum length) enclosed by the device. Alternatively or additionally, the central longitudinal axis is defined as a line connecting the center points of a plurality of parallel circular cross-sections along a length of the device, wherein at each point along the entire length of the shape, the circular cross-section is the largest circle contained within the device. For example, in a device comprising a cylindrical intermediate portion having a tapered end, the longitudinal central axis may be defined as the central axis extending through the center of the cylindrical intermediate portion and through the tapered end of a cone. For example, in a curved and/or curved tubular device, the central longitudinal axis follows the curve of the device.

In some embodiments, the obstructive material extends over at least one protrusion, wherein the material entering below is within 30% to 95%, or 40% to 90%, or 50% to 80% or lower, or higher, or a plurality of intermediate ranges or percentages of the length of the protrusion.

In some embodiments, a protrusion is sized large enough to accommodate multiple clots beneath it. In some embodiments, the device is moved within the blood vessel to hold multiple clots beneath one or more protrusions.

In some embodiments, one or more protrusions are circular, for example, to potentially prevent damage to the blood vessel during expansion of the device within the blood vessel and/or during movement of the device.

One aspect of some embodiments of the invention relates to attaching a clump of material to at least two portions of an expandable device, for example, between two wires (e.g., multiple nitinol wires). In some embodiments, the space between the portions is large enough to accept at least a portion of a clump and/or a portion of the clump is large enough to attach the clump to the device. In some embodiments, the obstructing material is clamped between the at least two device portions.

In some embodiments, the space includes a radial component.

In some embodiments, the angle between a shortest distance between the two conductors and the central longitudinal axis is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, and the two conductors define a space and a radial straight line connecting the protruding conductors.

In some embodiments, the clump material is held between two portions, the two portions including a protruding portion and a second portion of the device (in at least one dimension) closest to the protruding portion.

In some embodiments, one or more portions define a space having a radial separation different from the central axis of the device. Alternatively, in some embodiments, one or more portions define a space having an angular orientation different from the central axis of the device, for example, a different circumferential position on an outer surface of the device.

In one exemplary embodiment, the device expands to increase a radial space between two device portions as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

In some embodiments, once the clump material has entered a space within the device (e.g., between two sections and/or under a protrusion), the space is reduced (e.g., one or more dimensions) to accommodate the clump within the device, for example.

In some embodiments, the clump material is held between two or more portions, such as 3, 4, 5, or 3 to 10, or smaller, larger, or a plurality of intermediate portions.

Optionally, in some embodiments, the device is delivered to a clot site within a patient's body and expanded, for example, to expand the space below and/or between multiple portions of the device. Additionally or alternatively, in some embodiments, the multiple spaces are expanded by bending and/or twisting and/or rotating the device.

In one exemplary embodiment, a device includes a plurality of wire pairs, and the expansion (and/or bending and/or rotation) of the device causes one of the wires in the wire pairs to protrude axially from a central axis of the device beyond the other wires in the wire pairs.

In some embodiments, once the clotted material is held within the device, the device is moved within the blood vessel to move the clotted material contained between the device and the vessel wall.

In some embodiments, as the device is moved within the blood vessel, a shape of the device is altered and/or has been altered to maintain contact and/or engagement between the device and the clot material within the changing geometry of the blood vessel.

In some embodiments, the dimensions of multiple spaces below multiple protrusions and/or between multiple portions of the device are adapted to grip clot material in a range of device dimensions, potentially allowing clot removal from a range of multiple vessel dimensions.

In some embodiments, the size of a space in one or more dimensions (e.g., suitable for holding clumps of material) is 0.005 to 0.5 mm, or 0.01 to 0.2 mm, or 0.5 to 0.1 mm, or lower, or higher, or a plurality of intermediate ranges or sizes.

In some embodiments, the device can be expanded to a range or size with a diameter (e.g., a device suitable for use within the diameter of a blood vessel) of 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher, or intermediate. The term "diameter" refers to the diameter of a cylindrical portion of the device, and/or the average diameter of the expandable portion of the device, and/or the diameter of a cylinder completely enclosing the expandable device.

In some embodiments, the device includes a plurality of ranges or sizes with a contracted and/or unexpanded diameter of 0.3 to 2 mm, or 0.3 to 1.5 mm, or 0.4 to 1 mm, or lower, or higher, or intermediate.

In some embodiments, a device may be expanded to a range of different diameters, wherein a maximum diameter of the device (e.g., the diameter of the cylinder having the largest volume and/or diameter in the device) is 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher or intermediate ranges or sizes.

In some embodiments, a pair of conductors comprises at least two portions (e.g., multiple elongated components) joined together at two points, wherein the lengths of a first portion and a second portion between the two joint points are different. In some embodiments, changing a shortest distance between the two points (e.g., during device expansion) increases the space between the conductors.

In some embodiments, a wire pair comprises at least two parts (e.g., multiple elongated components), each part including a curved portion, wherein the multiple curved portions are spatially arranged with a phase difference, the phase difference forming a space between the portions in at least one dimension.

Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of its construction and the arrangement of components and/or methods illustrated in the following description and/or figures and/or embodiments. The present invention can be implemented or applied in other embodiments or in various methods.

Several exemplary methods for removing blocking:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention.

In step 100, in some embodiments, the location of a vascular obstruction (also referred to herein as an obstruction) is confirmed using images, for example using ultrasound (e.g., Doppler ultrasound) and/or magnetic resonance imaging (MRI) and/or computed tomography (CT) and/or X-ray imaging.

In step 102, a device is positioned near (also referred to herein as "in the vicinity") the blockage, for example, at a location within the blood vessel, such that at least a portion of the device overlaps with the clot in an axial direction of the blood vessel. For example, the device is positioned at a distance of 0 to 30 mm, or 0 to 10 mm, or 0.5 to 10 mm, or 1 to 10 mm, or lower, or higher, or in between from the blockage.

In some embodiments, a device is introduced into a blood vessel at a distance from the obstruction, for example, by pushing it in through an inlet (e.g., an incision) (e.g., using a sufficiently long elongated component attached to the device), until the device approaches the obstruction, for example, at the location of the obstruction. In some embodiments, such as in the case of a large obstruction extending a length through the blood vessel, the device is positioned in a desired location, for example, selected by a physician.

In some embodiments, the device is guided to the location of the obstruction by using imaging (e.g., computed tomography, X-ray, ultrasound, magnetic resonance imaging), and optionally a contrast agent is used to guide it into the blood vessel.

In one exemplary embodiment, a lead wire is first set up, then a conduit is inserted into the lead wire, and then the device is inserted through the conduit.

In some embodiments, the device is positioned near the obstruction such that at least a portion of the obstruction is connected to the device, wherein, for example, at least a portion of the obstruction enters a space within the device. In some embodiments, at least a portion of the obstruction radially enters a space below a portion of the device (e.g., as described herein).

In some embodiments, a portion of the device (e.g., at least a portion of an expandable structure) is pushed into and/or through an obstructing material before being removed. In an exemplary embodiment, at least a portion of an expandable structure is pushed into and/or through an obstructing material to be removed in a contracted configuration. In some embodiments, the structure is then expanded before being removed. In some embodiments, as the expandable structure is removed, one or more protrusions are highlighted and the obstructing material is removed (e.g., "scraped").

In step 104, the device is expanded. In some embodiments, the device is expanded to engage the device with at least a portion of the obstructive material.

In some embodiments, the device is expanded to form and/or expand at least a space below at least a portion of the device. In some embodiments, the device is expanded to form a space sized to allow obstructive substances to enter.

In some embodiments, one or more spaces are created and/or expanded within the device by twisting and/or bending and/or rotating the device.

In some embodiments, an elongated component connected to the device is pulled and/or pushed and/or rotated to expand the device and/or one or more spaces within the device (e.g., device diameter and/or maximum radial range).

In some embodiments, a space is formed and/or expanded by a separation of a portion of the device from a central axial axis of the device, thereby increasing the size of at least one radial space in the device.

In some embodiments, a space is formed and/or expanded by a separation between one or more parts of the device, increasing in at least one dimension, and in an exemplary embodiment, at least one radial dimension.

In some embodiments, the expansion of the device between one or more portions of the device adds one or more spaces to the surface of the device (e.g., tangential to and/or parallel to the central longitudinal axis).

In some embodiments, expanding the device may include, for example, increasing multiple radial dimensions of the device and/or one or more cross-sectional areas of the device perpendicular to its long axis (e.g., the average cross-sectional area of the device). In some embodiments, one or more radial dimensions of the device are increased and the longitudinal length of the device is correspondingly reduced.

In step 106, at least a portion of the obstruction enters below at least a portion of the device.

In some embodiments, expanding the device causes at least a portion of the obstruction to enter the device, for example, axially into a space below a portion of the device (e.g., a space axially approaching a longitudinal central axis of the device).

In some embodiments, expanding the device results in a separation between two parts of the device to increase the entry of obstructive substances into the device (e.g., as described above according to FIG. 2B).

Alternatively or additionally, in some embodiments, the insertion device allows material to enter beneath one or more portions of the device.

Alternatively or optionally, in some embodiments, during and/or after the expansion and/or insertion of the device, the device is moved (e.g., rotated about the central longitudinal axis and/or moved axially within the blood vessel) to allow obstructive material to enter one or more spaces within the device.

Optionally, in some embodiments, the device is then contracted (e.g., partially contracted) to reduce one or more spaces suitable for the entry of the clump material (e.g., at least in one dimension), for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before and/or during its removal.

In step 106, in some embodiments, the device is removed (e.g., by pulling an elongated component connected to the device). In some embodiments, removal of the device reduces the size of one or more spaces that could potentially contain obstructive material. Optionally, in some embodiments, the device conforms to the shape of the blood vessel wall, for example, by altering the cross-sectional area and/or conforming to multiple bends in the blood vessel, potentially retaining a clot between the device and the blood vessel wall.

Space of one or more exemplary devices:

Please now refer to Figures 2A and 2B. Figure 2A is a simplified cross-sectional schematic diagram of two parts 212, 214 of a device according to some embodiments of the present invention located within a blood vessel 204 having a blockage 202.

Embodiments of multiple spaces within a variety of exemplary devices include:

Figure 6A shows a space formed between multiple parts of the device body 610 and the protrusions 610 of the device body 610.

Figure 7A shows multiple spaces formed within and/or between multiple loops 708 and/or between a single loop and the device body 710.

Figure 8B shows the location where a space is formed, for example, between multiple conductors 812 and 814.

Figures 2A to 2C show schematic cross-sectional views of the device, wherein the cross-section is perpendicular to a longitudinal axis of the device, and only a portion of the vessel wall 204 is shown.

In some embodiments, expansion of the device causes an increase in the separation between the plurality of portions 212, 214 in one or more dimensions. For example, in some embodiments, when the device expands, a space between two portions of the device increases along a direction perpendicular to the central longitudinal axis of the device and along the surface of the device (e.g., tangentially and/or parallel to the central longitudinal axis).

In some embodiments, the expansion of the device causes an increase in separation between the plurality of portions 212, 214 in one dimension and a decrease in another dimension, as illustrated, for example, in Figures 12A to 12C.

Figure 2B is a simplified cross-sectional schematic diagram of two portions of a device according to some embodiments of the present invention located behind an intravascular dilation device having an obstruction. In an exemplary embodiment, the dilation of the device increases radial separation T', 1014: T' > T between multiple portions 212 and/or tangential separation D1', D1' > D1 between multiple portions.

As previously described, in some embodiments, the device is inserted into the obstructing material and/or placed near the obstructing material such that the material enters beneath one or more portions of the device. Referring now to FIG2A, in some embodiments, upon insertion of the device, the clump material 202 enters a space between two portions 212, 214 of the device (e.g., a pair of wires). In some embodiments, the plurality of portions 212, 214 are separated by one or more dimensions. For example, as shown in FIG2A, in an exemplary embodiment, the plurality of portions 212, 214 are axially separated (relative to a longitudinal axis of the device) by a distance D1 and tangentially separated (relative to the longitudinal axis of the device) by a distance T.

As previously described, in some embodiments (e.g., after the device expands), the device is then contracted (e.g., partially contracted) to reduce the space of one or more spaces into which the clump material (e.g., in at least one dimension) has entered, for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before it is removed and/or before the device is removed.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction. In some embodiments, after contraction, the separation between the multiple parts is reduced by one or more dimensions, for example: T" < T'; and/or D" < D'.

Although in Figure 2C, the space between the plurality of portions 212, 214 is radially reduced due to the movement of portion 214 away from blood vessel 204, in some embodiments, for example, a radial dimension of the space is reduced, for example, when clamping material between the plurality of portions of the device, by moving portion 212, for example, along the radial direction, while, for example, maintaining radial pressure of portion 214 on obstructive material 202.

In some embodiments, as described elsewhere in more detail (e.g., Figures 12A-D), the device expands to increase a radial space between portions of the two devices as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus 200 according to some embodiments of the present invention, including a protruding portion 214.

In some embodiments, the protruding portion 214 protrudes above a body of the device 242. The largest circular cross-section 242, which completely encloses the plurality of portions of the device (circles with solid outlines as shown in Figures 2D and 2E), may define the body of the device.

In some embodiments, a space between the protruding portion 214 of the device 212 and a closest other portion of the device 212 includes a radial component: in some embodiments, an angle θ1 between a radial line extending from a central longitudinal point of the device 236 and a radial line from the closest portion 212 of the device to the protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

In some embodiments, a central longitudinal axis of a device (e.g., non-cylindrical) is defined as extending from the longitudinal central axis of the largest cylinder completely enclosing the device. FIG2E is a simplified cross-sectional view of a device 200 including a protruding portion 214 according to some embodiments of the invention. In some embodiments, one or more portions of the device comprise a non-circular cross-section, such as the elliptical cross-section shown in FIG2E (multiple device portions are represented by multiple solid-outline circles). Circle 242 represents a largest circular cross-section enclosed by the device at this point and defines a central longitudinal point 236 (the largest circular cross-section completely enclosed by the device defines multiple defining longitudinal points and a central longitudinal axis).

In some embodiments, an angle θ2 between a radial line extending from a central longitudinal point of the device 236 and a radial line from a closest portion 212 of the device to a protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

An exemplary insertion and expansion of a device:

In one exemplary embodiment, the obstruction is a blood clot blocking a blood vessel.

Figure 3A is a simplified cross-sectional view of a clot 302 in a blood vessel 304, the clot 300 substantially blocking the entire portion of the blood vessel (e.g., the blockage substantially fills at least a portion of the cross-section of the blood vessel).

Figure 3B is a simplified cross-sectional schematic diagram of a clot 302 in a blood vessel 304 and an expandable device 300 delivered to the vicinity of the clot 302 according to some embodiments of the present invention. In some embodiments, insertion of the device 300 displaces at least a portion of the clot, for example, by displacing a portion of the clot 302 from a blood vessel wall. In some embodiments, insertion of the device 300 causes multiple portions 306 of the clot 302 to enter the device 300, for example, into multiple spaces within the device (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device).

In some embodiments, the device 300 is expanded such that at least a portion of the clot 302 enters at least one space within the device 300. Figure 3C is a simplified cross-sectional schematic diagram of a device 300 expanding within a blood vessel 304 and grasping the clot 302 according to some embodiments of the present invention.

Figure 3D is a simplified cross-sectional view of an axial expansion of a device 300 within a blood vessel 303 of a clot 302 according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

In some embodiments, FIG3D is a cross-section taken at plane A-A as shown in FIG3C. In some embodiments, the clump material 302a enters at least one space within the expanded device 300.

An example of removing an obstruction:

As previously described, in some embodiments, during the removal of the obstruction, including during the period when the blood vessel changes direction and/or dimensional position, a device holds an obstruction (e.g., a clot) against a blood vessel wall.

In some embodiments, during the period when the device holds obstructive material between the device and multiple vessel walls and/or within the space of one or more devices, one or more portions of the device (e.g., one or more protrusions) maintain sufficient outward force on the obstructive material, optionally causing the obstructive material to move with the device within the vessel during changes in the geometry and size of the vessel.

For example, in some embodiments, one or more protrusions (e.g., protruding portion 608) remain in contact with the vessel wall in various cross-sectional areas of the blood vessel.

Figure 4A is a simplified side view of an expandable device 400 and a grasped clot 402 in a blood vessel 404 according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device 400 according to some embodiments of the present invention removing a clot 402 through a bend in a blood vessel 404.

Figure 4C is a simplified side view schematic diagram of an expandable device 400 removing a clot through an expanded portion of a blood vessel 404 according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device 400 according to some embodiments of the present invention guiding a bend and a blood vessel 404 in a cross-sectional area during the removal of clotted material 402.

Exemplary interaction between device insertion and obstruction:

In some embodiments, the insertion and/or placement of the device places the device between an obstruction and a wall of the blood vessel (e.g., as shown in Figures 3B and 3C).

In some embodiments, a device is inserted into an obstruction. In some embodiments, the device is inserted into an obstruction and obstructive material is pushed away from the device. Alternatively or additionally, in some embodiments, the device is inserted into an obstruction such that some of the obstructive material enters the space of one or more of the devices (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device (e.g., 610, 810)). In some embodiments, the obstructive material at least partially covers the walls of the plurality of blood vessels, for example, as shown in FIG6A.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device 500 being delivered to a vicinity of a clot 502 within a blood vessel 504, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot 504 according to some embodiments of the present invention.

Several exemplary devices:

Figure 6A is a simplified side view of a device 600 expanding near an obstruction 602 of a blood vessel 604 according to some embodiments of the present invention.

In an exemplary embodiment (e.g., as shown in FIG6A), a device (e.g., under uniform external pressure) includes: a central portion having a cylindrical shape; and a plurality of ends having tapered shapes.

Alternatively or additionally, in some embodiments, the device includes an elliptical cross-sectional portion (e.g., a central portion). Alternatively or additionally, in some embodiments, the device includes an irregular shape.

In some embodiments, the device 600 includes an expandable structure consisting of a plurality of wires, wherein one or more of the plurality of wires are connected at different radial locations at a distal end and a proximal end of the structure.

In some embodiments, an apparatus includes a plurality of conductors, each of which extends a path from the distal end to the proximal end, the path including multiple variations in the radial position (e.g., the angle from a central longitudinal axis) of the conductor (e.g., a helical path). In some embodiments, a single conductor passes through other conductors along the path of the single conductor and below the single conductor. In an exemplary embodiment, for example, as shown in Figures 6A-6B, the plurality of conductors may alternatively pass below and above multiple consecutive lines along the path of the plurality of conductors, for example forming a grid.

In some embodiments, one or more wires are connected at the distal and/or proximal ends of one or more other wires. In some embodiments, the multiple wires are connected by, for example, soldering and/or gluing together.

In some embodiments, the plurality of wires are connected to one or more ends via one or more components. For example, in some embodiments, the plurality of wires are connected to a proximal end of an elongated component 616 by a user applying force to the device (by pushing and/or pulling the device by applying force to the elongated component). In some embodiments, the plurality of wires are connected to a distal end of an expandable structure via a capped end 620.

In some embodiments, more than one wire extends from the proximal end to the distal end, the wire being composed of a single wire that passes from a proximal end to the distal end more than once.

In some embodiments, a plurality of wires forming the device form a tubular mesh surface between the distal end and the proximal end, and a body of the device 610.

In some embodiments, the expandable structure is expanded, for example, by reducing a longitudinal distance between the end 620 and the elongated component 616, for example by using a component to connect the end 620 (e.g., as shown in FIG8B, component 824 is connected to the end 820).

Several exemplary protrusions:

In some embodiments, a device (e.g., 600, 700, 800) includes one or more protruding portions (e.g., 608, 708, 812) that (e.g., as previously described) hold the clump material below the one or more protruding portions.

In some embodiments, as the device is removed, the protruding portion (e.g., 608) remains protruding, for example, non-flat and/or folded back (e.g., opposite the body 610 of the device). In some embodiments, one or more protruding portions consist of multiple conductors selected to be strong enough to remain protruding when the device is removed. For example, in some embodiments, one or more protruding portions consist of conductors having multiple dimensions of cross-section (e.g., as described below), wherein the dimensions of the cross-sections are selected to provide sufficient drag and/or moment of inertia.

In some embodiments, one or more protrusions exert an outward (e.g., elastic) force on the blood vessel, potentially maintaining contact between the one or more protrusions and the vessel wall as the cross-section of the blood vessel changes in multiple dimensions. In an exemplary embodiment, a dimension of the elastically released cross-section of the device includes the plurality of protrusions larger than the largest blood vessel through which the device travels to remove the clot (e.g., the plurality of protrusions maintain elastic force on the obstructive material and/or the vessel wall, and do not elastically relax during the removal of the obstructive material by the device and/or during the removal of the device).

In one exemplary embodiment, the plurality of protruding portions 608 are circular, which potentially reduces the risk of damage (e.g., to multiple vessel walls) during use of the device, such as when the device is expanded and/or moved through the vessel wall.

In some embodiments, a circular protrusion includes a tip (the most radially protruding portion), wherein the width of the tip is at least 20%, or at least 30%, or at least 40% of the length of the protrusion, wherein the length of the protrusion is measured as the axial length of the wire from where the wire extends radially from the body of the device.

Exemplary angle relative to the protrusion of the device body:

In some embodiments, one or more protrusions are angled, wherein a distal profile of the protrusion forms an acute angle θ with the removal direction 630 of the device.

In some embodiments, during the expansion of the device 600, the angle θ increases, also increasing the axial space beneath the plurality of protrusions 608. In some embodiments, during the contraction of the device 600, the angle θ decreases, potentially retaining the clump material.

In some embodiments, during movement of the device, one or more protrusions are angled to grip the clump material, for example, one or more protrusions are angled at an acute angle to a central axis of the device and/or the direction of movement of the device.

Exemplary multiple loop protrusions:

In some embodiments, one or more protruding portions are loop structures (e.g., 608, 708). For example, a conductor forming the loop includes a distal end and a proximal end, both of which are connected to either the proximal or distal end of the device. For example, the device shown in FIG6A includes a plurality of protrusions 608, wherein the protrusions are formed by a conductor connected to both ends of an elongated assembly 616.

In some embodiments, the ends of the plurality of loops are connected to different parts of the device.

In some embodiments, multiple wires forming one or more protruding portions follow a path to and from the surface of a tubular expandable device. In some embodiments (e.g., as described elsewhere), the wires form a protrusion extending radially from the tubular surface 610. In some embodiments, the wires also extend longitudinally along the device.

Exemplary protrusions forming an integral part of the device:

In some embodiments, a protruding portion forms a main body portion of the device. For example, as shown in FIG6A, in some embodiments, a plurality of protruding portions 608 are formed by a plurality of wires, which also form part of a device body 610.

In some embodiments, one or more protrusions are formed by a conductor extending around and/or along the device (e.g., approximately 10 to 90%, 50 to 80% of the circumference of the device and/or 10 to 90% or 50 to 80% of the length of the device). For example, multiple conductors form multiple protrusions 608 comprising one or more portions that follow a path around the tubular expandable device body 610.

In some embodiments, a protrusion is formed by applying a force (e.g., tension) to the expandable device via a wire directly connected to an elongated member (e.g., protrusion 608 is connected to the elongated component 616).

Potentially, a protrusion forming a main body portion of the device can more effectively transmit the force applied to the device, for example, to apply force to the clot (e.g., to move the clot).

Exemplary locations of multiple protrusions:

In some embodiments, a plurality of protrusions 608 are each positioned at a different radial angle from a central longitudinal axis of the device, the plurality of protrusions potentially removing obstructive material from different regions of the blood vessel wall. In some embodiments, positioning a plurality of protrusions at different radial angles allows a device to be inserted between blood vessel walls within a range of rotational orientations, and allows one or more protrusions to interact with the obstruction, for example, the operation of the device is potentially unaffected by rotational positioning relative to the obstruction.

In one exemplary embodiment, the device 600 includes four protrusions, which are positioned 90° apart from their centers when viewed at an angle perpendicular to a longitudinal central axis of the device. In one exemplary embodiment, the protrusions are substantially equal in size and protrude substantially equally (assuming equal pressure on each protrusion). In one exemplary embodiment, the center of each protrusion satisfies that a surface of the device body 610 forms a plane perpendicular to a longitudinal axis of the device.

Figure 6B shows the clump material 602 being held beneath a plurality of protrusions 608, for example, between the protrusions 608 and the device body 610.

In some embodiments, the protrusions on the device have different sizes and/or orientations and/or axial positions.

Figure 7A is a simplified side view of an expandable device 700 including a plurality of protrusions 708 according to some embodiments of the present invention. In some embodiments, the plurality of protrusions 708 are distributed along a longitudinal axis of the device 700.

In some embodiments, the expandable structure 700 includes a plurality of wires connecting the distal end 701d and the proximal end 701p of the structure. In some embodiments (e.g., as shown in FIG6A), the plurality of wires form a tubular mesh.

In some embodiments, the plurality of protrusions are composed of loops 708 formed by multiple wires extending from and returning to the proximal end 701p. In some embodiments, the plurality of loops 708 pass through a tubular mesh 710 along a path (the plurality of coils pass through the interior of the tubular mesh 708) and protrude through multiple gaps in the tubular mesh. In some embodiments, each loop protrudes through the mesh at a different location, for example, each coil protrudes at a radial and longitudinal location on the mesh, such as a unique radial and/or longitudinal location on the mesh.

Figure 7B is a simplified side view of an expandable device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7C is a simplified side view of a contraction device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7D is a simplified side view of an expandable device 700 inserted and passed through an obstruction 702 within a blood vessel 704, according to some embodiments of the present invention. As previously described, in some embodiments, a device is pushed into and/or through an obstruction, then expanded, and then the obstruction is pulled to remove (e.g., rake) the obstruction 702 from its original position within the blood vessel 704.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel. In some embodiments, the obstructive substance enters between a plurality of loops 702b and/or a plurality of loops 702c. In some embodiments, the obstructive substance 702a located between the device 700 and a plurality of blood vessel walls is moved and/or removed by pulling the device through the blood vessel 704.

As previously mentioned, optionally, in some embodiments, a plurality of coils 708 apply an outward force (e.g., elastic force) to the obstructive material and/or the blood vessel wall.

In some embodiments, during and/or after the expansion of the device, clump material 702 enters into a plurality of spaces 739 between the plurality of protrusions 708. In some embodiments, the contraction of the device reduces one or more spaces between the plurality of protrusions (e.g., the plurality of spaces 739a are greater than the plurality of spaces 739b) in at least one dimension, and in some embodiments, in a radial direction.

During and/or after the expansion of the device, the clump material 702 enters into the plurality of spaces 738 between the plurality of protrusions 708. In some embodiments, during and/or after the expansion of the device, a space within a protrusion increases in one or more dimensions and/or in a radial direction. Conversely, in some embodiments, during the contraction and/or removal of the device, a space in a protrusion decreases in size in one or more dimensions and/or in a radial direction.

The exemplary device includes multiple pairs of wires protruding from the portion:

Figure 8A is a simplified side view of an expandable device 800 according to some embodiments of the present invention. Figure 8B is a simplified side view of an expandable device 800 according to some embodiments of the present invention.

Please now refer to Figure 8B, which is an enlarged view of a portion of the apparatus shown in Figure 8A:

In some embodiments, the device 800 (e.g., under uniform pressure) has an outer surface of the device that is widened at a narrowed distal end toward a longitudinal central portion of the device, and then the outer surface of the device narrows toward a proximal end of the device.

In one exemplary embodiment, device 800 includes an elongated component 816 connected to a body of the device, for example, for moving device 800 within a blood vessel. In some embodiments, the elongated component of the device (e.g., 816, 616, 716) is resilient. In some embodiments, a first end 818 of a plurality of wires constituting the device is connected to the elongated component 816.

In some embodiments, the device 800 includes an end portion 820 to which a second end portion 822 of a plurality of wires is connected. In some embodiments, a control portion 824 (e.g., a wire) is connected to the end portion 822 and passes through the device, and optionally through a hollow portion of an elongated assembly 816. In some embodiments, the control line 824 is retracted (e.g., pulled) through the elongated assembly 816 to change the geometry of the device 800. In some embodiments, the control line 824 follows a central longitudinal axis of the device.

In some embodiments, the retraction control line 824 of the elongated component is used to expand an average cross-sectional area of the device and reduce a longitudinal length of the device.

In some embodiments, the end portion 820 is located where two or more wires of the device are connected to each other (e.g., by welding). In some embodiments, the multiple wires follow a path from the elongated component 816 to the end portion 820, wherein the end portion 820 is located where each wire passes under and/or under at least one other wire. In some embodiments, one or more wires connecting the end portion 820 to the elongated component 816 have a longer length, and one or more other wires, and in some embodiments, the wire forms a protrusion (e.g., wire 812). In some embodiments, one or more wires are shaped (e.g., by heat treatment as described herein) to have a shape that includes a protrusion.

Several exemplary wire pairs:

In some embodiments, a device 800 includes one or more wire pairs, wherein the wire pairs include a separation, such as multiple separations D2, D4, D6, D8, at least to some extent of expansion of the device.

Please refer to an example conductor pair and a disconnect, where disconnect D2 is located between conductors 812 and 814.

Figures 9A and 9B show enlarged views of a pair of wires in a device, such as a portion of a pair of wires shown in region R of Figure 8B.

Figure 9A is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

Figure 9B is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

In some embodiments, FIG9B illustrates the conductor pair 800 of FIG9B after the cross-sectional area of the device (e.g., device 800) has been reduced (e.g., by advancing control line 824). In some embodiments, a separation between the plurality of conductors 912, 914 of the conductor pair is reduced; D2” < D'. In some embodiments, the reduction of separation is associated with a reduction in the curvature of the plurality of conductors 912 and/or 914.

Exemplary connection of the obstructive material to the device, one or more interlacing portions:

In some embodiments, the clump material is held in a mesh device portion.

In some embodiments, the clump material is held by a portion of the device comprising multiple interwoven portions (also referred to herein as a "mesh"), for example, one or more portions following a path below or above one or more portions (e.g., below and above are in a radial direction).

Figure 10 is a simplified top view of a clump material 1002 being held in a grid device portion according to some embodiments of the present invention.

In some embodiments, at least a portion of a device includes a mesh structure in which one or more conductors are interwoven with other conductors, for example, passing through some conductors and under others. In an exemplary embodiment, the device includes warp 1026 and weft 1028, wherein the warp 1026 and weft 1028 are, for example, evenly spaced apart.

In some embodiments, multiple conductor pairs are formed at multiple intersections of multiple meridians and multiple parallels (also referred to herein as multiple connections).

Figure 11 is a simplified top view schematic diagram of a clump of material being held in a mesh device portion according to some embodiments of the present invention. In some embodiments, the obstructing material within the device distorts the device structure, for example, due to the hardness of the obstructing material.

Figure 12A is a simplified top view of a lumpy material 1202 and a mesh device portion 1200 according to some embodiments of the present invention. In some embodiments, the contact (contact lengths c1, c2, c3, and c4) between the lumpy material 1202 and the device is partial, for example, the lumpy material 1202 contacts 5 to 95%, or 10 to 90%, or 50 to 80%, or lower, or higher, or a plurality of intermediate ranges or percentages of a length of a warp between multiple warps (a) and/or a length of a weft between multiple wefts (b), for example: c1 divided by a multiplied by 100% equals 50 to 90%.

In some embodiments, the expansion of the device alters an angle between one set of conductors (e.g., multiple meridians) and another set of conductors (e.g., multiple parallels). Figure 12B is a simplified top view of the device portion of Figure 12A after the expansion device, according to some embodiments of the invention. In some embodiments, during the expansion of the device, an angle between the meridians and parallels changes, for example, from 90° in Figure 12A to 45° in Figure 12A.

In some embodiments, during the expansion, a variation of the angle α between the meridians and parallels is 10° to 90°, or 20° to 70°, or 40° to 50°, or smaller, or larger, or a plurality of intermediate angles.

In some embodiments, a device includes a range of angle α, for example, corresponding to different degrees of expansion of the device, such as 5° to 175°, or 10° to 165°, or 45° to 110°, or lower, or higher, or in between, a plurality of ranges or a plurality of angles.

In some embodiments, the space decreases simultaneously in one dimension (e.g., radially between meridians and parallels) and increases simultaneously in another dimension (in the plane of meridians and parallels, as shown in Figures 12A to 12B), and the structure potentially receives and holds clump material simultaneously.

Figures 12C and 12D illustrate side views of clump material held between a meridian 1212 and a parallel 1214 as the device expands according to some embodiments of the invention.

In some embodiments, the clump material is located between multiple intersecting portions of the device, for example, where a warp crosses a weft. Figure 12E is a simplified side view of the clump material 1202 between multiple conductors 1214 according to some embodiments of the invention. In some embodiments, the clump material 1202 contacts a portion of the length of a portion below another portion, ranging from 5% to 95%, or 10% to 90%, or 50% to 80%, or lower, or higher, or in between, length c as shown in Figure 12B.

Multiple exemplary wire pairs include multiple connections:

In some embodiments, a space is created and/or expanded between two or more conductors connected at two or more points. In some embodiments, a length of a first conductor between two points is longer than the length of a second conductor connected to the same two points. In some embodiments, a distance between the two connections is reduced, while a distance between the two conductors is increased (e.g., in a space of at least one dimension).

Figure 13A is a simplified side view of an expandable device 1300 according to some embodiments of the present invention, comprising a conductor having a plurality of connections 1332, 1334 between a plurality of conductors 1312, 1314.

In some embodiments, one or more of connection points 1332, 1334 are a connection point between a plurality of wires 1312, 1314. One or more of connection points 1332, 1334 are points through which one wire passes through and/or around another wire.

Figure 13B is a simplified side view of the device of Figure 13A according to some embodiments of the present invention, after the space 1338 between the wires has been expanded.

In some embodiments, a length (from L to L’; L < L’) between the connections 1332, 1334 is reduced to increase the size of a space 1338 between the plurality of conductors 1312, 1314 in at least one dimension, where d is the radial dimension of the space 1338 and d < d’. For example, a length of the first conductor 1314 measured along a central axis of the first conductor is greater than the length of the second conductor 1312 measured along a central axis of the second conductor.

In some embodiments, a space 1338 is located between two portions protruding from the cylinder C, as shown in FIG13A, wherein the wire 1312 is bent on one surface of the cylinder C, and in FIG13B, wherein the wire 1312 is bent on the surface of the cylinder C'.

In some embodiments, the radius R of the device 1300 is increased (e.g., from R to R') to reduce the separation L (e.g., from L to L') between the plurality of connections.

As previously described, in some embodiments, the expansion of the radius R of the device (e.g., from R to R' as shown in Figures 13A to B; R < R') reduces a length of the device 1300, wherein the radius is measured from a central longitudinal axis of the device 1336. In some embodiments, the plurality of cylinders C and C' are an outer surface or a body of the device (e.g., excluding the plurality of protrusions).

In some embodiments, the device 1300 is cylindrical, as shown in Figures 13A and 13B. In some embodiments, the device, for example, has a non-cylindrical shape (e.g., as shown in Figure 6A, Figure 7B, as described herein), and the plurality of cylinders C and C' are the plurality of largest diameter cylinders completely enclosing the device.

Exemplary wire pairs including phase difference:

In some embodiments, an expandable structure includes one or more curved portions, wherein the plurality of curved portions are spatially disposed on the structure such that a space exists between the plurality of curves. In an exemplary embodiment, a conductor pair includes a first conductor and a second conductor, the first conductor having a sinusoidal portion and the second conductor having a sinusoidal portion, wherein the plurality of sinusoidal portions are disposed on the expandable structure and have a phase difference, the phase difference implying that a space exists between the conductors in at least one dimension. In some embodiments, the means is expanded (e.g., as shown in Figures 13A to 13B) to increase the space between the conductors.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions 1412, 1414, and the shrinking device being arranged in space with a phase difference between the plurality of portions.

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions 1412, 1414, and the expandable device being spatially positioned with a phase difference between the plurality of portions.

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions 1412, 1414, and the device being arranged in space with a phase difference between the plurality of portions.

In some embodiments, when the expandable structure contracts (the radius of the largest enclosed cylinder is D”, where line 1436 represents a central longitudinal axis of the cylinder), the dimension a” between the plurality of curved portions is less than the dimension a between the plurality of curved portions when the expandable structure partially expands (the radius of the largest enclosed cylinder is D), wherein the dimension a is less than a dimension a’ when the expandable structure expands (the radius of the largest enclosed cylinder is d):

A"<a<a' and D"<D<D'.

In some embodiments, one or more spacer components 1440 (e.g., posts) are disposed between two or more portions of the device (e.g., multiple conductors) to maintain a phase difference between the multiple conductors. In some embodiments, one or more posts are inserted into the structure, for example, during processing (e.g., heat treatment). In some embodiments, one or more posts are used in the processing to form shape memory in multiple conductors comprising a hyperelastic material (e.g., nitinol). In some embodiments, one or more spacer components 1440 are removed during manufacturing and/or before using the device.

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer post 1640 holds a space between two portions 1612, 1614 of the apparatus.

Materials and construction of several exemplary expandable devices:

In some embodiments, an expandable device (e.g., as described herein, such as Figures 6A-B and 8A-B) is constructed using multiple wires, for example, a body of the device is constructed of a wire mesh (e.g., a cross-woven mesh).

In some embodiments, at least a portion of the device comprises a flexible and/or elastic and/or biocompatible material, such as nitinol, and/or cobalt-chromium and/or stainless steel. In some embodiments, at least a portion of the device comprises a shape memory and/or hyperelastic material (e.g., nitinol).

In one exemplary embodiment, at least a portion of the device is composed of a plurality of nitinol wires.

In some embodiments, a portion of the device for grasping obstructive material (e.g., an expandable structure) is composed of multiple wires, the largest cross-sectional dimension (e.g., diameter) of which is 10 to 150 micrometers, 25 to 150 micrometers, or 12 to 100 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires with a diameter of 75 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires having a flat cross-sectional shape, such as a circular shape, having a largest cross-sectional dimension of 100 micrometers, and a cross-sectional dimension perpendicular to the largest cross-sectional dimension of 50 micrometers (e.g., a "band" with a cross-section of 50 × 100 micrometers).

In some embodiments, additional material is added to the mesh apparatus after it has been constructed (e.g., by weaving). In some embodiments, one or more additional threads are woven into an existing structure; for example, in some embodiments, one or more additional wires are wrapped around an existing wire.

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including a plurality of additional conductors 1544 connected to a plurality of baselines 1546. In some embodiments, a plurality of spaces 1538 (e.g., as described herein) are formed between the additional conductors 1544 and the baselines 1546.

Several exemplary treatments:

In some embodiments, the device (e.g., as described herein) is used to remove blood clots from a blood vessel. In an exemplary embodiment, the device (e.g., as described herein) is used to remove an obstruction (e.g., a clot) from a blood vessel in the brain, such as in a stroke.

In some embodiments, additional or alternative substances other than clot material, such as fatty deposits and/or plaques and/or thrombi and/or platelet aggregates and/or foreign matter and/or calcified deposits. In this context, the terms "clot" or "clot material" are used to indicate any obstructive substance within a blood vessel that completely and/or partially blocks said blood vessel.

In some embodiments, the device (e.g., as described herein) is used to remove pulmonary embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove peripheral embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove cardiovascular embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used for revascularization in postoperative restenosis.

General Discussion:

As used and referenced in this document, the terms “about” and “approximately” indicate ±20%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”, and their morphological variations refer to “including but not limited to”.

The term "consisting of" means "including and not limited to".

The term "consisting essentially of" means that the composition, method, or structure may include additional ingredients, steps, and/or components, but only if the additional ingredients, steps, and/or components do not substantially alter the essential or novel characteristics of the claimed composition, method, or structure.

As used herein, the singular forms “a,” “an,” and “the” may include multiple references unless explicitly indicated by the context. For example, the terms “a compound” or “at least one compound” may include multiple compounds, including mixtures thereof.

Throughout this application, various embodiments of the invention may be presented in a range format in conjunction with the references. It should be understood that the range format description is merely for convenience and brevity and should not be construed as a strict limitation on the scope of the invention. Therefore, the description of a range should be considered as all possible possible sub-ranges specifically disclosed, as well as the various numerical values within the range. For example, describing a range as "from 1 to 6" should be understood as disclosing multiple sub-ranges such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc.; and also disclosing various numbers within this range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

Unless the context explicitly indicates a numerical range, it means any number (fraction or integer) included within the indicated range. The phrases “ranging” or “ranges between” for the first and second indicated numbers, and “ranging” or “ranges from” for the first indicated number and “to” the second indicated number, are used interchangeably herein and mean including the first and second indicated numbers and all fractions and integers between them.

As used herein, the term "method" refers to the manner, means, technique, and procedures used to accomplish a particular task, including but not limited to those manner, means, techniques, and procedures that are known or readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine from known manner, means, techniques, or procedures.

As used in this article, the term "treatment" includes terminating, substantially inhibiting, slowing or reversing the progression of a disease, substantially improving the clinical or psychological symptoms of a disease, or substantially preventing the occurrence of the clinical or psychological symptoms of a disease.

It is understood that certain features of the invention, for clarity, are described in the context of independent embodiments, or may be provided in combination in a single embodiment. Conversely, various features of the invention, for brevity, are described in the context of a single embodiment, or may be provided individually or in any suitable sub-combination or in embodiments suitable for any other description of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments do not function without these components.

While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that numerous alternatives, modifications, and variations will be readily apparent. Therefore, the invention is intended to cover all such alternatives, modifications, and variations falling within the spirit and scope of the claims.

All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety as if each independent publication, patent, or patent application were expressly and individually indicated as being incorporated herein by reference. Furthermore, any reference or endorsement in this application should not be construed as an admission that such reference is prior art to the invention. Heading portions in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations.

This application is a divisional application of application number 201680031844.X (PCT application number PCT/IL2016/050763), filed on July 14, 2016, entitled "Apparatus and Method for Removing Vascular Obstructions".

Technical Field and Background Technology

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing obstructive substances from a blood vessel.

Summary of the Invention

According to one aspect of some embodiments of the present invention, an apparatus for removing obstructive material from a blood vessel is provided, the apparatus comprising:

An expandable structure, the expandable structure being sized to be inserted into the blood vessel; and

One or more portions protrude radially from a central longitudinal axis of the expandable structure, such that a space between the protrusion and a closest portion of the expandable structure contains a radial component;

The space is sized and shaped to receive an obstructive substance.

According to some embodiments of the present invention, the device includes multiple wires, wherein one or more protruding portions are part of one wire.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is tangent to the central longitudinal axis of the device.

According to some embodiments of the invention, the space between the protruding portion and the closest portion of the expandable structure includes a component that is parallel to the central longitudinal axis of the device.

According to some embodiments of the present invention, the device includes an interlacing structure, wherein the protruding portion and the closest portion are a warp and a weft of the interlacing structure.

According to some embodiments of the present invention, the one or more protruding portions are circular.

According to some embodiments of the invention, the radial component of the space is between 0.01 and 0.2 mm.

According to some embodiments of the present invention, the central longitudinal axis of the expandable structure is a central longitudinal axis that can enclose a maximum cylindrical space within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the longest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is a cylindrical space with the largest diameter that can be enclosed within the structure.

According to some embodiments of the present invention, the largest cylindrical space is the largest cylindrical space that can be enclosed within the structure.

According to some embodiments of the present invention, the expandable structure is configured to have a contracted state and a plurality of expanded shapes within a range, the structure being expandable to a maximum expanded state;

The diameter of the largest cylindrical space in the contracted state is smaller than the volume of the largest cylindrical space in the maximum expanded state.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the contraction space is 0.3 to 2 mm.

According to some embodiments of the present invention, the diameter of the largest cylindrical space in the maximum expansion state is 1 to 7 millimeters.

According to some embodiments of the present invention, when the structure is in each of a plurality of expanded states of the range, the radial component of the space is greater than a radial component of the space when the device is in the contracted state.

According to some embodiments of the present invention, the protruding portion and the nearest device portion are connected at at least two connection points, wherein an axial length of the protruding portion between the two connection points is greater than an axial length of the nearest device portion between the two connection points.

According to some embodiments of the invention, the protruding portion and the closest device portion are spatially curved to create a phase difference between the plurality of portions.

According to some embodiments of the present invention, the expandable structure includes a plurality of protruding portions.

According to some embodiments of the invention, a plurality of protruding portions are disposed at a plurality of different radial positions around an axial position of the expandable structure.

According to some embodiments of the invention, one or more of the plurality of protruding portions are distributed along the expandable structure at an axial position different from one or more other protruding portions.

According to some embodiments of the present invention, the structure includes:

Multiple wires, each wire being connected to a different radial position at a distal end and a proximal end of the structure;

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least a portion of one of the conductors includes a protrusion at which the conductor path extends radially from the surface of the tubular mesh and then extends axially to define the space between the portion and the surface of the tubular mesh.

According to some embodiments of the present invention, the path including the change of radial position is a spiral path.

According to some embodiments of the present invention, the apparatus includes:

At least one loop is attached to the proximal end of the structure and extends radially from the central longitudinal axis;

The space therein is located within the loop.

According to some embodiments of the present invention, the apparatus includes:

Multiple wire loops, each of the wire loops being attached to the proximal end of the structure;

The space described therein is located between two loops.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described herein, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

One or more of the loops protrude radially from the surface of the tubular mesh.

According to some embodiments of the present invention, the apparatus includes:

Multiple conductors, each conductor connected at a different radial position at a distal end and a proximal end of the structure; and

Each of the wires runs through a path from the distal end to the proximal end, the path including multiple variations in radial position;

In the path described, one or more wires pass above and below one or more other wires.

The plurality of wires form a tubular mesh surface between the distal end and the proximal end; and

At least one of the wires contains a protruding portion.

According to some embodiments of the invention, the shape is sized and shaped to receive at least a portion of the obstructive material.

According to one aspect of some embodiments of the present invention, a method for removing obstructive material from a blood vessel is provided, the method comprising:

A contractile expandable structure is provided near one axial direction of the obstructive material;

Connect the structure to the obstructive material, allowing the obstructive material to enter at least one space between a structurally protruding portion of the device and a central longitudinal axis; and

The obstructive substance is removed from the blood vessel by removing the structure.

According to some embodiments of the present invention, the at least one space is a plurality of spaces.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different positions along a longitudinal axis of the structure.

According to some embodiments of the present invention, the plurality of spaces comprises a plurality of spaces located at a plurality of different radial positions.

According to some embodiments of the present invention, the connection includes connecting multiple different portions of the obstructive material such that each portion is connected to a different space among the multiple spaces.

According to some embodiments of the present invention, the connection includes: expanding the structure.

According to some embodiments of the present invention, the expansion includes increasing the size of the space in at least one dimension.

According to some embodiments of the present invention, the expansion includes: reducing the size of the space in at least one dimension.

According to some embodiments of the present invention, the at least one space is located between a structurally protruding portion and a second structural portion.

According to some embodiments of the invention, the connection includes: pulling the expandable structure through the vicinity of the obstructive material along its axis.

According to some embodiments of the present invention, the connection includes: pushing the expandable structure into the obstructive material.

According to some embodiments of the present invention, the method includes: shrinking the at least one space in at least one dimension.

According to some embodiments of the present invention, the removal includes: moving the device through multiple portions of the blood vessel by means of changes in multiple directions and geometry.

According to some embodiments of the present invention, the expansion includes: expanding the device until the device applies an external force to the plurality of blood vessel walls.

According to some embodiments of the present invention, the device applies an outward force to the plurality of blood vessel walls during the removal process.

Unless otherwise stated, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While embodiments of the invention may be implemented or tested by any methods and substances similar to or equivalent to those described in the embodiments of the invention, the embodiments, enumerated methods, and/or substances of the invention have been described below. In case of conflict, the definitions included in this specification will be used for control. Furthermore, substances, methods, and embodiments are illustrative only and are not necessarily intended to be limiting.

Attached Figure Description

Some embodiments of the present invention described herein are by way of example only and with reference to the accompanying drawings. The detailed description of the drawings and specific references emphasizes that the details shown are merely illustrative and are intended to illustrate the purpose of the embodiments of the present invention. Based on this, the embodiments of the present invention will be clearly understood by those skilled in the art in conjunction with the accompanying drawings and description.

In the attached diagram:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention;

Figure 2A is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located within a blood vessel having an obstruction;

Figure 2B is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 2E is a simplified cross-sectional schematic diagram of an apparatus including a protruding portion according to some embodiments of the present invention;

Figure 3A is a simplified cross-sectional view of a clot in a blood vessel;

Figure 3B is a simplified cross-sectional schematic diagram of a clot in a blood vessel and a device delivered to the vicinity of the clot according to some embodiments of the present invention.

Figure 3C is a simplified cross-sectional schematic diagram of a device according to some embodiments of the present invention expanding and grasping the clot in a blood vessel;

Figure 3D is a simplified cross-sectional view of an axial expansion of a clot within a blood vessel by a device according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

Figure 4A is a simplified side view of an expandable device for removing and holding multiple clots in a blood vessel according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device according to some embodiments of the present invention removing a clot through a bend in a blood vessel.

Figure 4C is a simplified side view schematic diagram of an expandable device removing a clot through an expanded portion of a blood vessel according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device according to some embodiments of the present invention guiding a bend and multiple variations of a blood vessel in a cross-sectional area when removing clotted material.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device being delivered to the vicinity of a clot within a blood vessel, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot according to some embodiments of the present invention;

Figure 6A is a simplified side view of a device expanding near a clot in a blood vessel according to some embodiments of the present invention.

Figure 6B illustrates a clump of material held by a plurality of protrusions, for example, between a plurality of protrusions and the body of the device, according to some embodiments of the present invention.

Figure 7A is a simplified side view of an expandable device including a plurality of protrusions according to some embodiments of the present invention;

Figure 7B is a simplified side view of an expandable device in a blood vessel according to some embodiments of the present invention;

Figure 7C is a simplified side view of a contraction device within a blood vessel according to some embodiments of the present invention;

Figure 7D is a simplified side view of an expandable device inserted through an obstructive substance within a blood vessel, according to some embodiments of the present invention.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel.

Figure 8A is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 8B is a simplified side view of an expandable device according to some embodiments of the present invention;

Figure 9A is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention;

Figure 9B is a simplified side view of a guide wire grasping a clump of material according to some embodiments of the present invention.

Figure 10 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 11 is a simplified top view of a portion of a grid device holding a clump of material according to some embodiments of the present invention;

Figure 12A is a simplified top view of a clump material and a mesh device portion according to some embodiments of the present invention.

Figure 12B is a simplified top view of the device portion after device expansion according to some embodiments of the present invention;

Figures 12C and 12D show side views of the clump of material held between a meridian and a parallel during the expansion of the device;

Figure 12E is a simplified side view of a clump of material between multiple conductors according to some embodiments of the present invention;

Figure 13A is a simplified side view of an expandable device according to some embodiments of the present invention, comprising a conductor having multiple connections between multiple conductors.

Figure 13B is a simplified side view of the device of Figure 13A after the space between the wires has been expanded, according to some embodiments of the present invention.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions, and the shrinking device being spatially positioned with a phase difference between the plurality of portions;

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions, and the expandable device being spatially positioned with a phase difference between the plurality of portions;

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions, and the device being arranged in space with a phase difference between the plurality of portions;

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including multiple additional wires connected to multiple baselines; and

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer bar holds a space between two portions of the apparatus.

Specific Implementation

The present invention and some embodiments thereof relate to various devices and methods for removing multiple obstructive substances from multiple blood vessels, particularly, but not limited to, an expandable device for removing multiple obstructions from multiple blood vessels.

Overview:

A broad aspect of some embodiments of the present invention relates to various expandable apparatuses and methods for removing multiple obstructions from multiple blood vessels. In some embodiments, an apparatus is engaged with an obstruction, and then the apparatus is removed from the blood vessel along the obstruction.

In some embodiments, the engagement between the device and the obstruction is maintained at least partially when the device changes dimension (e.g., along a radial direction perpendicular to the longitudinal axis of the device) and/or when the device bends and/or contracts. For example, during device removal, the device passes through multiple changes in blood vessel direction (e.g., bending) and/or geometry.

One aspect of some embodiments of the invention involves engaging the device with the blockage by holding at least a portion of the blockage (e.g., a clump of material) beneath a portion of the expandable device. For example, holding at least a portion of the blockage within a space in the device, the space having a radial component (e.g., the space comprising a dimension in a radial direction of a central longitudinal axis of the device). For example, holding at least a portion of the blockage within a space between a protruding portion (also referred to as a "protrusion") and the closest portion of the protruding portion (e.g., having the shortest vector connecting the two portions).

In some embodiments, the clump material is held below a radially projecting portion of the device, wherein the radial direction is measured from a central longitudinal axis of the device. For example, the clump material is held between a longitudinal central axis of the device and the projecting portion (in a radial direction).

In some embodiments, a device is expanded within a blood vessel such that and/or until one or more protrusions of the device contact the vessel wall, for example, by gripping the obstructive material beneath the protrusions (e.g., when the device is pulled past the obstructive material). In some embodiments, when the device is removed, one or more protrusions remain in contact with the vessel wall, for example, during multiple geometrical changes in the blood vessel (e.g., bending and/or changes in cross-sectional area and/or shape).

In some embodiments, the device has a non-cylindrical and/or irregular shape (e.g., curved, irregularly shaped cross-section), and the central longitudinal axis is defined as a longitudinal central axis extending from the maximum volume (and/or maximum diameter and/or maximum length) enclosed by the device. Alternatively or additionally, the central longitudinal axis is defined as a line connecting the center points of a plurality of parallel circular cross-sections along a length of the device, wherein at each point along the entire length of the shape, the circular cross-section is the largest circle contained within the device. For example, in a device comprising a cylindrical intermediate portion having a tapered end, the longitudinal central axis may be defined as the central axis extending through the center of the cylindrical intermediate portion and through the tapered end of a cone. For example, in a curved and/or curved tubular device, the central longitudinal axis follows the curve of the device.

In some embodiments, the obstructive material extends over at least one protrusion, wherein the material entering below is within 30% to 95%, or 40% to 90%, or 50% to 80% or lower, or higher, or a plurality of intermediate ranges or percentages of the length of the protrusion.

In some embodiments, a protrusion is sized large enough to accommodate multiple clots beneath it. In some embodiments, the device is moved within the blood vessel to hold multiple clots beneath one or more protrusions.

In some embodiments, one or more protrusions are circular, for example, to potentially prevent damage to the blood vessel during expansion of the device within the blood vessel and/or during movement of the device.

One aspect of some embodiments of the invention relates to attaching a clump of material to at least two portions of an expandable device, for example, between two wires (e.g., multiple nitinol wires). In some embodiments, the space between the portions is large enough to accept at least a portion of a clump and/or a portion of the clump is large enough to attach the clump to the device. In some embodiments, the obstructing material is clamped between the at least two device portions.

In some embodiments, the space includes a radial component.

In some embodiments, the angle between a shortest distance between the two conductors and the central longitudinal axis is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, and the two conductors define a space and a radial straight line connecting the protruding conductors.

In some embodiments, the clump material is held between two portions, the two portions including a protruding portion and a second portion of the device (in at least one dimension) closest to the protruding portion.

In some embodiments, one or more portions define a space having a radial separation different from the central axis of the device. Alternatively, in some embodiments, one or more portions define a space having an angular orientation different from the central axis of the device, for example, a different circumferential position on an outer surface of the device.

In one exemplary embodiment, the device expands to increase a radial space between two device portions as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

In some embodiments, once the clump material has entered a space within the device (e.g., between two sections and/or under a protrusion), the space is reduced (e.g., one or more dimensions) to accommodate the clump within the device, for example.

In some embodiments, the clump material is held between two or more portions, such as 3, 4, 5, or 3 to 10, or smaller, larger, or a plurality of intermediate portions.

Optionally, in some embodiments, the device is delivered to a clot site within a patient's body and expanded, for example, to expand the space below and/or between multiple portions of the device. Additionally or alternatively, in some embodiments, the multiple spaces are expanded by bending and/or twisting and/or rotating the device.

In one exemplary embodiment, a device includes a plurality of wire pairs, and the expansion (and/or bending and/or rotation) of the device causes one of the wires in the wire pairs to protrude axially from a central axis of the device beyond the other wires in the wire pairs.

In some embodiments, once the clotted material is held within the device, the device is moved within the blood vessel to move the clotted material contained between the device and the vessel wall.

In some embodiments, as the device is moved within the blood vessel, a shape of the device is altered and/or has been altered to maintain contact and/or engagement between the device and the clot material within the changing geometry of the blood vessel.

In some embodiments, the dimensions of multiple spaces below multiple protrusions and/or between multiple portions of the device are adapted to grip clot material in a range of device dimensions, potentially allowing clot removal from a range of multiple vessel dimensions.

In some embodiments, the size of a space in one or more dimensions (e.g., suitable for holding clumps of material) is 0.005 to 0.5 mm, or 0.01 to 0.2 mm, or 0.5 to 0.1 mm, or lower, or higher, or a plurality of intermediate ranges or sizes.

In some embodiments, the device can be expanded to a range or size with a diameter (e.g., a device suitable for use within the diameter of a blood vessel) of 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher, or intermediate. The term "diameter" refers to the diameter of a cylindrical portion of the device, and/or the average diameter of the expandable portion of the device, and/or the diameter of a cylinder completely enclosing the expandable device.

In some embodiments, the device includes a plurality of ranges or sizes with a contracted and/or unexpanded diameter of 0.3 to 2 mm, or 0.3 to 1.5 mm, or 0.4 to 1 mm, or lower, or higher, or intermediate.

In some embodiments, a device may be expanded to a range of different diameters, wherein a maximum diameter of the device (e.g., the diameter of the cylinder having the largest volume and/or diameter in the device) is 1 to 7 mm, or 2 to 6 mm, or 1 to 5 mm, or lower, or higher or intermediate ranges or sizes.

In some embodiments, a pair of conductors comprises at least two portions (e.g., multiple elongated components) joined together at two points, wherein the lengths of a first portion and a second portion between the two joint points are different. In some embodiments, changing a shortest distance between the two points (e.g., during device expansion) increases the space between the conductors.

In some embodiments, a wire pair comprises at least two parts (e.g., multiple elongated components), each part including a curved portion, wherein the multiple curved portions are spatially arranged with a phase difference, the phase difference forming a space between the portions in at least one dimension.

Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of its construction and the arrangement of components and/or methods illustrated in the following description and/or figures and/or embodiments. The present invention can be implemented or applied in other embodiments or in various methods.

Several exemplary methods for removing blocking:

Figure 1 is a flowchart of an example method for removing an obstruction from a blood vessel according to some embodiments of the present invention.

In step 100, in some embodiments, the location of a vascular obstruction (also referred to herein as an obstruction) is confirmed using images, for example using ultrasound (e.g., Doppler ultrasound) and/or magnetic resonance imaging (MRI) and/or computed tomography (CT) and/or X-ray imaging.

In step 102, a device is positioned near (also referred to herein as "in the vicinity") the blockage, for example, at a location within the blood vessel, such that at least a portion of the device overlaps with the clot in an axial direction of the blood vessel. For example, the device is positioned at a distance of 0 to 30 mm, or 0 to 10 mm, or 0.5 to 10 mm, or 1 to 10 mm, or lower, or higher, or in between from the blockage.

In some embodiments, a device is introduced into a blood vessel at a distance from the obstruction, for example, by pushing it in through an inlet (e.g., an incision) (e.g., using a sufficiently long elongated component attached to the device), until the device approaches the obstruction, for example, at the location of the obstruction. In some embodiments, such as in the case of a large obstruction extending a length through the blood vessel, the device is positioned in a desired location, for example, selected by a physician.

In some embodiments, the device is guided to the location of the obstruction by using imaging (e.g., computed tomography, X-ray, ultrasound, magnetic resonance imaging), and optionally a contrast agent is used to guide it into the blood vessel.

In one exemplary embodiment, a lead wire is first set up, then a conduit is inserted into the lead wire, and then the device is inserted through the conduit.

In some embodiments, the device is positioned near the obstruction such that at least a portion of the obstruction is connected to the device, wherein, for example, at least a portion of the obstruction enters a space within the device. In some embodiments, at least a portion of the obstruction radially enters a space below a portion of the device (e.g., as described herein).

In some embodiments, a portion of the device (e.g., at least a portion of an expandable structure) is pushed into and/or through an obstructing material before being removed. In an exemplary embodiment, at least a portion of an expandable structure is pushed into and/or through an obstructing material to be removed in a contracted configuration. In some embodiments, the structure is then expanded before being removed. In some embodiments, as the expandable structure is removed, one or more protrusions are highlighted and the obstructing material is removed (e.g., "scraped").

In step 104, the device is expanded. In some embodiments, the device is expanded to engage the device with at least a portion of the obstructive material.

In some embodiments, the device is expanded to form and/or expand at least a space below at least a portion of the device. In some embodiments, the device is expanded to form a space sized to allow obstructive substances to enter.

In some embodiments, one or more spaces are created and/or expanded within the device by twisting and/or bending and/or rotating the device.

In some embodiments, an elongated component connected to the device is pulled and/or pushed and/or rotated to expand the device and/or one or more spaces within the device (e.g., device diameter and/or maximum radial range).

In some embodiments, a space is formed and/or expanded by a separation of a portion of the device from a central axial axis of the device, thereby increasing the size of at least one radial space in the device.

In some embodiments, a space is formed and/or expanded by a separation between one or more parts of the device, increasing in at least one dimension, and in an exemplary embodiment, at least one radial dimension.

In some embodiments, the expansion of the device between one or more portions of the device adds one or more spaces to the surface of the device (e.g., tangential to and/or parallel to the central longitudinal axis).

In some embodiments, expanding the device may include, for example, increasing multiple radial dimensions of the device and/or one or more cross-sectional areas of the device perpendicular to its long axis (e.g., the average cross-sectional area of the device). In some embodiments, one or more radial dimensions of the device are increased and the longitudinal length of the device is correspondingly reduced.

In step 106, at least a portion of the obstruction enters below at least a portion of the device.

In some embodiments, expanding the device causes at least a portion of the obstruction to enter the device, for example, axially into a space below a portion of the device (e.g., a space axially approaching a longitudinal central axis of the device).

In some embodiments, expanding the device results in a separation between two parts of the device to increase the entry of obstructive substances into the device (e.g., as described above according to FIG. 2B).

Alternatively or additionally, in some embodiments, the insertion device allows material to enter beneath one or more portions of the device.

Alternatively or optionally, in some embodiments, during and/or after the expansion and/or insertion of the device, the device is moved (e.g., rotated about the central longitudinal axis and/or moved axially within the blood vessel) to allow obstructive material to enter one or more spaces within the device.

Optionally, in some embodiments, the device is then contracted (e.g., partially contracted) to reduce one or more spaces suitable for the entry of the clump material (e.g., at least in one dimension), for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before and/or during its removal.

In step 106, in some embodiments, the device is removed (e.g., by pulling an elongated component connected to the device). In some embodiments, removal of the device reduces the size of one or more spaces that could potentially contain obstructive material. Optionally, in some embodiments, the device conforms to the shape of the blood vessel wall, for example, by altering the cross-sectional area and/or conforming to multiple bends in the blood vessel, potentially retaining a clot between the device and the blood vessel wall.

Space of one or more exemplary devices:

Please now refer to Figures 2A and 2B. Figure 2A is a simplified cross-sectional schematic diagram of two parts 212, 214 of a device according to some embodiments of the present invention located within a blood vessel 204 having a blockage 202.

Embodiments of multiple spaces within a variety of exemplary devices include:

Figure 6A shows a space formed between multiple parts of the device body 610 and the protrusions 610 of the device body 610.

Figure 7A shows multiple spaces formed within and/or between multiple loops 708 and/or between a single loop and the device body 710.

Figure 8B shows the location where a space is formed, for example, between multiple conductors 812 and 814.

Figures 2A to 2C show schematic cross-sectional views of the device, wherein the cross-section is perpendicular to a longitudinal axis of the device, and only a portion of the vessel wall 204 is shown.

In some embodiments, expansion of the device causes an increase in the separation between the plurality of portions 212, 214 in one or more dimensions. For example, in some embodiments, when the device expands, a space between two portions of the device increases along a direction perpendicular to the central longitudinal axis of the device and along the surface of the device (e.g., tangentially and/or parallel to the central longitudinal axis).

In some embodiments, the expansion of the device causes an increase in separation between the plurality of portions 212, 214 in one dimension and a decrease in another dimension, as illustrated, for example, in Figures 12A to 12C.

Figure 2B is a simplified cross-sectional schematic diagram of two portions of a device according to some embodiments of the present invention located behind an intravascular dilation device having an obstruction. In an exemplary embodiment, the dilation of the device increases radial separation T', 1014: T' > T between multiple portions 212 and/or tangential separation D1', D1' > D1 between multiple portions.

As previously described, in some embodiments, the device is inserted into the obstructing material and/or placed near the obstructing material such that the material enters beneath one or more portions of the device. Referring now to FIG2A, in some embodiments, upon insertion of the device, the clump material 202 enters a space between two portions 212, 214 of the device (e.g., a pair of wires). In some embodiments, the plurality of portions 212, 214 are separated by one or more dimensions. For example, as shown in FIG2A, in an exemplary embodiment, the plurality of portions 212, 214 are axially separated (relative to a longitudinal axis of the device) by a distance D1 and tangentially separated (relative to the longitudinal axis of the device) by a distance T.

As previously described, in some embodiments (e.g., after the device expands), the device is then contracted (e.g., partially contracted) to reduce the space of one or more spaces into which the clump material (e.g., in at least one dimension) has entered, for example, by gripping and/or holding the clump material under and/or between multiple portions of the device. In some embodiments, the device has been contracted before it is removed and/or before the device is removed.

Figure 2C is a simplified cross-sectional schematic diagram of two parts of a device according to some embodiments of the present invention located behind an intravascular dilator having an obstruction. In some embodiments, after contraction, the separation between the multiple parts is reduced by one or more dimensions, for example: T" < T'; and/or D" < D'.

Although in Figure 2C, the space between the plurality of portions 212, 214 is radially reduced due to the movement of portion 214 away from blood vessel 204, in some embodiments, for example, a radial dimension of the space is reduced, for example, when clamping material between the plurality of portions of the device, by moving portion 212, for example, along the radial direction, while, for example, maintaining radial pressure of portion 214 on obstructive material 202.

In some embodiments, as described elsewhere in more detail (e.g., Figures 12A-D), the device expands to increase a radial space between portions of the two devices as one dimension of the space between the plurality of portions in different dimensions (e.g., perpendicular to the radial direction) decreases. Movement of the plurality of portions, for example, may potentially trap obstructive material within the space.

Figure 2D is a simplified cross-sectional schematic diagram of an apparatus 200 according to some embodiments of the present invention, including a protruding portion 214.

In some embodiments, the protruding portion 214 protrudes above a body of the device 242. The largest circular cross-section 242, which completely encloses the plurality of portions of the device (circles with solid outlines as shown in Figures 2D and 2E), may define the body of the device.

In some embodiments, a space between the protruding portion 214 of the device 212 and a closest other portion of the device 212 includes a radial component: in some embodiments, an angle θ1 between a radial line extending from a central longitudinal point of the device 236 and a radial line from the closest portion 212 of the device to the protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

In some embodiments, a central longitudinal axis of a device (e.g., non-cylindrical) is defined as extending from the longitudinal central axis of the largest cylinder completely enclosing the device. FIG2E is a simplified cross-sectional view of a device 200 including a protruding portion 214 according to some embodiments of the invention. In some embodiments, one or more portions of the device comprise a non-circular cross-section, such as the elliptical cross-section shown in FIG2E (multiple device portions are represented by multiple solid-outline circles). Circle 242 represents a largest circular cross-section enclosed by the device at this point and defines a central longitudinal point 236 (the largest circular cross-section completely enclosed by the device defines multiple defining longitudinal points and a central longitudinal axis).

In some embodiments, an angle θ2 between a radial line extending from a central longitudinal point of the device 236 and a radial line from a closest portion 212 of the device to a protruding portion 214 is less than 90°, or 5° to 89°, or 10° to 85°, or lower, or higher, or an intermediate range or multiple angles.

An exemplary insertion and expansion of a device:

In one exemplary embodiment, the obstruction is a blood clot blocking a blood vessel.

Figure 3A is a simplified cross-sectional view of a clot 302 in a blood vessel 304, the clot 300 substantially blocking the entire portion of the blood vessel (e.g., the blockage substantially fills at least a portion of the cross-section of the blood vessel).

Figure 3B is a simplified cross-sectional schematic diagram of a clot 302 in a blood vessel 304 and an expandable device 300 delivered to the vicinity of the clot 302 according to some embodiments of the present invention. In some embodiments, insertion of the device 300 displaces at least a portion of the clot, for example, by displacing a portion of the clot 302 from a blood vessel wall. In some embodiments, insertion of the device 300 causes multiple portions 306 of the clot 302 to enter the device 300, for example, into multiple spaces within the device (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device).

In some embodiments, the device 300 is expanded such that at least a portion of the clot 302 enters at least one space within the device 300. Figure 3C is a simplified cross-sectional schematic diagram of a device 300 expanding within a blood vessel 304 and grasping the clot 302 according to some embodiments of the present invention.

Figure 3D is a simplified cross-sectional view of an axial expansion of a device 300 within a blood vessel 303 of a clot 302 according to some embodiments of the present invention, wherein the cross-section is taken from a longitudinal axis perpendicular to the device.

In some embodiments, FIG3D is a cross-section taken at plane A-A as shown in FIG3C. In some embodiments, the clump material 302a enters at least one space within the expanded device 300.

An example of removing an obstruction:

As previously described, in some embodiments, during the removal of the obstruction, including during the period when the blood vessel changes direction and/or dimensional position, a device holds an obstruction (e.g., a clot) against a blood vessel wall.

In some embodiments, during the period when the device holds obstructive material between the device and multiple vessel walls and/or within the space of one or more devices, one or more portions of the device (e.g., one or more protrusions) maintain sufficient outward force on the obstructive material, optionally causing the obstructive material to move with the device within the vessel during changes in the geometry and size of the vessel.

For example, in some embodiments, one or more protrusions (e.g., protruding portion 608) remain in contact with the vessel wall in various cross-sectional areas of the blood vessel.

Figure 4A is a simplified side view of an expandable device 400 and a grasped clot 402 in a blood vessel 404 according to some embodiments of the present invention.

Figure 4B is a simplified side view of an expandable device 400 according to some embodiments of the present invention removing a clot 402 through a bend in a blood vessel 404.

Figure 4C is a simplified side view schematic diagram of an expandable device 400 removing a clot through an expanded portion of a blood vessel 404 according to some embodiments of the present invention.

Figure 4D is a simplified cross-sectional schematic diagram of an expandable device 400 according to some embodiments of the present invention guiding a bend and a blood vessel 404 in a cross-sectional area during the removal of clotted material 402.

Exemplary interaction between device insertion and obstruction:

In some embodiments, the insertion and/or placement of the device places the device between an obstruction and a wall of the blood vessel (e.g., as shown in Figures 3B and 3C).

In some embodiments, a device is inserted into an obstruction. In some embodiments, the device is inserted into an obstruction and obstructive material is pushed away from the device. Alternatively or additionally, in some embodiments, the device is inserted into an obstruction such that some of the obstructive material enters the space of one or more of the devices (e.g., radially below and/or within one or more protrusions in the device and/or within the body of the device (e.g., 610, 810)). In some embodiments, the obstructive material at least partially covers the walls of the plurality of blood vessels, for example, as shown in FIG6A.

Figure 5A is a simplified cross-sectional schematic diagram of an expandable device 500 being delivered to a vicinity of a clot 502 within a blood vessel 504, according to some embodiments of the present invention.

Figure 5B is a simplified cross-sectional schematic diagram of the device of Figure 5A expanding to grasp the clot 504 according to some embodiments of the present invention.

Several exemplary devices:

Figure 6A is a simplified side view of a device 600 expanding near an obstruction 602 of a blood vessel 604 according to some embodiments of the present invention.

In an exemplary embodiment (e.g., as shown in FIG6A), a device (e.g., under uniform external pressure) includes: a central portion having a cylindrical shape; and a plurality of ends having tapered shapes.

Alternatively or additionally, in some embodiments, the device includes an elliptical cross-sectional portion (e.g., a central portion). Alternatively or additionally, in some embodiments, the device includes an irregular shape.

In some embodiments, the device 600 includes an expandable structure consisting of a plurality of wires, wherein one or more of the plurality of wires are connected at different radial locations at a distal end and a proximal end of the structure.

In some embodiments, an apparatus includes a plurality of conductors, each of which extends a path from the distal end to the proximal end, the path including multiple variations in the radial position (e.g., the angle from a central longitudinal axis) of the conductor (e.g., a helical path). In some embodiments, a single conductor passes through other conductors along the path of the single conductor and below the single conductor. In an exemplary embodiment, for example, as shown in Figures 6A-6B, the plurality of conductors may alternatively pass below and above multiple consecutive lines along the path of the plurality of conductors, for example forming a grid.

In some embodiments, one or more wires are connected at the distal and/or proximal ends of one or more other wires. In some embodiments, the multiple wires are connected by, for example, soldering and/or gluing together.

In some embodiments, the plurality of wires are connected to one or more ends via one or more components. For example, in some embodiments, the plurality of wires are connected to a proximal end of an elongated component 616 by a user applying force to the device (by pushing and/or pulling the device by applying force to the elongated component). In some embodiments, the plurality of wires are connected to a distal end of an expandable structure via a capped end 620.

In some embodiments, more than one wire extends from the proximal end to the distal end, the wire being composed of a single wire that passes from a proximal end to the distal end more than once.

In some embodiments, a plurality of wires forming the device form a tubular mesh surface between the distal end and the proximal end, and a body of the device 610.

In some embodiments, the expandable structure is expanded, for example, by reducing a longitudinal distance between the end 620 and the elongated component 616, for example by using a component to connect the end 620 (e.g., as shown in FIG8B, component 824 is connected to the end 820).

Several exemplary protrusions:

In some embodiments, a device (e.g., 600, 700, 800) includes one or more protruding portions (e.g., 608, 708, 812) that (e.g., as previously described) hold the clump material below the one or more protruding portions.

In some embodiments, as the device is removed, the protruding portion (e.g., 608) remains protruding, for example, non-flat and/or folded back (e.g., opposite the body 610 of the device). In some embodiments, one or more protruding portions consist of multiple conductors selected to be strong enough to remain protruding when the device is removed. For example, in some embodiments, one or more protruding portions consist of conductors having multiple dimensions of cross-section (e.g., as described below), wherein the dimensions of the cross-sections are selected to provide sufficient drag and/or moment of inertia.

In some embodiments, one or more protrusions exert an outward (e.g., elastic) force on the blood vessel, potentially maintaining contact between the one or more protrusions and the vessel wall as the cross-section of the blood vessel changes in multiple dimensions. In an exemplary embodiment, a dimension of the elastically released cross-section of the device includes the plurality of protrusions larger than the largest blood vessel through which the device travels to remove the clot (e.g., the plurality of protrusions maintain elastic force on the obstructive material and/or the vessel wall, and do not elastically relax during the removal of the obstructive material by the device and/or during the removal of the device).

In one exemplary embodiment, the plurality of protruding portions 608 are circular, which potentially reduces the risk of damage (e.g., to multiple vessel walls) during use of the device, such as when the device is expanded and/or moved through the vessel wall.

In some embodiments, a circular protrusion includes a tip (the most radially protruding portion), wherein the width of the tip is at least 20%, or at least 30%, or at least 40% of the length of the protrusion, wherein the length of the protrusion is measured as the axial length of the wire from where the wire extends radially from the body of the device.

Exemplary angle relative to the protrusion of the device body:

In some embodiments, one or more protrusions are angled, wherein a distal profile of the protrusion forms an acute angle θ with the removal direction 630 of the device.

In some embodiments, during the expansion of the device 600, the angle θ increases, also increasing the axial space beneath the plurality of protrusions 608. In some embodiments, during the contraction of the device 600, the angle θ decreases, potentially retaining the clump material.

In some embodiments, during movement of the device, one or more protrusions are angled to grip the clump material, for example, one or more protrusions are angled at an acute angle to a central axis of the device and/or the direction of movement of the device.

Exemplary multiple loop protrusions:

In some embodiments, one or more protruding portions are loop structures (e.g., 608, 708). For example, a conductor forming the loop includes a distal end and a proximal end, both of which are connected to either the proximal or distal end of the device. For example, the device shown in FIG6A includes a plurality of protrusions 608, wherein the protrusions are formed by a conductor connected to both ends of an elongated assembly 616.

In some embodiments, the ends of the plurality of loops are connected to different parts of the device.

In some embodiments, multiple wires forming one or more protruding portions follow a path to and from the surface of a tubular expandable device. In some embodiments (e.g., as described elsewhere), the wires form a protrusion extending radially from the tubular surface 610. In some embodiments, the wires also extend longitudinally along the device.

Exemplary protrusions forming an integral part of the device:

In some embodiments, a protruding portion forms a main body portion of the device. For example, as shown in FIG6A, in some embodiments, a plurality of protruding portions 608 are formed by a plurality of wires, which also form part of a device body 610.

In some embodiments, one or more protrusions are formed by a conductor extending around and/or along the device (e.g., approximately 10 to 90%, 50 to 80% of the circumference of the device and/or 10 to 90% or 50 to 80% of the length of the device). For example, multiple conductors form multiple protrusions 608 comprising one or more portions that follow a path around the tubular expandable device body 610.

In some embodiments, a protrusion is formed by applying a force (e.g., tension) to the expandable device via a wire directly connected to an elongated member (e.g., protrusion 608 is connected to the elongated component 616).

Potentially, a protrusion forming a main body portion of the device can more effectively transmit the force applied to the device, for example, to apply force to the clot (e.g., to move the clot).

Exemplary locations of multiple protrusions:

In some embodiments, a plurality of protrusions 608 are each positioned at a different radial angle from a central longitudinal axis of the device, the plurality of protrusions potentially removing obstructive material from different regions of the blood vessel wall. In some embodiments, positioning a plurality of protrusions at different radial angles allows a device to be inserted between blood vessel walls within a range of rotational orientations, and allows one or more protrusions to interact with the obstruction, for example, the operation of the device is potentially unaffected by rotational positioning relative to the obstruction.

In one exemplary embodiment, the device 600 includes four protrusions, which are positioned 90° apart from their centers when viewed at an angle perpendicular to a longitudinal central axis of the device. In one exemplary embodiment, the protrusions are substantially equal in size and protrude substantially equally (assuming equal pressure on each protrusion). In one exemplary embodiment, the center of each protrusion satisfies that a surface of the device body 610 forms a plane perpendicular to a longitudinal axis of the device.

Figure 6B shows the clump material 602 being held beneath a plurality of protrusions 608, for example, between the protrusions 608 and the device body 610.

In some embodiments, the protrusions on the device have different sizes and/or orientations and/or axial positions.

Figure 7A is a simplified side view of an expandable device 700 including a plurality of protrusions 708 according to some embodiments of the present invention. In some embodiments, the plurality of protrusions 708 are distributed along a longitudinal axis of the device 700.

In some embodiments, the expandable structure 700 includes a plurality of wires connecting the distal end 701d and the proximal end 701p of the structure. In some embodiments (e.g., as shown in FIG6A), the plurality of wires form a tubular mesh.

In some embodiments, the plurality of protrusions are composed of loops 708 formed by multiple wires extending from and returning to the proximal end 701p. In some embodiments, the plurality of loops 708 pass through a tubular mesh 710 along a path (the plurality of coils pass through the interior of the tubular mesh 708) and protrude through multiple gaps in the tubular mesh. In some embodiments, each loop protrudes through the mesh at a different location, for example, each coil protrudes at a radial and longitudinal location on the mesh, such as a unique radial and/or longitudinal location on the mesh.

Figure 7B is a simplified side view of an expandable device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7C is a simplified side view of a contraction device 700 within a blood vessel 704 according to some embodiments of the present invention.

Figure 7D is a simplified side view of an expandable device 700 inserted and passed through an obstruction 702 within a blood vessel 704, according to some embodiments of the present invention. As previously described, in some embodiments, a device is pushed into and/or through an obstruction, then expanded, and then the obstruction is pulled to remove (e.g., rake) the obstruction 702 from its original position within the blood vessel 704.

Figure 7E is a simplified side view of an expandable device according to some embodiments of the present invention being pulled through an obstructive substance within a blood vessel. In some embodiments, the obstructive substance enters between a plurality of loops 702b and/or a plurality of loops 702c. In some embodiments, the obstructive substance 702a located between the device 700 and a plurality of blood vessel walls is moved and/or removed by pulling the device through the blood vessel 704.

As previously mentioned, optionally, in some embodiments, a plurality of coils 708 apply an outward force (e.g., elastic force) to the obstructive material and/or the blood vessel wall.

In some embodiments, during and/or after the expansion of the device, clump material 702 enters into a plurality of spaces 739 between the plurality of protrusions 708. In some embodiments, the contraction of the device reduces one or more spaces between the plurality of protrusions (e.g., the plurality of spaces 739a are greater than the plurality of spaces 739b) in at least one dimension, and in some embodiments, in a radial direction.

During and/or after the expansion of the device, the clump material 702 enters into the plurality of spaces 738 between the plurality of protrusions 708. In some embodiments, during and/or after the expansion of the device, a space within a protrusion increases in one or more dimensions and/or in a radial direction. Conversely, in some embodiments, during the contraction and/or removal of the device, a space in a protrusion decreases in size in one or more dimensions and/or in a radial direction.

The exemplary device includes multiple pairs of wires protruding from the portion:

Figure 8A is a simplified side view of an expandable device 800 according to some embodiments of the present invention. Figure 8B is a simplified side view of an expandable device 800 according to some embodiments of the present invention.

Please now refer to Figure 8B, which is an enlarged view of a portion of the apparatus shown in Figure 8A:

In some embodiments, the device 800 (e.g., under uniform pressure) has an outer surface of the device that is widened at a narrowed distal end toward a longitudinal central portion of the device, and then the outer surface of the device narrows toward a proximal end of the device.

In one exemplary embodiment, device 800 includes an elongated component 816 connected to a body of the device, for example, for moving device 800 within a blood vessel. In some embodiments, the elongated component of the device (e.g., 816, 616, 716) is resilient. In some embodiments, a first end 818 of a plurality of wires constituting the device is connected to the elongated component 816.

In some embodiments, the device 800 includes an end portion 820 to which a second end portion 822 of a plurality of wires is connected. In some embodiments, a control portion 824 (e.g., a wire) is connected to the end portion 822 and passes through the device, and optionally through a hollow portion of an elongated assembly 816. In some embodiments, the control line 824 is retracted (e.g., pulled) through the elongated assembly 816 to change the geometry of the device 800. In some embodiments, the control line 824 follows a central longitudinal axis of the device.

In some embodiments, the retraction control line 824 of the elongated component is used to expand an average cross-sectional area of the device and reduce a longitudinal length of the device.

In some embodiments, the end portion 820 is located where two or more wires of the device are connected to each other (e.g., by welding). In some embodiments, the multiple wires follow a path from the elongated component 816 to the end portion 820, wherein the end portion 820 is located where each wire passes under and/or under at least one other wire. In some embodiments, one or more wires connecting the end portion 820 to the elongated component 816 have a longer length, and one or more other wires, and in some embodiments, the wire forms a protrusion (e.g., wire 812). In some embodiments, one or more wires are shaped (e.g., by heat treatment as described herein) to have a shape that includes a protrusion.

Several exemplary wire pairs:

In some embodiments, a device 800 includes one or more wire pairs, wherein the wire pairs include a separation, such as multiple separations D2, D4, D6, D8, at least to some extent of expansion of the device.

Please refer to an example conductor pair and a disconnect, where disconnect D2 is located between conductors 812 and 814.

Figures 9A and 9B show enlarged views of a pair of wires in a device, such as a portion of a pair of wires shown in region R of Figure 8B.

Figure 9A is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

Figure 9B is a simplified side view of a conductor pair 912, 914 gripping a clump of material according to some embodiments of the present invention.

In some embodiments, FIG9B illustrates the conductor pair 800 of FIG9B after the cross-sectional area of the device (e.g., device 800) has been reduced (e.g., by advancing control line 824). In some embodiments, a separation between the plurality of conductors 912, 914 of the conductor pair is reduced; D2” < D'. In some embodiments, the reduction of separation is associated with a reduction in the curvature of the plurality of conductors 912 and/or 914.

Exemplary connection of the obstructive material to the device, one or more interlacing portions:

In some embodiments, the clump material is held in a mesh device portion.

In some embodiments, the clump material is held by a portion of the device comprising multiple interwoven portions (also referred to herein as a "mesh"), for example, one or more portions following a path below or above one or more portions (e.g., below and above are in a radial direction).

Figure 10 is a simplified top view of a clump material 1002 being held in a grid device portion according to some embodiments of the present invention.

In some embodiments, at least a portion of a device includes a mesh structure in which one or more conductors are interwoven with other conductors, for example, passing through some conductors and under others. In an exemplary embodiment, the device includes warp 1026 and weft 1028, wherein the warp 1026 and weft 1028 are, for example, evenly spaced apart.

In some embodiments, multiple conductor pairs are formed at multiple intersections of multiple meridians and multiple parallels (also referred to herein as multiple connections).

Figure 11 is a simplified top view schematic diagram of a clump of material being held in a mesh device portion according to some embodiments of the present invention. In some embodiments, the obstructing material within the device distorts the device structure, for example, due to the hardness of the obstructing material.

Figure 12A is a simplified top view of a lumpy material 1202 and a mesh device portion 1200 according to some embodiments of the present invention. In some embodiments, the contact (contact lengths c1, c2, c3, and c4) between the lumpy material 1202 and the device is partial, for example, the lumpy material 1202 contacts 5 to 95%, or 10 to 90%, or 50 to 80%, or lower, or higher, or a plurality of intermediate ranges or percentages of a length of a warp between multiple warps (a) and/or a length of a weft between multiple wefts (b), for example: c1 divided by a multiplied by 100% equals 50 to 90%.

In some embodiments, the expansion of the device alters an angle between one set of conductors (e.g., multiple meridians) and another set of conductors (e.g., multiple parallels). Figure 12B is a simplified top view of the device portion of Figure 12A after the expansion device, according to some embodiments of the invention. In some embodiments, during the expansion of the device, an angle between the meridians and parallels changes, for example, from 90° in Figure 12A to 45° in Figure 12A.

In some embodiments, during the expansion, a variation of the angle α between the meridians and parallels is 10° to 90°, or 20° to 70°, or 40° to 50°, or smaller, or larger, or a plurality of intermediate angles.

In some embodiments, a device includes a range of angle α, for example, corresponding to different degrees of expansion of the device, such as 5° to 175°, or 10° to 165°, or 45° to 110°, or lower, or higher, or in between, a plurality of ranges or a plurality of angles.

In some embodiments, the space decreases simultaneously in one dimension (e.g., radially between meridians and parallels) and increases simultaneously in another dimension (in the plane of meridians and parallels, as shown in Figures 12A to 12B), and the structure potentially receives and holds clump material simultaneously.

Figures 12C and 12D illustrate side views of clump material held between a meridian 1212 and a parallel 1214 as the device expands according to some embodiments of the invention.

In some embodiments, the clump material is located between multiple intersecting portions of the device, for example, where a warp crosses a weft. Figure 12E is a simplified side view of the clump material 1202 between multiple conductors 1214 according to some embodiments of the invention. In some embodiments, the clump material 1202 contacts a portion of the length of a portion below another portion, ranging from 5% to 95%, or 10% to 90%, or 50% to 80%, or lower, or higher, or in between, length c as shown in Figure 12B.

Multiple exemplary wire pairs include multiple connections:

In some embodiments, a space is created and/or expanded between two or more conductors connected at two or more points. In some embodiments, a length of a first conductor between two points is longer than the length of a second conductor connected to the same two points. In some embodiments, a distance between the two connections is reduced, while a distance between the two conductors is increased (e.g., in a space of at least one dimension).

Figure 13A is a simplified side view of an expandable device 1300 according to some embodiments of the present invention, comprising a conductor having a plurality of connections 1332, 1334 between a plurality of conductors 1312, 1314.

In some embodiments, one or more of connection points 1332, 1334 are a connection point between a plurality of wires 1312, 1314. One or more of connection points 1332, 1334 are points through which one wire passes through and/or around another wire.

Figure 13B is a simplified side view of the device of Figure 13A according to some embodiments of the present invention, after the space 1338 between the wires has been expanded.

In some embodiments, a length (from L to L’; L < L’) between the connections 1332, 1334 is reduced to increase the size of a space 1338 between the plurality of conductors 1312, 1314 in at least one dimension, where d is the radial dimension of the space 1338 and d < d’. For example, a length of the first conductor 1314 measured along a central axis of the first conductor is greater than the length of the second conductor 1312 measured along a central axis of the second conductor.

In some embodiments, a space 1338 is located between two portions protruding from the cylinder C, as shown in FIG13A, wherein the wire 1312 is bent on one surface of the cylinder C, and in FIG13B, wherein the wire 1312 is bent on the surface of the cylinder C'.

In some embodiments, the radius R of the device 1300 is increased (e.g., from R to R') to reduce the separation L (e.g., from L to L') between the plurality of connections.

As previously described, in some embodiments, the expansion of the radius R of the device (e.g., from R to R' as shown in Figures 13A to B; R < R') reduces a length of the device 1300, wherein the radius is measured from a central longitudinal axis of the device 1336. In some embodiments, the plurality of cylinders C and C' are an outer surface or a body of the device (e.g., excluding the plurality of protrusions).

In some embodiments, the device 1300 is cylindrical, as shown in Figures 13A and 13B. In some embodiments, the device, for example, has a non-cylindrical shape (e.g., as shown in Figure 6A, Figure 7B, as described herein), and the plurality of cylinders C and C' are the plurality of largest diameter cylinders completely enclosing the device.

Exemplary wire pairs including phase difference:

In some embodiments, an expandable structure includes one or more curved portions, wherein the plurality of curved portions are spatially disposed on the structure such that a space exists between the plurality of curves. In an exemplary embodiment, a conductor pair includes a first conductor and a second conductor, the first conductor having a sinusoidal portion and the second conductor having a sinusoidal portion, wherein the plurality of sinusoidal portions are disposed on the expandable structure and have a phase difference, the phase difference implying that a space exists between the conductors in at least one dimension. In some embodiments, the means is expanded (e.g., as shown in Figures 13A to 13B) to increase the space between the conductors.

Figure 14A is a simplified side view of a portion of a shrinking device according to some embodiments of the present invention, the shrinking device including a plurality of curved portions 1412, 1414, and the shrinking device being arranged in space with a phase difference between the plurality of portions.

Figure 14B is a simplified side view of an expandable device according to some embodiments of the present invention, the expandable device including a plurality of curved portions 1412, 1414, and the expandable device being spatially positioned with a phase difference between the plurality of portions.

Figure 14C is a simplified side view of a portion of a device that partially expands and/or partially contracts according to some embodiments of the present invention, the device including a plurality of curved portions 1412, 1414, and the device being arranged in space with a phase difference between the plurality of portions.

In some embodiments, when the expandable structure contracts (the radius of the largest enclosed cylinder is D”, where line 1436 represents a central longitudinal axis of the cylinder), the dimension a” between the plurality of curved portions is less than the dimension a between the plurality of curved portions when the expandable structure partially expands (the radius of the largest enclosed cylinder is D), wherein the dimension a is less than a dimension a’ when the expandable structure expands (the radius of the largest enclosed cylinder is d):

A"<a<a' and D"<D<D'.

In some embodiments, one or more spacer components 1440 (e.g., posts) are disposed between two or more portions of the device (e.g., multiple conductors) to maintain a phase difference between the multiple conductors. In some embodiments, one or more posts are inserted into the structure, for example, during processing (e.g., heat treatment). In some embodiments, one or more posts are used in the processing to form shape memory in multiple conductors comprising a hyperelastic material (e.g., nitinol). In some embodiments, one or more spacer components 1440 are removed during manufacturing and/or before using the device.

Figure 16 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, wherein a spacer post 1640 holds a space between two portions 1612, 1614 of the apparatus.

Materials and construction of several exemplary expandable devices:

In some embodiments, an expandable device (e.g., as described herein, such as Figures 6A-B and 8A-B) is constructed using multiple wires, for example, a body of the device is constructed of a wire mesh (e.g., a cross-woven mesh).

In some embodiments, at least a portion of the device comprises a flexible and/or elastic and/or biocompatible material, such as nitinol, and/or cobalt-chromium and/or stainless steel. In some embodiments, at least a portion of the device comprises a shape memory and/or hyperelastic material (e.g., nitinol).

In one exemplary embodiment, at least a portion of the device is composed of a plurality of nitinol wires.

In some embodiments, a portion of the device for grasping obstructive material (e.g., an expandable structure) is composed of multiple wires, the largest cross-sectional dimension (e.g., diameter) of which is 10 to 150 micrometers, 25 to 150 micrometers, or 12 to 100 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires with a diameter of 75 micrometers. In an exemplary embodiment, the device comprises at least a portion composed of multiple wires having a flat cross-sectional shape, such as a circular shape, having a largest cross-sectional dimension of 100 micrometers, and a cross-sectional dimension perpendicular to the largest cross-sectional dimension of 50 micrometers (e.g., a "band" with a cross-section of 50 × 100 micrometers).

In some embodiments, additional material is added to the mesh apparatus after it has been constructed (e.g., by weaving). In some embodiments, one or more additional threads are woven into an existing structure; for example, in some embodiments, one or more additional wires are wrapped around an existing wire.

Figure 15 is a simplified side view of a portion of an apparatus according to some embodiments of the present invention, the apparatus including a plurality of additional conductors 1544 connected to a plurality of baselines 1546. In some embodiments, a plurality of spaces 1538 (e.g., as described herein) are formed between the additional conductors 1544 and the baselines 1546.

Several exemplary treatments:

In some embodiments, the device (e.g., as described herein) is used to remove blood clots from a blood vessel. In an exemplary embodiment, the device (e.g., as described herein) is used to remove an obstruction (e.g., a clot) from a blood vessel in the brain, such as in a stroke.

In some embodiments, additional or alternative substances other than clot material, such as fatty deposits and/or plaques and/or thrombi and/or platelet aggregates and/or foreign matter and/or calcified deposits. In this context, the terms "clot" or "clot material" are used to indicate any obstructive substance within a blood vessel that completely and/or partially blocks said blood vessel.

In some embodiments, the device (e.g., as described herein) is used to remove pulmonary embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove peripheral embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used to remove cardiovascular embolism and/or thrombus and/or obstruction. In some embodiments, the device (e.g., as described herein) is used for revascularization in postoperative restenosis.

General Discussion:

As used and referenced in this document, the terms “about” and “approximately” indicate ±20%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”, and their morphological variations refer to “including but not limited to”.

The term "consisting of" means "including and not limited to".

The term "consisting essentially of" means that the composition, method, or structure may include additional ingredients, steps, and/or components, but only if the additional ingredients, steps, and/or components do not substantially alter the essential or novel characteristics of the claimed composition, method, or structure.

As used herein, the singular forms “a,” “an,” and “the” may include multiple references unless explicitly indicated by the context. For example, the terms “a compound” or “at least one compound” may include multiple compounds, including mixtures thereof.

Throughout this application, various embodiments of the invention may be presented in a range format in conjunction with the references. It should be understood that the range format description is merely for convenience and brevity and should not be construed as a strict limitation on the scope of the invention. Therefore, the description of a range should be considered as all possible possible sub-ranges specifically disclosed, as well as the various numerical values within the range. For example, describing a range as "from 1 to 6" should be understood as disclosing multiple sub-ranges such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc.; and also disclosing various numbers within this range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

Unless the context explicitly indicates a numerical range, it means any number (fraction or integer) included within the indicated range. The phrases “ranging” or “ranges between” for the first and second indicated numbers, and “ranging” or “ranges from” for the first indicated number and “to” the second indicated number, are used interchangeably herein and mean including the first and second indicated numbers and all fractions and integers between them.

As used herein, the term "method" refers to the manner, means, technique, and procedures used to accomplish a particular task, including but not limited to those manner, means, techniques, and procedures that are known or readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine from known manner, means, techniques, or procedures.

As used in this article, the term "treatment" includes terminating, substantially inhibiting, slowing or reversing the progression of a disease, substantially improving the clinical or psychological symptoms of a disease, or substantially preventing the occurrence of the clinical or psychological symptoms of a disease.

It is understood that certain features of the invention, for clarity, are described in the context of independent embodiments, or may be provided in combination in a single embodiment. Conversely, various features of the invention, for brevity, are described in the context of a single embodiment, or may be provided individually or in any suitable sub-combination or in embodiments suitable for any other description of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments do not function without these components.

While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that numerous alternatives, modifications, and variations will be readily apparent. Therefore, the invention is intended to cover all such alternatives, modifications, and variations falling within the spirit and scope of the claims.

All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety as if each independent publication, patent, or patent application were expressly and individually indicated as being incorporated herein by reference. Furthermore, any reference or endorsement in this application should not be construed as an admission that such reference is prior art to the invention. Heading portions in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations.

Claims (15)

1. A device for removing obstructive material from a blood vessel, characterized in that: the device comprises: an expandable structure sized for insertion into the blood vessel, the expandable structure including a plurality of wire pairs; the expandable structure including a proximal end and a distal end; each of the plurality of wires in the plurality of wire pairs passing through a path from the distal end of the expandable structure to the proximal end of the expandable structure; the plurality of wires in the plurality of wire pairs including a plurality of variations in radial position along the passing path; one wire bypassing another wire during the path of the plurality of wire pairs; the plurality of wire pairs forming a tubular mesh surface between the distal end and the proximal end;

The cross-sectional area of the plurality of conductor pairs is between 10 micrometers and 150 micrometers.

2. The apparatus according to claim 1, wherein each of the plurality of conductor pairs includes one or more curved portions along each of the plurality of conductor pairs, wherein the curved portions are spatially configured to have a phase difference that creates a space in at least one dimension between the curved portions.

3. The device according to claim 2, wherein the size of a space between the curved portions is adapted to be large enough to accommodate at least a portion of the obstructive material.

4. The apparatus according to claim 3, wherein the space includes a radial component.

5. The apparatus according to claim 4, wherein the radial component of the space is between 0.01 and 0.2 mm.

6. The device according to claim 1, wherein the bending of the device causes one of the wires in the wire pair to protrude more radially from a central axis of the device than the other wire in the wire pair.

7. The apparatus according to claim 1, wherein rotation of the apparatus causes one of the wires in the wire pair to protrude more radially from the central axis of the apparatus than the other wire in the wire pair.

8. The apparatus according to claim 2, characterized in that: expanding the apparatus increases a radial space between the two curved portions while decreasing a dimension perpendicular to the radial space between the curved portions.

9. The device according to claim 1, wherein the expandable structure comprises a non-cylindrical shape.

10. The device according to claim 1, wherein the expandable structure comprises an irregular shape.

11. The apparatus according to claim 1, wherein a longitudinal central axis is defined as extending from a cylindrical shape of the largest volume completely enclosed by the apparatus.

12. The apparatus according to claim 1, wherein a longitudinal central axis is defined as a straight line connecting a plurality of center points of a plurality of parallel circular cross-sections along a length of the apparatus, wherein at each point along the full length of a shape, the circular cross-section is the largest circle contained in the apparatus.

13. The device according to claim 1, wherein the plurality of wires are made of one or more of a superelastic material, a flexible material, and a biocompatible material.

14. The device according to claim 1, wherein the device is expandable to a diameter between 1 and 7 millimeters.

15. The device according to any one of claims 1 to 14, characterized in that: the size of the device is adapted to remove an obstruction from a blood vessel in the brain.